CFR 2016 Title21 Vol2 ChapI

Title 21—Food and
Drugs
(This book contains parts 100 to 169)
Part
CHAPTER I—Food and Drug Administration, Department of

Health and Human Services (Continued) ........................... 100
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CHAPTER I—FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF HEALTH
AND HUMAN SERVICES (CONTINUED)
(Parts 100 to 169)
EDITORIAL NOTES: 1. Nomenclature changes to chapter I appear at 59 FR 14366, Mar. 28, 1994,
59 FR 24879, May 9, 1994, 68 FR 13717, Mar. 24, 2004, 69 FR 18803, Apr. 9, 2004, 70 FR 40880, July
15, 2005, and 70 FR 67650, Nov. 8, 2005.
SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
Part Page
100 General .................................................................... 5
101 Food labeling ........................................................... 10
102 Common or usual name for nonstandardized foods 177
104 Nutritional quality guidelines for foods ................. 184
105 Foods for special dietary use ................................... 188
106 Infant formula requirements pertaining to current
good manufacturing practice, quality control
procedures, quality factors, records and reports,
and notifications .................................................. 190
107 Infant formula ......................................................... 217
108 Emergency permit control ...................................... 228
109 Unavoidable contaminants in food for human con-
sumption and food-packaging material ................ 238
110 Current good manufacturing practice in manufac-
turing, packing, or holding human food ............... 244
111 Current good manufacturing practice in manufac-
turing, packaging, labeling, or holding oper-
ations for dietary supplements ............................ 254
112 Standards for the growing, harvesting, packing,
and holding of produce for human consumption .. 283
113 Thermally processed low-acid foods packaged in
hermetically sealed containers ............................ 321
114 Acidified foods ......................................................... 356

115 Shell eggs ................................................................ 362
21 CFR Ch. I (4–1–16 Edition)
Part Page
117 Current good manufacturing practice, hazard anal-
ysis, and risk–based preventive controls for
human food ........................................................... 365
118 Production, storage, and transportation of shell
eggs ...................................................................... 405
119 Dietary supplements that present a significant or
unreasonable risk ................................................. 416
120 Hazard Analysis and Critical Control Point
(HACCP) systems ................................................. 416
123 Fish and fishery products ........................................ 425
129 Processing and bottling of bottled drinking water 433
130 Food standards: General ......................................... 438
131 Milk and cream ....................................................... 446
133 Cheeses and related cheese products ....................... 464
135 Frozen desserts ........................................................ 516
136 Bakery products ...................................................... 523
137 Cereal flours and related products .......................... 528
139 Macaroni and noodle products ................................ 543
145 Canned fruits ........................................................... 553
146 Canned fruit juices .................................................. 593
150 Fruit butters, jellies, preserves, and related prod-
ucts ...................................................................... 607
152 Fruit pies ................................................................ 613
155 Canned vegetables ................................................... 614
156 Vegetable juices ...................................................... 637
158 Frozen vegetables .................................................... 639
160 Eggs and egg products ............................................. 642
161 Fish and shellfish .................................................... 647
163 Cacao products ........................................................ 664
164 Tree nut and peanut products ................................. 672
165 Beverages ................................................................ 676
166 Margarine ................................................................ 695
168 Sweeteners and table sirups .................................... 698
169 Food dressings and flavorings ................................. 703
SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
PART 100—GENERAL (b) Definitions. (1) Act means the Fed-

eral Food, Drug, and Cosmetic Act (21
Subpart A—State and Local Requirements U.S.C. 321 et seq.).
(2) Agency means the Food and Drug
Sec. Administration.
100.1 Petitions requesting exemption from (3) Commissioner means the Commis-
preemption for State or local require-
sioner of Food and Drugs.
ments.
100.2 State enforcement of Federal regula- (4) State means a State as defined in
tions. section 201(a)(1) of the act (which in-
cludes a territory of the United States,
Subparts B–E [Reserved] the District of Columbia, and Puerto
Rico) or any political subdivision of a
Subpart F—Misbranding for Reasons Other State having authority to issue food
Than Labeling standards and food labeling regulations
100.100 Misleading containers. having force of law.
(5) State requirement means any stat-
Subpart G—Specific Administrative Rulings ute, standard, regulation, or other re-
and Decisions quirement that is issued by a State.
(c) Prerequisites for petitions for exemp-
100.155 Salt and iodized salt. tion from preemption. The Food and
AUTHORITY: 21 U.S.C. 321, 331, 337, 342, 343, Drug Administration will consider a
348, 371. petition for exemption from preemp-
SOURCE: 42 FR 14306, Mar. 15, 1977, unless tion on its merits only if the petition
otherwise noted. demonstrates that:
(1) The State requirement was en-
Subpart A—State and Local acted or was issued as a final rule by
Requirements an authorized official of the State and
is in effect or would be in effect but for
§ 100.1 Petitions requesting exemption the provisions of section 403A of the
from preemption for State or local act.
requirements. (2) The State requirement is subject
(a) Scope and purpose. (1) This subpart to preemption under section 403A(a) of
applies to the submission and consider- the act because of a statutory provi-
ation of petitions under section 403A(b) sion listed in that section or because of
of the Federal Food, Drug, and Cos- a Federal standard or other Federal
metic Act (the act), by a State or a po- regulation that is in effect, or that has
litical subdivision of a State, request- been published as a final rule with a
ing exemption of a State requirement designated effective date, and that was
from preemption under section 403A(a) issued under the authority of a statu-
of the act. tory provision listed in that section.
(2) Section 403A(b) of the act provides For the purposes of this subpart, all pe-
that where a State requirement has titions seeking exemption from pre-
been preempted under section 403A(a) emption under section 403A(a)(3)
of the act, the State may petition the through (a)(5) of the act submitted be-
agency for an exemption. The agency fore May 8, 1992, will be considered
may grant the exemption, under such timely even though the applicable stat-
conditions as it may prescribe by regu- utory provisions or regulations are not
lation, if the agency finds that the yet in effect.
State requirement will not cause any (3) The petitioner is an official of a
food to be in violation of any applica- State having authority to act for, or on
ble requirement under Federal law, behalf of, the Government in applying
will not unduly burden interstate com- for an exemption of State requirements
merce, and is designed to address a par- from preemption.
ticular need for information that is not (4) The State requirement is subject
met by the preemptive Federal require- to preemption under section 403A(a) of
ment. the act because it is not identical to
§ 100.1 21 CFR Ch. I (4–1–16 Edition)
the requirement of the preemptive Fed- A. Action Requested

eral statutory provision or regulation 1. Identify and give the exact wording of
including a standard of identity, qual- the State requirement and give date it was
ity, and fill. ‘‘Not identical to’’ does enacted or issued in final form.
not refer to the specific words in the 2. Identify the specific standard or regula-
requirement but instead means that tion that is believed to preempt the State re-
the State requirement directly or indi- quirement and the section and paragraph of
the act that the standard or regulation im-
rectly imposes obligations or contains
plements.
provisions concerning the composition
or labeling of food, or concerning a B. Documentation of State Requirement
food container, that: Provide a copy of the State requirement
(i) Are not imposed by or contained that is the subject of the application. Where
in the applicable provision (including available, the application should also include
any implementing regulation) of sec- copies of any legislative history or back-
tion 401 or 403 of the act; or ground materials used in issuing the require-
(ii) Differ from those specifically im- ment, including hearing reports or studies
concerning the development or consideration
posed by or contained in the applicable
of the requirement.
provision (including any implementing
regulation) of section 401 or 403 of the C. Statement of Grounds
act. A petition for an exemption from preemp-
(d) Form of petition. (1) All information should contain the following:
tion included in the petition should 1. An explanation of the State requirement
meet the general requirements of and its rationale, and a comparison of State
§ 10.20(c) of this chapter. and Federal requirements to show dif-
(2) An original and one copy of the ferences.
petition shall be submitted, or the peti- 2. An explanation of why compliance with
the State requirement would not cause a
tioner may submit an original and a
food to be in violation of any applicable re-
computer readable disk containing the quirement under Federal law.
petition. Contents of the disk should be 3. Information on the effect that granting
in a standard format, such as ASCII the State petition will have on interstate
format. (Petitioners interested in sub- commerce. The petition should contain in-
mitting a disk should contact the Cen- formation on economic feasibility, i.e.,
ter for Food Safety and Applied Nutri- whether the State and Federal requirements
have significantly different effects on the
tion for details.)
production and distribution of the food prod-
(3) Petitions for exemption from pre- uct; comparison of the costs of compliance as
emption for a State requirement shall shown by data or information on the actual
be submitted to the Division of Dock- or anticipated effect of the State and Fed-
ets Management in the following form: eral requirements on the sale and price of
the food product in interstate commerce; and
(Date) llllllll the effect of the State requirement on the
Division of Dockets Management, availability of the food product to con-
Food and Drug Administration, sumers. To the extent possible, the petition
Department of Health and Human Services, should include information showing that it
5630 Fishers Lane, rm. 1061, is practical and feasible for producers of food
Rockville, MD 20852. products to comply with the State require-
ment. Such information may be submitted in
PETITION REQUESTING EXEMPTION FROM the form of statements from affected persons
PREEMPTION FOR STATE REQUIREMENT indicating their ability to comply.
4. Identification of a particular need for in-
The undersigned submits this petition
formation that the State requirement is de-
under section 403A(b)of the Federal Food,
signed to meet, which need is not met by
Drug, and Cosmetic Act to request that the
Federal law. The petition should describe the
Food and Drug Administration exempt a
conditions that require the State to petition
State requirement from preemption.
for an exemption, the information need that
The undersigned has authority to act for, the State requirement fulfills, the inad-
or on behalf of, the (identify State or political equacy of the Federal requirement in ad-
subdivision of the State) because (document pe- dressing this need, and the geographical area
titioner’s authority to submit petition on behalf or political subdivision in which such need
of the State). exists.
Food and Drug Administration, HHS § 100.2
D. Environmental Impact writing of the filing and docket number
The petition shall contain a claim for cat- of a petition.
egorical exclusion under 21 CFR 25.24 or an (4) Any interested person may submit
environmental assessment under 21 CFR written comments to the Division of
25.31. Dockets Management on a filed peti-
E. Notification tion as provided in § 10.30(d) of this
chapter.
Provide name and address of person,
(5) Within 90 days of the date of filing
branch, department, or other instrumen-
tality of the State government that should the agency will furnish a response to
be notified of the Commissioner’s action con- the petitioner. The response will ei-
cerning the petition. ther:
(i) State that the agency has ten-
F. Certification
tatively determined that the petition
The undersigned certifies, that, to the best merits the granting of an exemption,
knowledge and belief of the undersigned, this and that it intends to publish in the
petition includes all information and views FEDERAL REGISTER a proposal to grant
on which the petition relies.
(Signature) llllllllllll
the exemption through rulemaking;
(Name of petitioner) llllllll (ii) Deny the petition and state the
(Mailing address) lllllllll reasons for such denial; or
(Telephone number) llllllll (iii) Provide a tentative response in-
(Information collection requirements in dicating why the agency has been un-
this section were approved by the Office of able to reach a decision on the peti-
Management and Budget (OMB) and assigned
OMB number 0910–0277)
tion, e.g., because of other agency pri-
orities or a need for additional infor-
(e) Submission of petition for exemption; mation.
public disclosure. The availability for (g) If a State submitted a petition for
public disclosure of a petition for ex- exemption of a State requirement from
emption will be governed by the rules preemption under section 403A(a)(3)
specified in § 10.20(j) of this chapter. through (a)(5) of the act before May 8,
(f) Agency consideration of petitions. (1) 1992, that State requirement will not
Unless otherwise specified in this sec- be subject to preemption until:
tion, all relevant provisions and re- (1) November 8, 1992; or
quirements of subpart B of part 10 of (2) Action on the petition, whichever
this chapter, are applicable to State occurs later.
petitions requesting exemption from
Federal preemption under section [58 FR 2468, Jan. 6, 1993]
403A(b) of the act.
(2) If a petition does not meet the § 100.2 State enforcement of Federal
regulations.
prerequisite requirements of paragraph
(c) of this section, the agency will issue (a) Under section 307 of the Federal
a letter to the petitioner denying the Food, Drug, and Cosmetic Act (the
petition and stating in what respect act), a State may bring, in its own
the petition does not meet these re- name and within its own jurisdiction,
quirements. proceedings for the civil enforcement,
(3) If a petition appears to meet the or to restrain violations, of sections
prerequisite requirements in paragraph 401, 403(b), 403(c), 403(d), 403(e), 403(f),
(c) of this section, it will be filed by the 403(g), 403(h), 403(i), 403(k), 403(q), or
Division of Dockets Management, 403(r) of the act if the food that is the
stamped with the date of filing, and as- subject of the proceedings is located in
signed a docket number. The docket the State.
number identifies the file established (b) No proceeding may be commenced
by the Division of Dockets Manage- by a State under paragraph (a) of this
ment for all submissions relating to section:
the petition, as provided in this part. (1) Before 30 days after the State has
Subsequent submissions relating to the given notice to the Food and Drug Ad-
matter must refer to the docket num- ministration (FDA) that the State in-
ber and will be filed in the docket file. tends to bring such proceeding.
The Division of Dockets Management (2) Before 90 days after the State has
will promptly notify the petitioner in given notice to FDA of such intent if
§ 100.2 21 CFR Ch. I (4–1–16 Edition)
FDA has, within such 30 days, com- H. Name of firm against which action is
menced an informal or formal enforce- anticipated (if applicable).
ment action pertaining to the food I. Type of enforcement action.
which would be the subject of such pro- Yours very truly,
ceeding. Reporting Agency
(3) If FDA is diligently prosecuting a By llllll
proceeding in court pertaining to such (Indicate authority)
food, has settled such proceeding, or (e) The letter of notification should
has settled the informal or formal en- be signed by a State official authorized
forcement action pertaining to such by the State to institute the con-
food. templated enforcement actions.
(c) A State may intervene as a mat- (f) The letter of notification should
ter of right, in any court proceeding be sent to the Division of Enforcement
described in paragraph (b)(3) of this (HFS–605), Center for Food Safety and
section. Applied Nutrition, Food and Drug Ad-
(d) The notification that a State sub-
ministration, 5100 Paint Branch Pkwy.,
mits in accordance with paragraph (b)
College Park, MD 20740, FAX number
of this section should include the fol-
202–205–4642.
lowing information and be submitted
(g) FDA will notify the State of the
in the following recommended format:
date in which its letter of notification
(Date) llllllll was received by FDA, Center for Food
Name of State agency llllll Safety and Applied Nutrition, Division
Post office address llllll
of Enforcement (HFS–605) (within 2
Street address llllll
City, State, and ZIP code llllll working days after date of receipt).
Name of product(s) covered by the notifica- This date will be the date of notifica-
tion llllll tion for the purposes of paragraph (b)
Reporting official, title, and telephone no. of this section.
llllll (h) The Director, Division of Enforce-
FAX No. llllll ment, Office of Field Programs, Center
Agency contact (if different from reporting
official), title, and telephone no. for Food Safety and Applied Nutrition,
llllll FDA, will respond to the State’s notifi-
cation within 30 days of the date of no-
Director,
tification by advising:
Division of Enforcement (HFS–605),
Center for Food Safety and Applied Nutri- (1) Whether FDA has commenced an
tion, informal or formal enforcement action
Food and Drug Administration, pertaining to the food that is the sub-
5100 Paint Branch Pkwy., ject of the notification; or
College Park, MD 20740. (2) Whether FDA is prosecuting a
To Whom It May Concern: proceeding in court pertaining to such
The undersigned, lll, submits this letter food, has settled such proceeding, or
of notification pursuant to section 307(b)(1) has settled informal or formal enforce-
of the Federal Food, Drug, and Cosmetic Act
ment action pertaining to such food.
(21 U.S.C. 337(b)(1)) with respect to llll.
(name of products covered by the notifica- (i) Information contained in State
tion and the enforcement action that is to be notification letters shall be exempt
initiated) from public disclosure to the same ex-
Attached hereto, and constituting a part of tent to which such information would
this letter of notification are the following: be so exempt pursuant to §§ 20.61, 20.64,
A. The name of the product. and 20.88 of this chapter.
B. The type and size of each product con-
tainer. (j) Definitions. (1) Informal enforcement
C. Copy of the label and labeling of the actions include warning letters, recalls,
product. detentions, or other administrative en-
D. Manufacturing code (if applicable). forcement actions that pertain to the
E. Name and address of firm believed to be food in question.
responsible for violations.
(2) Formal enforcement actions include
F. Name and address of parent firm (if
known). seizures, injunctions, or other civil ju-
G. Reason for the anticipated State en- dicial enforcement actions that pertain
forcement action (list specific violations, in- to the food in question. (Information
cluding sections of the law violated). collection requirements in this section
were approved by the Office of Manage- date required food labeling (excluding
ment and Budget (OMB) and assigned any vignettes or other nonmandatory
OMB control number 0910–0275.) designs or label information), discour-
age pilfering, facilitate handling, or ac-
[58 FR 2460, Jan. 6, 1993; 58 FR 17097, Apr. 1,
1993, as amended at 66 FR 56035, Nov. 6, 2001] commodate tamper-resistant devices).
(b) [Reserved]
Subparts B–E [Reserved] [59 FR 537, Jan. 5, 1994]
Subpart F—Misbranding for Subpart G—Specific Administra-

Reasons Other Than Labeling tive Rulings and Decisions
§ 100.100 Misleading containers. § 100.155 Salt and iodized salt.
In accordance with section 403(d) of (a) For the purposes of this section,
the act, a food shall be deemed to be the term iodized salt or iodized table salt
misbranded if its container is so made, is designated as the name of salt for
formed, or filled as to be misleading. human food use to which iodide has
(a) A container that does not allow been added in the form of cuprous io-
the consumer to fully view its contents dide or potassium iodide permitted by
shall be considered to be filled as to be §§ 184.1265 and 184.1634 of this chapter.
misleading if it contains nonfunctional In the labeling of such products, all
slack-fill. Slack-fill is the difference words in the name shall be equal in
between the actual capacity of a con- prominence and type size. The state-
tainer and the volume of product con- ment ‘‘This salt supplies iodide, a nec-
tained therein. Nonfunctional slack-fill essary nutrient’’ shall appear on the
is the empty space in a package that is label immediately following the name
filled to less than its capacity for rea- and shall be in letters which are not
sons other than: less in height than those required for
(1) Protection of the contents of the the declaration of the net quantity of
package; contents as specified in § 101.105 of this
(2) The requirements of the machines chapter.
used for enclosing the contents in such (b) Salt or table salt for human food
package; use to which iodide has not been added
(3) Unavoidable product settling dur- shall bear the statement, ‘‘This salt
ing shipping and handling; does not supply iodide, a necessary nu-
(4) The need for the package to per- trient.’’ This statement shall appear
form a specific function (e.g., where immediately following the name of the
packaging plays a role in the prepara- food and shall be in letters which are
tion or consumption of a food), where not less in height than those required
such function is inherent to the nature for the declaration of the net quantity
of the food and is clearly commu- of contents as specified in § 101.105 of
nicated to consumers; this chapter.
(5) The fact that the product consists (c) Salt, table salt, iodized salt, or io-
of a food packaged in a reusable con- dized table salt to which anticaking
tainer where the container is part of agents have been added may bear in ad-
the presentation of the food and has dition to the ingredient statement des-
value which is both significant in pro- ignating the anticaking agent(s), a
portion to the value of the product and label statement describing the charac-
independent of its function to hold the teristics imparted by such agent(s) (for
food, e.g., a gift product consisting of a example, ‘‘free flowing’’), providing
food or foods combined with a con- such statement does not appear with
tainer that is intended for further use greater prominence or in type size larg-
after the food is consumed; or durable er than the statements which imme-
commemorative or promotional pack- diately follow the name of the food as
ages; or required by paragraphs (a) and (b) of
(6) Inability to increase level of fill this section.
or to further reduce the size of the (d) Individual serving-sized packages

package (e.g., where some minimum containing less than 1⁄2 ounce and pack-
package size is necessary to accommo- ages containing more than 21⁄2 pounds
Pt. 101 21 CFR Ch. I (4–1–16 Edition)
of a food described in this section shall Subpart C—Specific Nutrition Labeling

be exempt from declaration of the Requirements and Guidelines
statements which paragraphs (a) and
101.36 Nutrition labeling of dietary supple-
(b) of this section require immediately
ments.
following the name of the food. Such 101.42 Nutrition labeling of raw fruit, vege-
exemption shall not apply to the outer tables, and fish.
container or wrapper of a multiunit re- 101.43 Substantial compliance of food retail-
tail package. ers with the guidelines for the voluntary
(e) All salt, table salt, iodized salt, or nutrition labeling of raw fruit, vegeta-
iodized table salt in packages intended bles, and fish.
for retail sale shipped in interstate 101.44 Identification of the 20 most fre-
quently consumed raw fruit, vegetables,
commerce 18 months after the date of
and fish in the United States.
publication of this statement of policy 101.45 Guidelines for the voluntary nutri-
in the FEDERAL REGISTER, shall be lation labeling of raw fruit, vegetables, and
beled as prescribed by this section; and fish.
if not so labeled, the Food and Drug
Administration will regard them as Subpart D—Specific Requirements for
misbranded within the meaning of sec- Nutrient Content Claims
tions 403 (a) and (f) of the Federal
101.54 Nutrient content claims for ‘‘good
Food, Drug, and Cosmetic Act. source,’’ ‘‘high,’’ ‘‘more,’’ and ‘‘high po-
[42 FR 14306, Mar. 15, 1977, as amended at 48 tency.’’
FR 10811, Mar. 15, 1983; 49 FR 24119, June 12, 101.56 Nutrient content claims for ‘‘light’’
1984] or ‘‘lite.’’
101.60 Nutrient content claims for the cal-
orie content of foods.
PART 101—FOOD LABELING 101.61 Nutrient content claims for the so-
dium content of foods.
Subpart A—General Provisions 101.62 Nutrient content claims for fat, fatty
acid, and cholesterol content of foods.
Sec. 101.65 Implied nutrient content claims and
101.1 Principal display panel of package related label statements.
form food. 101.67 Use of nutrient content claims for
101.2 Information panel of package form butter.
food. 101.69 Petitions for nutrient content claims.
101.3 Identity labeling of food in packaged
form. Subpart E—Specific Requirements for
101.4 Food; designation of ingredients. Health Claims
101.5 Food; name and place of business of
manufacturer, packer, or distributor. 101.70 Petitions for health claims.
101.8 Vending machines. 101.71 Health claims: claims not authorized.
101.72 Health claims: calcium, vitamin D,
101.9 Nutrition labeling of food.
and osteoporosis.
101.10 Nutrition labeling of restaurant
101.73 Health claims: dietary lipids and can-
foods.
cer.
101.12 Reference amounts customarily con- 101.74 Health claims: sodium and hyper-
sumed per eating occasion. tension.
101.13 Nutrient content claims—general 101.75 Health claims: dietary saturated fat
principles. and cholesterol and risk of coronary
101.14 Health claims: general requirements. heart disease.
101.15 Food; prominence of required state- 101.76 Health claims: fiber-containing grain
ments. products, fruits, and vegetables and can-
101.17 Food labeling warning, notice, and cer.
safe handling statements. 101.77 Health claims: fruits, vegetables, and
101.18 Misbranding of food. grain products that contain fiber, par-
ticularly soluble fiber, and risk of coro-
Subpart B—Specific Food Labeling nary heart disease.
Requirements 101.78 Health claims: fruits and vegetables
and cancer.
101.22 Foods; labeling of spices, flavorings, 101.79 Health claims: Folate and neural tube
colorings and chemical preservatives. defects.
101.30 Percentage juice declaration for foods 101.80 Health claims: dietary noncariogenic
purporting to be beverages that contain carbohydrate sweeteners and dental car-
fruit or vegetable juice. ies.
10
101.81 Health claims: Soluble fiber from cer- mation required to be placed thereon
tain foods and risk of coronary heart dis- by this part with clarity and conspicu-
ease (CHD). ousness and without obscuring design,
101.82 Health claims: Soy protein and risk
of coronary heart disease (CHD).
vignettes, or crowding. Where packages
101.83 Health claims: plant sterol/stanol bear alternate principal display panels,
esters and risk of coronary heart disease information required to be placed on
(CHD). the principal display panel shall be du-
plicated on each principal display
Subpart F—Specific Requirements for De- panel. For the purpose of obtaining
scriptive Claims That Are Neither Nutri- uniform type size in declaring the
ent Content Claims nor Health Claims quantity of contents for all packages of
101.91 Gluten-free labeling of food.
substantially the same size, the term
101.93 Certain types of statements for die- area of the principal display panel means
tary supplements. the area of the side or surface that
101.95 ‘‘Fresh,’’ ‘‘freshly frozen,’’ ‘‘fresh fro- bears the principal display panel,
zen,’’ ‘‘frozen fresh.’’ which area shall be:
(a) In the case of a rectangular pack-
Subpart G—Exemptions From Food age where one entire side properly can
Labeling Requirements be considered to be the principal dis-
101.100 Food; exemptions from labeling. play panel side, the product of the
101.105 Declaration of net quantity of con- height times the width of that side;
tents when exempt. (b) In the case of a cylindrical or
101.108 Temporary exemptions for purposes nearly cylindrical container, 40 percent
of conducting authorized food labeling of the product of the height of the con-
experiments. tainer times the circumference;
APPENDIX A TO PART 101—MONIER-WILLIAMS (c) In the case of any otherwise
PROCEDURE (WITH MODIFICATIONS) FOR shaped container, 40 percent of the
SULFITES IN FOOD, CENTER FOR FOOD
SAFETY AND APPLIED NUTRITION, FOOD
total surface of the container: Provided,
AND DRUG ADMINISTRATION (NOVEMBER
however, That where such container
1985) presents an obvious ‘‘principal display
APPENDIX B TO PART 101—GRAPHIC ENHANCE- panel’’ such as the top of a triangular
MENTS USED BY THE FDA or circular package of cheese, the area
APPENDIX C TO PART 101—NUTRITION FACTS shall consist of the entire top surface.
FOR RAW FRUITS AND VEGETABLES In determining the area of the prin-
APPENDIX D TO PART 101—NUTRITION FACTS cipal display panel, exclude tops, bot-
FOR COOKED FISH
toms, flanges at tops and bottoms of
AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 cans, and shoulders and necks of bot-
U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, tles or jars. In the case of cylindrical
264, 271. or nearly cylindrical containers, infor-
SOURCE: 42 FR 14308, Mar. 15, 1977, unless mation required by this part to appear
otherwise noted. on the principal display panel shall ap-
EDITORIAL NOTE: Nomenclature changes to pear within that 40 percent of the cir-
part 101 appear at 63 FR 14035, Mar. 24, 1998, cumference which is most likely to be
66 FR 17358, Mar. 30, 2001, and 66 FR 56035, displayed, presented, shown, or exam-
Nov. 6, 2001. ined under customary conditions of dis-
play for retail sale.
Subpart A—General Provisions
§ 101.2 Information panel of package
§ 101.1 Principal display panel of pack- form food.
age form food. (a) The term information panel as it
The term principal display panel as it applies to packaged food means that
applies to food in package form and as part of the label immediately contig-
used in this part, means the part of a uous and to the right of the principal
label that is most likely to be dis- display panel as observed by an indi-
played, presented, shown, or examined vidual facing the principal display
under customary conditions of display panel with the following exceptions:
for retail sale. The principal display (1) If the part of the label imme-
panel shall be large enough to accom- diately contiguous and to the right of
modate all the mandatory label infor- the principal display panel is too small
11
§ 101.2 21 CFR Ch. I (4–1–16 Edition)
to accommodate the necessary infor- requirement of this section other than

mation or is otherwise unusable label the exemptions created by § 1.24(a)(5)
space, e.g., folded flaps or can ends, the (ii) and (v) of this chapter and the label
panel immediately contiguous and to shall bear all required information in
the right of this part of the label may the specified minimum type size, ex-
be used. cept the label will not be required to
(2) If the package has one or more al- bear the information required by § 101.5
ternate principal display panels, the in- if this information appears on the bot-
formation panel is immediately contig- tle closure or on the lid of the can in a
uous and to the right of any principal type size not less than one-sixteenth
display panel. inch in height, or if embossed on the
(3) If the top of the container is the lid of the can in a type size not less
principal display panel and the pack- than one-eighth inch in height.
age has no alternate principal display (B) If the soft drink is packaged in a
panel, the information panel is any bottle which does not bear a paper,
panel adjacent to the principal display plastic foam jacket or foil label, or is
panel. packaged in a reusable bottle bearing a
(b) All information required to ap- label lithographed onto the surface of
pear on the label of any package of the bottle:
food under §§ 101.4, 101.5, 101.8, 101.9, (1) Neither the bottle nor the closure
101.13, 101.17, 101.36, subpart D of part is required to bear nutrition labeling in
101, and part 105 of this chapter shall compliance with § 101.9, except that any
appear either on the principal display multiunit retail package in which it is
panel or on the information panel, un- contained shall bear nutrition labeling
less otherwise specified by regulations if required by § 101.9; and any vending
in this chapter. machine in which it is contained shall
(c) All information appearing on the bear nutrition labeling if nutrition la-
principal display panel or the informa- beling is not present on the bottle or
tion panel pursuant to this section closure, if required by § 101.9.
shall appear prominently and conspicu- (2) All other information pursuant to
ously, but in no case may the letters this section shall appear on the top of
and/or numbers be less than one-six- the bottle closure prominently and
teenth inch in height unless an exemp- conspicuously in letters and/or num-
tion pursuant to paragraph (f) of this bers no less than one thirty-second
section is established. The require- inch in height, except that if the infor-
ments for conspicuousness and leg- mation required by § 101.5 is placed on
ibility shall include the specifications the side of the closure in accordance
of §§ 101.105(h) (1) and (2) and 101.15. with § 1.24(a)(5)(ii) of this chapter, such
(1)(i) Soft drinks packaged in bottles information shall appear in letters and/
manufactured before October 31, 1975 or numbers no less than one-sixteenth
shall be exempt from the requirements inch in height.
prescribed by this section to the extent (3) Upon the petition of any inter-
that information which is blown, ested person demonstrating that the
lithographed, or formed onto the sur- bottle closure is too small to accom-
face of the bottle is exempt from the modate this information, the Commis-
size and placement requirements of sioner may by regulation establish an
this section. alternative method of disseminating
(ii) Soft drinks packaged in bottles such information. Information appear-
shall be exempt from the size and ing on the closure shall appear in the
placement requirements prescribed by following priority:
this section if all of the following con- (i) The statement of ingredients.
ditions are met: (ii) The name and address of the man-
(A) If the soft drink is packaged in a ufacturer, packer, or distributor.
bottle bearing a paper, plastic foam (iii) The statement of identity.
jacket, or foil label, or is packaged in (2) Individual serving-size packages
a nonreusable bottle bearing a label of food served with meals in res-
lithographed onto the surface of the taurants, institutions, and on board

bottle or is packaged in metal cans, the passenger carriers, and not intended
product shall not be exempt from any for sale at retail, are exempt from
12
type-size requirements of this para- (iii) The statement of ingredients re-

graph, provided: quired by § 101.4 shall not be required
(i) The package has a total area of 3 on the lid if this information appears
square inches or less available to bear on the container body in accordance
labeling; with this section. Further, the state-
(ii) There is insufficient area on the ment of ingredients is not required on
package available to print all required the container body if this information
information in a type size of 1⁄16 inch in appears on the lid in accordance with
height; this section.
(iii) The information required by (e) All information appearing on the
paragraph (b) of this section appears on information panel pursuant to this sec-
the label in accordance with the provi- tion shall appear in one place without
sions of this paragraph, except that the other intervening material.
type size is not less than 1⁄32 inch in (f) If the label of any package of food
height. is too small to accommodate all of the
(d)(1) Except as provided by information required by §§ 101.4, 101.5,
§§ 101.9(j)(13) and (j)(17) and 101.36(i)(2) 101.8, 101.9, 101.13, 101.17, 101.36, subpart
and (i)(5), all information required to D of part 101, and part 105 of this chap-
appear on the principal display panel ter, the Commissioner may establish
or on the information panel under this by regulation an acceptable alternative
section shall appear on the same panel method of disseminating such informa-
unless there is insufficient space. In de- tion to the public, e.g., a type size
termining the sufficiency of the avail- smaller than one-sixteenth inch in
able space, except as provided by height, or labeling attached to or in-
§§ 101.9(j)(17) and 101.36(i)(5), any vi- serted in the package or available at
gnettes, designs, and other nonmanda- the point of purchase. A petition re-
tory label information shall not be con- questing such a regulation, as an
sidered. If there is insufficient space amendment to this paragraph, shall be
for all of this information to appear on submitted under part 10 of this chap-
a single panel, it may be divided be- ter.
tween these two panels, except that the [42 FR 14308, Mar. 15, 1977, as amended at 42
information required under any given FR 15673, Mar. 22, 1977; 42 FR 45905, Sept. 13,
section or part shall all appear on the 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006,
same panel. A food whose label is re- Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR
16068, May 5, 1988; 58 FR 44030, Aug. 18, 1993;
quired to bear the ingredient state-
60 FR 17205, Apr. 5, 1995; 62 FR 43074, Aug. 12,
ment on the principal display panel 1997; 62 FR 49847, Sept. 23, 1997; 63 FR 14817,
may bear all other information speci- Mar. 27, 1998]
fied in paragraph (b) of this section on
the information panel. § 101.3 Identity labeling of food in
(2) Any food, not otherwise exempted packaged form.
in this section, if packaged in a con- (a) The principal display panel of a
tainer consisting of a separate lid and food in package form shall bear as one
body, and bearing nutrition labeling of its principal features a statement of
pursuant to § 101.9, and if the lid quali- the identity of the commodity.
fies for and is designed to serve as a (b) Such statement of identity shall
principal display panel, shall be ex- be in terms of:
empt from the placement requirements (1) The name now or hereafter speci-
of this section in the following re- fied in or required by any applicable
spects: Federal law or regulation; or, in the
(i) The name and place of business in- absence thereof,
formation required by § 101.5 shall not (2) The common or usual name of the
be required on the body of the con- food; or, in the absence thereof,
tainer if this information appears on (3) An appropriately descriptive
the lid in accordance with this section. term, or when the nature of the food is
(ii) The nutrition information re- obvious, a fanciful name commonly
quired by § 101.9 shall not be required used by the public for such food.
on the lid if this information appears (c) Where a food is marketed in var-
on the container body in accordance ious optional forms (whole, slices,
with this section. diced, etc.), the particular form shall
13
§ 101.3 21 CFR Ch. I (4–1–16 Edition)
be considered to be a necessary part of or usual name regulation pursuant to

the statement of identity and shall be part 102 of this chapter, or in a regula-
declared in letters of a type size bear- tion establishing a nutritional quality
ing a reasonable relation to the size of guideline pursuant to part 104 of this
the letters forming the other compo- chapter), and which complies with all
nents of the statement of identity; ex- of the applicable requirements of such
cept that if the optional form is visible regulation(s), shall not be deemed to be
through the container or is depicted by an imitation.
an appropriate vignette, the particular (4) Nutritional inferiority includes:
form need not be included in the state- (i) Any reduction in the content of an
ment. This specification does not affect essential nutrient that is present in a
the required declarations of identity measurable amount, but does not in-
under definitions and standards for clude a reduction in the caloric or fat
foods promulgated pursuant to section content provided the food is labeled
401 of the act. pursuant to the provisions of § 101.9,
(d) This statement of identity shall and provided the labeling with respect
be presented in bold type on the prin- to any reduction in caloric content
cipal display panel, shall be in a size complies with the provisions applicable
reasonably related to the most promi- to caloric content in part 105 of this
nent printed matter on such panel, and chapter.
shall be in lines generally parallel to (ii) For the purpose of this section, a
the base on which the package rests as measurable amount of an essential nu-
it is designed to be displayed. trient in a food shall be considered to
(e) Under the provisions of section be 2 percent or more of the Daily Ref-
403(c) of the Federal Food, Drug, and erence Value (DRV) of protein listed
Cosmetic Act, a food shall be deemed under § 101.9(c)(7)(iii) and of potassium
to be misbranded if it is an imitation of listed under § 101.9(c)(9) per reference
another food unless its label bears, in amount customarily consumed and 2
type of uniform size and prominence, percent or more of the Reference Daily
the word ‘‘imitation’’ and, immediately Intake (RDI) of any vitamin or mineral
thereafter, the name of the food imi- listed under § 101.9(c)(8)(iv) per ref-
tated. erence amount customarily consumed,
(1) A food shall be deemed to be an except that selenium, molybdenum,
imitation and thus subject to the re- chromium, and chloride need not be
quirements of section 403(c) of the act considered.
if it is a substitute for and resembles (iii) If the Commissioner concludes
another food but is nutritionally infe- that a food is a substitute for and re-
rior to that food. sembles another food but is inferior to
(2) A food that is a substitute for and the food imitated for reasons other
resembles another food shall not be than those set forth in this paragraph,
deemed to be an imitation provided it he may propose appropriate revisions
meets each of the following require- to this regulation or he may propose a
ments: separate regulation governing the par-
(i) It is not nutritionally inferior to ticular food.
the food for which it substitutes and (f) A label may be required to bear
which it resembles. the percentage(s) of a characterizing
(ii) Its label bears a common or usual ingredient(s) or information con-
name that complies with the provisions cerning the presence or absence of an
of § 102.5 of this chapter and that is not ingredient(s) or the need to add an in-
false or misleading, or in the absence gredient(s) as part of the common or
of an existing common or usual name, usual name of the food pursuant to
an appropriately descriptive term that subpart B of part 102 of this chapter.
is not false or misleading. The label (g) Dietary supplements shall be
may, in addition, bear a fanciful name identified by the term ‘‘dietary supple-
which is not false or misleading. ment’’ as a part of the statement of
(3) A food for which a common or identity, except that the word ‘‘die-
usual name is established by regulation tary’’ may be deleted and replaced by

(e.g., in a standard of identity pursuant the name of the dietary ingredients in
to section 401 of the act, in a common the product (e.g., calcium supplement)
14
or an appropriately descriptive term Acts by the U.S. Department of Agri-

indicating the type of dietary ingredi- culture, or conforms to a definition and
ents that are in the product (e.g., herb- standard of identity established pursu-
al supplement with vitamins). ant to section 401 of the Federal Food,
[42 FR 14308, Mar. 15, 1977, as amended at 48
Drug, and Cosmetic Act, shall be des-
FR 10811, Mar. 15, 1983; 58 FR 2227, Jan. 6, ignated in the statement of ingredients
1993; 60 FR 67174, Dec. 28, 1995; 62 FR 49847, on the label of such food by either of
Sept. 23, 1997] the following alternatives:
(i) By declaring the established com-
§ 101.4 Food; designation of ingredi- mon or usual name of the ingredient
ents. followed by a parenthetical listing of
(a)(1) Ingredients required to be de- all ingredients contained therein in de-
clared on the label or labeling of a scending order of predominance except
food, including foods that comply with that, if the ingredient is a food subject
standards of identity, except those in- to a definition and standard of identity
gredients exempted by § 101.100, shall be established in subchapter B of this
listed by common or usual name in de- chapter that has specific labeling pro-
scending order of predominance by visions for optional ingredients, op-
weight on either the principal display tional ingredients may be declared
panel or the information panel in ac- within the parenthetical listing in ac-
cordance with the provisions of § 101.2, cordance with those provisions.
except that ingredients in dietary sup- (ii) By incorporating into the state-
plements that are listed in the nutri- ment of ingredients in descending order
tion label in accordance with § 101.36 of predominance in the finished food,
need not be repeated in the ingredient the common or usual name of every
list. Paragraph (g) of this section de- component of the ingredient without
scribes the ingredient list on dietary listing the ingredient itself.
supplement products. (3) Skim milk, concentrated skim
(2) The descending order of predomi- milk, reconstituted skim milk, and
nance requirements of paragraph (a)(1) nonfat dry milk may be declared as
of this section do not apply to ingredi- ‘‘skim milk’’ or ‘‘nonfat milk’’.
ents present in amounts of 2 percent or (4) Milk, concentrated milk, reconsti-
less by weight when a listing of these tuted milk, and dry whole milk may be
ingredients is placed at the end of the declared as ‘‘milk’’.
ingredient statement following an ap- (5) Bacterial cultures may be de-
propriate quantifying statement, e.g., clared by the word ‘‘cultured’’ followed
‘‘Contains l percent or less of lll’’ by the name of the substrate, e.g.,
or ‘‘Less than l percent of lll.’’ The ‘‘made from cultured skim milk or cul-
blank percentage within the quanti- tured buttermilk’’.
fying statement shall be filled in with (6) Sweetcream buttermilk, con-
a threshold level of 2 percent, or, if de- centrated sweetcream buttermilk, re-
sired, 1.5 percent, 1.0 percent, or 0.5 constituted sweetcream buttermilk,
percent, as appropriate. No ingredient and dried sweetcream buttermilk may
to which the quantifying phrase applies be declared as ‘‘buttermilk’’.
may be present in an amount greater (7) Whey, concentrated whey, recon-
than the stated threshold. stituted whey, and dried whey may be
(b) The name of an ingredient shall declared as ‘‘whey’’.
be a specific name and not a collective (8) Cream, reconstituted cream, dried
(generic) name, except that: cream, and plastic cream (sometimes
(1) Spices, flavorings, colorings and known as concentrated milk fat) may
chemical preservatives shall be de- be declared as ‘‘cream’’.
clared according to the provisions of (9) Butteroil and anhydrous butterfat
§ 101.22. may be declared as ‘‘butterfat’’.
(2) An ingredient which itself con- (10) Dried whole eggs, frozen whole
tains two or more ingredients and eggs, and liquid whole eggs may be de-
which has an established common or clared as ‘‘eggs’’.
usual name, conforms to a standard es- (11) Dried egg whites, frozen egg
tablished pursuant to the Meat Inspec- whites, and liquid egg whites may be
tion or Poultry Products Inspection declared as ‘‘egg whites’’.
15
§ 101.4 21 CFR Ch. I (4–1–16 Edition)
(12) Dried egg yolks, frozen egg yolks, oil ingredients not present in the prod-
and liquid egg yolks may be declared as uct may be listed if they may some-
‘‘egg yolks’’. times be used in the product. Such in-
(13) [Reserved] gredients shall be identified by words
(14) Each individual fat and/or oil in- indicating that they may not be
gredient of a food intended for human present, such as ‘‘or’’, ‘‘and/or’’, ‘‘con-
consumption shall be declared by its tains one or more of the following:’’,
specific common or usual name (e.g., e.g., ‘‘vegetable oil shortening (con-
‘‘beef fat’’, ‘‘cottonseed oil’’) in its tains one or more of the following: cot-
order of predominance in the food ex- tonseed oil, palm oil, soybean oil)’’. No
cept that blends of fats and/or oils may fat or oil ingredient shall be listed un-
be designated in their order of pre- less actually present if the fats and/or
dominance in the foods as ‘‘lll oils constitute the predominant ingre-
shortening’’ or ‘‘blend of lll oils’’, dient of the product, as defined in this
the blank to be filled in with the word paragraph (b)(14).
‘‘vegetable’’, ‘‘animal’’, ‘‘marine’’, with (15) When all the ingredients of a
or without the terms ‘‘fat’’ or ‘‘oils’’, wheat flour are declared in an ingre-
or combination of these, whichever is dient statement, the principal ingre-
applicable if, immediately following dient of the flour shall be declared by
the term, the common or usual name of the name(s) specified in §§ 137.105,
each individual vegetable, animal, or 137.200, 137.220 and 137.225 of this chap-
marine fat or oil is given in paren- ter, i.e., the first ingredient designated
theses, e.g., ‘‘vegetable oil shortening in the ingredient list of flour, or
(soybean and cottonseed oil)’’. For bromated flour, or enriched flour, or
products that are blends of fats and/or self-rising flour is ‘‘flour’’, ‘‘white
oils and for foods in which fats and/or flour’’, ‘‘wheat flour’’, or ‘‘plain flour’’;
oils constitute the predominant ingre- the first ingredient designated in the
dient, i.e., in which the combined ingredient list of durum flour is
weight of all fat and/or oil ingredients ‘‘durum flour’’; the first ingredient des-
equals or exceeds the weight of the ignated in the ingredient list of whole
most predominant ingredient that is wheat flour, or bromated whole wheat
not a fat or oil, the listing of the com- flour is ‘‘whole wheat flour’’, ‘‘graham
mon or usual names of such fats and/or flour’’, or ‘‘entire wheat flour’’; and the
oils in parentheses shall be in descend- first ingredient designated in the ingre-
ing order of predominance. In all other dient list of whole durum wheat flour
foods in which a blend of fats and/or is ‘‘whole durum wheat flour’’.
oils is used as an ingredient, the listing (16) Ingredients that act as leavening
of the common or usual names in pa- agents in food may be declared in the
rentheses need not be in descending ingredient statement by stating the
order of predominance if the manufac- specific common or usual name of each
turer, because of the use of varying individual leavening agent in paren-
mixtures, is unable to adhere to a con- theses following the collective name
stant pattern of fats and/or oils in the ‘‘leavening’’, e.g., ‘‘leavening (baking
product. If the fat or oil is completely soda, monocalcium phosphate, and cal-
hydrogenated, the name shall include cium carbonate)’’. The listing of the
the term hydrogenated, or if partially common or usual name of each indi-
hydrogenated, the name shall include vidual leavening agent in parentheses
the term partially hydrogenated. If each shall be in descending order of pre-
fat and/or oil in a blend or the blend is dominance: Except, That if the manu-
completely hydrogenated, the term facturer is unable to adhere to a con-
‘‘hydrogenated’’ may precede the stant pattern of leavening agents in
term(s) describing the blend, e.g., ‘‘hy- the product, the listing of individual
drogenated vegetable oil (soybean, cot- leavening agents need not be in de-
tonseed, and palm oils)’’, rather than scending order of predominance. Leav-
preceding the name of each individual ening agents not present in the product
fat and/or oil; if the blend of fats and/ may be listed if they are sometimes
or oils is partially hydrogenated, the used in the product. Such ingredients

term ‘‘partially hydrogenated’’ may be shall be identified by words indicating
used in the same manner. Fat and/or that they may not be present, such as
16
‘‘or’’, ‘‘and/or’’, ‘‘contains one or more stating the specific common or usual
of the following:’’. name of each individual firming agent
(17) Ingredients that act as yeast nu- in descending order of predominance in
trients in foods may be declared in the parentheses following the collective
ingredient statement by stating the name ‘‘firming agents’’. If the manu-
specific common or usual name of each facturer is unable to adhere to a con-
individual yeast nutrient in paren- stant pattern of firming agents in the
theses following the collective name food, the listing of the individual firm-
‘‘yeast nutrients’’, e.g., ‘‘yeast nutri- ing agents need not be in descending
ents (calcium sulfate and ammonium order of predominance. Firming agents
phosphate)’’. The listing of the com- not present in the product may be list-
mon or usual name of each individual ed if they are sometimes used in the
yeast nutrient in parentheses shall be product. Such ingredients shall be
in descending order of predominance: identified by words indicating that
Except, That if the manufacturer is un- they may not be present, such as ‘‘or’’,
able to adhere to a constant pattern of ‘‘and/or’’, ‘‘contains one or more of the
yeast nutrients in the product, the list- following:’’.
ing of the common or usual names of (20) For purposes of ingredient label-
individual yeast nutrients need not be ing, the term sugar shall refer to su-
in descending order of predominance. crose, which is obtained from sugar
Yeast nutrients not present in the cane or sugar beets in accordance with
product may be listed if they are some- the provisions of § 184.1854 of this chap-
times used in the product. Such ingre- ter.
dients shall be identified by words indi- (21) [Reserved]
cating that they may not be present, (22) Wax and resin ingredients on
such as ‘‘or’’, ‘‘and/or’’, or ‘‘contains fresh produce when such produce is
one or more of the following:’’. held for retail sale, or when held for
(18) Ingredients that act as dough other than retail sale by packers or re-
conditioners may be declared in the in- packers shall be declared collectively
gredient statement by stating the spe- by the phrase ‘‘coated with food-grade
cific common or usual name of each in- animal-based wax, to maintain
dividual dough conditioner in paren- freshness’’ or the phrase ‘‘coated with
theses following the collective name food-grade vegetable-, petroleum-,
‘‘dough conditioner’’, e.g., ‘‘dough con- beeswax-, and/or shellac-based wax or
ditioners (L-cysteine, ammonium sul- resin, to maintain freshness’’ as appro-
fate)’’. The listing of the common or priate. The terms ‘‘food-grade’’ and ‘‘to
usual name of each dough conditioner maintain freshness’’ are optional. The
in parentheses shall be in descending term lac-resin may be substituted for
order of predominance: Except, That if the term shellac.
the manufacturer is unable to adhere (23) When processed seafood products
to a constant pattern of dough condi- contain fish protein ingredients con-
tioners in the product, the listing of sisting primarily of the myofibrillar
the common or usual names of indi- protein fraction from one or more fish
vidual dough conditioners need not be species and the manufacturer is unable
in descending order of predominance. to adhere to a constant pattern of fish
Dough conditioners not present in the species in the fish protein ingredient,
product may be listed if they are some- because of seasonal or other limita-
times used in the product. Such ingre- tions of species availability, the com-
dients shall be identified by words indi- mon or usual name of each individual
cating that they may not be present, fish species need not be listed in de-
such as ‘‘or’’, ‘‘and/or’’, or ‘‘contains scending order of predominance. Fish
one or more of the following:’’. species not present in the fish protein
(19) Ingredients that act as firming ingredient may be listed if they are
agents in food (e.g., salts of calcium sometimes used in the product. Such
and other safe and suitable salts in ingredients must be identified by words
canned vegetables) may be declared in indicating that they may not be
the ingredient statement, in order of present, such as ‘‘or’’, ‘‘and/or’’, or

predominance appropriate for the total ‘‘contains one or more of the fol-
of all firming agents in the food, by lowing:’’ Fish protein ingredients may
17
§ 101.4 21 CFR Ch. I (4–1–16 Edition)
be declared in the ingredient statement (g) When present, the ingredient list
by stating the specific common or on dietary supplement products shall
usual name of each fish species that be located immediately below the nu-
may be present in parentheses fol- trition label, or, if there is insufficient
lowing the collective name ‘‘fish pro- space below the nutrition label, imme-
tein’’, e.g., ‘‘fish protein (contains one diately contiguous and to the right of
or more of the following: Pollock, cod, the nutrition label and shall be pre-
and/or pacific whiting)’’. ceded by the word ‘‘Ingredients,’’ un-
(c) When water is added to reconsti- less some ingredients (i.e., sources) are
tute, completely or partially, an ingre- identified within the nutrition label in
dient permitted by paragraph (b) of accordance with § 101.36(d), in which
this section to be declared by a class case the ingredients listed outside the
name, the position of the ingredient nutrition label shall be in a list pre-
class name in the ingredient statement ceded by the words ‘‘Other ingredi-
shall be determined by the weight of ents.’’ Ingredients in dietary supple-
the unreconstituted ingredient plus the ments that are not dietary ingredients
weight of the quantity of water added or that do not contain dietary ingredi-
to reconstitute that ingredient, up to ents, such as excipients, fillers, artifi-
the amount of water needed to recon- cial colors, artificial sweeteners, fla-
stitute the ingredient to single vors, or binders, shall be included in
strength. Any water added in excess of the ingredient list.
the amount of water needed to recon- (h) The common or usual name of in-
stitute the ingredient to single gredients of dietary supplements that
strength shall be declared as ‘‘water’’ are botanicals (including fungi and
in the ingredient statement. algae) shall be consistent with the
(d) When foods characterized on the names standardized in Herbs of Com-
label as ‘‘nondairy’’ contain a casein- merce, 1992 edition, which is incor-
ate ingredient, the caseinate ingre- porated by reference in accordance
dient shall be followed by a parenthet- with 5 U.S.C. 552(a) and 1 CFR part 51.
ical statement identifying its source. Copies may be obtained from the Amer-
For example, if the manufacturer uses ican Herbal Products Association, 8484
the term ‘‘nondairy’’ on a creamer that Georgia Ave., suite 370, Silver Spring,
contains sodium caseinate, it shall in- MD 20910, 301-588-1171, FAX 301-588-1174,
clude a parenthetical term such as ‘‘a e-mail: ahpa@ahpa.org, or may be ex-
milk derivative’’ after the listing of so- amined at the Food and Drug Adminis-
dium caseinate in the ingredient list. tration’s Main Library, 10903 New
(e) If the percentage of an ingredient Hampshire Ave., Bldg. 2, Third Floor,
is included in the statement of ingredi- Silver Spring, MD 20993, 301–796–2039, or
ents, it shall be shown in parentheses at the National Archives and Records
following the name of the ingredient Administration (NARA). For informa-
and expressed in terms of percent by tion on the availability of this mate-
weight. Percentage declarations shall rial at NARA, call 202–741–6030, or go
be expressed to the nearest 1 percent, to:http://www.archives.gov/
except that where ingredients are federallregister/
present at levels of 2 percent or less, codeloflfederallregulations/
they may be grouped together and ex- ibrllocations.html. The listing of these
pressed in accordance with the quanti- names on the label shall be followed by
fying guidance set forth in paragraph statements of:
(a)(2) of this section. (1) The part of the plant (e.g., root,
(f) Except as provided in § 101.100, in- leaves) from which the dietary ingre-
gredients that must be declared on la- dient is derived (e.g., ‘‘Garlic bulb’’ or
beling because there is no label for the ‘‘Garlic (bulb)’’), except that this des-
food, including foods that comply with ignation is not required for algae. The
standards of identity, shall be listed name of the part of the plant shall be
prominently and conspicuously by expressed in English (e.g., ‘‘flower’’
common or usual name in the manner rather than ‘‘flos’’);

prescribed by paragraph (b) of this sec- (2) The Latin binomial name of the
tion. plant, in parentheses, except that this
18
name is not required when it is avail- § 101.5 Food; name and place of busi-
able in the reference entitled: Herbs of ness of manufacturer, packer, or
Commerce for the common or usual distributor.
name listed on the label, and, when re- (a) The label of a food in packaged
quired, the Latin binomial name may form shall specify conspicuously the
be listed before the part of the plant. name and place of business of the man-
Any name in Latin form shall be in ac- ufacturer, packer, or distributor.
cordance with internationally accepted (b) The requirement for declaration
rules on nomenclature, such as those of the name of the manufacturer, pack-
found in the International Code of Bo- er, or distributor shall be deemed to be
tanical Nomenclature and shall include satisfied, in the case of a corporation,
the designation of the author or au- only by the actual corporate name,
thors who published the Latin name, which may be preceded or followed by
when a positive identification cannot the name of the particular division of
be made in its absence. The Inter- the corporation. In the case of an indi-
national Code of Botanical Nomenclature vidual, partnership, or association, the
(Tokyo Code), 1994 edition, a publica- name under which the business is con-
tion of the International Association ducted shall be used.
for Plant Taxonomy, is incorporated by (c) Where the food is not manufac-
reference in accordance with 5 U.S.C. tured by the person whose name ap-
552(a) and 1 CFR part 51. Copies of the pears on the label, the name shall be
International Code of Botanical Nomen- qualified by a phrase that reveals the
clature may be obtained from Koeltz connection such person has with such
Scientific Books, D–61453 Konigstein, food; such as ‘‘Manufactured for
Germany, and University Bookstore, lll’’, ‘‘Distributed by lll’’, or any
Southern Illinois University, other wording that expresses the facts.
Carbondale, IL 62901–4422, 618–536–3321, (d) The statement of the place of
FAX 618–453–5207, or may be examined business shall include the street ad-
at the Food and Drug Administration’s dress, city, State, and ZIP code; how-
Main Library, 10903 New Hampshire ever, the street address may be omitted
Ave., Bldg. 2, Third Floor, Silver if it is shown in a current city direc-
Spring, MD 20993, 301–796–2039, or at the tory or telephone directory. The re-
National Archives and Records Admin- quirement for inclusion of the ZIP code
istration (NARA). For information on shall apply only to consumer com-
the availability of this material at modity labels developed or revised
NARA, call 202–741–6030, or go to: http:// after the effective date of this section.
www.archives.gov/federallregister/ In the case of nonconsumer packages,
codeloflfederallregulations/ the ZIP code shall appear either on the
ibrllocations.html. label or the labeling (including in-
(3) On labels of single-ingredient die- voice).
tary supplements that do not include (e) If a person manufactures, packs,
an ingredient list, the identification of or distributes a food at a place other
the Latin binomial name, when needed, than his principal place of business, the
and the part of the plant may be label may state the principal place of
prominently placed on the principal business in lieu of the actual place
display panel or information panel, or where such food was manufactured or
included in the nutrition label. packed or is to be distributed, unless
[42 FR 14308, Mar. 15, 1977, as amended at 43 such statement would be misleading.
FR 12858, Mar. 28, 1978; 43 FR 24519, June 6,
1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, § 101.8 Vending machines.
Apr. 25, 1990; 58 FR 2875, Jan. 6, 1993; 62 FR
(a) Definitions. The definitions of
49847, Sept. 23, 1997; 62 FR 64634, Dec. 8, 1997;
64 FR 50448, Sept. 17, 1999; 66 FR 17358, Mar.
terms in section 201 of the Federal
30, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Food, Drug, and Cosmetic Act apply to
Mar. 31, 2003; 81 FR 5590, Feb. 3, 2016] such terms when used in this section.
In addition, for the purposes of this
section:
19
§ 101.8 21 CFR Ch. I (4–1–16 Edition)
Authorized official of a vending ma- of an actual Nutrition Facts label that

chine operator means an owner, oper- complies with § 101.9 for a vending ma-
ator, agent in charge, or any other per- chine food, is presented in a size that
son authorized by a vending machine permits the prospective purchaser to be
operator who is not otherwise subject able to easily read the nutrition infor-
to section 403(q)(5)(H)(viii) of the Fed- mation, and the calories, serving size,
eral Food, Drug, and Cosmetic Act (21 and servings per container are dis-
U.S.C. 343(q)(5)(H)(viii)), to register the played by the vending machine before
vending machine operator with the the prospective purchaser makes his or
Food and Drug Administration her purchase; or
(‘‘FDA’’) for purposes of paragraph (d) (2) The prospective purchaser can
of this section. otherwise view visible nutrition infor-
Vending machine means a self-service mation, including, at a minimum the
machine that, upon insertion of a coin, total number of calories for the article
paper currency, token, card, or key, or of food as sold at the point of purchase.
by optional manual operation, dis- This visible nutrition information
penses servings of food in bulk or in must appear on the food label itself.
packages, or prepared by the machine, The visible nutrition information must
without the necessity of replenishing be clear and conspicuous and able to be
the machine between each vending op- easily read on the article of food while
eration. in the vending machine, in a type size
Vending machine operator means a at least 50 percent of the size of the
person(s) or entity that controls or di- largest printed matter on the label and
rects the function of the vending ma- with sufficient color and contrasting
chine, including deciding which arti- background to other print on the label
cles of food are sold from the machine to permit the perspective purchaser to
or the placement of the articles of food clearly distinguish the information.
within the vending machine, and is (c) Requirements for calorie labeling for
compensated for the control or direc- certain food sold from vending machines—
tion of the function of the vending ma- (1) Applicability; covered vending ma-
chine. chine food. For the purposes of this sec-
(b) Articles of food not covered. Arti- tion, the term ‘‘covered vending ma-
cles of food sold from a vending machine food’’ means an article of food
chine are not covered vending machine that is:
food if: (i) Sold from a vending machine that
(1) The prospective purchaser can does not permit the prospective pur-
view: chaser to examine the Nutrition Facts
(i) The calories, serving size, and label prior to purchase as provided in
servings per container listed in the Nu- paragraph (b)(1) of this section or oth-
trition Facts label on the vending ma- erwise provide visible nutrition infor-
chine food without any obstruction. mation at the point of purchase as pro-
The Nutrition Facts label must be in vided in paragraph (b)(2) of this sec-
the format required in § 101.9(c) and (d). tion; and
The Nutrition Facts label must be in a (ii) Sold from a vending machine
size that permits the prospective pur- that:
chaser to be able to easily read the nu- (A) Is operated by a person engaged
trition information contained in the in the business of owning or operating
Nutrition Facts label on the article of 20 or more vending machines; or
food in the vending machine. Smaller (B) Is operated by a vending machine
formats allowed for Nutrition Facts for operator that has voluntarily elected
certain food labeling under FDA regu- to be subject to the requirements of
lation at § 101.9 are not considered to be this section by registering with FDA
a size that a prospective purchaser is under paragraph (d) of this section.
able to easily read; or (2) Calorie declaration. (i) The number
(ii) The calories, serving size, and of calories for a covered vending ma-
servings per container listed in a repro- chine food must be declared in the fol-
duction of the Nutrition Facts label on lowing manner:

the vending machine food, provided (A) To the nearest 5-calorie incre-
that the reproduction is a reproduction ment up to and including 50 calories
20
and 10-calorie increment above 50 cal- tion number, or price of the food item
ories, except that amounts less than 5 as displayed on the machine.
calories may be expressed as zero. (C) When the calorie declaration is
(B) The term ‘‘Calories’’ or ‘‘Cal’’ on a sign adjacent to the vending ma-
must appear adjacent to the caloric chine, the calorie declaration must be
content value for each food in the in a type size large enough to render it
vending machine. likely to be read and understood by the
(C) The calorie declaration for a prospective purchaser under customary
packaged food must include the total conditions of purchase and use, and in
calories present in the packaged food, a type that is all black or one color on
regardless of whether the packaged a white or other neutral background
food contains a single serving or mul- that contrasts with the type color.
tiple servings. The vending machine (D) Where the vending machine only
operator may voluntarily disclose cal- displays a picture or other representa-
ories per serving in addition to the tion or name of the food item, the cal-
total calories for the food. orie declaration must be in close prox-
(D) If a covered vending machine food imity to the picture or other represen-
is one where the prospective purchaser tation or name, or in close proximity
selects among options to produce a to the selection button.
final vended product (e.g., vended cof- (E) For electronic vending machines
fee, hot chocolate or tea with options (e.g., machines with digital or elec-
for added sugar, sugar substitute, milk, tronic or liquid crystal display (LCD)
and cream), calories must be declared displays), the calorie declaration must
per option or for the final vended prod- be displayed before the prospective
ucts. purchaser makes his or her purchase.
(ii) Calorie declarations for covered (F) For vending machines with few
vending machine food must be clear choices, e.g., popcorn, the calorie dec-
and conspicuous and placed promi- laration may appear on the face of the
nently in the following manner: machine so long as the declaration is
(A) The calorie declarations may be prominent, not crowded by other label-
placed on a sign in close proximity to ing on the machine, and the type size is
the article of food or selection button, no smaller than the name of the food
i.e., in, on, or adjacent to the vending on the machine (not the label), selec-
machine, but not necessarily attached tion number, or price of the food as dis-
to the vending machine, so long as the played on the vending machine, which-
calorie declaration is visible at the ever is smallest.
same time as the food, its name, price, (d) Voluntary provision of calorie label-
selection button, or selection number ing for foods sold from vending ma-
is visible. The sign must give calorie chines—(1) Applicability. A vending ma-
declarations for those articles of food chine operator that is not subject to
that are sold from that particular the requirements of section
vending machine. 403(q)(5)(H)(viii) of the Federal Food,
(B) When the calorie declaration is in Drug, and Cosmetic Act may, through
or on the vending machine, the calorie its authorized official, voluntarily reg-
declaration must be in a type size no ister with FDA to be subject to the re-
smaller than the name of the food on quirements established in paragraph
the machine (not the label), selection (c)(2) of this section. An authorized of-
number, or price of the food as dis- ficial of a vending machine operator
played on the vending machine, which- that voluntarily registers cannot be
ever is smallest, with the same promi- subject to any State or local nutrition
nence, i.e., the same color, or in a color labeling requirements that are not
at least as conspicuous, as the color of identical to the requirements in
the name, if applicable, or price of the 403(q)(5)(H) of the Federal Food, Drug,
food or selection number, and the same and Cosmetic Act.
contrasting background, or a back- (2) Who may register? A vending ma-
ground at least as contrasting as the chine operator that is not otherwise

background used for the item it is in subject to the requirements of section
closest proximity to, i.e., name, selec- 403(q)(5)(H) of the Federal Food, Drug,
21
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
and Cosmetic Act may register with days prior to the expiration of the
FDA. vending machine operator’s current
(3) What information is required? The registration with FDA. Registration
vending machine operator must pro- will automatically expire if not re-
vide FDA with the following informa- newed.
tion: (e) Vending machine operator contact
(i) The contact information (includ- information. (1) A vending machine op-
ing name, address, phone number, erator that is subject to section
email address), for the vending ma- 403(q)(5)(H)(viii) of the Federal Food,
chine operator; Drug, and Cosmetic Act or a vending
(ii) The address of the location of machine operator that voluntarily reg-
each vending machine owned or oper- isters to be subject to the requirements
ated by the vending machine operator under paragraph (d) of this section
that is being registered; must provide its contact information
(iii) Preferred mailing address (if dif- for vending machines selling covered
ferent from the vending machine oper- vending machine food. The contact in-
ator address), for purposes of receiving formation must list the vending ma-
correspondence; and chine operator’s name, telephone num-
(iv) Certification that the informa- ber, and mailing address or email ad-
tion submitted is true and accurate, dress.
that the person or firm submitting it is (2) The contact information must be
authorized to do so, and that each reg- readable and may be placed on the face
istered vending machine will be subject of the vending machine, or otherwise
to the requirements of this section. must be placed with the calorie dec-
(v) Information should be submitted larations as described in paragraph
by email by typing complete informa- (c)(2)(ii) of this section (i.e., on the sign
tion into the portable document format in, on, or adjacent to the vending ma-
(PDF) form, saving it on the reg- chine).
istrant’s computer, and sending it by (f) Signatures. Signatures obtained
email to under paragraph (d) of this section that
menulawregistration@fda.hhs.gov. If meet the definition of electronic signa-
email is not available, the registrant tures in § 11.3(b)(7) of this chapter are
can either fill in the PDF form and exempt from the requirements of part
print it out (or print out the blank 11 of this chapter.
PDF and fill in the information by [79 FR 71293, Dec. 1, 2014]
hand or typewriter), and either fax the EFFECTIVE DATE NOTE: At 79 FR 71291, Dec.
completed form to 301–436–2804 or mail 1, 2014, § 101.8 was added, effective Dec. 1,
it to FDA, CFSAN Menu and Vending 2016.
Machine Labeling Registration, White
Oak Building 22, rm. 0209, 10903 New § 101.9 Nutrition labeling of food.
Hampshire Ave., Silver Spring, MD (a) Nutrition information relating to
20993. food shall be provided for all products
(vi) Authorized officials of a vending intended for human consumption and
machine operator who elect to be sub- offered for sale unless an exemption is
ject to the Federal requirements can provided for the product in paragraph
register by visiting http://www.fda.gov/ (j) of this section.
food/ingredientspackaginglabeling/ (1) When food is in package form, the
labelingnutrition/ucm217762.htm. FDA required nutrition labeling information
has created a form that contains fields shall appear on the label in the format
requesting the information in para- specified in this section.
graph (d) of this section and made the (2) When food is not in package form,
form available at this Web site. Reg- the required nutrition labeling infor-
istrants must use this form to ensure mation shall be displayed clearly at
that complete information is sub- the point of purchase (e.g., on a
mitted. counter card, sign, tag affixed to the
(vii) To keep the establishment’s reg- product, or some other appropriate de-
istration active, the authorized official vice). Alternatively, the required infor-
of the vending machine operator must mation may be placed in a booklet,
register every other year within 60 looseleaf binder, or other appropriate
22
format that is available at the point of that appear in § 101.12(b) using the pro-
purchase. cedures described below. For products
(3) Solicitation of requests for nutri- that are both intended for weight con-
tion information by a statement ‘‘For trol and available only through a
nutrition information write to weight-control program, a manufac-
lllllllllll ’’ on the label or turer may determine the serving size
in the labeling or advertising for a that is consistent with the meal plan of
food, or providing such information in the program. Such products must bear
a direct written reply to a solicited or a statement, ‘‘for sale only through the
unsolicited request, does not subject lll program’’ (fill in the blank with
the label or the labeling of a food ex- the name of the appropriate weight-
empted under paragraph (j) of this sec- control program, e.g., Smith’s Weight
tion to the requirements of this section Control), on the principal display
if the reply to the request conforms to panel. However, the reference amounts
the requirements of this section. in § 101.12(b) shall be used for purposes
(4) If any vitamin or mineral is added of evaluating whether weight-control
to a food so that a single serving pro- products that are available only
vides 50 percent or more of the Ref- through a weight-control program
erence Daily Intake (RDI) for the age qualify for nutrient content claims or
group for which the product is in- health claims.
tended, as specified in paragraph (i) For products in discrete units
(c)(8)(iv) of this section, of any one of (e.g., muffins, sliced products, such as
the added vitamins or minerals, unless sliced bread, or individually packaged
such addition is permitted or required products within a multiserving pack-
in other regulations, e.g., a standard of age) and for products which consist of
identity or nutritional quality guide- two or more foods packaged and pre-
line, or is otherwise exempted by the sented to be consumed together where
Commissioner, the food shall be consid- the ingredient represented as the main
ered a food for special dietary use with- ingredient is in discrete units (e.g.,
in the meaning of § 105.3(a)(1)(iii) of pancakes and syrup), the serving size
this chapter. shall be declared as follows:
(b) Except as provided in § 101.9(h)(3), (A) If a unit weighs 50 percent or less
all nutrient and food component quan- of the reference amount, the serving
tities shall be declared in relation to a size shall be the number of whole units
serving as defined in this section. that most closely approximates the ref-
(1) The term serving or serving size erence amount for the product cat-
means an amount of food customarily egory;
consumed per eating occasion by per- (B) If a unit weighs more than 50 per-
sons 4 years of age or older which is ex- cent, but less than 67 percent of the
pressed in a common household meas- reference amount, the manufacturer
ure that is appropriate to the food. may declare one unit or two units as
When the food is specially formulated the serving size;
or processed for use by infants or by (C) If a unit weighs 67 percent or
toddlers, a serving or serving size more, but less than 200 percent of the
means an amount of food customarily reference amount, the serving size
consumed per eating occasion by in- shall be one unit;
fants up to 12 months of age or by chil- (D) If a unit weighs 200 percent or
dren 1 through 3 years of age, respec- more of the reference amount, the
tively. manufacturer may declare one unit as
(2) Except as provided in paragraphs the serving size if the whole unit can
(b)(3), (b)(4), and (b)(6) of this section reasonably be consumed at a single-
and for products that are intended for eating occasion.
weight control and are available only (E) For products that have reference
through a weight-control or weight- amounts of 100 grams (g) (or milliliter
maintenance program, serving size de- (mL)) or larger and are individual units
clared on a product label shall be deter- within a multiserving package, if a
mined from the ‘‘Reference Amounts unit contains more than 150 percent
Customarily Consumed Per Eating Oc- but less than 200 percent of the ref-
casion * * * *’’ (reference amounts) erence amount, the manufacturer may
23
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
decide whether to declare the indi- reference amount for the unprepared
vidual unit as 1 or 2 servings. product determined in § 101.12(c) or the
(F) The serving size for maraschino fraction of the large discrete unit rep-
cherries shall be expressed as 1 cherry resented as the main ingredient plus
with the parenthetical metric measure proportioned minor ingredients used to
equal to the average weight of a me- make the reference amount for the
dium size cherry. combined product determined in
(G) The serving size for products that § 101.12(f). In expressing the fractional
naturally vary in size (e.g., pickles, slice, manufacturers shall use 1⁄2, 1⁄3, 1⁄4,
shellfish, whole fish, and fillet of fish) 1⁄5, 1⁄6, or smaller fractions that can be
may be the amount in ounces that generated by further division by 2 or 3.

most closely approximates the ref- (iii) For nondiscrete bulk products
erence amount for the product cat- (e.g., breakfast cereal, flour, sugar, dry
egory. Manufacturers shall adhere to mixes, concentrates, pancake mixes,
the requirements in paragraph macaroni and cheese kits), and for
(b)(5)(vi) of this section for expressing products which consist of two or more
the serving size in ounces. foods packaged and presented to be
(H) For products which consist of two consumed together where the ingre-
or more foods packaged and presented dient represented as the main ingre-
to be consumed together where the in- dient is a bulk product (e.g., peanut
gredient represented as the main ingre- butter and jelly), the serving size shall
dient is in discrete units (e.g., pan- be the amount in household measure
cakes and syrup), the serving size may that most closely approximates the ref-
be the number of discrete units rep- erence amount for the product cat-
resented as the main ingredient plus egory and may be the amount of the
proportioned minor ingredients used to bulk product represented as the main
make the reference amount for the ingredient plus proportioned minor in-
combined product determined in gredients used to make the reference
§ 101.12(f). amount for the combined product de-
(I) For packages containing several termined in § 101.12(f).
individual single-serving containers, (3) The serving size for meal products
each of which is labeled with all re- and main dish products as defined in
quired information including nutrition § 101.13 (l) and (m) that comes in single-
labeling as specified in § 101.9 (that is, serving containers as defined in para-
are labeled appropriately for individual graph (b)(6) of this section shall be the
sale as single-serving containers), the entire content (edible portion only) of
serving size shall be 1 unit. the package. Serving size for meal
(ii) For products in large discrete products and main dish products in
units that are usually divided for con- multiserving containers shall be based
sumption (e.g., cake, pie, pizza, melon, on the reference amount applicable to
cabbage), for unprepared products the product in § 101.12(b) if the product
where the entire contents of the pack- is listed in § 101.12(b). Serving size for
age is used to prepare large discrete meal products and main dish products
units that are usually divided for con- in multiserving containers that are not
sumption (e.g., cake mix, pizza kit), listed in § 101.12(b) shall be based on the
and for products which consist of two reference amount according to
or more foods packaged and presented § 101.12(f).
to be consumed together where the in- (4) A variety pack, such as a package
gredient represented as the main ingre- containing several varieties of single-
dient is a large discrete unit usually di- serving units as defined in paragraph
vided for consumption (e.g., prepared (b)(2)(i) of this section, and a product
cake packaged with a can of frosting), having two or more compartments
the serving size shall be the fractional with each compartment containing a
slice of the ready-to-eat product (e.g., different food, shall provide nutrition
1⁄12 cake, 1⁄8 pie, 1⁄4 pizza, 1⁄4 melon, 1⁄6 information for each variety or food
cabbage) that most closely approxi- per serving size that is derived from
mates the reference amount for the the reference amount in § 101.12(b) ap-
product category, and may be the frac- plicable for each variety or food and
tion of the package used to make the the procedures to convert the reference
24
amount to serving size in paragraph (vii) As provided for in § 101.9(h)(1),

(b)(2) of this section. for products that consist of two or
(5) For labeling purposes, the term more distinct ingredients or compo-
common household measure or common nents packaged and presented to be
household unit means cup, tablespoon, consumed together (e.g. dry macaroni
teaspoon, piece, slice, fraction (e.g., 1⁄4 and cheese mix, cake and muffin mixes
pizza), ounce (oz), fluid ounce (fl oz), or with separate ingredient packages,
other common household equipment pancakes and syrup), nutrition infor-
used to package food products (e.g., jar, mation may be declared for each com-
tray). In expressing serving size in ponent or as a composite. The serving
household measures, except as speci- size may be provided in accordance
fied in paragraphs (b)(5)(iv), (b)(5)(v), with the provisions of paragraphs
(b)(5)(vi), and (b)(5)(vii) of this section, (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this
the following rules shall be used: section, or alternatively in ounces with
(i) Cups, tablespoons, or teaspoons an appropriate visual unit of measure,
shall be used wherever possible and ap- as described in paragraph (b)(5)(iii) of
propriate except for beverages. For this section (e.g., declared as separate
beverages, a manufacturer may use components: ‘‘3 oz dry macaroni (84 g/
fluid ounces. Cups shall be expressed in about 2⁄3 cup)’’ and ‘‘1 oz dry cheese mix
1/4- or 1/3-cup increments. Tablespoons (28 g/about 2 tbsp);’’ declared as a com-
shall be expressed as 1, 1 1/3, 1 1/2, 1 2/ posite value: ‘‘4 oz (112 g/about 2⁄3 cup
3, 2, or 3 tablespoons. Teaspoons shall macaroni and 2 tbsp dry cheese mix)’’).
be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 (viii) For nutrition labeling purposes,
teaspoons. a teaspoon means 5 milliliters (mL), a
(ii) If cups, tablespoons or teaspoons tablespoon means 15 mL, a cup means
are not applicable, units such as piece, 240 mL, 1 fl oz means 30 mL, and 1 oz in
slice, tray, jar, and fraction shall be weight means 28 g.
used. (ix) When a serving size, determined
(iii) If paragraphs (b)(5)(i) and from the reference amount in § 101.12(b)
(b)(5)(ii) of this section are not applica- and the procedures described in this
ble, ounces may be used with an appro- section, falls exactly half way between
priate visual unit of measure such as a two serving sizes, e.g., 2.5 tbsp, manu-
dimension of a piece, e.g., 1 oz (28 g/ facturers shall round the serving size
about 1⁄2 pickle). Ounce measurements up to the next incremental size.
shall be expressed in 0.5 oz increments (6) A product that is packaged and
most closely approximating the ref- sold individually and that contains less
erence amount. than 200 percent of the applicable ref-
(iv) A description of the individual erence amount shall be considered to
container or package shall be used for be a single-serving container, and the
single serving containers and for indi- entire content of the product shall be
vidually packaged products within labeled as one serving except for prod-
multiserving containers (e.g., can, box, ucts that have reference amounts of 100
package). A description of the indi- g (or mL) or larger, manufacturers may
vidual unit shall be used for other decide whether a package that contains
products in discrete units (e.g., piece, more than 150 percent but less than 200
slice, cracker, bar). percent of the reference amount is 1 or
(v) For unprepared products where 2 servings. Packages sold individually
the entire contents of the package is that contain 200 percent or more of the
used to prepare large discrete units applicable reference amount may be la-
that are usually divided for consump- beled as a single-serving if the entire
tion (e.g., cake mix, pizza kit), the content of the package can reasonably
fraction or portion of the package may be consumed at a single-eating occa-
be used. sion.
(vi) Ounces with an appropriate vis- (7) A label statement regarding a
ual unit of measure, as described in serving shall be the serving size ex-
paragraph (b)(5)(iii) of this section, pressed in common household measures
may be used for products that natu- as set forth in paragraphs (b)(2)
rally vary in size as provided for in through (b)(6) of this section and shall
paragraph (b)(2)(i)(G) of this section. be followed by the equivalent metric
25
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
quantity in parenthesis (fluids in milli- clared by different manufacturers, FDA

liters and all other foods in grams) ex- has provided a guidance document enti-
cept for single-serving containers. tled, ‘‘Guidelines for Determining the
(i) For a single-serving container, the Gram Weight of the Household Meas-
parenthetical metric quantity, which ure.’’ The guidance document can be
will be presented as part of the net obtained from the Office of Nutritional
weight statement on the principal dis- Products, Labeling and Dietary Supple-
play panel, is not required except ments (HFS–800), Center for Food Safe-
where nutrition information is re- ty and Applied Nutrition, Food and
quired on a drained weight basis ac- Drug Administration, 5100 Paint
cording to § 101.9(b)(9). However, if a Branch Pkwy., College Park, MD 20740.
manufacturer voluntarily provides the (8) Determination of the number of
metric quantity on products that can servings per container shall be based
be sold as single servings, then the nu- on the serving size of the product de-
merical value provided as part of the termined by following the procedures
serving size declaration must be iden- described in this section.
tical to the metric quantity declara- (i) The number of servings shall be
tion provided as part of the net quan- rounded to the nearest whole number
tity of contents statement. except for the number of servings be-
(ii) The gram or milliliter quantity tween 2 and 5 servings and random
equivalent to the household measure weight products. The number of
should be rounded to the nearest whole servings between 2 and 5 servings shall
number except for quantities that are be rounded to the nearest 0.5 serving.
less than 5 g (mL). The gram (mL) Rounding should be indicated by the
quantity between 2 and 5 g (mL) should use of the term about (e.g., about 2
be rounded to the nearest 0.5 g (mL) servings, about 3.5 servings).
and the g (mL) quantity less than 2 g
(ii) When the serving size is required
(mL) should be expressed in 0.1-g (mL)
to be expressed on a drained solids
increments.
basis and the number of servings varies
(iii) In addition, serving size may be
declared in ounce and fluid ounce, in because of a natural variation in unit
parenthesis, following the metric size (e.g., maraschino cherries, pick-
measure separated by a slash where les), the manufacturer may state the
other common household measures are typical number of servings per con-
used as the primary unit for serving tainer (e.g., usually 5 servings).
size, e.g., 1 slice (28 g/1 oz) for sliced (iii) For random weight products, a
bread. The ounce quantity equivalent manufacturer may declare ‘‘varied’’ for
to the metric quantity should be ex- the number of servings per container
pressed in 0.1 oz increments. provided the nutrition information is
(iv) If a manufacturer elects to use based on the reference amount ex-
abbreviations for units, the following pressed in ounces. The manufacturer
abbreviations shall be used: tbsp for ta- may provide the typical number of
blespoon, tsp for teaspoon, g for gram, servings in parenthesis following the
mL for milliliter, oz for ounce, and fl ‘‘varied’’ statement.
oz for fluid ounce. (iv) For packages containing several
(v) For products that only require individual single-serving containers,
the addition of water or another ingre- each of which is labeled with all re-
dient that contains insignificant quired information including nutrition
amounts of nutrients in the amount labeling as specified in § 101.9 (that is,
added and that are prepared in such a are labeled appropriately for individual
way that there are no significant sale as single-serving containers), the
changes to the nutrient profile, the number of servings shall be the number
amount of the finished product may be of individual packages within the total
declared in parentheses at the end of package.
the serving size declaration (e.g., 1⁄2 cup (v) For packages containing several
(120 mL) concentrated soup (makes 1 individually packaged multiserving
cup prepared)). units, the number of servings shall be

(vi) To promote uniformity in label determined by multiplying the number
serving sizes in household measures de- of individual multiserving units in the
26
total package by the number of cept for those nutrients whose inclu-
servings in each individual unit. sion, and the declaration of amounts, is
(9) The declaration of nutrient and voluntary as set forth in this para-
food component content shall be on the graph. No nutrients or food compo-
basis of food as packaged or purchased nents other than those listed in this
with the exception of raw fish covered paragraph as either mandatory or vol-
under § 101.42 (see 101.44), packaged sin- untary may be included within the nu-
gle-ingredient products that consist of trition label. Except as provided for in
fish or game meat as provided for in paragraphs (f) or (j) of this section, nu-
paragraph (j)(11) of this section, and of trient information shall be presented
foods that are packed or canned in using the nutrient names specified and
water, brine, or oil but whose liquid in the following order in the formats
packing medium is not customarily specified in paragraphs (d) or (e) of this
consumed (e.g., canned fish, mara- section.
schino cherries, pickled fruits, and (1) ‘‘Calories, total,’’ ‘‘Total cal-
pickled vegetables). Declaration of nu- ories,’’ or ‘‘Calories’’: A statement of
trient and food component content of the caloric content per serving, ex-
raw fish shall follow the provisions in pressed to the nearest 5-calorie incre-
§ 101.45. Declaration of the nutrient and ment up to and including 50 calories,
food component content of foods that and 10-calorie increment above 50 cal-
are packed in liquid which is not cus- ories, except that amounts less than 5
tomarily consumed shall be based on calories may be expressed as zero. En-
the drained solids.
ergy content per serving may also be
(10) Another column of figures may
expressed in kilojoule units, added in
be used to declare the nutrient and
parentheses immediately following the
food component information:
statement of the caloric content.
(i) Per 100 g or 100 mL, or per 1 oz or
1 fl oz of the food as packaged or pur- (i) Caloric content may be calculated
chased; by the following methods. Where either
(ii) Per one unit if the serving size of specific or general food factors are
a product in discrete units in a multi- used, the factors shall be applied to the
serving container is more than 1 unit; actual amount (i.e., before rounding) of
(iii) Per cup popped for popcorn in a food components (e.g., fat, carbo-
multiserving container. hydrate, protein, or ingredients with
(11) If a product is promoted on the specific food factors) present per serv-
label, labeling, or advertising for a use ing.
that differs in quantity by twofold or (A) Using specific Atwater factors (i.
greater from the use upon which the e., the Atwater method) given in Table
reference amount in § 101.12(b) was 13, ‘‘Energy Value of Foods—Basis and
based (e.g., liquid cream substitutes Derivation,’’ by A. L. Merrill and B. K.
promoted for use with breakfast cere- Watt, United States Department of Ag-
als), the manufacturer shall provide a riculture (USDA) Handbook No. 74
second column of nutrition informa- (slightly revised, 1973), which is incor-
tion based on the amount customarily porated by reference in accordance
consumed in the promoted use, in addi- with 5 U.S.C. 552(a) and 1 CFR part 51
tion to the nutrition information per and is available from the Office of Nu-
serving derived from the reference tritional Products, Labeling and Die-
amount in § 101.12(b), except that non- tary Supplements (HFS–800), Center for
discrete bulk products that are used Food Safety and Applied Nutrition,
primarily as ingredients (e.g., flour, Food and Drug Administration, 5100
sweeteners, shortenings, oils), or tradi- Paint Branch Pkwy., College Park, MD
tionally used for multipurposes (e.g., 20740, or may be inspected at the Na-
eggs, butter, margarine), and multipur- tional Archives and Records Adminis-
pose baking mixes are exempt from tration (NARA). For information on
this requirement. the availability of this material at
(c) The declaration of nutrition infor- NARA, call 202–741–6030, or go to: http://
mation on the label and in labeling of www.archives.gov/federallregister/

a food shall contain information about codeloflfederallregulations/
the level of the following nutrients, ex- ibrllocations.html.;
27
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
(B) Using the general factors of 4, 4, the table of nutrient values in the
and 9 calories per gram for protein, same type size.
total carbohydrate, and total fat, re- (iii) ‘‘Calories from saturated fat’’ or
spectively, as described in USDA Hand- ‘‘Calories from saturated’’ (VOL-
book No. 74 (slightly revised 1973) pp. 9– UNTARY): A statement of the caloric
11, which is incorporated by reference content derived from saturated fat as
in accordance with 5 U.S.C. 552(a) and 1 defined in paragraph (c)(2)(i) of this
CFR part 51 (the availability of this in- section in a serving may be declared
corporation by reference is given in voluntarily, expressed to the nearest 5-
paragraph (c)(1)(i)(A) of this section); calorie increment, up to and including
(C) Using the general factors of 4, 4, 50 calories, and the nearest 10-calorie
and 9 calories per gram for protein, increment above 50 calories, except
total carbohydrate less the amount of that amounts less than 5 calories may
insoluble dietary fiber, and total fat, be expressed as zero. This statement
respectively, as described in USDA shall be indented under the statement
Handbook No. 74 (slightly revised 1973) of calories from fat as provided in para-
pp. 9–11, which is incorporated by ref-
graph (d)(5) of this section.
erence in accordance with 5 U.S.C.
(2) ‘‘Fat, total’’ or ‘‘Total fat’’: A
552(a) and 1 CFR part 51 (the avail-
statement of the number of grams of
ability of this incorporation by ref-
erence is given in paragraph (c)(1)(i)(A) total fat in a serving defined as total
of this section; lipid fatty acids and expressed as
(D) Using data for specific food fac- triglycerides. Amounts shall be ex-
tors for particular foods or ingredients pressed to the nearest 0.5 (1/2) gram in-
approved by the Food and Drug Admin- crement below 5 grams and to the near-
istration (FDA) and provided in parts est gram increment above 5 grams. If
172 or 184 of this chapter, or by other the serving contains less than 0.5 gram,
means, as appropriate; or the content shall be expressed as zero.
(E) Using bomb calorimetry data sub- (i) ‘‘Saturated fat,’’ or ‘‘Saturated’’:
tracting 1.25 calories per gram protein A statement of the number of grams of
to correct for incomplete digestibility, saturated fat in a serving defined as
as described in USDA Handbook No. 74 the sum of all fatty acids containing no
(slightly revised 1973) p. 10, which is in- double bonds, except that label dec-
corporated by reference in accordance laration of saturated fat content infor-
with 5 U.S.C. 552(a) and 1 CFR part 51 mation is not required for products
(the availability of this incorporation that contain less than 0.5 gram of total
by reference is given in paragraph fat in a serving if no claims are made
(c)(1)(i)(A) of this section). about fat, fatty acid, or cholesterol
(ii) ‘‘Calories from fat’’: A statement content, and if ‘‘calories from satu-
of the caloric content derived from rated fat’’ is not declared. Except as
total fat as defined in paragraph (c)(2) provided for in paragraph (f) of this
of this section in a serving, expressed section, if a statement of the saturated
to the nearest 5-calorie increment, up fat content is not required and, as a re-
to and including 50 calories, and the sult, not declared, the statement ‘‘Not
nearest 10-calorie increment above 50 a significant source of saturated fat’’
calories, except that label declaration shall be placed at the bottom of the
of ‘‘calories from fat’’ is not required table of nutrient values. Saturated fat
on products that contain less than 0.5 content shall be indented and expressed
gram of fat in a serving and amounts as grams per serving to the nearest 0.5
less than 5 calories may be expressed as gram (1/2) gram increment below 5
zero. This statement shall be declared grams and to the nearest gram incre-
as provided in paragraph (d)(5) of this ment above 5 grams. If the serving con-
section. Except as provided for in para-
tains less than 0.5 gram, the content
graph (f) of this section, if ‘‘Calories
shall be expressed as zero.
from fat’’ is not required and, as a re-
(ii) ‘‘Trans fat’’ or ‘‘Trans’’: A state-

sult, not declared, the statement ‘‘Not
a significant source of calories from ment of the number of grams of trans
fat’’ shall be placed at the bottom of fat in a serving, defined as the sum of
28
all unsaturated fatty acids that con- fat is required. Monounsaturated fat
tain one or more isolated (i.e., noncon- content shall be indented and expressed
jugated) double bonds in a trans con- as grams per serving to the nearest 0.5
figuration, except that label declara- (1/2) gram increment below 5 grams and
tion of trans fat content information is to the nearest gram increment above 5
not required for products that contain grams. If the serving contains less than
less than 0.5 gram of total fat in a serv- 0.5 gram, the content shall be expressed
ing if no claims are made about fat, as zero.
fatty acid or cholesterol content. The (3) ‘‘Cholesterol’’: A statement of the
word ‘‘trans’’ may be italicized to indi- cholesterol content in a serving ex-
cate its Latin origin. Trans fat content pressed in milligrams to the nearest 5-
shall be indented and expressed as milligram increment, except that label
grams per serving to the nearest 0.5 (1/ declaration of cholesterol information
2)-gram increment below 5 grams and is not required for products that con-
to the nearest gram increment above 5 tain less than 2 milligrams cholesterol
grams. If the serving contains less than in a serving and make no claim about
0.5 gram, the content, when declared, fat, fatty acids, or cholesterol content,
shall be expressed as zero. Except as or such products may state the choles-
provided for in paragraph (f) of this terol content as zero. Except as pro-
section, if a statement of the trans fat vided for in paragraph (f) of this sec-
content is not required and, as a result, tion, if cholesterol content is not re-
not declared, the statement ‘‘Not a sig- quired and, as a result, not declared,
nificant source of trans fat’’ shall be the statement ‘‘Not a significant
placed at the bottom of the table of nu- source of cholesterol’’ shall be placed
trient values. at the bottom of the table of nutrient
(iii) ‘‘Polyunsaturated fat’’ or ‘‘Poly- values in the same type size. If the food
unsaturated’’ (VOLUNTARY): A state- contains 2 to 5 milligrams of choles-
ment of the number of grams of poly- terol per serving, the content may be
unsaturated fat in a serving defined as stated as ‘‘less than 5 milligrams.’’
cis,cis-methylene-interrupted poly- (4) ‘‘Sodium’’: A statement of the
unsaturated fatty acids may be de- number of milligrams of sodium in a
clared voluntarily, except that when specified serving of food expressed as
monounsaturated fat is declared, or zero when the serving contains less
when a claim about fatty acids or cho- than 5 milligrams of sodium, to the
lesterol is made on the label or in la- nearest 5-milligram increment when
beling of a food other than one that the serving contains 5 to 140 milli-
meets the criteria in § 101.62(b)(1) for a grams of sodium, and to the nearest 10-
claim for ‘‘fat free,’’ label declaration milligram increment when the serving
of polyunsaturated fat is required. contains greater than 140 milligrams.
Polyunsaturated fat content shall be (5) ‘‘Potassium’’ (VOLUNTARY): A
indented and expressed as grams per statement of the number of milligrams
serving to the nearest 0.5 (1/2) gram in- of potassium in a specified serving of
crement below 5 grams and to the near- food may be declared voluntarily, ex-
est gram increment above 5 grams. If cept that when a claim is made about
the serving contains less than 0.5 gram, potassium content, label declaration
the content shall be expressed as zero. shall be required. Potassium content
(iv) ‘‘Monounsaturated fat’’ or shall be expressed as zero when the
‘‘Monounsaturated’’ (VOLUNTARY): A serving contains less than 5 milligrams
statement of the number of grams of of potassium, to the nearest 5-milli-
monounsaturated fat in a serving de- gram increment when the serving con-
fined as cis-monounsaturated fatty tains less than or equal to 140 milli-
acids may be declared voluntarily ex- grams of potassium, and to the nearest
cept that when polyunsaturated fat is 10-milligram increment when the serv-
declared, or when a claim about fatty ing contains more than 140 milligrams.
acids or cholesterol is made on the (6) ‘‘Carbohydrate, total’’ or ‘‘Total
label or in labeling of a food other than carbohydrate’’: A statement of the
one that meets the criteria in number of grams of total carbohydrate

§ 101.62(b)(1) for a claim for ‘‘fat free,’’ in a serving expressed to the nearest
label declaration of monounsaturated gram, except that if a serving contains
29
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
less than 1 gram, the statement ‘‘Con- declaration shall be required. Insoluble
tains less than 1 gram’’ or ‘‘less than 1 fiber content shall be indented under
gram’’ may be used as an alternative, dietary fiber and expressed to the near-
or if the serving contains less than 0.5 est gram except that if a serving con-
gram, the content may be expressed as tains less than 1 gram, the statement
zero. Total carbohydrate content shall ‘‘Contains less than 1 gram’’ or ‘‘less
be calculated by subtraction of the sum than 1 gram’’ may be used as an alter-
of the crude protein, total fat, mois- native, and if the serving contains less
ture, and ash from the total weight of than 0.5 gram, the content may be ex-
the food. This calculation method is pressed as zero.
described in A. L. Merrill and B. K. (ii) ‘‘Sugars’’: A statement of the
Watt, ‘‘Energy Value of Foods—Basis number of grams of sugars in a serving,
and Derivation,’’ USDA Handbook 74 except that label declaration of sugars
(slightly revised 1973) pp. 2 and 3, which content is not required for products
is incorporated by reference in accord- that contain less than 1 gram of sugars
ance with 5 U.S.C. 552(a) and 1 CFR in a serving if no claims are made
part 51 (the availability of this incorpo- about sweeteners, sugars, or sugar al-
ration by reference is given in para- cohol content. Except as provided for
graph (c)(1)(i)(A) of this section). in paragraph (f) of this section, if a
(i) ‘‘Dietary fiber’’: A statement of statement of the sugars content is not
the number of grams of total dietary required and, as a result, not declared,
fiber in a serving, indented and ex- the statement ‘‘Not a significant
pressed to the nearest gram, except source of sugars’’ shall be placed at the
that if a serving contains less than 1 bottom of the table of nutrient values
gram, declaration of dietary fiber is in the same type size. Sugars shall be
not required or, alternatively, the defined as the sum of all free mono-
statement ‘‘Contains less than 1 gram’’ and disaccharides (such as glucose,
or ‘‘less than 1 gram’’ may be used, and fructose, lactose, and sucrose). Sugars
if the serving contains less than 0.5 content shall be indented and expressed
gram, the content may be expressed as to the nearest gram, except that if a
zero. Except as provided for in para- serving contains less than 1 gram, the
graph (f) of this section, if dietary fiber statement ‘‘Contains less then 1 gram’’
content is not required and as a result, or ‘‘less than 1 gram’’ may be used as
not declared, the statement ‘‘Not a sig- an alternative, and if the serving con-
nificant source of dietary fiber’’ shall tains less than 0.5 gram, the content
be placed at the bottom of the table of may be expressed as zero.
nutrient values in the same type size. (iii) ‘‘Sugar alcohol’’ (VOLUNTARY):
(A) ‘‘Soluble fiber’’ (VOLUNTARY): A statement of the number of grams of
A statement of the number of grams of sugar alcohols in a serving may be de-
soluble dietary fiber in a serving may clared voluntarily on the label, except
be declared voluntarily except when a that when a claim is made on the label
claim is made on the label or in label- or in labeling about sugar alcohol or
ing about soluble fiber, label declara- sugars when sugar alcohols are present
tion shall be required. Soluble fiber in the food, sugar alcohol content shall
content shall be indented under dietary be declared. For nutrition labeling pur-
fiber and expressed to the nearest poses, sugar alcohols are defined as the
gram, except that if a serving contains sum of saccharide derivatives in which
less than 1 gram, the statement ‘‘Con- a hydroxyl group replaces a ketone or
tains less than 1 gram’’ or ‘‘less than 1 aldehyde group and whose use in the
gram’’ may be used as an alternative, food is listed by FDA (e.g., mannitol or
and if the serving contains less than 0.5 xylitol) or is generally recognized as
gram, the content may be expressed as safe (e.g., sorbitol). In lieu of the term
zero. ‘‘sugar alcohol,’’ the name of the spe-
(B) ‘‘Insoluble fiber’’ (VOLUNTARY): cific sugar alcohol (e.g., ‘‘xylitol’’)
A statement of the number of grams of present in the food may be used in the
insoluble dietary fiber in a serving may nutrition label provided that only one
be declared voluntarily except that sugar alcohol is present in the food.

when a claim is made on the label or in Sugar alcohol content shall be in-
labeling about insoluble fiber, label dented and expressed to the nearest
30
gram, except that if a serving contains Value (DRV) or Reference Daily Intake
less than 1 gram, the statement ‘‘Con- (RDI), as appropriate, for protein and
tains less then 1 gram’’ or ‘‘less than 1 expressed as Percent of Daily Value.
gram’’ may be used as an alternative, When the protein quality in a food as
and if the serving contains less than 0.5 measured by the Protein Efficiency
gram, the content may be expressed as Ratio (PER) is less than 40 percent of
zero. the reference standard (casein) for a
(iv) ‘‘Other carbohydrate’’ (VOL- food represented or purported to be for
UNTARY): A statement of the number infants, the statement ‘‘not a signifi-
of grams of other carbohydrates may cant source of protein’’ shall be placed
be declared voluntarily. Other carbo- adjacent to the declaration of protein
hydrates shall be defined as the dif- content. Protein content may be cal-
ference between total carbohydrate and culated on the basis of the factor of 6.25
the sum of dietary fiber, sugars, and times the nitrogen content of the food
sugar alcohol, except that if sugar al- as determined by the appropriate
cohol is not declared (even if present), method of analysis as given in the ‘‘Of-
it shall be defined as the difference be- ficial Methods of Analysis of the AOAC
tween total carbohydrate and the sum International’’ (formerly the Associa-
of dietary fiber and sugars. Other car- tion of Official Analytical Chemists),
bohydrate content shall be indented 15th Ed. (1990), which is incorporated
and expressed to the nearest gram, ex- by reference in accordance with 5
cept that if a serving contains less U.S.C. 552(a) and 1 CFR part 51, except
than 1 gram, the statement ‘‘Contains when the official procedure for a spe-
less than 1 gram’’ or ‘‘less than 1 cific food requires another factor. Cop-
gram’’ may be used as an alternative, ies may be obtained from AOAC
and if the serving contains less than 0.5 INTERNATIONAL, 481 North Frederick
gram, the content may be expressed as Ave., suite 500, Gaithersburg, MD 20877,
zero. or may be inspected at the National
(7) ‘‘Protein’’: A statement of the Archives and Records Administration
number of grams of protein in a serv- (NARA). For information on the avail-
ing, expressed to the nearest gram, ex- ability of this material at NARA, call
cept that if a serving contains less 202–741–6030, or go to: http://
than 1 gram, the statement ‘‘Contains www.archives.gov/federallregister/
less than 1 gram’’ or ‘‘less than 1 codeloflfederallregulations/
gram’’ may be used as an alternative, ibrllocations.html.
and if the serving contains less than 0.5 (i) A statement of the corrected
gram, the content may be expressed as amount of protein per serving, as de-
zero. When the protein in foods rep- termined in paragraph (c)(7)(ii) of this
resented or purported to be for adults section, calculated as a percentage of
and children 4 or more years of age has the RDI or DRV for protein, as appro-
a protein quality value that is a propriate, and expressed as Percent of
tein digestibility-corrected amino acid Daily Value, may be placed on the
score of less than 20 expressed as a per- label, except that such a statement
cent, or when the protein in a food rep- shall be given if a protein claim is
resented or purported to be for children made for the product, or if the product
greater than 1 but less than 4 years of is represented or purported to be for
age has a protein quality value that is use by infants or children under 4 years
a protein digestibility-corrected amino of age. When such a declaration is pro-
acid score of less than 40 expressed as a vided, it shall be placed on the label
percent, either of the following shall be adjacent to the statement of grams of
placed adjacent to the declaration of protein and aligned under the column
protein content by weight: The state- headed ‘‘Percent Daily Value,’’ and ex-
ment ‘‘not a significant source of pro- pressed to the nearest whole percent.
tein,’’ or a listing aligned under the However, the percentage of the RDI for
column headed ‘‘Percent Daily Value’’ protein shall not be declared if the food
of the corrected amount of protein per is represented or purported to be for
serving, as determined in paragraph use by infants and the protein quality

(c)(7)(ii) of this section, calculated as a value is less than 40 percent of the ref-
percentage of the Daily Reference erence standard.
31
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
(ii) The ‘‘corrected amount of protein 14 grams, 60 grams, and 65 grams, re-
(gram) per serving’’ for foods rep- spectively.
resented or purported for adults and (8) Vitamins and minerals: A state-
children 1 or more years of age is equal ment of the amount per serving of the
to the actual amount of protein (gram) vitamins and minerals as described in
per serving multiplied by the amino this paragraph, calculated as a percent
acid score corrected for protein digest- of the RDI and expressed as percent of
ibility. If the corrected score is above Daily Value.
1.00, then it shall be set at 1.00. The (i) For purposes of declaration of per-
protein digestibility-corrected amino cent of Daily Value as provided for in
acid score shall be determined by paragraphs (d), (e), and (f) of this sec-
methods given in sections 5.4.1, 7.2.1, tion, foods represented or purported to
and 8.00 in ‘‘Protein Quality Evalua- be for use by infants, children less than
tion, Report of the Joint FAO/WHO Ex- 4 years of age, pregnant women, or lac-
pert Consultation on Protein Quality tating women shall use the RDI’s that
Evaluation,’’ Rome, 1990, except that are specified for the intended group.
when official AOAC procedures de- For foods represented or purported to
scribed in section (c)(7) of this para- be for use by both infants and children
graph require a specific food factor under 4 years of age, the percent of
other than 6.25, that specific factor Daily Value shall be presented by sepa-
shall be used. The ‘‘Report of the Joint rate declarations according to para-
FAO/WHO Expert Consultation on Pro- graph (e) of this section based on the
tein Quality Evaluation’’ as published RDI values for infants from birth to 12
by the Food and Agriculture Organiza- months of age and for children under 4
tion of the United Nations/World years of age. Similarly, the percent of
Health Organization is incorporated by Daily Value based on both the RDI val-
reference in accordance with 5 U.S.C. ues for pregnant women and for lac-
552(a) and 1 CFR part 51. Copies are tating women shall be declared sepa-
available from the Center for Food rately on foods represented or pur-
Safety and Applied Nutrition (HFS– ported to be for use by both pregnant
800), Food and Drug Administration, and lactating women. When such dual
5100 Paint Branch Pkwy., College Park, declaration is used on any label, it
MD 20740, or may be inspected at the shall be included in all labeling, and
National Archives and Records Admin- equal prominence shall be given to
istration (NARA). For information on both values in all such labeling. All
the availability of this material at other foods shall use the RDI for adults
NARA, call 202–741–6030, or go to: http:// and children 4 or more years of age.
www.archives.gov/federallregister/ (ii) The declaration of vitamins and
codeloflfederallregulations/ minerals as a percent of the RDI shall
ibrllocations.html. For foods rep- include vitamin A, vitamin C, calcium,
resented or purported for infants, the and iron, in that order, and shall in-
corrected amount of protein (grams) clude any of the other vitamins and
per serving is equal to the actual minerals listed in paragraph (c)(8)(iv)
amount of protein (grams) per serving of this section when they are added as
multiplied by the relative protein qual- a nutrient supplement, or when a claim
ity value. The relative protein quality is made about them. Other vitamins
value shall be determined by dividing and minerals need not be declared if
the subject food protein PER value by neither the nutrient nor the compo-
the PER value for casein. If the rel- nent is otherwise referred to on the
ative protein value is above 1.00, it label or in labeling or advertising and
shall be set at 1.00. the vitamins and minerals are:
(iii) For the purpose of labeling with (A) Required or permitted in a stand-
a percent of the Daily Reference Value ardized food (e.g., thiamin, riboflavin,
(DRV) or RDI, a value of 50 grams of and niacin in enriched flour) and that
protein shall be the DRV for adults and standardized food is included as an in-
children 4 or more years of age, and the gredient (i.e., component) in another
RDI for protein for children less than 4 food; or

years of age, infants, pregnant women, (B) Included in a food solely for tech-
and lactating women shall be 16 grams, nological purposes and declared only in
32
the ingredient statement. The declara- Biotin, 300 micrograms

tion may also include any of the other Pantothenic acid, 10 milligrams
vitamins and minerals listed in para- Phosphorus, 1,000 milligrams
graph (c)(8)(iv) of this section when Iodine, 150 micrograms
Magnesium, 400 milligrams
they are naturally occurring in the Zinc, 15 milligrams
food. The additional vitamins and min- Selenium, 70 micrograms
erals shall be listed in the order estab- Copper, 2.0 milligrams
lished in paragraph (c)(8)(iv) of this Manganese, 2.0 milligrams
section. Chromium, 120 micrograms
(iii) The percentages for vitamins Molybdenum, 75 micrograms
and minerals shall be expressed to the Chloride, 3,400 milligrams
nearest 2-percent increment up to and (v) The following synonyms may be
including the 10-percent level, the added in parentheses immediately fol-
nearest 5-percent increment above 10 lowing the name of the nutrient or die-
percent and up to and including the 50- tary component:
percent level, and the nearest 10-per-
cent increment above the 50-percent Calories—Energy
level. Amounts of vitamins and min- Vitamin C—Ascorbic acid
erals present at less than 2 percent of Thiamin—Vitamin B1
Riboflavin—Vitamin B2
the RDI are not required to be declared
Folate—Folic acid or Folacin.
in nutrition labeling but may be de- Alternatively, folic acid or folacin may be
clared by a zero or by the use of an as- listed without parentheses in place of
terisk (or other symbol) that refers to folate.
another asterisk (or symbol) that is
placed at the bottom of the table and (vi) A statement of the percent of vi-
that is followed by the statement tamin A that is present as beta-caro-
‘‘Contains less than 2 percent of the tene may be declared voluntarily.
Daily Value of this (these) nutrient When the vitamins and minerals are
(nutrients)’’ or ‘‘Contains <2 percent of listed in a single column, the state-
the Daily Value of this (these) nutrient ment shall be indented under the infor-
(nutrients).’’ Alternatively, except as mation on vitamin A. When vitamins
provided for in paragraph (f) of this and minerals are arrayed horizontally,
section, if vitamin A, vitamin C, cal- the statement of percent shall be pre-
cium, or iron is present in amounts less sented in parenthesis following the dec-
than 2 percent of the RDI, label declaration of vitamin A and the percent
laration of the nutrient(s) is not re- DV of vitamin A in the food (e.g.,
quired if the statement ‘‘Not a signifi- ‘‘Percent Daily Value: Vitamin A 50 (90
cant source of l (listing the vitamins percent as beta-carotene)’’). When de-
or minerals omitted)’’ is placed at the clared, the percentages shall be ex-
bottom of the table of nutrient values. pressed in the same increments as are
Either statement shall be in the same provided for vitamins and minerals in
type size as nutrients that are in- paragraph (c)(8)(iii) of this section.
dented. (9) For the purpose of labeling with a
(iv) The following RDI’s and nomen- percent of the DRV, the following
clature are established for the fol- DRV’s are established for the following
lowing vitamins and minerals which food components based on the reference
are essential in human nutrition: caloric intake of 2,000 calories:
Vitamin A, 5,000 International Units Unit of measure-
Food component DRV
ment
Vitamin C, 60 milligrams
Calcium, 1,000 milligrams Fat ....................................... gram (g) ............... 65
Iron, 18 milligrams Saturated fatty acids ........... do ......................... 20
Vitamin D, 400 International Units Cholesterol .......................... milligrams (mg) .... 300
Vitamin E, 30 International Units Total carbohydrate .............. grams (g) ............. 300
Vitamin K, 80 micrograms Fiber .................................... do ......................... 25
Thiamin, 1.5 milligrams Sodium ................................ milligrams (mg) .... 2,400
Riboflavin, 1.7 milligrams Potassium ........................... do ......................... 3,500
Niacin, 20 milligrams Protein ................................. grams (g) ............. 50
Vitamin B6, 2.0 milligrams

Folate, 400 micrograms (d)(1) Nutrient information specified
Vitamin B12, 6 micrograms in paragraph (c) of this section shall be
33
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
presented on foods in the following for- tion (i.e., ‘‘Calories,’’ ‘‘Total Fat,’’
mat, as shown in paragraph (d)(12) of ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total Car-
this section, except on foods on which bohydrate,’’ and ‘‘Protein’’), and the
dual columns of nutrition information percentage amounts required by para-
are declared as provided for in paragraph (d)(7)(ii) of this section shall be
graph (e) of this section, on those food highlighted by bold or extra bold type
products on which the simplified for- or other highlighting (reverse printing
mat is required to be used as provided is not permitted as a form of high-
for in paragraph (f) of this section, on lighting) that prominently distin-
foods for infants and children less than guishes it from other information. No
4 years of age as provided for in para- other information shall be highlighted.
graph (j)(5) of this section, and on foods (v) A hairline rule that is centered
in small or intermediate-sized pack- between the lines of text shall separate
ages as provided for in paragraph (j)(13) ‘‘Amount Per Serving’’ from the cal-
of this section. In the interest of uni- orie statements required in paragraph
formity of presentation, FDA urges (d)(5) of this section and shall separate
that the nutrition information be pre- each nutrient and its corresponding
sented using the graphic specifications percent Daily Value required in para-
set forth in appendix B to part 101. graphs (d)(7)(i) and (d)(7)(ii) of this sec-
(i) The nutrition information shall be tion from the nutrient and percent
set off in a box by use of hairlines and Daily Value above and below it, as
shall be all black or one color type, shown in paragraph (d)(12) of this sec-
printed on a white or other neutral tion.
contrasting background whenever prac- (2) The information shall be pre-
tical. sented under the identifying heading of
(ii) All information within the nutri- ‘‘Nutrition Facts’’ which shall be set in
tion label shall utilize: a type size larger than all other print
(A) Except as provided for in para- size in the nutrition label and, except
graph (c)(2)(ii) of this section, a single for labels presented according to the
easy-to-read type style, format provided for in paragraph (d)(11)
(B) Upper and lower case letters, of this section, unless impractical,
(C) At least one point leading (i.e., shall be set the full width of the infor-
space between two lines of text) except mation provided under paragraph (d)(7)
that at least four points leading shall of this section, as shown in paragraph
be utilized for the information required (d)(12) of this section.
by paragraphs (d)(7) and (d)(8) of this (3) Information on serving size shall
section as shown in paragraph (d)(12), immediately follow the heading as
and shown in paragraph (d)(12) of this sec-
(D) Letters should never touch. tion. Such information shall include:
(iii) Information required in para- (i) ‘‘Serving Size’’: A statement of
graphs (d)(3), (d)(5), (d)(7), and (d)(8) of the serving size as specified in para-
this section shall be in type size no graph (b)(7) of this section.
smaller than 8 point. Except for the (ii) ‘‘Servings Per Container’’: The
heading ‘‘Nutrition Facts,’’ the infor- number of servings per container, ex-
mation required in paragraphs (d)(4), cept that this statement is not re-
(d)(6), and (d)(9) of this section and all quired on single serving containers as
other information contained within the defined in paragraph (b)(6) of this sec-
nutrition label shall be in type size no tion or on other food containers when
smaller than 6 point. When provided, this information is stated in the net
the information described in paragraph quantity of contents declaration.
(d)(10) of this section shall also be in (4) A subheading ‘‘Amount Per Serv-
type no smaller than 6 point. ing’’ shall be separated from serving
(iv) The headings required by para- size information by a bar as shown in
graphs (d)(2), (d)(4), and (d)(6) of this paragraph (d)(12) of this section.
section (i.e., ‘‘Nutrition Facts,’’ (5) Information on calories shall im-
‘‘Amount per Serving,’’ and ‘‘% Daily mediately follow the heading ‘‘Amount
Value*’’), the names of all nutrients Per Serving’’ and shall be declared in
that are not indented according to re- one line, leaving sufficient space be-
quirements of paragraph (c) of this sec- tween the declaration of ‘‘Calories’’
34
and ‘‘Calories from fat’’ to allow clear as specified in paragraph (c)(7)(ii) of

differentiation, or, if ‘‘Calories from this section. The numerical value shall
saturated fat’’ is declared, in a column be followed by the symbol for percent
with total ‘‘Calories’’ at the top, fol- (i.e., %).
lowed by ‘‘Calories from fat’’ (in- (8) Nutrient information for vitamins
dented), and ‘‘Calories from saturated and minerals shall be separated from
fat’’ (indented). information on other nutrients by a
(6) The column heading ‘‘% Daily bar and shall be arrayed horizontally
Value,’’ followed by an asterisk (e.g., (e.g., Vitamin A 4%, Vitamin C 2%,
‘‘% Daily Value*’’), shall be separated Calcium 15%, Iron 4%) or may be listed
from information on calories by a bar in two columns as shown in paragraph
as shown in paragraph (d)(12) of this (d)(12) of this section, except that when
section. The position of this column more than four vitamins and minerals
heading shall allow for a list of nutri- are declared, they may be declared
ent names and amounts as described in vertically with percentages listed
paragraph (d)(7) of this section to be to under the column headed ‘‘% Daily
the left of, and below, this column Value.’’
heading. The column headings ‘‘Per-
(9) A footnote, preceded by an aster-
cent Daily Value,’’ ‘‘Percent DV,’’ or
isk, shall be placed beneath the list of
‘‘% DV’’ may be substituted for ‘‘%
vitamins and minerals and shall be sep-
Daily Value.’’
(7) Except as provided for in para- arated from that list by a hairline.
graph (j)(13) of this section, nutrient (i) The footnote shall state:
information for both mandatory and Percent Daily Values are based on a
any voluntary nutrients listed in para- 2,000 calorie diet.
graph (c) of this section that are to be Your daily values may be higher or
declared in the nutrition label, except lower depending on your calorie needs.
vitamins and minerals, shall be de-
Calories: 2,000 2,500
clared as follows:
(i) The name of each nutrient, as Total fat ....................... Less than 65 g 80 g
specified in paragraph (c) of this sec- Saturated fat ................ Less than 20 g 25 g
tion, shall be given in a column and Cholesterol .................. Less than 300 mg 300 mg
followed immediately by the quan- Sodium ........................ Less than 2,400 mg 2,400 mg
Total carbohydrate ...... 300 g 375 g
titative amount by weight for that nu- Dietary fiber ................. 25 g 30 g
trient appended with a ‘‘g’’ for grams
or a ‘‘mg’’ for milligrams as shown in
(ii) If the percent of Daily Value is
paragraph (d)(12) of this section. The
given for protein in the Percent of
symbol ‘‘<’’ may be used in place of
Daily Value column as provided in
‘‘less than.’’
paragraph (d)(7)(ii) of this section, pro-
(ii) A listing of the percent of the
tein shall be listed under dietary fiber,
DRV as established in paragraphs
and a value of 50 g shall be inserted on
(c)(7)(iii) and (c)(9) of this section shall
the same line in the column headed
be given in a column aligned under the
heading ‘‘% Daily Value’’ established ‘‘2,000’’ and a value of 65 g in the col-
in paragraph (d)(6) of this section with umn headed ‘‘2,500’’.
the percent expressed to the nearest (iii) If potassium is declared in the
whole percent for each nutrient de- column described in paragraph (d)(7)(i)
clared in the column described in para- of this section, potassium shall be list-
graph (d)(7)(i) of this section for which ed under sodium and the DRV estab-
a DRV has been established, except lished in paragraph (c)(9) of this sec-
that the percent for protein may be tion shall be inserted on the same line
omitted as provided in paragraph (c)(7) in the numeric columns.
of this section. The percent shall be (iv) The abbreviations established in
calculated by dividing either the paragraph (j)(13)(ii)(B) of this section
amount declared on the label for each may be used within the footnote.
nutrient or the actual amount of each (10) Caloric conversion information
nutrient (i.e., before rounding) by the on a per gram basis for fat, carbo-
DRV for the nutrient, except that the hydrate, and protein may be presented
percent for protein shall be calculated beneath the information required in
35
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
paragraph (d)(9) of this section, sepa- (ii) If the space beneath the manda-
rated from that information by a hair- tory declaration of iron is not adequate
line. This information may be pre- to accommodate any remaining vita-
sented horizontally as shown in para- mins and minerals to be declared or the
graph (d)(12) of this section (i.e., ‘‘Cal- information required in paragraph
ories per gram: fat 9, carbohydrate 4, (d)(9) of this section, the remaining in-
protein 4’’) or vertically in columns. formation may be moved to the right
(11)(i) If the space beneath the infor- and set off by a line that distinguishes
mation on vitamins and minerals is not it and sets it apart from the nutrients
adequate to accommodate the informa- and the percent DV information given
to the left. The caloric conversion in-
tion required in paragraph (d)(9) of this
formation provided for in paragraph
section, the information required in
(d)(10) of this section may be presented
paragraph (d)(9) may be moved to the beneath either side or along the full
right of the column required in para- length of the nutrition label.
graph (d)(7)(ii) of this section and set (iii) If there is not sufficient contin-
off by a line that distinguishes it and uous vertical space (i.e., approximately
sets it apart from the percent Daily 3 in) to accommodate the required
Value information. The caloric conver- components of the nutrition label up to
sion information provided for in para- and including the mandatory declara-
graph (d)(10) of this section may be pre- tion of iron, the nutrition label may be
sented beneath either side or along the presented in a tabular display as shown
full length of the nutrition label. below.
36
ER11JY03.000</GPH>
(12) The following sample label illus- (13)(i) Nutrition labels on the outer
trates the provisions of paragraph (d) label of packages of products that con-
of this section. tain two or more separately packaged
foods that are intended to be eaten in-
dividually (e.g., variety packs of cere-
als or snack foods) or of packages that
are used interchangeably for the same
type of food (e.g., round ice cream con-
tainers) may use an aggregate display.
(ii) Aggregate displays shall comply
with the format requirements of para-
graph (d) of this section to the max-
imum extent possible, except that the
identity of each food shall be specified
immediately under the ‘‘Nutrition
Facts’’ title, and both the quantitative
amount by weight (i.e., g/mg amounts)
and the percent Daily Value for each
nutrient shall be listed in separate col-
umns under the name of each food. The
following sample label illustrates an
aggregate display.
37
ER11JY03.001</GPH>
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
(14) In accordance with § 101.15(c)(2), (b) of this section, or for two or more
when nutrition labeling must appear in groups for which RDI’s are established
a second language, the nutrition infor- (e.g., both infants and children less
mation may be presented in a separate than 4 years of age) as shown in para-
nutrition label for each language or in graph (e)(5) of this section. When such
one nutrition label with the informa- dual labeling is provided, equal promi-
tion in the second language following nence shall be given to both sets of val-
that in English. Numeric characters ues. Information shall be presented in a
that are identical in both languages format consistent with paragraph (d) of
need not be repeated (e.g., ‘‘Protein/ this section, except that:
Proteinas 2 g’’). All required informa- (1) Following the subheading of
tion must be included in both lan- ‘‘Amount Per Serving,’’ there shall be
guages. two or more column headings accu-
(e) Nutrition information may be pre- rately describing the forms of the same
sented for two or more forms of the food (e.g., ‘‘Mix’’ and ‘‘Baked’’), the
same food (e.g., both ‘‘as purchased’’ combinations of food, the units, or the
and ‘‘as prepared’’) or for common com- RDI groups that are being declared.
binations of food as provided for in The column representing the product
paragraph (h)(4) of this section, for dif- as packaged and according to the label
ferent units (e.g., slices of bread or per
serving size based on the reference
100 grams) as provided for in paragraph
38
ER11JY03.002</GPH>
amount in § 101.12(b) shall be to the left (B) If such additional quantitative in-
of the numeric columns. formation is given in a footnote, it
(2) When the dual labeling is pre- shall be declared in the same order as
sented for two or more forms of the the nutrients are listed in the nutri-
same food, for combinations of food, or tion label. The additional quantitative
for different units, total calories and information may state the total nutri-
calories from fat (and calories from ent content of the product identified in
saturated fat, when declared) shall be the second column or the nutrient
listed in a column and indented as
amounts added to the product as pack-
specified in paragraph (d)(5) of this sec-
aged for only those nutrients that are
tion with quantitative amounts de-
clared in columns aligned under the present in different amounts than the
column headings set forth in paragraph amounts declared in the required quan-
(e)(1) of this section. titative information. The footnote
(3) Quantitative information by shall clearly identify which amounts
weight required in paragraph (d)(7)(i) of are declared. Any subcomponents de-
this section shall be specified for the clared shall be listed parenthetically
form of the product as packaged and after principal components (e.g., 1⁄2 cup
according to the label serving size skim milk contributes an additional 40
based on the reference amount in calories, 65 mg sodium, 6 g total carbo-
§ 101.12(b). hydrate (6 g sugars), and 4 g protein).
(i) Quantitative information by (ii) Total fat and its quantitative
weight may be included for other forms amount by weight shall be followed by
of the product represented by the addi- an asterisk (or other symbol) (e.g.,
tional column(s) either immediately ‘‘Total fat (2 g)*’’) referring to another
adjacent to the required quantitative asterisk (or symbol) at the bottom of
information by weight for the product the nutrition label identifying the
as packaged and according to the label form(s) of the product for which quan-
serving size based on the reference
titative information is presented.
amount in § 101.12(b) or as a footnote.
(A) If such additional quantitative (4) Information required in para-
information is given immediately adja- graphs (d)(7)(ii) and (d)(8) of this sec-
cent to the required quantitative infor- tion shall be presented under the sub-
mation, it shall be declared for all nu- heading ‘‘% DAILY VALUE’’ and in
trients listed and placed immediately columns directly under the column
following and differentiated from the headings set forth in paragraph (e)(1) of
required quantitative information this section.
(e.g., separated by a comma). Such in- (5) The following sample label illus-
formation shall not be put in a sepa- trates the provisions of paragraph (e)
rate column. of this section:
39
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
(f) The declaration of nutrition infor- dietary fiber, sugars, protein, vitamin
mation may be presented in the sim- A, vitamin C, calcium, and iron.
plified format set forth herein when a (1) An ‘‘insignificant amount’’ shall
food product contains insignificant be defined as that amount that allows
amounts of eight or more of the fol- a declaration of zero in nutrition label-
lowing: Calories, total fat, saturated ing, except that for total carbohydrate,
fat, trans fat, cholesterol, sodium, total dietary fiber, and protein, it shall be an
carbohydrate, dietary fiber, sugars, amount that allows a declaration of
protein, vitamin A, vitamin C, calcium, ‘‘less than 1 gram.’’
and iron; except that for foods intended (2) The simplified format shall in-
for children less than 2 years of age to clude information on the following nu-
which § 101.9(j)(5)(i) applies, nutrition trients:
information may be presented in the (i) Total calories, total fat, total car-
simplified format when a food product bohydrate, protein, and sodium;
contains insignificant amounts of six (ii) Calories from fat and any other
or more of the following: Calories, nutrients identified in paragraph (f) of
total fat, sodium, total carbohydrate, this section that are present in the
40
ER11JY03.003</GPH>
food in more than insignificant a lot. Unless a particular method of

amounts; and analysis is specified in paragraph (c) of
(iii) Any vitamins and minerals list- this section, composites shall be ana-
ed in paragraph (c)(8)(iv) of this section lyzed by appropriate methods as given
when they are required to be added as in the ‘‘Official Methods of Analysis of
a nutrient supplement to foods for the AOAC International,’’ 15th Ed.
which a standard of identity exists. (1990), which is incorporated by ref-
(iv) Any vitamins or minerals listed erence in accordance with 5 U.S.C.
in paragraph (c)(8)(iv) of this section 552(a) or 1 CFR part 51 or, if no AOAC
voluntarily added to the food as nutri- method is available or appropriate, by
ent supplements. other reliable and appropriate analyt-
(3) Other nutrients that are naturally ical procedures. The availability of this
present in the food in more than insig- incorporation by reference is given in
nificant amounts may be voluntarily paragraph (c)(7) of this section.
declared as part of the simplified for- (3) Two classes of nutrients are de-
mat. fined for purposes of compliance:
(4) If any nutrients are declared as (i) Class I. Added nutrients in for-
provided in paragraphs (f)(2)(iii), tified or fabricated foods; and
(f)(2)(iv), or (f)(3) of this section as part (ii) Class II. Naturally occurring (in-
of the simplified format or if any nutri- digenous) nutrients. If any ingredient
tion claims are made on the label or in which contains a naturally occurring
labeling, the statement ‘‘Not a signifi- (indigenous) nutrient is added to a
cant source of lll’’ (with the blank food, the total amount of such nutrient
filled in with the name(s) of any nutri- in the final food product is subject to
ent(s) identified in § 101.9(f) and cal- class II requirements unless the same
ories from fat that are present in insig- nutrient is also added.
nificant amounts) shall be included at (4) A food with a label declaration of
the bottom of the nutrition label. a vitamin, mineral, protein, total car-
(5) Except as provided for in para- bohydrate, dietary fiber, other carbo-
graphs (j)(5) and (j)(13) of this section, hydrate, polyunsaturated or
nutrient information declared in the monounsaturated fat, or potassium
simplified format shall be presented in shall be deemed to be misbranded
the same manner as specified in para- under section 403(a) of the Federal
graphs (d) or (e) of this section, except Food, Drug, and Cosmetic Act (the act)
that the footnote required in paragraph unless it meets the following require-
(d)(9) of this section is not required. ments:
When the footnote is omitted, an aster- (i) Class I vitamin, mineral, protein, di-
isk shall be placed at the bottom of the etary fiber, or potassium. The nutrient
label followed by the statement ‘‘Per- content of the composite is at least
cent Daily Values are based on a 2,000 equal to the value for that nutrient de-
calorie diet’’ and, if the term ‘‘Daily clared on the label.
Value’’ is not spelled out in the head- (ii) Class II vitamin, mineral, protein,
ing, a statement that ‘‘DV’’ represents total carbohydrate, dietary fiber, other
‘‘Daily Value.’’ carbohydrate, polyunsaturated or
(g) Compliance with this section monounsaturated fat, or potassium. The
shall be determined as follows: nutrient content of the composite is at
(1) A collection of primary containers least equal to 80 percent of the value
or units of the same size, type, and for that nutrient declared on the label.
style produced under conditions as Provided, That no regulatory action
nearly uniform as possible, designated will be based on a determination of a
by a common container code or mark- nutrient value that falls below this
ing, or in the absence of any common level by a factor less than the varia-
container code or marking, a day’s pro- bility generally recognized for the ana-
duction, constitutes a ‘‘lot.’’ lytical method used in that food at the
(2) The sample for nutrient analysis level involved.
shall consist of a composite of 12 sub- (5) A food with a label declaration of
samples (consumer units), taken 1 from calories, sugars, total fat, saturated
each of 12 different randomly chosen fat, trans fat, cholesterol, or sodium
shipping cases, to be representative of shall be deemed to be misbranded
41
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
under section 403(a) of the act if the (9) When it is not technologically fea-
nutrient content of the composite is sible, or some other circumstance
greater than 20 percent in excess of the makes it impracticable, for firms to
value for that nutrient declared on the comply with the requirements of this
label. Provided, That no regulatory ac- section (e.g., to develop adequate nutri-
tion will be based on a determination ent profiles to comply with the require-
of a nutrient value that falls above this ments of paragraph (c) of this section),
level by a factor less than the varia- FDA may permit alternative means of
bility generally recognized for the ana- compliance or additional exemptions
lytical method used in that food at the to deal with the situation. Firms in
level involved. need of such special allowances shall
(6) Reasonable excesses of a vitamin, make their request in writing to the
mineral, protein, total carbohydrate, Center for Food Safety and Applied Nu-
dietary fiber, other carbohydrate, poly- trition (HFS–800), Food and Drug Ad-
unsaturated or monounsaturated fat, ministration, 5100 Paint Branch Pkwy.,
or potassium over labeled amounts are College Park, MD 20740.
acceptable within current good manu- (h) Products with separately pack-
facturing practice. Reasonable defi- aged ingredients or foods, with assort-
ciencies of calories, sugars, total fat, ments of food, or to which other ingre-
saturated fat, trans fat, cholesterol, or dients are added by the user may be la-
sodium under labeled amounts are ac- beled as follows:
ceptable within current good manufac- (1) If a product consists of two or
turing practice. more separately packaged ingredients
(7) Compliance will be based on the enclosed in an outer container or of as-
metric measure specified in the label sortments of the same type of food
statement of serving size. (e.g., assorted nuts or candy mixtures)
(8) Compliance with the provisions in the same retail package, nutrition
set forth in paragraphs (g)(1) through labeling shall be located on the outer
(g)(6) of this section may be provided container or retail package (as the case
by use of an FDA approved data base may be) to provide information for the
that has been computed following FDA consumer at the point of purchase.
guideline procedures and where food However, when two or more food prod-
samples have been handled in accord- ucts are simply combined together in
ance with current good manufacturing such a manner that no outer container
practice to prevent nutrition loss. FDA is used, or no outer label is available,
approval of a data base shall not be each product shall have its own nutri-
considered granted until the Center for tion information, e.g., two boxes taped
Food Safety and Applied Nutrition has together or two cans combined in a
agreed to all aspects of the data base in clear plastic overwrap. When sepa-
writing. The approval will be granted rately packaged ingredients or assort-
where a clear need is presented (e.g., ments of the same type of food are in-
raw produce and seafood). Approvals tended to be eaten at the same time,
will be in effect for a limited time, e.g., the nutrition information may be spec-
10 years, and will be eligible for re- ified per serving for each component or
newal in the absence of significant as a composite value.
changes in agricultural or industry (2) If a product consists of two or
practices. Approval requests shall be more separately packaged foods that
submitted in accordance with the pro- are intended to be eaten individually
visions of § 10.30 of this chapter. Guid- and that are enclosed in an outer con-
ance in the use of data bases may be tainer (e.g., variety packs of cereals or
found in the ‘‘FDA Nutrition Labeling snack foods), the nutrition information
Manual—A Guide for Developing and shall:
Using Data Bases,’’ available from the (i) Be specified per serving for each
Office of Nutritional Products, Label- food in a location that is clearly visible
ing and Dietary Supplements (HFS– to the consumer at the point of pur-
800), Center for Food Safety and Ap- chase; and
plied Nutrition, Food and Drug Admin- (ii) Be presented in separate nutri-
istration, 5100 Paint Branch Pkwy., tion labels or in one aggregate nutri-
College Park, MD 20740. tion label with separate columns for
42
the quantitative amount by weight and mation under paragraph (h) of this sec-
the percent Daily Value for each food. tion if it is not specifically listed in a
(3) If a package contains a variety of promotional catalogue as being present
foods, or an assortment of foods, and is in the gift package, and:
in a form intended to be used as a gift, (A) It is used in small quantities pri-
the nutrition labeling shall be in the marily to enhance the appearance of
form required by paragraphs (a) the gift package; or
through (f) of this section, but it may (B) It is included in the gift package
be modified as follows: as a free gift or promotional item.
(i) Nutrition information may be pre- (4) If a food is commonly combined
sented on the label of the outer pack- with other ingredients or is cooked or
age or in labeling within or attached to otherwise prepared before eating, and
the outer package. directions for such combination or
(ii) In the absence of a reference preparations are provided, another col-
amount customarily consumed in umn of figures may be used to declare
§ 101.12(b) that is appropriate for the nutrition information on the basis of
variety or assortment of foods in a gift the food as consumed in the format re-
package, 1 ounce for solid foods, 2 fluid quired in paragraph (e) of this section
ounces for nonbeverage liquids (e.g., (e.g., a dry ready-to-eat cereal may be
syrups), and 8 fluid ounces for bev- described with one set of Percent Daily
erages may be used as the standard Values for the cereal as sold (e.g., per
serving size for purposes of nutrition ounce), and another set for the cereal
labeling of foods subject to this para- and milk as suggested in the label (e.g.,
graph. However, the reference amounts per ounce of cereal and 1⁄2 cup of vita-
customarily consumed in § 101.12(b) min D fortified skim milk); and a cake
shall be used for purposes of evaluating mix may be labeled with one set of Per-
whether individual foods in a gift pack- cent Daily Values for the dry mix (per
age qualify for nutrient content claims serving) and another set for the serving
or health claims. of the final cake when prepared): Pro-
(iii) The number of servings per con- vided, That, the type and quantity of
tainer may be stated as ‘‘varied.’’ the other ingredients to be added to
(iv) Nutrition information may be the product by the user and the specific
provided per serving for individual method of cooking and other prepara-
foods in the package, or, alternatively, tion shall be specified prominently on
as a composite per serving for reason- the label.
able categories of foods in the package (i) Except as provided in paragraphs
having similar dietary uses and similar (j)(13) and (j)(17) of this section, the lo-
significant nutritional characteristics. cation of nutrition information on a
Reasonable categories of foods may be label shall be in compliance with
used only if accepted by FDA. In deter- § 101.2.
mining whether a proposed category is (j) The following foods are exempt
reasonable, FDA will consider whether from this section or are subject to spe-
the values of the characterizing nutri- cial labeling requirements:
ents in the foods proposed to be in the (1)(i) Food offered for sale by a person
category meet the compliance criteria who makes direct sales to consumers
set forth in paragraphs (g)(3) through (e.g., a retailer) who has annual gross
(g)(6) of this section. Proposals for such sales made or business done in sales to
categories may be submitted in writing consumers that is not more than
to the Office of Nutritional Products, $500,000 or has annual gross sales made
Labeling and Dietary Supplements or business done in sales of food to con-
(HFS–800), Center for Food Safety and sumers of not more than $50,000, Pro-
Applied Nutrition, Food and Drug Ad- vided, That the food bears no nutrition
ministration, 5100 Paint Branch Pkwy., claims or other nutrition information
College Park, MD 20740. in any context on the label or in label-
(v) If a food subject to paragraph ing or advertising. Claims or other nu-
(j)(13) of this section because of its trition information subject the food to
small size is contained in a gift pack- the provisions of this section.

age, the food need not be included in (ii) For purposes of this paragraph,
the determination of nutrition infor- calculation of the amount of sales shall
43
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
be based on the most recent 2-year av- (v) Sold by a distributor who prin-
erage of business activity. Where firms cipally sells food to such facilities: Pro-
have been in business less than 2 years, vided, That:
reasonable estimates must indicate (A) This exemption shall not be
that annual sales will not exceed the available for those foods that are man-
amounts specified. For foreign firms ufactured, processed, or repackaged by
that ship foods into the United States, that distributor for sale to any persons
the business activities to be included other than restaurants or other estab-
shall be the total amount of food sales, lishments that serve food for imme-
as well as other sales to consumers, by diate human consumption, and
the firm in the United States. (B) The manufacturer of such prod-
(2) Food products which are: ucts is responsible for providing the
nutrition information on the products
(i) Served in restaurants, Provided,
if there is a reasonable possibility that
That the food bears no nutrition claims
the product will be purchased directly
or other nutrition information in any by consumers.
context on the label or in labeling or (3) Food products that are:
advertising. Claims or other nutrition (i) Of the type of food described in
information subject the food to the paragraphs (j)(2)(i) and (j)(2)(ii) of this
provisions of this section; section,
(ii) Served in other establishments in (ii) Ready for human consumption,
which food is served for immediate (iii) Offered for sale to consumers but
human consumption (e.g., institutional not for immediate human consump-
food service establishments, such as tion,
schools, hospitals, and cafeterias; (iv) Processed and prepared primarily
transportation carriers, such as trains in a retail establishment, and
and airplanes; bakeries, delicatessens, (v) Not offered for sale outside of
and retail confectionery stores where that establishment (e.g., ready-to-eat
there are facilities for immediate con- foods that are processed and prepared
sumption on the premises; food service on-site and sold by independent deli-
vendors, such as lunch wagons, ice catessens, bakeries, or retail confec-
cream shops, mall cookie counters, tionery stores where there are no fa-
vending machines, and sidewalk carts cilities for immediate human consump-
where foods are generally consumed tion; by in-store delicatessen, bakery,
immediately where purchased or while or candy departments; or at self-serv-
the consumer is walking away, includ- ice food bars such as salad bars), Pro-
ing similar foods sold from convenience vided, That the food bears no nutrition
stores; and food delivery systems or es- claims or other nutrition information
tablishments where ready-to-eat foods in any context on the label or in label-
are delivered to homes or offices), Pro- ing or advertising. Claims or other nu-
trition information subject the food to
vided, That the food bears no nutrition
the provisions of this section.
claims or other nutrition information
(4) Foods that contain insignificant
in any context on the label or in label-
amounts of all of the nutrients and
ing or advertising. Claims or other nu- food components required to be in-
trition information subject the food to cluded in the declaration of nutrition
the provisions of this section; information under paragraph (c) of this
(iii) Sold only in such facilities, Pro- section, Provided, That the food bears
vided, That the food bears no nutrition no nutrition claims or other nutrition
claims or other nutrition information information in any context on the label
in any context on the label or in label- or in labeling or advertising. Claims or
ing or advertising. Claims or other nu- other nutrition information subject the
trition information subject the food to food to the provisions of this section.
the provisions of this section; An insignificant amount of a nutrient
(iv) Used only in such facilities and or food component shall be that
not served to the consumer in the amount that allows a declaration of
package in which they are received zero in nutrition labeling, except that
(e.g., foods that are not packaged in infor total carbohydrate, dietary fiber,
dividual serving containers); or and protein, it shall be an amount that
44
allows a declaration of ‘‘less than 1 agement of a disease or condition for

gram.’’ Examples of foods that are ex- which distinctive nutritional require-
empt under this paragraph include cof- ments, based on recognized scientific
fee beans (whole or ground), tea leaves, principles, are established by medical
plain unsweetened instant coffee and evaluation. A food is subject to this ex-
tea, condiment-type dehydrated vege- emption only if:
tables, flavor extracts, and food colors. (i) It is a specially formulated and
(5)(i) Foods, other than infant for- processed product (as opposed to a nat-
mula, represented or purported to be urally occurring foodstuff used in its
specifically for infants and children natural state) for the partial or exclu-
less than 2 years of age shall bear nu- sive feeding of a patient by means of
trition labeling, except as provided in oral intake or enteral feeding by tube;
paragraph (j)(5)(ii) and except that (ii) It is intended for the dietary
such labeling shall not include calories management of a patient who, because
from fat (paragraph (c)(1)(ii) of this of therapeutic or chronic medical
section), calories from saturated fat needs, has limited or impaired capacity
((c)(1)(iii)), saturated fat ((c)(2)(i)), to ingest, digest, absorb, or metabolize
polyunsaturated fat ((c)(2)(ii)), ordinary foodstuffs or certain nutri-
monounsaturated fat ((c)(2)(iii)), and ents, or who has other special medi-
cholesterol ((c)(3)). cally determined nutrient require-
(ii) Foods, other than infant formula, ments, the dietary management of
represented or purported to be specifi- which cannot be achieved by the modi-
cally for infants and children less than fication of the normal diet alone;
4 years of age shall bear nutrition la-
(iii) It provides nutritional support
beling, except that:
specifically modified for the manage-
(A) Such labeling shall not include
ment of the unique nutrient needs that
declarations of percent of Daily Value
result from the specific disease or con-
for total fat, saturated fat, cholesterol,
dition, as determined by medical eval-
sodium, potassium, total carbohydrate,
uation;
and dietary fiber;
(B) Nutrient names and quantitative (iv) It is intended to be used under
amounts by weight shall be presented medical supervision; and
in two separate columns. (v) It is intended only for a patient
(C) The heading ‘‘Percent Daily receiving active and ongoing medical
Value’’ required in paragraph (d)(6) of supervision wherein the patient re-
this section shall be placed imme- quires medical care on a recurring
diately below the quantitative infor- basis for, among other things, instruc-
mation by weight for protein; tions on the use of the medical food.
(D) Percent of Daily Value for pro- (9) Food products shipped in bulk
tein, vitamins, and minerals shall be form that are not for distribution to
listed immediately below the heading consumers in such form and that are
‘‘Percent Daily Value’’; and for use solely in the manufacture of
(E) Such labeling shall not include other foods or that are to be processed,
the footnote specified in paragraph labeled, or repacked at a site other
(d)(9) of this section. than where originally processed or
(6) Dietary supplements, except that packed.
such foods shall be labeled in compli- (10) Raw fruits, vegetables, and fish
ance with § 101.36. subject to section 403(q)(4) of the act,
(7) Infant formula subject to section except that the labeling of such foods
412 of the act, as amended, except that should adhere to guidelines in § 101.45.
such foods shall be labeled in compli- This exemption is contingent on the
ance with part 107 of this chapter. food bearing no nutrition claims or
(8) Medical foods as defined in section other nutrition information in any
5(b) of the Orphan Drug Act (21 U.S.C. context on the label or in labeling or
360ee(b)(3)). A medical food is a food advertising. Claims or other nutrition
which is formulated to be consumed or information subject the food to nutri-
administered enterally under the su- tion labeling in accordance with

pervision of a physician and which is § 101.45. The term fish includes fresh-
intended for the specific dietary man- water or marine fin fish, crustaceans,
45
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
and mollusks, including shellfish, am- packages that qualify for and use this
phibians, and other forms of aquatic exemption an address or telephone
animal life. number that a consumer can use to ob-
(11) Packaged single-ingredient prod- tain the required nutrition information
ucts that consist of fish or game meat (e.g., ‘‘For nutrition information, call
(i.e., animal products not covered 1–800–123–4567’’).
under the Federal Meat Inspection Act (B) When such products bear nutri-
or the Poultry Products Inspection tion labeling, either voluntarily or be-
Act, such as flesh products from deer, cause nutrition claims or other nutri-
bison, rabbit, quail, wild turkey, or os- tion information is provided, all re-
trich) subject to this section may pro- quired information shall be in type size
vide required nutrition information for no smaller than 6 point or all upper-
a 3-ounce cooked edible portion (i.e., on case type of 1⁄16 inches minimum
an ‘‘as prepared’’ basis), except that: height, except that individual serving-
(i) Such products that make claims size packages of food served with meals
that are based on values as packaged in restaurants, institutions, and on
must provide nutrition information on board passenger carriers, and not in-
an as packaged basis, and tended for sale at retail, may comply
(ii) Nutrition information is not re- with § 101.2(c)(5).
quired for custom processed fish or (ii) Foods in packages that have a
game meats. total surface area available to bear la-
(12) Game meats (i.e., animal prod- beling of 40 or less square inches may
ucts not covered under the Federal modify the requirements of paragraphs
Meat Inspection Act or the Poultry (c) through (f) and (i) of this section by
Products Inspection Act, such as flesh one or more of the following means:
products from deer, bison, rabbit, (A) Presenting the required nutrition
quail, wild turkey, or ostrich) may pro- information in a tabular or, as pro-
vide required nutrition information on vided below, linear (i.e., string) fashion
labeling in accordance with the provi- rather than in vertical columns if the
sions of paragraph (a)(2) of this section. product has a total surface area avail-
(13)(i) Foods in small packages that able to bear labeling of less than 12
have a total surface area available to square inches, or if the product has a
bear labeling of less than 12 square total surface area available to bear la-
inches, Provided, That the labels for beling of 40 or less square inches and
these foods bear no nutrition claims or the package shape or size cannot ac-
other nutrition information in any commodate a standard vertical column
context on the label or in labeling or or tabular display on any label panel.
advertising. Claims or other nutrition Nutrition information may be given in
information subject the food to the a linear fashion only if the label will
provisions of this section. not accommodate a tabular display.
(A) The manufacturer, packer, or dis- (1) The following sample label illus-
tributor shall provide on the label of trates the tabular display.
46
ER11JY03.004</GPH>
(2) The following sample label illus- voluntarily for the nutrient names for
trates the linear display. When nutri- ‘‘Calories,’’ ‘‘Total fat,’’ ‘‘Cholesterol,’’
tion information is given in a linear ‘‘Sodium,’’ ‘‘Total carbohydrate,’’ and
fashion, bolding is required only on the ‘‘Protein.’’
title ‘‘Nutrition Facts‘‘ and is allowed
(B) Using any of the following abbre- (ii) The unit containers are securely
viations: enclosed within and not intended to be
Serving size—Serv size
separated from the retail package
Servings per container—Servings under conditions of retail sale; and
Calories from fat—Fat cal (iii) Each unit container is labeled
Calories from saturated fat—Sat fat cal with the statement ‘‘This Unit Not La-
Saturated fat—Sat fat beled For Retail Sale’’ in type size not
Monounsaturated fat—Monounsat fat less than 1/16-inch in height, except
Polyunsaturated fat—Polyunsat fat that this statement shall not be re-
Cholesterol—Cholest quired when the inner unit containers
Total carbohydrate—Total carb
bear no labeling at all. The word ‘‘in-
Dietary fiber—Fiber
Soluble fiber—Sol fiber
dividual’’ may be used in lieu of or im-
Insoluble fiber—Insol fiber mediately preceding the word ‘‘Retail’’
Sugar alcohol—Sugar alc in the statement.
Other carbohydrate—Other carb (16) Food products sold from bulk
containers: Provided, That nutrition in-
(C) Omitting the footnote required in
formation required by this section be
paragraph (d)(9) of this section and
displayed to consumers either on the
placing another asterisk at the bottom
of the label followed by the statement labeling of the bulk container plainly
‘‘Percent Daily Values are based on a in view or in accordance with the pro-
2,000 calorie diet‘‘ and, if the term visions of paragraph (a)(2) of this sec-
‘‘Daily Value’’ is not spelled out in the tion.
heading, a statement that ‘‘DV’’ rep- (17) Foods in packages that have a
resents ‘‘Daily Value.’’ total surface area available to bear la-
(D) Presenting the required nutrition beling greater than 40 square inches
information on any label panel. but whose principal display panel and
(14) Shell eggs packaged in a carton information panel do not provide suffi-
that has a top lid designed to conform cient space to accommodate all re-
to the shape of the eggs are exempt quired information may use any alter-
from outer carton label requirements nate panel that can be readily seen by
where the required nutrition informa- consumers for the nutrition label. The
tion is clearly presented immediately space needed for vignettes, designs, and
beneath the carton lid or in an insert other nonmandatory label information
that can be clearly seen when the car- on the principal display panel may be
ton is opened. considered in determining the suffi-
(15) The unit containers in a multi- ciency of available space on the prin-
unit retail food package where: cipal display panel for the placement of
(i) The multiunit retail food package the nutrition label. Nonmandatory
labeling contains all nutrition infor- label information on the information

mation in accordance with the require- panel shall not be considered in deter-
ments of this section; mining the sufficiency of available
47
ER11JY03.005</GPH>
§ 101.9 21 CFR Ch. I (4–1–16 Edition)
space for the placement of the nutri- (iii) If a person claims an exemption
tion label. under paragraphs (j)(18)(i) or (j)(18)(ii)
(18) Food products that are low-vol- of this section for a food product and
ume (that is, they meet the require- then, during the period of such exemp-
ments for units sold in paragraphs tion, the number of full-time equiva-
(j)(18)(i) or (j)(18)(ii) of this section); lent employees of such person exceeds
that, except as provided in paragraph the appropriate number, or the number
(j)(18)(iv) of this section, are the sub- of food products sold in the United
ject of a claim for an exemption that States exceeds the appropriate number,
provides the information required or, if at the end of the period of such
under paragraph (j)(18)(iv) of this sec- exemption, the food product no longer
tion, that is filed before the beginning qualifies for an exemption under the
of the time period for which the exemp- provisions of paragraphs (j)(18)(i) or
tion is claimed, and that is filed by a (j)(18)(ii) of this section, such person
person, whether it is the manufacturer, shall have 18 months from the date
packer, or distributor, that qualifies to that the product was no longer quali-
claim the exemption under the require- fied as a low-volume product of a small
ments for average full-time equivalent business to comply with this section.
employees in paragraphs (j)(18)(i) or (iv) A notice shall be filed with the
(j)(18)(ii) of this section; and whose la- Office of Nutritional Products, Label-
bels, labeling, and advertising do not ing and Dietary Supplements (HFS–
provide nutrition information or make 800), Center for Food Safety and Ap-
a nutrient content or health claim. plied Nutrition, Food and Drug Admin-
(i) For food products first introduced istration, 5100 Paint Branch Pkwy.,
into interstate commerce before May 8, College Park, MD 20740 and contain the
1994, the product shall be exempt for following information, except that if
the period: the person is not an importer and has
(A) Between May 8, 1995, and May 7, fewer than 10 full-time equivalent em-
1996, if, for the period between May 8, ployees, that person does not have to
1994, and May 7, 1995, the person claim- file a notice for any food product with
ing the exemption employed fewer than annual sales of fewer than 10,000 total
an average of 300 full-time equivalent units:
employees and fewer than 400,000 units
(A) Name and address of person re-
of that product were sold in the United
questing exemption. This should in-
States; and
clude a telephone number or FAX num-
(B) Between May 8, 1996, and May 7,
ber that can be used to contact the per-
1997, if for the period between May 8,
son along with the name of a specific
1995, and May 7, 1996, the person claim-
ing the exemption employed fewer than contact;
an average of 200 full-time equivalent (B) Names of the food products (in-
employees and fewer than 200,000 units cluding the various brand names) for
of that product were sold in the United which exemption is claimed;
States. (C) Name and address of the manufac-
(ii) For all other food products, the turer, distributor, or importer of the
product shall be eligible for an exemp- food product for which an exemption is
tion for any 12-month period if, for the claimed, if different than the person
preceding 12 months, the person claim- that is claiming the exemption;
ing the exemption employed fewer than (D) The number of full-time equiva-
an average of 100 full-time equivalent lent employees. Provide the average
employees and fewer than 100,000 units number of full-time equivalent individ-
of that product were sold in the United uals employed by the person and its af-
States, or in the case of a food product filiates for the 12 months preceding the
that was not sold in the 12-month pe- period for which a small business ex-
riod preceding the period for which exemption is claimed for a product. The
emption is claimed, fewer than 100,000 average number of full-time equivalent
units of such product are reasonably employees is to be determined by divid-
anticipated to be sold in the United ing the total number of hours of salary
States during the period for which ex- or wages paid to employees of the per-
emption is claimed. son and its affiliates by the number of
48
hours of work in a year, 2,080 hours (B) Food product means food in any
(i.e., 40 hours × 52 weeks); sized package which is manufactured
(E) Approximate total number of by a single manufacturer or which
units of the food product sold by the bears the same brand name, which
person in the United States in the 12- bears the same statement of identity,
month period preceding that for which and which has similar preparation
a small business exemption is claimed. methods.
Provide the approximate total number (C) Person means all domestic and
of units sold, or expected to be sold, in foreign affiliates, as defined in 13 CFR
a 12-month period for each product for 121.401, of the corporation, in the case
which an exemption is claimed. For of a corporation, and all affiliates, as
products that have been in production defined in 13 CFR 121.401, of a firm or
for 1 year or more prior to the period other entity, when referring to a firm
for which exemption is claimed, the 12- or other entity that is not a corpora-
month period is the period imme- tion.
diately preceding the period for which (D) Full-time equivalent employee
an exemption is claimed. For other means all individuals employed by the
products, the 12-month period is the pe- person claiming the exemption. This
riod for which an exemption is claimed; number shall be determined by divid-
and ing the total number of hours of salary
(F) The notice shall be signed by a re- or wages paid directly to employees of
sponsible individual for the person who the person and of all of its affiliates by
can certify the accuracy of the infor- the number of hours of work in a year,
mation presented in the notice. The in- 2,080 hours (i.e., 40 hours × 52 weeks).
dividual shall certify that the informa- (k) A food labeled under the provi-
tion contained in the notice is a com- sions of this section shall be deemed to
plete and accurate statement of the av- be misbranded under sections 201(n)
erage number of full-time equivalent and 403(a) of the act if its label or la-
employees of this person and its affili- beling represents, suggests, or implies:
ates and of the number of units of the (1) That the food, because of the pres-
product for which an exemption is ence or absence of certain dietary prop-
claimed sold by the person. The indi- erties, is adequate or effective in the
vidual shall also state that should the prevention, cure, mitigation, or treat-
average number of full-time equivalent ment of any disease or symptom. Infor-
employees or the number of units of mation about the relationship of a die-
food products sold in the United States tary property to a disease or health-re-
by the person exceed the applicable lated condition may only be provided
numbers for the time period for which in conformance with the requirements
exemption is claimed, the person will of § 101.14 and part 101, subpart E.
notify FDA of that fact and the date on (2) That the lack of optimum nutri-
which the number of employees or the tive quality of a food, by reason of the
number of products sold exceeded the soil on which that food was grown, is or
standard. may be responsible for an inadequacy
(v) FDA may by regulation lower the or deficiency in the quality of the daily
employee or units of food products re- diet.
quirements of paragraph (j)(18)(ii) of (3) That the storage, transportation,
this section for any food product first processing, or cooking of a food is or
introduced into interstate commerce may be responsible for an inadequacy
after May 8, 2002, if the agency deter- or deficiency in the quality of the daily
mines that the cost of compliance with diet.
such lower requirement will not place (4) That a natural vitamin in a food
an undue burden on persons subject to is superior to an added or synthetic vi-
it. tamin.
(vi) For the purposes of this para- [58 FR 2175, Jan. 6, 1993]
graph, the following definitions apply: EDITORIAL NOTE: For FEDERAL REGISTER ci-
(A) Unit means the packaging or, if tations affecting § 101.9, see the List of CFR
there is no packaging, the form in Sections Affected, which appears in the

which a food product is offered for sale Finding Aids section of the printed volume
to consumers. and at www.fdsys.gov.
49
§ 101.10 21 CFR Ch. I (4–1–16 Edition)
EFFECTIVE DATE NOTE: At 79 FR 71293, Dec. (13)(i) Foods in small packages that have a
1, 2014, § 101.9 was amended by revising para- total surface area available to bear labeling
graphs (j)(2)(ii) and (j)(4) and the introduc- of less than 12 square inches, Provided, That
tory text of paragraph (j)(13)(i), effective the labels for these foods bear no nutrition
Dec. 1, 2016. For the convenience of the user, claims or other nutrition information in any
the revised text is set forth as follows: context on the label or in labeling or adver-
tising, except as provided in § 101.8(c). Claims
§ 101.9 Nutrition labeling of food. or other nutrition information, except as
provided in § 101.8(c), subject the food to the
* * * * * provisions of this section.
(j) * * *
(2) * * *
* * * * *
(ii) Served in other establishments in
which food is served for immediate human
§ 101.10 Nutrition labeling of res-
taurant foods.
consumption (e.g., institutional food service
establishments, such as schools, hospitals, Nutrition labeling in accordance with
and cafeterias; transportation carriers, such § 101.9 shall be provided upon request
as trains and airplanes; bakeries, delicates- for any restaurant food or meal for
sens, and retail confectionery stores where which a nutrient content claim (as de-
there are facilities for immediate consump- fined in § 101.13 or in subpart D of this
tion on the premises; food service vendors,
such as lunch wagons, ice cream shops, mall
part) or a health claim (as defined in
cookie counters, vending machines, and side- § 101.14 and permitted by a regulation
walk carts where foods are generally con- in subpart E of this part) is made, ex-
sumed immediately where purchased or cept that information on the nutrient
while the consumer is walking away, includ- amounts that are the basis for the
ing similar foods sold from convenience claim (e.g., ‘‘low fat, this meal provides
stores; and food delivery systems or estab- less than 10 grams of fat’’) may serve
lishments where ready-to-eat foods are deliv- as the functional equivalent of com-
ered to homes or offices), Provided, That the plete nutrition information as de-
food bears no nutrition claims or other nu-
trition information in any context on the
scribed in § 101.9. Nutrient levels may
label or in labeling or advertising, except as be determined by nutrient data bases,
provided in § 101.8(c). Claims or other nutri- cookbooks, or analyses or by other rea-
tion information, except as provided in sonable bases that provide assurance
§ 101.8(c), subject the food to the provisions of that the food or meal meets the nutri-
this section; ent requirements for the claim. Presen-
tation of nutrition labeling may be in
* * * * * various forms, including those provided
in § 101.45 and other reasonable means.
(4) Foods that contain insignificant
amounts of all of the nutrients and food [61 FR 40332, Aug. 2, 1996]
components required to be included in the
declaration of nutrition information under § 101.12 Reference amounts custom-
paragraph (c) of this section, Provided, That arily consumed per eating occasion.
the food bears no nutrition claims or other
(a) The general principles and factors
nutrition information in any context on the
label or in labeling or advertising, except as
that the Food and Drug Administra-
provided in § 101.8(c). Claims or other nutrition (FDA) considered in arriving at
tion information, except as provided in the reference amounts customarily
§ 101.8(c), subject the food to the provisions of consumed per eating occasion (ref-
this section. An insignificant amount of a erence amounts) which are set forth in
nutrient or food component shall be that paragraph (b) of this section, are that:
amount that allows a declaration of zero in (1) FDA calculated the reference
nutrition labeling, except that for total car- amounts for persons 4 years of age or
bohydrate, dietary fiber, and protein, it shall
be an amount that allows a declaration of
older to reflect the amount of food cus-
‘‘less than 1 gram.’’ Examples of foods that tomarily consumed per eating occasion
are exempt under this paragraph include cof- by persons in this population group.
fee beans (whole or ground), tea leaves, plain These reference amounts are based on
unsweetened instant coffee and tea, con- data set forth in appropriate national
diment-type dehydrated vegetables, flavor food consumption surveys.
extracts, and food colors. (2) FDA calculated the reference

amounts for an infant or child under 4
* * * * * years of age to reflect the amount of
50
food customarily consumed per eating (ii) Serving sizes recommended in

occasion by infants up to 12 months of comments;
age or by children 1 through 3 years of (iii) Serving sizes used by manufac-
age, respectively. These reference turers and grocers; and
amounts are based on data set forth in (iv) Serving sizes used by other coun-
appropriate national food consumption tries.
surveys. Such reference amounts are to (6) Because they reflect the amount
be used only when the food is specially customarily consumed, the reference
formulated or processed for use by an amount and, in turn, the serving size
infant or by a child under 4 years of declared on the product label are based
age. on only the edible portion of food, and
(3) An appropriate national food con- not bone, seed, shell, or other inedible
sumption survey includes a large sam- components.
ple size representative of the demo- (7) The reference amount is based on
graphic and socioeconomic characteris- the major intended use of the food
tics of the relevant population group (e.g., milk as a beverage and not as an
and must be based on consumption addition to cereal).
data under actual conditions of use. (8) The reference amounts for prod-
(4) To determine the amount of food ucts that are consumed as an ingre-
customarily consumed per eating occa- dient of other foods, but that may also
sion, FDA considered the mean, me- be consumed in the form in which they
dian, and mode of the consumed are purchased (e.g., butter), are based
amount per eating occasion. on use in the form purchased.
(5) When survey data were insuffi- (9) FDA sought to ensure that foods
cient, FDA took various other sources that have similar dietary usage, prod-
of information on serving sizes of food uct characteristics, and customarily
into consideration. These other sources consumed amounts have a uniform ref-
of information included: erence amount.
(i) Serving sizes used in dietary guid- (b) The following reference amounts
ance recommendations or rec- shall be used as the basis for deter-
ommended by other authoritative sys- mining serving sizes for specific prod-
tems or organizations; ucts:
TABLE 1—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: INFANT AND
TODDLER FOODS 1 2 3 4
Product category Reference amount Label statement 5
Cereals, dry instant .................................................................... 15 g ........................ l cup (l g)

Cereals, prepared, ready-to-serve ............................................. 110 g ...................... l cup(s) (l g)
Other cereal and grain products, dry ready-to-eat, e.g., ready- 7 g for infants and l cup(s) (l g) for ready-to-eat cereals;
to-eat cereals, cookies, teething biscuits, and toasts. 20 g for toddlers l piece(s) (l g) for others
for ready-to-eat
cereals; 7 g for all
others.
Dinners, desserts, fruits, vegetables or soups, dry mix ............. 15 g ........................ l tbsp(s) (l g); l cup(s) (l g)
Dinners, desserts, fruits, vegetables or soups, ready-to-serve, 110 g ...................... l cup(s) (l g); l cup(s) (l mL)
junior type.
Dinners, desserts, fruits, vegetables or soups, ready-to-serve, 60 g ........................ l cup(s) (l g); l cup(s) (l mL)
strained type.
Dinners, stews or soups for toddlers, ready-to-serve ................ 170 g ...................... l cup(s) (l g); l cup(s) (l mL)
Fruits for toddlers, ready-to-serve .............................................. 125 g ...................... l cup(s) (l g)
Vegetables for toddlers, ready-to- serve .................................... 70 g ........................ l cup(s) (l g)
Eggs/egg yolks, ready-to-serve .................................................. 55 g ........................ l cup(s) (l g)
Juices, all varieties ..................................................................... 120 mL ................... 4 fl oz (120 mL)
1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the
1977–1978 and the 1987–1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture.
2 Unless otherwise noted in the Reference amount column, the reference amounts are for the ready-to-serve or almost ready-
to-serve form of the product (i.e., heat and serve, brown and serve). If not listed separately, the reference amount for the unpre-
pared form (e.g., dry cereal) is the amount required to make the reference amount of the prepared form. Prepared means pre-
pared for consumption (e.g., cooked).
3 Manufacturers are required to convert the reference amount to the label serving size in a household measure most appro-
priate to their specific product using the procedures in 21 CFR 101.9(b).

4Copies of the list of products for each product category are available from the Office of Nutritional Products, Labeling and Di-
etary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740.
51
§ 101.12 21 CFR Ch. I (4–1–16 Edition)
5 The label statements are meant to provide guidance to manufacturers on the presentation of serving size information on the
label, but they are not required. The term ‘‘piece’’ is used as a generic description of a discrete unit. Manufacturers should use
the description of a unit that is most appropriate for the specific product (e.g., sandwich for sandwiches, cookie for cookies, and
bar for frozen novelties).
TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD
SUPPLY 1 2 3 4
Product category Reference amount Label statement5
Bakery products:
Biscuits, croissants, bagels, tortillas, soft bread sticks, 55 g ........................ l piece(s) (l g)
soft pretzels, corn bread, hush puppies.
Breads (excluding sweet quick type), rolls .................. 50 g ........................ l piece(s) (l g) for sliced bread and
distinct pieces (e.g., rolls); 2 oz (56 g/
l inch slice) for unsliced bread
Bread sticks—see crackers ......................................... .................................
Toaster pastries—see coffee cakes ............................ .................................
Brownies ...................................................................... 40 g ........................ l piece(s) (l g) for distinct pieces;
fractional slice (l g) for bulk
Cakes, heavy weight (cheese cake; pineapple up- 125 g ...................... l piece(s) (l g) for distinct pieces
side-down cake; fruit, nut, and vegetable cakes (e.g., sliced or individually packaged
with more than or equal to 35 percent of the fin- products); l fractional slice (l g) for
ished weight as fruit, nuts, or vegetables or any of large discrete units
these combined) 6.
Cakes, medium weight (chemically leavened cake 80 g ........................ l piece(s) (l g) for distinct pieces
with or without icing or filling except those classi- (e.g., cupcake); l fractional slice (l
fied as light weight cake; fruit, nut, and vegetable g) for large discrete units
cake with less than 35 percent of the finished
weight as fruit, nuts, or vegetables or any of these
combined; light weight cake with icing; Boston
cream pie; cupcake; eclair; cream puff) 7.
Cakes, light weight (angel food, chiffon, or sponge 55 g ........................ l piece(s) (l g) for distinct pieces
cake without icing or filling) 8. (e.g., sliced or individually packaged
products); l fractional slice (l g) for
large discrete units
Coffee cakes, crumb cakes, doughnuts, Danish, 55 g ........................ l piece(s) (l g) for sliced bread and
sweet rolls, sweet quick type breads, muffins, distinct pieces (e.g., doughnut); 2 oz
toaster pastries. (56 g/visual unit of measure) for bulk
products (e.g., unsliced bread)
Cookies ........................................................................ 30 g ........................ l piece(s) (l g)
Crackers that are usually not used as snack, melba 15 g ........................ l piece(s) (l g)
toast, hard bread sticks, ice cream cones 9.
Crackers that are usually used as snacks .................. 30 g ........................ l piece(s) (l g)
Croutons ....................................................................... 7 g .......................... l tbsp(s) (l g); l cup(s) (l g); l
piece(s) (l g) for large pieces
French toast, pancakes, variety mixes ........................ 110 g prepared for l piece(s) (l g); l cup(s) (l g) for
french toast and dry mix
pancakes; 40 g
dry mix for variety
mixes.
Grain-based bars with or without filling or coating, 40 g ........................ l piece(s) (l g)
e.g., breakfast bars, granola bars, rice cereal bars.
Ice cream cones—see crackers .................................. .................................
Pies, cobblers, fruit crisps, turnovers, other pastries .. 125 g ...................... l piece(s) (lg) for distinct pieces; l
fractional slice (l g) for large discrete
units
Pie crust ....................................................................... 1/6 of 8 inch crust; 1/6 of 8 inch crust (l g); 1⁄8 of 9 inch
1⁄8 of 9 inch crust. crust (l g)
Pizza crust ................................................................... 55 g ........................ l fractional slice (l g)
Taco shells, hard ......................................................... 30 g ........................ l shell(s) (l g)
Waffles ......................................................................... 85 g ........................ l piece(s) (l g)
Beverages:
Carbonated and noncarbonated beverages, wine 240 mL ................... 8 fl oz (240 mL)
coolers, water.
Coffee or tea, flavored and sweetened ....................... 240 mL prepared .... 8 fl oz (240 mL)
Cereal and Other Grain Products:
Breakfast cereals (hot cereal type), hominy grits ........ 1 cup prepared; 40 l cup(s) (l g)
g plain dry cereal;
55 g flavored,
sweetened dry
cereal.
Breakfast cereals, ready-to-eat, weighing less than 20 15 g ........................ l cup(s) (l g)
g per cup, e.g., plain puffed cereal grains.
52
SUPPLY 1 2 3 4—Continued
Breakfast cereals, ready-to-eat weighing 20 g or 30 g ........................ l cup(s) (l g)

more but less than 43 g per cup; high fiber cereals
containing 28 g or more of fiber per 100 g.
Breakfast cereals, ready-to-eat, weighing 43 g or 55 g ........................ l piece(s) (l g) for large distinct
more per cup; biscuit types. pieces (e.g., biscuit type);l cup(s) (l
g) for all others
Bran or wheat germ ..................................................... 15 g ........................ l tbsp(s) (l g); l cup(s) (l g)
Flours or cornmeal ....................................................... 30 g ........................ l tbsp(s) (l g); l cup(s) (l g)
Grains, e.g., rice, barley, plain ..................................... 140 g prepared; 45 l cup(s) (l g)
g dry.
Pastas, plain ................................................................ 140 g prepared; 55 l cup(s) (l g); l piece(s) (l g) for
g dry. large pieces (e.g., large shells or
lasagna noodles) or 2 oz (56 g/visual
unit of measure) for dry bulk products
(e.g., spaghetti)
Pastas, dry, ready-to-eat, e.g., fried canned chow 25 g ........................ l cup(s) (l g)
mein noodles.
Starches, e.g., cornstarch, potato starch, tapioca, etc. 10 g ........................ l tbsp (l g)
Stuffing ......................................................................... 100 g ...................... l cup(s) (l g)
Dairy Products and Substitutes:
Cheese, cottage ........................................................... 110 g ...................... l cup (l g)
Cheese used primarily as ingredients, e.g., dry cot- 55 g ........................ l cup (l g)
tage cheese, ricotta cheese.
Cheese, grated hard, e.g., Parmesan, Romano ......... 5 g .......................... l tbsp (l g)
Cheese, all others except those listed as separate 30 g ........................ l piece(s) (l g) for distinct pieces;l
categories—includes cream cheese and cheese tbsp(s) (l g) for cream cheese and
spread. cheese spread; 1 oz (28 g/visual unit
of measure) for bulk
Cheese sauce—see sauce category.
Cream or cream substitutes, fluid ................................ 15 mL ..................... 1 tbsp (15 mL)
Cream or cream substitutes, powder .......................... 2 g .......................... l tsp (l g)
Cream, half & half ........................................................ 30 mL ..................... 2 tbsp (30 mL)
Eggnog ......................................................................... 120 mL ................... 1/2 cup (120 mL); 4 fl oz (120 mL)
Milk, condensed, undiluted .......................................... 30 mL ..................... 2 tbsp (30 mL)
Milk, evaporated, undiluted .......................................... 30 mL ..................... 2 tbsp (30 mL)
Milk, milk-based drinks, e.g., instant breakfast, meal 240 mL ................... 1 cup (240 mL); 8 fl oz (240 mL)
replacement, cocoa.
Shakes or shake substitutes, e.g., dairy shake mixes, 240 mL ................... 1 cup (240 mL); 8 fl oz (240 mL)
fruit frost mixes.
Sour cream .................................................................. 30 g ........................ l tbsp (l g)
Yogurt ........................................................................... 225 g ...................... l cup (l g)
Desserts:
Ice cream, ice milk, frozen yogurt, sherbet: all types, 1/2 cup-includes the l piece(s) (l g) for individually
bulk and novelties (e.g., bars, sandwiches, cones). volume for coat- wrapped or packaged products; 1⁄2
ings and wafers cup (l g) for others
for the novelty
type varieties.
Frozen flavored and sweetened ice and pops, frozen 85 g ........................ l piece(s) (l g) for individually
fruit juices: all types, bulk and novelties (e.g., bars, wrapped or packaged products; l
cups). cup(s) (l g) for others
Sundae ......................................................................... 1 cup ....................... 1 cup (l g)
Custards, gelatin or pudding ........................................ 1/2 cup .................... l piece(s) (l g) for distinct unit (e.g.,
individually packaged products); 1⁄2
cup (l g) for bulk
Dessert Toppings and Fillings:
Cake frostings or icings ............................................... 35 g ........................ l tbsp(s) (l g)
Other dessert toppings, e.g., fruits, syrups, spreads, 2 tbsp ...................... 2 tbsp (l g); 2 tbsp (30 mL)
marshmallow cream, nuts, dairy and nondairy
whipped toppings.
Pie fillings ..................................................................... 85 g ........................ l cup(s) (l g)
Egg and Egg Sustitutes:
Egg mixtures, e.g., egg foo young, scrambled eggs, 110 g ...................... l piece(s) (l g) for discrete pieces; l
omelets. cup(s) (l g)
Eggs (all sizes) 9 .......................................................... 50 g ........................ 1 large, medium, etc. (l g)
Egg substitutes ............................................................ An amount to make l cup(s) (l g); l cup(s) (l mL)
1 large (50 g) egg.
Fats and Oils:

Butter, margarine, oil, shortening ................................ 1 tbsp ...................... 1 tbsp (l g); 1 tbsp (15 mL)
Butter replacement, powder ......................................... 2 g .......................... l tsp(s) (l g)
Dressings for salads .................................................... 30 g ........................ l tbsp (l g); l tbsp (l mL)
53
§ 101.12 21 CFR Ch. I (4–1–16 Edition)
Mayonnaise, sandwich spreads, mayonnaise-type 15 g ........................ l tbsp (l g)

dressings.
Spray types .................................................................. 0.25 g ..................... About l seconds spray (l g)
Fish, Shellfish, Game Meats 10, and Meat or Poultry Sub-
stitutes:
Bacon substitutes, canned anchovies, 11 anchovy 15 g ........................ l piece(s) (l g) for discrete pieces; l
pastes, caviar. tbsp(s) (l g) for others
Dried, e.g., jerky ........................................................... 30 g ........................ l piece(s) (l g)
Entrees with sauce, e.g., fish with cream sauce, 140 g cooked .......... l cup(s) (l g); 5 oz (140 g/visual unit
shrimp with lobster sauce. of measure) if not measurable by cup
Entrees without sauce, e.g., plain or fried fish and 85 g cooked; 110 g l piece(s) (l g) for discrete pieces; l
shellfish, fish and shellfish cake. uncooked 12. cup(s) (l g); l oz (l g/visual unit of
measure) if not measurable by cup 13
Fish, shellfish or game meat 10, canned 11 .................. 55 g ........................ l piece(s) (l g) for discrete pieces; l
cup(s) (l g); 2 oz (56 g/l cup) for
products that are difficult to measure
the g weight of cup measure (e.g.,
tuna); 2 oz (56 g/l pieces) for prod-
ucts that naturally vary in size (e.g.,
sardines)
Substitute for luncheon meat, meat spreads, Cana- 55 g ........................ l piece(s) (l g) for distinct pieces
dian bacon, sausages and frankfurters. (e.g., slices, links); l cup(s) (l g); 2
oz (56 g/visual unit of measure) for
nondiscrete bulk product
Smoked or pickled 11 fish, shellfish, or game meat 10; 55 g ........................ l piece(s) (l g) for distinct pieces
fish or shellfish spread. (e.g., slices, links) or l cup(s) (l g);
2 oz (56 g/visual unit of measure) for
nondiscrete bulk product
Substitutes for bacon bits—see miscellaneous cat-
egory.
Fruits and Fruit Juices:
Candied or pickled 11 ................................................... 30 g ........................ l piece(s) (l g)
Dehydrated fruits—see snacks category ..................... .................................
Dried ............................................................................. 40 g ........................ l piece(s) (l g) for large pieces (e.g.,
dates, figs, prunes); l cup(s) (l g)
for small pieces (e.g., raisins)
Fruits for garnish or flavor, e.g., maraschino cher- 4 g .......................... 1 cherry (l g)
ries 11.
Fruit relishes, e.g., cranberry sauce, cranberry relish 70 g ........................ l cup(s) (l g)
Fruits used primarily as ingredients, avocado ............. 30 g ........................ See footnote 13
Fruits used primarily as ingredients, others (cran- 55 g ........................ l piece(s) (l g) for large fruits; l
berries, lemon, lime). cup(s) (l g) for small fruits measur-
able by cup 13
Watermelon .................................................................. 280 g ...................... See footnote 13
All other fruits (except those listed as separate cat- 140 g ...................... l piece(s) (l g) for large pieces (e.g.,
egories), fresh, canned, or frozen. strawberries, prunes, apricots, etc.); l
cup(s) (l g) for small pieces (e.g.,
blueberries, raspberries, etc.) 13
Juices, nectars, fruit drinks .......................................... 240 mL ................... 8 fl oz (240 mL)
Juices used as ingredients, e.g., lemon juice, lime 5 mL ....................... 1 tsp (5 mL)
juice.
Legumes:
Bean cake (tofu) 11, tempeh ......................................... 85 g ........................ l piece(s) (l g) for discrete pieces; 3
oz (84 g/visual unit of measure) for
bulk products
Beans, plain or in sauce .............................................. 130 g for beans in l cup (l g)
sauce or canned
in liquid and
refried beans pre-
pared; 90 g for
others prepared;
35 g dry.
Miscellaneous Category:
Baking powder, baking soda, pectin ............................ 0.6 g ....................... l tsp (l g)
Baking decorations, e.g., colored sugars and sprin- 1 tsp or 4 g if not l piece(s) (l g) for discrete pieces; 1
kles for cookies, cake decorations. measurable by tsp (l g)

teaspoon.
Batter mixes, bread crumbs ......................................... 30 g ........................ l tbsp(s) (l g);l cup(s) (l g)
Cooking wine ............................................................... 30 mL ..................... 2 tbsp (30 mL)
54
Dietary supplements .................................................... The maximum l tablet(s), l capsule(s), l packet(s),

amount rec- l tsp(s) (l g), etc.
ommended, as
appropriate, on
the label for con-
sumption per eat-
ing occasion, or,
in the absence of
recommendations,
1 unit, e.g., tablet,
capsule, packet,
teaspoonsful, etc..
Drink mixers (without alcohol) ...................................... Amount to make l fl oz (l mL)
240 mL drink
(without ice).
Chewing gum 9 ............................................................. 3 g .......................... l piece(s) (l g)
Meat, poultry and fish coating mixes, dry; seasoning Amount to make l tsp(s) (l g); l tbsp(s) (l g)
mixes, dry, e.g., chili seasoning mixes, pasta salad one reference
seasoning mixes. amount of final
dish.
Salad and potato toppers, e.g., salad crunchies, 7 g .......................... l tbsp(s) (l g)
salad crispins, substitutes for bacon bits.
Salt, salt substitutes, seasoning salts (e.g., garlic salt) ...... 1/4 tsp ..................... 1/4 tsp (lg); lpiece(s) (lg) for dis-
crete pieces (e.g., individually pack-
aged products)
Spices, herbs (other than dietary supplements) .......... 1/4 tsp or 0.5 g if 1/4 tsp (l g); l piece(s) (l g) if not
not measurable measurable by teaspoons (e.g., bay
by teaspoon. leaf)
Mixed Dishes:
Measurable with cup, e.g., casseroles, hash, maca- 1 cup ....................... 1 cup (l g)
roni and cheese, pot pies, spaghetti with sauce,
stews, etc..
Not measurable with cup, e.g., burritos, egg rolls, en- 140 g, add 55 g for l piece(s) (l g) for discrete pieces; l
chiladas, pizza, pizza rolls, quiche, all types of products with fractional slice (l g) for large discrete
sandwiches. gravy or sauce units
topping, e.g., en-
chilada with
cheese sauce,
crepe with white
sauce 14.
Nuts and Seeds:
Nuts, seeds, and mixtures, all types: sliced, chopped, 30 g ........................ l piece(s) (l g) for large pieces (e.g.,
slivered, and whole. unshelled nuts);l tbsp(s) (l g) ;l
cup(s) (l g) for small pieces (e.g.,
peanuts, sunflower seeds)
Nut and seed butters, pastes, or creams .................... 2 tbsp ...................... 2 tbsp (l g)
Coconut, nut and seed flours ...................................... 15 g ........................ l tbsp(s) (l g); l cup (l g)
Potatoes and Sweet Potatoes/Yams:
French fries, hash browns, skins, or pancakes ........... 70 g prepared; 85 g l piece(s) (l g) for large distinct
for frozen unpre- pieces (e.g., patties, skins); 2.5 oz (70
pared french fries. g/l pieces) for prepared fries; 3 oz
(84 g/l pieces) for unprepared fries
Mashed, candied, stuffed, or with sauce ..................... 140 g ...................... l piece(s) (l g) for discrete pieces
(e.g., stuffed potato); l cup(s) (l g)
Plain, fresh, canned, or frozen .................................... 110 g for fresh or l piece(s) (l g) for discrete pieces;l
frozen; 125 g for cup(s) (l g) for sliced or chopped
vacuum packed; products
160 g for canned
in liquid.
Salads:
Gelatin salad ................................................................ 120 g ...................... l cup (l g)
Pasta or potato salad ................................................... 140 g ...................... l cup(s) (l g)
All other salads, e.g., egg, fish, shellfish, bean, fruit, 100 g ...................... l cup(s) (l g)
or vegetable salads.
Sauces, Dips, Gravies and Condiments:
Barbecue sauce, hollandaise sauce, tartar sauce, 2 tbsp ...................... 2 tbsp (l g); 2 tbsp (30 mL)
other sauces for dipping (e.g., mustard sauce,

sweet and sour sauce), all dips (e.g., bean dips,
dairy-based dips, salsa).
Major main entree sauces, e.g., spaghetti sauce ....... 125 g ...................... l cup (l g); l cup (l mL)
55
§ 101.12 21 CFR Ch. I (4–1–16 Edition)
Minor main entree sauces (e.g., pizza sauce, pesto 1/4 cup .................... 1/4 cup (l g); 1⁄4 cup (60 mL)
sauce), other sauces used as toppings (e.g., gravy,
white sauce, cheese sauce), cocktail sauce.
Major condiments, e.g., catsup, steak sauce, soy 1 tbsp ...................... 1 tbsp (l g); 1 tbsp (15 mL)
sauce, vinegar, teriyaki sauce, marinades.
Minor condiments, e.g., horseradish, hot sauces, 1 tsp ........................ 1 tsp (l g); 1 tsp (5 mL)
mustards, worcestershire sauce.
Snacks:
All varieties, chips, pretzels, popcorns, extruded 30 g ........................ l cup(s) (l g) for small pieces (e.g.,
snacks, fruit- based snacks (e.g., fruit chips,) grain- popcorn) l piece(s) (l g) for large
based snack mixes. pieces (e.g., large pretzels; pressed
dried fruit sheet); 1 oz (28 g/visual unit
of measure) for bulk products (e.g.,
potato chips)
Soups:
All varieties ................................................................... 245 g ...................... l cup (l g); l cup (l mL)
Sugars and Sweets:
Baking candies (e.g., chips) ........................................ 15 g ........................ l piece(s) (l g) for large pieces; l
tbsp(s) (l g) for small pieces; 1⁄2 oz
(14 g/visual unit of measure) for bulk
products
Hard candies, breath mints .......................................... 2 g .......................... l piece(s) (l g)
Hard candies, roll-type, mini-size in dispenser pack- 5 g .......................... l piece(s) (l g)
ages.
Hard candies, others .................................................... 15 g ........................ l piece(s) (l g) for large pieces;l
tbsp(s) (l g) for ‘‘mini-size’’ candies
measurable by tablespoon; 1⁄2 oz (14
g/visual unit of measure) for bulk prod-
ucts
All other candies .......................................................... 40 g ........................ l piece(s) (l g); 11⁄2 oz (42 g/visual
unit of measure) for bulk products
Confectioner’s sugar .................................................... 30 g ........................ l cup (l g)
Honey, jams, jellies, fruit butter, molasses .................. 1 tbsp ...................... 1 tbsp (l g); 1 tbsp (15 mL)
Marshmallows .............................................................. 30 g ........................ l cup(s) (l g) for small pieces; l
piece(s) (l g) for large pieces
Sugar ............................................................................ 4 g .......................... l tsp (l g) ; l piece(s) (l g) for dis-
crete pieces (e.g., sugar cubes, indi-
vidually packaged products)
Sugar substitutes ......................................................... An amount equiva- l tsp(s) (l g) for solids; l drop(s) (l
lent to one ref- g) for liquid; l piece(s) (l g) (e.g.,
erence amount for individually packaged products)
sugar in sweet-
ness.
Syrups .......................................................................... 30 mL for syrups 2 tbsp (30 mL) for syrups used primarily
used primarily as as an ingredient; 1⁄4 cup (60 mL) for
an ingredient all others
(e.g., light or dark
corn syrup); 60
mL for all others.
Vegetables:
Vegetables primarily used for garnish or flavor, e.g., 4 g .......................... l piece(s) (l g); l tbsp(s) (l g) for
pimento, parsley. chopped products
Chili pepper, green onion ............................................ 30 g ........................ l piece(s) (l g) 13; l tbsp(s) (l g); l
cup(s) (l g) for sliced or chopped
products
All other vegetables without sauce: fresh, canned, or 85 g for fresh or fro- l piece(s) (l g) for large pieces (e.g.,
frozen. zen; 95 g for vac- brussel sprouts); l cup(s) (l g) for
uum packed; 130 small pieces (e.g., cut corn, green
g for canned in peas); 3 oz (84 g/visual unit of meas-
liquid, cream-style ure) if not measurable by cup 13
corn, canned or
stewed tomatoes,
pumpkin, or win-
ter squash.
All other vegetables with sauce: fresh, canned, or fro- 110 g ...................... l piece(s) (l g) for large pieces (e.g.,
zen. brussel sprouts); l cup(s) (l g) for
small pieces (e.g., cut corn, green

peas); 4 oz (112 g/visual unit of meas-
ure) if not measurable by cup
Vegetable juice ............................................................ 240 mL ................... 8 fl oz (240 mL)
56
Olives 11 ........................................................................ 15 g ........................ l piece(s) (l g); l tbsp(s) (l g) for

sliced products
Pickles, all types 11 ....................................................... 30 g ........................ 1 oz (28 g/visual unit of measure)
Pickle relishes .............................................................. 15 g ........................ l tbsp (l g)
Vegetable pastes, e.g., tomato paste .......................... 30 g ........................ l tbsp (l g)
Vegetable sauces or purees, e.g, tomato sauce, to- 60 g ........................ l cup (l g); l cup (l mL)
mato puree.
1 These values represent the amount (edible portion) of food customarily consumed per eating occasion and were primarily de-
rived from the 1977–1978 and the 1987–1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of
Argiculture.
2 Unless otherwise noted in the Reference Amount column, the reference amounts are for the ready-to-serve or almost ready-
to-serve form of the product (i.e., heat and serve, brown and serve). If not listed separately, the reference amount for the unpre-
pared form (e.g., dry mixes; concentrates; dough; batter; fresh and frozen pasta) is the amount required to make the reference
amount of the prepared form. Prepared means prepared for consumption (e.g., cooked).
3 Manufacturers are required to convert the reference amount to the label serving size in a household measure most appro-
priate to their specific product using the procedures in 21 CFR 101.9(b).
4 Copies of the list of products for each product category are available from the Office of Nutritional Products, Labeling and Di-
etary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740.
5 The label statements are meant to provide guidance to manufacturers on the presentation of serving size information on the
label, but they are not required. The term ‘‘piece’’ is used as a generic description of a discrete unit. Manufacturers should use
the description of a unit that is most appropriate for the specific product (e.g., sandwich for sandwiches, cookie for cookies, and
bar for ice cream bars). The guidance provided is for the label statement of products in ready-to-serve or almost ready-to-serve
form. The guidance does not apply to the products which require further preparation for consumption (e.g., dry mixes, con-
centrates) unless specifically stated in the product category, reference amount, or label statement column that it is for these
forms of the product. For products that require further preparation, manufacturers must determine the label statement following
the rules in § 101.9(b) using the reference amount determined according to § 101.12(c).
6 Includes cakes that weigh 10 g or more per cubic inch.
7 Includes cakes that weigh 4 g or more per cubic inch but less than 10 g per cubic inch.
8 Includes cakes that weigh less than 4 g per cubic inch.
9 Label serving size for ice cream cones and eggs of all sizes will be 1 unit. Label serving size of all chewing gums that weigh
more than the reference amount that can reasonably be consumed at a single-eating occasion will be 1 unit.
10 Animal products not covered under the Federal Meat Inspection Act or the Poultry Products Inspection Act, such as flesh
products from deer, bison, rabbit, quail, wild turkey, geese, ostrich, etc.
11 If packed or canned in liquid, the reference amount is for the drained solids, except for products in which both the solids and
liquids are customarily consumed (e.g., canned chopped clam in juice).
12 The reference amount for the uncooked form does not apply to raw fish in § 101.45 or to single-ingredient products that con-
sist of fish or game meat as provided for in § 101.9(b)(j)(11).
13 For raw fruit, vegetables, and fish, manufacturers should follow the label statement for the serving size specified in Appen-
dices A and B to the regulation entitled ‘‘Food Labeling; Guidelines for Voluntary Nutrition Labeling; and Identification of the 20
Most Frequently Consumed Raw Fruits, Vegetables, and Fish; Definition of Substantial Compliance; Correction’’ (56 FR 60880
as amended 57 FR 8174, March 6, 1992).
14 Pizza sauce is part of the pizza and is not considered to be sauce topping.
(c) If a product requires further prep- product required to make the fraction
aration, e.g., cooking or the addition of of the large discrete unit closest to the
water or other ingredients, and if para- reference amount for the prepared
graph (b) of this section provides a ref- product as established in paragraph (b)
erence amount for the product in the of this section.
prepared but not the unprepared form, (d) The reference amount for an imi-
then the reference amount for the un- tation or substitute food or altered
prepared product shall be determined food, such as a ‘‘low calorie’’ version,
using the following rules: shall be the same as for the food for
(1) Except as provided for in para- which it is offered as a substitute.
graph (c)(2) of this section, the ref- (e) If a food is modified by incor-
erence amount for the unprepared porating air (aerated), and thereby the
product shall be the amount of the un- density of the food is lowered by 25 per-
prepared product required to make the cent or more in weight than that of an
reference amount for the prepared appropriate reference regular food as
product as established in paragraph (b) described in § 101.13(j)(1)(ii)(A), and the
of this section. reference amount of the regular food is
(2) For products where the entire in grams, the manufacturer may deter-
contents of the package is used to pre- mine the reference amount of the aer-
pare one large discrete unit usually di- ated food by adjusting for the dif-
vided for consumption, the reference ference in density of the aerated food
amount for the unprepared product relative to the density of the appro-
shall be the amount of the unprepared priate reference food provided that the
57
§ 101.12 21 CFR Ch. I (4–1–16 Edition)
manufacturer will show FDA detailed (1) For bulk products (e.g., peanut
protocol and records of all data that butter and jelly), the reference amount
were used to determine the density-ad- for the combined product shall be the
justed reference amount for the aer- reference amount, as established in
ated food. The reference amount for paragraph (b) of this section, for the in-
the aerated food shall be rounded to gredient that is represented as the
the nearest 5-g increment. Such prod- main ingredient plus proportioned
ucts shall bear a descriptive term indi- amounts of all minor ingredients.
cating that extra air has been incor- (2) For products where the ingredient
porated (e.g., whipped, aerated). The represented as the main ingredient is
density-adjusted reference amounts de- one or more discrete units (e.g., crack-
scribed in paragraph (b) of this section er and cheese pack, pancakes and
may not be used for cakes except for syrup, cake and frosting), the reference
cheese cake. The differences in the den- amount for the combined product shall
sities of different types of cakes having be either the number of small discrete
different degrees of air incorporation units or the fraction of the large dis-
have already been taken into consider- crete unit that is represented as the
ation in determining the reference main ingredient that is closest to the
amounts for cakes in § 101.12(b). In de-
reference amount for that ingredient as
termining the difference in density of
established in paragraph (b) of this sec-
the aerated and the regular food, the
tion plus proportioned amounts of all
manufacturer shall adhere to the fol-
minor ingredients.
lowing:
(3) If the reference amounts are in
(1) The regular and the aerated prod-
compatible units, they shall be
uct must be the same in size, shape,
and volume. To compare the densities summed (e.g., the reference amount for
of products having nonsmooth surfaces equal volumes of peanut butter and
(e.g., waffles), manufacturers shall use jelly for which peanut butter is rep-
a device or method that ensures that resented as the main ingredient would
the volumes of the regular and the aer- be 4 tablespoons (tbsp) (2 tbsp peanut
ated products are the same. butter plus 2 tbsp jelly). If the ref-
(2) Sample selections for the density erence amounts are in incompatible
measurements shall be done in accord- units, the weights of the appropriate
ance with the provisions in § 101.9(g). volumes should be used (e.g., 110 grams
(3) Density measurements of the reg- (g) pancakes plus the gram weight of
ular and the aerated products shall be the proportioned amount of syrup).
conducted by the same trained oper- (g) The reference amounts set forth
ator using the same methodology (e.g., in paragraphs (b) through (f) of this
the same equipment, procedures, and section shall be used in determining
techniques) under the same conditions. whether a product meets the criteria
(4) Density measurements shall be for nutrient content claims, such as
replicated a sufficient number of times ‘‘low calorie,’’ and for health claims. If
to ensure that the average of the meas- the serving size declared on the prod-
urements is representative of the true uct label differs from the reference
differences in the densities of the reg- amount, and the product meets the cri-
ular and the ‘‘aerated’’ products. teria for the claim only on the basis of
(f) For products that have no ref- the reference amount, the claim shall
erence amount listed in paragraph (b) be followed by a statement that sets
of this section for the unprepared or forth the basis on which the claim is
the prepared form of the product and made. That statement shall include the
that consist of two or more foods pack- reference amount as it appears in para-
aged and presented to be consumed to- graph (b) of this section followed, in
gether (e.g., peanut putter and jelly, parenthesis, by the amount in common
cracker and cheese pack, pancakes and household measure if the reference
syrup, cake and frosting), the reference amount is expressed in measures other
amount for the combined product shall than common household measures
be determined using the following (e.g., for a beverage, ‘‘Very low sodium,
rules: 35 mg or less per 240 mL (8 fl oz)’’).
58
(h) The Commissioner of Food and household measures would be more ap-
Drugs, either on his or her own initia- propriate if products within the same
tive or in response to a petition subcategory differ substantially in den-
mitted pursuant to part 10 of this chap- sity, such as frozen desserts.
ter, may issue a proposal to establish (i) In expressing the reference
or amend a reference amount in para- amounts in milliliters, the following
graph (b) of this section. A petition to rules shall be followed:
establish or amend a reference amount (A) For volumes greater than 30 mil-
shall include: liliters (mL), the volume shall be ex-
(1) Objective of the petition; pressed in multiples of 30 mL.
(2) A description of the product; (B) For volumes less than 30 mL, the
(3) A complete sample product label volume shall be expressed in milliliters
including nutrition label, using the for- equivalent to a whole number of
mat established by regulation; teaspoons or 1 tbsp, i.e., 5, 10, or 15 mL.
(4) A description of the form (e.g., dry (ii) In expressing the reference
mix, frozen dough) in which the prod- amounts in grams, the following gen-
uct will be marketed; eral rules shall be followed:
(5) The intended dietary uses of the (A) For quantities greater than 10 g,
product with the major use identified the quantity shall be expressed in the
(e.g., milk as a beverage and chips as a nearest 5-g increment.
snack);
(B) For quantities less than 10 g,
(6) If the intended use is primarily as
exact gram weights shall be used.
an ingredient in other foods, list of
foods or food categories in which the (11) A petition to create a new sub-
product will be used as an ingredient category of food with its own reference
with information on the prioritization amount shall include the following ad-
of the use; ditional information:
(7) The population group for which (i) Data that demonstrate that the
the product will be offered for use (e.g., new subcategory of food will be con-
infants, children under 4 years of age); sumed in amounts that differ enough
(8) The names of the most closely re- from the reference amount for the par-
lated products (or in the case of foods ent category to warrant a separate ref-
for special dietary use and imitation or erence amount. Data must include
substitute foods, the names of the sample size; and the mean, standard de-
products for which they are offered as viation, median, and modal consumed
substitutes); amount per eating occasion for the pe-
(9) The suggested reference amount titioned product and for other products
(the amount of edible portion of food as in the category, excluding the peti-
consumed, excluding bone, seed, shell, tioned product. All data must be de-
or other inedible components) for the rived from the same survey data.
population group for which the product (ii) Documentation supporting the
is intended with full description of the difference in dietary usage and product
methodology and procedures that were characteristics that affect the con-
used to determine the suggested ref- sumption size that distinguishes the
erence amount. In determining the ref- petitioned product from the rest of the
erence amount, general principles and products in the category.
factors in paragraph (a) of this section (12) A claim for categorical exclusion
should be followed. under § 25.30 or § 25.32 of this chapter or
(10) The suggested reference amount an environmental assessment under
shall be expressed in metric units. Ref- § 25.40 of this chapter, and
erence amounts for fluids shall be ex- (13) In conducting research to collect
pressed in milliliters. Reference or process food consumption data in
amounts for other foods shall be ex- support of the petition, the following
pressed in grams except when common general guidelines should be followed.
household units such as cups, table- (i) Sampled population selected
spoons, and teaspoons, are more appro- should be representative of the demo-
priate or are more likely to promote graphic and socioeconomic characteris-

uniformity in serving sizes declared on tics of the target population group for
product labels. For example, common which the food is intended.
59
§ 101.13 21 CFR Ch. I (4–1–16 Edition)
(ii) Sample size (i.e., number of eat- (i) Describes the food or an ingre-
ers) should be large enough to give reli- dient therein in a manner that sug-
able estimates for customarily con- gests that a nutrient is absent or
sumed amounts. present in a certain amount (e.g.,
(iii) The study protocol should iden- ‘‘high in oat bran’’); or
tify potential biases and describe how (ii) Suggests that the food, because of
potential biases are controlled for or, if its nutrient content, may be useful in
not possible to control, how they affect maintaining healthy dietary practices
interpretation of results. and is made in association with an ex-
(iv) The methodology used to collect plicit claim or statement about a nu-
or process data should be fully docu- trient (e.g., ‘‘healthy, contains 3 grams
mented and should include: study de- (g) of fat’’).
sign, sampling procedures, materials (3) Except for claims regarding vita-
used (e.g., questionnaire, and inter- mins and minerals described in para-
viewer’s manual), procedures used to graph (q)(3) of this section, no nutrient
collect or process data, methods or pro- content claims may be made on food
cedures used to control for unbiased es- intended specifically for use by infants
timates, and procedures used to correct and children less than 2 years of age
for nonresponse. unless the claim is specifically pro-
(14) A statement concerning the fea- vided for in parts 101, 105, or 107 of this
sibility of convening associations, cor- chapter.
porations, consumers, and other inter- (4) Reasonable variations in the spell-
ested parties to engage in negotiated ing of the terms defined in part 101 and
rulemaking to develop a proposed rule
their synonyms are permitted provided
consistent with the Negotiated Rule-
these variations are not misleading
making Act (5 U.S.C. 561).
(e.g., ‘‘hi’’ or ‘‘lo’’).
[58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. (5) For dietary supplements, claims
15, 1993, as amended at 59 FR 371, Jan. 4, 1994; for calories, fat, saturated fat, and cho-
59 FR 24039, May 10, 1994; 62 FR 40598, July 29, lesterol may not be made on products
1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14818,
Mar. 27, 1998; 64 FR 12890, Mar. 16, 1999; 66 FR
that meet the criteria in § 101.60(b)(1) or
56035, Nov. 6, 2001] (b)(2) for ‘‘calorie free’’ or ‘‘low cal-
orie’’ claims, except, in the case of cal-
§ 101.13 Nutrient content claims—gen- orie claims, when an equivalent
eral principles. amount of a similar dietary supple-
(a) This section and the regulations ment (e.g., another protein supple-
in subpart D of this part apply to foods ment) that the labeled food resembles
that are intended for human consump- and for which it substitutes, normally
tion and that are offered for sale, in- exceeds the definition for ‘‘low calorie’’
cluding conventional foods and dietary in § 101.60(b)(2).
supplements. (c) Information that is required or
(b) A claim that expressly or implic- permitted by § 101.9 or § 101.36, as appli-
itly characterizes the level of a nutri- cable, to be declared in nutrition label-
ent of the type required to be in nutri- ing, and that appears as part of the nu-
tion labeling under § 101.9 or under trition label, is not a nutrient content
§ 101.36 (that is, a nutrient content claim and is not subject to the require-
claim) may not be made on the label or ments of this section. If such informa-
in labeling of foods unless the claim is tion is declared elsewhere on the label
made in accordance with this regula- or in labeling, it is a nutrient content
tion and with the applicable regula- claim and is subject to the require-
tions in subpart D of this part or in ments for nutrient content claims.
part 105 or part 107 of this chapter. (d) A ‘‘substitute’’ food is one that
(1) An expressed nutrient content may be used interchangeably with an-
claim is any direct statement about other food that it resembles, i.e., that
the level (or range) of a nutrient in the it is organoleptically, physically, and
food, e.g., ‘‘low sodium’’ or ‘‘contains functionally (including shelf life) simi-
100 calories.’’ lar to, and that it is not nutritionally

(2) An implied nutrient content claim inferior to unless it is labeled as an
is any claim that: ‘‘imitation.’’
60
(1) If there is a difference in perform- and children less than 2 years of age,
ance characteristics that materially contains more than 13.0 g of fat, 4.0 g of
limits the use of the food, the food may saturated fat, 60 milligrams (mg) of
still be considered a substitute if the cholesterol, or 480 mg of sodium per
label includes a disclaimer adjacent to reference amount customarily con-
the most prominent claim as defined in sumed, per labeled serving, or, for a
paragraph (j)(2)(iii) of this section, in- food with a reference amount custom-
forming the consumer of such dif- arily consumed of 30 g or less or 2 ta-
ference (e.g., ‘‘not recommended for blespoons or less, per 50 g (for dehy-
frying’’). drated foods that must be reconsti-
(2) This disclaimer shall be in easily tuted before typical consumption with
legible print or type and in a size no water or a diluent containing an insig-
less than that required by § 101.105(i) nificant amount, as defined in
for the net quantity of contents state- § 101.9(f)(1), of all nutrients per ref-
ment, except where the size of the erence amount customarily consumed,
claim is less than two times the re- the per 50 g criterion refers to the ‘‘as
quired size of the net quantity of con- prepared’’ form), then that food must
tents statement, in which case the dis- bear a statement disclosing that the
claimer shall be no less than one-half nutrient exceeding the specified level
the size of the claim but no smaller is present in the food as follows: ‘‘See
than one-sixteenth of an inch, unless nutrition information for ll content’’
the package complies with § 101.2(c)(5), with the blank filled in with the iden-
in which case the disclaimer may be in tity of the nutrient exceeding the spec-
type of not less than one thirty-second ified level, e.g., ‘‘See nutrition infor-
of an inch. mation for fat content.’’
(e)(1) Because the use of a ‘‘free’’ or (2) If a food is a meal product as de-
‘‘low’’ claim before the name of a food fined in § 101.13(l), and contains more
implies that the food differs from other than 26 g of fat, 8.0 g of saturated fat,
foods of the same type by virtue of its 120 mg of cholesterol, or 960 mg of so-
having a lower amount of the nutrient, dium per labeled serving, then that
only foods that have been specially food must disclose, in accordance with
processed, altered, formulated, or re- the requirements as provided in para-
formulated so as to lower the amount graph (h)(1) of this section, that the
of the nutrient in the food, remove the nutrient exceeding the specified level
nutrient from the food, or not include is present in the food.
the nutrient in the food, may bear such (3) If a food is a main dish product as
a claim (e.g., ‘‘low sodium potato defined in § 101.13(m), and contains
chips’’). more than 19.5 g of fat, 6.0 g of satu-
(2) Any claim for the absence of a nu- rated fat, 90 mg of cholesterol, or 720
trient in a food, or that a food is low in mg of sodium per labeled serving, then
a nutrient when the food has not been that food must disclose, in accordance
specially processed, altered, formu- with the requirements as provided in
lated, or reformulated to qualify for paragraph (h)(1) of this section, that
that claim shall indicate that the food the nutrient exceeding the specified
inherently meets the criteria and shall level is present in the food.
clearly refer to all foods of that type (4)(i) The disclosure statement ‘‘See
and not merely to the particular brand nutrition information for ll content’’
to which the labeling attaches (e.g., shall be in easily legible boldface print
‘‘corn oil, a sodium-free food’’). or type, in distinct contrast to other
(f) A nutrient content claim shall be printed or graphic matter, and in a size
in type size no larger than two times no less than that required by § 101.105(i)
the statement of identity and shall not for the net quantity of contents state-
be unduly prominent in type style comment, except where the size of the
pared to the statement of identity. claim is less than two times the re-
(g) [Reserved] quired size of the net quantity of con-
(h)(1) If a food, except a meal product tents statement, in which case the dis-
as defined in § 101.13(l), a main dish closure statement shall be no less than

product as defined in § 101.13(m), or food one-half the size of the claim but no
intended specifically for use by infants smaller than one-sixteenth of an inch,
61
§ 101.13 21 CFR Ch. I (4–1–16 Edition)
unless the package complies with which case the disclaimer shall be no
§ 101.2(c)(2), in which case the disclo- less than one-half the size of the claim
sure statement may be in type of not but no smaller than one-sixteenth of an
less than one thirty-second of an inch. inch unless the package complies with
(ii) The disclosure statement shall be § 101.2(c)(5), in which case the dis-
immediately adjacent to the nutrient claimer may be in type of not less less
content claim and may have no inter- than one thirty-second of an inch, or
vening material other than, if applica- (3) The statement does not in any
ble, other information in the statement way implicitly characterize the level of
of identity or any other information the nutrient in the food and it is not
that is required to be presented with false or misleading in any respect (e.g.,
the claim under this section (e.g., see ‘‘100 calories’’ or ‘‘5 grams of fat’’), in
paragraph (j)(2) of this section) or which case no disclaimer is required.
under a regulation in subpart D of this (4) ‘‘Percent fat free’’ claims are not
part (e.g., see §§ 101.54 and 101.62). If the authorized by this paragraph. Such
nutrient content claim appears on claims shall comply with § 101.62(b)(6).
more than one panel of the label, the (j) A food may bear a statement that
disclosure statement shall be adjacent compares the level of a nutrient in the
to the claim on each panel except for food with the level of a nutrient in a
the panel that bears the nutrition in- reference food. These statements shall
formation where it may be omitted. be known as ‘‘relative claims’’ and in-
(iii) If a single panel of a food label or clude ‘‘light,’’ ‘‘reduced,’’ ‘‘less’’ (or
labeling contains multiple nutrient ‘‘fewer’’), and ‘‘more’’ claims.
content claims or a single claim re- (1) To bear a relative claim about the
peated several times, a single disclo- level of a nutrient, the amount of that
sure statement may be made. The nutrient in the food must be compared
statement shall be adjacent to the to an amount of nutrient in an appro-
claim that is printed in the largest priate reference food as specified
type on that panel. below.
(i) Except as provided in § 101.9 or (i)(A) For ‘‘less’’ (or ‘‘fewer’’) and
§ 101.36, as applicable, or in paragraph ‘‘more’’ claims, the reference food may
(q)(3) of this section, the label or label- be a dissimilar food within a product
ing of a product may contain a state- category that can generally be sub-
ment about the amount or percentage stituted for one another in the diet
of a nutrient if: (e.g., potato chips as reference for pret-
(1) The use of the statement on the zels, orange juice as a reference for vi-
food implicitly characterizes the level tamin C tablets) or a similar food (e.g.,
of the nutrient in the food and is con- potato chips as reference for potato
sistent with a definition for a claim, as chips, one brand of multivitamin as
provided in subpart D of this part, for reference for another brand of multi-
the nutrient that the label addresses. vitamin).
Such a claim might be, ‘‘less than 3 g (B) For ‘‘light,’’ ‘‘reduced,’’ ‘‘added,’’
of fat per serving;’’ ‘‘extra,’’ ‘‘plus,’’ ‘‘fortified,’’ and ‘‘en-
(2) The use of the statement on the riched’’ claims, the reference food shall
food implicitly characterizes the level be a similar food (e.g., potato chips as
of the nutrient in the food and is not a reference for potato chips, one brand
consistent with such a definition, but of multivitamin for another brand of
the label carries a disclaimer adjacent multivitamin), and
to the statement that the food is not (ii)(A) For ‘‘light’’ claims, the ref-
‘‘low’’ in or a ‘‘good source’’ of the nu- erence food shall be representative of
trient, such as ‘‘only 200 mg sodium per the type of food that includes the prod-
serving, not a low sodium food.’’ The uct that bears the claim. The nutrient
disclaimer must be in easily legible value for the reference food shall be
print or type and in a size no less than representative of a broad base of foods
that required by § 101.105(i) for the net of that type; e.g., a value in a rep-
quantity of contents statement except resentative, valid data base; an average
where the size of the claim is less than value determined from the top three
two times the required size of the net national (or regional) brands, a market
quantity of contents statement, in basket norm; or, where its nutrient
62
value is representative of the food (A) A claim on the principal display

type, a market leader. Firms using panel adjacent to the statement of
such a reference nutrient value as a identity;
basis for a claim, are required to pro- (B) A claim elsewhere on the prin-
vide specific information upon which cipal display panel;
the nutrient value was derived, on re- (C) A claim on the information panel;
quest, to consumers and appropriate or
regulatory officials. (D) A claim elsewhere on the label or
(B) For relative claims other than labeling.
‘‘light,’’ including ‘‘less’’ and ‘‘more’’ (iv) The label or labeling must also
claims, the reference food may be the bear:
same as that provided for ‘‘light’’ in (A) Clear and concise quantitative in-
paragraph (j)(1)(ii)(A) of this section, formation comparing the amount of
or it may be the manufacturer’s reg- the subject nutrient in the product per
ular product, or that of another manu- labeled serving with that in the ref-
facturer, that has been offered for sale erence food; and
to the public on a regular basis for a (B) This statement shall appear adja-
substantial period of time in the same cent to the most prominent claim or to
geographic area by the same business the nutrition label, except that if the
entity or by one entitled to use its nutrition label is on the information
trade name. The nutrient values used panel, the quantitative information
to determine the claim when com- may be located elsewhere on the infor-
paring a single manufacturer’s product mation panel in accordance with § 101.2.
to the labeled product shall be either (3) A relative claim for decreased lev-
the values declared in nutrition label- els of a nutrient may not be made on
ing or the actual nutrient values, pro- the label or in labeling of a food if the
vided that the resulting label is inter- nutrient content of the reference food
nally consistent to (i.e., that the val- meets the requirement for a ‘‘low’’
ues stated in the nutrition informa- claim for that nutrient (e.g., 3 g fat or
tion, the nutrient values in the accom- less).
panying information and the declara- (k) The term ‘‘modified’’ may be used
tion of the percentage of nutrient by in the statement of identity of a food
which the food has been modified are that bears a relative claim that com-
plies with the requirements of this
consistent and will not cause consumer
part, followed immediately by the
confusion when compared), and that
name of the nutrient whose content
the actual modification is at least
has been altered (e.g., ‘‘Modified fat
equal to the percentage specified in the cheesecake’’). This statement of iden-
definition of the claim. tity must be immediately followed by
(2) For foods bearing relative claims: the comparative statement such as
(i) The label or labeling must state ‘‘Contains 35 percent less fat than
the identity of the reference food and lll.’’ The label or labeling must also
the percentage (or fraction) of the bear the information required by para-
amount of the nutrient in the reference graph (j)(2) of this section in the man-
food by which the nutrient in the la- ner prescribed.
beled food differs (e.g., ‘‘50 percent less (l) For purposes of making a claim, a
fat than (reference food)’’ or ‘‘1/3 fewer ‘‘meal product shall be defined as a
calories than (reference food)’’), food that:
(ii) This information shall be imme- (1) Makes a major contribution to the
diately adjacent to the most prominent total diet by:
claim. The type size shall be in accord- (i) Weighing at least 10 ounces (oz)
ance with paragraph (h)(4)(i) of this per labeled serving; and
section. (ii) Containing not less than three 40-
(iii) The determination of which use g portions of food, or combinations of
of the claim is in the most prominent foods, from two or more of the fol-
location on the label or labeling will be lowing four food groups, except as
made based on the following factors, noted in paragraph (l)(1)(ii)(E) of this
considered in order: section.
63
§ 101.13 21 CFR Ch. I (4–1–16 Edition)
(A) Bread, cereal, rice, and pasta determining compliance with nutrition
group; labeling in § 101.9.
(B) Fruits and vegetables group; (p)(1) Unless otherwise specified, the
(C) Milk, yogurt, and cheese group; reference amount customarily con-
(D) Meat, poultry, fish, dry beans, sumed set forth in § 101.12(b) through (f)
eggs, and nuts group; except that; shall be used in determining whether a
(E) These foods shall not be sauces product meets the criteria for a nutri-
(except for foods in the above four food ent content claim. If the serving size
groups that are in the sauces), gravies, declared on the product label differs
condiments, relishes, pickles, olives, from the reference amount customarily
jams, jellies, syrups, breadings or consumed, and the amount of the nu-
garnishes; and trient contained in the labeled serving
(2) Is represented as, or is in a form does not meet the maximum or min-
commonly understood to be, a break- imum amount criterion in the defini-
fast, lunch, dinner, or meal. Such rep- tion for the descriptor for that nutri-
resentations may be made either by ent, the claim shall be followed by the
statements, photographs, or vignettes. criteria for the claim as required by
(m) For purposes of making a claim, § 101.12(g) (e.g., ‘‘very low sodium, 35
a ‘‘main dish product’’ shall be defined mg or less per 240 milliliters (8 fl oz.)’’).
as a food that: (2) The criteria for the claim shall be
immediately adjacent to the most
(1) Makes a major contribution to a
prominent claim in easily legible print
meal by
or type and in a size in accordance with
(i) Weighing at least 6 oz per labeled
paragraph (h)(4)(i) of this section.
serving; and
(q) The following exemptions apply:
(ii) Containing not less than 40 g of (1) Nutrient content claims that have
food, or combinations of foods, from not been defined by regulation and that
each of at least two of the following are contained in the brand name of a
four food groups, except as noted in specific food product that was the
paragraph (m)(1)(ii)(E) of this section. brand name in use on such food before
(A) Bread, cereal, rice, and pasta October 25, 1989, may continue to be
group; used as part of that brand name for
(B) Fruits and vegetables group; such product, provided that they are
(C) Milk, yogurt, and cheese group; not false or misleading under section
(D) Meat, poultry, fish, dry beans, 403(a) of the Federal Food, Drug, and
eggs, and nuts groups; except that: Cosmetic Act (the act). However, foods
(E) These foods shall not be sauces bearing such claims must comply with
(except for foods in the above four food section 403(f), (g), and (h) of the act;
groups that are in the sauces) gravies, (2) A soft drink that used the term
condiments, relishes, pickles, olives, diet as part of its brand name before
jams, jellies, syrups, breadings, or October 25, 1989, and whose use of that
garnishes; and term was in compliance with § 105.66 of
(2) Is represented as, or is in a form this chapter as that regulation ap-
commonly understood to be, a main peared in the Code of Federal Regula-
dish (e.g, not a beverage or a dessert). tions on that date, may continue to use
Such representations may be made ei- that term as part of its brand name,
ther by statements, photographs, or vi- provided that its use of the term is not
gnettes. false or misleading under section 403(a)
(n) Nutrition labeling in accordance of the act. Such claims are exempt
with § 101.9, § 101.10, or § 101.36, as appli- from the requirements of section
cable, shall be provided for any food for 403(r)(2) of the act (e.g., the disclosure
which a nutrient content claim is statement also required by § 101.13(h)).
made. Soft drinks marketed after October 25,
(o) Except as provided in § 101.10, 1989, may use the term ‘‘diet’’ provided
compliance with requirements for nu- they are in compliance with the cur-
trient content claims in this section rent § 105.66 of this chapter and the re-
and in the regulations in subpart D of quirements of § 101.13.

this part, will be determined using the (3)(i) A statement that describes the
analytical methodology prescribed for percentage of a vitamin or mineral in
64
the food, including foods intended spe- other establishments in which food is
cifically for use by infants and children served for immediate human consump-
less than 2 years of age, in relation to tion or which is sold for sale or use in
a Reference Daily Intake (RDI) as de- such establishments shall comply with
fined in § 101.9 may be made on the the requirements of this section and
label or in labeling of a food without a the appropriate definition in subpart D
regulation authorizing such a claim for of this part, except that:
a specific vitamin or mineral unless (i) Such claim is exempt from the re-
such claim is expressly prohibited by quirements for disclosure statements
regulation under section 403(r)(2)(A)(vi) in paragraph (h) of this section and
of the act. §§ 101.54(d), 101.62(c), (d)(1)(ii)(D),
(ii) Percentage claims for dietary (d)(2)(iii)(C), (d)(3), (d)(4)(ii)(C), and
supplements. Under section 403(r)(2)(F) (d)(5)(ii)(C); and
of the act, a statement that character- (ii) In lieu of analytical testing, com-
izes the percentage level of a dietary pliance may be determined using a rea-
ingredient for which a reference daily sonable basis for concluding that the
intake (RDI) or daily reference value food that bears the claim meets the
(DRV) has not been established may be definition for the claim. This reason-
made on the label or in labeling of die- able basis may derive from recognized
tary supplements without a regulation data bases for raw and processed foods,
that specifically defines such a state- recipes, and other means to compute
ment. All such claims shall be accom- nutrient levels in the foods or meals
panied by any disclosure statement re- and may be used provided reasonable
quired under paragraph (h) of this sec- steps are taken to ensure that the
tion. method of preparation adheres to the
(A) Simple percentage claims. When- factors on which the reasonable basis
ever a statement is made that charac- was determined (e.g., types and
terizes the percentage level of a die- amounts of ingredients, cooking tem-
tary ingredient for which there is no peratures, etc.). Firms making claims
RDI or DRV, the statement of the ac- on foods based on this reasonable basis
tual amount of the dietary ingredient criterion are required to provide to ap-
per serving shall be declared next to propriate regulatory officials on re-
the percentage statement (e.g., ‘‘40 per- quest the specific information on which
cent omega-3 fatty acids, 10 mg per their determination is based and rea-
capsule’’). sonable assurance of operational adher-
(B) Comparative percentage claims. ence to the preparation methods or
Whenever a statement is made that other basis for the claim; and
characterizes the percentage level of a (iii) A term or symbol that may in
dietary ingredient for which there is no some contexts constitute a claim under
RDI or DRV and the statement draws a this section may be used, provided that
comparison to the amount of the die- the use of the term or symbol does not
tary ingredient in a reference food, the characterize the level of a nutrient,
reference food shall be clearly identi- and a statement that clearly explains
fied, the amount of that food shall be the basis for the use of the term or
identified, and the information on the symbol is prominently displayed and
actual amount of the dietary ingre- does not characterize the level of a nu-
dient in both foods shall be declared in trient. For example, a term such as
accordance with paragraph (j)(2)(iv) of ‘‘lite fare’’ followed by an asterisk re-
this section (e.g., ‘‘twice the omega-3 ferring to a note that makes clear that
fatty acids per capsule (80 mg) as in 100 in this restaurant ‘‘lite fare’’ means
mg of menhaden oil (40 mg)’’). smaller portion sizes than normal; or
(4) The requirements of this section an item bearing a symbol referring to a
do not apply to: note that makes clear that this item
(i) Infant formulas subject to section meets the criteria for the dietary guid-
412(h) of the act; and ance established by a recognized die-
(ii) Medical foods defined by section tary authority would not be considered
5(b) of the Orphan Drug Act. a nutrient content claim under § 101.13.
(5) A nutrient content claim used on (6) Nutrient content claims that were
food that is served in restaurants or part of the common or usual names of
65
§ 101.14 21 CFR Ch. I (4–1–16 Edition)
foods that were subject to a standard of ing loss of essential nutrients, or pro-
identity on November 8, 1990, are not viding energy.
subject to the requirements of para- (4) Disqualifying nutrient levels means
graphs (b) and (h) of this section or to the levels of total fat, saturated fat,
definitions in subpart D of this part. cholesterol, or sodium in a food above
(7) Implied nutrient content claims which the food will be disqualified from
may be used as part of a brand name, making a health claim. These levels
provided that the use of the claim has are 13.0 grams (g) of fat, 4.0 g of satu-
been authorized by the Food and Drug rated fat, 60 milligrams (mg) of choles-
Administration. Petitions requesting terol, or 480 mg of sodium, per ref-
approval of such a claim may be sub- erence amount customarily consumed,
mitted under § 101.69(o). per label serving size, and, only for
(8) The term fluoridated, fluoride foods with reference amounts custom-
added or with added fluoride may be arily consumed of 30 g or less or 2 ta-
used on the label or in labeling of bot- blespoons or less, per 50 g. For dehy-
tled water that contains added fluo- drated foods that must have water
ride. added to them prior to typical con-
sumption, the per 50-g criterion refers
[58 FR 2410, Jan. 6, 1993; 58 FR 17341, 17342,
to the as prepared form. Any one of the
Apr. 2, 1993, as amended at 58 FR 44030, Aug.
18, 1993; 59 FR 393, Jan. 4, 1994; 59 FR 15051, levels, on a per reference amount cus-
Mar. 31, 1994; 60 FR 17205, Apr. 5, 1995; 61 FR tomarily consumed, a per label serving
11731, Mar. 22, 1996; 61 FR 40332, Aug. 2, 1996; size or, when applicable, a per 50 g
61 FR 67452, Dec. 23, 1996; 62 FR 31339, June 9, basis, will disqualify a food from mak-
1997; 62 FR 49867, Sept. 23, 1997; 63 FR 14818, ing a health claim unless an exception
Mar. 27, 1998; 63 FR 26980, May 15, 1998] is provided in subpart E of this part,
except that:
§ 101.14 Health claims: general re- (i) The levels for a meal product as
quirements.
defined in § 101.13(l) are 26.0 g of fat, 8.0
(a) Definitions. For purposes of this g of saturated fat, 120 mg of choles-
section, the following definitions terol, or 960 mg of sodium per label
apply: serving size, and
(1) Health claim means any claim (ii) The levels for a main dish product
made on the label or in labeling of a as defined in § 101.13(m) are 19.5 g of fat,
food, including a dietary supplement, 6.0 g of saturated fat, 90 mg of choles-
that expressly or by implication, in- terol, or 720 mg of sodium per label
cluding ‘‘third party’’ references, writ- serving size.
ten statements (e.g., a brand name in- (5) Disease or health-related condition
cluding a term such as ‘‘heart’’), sym- means damage to an organ, part, struc-
bols (e.g., a heart symbol), or vi- ture, or system of the body such that it
gnettes, characterizes the relationship does not function properly (e.g., cardio-
of any substance to a disease or health- vascular disease), or a state of health
related condition. Implied health leading to such dysfunctioning (e.g.,
claims include those statements, sym- hypertension); except that diseases re-
bols, vignettes, or other forms of com- sulting from essential nutrient defi-
munication that suggest, within the ciencies (e.g., scurvy, pellagra) are not
context in which they are presented, included in this definition (claims per-
that a relationship exists between the taining to such diseases are thereby
presence or level of a substance in the not subject to § 101.14 or § 101.70).
food and a disease or health-related (b) Eligibility. For a substance to be
condition. eligible for a health claim:
(2) Substance means a specific food or (1) The substance must be associated
component of food, regardless of with a disease or health-related condi-
whether the food is in conventional tion for which the general U.S. popu-
food form or a dietary supplement that lation, or an identified U.S. population
includes vitamins, minerals, herbs, or subgroup (e.g., the elderly) is at risk,
other similar nutritional substances. or, alternatively, the petition sub-
(3) Nutritive value means a value in mitted by the proponent of the claim
sustaining human existence by such otherwise explains the prevalence of
processes as promoting growth, replac- the disease or health-related condition
66
in the U.S. population and the rel- (2) When FDA has adopted a regula-
evance of the claim in the context of tion in subpart E of this part providing
the total daily diet and satisfies the for a health claim, firms may make
other requirements of this section. claims based on the regulation in sub-
(2) If the substance is to be consumed part E of this part, provided that:
as a component of a conventional food (i) All label or labeling statements
at decreased dietary levels, the sub- about the substance-disease relation-
stance must be a nutrient listed in 21 ship that is the subject of the claim are
U.S.C. 343(q)(1)(C) or (q)(1)(D), or one based on, and consistent with, the con-
that the Food and Drug Administra- clusions set forth in the regulations in
tion (FDA) has required to be included subpart E of this part;
in the label or labeling under 21 U.S.C. (ii) The claim is limited to describing
343(q)(2)(A); or the value that ingestion (or reduced in-
(3) If the substance is to be consumed gestion) of the substance, as part of a
at other than decreased dietary levels: total dietary pattern, may have on a
(i) The substance must, regardless of particular disease or health-related
whether the food is a conventional food condition;
or a dietary supplement, contribute (iii) The claim is complete, truthful,
taste, aroma, or nutritive value, or any and not misleading. Where factors
other technical effect listed in § 170.3(o) other than dietary intake of the sub-
stance affect the relationship between
of this chapter, to the food and must
the substance and the disease or
retain that attribute when consumed
health-related condition, such factors
at levels that are necessary to justify a
may be required to be addressed in the
claim; and
claim by a specific regulation in sub-
(ii) The substance must be a food or part E of this part;
a food ingredient or a component of a (iv) All information required to be in-
food ingredient whose use at the levels cluded in the claim appears in one
necessary to justify a claim has been place without other intervening mate-
demonstrated by the proponent of the rial, except that the principal display
claim, to FDA’s satisfaction, to be safe panel of the label or labeling may bear
and lawful under the applicable food the reference statement, ‘‘See lll
safety provisions of the Federal Food, for information about the relationship
Drug, and Cosmetic Act. between lll and lll,’’ with the
(c) Validity requirement. FDA will pro- blanks filled in with the location of the
mulgate regulations authorizing a labeling containing the health claim,
health claim only when it determines, the name of the substance, and the dis-
based on the totality of publicly avail- ease or health-related condition (e.g.,
able scientific evidence (including evi- ‘‘See attached pamphlet for informa-
dence from well-designed studies con- tion about calcium and osteoporosis’’),
ducted in a manner which is consistent with the entire claim appearing else-
with generally recognized scientific where on the other labeling, Provided
procedures and principles), that there that, where any graphic material (e.g.,
is significant scientific agreement, a heart symbol) constituting an ex-
among experts qualified by scientific plicit or implied health claim appears
training and experience to evaluate on the label or labeling, the reference
such claims, that the claim is sup- statement or the complete claim shall
ported by such evidence. appear in immediate proximity to such
(d) General health claim labeling re- graphic material;
quirements. (1) When FDA determines (v) The claim enables the public to
that a health claim meets the validity comprehend the information provided
requirements of paragraph (c) of this and to understand the relative signifi-
section, FDA will propose a regulation cance of such information in the con-
in subpart E of this part to authorize text of a total daily diet; and
the use of that claim. If the claim per- (vi) If the claim is about the effects
tains to a substance not provided for in of consuming the substance at de-
§ 101.9 or § 101.36, FDA will propose creased dietary levels, the level of the
amending that regulation to include substance in the food is sufficiently
declaration of the substance. low to justify the claim. To meet this
67
§ 101.14 21 CFR Ch. I (4–1–16 Edition)
requirement, if a definition for use of ments of paragraphs (d)(2)(vi) or

the term low has been established for (d)(2)(vii) of this section and provides
that substance under this part, the sub- that basis upon request.
stance must be present at a level that (3) Nutrition labeling shall be pro-
meets the requirements for use of that vided in the label or labeling of any
term, unless a specific alternative level food for which a health claim is made
has been established for the substance in accordance with § 101.9; for res-
in subpart E of this part. If no defini- taurant foods, in accordance with
tion for ‘‘low’’ has been established, § 101.10; or for dietary supplements, in
the level of the substance must meet accordance with § 101.36.
the level established in the regulation (e) Prohibited health claims. No ex-
authorizing the claim; or
pressed or implied health claim may be
(vii) If the claim is about the effects
made on the label or in labeling for a
of consuming the substance at other
food, regardless of whether the food is
than decreased dietary levels, the level
of the substance is sufficiently high in conventional food form or dietary
and in an appropriate form to justify supplement form, unless:
the claim. To meet this requirement, if (1) The claim is specifically provided
a definition for use of the term high for for in subpart E of this part; and
that substance has been established (2) The claim conforms to all general
under this part, the substance must be provisions of this section as well as to
present at a level that meets the re- all specific provisions in the appro-
quirements for use of that term, unless priate section of subpart E of this part;
a specific alternative level has been es- (3) None of the disqualifying levels
tablished for the substance in subpart identified in paragraph (a)(4) of this
E of this part. If no definition for section is exceeded in the food, unless
‘‘high’’ has been established (e.g., specific alternative levels have been es-
where the claim pertains to a food ei- tablished for the substance in subpart
ther as a whole food or as an ingredient E of this part; or unless FDA has per-
in another food), the claim must speci- mitted a claim despite the fact that a
fy the daily dietary intake necessary disqualifying level of a nutrient is
to achieve the claimed effect, as estab- present in the food based on a finding
lished in the regulation authorizing the that such a claim will assist consumers
claim; Provided That: in maintaining healthy dietary prac-
(A) Where the food that bears the tices, and, in accordance with the regu-
claim meets the requirements of para- lation in subpart E of this part that
graphs (d)(2)(vi) or (d)(2)(vii) of this makes such a finding, the label bears a
section based on its reference amount disclosure statement that complies
customarily consumed, and the labeled with § 101.13(h), highlighting the nutri-
serving size differs from that amount, ent that exceeds the disqualifying
the claim shall be followed by a state- level;
ment explaining that the claim is
(4) Except as provided in paragraph
based on the reference amount rather
(e)(3) of this section, no substance is
than the labeled serving size (e.g.,
present at an inappropriate level as de-
‘‘Diets low in sodium may reduce the
risk of high blood pressure, a disease termined in the specific provision au-
associated with many factors. A serv- thorizing the claim in subpart E of this
ing of l ounces of this product con- part;
forms to such a diet.’’). (5) The label does not represent or
(B) Where the food that bears the purport that the food is for infants and
claim is sold in a restaurant or in other toddlers less than 2 years of age except
establishments in which food that is if the claim is specifically provided for
ready for immediate human consump- in subpart E of this part; and
tion is sold, the food can meet the re- (6) Except for dietary supplements or
quirements of paragraphs (d)(2)(vi) or where provided for in other regulations
(d)(2)(vii) of this section if the firm in part 101, subpart E, the food con-
that sells the food has a reasonable tains 10 percent or more of the Ref-
basis on which to believe that the food erence Daily Intake or the Daily Ref-
that bears the claim meets the require- erence Value for vitamin A, vitamin C,
68
iron, calcium, protein, or fiber per ref- (5) Insufficiency of label space (for
erence amount customarily consumed the prominent placing of such word,
prior to any nutrient addition. statement, or information) resulting
(f) The requirements of this section from the use of label space to give ma-
do not apply to: terially greater conspicuousness to any
(1) Infant formulas subject to section other word, statement, or information,
412(h) of the Federal Food, Drug, and or to any design or device; or
Cosmetic Act, and (6) Smallness or style of type in
(2) Medical foods defined by section which such word, statement, or infor-
5(b) of the Orphan Drug Act. mation appears, insufficient back-
(g) Applicability. The requirements of ground contrast, obscuring designs or
this section apply to foods intended for vignettes, or crowding with other writ-
human consumption that are offered ten, printed, or graphic matter.
for sale, regardless of whether the (b) No exemption depending on insuf-
foods are in conventional food form or ficiency of label space, as prescribed in
dietary supplement form. regulations promulgated under section
[58 FR 2533, Jan. 6, 1993; 58 FR 17097, Apr. 1, 403 (e) or (i) of the act, shall apply if
1993, as amended at 58 FR 44038, Aug. 18, 1993; such insufficiency is caused by:
59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. 31, (1) The use of label space for any
1994; 61 FR 40332, Aug. 2, 1996; 62 FR 49867, word, statement, design, or device
Sept. 23, 1997; 63 FR 26980, May 15, 1998; 66 FR which is not required by or under au-
17358, Mar. 30, 2001]
thority of the act to appear on the
§ 101.15 Food; prominence of required label;
statements. (2) The use of label space to give
greater conspicuousness to any word,
(a) A word, statement, or other infor- statement, or other information than
mation required by or under authority
is required by section 403(f) of the act;
of the act to appear on the label may
or
lack that prominence and conspicuous-
ness required by section 403(f) of the (3) The use of label space for any rep-
act by reason (among other reasons) of: resentation in a foreign language.
(1) The failure of such word, state- (c)(1) All words, statements, and
ment, or information to appear on the other information required by or under
part or panel of the label which is pre- authority of the act to appear on the
sented or displayed under customary label or labeling shall appear thereon
conditions of purchase; in the English language: Provided, how-
(2) The failure of such word, state- ever, That in the case of articles dis-
ment, or information to appear on two tributed solely in the Commonwealth
or more parts or panels of the label, of Puerto Rico or in a Territory where
each of which has sufficient space the predominant language is one other
therefor, and each of which is so de- than English, the predominant lan-
signed as to render it likely to be, guage may be substituted for English.
under customary conditions of pur- (2) If the label contains any represen-
chase, the part or panel displayed; tation in a foreign language, all words,
(3) The failure of the label to extend statements, and other information re-
over the area of the container or pack- quired by or under authority of the act
age available for such extension, so as to appear on the label shall appear
to provide sufficient label space for the thereon in the foreign language: Pro-
prominent placing of such word, state- vided, however, That individual serving-
ment, or information; size packages of foods containing no
(4) Insufficiency of label space (for more than 11⁄2 avoirdupois ounces or no
the prominent placing of such word, more than 11⁄2 fluid ounces served with
statement, or information) resulting meals in restaurants, institutions, and
from the use of label space for any passenger carriers and not intended for
word, statement, design, or device sale at retail are exempt from the re-
which is not required by or under au- quirements of this paragraph (c)(2), if

thority of the act to appear on the the only representation in the foreign
label; language(s) is the name of the food.
69
§ 101.17 21 CFR Ch. I (4–1–16 Edition)
(3) If any article of labeling (other (iii) Products of a net quantity of

than a label) contains any representa- contents of less than 2 ounces that are
tion in a foreign language, all words, designed to release a measured amount
statements, and other information re- of product with each valve actuation.
quired by or under authority of the act (iv) Products of a net quantity of
to appear on the label or labeling shall contents of less than one-half ounce.
appear on such article of labeling. (c) Food containing or manufactured
with a chlorofluorocarbon or other ozone-
§ 101.17 Food labeling warning, notice, depleting substance. Labeling require-
and safe handling statements. ments for foods that contain or are
(a) Self-pressurized containers. (1) The manufactured with a
label of a food packaged in a self-pres- chlorofluorocarbon or other ozone-de-
surized container and intended to be pleting substance designated by the
expelled from the package under pres- Environmental Protection Agency
sure shall bear the following warning: (EPA) are set forth in 40 CFR part 82.
(d) Protein products. (1) The label and
WARNING—Avoid spraying in eyes. Con- labeling of any food product in liquid,
tents under pressure. Do not puncture or in- powdered, tablet, capsule, or similar
cinerate. Do not store at temperature above forms that derives more than 50 per-
120 °F. Keep out of reach of children. cent of its total caloric value from ei-
(2) In the case of products intended ther whole protein, protein hydroly-
for use by children, the phrase ‘‘except sates, amino acid mixtures, or a com-
under adult supervision’’ may be added bination of these, and that is rep-
at the end of the last sentence in the resented for use in reducing weight
warning required by paragraph (a)(1) of shall bear the following warning:
this section. WARNING: Very low calorie protein diets
(3) In the case of products packaged (below 400 Calories per day) may cause seri-
in glass containers, the word ‘‘break’’ ous illness or death. Do Not Use for Weight
may be substituted for the word Reduction in Such Diets Without Medical
‘‘puncture’’ in the warning required by Supervision. Not for use by infants, children,
or pregnant or nursing women.
paragraph (a)(1) of this section.
(4) The words ‘‘Avoid spraying in (2) Products described in paragraph
eyes’’ may be deleted from the warning (d)(1) of this section are exempt from
required by paragraph (a)(1) of this sec- the labeling requirements of that para-
tion in the case of a product not ex- graph if the protein products are rep-
pelled as a spray. resented as part of a nutritionally bal-
(b) Self-pressurized containers with anced diet plan providing 400 or more
halocarbon or hydrocarbon propellants. Calories (kilocalories) per day and the
(1) In addition to the warning required label or labeling of the product speci-
by paragraph (a) of this section, the fies the diet plan in detail or provides
label of a food packaged in a self-pres- a brief description of that diet plan and
surized container in which the propel- adequate information describing where
lant consists in whole or in part of a the detailed diet plan may be obtained
halocarbon or a hydrocarbon shall bear and the label and labeling bear the fol-
the following warning: lowing statement:
Notice: For weight reduction, use only as
WARNING—Use only as directed. Inten-
directed in the accompanying diet plan (the
tional misuse by deliberately concentrating
name and specific location in labeling of the
and inhaling the contents can be harmful or
diet plan may be included in this statement
fatal.
in place of ‘‘accompanying diet plan’’). Do
(2) The warning required by para- not use in diets supplying less than 400 Cal-
graph (b)(1) of this section is not re- ories per day without medical supervision.
quired for the following products: (3) The label and labeling of food
(i) Products expelled in the form of a products represented or intended for
foam or cream, which contain less than dietery (food) supplementation that de-
10 percent propellant in the container. rive more than 50 percent of their total
(ii) Products in a container with a caloric value from either whole pro-
physical barrier that prevents escape of tein, protein hydrolysates, amino acid
the propellant at the time of use. mixtures, or a combination of these,
70
that are represented specifically for nently and conspicuously on the infor-
purposes other than weight reduction; mation panel of the retail package
and that are not covered by the relabel.
quirements of paragraph (d) (1) and (2) (4) The warning statement shall ap-
of this section; shall bear the following pear on any labeling that contains
statement: warnings.
NOTICE: Use this product as a food supple-
(5) The warning statement required
ment only. Do not use for weight reduction. by paragraph (e)(1) of this section shall
be set off in a box by use of hairlines.
(4) The provisions of this paragraph (f) Foods containing psyllium husk. (1)
are separate from and in addition to Foods containing dry or incompletely
any labeling requirements promulgated hydrated psyllium husk, also known as
by the Federal Trade Commission for psyllium seed husk, and bearing a
protein supplements. health claim on the association be-
(5) Protein products shipped in bulk tween soluble fiber from psyllium husk
form for use solely in the manufacture and reduced risk of coronary heart dis-
of other foods and not for distribution ease, shall bear a label statement in-
to consumers in such container are ex- forming consumers that the appro-
empt from the labeling requirements of priate use of such foods requires con-
this paragraph. sumption with adequate amounts of
(6) The warning and notice state- fluids, alerting them of potential con-
ments required by paragraphs (d) (1), sequences of failing to follow usage
(2), and (3) of this section shall appear recommendations, and informing per-
prominently and conspicuously on the sons with swallowing difficulties to
principal display panel of the package avoid consumption of the product (e.g.,
label and any other labeling. ‘‘NOTICE: This food should be eaten
(e) Dietary supplements containing iron with at least a full glass of liquid. Eat-
or iron salts. (1) The labeling of any die- ing this product without enough liquid
tary supplement in solid oral dosage may cause choking. Do not eat this
form (e.g., tablets or capsules) that product if you have difficulty in swal-
contains iron or iron salts for use as an lowing.’’). However, a product in con-
iron source shall bear the following ventional food form may be exempt
statement: from this requirement if a viscous ad-
WARNING: Accidental overdose of iron- hesive mass is not formed when the
containing products is a leading cause of food is exposed to fluids.
fatal poisoning in children under 6. Keep this (2) The statement shall appear promi-
product out of reach of children. In case of nently and conspicuously on the infor-
accidental overdose, call a doctor or poison mation panel or principal display panel
control center immediately.
of the package label and any other la-
(2)(i) The warning statement required beling to render it likely to be read and
by paragraph (e)(1) of this section shall understood by the ordinary individual
appear prominently and conspicuously under customary conditions of pur-
on the information panel of the imme- chase and use. The statement shall be
diate container label. preceded by the word ‘‘NOTICE’’ in
(ii) If a product is packaged in unit- capital letters.
dose packaging, and if the immediate (g) Juices that have not been specifi-
container bears labeling but not a cally processed to prevent, reduce, or
label, the warning statement required eliminate the presence of pathogens. (1)
by paragraph (e)(1) of this section shall For purposes of this paragraph (g),
appear prominently and conspicuously ‘‘juice’’ means the aqueous liquid ex-
on the immediate container labeling in pressed or extracted from one or more
a way that maximizes the likelihood fruits or vegetables, purees of the edi-
that the warning is intact until all of ble portions of one or more fruits or
the dosage units to which it applies are vegetables, or any concentrate of such
used. liquid or puree.
(3) Where the immediate container is (2) The label of:
not the retail package, the warning (i) Any juice that has not been proc-
statement required by paragraph (e)(1) essed in the manner described in para-
of this section shall also appear promi- graph (g)(7) of this section; or
71
§ 101.17 21 CFR Ch. I (4–1–16 Edition)
(ii) Any beverage containing juice nism’’ is the most resistant microorga-
where neither the juice ingredient nor nism of public health significance that
the beverage has been processed in the is likely to occur in the juice.
manner described in paragraph (g)(7) of (h) Shell eggs. (1) The label of all shell
this section, shall bear the following eggs, whether in intrastate or inter-
warning statement: state commerce, shall bear the fol-
WARNING: This product has not been pas-
lowing statement:
teurized and, therefore, may contain harmful SAFE HANDLING INSTRUCTIONS: To
bacteria that can cause serious illness in prevent illness from bacteria: keep eggs re-
children, the elderly, and persons with weak- frigerated, cook eggs until yolks are firm,
ened immune systems. and cook foods containing eggs thoroughly.
(3) The warning statement required (2) The label statement required by
by this paragraph (g) shall not apply to paragraph (h)(1) of this section shall
juice that is not for distribution to re- appear prominently and conspicuously,
tail consumers in the form shipped and with the words ‘‘SAFE HANDLING IN-
that is for use solely in the manufac- STRUCTIONS’’ in bold type, on the
ture of other foods or that is to be principal display panel, the informa-
processed, labeled, or repacked at a tion panel, or on the inside of the lid of
site other than originally processed, egg cartons. If this statement appears
provided that for juice that has not on the inside of the lid, the words
been processed in the manner described ‘‘Keep Refrigerated’’ must appear on
in paragraph (g)(7) of this section, the the principal display panel or informa-
lack of such processing is disclosed in tion panel.
documents accompanying the juice, in (3) The label statement required by
accordance with the practice of the paragraph (h)(1) of this section shall be
trade. set off in a box by use of hairlines.
(4) The warning statement required (4) Shell eggs that have been, before
by paragraph (g)(2) of this section shall distribution to consumers, specifically
appear prominently and conspicuously processed to destroy all viable Sal-
on the information panel or on the monella shall be exempt from the re-
principal display panel of the label of quirements of paragraph (h) of this sec-
the container. tion.
(5) The word ‘‘WARNING’’ shall be (5) The safe handling statement for
capitalized and shall appear in bold shell eggs that are not for direct sale
type. to consumers, e.g., those that are to be
(6) The warning statement required repacked or labeled at a site other than
by paragraph (g)(2) of this section, where originally processed, or are sold
when on a label, shall be set off in a for use in food service establishments,
box by use of hairlines. may be provided on cartons or in label-
(7)(i) The requirements in this para- ing, e.g., invoices or bills of lading in
graph (g) shall not apply to a juice that accordance with the practice of the
has been processed in a manner that trade.
will produce, at a minimum, a reduc- (6) Under sections 311 and 361 of the
tion in the pertinent microorganism Public Health Service Act (PHS Act),
for a period at least as long as the shelf any State or locality that is willing
life of the product when stored under and able to assist the agency in the en-
normal and moderate abuse conditions, forcement of paragraphs (h)(1) through
of the following magnitude: (h)(5) of this section, and is authorized
(A) A 5-log (i.e., 100,000-fold) reduc- to inspect or regulate establishments
tion; or handling packed shell eggs, may in its
(B) A reduction that is equal to, or own jurisdiction, enforce paragraphs
greater than, the criterion established (h)(1) through (h)(5) of this section
for process controls by any final regu- through inspections under paragraph
lation requiring the application of Haz- (h)(8) of this section and through ad-
ard Analysis and Critical Control Point ministrative enforcement remedies
(HACCP) principles to the processing of identified in paragraph (h)(7) of this
juice. section until FDA notifies the State or

(ii) For the purposes of this para- locality in writing that such assistance
graph (g), the ‘‘pertinent microorga- is no longer needed. When providing
72
such assistance, a State or locality cordance with the EPIA (21 U.S.C. 1031
may follow the hearing procedures set et seq.) or destroyed by or under the su-
out in paragraphs (h)(7)(ii)(C) through pervision of the issuing entity, within
(h)(7)(ii)(D) of this section, sub- 10-working days from the date of re-
stituting, where necessary, appropriate ceipt of the order.
State or local officials for designated (B) Issuance of order. The order shall
FDA officials or may utilize State or include the following information:
local hearing procedures if such proce- (1) A statement that the shell eggs
dures satisfy due process. identified in the order are subject to
(7) This paragraph (h) is established relabeling, diversion for processing in
under authority of both the Federal accordance with the EPIA, or destruc-
Food, Drug, and Cosmetic Act (the act) tion;
and the PHS Act. Under the act, the (2) A detailed description of the facts
agency can enforce the food mis- that justify the issuance of the order;
branding provisions under 21 U.S.C. 331, (3) The location of the eggs;
332, 333, and 334. However, 42 U.S.C. 264 (4) A statement that these eggs shall
provides for the issuance of imple- not be sold, distributed, or otherwise
menting enforcement regulations; disposed of or moved except as pro-
therefore, FDA has established the fol- vided in paragraph (h)(7)(i)(E) of this
lowing administrative enforcement section;
procedures for the relabeling, diver- (5) Identification or description of
sion, or destruction of shell eggs and the eggs;
informal hearings under the PHS Act: (6) The order number;
(i) Upon finding that any shell eggs (7) The date of the order;
are in violation of this section an au- (8) The text of this entire section;
thorized FDA representative or State (9) A statement that the order may
or local representative in accordance be appealed by written appeal or by re-
with paragraph (h)(6) of this section questing an informal hearing;
may order such eggs to be relabeled (10) The name and phone number of
under the supervision of said represent- the person issuing the order; and
ative, diverted, under the supervision (11) The location and telephone num-
of said representative for processing in ber of the responsible office or agency
accordance with the Egg Products In- and the name of its director.
spection Act (EPIA) (21 U.S.C. 1031 et (C) Approval of director. An order, be-
seq.), or destroyed by or under the su- fore issuance, shall be approved by the
pervision of an officer or employee of director of the office or agency issuing
the FDA, or, if applicable, of the State the order. If prior written approval is
or locality, in accordance with the fol- not feasible, prior oral approval shall
lowing procedures: be obtained and confirmed by written
(A) Order for relabeling, diversion, or memorandum as soon as possible.
destruction under the PHS Act. Any dis- (D) Labeling or marking of shell eggs
trict office of the FDA or any State or under order. An FDA, State, or local
locality acting under paragraph (h)(6) representative issuing an order under
of this section, upon finding shell eggs paragraph (h)(7)(i)(A) of this section
held in violation of this regulation, shall label or mark the shell eggs with
may serve upon the person in whose official tags that include the following
possession such eggs are found a writ- information:
ten order that such eggs be relabeled (1) A statement that the shell eggs
with the required statement in para- are detained in accordance with regula-
graph (h)(1) of this section before fur- tions issued under section 361(a) of the
ther distribution. If the person chooses PHS Act (42 U.S.C. 264(a)).
not to relabel, the district office of the (2) A statement that the shell eggs
FDA or, if applicable, the appropriate shall not be sold, distributed or other-
State or local agency may serve upon wise disposed of or moved except, after
the person a written order that such notifying the issuing entity in writing,
eggs be diverted (from direct consumer to:
sale, e.g., to food service) under the su- (i) Relabel, divert them for proc-
pervision of an officer or employee of essing in accordance with the EPIA, or
the issuing entity, for processing in ac- destroy them, or
73
§ 101.17 21 CFR Ch. I (4–1–16 Edition)
(ii) Move them to another location mitted in connection with the hearing
for holding pending appeal. or from matters officially noticed. If
(3) A statement that the violation of the FDA Regional Food and Drug Di-
the order or the removal or alteration rector determines that a hearing is not
of the tag is punishable by fine or im- justified, written notice of the deter-
prisonment or both (section 368 of the mination will be given to the parties
PHS Act, 42 U.S.C. 271). explaining the reason for denial.
(4) The order number and the date of (C) Informal hearing. Appearance by
the order, and the name of the govern- any appellant at the hearing may be by
ment representative who issued the mail or in person, with or without
order. counsel. The informal hearing shall be
(E) Sale or other disposition of shell conducted by the FDA Regional Food
eggs under order. After service of the and Drug Director or his designee, and
order, the person in possession of the a written summary of the proceedings
shell eggs that are the subject of the shall be prepared by the FDA Regional
order shall not sell, distribute, or oth- Food and Drug Director.
erwise dispose of or move any eggs sub- (1) The FDA Regional Food and Drug
ject to the order unless and until the Director may direct that the hearing
notice is withdrawn after an appeal ex- be conducted in any suitable manner
cept, after notifying FDA’s district of- permitted by law and this section. The
fice or, if applicable, the State or local FDA Regional Food and Drug Director
agency in writing, to: has the power to take such actions and
(1) Relabel, divert, or destroy them make such rulings as are necessary or
as specified in paragraph (h)(7)(i) of appropriate to maintain order and to
this section, or conduct an informal fair, expeditious,
(2) Move them to another location for and impartial hearing, and to enforce
holding pending appeal. the requirements concerning the con-
(ii) The person on whom the order for
duct of hearings.
relabeling, diversion, or destruction is
(2) Employees of FDA will first give a
served may either comply with the
full and complete statement of the ac-
order or appeal the order to the FDA
Regional Food and Drug Director. tion which is the subject of the hear-
(A) Appeal of a detention order. Any ing, together with the information and
appeal shall be submitted in writing to reasons supporting it, and may present
the FDA District Director in whose dis- oral or written information relevant to
trict the shell eggs are located within the hearing. The party requesting the
5-working days of the issuance of the hearing may then present oral or writ-
order. If the appeal includes a request ten information relevant to the hear-
for an informal hearing, the hearing ing. All parties may conduct reason-
shall be held within 5-working days able examination of any person (except
after the appeal is filed or, if requested for the presiding officer and counsel for
by the appellant, at a later date, which the parties) who makes any statement
shall not be later than 20-calendar days on the matter at the hearing.
after the issuance of the order. The (3) The hearing shall be informal in
order may also be appealed within the nature, and the rules of evidence do not
same period of 5-working days by any apply. No motions or objections relat-
other person having an ownership or ing to the admissibility of information
proprietary interest in such shell eggs. and views will be made or considered,
The appellant of an order shall state but any party may comment upon or
the ownership or proprietary interest rebut any information and views pre-
the appellant has in the shell eggs. sented by another party.
(B) Summary decision. A request for a (4) The party requesting the hearing
hearing may be denied, in whole or in may have the hearing transcribed, at
part and at any time after a request for the party’s expense, in which case a
a hearing has been submitted, if the copy of the transcript is to be fur-
FDA Regional Food and Drug Director nished to FDA. Any transcript of the
or his or her designee determines that hearing will be included with the FDA
no genuine and substantial issue of fact Regional Food and Drug Director’s re-
has been raised by the material sub- port of the hearing.
74
(5) The FDA Regional Food and Drug gional Food and Drug Director after an
Director shall prepare a written report appeal and the person in possession of
of the hearing. All written material such eggs fails to relabel, divert, or de-
presented at the hearing will be at- stroy them within 10-working days, the
tached to the report. Whenever time FDA district office, or, if applicable,
permits, the FDA Regional Food and the State or local agency may des-
Drug Director may give the parties the ignate an officer or employee to divert
opportunity to review and comment on or destroy such eggs. It shall be unlaw-
the report of the hearing. ful to prevent or to attempt to prevent
(6) The FDA Regional Food and Drug such diversion or destruction of the
Director shall include as part of the re- shell eggs by the designated officer or
port of the hearing a finding on the employee.
credibility of witnesses (other than ex- (8) Persons engaged in handling or
pert witnesses) whenever credibility is storing packed shell eggs for retail dis-
a material issue, and shall include a tribution shall permit authorized rep-
recommended decision, with a state- resentatives of FDA to make at any
ment of reasons. reasonable time such inspection of the
(D) Written appeal. If the appellant establishment in which shell eggs are
appeals the detention order but does being held, including inspection and
not request a hearing, the FDA Re- sampling of the labeling of such eggs as
gional Food and Drug Director shall may be necessary in the judgment of
render a decision on the appeal affirm- such representatives to determine com-
ing or revoking the detention within 5- pliance with the provisions of this sec-
working days after the receipt of the tion. Inspections may be made with or
appeal. without notice and will ordinarily be
(E) Regional Food and Drug Director made during regular business hours.
decision. If, based on the evidence pre- (9) No State or local governing entity
sented at the hearing or by the appel- shall establish or continue in effect
lant in a written appeal, the FDA Re- any law, rule, regulation, or other re-
gional Food and Drug Director finds quirement requiring safe handling in-
that the shell eggs were held in viola- structions on unpasteurized shell eggs
tion of this section, he shall affirm the that are less stringent than those re-
order that they be relabeled, diverted quired in paragraphs (h)(1) through
under the supervision of an officer or (h)(5) of this section.
employee of the FDA for processing
under the EPIA, or destroyed by or
FR 22033, Apr. 29, 1977; 49 FR 13690, Apr. 6,
under the supervision of an officer or 1984; 49 FR 28548, July 13, 1984; 61 FR 20100,
employee of the FDA; otherwise, the May 3, 1996; 62 FR 2249, Jan. 15, 1997; 63 FR
FDA Regional Food and Drug Director 8118, Feb. 18, 1998; 63 FR 37055, July 8, 1998; 63
shall issue a written notice that the FR 63982, Nov. 18, 1998; 66 FR 17358, Mar. 30,
prior order is withdrawn. If the FDA 2001; 65 FR 76111, Dec. 5, 2000; 72 FR 46378,
Regional Food and Drug Director af- Aug. 20, 2007]
firms the order he shall order that the
relabeling, diversion, or destruction be § 101.18 Misbranding of food.
accomplished within 10-working days (a) Among representations in the la-
from the date of the issuance of his de- beling of a food which render such food
cision. The FDA Regional Food and misbranded is a false or misleading
Drug Director’s decision shall be ac- representation with respect to another
companied by a statement of the rea- food or a drug, device, or cosmetic.
sons for the decision. The decision of (b) The labeling of a food which con-
the FDA Regional Food and Drug Di- tains two or more ingredients may be
rector shall constitute final agency ac- misleading by reason (among other rea-
tion, reviewable in the courts. sons) of the designation of such food in
(F) No appeal. If there is no appeal of such labeling by a name which includes
the order and the person in possession or suggests the name of one or more
of the shell eggs that are subject to the but not all such ingredients, even
order fails to relabel, divert, or destroy though the names of all such ingredi-
them within 10-working days, or if the ents are stated elsewhere in the label-
demand is affirmed by the FDA Re- ing.
75
§ 101.22 21 CFR Ch. I (4–1–16 Edition)
(c) Among representations in the la- name; and from which no portion of
beling of a food which render such food any volatile oil or other flavoring prin-
misbranded is any representation that ciple has been removed. Spices include
expresses or implies a geographical ori- the spices listed in § 182.10 and part 184
gin of the food or any ingredient of the of this chapter, such as the following:
food except when such representation Allspice, Anise, Basil, Bay leaves, Caraway
is either: seed, Cardamon, Celery seed, Chervil, Cin-
(1) A truthful representation of geo- namon, Cloves, Coriander, Cumin seed, Dill
graphical origin. seed, Fennel seed, Fenugreek, Ginger,
(2) A trademark or trade name pro- Horseradish, Mace, Marjoram, Mustard
vided that as applied to the article in flour, Nutmeg, Oregano, Paprika, Parsley,
question its use is not deceptively Pepper, black; Pepper, white; Pepper, red;
misdescriptive. A trademark or trade Rosemary, Saffron, Sage, Savory, Star ani-
seed, Tarragon, Thyme, Turmeric.
name composed in whole or in part of
geographical words shall not be consid- Paprika, turmeric, and saffron or other
ered deceptively misdescriptive if it: spices which are also colors, shall be
(i) Has been so long and exclusively declared as ‘‘spice and coloring’’ unless
used by a manufacturer or distributor declared by their common or usual
that it is generally understood by the name.
consumer to mean the product of a par- (3) The term natural flavor or natural
ticular manufacturer or distributor; or flavoring means the essential oil, oleo-
(ii) Is so arbitrary or fanciful that it resin, essence or extractive, protein hy-
is not generally understood by the con- drolysate, distillate, or any product of
sumer to suggest geographic origin. roasting, heating or enzymolysis,
(3) A part of the name required by ap- which contains the flavoring constitu-
plicable Federal law or regulation. ents derived from a spice, fruit or fruit
(4) A name whose market signifi- juice, vegetable or vegetable juice, edi-
cance is generally understood by the ble yeast, herb, bark, bud, root, leaf or
consumer to connote a particular class, similar plant material, meat, seafood,
kind, type, or style of food rather than poultry, eggs, dairy products, or fer-
to indicate geographical origin. mentation products thereof, whose sig-
nificant function in food is flavoring
Subpart B—Specific Food Labeling rather than nutritional. Natural fla-
Requirements vors include the natural essence or ex-
tractives obtained from plants listed in
§ 101.22 Foods; labeling of spices, §§ 182.10, 182.20, 182.40, and 182.50 and
flavorings, colorings and chemical part 184 of this chapter, and the sub-
preservatives. stances listed in § 172.510 of this chap-
(a)(1) The term artificial flavor or arti- ter.
ficial flavoring means any substance, (4) The term artificial color or artificial
the function of which is to impart fla- coloring means any ‘‘color additive’’ as
vor, which is not derived from a spice, defined in § 70.3(f) of this chapter.
fruit or fruit juice, vegetable or vege- (5) The term chemical preservative
table juice, edible yeast, herb, bark, means any chemical that, when added
bud, root, leaf or similar plant mate- to food, tends to prevent or retard de-
rial, meat, fish, poultry, eggs, dairy terioration thereof, but does not in-
products, or fermentation products clude common salt, sugars, vinegars,
thereof. Artificial flavor includes the spices, or oils extracted from spices,
substances listed in §§ 172.515(b) and substances added to food by direct ex-
182.60 of this chapter except where posure thereof to wood smoke, or
these are derived from natural sources. chemicals applied for their insecticidal
(2) The term spice means any aro- or herbicidal properties.
matic vegetable substance in the (b) A food which is subject to the re-
whole, broken, or ground form, except quirements of section 403(k) of the act
for those substances which have been shall bear labeling, even though such
traditionally regarded as foods, such as food is not in package form.
onions, garlic and celery; whose signifi- (c) A statement of artificial fla-
cant function in food is seasoning rath- voring, artificial coloring, or chemical
er than nutritional; that is true to preservative shall be placed on the food
76
or on its container or wrapper, or on or usual name or may state ‘‘All flavor

any two or all three of these, as may be ingredients contained in this product
necessary to render such statement are approved for use in a regulation of
likely to be read by the ordinary per- the Food and Drug Administration.’’
son under customary conditions of pur- Any flavor ingredient not contained in
chase and use of such food. The specific one of these regulations, and any non-
artificial color used in a food shall be flavor ingredient, shall be separately
identified on the labeling when so re- listed on the label.
quired by regulation in part 74 of this (3) In cases where the flavor contains
chapter to assure safe conditions of use a solely natural flavor(s), the flavor
for the color additive. shall be so labeled, e.g., ‘‘strawberry
(d) A food shall be exempt from com- flavor’’, ‘‘banana flavor’’, or ‘‘natural
pliance with the requirements of sec- strawberry flavor’’. In cases where the
tion 403(k) of the act if it is not in flavor contains both a natural flavor
package form and the units thereof are and an artificial flavor, the flavor shall
so small that a statement of artificial be so labeled, e.g., ‘‘natural and artifi-
flavoring, artificial coloring, or chem- cial strawberry flavor’’. In cases where
ical preservative, as the case may be, the flavor contains a solely artificial
cannot be placed on such units with flavor(s), the flavor shall be so labeled,
such conspicuousness as to render it e.g., ‘‘artificial strawberry flavor’’.
likely to be read by the ordinary indi- (h) The label of a food to which flavor
vidual under customary conditions of is added shall declare the flavor in the
purchase and use. statement of ingredients in the fol-
(e) A food shall be exempt while held lowing way:
for sale from the requirements of sec- (1) Spice, natural flavor, and artifi-
tion 403(k) of the act (requiring label cial flavor may be declared as ‘‘spice’’,
statement of any artificial flavoring, ‘‘natural flavor’’, or ‘‘artificial flavor’’,
artificial coloring, or chemical preserv- or any combination thereof, as the case
atives) if said food, having been re- may be.
ceived in bulk containers at a retail es- (2) An incidental additive in a food,
tablishment, is displayed to the pur- originating in a spice or flavor used in
chaser with either (1) the labeling of the manufacture of the food, need not
the bulk container plainly in view or be declared in the statement of ingredi-
(2) a counter card, sign, or other appro- ents if it meets the requirements of
priate device bearing prominently and § 101.100(a)(3).
conspicuously the information required (3) Substances obtained by cutting,
to be stated on the label pursuant to grinding, drying, pulping, or similar
section 403(k). processing of tissues derived from fruit,
(f) A fruit or vegetable shall be ex- vegetable, meat, fish, or poultry, e.g.,
empt from compliance with the re- powdered or granulated onions, garlic
quirements of section 403(k) of the act powder, and celery powder, are com-
with respect to a chemical preservative monly understood by consumers to be
applied to the fruit or vegetable as a food rather than flavor and shall be de-
pesticide chemical prior to harvest. clared by their common or usual name.
(g) A flavor shall be labeled in the (4) Any salt (sodium chloride) used as
following way when shipped to a food an ingredient in food shall be declared
manufacturer or processor (but not a by its common or usual name ‘‘salt.’’
consumer) for use in the manufacture (5) Any monosodium glutamate used
of a fabricated food, unless it is a fla- as an ingredient in food shall be de-
vor for which a standard of identity clared by its common or usual name
has been promulgated, in which case it ‘‘monosodium glutamate.’’
shall be labeled as provided in the (6) Any pyroligneous acid or other ar-
standard: tificial smoke flavors used as an ingre-
(1) If the flavor consists of one ingredient in a food may be declared as arti-
dient, it shall be declared by its com- ficial flavor or artificial smoke flavor.
mon or usual name. No representation may be made, either
(2) If the flavor consists of two or directly or implied, that a food fla-
more ingredients, the label either may vored with pyroligneous acid or other
declare each ingredient by its common artificial smoke flavor has been
77
§ 101.22 21 CFR Ch. I (4–1–16 Edition)
smoked or has a true smoked flavor, or (ii) If none of the natural flavor used
that a seasoning sauce or similar prod- in the food is derived from the product
uct containing pyroligneous acid or whose flavor is simulated, the food in
other artificial smoke flavor and used which the flavor is used shall be la-
to season or flavor other foods will re- beled either with the flavor of the prod-
sult in a smoked product or one having uct from which the flavor is derived or
a true smoked flavor. as ‘‘artificially flavored.’’
(7) Because protein hydrolysates (iii) If the food contains both a char-
function in foods as both flavorings and acterizing flavor from the product
flavor enhancers, no protein hydroly- whose flavor is simulated and other
sate used in food for its effects on fla- natural flavor which simulates, resem-
vor may be declared simply as ‘‘fla- bles or reinforces the characterizing
vor,’’ ‘‘natural flavor,’’ or ‘‘flavoring.’’ flavor, the food shall be labeled in ac-
The ingredient shall be declared by its cordance with the introductory text
specific common or usual name as pro- and paragraph (i)(1)(i) of this section
vided in § 102.22 of this chapter. and the name of the food shall be im-
(i) If the label, labeling, or adver- mediately followed by the words ‘‘with
tising of a food makes any direct or in- other natural flavor’’ in letters not less
direct representations with respect to than one-half the height of the letters
the primary recognizable flavor(s), by used in the name of the characterizing
word, vignette, e.g., depiction of a flavor.
fruit, or other means, or if for any (2) If the food contains any artificial
other reason the manufacturer or dis- flavor which simulates, resembles or
tributor of a food wishes to designate reinforces the characterizing flavor,
the type of flavor in the food other the name of the food on the principal
than through the statement of ingredi- display panel or panels of the label
ents, such flavor shall be considered shall be accompanied by the common
the characterizing flavor and shall be or usual name(s) of the characterizing
declared in the following way: flavor, in letters not less than one-half
(1) If the food contains no artificial the height of the letters used in the
flavor which simulates, resembles or name of the food and the name of the
reinforces the characterizing flavor, characterizing flavor shall be accom-
the name of the food on the principal panied by the word(s) ‘‘artificial’’ or
display panel or panels of the label ‘‘artificially flavored’’, in letters not
shall be accompanied by the common less than one-half the height of the let-
or usual name of the characterizing fla- ters in the name of the characterizing
vor, e.g., ‘‘vanilla’’, in letters not less flavor, e.g., ‘‘artificial vanilla’’, ‘‘arti-
than one-half the height of the letters ficially flavored strawberry’’, or ‘‘grape
used in the name of the food, except artificially flavored’’.
that: (3) Wherever the name of the charac-
(i) If the food is one that is com- terizing flavor appears on the label
monly expected to contain a character- (other than in the statement of ingre-
izing food ingredient, e.g., strawberries dients) so conspicuously as to be easily
in ‘‘strawberry shortcake’’, and the seen under customary conditions of
food contains natural flavor derived purchase, the words prescribed by this
from such ingredient and an amount of paragraph shall immediately and con-
characterizing ingredient insufficient spicuously precede or follow such
to independently characterize the food, name, without any intervening writ-
or the food contains no such ingre- ten, printed, or graphic matter, except:
dient, the name of the characterizing (i) Where the characterizing flavor
flavor may be immediately preceded by and a trademark or brand are pre-
the word ‘‘natural’’ and shall be imme- sented together, other written, printed,
diately followed by the word ‘‘fla- or graphic matter that is a part of or is
vored’’ in letters not less than one-half associated with the trademark or
the height of the letters in the name of brand may intervene if the required
the characterizing flavor, e.g., ‘‘natural words are in such relationship with the
strawberry flavored shortcake,’’ or trademark or brand as to be clearly re-
‘‘strawberry flavored shortcake’’. lated to the characterizing flavor; and
78
(ii) If the finished product contains under section 303(c)(2) of the act shall
more than one flavor subject to the re- be applicable to the certifications pro-
quirements of this paragraph, the vided for in this section.
statements required by this paragraph (ii) Wherever possible, the Food and
need appear only once in each state- Drug Administration shall verify the
ment of characterizing flavors present accuracy of a reasonable number of
in such food, e.g., ‘‘artificially flavored certifications made pursuant to this
vanilla and strawberry’’. section, constituting a representative
(iii) If the finished product contains sample of such certifications, and shall
three or more distinguishable charac- not request all such certifications.
terizing flavors, or a blend of flavors
(iii) Where no person authorized to
with no primary recognizable flavor,
the flavor may be declared by an appro- provide such information is reasonably
priately descriptive generic term in available at the time of inspection, the
lieu of naming each flavor, e.g., ‘‘arti- certifying party shall arrange to have
ficially flavored fruit punch’’. such person and the relevant materials
(4) A flavor supplier shall certify, in and records ready for verification as
writing, that any flavor he supplies soon as practicable: Provided, That,
which is designated as containing no whenever the Food and Drug Adminis-
artificial flavor does not, to the best of tration has reason to believe that the
his knowledge and belief, contain any supplier or user may utilize this period
artificial flavor, and that he has added to alter inventories or records, such ad-
no artificial flavor to it. The require- ditional time shall not be permitted.
ment for such certification may be sat- Where such additional time is pro-
isfied by a guarantee under section vided, the Food and Drug Administra-
303(c)(2) of the act which contains such tion may require the certifying party
a specific statement. A flavor user to certify that relevant inventories
shall be required to make such a writ- have not been materially disturbed and
ten certification only where he adds to relevant records have not been altered
or combines another flavor with a fla- or concealed during such period.
vor which has been certified by a flavor (iv) The certifying party shall pro-
supplier as containing no artificial fla-
vide, to an officer or representative
vor, but otherwise such user may rely
duly designated by the Secretary, such
upon the supplier’s certification and
need make no separate certification. qualitative statement of the composi-
All such certifications shall be re- tion of the flavor or product covered by
tained by the certifying party through- the certification as may be reasonably
out the period in which the flavor is expected to enable the Secretary’s rep-
supplied and for a minimum of three resentatives to determine which rel-
years thereafter, and shall be subject evant raw and finished materials and
to the following conditions: flavor ingredient records are reason-
(i) The certifying party shall make ably necessary to verify the certifi-
such certifications available upon re- cations. The examination conducted by
quest at all reasonable hours to any the Secretary’s representative shall be
duly authorized office or employee of limited to inspection and review of in-
the Food and Drug Administration or ventories and ingredient records for
any other employee acting on behalf of those certifications which are to be
the Secretary of Health and Human verified.
Services. Such certifications are re- (v) Review of flavor ingredient
garded by the Food and Drug Adminis- records shall be limited to the quali-
tration as reports to the government tative formula and shall not include
and as guarantees or other under- the quantitative formula. The person
takings within the meaning of section verifying the certifications may make
301(h) of the act and subject the certi- only such notes as are necessary to en-
fying party to the penalties for making
able him to verify such certification.
any false report to the government
Only such notes or such flavor ingre-

under 18 U.S.C. 1001 and any false guar-
antee or undertaking under section dient records as are necessary to verify
303(a) of the act. The defenses provided
79
§ 101.30 21 CFR Ch. I (4–1–16 Edition)
such certification or to show a poten- be declared as ‘‘Artificial Color,’’ ‘‘Ar-

tial or actual violation may be re- tificial Color Added,’’ or ‘‘Color Added’’
moved or transmitted from the certi- (or by an equally informative term
fying party’s place of business: Pro- that makes clear that a color additive
vided, That, where such removal or has been used in the food). Alter-
transmittal is necessary for such pur- natively, such color additives may be
poses the relevant records and notes declared as ‘‘Colored with
shall be retained as separate docu- llllllll’’ or ‘‘llllllll
ments in Food and Drug Administra- color,’’ the blank to be filled in with
tion files, shall not be copied in other the name of the color additive listed in
reports, and shall not be disclosed pub- the applicable regulation in part 73 of
licly other than in a judicial pro- this chapter.
ceeding brought pursuant to the act or (3) When a coloring has been added to
18 U.S.C. 1001. butter, cheese, or ice cream, it need
(j) A food to which a chemical pre- not be declared in the ingredient list
servative(s) is added shall, except when unless such declaration is required by a
exempt pursuant to § 101.100 bear a regulation in part 73 or part 74 of this
label declaration stating both the com- chapter to ensure safe conditions of use
mon or usual name of the ingredient(s)
for the color additive. Voluntary dec-
and a separate description of its func-
laration of all colorings added to but-
tion, e.g., ‘‘preservative’’, ‘‘to retard
ter, cheese, and ice cream, however, is
spoilage’’, ‘‘a mold inhibitor’’, ‘‘to help
recommended.
protect flavor’’ or ‘‘to promote color
retention’’. [42 FR 14308, Mar. 15, 1977, as amended at 44
(k) The label of a food to which any FR 3963, Jan. 19, 1979; 44 FR 37220, June 26,
coloring has been added shall declare 1979; 54 FR 24891, June 12, 1989; 58 FR 2875,
the coloring in the statement of ingre- Jan. 6, 1993; 63 FR 14818, Mar. 27, 1998; 74 FR
dients in the manner specified in para- 216, Jan. 5, 2009]
graphs (k)(1) and (k)(2) of this section,
except that colorings added to butter, § 101.30 Percentage juice declaration
for foods purporting to be bev-
cheese, and ice cream, if declared, may erages that contain fruit or vege-
be declared in the manner specified in table juice.
paragraph (k)(3) of this section, and
colorings added to foods subject to (a) This section applies to any food
§§ 105.62 and 105.65 of this chapter shall that purports to be a beverage that
be declared in accordance with the re- contains any fruit or vegetable juice
quirements of those sections. (i.e., the product’s advertising, label, or
(1) A color additive or the lake of a labeling bears the name of, or variation
color additive subject to certification on the name of, or makes any other di-
under 721(c) of the act shall be declared rect or indirect representation with re-
by the name of the color additive listed spect to, any fruit or vegetable juice),
in the applicable regulation in part 74 or the label or labeling bears any vi-
or part 82 of this chapter, except that gnette (i.e., depiction of a fruit or vege-
it is not necessary to include the table) or other pictorial representation
‘‘FD&C’’ prefix or the term ‘‘No.’’ in of any fruit or vegetable, or the prod-
the declaration, but the term ‘‘Lake’’ uct contains color and flavor that gives
shall be included in the declaration of the beverage the appearance and taste
the lake of the certified color additive of containing a fruit or vegetable juice.
(e.g., Blue 1 Lake). Manufacturers may The beverage may be carbonated or
parenthetically declare an appropriate noncarbonated, concentrated, full-
alternative name of the certified color strength, diluted, or contain no juice.
additive following its common or usual For example, a soft drink (soda) that
name as specified in part 74 or part 82 does not represent or suggest by its
of this chapter. physical characteristics, name, label-
(2) Color additives not subject to cer- ing, ingredient statement, or adver-
tification and not otherwise required tising that it contains fruit or vege-
by applicable regulations in part 73 of table juice does not purport to contain

this chapter to be declared by their re- juice and therefore does not require a
spective common or usual names may percent juice declaration.
80
(b)(1) If the beverage contains fruit or percentage declaration as described in

vegetable juice, the percentage shall be paragraph (c) of this section and con-
declared by the words ‘‘Contains l pertains no fruit or vegetable juice, but
cent (or %) lll juice’’ or ‘‘l percent the labeling or color and flavor of the
(or %) juice,’’ or a similar phrase, with beverage represents, suggests, or im-
the first blank filled in with the per- plies that fruit or vegetable juice may
centage expressed as a whole number be present (e.g., the product adver-
not greater than the actual percentage tising or labeling bears the name, a
of the juice and the second blank (if variation of the name, or a pictorial
used) filled in with the name of the representation of any fruit or vege-
particular fruit or vegetable (e.g., table, or the product contains color
‘‘Contains 50 percent apple juice’’ or and flavor that give the beverage the
‘‘50 percent juice’’). appearance and taste of containing a
(2) If the beverage contains less than fruit or vegetable juice), then the label
1 percent juice, the total percentage shall declare ‘‘contains zero (0) percent
juice shall be declared as ‘‘less than 1 (or %) juice’’. Alternatively, the label
percent juice’’ or ‘‘less than 1 percent may declare ‘‘Containing (or contains)
lll juice’’ with the blank filled in no lll juice’’, or ‘‘no lll juice’’, or
with the name of the particular fruit or ‘‘does not contain lll juice’’, the
vegetable. blank to be filled in with the name of
(3) If the beverage contains 100 per- the fruits or vegetables represented,
cent juice and also contains non-juice suggested, or implied, but if there is a
ingredients that do not result in a dim- general suggestion that the product
inution of the juice soluble solids or, in contains fruit or vegetable juice, such
the case of expressed juice, in a change as the presence of fruit pulp, the blank
in the volume, when the 100 percent shall be filled in with the word ‘‘fruit’’
juice declaration appears on a panel of or ‘‘vegetable’’ as applicable (e.g.,
the label that does not also bear the in- ‘‘contains no fruit juice’’, or ‘‘does not
gredient statement, it must be accom- contain fruit juice’’).
panied by the phrase ‘‘with added (e) If the beverage is sold in a pack-
lll,’’ the blank filled in with a term age with an information panel as de-
such as ‘‘ingredient(s),’’ ‘‘preserva- fined in § 101.2, the declaration of
tive,’’ or ‘‘sweetener,’’ as appropriate amount of juice shall be prominently
(e.g., ‘‘100% juice with added sweet- placed on the information panel in
ener’’), except that when the presence lines generally parallel to other re-
of the non-juice ingredient(s) is de- quired information, appearing:
clared as a part of the statement of (1) Near the top of the information
identity of the product, this phrase panel, with no other printed label in-
need not accompany the 100 percent formation appearing above the state-
juice declaration. ment except the brand name, product
(c) If a beverage contains minor name, logo, or universal product code;
amounts of juice for flavoring and is la- and
beled with a flavor description using (2) In easily legible boldface print or
terms such as ‘‘flavor’’, ‘‘flavored’’, or type in distinct contrast to other
‘‘flavoring’’ with a fruit or vegetable printed or graphic matter, in a height
name and does not bear: not less than the largest type found on
(1) The term ‘‘juice’’ on the label the information panel except that used
other than in the ingredient statement; for the brand name, product name,
or logo, universal product code, or the
(2) An explicit vignette depicting the title phrase ‘‘Nutrition Facts’’ appear-
fruit or vegetable from which the fla- ing in the nutrition information as re-
vor derives, such as juice exuding from quired by § 101.9.
a fruit or vegetable; or (f) The percentage juice declaration
(3) Specific physical resemblance to a may also be placed on the principal dis-
juice or distinctive juice characteristic play panel, provided that the declara-
such as pulp then total percentage tion is consistent with that presented
juice declaration is not required. on the information panel.

(d) If the beverage does not meet the (g) If the beverage is sold in a pack-
criteria for exemption from total juice age that does not bear an information
81
§ 101.30 21 CFR Ch. I (4–1–16 Edition)
panel as defined in § 101.2, the percent- 100

age juice declaration shall be placed on Juice percent
juice 1
the principal display panel, in type size
not less than that required for the dec- Watermelon ............................................................... 7.8
laration of net quantity of contents Youngberry ................................................................ 10.0
statement in § 101.105(i), and be placed 1 Indicates
Brix value unless other value specified.
2 Indicates
anhydrous citrus acid percent by weight.
near the name of the food. 3 Brix
values determined by refractometer for citrus juices
(h)(1) In enforcing these regulations, may be corrected for citric acid.
the Food and Drug Administration will
calculate the labeled percentage of (2) If there is no Brix level specified
juice from concentrate found in a juice in paragraph (h)(1) of this section, the
or juice beverage using the minimum labeled percentage of that juice from
Brix levels listed below where single- concentrate in a juice or juice beverage
strength (100 percent) juice has at least will be calculated on the basis of the
the specified minimum Brix listed soluble solids content of the single-
below: strength (unconcentrated) juice used to
produce such concentrated juice.
100
Juice percent (i) Juices directly expressed from a
juice 1 fruit or vegetable (i.e., not con-
Acerola ....................................................................... 6.0 centrated and reconstituted) shall be
Apple .......................................................................... 11.5 considered to be 100 percent juice and
Apricot ........................................................................ 11.7 shall be declared as ‘‘100 percent juice.’’
Banana ...................................................................... 22.0
Blackberry .................................................................. 10.0 (j) Calculations of the percentage of
Blueberry ................................................................... 10.0 juice in a juice blend or a diluted juice
Boysenberry ............................................................... 10.0 product made directly from expressed
Cantaloupe Melon ..................................................... 9.6
Carambola ................................................................. 7.8 juice (i.e., not from concentrate) shall
Carrot ......................................................................... 8.0 be based on the percentage of the ex-
Casaba Melon ........................................................... 7.5 pressed juice in the product computed
Cashew (Caju) ........................................................... 12.0
Celery ........................................................................ 3.1 on a volume/volume basis.
Cherry, dark, sweet ................................................... 20.0 (k) If the product is a beverage that
Cherry, red, sour ....................................................... 14.0 contains a juice whose color, taste, or
Crabapple .................................................................. 15.4
Cranberry ................................................................... 7.5 other organoleptic properties have
Currant (Black) .......................................................... 11.0 been modified to the extent that the
Currant (Red) ............................................................. 10.5 original juice is no longer recognizable
Date ........................................................................... 18.5
Dewberry ................................................................... 10.0 at the time processing is complete, or
Elderberry .................................................................. 11.0 if its nutrient profile has been dimin-
Fig .............................................................................. 18.2 ished to a level below the normal nutri-
Gooseberry ................................................................ 8.3
Grape ......................................................................... 16.0 ent range for the juice, then that juice
Grapefruit ................................................................... 310.0
to which such a major modification has
Guanabana (soursop) ................................................ 16.0 been made shall not be included in the
Guava ........................................................................ 7.7
Honeydew melon ....................................................... 9.6 total percentage juice declaration.
Kiwi ............................................................................ 15.4 (l) A beverage required to bear a per-
Lemon ........................................................................ 2 4.5
centage juice declaration on its label,
Lime ........................................................................... 2 4.5
Loganberry ................................................................. 10.5 that contains less than 100 percent
Mango ........................................................................ 13.0 juice, shall not bear any other percent-
Nectarine ................................................................... 11.8 age declaration that describes the juice
Orange ....................................................................... 311.8
Papaya ....................................................................... 11.5 content of the beverage in its label or

Passion Fruit .............................................................. 14.0 in its labeling (e.g., ‘‘100 percent nat-
Peach ......................................................................... 10.5 ural’’ or ‘‘100 percent pure’’). However,
Pear ........................................................................... 12.0
Pineapple ................................................................... 12.8
the label or labeling may bear percent-
Plum ........................................................................... 14.3 age statements clearly unrelated to
Pomegranate ............................................................. 16.0 juice content (e.g., ‘‘provides 100 per-
Prune ......................................................................... 18.5 cent of U.S. RDA of vitamin C’’).
Quince ....................................................................... 13.3
Raspberry (Black) ...................................................... 11.1 (m) Products purporting to be bev-
Raspberry (Red) ........................................................ 9.2 erages that contain fruit or vegetable
Rhubarb ..................................................................... 5.7 juices are exempted from the provi-

Strawberry ................................................................. 8.0
Tangerine ................................................................... 311.8 sions of this section until May 8, 1994.
Tomato ....................................................................... 5.0 All products that are labeled on or
82
after that date shall comply with this etary supplement in quantitative
section. amounts by weight that exceed the
amount that can be declared as zero in
[58 FR 2925, Jan. 6, 1993, as amended at 58 FR
44063, Aug. 18, 1993; 58 FR 49192, Sept. 22, 1993] nutrition labeling of foods in accord-
ance with § 101.9(c). Calories from satu-
rated fat and polyunsaturated fat,
Subpart C—Specific Nutrition La- monounsaturated fat, soluble fiber, in-
beling Requirements and soluble fiber, sugar alcohol, and other
Guidelines carbohydrate may be declared, but
they shall be declared when a claim is
SOURCE: 55 FR 60890, Nov. 27, 1991, unless made about them. Any other vitamins
otherwise noted. or minerals listed in § 101.9(c)(8)(iv) or
(c)(9) may be declared, but they shall
§ 101.36 Nutrition labeling of dietary be declared when they are added to the
supplements. product for purposes of supplemen-
(a) The label of a dietary supplement tation, or when a claim is made about
that is offered for sale shall bear nutri- them. Any (b)(2)-dietary ingredients
tion labeling in accordance with this that are not present, or that are
regulation unless an exemption is pro- present in amounts that can be de-
vided for the product in paragraph (h) clared as zero in § 101.9(c), shall not be
of this section. declared (e.g., amounts corresponding
(b) The declaration of nutrition infor- to less than 2 percent of the RDI for vi-
mation on the label and in labeling tamins and minerals). Protein shall not
shall contain the following informa- be declared on labels of products that,
tion, using the subheadings and the other than ingredients added solely for
format specified in paragraph (e) of technological reasons, contain only in-
this section. dividual amino acids.
(1) Serving size. (i) The subheading (A) The names and the quantitative
‘‘Serving Size’’ shall be placed under amounts by weight of each (b)(2)-die-
the heading ‘‘Supplement Facts’’ and tary ingredient shall be presented
aligned on the left side of the nutrition under the heading ‘‘Amount Per Serv-
label. The serving size shall be deter- ing.’’ When the quantitative amounts
mined in accordance with §§ 101.9(b) and by weight are presented in a separate
101.12(b), Table 2. Serving size for die- column, the heading may be centered
tary supplements shall be expressed over a column of quantitative
using a term that is appropriate for the amounts, described by paragraph
form of the supplement, such as ‘‘tab- (b)(2)(ii) of this section, if space per-
lets,’’ ‘‘capsules,’’ ‘‘packets,’’ or ‘‘tea- mits. A heading consistent with the
spoonfuls.’’ declaration of the serving size, such as
(ii) The subheading ‘‘Servings Per ‘‘Each Tablet Contains,’’ or ‘‘Amount
Container’’ shall be placed under the Per 2 Tablets’’ may be used in place of
subheading ‘‘Serving Size’’ and aligned the heading ‘‘Amount Per Serving.’’
on the left side of the nutrition label, Other appropriate terms, such as cap-
except that this information need not sule, packet, or teaspoonful, also may
be provided when it is stated in the net be used in place of the term ‘‘Serving.’’
quantity of contents declaration. (B) The names of dietary ingredients
(2) Information on dietary ingredients that are declared under paragraph
that have a Reference Daily Intake (RDI) (b)(2)(i) of this section shall be pre-
or a Daily Reference Value (DRV) as es- sented in a column aligned on the left
tablished in § 101.9(c) and their subcompo- side of the nutrition label in the order
nents (hereinafter referred to as ‘‘(b)(2)- and manner of indentation specified in
dietary ingredients’’). (i) The (b)(2)-die- § 101.9(c), except that calcium and iron
tary ingredients to be declared, that is, shall follow pantothenic acid, and so-
total calories, calories from fat, total dium and potassium shall follow chlo-
fat, saturated fat, trans fat, choles- ride. This results in the following order
terol, sodium, total carbohydrate, die- for vitamins and minerals: Vitamin A,
tary fiber, sugars, protein, vitamin A, vitamin C, vitamin D, vitamin E, vita-

vitamin C, calcium and iron, shall be min K, thiamin, riboflavin, niacin, vi-
declared when they are present in a di- tamin B6, folate, vitamin B12, biotin,
83
§ 101.36 21 CFR Ch. I (4–1–16 Edition)
pantothenic acid, calcium, iron, phos- gredient (e.g., the weight of calcium
phorus, iodine, magnesium, zinc, sele- rather than that of calcium carbonate).
nium, copper, manganese, chromium, (A) These amounts shall be expressed
molybdenum, chloride, sodium, and po- in the increments specified in
tassium. The (b)(2)-dietary ingredients § 101.9(c)(1) through (c)(7), which in-
shall be listed according to the nomen- cludes increments for sodium and po-
clature specified in § 101.9 or in para- tassium.
graph (b)(2)(i)(B)(2) of this section. (B) The amounts of vitamins and
(1) When ‘‘Calories’’ are declared, minerals, excluding sodium and potas-
they shall be listed first in the column sium, shall be the amount of the vita-
of names, beneath a light bar sepa- min or mineral included in one serving
rating the heading ‘‘Amount Per Serv- of the product, using the units of meas-
ing’’ from the list of names. When urement and the levels of significance
‘‘Calories from fat’’ or ‘‘Calories from given in § 101.9(c)(8)(iv), except that
saturated fat’’ are declared, they shall zeros following decimal points may be
be indented beneath ‘‘Calories.’’ dropped, and additional levels of sig-
(2) The following synonyms may be nificance may be used when the num-
added in parentheses immediately fol- ber of decimal places indicated is not
lowing the name of these (b)(2)-dietary sufficient to express lower amounts
ingredients: Vitamin C (ascorbic acid), (e.g., the RDI for zinc is given in whole
thiamin (vitamin B1), riboflavin (vita- milligrams (mg), but the quantitative
min B2), folate (folacin or folic acid), amount may be declared in tenths of a
mg).
and calories (energy). Alternatively,
(iii) The percent of the Daily Value of
the term ‘‘folic acid’’ or ‘‘folacin’’ may
all dietary ingredients declared under
be listed without parentheses in place
paragraph (b)(2)(i) of this section shall
of ‘‘folate.’’ Energy content per serving
be listed, except that the percent for
may be expressed in kilojoule units,
protein may be omitted as provided in
added in parentheses immediately fol-
§ 101.9(c)(7); no percent shall be given
lowing the statement of caloric con-
for subcomponents for which DRV’s
tent.
have not been established (e.g., sugars);
(3) Beta-carotene may be declared as and, for labels of dietary supplements
the percent of vitamin A that is of vitamins and minerals that are rep-
present as beta-carotene, except that resented or purported to be for use by
the declaration is required when a infants, children less than 4 years of
claim is made about beta-carotene. age, or pregnant or lactating women,
When declared, the percent shall be de- no percent shall be given for total fat,
clared to the nearest whole percent, saturated fat, cholesterol, total carbo-
immediately adjacent to or beneath hydrate, dietary fiber, vitamin K, sele-
the name vitamin A (e.g., ‘‘Vitamin A nium, manganese, chromium, molyb-
(90% as beta-carotene)’’). The amount denum, chloride, sodium, or potassium.
of beta-carotene in terms of inter- (A) When information on the percent
national units (IU) may be included in of Daily Values is listed, this informa-
parentheses following the percent tion shall be presented in one column
statement (e.g., ‘‘Vitamin A (90% (4500 aligned under the heading of ‘‘% Daily
IU) as beta-carotene)’’). Value’’ and to the right of the column
(ii) The number of calories, if de- of amounts. The headings ‘‘% Daily
clared, and the quantitative amount by Value (DV),’’ ‘‘% DV,’’ ‘‘Percent Daily
weight per serving of each dietary in- Value,’’ or ‘‘Percent DV’’ may be sub-
gredient required to be listed under stituted for ‘‘% Daily Value.’’ The
paragraph (b)(2)(i) of this section shall heading ‘‘% Daily Value’’ shall be
be presented either in a separate col- placed on the same line as the heading
umn aligned to the right of the column ‘‘Amount Per Serving.’’ When the acro-
of names or immediately following the nym ‘‘DV’’ is unexplained in the head-
listing of names within the same col- ing and a footnote is required under
umn. The quantitative amounts by (b)(2)(iii)(D), (b)(2)(iii)(F), or (b)(3)(iv)
weight shall represent the weight of of this section, the footnote shall ex-
the dietary ingredient rather than the plain the acronym (e.g. ‘‘Daily Value
weight of the source of the dietary in- (DV) not established’’).
84
(B) The percent of Daily Value shall than one group, the percent of Daily
be calculated by dividing the quan- Value for each group shall be presented
titative amount by weight of each in separate columns as shown in para-
(b)(2)-dietary ingredient by the RDI as graph (e)(10)(ii) of this section.
established in § 101.9(c)(8)(iv) or the (F) For declared subcomponents that
DRV as established in § 101.9(c)(9) for have no DRV’s and, on the labels of di-
the specified dietary ingredient and etary supplements of vitamins and
multiplying by 100, except that the per- minerals that are represented or pur-
cent of Daily Value for protein, when ported to be for use by infants, children
present, shall be calculated as specified less that 4 years of age, or pregnant or
in § 101.9(c)(7)(ii). The quantitative
lactating women, for total fat, satu-
amount by weight of each dietary in-
rated fat, cholesterol, total carbo-
gredient in this calculation shall be the
unrounded amount, except that for hydrate, dietary fiber, vitamin K, sele-
total fat, saturated fat, cholesterol, so- nium, manganese, chromium, molyb-
dium, potassium, total carbohydrate, denum, chloride, sodium, or potassium,
and dietary fiber, the quantitative a symbol (e.g., an asterisk) shall be
amount by weight declared on the label placed in the ‘‘Percent Daily Value’’
(i.e, rounded amount) may be used. The column that shall refer to the same
numerical value shall be followed by symbol that is placed at the bottom of
the symbol for percent (i.e., %). the nutrition label, below the last
(C) The percentages based on RDI’s heavy bar and inside the box, and fol-
and on DRV’s shall be expressed to the lowed by the statement ‘‘Daily Value
nearest whole percent, except that for not established.’’
dietary ingredients for which DRV’s (G) When calories, calories from fat,
have been established, ‘‘Less than 1%’’ or calories from saturated fat are de-
or ‘‘<1%’’ shall be used to declare the clared, the space under the ‘‘% Daily
‘‘% Daily Value’’ when the quan- Value’’ column shall be left blank for
titative amount of the dietary ingre- these items. When there are no other
dient by weight is great enough to re- (b)(2)-dietary ingredients listed for
quire that the dietary ingredient be which a value must be declared in the
listed, but the amount is so small that ‘‘% Daily Value’’ column, the column
the ‘‘% Daily Value’’ when rounded to
may be omitted as shown in paragraph
the nearest percent is zero (e.g., a prod-
(e)(10)(vii) of this section. When the ‘‘%
uct that contains 1 gram of total car-
Daily Value’’ column is not required,
bohydrate would list the percent Daily
Value as ‘‘Less than 1%’’ or ‘‘<1%’’). but the dietary ingredients listed are
(D) If the percent of Daily Value is subject to paragraph (b)(2)(iii)(F) of
declared for total fat, saturated fat, this section, the symbol required in
total carbohydrate, dietary fiber, or that paragraph shall immediately fol-
protein, a symbol shall follow the value low the quantitative amount by weight
listed for those nutrients that refers to for each dietary ingredient listed under
the same symbol that is placed at the ‘‘Amount Per Serving.’’
bottom of the nutrition label, below (3) Information on dietary ingredients
the bar required under paragraph (e)(6) for which RDI’s and DRV’s have not been
of this section and inside the box, that established. (i) Dietary ingredients for
is followed by the statement ‘‘Percent which FDA has not established RDI’s
Daily Values are based on a 2,000 cal- or DRV’s and that are not subject to
orie diet.’’ regulation under paragraph (b)(2) of
(E) The percent of Daily Value shall this section (hereinafter referred to as
be based on RDI and DRV values for ‘‘other dietary ingredients’’) shall be
adults and children 4 or more years of declared by their common or usual
age, unless the product is represented name when they are present in a die-
or purported to be for use by infants, tary supplement, in a column that is
children less than 4 years of age, preg- under the column of names described in
nant women, or lactating women, in
paragraph (b)(2)(i)(B) of this section or,

which case the column heading shall
as long as the constituents of an other
clearly state the intended group. If the
product is for persons within more dietary ingredient are not listed, in a
85
§ 101.36 21 CFR Ch. I (4–1–16 Edition)
linear display, under the heavy bar de- (iii) The constituents of a dietary in-
scribed in paragraph (e)(6) of this sec- gredient described in paragraph (b)(3)(i)
tion, except that if no (b)(2)-dietary in- of this section may be listed indented
gredients are declared, other dietary under the dietary ingredient and fol-
ingredients shall be declared directly lowed by their quantitative amounts
beneath the heading ‘‘Amount Per by weight per serving, except that die-
Serving’’ described in paragraph tary ingredients described in paragraph
(b)(2)(i)(A) of this section. (b)(2) of this section shall be listed in
(ii) The quantitative amount by accordance with that section. When the
weight per serving of other dietary in- constituents of a dietary ingredient de-
gredients shall be presented in the scribed in paragraph (b)(3)(i) of this
same manner as the corresponding in- section are listed, all other dietary in-
formation required in paragraph gredients shall be declared in a col-
(b)(2)(ii) of this section or, when a lin- umn; however, the constituents them-
ear display is used, shall be presented selves may be declared in a column or
immediately following the name of the in a linear display.
other dietary ingredient. The quan- (iv) Other dietary ingredients shall
titative amount by weight shall be the bear a symbol (e.g., an asterisk) in the
weight of the other dietary ingredient column under the heading of ‘‘% Daily
listed and not the weight of any com- Value’’ that refers to the same symbol
ponent, or the source, of that dietary placed at the bottom of the nutrition
ingredient. label and followed by the statement
(A) These amounts shall be expressed ‘‘Daily Value not established,’’ except
using metric measures in appropriate that when the heading ‘‘% Daily
units (i.e., 1,000 or more units shall be Value’’ is not used, the symbol shall
declared in the next higher set of units, follow the quantitative amount by
e.g., 1,100 mg shall be declared as 1.1 g). weight for each dietary ingredient list-
(B) For any dietary ingredient that is ed.
a liquid extract from which the solvent (c) A proprietary blend of dietary in-
has not been removed, the quantity gredients shall be included in the list
listed shall be the volume or weight of of dietary ingredients described in
the total extract. Information on the paragraph (b)(3)(i) of this section and
condition of the starting material shall identified by the term ‘‘Proprietary
be indicated when it is fresh and may Blend’’ or other appropriately descrip-
be indicated when it is dried. Informa- tive term or fanciful name and may be
tion may be included on the concentra- highlighted by bold type. Except as
tion of the dietary ingredient and the specified in this paragraph, all other
solvent used, e.g., ‘‘fresh dandelion requirements for the listing of dietary
root extract, x (y:z) in 70% ethanol,’’ ingredients in dietary supplements are
where x is the number of milliliters applicable.
(mL) or mg of the entire extract, y is (1) Dietary ingredients contained in
the weight of the starting material and the proprietary blend that are listed
z is the volume (mL) of solvent. Where under paragraph (b)(2) of this section
the solvent has been partially removed shall be declared in accordance with
(not to dryness), the final concentra- paragraph (b)(2) of this section.
tion, when indicated, shall be stated (2) Dietary ingredients contained in
(e.g., if the original extract was 1:5 and the proprietary blend that are listed
50 percent of the solvent was removed, under paragraph (b)(3) of this section
then the final concentration shall be (i.e., ‘‘other dietary ingredients’’) shall
stated as 1:2.5). Where the name of the be declared in descending order of pre-
solvent used is not included in the nu- dominance by weight, in a column or
trition label, it is required to be listed linear fashion, and indented under the
in the ingredient statement in accord- term ‘‘Proprietary Blend’’ or other ap-
ance with § 101.4(g). propriately descriptive term or fanciful
(C) For a dietary ingredient that is name.
an extract from which the solvent has (3) The quantitative amount by
been removed, the weight of the ingre- weight specified for the proprietary
dient shall be the weight of the dried blend shall be the total weight of all
extract. other dietary ingredients contained in
86
the proprietary blend and shall be (2) When source ingredients are listed
placed on the same line to the right of within the nutrition label, and two or
the term ‘‘Proprietary Blend’’ or other more are used to provide a single die-
appropriately descriptive term or fan- tary ingredient, all of the sources shall
ciful name underneath the column of be listed within the parentheses in de-
amounts described in paragraph scending order by weight.
(b)(2)(ii) of this section. A symbol (e.g., (3) Representations that the source
asterisk), which refers to the same ingredient conforms to an official com-
symbol placed at the bottom of the nu- pendium may be included either in the
trition label that is followed by the nutrition label or in the ingredient list
statement ‘‘Daily Value not estab- (e.g., ‘‘Calcium (as calcium carbonate
lished,’’ shall be placed under the head- USP)’’).
ing ‘‘% Daily Value,’’ if present, or im- (e) Nutrition information specified in
mediately following the quantitative this section shall be presented as fol-
amount by weight for the proprietary lows:
blend. (1) The title, ‘‘Supplement Facts,’’
(4) The sample label shown in para- shall be set in a type size larger than
graph (e)(10)(v) of this section illus- all other print size in the nutrition
trates one method of nutrition labeling label and, unless impractical, shall be
a proprietary blend of dietary ingredi- set full width of the nutrition label.
ents. The title and all headings shall be
(d) The source ingredient that sup- bolded to distinguish them from other
plies a dietary ingredient may be iden- information.
tified within the nutrition label in pa- (2) The nutrition information shall be
rentheses immediately following or in- enclosed in a box by using hairlines.
dented beneath the name of a dietary (3) All information within the nutri-
ingredient and preceded by the words tion label shall utilize:
‘‘as’’ or ‘‘from’’, e.g., ‘‘Calcium (as cal- (i) A single easy-to-read type style,
cium carbonate),’’ except that manner (ii) All black or one color type, print-
of presentation is unnecessary when ed on a white or other neutral con-
the name of the dietary ingredient trasting background whenever prac-
(e.g., Oriental ginseng) or its synonym tical,
(e.g., ascorbic acid) is itself the source (iii) Upper- and lowercase letters, ex-
ingredient. When a source ingredient is cept that all uppercase lettering may
identified in parentheses within the nu- be utilized for packages that have a
trition label, or when the name of the total surface area available to bear la-
dietary ingredient or its synonym is beling of less than 12 square inches,
the source ingredient, it shall not be (iv) At least one point leading (i.e.,
required to be listed again in the ingre- space between lines of text), and
dient statement that appears outside of (v) Letters that do not touch.
the nutrition label. When a source in- (4) Except as provided for small and
gredient is not identified within the intermediate-sized packages under
nutrition label, it shall be listed in an paragraph (i)(2) of this section, infor-
ingredient statement in accordance mation other than the title, headings,
with § 101.4(g), which shall appear out- and footnotes shall be in uniform type
side and immediately below the nutri- size no smaller than 8 point. Type size
tion label or, if there is insufficient no smaller than 6 point may be used for
space below the nutrition label, imme- column headings (e.g., ‘‘Amount Per
diately contiguous and to the right of Serving’’ and ‘‘% Daily Value’’) and for
the nutrition label. footnotes (e.g., ‘‘Percent Daily Values
(1) Source ingredients shall be identi- are based on a 2,000 calorie diet’’).
fied in accordance with § 101.4 (i.e., (5) A hairline rule that is centered
shall be listed by common or usual between the lines of text shall separate
name, and the listing of botanicals each dietary ingredient required in
shall specify the part of the plant from paragraph (b)(2) and (b)(3) of this sec-
which the ingredient is derived) regard- tion from the dietary ingredient above
less of whether they are listed in an in- and beneath it, as shown in paragraph
gredient statement or in the nutrition (e)(10) of this section.
label. (6) A heavy bar shall be placed:
87
§ 101.36 21 CFR Ch. I (4–1–16 Edition)
(i) Beneath the subheading ‘‘Servings may be presented on a ‘‘per day’’ basis
Per Container’’ except that if in addition to the ‘‘per serving’’ basis
‘‘Servings Per Container’’ is not re- required by paragraphs (b)(2)(ii) and
quired and, as a result, not declared, (b)(2)(iii) of this section for (b)(2)-die-
the bar shall be placed beneath the sub- tary ingredients and (b)(3)(ii) and
heading ‘‘Serving Size,’’ (b)(3)(iv) of this section for other die-
(ii) Beneath the last dietary ingre- tary ingredients. If ‘‘per day’’ informa-
dient to be listed under paragraph tion is provided, it must be presented
(b)(2)(i) of this section, if any, and in additional columns to the right of
(iii) Beneath the last other dietary the ‘‘per serving’’ information and be
ingredient to be listed under paragraph clearly identified by appropriate head-
(b)(3) of this section, if any. ings and/or be presented in a parenthet-
(7) A light bar shall be placed be- ical statement as part of the ‘‘Serving
neath the headings ‘‘Amount Per Serv- Size’’ declaration. A sample illustra-
ing’’ and ‘‘% Daily Value.’’ tion for ‘‘per day’’ information in a col-
(8) If the product contains two or umn format is provided in paragraph
more separately packaged dietary sup- (e)(11)(viii) of this section. As illus-
plements that differ from each other trated, the additional ‘‘Per Day’’ col-
(e.g., the product has a packet of sup- umn heading is followed parentheti-
plements to be taken in the morning cally by the number of servings rec-
and a different packet to be taken in ommended per day in other parts of the
the afternoon), the quantitative label (e.g., ‘‘Per Day (3 Caplets)’’).
amounts and percent of Daily Value When the parenthetical statement for-
may be presented as specified in this mat following the ‘‘Serving Size’’ dec-
paragraph in individual nutrition la- laration is used as an alternative to
bels or in one aggregate nutrition label the column format, the statement
as illustrated in paragraph (e)(10)(iii) of must provide no more than simple in-
this section. structions regarding how to calculate
(9)(i) The quantitative amount by the ‘‘per day’’ amount for the number
weight (or volume, if permitted) and of servings per day recommended in
the percent of Daily Value of each die- other parts of the label (e.g., ‘‘Serving
tary ingredient may be presented on a Size: 1 Caplet (Multiply amounts by 3
‘‘per unit’’ basis in addition to the ‘‘per for total daily amount)’’). When the
serving’’ basis required by paragraphs parenthetical statement format fol-
(b)(2)(ii) and (b)(2)(iii) of this section lowing the ‘‘Serving Size’’ declaration
for (b)(2)-dietary ingredients and is used in addition to the column for-
(b)(3)(ii) and (b)(3)(iv) of this section mat, the statement must provide no
for other dietary ingredients. If ‘‘per more than a simple declaration of the
unit’’ information is provided, it must number of servings recommended in
be presented in additional columns to other parts of the label (e.g., ‘‘Serving
the right of the ‘‘per serving’’ informa- Size: 1 Caplet (Total daily amount: 3
tion and be clearly identified by appro- caplets per day)’’).
priate headings. (10) In the interest of uniformity of
(ii) Alternatively, if a recommenda- presentation, FDA urges that the infor-
tion is made in other parts of the label mation be presented using the graphic
that a dietary supplement be consumed specifications set forth in appendix B
more than once per day, the total to part 101, as applicable.
quantitative amount by weight (or vol- (11) The following sample labels are
ume, if permitted) and the percent of presented for the purpose of illustra-
Daily Value of each dietary ingredient tion:
88
89
ER23SE97.010</GPH>
§ 101.36 21 CFR Ch. I (4–1–16 Edition)
90
ER23SE97.011</GPH>
91
ER23SE97.012</GPH>
§ 101.36 21 CFR Ch. I (4–1–16 Edition)
(viii) Dietary supplement illustrating

‘‘per serving’’ and ‘‘per day’’ informa-

tion:
92
ER23SE97.013</GPH>
(12) If space is not adequate to list the right must be set off by a line that
the required information as shown in distinguishes it and sets it apart from
the sample labels in paragraph (e)(11) the dietary ingredients and percent of
of this section, the list may be split Daily Value information given to the
and continued to the right as long as left. The following sample label illus-
the headings are repeated. The list to trates this display:
93
ER13DE06.001</GPH>
§ 101.36 21 CFR Ch. I (4–1–16 Edition)
(f)(1) Compliance with this section a composite of 12 subsamples (con-

will be determined in accordance with sumer packages) or 10 percent of the

§ 101.9(g)(1) through (g)(8), except that
the sample for analysis shall consist of
94
ER23SE97.014</GPH>
number of packages in the same in- emption under the requirements for av-
spection lot, whichever is smaller, ran- erage full-time equivalent employees
domly selected to be representative of in § 101.9(j)(18)(i) or (j)(18)(ii), and whose
the lot. The criteria on class I and labels, labeling, and advertising do not
class II nutrients given in § 101.9(g)(3) provide nutrition information or make
and (g)(4) also are applicable to other a nutrient content or health claim;
dietary ingredients described in para- (3) Section 101.9(j)(9) for foods
graph (b)(3)(i) of this section. Reason- shipped in bulk form that are not for
able excesses of these other dietary in- distribution to consumers in such form
gredients over labeled amounts are ac- and that are for use solely in the man-
ceptable within current good manufac- ufacture of other dietary supplements
turing practice. or that are to be processed, labeled, or
(2) When it is not technologically fea- repacked at a site other than where
sible, or some other circumstance originally processed or packed.
makes it impracticable, for firms to (i) Dietary supplements are subject
comply with the requirements of this to the special labeling provisions speci-
section, FDA may permit alternative fied in:
means of compliance or additional ex- (1) Section 101.9(j)(5)(i) for foods,
emptions to deal with the situation in other than infant formula, represented
accordance with § 101.9(g)(9). Firms in or purported to be specifically for in-
need of such special allowances shall
fants and children less than 2 years of
make their request in writing to the
age, in that nutrition labels on such
Office of Nutritional Products, Label-
foods shall not include calories from
ing and Dietary Supplements (HFS–
fat, calories from saturated fat, satu-
800), Food and Drug Administration,
rated fat, polyunsaturated fat,
5100 Paint Branch Pkwy., College Park,
monounsaturated fat, and cholesterol;
MD 20740.
(g) Except as provided in paragraphs (2) Section 101.9(j)(13) for foods in
(i)(2) and (i)(5) of this section, the loca- small or intermediate-sized packages,
tion of nutrition information on a label except that:
shall be in compliance with § 101.2. (i) All information within the nutri-
(h) Dietary supplements are subject tion label on small-sized packages,
to the exemptions specified as follows which have a total surface area avail-
in: able to labeling of less than 12 square
(1) Section 101.9(j)(1) for foods that inches, shall be in type size no smaller
are offered for sale by a person who than 4.5 point;
makes direct sales to consumers (i.e., a (ii) All information within the nutri-
retailer) who has annual gross sales or tion label on intermediate-sized pack-
business done in sales to consumers ages, which have from 12 to 40 square
that is not more than $500,000 or has inches of surface area available to bear
annual gross sales made or business labeling, shall be in type size no small-
done in sales of food to consumers of er than 6 point, except that type size
not more than $50,000, and whose la- no smaller than 4.5 point may be used
bels, labeling, and advertising do not on packages that have less than 20
provide nutrition information or make square inches available for labeling and
a nutrient content or health claim; more than 8 dietary ingredients to be
(2) Section 101.9(j)(18) for foods that listed and on packages that have 20 to
are low-volume products (that is, they 40 square inches available for labeling
meet the requirements for units sold in and more than 16 dietary ingredients to
§ 101.9(j)(18)(i) or (j)(18)(ii)); that, except be listed.
as provided in § 101.9(j)(18)(iv), are the (iii) When the nutrition information
subject of a claim for an exemption is presented on any panel under
that provides the information required § 101.9(j)(13)(ii)(D), the ingredient list
under § 101.9(j)(18)(iv), that is filed be- shall continue to be located imme-
fore the beginning of the time period diately below the nutrition label, or, if
for which the exemption is claimed, there is insufficient space below the
and that is filed by a person, whether it nutrition label, immediately contig-

is the manufacturer, packer, or dis- uous and to the right of the nutrition
tributor, that qualifies to claim the ex- label as specified in § 101.4(g).
95
§ 101.42 21 CFR Ch. I (4–1–16 Edition)
(iv) When it is not possible for a in § 101.9(c), for raw fruit, vegetables,
small or intermediate-sized package and fish at the point-of-purchase. If re-
that is enclosed in an outer package to tailers choose to provide such informa-
comply with these type size require- tion, they should do so in a manner
ments, the type size of the nutrition that conforms to the guidelines in
label on the primary (inner) container § 101.45.
may be as small as needed to accom- (b) In § 101.44, FDA has listed the 20
modate all of the required label infor- varieties of raw fruit, vegetables, and
mation provided that the primary con- fish that are most frequently consumed
tainer is securely enclosed in outer
during a year and to which the guide-
packaging, the nutrition labeling on
lines apply.
the outer packaging meets the applica-
ble type size requirements, and such (c) FDA has also defined in § 101.43,
outer packaging is not intended to be the circumstances that constitute sub-
separated from the primary container stantial compliance by food retailers
under conditions of retail sale. with the guidelines.
(v) Where there is not sufficient (d) By May 8, 1993, FDA will issue a
space on a small or intermediate-sized report on actions taken by food retail-
package for a nutrition label that ers to provide consumers with nutri-
meets minimum type size requirements tion information for raw fruit, vegeta-
of 4.5 points if hairlines are used in ac- bles, and fish under the guidelines es-
cordance with paragraph (e)(5) of this tablished in § 101.45.
section, the hairlines may be omitted (1) The report will include a deter-
and replaced by a row of dots con- mination of whether there is substan-
necting the columns containing the tial compliance, as defined in § 101.43,
name of each dietary ingredient and with the guidelines.
the quantitative amounts (by weight (2) In evaluating substantial compli-
and as a percent of Daily Value). ance, FDA will consider only the 20 va-
(3) Section 101.9(j)(15) for foods in
rieties of raw fruit, vegetables, and fish
multiunit food containers;
most frequently consumed as identified
(4) Section 101.9(j)(16) for foods sold
in bulk containers; and in § 101.44.
(5) Section 101.9(j)(17) for foods in (e) If FDA finds that there is substan-
packages that have a total surface area tial compliance with the guidelines for
available to bear labeling greater than the nutrition labeling of raw fruit and
40 square inches but whose principal vegetables or of fish, the agency will so
display panel and information panel do state in the report, and the guidelines
not provide sufficient space to accom- will remain in effect. FDA will reevalu-
modate all required label information, ate the market place for substantial
except that the ingredient list shall compliance every 2 years.
continue to be located immediately (f) If FDA determines that there is
below the nutrition label, or, if there is not substantial compliance with the
insufficient space below the nutrition guidelines for raw fruit and vegetables
label, immediately contiguous and to or for raw fish, the agency will at that
the right of the nutrition label as spec- time issue proposed regulations requir-
ified in § 101.4(g). ing that any person who offers raw
(j) Dietary supplements shall be sub- fruit and vegetables or fish to con-
ject to the misbranding provisions of sumers provide, in a manner prescribed
§ 101.9(k). by regulations, the nutrition informa-
[62 FR 49849, Sept. 23, 1997, as amended at 63 tion required by § 101.9. Final regula-
FR 30620, June 5, 1998; 66 FR 56035, Nov. 6, tions would have to be issued 6 months
2001; 71 FR 51726, Aug. 31, 2006; 71 FR 74791, after issuance of proposed regulations,
Dec. 13, 2006]
and they would become effective 6
§ 101.42 Nutrition labeling of raw fruit, months after the date of their promul-
vegetables, and fish. gation.
(a) The Food and Drug Administra-

tion (FDA) urges food retailers to pro-
vide nutrition information, as provided
96
§ 101.43 Substantial compliance of pear, pineapple, plums, strawberries,

food retailers with the guidelines sweet cherries, tangerine, and water-
for the voluntary nutrition labeling melon.
of raw fruit, vegetables, and fish. (b) The 20 most frequently consumed
(a) The Food and Drug Administra- raw vegetables are: Asparagus, bell
tion (FDA) will judge a food retailer pepper, broccoli, carrot, cauliflower,
who sells raw agricultural commodities celery, cucumber, green (snap) beans,
or raw fish to be in compliance with green cabbage, green onion, iceberg let-
the guidelines in § 101.45 with respect to tuce, leaf lettuce, mushrooms, onion,
raw agricultural commodities if the re- potato, radishes, summer squash, sweet
tailer displays or provides nutrition la- corn, sweet potato, and tomato.
beling for at least 90 percent of the raw (c) The 20 most frequently consumed
agricultural commodities listed in raw fish are: Blue crab, catfish, clams,
§ 101.44 that it sells, and with respect to cod, flounder/sole, haddock, halibut,
raw fish if the retailer displays or pro- lobster, ocean perch, orange roughy,
vides nutrition labeling for at least 90 oysters, pollock, rainbow trout, rock-
percent of the types of raw fish listed fish, salmon (Atlantic/coho/Chinook/
in § 101.44 that it sells. To be in compli- sockeye, chum/pink), scallops, shrimp,
ance, the nutrition labeling shall: swordfish, tilapia, and tuna.
(1) Be presented in the store or other [71 FR 42044, July 25, 2006]
type of establishment in a manner that
is consistent with § 101.45(a)(1); § 101.45 Guidelines for the voluntary
(2) Be presented in content and for- nutrition labeling of raw fruits,
mat that are consistent with § 101.45 vegetables, and fish.
(a)(2), (a)(3), and (a)(4); and (a) Nutrition labeling for raw fruits,
(3) Include data that have been pro- vegetables, and fish listed in § 101.44
vided by FDA in appendices C and D to should be presented to the public in the
part 101 of this chapter, except that the following manner:
information on potassium is voluntary. (1) Nutrition labeling information
(b) To determine whether there is should be displayed at the point of pur-
substantial compliance by food retail- chase by an appropriate means such as
ers with the guidelines in § 101.45 for by a label affixed to the food or
the voluntary nutrition labeling of raw through labeling including shelf labels,
fruit and vegetables and of raw fish, signs, posters, brochures, notebooks, or
FDA will select a representative sam- leaflets that are readily available and
ple of 2,000 stores, allocated by store in close proximity to the foods. The nu-
type and size, for raw fruit and vegeta- trition labeling information may also
bles and for raw fish. be supplemented by a video, live dem-
(c) FDA will find that there is sub- onstration, or other media.
stantial compliance with the guide- (2) Serving sizes should be deter-
lines in § 101.45 if it finds based on para- mined, and nutrients declared, in ac-
graph (a) of this section that at least 60 cordance with § 101.9 (b) and (c), respec-
percent of all stores that are evaluated tively, except that the nutrition label-
are in compliance. ing data should be based on the raw ed-
(d) FDA will evaluate substantial ible portion for fruits and vegetables
compliance separately for raw agricul- and on the cooked edible portion for
tural commodities and for raw fish. fish. The methods used to cook fish
[55 FR 60890, Nov. 27, 1991, as amended at 61 should be those that do not add fat,
FR 42759, Aug. 16, 1996] breading, or seasoning (e.g., salt or
spices).
§ 101.44 What are the 20 most fre- (3) When nutrition labeling informa-
quently consumed raw fruits, vege- tion is provided for more than one raw
tables, and fish in the United fruit, vegetable, or fish on signs, post-
States? ers, brochures, notebooks, or leaflets,
(a) The 20 most frequently consumed it may be presented in charts with hor-
raw fruits are: Apple, avocado (Cali- izontal or vertical columns or as a
fornia), banana, cantaloupe, grapefruit, compilation of individual nutrition la-

grapes, honeydew melon, kiwifruit, bels. Nutrition labeling that is pre-
lemon, lime, nectarine, orange, peach, sented in a linear display (see
97
§ 101.45 21 CFR Ch. I (4–1–16 Edition)
§ 101.9(j)(13)(ii)(A)(2)) will not be consid- (4) When nutrition labeling is pro-

ered to be in compliance. The heading vided for individual raw fruits, vegeta-
‘‘Nutrition Facts’’ must be in a type bles, or fish on packages or on signs,
size larger than all other print in the posters, brochures, notebooks, or leaf-
nutrition label. The required informa- lets, it should be displayed in accord-
tion (i.e., headings, serving sizes, list of ance with § 101.9, except that the dec-
nutrients, quantitative amounts by laration of the number of servings per
weight (except for vitamins and min- container need not be included. For in-
erals), and percent of Daily Values dividual labels provided by retailers on
(DV’s) (except for sugars and protein) signs and posters, the footnote required
must be clearly presented and of suffi- in § 101.9(d)(9) may be shortened to
cient type size and color contrast to be ‘‘Percent Daily Values are based on a
plainly legible, with numeric values for 2,000 calorie diet.’’
percent of DV highlighted in contrast (b) Nutrition label values provided by
to the quantitative amounts by weight the Food and Drug Administration
and hairlines between all nutrients. (FDA) in Appendices C and D to part
(i) Declaration of the number of 101 for the 20 most frequently con-
servings per container need not be in- sumed raw fruits, vegetables, and fish
cluded in the nutrition labeling of raw listed in § 101.44 shall be used to ensure
fruits, vegetables, and fish. uniformity in declared values. FDA
(ii) Except for the statement ‘‘Per- will publish proposed updates of the 20
cent Daily Values are based on a 2,000 most frequently consumed raw fruits,
vegetables, and fish and nutrition label
calorie diet,’’ the footnote required in
data for these foods (or a notice that
§ 101.9(d)(9) is not required. However,
the data sets have not changed from
when labeling is provided in brochures,
the previous publication) at least every
notebooks, leaflets, or similar types of
4 years in the FEDERAL REGISTER.
materials, retailers are encouraged to
(1) The agency encourages the sub-
include the footnote.
mission of data bases with new or addi-
(iii) When retailers provide nutrition tional nutrient data for any of the
labeling information for more than one most frequently consumed raw fruits,
raw fruit or vegetable on signs or post- vegetables, and fish to the Office of Nu-
ers or in brochures, notebooks, or leaf- tritional Products, Labeling and Die-
lets, the listings for saturated fat, trans tary Supplements (HFS–800), Center for
fat, and cholesterol may be omitted Food Safety and Applied Nutrition,
from the charts or individual nutrition Food and Drug Administration, 5100
labels if a footnote states that most Paint Branch Pkwy., College Park, MD
fruits and vegetables provide negligible 20740, for review and evaluation. FDA
amounts of these nutrients, but that may incorporate these data in the next
avocados contain 0.5 gram (g) of satu- revision of the nutrition labeling infor-
rated fat per ounce (e.g., ‘‘Most fruits mation for the top 20 raw fruits, vege-
and vegetables provide negligible tables, and fish.
amounts of saturated fat, trans fat, and (i) Guidance in the development of
cholesterol; avocados provide 0.5 g of data bases may be found in the ‘‘FDA
saturated fat per ounce’’). The footnote Nutrition Labeling Manual: A Guide
also may contain information about for Developing and Using Data Bases,’’
the polyunsaturated and available from the FDA Office of Food
monounsaturated fat content of avoca- Labeling.
dos. (ii) The submission to FDA should in-
(iv) When retailers provide nutrition clude, but need not be limited to, infor-
labeling information for more than one mation on the following: Source of the
raw fish on signs or posters or in bro- data (names of investigators, name of
chures, notebooks, or leaflets, the list- organization, place of analyses, dates
ings for trans fat, dietary fiber, and of analyses), number of samples, sam-
sugars may be omitted from the charts pling design, analytical methods, and
or individual nutrition labels if the fol- statistical treatment of the data. Pro-
lowing footnote is used, ‘‘Fish provide posed quantitative label declarations

negligible amounts of trans fat, dietary may be included. The proposed values
fiber, and sugars.’’ for declaration should be determined in
98
accordance with the ‘‘FDA Nutrition tion labeling values if FDA monitoring
Labeling Manual: A Guide for Devel- suggests that the data base or nutri-
oping and Using Data Bases.’’ tion labeling values are no longer rep-
(2) [Reserved] resentative of the item sold in this
(c) Data bases of nutrient values for country. Approval requests shall be
raw fruits, vegetables, and fish that are submitted in accordance with the pro-
not among the 20 most frequently con- vision of § 101.30 of this chapter.
sumed may be used to develop nutri- (ii) [Reserved]
tion labeling values for these foods. [61 FR 42760, Aug. 16, 1996, as amended at 66
This includes data bases of nutrient FR 56035, Nov. 6, 2001; 71 FR 42044, July 25,
values for specific varieties, species, or 2006]
cultivars of raw fruits, vegetables, and
fish not specifically identified among Subpart D—Specific Requirements
the 20 most frequently consumed. for Nutrient Content Claims
(1) The food names and descriptions
for the fruits, vegetables, and fish
SOURCE: 58 FR 2413, Jan. 6, 1993, unless oth-
should clearly identify these foods as
erwise noted.
distinct from foods among the most
frequently consumed list for which § 101.54 Nutrient content claims for
FDA has provided data. ‘‘good source,’’ ‘‘high,’’ ‘‘more,’’ and
(2) Guidance in the development of ‘‘high potency.’’
data bases may be found in the ‘‘FDA (a) General requirements. Except as
Nutrition Labeling Manual: A Guide provided in paragraph (e) of this sec-
for Developing and Using Data Bases.’’ tion, a claim about the level of a nutri-
(3) Nutrition labeling values com- ent in a food in relation to the Ref-
puted from data bases are subject to erence Daily Intake (RDI) established
the compliance provisions of § 101.9(g). for that nutrient in § 101.9(c)(8)(iv) or
(i) Compliance with the provisions of Daily Reference Value (DRV) estab-
§ 101.9(g) may be achieved by use of a lished for that nutrient in § 101.9(c)(9),
data base that has been developed fol- (excluding total carbohydrates) may
lowing FDA guideline procedures and only be made on the label or in labeling
approved by FDA. of the food if:
(A) The submission to FDA for ap- (1) The claim uses one of the terms
proval should include but need not be defined in this section in accordance
limited to information on the fol- with the definition for that term;
lowing: Source of the data (names of (2) The claim is made in accordance
investigators, name of organization, with the general requirements for nu-
place of analyses, dates of analyses), trient content claims in § 101.13; and
number of samples, sampling design, (3) The food for which the claim is
analytical methods, statistical treat- made is labeled in accordance with
ment of the data, and proposed quan- § 101.9, § 101.10, or § 101.36, as applicable.
titative label declarations. The values (b) ‘‘High’’ claims. (1) The terms
for declaration should be determined in ‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source
accordance with the ‘‘FDA Nutrition of’’ may be used on the label and in the
Labeling Manual: A Guide for Devel- labeling of foods, except meal products
oping and Using Databases.’’ as defined in § 101.13(l) and main dish
(B) FDA approval of a data base and products as defined in § 101.13(m), pro-
nutrition labeling values shall not be vided that the food contains 20 percent
considered granted until the Center for or more of the RDI or the DRV per ref-
Food Safety and Applied Nutrition has erence amount customarily consumed.
agreed to all aspects of the data base in (2) The terms defined in paragraph
writing. Approvals will be in effect for (b)(1) of this section may be used on
a limited time, e.g., 10 years, and will the label and in the labeling of meal
be eligible for renewal in the absence of products as defined in § 101.13(l) and
significant changes in agricultural or main dish products as defined in
industry practices (e.g., a change oc- § 101.13(m), provided that:
curs in a predominant variety pro- (i) The product contains a food that
duced). FDA will take steps to revoke meets the definition of ‘‘high’’ in para-
its approval of the data base and nutri- graph (b)(1) of this section; and
99
§ 101.54 21 CFR Ch. I (4–1–16 Edition)
(ii) The label or labeling clearly iden- dish products as defined in § 101.13(m),
tifies the food that is the subject of the provided that:
claim (e.g., the serving of broccoli in (i) The food contains at least 10 per-
this product is high in vitamin C). cent more of the RDI for vitamins or
(c) ‘‘Good Source’’ claims. (1) The minerals or of the DRV for protein, die-
terms ‘‘good source,’’ ‘‘contains,’’ or tary fiber, or potassium (expressed as a
‘‘provides’’ may be used on the label percent of the Daily Value) per ref-
and in the labeling of foods, except erence amount customarily consumed
meal products as defined in § 101.13(l) than an appropriate reference food; and
and main dish products as defined in (ii) Where the claim is based on a nu-
§ 101.13(m), provided that the food con- trient that has been added to the food,
tains 10 to 19 percent of the RDI or the that fortification is in accordance with
DRV per reference amount customarily the policy on fortification of foods in
consumed. § 104.20 of this chapter; and
(2) The terms defined in paragraph (iii) As required in § 101.13(j)(2) for
(c)(1) of this section may be used on the relative claims:
label and in the labeling of meal prod- (A) The identity of the reference food
ucts as defined in § 101.13(l) and main and the percentage (or fraction) that
dish products as defined in 101.13(m), the nutrient is greater relative to the
provided that: RDI or DRV are declared in immediate
(i) The product contains a food that proximity to the most prominent such
meets the definition of ‘‘good source’’ claim (e.g., ‘‘contains 10 percent more
in paragraph (c)(1) of this section; and of the Daily Value for fiber than white
(ii) The label or labeling clearly iden- bread’’); and
tifies the food that is the subject of the (B) Quantitative information com-
claim (e.g., the serving of sweet pota- paring the level of the nutrient in the
toes in this product is a ‘‘good source’’ product per labeled serving with that
of fiber). of the reference food that it replaces
(d) ‘‘Fiber’’ claims. (1) If a nutrient (e.g., ‘‘Fiber content of white bread is 1
content claim is made with respect to gram (g) per serving; (this product) 3.5
the level of dietary fiber, that is, that g per serving’’) is declared adjacent to
the product is high in fiber, a good the most prominent claim or to the nu-
source of fiber, or that the food con- trition label, except that if the nutri-
tains ‘‘more’’ fiber, and the food is not tion label is on the information panel,
‘‘low’’ in total fat as defined in the quantitative information may be
§ 101.62(b)(2) or, in the case of a meal located elsewhere on the information
product, as defined in § 101.13(l), or panel in accordance with § 101.2.
main dish product, as defined in (2) A relative claim using the terms
§ 101.13(m), is not ‘‘low’’ in total fat as ‘‘more,’’ ‘‘fortified,’’ ‘‘enriched,’’
defined in § 101.62(b)(3), then the label ‘‘added,’’ ‘‘extra,’’ and ‘‘plus’’ may be
shall disclose the level of total fat per used on the label or in labeling to de-
labeled serving. scribe the level of protein, vitamins,
(2) The disclosure shall appear in im- minerals, dietary fiber or potassium,
mediate proximity to such claim, be in except as limited in § 101.13(j)(1)(i), in
a type size no less than one-half the meal products as defined in § 101.13(l) or
size of the claim and precede any dis- main dish products as defined in
closure statement required under § 101.13(m), provided that:
§ 101.13(h) (e.g., ‘‘contains [x amount] of (i) The food contains at least 10 per-
total fat per serving. See nutrition in- cent more of the RDI for vitamins or
formation for fat content’’). minerals or of the DRV for protein, die-
(e) ‘‘More’’ claims. (1) A relative claim tary fiber, or potassium (expressed as a
using the terms ‘‘more,’’ ‘‘fortified,’’ percent of the Daily Value) per 100 g of
‘‘enriched,’’ ‘‘added,’’ ‘‘extra,’’ and food than an appropriate reference
‘‘plus’’ may be used on the label or in food.
labeling of foods to describe the level (ii) Where the claim is based on a nu-
of protein, vitamins, minerals, dietary trient that has been added to the food,
fiber, or potassium, except as limited that fortification is in accordance with

by § 101.13(j)(1)(i) and except meal prod- the policy on fortification of foods in
ucts as defined in § 101.13(l) and main § 104.20 of this chapter; and
100
(iii) As required in § 101.13(j)(2) for on fortification of foods in § 104.20 of

relative claims: this chapter.
(A) The identity of the reference food (g) Nutrient content claims using the
and the percentage (or fraction) that term ‘‘antioxidant.’’ A nutrient content
the nutrient was increased relative to claim that characterizes the level of
the RDI or DRV are declared in imme- antioxidant nutrients present in a food
diate proximity to the most prominent may be used on the label or in the la-
such claim (e.g., ‘‘contains 10 percent beling of that food when:
more of the Daily Value for fiber per 3 (1) An RDI has been established for
oz than does ‘X brand of product’ ’’),
each of the nutrients;
and
(B) Quantitative information com- (2) The nutrients that are the subject
paring the level of the nutrient in the of the claim have recognized anti-
product per specified weight with that oxidant activity; that is, when there
of the reference food that it replaces exists scientific evidence that, fol-
(e.g., ‘‘The fiber content of ‘X brand of lowing absorption from the gastro-
product’ is 2 g per 3 oz. This product intestinal tract, the substance partici-
contains 4.5 g per 3 oz.’’) is declared ad- pates in physiological, biochemical, or
jacent to the most prominent claim or cellular processes that inactivate free
to the nutrition label, except that if radicals or prevent free radical-initi-
the nutrition label is on the informa- ated chemical reactions;
tion panel, the quantitative informa- (3) The level of each nutrient that is
tion may be located elsewhere on the the subject of the claim is sufficient to
information panel in accordance with qualify for the § 101.54 (b), (c), or (e)
§ 101.2. claim (e.g., to bear the claim ’’high in
(f) ‘‘High potency’’ claims. (1)(i) The antioxidant vitamin C,’’ the product
term ‘‘high potency’’ may be used on must contain 20 percent or more of the
the label or in the labeling of foods to RDI for vitamin C). Beta-carotene may
describe individual vitamins or min- be a subject of the claim when the level
erals that are present at 100 percent or of vitamin A present as beta-carotene
more of the RDI per reference amount
in the food that bears the claim is suf-
customarily consumed.
ficient to qualify for the claim. For ex-
(ii) When the term ‘‘high potency’’ is
ample, for the claim ‘‘good source of
used to describe individual vitamins or
minerals in a product that contains antioxidant beta-carotene,’’ 10 percent
other nutrients or dietary ingredients, or more of the RDI for vitamin A must
the label or labeling shall clearly iden- be present as beta-carotene per ref-
tify which vitamin or mineral is de- erence amount customarily consumed;
scribed by the term ‘‘high potency’’ and
(e.g., ‘‘Botanical ‘X’ with high potency (4) The names of the nutrients that
vitamin E’’). are the subject of the claim are in-
(2) The term ‘‘high potency’’ may be cluded as part of the claim (e.g., ‘‘high
used on the label or in the labeling of in antioxidant vitamins C and E’’). Al-
a multiingredient food product to de- ternatively, when used as part of a nu-
scribe the product if the product con- trient content claim, the term ‘‘anti-
tains 100 percent or more of the RDI for oxidant’’ or ‘‘antioxidants’’ (as in
at least two-thirds of the vitamins and ‘‘high in antioxidants’’) may be linked
minerals that are listed in by a symbol (e.g., an asterisk) that re-
§ 101.9(c)(8)(iv) and that are present in fers to the same symbol that appears
the product at 2 percent or more of the elsewhere on the same panel of a prod-
RDI (e.g., ‘‘High potency multivitamin, uct label followed by the name or
multimineral dietary supplement tab- names of the nutrients with recognized
lets’’). antioxidant activity. The list of nutri-
(3) Where compliance with para-
ents shall appear in letters of a type
graphs (f)(1)(i), (f)(1)(ii), or (f)(2) of this
size height no smaller than the larger
section is based on a nutrient that has
been added to a food (other than a die-

tary supplement), that fortification
shall be in accordance with the policy
101
§ 101.56 21 CFR Ch. I (4–1–16 Edition)
of one-half of the type size of the larg- (ii) Quantitative information com-
est nutrient content claim or 1⁄16 inch. paring the level of calories and fat con-
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2,
tent in the product per labeled serving
1993, as amended at 59 FR 394, Jan. 4, 1994; 59 size with that of the reference food
FR 15051, Mar. 31, 1994; 60 FR 17206, Apr. 5, that it replaces (e.g., ‘‘lite cheese-
1995; 61 FR 11731, Mar. 22, 1996; 62 FR 31339, cake—200 calories, 4 grams (g) fat per
June 9, 1997; 62 FR 49867, 49880, Sept. 23, 1997; serving; regular cheesecake—300 cal-
63 FR 26980, May 15, 1998; 66 FR 17358, Mar. 30, ories, 8 g fat per serving’’) is declared
2001] adjacent to the most prominent claim
§ 101.56 Nutrient content claims for or to the nutrition label, except that if
‘‘light’’ or ‘‘lite.’’ the nutrition label is on the informa-
tion panel, the quantitative informa-
(a) General requirements. A claim tion may be located elsewhere on the
using the term light or lite to describe information panel in accordance with
a food may only be made on the label § 101.2; and
or in labeling of the food if: (iii) If the labeled food contains less
(1) The claim uses one of the terms than 40 calories or less than 3 g fat per
defined in this section in accordance reference amount customarily con-
with the definition for that term;
sumed, the percentage reduction for
(2) The claim is made in accordance
that nutrient need not be declared.
with the general requirements for nu-
(4) A ‘‘light’’ claim may not be made
trient content claims in § 101.13; and
on a food for which the reference food
(3) The food is labeled in accordance
meets the definition of ‘‘low fat’’ and
with § 101.9 or § 101.10, where applicable.
‘‘low calorie.’’
(b) ‘‘Light’’ claims. The terms ‘‘light’’
or ‘‘lite’’ may be used on the label or in (c)(1)(i) A product for which the ref-
the labeling of foods, except meal prod- erence food contains 40 calories or less
ucts as defined in § 101.13(l) and main and 3 g fat or less per reference amount
dish products as defined in § 101.13(m), customarily consumed may use the
without further qualification, provided term ‘‘light’’ or ‘‘lite’’ without further
that: qualification if it is reduced by 50 per-
(1) If the food derives 50 percent or cent or more in sodium content com-
more of its calories from fat, its fat pared to the reference food; and
content is reduced by 50 percent or (ii) As required in § 101.13(j)(2) for rel-
more per reference amount custom- ative claims:
arily consumed compared to an appro- (A) The identity of the reference food
priate reference food as specified in and the percent (or fraction) that the
§ 101.13(j)(1); or sodium was reduced shall be declared
(2) If the food derives less than 50 per- in immediate proximity to the most
cent of its calories from fat: prominent such claim (e.g., 50 percent
(i) The number of calories is reduced less sodium than our regular soy
by at least one-third (331⁄3 percent) per sauce); and
reference amount customarily con- (B) Quantitative information com-
sumed compared to an appropriate ref- paring the level of sodium per labeled
erence food; or serving size with that of the reference
(ii) Its fat content is reduced by 50 food that it replaces (e.g., ‘‘lite soy
percent or more per reference amount sauce 500 milligrams (mg) sodium per
customarily consumed compared to the serving; regular soy sauce 1,000 mg per
reference food that it resembles or for serving’’) is declared adjacent to the
which it substitutes as specified in most prominent claim or to the nutri-
§ 101.13(j)(1); and tion label, except that if the nutrition
(3) As required in § 101.13(j)(2) for rel- label is on the information panel, the
ative claims: quantitative information may be lo-
(i) The identity of the reference food cated elsewhere on the information
and the percent (or fraction) that the panel in accordance with § 101.2.
calories and the fat were reduced are (2)(i) A product for which the ref-
declared in immediate proximity to the erence food contains more than 40 cal-
most prominent such claim, (e.g., ‘‘1/3 ories or more than 3 g fat per reference
fewer calories and 50 percent less fat amount customarily consumed may
than our regular cheese cake’’); use the term ‘‘light in sodium’’ or ‘‘lite
102
in sodium’’ if it is reduced by 50 per- dish product as defined in § 101.13(m),

cent or more in sodium content com- provided that the food meets the defi-
pared to the reference food, provided nition of ‘‘low in sodium’’ as defined in
that ‘‘light’’ or ‘‘lite’’ is presented in § 101.61(b)(5)(i); and
immediate proximity with ‘‘in sodium’’ (ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in so-
and the entire term is presented in uni- dium’’ are presented in uniform type
form type size, style, color, and promi- size, style, color, and prominence.
nence; and (e) Except as provided in paragraphs
(ii) As required in § 101.13(j)(2) for rel- (b) through (d) of this section, the term
ative claims: ‘‘light’’ or ‘‘lite’’ may not be used to
(A) The identity of the reference food refer to a food that is not reduced in
and the percent (or fraction) that the fat by 50 percent, or, if applicable, in
sodium was reduced shall be declared calories by 1⁄3 or, when properly quali-
in immediate proximity to the most fied, in sodium by 50 percent unless:
prominent such claim (e.g., 50 percent
(1) It describes some physical or
less sodium than our regular canned
organoleptic attribute of the food such
peas); and
as texture or color and the information
(B) Quantitative information com-
paring the level of sodium per labeled (e.g., ‘‘light in color’’ or ‘‘light in tex-
serving size with that of the reference ture’’) so stated, clearly conveys the
food that it replaces (e.g., ‘‘lite canned nature of the product; and
peas, 175 mg sodium per serving; reg- (2) The attribute (e.g., ‘‘color’’ or
ular canned peas 350 mg per serving’’) ‘‘texture’’) is in the same style, color,
is declared adjacent to the most promi- and at least one-half the type size as
nent claim or to the nutrition label, the word ‘‘light’’ and in immediate
except that if the nutrition label is on proximity thereto.
the information panel, the quantitative (f) If a manufacturer can dem-
information may be located elsewhere onstrate that the word ‘‘light’’ has
on the information panel in accordance been associated, through common use,
with § 101.2. with a particular food to reflect a phys-
(iii) Except for meal products as de- ical or organoleptic attribute (e.g.,
fined in § 101.13(l) and main dish prod- light brown sugar, light corn syrup, or
ucts as defined in § 101.13(m), a ‘‘light light molasses) to the point where it
in sodium’’ claim may not be made on has become part of the statement of
a food for which the reference food identity, such use of the term ‘‘light’’
meets the definition of ‘‘low in so- shall not be considered a nutrient con-
dium’’. tent claim subject to the requirements
(d)(1) The terms ‘‘light’’ or ‘‘lite’’ in this part.
may be used on the label or in the la- (g) The term ‘‘lightly salted’’ may be
beling of a meal product as defined in used on a product to which has been
§ 101.13(l) and a main dish product as added 50 percent less sodium than is
defined in § 101.13(m), provided that: normally added to the reference food as
(i) The food meets the definition of: described in § 101.13(j)(1)(i)(B) and
(A) ‘‘Low in calories’’ as defined in (j)(1)(ii)(B), provided that if the prod-
§ 101.60(b)(3); or uct is not ‘‘low in sodium’’ as defined
(B) ‘‘Low in fat’’ as defined in in § 101.61(b)(4), the statement ‘‘not a
§ 101.62(b)(3); and low sodium food,’’ shall appear adja-
(ii)(A) A statement appears on the cent to the nutrition label of the food
principal display panel that explains bearing the claim, or, if the nutrition
whether ‘‘light’’ is used to mean ‘‘low
label is on the information panel, it
fat,’’ ‘‘low calories,’’ or both (e.g.,
may appear elsewhere on the informa-
‘‘Light Delight, a low fat meal’’); and
tion panel in accordance with § 101.2
(B) The accompanying statement is
and the information required to accom-
no less than one-half the type size of
pany a relative claim shall appear on
the ‘‘light’’ or ‘‘lite’’ claim.
the label or labeling as specified in
(2)(i) The term ‘‘light in sodium’’ or
‘‘lite in sodium’’ may be used on the § 101.13(j)(2).

label or in the labeling of a meal prod- [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2,
uct as defined in § 101.13(l) and a main 1993, as amended at 60 FR 17206, Apr. 5, 1995]
103
§ 101.60 21 CFR Ch. I (4–1–16 Edition)
§ 101.60 Nutrient content claims for than 40 calories per reference amount
the calorie content of foods. customarily consumed; or
(a) General requirements. A claim (B) The food has a reference amount
about the calorie or sugar content of a customarily consumed of 30 g or less or
food may only be made on the label or 2 tablespoons or less and does not pro-
in the labeling of a food if: vide more than 40 calories per ref-
erence amount customarily consumed
(1) The claim uses one of the terms
and, except for sugar substitutes, per 50
defined in this section in accordance
g (for dehydrated foods that must be
with the definition for that term;
reconstituted before typical consump-
(2) The claim is made in accordance
tion with water or a diluent containing
with the general requirements for nu-
an insignificant amount, as defined in
trient content claims in § 101.13;
§ 101.9(f)(1), of all nutrients per ref-
(3) The food for which the claim is erence amount customarily consumed,
made is labeled in accordance with the per 50 g criterion refers to the ‘‘as
§ 101.9, § 101.10, or § 101.36, as applicable; prepared’’ form).
and (ii) If a food meets these conditions
(4) For dietary supplements, claims without the benefit of special proc-
regarding calories may not be made on essing, alteration, formulation, or re-
products that meet the criteria in formulation to vary the caloric con-
§ 101.60(b)(1) or (b)(2) for ‘‘calorie free’’ tent, it is labeled to clearly refer to all
or ‘‘low calorie’’ claims except when an foods of its type and not merely to the
equivalent amount of a similar dietary particular brand to which the label at-
supplement (e.g., another protein sup- taches (e.g., ‘‘celery, a low calorie
plement) that the labeled food resem- food’’).
bles and for which it substitutes, nor- (3) The terms defined in paragraph
mally exceeds the definition for ‘‘low (b)(2) of this section may be used on
calorie’’ in § 101.60(b)(2). the label or in labeling of meal prod-
(b) Calorie content claims. (1) The ucts as defined in § 101.13(l) or main
terms ‘‘calorie free,’’ ‘‘free of calories,’’ dish products as defined in § 101.13(m),
‘‘no calories,’’ ‘‘zero calories,’’ ‘‘with- provided that:
out calories,’’ ‘‘trivial source of cal- (i) The product contains 120 calories
ories,’’ ‘‘negligible source of calories,’’ or less per 100 g; and
or ‘‘dietarily insignificant source of (ii) If the product meets this condi-
calories’’ may be used on the label or tion without the benefit of special
in the labeling of foods, provided that: processing, alteration, formulation, or
(i) The food contains less than 5 cal- reformulation to lower the calorie con-
ories per reference amount customarily tent, it is labeled to clearly refer to all
consumed and per labeled serving. foods of its type and not merely to the
(ii) As required in § 101.13(e)(2), if the particular brand to which it attaches.
food meets this condition without the (4) The terms ‘‘reduced calorie,’’ ‘‘re-
benefit of special processing, alter- duced in calories,’’ ‘‘calorie reduced,’’
ation, formulation, or reformulation to ‘‘fewer calories,’’ ‘‘lower calorie,’’ or
lower the caloric content, it is labeled ‘‘lower in calories’’ may be used on the
to disclose that calories are not usu- label or in the labeling of foods, except
ally present in the food (e.g., ‘‘cider as limited by § 101.13(j)(1)(i) and except
vinegar, a calorie free food’’). meal products as defined in § 101.13(l)
(2) The terms ‘‘low calorie,’’ ‘‘few cal- and main dish products as defined in
ories,’’ ‘‘contains a small amount of § 101.13(m), provided that:
calories,’’ ‘‘low source of calories,’’ or (i) The food contains at least 25 per-
‘‘low in calories’’ may be used on the cent fewer calories per reference
label or in labeling of foods, except amount customarily consumed than an
meal products as defined in § 101.13(l) appropriate reference food as described
and main dish products as defined in in § 101.13(j)(1); and
§ 101.13(m), provided that: (ii) As required in § 101.13(j)(2) for rel-
(i)(A) The food has a reference ative claims:
amount customarily consumed greater (A) The identity of the reference food
than 30 grams (g) or greater than 2 ta- and the percent (or fraction) that the
blespoons and does not provide more calories differ between the two foods
104
are declared in immediate proximity to reference food meets the definition for
the most prominent such claim (e.g., ‘‘low calorie.’’
reduced calorie cupcakes ‘‘331⁄3 percent (c) Sugar content claims—(1) Use of
fewer calories than regular cupcakes’’); terms such as ‘‘sugar free,’’ ‘‘free of
and sugar,’’ ‘‘no sugar,’’ ‘‘zero sugar,’’
(B) Quantitative information com- ‘‘without sugar,’’ ‘‘sugarless,’’ ‘‘trivial
paring the level of the nutrient per la- source of sugar,’’ ‘‘negligible source of
beled serving size with that of the ref- sugar,’’ or ‘‘dietarily insignificant source
erence food that it replaces (e.g., ‘‘Cal- of sugar.’’ Consumers may reasonably
orie content has been reduced from 150 be expected to regard terms that rep-
to 100 calories per serving.’’) is declared resent that the food contains no sugars
adjacent to the most prominent claim or sweeteners e.g., ‘‘sugar free,’’ or ‘‘no
or to the nutrition label, except that if sugar,’’ as indicating a product which
the nutrition label is on the informa- is low in calories or significantly re-
tion panel, the quantitative informa- duced in calories. Consequently, except
tion may be located elsewhere on the as provided in paragraph (c)(2) of this
information panel in accordance with section, a food may not be labeled with
§ 101.2. such terms unless:
(iii) Claims described in paragraph (i) The food contains less than 0.5 g of
(b)(4) of this section may not be made sugars, as defined in § 101.9(c)(6)(ii), per
on the label or labeling of foods if the reference amount customarily con-
reference food meets the definition for sumed and per labeled serving or, in
‘‘low calorie.’’ the case of a meal product or main dish
(5) The terms defined in paragraph product, less than 0.5 g of sugars per la-
(b)(4) of this section may be used on beled serving; and
the label or in the labeling of meal (ii) The food contains no ingredient
products as defined in § 101.13(l) and that is a sugar or that is generally un-
main dish products as defined in derstood by consumers to contain sug-
§ 101.13(m), provided that: ars unless the listing of the ingredient
(i) The food contains at least 25 per- in the ingredient statement is followed
cent fewer calories per 100 g of food by an asterisk that refers to the state-
than an appropriate reference food as ment below the list of ingredients,
described in § 101.13(j)(1); and which states ‘‘adds a trivial amount of
(ii) As required in § 101.13(j)(2) for rel- sugar,’’ ‘‘adds a negligible amount of
ative claims: sugar,’’ or ‘‘adds a dietarily insignifi-
(A) The identity of the reference food cant amount of sugar;’’ and
and the percent (or fraction) that the (iii)(A) It is labeled ‘‘low calorie’’ or
calories differ between the two foods ‘‘reduced calorie’’ or bears a relative
are declared in immediate proximity to claim of special dietary usefulness la-
the most prominent such claim (e.g., beled in compliance with paragraphs
Larry’s Reduced Calorie Lasagna, ‘‘25 (b)(2), (b)(3), (b)(4), or (b)(5) of this sec-
percent fewer calories per oz (or 3 oz) tion, or, if a dietary supplement, it
than our regular Lasagna’’); and meets the definition in paragraph (b)(2)
(B) Quantitative information com- of this section for ‘‘low calorie’’ but is
paring the level of the nutrient in the prohibited by §§ 101.13(b)(5) and
product per specified weight with that 101.60(a)(4) from bearing the claim; or
of the reference food that it replaces (B) Such term is immediately accom-
(e.g., ‘‘Calorie content has been re- panied, each time it is used, by either
duced from 108 calories per 3 oz to 83 the statement ‘‘not a reduced calorie
calories per 3 oz.’’) is declared adjacent food,’’ ‘‘not a low calorie food,’’ or ‘‘not
to the most prominent claim or to the for weight control.’’
nutrition label, except that if the nu- (2) The terms ‘‘no added sugar,’’
trition label is on the information ‘‘without added sugar,’’ or ‘‘no sugar
panel, the quantitative information added’’ may be used only if:
may be located elsewhere on the infor- (i) No amount of sugars, as defined in
mation panel in accordance with § 101.2. § 101.9(c)(6)(ii), or any other ingredient
(iii) Claims described in paragraph that contains sugars that functionally

(b)(5) of this section may not be made substitute for added sugars is added
on the label or labeling of food if the during processing or packaging; and
105
§ 101.60 21 CFR Ch. I (4–1–16 Edition)
(ii) The product does not contain an most prominent such claim (e.g.,
ingredient containing added sugars ‘‘these corn flakes contain 25 percent
such as jam, jelly, or concentrated less sugar than our sugar coated corn
fruit juice; and flakes’’); and
(iii) The sugars content has not been (B) Quantitative information com-
increased above the amount present in paring the level of the sugar in the
the ingredients by some means such as product per labeled serving with that
the use of enzymes, except where the of the reference food that it replaces
intended functional effect of the proc- (e.g., ‘‘Sugar content has been lowered
ess is not to increase the sugars con- from 8 g to 6 g per serving.’’) is de-
tent of a food, and a functionally insig-
clared adjacent to the most prominent
nificant increase in sugars results; and
claim or to the nutrition label, except
(iv) The food that it resembles and
for which it substitutes normally con- that if the nutrition label is on the in-
tains added sugars; and formation panel, the quantitative in-
(v) The product bears a statement formation may be located elsewhere on
that the food is not ‘‘low calorie’’ or the information panel in accordance
‘‘calorie reduced’’ (unless the food with § 101.2.
meets the requirements for a ‘‘low’’ or (6) The terms defined in paragraph
‘‘reduced calorie’’ food) and that di- (c)(5) of this section may be used on the
rects consumers’ attention to the nu- label or in the labeling of a meal prod-
trition panel for further information uct as defined in § 101.13(l) and a main
on sugar and calorie content. dish product as defined in § 101.13(m),
(3) Paragraph (c)(1) of this section provided that:
shall not apply to a factual statement (i) The food contains at least 25 per-
that a food, including foods intended cent less sugars per 100 g of food than
specifically for infants and children an appropriate reference food as de-
less than 2 years of age, is unsweetened scribed in § 101.13(j)(1), and
or contains no added sweeteners in the (ii) As required in § 101.13(j)(2) for rel-
case of a food that contains apparent ative claims:
substantial inherent sugar content,
(A) The identity of the reference food
e.g., juices.
(4) The claims provided for in para- and the percent (or fraction) that the
graph (c)(1) and (c)(2) of this section sugars differ between the two foods are
may be used on labels or in labeling of declared in immediate proximity to the
dietary supplements of vitamins or most prominent such claim (e.g., re-
minerals that are intended specifically duced sweet and sour shrimp dinner,
for use by infants and children less ‘‘25 percent less sugar per 3 oz than our
than 2 years of age. regular sweet and sour shrimp din-
(5) The terms ‘‘reduced sugar,’’ ‘‘re- ner’’); and
duced in sugar,’’ ‘‘sugar reduced,’’ ‘‘less (B) Quantitative information com-
sugar,’’ ‘‘lower sugar’’ or ‘‘lower in paring the level of the nutrient in the
sugar’’ may be used on the label or in product per specified weight with that
labeling of foods, except meal products of the reference food that it replaces
as defined in § 101.13(l), main dish prod- (e.g., ‘‘Sugar content has been reduced
ucts as defined in § 101.13(m), and die- from 17 g per 3 oz to 13 g per 3 oz.’’) is
tary supplements of vitamins or min- declared adjacent to the most promi-
erals, provided that: nent claim or to the nutrition label,
(i) The food contains at least 25 per- except that if the nutrition label is on
cent less sugar per reference amount the information panel, the quantitative
customarily consumed than an appro- information may be located elsewhere
priate reference food as described in on the information panel in accordance
§ 101.13(j)(1); and
with § 101.2.
(ii) As required in § 101.13(j)(2) for rel-
ative claims: [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2,
(A) The identity of the reference food 1993, as amended at 58 FR 44031, Aug. 18, 1993;
and the percent (or fraction) that the 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5,
sugar differs between the two foods are 1995; 62 FR 15342, Mar. 31, 1997; 62 FR 49881,
declared in immediate proximity to the Sept. 23, 1997]
106
§ 101.61 Nutrient content claims for sodium per reference amount custom-
the sodium content of foods. arily consumed; or
(a) General requirements. A claim (B) The food has a reference amount
about the level of sodium or salt in a customarily consumed of 30 g or less or
food may only be made on the label or 2 tablespoons or less and contains 35
in the labeling of the food if: mg or less sodium per reference
(1) The claim uses one of the terms amount customarily consumed and per
defined in this section in accordance 50 g (for dehydrated foods that must be
with the definition for that term; reconstituted before typical consump-
(2) The claim is made in accordance tion with water or a diluent containing
with the general requirements for nu- an insignificant amount, as defined in
trient content claims in § 101.13; and § 101.9(f)(1), of all nutrients per ref-
(3) The food for which the claim is erence amount customarily consumed,
made is labeled in accordance with the per 50-g criterion refers to the ‘‘as
§ 101.9, § 101.10, or § 101.36, as applicable. prepared’’ form);
(b) Sodium content claims. (1) The (ii) If the food meets these conditions
terms ‘‘sodium free,’’ ‘‘free of sodium,’’ without the benefit of special proc-
‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without essing, alteration, formulation, or re-
sodium,’’ ‘‘trivial source of sodium,’’ formulation to vary the sodium con-
‘‘negligible source of sodium,’’ or ‘‘die- tent, it is labeled to clearly refer to all
tary insignificant source of sodium’’ foods of its type and not merely to the
may be used on the label or in the la- particular brand to which the label at-
beling of foods, provided that: taches (e.g., ‘‘potatoes, a very low-so-
(i) The food contains less than 5 mil- dium food’’).
ligrams (mg) of sodium per reference (3) The terms defined in paragraph
amount customarily consumed and per (b)(2) of this section may be used on
labeled serving or, in the case of a meal the label or in labeling of meal prod-
product or a main dish product, less ucts as defined in § 101.13(l) and main
than 5 mg of sodium per labeled serv- dish products as defined in § 101.13(m),
ing; and provided that:
(ii) The food contains no ingredient (i) The product contains 35 mg or less
that is sodium chloride or is generally of sodium per 100 g of product; and
understood by consumers to contain (ii) If the product meets this condi-
sodium, unless the listing of the ingre- tion without the benefit of special
dient in the ingredient statement is processing, alteration, formulation, or
followed by an asterisk that refers to reformulation to lower the sodium con-
the statement below the list of ingredi- tent, it is labeled to clearly refer to all
ents, which states: ‘‘Adds a trivial foods of its type and not merely to the
amount of sodium,’’ ‘‘adds a negligible particular brand to which the label at-
amount of sodium’’ or ‘‘adds a dietarily taches.
insignificant amount of sodium;’’ and (4) The terms ‘‘low sodium,’’ or ‘‘low
(iii) As required in § 101.13(e)(2) if the in sodium,’’ ‘‘little sodium,’’ ‘‘contains
food meets these conditions without a small amount of sodium,’’ or ‘‘low
the benefit of special processing, alter- source of sodium’’ may be used on the
ation, formulation, or reformulation to label or in the labeling of foods, except
lower the sodium content, it is labeled meal products as defined in § 101.13(l)
to disclose that sodium is not usually and main dish products as defined in
present in the food (e.g., ‘‘leaf lettuce, § 101.13(m), provided that:
a sodium free food’’). (i)(A) The food has a reference
(2) The terms ‘‘very low sodium,’’ or amount customarily consumed greater
‘‘very low in sodium,’’ may be used on than 30 g or greater than 2 tablespoons
the label or in labeling of foods, except and contains 140 mg or less sodium per
meal products as defined in § 101.13(l) reference amount customarily con-
and main dish products as defined in sumed; or
§ 101.13(m), provided that: (B) The food has a reference amount
(i)(A) The food has a reference customarily consumed of 30 g or less or
amount customarily consumed greater 2 tablespoons or less and contains 140

than 30 grams (g) or greater than 2 ta- mg or less sodium per reference
blespoons and contains 35 mg or less amount customarily consumed and per
107
§ 101.61 21 CFR Ch. I (4–1–16 Edition)
50 g (for dehydrated foods that must be (e.g., ‘‘Sodium content has been low-
reconstituted before typical consump- ered from 300 to 150 mg per serving.’’) is
tion with water or a diluent containing declared adjacent to the most promi-
an insignificant amount, as defined in nent claim or to the nutrition label,
§ 101.9(f)(1), of all nutrients per ref- except that if the nutrition label is on
erence amount customarily consumed, the information panel, the quantitative
the per 50-g criterion refers to the ‘‘as information may be located elsewhere
prepared’’ form); and on the information panel in accordance
(ii) If the food meets these conditions with § 101.2.
without the benefit of special proc- (iii) Claims described in paragraph
essing, alteration, formulation, or re- (b)(6) of this section may not be made
formulation to vary the sodium con- on the label or in the labeling of a food
tent, it is labeled to clearly refer to all if the nutrient content of the reference
foods of its type and not merely to the food meets the definition for ‘‘low so-
particular brand to which the label at- dium.’’
taches (e.g., ‘‘fresh spinach, a low so- (7) The terms defined in paragraph
dium food’’); and (b)(6) of this section may be used on
(5) The terms defined in paragraph the label or in the labeling of meal
(b)(4) of this section may be used on products as defined in § 101.13(l) and
the label or in labeling of meal prod- main dish products as defined in
ucts as defined in § 101.13(l) and main § 101.13(m), provided that:
dish products as defined in § 101.13(m), (i) The food contains at least 25 per-
provided that: cent less sodium per 100 g of food than
(i) The product contains 140 mg or an appropriate reference food as de-
less sodium per 100 g; and scribed in § 101.13(j)(1), and
(ii) If the product meets these condi- (ii) As required in § 101.13(j)(2) for rel-
tions without the benefit of special ative claims:
processing, alteration, formulation, or (A) The identity of the reference food
reformulation to lower the sodium con- and the percent (or fraction) that the
tent, it is labeled to clearly refer to all sodium differs from the reference food
foods of its type and not merely to the are declared in immediate proximity to
particular brand to which the label at- the most prominent such claim (e.g.,
taches. reduced sodium eggplant parmigiana
(6) The terms ‘‘reduced sodium,’’ dinner ‘‘30 percent less sodium per oz
‘‘reduced in sodium,’’ ‘‘sodium re- (or 3 oz) than our regular eggplant
duced,’’ ‘‘less sodium,’’ ‘‘lower so- parmigiana dinner’’).
dium,’’ or ‘‘lower in sodium’’ may be (B) Quantitative information com-
used on the label or in labeling of paring the level of sodium in the prod-
foods, except meal products as defined uct per specified weight with that of
in § 101.13(l) and main dish products as the reference food that it replaces (e.g.,
defined in § 101.13(m), provided that: ‘‘Sodium content has been reduced
(i) The food contains at least 25 per- from 217 mg per 3 oz to 150 mg per 3
cent less sodium per reference amount oz.’’) is declared adjacent to the most
customarily consumed than an appro- prominent claim or to the nutrition
priate reference food as described in label, except that if the nutrition label
§ 101.13(j)(1). is on the information panel, the quan-
(ii) As required for § 101.13(j)(2) for titative information may be located
relative claims: elsewhere on the information panel in
(A) The identity of the reference food accordance with § 101.2.
and the percent (or fraction) that the (iii) Claims described in paragraph
sodium differs from the labeled food (b)(7) of this section may not be made
are declared in immediate proximity to on the label or in the labeling of a food
the most prominent such claim (e.g., if the nutrient content of the reference
‘‘reduced sodium lll, 50 percent less food meets the definition for ‘‘low so-
sodium than regular lll’’); and dium.’’
(B) Quantitative information com- (c) The term ‘‘salt’’ is not synony-
paring the level of the sodium in the mous with ‘‘sodium.’’ Salt refers to so-
product per labeled serving with that dium chloride. However, references to
of the reference food that it replaces salt content such as ‘‘unsalted,’’ ‘‘no
108
salt,’’ ‘‘no salt added’’ are potentially (b) Fat content claims. (1) The terms
misleading. ‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’
(1) The term ‘‘salt free’’ may be used ‘‘zero fat,’’ ‘‘without fat,’’ ‘‘negligible
on the label or in labeling of foods only source of fat,’’ or ‘‘dietarily insignifi-
if the food is ‘‘sodium free’’ as defined cant source of fat’’ or, in the case of
in paragraph (b)(1) of this section. milk products, ‘‘skim’’ may be used on
(2) The terms ‘‘unsalted,’’ ‘‘without the label or in labeling of foods, pro-
added salt,’’ and ‘‘no salt added’’ may vided that:
be used on the label or in labeling of (i) The food contains less than 0.5
foods only if: gram (g) of fat per reference amount
(i) No salt is added during processing; customarily consumed and per labeled
(ii) The food that it resembles and for serving or, in the case of a meal prod-
which it substitutes is normally proc- uct or main dish product, less than 0.5
essed with salt; and g of fat per labeled serving; and
(iii) If the food is not sodium free, the (ii) The food contains no added ingre-
statement, ‘‘not a sodium free food’’ or dient that is a fat or is generally un-
‘‘not for control of sodium in the diet’’ derstood by consumers to contain fat
appears adjacent to the nutrition label unless the listing of the ingredient in
of the food bearing the claim, or, if the the ingredient statement is followed by
nutrition label is on the information an asterisk that refers to the state-
panel, it may appear elsewhere on the ment below the list of ingredients,
information panel in accordance with which states ‘‘adds a trivial amount of
§ 101.2. fat,’’ ‘‘adds a negligible amount of fat,’’
(3) Paragraph (c)(2) of this section or ‘‘adds a dietarily insignificant
shall not apply to a factual statement amount of fat;’’ and
that a food intended specifically for in- (iii) As required in § 101.13(e)(2), if the
fants and children less than 2 years of food meets these conditions without
age is unsalted, provided such state- the benefit of special processing, alter-
ment refers to the taste of the food and ation, formulation, or reformulation to
is not otherwise false and misleading. lower fat content, it is labeled to dis-
close that fat is not usually present in
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2,
1993, as amended at 58 FR 44032, Aug. 18, 1993; the food (e.g., ‘‘broccoli, a fat free
59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, food’’).
1995] (2) The terms ‘‘low fat,’’ ‘‘low in fat,’’
‘‘contains a small amount of fat,’’ ‘‘low
§ 101.62 Nutrient content claims for source of fat,’’ or ‘‘little fat’’ may be
fat, fatty acid, and cholesterol con- used on the label or in labeling of
tent of foods. foods, except meal products as defined
(a) General requirements. A claim in § 101.13(l) and main dish products as
about the level of fat, fatty acid, and defined in § 101.13(m), provided that:
cholesterol in a food may only be made (i)(A) The food has a reference
on the label or in the labeling of foods amount customarily consumed greater
if: than 30 g or greater than 2 tablespoons
(1) The claim uses one of the terms and contains 3 g or less of fat per ref-
defined in this section in accordance erence amount customarily consumed;
with the definition for that term; or
(2) The claim is made in accordance (B) The food has a reference amount
with the general requirements for nu- customarily consumed of 30 g or less or
trient content claims in § 101.13; 2 tablespoons or less and contains 3 g
(3) The food for which the claim is or less of fat per reference amount cus-
made is labeled in accordance with tomarily consumed and per 50 g of food
§ 101.9, § 101.10, or § 101.36, as applicable; (for dehydrated foods that must be re-
and constituted before typical consumption
(4) For dietary supplements, claims with water or a diluent containing an
for fat, saturated fat, and cholesterol insignificant amount, as defined in
may not be made on products that § 101.9(f)(1), of all nutrients per ref-
meet the criteria in § 101.60(b)(1) or erence amount customarily consumed,

(b)(2) for ‘‘calorie free’’ or ‘‘low cal- the per 50-g criterion refers to the ‘‘as
orie’’ claims. prepared’’ form); and
109
§ 101.62 21 CFR Ch. I (4–1–16 Edition)
(ii) If the food meets these conditions (iii) Claims described in paragraph
without the benefit of special proc- (b)(4) of this section may not be made
essing, alteration, formulation, or re- on the label or in the labeling of a food
formulation to lower fat content, it is if the nutrient content of the reference
labeled to clearly refer to all foods of food meets the definition for ‘‘low fat.’’
its type and not merely to the par- (5) The terms defined in paragraph
ticular brand to which the label at- (b)(4) of this section may be used on
taches (e.g., ‘‘frozen perch, a low fat the label or in the labeling of meal
food’’). products as defined in § 101.13(l) and
(3) The terms defined in paragraph main dish products as defined in
(b)(2) of this section may be used on § 101.13(m), provided that:
the label or in labeling of meal prod- (i) The food contains at least 25 per-
ucts as defined in § 101.13(l) or main cent less fat per 100 g of food than an
dish products as defined in § 101.13(m), appropriate reference food as described
provided that: in § 101.13(j)(1); and
(i) The product contains 3 g or less of (ii) As required in § 101.13(j)(2) for rel-
total fat per 100 g and not more than 30 ative claims:
percent of calories from fat; and (A) The identity of the reference food
(ii) If the product meets these condi- and the percent (or fraction) that the
tions without the benefit of special fat differs between the two foods are
processing, alteration, formulation, or declared in immediate proximity to the
reformulation to lower fat content, it most prominent such claim (e.g., re-
is labeled to clearly refer to all foods of duced fat spinach souffle, ‘‘33 percent
its type and not merely to the par- less fat per 3 oz than our regular spin-
ticular brand to which the label at- ach souffle’’); and
taches. (B) Quantitative information com-
(4) The terms ‘‘reduced fat,’’ ‘‘re- paring the level of fat in the product
duced in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ per specified weight with that of the
‘‘lower fat,’’ or ‘‘lower in fat’’ may be reference food that it replaces (e.g.,
used on the label or in the labeling of ‘‘Fat content has been reduced from 7.5
foods, except meal products as defined g per 3 oz to 5 g per 3 oz.’’) is declared
in § 101.13(l) and main dish products as adjacent to the most prominent claim,
defined in § 101.13(m), provided that: to the nutrition label, or, if the nutri-
(i) The food contains at least 25 per- tion label is located on the information
cent less fat per reference amount cus- panel, it may appear elsewhere on the
tomarily consumed than an appro- information panel in accordance with
priate reference food as described in § 101.2.
§ 101.13(j)(1); and (iii) Claims described in paragraph
(ii) As required in § 101.13(j)(2) for rel- (b)(5) of this section may not be made
ative claims: on the label or in the labeling of a food
(A) The identity of the reference food if the nutrient content of the reference
and the percent (or fraction) that the food meets the definition for ‘‘low fat.’’
fat differs between the two foods and (6) The term ‘‘l percent fat free’’
are declared in immediate proximity to may be used on the label or in the la-
the most prominent such claim (e.g., beling of foods, provided that:
‘‘reduced fat—50 percent less fat than (i) The food meets the criteria for
our regular brownies’’); and ‘‘low fat’’ in paragraph (b)(2) or (b)(3) of
(B) Quantitative information com- this section;
paring the level of fat in the product (ii) The percent declared and the
per labeled serving with that of the ref- words ‘‘fat free’’ are in uniform type
erence food that it replaces (e.g., ‘‘Fat size; and
content has been reduced from 8 g to 4 (iii) A ‘‘100 percent fat free’’ claim
g per serving.’’) is declared adjacent to may be made only on foods that meet
the most prominent claim or to the nu- the criteria for ‘‘fat free’’ in paragraph
trition label, except that if the nutri- (b)(1) of this section, that contain less
tion label is on the information panel, than 0.5 g of fat per 100 g, and that con-
the quantitative information may be tain no added fat.

located elsewhere on the information (c) Fatty acid content claims. The label
panel in accordance with § 101.2. or labeling of foods that bear claims
110
with respect to the level of saturated rated fat,’’ ‘‘adds a negligible amount
fat shall disclose the level of total fat of saturated fat,’’ or ‘‘adds a dietarily
and cholesterol in the food in imme- insignificant amount of saturated fat;’’
diate proximity to such claim each and
time the claim is made and in type (iii) As required in § 101.13(e)(2), if the
that shall be no less than one-half the food meets these conditions without
size of the type used for the claim with the benefit of special processing, alter-
respect to the level of saturated fat. ation, formulation, or reformulation to
Declaration of cholesterol content may lower saturated fat content, it is la-
be omitted when the food contains less beled to disclose that saturated fat is
than 2 milligrams (mg) of cholesterol not usually present in the food.
per reference amount customarily con- (2) The terms ‘‘low in saturated fat,’’
sumed or in the case of a meal or main ‘‘low saturated fat,’’ ‘‘contains a small
dish product less than 2 mg of choles- amount of saturated fat,’’ ‘‘low source
terol per labeled serving. Declaration of saturated fat,’’ or ‘‘a little saturated
of total fat may be omitted with the fat’’ may be used on the label or in the
term defined in paragraph (c)(1) of this labeling of foods, except meal products
section when the food contains less as defined in § 101.13(l) and main dish
than 0.5 g of total fat per reference products as defined in § 101.13(m), pro-
amount customarily consumed or, in vided that:
the case of a meal product or a main (i) The food contains 1 g or less of
dish product, when the product con- saturated fatty acids per reference
tains less than 0.5 g of total fat per la- amount customarily consumed and not
beled serving. The declaration of total more than 15 percent of calories from
fat may be omitted with the terms de- saturated fatty acids; and
fined in paragraphs (c)(2) through (c)(5) (ii) If a food meets these conditions
of this section when the food contains without benefit of special processing,
3 g or less of total fat per reference alteration, formulation, or reformula-
amount customarily consumed or in tion to lower saturated fat content, it
the case of a meal product or a main is labeled to clearly refer to all foods of
dish product, when the product con- its type and not merely to the par-
tains 3 g or less of total fat per 100 g ticular brand to which the label at-
and not more than 30 percent calories taches (e.g., ‘‘raspberries, a low satu-
from fat. rated fat food’’).
(1) The terms ‘‘saturated fat free,’’ (3) The terms defined in paragraph
‘‘free of saturated fat,’’ ‘‘no saturated (c)(2) of this section may be used on the
fat,’’ ‘‘zero saturated fat,’’ ‘‘without label or in the labeling of meal prod-
saturated fat,’’ ‘‘trivial source of satu- ucts as defined in § 101.13(l) and main
rated fat,’’ ‘‘negligible source of satu- dish products as defined in § 101.13(m),
rated fat,’’ or ‘‘dietarily insignificant provided that:
source of saturated fat’’ may be used (i) The product contains 1 g or less of
on the label or in the labeling of foods, saturated fatty acids per 100 g and less
provided that: than 10 percent calories from saturated
(i) The food contains less than 0.5 g of fat; and
saturated fat and less than 0.5 g trans (ii) If the product meets these condi-
fatty acid per reference amount cus- tions without the benefit of special
tomarily consumed and per labeled processing, alteration, formulation, or
serving, or in the case of a meal prod- reformulation to lower saturated fat
uct or main dish product, less than 0.5 content, it is labeled to clearly refer to
g of saturated fat and less than 0.5 g all foods of its type and not merely to
trans fatty acid per labeled serving; and the particular brand to which the label
(ii) The food contains no ingredient attaches.
that is generally understood by con- (4) The terms ‘‘reduced saturated
sumers to contain saturated fat unless fat,’’ ‘‘reduced in saturated fat,’’
the listing of the ingredient in the in- ‘‘saturated fat reduced,’’ ‘‘less satu-
gredient statement is followed by an rated fat,’’ ‘‘lower saturated fat,’’ or
asterisk that refers to the statement ‘‘lower in saturated fat’’ may be used
below the list of ingredients which on the label or in the labeling of foods,
states, ‘‘adds a trivial amount of satu- except as limited by § 101.13(j)(1)(i) and
111
§ 101.62 21 CFR Ch. I (4–1–16 Edition)
except meal products as defined in (B) Quantitative information com-

§ 101.13(l) and main dish products as de- paring the level of saturated fat in the
fined in § 101.13(m), provided that: product per specified weight with that
(i) The food contains at least 25 per- of the reference food that it replaces
cent less saturated fat per reference (e.g., ‘‘Saturated fat content has been
amount customarily consumed than an reduced from 2.5 g per 3 oz to 1.7 g per
appropriate reference food as described 3 oz.’’) is declared adjacent to the most
in § 101.13(j)(1); and prominent claim or to the nutrition
(ii) As required in § 101.13(j)(2) for rel- label, except that if the nutrition label
ative claims: in on the information panel, the quan-
(A) The identity of the reference food titative information may be located
and the percent (or fraction) that the elsewhere on the information panel in
saturated fat differs between the two accordance with § 101.2.
foods are declared in immediate prox- (iii) Claims described in paragraph
imity to the most prominent such (c)(5) of this section may not be made
claim (e.g., ‘‘reduced saturated fat. on the label or in the labeling of a food
Contains 50 percent less saturated fat if the nutrient content of the reference
than the national average for nondairy food meets the definition for ‘‘low satu-
creamers’’); and rated fat.’’
(d) Cholesterol content claims. (1) The
(B) Quantitative information com-
terms ‘‘cholesterol free,’’ ‘‘free of cho-
paring the level of saturated fat in the
lesterol,’’ ‘‘zero cholesterol,’’ ‘‘without
product per labeled serving with that
cholesterol,’’ ‘‘no cholesterol,’’ ‘‘trivial
of the reference food that it replaces
source of cholesterol,’’ ‘‘negligible
(e.g., ‘‘Saturated fat reduced from 3 g
source of cholesterol,’’ or ‘‘dietarily in-
to 1.5 g per serving’’) is declared adja-
significant source of cholesterol’’ may
cent to the most prominent claim or to
be used on the label or in the labeling
the nutrition label, except that if the
of foods, provided that:
nutrition label is on the information
(i) For foods that contain 13 g or less
panel, the quantitative information
of total fat per reference amount cus-
may be located elsewhere on the infor-
tomarily consumed, per labeled serv-
mation panel in accordance with § 101.2.
ing, and per 50 g if the reference
(iii) Claims described in paragraph amount customarily consumed is 30 g
(c)(4) of this section may not be made or less or 2 tablespoons or less (for de-
on the label or in the labeling of a food hydrated foods that must be reconsti-
if the nutrient content of the reference tuted before typical consumption with
food meets the definition for ‘‘low satu- water or a diluent containing an insig-
rated fat.’’ nificant amount, as defined in
(5) The terms defined in paragraph § 101.9(f)(1), of all nutrients per ref-
(c)(4) of this section may be used on the erence amount customarily consumed,
label or in the labeling of meal prod- the per 50-g criterion refers to the ‘‘as
ucts as defined in § 101.13(l) and main prepared’’ form), or, in the case of meal
dish products as defined in § 101.13(m), products, 26.0 g or less total fat per la-
provided that: beled serving, or, in the case of main
(i) The food contains at least 25 per- dish products, 19.5 g or less total fat
cent less saturated fat per 100 g of food per labeled serving:
than an appropriate reference food as (A) The food contains less than 2 mg
described in § 101.13(j)(1), and of cholesterol per reference amount
(ii) As required in § 101.13(j)(2) for rel- customarily consumed and per labeling
ative claims: serving or, in the case of a meal prod-
(A) The identity of the reference uct or main dish product, less than 2
food, and the percent (or fraction) that mg of cholesterol per labeled serving;
the fat differs between the two foods and
are declared in immediate proximity to (B) The food contains no ingredient
the most prominent such claim (e.g., that is generally understood by con-
reduced saturated fat Macaroni and sumers to contain cholesterol, unless
Cheese, ‘‘33 percent less saturated fat the listing of the ingredient in the in-
per 3 oz than our regular Macaroni and gredient statement is followed by an
Cheese’’). asterisk that refers to the statement
112
below the list of ingredients, which cholesterol,’’ or ‘‘adds a dietarily insig-

states ‘‘adds a trivial amount of choles- nificant amount of cholesterol;’’ and
terol,’’ ‘‘adds a negligible amount of (C) The food contains 2 g or less of
cholesterol,’’ or ‘‘adds a dietarily insig- saturated fatty acids per reference
nificant amount of cholesterol;’’ and amount cutomarily consumed or, in
(C) The food contains 2 g or less of the case of a meal product or main dish
saturated fatty acids per reference product less than 2 g of saturated fatty
amount customarily consumed or, in acids per labeled serving; and
the case of a meal product or main dish (D) The label or labeling discloses the
product, 2 g or less of saturated fatty level of total fat in a serving (as de-
acids per labeled serving; and clared on the label) of the food. Such
(D) As required in § 101.13(e)(2), if the disclosure shall appear in immediate
food contains less than 2 mg of choles- proximity to such claim preceding any
terol per reference amount customarily disclosure statement required under
consumed or in the case of a meal prod- § 101.13(h) in type that shall be no less
uct or main dish product, less than 2 than one-half the size of the type used
mg of cholesterol per labeled serving for such claim. If the claim appears on
without the benefit of special proc- more than one panel, the disclosure
essing, alteration, formulation, or re- shall be made on each panel except for
formulation to lower cholesterol con- the panel that bears nutrition labeling.
tent, it is labeled to disclose that cho- If the claim appears more than once on
lesterol is not usually present in the a panel, the disclosure shall be made in
food (e.g., ‘‘applesauce, a cholesterol-
immediate proximity to the claim that
free food’’).
is printed in the largest type; and
(ii) For food that contain more than
(E) As required in § 101.13(e)(2), if the
13 g of total fat per reference amount
food contains less than 2 mg of choles-
customarily consumed, per labeling
terol per reference amount customarily
serving, or per 50 g if the reference
consumed or in the case of a meal prod-
amount customarily consumed is 30 g
uct or main dish product less than 2 mg
or less or 2 tablespoons or less (for de-
hydrated foods that must be reconsti- of cholesterol per labeled serving with-
tuted before typical consumption with out the benefit of special processing,
water or a diluent containing an insig- alteration, formulation, or reformula-
nificant amount, as defined in tion to lower cholesterol content, it is
§ 101.9(f)(1), of all nutrients per ref- labeled to disclose that cholesterol is
erence amount customarily consumed, not usually present in the food (e.g.,
the per 50-g criterion refers to the ‘‘as ‘‘canola oil, a cholesterol-free food,
prepared’’ form), or in the case of a contains 14 g of fat per serving’’); or
meal product, more than 26 g of total (F) If the food contains less than 2
fat per labeled serving, or, in the case mg of cholesterol per reference amount
of a main dish product more than 19.5 g customarily consumed or in the case of
of total fat per labeled serving: a meal product or main dish product
(A) The food contains less than 2 mg less than 2 mg of cholesterol per la-
of cholesterol per reference amount beled serving only as a result of special
customarily consumed and per labeling processing, alteration, formulation, or
serving or, in the case of a meal prod- reformulation, the amount of choles-
uct or main dish product, less than 2 terol is substantially less (i.e., meets
mg of cholesterol per labeled serving; requirements of paragraph (d)(4)(ii)(A)
and of this section) than the food for which
(B) The food contains no ingredient it substitutes as specified in § 101.13(d)
that is generally understood by con- that has a significant (e.g., 5 percent or
sumers to contain cholesterol, unless more of a national or regional market)
the listing of the ingredient in the in- market share. As required in
gredient statement is followed by an § 101.13(j)(2) for relative claims:
asterisk that refers to the statement (1) The identity of the reference food
below the list of ingredients, which and the percent (or fraction) that the
states ‘‘adds a trivial amount of choles- cholesterol was reduced are declared in
terol,’’ ‘‘adds a negligible amount of immediate proximity to the most
113
§ 101.62 21 CFR Ch. I (4–1–16 Edition)
prominent such claim (e.g., ‘‘choles- erence amount customarily consumed,

terol-free margarine, contains 100 per- the per 50-g criterion refers to the ‘‘as
cent less cholesterol than butter’’); and prepared’’ form);
(2) Quantitative information com- (A) The food contains 20 mg or less of
paring the level of cholesterol in the cholesterol per reference amount cus-
product per labeled serving with that tomarily consumed and per 50 g (for de-
of the reference food that it replaces hydrated foods that must be reconsti-
(e.g., ‘‘Contains no cholesterol com- tuted before typical consumption with
pared with 30 mg cholesterol in one water or a diluent containing an insig-
serving of butter. Contains 13 g of fat nificant amount, as defined in
per serving.’’) is declared adjacent to § 101.9(f)(1), of all nutrients per ref-
the most prominent claim or to the nu- erence amount customarily consumed,
trition label, except that if the nutri- the per 50-g criterion refers to the ‘‘as
tion label is on the information panel, prepared’’ form);
the quantitative information may be (B) The food contains 2 g or less of
located elsewhere on the information saturated fatty acids per reference
panel in accordance with § 101.2. amount customarily consumed; and
(2) The terms ‘‘low in cholesterol,’’ (C) As required in § 101.13(e)(2), if the
‘‘low cholesterol,’’ ‘‘contains a small food meets these conditions without
amount of cholesterol,’’ ‘‘low source of the benefit of special processing, alter-
cholesterol,’’ or ‘‘little cholesterol’’ ation, formulation, or reformulation to
may be used on the label or in the la- lower cholesterol content, it is labeled
beling of foods, except meal products to clearly refer to all foods of that type
as defined in § 101.13(l) and main dish and not merely to the particular brand
products as defined in § 101.13(m), pro- to which the label attaches (e.g., ‘‘low
vided that: fat cottage cheese, a low cholesterol
(i) For foods that have a reference food’’).
amount customarily consumed greater (iii) For foods that have a reference
than 30 g or greater than 2 tablespoons amount customarily consumed greater
and contain 13 g or less of total fat per than 30 g or greater than 2 tablespoons
reference amount customarily con- and contain more than 13 g of total fat
sumed and per labeled serving: per reference amount customarily con-
(A) The food contains 20 mg or less of sumed or per labeled serving,
cholesterol per reference amount cus- (A) The food contains 20 mg or less of
tomarily consumed; cholesterol per reference amount cus-
(B) The food contains 2 g or less of tomarily consumed;
saturated fatty acids per reference (B) The food contains 2 g or less of
amount customarily consumed; and saturated fatty acids per reference
(C) As required in § 101.13(e)(2), if the amount customarily consumed;
food meets these conditions without (C) The label or labeling discloses the
the benefit of special processing, alter- level of total fat in a serving (as de-
ation, formulation, or reformulation to clared on the label) of the food. Such
lower cholesterol content, it is labeled disclosure shall appear in immediate
to clearly refer to all foods of that type proximity to such claim preceding any
and not merely to the particular brand disclosure statement required under
to which the label attaches (e.g., ‘‘low § 101.13(h) in type that shall be no less
fat cottage cheese, a low cholesterol than one-half the size of the type used
food.’’). for such claim. If the claim appears on
(ii) For foods that have a reference more than one panel, the disclosure
amount customarily consumed of 30 g shall be made on each panel except for
or less or 2 tablespoons or less and con- the panel that bears nutrition labeling.
tain 13 g or less of total fat per ref- If the claim is made more than once on
erence amount customarily consumed, a panel, the disclosure shall be made in
per labeled serving, and per 50 g (for de- immediate proximity to the claim that
hydrated foods that must be reconsti- is printed in the largest type; and
tuted before typical consumption with (D) As required in § 101.13(e)(2), if the
water or a diluent containing an insig- food meets these conditions without

nificant amount, as defined in the benefit of special processing, alter-
§ 101.9(f)(1), of all nutrients per ref- ation, formulation, or reformulation to
114
lower cholesterol content, it is labeled nificant amount, as defined in

to clearly refer to all foods of that type § 101.9(f)(1), of all nutrients per ref-
and not merely to the particular brand erence amount customarily consumed,
to which the label attaches; or the per 50-g criterion refers to the ‘‘as
(E) If the food contains 20 mg or less prepared’’ form),
of cholesterol only as a result of spe- (B) The food contains 2 g or less of
cial processing, alteration, formula- saturated fatty acids per reference
tion, or reformulation, the amount of amount customarily consumed;
cholesterol is substantially less (i.e., (C) The label or labeling discloses the
meets requirements of paragraph level of total fat in a serving (as de-
(d)(4)(ii)(A) of this section) than the clared on the label) of the food. Such
food for which it substitutes as speci- disclosure shall appear in immediate
fied in § 101.13(d) that has a significant proximity to such claim preceding any
(e.g., 5 percent or more of a national or disclosure statement required under
regional market) market share. As re- § 101.13(h) in type that shall be no less
quired in § 101.13(j)(2) for relative than one-half the size of the type used
claims: for such claim. If the claim appears on
(1) The identity of the reference food more than one panel, the disclosure
and the percent (or fraction) that the shall be made on each panel except for
cholesterol has been reduced are de- the panel that bears nutrition labeling.
clared in immediate proximity to the If the claim is made more than once on
most prominent such claim (e.g., ‘‘low- a panel, the disclosure shall be made in
cholesterol peanut butter sandwich immediate proximity to the claim that
crackers, contains 83 percent less cho- is printed in the largest type; and
lesterol than our regular peanut butter (D) As required in § 101.13(e)(2), if the
sandwich crackers’’); and food meets these conditions without
(2) Quantitative information com- the benefit of special processing, alter-
paring the level of cholesterol in the ation, formulation, or reformulation to
product per labeled serving with that lower cholesterol content, it is labeled
of the reference food that it replaces to clearly refer to all foods of that type
(e.g., ‘‘Cholesterol lowered from 30 mg and not merely to the particular brand
to 5 mg per serving; contains 13 g of fat to which the label attaches; or
per serving.’’) is declared adjacent to (E) If the food contains 20 mg or less
the most prominent claim or to the nu- of cholesterol only as a result of spe-
trition label, except that if the nutri- cial processing, alteration, formula-
tion label is on the information panel, tion, or reformulation, the amount of
the quantitative information may be cholesterol is substantially less (i.e.,
located elsewhere on the information meets requirements of paragraph
panel in accordance with § 101.2. (d)(4)(ii)(A) of this section) than the
(iv) For foods that have a reference food for which it substitutes as speci-
amount customarily consumed of 30 g fied in § 101.13(d) that has a significant
or less or 2 tablespoons or less and con- (i.e., 5 percent or more of a national or
tain more than 13 g of total fat per ref- regional market) market share. As re-
erence amount customarily consumed, quired in § 101.13(j)(2) for relative
per labeled serving, or per 50 g (for de- claims:
hydrated foods that must be reconsti- (1) The identity of the reference food
tuted before typical consumption with and the percent (or fraction) that the
water or a diluent containing an insig- cholesterol has been reduced are de-
nificant amount, as defined in clared in immediate proximity to the
§ 101.9(f)(1), of all nutrients per ref- most prominent such claim (e.g., ‘‘low-
erence amount customarily consumed, cholesterol peanut butter sandwich
the per 50-g criterion refers to the ‘‘as crackers, contains 83 percent less cho-
prepared’’ form), lesterol than our regular peanut butter
(A) The food contains 20 mg or less of sandwich crackers’’); and
cholesterol per reference amount cus- (2) Quantitative information com-
tomarily consumed and per 50 g (for de- paring the level of cholesterol in the
hydrated foods that must be reconsti- product per labeled serving with that
tuted before typical consumption with of the reference food that it replaces
water or a diluent containing an insig- (e.g., ‘‘Cholesterol lowered from 30 mg
115
§ 101.62 21 CFR Ch. I (4–1–16 Edition)
to 5 mg per serving; contains 13 g of fat (A) The food has been specifically
per serving.’’) is declared adjacent to formulated, altered, or processed to re-
the most prominent claim or to the nu- duce its cholesterol by 25 percent or
trition label, except that if the nutri- more from the reference food it resem-
tion label is on the information panel, bles as defined in § 101.13(j)(1) and for
the quantitative information may be which it substitutes as specified in
located elsewhere on the information § 101.13(d) that has a significant (i.e., 5
panel in accordance with § 101.2. percent or more) market share; and
(3) The terms defined in paragraph (B) The food contains 2 g or less of
(d)(2) of this section may be used on saturated fatty acids per reference
the label and in labeling of meal prod- amount customarily consumed; and
ucts as defined in § 101.13(l) or a main (C) As required in § 101.13(j)(2) for rel-
dish product as defined in § 101.13(m) ative claims:
provided that the product meets the re- (1) The identity of the reference food
quirements of paragraph (d)(2) of this and the percent (or fraction) that the
section except that the determination cholesterol has been reduced are de-
as to whether paragraph (d)(2)(i) or clared in immediate proximity to the
(d)(2)(iii) of this section applies to the most prominent such claim; and
product will be made only on the basis (2) Quantitative information com-
of whether the meal product contains paring the level of cholesterol in the
26 g or less of total fat per labeled serv- product per labeled serving with that
ing or the main dish product contain of the reference food that it replaces
19.5 g or less of total fat per labeled (e.g., ‘‘[labeled product] 50 mg choles-
serving, the requirement in paragraphs terol per serving; [reference product] 30
(d)(2)(i)(A) and (d)(2)(iii)(A) of this sec- mg cholesterol per serving’’) is de-
tion shall be limited to 20 mg of choles- clared adjacent to the most prominent
terol per 100 g, and the requirement in claim or to the nutrition label, except
paragraphs (d)(2)(i)(B) and (d)(2)(iii)(B) that if the nutrition label is on the in-
of this section shall be modified to re- formation panel, the quantitative in-
quire that the food contain 2 g or less formation may be located elsewhere on
of saturated fat per 100 g rather than the information panel in accordance
per reference amount customarily con- with § 101.2.
sumed. (ii) For foods that contain more than
(4) The terms ‘‘reduced cholesterol,’’ 13 g of total fat per reference amount
‘‘reduced in cholesterol,’’ ‘‘cholesterol customarily consumed, per labeled
reduced,’’ ‘‘less cholesterol,’’ ‘‘lower serving, or per 50 g if the reference
cholesterol,’’ or ‘‘lower in cholesterol’’ amount customarily consumed is 30 g
except as limited by § 101.13(j)(1)(i) may or less or 2 tablespoons or less (for de-
be used on the label or in labeling of hydrated foods that must be reconsti-
foods or foods that substitute for those tuted before typical consumption with
foods as specified in § 101.13(d), exclud- water or a diluent containing an insig-
ing meal products as defined in nificant amount, as defined in
§ 101.13(l) and main dish products as de- § 101.9(f)(1), of all nutrients per ref-
fined in § 101.13(m), provided that: erence amount customarily consumed,
(i) For foods that contain 13 g or less the per 50-g criterion refers to the ‘‘as
of total fat per reference amount cus- prepared’’ form):
tomarily consumed, per labeled serv- (A) The food has been specifically
ing, and per 50 g if the reference formulated, altered, or processed to re-
amount customarily consumed is 30 g duce its cholesterol by 25 percent or
or less or 2 tablespoons or less (for de- more from the reference food it resem-
hydrated foods that must be reconsti- bles as defined in § 101.13(j)(1) and for
tuted before typical consumption with which it substitutes as specified in
water or a diluent containing an insig- § 101.13(d) that has a significant (i.e., 5
nificant amount, as defined in percent or more of a national or re-
§ 101.9(f)(1), of all nutrients per ref- gional market) market share;
erence amount customarily consumed, (B) The food contains 2 g or less of

the per 50-g criterion refers to the ‘‘as saturated fatty acids per reference
prepared’’ form): amount customarily consumed;
116
(C) The label or labeling discloses the bles as defined in § 101.13(j)(1) and for
level of total fat in a serving (as de- which it substitutes as specified in
clared on the label) of the food. Such § 101.13(d) that has a significant (e.g., 5
disclosure shall appear in immediate percent or more of a national or re-
proximity to such claim preceding any gional market) market share;
disclosure statement required under (B) The food contains 2 g or less of
§ 101.13(h) in type that shall be no less saturated fatty acids per 100 g; and
than one-half the size of the type used (C) As required in § 101.13(j)(2) for rel-
for such claim. If the claim appears on ative claims:
more than one panel, the disclosure (1) The identity of the reference food,
shall be made on each panel except for and the percent (or fraction) that the
the panel that bears nutrition labeling. cholesterol has been reduced are de-
If the claim is made more than once on clared in immediate proximity to the
a panel, the disclosure shall be made in most prominent such claim (e.g., ‘‘25%
immediate proximity to the claim that less cholesterol per 3 oz than lll);
is printed in the largest type; and and
(D) As required in § 101.13(j)(2) for rel- (2) Quantitative information com-
ative claims: paring the level of cholesterol in the
(1) The identity of the reference food product per specified weight with that
and the percent (or fraction) that the of the reference food that it replaces
cholesterol has been reduced are de- (e.g., ‘‘Cholesterol content has been re-
clared in immediate proximity to the duced from 35 mg per 3 oz to 25 mg per
most prominent such claim (e.g., 25 3 oz.’’) is declared adjacent to the most
percent less cholesterol than lll); prominent claim or to the nutrition
and label, except that if the nutrition label
(2) Quantitative information com- is on the information panel, the quan-
paring the level of cholesterol in the titative information may be located
product per labeled serving with that elsewhere on the information panel in
of the reference food that it replaces accordance with § 101.2.
(e.g., ‘‘Cholesterol lowered from 55 mg (ii) For meal products that contain
to 30 mg per serving. Contains 13 g of more than 26.0 g of total fat per labeled
fat per serving.’’) is declared adjacent serving or for main dish products that
to the most prominent claim or to the contain more than 19.5 g of total fat
nutrition label, except that if the nu- per labeled serving:
trition label is on the information (A) The food has been specifically
panel, the quantitative information formulated, altered, or processed to re-
may be located elsewhere on the infor- duce its cholesterol by 25 percent or
mation panel in accordance with § 101.2. more from the reference food it resem-
(iii) Claims described in paragraph bles as defined in § 101.13(j)(1) and for
(d)(4) of this section may not be made which it substitutes as specified in
on the label or in labeling of a food if § 101.13(d) that has a significant (e.g., 5
the nutrient content of the reference percent or more of a national or re-
food meets the definition for ‘‘low cho- gional market) market share.
lesterol.’’ (B) The food contains 2 g or less of
(5) The terms defined in paragraph saturated fatty acids per 100 g;
(d)(4) of this section may be used on (C) The label or labeling discloses the
the label or in the labeling of meal level of total fat in a serving (as de-
products as defined in § 101.13(l) and clared on the label) of the food. Such
main dish products as defined in disclosure shall appear in immediate
§ 101.13(m), provided that: proximity to such claim preceding any
(i) For meal products that contain disclosure statement required under
26.0 g or less of total fat per labeled § 101.13(h) in type that shall be no less
serving or for main dish products that than one-half the size of the type used
contain 19.5 g or less of total fat per la- for such claim. If the claim appears on
beled serving; more than one panel the disclosure
(A) The food has been specifically shall be made on each panel except for
formulated, altered, or processed to re- the panel that bears nutrition labeling.
duce its cholesterol by 25 percent or If the claim is made more than once on
more from the reference food it resem- a panel, the disclosure shall be made in
117
§ 101.65 21 CFR Ch. I (4–1–16 Edition)
immediate proximity to the claim that rated fat, and less than 95 mg choles-
is printed in the largest type; and terol per 100 g and per labeled serving;
(D) As required in § 101.13(j)(2) for rel- (4) The term ‘‘extra lean’’ may be
ative claims: used on the label or in the labeling of
(1) The identity of the reference food foods except meal products as defined
and the percent (or fraction) that the in § 101.13(l) and main dish products as
cholesterol has been reduced are de- defined in § 101.13(m) provided that the
clared in immediate proximity to the food is a discrete seafood or game meat
most prominent such claim (e.g., 25 product and as packaged contains less
percent less cholesterol than lll); than 5 g total fat, less than 2 g satu-
and rated fat, and less than 95 mg choles-
(2) Quantitative information com- terol per reference amount customarily
paring the level of cholesterol in the consumed and per 100 g; and
product per specified weight with that (5) The term defined in paragraph
of the reference food that it replaces (e)(4) of this section may be used on the
(e.g., ‘‘Cholesterol lowered from 30 mg label or in labeling of meal products as
to 22 mg per 3 oz of product.’’) is de- defined in § 101.13(l) and main dish prod-
clared adjacent to the most prominent ucts as defined in § 101.13(m) provided
claim or to the nutrition label, except that the food contains less than 5 g of
that if the nutrition label is on the in- fat, less than 2 g of saturated fat, and
formation panel, the quantitative in- less than 95 mg of cholesterol per 100 g
formation may be located elsewhere on and per labeled serving.
the information panel in accordance (f) Misbranding. Any label or labeling
containing any statement concerning
with § 101.2.
fat, fatty acids, or cholesterol that is
(iii) Claims described in paragraph
not in conformity with this section
(d)(5) of this section may not be made
shall be deemed to be misbranded
on the label or in the labeling of a food under sections 201(n), 403(a), and 403(r)
if the nutrient content of the reference of the Federal Food, Drug, and Cos-
food meets the definition for ‘‘low cho- metic Act.
lesterol.’’
(e) ‘‘Lean’’ and ‘‘extra lean’’ claims. (1) [58 FR 2413, Jan. 6, 1993; 58 FR 17342, 17343,
The term ‘‘lean’’ may be used on the Apr. 2, 1993, as amended at 58 FR 44032, Aug.
18, 1993; 58 FR 60105, Nov. 15, 1993; 59 FR 394,
label or in labeling of foods except Jan. 4, 1994; 60 FR 17207, Apr. 5, 1995; 61 FR
meal products as defined in § 101.13(l) 59001, Nov. 20, 1996; 63 FR 26980, May 15, 1998;
and main dish products as defined in 72 FR 1459, Jan. 12, 2007]
§ 101.13(m) provided that the food is a
seafood or game meat product and as § 101.65 Implied nutrient content
packaged contains less than 10 g total claims and related label statements.
fat, 4.5 g or less saturated fat, and less (a) General requirements. An implied
than 95 mg cholesterol per reference nutrient content claim can only be
amount customarily consumed and per made on the label and in labeling of the
100 g; food if:
(2) The term defined in paragraph (1) The claim uses one of the terms
(e)(1) of this section may be used on the described in this section in accordance
label or in labeling of a mixed dish not with the definition for that term;
measurable with a cup as defined in (2) The claim is made in accordance
§ 101.12(b) in table 2, provided that the with the general requirements for nu-
food contains less than 8 g total fat, 3.5 trient content claims in § 101.13; and
g or less saturated fat and less than 80 (3) The food for which the claim is
mg cholesterol per reference amount made is labeled in accordance with
customarily consumed; § 101.9, § 101.10, or § 101.36, as applicable.
(3) The term defined in paragraph (b) Label statements that are not im-
(e)(1) of this section may be used on the plied claims. Certain label statements
label or in the labeling of meal prod- about the nature of a product are not
ucts as defined in § 101.13(l) or main nutrient content claims unless such
dish products as defined in § 101.13(m) statements are made in a context that

provided that the food contains less would make them an implied claim
than 10 g total fat, 4.5 g or less satu- under § 101.13(b)(2). The following types
118
of label statements are generally not present in a certain amount (e.g.,

implied nutrient content claims and, as ‘‘high in oat bran’’) are implied nutri-
such, are not subject to the require- ent content claims and must comply
ments of § 101.13 and this section: with paragraph (a) of this section.
(1) A claim that a specific ingredient (2) The phrases ‘‘contains the same
or food component is absent from a amount of [nutrient] as a [food]’’ and
product, provided that the purpose of ‘‘as much [nutrient] as a [food]’’ may
such claim is to facilitate avoidance of be used on the label or in the labeling
the substances because of food allergies of foods, provided that the amount of
(see § 105.62 of this chapter), food intol- the nutrient in the reference food is
erance, religious beliefs, or dietary enough to qualify that food as a ‘‘good
practices such as vegetarianism or source’’ of that nutrient, and the la-
other nonnutrition related reason, e.g., beled food, on a per serving basis, is an
‘‘100 percent milk free;’’ equivalent, good source of that nutri-
(2) A claim about a substance that is ent (e.g., ‘‘as much fiber as an apple,’’
nonnutritive or that does not have a ‘‘Contains the same amount of Vitamin
nutritive function, e.g., ‘‘contains no C as an 8 oz glass of orange juice.’’).
preservatives,’’ ‘‘no artificial colors;’’ (3) Claims may be made that a food
(3) A claim about the presence of an contains or is made with an ingredient
ingredient that is perceived to add that is known to contain a particular
value to the product, e.g., ‘‘made with nutrient, or is prepared in a way that
real butter,’’ ‘‘made with whole fruit,’’ affects the content of a particular nu-
or ‘‘contains honey,’’ except that trient in the food, if the finished food is
claims about the presence of ingredi- either ‘‘low’’ in or a ‘‘good source’’ of
ents other than vitamins or minerals the nutrient that is associated with the
or that are represented as a source of ingredient or type of preparation. If a
vitamins and minerals are not allowed more specific level is claimed (e.g.,
on labels or in labeling of dietary sup- ‘‘high in lll), that level of the nutri-
plements of vitamins and minerals that ent must be present in the food. For ex-
are not in conventional food form. ample, a claim that a food contains oat
(4) A statement of identity for a food bran is a claim that it is a good source
in which an ingredient constitutes es- of dietary fiber; that a food is made
sentially 100 percent of a food (e.g., only with vegetable oil is a claim that
‘‘corn oil,’’ ‘‘oat bran,’’ ‘‘dietary sup- it is low in saturated fat; and that a
plement of vitamin C 60 mg tablet’’). food contains no oil is a claim that it
(5) A statement of identity that is fat free.
names as a characterizing ingredient, (d) General nutritional claims. (1) This
an ingredient associated with a nutri- paragraph covers labeling claims that
ent benefit (e.g., ‘‘corn oil margarine,’’ are implied nutrient content claims be-
‘‘oat bran muffins,’’ or ‘‘whole wheat cause they:
bagels’’), unless such claim is made in (i) Suggest that a food because of its
a context in which label or labeling nutrient content may help consumers
statements, symbols, vignettes, or maintain healthy dietary practices;
other forms of communication suggest and
that a nutrient is absent or present in (ii) Are made in connection with an
a certain amount; and explicit or implicit claim or statement
(6) A label statement made in compli- about a nutrient (e.g., ‘‘healthy, con-
ance with a specific provision of part tains 3 grams of fat’’).
105 of this chapter, solely to note that (2) You may use the term ‘‘healthy’’
a food has special dietary usefulness or related terms (e.g., ‘‘health,’’
relative to a physical, physiological, ‘‘healthful,’’ ‘‘healthfully,’’ ‘‘health-
pathological, or other condition, where fulness,’’ ‘‘healthier,’’ ‘‘healthiest,’’
the claim identifies the special diet of ‘‘healthily,’’ and ‘‘healthiness’’) as an
which the food is intended to be a part. implied nutrient content claim on the
(c) Particular implied nutrient content label or in labeling of a food that is
claims. (1) Claims about the food or an useful in creating a diet that is con-
ingredient therein that suggest that a sistent with dietary recommendations

nutrient or an ingredient is absent or if:
119
§ 101.65 21 CFR Ch. I (4–1–16 Edition)
(i) The food meets the following conditions for fat, saturated fat, cholesterol,
and other nutrients:
The fat level must The saturated fat The cholesterol level The food must con-
If the food is... be... level must be... must be... tain...
(A) A raw fruit or vegetable Low fat as defined Low saturated fat as The disclosure level N/A
in § 101.62(b)(2) defined in for cholesterol
§ 101.62(c)(2) specified in
§ 101.13(h) or less
(B) A single-ingredient or a mix- Low fat as defined Low saturated fat as The disclosure level N/A
ture of frozen or canned fruits in § 101.62(b)(2) defined in for cholesterol
and vegetables1 § 101.62(c)(2) specified in
§ 101.13(h) or less
(C) An enriched cereal-grain Low fat as defined Low saturated fat as The disclosure level N/A
product that conforms to a in § 101.62(b)(2) defined in for cholesterol
standard of identity in part 136, § 101.62(c)(2) specified in
137 or 139 of this chapter § 101.13(h) or less
(D) A raw, single-ingredient sea- Less than 5 grams Less than 2 g satu- Less than 95 mg At least 10 percent
food or game meat (g) total fat per rated fat per RA cholesterol per RA of the RDI3 or the
RA2 and per 100 and per 100 g and per 100 g DRV4 per RA of
g one or more of vi-
tamin A, vitamin
C, calcium, iron,
protein, or fiber
(E) A meal product as defined in Low fat as defined Low saturated fat as 90 mg or less cho- At least 10 percent
§ 101.13(l) or a main dish prod- in § 101.62(b)(3) defined in lesterol per LS5 of the RDI or DRV
uct as defined in § 101.13(m) § 101.62(c)(3) per LS of two nu-
trients (for a main
dish product) or of
three nutrients (for
a meal product)
of: vitamin A, vita-
min C, calcium,
iron, protein, or
fiber
(F) A food not specifically listed in Low fat as defined Low saturated fat as The disclosure level At least 10 percent
this table in § 101.62(b)(2) defined in for cholesterol of the RDI or the
§ 101.62(c)(2) specified in DRV per RA of
§ 101.13(h) or less one or more of vi-
tamin A, vitamin
C, calcium, iron,
protein or fiber
1 May include ingredients whose addition does not change the nutrient profile of the fruit or vegetable.
2 RA means Reference Amount Customarily Consumed per Eating Occasion (§ 101.12(b)).
3 RDI means Reference Daily Intake (§ 101.9(c)(8)(iv)).
4 DRV means Daily Reference Value (§ 101.9(c)(9)).
5 LS means Labeled Serving, i.e., the serving size that is specified in the nutrition information on the product label (§ 101.9(b)).
(ii) The food meets the following con- If the food is... The sodium level must be...
ditions for sodium: (C) A meal product as defined 600 mg or less sodium per
in § 101.13(l) or a main dish LS
If the food is... The sodium level must be...
product as defined in
§ 101.13(m)
(A) A food with a RA that is 480 mg or less sodium per
greater than 30 g or 2 ta- RA and per LS 1 For dehydrated food that is typically reconstituted with
blespoons (tbsp.) water or a liquid that contains insignificant amounts per RA of
all nutrients (as defined in § 101.9(f)(1)), the 50 g refers to the
(B) A food with a RA that is 480 mg or less sodium per ‘‘prepared’’ form of the product.
equal to or less than 30 g 50 g1
or 2 tbsp. (iii) The food complies with the defi-
nition and declaration requirements in
this part 101 for any specific nutrient
content claim on the label or in label-
ing, and
(iv) If you add a nutrient to the food
specified in paragraphs (d)(2)(i)(D),
120
(d)(2)(i)(E), or (d)(2)(i)(F) of this section (b) Deviations from the ingredient

to meet the 10 percent requirement, provisions of 21 U.S.C. 321a must be the
that addition must be in accordance minimum necessary to achieve similar
with the fortification policy for foods performance characteristics as butter
in § 104.20 of this chapter. as produced under 21 U.S.C. 321a, or the
food will be deemed to be adulterated
[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, under section 402(b) of the act. The per-
1993, as amended at 59 FR 394, Jan. 4, 1994; 59
formance characteristics (e.g., physical
FR 24249, May 10, 1994; 59 FR 50828, Oct. 6,
1994; 62 FR 49858, Sept. 23, 1997; 63 FR 14355, properties, organoleptic characteris-
Mar. 25, 1998; 70 FR 56848, Sept. 29, 2005] tics, functional properties, shelf life) of
the product shall be similar to butter
§ 101.67 Use of nutrient content claims as produced under 21 U.S.C. 321a. If
for butter. there is a significant difference in per-
formance characteristics (that materi-
(a) Claims may be made to charac-
ally limits the uses of the product com-
terize the level of nutrients, including
pared to butter,) the label shall include
fat, in butter if: a statement informing the consumer of
(1) The claim complies with the re- such difference (e.g., if appropriate,
quirements of § 101.13 and with the re- ‘‘not recommended for baking pur-
quirements of the regulations in this poses’’). Such statement shall comply
subpart that define the particular nu- with the requirements of § 101.13(d).
trient content claim that is used and The modified product shall perform at
how it is to be presented. In deter- least one of the principal functions of
mining whether a claim is appropriate, butter substantially as well as butter
the calculation of the percent fat reas produced under 21 U.S.C. 321a.
duction in milkfat shall be based on (c)(1) Each of the ingredients used in
the 80 percent milkfat requirement the food shall be declared on the label
provided by the statutory standard for as required by the applicable sections
butter (21 U.S.C. 321a); of this part.
(2) The product contains cream or (2) Safe and suitable ingredients
milk, including milk constituents (in- added to improve texture, prevent syn-
cluding, but not limited to, whey, ca- eresis, add flavor, extend shelf life, im-
sein, modified whey, and salts of ca- prove appearance, or add sweetness and
sein), or both, with or without added water added to replace milkfat shall be
salt, with or without safe and suitable identified with an asterisk in the ingre-
colorings, with or without nutrients dient statement. The statement
added to comply with paragraph (a)(3) ‘‘*Ingredients not in regular butter’’
of this section, and with or without shall immediately follow the ingre-
safe and suitable bacterial cultures. dient statement in the same type size.
The product may contain safe and suit- [58 FR 2455, Jan. 6, 1993]
able ingredients to improve texture,
prevent syneresis, add flavor, extend § 101.69 Petitions for nutrient content
shelf life, improve appearance, and add claims.
sweetness. The product may contain (a) This section pertains to petitions
water to replace milkfat although the for claims, expressed or implied, that:
amount of water in the product shall (1) Characterize the level of any nu-
be less than the amount of cream, trient which is of the type required to
milk, or milk constituents; be in the label or labeling of food by
(3) The product is not nutritionally section 403(q)(1) or (q)(2) of the Federal
inferior, as defined in § 101.3(e)(4), to Food, Drug, and Cosmetic Act (the
butter as produced under 21 U.S.C. 321a; act); and
and (2) That are not exempted under sec-
(4) If the product would violate 21 tion 403(r)(5)(A) through (r)(5)(C) of the
U.S.C. 321a but for the nutrient content act from the requirements for such
claim that characterizes the level of claims in section 403(r)(2).
nutrients, that claim shall be an ex- (b) Petitions included in this section
plicit claim that is included as part of are:

the common or usual name of the prod- (1) Petitions for a new (heretofore un-
uct. authorized) nutrient content claim;
121
§ 101.69 21 CFR Ch. I (4–1–16 Edition)
(2) Petitions for a synonymous term shall include a statement regarding

(i.e., one that is consistent with a term each such clinical investigation relied
defined by regulation) for character- upon in the petition that the study ei-
izing the level of a nutrient; and ther was conducted in compliance with
(3) Petitions for the use of an implied the requirements for institutional re-
claim in a brand name. view set forth in part 56 of this chapter
(c) An original and one copy of the or was not subject to such require-
petition to be filed under the provi- ments in accordance with § 56.104 or
sions of section 403(r)(4) of the act shall § 56.105 of this chapter, and that it was
be submitted, or the petitioner may conducted in compliance with the re-
submit an original and a computer quirements for informed consent set
readable disk containing the petition. forth in part 50 of this chapter.
Contents of the disk should be in a (g) The availability for public disclo-
standard format, such as ASCII format. sure of petitions submitted to the
Petitioners interested in submitting a agency under this section will be gov-
disk should contact the Food and Drug erned by the rules specified in § 10.20(j)
Administration’s (FDA) Center for of this chapter.
Food Safety and Applied Nutrition for (h) All petitions submitted under this
details. If any part of the material sub- section shall include either a claim for
mitted is in a foreign language, it shall a categorical exclusion under § 25.30 or
be accompanied by an accurate and 25.32 of this chapter or an environ-
complete English translation. The peti- mental assessment under § 25.40 of this
tion shall state the petitioner’s post of- chapter.
fice address to which published notices (i) The data specified under the sev-
as required by section 403 of the act eral lettered headings should be sub-
may be sent. mitted on separate sheets or sets of
(d) Pertinent information may be in- sheets, suitably identified. If such data
corporated in, and will be considered as have already been submitted with an
part of, a petition on the basis of spe- earlier application from the petitioner,
cific reference to such information sub- the present petition may incorporate it
mitted to and retained in the files of by specific reference to the earlier peti-
FDA. However, any reference to unpub- tion.
lished information furnished by a per- (j) The petition must be signed by the
son other than the applicant will not petitioner or by his attorney or agent,
be considered unless use of such infor- or (if a corporation) by an authorized
mation is authorized (with the under- official.
standing that such information may in (k) The petition shall include a state-
whole or part be subject to release to ment signed by the person responsible
the public) in a written statement for the petition, that to the best of his
signed by the person who submitted it. knowledge, it is a representative and
Any reference to published information balanced submission that includes un-
should be accompanied by reprints or favorable information, as well as favor-
photostatic copies of such references. able information, known to him perti-
(e) If nonclinical laboratory studies nent to the evaluation of the petition.
are included in a petition submitted
(l) All applicable provisions of part
under section 403(r)(4) of the act, the
10—Administrative Practices and Pro-
petition shall include, with respect to
cedures, may be used by FDA, the peti-
each nonclinical study contained in the
tioner or any outside party with re-
petition, either a statement that the
spect to any agency action on the peti-
study has been, or will be, conducted in
tion.
compliance with the good laboratory
practice regulations as set forth in part (m)(1) Petitions for a new nutrient
58 of this chapter or, if any such study content claim shall include the fol-
was not conducted in compliance with lowing data and be submitted in the
such regulations, a brief statement of following form.
the reason for the noncompliance. (Date) llllll
(f) If clinical investigations are in- Name of petitioner llllll

cluded in a petition submitted under Post office address llllll
section 403(r)(4) of the act, the petition Subject of the petition llllll
122
Office of Nutritional Products, Labeling and tended for a specific group within the popu-
Dietary Supplements (HFS–800) lation, the above analysis shall specifically
Food and Drug Administration, address the dietary practices of such group
Department of Health and Human Services, and shall include data sufficient to dem-
Washington, DC 20204. onstrate that the dietary analysis is rep-
To Whom It May Concern: resentative of such group.
The undersigned, llllllllllll E. The petitioner is required to submit ei-
submits this petition under section 403(r)(4) ther a claim for categorical exclusion under
of the Federal Food, Drug, and Cosmetic Act § 25.30 or § 25.32 of this chapter or an environ-
(the act) with respect to (statement of the mental assessment under § 25.40 of this chap-
claim and its proposed use). ter.
Attached hereto and constituting a part of Yours very truly,
this petition, are the following: Petitioner llllll
A. A statement identifying the descriptive By llllll
term and the nutrient that the term is in- (Indicate authority)
tended to characterize with respect to the
level of such nutrient. The statement should (2) Within 15 days of receipt of the pe-
address why the use of the term as proposed tition, the petitioner will be notified
will not be misleading. The statement should by letter of the date on which the peti-
provide examples of the nutrient content tion was received by the agency. Such
claim as it will be used on labels or labeling, notice will inform the petitioner:
as well as the types of foods on which the (i) That the petition is undergoing
claim will be used. The statement shall agency review (in which case a docket
specify the level at which the nutrient must
be present or what other conditions con-
number will be assigned to the peti-
cerning the food must be met for the use of tion), and the petitioner will subse-
the term in labels or labeling to be appro- quently be notified of the agency’s de-
priate, as well as any factors that would cision to file or deny the petition; or
make the use of the term inappropriate. (ii) That the petition is incomplete,
B. A detailed explanation, supported by e.g., it lacks any of the data required
any necessary data, of why use of the food by this part, it presents such data in a
component characterized by the claim is of manner that is not readily understood,
importance in human nutrition by virtue of
its presence or absence at the levels that
or it has not been submitted in quadru-
such claim would describe. This explanation plicate, in which case the petition will
shall also state what nutritional benefit to be denied, and the petitioner will be
the public will derive from use of the claim notified as to what respect the petition
as proposed, and why such benefit is not is incomplete.
available through the use of existing terms (3) Within 100 days of the date of re-
defined by regulation under section ceipt of the petition, FDA will notify
403(r)(2)(A)(i) of the act. If the claim is in- the petitioner by letter that the peti-
tended for a specific group within the popu-
tion has either been filed or denied. If
lation, the analysis should specifically ad-
dress nutritional needs of such group, and denied, the notification shall state the
should include scientific data sufficient for reasons therefor. If filed, the date of
such purpose. the notification letter becomes the
C. Analytical data that shows the amount date of filing for the purposes of sec-
of the nutrient that is the subject of the tion 403(r)(4)(A)(i) of the act. If FDA
claim and that is present in the types of does not act within such 100 days, the
foods for which the claim is intended. The petition shall be deemed to be denied
assays should be performed on representative unless an extension is mutually agreed
samples using the AOAC INTERNATIONAL
(AOAC International) methods where avail-
upon by the FDA and the petitioner. A
able. If no AOAC International method is petition that has been denied, or has
available, the petitioner shall submit the been deemed to be denied, without fil-
assay method used, and data establishing the ing shall not be made available to the
validity of the method for assaying the nu- public. A filed petition shall be avail-
trient in the particular food. The validation able to the public as provided under
data should include a statistical analysis of paragraph (g) of this section.
the analytical and product variability. (4) Within 90 days of the date of filing
D. A detailed analysis of the potential ef- FDA will by letter of notification to
fect of the use of the proposed claim on food
consumption and of any corresponding
the petitioner:
changes in nutrient intake. The latter item (i) Deny the petition; or
shall specifically address the intake of nutri- (ii) Inform the petitioner that a pro-
ents that have beneficial and negative con- posed regulation to provide for the re-
sequences in the total diet. If the claim is in- quested use of the new term will be
123
§ 101.69 21 CFR Ch. I (4–1–16 Edition)
published in the FEDERAL REGISTER. characterizing the level of a nutrient. This

FDA will publish the proposal to item shall also state what nutritional ben-
amend the regulations to provide for efit to the public will derive from use of the
claim as proposed, and why such benefit is
the requested use of the nutrient con-
not available through the use of existing
tent claim in the FEDERAL REGISTER term defined by regulation. If the claim is
within 90 days of the date of filing. The intended for a specific group within the pop-
proposal will also announce the avail- ulation, the analysis should specifically ad-
ability of the petition for public disclo- dress nutritional needs of such group, and
sure. should include scientific data sufficient for
(iii) If FDA does not act within 90 such purpose.
days of the date of filing, the petition C. The petitioner is required to submit ei-
shall be deemed to be denied unless an ther a claim for categorical exclusion under
§ 25.30 or § 25.32 of this chapter or an environ-
extension is mutually agreed upon by
mental assessment under § 25.40 of this chap-
FDA and the petitioner. ter.
(5) If FDA issues a proposal, the rule- Yours very truly,
making shall be completed within 540 Petitioner llllll
days of the date of receipt of the peti- By llllll
tion. (Indicate authority)
(n)(1) Petitions for a synonymous (2) Within 15 days of receipt of the pe-
term shall include the following data tition the petitioner will be notified by
and be submitted in the following form. letter of the date on which the petition
(Date)llllll was received. Such notice will inform
Name of petitioner llllll the petitioner:
Post office address llllll (i) That the petition is undergoing
Subject of the petition llllll agency review (in which case a docket
Office of Nutritional Products, Labeling and
number will be assigned to the peti-
Dietary Supplements (HFS–800)
Food and Drug Administration, tion) and the petitioner will subse-
Department of Health and Human Services, quently be notified of the agency’s de-
Washington, DC 20204. cision to grant the petitioner permis-
To Whom It May Concern: sion to use the proposed term or to
The undersigned, llllll submits this deny the petition; or
petition under section 403(r)(4) of the Federal (ii) That the petition is incomplete,
Food, Drug, and Cosmetic Act (the act) with
respect to (statement of the synonymous
e.g., it lacks any of the data required
term and its proposed use in a nutrient con- by this part, it presents such data in a
tent claim that is consistent with an exist- manner that is not readily understood,
ing term that has been defined under section or it has not been submitted in quadru-
403(r)(2) of the act). plicate, in which case the petition will
Attached hereto and constituting a part of be denied, and the petitioner will be
this petition, are the following: notified as to what respect the petition
A. A statement identifying the synony-
mous descriptive term, the existing term de-
is incomplete.
fined by a regulation under section (3) Within 90 days of the date of re-
403(r)(2)(A)(i) of the act with which the syn- ceipt of the petition that is accepted
onymous term is claimed to be consistent. for review (i.e., that has not been found
The statement should address why the pro- to be incomplete and consequently de-
posed synonymous term is consistent with nied, FDA will notify the petitioner by
the term already defined by the agency, and letter of the agency’s decision to grant
why the use of the synonymous term as pro-
the petitioner permission to use the
posed will not be misleading. The statement
should provide examples of the nutrient con- proposed term, with any conditions or
tent claim as it will be used on labels or la- limitations on such use specified, or to
beling, as well as the types of foods on which deny the petition, in which case the
the claim will be used. The statement shall letter shall state the reasons therefor.
specify whether any limitations not applica- Failure of the petition to fully address
ble to the use of the defined term are in- the requirements of this section shall
tended to apply to the use of the synony- be grounds for denial of the petition.
mous term.
(4) As soon as practicable following
B. A detailed explanation, supported by
any necessary data, of why use of the pro- the agency’s decision to either grant or
posed term is requested, including an expla- deny the petition, FDA will publish a
nation of whether the existing defined term notice in the FEDERAL REGISTER in-
is inadequate for the purpose of effectively forming the public of his decision. If
124
the petition is granted the Food and mental assessment under § 25.40 of this chap-
Drug Administration will list, the ap- ter.
proved synonymous term in the regula- Yours very truly,
tions listing terms permitted for use in Petitioner llllll
nutrient content claims. By llllll
(o)(1) Petitions for the use of an im- (2) Within 15 days of receipt of the pe-
plied nutrient content claim in a brand tition the petitioner will be notified by
name shall include the following data letter of the date on which the petition
and be submitted in the following form:
was received. Such notice will inform
(Date)llllll the petitioner:
Name of petitioner llllll (i) That the petition is undergoing
Post office address llllll
Subject of the petition llllll
agency review (in which case a docket
Office of Nutritional Products, Labeling and number will be assigned to the peti-
Dietary Supplements (HFS–800), tion); or
Food and Drug Administration, (ii) That the petition is incomplete,
Department of Health and Human Services, e.g., it lacks any of the data required
Washington, DC 20204.
To Whom It May Concern: by this part, it presents such data in a
The undersigned, lllllllllll sub- manner that is not readily understood,
mits this petition under section 403(r)(4) of or it has not been submitted in quadru-
the Federal Food, Drug, and Cosmetic Act plicate, in which case the petition will
(the act) with respect to (statement of the be denied, and the petitioner will be
implied nutrient content claim and its pro-
notified as to what respect the petition
posed use in a brand name).
Attached hereto and constituting a part of is incomplete.
this petition, are the following: (3) FDA will publish a notice of the
A. A statement identifying the implied nu- petition in the FEDERAL REGISTER an-
trient content claim, the nutrient the claim nouncing its availability to the public
is intended to characterize, the cor-
and seeking comment on the petition.
responding term for characterizing the level
of such nutrient as defined by a regulation The petition shall be available to the
under section 403(r)(2)(A)(i) of the act, and public to the extent provided under
the brand name of which the implied claim is paragraph (g) of this section. The no-
intended to be a part. The statement should tice shall allow 30 days for comments.
address why the use of the brandname as pro- (4) Within 100 days of the date of re-
posed will not be misleading. It should ad-
dress in particular what information is receipt of the petition that is accepted
quired to accompany the claim or other ways for review (i.e., that has not been found
in which the claim meets the requirements to be incomplete and subsequently re-
of sections 201(n) and 403(a) of the act. The turned to the petitioner), FDA will:
statement should provide examples of the (i) Notify the petitioner by letter of
types of foods on which the brand name will
the agency’s decision to grant the peti-
appear. It shall also include data showing
that the actual level of the nutrient in the tioner permission to use the proposed
food qualifies the food to bear the cor- brand name if such use is not mis-
responding term defined by regulation. leading, with any conditions or limita-
Assay methods used to determine the level of tions on such use specified; or
a nutrient should meet the requirements (ii) Deny the petition, in which case
stated under petition format item C in para-
graph (k)(1) of this section. the letter shall state the reasons there-
B. A detailed explanation, supported by for. Failure of the petition to fully ad-
any necessary data, of why use of the pro- dress the requirements of this section
posed brand name is requested. This item shall be grounds for denial of the peti-
shall also state what nutritional benefit to tion. Should FDA not notify the peti-
the public will derive from use of the brand
tioner of his decision on the petition
name as proposed. If the branded product is
intended for a specific group within the pop- within 100 days, the petition shall be
ulation, the analysis should specifically ad- considered to be granted.
dress nutritional needs of such group and (5) As soon as practicable following
should include scientific data sufficient for the granting of a petition, the Commis-
such purpose.
sioner of Food and Drugs will publish a

C. The petitioner is required to submit ei-
ther a claim for categorical exclusion under
§ 25.30 or § 25.32 of this chapter or an environ-
125
§ 101.70 21 CFR Ch. I (4–1–16 Edition)
notice in the FEDERAL REGISTER in- (d) If clinical or other human inves-
forming the public of such fact. tigations are included in a petition, the
petition shall include a statement that
[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2,
1993, as amended at 58 FR 44033, Aug. 18, 1993;
they were either conducted in compli-
62 FR 40598, July 29, 1997; 63 FR 26718, May 14, ance with the requirements for institu-
1998; 63 FR 40024, July 27, 1998; 67 FR 9585, tional review set forth in part 56 of this
Mar. 4, 2002; 69 FR 16481, Mar. 30, 2004] chapter, or were not subject to such re-
quirements in accordance with § 56.104
Subpart E—Specific Requirements or § 56.105, and a statement that they
were conducted in compliance with the
for Health Claims requirements for informed consent set
§ 101.70 Petitions for health claims. forth in part 50 of this chapter.
(e) All data and information in a
(a) Any interested person may peti- health claim petition are available for
tion the Food and Drug Administration public disclosure after the notice of fil-
(FDA) to issue a regulation regarding a ing of petition is issued to the peti-
health claim. An original and one copy tioner, except that clinical investiga-
of the petition shall be submitted, or tion reports, adverse reaction reports,
the petitioner may submit an original product experience reports, consumer
and a computer readable disk con- complaints, and other similar data and
taining the petition. Contents of the information shall only be available
disk should be in a standard format, after deletion of:
such as ASCII format. (Petitioners in- (1) Names and any information that
terested in submitting a disk should would identify the person using the
contact the Center for Food Safety and product.
Applied Nutrition for details.) If any (2) Names and any information that
part of the material submitted is in a would identify any third party involved
foreign language, it shall be accom- with the report, such as a physician or
panied by an accurate and complete hospital or other institution.
English translation. The petition shall (f) Petitions for a health claim shall
state the petitioner’s post office ad- include the following data and be sub-
dress to which any correspondence re- mitted in the following form:
quired by section 403 of the Federal
(Date)llllll
Food, Drug, and Cosmetic Act may be Name of petitioner llllll
sent. Post office address llllll
(b) Pertinent information may be in- Subject of the petition llllll
corporated in, and will be considered as Food and Drug Administration,
part of, a petition on the basis of spe- Office of Nutritional Products, Labeling and
cific reference to such information sub- Dietary Supplements (HFS–800),
5100 Paint Branch Pkwy.,
mitted to and retained in the files of
College Park, MD 20740,
FDA. Such information may include The undersigned, lllllllll submits
any findings, along with the basis of this petition pursuant to section 403(r)(4) or
the findings, of an outside panel with 403(r)(5)(D) of the Federal Food, Drug, and
expertise in the subject area. Any ref- Cosmetic Act with respect to (statement of
erence to published information shall the substance and its health claim).
be accompanied by reprints, or easily Attached hereto, and constituting a part of
readable copies of such information. this petition, are the following:
A. Preliminary requirements. A complete
(c) If nonclinical laboratory studies explanation of how the substance conforms
are included in a petition, the petition to the requirements of § 101.14(b) (21 CFR
shall include, with respect to each non- 101.14(b)). For petitions where the subject
clinical study contained in the peti- substance is a food ingredient or a compo-
tion, either a statement that the study nent of a food ingredient, the petitioner
has been conducted in compliance with should compile a comprehensive list of the
the good laboratory practice regula- specific ingredients that will be added to the
food to supply the substance in the food
tions as set forth in part 58 of this
bearing the health claim. For each such in-
chapter, or, if any such study was not gredient listed, the petitioner should state
conducted in compliance with such reg- how the ingredient complies with the re-
ulations, a brief statement of the rea- quirements of § 101.14(b)(3)(ii), e.g., that its
son for the noncompliance. use is generally recognized as safe (GRAS),
126
listed as a food additive, or authorized by a the relevance of the claim in the context of
prior sanction issued by the agency, and the total daily diet.
what the basis is for the GRAS claim, the Also, the summary shall demonstrate that
food additive status, or prior sanctioned sta- the substance that is the subject of the pro-
tus. posed claim conforms to the definition of the
B. Summary of scientific data. The sum- term ‘‘substance’’ in § 101.14(a)(2).
mary of scientific data provides the basis C. Analytical data that show the amount
upon which authorizing a health claim can of the substance that is present in represent-
be justified as providing the health benefit. ative foods that would be candidates to bear
The summary must establish that, based on the claim should be obtained from represent-
the totality of publicly available scientific ative samples using methods from the AOAC
evidence (including evidence from well-de- INTERNATIONAL (AOAC), where available.
signed studies conducted in a manner which If no AOAC method is available, the peti-
is consistent with generally recognized sci- tioner shall submit the assay method used
entific procedures and principles), there is and data establishing the validity of the
significant scientific agreement among ex- method for assaying the substance in food.
perts qualified by scientific training and ex- The validation data should include a statis-
perience to evaluate such claims, that the tical analysis of the analytical and product
claim is supported by such evidence. variability.
The summary shall state what public D. Model health claim. One or more model
health benefit will derive from use of the health claims that represent label state-
claim as proposed. If the claim is intended ments that may be used on a food label or in
for a specific group within the population, labeling for a food to characterize the rela-
the summary shall specifically address nu- tionship between the substance in a food to
tritional needs of such group and shall in- a disease or health-related condition that is
clude scientific data showing how the claim justified by the summary of scientific data
is likely to assist in meeting such needs. provided in section C of the petition. The
The summary shall concentrate on the model health claim shall include:
findings of appropriate review articles, Na- 1. A brief capsulized statement of the rel-
tional Institutes of Health consensus devel- evant conclusions of the summary, and
opment conferences, and other appropriate 2. A statement of how this substance helps
resource materials. Issues addressed in the the consumer to attain a total dietary pat-
summary shall include answers to such ques- tern or goal associated with the health ben-
tions as: efit that is provided.
1. Is there an optimum level of the par- E. The petition shall include the following
ticular substance to be consumed beyond attachments:
which no benefit would be expected? 1. Copies of any computer literature
2. Is there any level at which an adverse ef- searches done by the petitioner (e.g.,
fect from the substance or from foods con- Medline).
taining the substance occurs for any seg- 2. Copies of articles cited in the literature
ment of the population? searches and other information as follows:
3. Are there certain populations that must a. All information relied upon for the sup-
receive special consideration? port of the health claim, including copies of
4. What other nutritional or health factors publications or other information cited in re-
(both positive and negative) are important to view articles and used to perform meta-anal-
consider when consuming the substance? yses.
In addition, the summary of scientific data b. All information concerning adverse con-
shall include a detailed analysis of the po- sequences to any segment of the population
tential effect of the use of the proposed (e.g., sensitivity to the substance).
claim on food consumption, specifically any c. All information pertaining to the U.S.
change due to significant alterations in eat- population.
ing habits and corresponding changes in nu- F. The petitioner is required to submit ei-
trient intake resulting from such changes in ther a claim for categorical exclusion under
food consumption. The latter item shall spe- § 25.30 or § 25.32 of this chapter or an environ-
cifically address the effect on the intake of mental assessment under § 25.40 of this chap-
nutrients that have beneficial and negative ter.
consequences in the total diet. Yours very truly,
If the claim is intended for a significant Petitioner llllll
subpopulation within the general U.S. popu- By llllll
lation, the analysis shall specifically address (Indicate authority)
the dietary practices of such group, and shall (g) The data specified under the sev-
include data sufficient to demonstrate that
eral lettered headings should be sub-
the dietary analysis is representative of such
group (e.g., adolescents or the elderly). mitted on separate pages or sets of
If appropriate, the petition shall explain pages, suitably identified. If such data
the prevalence of the disease or health-re- have already been submitted with an
lated condition in the U.S. population and earlier application from the petitioner
127
§ 101.71 21 CFR Ch. I (4–1–16 Edition)
or any other final petition, the present (i) Deny the petition, or
petition may incorporate it by specific (ii) Inform the petitioner that a pro-
reference to the earlier petition. posed regulation to provide for the re-
(h) The petition shall include a state- quested use of the health claim will be
ment signed by the person responsible published in the FEDERAL REGISTER. If
for the petition that, to the best of his/ the petition is denied, the notification
her knowledge, it is a representative will state the reasons therefor, includ-
and balanced submission that includes ing justification for the rejection of
unfavorable information as well as fa- any report from an authoritative sci-
vorable information, known to him/her entific body of the U.S. Government.
to be pertinent to the evaluation of the
FDA will publish the proposal to
proposed health claim.
amend the regulations to provide for
(i) The petition shall be signed by the
petitioner or by his/her attorney or the requested use of the health claim
agent, or (if a corporation) by an au- in the FEDERAL REGISTER within 90
thorized official. days of the date of filing. The proposal
(j) Agency action on the petition. (1) will also announce the availability of
Within 15 days of receipt of the peti- the petition for public review.
tion, the petitioner will be notified by (iii) If FDA does not act within 90
letter of the date on which the petition days of the date of filing, the petition
was received. Such notice will inform shall be deemed to be denied unless an
the petitioner that the petition is un- extension is mutually agreed upon by
dergoing agency review and that the FDA and the petitioner.
petitioner will subsequently be notified (4)(i) Within 270 of the date of publi-
of the agency’s decision to file for com- cation of the proposal, FDA will pub-
prehensive review or deny the petition. lish a final rule that either authorizes
(2) Within 100 days of the date of reuse of the health claim or explains why
ceipt of the petition, FDA will notify the agency has decided not to author-
the petitioner by letter that the peti- ize one.
tion has either been filed for com- (ii) For cause, FDA may extend, no
prehensive review or denied. The agen-
more than twice, the period in which it
cy will deny a petition without review-
will publish a final rule; each such ex-
ing the information contained in ‘‘B.
Summary of Scientific Data’’ if the in- tension will be for no more than 90
formation in ‘‘A. Preliminary Require- days. FDA will publish a notice of each
ments’’ is inadequate in explaining how extension in the FEDERAL REGISTER.
the substance conforms to the require- The document will state the basis for
ments of § 101.14(b). If the petition is the extension, the length of the exten-
denied, the notification will state the sion, and the date by which the final
reasons therefor, including justifica- rule will be published, which date shall
tion of the rejection of any report from be within 540 days of the date of receipt
an authoritative scientific body of the of the petition.
U.S. Government. If filed, the date of [58 FR 2534, Jan. 6, 1993; 58 FR 17097, Apr. 1,
the notification letter becomes the 1993, as amended at 59 FR 425, Jan. 4, 1994; 62
date of filing for the purposes of this FR 28232, May 22, 1997; 62 FR 40599, July 29,
regulation. If FDA does not act within 1997; 63 FR 26719, May 14, 1998; 63 FR 40024,
such 100 days, the petition shall be July 27, 1998; 66 FR 56035, Nov. 6, 2001]
deemed to be denied unless an exten-
sion is mutually agreed upon by FDA § 101.71 Health claims: claims not au-
and the petitioner. A petition that has thorized.
been denied, or has been deemed to be Health claims not authorized for
denied, without filing will not be made foods in conventional food form or for
available to the public. A filed petition
dietary supplements of vitamins, min-
will be available to the public to the
erals, herbs, or other similar sub-
extent provided under paragraph (e) of
this section. stances:
(3) Within 90 days of the date of fil- (a) Dietary fiber and cardiovascular
ing, FDA will by letter of notification disease.
to the petitioner:
128
(b) Zinc and immune function in the thought to be important in reducing

elderly. the rate of bone loss particularly in the
[58 FR 2534, Jan. 6, 1993, as amended at 58 FR
elderly and in women during the first
2548, 2578, 2620, 2639, 2664, 2714, Jan. 6, 1993; 58 decade following menopause, but a sig-
FR 17100, Apr. 1, 1993; 59 FR 437, Jan. 4, 1994; nificant protective effect is also seen
65 FR 58918, Oct. 3, 2000] among men and younger women.
(b) Significance of calcium or calcium
§ 101.72 Health claims: calcium, vita- and vitamin D. Adequate calcium in-
min D, and osteoporosis. take, or adequate calcium and vitamin
(a) Relationship between calcium, vita- D intake, is not the only recognized
min D, and osteoporosis. An inadequate risk factor in the development of
intake of calcium or calcium and vita- osteoporosis, which is a multifactorial
min D contributes to low peak bone bone disease. Maintenance of adequate
mass, which has been identified as one calcium and vitamin D intakes
of many risk factors in the develop- throughout life is necessary to achieve
ment of osteoporosis. Peak bone mass optimal peak bone mass and to reduce
is the total quantity of bone present at the risk of osteoporosis in later life.
maturity, and experts believe that it However, vitamin D is most effective
has the greatest bearing on whether a in this regard when calcium intake is
person will be at risk of developing adequate. Increasing intake of calcium
osteoporosis and related bone fractures has been shown to have beneficial ef-
later in life. Another factor that influ- fects on bone health independent of di-
ences total bone mass and suscepti- etary vitamin D.
bility to osteoporosis is the rate of (c) Requirements. (1) All requirements
bone loss after skeletal maturity. Vita- set forth in § 101.14 shall be met.
min D is required for normal absorp- (2) Specific requirements—(i) Nature of
tion of calcium and to prevent the oc- the claim. A health claim associating
currence of high serum parathyroid calcium or, when appropriate, calcium
hormone (PTH) concentration, which and vitamin D with a reduced risk of
stimulates mobilization of calcium osteoporosis may be made on the label
from the skeleton and can lower bone or labeling of a food described in para-
mass. Calcium, along with vitamin D graphs (c)(2)(ii) and (d)(1) of this sec-
and several other nutrients, is required tion, provided that:
for normal bone mineralization. While (A) The claim makes clear the impor-
vitamin D is required for optimal bone tance of adequate calcium intake, or
mineralization, it is more effective when appropriate, adequate calcium
when calcium intake is adequate. An and vitamin D intake, throughout life,
adequate intake of calcium and vita- in a healthful diet, are essential to re-
min D is thought to exert a positive ef- duce osteoporosis risk. The claim does
fect during adolescence and early not imply that adequate calcium in-
adulthood in optimizing the amount of take, or when appropriate, adequate
bone that is laid down. However, the calcium and vitamin D intake, is the
upper limit of peak bone mass is ge- only recognized risk factor for the de-
netically determined. The mechanism velopment of osteoporosis;
through which adequate intakes of cal- (B) The claim does not attribute any
cium and vitamin D and optimal peak degree of reduction in risk of
bone mass reduce the risk of osteoporosis to maintaining an ade-
osteoporosis is thought to be as fol- quate dietary calcium intake, or when
lows. All persons lose bone with age. appropriate, an adequate dietary cal-
Hence, those with higher bone mass at cium and vitamin D intake, through-
maturity take longer to reach the out life.
critically reduced mass at which bones (ii) Nature of the food. (A) The food
can fracture easily. The rate of bone shall meet or exceed the requirements
loss after skeletal maturity also influ- for a ‘‘high’’ level of calcium as defined
ences the amount of bone present at in § 101.54(b);
old age and can influence an individ- (B) The calcium content of the prod-
ual’s risk of developing osteoporosis. uct shall be assimilable;

Maintenance of adequate intakes of (C) Dietary supplements shall meet
calcium and vitamin D later in life is the United States Pharmacopeia (USP)
129
§ 101.73 21 CFR Ch. I (4–1–16 Edition)
standards for disintegration and dis- Adequate calcium as part of a healthful

solution applicable to their component diet, along with physical activity, may
calcium salts, except that dietary sup- reduce the risk of osteoporosis in later
plements for which no USP standards life.
exist shall exhibit appropriate assimi- (f) Model additional health claims for
lability under the conditions of use calcium and vitamin D. The following
stated on the product label; model health claims may be used in
(D) A food or total daily rec- food labeling to describe the relation-
ommended supplement intake shall not ship between calcium, vitamin D, and
contain more phosphorus than calcium osteoporosis:
on a weight per weight basis.
(d) Optional information. (1) The claim Adequate calcium and vitamin D
may include the term ‘‘vitamin D’’ if throughout life, as part of a well-bal-
the food meets or exceeds the require- anced diet, may reduce the risk of
ments for a ‘‘high’’ level of vitamin D osteoporosis.
as defined in § 101.54(b); Adequate calcium and vitamin D as
(2) The claim may include informa- part of a healthful diet, along with
tion from paragraphs (a) and (b) of this physical activity, may reduce the risk
section. of osteoporosis in later life.
(3) The claim may make reference to
physical activity. [73 FR 56486, Sept. 29, 2008]
(4) The claim may include informa-
tion on the number of people in the § 101.73 Health claims: dietary lipids
and cancer.
United States, including the number of
people in certain subpopulations in the (a) Relationship between fat and can-
United States, who have osteoporosis cer. (1) Cancer is a constellation of
or low bone density. The sources of this more than 100 different diseases, each
information must be identified, and it characterized by the uncontrolled
must be current information from the growth and spread of abnormal cells.
National Center for Health Statistics, Cancer has many causes and stages in
the National Institutes of Health, or its development. Both genetic and en-
the National Osteoporosis Foundation. vironmental risk factors may affect
(5) The claim may state that the role the risk of cancer. Risk factors include
of adequate calcium intake, or when a family history of a specific type of
appropriate, the role of adequate cal- cancer, cigarette smoking, alcohol con-
cium and vitamin D intake, through- sumption, overweight and obesity, ul-
out life is linked to reduced risk of traviolet or ionizing radiation, expo-
osteoporosis through the mechanism of sure to cancer-causing chemicals, and
optimizing peak bone mass during ado-
dietary factors.
lescence and early adulthood. The
(2) Among dietary factors, the
phrase ‘‘build and maintain good bone
health’’ may be used to convey the con- strongest positive association has been
cept of optimizing peak bone mass. The found between total fat intake and risk
claim may also state that adequate in- of some types of cancer. Based on the
take of calcium, or when appropriate, totality of the publicly available sci-
adequate intake of calcium and vita- entific evidence, there is significant
min D, is linked to reduced risk of scientific agreement among experts,
osteoporosis through the mechanism of qualified by training and experience to
slowing the rate of bone loss for per- evaluate such evidence, that diets high
sons with a family history of the dis- in total fat are associated with an in-
ease, post-menopausal women, and el- creased cancer risk. Research to date,
derly men and women. although not conclusive, demonstrates
(e) Model health claims. The following that the total amount of fats, rather
model health claims may be used in than any specific type of fat, is posi-
food labeling to describe the relation- tively associated with cancer risk. The
ship between calcium and osteoporosis: mechanism by which total fat affects
Adequate calcium throughout life, as cancer has not yet been established.
part of a well-balanced diet, may re- (3) A question that has been the sub-
duce the risk of osteoporosis. ject of considerable research is whether
130
the effect of fat on cancer is site-spe- (C) In specifying the nutrient, the
cific. Neither human nor animal stud- claim uses the term ‘‘total fat’’ or
ies are consistent in the association of ‘‘fat’’;
fat intake with specific cancer sites. (D) The claim does not specify types
(4) Another question that has been of fat or fatty acid that may be related
raised is whether the association of to the risk of cancer;
total fat intake to cancer risk is inde- (E) The claim does not attribute any
pendently associated with energy in- degree of cancer risk reduction to diets
takes, or whether the association of fat low in fat; and
with cancer risk is the result of the (F) The claim indicates that the de-
higher energy (caloric) intake nor- velopment of cancer depends on many
mally associated with high fat intake. factors.
(ii) Nature of the food. The food shall
FDA has concluded that evidence from
meet all of the nutrient content re-
both animal and human studies indi-
quirements of § 101.62 for a ‘‘low fat’’
cates that total fat intake alone, inde-
food; except that fish and game meats
pendent of energy intake, is associated (i.e., deer, bison, rabbit, quail, wild tur-
with cancer risk. key, geese, ostrich) may meet the re-
(b) Significance of the relationship be- quirements for ‘‘extra lean’’ in § 101.62.
tween fat intake and risk of cancer. (1) (d) Optional information. (1) The claim
Cancer is ranked as a leading cause of may identify one or more of the fol-
death in the United States. The overall lowing risk factors for development of
economic costs of cancer, including di- cancer: Family history of a specific
rect health care costs and losses due to type of cancer, cigarette smoking, al-
morbidity and mortality, are very cohol consumption, overweight and
high. obesity, ultraviolet or ionizing radi-
(2) U.S. diets tend to be high in fat ation, exposure to cancer-causing
and high in calories. The average U.S. chemicals, and dietary factors.
diet is estimated to contain 36 to 37 (2) The claim may include informa-
percent of calories from total fat. Cur- tion from paragraphs (a) and (b) of this
rent dietary guidelines from the Fed- section which summarize the relation-
eral Government and other national ship between dietary fat and cancer
health professional organizations rec- and the significance of the relation-
ommend that dietary fat intake be re- ship.
duced to a level of 30 percent or less of (3) The claim may indicate that it is
energy (calories) from total fat. In consistent with ‘‘Nutrition and Your
order to reduce intake of total fat, in- Health: Dietary Guidelines for Ameri-
dividuals should choose diets which are cans,’’ U.S. Department of Agriculture
high in vegetables, fruits, and grain (USDA) and Department of Health and
products (particularly whole grain Human Services (DHHS), Government
products), choose lean cuts of meats, Printing Office.
fish, and poultry, substitute low-fat (4) The claim may include informa-
dairy products for higher fat products, tion on the number of people in the
and use fats and oils sparingly. United States who have cancer. The
sources of this information must be
(c) Requirements. (1) All requirements
identified, and it must be current infor-
set forth in § 101.14 shall be met.
mation from the National Center for
(2) Specific requirements—(i) Nature of Health Statistics, the National Insti-
the claim. A health claim associating tutes of Health, or ‘‘Nutrition and Your
diets low in fat with reduced risk of Health: Dietary Guidelines for Ameri-
cancer may be made on the label or la- cans,’’ USDA and DHHS, Government
beling of a food described in paragraph Printing Office.
(c)(2)(ii) of this section, provided that: (e) Model health claims. The following
(A) The claim states that diets low in model health claims may be used in
fat ‘‘may’’ or ‘‘might’’ reduce the risk food labeling to describe the relation-
of some cancers; ship between dietary fat and cancer:
(B) In specifying the disease, the (1) Development of cancer depends on

claim uses the following terms: ‘‘some many factors. A diet low in total fat
types of cancer’’ or ‘‘some cancers’’; may reduce the risk of some cancers.
131
§ 101.74 21 CFR Ch. I (4–1–16 Edition)
(2) Eating a healthful diet low in fat but not all normotensive individuals as
may help reduce the risk of some types well.
of cancers. Development of cancer is (2) The populations at greatest risk
associated with many factors, includ- for high blood pressure, and those most
ing a family history of the disease, cig- likely to benefit from sodium reduc-
arette smoking, and what you eat. tion, include those with family his-
[58 FR 2801, Jan. 6, 1993; 58 FR 17343, Apr. 2, tories of high blood pressure, the elder-
1993] ly, males because they develop hyper-
tension earlier in life than females, and
§ 101.74 Health claims: sodium and hy- black males and females. Although
pertension. some population groups are at greater
(a) Relationship between sodium and risk than others, high blood-pressure is
hypertension (high blood pressure). (1) a disease of public health concern for
Hypertension, or high blood pressure, all population groups. Sodium intake,
generally means a systolic blood pres- alcohol consumption, and obesity are
sure of greater than 140 millimeters of identified risk factors for high blood
mercury (mm Hg) or a diastolic blood pressure.
pressure of greater than 90 mm Hg. (3) Sodium intakes exceed rec-
Normotension, or normal blood pres- ommended levels in almost every group
sure, is a systolic blood pressure below in the United States. One of the major
140 mm Hg and diastolic blood pressure public health recommendations rel-
below 90 mm Hg. Sodium is specified ative to high blood pressure is to de-
here as the chemical entity or electro- crease consumption of salt. On a popu-
lyte ‘‘sodium’’ and is distinguished lation-wide basis, reducing the average
from sodium chloride, or salt, which is sodium intake would have a small but
39 percent sodium by weight. significant effect on reducing the aver-
(2) The scientific evidence establishes age blood pressure, and, consequently,
that diets high in sodium are associ- reducing mortality from coronary
ated with a high prevalence of hyper- heart disease and stroke.
tension or high blood pressure and with (4) Sodium is an essential nutrient,
increases in blood pressure with age, and experts have recommended a safe
and that diets low in sodium are asso- minimum level of 500 milligrams (mg)
ciated with a low prevalence of hyper- sodium per day and an upper level of
tension or high blood pressure and with 2,400 mg sodium per day, the FDA
a low or no increase of blood pressure Daily Value for sodium.
with age. (c) Requirements. (1) All requirements
(b) Significance of sodium in relation to set forth in § 101.14 shall be met.
high blood pressure. (1) High blood pres- (2) Specific requirements—(i) Nature of
sure is a public health concern pri- the claim. A health claim associating
marily because it is a major risk factor diets low in sodium with reduced risk
for mortality from coronary heart dis- of high blood pressure may be made on
ease and stroke. Early management of the label or labeling of a food described
high blood pressure is a major public in paragraph (c)(2)(ii) of this section,
health goal that can assist in reducing provided that:
mortality associated with coronary (A) The claim states that diets low in
heart disease and stroke. There is a sodium ‘‘may’’ or ‘‘might’’ reduce the
continuum of mortality risk that in- risk of high blood pressure;
creases as blood pressures rise. Individ- (B) In specifying the disease, the
uals with high blood pressure are at claim uses the term ‘‘high blood pres-
greatest risk, and individuals with sure’’;
moderately high, high normal, and nor- (C) In specifying the nutrient, the
mal blood pressure are at steadily de- claim uses the term ‘‘sodium’’;
creasing risk. The scientific evidence (D) The claim does not attribute any
indicates that reducing sodium intake degree of reduction in risk of high
lowers blood pressure and associated blood pressure to diets low in sodium;
risks in many but not all hypertensive and
individuals. There is also evidence that (E) The claim indicates that develop-
reducing sodium intake lowers blood ment of high blood pressure depends on
pressure and associated risks in many many factors.
132
(ii) Nature of the food. The food shall (1) Diets low in sodium may reduce
meet all of the nutrient content re- the risk of high blood pressure, a dis-
quirements of § 101.61 for a ‘‘low so- ease associated with many factors.
dium’’ food. (2) Development of hypertension or
(d) Optional information. (1) The claim high blood pressure depends on many
may identify one or more of the fol- factors. [This product] can be part of a
lowing risk factors for development of low sodium, low salt diet that might
high blood pressure in addition to die- reduce the risk of hypertension or high
tary sodium consumption: Family his- blood pressure.
tory of high blood pressure, growing
[58 FR 2836, Jan. 6, 1993; 58 FR 17100, Apr. 1,
older, alcohol consumption, and excess 1993]
weight.
(2) The claim may include informa- § 101.75 Health claims: dietary satu-
tion from paragraphs (a) and (b) of this rated fat and cholesterol and risk of
section, which summarizes the rela- coronary heart disease.
tionship between dietary sodium and (a) Relationship between dietary satu-
high blood pressure and the signifi- rated fat and cholesterol and risk of coro-
cance of the relationship. nary heart disease. (1) Cardiovascular
(3) The claim may include informa- disease means diseases of the heart and
tion on the number of people in the circulatory system. Coronary heart
United States who have high blood disease is the most common and seri-
pressure. The sources of this informa- ous form of cardiovascular disease and
tion must be identified, and it must be refers to diseases of the heart muscle
current information from the National and supporting blood vessels. High
Center for Health Statistics, the Na- blood total- and low density
tional Institutes of Health, or ‘‘Nutri- lipoprotein (LDL)- cholesterol levels
tion and Your Health: Dietary Guide- are major modifiable risk factors in
lines for Americans,’’ U.S. Department the development of coronary heart dis-
of Health and Human Services (DHHS) ease. High coronary heart disease rates
and U.S. Department of Argiculture occur among people with high blood
(USDA), Government Printing Office. cholesterol levels of 240 milligrams/dec-
(4) The claim may indicate that it is aliter (mg/dL) (6.21 millimoles per liter
consistent with ‘‘Nutrition and Your (mmol/L)) or above and LDL-choles-
Health: U.S. Dietary Guidelines for terol levels of 160 mg/dL (4.13 mmol/L)
Americans, DHHS and USDA, Govern- or above. Borderline high risk blood
ment Printing Office. cholesterol levels range from 200 to 239
(5) In specifying the nutrient, the mg/dL (5.17 to 6.18 mmol/L) and 130 to
claim may include the term ‘‘salt’’ in 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-
addition to the term ‘‘sodium.’’ cholesterol. Dietary lipids (fats) in-
(6) In specifying the disease, the clude fatty acids and cholesterol. Total
claim may include the term ‘‘hyper- fat, commonly referred to as fat, is
tension’’ in addition to the term ‘‘high composed of saturated fat (fatty acids
blood pressure.’’ containing no double bonds), and
(7) The claim may state that individ- monounsaturated and polyunsaturated
uals with high blood pressure should fat (fatty acids containing one or more
consult their physicians for medical double bonds).
advice and treatment. If the claim de- (2) The scientific evidence establishes
fines high or normal blood pressure, that diets high in saturated fat and
then the health claim must state that cholesterol are associated with in-
individuals with high blood pressure creased levels of blood total- and LDL-
should consult their physicians for cholesterol and, thus, with increased
medical advice and treatment. risk of coronary heart disease. Diets
(e) Model health claims. The following low in saturated fat and cholesterol are
are model health claims that may be associated with decreased levels of
used in food labeling to describe the re- blood total- and LDL-cholesterol, and
lationship between dietary sodium and thus, with decreased risk of developing
high blood pressure: coronary heart disease.
133
§ 101.75 21 CFR Ch. I (4–1–16 Edition)
(b) Significance of the relationship be- or labeling of a food described in para-

tween dietary saturated fat and choles- graph (c)(2)(ii) of this section provided
terol and risk of coronary heart disease. that:
(1) Coronary heart disease is a major (A) The claim states that diets low in
public health concern in the United saturated fat and cholesterol ‘‘may’’ or
States, primarily because it accounts ‘‘might’’ reduce the risk of heart dis-
for more deaths than any other disease ease;
or group of diseases. Early manage- (B) In specifying the disease, the
ment of risk factors for coronary heart claim uses the terms ‘‘heart disease’’
disease is a major public health goal or ‘‘coronary heart disease;’’
that can assist in reducing risk of coro- (C) In specifying the nutrient, the
nary heart disease. There is a con- claim uses the terms ‘‘saturated fat’’
tinuum of mortality risk from coro- and ‘‘cholesterol’’ and lists both;
nary heart disease that increases with
(D) The claim does not attribute any
increasing levels of blood LDL-choles-
degree of risk reduction for coronary
terol. Individuals with high blood LDL-
heart disease to diets low in dietary
cholesterol are at greatest risk. A larg-
saturated fat and cholesterol; and
er number of individuals with more
(E) The claim states that coronary
moderately elevated cholesterol also
heart disease risk depends on many
have increased risk of coronary events;
factors.
such individuals comprise a substantial
proportion of the adult U.S. popu- (ii) Nature of the food. The food shall
lation. The scientific evidence indi- meet all of the nutrient content re-
cates that reducing saturated fat and quirements of § 101.62 for a ‘‘low satu-
cholesterol intakes lowers blood LDL- rated fat,’’ ‘‘low cholesterol,’’ and ‘‘low
cholesterol and risk of heart disease in fat’’ food; except that fish and game
most individuals. There is also evi- meats (i.e., deer, bison, rabbit, quail,
dence that reducing saturated fat and wild turkey, geese, and ostrich) may
cholesterol intakes in persons with meet the requirements for ‘‘extra lean’’
blood cholesterol levels in the normal in § 101.62.
range also reduces risk of heart dis- (d) Optional information. (1) The claim
ease. may identify one or more of the fol-
(2) Other risk factors for coronary lowing risk factors in addition to satu-
heart disease include a family history rated fat and cholesterol about which
of heart disease, high blood pressure, there is general scientific agreement
diabetes, cigarette smoking, obesity that they are major risk factors for
(body weight 30 percent greater than this disease: A family history of coro-
ideal body weight), and lack of regular nary heart disease, elevated blood total
physical exercise. and LDL-cholesterol, excess body
(3) Intakes of saturated fat exceed weight, high blood pressure, cigarette
recommended levels in many people in smoking, diabetes, and physical inac-
the United States. Intakes of choles- tivity.
terol are, on average, at or above rec- (2) The claim may indicate that the
ommended levels. One of the major relationship of saturated fat and cho-
public health recommendations rel- lesterol to heart disease is through the
ative to coronary heart disease risk is intermediate link of ‘‘blood choles-
to consume less than 10 percent of cal- terol’’ or ‘‘blood total- and LDL choles-
ories from saturated fat, and an aver- terol.’’
age of 30 percent or less of total cal- (3) The claim may include informa-
ories from all fat. Recommended daily tion from paragraphs (a) and (b) of this
cholesterol intakes are 300 mg or less section, which summarize the relation-
per day. ship between dietary saturated fat and
(c) Requirements. (1) All requirements cholesterol and risk of coronary heart
set forth in § 101.14 shall be met. disease, and the significance of the re-
(2) Specific requirements—(i) Nature of lationship.
the claim. A health claim associating (4) In specifying the nutrients, the
diets low in saturated fat and choles- claim may include the term ‘‘total fat’’
terol with reduced risk of coronary in addition to the terms ‘‘saturated
heart disease may be made on the label fat’’ and ‘‘cholesterol’’.
134
(5) The claim may include informa- and being overweight, contribute to de-
tion on the number of people in the veloping heart disease. A diet low in
United States who have coronary heart saturated fat, cholesterol, and total fat
disease. The sources of this informa- may help reduce the risk of heart dis-
tion shall be identified, and it shall be ease; and
current information from the National (5) Diets low in saturated fat, choles-
Center for Health Statistics, the Na- terol, and total fat may reduce the risk
tional Institutes of Health, or ‘‘Nutri- of heart disease. Heart disease is de-
tion and Your Health: Dietary Guide- pendent upon many factors, including
lines for Americans,’’ U.S. Department diet, a family history of the disease,
of Health and Human Services (DHHS) elevated blood LDL-cholesterol levels,
and U.S. Department of Agriculture and physical inactivity.
(USDA), Government Printing Office.
(6) The claim may indicate that it is [58 FR 2757, Jan. 6, 1993]
consistent with ‘‘Nutrition and Your
Health: Dietary Guidelines for Ameri- § 101.76 Health claims: fiber-con-
taining grain products, fruits, and
cans,’’ DHHS and USDA, Government vegetables and cancer.
Printing Office.
(7) The claim may state that individ- (a) Relationship between diets low in
uals with elevated blood total- or LDL- fat and high in fiber-containing grain
cholesterol should consult their physi- products, fruits, and vegetables and can-
cians for medical advice and treat- cer risk. (1) Cancer is a constellation of
ment. If the claim defines high or nor- more than 100 different diseases, each
mal blood total- or LDL-cholesterol characterized by the uncontrolled
levels, then the claim shall state that growth and spread of abnormal cells.
individuals with high blood cholesterol Cancer has many causes and stages in
should consult their physicians for its development. Both genetic and en-
medical advice and treatment. vironmental risk factors may affect
(e) Model health claims.The following the risk of cancer. Risk factors include:
are model health claims that may be A family history of a specific type of
used in food labeling to describe the re- cancer, cigarette smoking, overweight
lationship between dietary saturated and obesity, alcohol consumption, ul-
fat and cholesterol and risk of heart traviolet or ionizing radiation, expo-
disease: sure to cancer-causing chemicals, and
(1) While many factors affect heart dietary factors.
disease, diets low in saturated fat and (2) The scientific evidence establishes
cholesterol may reduce the risk of this that diets low in fat and high in fiber-
disease; containing grain products, fruits, and
(2) Development of heart disease de- vegetables are associated with a re-
pends upon many factors, but its risk duced risk of some types of cancer. Al-
may be reduced by diets low in satu- though the specific role of total dietary
rated fat and cholesterol and healthy fiber, fiber components, and the mul-
lifestyles; tiple nutrients and other substances
(3) Development of heart disease de- contained in these foods are not yet
pends upon many factors, including a fully understood, many studies have
family history of the disease, high shown that diets low in fat and high in
blood LDL-cholesterol, diabetes, high fiber-containing foods are associated
blood pressure, being overweight, ciga- with reduced risk of some types of can-
rette smoking, lack of exercise, and cer.
the type of dietary pattern. A healthful (b) Significance of the relationship be-
diet low in saturated fat, total fat, and tween consumption of diets low in fat and
cholesterol, as part of a healthy life- high in fiber-containing grain products,
style, may lower blood cholesterol lev- fruits, and vegetables and risk of cancer.
els and may reduce the risk of heart (1) Cancer is ranked as a leading cause
disease; of death in the United States. The
(4) Many factors, such as a family overall economic costs of cancer, in-
history of the disease, increased blood- cluding direct health care costs and
and LDL-cholesterol levels, high blood losses due to morbidity and mortality,
pressure, cigarette smoking, diabetes, are very high.
135
§ 101.76 21 CFR Ch. I (4–1–16 Edition)
(2) U.S. diets tend to be high in fat (B) The food shall meet the nutrient
and low in grain products, fruits, and content requirements of § 101.62 for a
vegetables. Studies in various parts of ‘‘low fat’’ food.
the world indicate that populations (C) The food shall meet, without for-
who habitually consume a diet high in tification, the nutrient content re-
plant foods have lower risks of some quirements of § 101.54 for a ‘‘good
cancers. These diets generally are low source’’ of dietary fiber.
in fat and rich in many nutrients, in- (d) Optional information. (1) The claim
cluding, but not limited to, dietary may include information from para-
fiber. Current dietary guidelines from graphs (a) and (b) of this section, which
summarize the relationship between
Federal government agencies and na-
diets low in fat and high in fiber-con-
tionally recognized health professional
taining grain products, fruits, and
organizations recommend decreased
vegetables, and some types of cancer
consumption of fats (less than 30 per- and the significance of the relation-
cent of calories), maintenance of desir- ship.
able body weight, and increased con- (2) The claim may identify one or
sumption of fruits and vegetables (five more of the following risk factors for
or more servings daily), and grain prod- development of cancer: Family history
ucts (six or more servings daily). of a specific type of cancer, cigarette
(c) Requirements. (1) All requirements smoking, overweight and obesity, alco-
set forth in § 101.14 shall be met. hol consumption, ultraviolet or ion-
(2) Specific requirements—(i) Nature of izing radiation, exposure to cancer
the claim. A health claim associating causing chemicals, and dietary factors.
diets low in fat and high in fiber-con- (3) The claim may indicate that it is
taining grain products, fruits, and consistent with ‘‘Nutrition and Your
vegetables with reduced risk of cancer Health: Dietary Guidelines for Ameri-
may be made on the label or labeling of cans,’’ U.S. Department of Agriculture
a food described in paragraph (c)(2)(ii) (USDA) and Department of Health and
of this section, provided that: Human Services (DHHS), Government
(A) The claim states that diets low in Printing Office.
fat and high in fiber-containing grain (4) The claim may include informa-
products, fruits, and vegetables ‘‘may’’ tion on the number of people in the
or ‘‘might’’ reduce the risk of some United States who have cancer. The
cancers; sources of this information must be
identified, and it must be current infor-
(B) In specifying the disease, the
mation from the National Center for
claim uses the following terms: ‘‘some
Health Statistics, the National Insti-
types of cancer,’’ or ‘‘some cancers’’;
tutes of Health, or ‘‘Nutrition and Your
(C) The claim is limited to grain Health: Dietary Guidelines for Ameri-
products, fruits, and vegetables that cans,’’ USDA and DHHS, Government
contain dietary fiber; Printing Office.
(D) The claim indicates that develop- (e) Model health claims. The following
ment of cancer depends on many fac- model health claims may be used in
tors; food labeling to characterize the rela-
(E) The claim does not attribute any tionship between diets low in fat and
degree of cancer risk reduction to diets high in fiber-containing grain products,
low in fat and high in fiber-containing fruits, and vegetables and cancer risk:
grain products, fruits, and vegetables; (1) Low fat diets rich in fiber-con-
(F) In specifying the dietary fiber taining grain products, fruits, and
component of the labeled food, the vegetables may reduce the risk of some
claim uses the term ‘‘fiber’’, ‘‘dietary types of cancer, a disease associated
fiber’’ or ‘‘total dietary fiber’’; and with many factors.
(G) The claim does not specify types (2) Development of cancer depends on
of dietary fiber that may be related to many factors. Eating a diet low in fat
risk of cancer. and high in grain products, fruits, and
(ii) Nature of the food. (A) The food vegetables that contain dietary fiber
shall be or shall contain a grain prod- may reduce your risk of some cancers.
uct, fruit, or vegetable. [58 FR 2548, Jan. 6, 1993]
136
§ 101.77 Health claims: fruits, vegeta- heart disease. These studies correlate
bles, and grain products that con- diets rich in fruits, vegetables, and
tain fiber, particularly soluble fiber, grain products and nutrients from
and risk of coronary heart disease. these diets, such as some types of fiber,
(a) Relationship between diets low in with reduced coronary heart disease
saturated fat and cholesterol and high in risk. Persons consuming these diets
fruits, vegetables, and grain products that frequently have high intakes of dietary
contain fiber, particularly soluble fiber, fiber, particularly soluble fibers. Cur-
and risk of coronary heart disease. (1) rently, there is not scientific agree-
Cardiovascular disease means diseases ment as to whether a particular type of
of the heart and circulatory system. soluble fiber is beneficial, or whether
Coronary heart disease is the most the observed protective effects of
common and serious form of cardio- fruits, vegetables, and grain products
vascular disease and refers to diseases against heart disease are due to other
of the heart muscle and supporting components, or a combination of com-
blood vessels. High blood total- and low ponents, in these diets, including, but
density lipoprotein (LDL)- cholesterol not necessarily limited to, some types
levels are major modifiable risk factors of soluble fiber, other fiber compo-
in the development of coronary heart nents, other characteristics of the com-
disease. High coronary heart disease plex carbohydrate content of these
rates occur among people with high foods, other nutrients in these foods, or
blood cholesterol levels of 240 milli- displacement of saturated fat and cho-
grams per deciliter (mg/dL) (6.21 lesterol from the diet.
(mmol/L)) or above and LDL-choles- (b) Significance of the relationship be-
terol levels of 160 mg/dL (4.13 mmol/L) tween diets low in saturated fat and cho-
or above. Borderline high risk blood lesterol, and high in fruits, vegetables,
cholesterol levels range from 200 to 239 and grain products that contain fiber,
mg/dL (5.17 to 6.18 mmol/L) and 130 to particularly soluble fiber, and risk of cor-
159 mg/dL (3.36 to 4.11 mmol/L) of LDL- onary heart disease. (1) Coronary heart
cholesterol. Dietary lipids (fats) in- disease is a major public health con-
clude fatty acids and cholesterol. Total cern in the United States, primarily
fat, commonly referred to as fat, is because it accounts for more deaths
composed of saturated fat (fatty acids than any other disease or group of dis-
containing no double bonds), and eases. Early management of risk fac-
monounsaturated and polyunsaturated tors for coronary heart disease is a
fat (fatty acids containing one or more major public health goal that can as-
double bonds). sist in reducing risk of coronary heart
(2) The scientific evidence establishes disease. There is a continuum of mor-
that diets high in saturated fat and tality risk from coronary heart disease
cholesterol are associated with in- that increases with increasing levels of
creased levels of blood total- and LDL- blood LDL-cholesterol. Individuals
cholesterol and, thus, with increased with high blood LDL-cholesterol are at
risk of coronary heart disease. Diets greatest risk. A larger number of indi-
low in saturated fat and cholesterol are viduals with more moderately elevated
associated with decreased levels of cholesterol also have increased risk of
blood total- and LDL-cholesterol, and coronary events; such individuals com-
thus, with decreased risk of developing prise a substantial proportion of the
coronary heart disease. adult U.S. population. The scientific
(3) Populations with relatively low evidence indicates that reducing satu-
blood cholesterol levels tend to have rated fat and cholesterol intakes low-
dietary patterns that are not only low ers blood LDL-cholesterol and risk of
in total fat, especially saturated fat heart disease in most individuals, in-
and cholesterol, but are also relatively cluding persons with blood cholesterol
high in fruits, vegetables, and grain levels in the normal range. Addition-
products. Although the specific roles of ally, consuming diets high in fruits,
these plant foods are not yet fully un- vegetables, and grain products, foods
derstood, many studies have shown that contain soluble fiber, may be a
that diets high in plant foods are asso- useful adjunct to a low saturated fat
ciated with reduced risk of coronary and low cholesterol diet.
137
§ 101.77 21 CFR Ch. I (4–1–16 Edition)
(2) Other risk factors for coronary (C) The claim is limited to those
heart disease include a family history fruits, vegetables, and grains that con-
of heart disease, high blood pressure, tain fiber;
diabetes, cigarette smoking, obesity (D) In specifying the dietary fiber,
(body weight 30 percent greater than the claim uses the term ‘‘fiber,’’ ‘‘die-
ideal body weight), and lack of regular tary fiber,’’ ‘‘some types of dietary
physical exercise. fiber,’’ ‘‘some dietary fibers,’’ or ‘‘some
(3) Intakes of saturated fat exceed fibers;’’ the term ‘‘soluble fiber’’ may
recommended levels in many people in be used in addition to these terms;
the United States. Intakes of choles- (E) In specifying the fat component,
terol are, on average, at or above rec- the claim uses the terms ‘‘saturated
ommended levels. Intakes of fiber-con- fat’’ and ‘‘cholesterol;’’ and
(F) The claim indicates that develop-
taining fruits, vegetables, and grain
ment of heart disease depends on many
products are about half of rec-
factors; and
ommended intake levels. One of the
(G) The claim does not attribute any
major public health recommendations
degree of risk reduction for coronary
relative to coronary heart disease risk heart disease to diets low in saturated
is to consume less than 10 percent of fat and cholesterol and high in fruits,
calories from saturated fat, and an av- vegetables, and grain products that
erage of 30 percent or less of total cal- contain fiber.
ories from all fat. Recommended daily (ii) Nature of the food. (A) The food
cholesterol intakes are 300 mg or less shall be or shall contain a fruit, vege-
per day. Recommended total dietary table, or grain product.
fiber intakes are about 25 grams (g) (B) The food shall meet the nutrient
daily, of which about 25 percent (about content requirements of § 101.62 for a
6 g) should be soluble fiber. ‘‘low saturated fat,’’ ‘‘low cholesterol,’’
(4) Current dietary guidance rec- and ‘‘low fat’’ food.
ommendations encourage decreased (C) The food contains, without for-
consumption of dietary fat, especially tification, at least 0.6 g of soluble fiber
saturated fat and cholesterol, and in- per reference amount customarily con-
creased consumption of fiber-rich foods sumed;
to help lower blood LDL-cholesterol (D) The content of soluble fiber shall
levels. Results of numerous studies be declared in the nutrition informa-
have shown that fiber-containing tion panel, consistent with
fruits, vegetables, and grain products § 101.9(c)(6)(i)(A).
can help lower blood LDL-cholesterol. (d) Optional information. (1) The claim
(c) Requirements. (1) All requirements may identify one or more of the fol-
set forth in § 101.14 shall be met. lowing risk factors for heart disease
about which there is general scientific
(2) Specific requirements—(i) Nature of
agreement: A family history of coro-
the claim. A health claim associating
nary heart disease, elevated blood-,
diets low in saturated fat and choles-
total- and LDL-cholesterol, excess
terol and high in fruits, vegetables, and
body weight, high blood pressure, ciga-
grain products that contain fiber, par- rette smoking, diabetes, and physical
ticularly soluble fiber, with reduced inactivity.
risk of heart disease may be made on (2) The claim may indicate that the
the label or labeling of a food described relationship of diets low in saturated
in paragraph (c)(2)(ii) of this section, fat and cholesterol, and high in fruits,
provided that: vegetables, and grain products that
(A) The claim states that diets low in contain fiber to heart disease is
saturated fat and cholesterol and high through the intermediate link of
in fruits, vegetables, and grain prod- ‘‘blood cholesterol’’ or ‘‘blood total-
ucts that contain fiber ‘‘may’’ or and LDL-cholesterol.’’
‘‘might’’ reduce the risk of heart dis- (3) The claim may include informa-
ease; tion from paragraphs (a) and (b) of this
(B) In specifying the disease, the section, which summarize the relation-
claim uses the following terms: ‘‘heart ship between diets low in saturated fat
disease’’ or ‘‘coronary heart disease;’’ and cholesterol and high in fruits,
138
vegetables, and grain products that § 101.78 Health claims: fruits and vege-
contain fiber and coronary heart dis- tables and cancer.
ease, and the significance of the rela- (a) Relationship between substances in
tionship. diets low in fat and high in fruits and
(4) In specifying the nutrients, the vegetables and cancer risk. (1) Cancer is
claim may include the term ‘‘total fat’’ a constellation of more than 100 dif-
in addition to the terms ‘‘saturated ferent diseases, each characterized by
fat’’ and ‘‘cholesterol.’’ the uncontrolled growth and spread of
(5) The claim may indicate that it is abnormal cells. Cancer has many
consistent with ‘‘Nutrition and Your causes and stages in its development.
Health: Dietary Guidelines for Ameri- Both genetic and environmental risk
cans,’’ U.S. Department of Agriculture factors may affect the risk of cancer.
(USDA) and Department of Health and Risk factors include a family history of
Human Services (DHHS), Government a specific type of cancer, cigarette
Printing Office (GPO). smoking, alcohol consumption, over-
(6) The claim may state that individ- weight and obesity, ultraviolet or ion-
uals with elevated blood total- and izing radiation, exposure to cancer-
LDL-cholesterol should consult their causing chemicals, and dietary factors.
(2) Although the specific roles of the
physicians for medical advice and
numerous potentially protective sub-
treatment. If the claim defines high or
stances in plant foods are not yet un-
normal blood total- and LDL-choles- derstood, many studies have shown
terol levels, then the claim shall state that diets high in plant foods are asso-
that individuals with high blood cho- ciated with reduced risk of some types
lesterol should consult their physicians of cancers. These studies correlate
for medical advice and treatment. diets rich in fruits and vegetables and
(7) The claim may include informa- nutrients from these diets, such as vi-
tion on the number of people in the tamin C, vitamin A, and dietary fiber,
United States who have heart disease. with reduced cancer risk. Persons con-
The sources of this information shall suming these diets frequently have
be identified, and it shall be current in- high intakes of these nutrients. Cur-
formation from the National Center for rently, there is not scientific agree-
Health Statistics, the National Insti- ment as to whether the observed pro-
tutes of Health, or ‘‘Nutrition and Your tective effects of fruits and vegetables
Health: Dietary Guidelines for Ameri- against cancer are due to a combina-
cans,’’ USDA and DHHS, GPO. tion of the nutrient components of
(e) Model health claims. The following diets rich in fruits and vegetables, in-
model health claims may be used in cluding but not necessarily limited to
food labeling to characterize the rela- dietary fiber, vitamin A (as beta-caro-
tionship between diets low in saturated tene) and vitamin C, to displacement of
fat and cholesterol and high in fruits, fat from such diets, or to intakes of
vegetables, and grain products that other substances in these foods which
contain soluble fiber: are not nutrients but may be protec-
(1) Diets low in saturated fat and tive against cancer risk.
cholesterol and rich in fruits, vegeta- (b) Significance of the relationship be-
bles, and grain products that contain tween consumption of diets low in fat and
some types of dietary fiber, particu- high in fruits and vegetables and risk of
larly soluble fiber, may reduce the risk cancer. (1) Cancer is ranked as a leading
of heart disease, a disease associated cause of death in the United States.
with many factors. The overall economic costs of cancer,
(2) Development of heart disease de- including direct health care costs and
pends on many factors. Eating a diet losses due to morbidity and mortality,
low in saturated fat and cholesterol are very high.
and high in fruits, vegetables, and (2) U.S. diets tend to be high in fat
and low in fruits and vegetables. Stud-
grain products that contain fiber may
ies in various parts of the world indi-
lower blood cholesterol levels and re-
cate that populations who habitually

duce your risk of heart disease.
consume a diet high in plant foods have
[58 FR 2578, Jan. 6, 1993] lower risks of some cancers. These
139
§ 101.78 21 CFR Ch. I (4–1–16 Edition)
diets generally are low in fat and rich (J) The claim indicates that develop-
in many nutrients, including, but not ment of cancer depends on many fac-
limited to, dietary fiber, vitamin A (as tors.
beta-carotene), and vitamin C. Current (ii) Nature of the food. (A) The food
dietary guidelines from Federal Gov- shall be or shall contain a fruit or veg-
ernment agencies and nationally recog- etable.
nized health professional organizations (B) The food shall meet the nutrient
recommend decreased consumption of content requirements of § 101.62 for a
fats (less than 30 percent of calories), ‘‘low fat’’ food.
maintenance of desirable body weight, (C) The food shall meet, without for-
and increased consumption of fruits tification, the nutrient content re-
and vegetables (5 or more servings quirements of § 101.54 for a ‘‘good
daily), particularly those fruits and source’’ of at least one of the following:
vegetables which contain dietary fiber, vitamin A, vitamin C, or dietary fiber.
vitamin A, and vitamin C. (d) Optional information. (1) The claim
(c) Requirements. (1) All requirements may include information from para-
set forth in § 101.14 shall be met. graphs (a) and (b) of this section, which
(2) Specific requirements—(i) Nature of summarize the relationship between
the claim. A health claim associating diets low in fat and high in fruits and
substances in diets low in fat and high vegetables and some types of cancer
in fruits and vegetables with reduced and the significance of the relation-
risk of cancer may be made on the ship.
label or labeling of a food described in (2) The claim may identify one or
paragraph (c)(2)(ii) of this section, pro- more of the following risk factors for
vided that: development of cancer: Family history
(A) The claim states that diets low in of a specific type of cancer, cigarette
fat and high in fruits and vegetables smoking, alcohol consumption, over-
‘‘may’’ or ‘‘might’’ reduce the risk of weight and obesity, ultraviolet or ion-
some cancers; izing radiation, exposure to cancer-
(B) In specifying the disease, the causing chemicals, and dietary factors.
claim uses the following terms: ‘‘some (3) The claim may use the word
types of cancer’’, or ‘‘some cancers’’; ‘‘beta-carotene’’ in parentheses after
the term vitamin A, provided that the
(C) The claim characterizes fruits
vitamin A in the food bearing the
and vegetables as foods that are low in
claim is beta-carotene.
fat and may contain vitamin A, vita-
(4) The claim may indicate that it is
min C, and dietary fiber;
consistent with ‘‘Nutrition and Your
(D) The claim characterizes the food
Health: Dietary Guidelines for Ameri-
bearing the claim as containing one or
cans,’’ U.S. Department of Agriculture
more of the following, for which the
(USDA) and the Department of Health
food is a good source under § 101.54: die-
and Human Services (DHHS), Govern-
tary fiber, vitamin A, or vitamin C;
ment Printing Office.
(E) The claim does not attribute any (5) The claim may include informa-
degree of cancer risk reduction to diets tion on the number of people in the
low in fat and high in fruits and vege- United States who have cancer. The
tables; sources of this information must be
(F) In specifying the fat component identified, and it must be current infor-
of the labeled food, the claim uses the mation from the National Center for
term ‘‘total fat’’ or ‘‘fat’’; Health Statistics, the National Insti-
(G) The claim does not specify types tutes of Health, or ‘‘Nutrition and Your
of fats or fatty acids that may be re- Health: Dietary Guidelines for Ameri-
lated to risk of cancer; cans,’’ USDA and DHHS, Government
(H) In specifying the dietary fiber Printing Office.
component of the labeled food, the (e) Model health claims. The following
claim uses the term ‘‘fiber’’, ‘‘dietary model health claims may be used in
fiber’’, or ‘‘total dietary fiber’’; food labeling to characterize the rela-
(I) The claim does not specify types tionship between substances in diets
of dietary fiber that may be related to low in fat and high in fruits and vege-
risk of cancer; and tables and cancer:
140
(1) Low fat diets rich in fruits and vational studies that reported
vegetables (foods that are low in fat periconceptional use of multivitamins
and may contain dietary fiber, vitamin containing 0 to 1,000 mcg of folic acid,
A, and vitamin C) may reduce the risk the Food and Drug Administration con-
of some types of cancer, a disease asso- cluded that most of these studies had
ciated with many factors. Broccoli is results consistent with the conclusion
high in vitamins A and C, and it is a that folate, at levels attainable in
good source of dietary fiber. usual diets, may reduce the risk of neu-
(2) Development of cancer depends on ral tube defects.
many factors. Eating a diet low in fat (b) Significance of folate—(1) Public
and high in fruits and vegetables, foods health concern. Neural tube defects
that are low in fat and may contain vi- occur in approximately 0.6 of 1,000 live
tamin A, vitamin C, and dietary fiber, births in the United States (i.e., ap-
may reduce your risk of some cancers. proximately 6 of 10,000 live births;
Oranges, a food low in fat, are a good about 2,500 cases among 4 million live
source of fiber and vitamin C. births annually). Neural tube defects
[58 FR 2639, Jan. 6, 1993] are believed to be caused by many fac-
tors. The single greatest risk factor for
§ 101.79 Health claims: Folate and neu- a neural tube defect-affected pregnancy
ral tube defects. is a personal or family history of a
(a) Relationship between folate and pregnancy affected with a such a de-
neural tube defects—(1) Definition. Neu- fect. However, about 90 percent of in-
ral tube defects are serious birth de- fants with a neural tube defect are
fects of the brain or spinal cord that born to women who do not have a fam-
can result in infant mortality or seri- ily history of these defects. The avail-
ous disability. The birth defects able evidence shows that diets ade-
anencephaly and spina bifida are the quate in folate may reduce the risk of
most common forms of neural tube de- neural tube defects but not of other
fects and account for about 90 percent birth defects.
of these defects. These defects result (2) Populations at risk. Prevalence
from failure of closure of the covering rates for neural tube defects have been
of the brain or spinal cord during early reported to vary with a wide range of
embryonic development. Because the factors including genetics, geography,
neural tube forms and closes during socioeconomic status, maternal birth
early pregnancy, the defect may occur cohort, month of conception, race, nu-
before a woman realizes that she is trition, and maternal health, including
pregnant. maternal age and reproductive history.
(2) Relationship. The available data Women with a close relative (i.e., sib-
show that diets adequate in folate may ling, niece, nephew) with a neural tube
reduce the risk of neural tube defects. defect, those with insulin-dependent di-
The strongest evidence for this rela- abetes mellitus, and women with sei-
tionship comes from an intervention zure disorders who are being treated
study by the Medical Research Council with valproic acid or carbamazepine
of the United Kingdom that showed are at significantly increased risk com-
that women at risk of recurrence of a pared with women without these char-
neural tube defect pregnancy who con- acteristics. Rates for neural tube de-
sumed a supplement containing 4 milli- fects vary within the United States,
grams (mg)(4,000 micrograms (mcg)) with lower rates observed on the west
folic acid daily before conception and coast than on the east coast.
continuing into early pregnancy had a (3) Those who may benefit. Based on a
reduced risk of having a child with a synthesis of information from several
neural tube defect. (Products con- studies, including those which used
taining this level of folic acid are multivitamins containing folic acid at
drugs). In addition, based on its review a daily dose level of ≥400 mcg (≥0.4 mg),
of a Hungarian intervention trial that the Public Health Service has inferred
reported periconceptional use of a that folate alone at levels of 400 mcg
multivitamin and multimineral prepa- (0.4 mg) per day may reduce the risk of
ration containing 800 mcg (0.8 mg) of neural tube defects. The protective ef-
folic acid, and its review of the obser- fect found in studies of lower dose
141
§ 101.79 21 CFR Ch. I (4–1–16 Edition)
folate measured by the reduction in (E) Reduction in risk. The claim shall
neural tube defect incidence, ranges not attribute any specific degree of re-
from none to substantial; a reasonable duction in risk of neural tube defects
estimate of the expected reduction in from maintaining an adequate folate
the United States is 50 percent. It is ex- intake throughout the childbearing
pected that consumption of adequate years. The claim shall state that some
folate will avert some, but not all, neu- women may reduce their risk of a neu-
ral tube defects. The underlying causes ral tube defect pregnancy by maintain-
of neural tube defects are not known. ing adequate intakes of folate during
Thus, it is not known what proportion their childbearing years. Optional
of neural tube defects will be averted statements about population-based es-
by adequate folate consumption. From timates of risk reduction may be made
the available evidence, the Public in accordance with paragraph (c)(3)(vi)
Health Service estimates that there is of this section.
the potential for averting 50 percent of
(F) Safe upper limit of daily intake.
cases that now occur (i.e., about 1,250
Claims on foods that contain more
cases annually). However, until further
research is done, no firm estimate of than 100 percent of the Daily Value
this proportion will be available. (DV) (400 mcg) when labeled for use by
(c) Requirements. The label or labeling adults and children 4 or more years of
of food may contain a folate/neural age, or 800 mcg when labeled for use by
tube defect health claim provided that: pregnant or lactating women) shall
(1) General requirements. The health identify the safe upper limit of daily
claim for a food meets all of the gen- intake with respect to the DV. The safe
eral requirements of § 101.14 for health upper limit of daily intake value of
claims, except that a food may qualify 1,000 mcg (1 mg) may be included in pa-
to bear the health claim if it meets the rentheses.
definition of the term ‘‘good source.’’ (G) The claim shall state that folate
(2) Specific requirements—(i) Nature of needs to be consumed as part of a
the claim—(A) Relationship. A health healthful diet.
claim that women who are capable of (ii) Nature of the food—(A) Require-
becoming pregnant and who consume ments. The food shall meet or exceed
adequate amounts of folate daily dur- the requirements for a ‘‘good source’’
ing their childbearing years may re- of folate as defined in § 101.54;
duce their risk of having a pregnancy (B) Dietary supplements. Dietary sup-
affected by spina bifida or other neural plements shall meet the United States
tube defects may be made on the label Pharmacopeia (USP) standards for dis-
or labeling of food provided that: integration and dissolution, except
(B) Specifying the nutrient. In speci-
that if there are no applicable USP
fying the nutrient, the claim shall use
standards, the folate in the dietary
the terms ‘‘folate,’’ ‘‘folic acid,’’
supplement shall be shown to be bio-
‘‘folacin,’’ ‘‘folate, a B vitamin,’’ ‘‘folic
available under the conditions of use
acid, a B vitamin,’’ or ‘‘folacin, a B vi-
stated on the product label.
tamin.’’
(C) Specifying the condition. In speci- (iii) Limitation. The claim shall not
fying the health- related condition, the be made on foods that contain more
claim shall identify the birth defects as than 100 percent of the RDI for vitamin
‘‘neural tube defects,’’ ‘‘birth defects A as retinol or preformed vitamin A or
spina bifida or anencephaly,’’ ‘‘birth vitamin D per serving or per unit.
defects of the brain or spinal cord (iv) Nutrition labeling. The nutrition
anencephaly or spina bifida,’’ ‘‘spina label shall include information about
bifida and anencephaly, birth defects of the amount of folate in the food. This
the brain or spinal cord,’’ ‘‘birth de- information shall be declared after the
fects of the brain or spinal cord;’’ or declaration for iron if only the levels of
‘‘brain or spinal cord birth defects.’’ vitamin A, vitamin C, calcium, and
(D) Multifactorial nature. The claim iron are provided, or in accordance
shall not imply that folate intake is with § 101.9 (c)(8) and (c)(9) if other op-
the only recognized risk factor for neu- tional vitamins or minerals are de-
ral tube defects. clared.
142
(3) Optional information—(i) Risk fac- cluded in the claim. Information con-
tors. The claim may specifically iden- tained in paragraph (b)(3) of this sec-
tify risk factors for neural tube de- tion may be used. If such an estimate
fects. Where such information is pro- (i.e., 50 percent) is provided, the esti-
vided, it may consist of statements mate shall be accompanied by addi-
from § 101.79(b)(1) or (b)(2) (e.g., Women tional information that states that the
at increased risk include those with a estimate is population-based and that
personal history of a neural tube de- it does not reflect risk reduction that
fect-affected pregnancy, those with a may be experienced by individual
close relative (i.e., sibling, niece, neph- women.
ew) with a neural tube defect; those (vii) Diets adequate in folate. The
with insulin-dependent diabetes claim may identify diets adequate in
mellitus; those with seizure disorders folate by using phrases such as
who are being treated with valproic ‘‘Sources of folate include fruits, vege-
acid or carbamazepine) or from other tables, whole grain products, fortified
parts of this paragraph (c)(3)(i). cereals, and dietary supplements.’’ or
(ii) Relationship between folate and ‘‘Adequate amounts of folate can be ob-
neural tube defects. The claim may in- tained from diets rich in fruits, dark
clude statements from paragraphs (a) green leafy vegetables, legumes, whole
and (b) of this section that summarize grain products, fortified cereals, or die-
the relationship between folate and tary supplements.’’ or ‘‘Adequate
neural tube defects and the signifi- amounts of folate can be obtained from
cance of the relationship except for in- diets rich in fruits, including citrus
formation specifically prohibited from fruits and juices, vegetables, including
the claim. dark green leafy vegetables, legumes,
(iii) Personal history of a neural tube whole grain products, including breads,
defect-affected pregnancy. The claim rice, and pasta, fortified cereals, or a
may state that women with a history dietary supplement.’’
of a neural tube defect pregnancy
(d) Model health claims. The following
should consult their physicians or
are examples of model health claims
health care providers before becoming
that may be used in food labeling to de-
pregnant. If such a statement is pro-
scribe the relationship between folate
vided, the claim shall also state that
and neural tube defects:
all women should consult a health care
provider when planning a pregnancy. (1) Examples 1 and 2. Model health
(iv) Daily value. The claim may iden- claims appropriate for foods containing
tify 100 percent of the DV (100% DV; 400 100 percent or less of the DV for folate
mcg) for folate as the target intake per serving or per unit (general popu-
goal. lation). The examples contain only the
(v) Prevalence. The claim may provide required elements:
estimates, expressed on an annual (i) Healthful diets with adequate
basis, of the number of neural tube de- folate may reduce a woman’s risk of
fect-affected births among live births having a child with a brain or spinal
in the United States. Current esti- cord birth defect.
mates are provided in § 101.79(b)(1), and (ii) Adequate folate in healthful diets
are approximately 6 of 10,000 live births may reduce a woman’s risk of having a
annually (i.e., about 2,500 cases among child with a brain or spinal cord birth
4 million live births annually). Data defect.
provided in § 101.79(b)(1) shall be used, (2) Example 3. Model health claim ap-
unless more current estimates from the propriate for foods containing 100 per-
U.S. Public Health Service are avail- cent or less of the DV for folate per
able, in which case the latter may be serving or per unit. The example con-
cited. tains all required elements plus op-
(vi) Reduction in risk. An estimate of tional information: Women who con-
the reduction in the number of neural sume healthful diets with adequate
tube defect-affected births that might folate throughout their childbearing
occur in the United States if all women years may reduce their risk of having a
consumed adequate folate throughout child with a birth defect of the brain or
their childbearing years may be in- spinal cord. Sources of folate include
143
§ 101.80 21 CFR Ch. I (4–1–16 Edition)
fruits, vegetables, whole grain prod- snacking. Frequent between-meal

ucts, fortified cereals, and dietary sup- snacks that are high in sugars and
plements. starches may be more harmful to teeth
(3) Example 4. Model health claim ap- than eating such foods at meals and
propriate for foods intended for use by then brushing.
the general population and containing (4) Noncariogenic carbohydrate
more than 100 percent of the DV of sweeteners, such as sugar alcohols, can
folate per serving or per unit: Women be used to replace dietary sugars, such
who consume healthful diets with ade- as sucrose and corn sweeteners, in
quate folate may reduce their risk of foods such as chewing gums and cer-
having a child with birth defects of the tain confectioneries. Noncariogenic
brain or spinal cord. Folate intake carbohydrate sweeteners are signifi-
should not exceed 250% of the DV (1,000 cantly less cariogenic than dietary sug-
mcg). ars and other fermentable carbo-
[61 FR 8779, Mar. 5, 1996; 61 FR 48529, Sept. 13, hydrates.
1996, as amended at 65 FR 58918, Oct. 3, 2000] (b) Significance of the relationship be-
tween noncariogenic carbohydrate sweet-
§ 101.80 Health claims: dietary eners and dental caries. Noncariogenic
noncariogenic carbohydrate sweet-
eners and dental caries. carbohydrate sweeteners do not pro-
mote dental caries. The noncariogenic
(a) Relationship between dietary carbo- carbohydrate sweeteners listed in para-
hydrates and dental caries. (1) Dental graph (c)(2)(ii) of this section are slow-
caries, or tooth decay, is a disease ly metabolized by bacteria to form
caused by many factors. Both environ- some acid. The rate and amount of acid
mental and genetic factors can affect production is significantly less than
the development of dental caries. Risk that from sucrose and other ferment-
factors include tooth enamel crystal able carbohydrates and does not cause
structure and mineral content, plaque the loss of important minerals from
quantity and quality, saliva quantity tooth enamel.
and quality, individual immune re-
(c) Requirements. (1) All requirements
sponse, types and physical characteris-
set forth in § 101.14 shall be met, except
tics of foods consumed, eating behav-
that noncariogenic carbohydrate
iors, presence of acid producing oral
sweetener-containing foods listed in
bacteria, and cultural influences.
(2) The relationship between con- paragraph (c)(2)(ii) of this section are
sumption of fermentable carbo- exempt from § 101.14(e)(6).
hydrates, i.e., dietary sugars and (2) Specific requirements—(i) Nature of
starches, and tooth decay is well estab- the claim. A health claim relating
lished. Sucrose, also known as sugar, is noncariogenic carbohydrate sweet-
one of the most, but not the only, eners, compared to other carbo-
cariogenic sugars in the diet. Bacteria hydrates, and the nonpromotion of den-
found in the mouth are able to metabo- tal caries may be made on the label or
lize most dietary carbohydrates, pro- labeling of a food described in para-
ducing acid and forming dental plaque. graph (c)(2)(iii) of this section, pro-
The more frequent and longer the expo- vided that:
sure of teeth to dietary sugars and (A) The claim shall state that fre-
starches, the greater the risk for tooth quent between-meal consumption of
decay. foods high in sugars and starches can
(3) Dental caries continues to affect a promote tooth decay.
large proportion of Americans. Al- (B) The claim shall state that the
though there has been a decline in the noncariogenic carbohydrate sweetener
prevalence of dental caries among chil- present in the food ‘‘does not pro-
dren in the United States, the disease mote,’’ ‘‘may reduce the risk of,’’
remains widespread throughout the ‘‘useful [or is useful] in not pro-
population, imposing a substantial bur- moting,’’ or ‘‘expressly [or is expressly]
den on Americans. Recent Federal gov- for not promoting’’ dental caries.
ernment dietary guidelines recommend (C) In specifying the nutrient, the

that Americans choose diets that are claim shall state ‘‘sugar alcohol,’’
moderate in sugars and avoid excessive ‘‘sugar alcohols,’’ or the name or
144
names of the substances listed in para- Dietary Components,’’ dated 1983, by T.

graph (c)(2)(ii) of this section, e.g., N. Imfeld, in Volume 11, Monographs in
‘‘sorbitol.’’ D-tagatose may be identi- Oral Science, 1983. The Director of the
fied as ‘‘tagatose.’’ Office of the Federal Register has ap-
(D) In specifying the disease, the proved the incorporation by reference
claim uses the following terms: ‘‘dental of this material in accordance with 5
caries’’ or ‘‘tooth decay.’’ U.S.C. 552(a) and 1 CFR part 51. You
(E) The claim shall not attribute any may obtain copies from Karger AG
degree of the reduction in risk of den- Publishing Co., P.O. Box, Ch–4009
tal caries to the use of the Basel, Switzerland, or you may exam-
noncariogenic carbohydrate sweetener- ine a copy at the Food and Drug Ad-
containing food. ministration’s Main Library, 10903 New
(F) The claim shall not imply that Hampshire Ave., Bldg. 2, Third Floor,
consuming noncariogenic carbohydrate Silver Spring, MD 20993, 301–796–2039, or
sweetener-containing foods is the only at the National Archives and Records
recognized means of achieving a re- Administration (NARA). For informa-
duced risk of dental caries. tion on the availability of this mate-
(G) Packages with less than 15 square rial at NARA, call 202–741–6030, or go
inches of surface area available for la- to: http://www.archives.gov/
beling are exempt from paragraphs (A) federallregister/
and (C) of this section. codeloflfederallregulations/
(H) When the substance that is the ibrllocations.html.
subject of the claim is a noncariogenic (d) Optional information. (1) The claim
sugar, the claim shall identify the sub- may include information from para-
stance as a sugar that, unlike other graphs (a) and (b) of this section, which
sugars, does not promote the develop- describe the relationship between diets
ment of dental caries. containing noncariogenic carbohydrate
(ii) Nature of the substance. Eligible sweeteners and dental caries.
noncariogenic carbohydrate sweeteners (2) The claim may indicate that de-
are: velopment of dental caries depends on
(A) The sugar alcohols xylitol, sor- many factors and may identify one or
bitol, mannitol, maltitol, isomalt, more of the following risk factors for
lactitol, hydrogenated starch hydroly- dental caries: Frequent consumption of
sates, hydrogenated glucose syrups, fermentable carbohydrates, such as di-
and erythritol, or a combination of etary sugars and starches; presence of
these. oral bacteria capable of fermenting
(B) The sugars D-tagatose and carbohydrates; length of time ferment-
isomaltulose. able carbohydrates are in contact with
(C) Sucralose. the teeth; lack of exposure to fluoride;
(iii) Nature of the food. (A) The food individual susceptibility; socio-
shall meet the requirement in economic and cultural factors; and
§ 101.60(c)(1)(i) with respect to sugars characteristics of tooth enamel, saliva,
content, except that the food may con- and plaque.
tain D-tagatose or isomaltulose. (3) The claim may indicate that oral
(B) A food whose labeling includes a hygiene and proper dental care may
health claim under this section shall help to reduce the risk of dental dis-
contain one or more of the ease.
noncariogenic carbohydrate sweeteners (4) The claim may indicate that a
listed in paragraph (c)(2)(ii) of this sec- substance listed in paragraph (c)(2)(ii)
tion. of this section serves as a sweetener.
(C) When carbohydrates other than (e) Model health claim. The following
those listed in paragraph (c)(2)(ii) of model health claims may be used in
this section are present in the food, the food labeling to describe the relation-
food shall not lower plaque pH below ship between noncariogenic carbo-
5.7 by bacterial fermentation either hydrate sweetener-containing foods
during consumption or up to 30 min- and dental caries.
utes after consumption, as measured (1) Examples of the full claim:

by the indwelling plaque pH test found (i) Frequent eating of foods high in
in ‘‘Identification of Low Caries Risk sugars and starches as between-meal
145
§ 101.81 21 CFR Ch. I (4–1–16 Edition)
snacks can promote tooth decay. The eases of the heart muscle and sup-
sugar alcohol [name, optional] used to porting blood vessels. High blood total
sweeten this food may reduce the risk cholesterol and low density lipoprotein
of dental caries. (LDL)-cholesterol levels are associated
(ii) Frequent between-meal consump- with increased risk of developing coro-
tion of foods high in sugars and starch- nary heart disease. High CHD rates
es promotes tooth decay. The sugar al- occur among people with high total
cohols in [name of food] do not pro- cholesterol levels of 240 milligrams per
mote tooth decay. deciliter (mg/dL) (6.21 (mmol/L)) or
(iii) Frequent eating of foods high in above and LDL-cholesterol levels of 160
sugars and starches as between-meal mg/dL (4.13 mmol/L) or above. Border-
snacks can promote tooth decay. line high risk total cholesterol levels
[Name of sugar from paragraph range from 200 to 239 mg/dL (5.17 to 6.18
(c)(2)(ii)(B) of this section], the sugar mmol/L) and 130 to 159 mg/dL (3.36 to
used to sweeten this food, unlike other 4.11 mmol/L) of LDL-cholesterol. The
sugars, may reduce the risk of dental scientific evidence establishes that
caries. diets high in saturated fat and choles-
(iv) Frequent between-meal consump- terol are associated with increased lev-
tion of foods high in sugars and starch- els of blood total- and LDL-cholesterol
es promotes tooth decay. [Name of and, thus, with increased risk of CHD.
sugar from paragraph (c)(2)(ii)(B) of (2) Populations with a low incidence
this section], the sugar in [name of of CHD tend to have relatively low
food], unlike other sugars, does not blood total cholesterol and LDL-cho-
promote tooth decay. lesterol levels. These populations also
(v) Frequent eating of foods high in tend to have dietary patterns that are
sugars and starches as between-meal not only low in total fat, especially
snacks can promote tooth decay. saturated fat and cholesterol, but are
Sucralose, the sweetening ingredient also relatively high in fiber-containing
used to sweeten this food, unlike sug- fruits, vegetables, and grain products,
ars, does not promote tooth decay. such as whole oat products.
(2) Example of the shortened claim (3) Scientific evidence demonstrates
for small packages: that diets low in saturated fat and cho-
(i) Does not promote tooth decay. lesterol may reduce the risk of CHD.
(ii) May reduce the risk of tooth Other evidence demonstrates that the
decay. addition of soluble fiber from certain
(iii) [Name of sugar from paragraph foods to a diet that is low in saturated
(c)(2)(ii)(B) of this section] sugar does fat and cholesterol may also help to re-
not promote tooth decay. duce the risk of CHD.
(iv) [Name of sugar from paragraph (b) Significance of the relationship be-
(c)(2)(ii)(B) of this section] sugar may tween diets that are low in saturated fat
reduce the risk of tooth decay. and cholesterol and that include soluble
fiber from certain foods and the risk of
[61 FR 43446, Aug. 23, 1996, as amended at 62
CHD. (1) CHD is a major public health
FR 63655, Dec. 2, 1997; 66 FR 66742, Dec. 27,
2001; 67 FR 71470, Dec. 2, 2002; 71 FR 15563, concern in the United States. It ac-
Mar. 29, 2006; 72 FR 52789, Sept. 17, 2007; 81 FR counts for more deaths than any other
5590, Feb. 3, 2016] disease or group of diseases. Early
management of risk factors for CHD is
§ 101.81 Health claims: Soluble fiber a major public health goal that can as-
from certain foods and risk of coro- sist in reducing risk of CHD. High
nary heart disease (CHD). blood total and LDL-cholesterol are
(a) Relationship between diets that are major modifiable risk factors in the de-
low in saturated fat and cholesterol and velopment of CHD.
that include soluble fiber from certain (2) Intakes of saturated fat exceed
foods and the risk of CHD. (1) Cardio- recommended levels in the diets of
vascular disease means diseases of the many people in the United States. One
heart and circulatory system. Coro- of the major public health rec-
nary heart disease (CHD) is one of the ommendations relative to CHD risk is
most common and serious forms of car- to consume less than 10 percent of cal-
diovascular disease and refers to dis- ories from saturated fat and an average
146
of 30 percent or less of total calories means of achieving a reduced risk of

from all fat. Recommended daily cho- CHD.
lesterol intakes are 300 milligrams (G) The claim specifies the daily die-
(mg) or less per day. Scientific evi- tary intake of the soluble fiber source
dence demonstrates that diets low in that is necessary to reduce the risk of
saturated fat and cholesterol are asso- coronary heart disease and the con-
ciated with lower blood total- and tribution one serving of the product
LDL-cholesterol levels. Soluble fiber makes to the specified daily dietary in-
from certain foods, when included in a take level. Daily dietary intake levels
low saturated fat and cholesterol diet, of soluble fiber sources listed in para-
also helps to lower blood total- and graph (c)(2)(ii) of this section that have
LDL-cholesterol levels. been associated with reduced risk coro-
(c) Requirements. (1) All requirements nary heart disease are:
set forth in § 101.14 shall be met. The (1) 3 g or more per day of b-glucan
label and labeling of foods containing soluble fiber from either whole oats or
psyllium husk shall be consistent with barley, or a combination of whole oats
the provisions of § 101.17(f). and barley.
(2) Specific requirements—(i) Nature of (2) 7 g or more per day of soluble fiber
the claim. A health claim associating from psyllium seed husk.
diets that are low in saturated fat and (ii) Nature of the substance—Eligible
cholesterol and that include soluble sources of soluble fiber. (A) Beta (b)
fiber from certain foods with reduced glucan soluble fiber from the whole oat
risk of heart disease may be made on and barley sources listed below. b-
the label or labeling of a food described glucan soluble fiber will be determined
in paragraph (c)(2)(iii) of this section, by method No. 992.28 from the ‘‘Official
provided that: Methods of Analysis of the AOAC
INTERNATIONAL,’’ 16th ed. (1995),
(A) The claim states that diets that
which is incorporated by reference in
are low in saturated fat and cholesterol
accordance with 5 U.S.C. 552(a) and 1
and that include soluble fiber from cer-
CFR part 51. Copies may be obtained
tain foods ‘‘may’’ or ‘‘might’’ reduce
from the AOAC INTERNATIONAL, 481
the risk of heart disease.
North Frederick Ave., suite 500, Gai-
(B) In specifying the disease, the thersburg, MD 20877, or may be exam-
claim uses the following terms: ‘‘heart ined at the Food and Drug Administra-
disease’’ or ‘‘coronary heart disease’’; tion’s Main Library, 10903 New Hamp-
(C) In specifying the substance, the shire Ave., Bldg. 2, Third Floor, Silver
claim uses the term ‘‘soluble fiber’’ Spring, MD 20993, 301–796–2039, or at the
qualified by the name of the eligible National Archives and Records Admin-
source of soluble fiber (provided in istration (NARA). For information on
paragraph (c)(2)(ii)) of this section. Ad- the availability of this material at
ditionally, the claim may use the name NARA, call 202–741–6030, or go to: http://
of the food product that contains the www.archives.gov/federallregister/
eligible source of soluble fiber; codeloflfederallregulations/
(D) In specifying the fat component, ibrllocations.html;
the claim uses the terms ‘‘saturated (1) Oat bran. Oat bran is produced by
fat’’ and ‘‘cholesterol’’; grinding clean oat groats or rolled oats
(E) The claim does not attribute any and separating the resulting oat flour
degree of risk reduction for CHD to by suitable means into fractions such
diets that are low in saturated fat and that the oat bran fraction is not more
cholesterol and that include soluble than 50 percent of the original starting
fiber from the eligible food sources material and provides at least 5.5 per-
from paragraph (c)(2)(ii) of this section; cent (dry weight basis (dwb)) b-glucan
and soluble fiber and a total dietary fiber
(F) The claim does not imply that content of 16 percent (dwb), and such
consumption of diets that are low in that at least one-third of the total die-
saturated fat and cholesterol and that tary fiber is soluble fiber;
include soluble fiber from the eligible (2) Rolled oats. Rolled oats, also
food sources from paragraph (c)(2)(ii) of known as oatmeal, produced from 100
this section is the only recognized percent dehulled, clean oat groats by
147
§ 101.81 21 CFR Ch. I (4–1–16 Edition)
steaming, cutting, rolling, and flaking, (AACC Method 55–99), published in Ap-
and provides at least 4 percent (dwb) of proved Methods of the American Asso-
b-glucan soluble fiber and a total die- ciation of Cereal Chemists, 10th ed.
tary fiber content of at least 10 per- (2000), pp. 1 and 2, which is incor-
cent. porated by reference in accordance
(3) Whole oat flour. Whole oat flour is with 5 U.S.C. 552(a) and 1 CFR part 51.
produced from 100 percent dehulled, Copies may be obtained from the Amer-
clean oat groats by steaming and ican Association of Cereal Chemists,
grinding, such that there is no signifi- Inc., 3340 Pilot Knob Rd., St. Paul, Min-
cant loss of oat bran in the final prod- nesota, 55121, or may be examined at
uct, and provides at least 4 percent the Food and Drug Administration’s
(dwb) of b-glucan soluble fiber and a Main Library, 10903 New Hampshire
total dietary fiber content of at least Ave., Bldg. 2, Third Floor, Silver
10 percent (dwb). Spring, MD 20993, 301–796–2039, or at the
(4) Oatrim. The soluble fraction of National Archives and Records Admin-
alpha-amylase hydrolyzed oat bran or istration (NARA). For information on
whole oat flour, also known as oatrim. the availability of this material at
Oatrim is produced from either oat NARA, call 202–741–6030, or go to: http://
bran as defined in paragraph www.archives.gov/federallregister/
(c)(2)(ii)(A)(1) of this section or whole codeloflfederallregulations/
oat flour as defined in paragraph ibrllocations.html. Barley meal is
(c)(2)(ii)(A)(3) of this section by unsifted, ground barley grain not sub-
solubilization of the starch in the jected to any processing to separate
starting material with an alpha-amy- the bran, germ, and endosperm. Sieved
lase hydrolysis process, and then re- barley meal is an endosperm cell wall-
moval by centrifugation of the insol- enriched fraction of ground barley sep-
uble components consisting of a high arated from meal by sieving or by air
portion of protein, lipid, insoluble die- classification.
tary fiber, and the majority of the fla- (6) Barley betafiber. Barley betafiber
vor and color components of the start- is the ethanol precipitated soluble frac-
ing material. Oatrim shall have a beta- tion of cellulase and alpha-amylase
glucan soluble fiber content up to 10 hydrolyzed whole grain barley. Barley
percent (dwb) and not less than that of betafiber is produced by hydrolysis of
the starting material (dwb). whole grain barley flour, as defined in
(5) Whole grain barley and dry milled paragraph (c)(2)(ii)(A)(5) of this sec-
barley. Dehulled and hull-less whole tion, with a cellulase and alpha-amy-
grain barley with a b-glucan soluble lase enzyme preparation, to produce a
fiber content of at least 4 percent (dwb) clear aqueous extract that contains
and a total dietary fiber content of at mainly partially hydrolyzed beta-
least 10 percent (dwb). Dry milled bar- glucan and substantially hydrolyzed
ley grain products include barley bran, starch. The soluble, partially
barley flakes, barley grits, pearl bar- hydrolyzed beta-glucan is separated
ley, barley flour, barley meal, and from the insoluble material by cen-
sieved barley meal that are produced trifugation, and after removal of the
from clean, sound dehulled or hull-less insoluble material, the partially
barley grain using standard dry milling hydrolyzed beta-glucan soluble fiber is
techniques, which may include steam- separated from the other soluble com-
ing or tempering, and that contain at pounds by precipitation with ethanol.
least 4 percent (dwb) of b-glucan solu- The product is then dried, milled and
ble fiber and at least 8 percent (dwb) of sifted. Barley betafiber shall have a
total dietary fiber, except barley bran beta-glucan soluble fiber content of at
and sieved barley meal for which the least 70 percent on a dry weight basis.
minimum b-glucan soluble fiber con- (B)(1) Psyllium husk from the dried
tent is 5.5 percent (dwb) and minimum seed coat (epidermis) of the seed of
total dietary fiber content is 15 percent Plantago (P.) ovata, known as blond
(dwb). Dehulled barley, hull-less bar- psyllium or Indian psyllium, P. indica,
ley, barley bran, barley flakes, barley or P. psyllium. To qualify for this
grits, pearl barley, and barley flour are claim, psyllium seed husk, also known
as defined in the Barley Glossary as psyllium husk, shall have a purity of
148
no less than 95 percent, such that it (1) One or more of the whole oat or
contains 3 percent or less protein, 4.5 barley foods from paragraphs
percent or less of light extraneous mat- (c)(2)(ii)(A)(1), (2), (3), and (5) of this
ter, and 0.5 percent or less of heavy ex- section, and the whole oat or barley
traneous matter, but in no case may foods shall contain at least 0.75 gram
the combined extraneous matter ex- (g) of soluble fiber per reference
ceed 4.9 percent, as determined by U.S. amount customarily consumed of the
Pharmacopeia (USP) methods de- food product; or
scribed in USP’s ‘‘The National For- (2) The food containing the oatrim
mulary,’’ USP 23, NF 18, p. 1341, (1995), from paragraph (c)(2)(ii)(A)(4) of this
which is incorporated by reference in section or the barley betafiber from
accordance with 5 U.S.C. 552(a) and 1 paragraph (c)(2)(ii)(A)(6) of this section
CFR part 51. Copies may be obtained shall contain at least 0.75 g of beta-
from the U.S. Pharmacopeial Conven- glucan soluble fiber per reference
tion, Inc., 12601 Twinbrook Pkwy., amount customarily consumed of the
Rockville, MD 20852, or may be exam- food product; or
ined at the Food and Drug Administra- (3) Psyllium husk that complies with
tion’s Main Library, 10903 New Hamp- paragraph (c)(2)(ii)(B) of this section,
shire Ave., Bldg. 2, Third Floor, Silver and the psyllium food shall contain at
Spring, MD 20993, 301–796–2039, or at the least 1.7 g of soluble fiber per reference
National Archives and Records Admin- amount customarily consumed of the
istration (NARA). For information on food product;
the availability of this material at
(B) The amount of soluble fiber shall
NARA, call 202–741–6030, or go to: http://
be declared in the nutrition label, con-
www.archives.gov/federallregister/
sistent with § 101.9(c)(6)(i)(A).
codeloflfederallregulations/
ibrllocations.html; (C) The food shall meet the nutrient
content requirement in § 101.62 for a
(2) FDA will determine the amount of
‘‘low saturated fat’’ and ‘‘low choles-
soluble fiber that is provided by psyl-
terol’’ food; and
lium husk by using a modification of
the Association of Official Analytical (D) The food shall meet the nutrient
Chemists’ International (AOAC’s) content requirement in § 101.62(b)(2) for
method for soluble dietary fiber (991.43) a ‘‘low fat’’ food, unless the food ex-
described by Lee et al., ‘‘Determination ceeds this requirement due to fat con-
of Soluble and Insoluble Dietary Fiber tent derived from whole oat sources
in Psyllium-containing Cereal Prod- listed in paragraph (c)(2)(ii)(A) of this
ucts,’’ Journal of the AOAC Inter- section.
national, 78 (No. 3):724–729, 1995, which (d) Optional information. (1) The claim
is incorporated by reference in accord- may state that the development of
ance with 5 U.S.C. 552(a) and 1 CFR heart disease depends on many factors
part 51. Copies may be obtained from and may identify one or more of the
the AOAC INTERNATIONAL, 481 North following risk factors for heart disease
Frederick Ave., suite 500, Gaithersburg, about which there is general scientific
MD 20877, or may be examined at the agreement: A family history of CHD;
Food and Drug Administration’s Main elevated blood total and LDL-choles-
Library, 10903 New Hampshire Ave., terol; excess body weight; high blood
Bldg. 2, Third Floor, Silver Spring, MD pressure; cigarette smoking; diabetes;
20993, 301–796–2039 or at the National and physical inactivity. The claim may
Archives and Records Administration also provide additional information
(NARA). For information on the avail- about the benefits of exercise and man-
ability of this material at NARA, call agement of body weight to help lower
202–741–6030, or go to: http:// the risk of heart disease;
www.archives.gov/federallregister/ (2) The claim may state that the re-
codeloflfederallregulations/ lationship between intake of diets that
ibrllocations.html; are low in saturated fat and cholesterol
(iii) Nature of the food eligible to bear and that include soluble fiber from the
the claim. (A) The food product shall ineligible food sources from paragraph
clude: (c)(2)(ii) of this section and reduced
149
§ 101.82 21 CFR Ch. I (4–1–16 Edition)
risk of heart disease is through the in- paragraph (c)(2)(i)(G) of this section]
termediate link of ‘‘blood cholesterol’’ soluble fiber from [name of the soluble
or ‘‘blood total- and LDL-cholesterol;’’ fiber source from paragraph (c)(2)(ii) of
(3) The claim may include informa- this section] necessary per day to have
tion from paragraphs (a) and (b) of this this effect.
section, which summarize the relation- (2) Diets low in saturated fat and
ship between diets that are low in satu- cholesterol that include [llll grams
rated fat and cholesterol and that in- of soluble fiber specified in paragraph
clude soluble fiber from certain foods (c)(2)(i)(G) of this section] of soluble
and coronary heart disease and the sig- fiber per day from [name of soluble
nificance of the relationship; fiber source from paragraph (c)(2)(ii) of
(4) The claim may specify the name this section and, if desired, the name of
of the eligible soluble fiber; the food product] may reduce the risk
(5) The claim may state that a diet of heart disease. One serving of [name
low in saturated fat and cholesterol of food] provides llll grams of this
that includes soluble fiber from whole soluble fiber.
oats or barley is consistent with ‘‘Nu- [62 FR 3600, Jan. 23, 1997, as amended at 62
trition and Your Health: Dietary FR 15344, Mar. 31, 1997; 63 FR 8119, Feb. 18,
Guidelines for Americans,’’ U.S. De- 1998; 66 FR 66742, Dec. 27, 2001; 67 FR 61782,
partment of Agriculture (USDA) and Oct. 2, 2002; 68 FR 15355, Mar. 31, 2003; 70 FR
Department of Health and Human 40880, July 15, 2005; 70 FR 76162, Dec. 23, 2005;
Services (DHHS), Government Printing 73 FR 9947, Feb. 25, 2008; 73 FR 23953, May 1,
2008; 81 FR 5590, Feb. 3, 2016]
Office (GPO);
(6) The claim may state that individ- § 101.82 Health claims: Soy protein and
uals with elevated blood total- and risk of coronary heart disease
LDL-cholesterol should consult their (CHD).
physicians for medical advice and (a) Relationship between diets that are
treatment. If the claim defines high or low in saturated fat and cholesterol and
normal blood total- and LDL-choles- that include soy protein and the risk of
terol levels, then the claim shall state CHD. (1) Cardiovascular disease means
that individuals with high blood cho- diseases of the heart and circulatory
lesterol should consult their physicians system. CHD is one of the most com-
for medical advice and treatment; mon and serious forms of cardio-
(7) The claim may include informa- vascular disease and refers to diseases
tion on the number of people in the of the heart muscle and supporting
United States who have heart disease. blood vessels. High blood total choles-
The sources of this information shall terol and low density lipoprotein
be identified, and it shall be current in- (LDL)-cholesterol levels are associated
formation from the National Center for with increased risk of developing CHD.
Health Statistics, the National Insti- High CHD rates occur among people
tutes of Health, or ‘‘Nutrition and Your with high total cholesterol levels of 240
Health: Dietary Guidelines for Ameri- milligrams per deciliter (mg/dL) (6.21
cans,’’ USDA and DHHS, GPO. millimole per liter (mmol/L)) or above
(e) Model health claim. The following and LDL-cholesterol levels of 160 mg/
model health claims may be used in dL (4.13 mmol/L) or above. Borderline
food labeling to describe the relation- high risk total cholesterol levels range
ship between diets that are low in satu- from 200 to 239 mg/dL (5.17 to 6.18
rated fat and cholesterol and that in- mmol/L) and 130 to 159 mg/dL (3.36 to
clude soluble fiber from certain foods 4.11 mmol/L) of LDL-cholesterol. The
and reduced risk of heart disease: scientific evidence establishes that
(1) Soluble fiber from foods such as diets high in saturated fat and choles-
[name of soluble fiber source from terol are associated with increased lev-
paragraph (c)(2)(ii) of this section and, els of blood total and LDL-cholesterol
if desired, the name of food product], as and, thus, with increased risk of CHD.
part of a diet low in saturated fat and (2) Populations with a low incidence
cholesterol, may reduce the risk of of CHD tend to have relatively low
heart disease. A serving of [ name of blood total cholesterol and LDL-cho-

food] supplies llll grams of the lesterol levels. These populations also
[grams of soluble fiber specified in tend to have dietary patterns that are
150
not only low in total fat, especially (B) In specifying the disease, the
saturated fat and cholesterol, but are claim uses the following terms: ‘‘heart
also relatively high in plant foods that disease’’ or ‘‘coronary heart disease’’;
contain dietary fiber and other compo- (C) In specifying the substance, the
nents. claim uses the term ‘‘soy protein’’;
(3) Scientific evidence demonstrates (D) In specifying the fat component,
that diets low in saturated fat and cho- the claim uses the terms ‘‘saturated
lesterol may reduce the risk of CHD. fat’’ and ‘‘cholesterol’’;
Other evidence demonstrates that the (E) The claim does not attribute any
addition of soy protein to a diet that is degree of risk reduction for CHD to
low in saturated fat and cholesterol diets that are low in saturated fat and
may also help to reduce the risk of cholesterol and that include soy pro-
CHD. tein;
(b) Significance of the relationship be- (F) The claim does not imply that
tween diets that are low in saturated fat consumption of diets that are low in
and cholesterol and that include soy pro- saturated fat and cholesterol and that
tein and the risk of CHD. (1) CHD is a include soy protein is the only recog-
major public health concern in the nized means of achieving a reduced
United States. It accounts for more risk of CHD; and
deaths than any other disease or group (G) The claim specifies the daily die-
of diseases. Early management of risk tary intake of soy protein that is nec-
factors for CHD is a major public essary to reduce the risk of coronary
health goal that can assist in reducing heart disease and the contribution one
risk of CHD. High blood total and LDL- serving of the product makes to the
cholesterol are major modifiable risk specified daily dietary intake level.
factors in the development of CHD. The daily dietary intake level of soy
(2) Intakes of saturated fat exceed protein that has been associated with
recommended levels in the diets of reduced risk of coronary heart disease
many people in the United States. One is 25 grams (g) or more per day of soy
of the major public health rec- protein.
ommendations relative to CHD risk is (ii) Nature of the substance. (A) Soy
to consume less than 10 percent of cal- protein from the legume seed Glycine
ories from saturated fat and an average max.
of 30 percent or less of total calories (B) FDA will assess qualifying levels
from all fat. Recommended daily cho- of soy protein in the following fashion:
lesterol intakes are 300 mg or less per FDA will measure total protein con-
day. Scientific evidence demonstrates tent by the appropriate method of
that diets low in saturated fat and cho- analysis given in the ‘‘Official Methods
lesterol are associated with lower blood of Analysis of the AOAC Inter-
total and LDL-cholesterol levels. Soy national,’’ as described at § 101.9(c)(7).
protein, when included in a low satu- For products that contain no sources of
rated fat and cholesterol diet, also protein other than soy, FDA will con-
helps to lower blood total and LDL- sider the amount of soy protein as
cholesterol levels. equivalent to the total protein content.
(c) Requirements. (1) All requirements For products that contain a source or
set forth in § 101.14 shall be met. sources of protein in addition to soy,
(2) Specific requirements—(i) Nature of FDA will, using the measurement of
the claim. A health claim associating total protein content, calculate the soy
diets that are low in saturated fat and protein content based on the ratio of
cholesterol and that include soy pro- soy protein ingredients to total protein
tein with reduced risk of heart disease ingredients in the product. FDA will
may be made on the label or labeling of base its calculation on information
a food described in paragraph (c)(2)(iii) identified and supplied by manufactur-
of this section, provided that: ers, such as nutrient data bases or
(A) The claim states that diets that analyses, recipes or formulations, pur-
are low in saturated fat and cholesterol chase orders for ingredients, or any
and that include soy protein ‘‘may’’ or other information that reasonably sub-
‘‘might’’ reduce the risk of heart dis- stantiates the ratio of soy protein to
ease; total protein. Manufacturers must
151
§ 101.83 21 CFR Ch. I (4–1–16 Edition)
maintain records sufficient to substan- Services (DHHS), Government Printing

tiate the claim for as long as the prod- Office (GPO);
ucts are marketed and provide these (5) The claim may state that individ-
records, on written request, to appro- uals with elevated blood total and
priate regulatory officials. LDL-cholesterol should consult their
(iii) Nature of the food eligible to bear physicians for medical advice and
the claim. (A) The food product shall treatment. If the claim defines high or
contain at least 6.25 g of soy protein normal blood total and LDL-choles-
per reference amount customarily con- terol levels, then the claim shall state
sumed of the food product; that individuals with high blood cho-
(B) The food shall meet the nutrient lesterol should consult their physicians
content requirements in § 101.62 for a for medical advice and treatment;
‘‘low saturated fat’’ and ‘‘low choles- (6) The claim may include informa-
terol’’ food; and tion on the number of people in the
(C) The food shall meet the nutrient United States who have heart disease.
content requirement in § 101.62 for a The sources of this information shall
‘‘low fat’’ food, unless it consists of or be identified, and it shall be current in-
is derived from whole soybeans and formation from the National Center for
contains no fat in addition to the fat Health Statistics, the National Insti-
inherently present in the whole soy- tutes of Health, or ‘‘Nutrition and Your
beans it contains or from which it is Health: Dietary Guidelines for Ameri-
derived. cans,’’ USDA and DHHS, GPO;
(d) Optional information. (1) The claim (e) Model health claim. The following
may state that the development of model health claims may be used in
heart disease depends on many factors food labeling to describe the relation-
and may identify one or more of the ship between diets that are low in satu-
following risk factors for heart disease rated fat and cholesterol and that in-
about which there is general scientific clude soy protein and reduced risk of
agreement: A family history of CHD; heart disease:
elevated blood total and LDL-choles- (1) 25 grams of soy protein a day, as
terol; excess body weight; high blood part of a diet low in saturated fat and
pressure; cigarette smoking; diabetes; cholesterol, may reduce the risk of
and physical inactivity. The claim may heart disease. A serving of [name of
also provide additional information food] supplies ll grams of soy pro-
about the benefits of exercise and man- tein.
agement of body weight to help lower (2) Diets low in saturated fat and
the risk of heart disease; cholesterol that include 25 grams of
(2) The claim may state that the re- soy protein a day may reduce the risk
lationship between intake of diets that of heart disease. One serving of [name
are low in saturated fat and cholesterol of food] provides ll grams of soy pro-
and that include soy protein and re- tein.
duced risk of heart disease is through [64 FR 57732, Oct. 26, 1999]
the intermediate link of ‘‘blood choles-
terol’’ or ‘‘blood total and LDL-choles- EFFECTIVE DATE NOTE: At 64 FR 57732, Oct.
terol’’; 26, 1999, § 101.82 was added. Paragraph
(c)(2)(ii)(B) contains information collection
and recordkeeping requirements and will not
tion from paragraphs (a) and (b) of this become effective until approval has been
section, which summarize the relation- given by the Office of Management and
ship between diets that are low in satu- Budget.
rated fat and cholesterol and that in-
clude soy protein and CHD and the sig- § 101.83 Health claims: plant sterol/
nificance of the relationship; stanol esters and risk of coronary
(4) The claim may state that a diet heart disease (CHD).
low in saturated fat and cholesterol (a) Relationship between diets that in-
that includes soy protein is consistent clude plant sterol/stanol esters and the
with ‘‘Nutrition and Your Health: Die- risk of CHD. (1) Cardiovascular disease
tary Guidelines for Americans,’’ U.S. means diseases of the heart and cir-
Department of Agriculture (USDA) and culatory system. Coronary heart dis-
Department of Health and Human ease (CHD) is one of the most common
152
and serious forms of cardiovascular dis- esters with reduced risk of heart dis-
ease and refers to diseases of the heart ease may be made on the label or label-
muscle and supporting blood vessels. ing of a food described in paragraph
High blood total cholesterol and low (c)(2)(iii) of this section, provided that:
density lipoprotein (LDL) cholesterol (A) The claim states that plant ste-
levels are associated with increased rol/stanol esters should be consumed as
risk of developing coronary heart dis- part of a diet low in saturated fat and
ease. High CHD rates occur among peo- cholesterol;
ple with high total cholesterol levels of (B) The claim states that diets that
240 milligrams per deciliter (mg/dL) include plant sterol/stanol esters
(6.21 millimole per liter (mmol/l)) or ‘‘may’’ or ‘‘might’’ reduce the risk of
above and LDL cholesterol levels of 160 heart disease;
mg/dL (4.13 mmol/l) or above. Border- (C) In specifying the disease, the
line high risk blood cholesterol levels claim uses the following terms: ‘‘heart
range from 200 to 239 mg/dL (5.17 to 6.18 disease’’ or ‘‘coronary heart disease’’;
mmol/l) for total cholesterol, and 130 to (D) In specifying the substance, the
159 mg/dL (3.36 to 4.11 mmol/l) of LDL claim uses the term ‘‘plant sterol
cholesterol. esters’’ or ‘‘plant stanol esters,’’ except
(2) Populations with a low incidence that if the sole source of the plant
of CHD tend to have relatively low sterols or stanols is vegetable oil, the
blood total cholesterol and LDL choles- claim may use the term ‘‘vegetable oil
terol levels. These populations also sterol esters’’ or ‘‘vegetable oil stanol
tend to have dietary patterns that are esters’’;
not only low in total fat, especially
(E) The claim does not attribute any
saturated fat and cholesterol, but are
degree of risk reduction for CHD to
also relatively high in plant foods that
diets that include plant sterol/stanol
contain dietary fiber and other compo-
esters;
nents.
(F) The claim does not imply that
(3) Scientific evidence demonstrates
consumption of diets that include plant
that diets that include plant sterol/
sterol/stanol esters is the only recog-
stanol esters may reduce the risk of
nized means of achieving a reduced
CHD.
risk of CHD; and
(b) Significance of the relationship be-
tween diets that include plant sterol/ (G) The claim specifies the daily die-
stanol esters and the risk of CHD. (1) tary intake of plant sterol or stanol
CHD is a major public health concern esters that is necessary to reduce the
in the United States. It accounts for risk of CHD and the contribution one
more deaths than any other disease or serving of the product makes to the
group of diseases. Early management specified daily dietary intake level.
of risk factors for CHD is a major pub- Daily dietary intake levels of plant
lic health goal that can assist in reduc- sterol and stanol esters that have been
ing risk of CHD. High blood total and associated with reduced risk of are:
LDL cholesterol are major modifiable (1) 1.3 g or more per day of plant ste-
risk factors in the development of rol esters.
CHD. (2) 3.4 g or more per day of plant
(2) The scientific evidence establishes stanol esters.
that including plant sterol/stanol (H) The claim specifies that the daily
esters in the diet helps to lower blood dietary intake of plant sterol or stanol
total and LDL cholesterol levels. esters should be consumed in two
(c) Requirements—(1) General. All re- servings eaten at different times of the
quirements set forth in § 101.14 shall be day with other foods.
met, except § 101.14(a)(4) with respect to (ii) Nature of the substance—(A) Plant
the disqualifying level for total fat per sterol esters. (1) Plant sterol esters pre-
50 grams (g) in dressings for salad and pared by esterifying a mixture of plant
spreads and § 101.14(e)(6) with respect to sterols from edible oils with food-grade
dressings for salad. fatty acids. The plant sterol mixture
(2) Specific requirements—(i) Nature of shall contain at least 80 percent beta-

the claim. A health claim associating sitosterol, campesterol, and stigmas-
diets that include plant sterol/stanol terol (combined weight).
153
§ 101.83 21 CFR Ch. I (4–1–16 Edition)
(2) FDA will measure plant sterol Silver Spring, MD 20993, 301–796–2039,
esters by the method entitled ‘‘Deter- and at the National Archives and
mination of the Sterol Content in Mar- Records Administration (NARA). For
garines, Halvarines, Dressings, Fat information on the availability of this
Blends and Sterol Fatty Acid Ester material at NARA, call 202–741–6030, or
Concentrates by Capillary Gas Chroma- go to: http://www.archives.gov/
tography,’’ developed by Unilever federallregister/
United States, Inc., dated February 1, codeloflfederallregulations/
2000. The method, which is incor- ibrllocations.html.
porated by reference in accordance (iii) Nature of the food eligible to bear
with 5 U.S.C. 552(a) and 1 CFR part 51, the claim. (A) The food product shall
may be obtained from the Center for contain:
Food Safety and Applied Nutrition, Of- (1) At least 0.65 g of plant sterol
fice of Nutrition, Labeling and Dietary esters that comply with paragraph
Supplements, Nutrition Programs (c)(2)(ii)(A)(1) of this section per ref-
Staff, 5100 Paint Branch Pkwy., College erence amount customarily consumed
Park, MD 20740, and may be examined of the food products eligible to bear the
at the Food and Drug Administration’s health claim, specifically spreads and
Main Library, 10903 New Hampshire dressings for salad, or
Ave., Bldg. 2, Third Floor, Silver (2) At least 1.7 g of plant stanol
Spring, MD 20993, 301–796–2039, or at the esters that comply with paragraph
National Archives and Records Admin- (c)(2)(ii)(B)(1) of this section per ref-
istration (NARA). For information on erence amount customarily consumed
the availability of this material at of the food products eligible to bear the
NARA, call 202–741–6030, or go to: http:// health claim, specifically spreads,
www.archives.gov/federallregister/ dressings for salad, snack bars, and die-
codeloflfederallregulations/ tary supplements in softgel form.
ibrllocations.html. (B) The food shall meet the nutrient
(B) Plant stanol esters. (1) Plant stanol content requirements in § 101.62 for a
esters prepared by esterifying a mix- ‘‘low saturated fat’’ and ‘‘low choles-
ture of plant stanols derived from edi- terol’’ food; and
ble oils or byproducts of the kraft (C) The food must meet the limit for
paper pulping process with food-grade total fat in § 101.14(a)(4), except that
fatty acids. The plant stanol mixture spreads and dressings for salad are not
shall contain at least 80 percent required to meet the limit for total fat
sitostanol and campestanol (combined per 50 g if the label of the food bears a
weight). disclosure statement that complies
(2) FDA will measure plant stanol with § 101.13(h); and
esters by the following methods devel- (D) The food must meet the min-
oped by McNeil Consumer Heathcare imum nutrient contribution require-
dated February 15, 2000: ‘‘Determina- ment in § 101.14(e)(6) unless it is a dress-
tion of Stanols and Sterols in Benecol ing for salad.
Tub Spread’’; ‘‘Determination of (d) Optional information. (1) The claim
Stanols and Sterols in Benecol Dress- may state that the development of
ing’’; ‘‘Determination of Stanols and heart disease depends on many factors
Sterols in Benecol Snack Bars’’; or and may identify one or more of the
‘‘Determination of Stanols and Sterols following risk factors for heart disease
in Benecol Softgels.’’ These methods about which there is general scientific
are incorporated by reference in ac- agreement: A family history of CHD;
cordance with 5 U.S.C. 552(a) and 1 CFR elevated blood total and LDL choles-
part 51. Copies may be obtained from terol; excess body weight; high blood
the Center for Food Safety and Applied pressure; cigarette smoking; diabetes;
Nutrition, Office of Nutrition, Labeling and physical inactivity. The claim may
and Dietary Supplements, Nutrition also provide additional information
Programs Staff, 5100 Paint Branch about the benefits of exercise and man-
Pkwy., College Park, MD 20740, or may agement of body weight to help lower
be examined at the Food and Drug Ad- the risk of heart disease.
ministration’s Main Library, 10903 New (2) The claim may state that the re-
Hampshire Ave., Bldg. 2, Third Floor, lationship between intake of diets that
154
include plant sterol/stanol esters and be identified, and it shall be current in-
reduced risk of heart disease is through formation from the National Center for
the intermediate link of ‘‘blood choles- Health Statistics, the National Insti-
terol’’ or ‘‘blood total and LDL choles- tutes of Health, or ‘‘Nutrition and Your
terol.’’ Health: Dietary Guidelines for Ameri-
(3) The claim may include informa- cans,’’ U.S. Department of Agriculture
tion from paragraphs (a) and (b) of this (USDA) and Department of Health and
section, which summarize the relation- Human Services (DHHS), Government
ship between diets that include plant Printing Office (GPO).
sterol/stanol esters and the risk of CHD (e) Model health claim. The following
and the significance of the relation-
model health claims may be used in
ship.
food labeling to describe the relation-
tion from the following paragraph on ship between diets that include plant
the relationship between saturated fat sterol or stanol esters and reduced risk
and cholesterol in the diet and the risk of heart disease:
of CHD: The scientific evidence estab- (1) For plant sterol esters: (i) Foods
lishes that diets high in saturated fat containing at least 0.65 g per serving of
and cholesterol are associated with in- plant sterol esters, eaten twice a day
creased levels of blood total and LDL with meals for a daily total intake of
cholesterol and, thus, with increased at least 1.3 g, as part of a diet low in
risk of CHD. Intakes of saturated fat saturated fat and cholesterol, may re-
exceed recommended levels in the diets duce the risk of heart disease. A serv-
of many people in the United States. ing of [name of the food] supplies
One of the major public health rec- lllgrams of vegetable oil sterol
ommendations relative to CHD risk is esters.
to consume less than 10 percent of cal- (ii) Diets low in saturated fat and
ories from saturated fat and an average cholesterol that include two servings of
of 30 percent or less of total calories foods that provide a daily total of at
from all fat. Recommended daily cho- least 1.3 g of vegetable oil sterol esters
lesterol intakes are 300 mg or less per in two meals may reduce the risk of
day. Scientific evidence demonstrates
heart disease. A serving of [name of the
that diets low in saturated fat and cho-
food] supplies lllgrams of vegetable
lesterol are associated with lower blood
oil sterol esters.
total and LDL cholesterol levels.
(5) The claim may state that diets (2) For plant stanol esters: (i) Foods
that include plant sterol or stanol containing at least 1.7 g per serving of
esters and are low in saturated fat and plant stanol esters, eaten twice a day
cholesterol are consistent with ‘‘Nu- with meals for a total daily intake of
trition and Your Health: Dietary at least 3.4 g, as part of a diet low in
Guidelines for Americans,’’ U.S. De- saturated fat and cholesterol, may re-
partment of Agriculture (USDA) and duce the risk of heart disease. A serv-
Department of Health and Human ing of [name of the food] supplies
Services (DHHS), Government Printing lllgrams of plant stanol esters.
Office (GPO). (ii) Diets low in saturated fat and
(6) The claim may state that individ- cholesterol that include two servings of
uals with elevated blood total and LDL foods that provide a daily total of at
cholesterol should consult their physi- least 3.4 g of vegetable oil stanol esters
cians for medical advice and treat- in two meals may reduce the risk of
ment. If the claim defines high or nor- heart disease. A serving of [name of the
mal blood total and LDL cholesterol food] supplies lllgrams of vegetable
levels, then the claim shall state that oil stanol esters.
individuals with high blood cholesterol
should consult their physicians for [65 FR 54717, Sept. 8, 2000; 65 FR 70466, Nov.
medical advice and treatment. 24, 2000, as amended at 66 FR 66742, Dec. 27,
(7) The claim may include informa- 2001; 68 FR 15355, Mar. 31, 2003; 70 FR 41958,
tion on the number of people in the July 21, 2005; 81 FR 5590, Feb. 2, 2016]
United States who have heart disease.
The sources of this information shall
155
§ 101.91 21 CFR Ch. I (4–1–16 Edition)
Subpart F—Specific Requirements (a)(3) of this section will be deemed

for Descriptive Claims That misbranded.
(3) A food that bears the term
Are Neither Nutrient Content ‘‘wheat’’ in the ingredient list or in a
Claims nor Health Claims separate ‘‘Contains wheat’’ statement
§ 101.91 Gluten-free labeling of food. in its labeling, as required by 21 U.S.C.
343(w)(1)(A), and also bears the claim
(a) Definitions. (1) The term ‘‘gluten- ‘‘gluten-free’’ or a claim identified in
containing grain’’ means any one of paragraph (b)(2) of this section will be
the following grains or their crossbred deemed misbranded unless the word
hybrids (e.g., triticale, which is a cross ‘‘wheat’’ in the ingredient list or in the
between wheat and rye): ‘‘Contains wheat’’ statement is fol-
(i) Wheat, including any species be- lowed immediately by an asterisk (or
longing to the genus Triticum; other symbol) that refers to another
(ii) Rye, including any species be- asterisk (or other symbol) in close
longing to the genus Secale; or proximity to the ingredient statement
(iii) Barley, including any species be- that immediately precedes the fol-
longing to the genus Hordeum. lowing: ‘‘The wheat has been processed
(2) The term ‘‘gluten’’ means the pro- to allow this food to meet the Food and
teins that naturally occur in a gluten- Drug Administration (FDA) require-
containing grain and that may cause ments for gluten-free foods.’’
adverse health effects in persons with (c) Compliance. When compliance with
celiac disease (e.g., prolamins and paragraph (b) of this section is based
glutelins). on an analysis of the food, FDA will
(3) The labeling claim ‘‘gluten-free’’ use a scientifically valid method that
means: can reliably detect the presence of 20
(i) That the food bearing the claim in ppm gluten in a variety of food mat-
its labeling: rices, including both raw and cooked or
(A) Does not contain any one of the baked products.
following: (d) Preemption. A State or political
(1) An ingredient that is a gluten- subdivision of a State may not estab-
containing grain (e.g., spelt wheat); lish or continue into effect any law,
(2) An ingredient that is derived from rule, regulation, or other requirement
a gluten-containing grain and that has that is different from the requirements
not been processed to remove gluten in this section for the definition and
(e.g., wheat flour); or use of the claim ‘‘gluten-free,’’ as well
(3) An ingredient that is derived from as the claims ‘‘no gluten,’’ ‘‘free of glu-
a gluten-containing grain and that has ten,’’ or ‘‘without gluten.’’
been processed to remove gluten (e.g., [78 FR 47178, Aug. 5, 2013]
wheat starch), if the use of that ingre-
dient results in the presence of 20 parts § 101.93 Certain types of statements
per million (ppm) or more gluten in the for dietary supplements.
food (i.e., 20 milligrams (mg) or more (a)(1) No later than 30 days after the
gluten per kilogram (kg) of food); or first marketing of a dietary supple-
(B) Inherently does not contain glu- ment that bears one of the statements
ten; and listed in section 403(r)(6) or the Federal
(ii) Any unavoidable presence of glu- Food, Drug, and Cosmetic Act, the
ten in the food bearing the claim in its manufacturer, packer, or distributor of
labeling is below 20 ppm gluten (i.e., the dietary supplement shall notify the
below 20 mg gluten per kg of food). Office of Nutritional Products, Label-
(b) Requirements. (1) A food that bears ing and Dietary Supplements (HFS–
the claim ‘‘gluten-free’’ in its labeling 810), Center for Food Safety and Ap-
and fails to meet the requirements of plied Nutrition, Food and Drug Admin-
paragraph (a)(3) of this section will be istration, 5100 Paint Branch Pkwy.,
deemed misbranded. College Park, MD 20740, that it has in-
(2) A food that bears the claim ‘‘no cluded such a statement on the label or
gluten,’’ ‘‘free of gluten,’’ or ‘‘without in the labeling of its product. An origi-

gluten’’ in its labeling and fails to nal and two copies of this notification
meet the requirements of paragraph shall be submitted.
156
(2) The notification shall include the diagnose, treat, cure, or prevent any
following: disease.
(i) The name and address of the man- (d) Placement. The disclaimer shall be
ufacturer, packer, or distributor of the placed adjacent to the statement with
dietary supplement that bears the no intervening material or linked to
statement; the statement with a symbol (e.g., an
(ii) The text of the statement that is asterisk) at the end of each such state-
being made; ment that refers to the same symbol
(iii) The name of the dietary ingre- placed adjacent to the disclaimer speci-
dient or supplement that is the subject fied in paragraphs (c)(1) or (c)(2) of this
of the statement, if not provided in the section. On product labels and in label-
text of the statement; and ing (e.g., pamphlets, catalogs), the dis-
(iv) The name of the dietary supple- claimer shall appear on each panel or
ment (including brand name), if not page where there such is a statement.
provided in response to paragraph The disclaimer shall be set off in a box
(a)(2)(iii) on whose label, or in whose where it is not adjacent to the state-
labeling, the statement appears. ment in question.
(3) The notice shall be signed by a re- (e) Typesize. The disclaimer in para-
sponsible individual or the person who graph (c) of this section shall appear in
can certify the accuracy of the infor- boldface type in letters of a typesize no
mation presented and contained in the smaller than one-sixteenth inch.
notice. The individual shall certify (f) Permitted structure/function state-
that the information contained in the ments. Dietary supplement labels or la-
notice is complete and accurate, and beling may, subject to the require-
that the notifying firm has substan- ments in paragraphs (a) through (e) of
tiation that the statement is truthful this section, bear statements that de-
and not misleading. scribe the role of a nutrient or dietary
(b) Disclaimer. The requirements in ingredient intended to affect the struc-
this section apply to the label or label- ture or function in humans or that
ing of dietary supplements where the characterize the documented mecha-
dietary supplement bears a statement nism by which a nutrient or dietary in-
that is provided for by section 403(r)(6) gredient acts to maintain such struc-
of the Federal Food, Drug, and Cos- ture or function, provided that such
metic Act (the act), and the manufac- statements are not disease claims
turer, packer, or distributor wishes to under paragraph (g) of this section. If
take advantage of the exemption to the label or labeling of a product mar-
section 201(g)(1)(C) of the act that is keted as a dietary supplement bears a
provided by compliance with section disease claim as defined in paragraph
403(r)(6) of the act. (g) of this section, the product will be
(c) Text for disclaimer. (1) Where there subject to regulation as a drug unless
is one statement, the disclaimer shall the claim is an authorized health claim
be placed in accordance with paragraph for which the product qualifies.
(d) of this section and shall state: (g) Disease claims. (1) For purposes of
21 U.S.C. 343(r)(6), a ‘‘disease’’ is dam-
This statement has not been evaluated by age to an organ, part, structure, or sys-
the Food and Drug Administration. This tem of the body such that it does not
product is not intended to diagnose, treat,
function properly (e.g., cardiovascular
cure, or prevent any disease.
disease), or a state of health leading to
(2) Where there is more than one such such dysfunctioning (e.g., hyper-
statement on the label or in the label- tension); except that diseases resulting
ing, each statement shall bear the dis- from essential nutrient deficiencies
claimer in accordance with paragraph (e.g., scurvy, pellagra) are not included
(c)(1) of this section, or a plural dis- in this definition.
claimer may be placed in accordance (2) FDA will find that a statement
with paragraph (d) of this section and about a product claims to diagnose,
shall state: mitigate, treat, cure, or prevent dis-
These statements have not been eval- ease (other than a classical nutrient
uated by the Food and Drug Adminis- deficiency disease) under 21 U.S.C.
tration. This product is not intended to 343(r)(6) if it meets one or more of the
157
§ 101.95 21 CFR Ch. I (4–1–16 Edition)
criteria listed below. These criteria are (v) Belongs to a class of products
not intended to classify as disease that is intended to diagnose, mitigate,
claims statements that refer to the treat, cure, or prevent a disease;
ability of a product to maintain (vi) Is a substitute for a product that
healthy structure or function, unless is a therapy for a disease;
the statement implies disease preven- (vii) Augments a particular therapy
tion or treatment. In determining or drug action that is intended to diag-
whether a statement is a disease claim nose, mitigate, treat, cure, or prevent a
under these criteria, FDA will consider disease or class of diseases;
the context in which the claim is pre- (viii) Has a role in the body’s re-
sented. A statement claims to diag- sponse to a disease or to a vector of
nose, mitigate, treat, cure, or prevent disease;
disease if it claims, explicitly or im- (ix) Treats, prevents, or mitigates ad-
plicitly, that the product: verse events associated with a therapy
(i) Has an effect on a specific disease for a disease, if the adverse events con-
or class of diseases; stitute diseases; or
(ii) Has an effect on the char- (x) Otherwise suggests an effect on a
acteristic signs or symptoms of a spe- disease or diseases.
cific disease or class of diseases, using [62 FR 49886, Sept. 23, 1997, as amended at 62
scientific or lay terminology; FR 49867, Sept. 23, 1997; 65 FR 1050, Jan. 6,
(iii) Has an effect on an abnormal 2000; 66 FR 17358, Mar. 30, 2001; 66 FR 56035,
condition associated with a natural Nov. 6, 2001]
state or process, if the abnormal condi-
tion is uncommon or can cause signifi- § 101.95 ‘‘Fresh,’’ ‘‘freshly frozen,’’
cant or permanent harm; ‘‘fresh frozen,’’ ‘‘frozen fresh.’’
(iv) Has an effect on a disease or dis- The terms defined in this section
eases through one or more of the fol- may be used on the label or in labeling
lowing factors: of a food in conformity with the provi-
(A) The name of the product; sions of this section. The requirements
(B) A statement about the formula- of the section pertain to any use of the
tion of the product, including a claim subject terms as described in para-
that the product contains an ingre- graphs (a) and (b) of this section that
dient (other than an ingredient that is expressly or implicitly refers to the
an article included in the definition of food on labels or labeling, including
‘‘dietary supplement’’ under 21 U.S.C. use in a brand name and use as a sen-
321(ff)(3)) that has been regulated by sory modifier. However, the use of the
FDA as a drug and is well known to term ‘‘fresh’’ on labels or labeling is
consumers for its use or claimed use in not subject to the requirements of
preventing or treating a disease; paragraph (a) of this section if the
term does not suggest or imply that a
(C) Citation of a publication or ref-
food is unprocessed or unpreserved. For
erence, if the citation refers to a dis-
example, the term ‘‘fresh’’ used to de-
ease use, and if, in the context of the
scribe pasteurized whole milk is not
labeling as a whole, the citation im-
subject to paragraph (a) of this section
plies treatment or prevention of a dis- because the term does not imply that
ease, e.g., through placement on the the food is unprocessed (consumers
immediate product label or packaging, commonly understand that milk is
inappropriate prominence, or lack of nearly always pasteurized). However,
relationship to the product’s express the term ‘‘fresh’’ to describe pasta
claims; sauce that has been pasteurized or that
(D) Use of the term ‘‘disease’’ or contains pasteurized ingredients would
‘‘diseased,’’ except in general state- be subject to paragraph (a) of this sec-
ments about disease prevention that do tion because the term implies that the
not refer explicitly or implicitly to a food is not processed or preserved. Uses
specific disease or class of diseases or of fresh not subject to this regulation
to a specific product or ingredient; or will be governed by the provisions of

(E) Use of pictures, vignettes, sym- 403(a) of the Federal Food, Drug, and
bols, or other means; Cosmetic Act (the act).
158
(a) The term ‘‘fresh,’’ when used on (1) An assortment of different items
the label or in labeling of a food in a of food, when variations in the items
manner that suggests or implies that that make up different packages
the food is unprocessed, means that the packed from such assortment normally
food is in its raw state and has not occur in good packing practice and
been frozen or subjected to any form of when such variations result in vari-
thermal processing or any other form ations in the ingredients in different
of preservation, except as provided in packages, with respect to any ingre-
paragraph (c) of this section. dient that is not common to all pack-
(b) The terms ‘‘fresh frozen’’ and ages. Such exemption, however, shall
‘‘frozen fresh,’’ when used on the label be on the condition that the label shall
or in labeling of a food, mean that the bear, in conjunction with the names of
food was quickly frozen while still such ingredients as are common to all
fresh (i.e., the food had been recently packages, a statement (in terms that
harvested when frozen). Blanching of are as informative as practicable and
the food before freezing will not pre- that are not misleading) indicating by
clude use of the term ‘‘fresh frozen’’ to name other ingredients which may be
describe the food. ‘‘Quickly frozen’’ present.
means frozen by a freezing system such (2) A food having been received in
as blast-freezing (sub-zero Fahrenheit bulk containers at a retail establish-
temperature with fast moving air diment, if displayed to the purchaser
rected at the food) that ensures the with either:
food is frozen, even to the center of the (i) The labeling of the bulk container
food, quickly and that virtually no de- plainly in view, provided ingredient in-
terioration has taken place. formation appears prominently and
(c) Provisions and restrictions. (1) The conspicuously in lettering of not less
following do not preclude the food from than one-fourth of an inch in height; or
use of the term ‘‘fresh:’’ (ii) A counter card, sign, or other ap-
propriate device bearing prominently
(i) The addition of approved waxes or
and conspicuously, but in no case with
coatings;
lettering of less than one-fourth of an
(ii) The post-harvest use of approved inch in height, the information re-
pesticides; quired to be stated on the label pursu-
(iii) The application of a mild chlo- ant to section 403(i)(2) of the Federal
rine wash or mild acid wash on Food, Drug, and Cosmetic Act (the
produce; or act).
(iv) The treatment of raw foods with (3) Incidental additives that are
ionizing radiation not to exceed the present in a food at insignificant levels
maximum dose of 1 kiloGray in accord- and do not have any technical or func-
ance with § 179.26 of this chapter. tional effect in that food. For the pur-
(2) A food meeting the definition in poses of this paragraph (a)(3), inci-
paragraph (a) of this section that is re- dental additives are:
frigerated is not precluded from use of (i) Substances that have no technical
‘‘fresh’’ as provided by this section. or functional effect but are present in a
[58 FR 2426, Jan. 6, 1993]
food by reason of having been incor-
porated into the food as an ingredient
of another food, in which the substance
Subpart G—Exemptions From did have a functional or technical ef-
Food Labeling Requirements fect.
(ii) Processing aids, which are as fol-
§ 101.100 Food; exemptions from label- lows:
ing. (a) Substances that are added to a
(a) The following foods are exempt food during the processing of such food
from compliance with the require- but are removed in some manner from
ments of section 403(i)(2) of the act (re- the food before it is packaged in its fin-
quiring a declaration on the label of ished form.
the common or usual name of each in- (b) Substances that are added to a
gredient when the food is fabricated food during processing, are converted
from two or more ingredients). into constituents normally present in
159
§ 101.100 21 CFR Ch. I (4–1–16 Edition)
the food, and do not significantly in- lowing provisions of the act if the con-
crease the amount of the constitutents ditions specified are met.
naturally found in the food. (1) Section 403(e)(1) of the act (requir-
(c) Substances that are added to a ing a statement on the label of the
food for their technical or functional name and place of business of the man-
effect in the processing but are present ufacturer, packer, or distributor).
in the finished food at insignificant (2) Section 403(g)(2) of the act (requir-
levels and do not have any technical or ing the label of a food which purports
functional effect in that food. to be or is represented as one for which
(iii) Substances migrating to food a definition and standard of identity
from equipment or packaging or other- has been prescribed to bear the name of
wise affecting food that are not food the food specified in the definition and
additives as defined in section 201(s) of standard and, insofar as may be re-
the act; or if they are food additives as quired by the regulation establishing
so defined, they are used in conformity the standard the common names of the
with regulations established pursuant optional ingredients present in the
to section 409 of the act. food), if the food is displayed to the
(4) For the purposes of paragraph purchaser with its interstate labeling
(a)(3) of this section, any sulfiting clearly in view, or with a counter card,
agent (sulfur dioxide, sodium sulfite, sign, or other appropriate device bear-
sodium bisulfite, potassium bisulfite, ing prominently and conspicuously the
sodium metabisulfite, and potassium information required by these provi-
metabisulfite) that has been added to sions.
any food or to any ingredient in any (3) Section 403(i)(1) of the act (requir-
food and that has no technical effect in ing the label to bear the common or
that food will be considered to be usual name of the food), if the food is
present in an insignificant amount displayed to the purchaser with its
only if no detectable amount of the interstate labeling clearly in view, or
agent is present in the finished food. A with a counter card, sign, or other ap-
detectable amount of sulfiting agent is propriate device bearing prominently
10 parts per million or more of the sul- and conspicuously the common or
fite in the finished food. Compliance usual name of the food, or if the com-
with this paragraph will be determined mon or usual name of the food is clear-
using sections 20.123–20.125, ‘‘Total Sul- ly revealed by its appearance.
furous Acid,’’ in ‘‘Official Methods of (c) An open container (a container of
Analysis of the Association of Official rigid or semirigid construction, which
Analytical Chemists,’’ 14th Ed. (1984), is not closed by lid, wrapper, or other-
which is incorporated by reference and wise other than by an uncolored trans-
the refinements of the ‘‘Total Sulfu- parent wrapper which does not obscure
rous Acid’’ procedure in the ‘‘Monier- the contents) of a fresh fruit or fresh
Williams Procedure (with Modifica- vegetable, the quantity of contents of
tions) for Sulfites in Foods,’’ which is which is not more than 1 dry quart,
appendix A to part 101. A copy of sec- shall be exempt from the labeling re-
tions 20.123–20–125 of the Official Meth- quirements of sections 403(e), (g)(2)
ods of Analysis of the Association of (with respect to the name of the food
Official Analytical Chemists’’ is avail- specified in the definition and stand-
able from the AOAC INTER- ard), and (i)(1) of the act; but such ex-
NATIONAL, 481 North Frederick Ave., emption shall be on the condition that
suite 500, Gaithersburg, MD 20877, or if two or more such containers are en-
available for inspection at the National closed in a crate or other shipping
Archives and Records Administration package, such crate or package shall
(NARA). For information on the avail- bear labeling showing the number of
ability of this material at NARA, call such containers enclosed therein and
202–741–6030, or go to: http:// the quantity of the contents of each.
www.archives.gov/federallregister/ (d) Except as provided by paragraphs
codeloflfederallregulations/ (e) and (f) of this section, a shipment or
ibrllocations.html. other delivery of a food which is, in ac-

(b) A food repackaged in a retail es- cordance with the practice of the trade,
tablishment is exempt from the fol- to be processed, labeled, or repacked in
160
substantial quantity at an establish- less than 1.4 percent, subject also to

ment other than that where originally the conditions that:
processed or packed, shall be exempt, (i) The agreement required in para-
during the time of introduction into graph (d)(2) of this section shall also
and movement in interstate commerce state that the operator agrees to uti-
and the time of holding in such estab- lize such unpasteurized egg products in
lishment, from compliance with the la- the processing of acidic dressings ac-
beling requirements of section 403 (c), cording to the specifications for pH and
(e), (g), (h), (i), (k), and (q) of the act if: acidity set forth in this paragraph,
(1) The person who introduced such agrees not to deliver the acidic dress-
shipment or delivery into interstate ing to a user until at least 72 hours
commerce is the operator of the estab- after such egg product is incorporated
lishment where such food is to be proc- in such acidic dressing, and agrees to
essed, labeled, or repacked; or maintain for inspection adequate
(2) In case such person is not such op- records covering such processing for 2
erator, such shipment or delivery is years after such processing.
made to such establishment under a (ii) In addition to the caution state-
written agreement, signed by and con- ment referred to above, the container
taining the post office addresses of of such egg product shall also bear the
such person and such operator, and statement ‘‘Unpasteurized lll for
containing such specifications for the use in acidic dressings only’’, the blank
processing, labeling, or repacking, as being filled in with the applicable
the case may be, of such food in such name of the eggs or egg product.
establishment as will ensure, if such (e) Conditions affecting expiration of
specifications are followed, that such exemptions:
food will not be adulterated or mis- (1) An exemption of a shipment or
branded within the meaning of the act other delivery of a food under para-
upon completion of such processing, la- graph (d) (1) or (3) of this section shall,
beling, or repacking. Such person and at the beginning of the act of removing
such operator shall each keep a copy of such shipment or delivery, or any part
such agreement until 2 years after the thereof, from such establishment be-
final shipment or delivery of such food come void ab initio if the food com-
from such establishment, and shall prising such shipment, delivery, or part
make such copies available for inspec- is adulterated or misbranded within
tion at any reasonable hour to any offi- the meaning of the act when so re-
cer or employee of the Department who moved.
requests them. (2) An exemption of a shipment or
(3) The article is an egg product sub- other delivery of a food under para-
ject to a standard of identity promul- graph (d) (2) or (3) of this section shall
gated in part 160 of this chapter, is to become void ab initio with respect to
be shipped under the conditions speci- the person who introduced such ship-
fied in paragraph (d) (1) or (2) of this ment or delivery into interstate com-
section and for the purpose of pasteur- merce upon refusal by such person to
ization or other treatment as required make available for inspection a copy of
in such standard, and each container of the agreement, as required by para-
such egg product bears a conspicuous graph (d) (2) or (3) of this section.
tag or label reading ‘‘Caution—This (3) An exemption of a shipment or
egg product has not been pasteurized or other delivery of a food under para-
otherwise treated to destroy viable graph (d) (2) or (3) of this section shall
Salmonella microorganisms’’. In addi- expire:
tion to safe and suitable bactericidal (i) At the beginning of the act of re-
processes designed specifically for Sal- moving such shipment or delivery, or
monella destruction in egg products, any part thereof, from such establish-
the term ‘‘other treatment’’ in the first ment if the food constituting such
sentence of this paragraph shall in- shipment, delivery, or part is adulter-
clude use in acidic dressings in the ated or misbranded within the meaning
processing of which the pH is not above of the act when so removed; or

4.1 and the acidity of the aqueous (ii) Upon refusal by the operator of
phase, expressed as acetic acid, is not the establishment where such food is to
161
§ 101.100 21 CFR Ch. I (4–1–16 Edition)
be processed, labeled, or repacked, to commences, and to each such cheese or

make available for inspection a copy of its wrapper or immediate container
the agreement, as required by such shall be affixed a removable tag read-
paragraph. ing, ‘‘lll cheese made from
(f) The word ‘‘processed’’ as used in unpasteurized milk. For completion of
this paragraph shall include the hold- curing and proper labeling’’, the blank
ing of cheese in a suitable warehouse at being filled in with the applicable
a temperature of not less than 35 °F for name of the variety of cheese.
the purpose of aging or curing to bring (3) In the case of cheddar cheese,
the cheese into compliance with re- washed curd cheese, colby cheese,
quirements of an applicable definition granular cheese, and brick cheese made
and standard of identity. The exemp- from unpasteurized milk, each such
tions provided for in paragraph (d) of cheese shall bear a legible mark on the
this section shall apply to cheese which cheese showing the date at which the
is, in accordance with the practice of preliminary manufacturing process has
the trade, shipped to a warehouse for been completed and at which date cur-
aging or curing, on condition that the ing commences, and to each such
cheese is identified in the manner set cheese or its wrapper or immediate
forth in one of the applicable following container shall be affixed a removable
paragraphs, and in such case the provi- tag reading ‘‘lll cheese made from
sions of paragraph (e) of this section unpasteurized milk. For completion of
shall also apply: curing and proper labeling, or for label-
(1) In the case of varieties of cheese ing as lll cheese for manufac-
for which definitions and standards of turing’’, the blank being filled in with
identity require a period of aging the applicable name of the variety of
whether or not they are made from cheese.
pasteurized milk, each such cheese (g) The label declaration of a harm-
shall bear on the cheese a legible mark
less marker used to identify a par-
showing the date at which the prelimi-
ticular manufacturer’s product may re-
nary manufacturing process has been
sult in unfair competition through re-
completed and at which date curing
vealing a trade secret. Exemption from
commences, and to each cheese, on its
the label declaration of such a marker
wrapper or immediate container, shall
is granted, therefore, provided that the
be affixed a removable tag bearing the
following conditions are met:
statement ‘‘Uncured lll cheese for
completion of curing and proper label- (1) The person desiring to use the
ing’’, the blank being filled in with the marker without label declaration of its
applicable name of the variety of presence has submitted to the Commis-
cheese. In the case of swiss cheese, the sioner of Food and Drugs full informa-
date at which the preliminary manu- tion concerning the proposed usage and
facturing process had been completed the reasons why he believes label dec-
and at which date curing commences is laration of the marker should be sub-
the date on which the shaped curd is ject to this exemption; and
removed from immersion in saturated (2) The person requesting the exemp-
salt solution as provided in the definition has received from the Commis-
tion and standard of identity for swiss sioner of Food and Drugs a finding that
cheese, and such cheese shall bear a re- the marker is harmless and that the
movable tag reading, ‘‘To be cured and exemption has been granted.
labeled as ‘swiss cheese,’ but if eyes do (h) Wrapped fish fillets of nonuniform
not form, to be labeled as ‘swiss cheese weight intended to be unpacked and
for manufacturing’ ’’. marked with the correct weight at or
(2) In the case of varieties of cheeses before the point of retail sale in an es-
which when made from unpasteurized tablishment other than that where
milk are required to be aged for not originally packed shall be exempt from
less than 60 days, each such cheese the requirement of section 403(e)(2) of
shall bear a legible mark on the cheese the act during introduction and move-
showing the date at which the prelimi- ment in interstate commerce and while
nary manufacturing process has been held for sale prior to weighing and
completed and at which date curing marking:
162
(1) Provided, That (i) The outside con- retail sale without an accurate net
tainer bears a label declaration of the weight statement or alternatively
total net weight; and without weighing at the time of sale
(ii) The individual packages bear a shall be deemed an act which results in
conspicuous statement ‘‘To be weighed the product’s being misbranded while
at or before time of sale’’ and a correct held for sale. Nothing in this paragraph
statement setting forth the weight of shall be construed as requiring net-
the wrapper; weight statements for clusters (con-
(2) Provided further, That it is the sumer units) delivered into institu-
practice of the retail establishment to tional trade, provided that the master
weigh and mark the individual pack- container or carton bears the required
ages with a correct net-weight state- information.
ment prior to or at the point of retail [42 FR 14308, Mar. 15, 1977, as amended at 51
sale. A statement of the weight of the FR 25017, July 9, 1986; 58 FR 2188, 2876, Jan. 6,
wrapper shall be set forth so as to be 1993; 66 FR 17358, Mar. 30, 2001]
readily read and understood, using
such term as ‘‘wrapper tare—ounce’’, § 101.105 Declaration of net quantity
the blank being filled in with the cor- of contents when exempt.
rect average weight of the wrapper (a) The principal display panel of a
used. food in package form shall bear a dec-
(3) The act of delivering the wrapped laration of the net quantity of con-
fish fillets during the retail sale with- tents. This shall be expressed in the
out the correct net-weight statement terms of weight, measure, numerical
shall be deemed an act which results in count, or a combination of numerical
the product’s being misbranded while count and weight or measure. The
held for sale. Nothing in this paragraph statement shall be in terms of fluid
shall be construed as requiring net- measure if the food is liquid, or in
weight statements for wrapped fish fil- terms of weight if the food is solid,
lets delivered into institutional trade semisolid, or viscous, or a mixture of
provided the outside container bears solid and liquid; except that such state-
the required information. ment may be in terms of dry measure
(i) Wrapped clusters (consumer units) if the food is a fresh fruit, fresh vege-
of bananas of nonuniform weight in- table, or other dry commodity that is
tended to be unpacked from a master customarily sold by dry measure. If
carton or container and weighed at or there is a firmly established general
before the point of retail sale in an es- consumer usage and trade custom of
tablishment other than that where declaring the contents of a liquid by
originally packed shall be exempt from weight, or a solid, semisolid, or viscous
the requirements of section 403(e)(2) of product by fluid measure, it may be
the act during introduction and move- used. Whenever the Commissioner de-
ment in interstate commerce and while termines that an existing practice of
held for sale prior to weighing: declaring net quantity of contents by
(1) Provided, That (i) The master car- weight, measure, numerical count, or a
ton or container bears a label declara- combination in the case of a specific
tion of the total net weight; and packaged food does not facilitate value
(ii) The individual packages bear a comparisons by consumers and offers
conspicuous statement ‘‘To be weighed opportunity for consumer confusion, he
at or before the time of sale’’ and a cor- will by regulation designate the appro-
rect statement setting forth the weight priate term or terms to be used for
of the wrapper; using such term as such commodity.
‘‘wrapper tare l ounce’’, the blank (b)(1) Statements of weight shall be
being filled in with the correct average in terms of avoirdupois pound and
weight of the wrapper used; ounce.
(2) Provided further, That it is the (2) Statements of fluid measure shall
practice of the retail establishment to be in terms of the U.S. gallon of 231
weigh the individual packages either cubic inches and quart, pint, and fluid
prior to or at the time of retail sale. ounce subdivisions thereof, and shall:
(3) The act of delivering the wrapped (i) In the case of frozen food that is
clusters (consumer units) during the sold and consumed in a frozen state,
163
§ 101.105 21 CFR Ch. I (4–1–16 Edition)
express the volume at the frozen tem- quart’’ and ‘‘full gallon’’) that tends to
perature. exaggerate the amount of the food in
(ii) In the case of refrigerated food the container. It shall be placed on the
that is sold in the refrigerated state, principal display panel within the bot-
express the volume at 40 °F (4 °C). tom 30 percent of the area of the label
(iii) In the case of other foods, ex- panel in lines generally parallel to the
press the volume at 68 °F (20 °C). base on which the package rests as it is
(3) Statements of dry measure shall designed to be displayed: Provided,
be in terms of the U.S. bushel of That on packages having a principal
2,150.42 cubic inches and peck, dry display panel of 5 square inches or less,
quart, and dry pint subdivisions there- the requirement for placement within
of. the bottom 30 percent of the area of the
(c) When the declaration of quantity label panel shall not apply when the
of contents by numerical count does declaration of net quantity of contents
not give adequate information as to meets the other requirements of this
the quantity of food in the package, it part.
shall be combined with such statement (g) The declaration shall accurately
of weight, measure, or size of the indi- reveal the quantity of food in the pack-
vidual units of the foods as will provide age exclusive of wrappers and other
such information. material packed therewith: Provided,
(d) The declaration may contain That in the case of foods packed in con-
common or decimal fractions. A com- tainers designed to deliver the food
mon fraction shall be in terms of under pressure, the declaration shall
halves, quarters, eighths, sixteenths, or state the net quantity of the contents
thirty-seconds; except that if there ex- that will be expelled when the instruc-
ists a firmly established general con- tions for use as shown on the container
sumer usage and trade custom of em- are followed. The propellant is included
ploying different common fractions in in the net quantity declaration.
the net quantity declaration of a par-
(h) The declaration shall appear in
ticular commodity, they may be em-
conspicuous and easily legible boldface
ployed. A common fraction shall be re-
print or type in distinct contrast (by
duced to its lowest terms; a decimal
typography, layout, color, embossing,
fraction shall not be carried out to
or molding) to other matter on the
more than two places. A statement
package; except that a declaration of
that includes small fractions of an
net quantity blown, embossed, or mold-
ounce shall be deemed to permit small-
ed on a glass or plastic surface is per-
er variations than one which does not
include such fractions. missible when all label information is
(e) The declaration shall be located so formed on the surface. Requirements
on the principal display panel of the of conspicuousness and legibility shall
label, and with respect to packages include the specifications that:
bearing alternate principal panels it (1) The ratio of height to width (of
shall be duplicated on each principal the letter) shall not exceed a differen-
display panel. tial of 3 units to 1 unit (no more than
(f) The declaration shall appear as a 3 times as high as it is wide).
distinct item on the principal display (2) Letter heights pertain to upper
panel, shall be separated (by at least a case or capital letters. When upper and
space equal to the height of the let- lower case or all lower case letters are
tering used in the declaration) from used, it is the lower case letter ‘‘o’’ or
other printed label information appear- its equivalent that shall meet the min-
ing above or below the declaration and imum standards.
(by at least a space equal to twice the (3) When fractions are used, each
width of the letter ‘‘N’’ of the style of component numeral shall meet one-
type used in the quantity of contents half the minimum height standards.
statement) from other printed label in- (i) The declaration shall be in letters
formation appearing to the left or right and numerals in a type size established
of the declaration. It shall not include in relationship to the area of the prin-
any term qualifying a unit of weight, cipal display panel of the package and
measure, or count (such as ‘‘jumbo shall be uniform for all packages of
164
substantially the same size by com- of the pound carried out to not more
plying with the following type speci- than two decimal places. When the net
fications: weight does not exceed 1 pound, the
(1) Not less than one-sixteenth inch declaration on the random package
in height on packages the principal dis- may be in decimal fractions of the
play panel of which has an area of 5 pound in lieu of ounces (see example in
square inches or less. paragraph (m)(5) of this section).
(2) Not less than one-eighth inch in (3) The declaration may appear in
height on packages the principal dis- more than one line. The term ‘‘net
play panel of which has an area of more weight’’ shall be used when stating the
than 5 but not more than 25 square net quantity of contents in terms of
inches. weight. Use of the terms ‘‘net’’ or ‘‘net
(3) Not less than three-sixteenths contents’’ in terms of fluid measure or
inch in height on packages the prin- numerical count is optional. It is suffi-
cipal display panel of which has an cient to distinguish avoirdupois ounce
area of more than 25 but not more than from fluid ounce through association of
100 square inches. terms; for example, ‘‘Net wt. 6 oz’’ or
(4) Not less than one-fourth inch in ‘‘6 oz Net wt.’’ and ‘‘6 fl oz’’ or ‘‘Net
height on packages the principal dis- contents 6 fl oz’’.
play panel of which has an area of more (k) On packages containing 4 pounds
than 100 square inches, except not less or 1 gallon or more and labeled in
than 1⁄2 inch in height if the area is terms of weight or fluid measure, the
more than 400 square inches. declaration shall be expressed in
Where the declaration is blown, em- pounds for weight units with any re-
bossed, or molded on a glass or plastic mainder in terms of ounces or common
surface rather than by printing, typ- or decimal fraction of the pound, or in
ing, or coloring, the lettering sizes the case of fluid measure, it shall be
specified in paragraphs (h)(1) through expressed in the largest whole unit
(4) of this section shall be increased by (gallons followed by common or dec-
one-sixteenth of an inch. imal fraction of a gallon or by the next
(j) On packages containing less than smaller whole unit or units (quarts, or
4 pounds or 1 gallon and labeled in quarts and pints)) with any remainder
terms of weight or fluid measure: in terms of fluid ounces or common or
(1) The declaration shall be expressed decimal fractions of the pint or quart
both in ounces, with identification by (see paragraph (m)(6) of this section).
weight or by liquid measure and, if ap- (l) [Reserved]
plicable (1 pound or 1 pint or more) fol- (m) Examples:
lowed in parentheses by a declaration (1) A declaration of 11⁄2 pounds weight
in pounds for weight units, with any re- shall be expressed as ‘‘Net Wt. 24 oz (1
mainder in terms of ounces or common lb 8 oz),’’ ‘‘Net Wt. 24 oz (11⁄2 lb),’’ or
or decimal fractions of the pound (see ‘‘Net Wt. 24 oz (1.5 lb)’’.
examples set forth in paragraphs (m) (2) A declaration of three-fourths
(1) and (2) of this section), or in the pound avoirdupois weight shall be ex-
case of liquid measure, in the largest pressed as ‘‘Net Wt. 12 oz’’.
whole units (quarts, quarts and pints, (3) A declaration of 1 quart liquid
or pints, as appropriate) with any re- measure shall be expressed as ‘‘Net 32 fl
mainder in terms of fluid ounces or oz (1 qt)’’.
common or decimal fractions of the (4) A declaration of 13⁄4 quarts liquid
pint or quart (see examples in para- measure shall be expressed as ‘‘Net
graphs (m) (3) and (4) of this section). contents 56 fluid ounces (1 quart 11⁄2
(2) If the net quantity of contents pints)’’ or as ‘‘Net 56 fluid oz (1 qt 1 pt
declaration appears on a random pack- 8 oz)’’, but not in terms of quart and
age, that is a package which is one of ounce such as ‘‘Net 56 fluid oz (1 quart
a lot, shipment, or delivery of packages 24 ounces)’’.
of the same consumer commodity with (5) On a random package, declaration
varying weights and with no fixed of three-fourths pound avoirdupois may
weight pattern, it may, when the net be expressed as ‘‘Net Wt. .75 lb’’.
weight exceeds 1 pound, be expressed in (6) A declaration of 21⁄2 gallons liquid
terms of pounds and decimal fractions measure shall be expressed as ‘‘Net
165
§ 101.105 21 CFR Ch. I (4–1–16 Edition)
contents 21⁄2 gallons,’’ ‘‘Net contents 2.5 the U.S. gallon of 231 cubic inches and
gallons,’’ or ‘‘Net contents 2 gallons 2 quart, pint, and fluid ounce subdivi-
quarts’’ and not as ‘‘2 gallons 4 pints’’. sions thereof.
(n) For quantities, the following ab- (s) On a multiunit retail package, a
breviations and none other may be em- statement of the quantity of contents
ployed (periods and plural forms are shall appear on the outside of the pack-
optional): age and shall include the number of in-
weight wt pint pt dividual units, the quantity of each in-
ounce oz quart qt dividual unit, and, in parentheses, the
pound lb fluid fl total quantity of contents of the multi-
gallon gal unit package in terms of avoirdupois or
(o) Nothing in this section shall pro- fluid ounces, except that such declara-
hibit supplemental statements at location of total quantity need not be fol-
tions other than the principal display lowed by an additional parenthetical
panel(s) describing in nondeceptive declaration in terms of the largest
terms the net quantity of contents; whole units and subdivisions thereof,
Provided, that such supplemental state- as required by paragraph (j)(1) of this
ments of net quantity of contents shall section. A multiunit retail package
not include any term qualifying a unit may thus be properly labeled: ‘‘6–16 oz
of weight, measure, or count that tends bottles—(96 fl oz)’’ or ‘‘3–16 oz cans—
to exaggerate the amount of the food (net wt. 48 oz)’’. For the purposes of
contained in the package; for example, this section, ‘‘multiunit retail pack-
‘‘jumbo quart’’ and ‘‘full gallon’’. Dual age’’ means a package containing two
or combination declarations of net or more individually packaged units of
quantity of contents as provided for in the identical commodity and in the
paragraphs (a), (c), and (j) of this sec- same quantity, intended to be sold as
tion (for example, a combination of net part of the multiunit retail package
weight plus numerical count, net con- but capable of being individually sold
tents plus dilution directions of a con- in full compliance with all require-
centrate, etc.) are not regarded as sup- ments of the regulations in this part.
plemental net quantity statements and Open multiunit retail packages that do
may be located on the principal display not obscure the number of units or pre-
panel. vent examination of the labeling on
(p) A separate statement of the net each of the individual units are not
quantity of contents in terms of the subject to this paragraph if the label-
metric system is not regarded as a sup- ing of each individual unit complies
plemental statement and an accurate with the requirements of paragraphs (f)
statement of the net quantity of con- and (i) of this section. The provisions
tents in terms of the metric system of of this section do not apply to that
weight or measure may also appear on butter or margarine covered by the ex-
the principal display panel or on other emptions in § 1.24(a) (10) and (11) of this
panels. chapter.
(q) The declaration of net quantity of (t) Where the declaration of net
contents shall express an accurate quantity of contents is in terms of net
statement of the quantity of contents weight and/or drained weight or vol-
of the package. Reasonable variations ume and does not accurately reflect
caused by loss or gain of moisture dur- the actual quantity of the contents or
ing the course of good distribution the product falls below the applicable
practice or by unavoidable deviations standard of fill of container because of
in good manufacturing practice will be equipment malfunction or otherwise
recognized. Variations from stated unintentional product variation, and
quantity of contents shall not be un- the label conforms in all other respects
reasonably large. to the requirements of this chapter (ex-
(r) The declaration of net quantity of cept the requirement that food falling
contents on pickles and pickle prod- below the applicable standard of fill of
ucts, including relishes but excluding container shall bear the general state-
one or two whole pickles in clear plas- ment of substandard fill specified in
tic bags which may be declared by § 130.14(b) of this chapter), the mis-
count, shall be expressed in terms of labeled food product, including any
166
food product that fails to bear the gen- § 101.108 Temporary exemptions for
eral statement of substandard fill spec- purposes of conducting authorized
ified in § 130.14(b) of this chapter, may food labeling experiments.
be sold by the manufacturer or proc- (a) The food industry is encouraged
essor directly to institutions operated to experiment voluntarily, under con-
by Federal, State or local governments trolled conditions and in collaboration
(schools, prisons, hospitals, etc.): Pro- with the Food and Drug Administra-
vided, That: tion, with and other formats for pre-
(1) The purchaser shall sign a state- senting nutrition and other related
ment at the time of sale stating that food labeling information that is con-
he is aware that the product is mis- sistent with the current quantitative
labeled to include acknowledgment of system in §§ 101.9 and 105.66 of this
the nature and extent of the chapter.
mislabeling, (e.g., ‘‘Actual net weight (b) Any firm that intends to under-
may be as low as l% below labeled take a labeling experiment that re-
quantity’’) and that any subsequent
quires exemptions from certain re-
distribution by him of said product ex-
quirements of §§ 101.9 and 105.66 of this
cept for his own institutional use is un-
chapter should submit a written pro-
lawful. This statement shall be kept on
posal containing a thorough discussion
file at the principal place of business of
of each of the following information
the manufacturer or processor for 2
years subsequent to the date of ship- items that apply to the particular ex-
ment of the product and shall be avail- periment:
able to the Food and Drug Administra- (1) A description of the labeling for-
tion upon request. mat to be tested;
(2) The product shall be labeled on (2) A statement of the criteria to be
the outside of its shipping container used in the experiment for assigning
with the statement(s): foods to categories, e.g., nutrient or
(i) When the variation concerns net other values defining ‘‘low’’ and ‘‘re-
weight and/or drained weight or vol- duced’’;
ume, ‘‘Product Mislabeled. Actual net (3) A draft of the material to be used
weight (drained weight or volume in the store, e.g., shelf tags, booklets,
where appropriate) may be as low as posters, etc.;
l% below labeled quantity. This Prod- (4) The dates on which the experi-
uct Not for Retail Distribution’’, the ment will begin and end and on which
blank to be filled in with the maximum a written report of analysis of the ex-
percentage variance between the la- perimental data will be submitted to
beled and actual weight or volume of FDA, together with a commitment not
contents of the individual packages in to continue the experiment beyond the
the shipping container, and proposed ending date without FDA ap-
(ii) When the variation is in regard to proval;
a fill of container standard, ‘‘Product (5) The geographic area or areas in
Mislabeled. Actual fill may be as low which the experiment is to be con-
as l% below standard of fill. This ducted;
Product Not for Retail Distribution’’. (6) The mechanism to measure the ef-
(3) The statements required by para- fectiveness of the experiment;
graphs (t)(2) (i) and (ii) of this section, (7) The method for conveying to con-
which may be consolidated where ap- sumers the required nutrition and
propriate, shall appear prominently other labeling information that is ex-
and conspicuously as compared to empted from the label during the ex-
other printed matter on the shipping periment;
container and in boldface print or type (8) The method that will be or has
on a clear, contrasting background in been used to determine the actual nu-
order to render them likely to be read tritional characteristics of foods for
and understood by the purchaser under which a claim is made; and
ordinary conditions of purchase. (9) A statement of the sections of the

[42 FR 14308, Mar. 15, 1977, as amended at 42 regulations for which an exemption is
FR 15673, Mar. 22, 1977] sought.
167
Pt. 101, App. A 21 CFR Ch. I (4–1–16 Edition)
(c) The written proposal should be a hose connector (Kontes K–183000 or equiva-
sent to the Division of Dockets Man- lent) is required to provide a means of apply-
agement (HFA–305), Food and Drug Ad- ing a head of pressure above the solution. (A
pressure equalizing dropping funnel is not
ministration, 5630 Fishers Lane, rm. recommended because condensate, perhaps
1061, Rockville, MD 20852. The proposal with sulfur dioxide, is deposited in the funnel
should be clearly identified as a re- and the side arm.) The round bottom flask,
quest for a temporary exemption for C, is a 1000 ml flask with three 24/40 tapered
purposes of conducting authorized food joints. The gas inlet tube, D, (Kontes K–
labeling experiments and submitted as 179000 or equivalent) should be of sufficient
a citizen petition under § 10.30 of this length to permit introduction of the nitro-
chapter. gen within 2.5 cm of the bottom of the flask.
The Allihn condenser, E, (Kontes K–431000–
(d) Approval for food labeling experi- 2430 or equivalent) has a jacket length of 300
ments will be given by FDA in writing. mm. The bubbler, F, was fabricated from
Foods labeled in violation of existing glass according to the dimensions given in
regulations will be subject to regu- Fig. 2. The 3% hydrogen peroxide solution
latory action unless an FDA-approved can be contained in a vessel, G, with an i.d.
exemption to the specific regulation of ca. 2.5 cm and a depth of 18 cm.
has been granted for that specific prod- Buret—A 10 ml buret (Fisher Cat. No. 03–
uct. 848–2A or equivalent) with overflow tube and
hose connections for an Ascarite tube or
(e) Reporting requirements contained equivalent air scrubbing apparatus. This will
in § 101.108(b) have been approved by permit the maintenance of a carbon dioxide-
this Office of Management and Budget free atmosphere over the standardized 0.01N
and assigned number 0910–0151. sodium hydroxide.
Chilled Water Circulator—The condensor
[48 FR 15240, Apr. 8, 1983, as amended at 59
must be chilled with a coolant, such as 20%
FR 14364, Mar. 28, 1994; 62 FR 15343, Mar. 31,
methanol-water, maintained at 5 °C. A circu-
1997]
lating pump equivalent to the Neslab
Coolflow 33 is suitable.
APPENDIX A TO PART 101—MONIER-WIL-
LIAMS PROCEDURE (WITH MODIFICA- Reagents
TIONS) FOR SULFITES IN FOOD, CEN-
(a) Aqueous hydrochloric acid, 4N.—For each
TER FOR FOOD SAFETY AND APPLIED analysis prepare 90 ml of hydrochloric acid
NUTRITION, FOOD AND DRUG ADMIN- by adding 30 ml of concentrated hydrochloric
ISTRATION (NOVEMBER 1985) acid (12N) to 60 ml of distilled water.
(b) Methyl red indicator—Dissolve 250 mg of
The AOAC official method for sulfites methyl red in 100 ml ethanol.
(Official Methods of Analysis, 14th Edition, (c) Hydrogen peroxide solution, 3%—Dilute
20.123–20.125, AOAC INTERNATIONAL) has ACS reagent grade 30% hydrogen peroxide to
been modified, in FDA laboratories, to facili- 3% with distilled water. Just prior to use,
tate the determination of sulfites at or near add three drops of methyl red indicator and
10 ppm in food. Method instructions, includ- titrate to a yellow end-point using 0.01N so-
ing modifications, are described below. dium hydroxide. If the end-point is exceeded
Apparatus—The apparatus shown diagram- discard the solution and prepare another 3%
matically (Figure 1) is designed to accom- H2O2 solution.
plish the selective transfer of sulfur dioxide (d) Standardized titrant, 0.01N NaOH—Cer-
from the sample in boiling aqueous hydro- tified reagent may be used (Fisher SO–5–284).
chloric acid to a solution of 3% hydrogen It should be standardized with reference
peroxide. This apparatus is easier to assem- standard potassium hydrogen phthalate.
ble than the official apparatus and the back (e) Nitrogen—A source of high purity nitro-
pressure inside the apparatus is limited to gen is required with a flow regulator that
the unavoidable pressure due to the height of will maintain a flow of 200 cc per minute. To
the 3% H2O2 solution above the tip of the guard against the presence of oxygen in the
bubbler (F). Keeping the backpressure as low nitrogen, an oxygen scrubbing solution such
as possible reduces the likelihood that sulfur as an alkaline pyrogallol trap may be used.
dioxide will be lost through leaks. Prepare pyrogallol trap as follows:
The apparatus should be assembled as 1. Add 4.5 g pyrogallol to the trap.
shown in Fig. 1 with a thin film of stopcock 2. Purge trap with nitrogen for 2 to 3 min-
grease on the sealing surfaces of all the utes.
joints except the joint between the sepa- 3. Prepare a KOH solution prepared by add-
ratory funnel and the flask. Each joint ing 65g KOH to 85 ml distilled water (cau-
should be clamped together to ensure a com- tion: heat).
plete seal throughout the analysis. The sepa- 4. Add the KOH solution to the trap while
ratory funnel, B, should have a capacity of maintaining an atmosphere of nitrogen in
100 ml or greater. An inlet adapter, A, with the trap.
168
Food and Drug Administration, HHS Pt. 101, App. A
Determination gen flow through the 3% hydrogen peroxide
solution should resume as soon as the funnel,
Assemble the apparatus as shown in Fig. 1.
B, is re-inserted into the appropriate joint in
The flask C must be positioned in a heating
flask C. Examine each joint to ensure that it
mantle that is controlled by a power regu-
lating device such as Variac or equivalent. is sealed.
Add 400 ml of distilled water to flask C. Close Apply a head pressure above the hydro-
the stopcock of separatory funnel, B, and add chloric acid solution in B with a rubber bulb
90 ml of 4N hydrochloric acid to the sepa- equipped with a valve. Open the stopcock in
ratory funnel. Begin the flow of nitrogen at B and permit the hydrochloric acid solution
a rate of 200±10 cc/min. The condenser cool- to flow into flask C. Continue to maintain
ant flow must be initiated at this time. Add sufficient pressure above the acid solution to
30 ml of 3% hydrogen peroxide, which has force the solution into the flask C. The stop-
been titrated to a yellow end-point with cock may be closed, if necessary, to pump up
0.01N NaOH, to container G. After fifteen the pressure above the acid and then opened
minutes the apparatus and the distilled again. Close the stopcock before the last few
water will be thoroughly de-oxygenated and milliliters drain out of the separatory fun-
the apparatus is ready for sample introduc- nel, B, to guard against the escape of sulfur
tion. dioxide into the separatory funnel.
Sample preparation (solids)—Transfer 50 g of Apply the power to the heating mantle.
food, or a quantity of food with a convenient Use a power setting which will cause 80 to 90
quantity of SO2 (500 to 1500 mcg SO2), to a drops per minute of condensate to return to
food processor or blender. Add 100 ml of 5% the flask from condenser, E. After 1.75 hours
ethanol in water and briefly grind the mix- of boiling the contents of the 1000 ml flask
ture. Grinding or blending should be contin- and remove trap G.
ued only until the food is chopped into pieces Titration.—Titrate the contents with 0.01N
small enough to pass through the 24/40 point sodium hydroxide. Titrate with 0.01N NaOH
of flask C. to a yellow end-point that persists for at
Sample preparation (liquids)—Mix 50 g of the least twenty seconds. Compute the sulfite
sample, or a quantity with a convenient content, expressed as micrograms sulfur di-
quantity of SO2 (500 to 1500 mcg SO2), with oxide per gram of food (ppm) as follows:
100 ml of 5% ethanol in water. ppm = (32.03 × VB × N × 1000) ÷ Wt
Sample introduction and distillation—Re-
move the separatory funnel B, and quan- where 32.03 = milliequivalent weight of sulfur
titatively transfer the food sample in aque- dioxide; VB = volume of sodium hydrox-
ous ethanol to flask C. Wipe the tapered ide titrant of normality, N, required to
joint clean with a laboratory tissue, apply reach endpoint; the factor, 1000, converts
stopcock grease to the outer joint of the milliequivalents to microequivalents and
separatory funnel, and return the separatory Wt = weight (g) of food sample intro-
funnel, B, to tapered joint flask C. The nitro- duced into the 1000 ml flask.
169
Pt. 101, App. A 21 CFR Ch. I (4–1–16 Edition)
FIGURE 1. THE OPTIMIZED MONIER-WILLIAMS APPARATUS. COMPONENT IDENTIFICATION IS GIVEN IN

TEXT.
170
ER01JA93.362
Food and Drug Administration, HHS Pt. 101, App. B
FIGURE 2. DIAGRAM OF BUBBLER (F IN FIGURE 1). LENGTHS ARE GIVEN IN MM.
[42 FR 14308, Mar. 15, 1977, as amended at 51 APPENDIX B TO PART 101—GRAPHIC

FR 25017, July 9, 1986] ENHANCEMENTS USED BY THE FDA
171
ER01JA93.363
Pt. 101, App. B 21 CFR Ch. I (4–1–16 Edition)
172
ER01JA93.364</GPH>
Food and Drug Administration, HHS Pt. 101, App. B
[58 FR 17332, Apr. 2, 1993, as amended at 68 FR 41506, July 11, 2003]

173
ER11JY03.006</GPH>
Pt. 101, App. C 21 CFR Ch. I (4–1–16 Edition)
APPENDIX C TO PART 101—NUTRITION FACTS FOR RAW FRUITS AND VEGETABLES

174
ER17AU06.007</GPH>
Food and Drug Administration, HHS Pt. 101, App. C
[71 FR 47439, Aug. 17, 2006]

175
ER17AU06.008</GPH>
Pt. 101, App. D 21 CFR Ch. I (4–1–16 Edition)
APPENDIX D TO PART 101—NUTRITION FACTS FOR COOKED FISH
[71 FR 47439, Aug. 17, 2006]

176
ER17AU06.009</GPH>
PART 102—COMMON OR USUAL component(s) when the proportion of

NAME FOR NONSTANDARDIZED such ingredient(s) or component(s) in
FOODS the food has a material bearing on
price or consumer acceptance or when
Subpart A—General Provisions the labeling or the appearance of the
food may otherwise create an erro-
Sec. neous impression that such ingre-
102.5 General principles. dient(s) or component(s) is present in
102.19 Petitions.
an amount greater than is actually the
Subpart B—Requirements for Specific case. The following requirements shall
Nonstandardized Foods apply unless modified by a specific reg-
ulation in subpart B of this part.
102.22 Protein hydrolysates. (1) The percentage of a characterizing
102.23 Peanut spreads.
102.26 Frozen ‘‘heat and serve’’ dinners.
ingredient or component shall be de-
102.28 Foods packaged for use in the prepa- clared on the basis of its quantity in
ration of ‘‘main dishes’’ or ‘‘dinners.’’ the finished product (i.e., weight/
102.33 Beverages that contain fruit or vege- weight in the case of solids, or volume/
table juice. volume in the case of liquids).
102.37 Mixtures of edible fat or oil and olive (2) The percentage of a characterizing
oil.
102.39 Onion rings made from diced onion.
ingredient or component shall be de-
102.41 Potato chips made from dried pota- clared by the words ‘‘containing (or
toes. contains) l percent (or %) lll’’ or
102.45 Fish sticks or portions made from ‘‘l percent (or %) lll’’ with the first
minced fish. blank filled in with the percentage ex-
102.46 Pacific whiting. pressed as a whole number not greater
102.47 Bonito.
than the actual percentage of the in-
102.49 Fried clams made from minced clams.
102.50 Crabmeat. gredient or component named and the
102.54 Seafood cocktails. second blank filled in with the common
102.55 Nonstandardized breaded composite or usual name of the ingredient or
shrimp units. component. The word ‘‘containing’’ (or
102.57 Greenland turbot (Reinhardtius ‘‘contains’’), when used, shall appear
hippoglossoides). on a line immediately below the part of
AUTHORITY: 21 U.S.C. 321, 343, 371. the common or usual name of the food
SOURCE: 42 FR 14322, Mar. 15, 1977, unless required by paragraph (a) of this sec-
otherwise noted. tion. For each characterizing ingre-
dient or component, the words ‘‘l per-
Subpart A—General Provisions cent or %) lll’’ shall appear fol-
lowing or directly below the word
§ 102.5 General principles. ‘‘containing’’ (or contains), or directly
(a) The common or usual name of a below the part of the common or usual
food, which may be a coined term, shall name of the food required by paragraph
accurately identify or describe, in as (a) of this section when the word ‘‘con-
simple and direct terms as possible, the taining’’ (or contains) is not used, in
basic nature of the food or its charac- easily legible boldface print or type in
terizing properties or ingredients. The distinct contrast to other printed or
name shall be uniform among all iden- graphic matter, and in a height not
tical or similar products and may not less than the larger of the following al-
be confusingly similar to the name of ternatives:
any other food that is not reasonably (i) Not less than one-sixteenth inch
encompassed within the same name. in height on packages having a prin-
Each class or subclass of food shall be cipal display panel with an area of 5
given its own common or usual name square inches or less and not less than
that states, in clear terms, what it is in one-eighth inch in height if the area of
a way that distinguishes it from dif- the principal display panel is greater
ferent foods. than 5 square inches; or
(b) The common or usual name of a (ii) Not less than one-half the height
food shall include the percentage(s) of of the largest type appearing in the
any characterizing ingredient(s) or part of the common or usual name of
177
§ 102.19 21 CFR Ch. I (4–1–16 Edition)
the food required by paragraph (a) of on behalf of any interested person who
this section. has submitted a petition, may publish
(c) The common or usual name of a a proposal to issue, amend, or revoke,
food shall include a statement of the under this part, a regulation pre-
presence or absence of any character- scribing a common or usual name for a
izing ingredient(s) or component(s) food, pursuant to part 10 of this chap-
and/or the need for the user to add any ter.
characterizing ingredient(s) or compo- (b) If the principal display panel of a
nent(s) when the presence or absence of food for which a common or usual
such ingredient(s) or component(s) in name regulation is established is too
the food has a material bearing on small to accommodate all mandatory
price or consumer acceptance or when requirements, the Commissioner may
the labeling or the appearance of the establish by regulation an acceptable
food may otherwise create an erro- alternative, e.g., a smaller type size. A
neous impression that such ingre- petition requesting such a regulation,
dient(s) or component(s) is present which would amend the applicable reg-
when it is not, and consumers may oth- ulation, shall be submitted pursuant to
erwise be misled about the presence or part 10 of this chapter.
absence of the ingredient(s) or compo- [42 FR 14322, Mar. 15, 1977, as amended at 42
nent(s) in the food. The following re- FR 15673, Mar. 22, 1977]
quirements shall apply unless modified
by a specific regulation in subpart B of Subpart B—Requirements for
this part.
(1) The presence or absence of a char-
Specific Nonstandardized Foods
acterizing ingredient or component § 102.22 Protein hydrolysates.
shall be declared by the words ‘‘con-
taining (or contains) lll’’ or ‘‘con- The common or usual name of a pro-
taining (or contains) no lll’’ or ‘‘no tein hydrolysate shall be specific to the
lll’’ or ‘‘does not contain lll’’, ingredient and shall include the iden-
with the blank being filled in with the tity of the food source from which the
common or usual name of the ingre- protein was derived.
dient or component. (a) ‘‘Hydrolyzed wheat gluten,’’
(2) The need for the user of a food to ‘‘hydrolyzed soy protein,’’ and
add any characterizing ingredient(s) or ‘‘autolyzed yeast extract’’ are exam-
component(s) shall be declared by an ples of acceptable names. ‘‘Hydrolyzed
appropriate informative statement. casein’’ is also an example of an ac-
(3) The statement(s) required under ceptable name, whereas ‘‘hydrolyzed
paragraph (c)(1) and/or (2) of this sec- milk protein’’ is not an acceptable
tion shall appear following or directly name for this ingredient because it is
below the part of the common or usual not specific to the ingredient (hydroly-
name of the food required by para- sates can be prepared from other milk
graphs (a) and (b) of this section, in proteins). The names ‘‘hydrolyzed vege-
easily legible boldface print or type in table protein’’ and ‘‘hydrolyzed pro-
distinct contrast to other printed or tein’’ are not acceptable because they
graphic matter, and in a height not do not identify the food source of the
less than the larger of the alternatives protein.
established under paragraphs (b)(2) (i) (b) [Reserved]
and (ii) of this section. [58 FR 2876, Jan. 6, 1993]
(d) A common or usual name of a
food may be established by common § 102.23 Peanut spreads.
usage or by establishment of a regula- (a) The common or usual name of a
tion in subpart B of this part, in part spreadable peanut product that does
104 of this chapter, in a standard of not conform to § 164.150 of this chapter,
identity, or in other regulations in this and more than 10 percent of which con-
chapter. sists of nonpeanut ingredients, shall
consist of the term ‘‘peanut spread’’
§ 102.19 Petitions. and a statement of the percentage by

(a) The Commissioner of Food and weight of peanuts in the product in the
Drugs, either on his own initiative or manner set forth in § 102.5(b), except
178
that peanut percentages shall be based ability of this material at NARA, call
on the amount of peanuts used to make 202–741–6030, or go to: http://
the finished food and shall be declared www.archives.gov/federallregister/
in 5-percent increments expressed as a codeloflfederallregulations/
multiple of 5, not to exceed the actual ibrllocations.html.
percentage of peanuts in the products. (2) Biological quality of protein:
(b) A spreadable peanut product that AOAC, 13th Ed. (1980), using the meth-
is nutritionally inferior to peanut but- od described in sections 43.212–43.216,
ter shall be labeled as an imitation of which is incorporated by reference. The
peanut butter under § 101.3(e)(2) of this availability of this incorporation by
chapter; a spreadable peanut product reference is given in paragraph (c)(1) of
shall be considered nutritionally equiv- this section.
alent to peanut butter if it meets all of (3) Niacin: AOAC, 13th Ed. (1980),
the following conditions: using the method described in sections
(1) Protein. (i) The protein content of 43.044–43.046, which is incorporated by
the product is at least 24 percent by reference. The availability of this in-
weight of the finished product, and the corporation by reference is given in
overall biological quality of the pro- paragraph (c)(1) of this section.
tein contained in the product is at (4) Vitamin B6: AOAC, 13th Ed. (1980),
least 68 percent that of casein; or using the method described in sections
(ii) The protein content of the prod-
43.188–43.193, which is incorporated by
uct is at least 16.6 percent by weight of
reference. The availability of this in-
the finished product, and the overall
corporation by reference is given in
biological quality of the protein con-
paragraph (c)(1) of this section.
tained in the product is equal to or
greater than that of casein. (5) Folic acid: Using the method de-
(2) Other nutrients. The product con- scribed in U.S. Department of Agri-
tains the following levels of nutrients culture Handbook No. 29, modified by
per 100 grams of product: use of ascorbate buffer as described by
Ford and Scott, Journal of Dairy Re-
Amount search, 35:85–90 (1968), which is incor-
Nutrient (milli-
grams) porated by reference. Copies are avail-
able from the Center for Food Safety
Niacin ................................................................... 15.3 and Applied Nutrition (HFS–800), Food
Vitamin B6 ............................................................ 0.33
Folic acid ............................................................. 0.08 and Drug Administration, 5100 Paint
Iron ....................................................................... 2.0 Branch Pkwy., College Park, MD 20740,
Zinc ...................................................................... 2.9 or available for inspection at the Na-
Magnesium .......................................................... 173.0
Copper ................................................................. 0.6
tional Archives and Records Adminis-
tration (NARA). For information on
(c) Compliance with the require- the availability of this material at
ments of paragraph (b) of this section NARA, call 202–741–6030, or go to: http://
shall be determined by methods de- www.archives.gov/federallregister/
scribed in the following references ex- codeloflfederallregulations/
cept that in determining protein quan- ibrllocations.html.
tity in products with mixed protein (6) Iron: AOAC, 13th Ed. (1980), using
sources a nitrogen conversion factor of the method described in sections 43.217–
6.25 may be used. 43.219, which is incorporated by ref-
(1) Protein quantity: ‘‘Official Meth- erence. The availability of this incor-
ods of Analysis of the Association of poration by reference is given in para-
Official Analytical Chemists’’ (AOAC), graph (c)(1) of this section.
13th Ed. (1980), using the method de- (7) Zinc: AOAC, 13th Ed. (1980), using
scribed in section 27.007, which is incor- the method described in sections 25.150–
porated by reference. Copies may be 25.153, which is incorporated by ref-
obtained from the AOAC INTER- erence. The availability of this incor-
NATIONAL, 481 North Frederick Ave., poration by reference is given in para-
suite 500, Gaithersburg, MD 20877, or graph (c)(1) of this section.
may be examined at the National Ar- (8) Copper: AOAC, 13th Ed. (1980),
chives and Records Administration using the method described in sections
(NARA). For information on the avail- 25.038–25.043, which is incorporated by
179
§ 102.26 21 CFR Ch. I (4–1–16 Edition)
reference. The availability of this in- dominance by weight. This part of the
corporation by reference is given in name shall be placed immediately fol-
paragraph (c)(1) of this section. lowing or directly below the part speci-
(9) Magnesium: AOAC, 13th Ed. (1980), fied in paragraph (b)(1) of this section
using the method described in sections in the manner set forth in § 102.5(c)(3).
2.109–2.113, which is incorporated by The words ‘‘contains’’ or ‘‘containing’’
reference. The availability of this in- are optional.
corporation by reference is given in (3) If the labeling implies that the
paragraph (c)(1) of this section. package contains other foods and these
[42 FR 36455, July 15, 1977, as amended at 47 foods are not present in the package,
FR 11821, Mar. 19, 1982; 49 FR 5609, Feb. 14, e.g., if a vignette on the package de-
1984; 54 FR 24891, June 12, 1989; 61 FR 14479, picts a ‘‘serving suggestion’’ which in-
Apr. 2, 1996; 63 FR 14035, Mar. 24, 1998; 66 FR cludes any foods not present in the
17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001] package, the principal display panel
shall bear a statement that such foods
§ 102.26 Frozen ‘‘heat and serve’’ din-
ners. are not present, in type size not less
than that specified in § 102.5(b)(2)(i).
(a) A frozen ‘‘heat and serve’’ dinner:
(1) Shall contain at least three com- § 102.28 Foods packaged for use in the
ponents, one of which shall be a signifi- preparation of ‘‘main dishes’’ or
cant source of protein and each of ‘‘dinners.’’
which shall consist of one or more of (a) The common or usual name of a
the following: meat, poultry, fish, packaged food which is represented on
cheese, eggs, vegetables, fruit, pota- the principal display panel by word or
toes, rice, or other cereal based prod- vignette to be used in the preparation
ucts (other than bread or rolls). of a ‘‘main dish’’, ‘‘dinner’’, or other
(2) May also contain other servings of such food serving, and to which some
food (e.g., soup, bread or rolls, bev- other important characterizing ingre-
erage, dessert). dient(s) or component(s) not present in
(b) The common or usual name of the the package must be added, consists of
food consists of all of the following: all the following:
(1) The phrase ‘‘frozen ‘heat and
(1) The common or usual name of
serve’ dinner,’’ except that the name of
each important ingredient or compo-
the predominant characterizing ingre-
nent in the package, in descending
dient or other appropriately descrip-
tive term may immediately precede order of predominance by weight (e.g.,
the word ‘‘dinner’’ (e.g., ‘‘frozen chick- ‘‘noodles and tomato sauce’’).
en dinner’’ or ‘‘frozen heat and serve (2) An appropriate informative state-
beef dinner’’). The words ‘‘heat and ment identifying the food to be pre-
serve’’ are optional. The word ‘‘frozen’’ pared by use of the package contents
is also optional, provided that the (e.g., ‘‘for preparation of chicken cas-
words ‘‘Keep Frozen’’ or the equivalent serole’’).
are prominently and conspicuously (3) An appropriate informative state-
placed on the principal display panel in ment that additional characterizing in-
type size not less than that specified in gredient(s) or component(s) must be
§ 102.5(b)(2)(i). added and which names the additional
(2) The phrase ‘‘containing (or con- characterizing ingredient(s) or compo-
tains) lll’’ the blank to be filled in nent(s) (e.g., ‘‘you must add lll to
with an accurate description of each of complete the recipe,’’ the blank to be
the three or more dish components list- filled in with the name(s) of the impor-
ed in paragraph (a)(1) of this section in tant characterizing ingredient(s) or
their order of descending predominance component(s) that must be added).
by weight (e.g., ham, mashed potatoes, (b) The labeling required by para-
and peas), followed by any of the other graph (a) of this section shall appear on
servings specified in paragraph (a)(2) of the principal display panel.
this section contained in the package (1) No word in the statement required
(e.g., onion soup, enriched white bread, by paragraph (a)(2) of this section may
and artificially flavored vanilla pud- appear on the principal display panel
ding) in their order of descending pre- more conspicuously or in larger type
180
than the smallest and least con- § 102.33 Beverages that contain fruit
spicuous type employed on the panel or vegetable juice.
for any word, phrase or statement (a) For a carbonated or noncarbon-
within the scope of paragraph (a)(1) of
ated beverage that contains less than
this section.
100 percent and more than 0 percent
(2) Every word in the statement re-
fruit or vegetable juice, the common or
quired by paragraph (a)(3) of this sec-
usual name shall be a descriptive name
tion shall appear on the principal dis-
that meets the requirements of
play panel in easily legible bold face
§ 102.5(a) and, if the common or usual
print or type in distinct contrast to
name uses the word ‘‘juice,’’ shall in-
other printed or graphic matter, and in
clude a qualifying term such as ‘‘bev-
a height not less than the larger of the
erage,’’ ‘‘cocktail,’’ or ‘‘drink’’ appro-
following alternatives:
priate to advise the consumer that the
(i) Not less than one-sixteenth inch
in height on packages having a prin- product is less than 100 percent juice
cipal display panel with an area of 5 (e.g., ‘‘diluted grape juice beverage’’ or
square inches or less and not less than ‘‘grape juice drink’’).
one-eighth inch in height if the area of (b) If the product is a diluted mul-
the principal display panel is greater tiple-juice beverage or blend of single-
than 5 square inches; or strength juices and names, other than
(ii) Not less than one-half the height in the ingredient statement, more than
of the largest type appearing in the one juice, then the names of those
part of the common or usual name of juices, except in the ingredient state-
the food required by paragraphs (a) (1) ment, must be in descending order of
and (2) of this section. predominance by volume unless the
(c) Any vignette which shows any name specifically shows that the juice
food or characterizing ingredient(s) or with the represented flavor is used as a
component(s) not included in the pack- flavor (e.g., raspberry-flavored apple
age shall be accompanied either by the and pear juice drink). In accordance
statement required by paragraph (a)(3) with § 101.22(i)(1)(iii) of this chapter,
of this section or by a separate state- the presence of added natural flavors is
ment specifying the food or character- not required to be declared in the name
izing ingredient(s) or component(s) of the beverage unless the declared
shown in the vignette but not included juices alone do not characterize the
in the package. product before the addition of the
(d) If the statement specified in para- added flavors.
graph (a)(2) of this section is used on (c) If a diluted multiple-juice bev-
any panel in addition to the principal erage or blend of single-strength juices
display panel as a product identifica- contains a juice that is named or im-
tion statement, the complete common plied on the label or labeling other
or usual name shall appear on such than in the ingredient statement (rep-
panel in the manner specified in para- resented juice), and also contains a
graph (b) of this section. juice other than the named or implied
(e) When a brand name or other juice (nonrepresented juice), then the
prominent product designation con- common or usual name for the product
tains a word or words that includes or shall indicate that the represented
suggests an important characterizing juice is not the only juice present (e.g.,
ingredient(s) or component(s) that ‘‘Apple blend; apple juice in a blend of
must be added, or otherwise states or two other fruit juices.’’)
implies that the package contains a (d) In a diluted multiple-juice bev-
complete main dish, dinner, or other erage or blend of single-strength juices
food serving, the part of the common where one or more, but not all, of the
or usual name of the food required by juices are named on the label other
paragraph (a)(3) of this section shall than in the ingredient statement, and
appear in direct conjunction with such where the named juice is not the pre-
brand name or other designation and in dominant juice, the common or usual
type size not less than one-half the name for the product shall:
height of the largest type appearing in (1) Indicate that the named juice is
such brand name or other designation. present as a flavor or flavoring (e.g.,
181
§ 102.37 21 CFR Ch. I (4–1–16 Edition)
‘‘Raspcranberry’’; raspberry and cran- beled with the term ‘‘from con-
berry flavored juice drink); or centrate’’ or ‘‘reconstituted.’’
(2) Include the amount of the named [58 FR 2926, Jan. 6, 1993; 58 FR 17103, Apr. 1,
juice, declared in a 5- percent range 1993, as amended at 58 FR 44063, Aug. 18, 1993;
(e.g., Raspcranberry; raspberry and 62 FR 15343, Mar. 31, 1997]
cranberry juice beverage, 10- to 15-per-
cent cranberry juice and 3- to 8-percent § 102.37 Mixtures of edible fat or oil
and olive oil.
raspberry juice). The 5-percent range,
when used, shall be declared in the The common or usual name of a mix-
manner set forth in § 102.5(b)(2). ture of edible fats and oils containing
(e) The common or usual name of a less than 100 percent and more than 0
juice that has been modified shall in- percent olive oil shall be as follows:
(a) A descriptive name for the prod-
clude a description of the exact nature
uct meeting the requirements of
of the modification (e.g., ‘‘acid-reduced
§ 102.5(a), e.g., ‘‘cottonseed oil and olive
cranberry juice,’’ ‘‘deflavored, de- oil’’ or another descriptive phrase, and
colored grape juice’’). (b) When the label bears any rep-
(f) If the product is a beverage that resentation, other than in the ingre-
contains a juice whose color, taste, or dient listing, of the presence of olive
other organoleptic properties have oil in the mixture, the descriptive
been modified to the extent that the name shall be followed by a statement
original juice is no longer recognizable of the percentage of olive oil contained
at the time processing is complete, or in the product in the manner set forth
if its nutrient profile has been dimin- in § 102.5(b)(2).
ished to a level below the normal nutri-
ent range for the juice, then the source § 102.39 Onion rings made from diced
onion.
fruits or vegetables from which the
modified juice was derived may not be (a) The common or usual name of the
depicted on the label by vignette or food product that resembles and is of
other pictorial representation. the same composition as onion rings,
(g)(1) If one or more juices in a juice except that it is composed of
comminuted onions, shall be as follows:
beverage is made from concentrate, the
(1) When the product is composed of
name of the juice must include a term
dehydrated onions, the name shall be
indicating that fact, such as ‘‘from ‘‘onion rings made from dried diced on-
concentrate,’’ or ‘‘reconstituted.’’ Such ions.’’
terms must be included in the name of (2) When the product is composed of
each individual juice or it may be stat- any form of onion other than dehy-
ed once adjacent to the product name drated, the name shall be ‘‘onion rings
so that it applies to all the juices, (e.g., made from diced onions.’’
‘‘cherry juice (from concentrate) in a (b) The words ‘‘made from dried diced
blend of two other juices’’ or ‘‘cherry onions’’ or ‘‘made from diced onions’’
juice in a blend of 2 other juices (from shall immediately follow or appear on
concentrate)’’). The term shall be in a a line(s) immediately below the words
type size no less than one-half the ‘‘onion rings’’ in easily legible boldface
height of the letters in the name of the print or type in distinct contrast to
juice. other printed or graphic matter, and in
(2) If the juice is 100 percent single a height not less than the larger of the
species juice consisting of juice di- following alternatives:
rectly expressed from a fruit or vege- (1) Not less than one-sixteenth inch
table whose Brix level has been raised in height on packages having a prin-
by the addition of juice concentrate cipal display panel with an area of 5
from the same fruit or vegetable, the square inches or less and not less than
one-eighth inch in height if the area of
name of the juice need not include a
the principal display panel is greater
statement that the juice is from con-
than 5 square inches; or
centrate. However, if water is added to (2) Not less than one-half the height
this 100 percent juice mixture to adjust of the largest type used in the words
the Brix level, the product shall be la- ‘‘onion rings.’’
182
§ 102.41 Potato chips made from dried § 102.46 Pacific whiting.

potatoes.
‘‘Pacific whiting’’ or ‘‘North Pacific
(a) The common or usual name of the whiting’’ is the common or usual name
food product that resembles and is of of the food fish Merluccius productus.
the same composition as potato chips,
[44 FR 45617, Aug. 3, 1979]
except that it is composed of dehy-
drated potatoes (buds, flakes, granules, § 102.47 Bonito.
or other form), shall be ‘‘potato chips
made from dried potatoes.’’ ‘‘Bonito’’ or ‘‘bonito fish’’ is the com-
(b) The words ‘‘made from dried pota- mon or usual name of the following
toes’’ shall immediately follow or ap- food fishes:
pear on a line(s) immediately below the Cybiosarda elegans (Whitely, 1935)—Leaping
words ‘‘potato chips’’ in easily legible bonito
boldface print or type in distinct con- Gymnosarda unicolor (Ruppell, 1838)—
trast to other printed or graphic mat- Dogtooth tuna
ter, and in a height not less than the Orcynopsis unicolor (Geoffroy St. Hilaire,
larger of the following alternatives: 1817)—Plain bonito
Sarda australis (Macleay, 1880)—Australian
(1) Not less than one-sixteenth inch bonito
in height on packages having a prin- Sarda chiliensis (Cuvier, 1831)—Eastern Pa-
cipal display panel with an area of 5 cific bonito
square inches or less and not less than Sarda orientalis (Temminck and Schlegel,
one-eighth inch in height if the area of 1844)—Striped bonito
the principal display panel is greater Sarda sarda (Bloch, 1793)—Atlantic bonito
than 5 square inches; or [55 FR 45797, Oct. 31, 1990]
(2) Not less than one-half the height
of the largest type used in the words § 102.49 Fried clams made from
‘‘potato chips.’’ minced clams.
(a) The common or usual name of the
§ 102.45 Fish sticks or portions made
from minced fish. food product that resembles and is of
the same composition as fried clams,
(a) The common or usual name of the except that it is composed of
food product that resembles and is of comminuted clams, shall be ‘‘fried
the same composition as fish sticks or clams made from minced clams.’’
fish portions, except that it is com- (b) The words ‘‘made from minced
posed of comminuted fish flesh, shall clams’’ shall immediately follow or ap-
be ‘‘fish lll made from minced fish,’’ pear on a line(s) immediately below the
the blank to be filled in with the word words ‘‘fried clams’’ and in easily leg-
‘‘sticks’’ or ‘‘portions’’ as the case may ible boldface print or type in distinct
be. contrast to other printed or graphic
(b) The words ‘‘made from minced matter, and in a height not less than
fish’’ shall immediately follow or ap- the larger of the following alternatives:
pear on a line(s) immediately below the (1) Not less than one-sixteenth inch
words ‘‘fish lll’’ in easily legible in height on packages having a prin-
boldface print or type in distinct con- cipal display panel with an area of 5
trast to other printed or graphic mat- square inches or less and not less than
ter, and in a height not less than the one-eighth inch in height if the area of
larger of the following alternatives: the principal display panel is greater
(1) Not less than one-sixteenth inch than 5 square inches; or
in height on packages having a prin- (2) Not less than one-half the height
cipal display panel with an area of 5 of the largest type used in the words
square inches or less and not less than ‘‘fried clams.’’
one-eighth inch in height if the area of
the principal display panel is greater § 102.50 Crabmeat.
than 5 square inches; or The common or usual name of crab-
(2) Not less than one-half the height meat derived from each of the fol-
of the largest type used in the words lowing designated species of crabs shall
‘‘fish lll.’’ be as follows:
183
§ 102.54 21 CFR Ch. I (4–1–16 Edition)
Scientific name of crab Common or usual name of tion in easily legible boldface print or
crabmeat type in distinct contrast to other
Chionoecetes opilio, Snow crabmeat. printed or graphic matter, and in a
Chionoecetes tanneri, height not less than the larger of the
Chionoecetes bairdii, and
Chionoecetes angulatus
following alternatives:
Erimacrus isenbeckii Korean variety crabmeat or (1) Not less than one-sixteenth inch
Kegani crabmeat. in height on packages having a prin-
Lithodes aequispina Brown King crabmeat.
Paralithodes brevipes King crabmeat or Hanasaki
cipal display panel with an area of 5
crabmeat. square inches or less and no less than
Paralithodes camtschaticus King crabmeat and one-eighth inch in height if the area of
Paralithodes Platypus. the principal display panel is greater
than 5 square inches; or
[42 FR 14322, Mar. 15, 1977, as amended at 60 (2) Not less than one-half the height
FR 34460, July 3, 1995] of the largest type used in the words
‘‘breaded shrimp sticks’’ or the other
§ 102.54 Seafood cocktails. comparable words required by this sec-
The common or usual name of a sea- tion.
food cocktail in package form fab-
ricated with one or more seafood ingre- § 102.57 Greenland turbot
dients shall be: (Reinhardtius hippoglossoides).
(a) When the cocktail contains only ‘‘Greenland turbot’’ is the common
one seafood ingredient, the name of the or usual name of the food fish
seafood ingredient followed by the Reinhardtius hippoglossoides, a species
word ‘‘cocktail’’ (e.g., shrimp cocktail, of Pleuronectidae right-eye flounders.
crabmeat cocktail) and a statement of The term ‘‘halibut’’ may be associated
the percentage by weight of that sea- only with Atlantic halibut
food ingredient in the product in the (Hippoglossus hippoglossus) or Pacific
manner set forth in § 102.5(b). halibut (Hippoglossus stenolepis).
(b) When the cocktail contains more
than one seafood ingredient, the term PART 104—NUTRITIONAL QUALITY
‘‘seafood cocktail’’ and a statement of
the percentage by weight of each sea-
GUIDELINES FOR FOODS
food ingredient in the product in the
manner set forth in § 102.5(b). Subpart A—General Provisions
Sec.
§ 102.55 Nonstandardized breaded 104.5 General principles.
composite shrimp units.
(a) The common on usual name of the Subpart B—Fortification Policy
food product that conforms to the defi-
104.20 Statement of purpose.
nition and standard of identity de-
scribed by § 161.175(c)(6) of this chapter, Subpart C—Specific Nutritional Quality
except that the food is made from Guidelines
comminuted shrimp and is not in raw
frozen form, shall be ‘‘lll made from 104.47 Frozen ‘‘heat and serve’’ dinner.
minced shrimp,’’ the blank to be filled AUTHORITY: 21 U.S.C. 321, 343, 371(a).
in with the words ‘‘breaded shrimp
sticks’’ or ‘‘breaded shrimp cutlets’’ de- SOURCE: 42 FR 14327, Mar. 15, 1977, unless
otherwise noted.
pending upon the shape of the product,
or if prepared in a shape other than
that of sticks or cutlets ‘‘breaded Subpart A—General Provisions
shrimp lll made from minced
shrimp,’’ the blank to be filled by a § 104.5 General principles.
word or phrase that accurately de- (a) A nutritional quality guideline
scribes the shape and that is not mis- prescribes the minimum level or range
leading. of nutrient composition (nutritional
(b) The words ‘‘made from minced quality) appropriate for a given class of
shrimp’’ shall immediately follow or food.

appear on a line(s) immediately below (b) Labeling for a product which com-
the other words required by this sec- plies with all of the requirements of
184
the nutritional quality guideline estab- the guideline, shall be ineligible to

lished for its class of food may state bear the guideline statement provided
‘‘This product provides nutrients in for in paragraph (b) of this section, and
amounts appropriate for this class of such a product shall also be deemed to
food as determined by the U.S. Govern- be misbranded under the act unless the
ment,’’ except that the words ‘‘this label and all labeling bear the fol-
product’’ are optional. This statement, lowing prominent and conspicuous
if used, shall be printed on the prin- statement: ‘‘The addition of lll to
cipal display panel, and may also be (or ‘‘The addition of lll at the level
printed on the information panel, in contained in) this product has been de-
letters not larger than twice the size of termined by the U.S. Government to be
the minimum type required for the unnecessary and inappropriate and
declaration of net quantity of contents does not increase the dietary value of
by § 101.105 of this chapter. Labeling of the food,’’ the blank to be filled in with
noncomplying products may not in- the common or usual name of the nu-
clude any such statement or otherwise trient(s) involved.
represent, suggest, or imply the prod-
uct as being, in whole or in part, in FR 14818, Mar. 27, 1998]
compliance with a guideline.
(c) A product bearing the statement
provided for in paragraph (b) of this Subpart B—Fortification Policy
section, in addition to meeting the re-
quirements of the applicable nutri- § 104.20 Statement of purpose.
tional quality guideline, shall comply (a) The fundamental objective of this
with the following requirements: subpart is to establish a uniform set of
(1) The label of the product shall bear principles that will serve as a model for
the common or usual name of the food the rational addition of nutrients to
in accordance with the provisions of foods. The achievement and mainte-
the guideline and §§ 101.3 and 102.5(a) of nance of a desirable level of nutritional
this chapter. quality in the nation’s food supply is
(2) The label of the product shall bear an important public health objective.
nutrition labeling in accordance with The addition of nutrients to specific
§§ 101.2 and 101.9 of this chapter and all foods can be an effective way of main-
other labeling required by applicable taining and improving the overall nu-
sections of part 101 of this chapter. tritional quality of the food supply.
(d) No claim or statement may be However, random fortification of foods
made on the label or in labeling rep- could result in over- or underfortifica-
resenting, suggesting, or implying any tion in consumer diets and create nu-
nutritional or other differences be- trient imbalances in the food supply. It
tween a product to which nutrient ad- could also result in deceptive or mis-
dition has or has not been made in leading claims for certain foods. The
order to meet the guideline, except Food and Drug Administration does
that a nutrient addition shall be de- not encourage indiscriminate addition
clared in the ingredient statement. of nutrients to foods, nor does it con-
(e) Compliance with a nutrient level sider it appropriate to fortify fresh
specified in a nutritional quality guide- produce; meat, poultry, or fish prod-
line shall be determined by the proce- ucts; sugars; or snack foods such as
dures and requirements established in candies and carbonated beverages. To
§ 101.9(g) of this chapter. preserve a balance of nutrients in the
(f) A product within a class of food diet, manufacturers who elect to for-
for which a nutritional quality guide- tify foods are urged to utilize these
line has been established and to which principles when adding nutrients to
has been added a discrete nutrient ei- food. It is reasonable to anticipate that
ther for which no minimum nutrient the Reference Daily Intakes (RDI’s) as
level or nutrient range or other allow- delineated in § 101.9 of this chapter and
ance has been established as appro- in paragraph (d) of this section will be
priate in the nutritional quality guide- amended from time to time to list ad-
line, or at a level that exceeds any ditional nutrients and/or to change the
maximum established as appropriate in levels of specific RDI’s as improved
185
§ 104.20 21 CFR Ch. I (4–1–16 Edition)
knowledge about human nutrient re- contribute nutrients are considered in

quirements and allowances develops. determining restoration levels; and
The policy set forth in this section is (4) The food is not the subject of any
based on U.S. dietary practices and nu- other Federal regulation that requires
tritional needs and may not be applica- or prohibits nutrient addition(s), or the
ble in other countries. food has not been fortified in accord-
(b) A nutrient(s) listed in paragraph ance with any other Federal regulation
(d)(3) of this section may appropriately that permits voluntary nutrient addi-
be added to a food to correct a dietary tions.
insufficiency recognized by the sci- (d) A nutrient(s) listed in paragraph
entific community to exist and known (d)(3) of this section may be added to a
to result in nutritional deficiency dis- food in proportion to the total caloric
ease if: content of the food, to balance the vi-
(1) Sufficient information is available tamin, mineral, and protein content if:
to identify the nutritional problem and (1) A normal serving of the food con-
the affected population groups, and the tains at least 40 kilocalories (that is, 2
food is suitable to act as a vehicle for percent of a daily intake of 2,000
the added nutrients. Manufacturers kilocalories);
contemplating using this principle are (2) The food is not the subject of any
urged to contact the Food and Drug other Federal regulation for a food or
Administration before implementing a class of food that requires, permits, or
fortification plan based on this prin- prohibits nutrient additions; and
ciple. (3) The food contains all of the fol-
(2) The food is not the subject of any lowing nutrients per 100 calories based
other Federal regulation for a food or on 2,000 calorie total intake as a daily
class of food that requires, permits, or standard:
prohibits nutrient additions. (Other Amount
DRV or
Federal regulations include, but are Nutrient Unit of measurement per 100
RDI 1 calories
not limited to, standards of identity
promulgated under section 401 of the Protein .............. grams (g) .................. 50 2.5
Federal Food, Drug, and Cosmetic Act, Vitamin A .......... International Unit (IU) 5,000 250
Vitamin C .......... milligrams (mg) ......... 60 3
nutritional quality guidelines estab- Calcium ............. g ............................... 1 0.05
lished in subpart C of this part, and Iron .................... mg ............................ 18 0.9
common or usual name regulations es- Vitamin D .......... IU .............................. 400 20
Vitamin E .......... do ............................. 30 1.5
tablished in part 102 of this chapter.) Thiamin ............. mg ............................ 1.5 0.08
(c) A nutrient(s) listed in paragraph Riboflavin .......... do ............................. 1.7 0.09
(d)(3) of this section may appropriately Niacin ................ do ............................. 20 1
Vitamin B6 ......... do ............................. 2.0 0.1
be added to a food to restore such nu- Folate ................ micrograms (μg) ....... 400 20
trient(s) to a level(s) representative of Vitamin B12 ....... do ............................. 6.0 0.3
the food prior to storage, handling, and Biotin ................. mg ............................ 0.3 0.015
processing, when: Pantothenic acid do ............................. 10 0.5
Phosphorus ....... g ............................... 1.0 0.05
(1) The nutrient is shown by adequate Magnesium ....... mg ............................ 400 20
scientific documentation to have been Zinc ................... do ............................. 15 0.8
lost in storage, handling, or processing Iodine ................ μg ............................. 150 7.5
Copper .............. mg ............................ 2.0 0.1
in a measurable amount equal to at Potassium ......... do ............................. 3,500 175
least 2 percent of the Daily Reference
1 RDI’s for adults and children 4 or more years of age.
Value (DRV) of protein and of potas-
sium and 2 percent of the Reference (e) A nutrient(s) may appropriately
Daily Intake (RDI) in a normal serving be added to a food that replaces tradi-
of the food. tional food in the diet to avoid nutri-
(2) Good manufacturing practices and tional inferiority in accordance with
normal storage and handling proce- § 101.3(e)(2) of this chapter.
dures cannot prevent the loss of such (f) Nutrient(s) may be added to foods
nutrient(s), as permitted or required by applicable
(3) All nutrients, including protein, regulations established elsewhere in
iodine and vitamin D, that are lost in this chapter.

a measurable amount are restored and (g) A nutrient added to a food is ap-
all ingredients of the food product that propriate only when the nutrient:
186
(1) Is stable in the food under cus- added pursuant to paragraph (e) of this
tomary conditions of storage, distribu- section.
tion, and use;
[45 FR 6323, Jan. 25, 1980, as amended at 58
(2) Is physiologically available from FR 2228, Jan. 6, 1993]
the food;
(3) Is present at a level at which
there is a reasonable assurance that
Subpart C—Specific Nutritional
consumption of the food containing the Quality Guidelines
added nutrient will not result in an ex- § 104.47 Frozen ‘‘heat and serve’’ din-
cessive intake of the nutrient, consid- ner.
ering cumulative amounts from other
sources in the diet; and (a) A product, for which a common or
(4) Is suitable for its intended pur- usual name is established in § 102.26 of
pose and is in compliance with applica- this chapter, in order to be eligible to
ble provisions of the act and regula- bear the guideline statement set forth
tions governing the safety of sub- at § 104.5(b), shall contain at least the
stances in food. following three components:
(h) Any claims or statements in the (1) One or more sources of protein de-
labeling of food about the addition of a rived from meat, poultry, fish, cheese,
vitamin, mineral, or protein to a food or eggs.
shall be made only if the claim or (2) One or more vegetables or vege-
statement is not false or misleading table mixtures other than potatoes,
and otherwise complies with the act rice, or cereal-based product.
and any applicable regulations. The (3) Potatoes, rice, or cereal-based
following label claims are acceptable: product (other than bread or rolls) or
(1) The labeling claim ‘‘fully restored another vegetable or vegetable mix-
with vitamins and minerals’’ or ‘‘fully ture.
restored with vitamins and minerals to (b) The three or more components
the level of unprocessed lll’’ (the named in paragraph (a) of this section,
blank to be filled in with the common including their sauces, gravies,
or usual name of the food) may be used breading, etc.:
to describe foods fortified in accord- (1) Shall contribute not less than the
ance with the principles established in minimum levels of nutrients prescribed
paragraph (c) of the section. in paragraph (d) of this section.
(2) The labeling claim, ‘‘vitamins and (2) Shall be selected so that one or
minerals (and ‘‘protein’’ when appro- more of the listed protein sources of
priate) added are in proportion to ca- paragraph (a)(1) of this section, exclud-
loric content’’ may be used to describe ing their sauces, gravies, breading,
food fortified in accordance with the etc., shall provide not less than 70 per-
principles established in paragraph (d) cent of the total protein supplied by
of this section. the components named in paragraph (a)
(3) When labeling claims are per- of this section.
mitted, the term ‘‘enriched,’’ ‘‘for- (c) If it is necessary to add any nutri-
tified,’’ ‘‘added,’’ or similar terms may ent(s) in order to meet the minimum
be used interchangeably to indicate the nutrient levels prescribed in paragraph
addition of one or more vitamins or (d) of this section, the addition of each
minerals or protein to a food, unless an such nutrient may not result in a total
applicable Federal regulation requires nutrient level exceeding 150 percent of
the use of specific words or statements. the minimum level prescribed. Nutri-
(i) It is inappropriate to make any ents used for such addition shall be bio-
claim or statement on a label or in la- logically available in the final product.
beling, other than in a listing of the (d) Minimum levels of nutrients for a
nutrient ingredients as part of the in- frozen ‘‘heat and serve’’ dinner are as
follows:
gredient statement, that any vitamin,

mineral, or protein has been added to a
food to which nutrients have been
187
Minimum levels for fro- (f) For the purposes of labeling, an

zen ‘‘heat and serve’’ ‘‘average serving’’ shall be one entire
dinner—
frozen ‘‘heat and serve’’ dinner.
For each
100 Cal- [42 FR 14327, Mar. 5, 1977]
Nutrient For the
ories (keal) total com-
of the total ponents
compo-
nents specified in PART 105—FOODS FOR SPECIAL
par. (a)
specified in DIETARY USE
par. (a)
Protein, grams ............................... 4.60 16.0 Subpart A—General Provisions

Vitamin A, IU ................................. 150.00 520.0
Thiamine, mg ................................. .05 .2 Sec.
Riboflavin, mg ................................ .06 .2 105.3 Definitions and interpretations.
Niacin, mg ..................................... .99 3.4
Pantothenic acid, mg ..................... .32 1.1 Subpart B—Label Statements
Vitamin, B6, mg ............................. .15 .5
105.62 Hypoallergenic foods.
Vitamin, B1 ..................................... .33 1.1
Iron, mg ......................................... .62 2.2
105.65 Infant foods.
105.66 Label statements relating to useful-
ness in reducing or maintaining body
(1) A frozen ‘‘heat and serve’’ dinner weight.
prepared from conventional food ingre-
dients listed in paragraph (a) of this Subpart C [Reserved]
section will also contain folic acid,
magnesium, iodine, calcium, and zinc. Subpart D—Standards of Identity
Minimum levels for these nutrients [Reserved]
cannot be established at the present
time but may be specified as additional AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 350,
data are obtained. 371, 379e.
(2) The minimum levels for panto- SOURCE: 42 FR 14328, Mar. 15, 1977, unless
thenic acid, vitamin B–6, and vitamin otherwise noted.
B–12 are tentative. Final levels will be
established when sufficient data are Subpart A—General Provisions
available. Until final levels are estab-
lished, a product containing less than § 105.3 Definitions and interpretations.
the tentative levels will not be deemed The definitions and interpretations
to be misbranded when labeled in ac- of terms contained in section 201 of the
cordance with § 104.5(b). Federal Food, Drug, and Cosmetic Act
(3) When technologically practicable, (hereafter ‘‘the act’’) shall be applica-
iodized salt shall be used or iodine ble with the following additions:
shall be present at a level equivalent to (a)(1) The term special dietary uses, as
that which would be present if iodized applied to food for man, means par-
salt were used in the manufacture of ticular (as distinguished from general)
the product. uses of food, as follows:
(4) When technologically practicable, (i) Uses for supplying particular die-
product components and ingredients tary needs which exist by reason of a
shall be selected to obtain the desir- physical, physiological, pathological or
able calcium to phosphorous ratio of other condition, including but not lim-
1:1. Technological addition of ited to the conditions of diseases, con-
phosphates shall be minimized and valescence, pregnancy, lactation, aller-
shall not exceed the amount necessary gic hypersensitivity to food, under-
for the intended effect. weight, and overweight;
(e) If the product includes servings of (ii) Uses for supplying particular die-
food which are not prescribed by para- tary needs which exist by reason of
graph (a) of this section (e.g., soup, age, including but not limited to the
bread or rolls, beverage, or dessert), ages of infancy and childhood;
their contribution shall not be consid- (iii) Uses for supplementing or for-
ered in determining compliance with tifying the ordinary or usual diet with
the nutrient levels established in para- any vitamin, mineral, or other dietary
graph (d) of this section but shall be in- property. Any such particular use of a
cluded in any nutrition labeling. food is a special dietary use, regardless
188
of whether such food also purports to erals alone) purports to be or is rep-

be or is represented for general use. resented for special dietary use for in-
(2) The use of an artificial sweetener fants, the label shall bear, if such food
in a food, except when specifically and is fabricated from two or more ingredi-
solely used for achieving a physical ents, the common or usual name of
characteristic in the food which cannot each ingredient, including spices, fla-
be achieved with sugar or other nutri- voring, and coloring.
tive sweetener, shall be considered a (b) If such food, or any ingredient
use for regulation of the intake of cal- thereof, consists in whole or in part of
ories and available carbohydrate, or for plant or animal matter and the name
use in the diets of diabetics and is of such food or ingredient does not
therefore a special dietary use. clearly reveal the specific plant or ani-
(b)–(d) [Reserved] mal which is its source, such name
(e) For the purposes of the regula- shall be so qualified as to reveal clear-
tions in this part, the terms infant, ly the specific plant or animal that is
child, and adult mean persons not more such source.
than 12 months old, more than 12
months but less than 12 years old, and [42 FR 14328, Mar. 15, 1977, as amended at 47
FR 947, Jan. 8, 1982; 49 FR 10090, Mar. 19, 1984;
12 years or more old, respectively. 50 FR 1840, Jan. 14, 1985]
FR 16006, Mar. 16, 1979; 44 FR 49665, Aug. 24, § 105.66 Label statements relating to
1979] usefulness in reducing or maintain-
ing body weight.
Subpart B—Label Statements (a) General requirements. Any food
that purports to be or is represented
§ 105.62 Hypoallergenic foods. for special dietary use because of use-
If a food purports to be or is rep- fulness in reducing or maintaining
resented for special dietary use by rea- body weight shall bear:
son of the decrease or absence of any (1) Nutrition labeling in conformity
allergenic property or by reason of with § 101.9, or, where applicable,
being offered as food suitable as a sub- § 101.36 of this chapter, unless exempt
stitute for another food having an al- under that section; and
lergenic property, the label shall bear: (2) A conspicuous statement of the
(a) The common or usual name and basis upon which the food claims to be
the quantity or proportion of each in- of special dietary usefulness.
gredient (including spices, flavoring, (b) Nonnutritive ingredients. (1) Any
and coloring) in case the food is fab- food subject to paragraph (a) of this
ricated from two or more ingredients. section that achieves its special die-
(b) A qualification of the name of the tary usefulness by use of a nonnutri-
food, or the name of each ingredient tive ingredient (i.e., one not utilized in
thereof in case the food is fabricated normal metabolism) shall bear on its
from two or more ingredients, to reveal label a statement that it contains a
clearly the specific plant or animal nonnutritive ingredient and the per-
that is the source of such food or of centage by weight of the nonnutritive
such ingredient, if such food or such in- ingredient.
gredient consists in whole or in part of (2) A special dietary food may con-
plant or animal matter and such name tain a nonnutritive sweetener or other
does not reveal clearly the specific ingredient only if the ingredient is safe
plant or animal that is such a source. for use in the food under the applicable
(c) An informative statement of the law and regulations of this chapter.
nature and effect of any treatment or Any food that achieves its special die-
processing of the food or any ingre- tary usefulness in reducing or main-
dient thereof, if the changed allergenic taining body weight through the use of
property results from such treatment a nonnutritive sweetener shall bear on
or processing. its label the statement required by
paragraph (b)(1) of this section, but
§ 105.65 Infant foods. need not state the percentage by

(a) If a food (other than a dietary weight of the nonnutritive sweetener.
supplement of vitamins and/or min- If a nutritive sweetener(s) as well as
189
nonnutritive sweetener(s) is added, the Subpart D—Standards of Identity

statement shall indicate the presence [Reserved]
of both types of sweetener, e.g.,
‘‘Sweetened with nutritive sweetener(s)
and nonnutritive sweetener(s).’’ PART 106—INFANT FORMULA RE-
(c) ‘‘Low calorie’’ foods. A food pur- QUIREMENTS PERTAINING TO
porting to be ‘‘low calorie’’ must com- CURRENT GOOD MANUFAC-
ply with the criteria set forth for such TURING PRACTICE, QUALITY
foods in § 101.60(b)(2) and (b)(3) of this CONTROL PROCEDURES, QUALITY
chapter. FACTORS, RECORDS AND RE-
(d) ‘‘Reduced calorie’’ foods and other PORTS, AND NOTIFICATIONS
comparative calorie claims. A food pur-
porting to be ‘‘reduced calorie’’ or oth- Subpart A—General Provisions
erwise containing fewer calories than a
reference food must comply with the Sec.
criteria set forth for such food in 106.1 Status and applicability of the regula-
§ 101.60(b)(4) and (b)(5) of this chapter. tions in part 106.
106.3 Definitions.
(e) Label terms suggesting usefulness as
low calorie or reduced calorie foods. (1) Subpart B—Current Good Manufacturing
Except as provided in paragraphs (e)(2) Practice
and (e)(3) of this section, and in
§ 101.13(q)(2) of this chapter for soft 106.5 Current good manufacturing practice.
drinks, a food may be labeled with 106.6 Production and in-process control sys-
terms such as ‘‘diet,’’ ‘‘dietetic,’’ ‘‘ar- tem.
tificially sweetened,’’ or ‘‘sweetened 106.10 Controls to prevent adulteration by
with nonnutritive sweetener’’ only if workers.
the claim is not false and misleading, 106.20 Controls to prevent adulteration
caused by facilities.
and the food is labeled ‘‘low calorie’’ or
106.30 Controls to prevent adulteration
‘‘reduced calorie’’ or bears another caused by equipment or utensils.
comparative calorie claim in compli- 106.35 Controls to prevent adulteration due
ance with part 101 of this chapter and to automatic (mechanical or electronic)
this section. equipment.
(2) Paragraph (e)(1) of this section 106.40 Controls to prevent adulteration
shall not apply to any use of such caused by ingredients, containers, and
terms that is specifically authorized by closures.
regulation governing a particular food, 106.50 Controls to prevent adulteration dur-
ing manufacturing.
or, unless otherwise restricted by regu-
106.55 Controls to prevent adulteration from
lation, to any use of the term ‘‘diet’’ microorganisms.
that clearly shows that the food is of- 106.60 Controls to prevent adulteration dur-
fered solely for a dietary use other ing packaging and labeling of infant for-
than regulating body weight, e.g., ‘‘for mula.
low-sodium diets.’’ 106.70 Controls on the release of finished in-
(3) Paragraph (e)(1) of this section fant formula.
shall not apply to any use of such 106.80 Traceability.
terms on a formulated meal replace- 106.90 Audits of current good manufacturing
ment or other food that is represented practice.
to be of special dietary use as a whole
Subpart C—Quality Control Procedures
meal, pending the issuance of a regula-
tion governing the use of such terms on 106.91 General quality control.
foods. 106.92 Audits of quality control procedures.
(f) ‘‘Sugar free,’’ and ‘‘no added
sugar.’’ Criteria for the use of the Subpart D—Conduct of Audits
terms ‘‘sugar free’’ and ‘‘no added 106.94 Audit plans and procedures.
sugar’’ are provided for in § 101.60(c) of
this chapter. Subpart E—Quality Factors for Infant
[58 FR 2430, Jan. 6, 1993] Formulas

106.96 Requirements for quality factors for
Subpart C [Reserved] infant formulas.
190
Subpart F—Records and Reports mula, the formula will be deemed to be

adulterated under section 412(a)(2) of
106.100 Records.
the Federal Food, Drug, and Cosmetic
Subpart G—Registration, Submission, and Act. If an infant formula manufacturer
Notification Requirements fails to comply with the good manufac-
turing practices or quality control pro-
106.110 New infant formula registration. cedures record requirements in subpart
106.120 New infant formula submission. F of this part with respect to an infant
106.121 Quality factor assurances for infant
formula, the infant formula will be
formulas.
106.130 Verification submission. deemed to be adulterated under section
106.140 Submission concerning a change in 412(a)(3) of the Federal Food, Drug, and
infant formula that may adulterate the Cosmetic Act. The criteria set forth in
product. subpart F of this part also implement
106.150 Notification of an adulterated or record retention requirements under
misbranded infant formula. section 412(b)(4) of the Federal Food,
106.160 Incorporation by reference.
Drug, and Cosmetic Act. Failure to
AUTHORITY: 21 U.S.C. 321, 342, 350a, 371. comply with any regulation in subpart
SOURCE: 79 FR 8059, Feb. 10, 2014, unless F of this part is a violation of section
otherwise noted. 301(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(e)).
Subpart A—General Provisions (d) The criteria set forth in subpart G
of this part describe, in part, certain
§ 106.1 Status and applicability of the good manufacturing practices, quality
regulations in part 106. control procedures, and quality factor
(a) The criteria set forth in subparts records requirements under section
B, C, and D of this part prescribe the 412(b)(1) and (b)(2) of the Federal Food,
steps that manufacturers shall take Drug and Cosmetic Act. If an infant
under section 412(b)(2) and (b)(3) of the formula manufacturer fails to comply
Federal Food, Drug, and Cosmetic Act with such records requirements with
(21 U.S.C. 350a(b)(2) and (b)(3)) in proc- respect to an infant formula, the infant
essing infant formula. If the processing formula will be deemed to be adulter-
of the formula does not comply with ated under section 412(a)(2) or (a)(3) of
any regulation in subparts B, C, or D of the Federal Food, Drug, and Cosmetic
this part, the formula will be deemed Act, as applicable. The criteria set
to be adulterated under section forth in subpart G of this part also de-
412(a)(3) of the Federal Food, Drug, and scribe the circumstances in which an
Cosmetic Act. infant formula manufacturer is re-
(b) The criteria set forth in subpart E quired to register with, submit to, or
of this part prescribe the requirements notify the Food and Drug Administra-
for quality factors that infant formula tion, and the content of a registration,
shall meet under section 412(b)(1) of the submission, or notification, under sec-
Federal Food, Drug, and Cosmetic Act. tion 412(c), (d), and (e) of the Federal
If the formula fails to comply with any Food, Drug, and Cosmetic Act. Failure
regulation in subpart E of this part, it to comply with any regulation in sub-
will be deemed to be adulterated under part G of this part is a violation of sec-
section 412(a)(2) of the Federal Food, tion 301(s) of the Federal Food, Drug,
Drug, and Cosmetic Act. and Cosmetic Act.
(c) The criteria set forth in subpart F
of this part prescribe records require- § 106.3 Definitions.
ments for quality factors under section The definitions in this section and
412(b)(1) of the Federal Food, Drug, and the definitions contained in section 201
Cosmetic Act and for good manufac- of the Federal Food, Drug, and Cos-
turing practices and quality control metic Act (21 U.S.C. 321) shall apply to
procedures, including distribution and infant formula requirements in 21 CFR
audit records, under section 412(b)(2). If parts 106 and 107 of this chapter.
an infant formula manufacturer fails Eligible infant formula means an in-
to comply with the quality factor fant formula that could be lawfully dis-
record requirements in subpart F of tributed in the United States on De-
this part with respect to an infant for- cember 8, 2014.
191
§ 106.3 21 CFR Ch. I (4–1–16 Edition)
Final product stage means the point in Drug, and Cosmetic Act (21 U.S.C.
the manufacturing process, before dis- 350a(i)), such as taurine or L-carnitine;
tribution of an infant formula, at (6) Any infant formula processed by a
which the infant formula is homo- manufacturer on new equipment that
geneous and is not subject to further utilizes a new technology or principle
degradation due to processing. (e.g., from terminal sterilization to
Indicator nutrient means a nutrient aseptic processing); or
whose concentration is measured dur- (7) An infant formula for which there
ing the manufacture of an infant for- has been a fundamental change in the
mula to confirm complete addition and type of packaging used (e.g., changing
uniform distribution of a premix or from metal cans to plastic pouches).
other substance of which the indicator Manufacturer means a person who
nutrient is a part. prepares, reconstitutes, or otherwise
Infant means a person not more than changes the physical or chemical char-
12 months of age. acteristics of an infant formula or
Infant formula means a food which packages or labels the product in a
purports to be or is represented for spe- container for distribution. The term
cial dietary use solely as a food for in- ‘‘manufacturer’’ does not include a per-
fants by reason of its simulation of son who prepares, reconstitutes, or
human milk or its suitability as a com- mixes infant formula exclusively for an
plete or partial substitute for human infant under his/her direct care or the
milk. direct care of the institution employ-
In-process production aggregate means ing such person.
a combination of ingredients at any Microorganisms means yeasts, molds,
point in the manufacturing process be- bacteria, and viruses and includes, but
fore packaging. is not limited to, species having public
Major change in an infant formula health significance.
means any new formulation, or any New infant formula means:
change of ingredients or processes (1) An infant formula manufactured
where experience or theory would pre- by a person that has not previously
dict a possible significant adverse im- manufactured an infant formula, and
pact on levels of nutrients or bio- (2) An infant formula manufactured
availability of nutrients, or any change by a person that has previously manu-
that causes an infant formula to differ factured infant formula and in which
fundamentally in processing or in com- there is a major change in processing
position from any previous formulation or formulation from a current or any
produced by the manufacturer. Exam- previous formulation produced by such
ples of infant formulas deemed to differ manufacturer, or which has not pre-
fundamentally in processing or in com- viously been the subject of a submis-
position include: sion under section 412(c) of the Federal
(1) Any infant formula produced by a Food, Drug, and Cosmetic Act for the
manufacturer who is entering the U.S. U.S. market.
market; Nutrient means any vitamin, mineral,
(2) Any infant formula powder proc- or other substance or ingredient that is
essed and distributed by a manufac- required in accordance with the ‘‘Nu-
turer who previously only produced liq- trients’’ table set out in section
uids (or vice versa); 412(i)(1) of the Federal Food, Drug, and
(3) Any infant formula having a sig- Cosmetic Act or by regulations issued
nificant revision, addition, or substi- under section 412(i)(2) or that is identi-
tution of a macronutrient (i.e., protein, fied as essential for infants by the Food
fat, or carbohydrate), with which the and Nutrition Board of the Institute of
manufacturer has not had previous ex- Medicine through its development of a
perience; Dietary Reference Intake, or that has
(4) Any infant formula manufactured been identified as essential for infants
on a new processing line or in a new by the Food and Drug Administration
plant; through a FEDERAL REGISTER publica-
(5) Any infant formula manufactured tion.

containing a new constituent not listed Nutrient premix means a combination
in section 412(i) of the Federal Food, of ingredients containing two or more
192
nutrients received from a supplier or nutrients required under § 107.100 of

prepared by an infant formula manu- this chapter and is manufactured in a
facturer. manner designed to prevent its adulter-
Production aggregate means a quan- ation. A liquid infant formula that is a
tity of product, or, in the case of an in- thermally processed low-acid food
fant formula produced by continuous packaged in a hermetically sealed con-
process, a specific identified amount tainer is also subject to the regulations
produced in a unit of time, that is in- in part 113 of this chapter, and an in-
tended to have uniform composition, fant formula that is an acidified food,
character, and quality, within specified as defined in § 114.3(b) of this chapter, is
limits, and is produced according to a also subject to the regulations in part
master manufacturing order. 114 of this chapter.
Production unit means a specific (b) The failure to comply with any
quantity of an infant formula produced regulation in this subpart in the manu-
during a single cycle of manufacture facture, processing, packing, or holding
that has uniform composition, char- of an infant formula shall render such
acter, and quality, within specified infant formula adulterated under sec-
limits. tion 412(a)(3) of the Federal Food,
Production unit number or production Drug, and Cosmetic Act (21 U.S.C.
aggregate number means any distinctive 350a(a)(3)); the failure to comply with
combination of letters, numbers, sym- any regulation in part 113 of this chap-
bols, or any combination of them, from ter in the manufacture, processing,
which the complete history of the man- packing, or holding of a liquid infant
ufacture, processing, packing, holding, formula shall render such infant for-
and distribution of a production aggre- mula adulterated under section
gate or a production unit of infant for- 412(a)(3); and the failure to comply
mula can be determined. with any regulation in part 114 of this
Quality factors means those factors chapter in the manufacture, proc-
necessary to demonstrate the safety of essing, packing, or holding of an infant
the infant formula and the bio- formula that is an acidified food shall
availability of its nutrients, as pre- render such infant formula adulterated
pared for market and when fed as the under section 412(a)(3).
sole source of nutrition, to ensure the
healthy growth of infants. § 106.6 Production and in-process con-
Representative sample means a sample trol system.
that consists of a number of units that (a) A manufacturer shall conform to
are drawn based on rational criteria,
the requirements of this subpart by im-
such as random sampling, and intended
plementing a system of production and
to ensure that the sample accurately
in-process controls. This production
portrays the material being sampled.
and in-process control system shall
Shall is used to state mandatory re-
cover all stages of processing, from the
quirements.
receipt and acceptance of the raw ma-
[79 FR 8059, Feb. 10, 2014, as amended at 79 terials, ingredients, and components
FR 33070, June 10, 2014] through the storage and distribution of
the finished product and shall be de-
Subpart B—Current Good signed to ensure that all the require-
Manufacturing Practice ments of this subpart are met.
(b) The production and in-process
§ 106.5 Current good manufacturing control system shall be set out in a
practice. written plan or set of procedures that
(a) The regulations set forth in this is designed to ensure that an infant
subpart define the minimum current formula is manufactured in a manner
good manufacturing practices that are that will prevent adulteration of the
to be used in, and the facilities or con- infant formula.
trols that are to be used for, the manu- (c) At any point, step, or stage in the
facture, processing, packing, or holding production process where control is
of an infant formula. Compliance with necessary to prevent adulteration, a

these provisions is necessary to ensure manufacturer shall:
that such infant formula provides the (1) Establish specifications to be met;
193
§ 106.10 21 CFR Ch. I (4–1–16 Edition)
(2) Monitor the production and in- (1) Wearing clean outer garments
process control point, step, or stage; and, as necessary, protective apparel
(3) Establish a corrective action plan such as head, face, hand, and arm cov-
for use when a specification established erings; and
in accordance with paragraph (c)(1) of (2) Washing hands thoroughly in a
this section is not met; hand washing facility with soap and
(4) Review the results of the moni- running water at a suitable tempera-
toring required by paragraph (c)(2) of ture before starting work, after each
this section, and review and evaluate absence from the work station, and at
the public health significance of any any other time when the hands may be-
deviation from specifications that have come soiled or contaminated.
been established in accordance with (c) Any person who reports that he or
paragraph (c)(1) of this section. For she has, or appears by medical exam-
any specification established in accord- ination or supervisory observation to
ance with paragraph (c)(1) of this sec- have, an illness, open lesion (including
tion that a manufacturer fails to meet, boils, sores, or infected wounds), or any
an individual qualified by education, other source of microbial contamina-
training, or experience shall conduct a tion that creates a reasonable possi-
documented review and shall make a bility that the safety of an infant for-
material disposition decision to reject mula may be adversely affected, shall
the affected article, to reprocess or be excluded from direct contact with
otherwise recondition the affected arti- ingredients, containers, closures, in-
cle, or to approve and release the arti- process materials, equipment, utensils,
cle for use or distribution; and and infant formula product until the
(5) Establish recordkeeping proce- condition is corrected or determined by
dures, in accordance with § 106.100(e)(3), competent medical personnel not to
that ensure that compliance with the jeopardize the safety of the infant for-
requirements of this section is docu- mula.
mented.
(d) Any article that fails to meet a § 106.20 Controls to prevent adultera-
tion caused by facilities.
specification established in accordance
with paragraph (c)(1) of this section (a) Buildings used in the manufac-
shall be controlled under a quarantine ture, processing, packing, or holding of
system designed to prevent its use infant formula shall be maintained in a
pending the completion of a docu- clean and sanitary condition and shall
mented review and material disposi- have space for the separation of incom-
tion decision. patible operations, such as the han-
dling of raw materials, the manufac-
§ 106.10 Controls to prevent adultera- ture of the product, and packaging and
tion by workers. labeling operations.
(a) A manufacturer shall employ suf- (b) Separate areas or another system
ficient personnel, qualified by edu- of separation, such as a computerized
cation, training, or experience, to per- inventory control, a written card sys-
form all operations, including all re- tem, or an automated system of seg-
quired recordkeeping, in the manufac- regation, shall be used for holding raw
ture, processing, packing, and holding materials, in-process materials, and
of each infant formula and to supervise final infant formula product at the fol-
such operations to ensure that the op- lowing times:
erations are correctly and fully per- (1) Pending release for use in infant
formed. formula production or pending release
(b) Personnel working directly with of the final product;
infant formula, infant formula raw ma- (2) After rejection for use in, or as,
terials, infant formula packaging, or infant formula; and
infant formula equipment or utensil (3) After release for use in infant for-
contact surfaces shall practice good mula production or after release of the
personal hygiene to protect the infant final product.

formula against contamination. Good (c) Lighting shall allow easy identi-
personal hygiene includes: fication of raw materials, packaging,
194
labeling, in-process materials, and fin- tests less frequently than annually for
ished products that have been released chemical contaminants, every 4 years
for use in infant formula production for radiological contaminants, and
and shall permit the easy reading of in- weekly for bacteriological contami-
struments and controls necessary in nants.
processing, packaging, and laboratory (4) A manufacturer shall make and
analysis. Any lighting fixtures directly retain records, in accordance with
over or adjacent to exposed raw mate- § 106.100(f)(1), of the frequency and re-
rials, in-process materials, or bulk sults of testing of the water used in the
(unpackaged) finished product shall be production of infant formula.
protected to prevent glass from con- (g) There shall be no backflow from,
taminating the product in the event of or cross-connection between, piping
breakage. systems that discharge waste water or
(d) A manufacturer shall provide ade- sewage and piping systems that carry
quate ventilation or control equipment water for infant formula manufac-
to minimize odors and vapors (includ- turing.
ing steam and noxious fumes) in areas (h) Only culinary steam shall be used
where they may contaminate the in- at all direct infant formula product
fant formula; and shall minimize the contact points. Culinary steam shall be
potential for contamination of raw main compliance with the 3–A Sanitary
terials, in-process materials, final Standards, No. 60903, which is incor-
product infant formula, packing mate- porated by reference at § 106.160. Boiler
rials, and infant formula-contact sur- water additives in the steam shall be
faces, through the use of appropriate used in accordance with § 173.310 of this
measures, which may include the use of chapter.
air filtration. (i) Each infant formula manufac-
(e) All rodenticides, insecticides, fun- turing site shall provide its employees
gicides, fumigating agents, and clean- with readily accessible toilet facilities
ing and sanitizing agents shall be and hand washing facilities that in-
stored and used in a manner that pro- clude hot and cold water, soap or deter-
tects against contamination of infant gent, single-service towels or air dryers
formula. in toilet facilities. These facilities
(f) Potable water used in the manu- shall be maintained in good repair and
facture of infant formula shall meet in a sanitary condition at all times.
the standards prescribed in the Envi- These facilities shall provide for proper
ronmental Protection Agency’s (EPA’s) disposal of the sewage. Doors to the
Primary Drinking Water regulations in toilet facility shall not open into areas
40 CFR part 141, except that the water where infant formula, ingredients, con-
used in infant formula manufacturing tainers, or closures are processed, han-
shall not be fluoridated or shall be dled, or stored, except where alternate
defluoridated to a level as low as pos- means have been taken to protect
sible prior to use. against contamination.
(1) The water shall be supplied under
continuous positive pressure in a [79 FR 8059, Feb. 10, 2014, as amended at 79
plumbing system that is free of defects FR 33070, June 10, 2014]
that could contaminate an infant for-
mula. § 106.30 Controls to prevent adultera-
(2) A manufacturer shall test rep- tion caused by equipment or uten-
sils.
resentative samples of the potable
water drawn at a point in the system (a) A manufacturer shall ensure that
at which the water is in the same con- equipment and utensils used in the
dition that it will be when it is used in manufacture, processing, packing, or
infant formula manufacturing. holding of an infant formula are of ap-
(3) A manufacturer shall conduct the propriate design and are installed to fa-
tests required by paragraph (f)(2) of cilitate their intended function and
this section with sufficient frequency their cleaning and maintenance.
to ensure that the water meets the (b) A manufacturer shall ensure that
EPA’s Primary Drinking Water Regu- equipment and utensils used in the
lations but shall not conduct these manufacture, processing, packing, or
195
§ 106.30 21 CFR Ch. I (4–1–16 Edition)
holding of an infant formula are con- control, or at routine intervals other-

structed so that surfaces that contact wise deemed necessary to ensure the
ingredients, in-process materials, or in- accuracy of the instrument or control.
fant formula are made of nontoxic ma- A manufacturer shall make and retain
terials and are not reactive or absorp- records of the calibration activities in
tive. A manufacturer shall ensure that accordance with § 106.100(f)(2).
such equipment and utensils are de- (2) Instruments and controls that
signed to be easily cleanable and to cannot be adjusted to agree with the
withstand the environment of their in- reference standard shall be repaired or
tended use and that all surfaces that replaced.
contact ingredients, in-process mate- (3) If calibration of an instrument
rials, or infant formula are cleaned and shows a failure to meet a specification
sanitized, as necessary, and are main- for a point where control is deemed
tained to protect infant formula from necessary to prevent adulteration of
being contaminated by any source. All infant formula product, a written eval-
sanitizing agents used on such equip- uation of all affected product, and of
ment and utensils that are regulated as any actions that need to be taken with
pesticide chemicals under 21 U.S.C. respect to that product, shall be made,
346a(a) shall comply with the Environ- in accordance with § 106.100(f)(2).
mental Protection Agency’s regula- (e) The following provisions apply to
tions established under such section,
thermal processing and cold storage of
and all other such sanitizers shall com-
infant formulas:
ply with all applicable Food and Drug
(1) Equipment and procedures for
Administration laws and regulations.
thermal processing of infant formula
(c) A manufacturer shall ensure that
packaged in hermetically sealed con-
any substance, such as a lubricant or a
tainers shall conform to the require-
coolant, that is required for operation
ments in 21 CFR parts 108 and 113.
of infant formula manufacturing equip-
ment and which would render the in- (2)(i) Except as provided in paragraph
fant formula adulterated if such sub- (e)(2)(ii) of this section, a manufacturer
stance were to come in contact with shall maintain all areas of cold storage
the formula, does not come in contact at a temperature of 40 °F (4.4 °C) or
with formula ingredients, containers, below.
closures, in-process materials, or with (ii) A manufacturer may maintain a
infant formula product during the cold storage area for an in-process in-
manufacture of an infant formula. fant formula or for a final infant for-
(d) A manufacturer shall ensure that mula at a temperature not to exceed 45
each instrument used for measuring, °F (7.2 °C) for a defined period of time
regulating, or controlling mixing time provided that the manufacturer has
and speed, temperature, pressure, mois- scientific data and other information
ture, water activity, or other param- to demonstrate that the time and tem-
eter at any point, step, or stage where perature conditions of such storage are
control is necessary to prevent adulter- sufficient to ensure that there is no
ation of an infant formula during proc- significant growth of microorganisms
essing is accurate, easily read, properly of public health significance during the
maintained, and present in sufficient period of storage of the in-process or
number for its intended use. final infant formula product.
(1) The instruments and controls (3)(i) Cold storage compartments and
shall be calibrated against a known ref- thermal processing equipment shall be
erence standard at the time of or be- equipped with easily readable, accurate
fore first use and thereafter at routine temperature-indicating devices.
intervals, as specified in writing by the (ii) A manufacturer shall ensure that
manufacturer of the instrument or con- the temperature of each cold storage
trol, or as otherwise deemed necessary compartment is maintained by:
to ensure the accuracy of the instru- (A) Monitoring the temperature of
ment or control. The known reference the cold storage compartment on a
standard shall be certified for accuracy temperature-indicating device and re-

at the intervals specified in writing by cording this temperature in a record
the manufacturer of the instrument or with such frequency as is necessary to
196
ensure that temperature control is equipment, or that come into contact

maintained; with any other surface that contacts
(B) Equipping the cold storage com- ingredients, in-process materials, or in-
partment with one or more tempera- fant formula product are treated in
ture-recording devices that will reflect, such a way that their use will not con-
on a continuing basis, the true tem- taminate the infant formula with un-
perature, within the compartment; lawful or other chemical, physical, or
(C) Equipping the cold storage com- microbiological contaminants. When
partment with a high temperature compressed gases are used at product
alarm that has been validated to func- filling machines to replace air removed
tion properly and recording the tem- from the headspace of containers, a
perature in a record with such fre- manufacturer shall install, as close as
quency as is necessary to ensure that practical to the end of the gas line that
temperature control is maintained; or feeds gas into the space, a filter capa-
(D) Equipping the cold storage com- ble of retaining particles 0.5 microm-
partment with a maximum-indicating eter or smaller.
thermometer that has been validated [79 FR 8059, Feb. 10, 2014, as amended at 79
to function properly and recording this FR 33071, June 10, 2014]
temperature in a record with such fre-
quency as is necessary to ensure that § 106.35 Controls to prevent adultera-
temperature control is maintained. tion due to automatic (mechanical
(iii) A manufacturer shall, in accord- or electronic) equipment.
ance with § 106.100(f)(3), make and re- (a) For the purposes of this section:
tain records of the temperatures re- (1) ‘‘Hardware’’ means all automatic
corded in compliance with equipment, including mechanical and
§ 106.30(e)(3)(ii). electronic equipment (such as com-
(4) When a manufacturer uses a tem- puters), that is used in production or
perature-recording device for a cold quality control of infant formula.
storage compartment, such device shall (2) ‘‘Software’’ means any programs,
not read lower than the reference tem- procedures, rules, and associated docu-
perature-indicating device. mentation used in the operation of a
(5) A manufacturer shall monitor the system.
temperature in thermal processing (3) ‘‘System’’ means a collection of
equipment at points where tempera- components (including software and
ture control is necessary to prevent hardware) organized to accomplish a
adulteration. Such monitoring shall be specific function or set of functions in
at such frequency as is required by reg- a specified environment.
ulation or is necessary to ensure that (4) ‘‘Validation’’ means establishing
temperature control is maintained. documented evidence that provides a
(f) A manufacturer shall ensure that high degree of assurance that a system
equipment and utensils used in the will consistently produce a product
manufacture of infant formula are meeting its predetermined specifica-
cleaned, sanitized, and maintained at tions and quality characteristics. Vali-
regular intervals to prevent adultera- dation can be accomplished through
tion of the infant formula. any suitable means, such as
(1) An individual qualified by edu- verification studies or modeling.
cation, training, or experience to con- (b) All systems shall be designed, in-
duct such a review shall review all stalled, tested, and maintained in a
cleaning, sanitizing, and maintenance manner that will ensure that they are
to ensure that it has been satisfac- capable of performing their intended
torily completed. function and of producing or analyzing
(2) A manufacturer shall make and infant formula in accordance with this
retain records on equipment cleaning, subpart and subpart C of this part.
sanitizing, and maintenance, in accord- (1) A manufacturer shall ensure, at
ance with § 106.100(f)(4). any point, step, or stage where control
(g) A manufacturer shall ensure that is necessary to prevent adulteration of
compressed air or other gases that are the infant formula, that all hardware is
mechanically introduced into infant routinely inspected and checked ac-
formula, that are used to clean any cording to written procedures and that
197
§ 106.40 21 CFR Ch. I (4–1–16 Edition)
hardware that is capable of being cali- that comes in contact with an infant
brated is routinely calibrated accord- formula:
ing to written procedures. (1) A food additive that is the subject
(2) A manufacturer shall check and of a regulation issued under section
document the accuracy of input into, 409(c) of the Federal Food, Drug, and
and output generated by, any system Cosmetic Act (21 U.S.C. 348(c)) and is
used in the production or quality con- used consistent with the conditions of
trol of an infant formula to ensure that use of that regulation;
the infant formula is not adulterated. (2) A food contact substance that is
The degree and frequency of input/out- the subject of an effective notification
put verification shall be based on the under section 409(h) of the Federal
complexity and reliability of the sys- Food, Drug, and Cosmetic Act and is
tem and the level of risk associated used consistent with the conditions of
with the safe operation of the system. use in that notification;
(3) A manufacturer shall ensure that (3) A substance that is exempt from
each system is validated prior to the regulation as a food additive under
release for distribution of any infant § 170.39 of this chapter and its use con-
formula manufactured using the sys- forms to the use identified in the ex-
tem. emption letter;
(4) A manufacturer shall ensure that (4) A substance that is generally rec-
any system that is modified is revali- ognized as safe for use in or on infant
dated following the modification and formula or for use in infant formula
prior to the release for distribution of packaging;
any infant formula manufactured using (5) A substance the use of which is
the modified system. All modifications authorized by a prior sanction from the
to software shall be made by a des- Food and Drug Administration or from
ignated individual and shall be checked the U.S. Department of Agriculture;
by the infant formula manufacturer to and
ensure that infant formula that is pro-
(6) A substance that is not a food ad-
duced or analyzed using the modified
ditive within the meaning of section
software complies with this subpart
201(s) of the Federal Food, Drug, and
and with subpart C of this part.
Cosmetic Act (21 U.S.C. 321(s)) because
(c) A manufacturer shall make and the substance is not reasonably ex-
retain records, in accordance with pected to become a component of food
§ 106.100(f)(5), concerning mechanical or or otherwise affect the characteristics
electronic equipment. of food.
[79 FR 8059, Feb. 10, 2014, as amended at 79 (c) Ingredients, containers, and clo-
FR 33071, June 10, 2014] sures used in the manufacture of infant
formula shall be identified with a lot
§ 106.40 Controls to prevent adultera- number to be used in recording their
tion caused by ingredients, con- disposition.
tainers, and closures.
(d) A manufacturer shall develop
(a) The only substances that may be written specifications for ingredients,
used in an infant formula are sub- containers, and closures used in manu-
stances that are safe and suitable for facturing infant formula and shall de-
use in infant formula under the appli- velop and follow written procedures to
cable food safety provisions of the Fed- determine whether all ingredients, con-
eral Food, Drug, and Cosmetic Act; tainers, and closures meet these speci-
that is, a substance is used in accord- fications. When any specification is not
ance with the Agency’s food additive met, an individual qualified by edu-
regulations, is generally recognized as cation, training, or experience shall
safe (GRAS) for such use, or is author- conduct a documented review, shall de-
ized by a prior sanction. termine whether a failure to meet such
(b) Infant formula containers and clo- a specification could result in an adul-
sures shall not be reactive or absorp- terated infant formula, and shall make
tive so as to affect the safety of the in- and document a material disposition
fant formula. The following substances decision to reject the ingredient, con-
may be used as packaging material tainer, or closure or the affected infant
198
formula; to reprocess or otherwise re- lieves that an ingredient, container, or

condition the ingredient, container, or closure that complies with a manufac-
closure or the affected infant formula; turer’s specifications, or that has been
or to approve and release the ingre- released for use following a material
dient, container, or closure or the af- review and disposition decision, has
fected infant formula for use. been exposed to air, heat, or other con-
(e) Ingredients, containers, and clo- ditions that may adversely affect it,
sures shall be stored in separate areas the ingredient, container, or closure
or separated by a system of segrega- shall be quarantined under a system
tion, such as a computerized inventory designed to prevent its use in the man-
control, a written card system, or an ufacture of infant formula until an in-
automated system of segregation,
dividual qualified by education, train-
clearly designated for materials pend-
ing, or experience has conducted a doc-
ing release for use; materials released
for use; or materials rejected for use in umented review and has made and doc-
infant formula production. umented a material disposition deci-
(1) Any lot of an ingredient, a con- sion to reject the ingredient, container,
tainer, or a closure that does not meet or closure; to reprocess or otherwise re-
the manufacturer’s specifications shall condition the ingredient, container, or
be quarantined under a system de- closure; or to approve and release the
signed to prevent its use in the manu- ingredient, container, or closure for
facture of infant formula until an indi- use.
vidual qualified by education, training, (1) Any ingredient, container, or clo-
or experience has conducted a docu- sure that is reprocessed or otherwise
mented review, has determined wheth- reconditioned shall be retested or reex-
er such failure could result in an adul- amined and be the subject of a docu-
terated infant formula, and has made mented review and material disposi-
and documented a material disposition tion decision by an individual qualified
decision to reject the ingredient, con- by education, training, or experience to
tainer, closure, or the affected infant determine whether the ingredient, con-
formula; to reprocess or otherwise re- tainer, or closure should be rejected,
condition the ingredient, container, further reprocessed or otherwise fur-
closure, or the affected infant formula; ther reconditioned, or approved and re-
or to approve and release the ingre-
leased for use.
dient, container, closure, or the af-
(2) Any rejected ingredient, con-
fected infant formula for use.
(2) Any ingredient, container, or clo- tainer, or closure shall be clearly iden-
sure that has been reprocessed or oth- tified as having been rejected for use in
erwise reconditioned shall be the sub- infant formula manufacturing or proc-
ject of a documented review and mate- essing operations and shall be con-
rial disposition decision by an indi- trolled under a quarantine system de-
vidual qualified by education, training, signed to prevent its use in infant for-
or experience to determine whether it mula manufacturing or processing op-
may be released for use. erations.
(3) A manufacturer shall not reproc- (3) Any ingredient, container, or clo-
ess or otherwise recondition an ingre- sure that has not been manufactured,
dient, container, or closure rejected be- packaged, labeled, or held under condi-
cause it is contaminated with micro- tions to prevent adulteration under
organisms of public health significance section 402(a)(1) through (a)(4) of the
or other contaminants, such as heavy Federal Food, Drug, and Cosmetic Act
metals. (21 U.S.C. 342(a)(1) through (a)(4)) shall
(f) If an ingredient, container, or clo- not be approved and released for use.
sure that complies with a manufactur- (g) A manufacturer shall make and
er’s specifications, or that has been re- retain records, in accordance with
leased for use following a material re-
§ 106.100(f)(6), on the ingredients, con-
view and disposition decision, is subse-
tainers, and closures used in the manu-

quently exposed to air, heat, or other
conditions that may adversely affect facture of infant formula.
it, or if a manufacturer reasonably be-
199
§ 106.50 21 CFR Ch. I (4–1–16 Edition)
§ 106.50 Controls to prevent adultera- ensure the addition of required ingredi-

tion during manufacturing. ents to, and the homogeneity of, the
(a) A manufacturer shall prepare and formula;
follow a written master manufacturing (2) The spray-drying process for pow-
order that establishes controls and pro- dered infant formula, including the fil-
cedures for the production of an infant tering of the intake air before heating,
formula. to prevent microbial and other con-
(1) The manufacturer shall make and tamination;
retain records, in accordance with (3) The removal of air from the fin-
§ 106.100(e), that include complete infor- ished product to ensure that nutrient
mation relating to the production and deterioration does not occur;
control of the production aggregate. (4) Ensuring that each container of
An individual qualified by education, finished product is properly sealed.
training, or experience shall conduct Such controls shall involve use of es-
an investigation of any deviations from tablished procedures, specifications,
the master manufacturing order and and intervals of examination that are
document any corrective action taken. designed by qualified individuals and
(2) Changes made to the master man- are sufficient to:
ufacturing order shall be reviewed and (i) Detect visible closure or seal de-
approved by a responsible official and fects, and
include an evaluation of the effect of (ii) Determine closure strength
the change on the nutrient content and through destructive testing. A manu-
the suitability of the formula for in- facturer of a liquid infant formula that
fants. is a thermally processed low-acid food
(b) A manufacturer shall establish packaged in a hermetically sealed con-
controls to ensure that each raw or in- tainer shall perform such closure integ-
process ingredient required by the mas- rity testing in accordance with
ter manufacturing order is examined § 113.60(a) of this chapter.
by one person and checked by a second (e) A manufacturer shall establish
person or system. This checking shall controls that ensure that the equip-
ensure that the correct ingredient is ment used at points where control is
added during the manufacturing proc- deemed necessary to prevent adultera-
ess, that the ingredient has been re- tion is monitored, so that personnel
leased for use in infant formula, and will be alerted to malfunctions.
that the correct weight or measure of (f) A manufacturer shall establish
the ingredient is added to the produc- controls for in-process material as fol-
tion unit. lows:
(c) A manufacturer shall establish a (1) For any specification established
system of identification for the con- in accordance with § 106.6(c)(1) that a
tents of all compounding and storage manufacturer fails to meet for in-proc-
containers, processing lines, and major ess material, an individual qualified by
equipment used during the manufac- education, training, or experience shall
ture of a production aggregate of an in- conduct a documented review and shall
fant formula. The system shall permit make a material disposition decision
the identification of the processing to reject the affected in-process mate-
stage and the unique identification rial, to reprocess or otherwise recondi-
number for the particular production tion the affected in-process material,
unit or production aggregate of infant or to approve and release the affected
formula. in-process material for use or distribu-
(d) A manufacturer shall establish tion;
controls to ensure that the nutrient (2) Pending a documented review and
levels required by § 107.100 of this chap- material disposition decision, any in-
ter are maintained in the formula, and process material that fails to meet any
that the formula is not contaminated specification established in accordance
with microorganisms or other contami- with § 106.6(c)(1) shall be clearly identi-
nants. Such controls shall include: fied as such and shall be controlled
(1) The mixing time; the speed, tem- under a quarantine system designed to
perature, and flow rate of product; and prevent its use in manufacturing or
other critical parameters necessary to processing operations until completion
200
of the documented review and material essed low-acid foods packaged in her-
disposition decision; metically sealed containers and part
(3) Any in-process material that has 114 of this chapter for acidified foods.
been reprocessed or otherwise recondi- (c) A manufacturer of powdered in-
tioned shall be the subject of a docu- fant formula shall test representative
mented review and material disposi- samples of each production aggregate
tion decision by an individual qualified of powdered infant formula at the final
by education, training, or experience to product stage, before distribution, to
determine whether it may be released ensure that each production aggregate
for use; and
meets the microbiological quality
(4) Any rejected in-process material
standards in the table in paragraph (e)
shall be clearly identified as having
of this section.
been rejected for use in infant formula
and shall be controlled under a quar- (d) A manufacturer shall make and
antine system designed to prevent its retain records, in accordance with
use in infant formula manufacturing or § 106.100(e)(5)(ii) and (f)(7), on the test-
processing operations. ing of infant formulas for microorga-
nisms.
[79 FR 8059, Feb. 10, 2014, as amended at 79
FR 33071, June 10, 2014]
(e) A powdered infant formula that
contains any microorganism that ex-
§ 106.55 Controls to prevent adultera- ceeds the M value listed for that micro-
tion from microorganisms. organism in the table in paragraph (e)
(a) A manufacturer of infant formula of this section shall be deemed adulter-
shall establish a system of process con- ated under sections 402(a)(1), 402(a)(4),
trols covering all stages of processing and 412(a)(3) of the Federal Food, Drug,
that is designed to ensure that infant and Cosmetic Act (21 U.S.C. 350a(a)(3)).
formula does not become adulterated The Food and Drug Administration
due to the presence of microorganisms will determine compliance with the M
in the formula or in the processing en- values listed below using the latest edi-
vironment. tion of the Bacteriological Analytical
(b) A manufacturer of liquid infant Manual (BAM) (http://www.fda.gov/Food/
formula shall comply, as appropriate, FoodScienceResearch/LaboratoryMethods/
with the procedures specified in part BacteriologicalAnalyticalManualBAM/de-
113 of this chapter for thermally proc- fault.htm) (accessed April 8, 2013).
Microorganism n1 Sample size M value
Cronobacter spp. ............................................. 30 10 g (grams) .................................................... 2 0.
Salmonella spp. ............................................... 60 25 g ................................................................. 2 0.
1 Number of samples.
2 None detected.
§ 106.60 Controls to prevent adultera- (c) Packaging used to hold multiple

tion during packaging and labeling containers of an infant formula prod-
of infant formula. uct shall be labeled as follows:
(a) A manufacturer shall examine (1) Where all containers are the same
packaged and labeled infant formula infant formula product and all bear the
during finishing operations to ensure same code established under § 106.80,
that all containers and packages in the the packaging label shall include the
production aggregate have the correct product name, the name of the manu-
facturer, distributor, or shipper, and
label, the correct use-by date, and the
the code established under § 106.80.
correct code established under § 106.80.
(2) Where the containers are not the
(b) Labels shall be designed, printed,
same infant formula product or do not
and applied so that the labels remain
all bear the same code established
legible and attached during the condi- under § 106.80, the packaging label
tions of processing, storage, handling, shall:

distribution, and use. (i) Include the product name of each
product, the name of the manufacturer,
201
§ 106.70 21 CFR Ch. I (4–1–16 Edition)
distributor, or shipper of each product, or experience to determine whether it

the code established under § 106.80 for may be released for use or distribution.
each product, and a ‘‘use by’’ date that (c) Any rejected infant formula shall
is no later than the ‘‘use by’’ date of be clearly identified as having been re-
the container exhibiting the closest jected for use and shall be controlled
‘‘use by’’ date applied to satisfy the re- under a quarantine system designed to
quirement of § 107.20(c) of this chapter; prevent its release or distribution.
or (d) A production aggregate of infant
(ii) Include a unique identification formula, including a reprocessed or re-
number assigned by the packager, pro- conditioned production aggregate, that
vided that the distributor of the pack- does not meet the nutrient require-
age maintains a record linked to such ments of section 412(i) of the Federal
unique number that identifies the prod- Food, Drug, and Cosmetic Act (21
uct name of each product, the name of U.S.C. 350a(i)) or that has not been
the manufacturer, distributor, or ship- manufactured, packaged, labeled, and
per of each product, the code estab- held under conditions to prevent adul-
lished under § 106.80 for each product, teration under sections 402(a)(1)
and the ‘‘use by’’ date for each product through (a)(4) of the Federal Food,
applied to satisfy the requirement of Drug, and Cosmetic Act (21 U.S.C.
§ 107.20(c) of this chapter. 342(a)(1) through (a)(4)) shall not be ap-
proved and released for distribution.
§ 106.70 Controls on the release of fin-
ished infant formula. § 106.80 Traceability.
(a) A manufacturer shall control Each production aggregate of infant
under a quarantine system designed to formula shall be coded with a sequen-
prevent use or distribution of each pro- tial number that identifies the product
duction aggregate of infant formula and the establishment where the prod-
until it determines that the production uct was packed and that permits trac-
aggregate meets all of the manufacturing of all stages of manufacture of that
er’s specifications, including those production aggregate, including the
adopted to meet the standards of year, the days of the year, and the pe-
§ 106.55 on microbiological contamina- riod during those days that the product
tion and of § 106.91(a) on quality control was packed, and the receipt and han-
procedures, or until the documented re- dling of raw materials used.
view of the failure to meet any of the
manufacturer’s specifications finds § 106.90 Audits of current good manu-
that the failure does not result in, or facturing practice.
could not lead to, adulteration of the (a) A manufacturer of an infant for-
product. mula, or an agent of such manufac-
(b) Any production aggregate of in- turer, shall conduct regularly sched-
fant formula that fails to meet any of uled audits to determine whether the
the manufacturer’s specifications shall manufacturer has complied with the
be quarantined under a system de- current good manufacturing practice
signed to prevent its use in the manu- regulations in this subpart. Such au-
facture of infant formula or its dis- dits shall be conducted at a frequency
tribution until an individual qualified that is required to ensure compliance
by education, training, or experience with such regulations.
has conducted a documented review (b) The audits required by paragraph
and has made and documented a mate- (a) of this section shall be performed by
rial disposition decision to reject the an individual or a team of individuals
infant formula; to reprocess or other- who, as a result of education, training,
wise recondition the infant formula; or or experience, is knowledgeable in all
to approve and release the infant for- aspects of infant formula production
mula. Any production aggregate of in- and of the Agency’s regulations con-
fant formula that is reprocessed or oth- cerning current good manufacturing
erwise reconditioned shall be the sub- practice that such individual or team
ject of a documented review and mate- is responsible for auditing. This indi-
rial disposition decision by an individual or team of individuals shall
vidual qualified by education, training, have no direct responsibility for the
202
matters that such individual or team is and evaluate the levels of all nutrients
auditing and shall have no direct inter- required under § 107.100 of this chapter
est in the outcome of the audit. and all other nutrients added by the
manufacturer. The manufacturer shall
Subpart C—Quality Control repeat such testing every 4 months
Procedures thereafter throughout the shelf life of
the product.
§ 106.91 General quality control. (ii) The Food and Drug Administra-
(a) During manufacture, a manufac- tion will exempt the manufacturer
turer shall test each production aggre- from the requirements of paragraph
gate for nutrients as follows: (b)(1)(i) of this section if the manufac-
(1) Each nutrient premix used in the turer of a new infant formula requests
manufacture of an infant formula shall an exemption and provides analytical
be tested for each nutrient (required data, as required under § 106.120(b)(7),
under § 107.100 of this chapter or other- that demonstrates that the stability of
wise added by the manufacturer) that the new infant formula will likely not
the manufacturer is relying on the pre- differ from the stability of formulas
mix to provide, to ensure that the pre- with similar composition, processing,
mix is in compliance with the manu- and packaging for which there are ex-
facturer’s specifications; tensive stability data. A manufacturer
(2) During the manufacturing proc- exempt from the requirements of para-
ess, after the addition of the premix, or graph (b)(1)(i) of this section would be
at the final product stage but before required to test the first production ag-
distribution, each production aggre- gregate according to the requirements
gate of infant formula shall be tested of § 106.91(b)(2).
for at least one indicator nutrient for (2) The manufacturer shall collect,
each of the nutrient premixes used in from each manufacturing site and at
the infant formula to confirm that the the final product stage, a representa-
nutrients supplied by each of the pre- tive sample of each subsequent produc-
mixes are present, in the proper con- tion aggregate of packaged, finished
centration, in the production aggregate formula in each physical form (powder,
of infant formula. ready-to-feed, or concentrate) and
(3) At the final product stage, before evaluate the levels of all nutrients re-
distribution of an infant formula, each quired under § 107.100 of this chapter
production aggregate shall be tested and all other nutrients added by the
for vitamins A, C, E, and thiamin. manufacturer. The manufacturer shall
(4) During the manufacturing process repeat such testing at the end of the
or at the final product stage, before shelf life of the product.
distribution, each production aggre- (3) If the results of the testing re-
gate shall be tested for all nutrients required by paragraph (b)(1) of this sec-
quired to be included in such formula tion do not substantiate the shelf life
under § 107.100 of this chapter for which of the infant formula, the manufac-
testing is not conducted for compliance turer shall address, as appropriate, all
with paragraphs (a)(1) or (a)(3) of this production aggregates of formula re-
section and for any nutrient added by leased and pending release for distribu-
the manufacturer for which testing is tion that are implicated by the testing
not conducted for compliance with results, such as by conducting the test-
paragraph (a)(1) of this section. ing required by paragraph (b)(1) of this
(b) A manufacturer shall test each section on a subsequently produced
production aggregate of finished prod- production aggregate to substantiate
uct for nutrients as follows: the shelf life of the infant formula or
(1)(i) For an infant formula that is a revising the use by date for such prod-
new infant formula the manufacturer uct so that such date is substantiated
shall collect, from each manufacturing by the stability testing results.
site and at the final product stage, a (4) If results of the testing required
representative sample of the first pro- by paragraph (b)(2) of this section show
duction aggregate of packaged, fin- that any required nutrient is not

ished formula in each physical form present in the production aggregate of
(powder, ready-to-feed, or concentrate) infant formula at the level required by
203
§ 106.92 21 CFR Ch. I (4–1–16 Edition)
§ 107.100 of this chapter or that any nu- aspects of infant formula production
trient added by the manufacturer is and of the regulations concerning qual-
not present at the level declared on the ity control procedures that such indi-
label of the production aggregate of in- vidual or team is responsible for audit-
fant formula, the manufacturer shall: ing. This individual or team of individ-
(i) Investigate the cause of such vari- uals shall have no direct responsibility
ance in the level of any required or for the matters that such individual or
added nutrient; team is auditing and shall have no di-
(ii) Evaluate the significance, if any,
rect interest in the outcome of the
of the results for other production ag-
audit.
gregates of the same formula that have
been released for distribution;
(iii) Address, as appropriate, all pro- Subpart D—Conduct of Audits
duction aggregates of formula released
and pending release for distribution § 106.94 Audit plans and procedures.
that are implicated by the testing re- (a) A manufacturer shall develop and
sults; and follow a written audit plan that is
(iv) Determine whether it is nec- available at the manufacturing facility
essary to conduct the testing required for Food and Drug Administration in-
by paragraph (b)(1) of this section. spection.
(5) The testing required by para-
(b) The audit plan shall include audit
graphs (b)(1) and (b)(2) of this section is
procedures that set out the methods
not required to evaluate the level of
the manufacturer uses to determine
minerals present in the infant formula.
(c) All quality control testing shall whether the facility is operating in ac-
be conducted using appropriate, sci- cordance with current good manufac-
entifically valid test methods. turing practice, with the quality con-
(d) A manufacturer shall make and trol procedures that are necessary to
retain quality control records in ac- ensure that an infant formula provides
cordance with § 106.100(e)(5)(i). nutrients in accordance with sections
412(b) and (i) of the Federal Food, Drug,
FR 33071, June 10, 2014] and Cosmetic Act, and in a manner de-
signed to prevent adulteration of the
§ 106.92 Audits of quality control pro- infant formula.
cedures. (c) The audit procedures shall in-
(a) A manufacturer of an infant for- clude:
mula, or an agent of such a manufac- (1) An evaluation of the production
turer, shall conduct regularly sched- and in-process control system estab-
uled audits to determine whether the lished under § 106.6(b) by:
manufacturer has complied with the (i) Observing the production of infant
requirements for quality control proce- formula and comparing the observed
dures that are necessary to ensure that process to the written production and
an infant formula provides nutrients in in-process control plan required under
accordance with section 412(b) and (i) § 106.6(b);
of the Federal Food, Drug, and Cos-
(ii) Reviewing records of the moni-
metic Act (21 U.S.C. 350a(b) and (i)) and
toring of points, steps, or stages where
is manufactured in a manner designed
control is deemed necessary to prevent
to prevent adulteration of the infant
formula under section 412(a)(1) and adulteration; and
(a)(3) of the Federal Food, Drug, and (iii) Reviewing records of how devi-
Cosmetic Act. Such audits shall be con- ations from any specification at points,
ducted at a frequency that is required steps, or stages where control is
to ensure compliance with the require- deemed necessary to prevent adultera-
ments for quality control procedures. tion were handled; and
(b) The audits required by paragraph (2) A review of a representative sam-
(a) of this section shall be performed by ple of all records maintained in accord-
an individual or a team of individuals ance with § 106.100(e) and (f).

who, as a result of education, training,
or experience, is knowledgeable in all
204
Subpart E—Quality Factors for the requirements of paragraph (b) of

Infant Formulas this section, if:
(1) The manufacturer requests an ex-
§ 106.96 Requirements for quality fac- emption and provides assurances, as re-
tors for infant formulas. quired under § 106.121(b), that the
The regulations set forth in this sub- changes made by the manufacturer to
part define the minimum requirements an existing infant formula are limited
for quality factors for infant formulas: to changing the type of packaging of
(a) An infant formula shall meet the an existing infant formula (e.g., chang-
quality factor of normal physical ing from metal cans to plastic pouch-
growth. es); or
(b) A manufacturer of an infant for- (2) The manufacturer requests an ex-
mula that is not an eligible infant for- emption and provides assurances, as re-
mula shall demonstrate that a formula quired under § 106.121, which dem-
supports normal physical growth in in- onstrate that:
fants when fed as a sole source of nutri- (i) An alternative method or study
tion by conducting, in accordance with design that is based on sound scientific
good clinical practice, an adequate and principles is available to show that the
well-controlled growth monitoring formula supports normal physical
study of the infant formula that: growth in infants when the formula is
(1) Is no less than 15 weeks in dura- fed as the sole source of nutrition;
tion, enrolling infants no more than 2 (ii) The change made by the manu-
weeks old at time of entry into the facturer to an existing formula does
study; not affect the ability of the formula to
(2) Includes the collection and main- support normal physical growth; or
tenance of data on formula intake and (iii) The manufacturer markets a for-
anthropometric measures of physical mulation in more than one form (e.g.,
growth, including body weight, recum- liquid and powdered forms) and the
bent length, head circumference, aver- quality factor requirements are met by
age daily weight increment, and aver- the form of the formula that is proc-
age daily recumbent length increment; essed using the method that has the
(3) Includes anthropometric measure- greatest potential for adversely affect-
ments made at the beginning and end ing nutrient content and bio-
of the study, and at least four addi- availability.
tional measurements made at inter- (d) A manufacturer of a new infant
mediate time points with three of the formula that is not an eligible infant
six total measurements made within formula shall, in accordance with
the first 4 weeks of the study and three § 106.100(p)(1), make and retain records
measurements made at approximately demonstrating that the formula meets
4-week intervals over the remaining 11 the quality factor of normal physical
weeks of the study; growth.
(4) Compares the anthropometric (e) An infant formula shall meet the
data for the test group to a concurrent quality factor of sufficient biological
control group or groups at each time quality of protein.
point and compares the anthropo- (f) A manufacturer of an infant for-
metric data for each infant (body mula that is not an eligible infant for-
weight for age, body length for age, mula shall demonstrate that a formula
head circumference for age, and weight meets the quality factor of sufficient
for length) in the test group and the biological quality of protein by estab-
control group to the 2009 CDC growth lishing the biological quality of the
charts, which are incorporated by ref- protein in the infant formula when fed
erence at § 106.160; and as the sole source of nutrition using an
(5) Compares the data on formula inappropriate modification of the Pro-
take of the test group with a concur- tein Efficiency Ratio (PER) rat bio-
rent control group or groups and a sci- assay described in the ‘‘Official Meth-
entifically appropriate reference. ods of Analysis of AOAC Inter-

(c) The Food and Drug Administra- national,’’ 18th ed., sections 45.3.04 and
tion will exempt a manufacturer from 45.3.05, ‘‘AOAC Official Method 960.48
205
§ 106.96 21 CFR Ch. I (4–1–16 Edition)
Protein Efficiency Ratio Rat Bio- (ii) The scientific evidence on such
assay,’’ which is incorporated by ref- infant formula meets the following
erence at § 106.160. The PER rat bio- provisions:
assay shall be conducted on a formula (A) The evidence is an adequate and
and the results evaluated prior to the well-controlled growth study, con-
initiation of a growth monitoring ducted in accordance with good clinical
study of the formula that is required practice, to determine whether an in-
under paragraph (b) of this section. fant formula supports normal physical
(g) The Food and Drug Administra- growth in infants when the formula is
tion will exempt a manufacturer from fed as the sole source of nutrition;
the requirements of paragraph (f) of (B) The growth study is no less than
this section, if: 4 months in duration, enrolling infants
(1) The manufacturer requests an ex- no more than 1 month old at time of
emption and provides assurances as re- entry into the study;
quired under § 106.121(g) that the (C) The growth study collects from
changes made by the manufacturer to the study subjects data on anthropo-
an existing infant formula are limited metric measures of physical growth,
including body weight, recumbent
to changing the type of packaging of
length, head circumference, and aver-
an existing infant formula (e.g., chang-
age daily weight increment, and plots
ing from metal cans to plastic pouch-
the data on the following charts from
es); or
‘‘Physical Growth: National Center for
(2) The manufacturer requests an ex- Health Statistics Percentiles’’ for body
emption and provides assurances, as re- weight, body length, and head circum-
quired under § 106.121(h), that dem- ference, which are incorporated by ref-
onstrate that the change made by the erence at § 106.160:
manufacturer to an existing formula (1) Figure 1. Length by age percent-
does not affect the bioavailability of iles for girls aged birth–36 months (p.
the protein. 609);
(3) The manufacturer requests an ex- (2) Figure 2. Length by age percent-
emption and provides assurances, as re- iles for boys aged birth–36 months (p.
quired under § 106.121(i), that dem- 610);
onstrate that an alternative method to (3) Figure 3. Weight by age percentiles
the PER that is based on sound sci- for girls aged birth–36 months (p. 611);
entific principles is available to dem- (4) Figure 4. Weight by age percentiles
onstrate that the formula supports the for boys aged birth–36 months (p. 612);
quality factor for the biological qual- (5) Figure 5. Head circumference by
ity of the protein. age percentiles for girls aged birth–36
(h) A manufacturer of a new infant months (p. 613);
formula that is not an eligible infant (6) Figure 6. Weight by length per-
formula shall, in accordance with centiles for girls aged birth–36 months
§ 106.100(q), make and retain records (p. 613);
demonstrating that the formula meets (7) Figure 7. Head circumference by
the quality factor of sufficient biologi- age percentiles for boys aged birth–36
cal quality of protein. months (p. 614); and
(i) The following provisions for re- (8) Figure 8. Weight by length per-
quirements for quality factors apply centiles for boys aged birth–36 months
only to an ‘‘eligible infant formula’’ as (p. 614); and
defined in § 106.3: (D) The growth study collects an-
(1) An eligible infant formula that thropometric measurements at the be-
fulfills one or more of the following ginning of the growth study, at 2
criteria meets the quality factor of weeks, at 4 weeks, at least monthly
normal physical growth: thereafter, and at the conclusion of the
(i) The scientific evidence on such in- study; or
fant formula meets the requirements of (iii) The scientific evidence on such
paragraph (b) of this section that apply infant formula otherwise demonstrates
to infant formula that is not an eligi- that such formula supports normal
ble infant formula; physical growth.
206
(2) An eligible infant formula that protein in such infant formula is of suf-
fulfills one or more of the following ficient biological quality. The records
criteria meets the quality factor of suf- required by this paragraph shall in-
ficient biological quality of the pro- clude all relevant scientific data and
tein: information and a narrative expla-
(i) The scientific evidence on such in- nation of why the data and information
fant formula meets the requirements of demonstrate that the formula supports
paragraph (f) of this section that apply normal physical growth and a nar-
to infant formula that is not an eligi- rative explanation of why the data and
ble infant formula; information demonstrate that the pro-
(ii) The scientific evidence on such tein in such infant formula is of suffi-
infant formula is a study that estab- cient biological quality.
lishes the biological quality of the pro-
tein in an infant formula by dem- [79 FR 8059, Feb. 10, 2014, as amended at 79
FR 33071, June 10, 2014]
onstrating that the protein source sup-
ports adequate growth using the Pro-
tein Efficiency Ratio (PER) rat bio- Subpart F—Records and Reports
assay described in sections 45.3.04 and
45.3.05 of the ‘‘Official Methods of Anal- § 106.100 Records.
ysis of the Association of Official Ana- (a) Every manufacturer of infant for-
lytical Chemists,’’ 16th ed., which are mula shall maintain the records speci-
incorporated by reference at § 106.160; fied in this regulation in order to per-
or mit the Food and Drug Administration
(iii) The scientific evidence on such to determine whether each manufac-
infant formula otherwise demonstrates turer is in compliance with section 412
that the protein in such infant formula of the Federal Food, Drug, and Cos-
is of sufficient biological quality. metic Act (21 U.S.C. 350a)).
(3) The manufacturer of an eligible (b) The manufacturer shall maintain
infant formula may, not later than No- all records that pertain to food-pack-
vember 12, 2015, submit a petition to aging materials subject to § 174.5 of this
the Food and Drug Administration chapter and that bear on whether such
under § 10.30 of this chapter that: materials would cause an infant for-
(i) Demonstrates that such formula mula to be adulterated within the
fulfills one or more of the criteria in meaning of section 402(a)(2)(C) of the
paragraph (i)(1) of this section; or Federal Food, Drug, and Cosmetic Act
(ii) Demonstrates that such formula (21 U.S.C. 342(a)(2)(C)).
fulfills one or more of the criteria in
(c) The manufacturer shall maintain
paragraph (i)(2) of this section.
all records that pertain to nutrient
(4) A petition filed under paragraph
premix testing that it generates or re-
(i)(3) of this section shall address only
one infant formula formulation and ceives. Such records shall include, but
shall contain all data and information are not limited to:
relied upon by the manufacturer to (1) Any results of testing conducted
demonstrate that such formulation ful- to ensure that each nutrient premix is
fills one or more of the criteria in para- in compliance with the premix certifi-
graph (i)(1) or in paragraph (i)(2) of this cate and guarantee and specifications
section. A manufacturer may combine that have been provided to the manu-
petitions submitted under paragraphs facturer by the premix supplier, includ-
(i)(3)(i) and (i)(3)(ii) of this section that ing tests conducted when nutrients ex-
relate to the same formulation. ceed their expiration date or shelf life
(5) The manufacturer of each eligible (retest date).
infant formula shall make and retain, (2) All certificates and guarantees
in accordance with § 106.100(p)(2), given by premix suppliers concerning
records to demonstrate that such for- the nutrients required by section 412(i)
mula supports normal physical growth of the Federal Food, Drug, and Cos-
in infants when fed as the sole source metic Act and § 107.100 of this chapter.
of nutrition and shall make and retain, (d) The premix supplier shall main-
in accordance with § 106.100(q)(2), tain the results of all testing con-
records to demonstrate that that the ducted to provide all certificates and
207
§ 106.100 21 CFR Ch. I (4–1–16 Edition)
guarantees concerning nutrient pre- (2) Any deviations from the master
mixes for infant formulas. Such records manufacturing order and any correc-
shall include but are not limited to: tive actions taken because of the devi-
(1) The results of tests conducted to ations.
determine the purity of each nutrient (3) Documentation, in accordance
required by section 412(i) of the Federal with § 106.6(c), of the monitoring at any
Food, Drug, and Cosmetic Act or point, step, or stage in the manufac-
§ 107.100 of this chapter and any other turer ’s production process where con-
nutrient listed in the certificate and trol is deemed necessary to prevent
guarantee; adulteration. These records shall in-
(2) The weight of each nutrient clude:
added; (i) A list of the specifications estab-
(3) The results of any quantitative lished at each point, step, or stage in
tests conducted to determine the the production process where control is
amount of each nutrient certified or deemed necessary to prevent adultera-
guaranteed; and tion, in accordance with § 106.6(c)(1), in-
(4) The results of any quantitative cluding documentation of the scientific
tests conducted to identify the nutri- basis for each specification;
ent levels present when nutrient pre- (ii) The actual values obtained during
mixes exceed their expiration date or the monitoring operation, any devi-
shelf life (retest date). ations from established specifications,
(e) For each production aggregate of and any corrective actions taken; and
infant formula, a manufacturer shall (iii) Identification of the person mon-
prepare and maintain records that in- itoring each point, step, or stage in the
clude complete information relating to production process where control is
the production and control of the pro- deemed necessary to prevent adultera-
duction aggregate. These records shall tion.
include: (4) The conclusions and followup,
(1) The master manufacturing order. along with the identity of the indi-
The master manufacturing order shall vidual qualified by education, training,
include: or experience who investigated:
(i) The significant steps in the pro- (i) Any deviation from the master
duction of the production aggregate manufacturing order and any correc-
and the date on which each significant tive actions taken;
step occurred; (ii) A finding that a production ag-
(ii) For a manufacturing facility that gregate or any of its ingredients failed
has more than one set of equipment or to meet the infant formula manufac-
more than one processing line, the turer’s specifications; and
identity of equipment and processing (iii) A failure to meet any specifica-
lines for which the manufacturer has tion at any point, step, or stage in the
identified points, steps, or stages in the production process where control is
production process where control is deemed necessary to prevent adultera-
necessary to prevent adulteration; tion.
(iii) The identity of each lot of ingre- (5) The results of all testing per-
dients, containers, and closures used in formed on the production aggregate of
producing the production aggregate of infant formula, including testing on
formula; the in-process production aggregate, at
(iv) The amount of each ingredient to the final product stage, and on finished
be added to the production aggregate of product throughout the shelf life of the
infant formula and a check product. The results recorded shall in-
(verification) that the correct amount clude:
was added; and (i) The results of all quality control
(v) A copy of each infant formula testing conducted in accordance with
label used on a finished production ag- § 106.91(a) and (b) to verify that each
gregate of infant formula and the re- nutrient required by § 107.100 of this
sults of examinations conducted during chapter is present in each production
the finishing operations to provide as- aggregate of infant formula at the

surance that the containers and pack- level required by § 107.100 of this chap-
ages have the correct label. ter, and that all other nutrients added
208
by the manufacturer are present at the ment startup and shutdown for clean-
appropriate level. The record of the re- ing, sanitizing, and maintenance. The
sults of the quality control testing person performing and checking the
shall include: cleaning, sanitizing, and maintenance
(A) A summary document identifying shall date and sign or initial the record
the stages of the manufacturing proc- indicating that the work was per-
ess at which the nutrient analysis for formed.
each required nutrient is conducted as (5) Records, in accordance with
required under § 106.91(a); and § 106.35(c), on all mechanical and elec-
(B) A summary document on the sta- tronic equipment used in the produc-
bility testing program conducted under tion or quality control of infant for-
§ 106.91(b), including the nutrients test- mula. These records shall include:
ed and the frequency of nutrient test- (i) A list of all systems used with a
ing throughout the shelf life of the description of the computer files and
product. the defined capabilities and inherent
(ii) For powdered infant formula, the limitations of each system;
results of any testing conducted in ac- (ii) A copy of all software used;
cordance with § 106.55(c) to verify com- (iii) Records that document installa-
pliance with the microbiological qual- tion, calibration, testing or validation,
ity standards in § 106.55(e). and maintenance of the systems used;
(f) A manufacturer shall make and (iv) A list of all persons authorized to
retain all records described in subparts create or modify software;
B and C of this part, including: (v) Records that document modifica-
(1) Records, in accordance with tions to software, including the iden-
§ 106.20(f)(4), of the frequency and re- tity of the person who modified the
sults of testing of the water used in the software;
production of infant formula; (vi) Records that document retesting
(2) Records, in accordance with or revalidation of modified systems;
§ 106.30(d), of accuracy checks of instru- and
ments and controls. A certification of (vii) A backup file of data entered
accuracy of any known reference into a computer or related system. The
standard used and a history of recer- backup file shall consist of a hard copy
tification shall be maintained. At a or alternative system, such as dupli-
minimum, such records shall specify cate electronic records, tapes, or
the instrument or control being microfilm, designed to ensure that
checked, the date of the accuracy backup data are exact and complete,
check, the standard used, the calibra- and that they are secure from alter-
tion method used, the results found, ation, inadvertent erasures, or loss.
any actions taken if the instrument is (6) Records, in accordance with
found to be out of calibration, and the § 106.40(g), on ingredients, containers,
initials or name of the individual per- and closures used in the manufacture
forming the test. If calibration of an of infant formula. These records shall
instrument shows that a specification include:
at a point, step, or stage in the produc- (i) The identity and quantity of each
tion process where control is deemed lot of ingredients, containers, and clo-
necessary to prevent adulteration has sures;
not been met, a written evaluation of (ii) The name of the supplier;
all affected product, and any actions (iii) The supplier’s lot numbers;
that need to be taken with respect to (iv) The name and location of the
that product, shall be made. manufacturer of the ingredient, con-
(3) Records, in accordance with tainer, or closure, if different from the
§ 106.30(e)(3)(iii). supplier;
(4) Records, in accordance with (v) The date of receipt;
§ 106.30(f), on equipment cleaning, sani- (vi) The receiving code as specified;
tizing, and maintenance that show the and
date and time of such cleaning, sani- (vii) The results of any test or exam-
tizing, and maintenance and the pro- ination (including retesting and reex-
duction aggregate number of each in- amination) performed on the ingredi-
fant formula processed between equip- ents, containers, or closures and the
209
§ 106.100 21 CFR Ch. I (4–1–16 Edition)
conclusions derived there from and the cerns about the possible existence of a
disposition of all ingredients, con- hazard to health and about appearance,
tainers, or closures. taste, odor, and quality. Correspond-
(7) A full description of the method- ence about prices, package size or
ology used to test powdered infant for- shape, or other matters that could not
mula to verify compliance with the possibly reveal the existence of a haz-
microbiological quality standards of ard to health shall not, for compliance
§ 106.55(c) and the methodology used to purposes, be considered a complaint
do quality control testing, in accord- and therefore need not be made avail-
ance with § 106.91(a). able to a Food and Drug Administra-
(g) A manufacturer shall maintain all tion investigator.
records pertaining to distribution of (2) When a complaint shows that a
the infant formula, including records hazard to health possibly exists, the
that show that formula produced for manufacturer shall conduct an inves-
export only is exported. Such records tigation into the validity of the com-
shall include all information and data plaint. Where such an investigation is
necessary to effect and monitor recalls conducted, the manufacturer shall in-
of the manufacturer’s infant formula clude in its file on the complaint the
products in accordance with subpart E determination as to whether a hazard
of part 107 of this chapter. to health exists and the basis for that
(h) The manufacturer shall maintain determination. No investigation is nec-
all records pertaining to the micro- essary when the manufacturer deter-
biological quality and purity of raw mines that there is no possibility of a
materials and finished powdered infant hazard to health. When no investiga-
formula. tion is necessary, the manufacturer
(i) [Reserved] shall include in the record the reason
(j) The manufacturer shall make and that an investigation was found to be
retain records pertaining to regularly unnecessary and the name of the re-
scheduled audits, including the audit sponsible person making that deter-
plans and procedures, the findings of mination.
the audit, and a listing of any changes (3) When there is a reasonable possi-
made in response to these findings. The bility of a causal relationship between
manufacturer shall make readily avail- the consumption of an infant formula
able for authorized inspection the audit and an infant’s death, the manufac-
plans and procedures and a statement turer shall, within 15 days of receiving
of assurance that the regularly sched- such information, conduct an inves-
uled audits are being conducted. The tigation and notify the Agency as re-
findings of the audit and any changes quired in § 106.150.
made in response to these findings (4) The manufacturer shall maintain
shall be maintained for the time period in designated files all records per-
required under paragraph (n) of this taining to the complaints it receives.
section, but need not be made available The manufacturer shall separate the
to the Food and Drug Administration. files into two classes:
(k) The manufacturer shall maintain (i) Those complaints that allege that
procedures describing how all written the infant became ill from consuming
and oral complaints regarding infant the product or required treatment by a
formula will be handled. The manufac- physician or health care provider and
turer shall follow these procedures and (ii) Those complaints that may in-
shall include in them provisions for the volve a possible existence of a hazard
review of any complaint involving an to health but do not refer to an infant
infant formula and for determining the becoming ill or the need for treatment
need for an investigation of the pos- by physician or a health care provider.
sible existence of a hazard to health. (5) The manufacturer shall include in
(1) For purposes of this section, every a complaint file the following informa-
manufacturer shall interpret a ‘‘com- tion concerning the complaint:
plaint’’ as any communication that (i) The name of the infant formula;
contains any allegation, written or (ii) The production aggregate num-

oral, expressing dissatisfaction with a ber;
product for any reason, including con- (iii) The name of complainant;
210
(iv) A copy of the complaint or a a manner that ensures that both the
memo of the telephone conversation or manufacturer and the Food and Drug
meeting and all correspondence with Administration can be provided with
the complainant; access to such records within 24 hours.
(v) By reference or copy, all the asso- The manufacturer may maintain the
ciated manufacturing records and com- records required under this part as
plaint investigation records needed to original records, as true copies such as
evaluate the complaint. When copies of photocopies, microfilm, microfiche, or
such records are not maintained in the other accurate reproductions of the
complaint file, they must be available original records, or as electronic
within 24 hours when requested by a records. Where reduction techniques,
Food and Drug Administration official. such as microfilming, are used, suit-
(vi) All actions taken to followup on able reader and photocopying equip-
the complaint; and ment shall be readily available. All
(vii) All findings and evaluations of electronic records maintained under
the complaint. this part shall comply with part 11 of
(6) The manufacturer should main- this chapter.
tain the files regarding infant formula (n) Production control, product test-
complaints at the establishment where ing, testing results, complaints, and
the infant formula was manufactured, distribution records necessary to verify
processed, or packed. When the manu- compliance with parts 106, 107, 109, 110,
facturer wishes to maintain all con- 113, and 117 of this chapter, or with
sumer complaints for the entire firm at other appropriate regulations, shall be
one location other than at the facility retained for 1 year after the expiration
where an infant formula was manufac- of the shelf life of the infant formula or
tured, processed, or packed, the manu- 3 years from the date of manufacture,
facturer may do so as long as all whichever is greater.
records required by this section are
(o) The manufacturer shall maintain
available within 24 hours of request for
quality control records that contain
inspection at that facility. However,
sufficient information to permit a pub-
all records of consumer complaints, in-
lic health evaluation of any production
cluding summaries, any reports, and
aggregate of infant formula.
any files, maintained at the manufac-
(p) A manufacturer shall make and
turing facility or at any other facility
retain records that demonstrate that
shall be made available to investiga-
the formula meets the quality factor of
tors for review and copying upon re-
normal physical growth.
quest.
(l) The manufacturer shall make (1) For an infant formula that is not
readily available for authorized inspec- an eligible infant formula, in accord-
tion all records required under this ance with § 106.96(d), these records shall
part or copies of such records. Records include:
shall be available at any reasonable (i) Records demonstrating compli-
time at the establishment where the ance with the requirements in
activities described in such records oc- § 106.96(b), including records made in
curred. (Infant formula complaint files compliance with § 106.121; or
may be maintained at one facility, as (ii) Records demonstrating satisfac-
provided in paragraph (k)(6) of this section of an applicable exemption under
tion, if all required records are readily § 106.96(c), including records made in
available at that facility.) These compliance with § 106.121.
records or copies thereof shall be sub- (2) For an eligible infant formula, in
ject to photocopying or other means of accordance with § 106.96(i)(5), these
reproduction as part of such inspec- records shall include records dem-
tion. Records that can be immediately onstrating that the formula fulfills one
retrieved from another location by or more of the criteria listed in
electronic means shall be considered as § 106.96(i)(1).
meeting the requirements of this para- (q) A manufacturer shall make and
graph. retain records that demonstrate that a

(m) A manufacturer shall maintain formula meets the quality factor of
all records required under this part in sufficient biological quality of protein.
211
§ 106.110 21 CFR Ch. I (4–1–16 Edition)
(1) For an infant formula that is not Administration, Center for Food Safety
an eligible infant formula, in accord- and Applied Nutrition, Office of Nutri-
ance with § 106.96(h), these records shall tion, Labeling, and Dietary Supple-
include: ments, Infant Formula and Medical
(i) Records demonstrating compli- Foods Staff (HFS–850), 5100 Paint
ance with the requirements in Branch Pkwy., College Park, MD 20740–
§ 106.96(f), including records made in 3835.
compliance with § 106.121; or (b) The new infant formula registra-
(ii) Records demonstrating satisfaction shall include:
tion of an applicable exemption under (1) The name of the new infant for-
§ 106.96(g), including records made in mula;
compliance with § 106.121. (2) The name of the manufacturer;
(2) For an eligible infant formula, in
(3) The street address of the place of
accordance with § 106.96(i)(5), these
business of the manufacturer; and
records shall include records dem-
onstrating that the formula fulfills one (4) The name and street address of
or more of the criteria listed in each establishment at which the manu-
§ 106.96(i)(2). facturer intends to manufacture such
(r) The failure to comply with the new infant formula.
records requirements in this section
applicable to the quality factors shall § 106.120 New infant formula submis-
sion.
render the formula adulterated under
section 412(a)(2) of the Federal Food, (a) At least 90 days before a new in-
Drug, and Cosmetic Act. The failure to fant formula is introduced or delivered
comply with the records requirements for introduction into interstate com-
in this section applicable to the good merce, a manufacturer shall submit no-
manufacturing practices and quality tice of its intent to do so to the Food
control procedures, including distribu- and Drug Administration at the ad-
tion and audit records requirements, dress given in § 106.110(a). An original
with respect to an infant formula shall and two paper copies of such notice of
render the formula adulterated under intent shall be submitted, unless the
section 412(a)(3) of the Federal Food, notice is submitted in conformance
Drug, and Cosmetic Act. A failure to with part 11 of this chapter, in which
retain or make available records appli- case a single copy shall be sufficient.
cable to the quality factor require- (b) The new infant formula submis-
ments, quality control procedures, or sion shall include:
current good manufacturing practices (1) The name and description of the
requirements in compliance with para- physical form (e.g., powder, ready-to
graph (l), (m), or (n) of this section feed, or concentrate) of the infant for-
with respect to a formula shall render mula;
the formula adulterated under section (2) An explanation of why the for-
412(a)(2) or (a)(3) of the Federal Food, mula is a new infant formula;
Drug, and Cosmetic Act, as applicable. (3) The quantitative formulation of
[79 FR 8059, Feb. 10, 2014, as amended at 79 each form of the infant formula that is
FR 33072, June 10, 2014; 80 FR 56144, Sept. 17, the subject of the notice in units per
2015] volume or units per weight for liquid
formulas, specified either as sold or as
Subpart G—Registration, Submis- fed, and units per dry weight for pow-
sion, and Notification Require- dered formulas, and the weight of pow-
ments der to be reconstituted with a specified
volume of water, and, when applicable,
§ 106.110 New infant formula registra- a description of any reformulation of
tion. the infant formula, including a listing
(a) Before a new infant formula may of each new or changed ingredient and
be introduced or delivered for introduc- a discussion of the effect of such
tion into interstate commerce, includ- changes on the nutrient levels in the
ing a new infant formula for export formulation;

only, the manufacturer of the formula (4) A description, when applicable, of
shall register with the Food and Drug any change in processing of the infant
212
formula. Such description shall iden- likely not differ from the stability of
tify the specific change in processing, formulas with similar composition,
including side-by-side, detailed sche- processing, and packaging for which
matic diagrams comparing the new there are extensive stability data.
processing to the previous processing (c) For a new infant formula for ex-
and processing times and tempera- port only, a manufacturer may submit,
tures; in lieu of the information required
(5) Assurance that the infant formula under paragraphs (b)(5) and (b)(6) of
will not be marketed unless the for- this section, a statement certifying
mula meets the requirements for qual- that the infant formula meets the spec-
ity factors of section 412(b)(1) of the ifications of the foreign purchaser, the
Federal Food, Drug, and Cosmetic Act infant formula does not conflict with
(21 U.S.C. 350a(b)(1)) and the nutrient the laws of the country to which it is
content requirements of section 412(i) intended for export, the infant formula
of the Federal Food, Drug, and Cos- is labeled on the outside of the ship-
metic Act. ping package to indicate that it is in-
(i) Assurance that the formula meets tended for export only, and the infant
the requirements for quality factors, formula will not be sold or offered for
which are set forth in § 106.96, shall be sale in domestic commerce. Such man-
provided by a submission that complies ufacturer shall also submit a state-
with § 106.121; ment certifying that it has adequate
(ii) Assurance that the formula com- controls in place to ensure that such
plies with the nutrient content require- formula is actually exported.
ments, which are set forth in § 107.100 of (d) The submission will not con-
this chapter, shall be provided by a stitute notice under section 412 of the
statement that the formula will not be Federal Food, Drug, and Cosmetic Act
marketed unless it meets the nutrient unless it complies fully with paragraph
requirements of § 107.100 of this chap- (b) of this section, as applicable, and
ter, as demonstrated by testing re- the information that it contains is set
quired under subpart C of this part; and forth in a manner that is readily un-
(6) Assurance that the processing of derstandable. The Agency will notify
the infant formula complies with sec- the manufacturer if the notice is not
tion 412(b)(2) of the Federal Food, complete because it does not meet the
Drug, and Cosmetic Act. Such assur- requirements in section 412(c) and (d)
ance shall include: of the Federal Food, Drug, and Cos-
(i) A statement that the formula will metic Act.
be produced in accordance with sub- (e) If a new infant formula submis-
parts B and C of this part; and sion contains all the information re-
(ii) The basis on which each ingre- quired by paragraph (b) of this section,
dient meets the requirements of as applicable, the Food and Drug Ad-
§ 106.40(a), e.g. that it is an approved ministration will acknowledge its re-
food additive, that it is authorized by a ceipt and notify the manufacturer of
prior sanction, or that it is generally the date of receipt. The date that the
recognized as safe (GRAS) for its in- Agency receives a new infant formula
tended use. Any claim that an ingre- submission that is complete is the fil-
dient is GRAS shall be supported by a ing date for such submission. The man-
citation to the Agency’s regulations or ufacturer shall not market the new in-
by an explanation, including a list of fant formula before the date that is 90
published studies and a copy of those days after the filing date. If the infor-
publications, for why, based on the mation in the submission does not pro-
published studies, there is general rec- vide the assurances required under sec-
ognition of the safety of the use of the tion 412(d)(1) of the Federal Food,
ingredient in infant formula. Drug, and Cosmetic Act and the regula-
(7) If the manufacturer is requesting tions of this chapter, the Food and
an exemption under § 106.91(b)(1)(ii), the Drug Administration will so notify the
manufacturer shall include the sci- manufacturer before the expiration of
entific evidence that the manufacturer the 90th day.

is relying on to demonstrate that the (f) If the manufacturer provides addi-
stability of the new infant formula will tional information in support of a new
213
§ 106.121 21 CFR Ch. I (4–1–16 Edition)
infant formula submission, the Agency (ii) Calculations of the statistical

will determine whether the additional power of the study before study initi-
information is a substantive amend- ation and at study completion.
ment to the new infant formula sub- (4) A report on attrition and on all
mission. If the Agency determines that occurrences of adverse events during
the new submission is a substantive the study, which shall include:
amendment, the Food and Drug Admin- (i) Identification of the infant by sub-
istration will assign the new infant for- ject number and feeding group and a
mula submission a new filing date. The complete description of the adverse
Food and Drug Administration will ac- event, including comparisons of the
knowledge receipt of the additional in- frequency and nature of occurrence in
formation and, when applicable, notify each feeding group and information on
the manufacturer of the new filing the health of the infant during the
date, which is the date of receipt by course of the study, including the oc-
the Food and Drug Administration of currence and duration of any illness;
the information that constitutes the (ii) A clinical assessment by a health
substantive amendment to the new in- care provider of the infant’s health
fant formula submission. during each suspected adverse event;
and
(g) Submissions relating to exempt
(iii) A list of all subjects who did not
infant formulas are subject to the pro-
complete the study, including the sub-
visions of § 107.50 of this chapter.
ject number and the reason that each
[79 FR 8059, Feb. 10, 2014, as amended at 79 subject did not complete the study.
FR 33072, June 10, 2014] (b) If the manufacturer is requesting
an exemption from the growth moni-
§ 106.121 Quality factor assurances for toring study requirements under
infant formulas. § 106.96(c)(1), the manufacturer shall in-
To provide assurance that an infant clude a detailed description of the
formula meets the requirements for change made by the manufacturer to
quality factors set forth in § 106.96, the an existing infant formula and an ex-
manufacturer shall submit the fol- planation of why the change made by
lowing data and information: the manufacturer to an existing infant
(a) Unless the manufacturer of a new formula satisfies the criteria of
infant formula can claim an exemption § 106.96(c)(1).
under § 106.96(c)(1) or (c)(2), the fol- (c) If the manufacturer is requesting
lowing assurances shall be provided to an exemption under § 106.96(c)(2)(i), the
ensure that the requirements of manufacturer shall include a detailed
description of the alternative method
§ 106.96(a) and (b) have been met:
or alternative study design, an expla-
(1) An explanation, in narrative form,
nation of why the method or study de-
setting forth how requirements for sign is based on sound scientific prin-
quality factors in § 106.96(b) have been ciples, and data that demonstrate that
met; the formula supports normal physical
(2) Records that contain the informa- growth in infants when the formula is
tion required by § 106.96(b) to be col- fed as the sole source of nutrition.
lected during the study for each infant (d) If the manufacturer is requesting
enrolled in the study. The records shall an exemption under § 106.96(c)(2)(ii), the
be identified by subject number, age, manufacturer shall include a detailed
feeding group, gender, and study day of description of the change and an expla-
collection. nation of why the change made by the
(3) Data, which shall include: manufacturer to an existing infant for-
(i) Statistical evaluation for all mula does not the affect the ability of
measurements, including group means, the formula to support normal physical
group standard deviations, and meas- growth.
ures of statistical significance for all (e) If the manufacturer is requesting
measurements for each feeding group an exemption under § 106.96(c)(2)(iii),
at the beginning of the study and at the manufacturer shall include a de-
every point where measurements were tailed description of the two formula-
made throughout the study, and tions and an explanation of why the
214
quality factor requirement of normal written submission to the Food and

physical growth is met by the form of Drug Administration at the address
the formula that is processed using the given in § 106.110(a) that the infant for-
method that has the greatest potential mula complies with the requirements
for adversely affecting nutrient con- of the Federal Food, Drug, and Cos-
tent and bioavailability. metic Act and is not adulterated.
(f) Unless the manufacturer of a new (b) The verification submission shall
infant formula is requesting an exemp- include the following information:
tion under § 106.96(g), the results of the (1) The name of the new infant for-
Protein Efficiency Ratio bioassay shall mula; the filing date for the new infant
be provided in accordance with formula submission, in accordance
§ 106.96(f). with § 106.120, for the subject formula;
(g) If the manufacturer is requesting and the identification number assigned
an exemption under § 106.96(g)(1), the by the Agency to the new infant for-
manufacturer shall include a detailed mula submission:
description of the change made by the (2) A statement that the infant for-
manufacturer to an existing infant formula to be introduced into interstate
mula and an explanation of why the commerce is the same as the infant for-
change made by the manufacturer to mula that was the subject of the new
an existing infant formula satisfies the infant formula notification and for
criteria listed in § 106.96(g)(1). which the manufacturer provided as-
(h) If the manufacturer is requesting surances in accordance with the re-
an exemption under § 106.96(g)(2), the quirements of § 106.120;
manufacturer shall include a detailed (3) A summary of test results of the
description of the change and an expla- level of each nutrient required by
nation of why the change made by the § 107.100 of this chapter and any nutri-
manufacturer to an existing infant for- ent added by the manufacturer in the
mula does not affect the bio- formula, presented in units per 100
availability of the protein. kilocalories at the final product stage.
(i) If the manufacturer is requesting (4) A certification that the manufac-
an exemption under § 106.96(g)(3), the turer has established current good
manufacturer shall include a detailed manufacturing practices, including
explanation of the alternative method, quality control procedures and in-proc-
an explanation of why the method is ess controls, and testing required by
based on sound scientific principles, current good manufacturing practice,
and the data that demonstrate that the designed to prevent adulteration of
quality factor for the biological qual- this formula in accordance with sub-
ity of the protein has been met. parts B and C of this part.
(j) A statement certifying that the
(c) The submission shall not con-
manufacturer has collected and consid-
stitute written verification under sec-
ered all information and data con-
tion 412(d)(2) of the Federal Food,
cerning the ability of the infant for-
Drug, and Cosmetic Act (21 U.S.C.
mula to meet the requirements for
350a(d)(2)) when any data prescribed in
quality factors and that the manufac-
paragraph (b) of this section are lack-
turer is not aware of any information
ing or are not set forth so as to be read-
or data that would show that the for-
ily understood. In such circumstances,
mula does not meet the requirements
the Agency will notify the manufac-
for quality factors.
turer that the notice is not adequate.
FR 33072, June 10, 2014] § 106.140 Submission concerning a
change in infant formula that may
§ 106.130 Verification submission. adulterate the product.
(a) A manufacturer shall, after the (a) When a manufacturer makes a
first production and before the intro- change in the formulation or proc-
duction into interstate commerce of a essing of the formula that may affect
new infant formula (except for a new whether the formula is adulterated
infant formula that is for export only under section 412(a) of the Federal
for which a submission is received in Food, Drug, and Cosmetic Act (21
compliance with § 106.120(c)), verify in a U.S.C. 350a(a)), the manufacturer shall,
215
§ 106.150 21 CFR Ch. I (4–1–16 Edition)
before the first processing of such for- ject to the control of the manufac-
mula, make a submission to the Food turer:
and Drug Administration at the ad- (1) May not provide the nutrients re-
dress given in § 106.110(a). An original quired by section 412(i) of the Federal
and two copies shall be submitted. Food, Drug, and Cosmetic Act (21 U.S.C
(b) The submission shall include: 350d(i)) or by regulations issued under
(1) The name and physical form of section 412(i)(2); or
the infant formula (i.e., powder, ready- (2) May be otherwise adulterated or
to-feed, or concentrate); misbranded.
(2)(i) An explanation of why the (b) The notification made according
change in formulation or processing to paragraph (a) of this section shall be
may affect whether the formula is made by telephone, to the Director of
adulterated; and the appropriate Food and Drug Admin-
(ii) What steps will be taken to en- istration district office. After normal
sure that, before the formula is intro- business hours (8 a.m. to 4:30 p.m.), the
duced into interstate commerce, the Food and Drug Administration’s emer-
formula will not be adulterated; and gency number, 1–866–300–4374 shall be
(3) A statement that the submission used. The manufacturer shall promptly
complies with § 106.120(b)(3), (b)(4), send written confirmation of the notifi-
(b)(5), and (b)(6). When appropriate, a cation to the Food and Drug Adminis-
statement to the effect that the infor-
tration, Center for Food Safety and Ap-
mation required by § 106.120(b)(3), (b)(4),
plied Nutrition, Office of Compliance,
(b)(5), or (b)(6) has been provided to the
Division of Enforcement (HFS–605), Re-
Agency previously and has not been af-
call Coordinator, 5100 Paint Branch
fected by the changes that are the sub-
Pkwy., College Park, MD 20740, and to
ject of the current submission, to-
the appropriate Food and Drug Admin-
gether with the identification number
istration district office.
assigned by the Agency to the relevant
infant formula submission, may be pro- § 106.160 Incorporation by reference.
vided in lieu of such statement.
(c) The submission shall not con- (a) Certain material is incorporated
stitute notice under section 412 of the by reference into this part with the ap-
Federal Food, Drug, and Cosmetic Act proval of the Director of the Federal
unless it complies fully with paragraph Register under 5 U.S.C. 552(a) and 1
(b) of this section, and the information CFR part 51. To enforce any edition
that it contains is set forth in a man- other than that specified in this sec-
ner that is readily understandable. The tion, the Food and Drug Administra-
Agency will notify the manufacturer if tion must publish notice of change in
the notice is not adequate because it the FEDERAL REGISTER and the mate-
does not meet the requirements of sec- rial must be available to the public. All
tion 412(d)(3) of the Federal Food, approved material is available for in-
Drug, and Cosmetic Act. spection at the Food and Drug Admin-
istration library at 10903 New Hamp-
§ 106.150 Notification of an adulter- shire Ave., Building 2, Third Floor, Sil-
ated or misbranded infant formula. ver Spring, MD 20993, 301–796–2039, and
(a) A manufacturer shall promptly is available from the sources listed
notify the Food and Drug Administra- below. This material is also available
tion in accordance with paragraph (b) for inspection at the National Archives
of this section when the manufacturer and Records Administration (NARA).
has knowledge (that is, actual knowl- For information on the availability of
edge that the manufacturer had, or the this material at NARA, call 202–741–
knowledge which a reasonable person 6030 or go to: http://www.archives.gov/
would have had under like cir- federallregister/
cumstances or which would have been codeloflfederallregulations/
obtained upon the exercise of due care) ibrllocations.html.
that reasonably supports the conclu- (b) 3–A Sanitary Standards, Inc., 6888
sion that an infant formula that has Elm St., Suite 2D, McLean, VA 22101–
been processed by the manufacturer 3829, 703–790–0295, and may be ordered
and that has left an establishment sub- online at http://www.3-a.org/:
216
(1) 3–A Sanitary Standards, No. 609– PART 107—INFANT FORMULA

03: A Method of Producing Culinary
Steam, adopted November 21, 2004, into Subpart A—General Provisions
§ 106.20(h).
(2) [Reserved] Sec.
(c) American Society for Nutrition, 107.1 Status and applicability of the regula-
tions in part 107.
9650 Rockville Pike, Bethesda, MD
107.3 Definitions.
20814–3998, 301–634–7279, http://
www.nutrition.org: Subpart B—Labeling
(1) Physical growth: National Center for
Health Statistics percentiles, Hamill, 107.10 Nutrient information.
P.V.V., T.A. Drizd, C.L. Johnson, R.B. 107.20 Directions for use.
107.30 Exemptions.
Reed, A.F. Roche, and W.M. Moore,
American Journal of Clinical Nutrition, Subpart C—Exempt Infant Formulas
vol. 32, pp. 607–614, dated March 1979,
into § 106.96(i)(1)(ii)(c). 107.50 Terms and conditions.
(2) [Reserved]
(d) AOAC International, 481 North Subpart D—Nutrient Requirements
Frederick Ave., suite 500, Gaithersburg, 107.100 Nutrient specifications.
MD 20877–2417, 301–924–7078:
(1) Official Methods of Analysis of Subpart E—Infant Formula Recalls
AOAC International, 16th ed., dated
107.200 Food and Drug Administration-re-
1995, into § 106.96(i)(2)(ii):
quired recall.
(i) Section 45.3.04, AOAC Official 107.210 Firm-initiated product removals.
Method 960.48 Protein Efficiency Ratio 107.220 Scope and effect of infant formula
Rat Bioassay, and recalls.
(ii) Section 45.3.05, AOAC Official 107.230 Elements of an infant formula re-
Method 982.30 Protein Efficiency Ratio call.
Calculation Method. 107.240 Notification requirements.
(2) Official Methods of Analysis of 107.250 Termination of an infant formula re-
call.
AOAC International, 18th ed., dated
107.260 Revision of an infant formula recall.
2005, into § 106.96(f): 107.270 Compliance with this subpart.
(i) Section 45.3.04, AOAC Official 107.280 Records retention.
Method 960.48 Protein Efficiency Ratio
AUTHORITY: 21 U.S.C. 321, 343, 350a, 371.
Rat Bioassay, and
(ii) Section 45.3.05, AOAC Official SOURCE: 50 FR 1840, Jan. 14, 1985, unless
Method 982.30 Protein Efficiency Ratio otherwise noted.
Calculation Method.
(e) Centers for Disease Control and Subpart A—General Provisions
Prevention, 1600 Clifton Rd., Atlanta,
GA 30333, 1–800–232–4636, http:// § 107.1 Status and applicability of the
www.cdc.gov/growthcharts/ regulations in part 107.
wholcharts.htm. (a) The criteria in subpart B of this
(1) Birth to 24 months: Boys Head cir- part describe the labeling requirements
cumference-for-age and Weight-for- applicable to infant formula under sec-
length percentiles, dated November 1, tion 403 of the Federal Food, Drug, and
2009, into § 106.96(b)(4). Cosmetic Act (21 U.S.C 343). Failure to
(2) Birth to 24 months: Boys Length- comply with any regulation in subpart
for-age and Weight-for-age percentiles, B of this part will render an infant for-
dated November 1, 2009, into mula misbranded under section 403 of
§ 106.96(b)(4). the Federal Food, Drug, and Cosmetic
(3) Birth to 24 months: Girls Head cir- Act.
cumference-for-age and Weight-for- (b) The criteria in subpart C of this
length percentiles, dated November 1, part describe the terms and conditions
2009, into § 106.96(b)(4). for the exemption of an infant formula
(4) Birth to 24 months: Girls Length- from the requirements of section 412(a),
for-age and Weight-for-age percentiles, (b), and (c) of the Federal Food, Drug,
dated November 1, 2009, into and Cosmetic Act (21 U.S.C. 350a(a), (b),
§ 106.96(b)(4). and (c)). Failure to comply with any
217
§ 107.3 21 CFR Ch. I (4–1–16 Edition)
regulations in subpart C of this part the following information regarding

will result in withdrawal of the exemp- the product as prepared in accordance
tion given under section 412(h)(1) of the with label directions for infant con-
Federal Food, Drug, and Cosmetic Act. sumption:
(c) Subpart D of this part contains (1) A statement of the number of
the nutrient requirements for infant fluid ounces supplying 100 kilocalories
formula under section 412(i) of the Fed- (in case of food label statements, a
eral Food, Drug, and Cosmetic Act. kilocalorie is represented by the word
Failure to comply with any regulation ‘‘Calorie’’); and
in subpart D of this part will render an (2) A statement of the amount, sup-
infant formula adulterated under sec- plied by 100 kilocalories, of each of the
tion 412(a)(1) of the Federal Food, following nutrients and of any other
Drug, and Cosmetic Act. nutrient added by the manufacturer:
(d) An exempt infant formula is sub-
Nutrients Unit of measurement
ject to the provisions of § 107.50 and
other applicable Food and Drug Admin- Protein ............................................. Grams.
istration food regulations. Fat ................................................... Do.
Carbohydrate ................................... Do.
[79 FR 8074, Feb. 10, 2014] Water ............................................... Do.
Linoleic acid .................................... Milligrams.
Vitamins:
§ 107.3 Definitions. Vitamin A .................................. International units.
The following definitions shall apply, Vitamin D ................................. Do.
Vitamin E .................................. Do.
in addition to the definitions contained Vitamin K .................................. Micrograms.
in section 201 of the Federal Food, Thiamine (Vitamin B 1) ............. Do.
Drug, and Cosmetic Act (the act): Riboflavin (Vitamin B 2 ............. Do.
Vitamin B 6 ................................ Do.
Exempt formula. An exempt infant for- Vitamin B 12 .............................. Do.
mula is an infant formula intended for Niacin ....................................... Do.
commercial or charitable distribution Folic acid (Folacin) ................... Do.
Pantothenic acid ...................... Do.
that is represented and labeled for use Biotin ........................................ Do.
by infants who have inborn errors of Vitamin C (Ascorbic acid) ........ Milligrams.
metabolism or low birth weight, or who Choline ..................................... Do.
Inositol ...................................... Do.
otherwise have unusual medical or die- Minerals:
tary problems. Calcium .................................... Milligrams.
Manufacturer. A person who prepares, Phosphorus .............................. Do.
Magnesium ............................... Do.
reconstitutes, or otherwise changes the Iron ........................................... Do.
physical or chemical characteristics of Zinc .......................................... Do.
an infant formula or packages or labels Manganese .............................. Micrograms.
Copper ..................................... Do.
the product in a container for distribu- Iodine ....................................... Do.
tion. The term ‘‘manufacturer’’ does Sodium ..................................... Milligrams.
not include a person who prepares, re- Potassium ................................ Do.
constitutes, or mixes infant formula Chloride .................................... Do.
exclusively for an infant under his/her
direct care or the direct care of the in- (b) In addition the following apply:
stitution employing such person. (1) Vitamin A content may also be
References. References in this part to declared on the label in units of
regulatory sections of the Code of Fed- microgram retinol equivalents, vita-
eral Regulations are to chapter I of min D content in units of micrograms
title 21, unless otherwise noted. cholecalciferol, vitamin E content in
units of milligram alpha-tocopherol
[50 FR 48186, Nov. 22, 1985, as amended at 79 equivalents, and sodium, potassium,
FR 8074, Feb. 10, 2014] and chloride content in units of
millimoles, micromoles, or milli-
Subpart B—Labeling equivalents. When these declarations
are made they shall appear in paren-
§ 107.10 Nutrient information. theses immediately following the dec-
(a) The labeling of infant formulas, larations in International Units for vi-
as defined in section 201(z) of the Fed- tamins A, D, and E, and immediately
eral Food, Drug, and Cosmetic Act, following the declarations in milli-
shall bear in the order given, in the grams for sodium, potassium, and chlo-
units specified, and in tabular format, ride.
218
(2) Biotin, choline, and inositol con- be declared between iodine and sodium,
tent shall be declared except when they provided that any additionally de-
are not added to milk-based infant for- clared nutrient:
mulas. (i) Has been identified as essential by
(3) Each of the listed nutrients, and the Food and Nutrition Board of the
the caloric density, may also be de- Institute of Medicine through its devel-
clared on the label on other bases, such opment of a Dietary Reference Intake,
as per 100 milliliters or per liter, as or has been identified as essential by
prepared for infant consumption. the Food and Drug Administration
(4) One of the following statements through a FEDERAL REGISTER publica-
shall appear on the principal display tion; and
panel, as appropriate: (ii) Is provided at a level considered
(i) The statement ‘‘Infant Formula in these publications as having biologi-
With Iron’’, or a similar statement, if cal significance, when these levels are
the product contains 1 milligram or known.
more of iron in a quantity of product
that supplies 100 kilocalories when pre- [50 FR 1840, Jan. 14, 1985, as amended at 67
pared in accordance with label direc- FR 9585, Mar. 4, 2002; 79 FR 8074, Feb. 10, 2014]
tions for infant consumption. EFFECTIVE DATE NOTE: At 80 FR 35840, June
(ii) The statement ‘‘Additional Iron 23, 2015, § 107.10 was amended by revising
May Be Necessary’’, or a similar state- paragraph (a)(2), effective June 22, 2016. For
ment, if the product contains less than the convenience of the user, the revised text
1 milligram of iron in a quantity of is set forth as follows:
product that supplies 100 kilocalories § 107.10 Nutrient information.
when prepared in accordance with label (a) * * *
directions for infant consumption. (2) A statement of the amount, supplied by
(5) Any additional vitamin may be 100 kilocalories, of each of the following nu-
declared at the bottom of the vitamin trients and of any other nutrient added by
list and any additional minerals may the manufacturer:
Protein ............................................................................................................................................ Grams

Fat ................................................................................................................................................... Do.
Carbohydrate .................................................................................................................................. Do.
Water .............................................................................................................................................. Do.
Linoleic acid .................................................................................................................................... Milligrams
Vitamins
Vitamin A ........................................................................................................................................ International Units

Vitamin D ........................................................................................................................................ Do.
Vitamin E ........................................................................................................................................ Do.
Vitamin K ........................................................................................................................................ Micrograms
Thiamine (Vitamin B1) .................................................................................................................... Do.
Riboflavin (Vitamin B2) ................................................................................................................... Do.
Vitamin B6 ....................................................................................................................................... Do.
Vitamin B12 ..................................................................................................................................... Do.
Niacin .............................................................................................................................................. Do.
Folic acid (Folacin) ......................................................................................................................... Do.
Pantothenic acid ............................................................................................................................. Do.
Biotin ............................................................................................................................................... Do.
Vitamin C (Ascorbic acid) ............................................................................................................... Milligrams
Choline ............................................................................................................................................ Do.
Inositol ............................................................................................................................................ Do.
Minerals
Calcium ........................................................................................................................................... Milligrams

Phosphorus ..................................................................................................................................... Do.
Magnesium ..................................................................................................................................... Do.
Iron .................................................................................................................................................. Do.
Zinc ................................................................................................................................................. Do.
Manganese ..................................................................................................................................... Micrograms
Copper ............................................................................................................................................ Do.
Iodine .............................................................................................................................................. Do.

Selenium ......................................................................................................................................... Do.
Sodium ............................................................................................................................................ Milligrams
Potassium ....................................................................................................................................... Do.
219
§ 107.20 21 CFR Ch. I (4–1–16 Edition)
Chloride .......................................................................................................................................... Do.
* * * * *
§ 107.20 Directions for use.

In addition to the applicable labeling
requirements in parts 101 and 105 of
this chapter, the product label shall
bear:
(a) Under the heading ‘‘Directions
For Preparation and Use’’, directions
for:
(1) Storage of infant formula before
and after the container has been
opened, including a statement indi-
cating that prolonged storage at exces-
sive temperatures should be avoided;
(2) Agitating liquid infant formula
before opening the container, such as
‘‘Shake Well Before Opening’’;
(3) ‘‘Sterilization’’ of water, bottle,
and nipples when necessary for pre-
paring infant formula for use;
(4) Dilution of infant formula, when
appropriate. Directions for powdered
infant formula shall contain the weight
and volume of powdered formula to be
reconstituted.
(b) In close proximity to the ‘‘Direc-
tions for Preparation and Use’’ a picto-
gram depicting the major steps for
preparation of that infant formula,
such as (for a concentrated formula):
(c) A ‘‘Use by lll’’ date, the blank

to be filled in with the month and year
selected by the manufacturer, packer,
or distributor of the infant formula on
the basis of tests or other information
showing that the infant formula, until
that date, under the conditions of han-
dling, storage, preparation, and use
prescribed by label directions, will: (1)
when consumed, contain not less than
the quantity of each nutrient, as set
forth on its label; and (2) otherwise be
of an acceptable quality (e.g., pass
through an ordinary bottle nipple).
(d) The statement ‘‘Add Water’’ or
‘‘Do Not Add Water’’, as appropriate, to
appear on the principal display panel of

concentrated or ready-to-feed infant
formulas. In close proximity to the
220
ER01JA93.366</GPH>
statement ‘‘Add Water’’, a symbol such containers are securely enclosed within
as and are not intended to be separated
from the retail package under condi-
tions of retail sale; and (c) the label on
each individual container includes the
statement ‘‘This Unit Not Intended For
Individual Sale’’ in type size not less
than one-sixteenth inch in height. The
word ‘‘Retail’’ may be used in lieu of or
immediately following the word ‘‘Indi-
vidual’’ in the statement.
Subpart C—Exempt Infant

Formulas
§ 107.50 Terms and conditions.
(a) Terms and conditions. Section
412(f)(1) of the act exempts from the re-
quirements of section 412(a), (b), and
if the addition of water is necessary.
(c)(1)(A) of the act infant formulas that
The symbol shall be placed on a white
are represented and labeled for use by
background encircled by a dark border.
an infant who has an inborn error of
(e) A warning statement beneath or
metabolism or low brith weight or who
in close proximity to the ‘‘Directions
otherwise has an unusual medical or
For Preparation and Use’’ that cau-
dietary problem, if such formulas com-
tions against improper preparation or
ply with regulations prescribed by the
use of an infant formula, such as ‘‘THE
Secretary. The regulations in this sub-
HEALTH OF YOUR INFANT DE-
part establish the terms and conditions
PENDS ON CAREFULLY FOLLOWING
that a manufacturer must meet with
THE DIRECTIONS FOR PREPARA-
respect to such infant formulas.
TION AND USE’’.
(b) Infant formulas generally available
(f) A statement indicating that par-
at the retail level. (1) These exempt in-
ents should consult their physicians
fant formulas can generally be pur-
about the use of infant formulas, such
chased from retail store shelves that
as ‘‘USE AS DIRECTED BY A PHYSI-
are readily available to the public.
CIAN’’.
Such formulas are also typically rep-
[50 FR 1840, Jan. 14, 1985, as amended at 67 resented and labeled for use to provide
FR 9585, Mar. 4, 2002] dietary management for diseases or
conditions that are not clinically seri-
§ 107.30 Exemptions. ous or life-threatening, even though
When containers of ready-to-feed in- such formulas may also be represented
fant formula, to be sold at the retail and labeled for use in clinically serious
level, are contained within a multiunit or life-threatening disorders.
package, the labels of the individual (2) Except as provided in paragraphs
containers shall contain all of the label (b)(4) and (5) of this section, an infant
information required by section 403 of formula manufacturer shall, with re-
the Federal Food, Drug, and Cosmetic spect to each formula covered by this
Act (the act), §§ 107.10 and 107.20, and all paragraph, comply with the nutrient
appropriate sections of part 101 of this requirements of section 412(g) of the
chapter, except that the labels of the act or of regulations promulgated
individual containers contained within under section 412(a)(2) of the act, the
the outer package shall be exempt quality control procedure requirements
from compliance with the require- of part 106, and the labeling require-
ments of section 403 (e)(1) and (i)(2) of ments of subpart B of this part.
the act; and §§ 107.10 (a) and (b)(2) and (3) To retain the exempt status of an
107.20 (b), (e), and (f), provided that (a) infant formula covered by this para-
the multiunit package meets all the re- graph, the manufacturer shall submit
quirements of this part; (b) individual to the Food and Drug Administration
221
EC01MR93.000</GPH>
§ 107.50 21 CFR Ch. I (4–1–16 Edition)
(FDA), at the address specified in para- ly to provide dietary management for

graph (e)(1) of this section, on or before specific diseases or conditions that are
May 21, 1986, or on or before the 90th clinically serious or life-threatening
day before the first processing of the and generally are required for pro-
infant formula for commercial or char- longed periods of time. Exempt infant
itable distribution, whichever occurs formulas distributed directly to insti-
later, the label and other labeling of tutions such as hospitals, clinics, and
the infant formula, a complete quan- State or Federal agencies that are of
titative formulation for the infant for- the same formulation as those gen-
mula, and a detailed description of the erally available at the retail level are
medical conditions for which the infant subject to the requirements of para-
formula is represented. FDA will re- graph (b) of this section rather than to
view the information under paragraph the requirements of this paragraph.
(d) of this section. (2) Except as provided for in para-
(4) To retain the exempt status of an graph (c)(5) of this section, an infant
infant formula covered by this para- formula manufacturer shall, with re-
graph, when any change in ingredients spect to each formula covered by this
or processes that may result in an ad- paragraph, comply with the nutrient
verse impact on levels of nutrients or requirements of section 412(g) of the
availability of nutrients is instituted, act or of regulations promulgated
the manufacturer shall submit to FDA under section 412(a)(2) of the act, and
at the address specified in paragraph the labeling requirements of subpart B
(e)(1) of this section, before the first of this part.
processing of the infant formula, the
(3) Each manufacturer of an infant
label and other labeling of the infant
formula covered by this paragraph
formula, a complete quantitative for-
shall establish quality control proce-
mulation for the infant formula, a de-
dures designed to ensure that the in-
tailed description of the reformulation
fant formula meets applicable nutrient
and the rationale for the reformula-
requirements of this section, including
tion, a complete description of the
any special nutritional characteristics
change in processing, and a detailed de-
for the specific disorders or conditions
scription of the medical conditions for
for which the formula is represented
which the infant formula is rep-
resented. FDA will review that infor- for use. Each manufacturer shall main-
mation under paragraph (d) of this sec- tain records of such quality control
tion. procedures sufficient to permit a public
(5) A manufacturer may deviate from health evaluation of each manufac-
the requirements of paragraph (b)(2) of tured batch of infant formula and shall
this section only with respect to those permit any authorized FDA employee
specific requirements for which it sub- at all reasonable times to have access
mits to FDA, at the address specified to and to copy and verify the records
in paragraph (e)(1) of this section, the referred to in this paragraph.
medical, nutritional, scientific, or (4) To retain the exempt status of an
technological rationale (including any infant formula covered by this para-
appropriate animal or human clinical graph, the manufacturer shall submit
studies). FDA will review that informa- the information required by paragraphs
tion under paragraph (d) of this sec- (b)(3) and (4) of this section.
tion. (5) A manufacturer may deviate from
(c) Infant formulas not generally avail- the requirements of paragraph (c)(2) of
able at the retail level. (1) These exempt this section only with respect to those
infant formulas are not generally found specific requirements for which it sub-
on retail shelves for general consumer mits to FDA, at the address specified
purchase. Such formulas typically are in paragraph (e)(1) of this section, the
prescribed by a physician, and must be medical, nutritional, scientific, or
requested from a pharmacist or are dis- technological rationale (including any
tributed directly to institutions such appropriate animal or human clinical
as hospitals, clinics, and State or Fed- studies). FDA will review that informa-
eral agencies. Such formulas are also tion under paragaraph (d) of this sec-
generally represented and labeled sole- tion.
222
(6) The requirements of this section sons stated in the decision. If the agen-
do not apply to an infant formula spe- cy determines that a health hazard
cially and individually prepared for one may exist and so notifies the manufac-
or more specific infants on a physi- turer, withdrawal of a product’s ex-
cian’s request. empt status shall be effective on the
(d) FDA review of exempt status. (1) date of receipt of notification from the
FDA’s Center for Food Safety and Ap- Director of the Center for Food Safety
plied Nutrition will review information and Applied Nutrition. Additional or
submitted by infant formula manufac- modified requirements, or the with-
turers under paragraph (b) (3), (b) (4), drawal of an exemption, apply only to
or (c)(4) of this section. On the basis of those formulas that are manufactured
such review and other information after the compliance date. A postpone-
available to the agency, the Center for ment of the compliance date may be
Food Safety and Applied Nutrition granted for good cause.
may impose additional conditions on, (3) FDA may decide that withdrawal
or modify requirements for, the quality of an exemption is necessary when, on
control procedures, nutrient specifica- the basis of its review under paragraph
tions, or labeling of an infant formula, (d)(1) of this section, it concludes that
or withdraw a product’s exempt status. quality control procedures are not ade-
Such determinations will be made by quate to ensure that the formula con-
the Director of the Center for Food tains all required nutrients, that devi-
Safety and Applied Nutrition. ations in nutrient levels are not sup-
(2)(i) If after completing its review of ported by generally accepted scientific,
all information submitted, the Center nutritional, or medical rationale, or
for Food Safety and Applied Nutrition that deviations from subpart B of this
concludes that additional or modified part are not necessary to provide ap-
quality control, nutrient, or labeling propriate directions for preparation
requirements are needed, or that a and use of the infant formula, or that
product’s exempt status is withdrawn, additional labeling information is nec-
the Center for Food Safety and Applied essary.
Nutrition will so notify the manufac- (4) FDA will use the following cri-
turer and this notification will specify teria in determining whether devi-
the reasons therefor. Upon receipt of ations from the requirements of this
this notification, the manufacturer has subpart are necessary and will ade-
10 working days to have the decision quately protect the public health:
reviewed under § 10.75 by the office of (i) A deviation from the nutrient re-
the Commissioner of Food and Drugs. quirements of section 412(g) of the act
A determination by the Director of the or of regulations promulgated under
Center for Food Safety and Applied Nu- section 412(a)(2) of the act is necessary
trition that is not appealed becomes a to provide an infant formula that is ap-
final agency decision. propriate for the dietary management
(ii) After a final decision by the Di- of a specific disease, disorder, or med-
rector or by the office of the Commis- ical condition;
sioner that a product’s exempt status (ii) For exempt infant formulas sub-
is withdrawn, the manufacturer shall ject to paragraph (b) of this section, a
comply with the nutrient requirements deviation from the quality control pro-
of section 412(g) of the act or of regula- cedures requirements of part 106 is nec-
tions promulgated under section essary because of unusal or difficult
412(a)(2) of the act, the quality control technological problems in manufac-
requirements of part 106, and the label- turing the infant formula; and
ing requirements of subpart B of this (iii) A deviation from the labeling re-
part. quirements of subpart B of this part is
(iii) The compliance date for the necessary because label information,
withdrawal of a product’s exempt sta- including pictograms and symbols re-
tus or the imposition of additional or quired by those regulations, could lead
modified quality control, nutrient, or to inappropriate use of the product.
labeling requirements is 60 calendar (e) Notification requirements. (1) Infor-

days after issuance of the final decision mation required by paragraphs (b) and
except as otherwise provided for rea- (c) of this section shall be submitted to
223
§ 107.100 21 CFR Ch. I (4–1–16 Edition)
the Food and Drug Administration, Unit of measure- Min- Max-

Nutrients imum imum
Center for Food Safety and Applied Nu- ment level level
trition, Office of Nutrition, Labeling,
and Dietary Supplements, Infant For- Protein Grams 1.8 4.5
Fat do 3.3 6.0
mula and Medical Foods Staff (HFS– Percent calories 30 54
850), Food and Drug Administration, Linoleic acid Milligrams 300 ..........
5100 Paint Branch Pkwy., College Park, Percent calories 2.7 ..........
MD 20740. Vitamins
(2) The manufacturer shall promptly
Vitamin A International Units 250 750
notify the Food and Drug Administra- Vitamin D do 40 100
tion when the manufacturer has knowl- Vitamin E do 0.7 ..........
edge (as defined in section 412(c)(2) of Vitamin K Micrograms 4 ..........
Thiamine (vitamin B1) do 40 ..........
the Federal Food, Drug, and Cosmetic Riboflavin (vitamin B2) do 60 ..........
Act) that reasonably supports the con- Vitamin B6 do 35 ..........
clusion that an exempt infant formula Vitamin B12 do 0.15 ..........
Niacin 1 do 250 ..........
that has been processed by the manu- Folic acid (folacin) do 4 ..........
facturer and that has left an establish- Pantothenic acid do 300 ..........
ment subject to the control of the man- Biotin 2 do 1.5 ..........
Vitamin C (ascorbic Milligrams 8 ..........
ufacturer may not provide the nutri- acid)
ents required by paragraph (b) or (c) of Choline 2 do 7 ..........
this section, or when there is an ex- Inositol 2 do 4 ..........
empt infant formula that may be oth- Minerals
erwise adulterated or misbranded and
if so adulterated or misbranded pre- Calcium do 60 ..........
Phosphorus do 30 ..........
sents a risk of human health. This no- Magnesium do 6 ..........
tification shall be made, by telephone, Iron do 0.15 3.0
to the Director of the appropriate Food Zinc do 0.5 ..........
Manganese Micrograms 5 ..........
and Drug Administration district office Copper Micrograms 60 ..........
specified in part 5, subpart M of this Iodine do 5 75
chapter. After normal business hours (8 Sodium Milligrams 20 60
a.m. to 4:30 p.m.), contact the Food and Potassium do 80 200
Chloride do 55 150
Drug Administration Emergency Call
1 The generic term ‘‘niacin’’ includes niacin (nicotinic acid)
Center at 866–300–4374. The manufac- and niacinamide (nicotinamide).
turer shall send a followup written con- 2 Required only for non-milk-based infant formulas.
firmation to the Center for Food Safe-

ty and Applied Nutrition (HFS–605), In addition to the specifications estab-
Food and Drug Administration, 5100 lished in the table in this paragraph for
Paint Branch Pkwy., College Park, MD vitamins and minerals, the following
20740, and to the appropriate FDA dis- also apply:
trict office specified in part 5, subpart (b) Vitamin E shall be present at a
M of this chapter. level of at least 0.7 International Unit
of vitamin E per gram of linoleic acid.
[50 FR 48187, Nov. 22, 1985, as amended at 61 (c) Any vitamin K added shall be in
FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30, the form of phylloquinone.
2001; 66 FR 56035, Nov. 6, 2001; 67 FR 9585, (d) Vitamin B6 shall be present at a
Mar. 4, 2002; 75 FR 32659, June 9, 2010; 79 FR
level of at least 15 micrograms of vita-
8074, Feb. 10, 2014]
min B6 for each gram of protein in ex-
cess of 1.8 grams of protein per 100
Subpart D—Nutrient Requirements kilocalories of infant formula in the
form prepared for consumption as di-
§ 107.100 Nutrient specifications. rected on the container.
(a) An infant formula shall contain (e) The ratio of calcium to phos-
the following nutrients at a level not phorus in infant formula in the form
less than the minimum level specified prepared for consumption as directed
and not more than the maximum level on the container shall be no less than
specified for each 100 kilocalories of 1.1 and not more than 2.0.
the infant formula in the form pre- (f) Protein shall be present in an
pared for consumption as directed on amount not to exceed 4.5 grams per 100
the container: kilocalories regardless of quality, and
224
not less than 1.8 grams per 100 logical quality less than 70 percent of
kilocalories of infant formula in the casein shall be used.
form prepared for consumption as di- [50 FR 45108, Oct. 30, 1985]
rected on the container when its bio-
EFFECTIVE DATE NOTE: At 80 FR 35841, June
logical quality is equivalent to or bet-
23, 2015, § 107.100 was amended by revising
ter than that of casein. If the biologi- paragraph (a), effective June 22, 2016. For the
cal quality of the protein is less than convenience of the user, the revised text is
that of casein, the minimum amount of set forth as follows:
protein shall be increased proportion-
§ 107.100 Nutrient specifications.
ately to compensate for its lower bio-
(a) An infant formula shall contain the fol-
logical quality. For example, an infant
lowing nutrients at a level not less than the
formula containing protein with a bio- minimum level specified and not more than
logical quality of 75 percent of casein the maximum level specified for each 100
shall contain at least 2.4 grams of pro- kilocalories of the infant formula in the
tein (1.8/0.75). No protein with a bio- form prepared for consumption as directed
on the container:
Nutrients Unit of measurement Minimum level Maximum level
Protein .................................................................. Grams ................................................. 1.8 4.5

Fat ........................................................................ Do. ...................................................... 3.3 6.0
Percent calories .................................. 30 54
Linoleic acid ......................................................... Milligrams ............................................ 300
Percent calories .................................. 2.7
Vitamins
Vitamin A .............................................................. International Units ............................... 250 750

Vitamin D ............................................................. Do. ...................................................... 40 100
Vitamin E .............................................................. Do. ...................................................... 0.7
Vitamin K .............................................................. Micrograms ......................................... 4
Thiamine (Vitamin B1) .......................................... Do. ...................................................... 40
Riboflavin (Vitamin B2) ......................................... Do. ...................................................... 60
Vitamin B6 ............................................................ Do. ...................................................... 35
Vitamin B12 ........................................................... Do. ...................................................... 0.15
Niacin 1 ................................................................. Do. ...................................................... 250
Folic acid (Folacin) ............................................... Do. ...................................................... 4
Pantothenic acid .................................................. Do. ...................................................... 300
Biotin 2 .................................................................. Do. ...................................................... 1.5
Vitamin C (Ascorbic acid) .................................... Milligrams ............................................ 8
Choline 2 ............................................................... Do. ...................................................... 7
Inositol 2 ................................................................ Do. ...................................................... 4
Minerals
Calcium ................................................................ Do. ...................................................... 60

Phosphorus .......................................................... Do. ...................................................... 30
Magnesium ........................................................... Do. ...................................................... 6
Iron ....................................................................... Do. ...................................................... 0.15 3.0
Zinc ...................................................................... Do. ...................................................... 0.5
Manganese .......................................................... Micrograms ......................................... 5
Copper ................................................................. Do. ...................................................... 60
Iodine ................................................................... Do. ...................................................... 5 75
Selenium .............................................................. Do. ...................................................... 2 7
Sodium ................................................................. Milligrams ............................................ 20 60
Potassium ............................................................ Do. ...................................................... 80 200
Chloride ................................................................ Do. ...................................................... 55 150
1 The generic term ‘‘niacin’’ includes niacin (nicotinic acid) and niacinamide (nicotinamide).
2 Required only for non-milk-based infant formulas.
* * * * * § 107.200 Food and Drug Administra-

tion-required recall.
Subpart E—Infant Formula Recalls When the Food and Drug Administra-
tion determines that an adulterated or
SOURCE: 54 FR 4008, Jan. 27, 1989, unless misbranded infant formula presents a
otherwise noted. risk to human health, a manufacturer
225
§ 107.210 21 CFR Ch. I (4–1–16 Edition)
shall immediately take all actions nec- (iii) Does not present a human risk.
essary to recall that formula, extend- (b) The Food and Drug Administra-
ing to and including the retail level, tion will monitor continually the re-
consistent with the requirements of call action and will take appropriate
this subpart. actions to ensure that the violative in-
fant formula is removed from the mar-
§ 107.210 Firm-initiated product re- ket.
movals.
(a) If a manufacturer has determined § 107.230 Elements of an infant for-
to recall voluntarily from the market mula recall.
an infant formula that is not subject to A recalling firm shall conduct an in-
§ 107.200 but that otherwise violates the fant formula recall with the following
laws and regulations administered by elements:
the Food and Drug Administration (a) The recalling firm shall evaluate
(FDA) and that would be subject to
in writing the hazard to human health
legal action, the manufacturer, upon
associated with the use of the infant
prompt notification to FDA, shall ad-
formula. This health hazard evaluation
minister such voluntary recall con-
shall include consideration of any dis-
sistent with the requirements of this
ease, injury, or other adverse physio-
subpart.
logical effect that has been or that
(b) If a manufacturer has determined
could be caused by the infant formula
to withdraw voluntarily from the mar-
and of the seriousness, likelihood, and
ket an infant formula that is adulter-
consequences of the diseases, injury, or
ated or misbranded in only a minor
other adverse physiological effect. The
way and that would not be subject to
legal action, such removal from the Food and Drug Administration will
market is deemed to be a market with- conduct its own health hazard evalua-
drawal, as defined in § 7.3(j) of this tion and promptly notify the recalling
chapter. As required by § 107.240(a), the firm of the results of that evaluation if
manufacturer shall promptly notify the criteria for recall under § 107.200
FDA of such violative formula and have been met.
may, but is not required to, conduct (b) The recalling firm shall devise a
such market withdrawal consistent written recall strategy suited to the in-
with the requirements of this subpart dividual circumstances of the par-
pertaining to product recalls. ticular recall. The recall strategy shall
take into account the health hazard
§ 107.220 Scope and effect of infant evaluation and specify the following:
formula recalls. The extent of the recall; if necessary,
(a) The requirements of this subpart the public warning to be given about
apply: any hazard presented by the infant for-
(1) When the Food and Drug Adminis- mula; the disposition of the recalled in-
tration has determined that it is nec- fant formula; and the effectiveness
essary to remove from the market a checks that will be made to determine
distributed infant formula that is in that the recall is carried out.
violation of the laws and regulations (c) The recalling firm shall promptly
administered by the Food and Drug Ad- notify each of its affected direct ac-
ministration and that poses a risk to counts about the recall. The format of
human health; or a recall communication shall be dis-
(2) When a manufacturer has deter- tinctive, and the content and extent of
mined that it is necessary to remove a recall communication shall be com-
from the market a distributed infant mensurate with the hazard of the in-
formula that: fant formula being recalled and the
(i) Is no longer subject to the manu- strategy developed for the recall. The
facturer’s control; recall communication shall instruct
(ii) Is in violation of the laws and consignees to report back quickly to
regulations administered by the Food the recalling firm about whether they
and Drug Administration and against are in possession of the recalled infant
which the agency could initiate legal formula and shall include a means of
or regulatory action; and doing so. The recalled communication
226
shall also advise consignees how to re- (1) Number of consignees notified of
turn the recall infant formula to the the recall and date and method of noti-
manufacturer or otherwise dispose of fication, including recalls required by
it. The recalling firm shall send a fol- § 107.200, information about the notice
lowup recall communication to any provided for retail display, and the re-
consignee that does not respond to the quest for its display.
initial recall communication. (2) Number of consignees responding
(d) If the infant formula presents a to the recall communication and quan-
risk to human health, the recalling tity of recalled infant formula on hand
firm shall request that each establish- at each consignee at the time the com-
ment, at which such infant formula is munication was received.
sold or available for sale, post at the (3) Quantity of recalled infant for-
point of purchase of such formula a no- mula returned or corrected by each
tice of such recall at such establish- consignee contacted and the quantity
ment. The notice shall be provided by of recalled infant formula accounted
the recalling firm after approval of the for.
notice by the Food and Drug Adminis- (4) Number and results of effective-
tration. The recalling firm shall also ness checks that were made.
request that each retail establishment
(5) Estimated timeframes for comple-
maintain such notice on display until
tion of the recall.
such time as the Food and Drug Ad-
ministration notifies the recalling firm (c) Status reports. The recalling firm
that the agency considers the recall shall submit to the appropriate FDA
completed. district office a written status report
(e) The recalling firm shall furnish on the recall at least every 14 days
promptly to the appropriate Food and until the recall is terminated. The sta-
Drug Administration district office tus report shall describe the steps
listed in part 5, subpart M of this chap- taken by the recalling firm to carry
ter, as they are available, copies of the out the recall since the last report and
health hazard evaluation, the recall the results of these steps.
strategy, and all recall communica- [79 FR 8074, Feb. 10, 2014]
tions (including, for a recall under
§ 107.200, the notice to be displayed at § 107.250 Termination of an infant for-
retail establishments) directed to con- mula recall.
signees, distributors, retailers, and The recalling firm may submit a rec-
members of the public. ommendation for termination of the
[54 FR 4008, Jan. 27, 1989, as amended at 66 recall to the appropriate FDA district
FR 17358, Mar. 30, 2001; 69 FR 17291, Apr. 2, office for transmittal to the Recall Co-
2004] ordinator, Division of Enforcement
(HFS–605), Office of Compliance, Center
§ 107.240 Notification requirements. for Food Safety and Applied Nutrition,
(a) Telephone report. When a deter- 5100 Paint Branch Pkwy., College Park,
mination is made that an infant for- MD 20740, or by email to
mula is to be recalled, the recalling CFSAN.RECALL@fda.hhs.gov, for ac-
firm shall telephone within 24 hours tion. Any such recommendation shall
the appropriate Food and Drug Admin- contain information supporting a con-
istration district office listed in § 5.115 clusion that the recall strategy has
of this chapter and shall provide rel- been effective. The Agency will respond
evant information about the infant for- within 15 days of receipt by the Divi-
mula that is to be recalled. sion of Enforcement of the request for
(b) Initial written report. Within 14 termination. The recalling firm shall
days after the recall has begun, the re- continue to implement the recall strat-
calling firm shall provide a written re- egy until it receives final written noti-
port to the appropriate FDA district fication from the Agency that the re-
office. The report shall contain rel- call has been terminated. The Agency
evant information, including the fol- will send such notification, unless the
lowing cumulative information con- Agency has information from FDA’s

cerning the infant formula that is own audits or from other sources dem-
being recalled: onstrating that the recall has not been
227
§ 107.260 21 CFR Ch. I (4–1–16 Edition)
effective. The Agency may conclude records respecting the distribution of

that a recall has not been effective if: the infant formula through any estab-
(a) The recalling firm’s distributors lishment owned or operated by such
have failed to retrieve the recalled in- manufacturer as may be necessary to
fant formula; or effect and monitor recalls of the for-
(b) Stocks of the recalled infant formula. Such records shall be retained
mula remain in distribution channels for at least 1 year after the expiration
that are not in direct control of the re- of the shelf life of the infant formula.
calling firm.
[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 9585, Mar. 4, 2002]
FR 14479, Apr. 2, 1996; 66 FR 17359, Mar. 30,
2001; 69 FR 17291, Apr. 2, 2004; 79 FR 8075, Feb. PART 108—EMERGENCY PERMIT
10, 2014]
CONTROL
§ 107.260 Revision of an infant formula
recall. Subpart A—General Provisions
If after a review of the recalling Sec.
firm’s recall strategy or periodic re- 108.3 Definitions.
ports or other monitoring of the recall, 108.5 Determination of the need for a per-
the Food and Drug Administration con- mit.
cludes that the actions of the recalling 108.6 Revocation of determination of need
for permit.
firm are deficient, the agency shall no- 108.7 Issuance or denial of permit.
tify the recalling firm of any serious 108.10 Suspension and reinstatement of per-
deficiency. The agency may require the mit.
firm to: 108.12 Manufacturing, processing, or pack-
(a) Change the extent of the recall, if ing without a permit, or in violation of a
the agency concludes on the basis of permit.
available data that the depth of the re- 108.19 Establishment of requirements for ex-
call is not adequate in light of the risk emption from section 404 of the act.
to human health presented by the in- Subpart B—Specific Requirements and
fant formula. Conditions for Exemption From or
(b) Carry out additional effectiveness Compliance With an Emergency Per-
checks, if the agency’s audits, or other mit
information, demonstrate that the re-
call has not been effective. 108.25 Acidified foods.
(c) Issue additional notifications to 108.35 Thermal processing of low-acid foods
the firm’s direct accounts, if the agen- packaged in hermetically sealed con-
cy’s audits, or other information dem- tainers.
onstrate that the original notifications AUTHORITY: 21 U.S.C. 342, 344, 371.
were not received, or were disregarded SOURCE: 42 FR 14334, Mar. 15, 1977, unless
in a significant number of cases. otherwise noted.
§ 107.270 Compliance with this sub-

part. Subpart A—General Provisions
A recalling firm may satisfy the re- § 108.3 Definitions.
quirements of this subpart by any
(a) The definitions contained in sec-
means reasonable calculated to meet
tion 201 of the Federal Food, Drug, and
the obligations set forth in this Sub-
Cosmetic Act are applicable to such
part E. The recall guidance in subpart
terms when used in this part.
C of part 7 of this chapter specify pro- (b) Commissioner means the Commis-
cedures that may be useful to a recall- sioner of Food and Drugs.
ing firm in determining how to comply (c) Act means the Federal Food,
with these regulations. Drug, and Cosmetic Act, as amended.
[54 FR 4008, Jan. 27, 1989, as amended at 65 (d) Permit means an emergency per-
FR 56479, Sept. 19, 2000] mit issued by the Commissioner pursu-
ant to section 404 of the act for such
§ 107.280 Records retention. temporary period of time as may be

Each manufacturer of an infant for- necessary to protect the public health.
mula shall make and retain such (e) Manufacture, processing, or packing
of food in any locality means activities
228
conducted in a single plant or estab- Drug Administration’s witnesses and

lishment, a series of plants under a sin- to present witnesses on his own behalf.
gle management, or all plants in an in- (c) Within 5 working days after the
dustry or region, by a manufacturer, hearing, and based on the evidence pre-
processor, or packer. sented at the hearing, the Commis-
sioner shall determine whether a per-
§ 108.5 Determination of the need for a mit is required and shall so inform the
permit. manufacturer, processor, or packer in
(a) Whenever the Commissioner de- writing, with the reasons for his deci-
termines after investigation that a sion.
manufacturer, processor, or packer of a (d) The Commissioner’s determina-
food for which a regulation has been tion of the need for a permit con-
promulgated in subpart B of this part stitutes final agency action from which
appeal lies to the courts. The Commis-
does not meet the mandatory condi-
sioner will not stay a determination of
tions and requirements established in
the need for a permit pending court ap-
such regulation, he shall issue to such
peal except in unusual circumstances,
manufacturer, processor, or packer an
but will participate in expediting any
order determining that a permit shall
such appeal.
be required before the food may be in-
troduced or delivered for introduction [42 FR 14334, Mar. 15, 1977, as amended at 54
into interstate commerce by that per- FR 24891, June 12, 1989; 61 FR 14479, Apr. 2,
son. The order shall specify the manda- 1996; 66 FR 56035, Nov. 6, 2001]
tory conditions and requirements with § 108.6 Revocation of determination of
which there is a lack of compliance. need for permit.
(1) The manufacturer, processor, or
(a) A permit shall be required only
packer shall have 3 working days after
during such temporary period as is nec-
receipt of such order within which to essary to protect the public health.
file objections. Such objections may be (b) Whenever the Commissioner has
filed by telegram, telex, or any other reason to believe that a permit holder
mode of written communication ad- is in compliance with the mandatory
dressed to the Center for Food Safety requirements and conditions estab-
and Applied Nutrition, Food and Drug lished in subpart B of this part and is
Administration (HFS–605), 5100 Paint likely to remain in compliance, he
Branch Pkwy., College Park, MD 20740. shall, on his own initiative or on the
If such objections are filed, the deter- application of the permit holder, re-
mination is stayed pending a hearing voke both the determination of need
to be held within 5 working days after for a permit and the permit that had
the filing of objections on the issues in- been issued. If denied, the applicant
volved unless the Commissioner deter- shall, upon request, be afforded a hear-
mines that the objections raise no gen- ing conducted in accordance with § 108.5
uine and substantial issue of fact to (b) and (c) as soon as practicable. Such
justify a hearing. revocation is without prejudice to the
(2) If the Commissioner finds that initiation of further permit pro-
there is an imminent hazard to health, ceedings with respect to the same man-
the order shall contain this finding and ufacturer, processor, or packer should
the reasons therefor, and shall state later information again show the need
that the determination of the need for for a permit.
a permit is effective immediately pend-
ing an expedited hearing. § 108.7 Issuance or denial of permit.
(b) A hearing under this section shall (a) After a determination and notifi-
be conducted by the Commissioner or cation by the Commissioner in accord-
his designee at a location agreed upon ance with the provisions of § 108.5 that
by the objector and the Commissioner a manufacturer, processor, or packer
or, if such agreement cannot be requires a permit, such manufacturer,
reached, at a location designated by processor, or packer may not there-
the Commissioner. The manufacturer, after introduce or deliver for introduc-

processor, or packer shall have the tion into interstate commerce any
right to cross-examine the Food and such food manufactured, processed, or
229
§ 108.10 21 CFR Ch. I (4–1–16 Edition)
packed by him unless he holds a permit (b) Upon application for reinstate-
issued by the Commissioner or obtains ment of a permit, the Commissioner
advance written approval of the Food shall, within 10 working days, reinstate
and Drug Administration pursuant to the permit if he finds that the person is
§ 108.12(a). in compliance with the mandatory re-
(b) Any manufacturer, processor, or quirements and conditions established
packer for whom the Commissioner has by the permit or deny the application.
made a determination that a permit is (c) Any person whose permit has been
necessary may apply to the Commis- suspended or whose application for re-
sioner for the issuance of such a per- instatement has been denied may re-
mit. The application shall contain such quest a hearing. The hearing shall be
data and information as is necessary to conducted by the Commissioner or his
show that all mandatory requirements designee within 5 working days of re-
and conditions for the manufacturer, ceipt of the request at a location
processing or packing of a food for agreed upon by the objector and the
which regulations are established in Commissioner or, if an agreement can-
subpart B of this part are met and, in not be reached, at a location des-
particular, shall show that the devi- ignated by the Commissioner. The per-
ations specified in the Commissioner’s mit holder shall have the right to
determination of the need for a permit present witnesses on his own behalf
have been corrected or suitable interim and to cross-examine the Food and
measures established. Within 10 work- Drug Administration’s witnesses.
ing days after receipt of such applica- (d) Within 5 working days after the
tion, (except that the Commissioner hearing, and based on the evidence pre-
may extend such time an additional 10 sented at the hearing, the Commis-
working days where necessary), the sioner shall determine whether the per-
Commissioner shall issue a permit, mit shall be reinstated and shall so in-
deny the permit, or offer the applicant form the permit holder, with the rea-
a hearing conducted in accordance with sons for his decision.
§ 108.5 (b) and (c) as to whether the per- (e) Denial of an application for rein-
mit should be issued. The Commis- statement of a permit constitutes final
sioner shall issue such a permit to agency action from which appeal lies
which shall be attached, in addition to to the courts. The Commissioner will
the mandatory requirements and con- not stay such denial pending court ap-
peal except in unusual circumstances,
ditions of subpart B of this part, any
but will participate in expediting any
additional requirements or conditions
such appeal.
which may be necessary to protect the
public health if he finds that all man- § 108.12 Manufacturing, processing, or
datory requirements and conditions of packing without a permit, or in vio-
subpart B of this part are met or suit- lation of a permit.
able interim measures are established. (a) A manufacturer, processor, or
(c) Denial of a permit constitutes packer may continue at his own risk to
final agency action from which appeal manufacture, process, or pack without
lies to the courts. The Commissioner a permit a food for which the Commis-
will not stay such denial pending court sioner has determined that a permit is
appeal except in unusual cir- required. All food so manufactured,
cumstances, but will participate in ex- processed, or packed during such period
pediting any such appeal. without a permit shall be retained by
the manufacturer, processor, or packer
§ 108.10 Suspension and reinstatement and may not be introduced or delivered
of permit.
for introduction into interstate com-
(a) Whenever the Commissioner finds merce without the advance written ap-
that a permit holder is not in compli- proval of the Food and Drug Adminis-
ance with the mandatory requirements tration. Such approval may be granted
and conditions established by the per- only upon an adequate showing that
mit, he shall immediately suspend the such food is free from microorganisms
permit and so inform the permit hold- of public health significance. The man-
er, with the reasons for the suspension. ufacturer, processor, or packer may
230
provide to the Commissioner, for his or in response to a petition from any

consideration in making any such de- interested person pursuant to part 10 of
termination, an evaluation of the po- this chapter.
tential public health significance of (b) A manufacturer, processor, or
such food by a competent authority in packer of a food for which a regulation
accordance with procedures recognized has been promulgated in subpart B of
as being adequate to detect any poten- this part shall be exempt from the re-
tial hazard to public health. Within 20 quirement for a permit only if he meets
working days after receipt of a written all of the mandatory requirements and
request for such written approval the conditions established in that regula-
Food and Drug Administration shall ei- tion.
ther issue such written approval or [42 FR 14334, Mar. 15, 1977, as amended at 42
deny the request. If the request is de- FR 15673, Mar. 22, 1977]
nied, the applicant shall, upon request,
be afforded a prompt hearing con-
ducted in accordance with § 108.5 (b) Subpart B—Specific Requirements
and (c). and Conditions for Exemption
(b) Except as provided in paragraph From or Compliance With an
(a) of this section, no manufacturer, Emergency Permit
processor, or packer may introduce or
deliver for introduction into interstate § 108.25 Acidified foods.
commerce without a permit or in viola- (a) Inadequate or improper manufac-
tion of a permit a food for which the ture, processing, or packing of acidified
Commissioner has determined that a foods may result in the distribution in
permit is required. Where a manufac- interstate commerce of processed foods
turer, processor, or packer utilizes a that may be injurious to health. The
consolidation warehouse or other stor- harmful nature of such foods cannot be
age facility under his control, inter- adequately determined after these
state shipment of any such food from foods have entered into interstate com-
the point of production to that ware- merce. The Commissioner of Food and
house or storage facility shall not vio- Drugs therefore finds that, to protect
late this paragraph, provided that no the public health, it may be necessary
further introduction or delivery for in- to require any commericial processor,
troduction into interstate commerce is in any establishment engaged in the
made from that consolidated ware- manufacture, processing, or packing of
house or storage facility except as pro- acidified foods, to obtain and hold a
vided in paragraph (a) of this section. temporary emergency permit provided
for under section 404 of the Federal
§ 108.19 Establishment of require- Food, Drug, and Cosmetic Act. Such a
ments for exemption from section permit may be required whenever the
404 of the act. Commissioner finds, after investiga-
(a) Whenever the Commissioner finds tion, that the commercial processor
after investigation that the distribu- has failed to fulfill all the require-
tion in interstate commerce of any ments of this section, including reg-
class of food may, by reason of con- istration and filing of process informa-
tamination with microorganisms dur- tion, and the mandatory portions of
ing the manufacture, processing, or §§ 114.10, 114.80(a) (1) and (2), and (b),
packing thereof in any locality, be in- 114.83, 114.89, and 114.100 (b), (c), and (d)
jurious to health, and that such inju- of this chapter as they relate to acidi-
rious nature cannot be adequately de- fied foods. These requirements are in-
termined after such articles have en- tended to ensure safe manufacturing,
tered interstate commerce, he shall processing, and packing processes and
promulgate regulations in Subpart B of to permit the Food and Drug Adminis-
this part establishing requirements and tration to verify that these processes
conditions governing the manufacture, are being followed. Failure to meet
processing, or packing of the food nec- these requirements shall constitute a
essary to protect the public health. prima facie basis for the immediate ap-
Such regulations may be proposed by plication of the emergency permit con-
the Commissioner on his own initiative trol provisions of section 404 of the act
231
§ 108.25 21 CFR Ch. I (4–1–16 Edition)
to that establishment, under the proce- days after registration, and before
dures established in subpart A of this packing any new product, provide the
part. Food and Drug Administration infor-
(b) The definitions in § 114.3 of this mation on the scheduled processes in-
chapter are applicable when those cluding, as necessary, conditions for
terms are used in this section. heat processing and control of pH, salt,
(c)(1) Registration. A commercial sugar, and preservative levels and
processor, when first engaging in the source and date of the establishment of
manufacture, processing, or packing of the process, for each acidified food in
acidified foods in any State, as defined each container size. Filing of this in-
in section 201(a)(1) of the act, shall, not formation does not constitute approval
later than 10 days after first so engag- of the information by the Food and
ing, register and file with the Food and Drug Administration, and information
Drug Administration on Form FDA concerning processes and other data so
2541 (food canning establishment reg- filed shall be regarded as trade secrets
istration) information including, but within the meaning of 21 U.S.C. 331(j)
not limited to, the name of the estab- and 18 U.S.C. 1905. This information
lishment, principal place of business, shall be submitted on form FDA 2541a
the location of each establishment in (food canning establishment process
which that processing is carried on, the filing form for all methods except asep-
processing method in terms of acidity tic). Forms are available from the
and pH control, and a list of foods so LACF Registration Coordinator (HFS–
processed in each establishment. These
618), Center for Food Safety and Ap-
forms are available from the LACF
plied Nutrition, Food and Drug Admin-
Registration Coordinator (HFS–618),
istration, 5100 Paint Branch Pkwy.,
Center for Food Safety and Applied Nu-
College Park, MD 20740, or at Food and
trition, Food and Drug Administration,
Drug Administration district office.
5100 Paint Branch Pkwy., College Park,
The completed form shall be submitted
MD 20740, or at any Food and Drug Ad-
to the LACF Registration Coordinator
ministration district office. The com-
(HFS–618), Center for Food Safety and
pleted form shall be submitted to the
Applied Nutrition, Food and Drug Ad-
Center for Food Safety and Applied Nu-
ministration, 5100 Paint Branch Pkwy.,
trition (HFS–565), Food and Drug Ad-
ministration, 5100 Paint Branch Pkwy., College Park, MD 20740.
College Park, MD 20740. Commercial (3) Process adherence and information—
processors presently so engaged shall (i) Scheduling. A commercial processor
register within 120 days after the effec- engaged in processing acidified foods in
tive date of this regulation. Foreign any registered establishment shall
processors shall register within 120 process each food in conformity with at
days after the effective date of this reg- least the scheduled processes filed
ulation or before any offering of foods under paragraph (c)(2) of this section.
for import into the United States, (ii) Process and pH information avail-
whichever is later. Commercial proc- ability. When requested by the Food
essors duly registered under this sec- and Drug Administration in writing, a
tion shall notify the Food and Drug commercial processor engaged in the
Administration not later than 90 days processing of acidified foods shall pro-
after the commercial processor ceases vide the Food and Drug Administration
or discontinues the manufacture, proc- with any process and procedure infor-
essing, or packing of the foods in any mation that the Food and Drug Admin-
establishment, except that this notifi- istration deems necessary to determine
cation shall not be required for tem- the adequacy of the process. Fur-
porary cessations due to the seasonal nishing of this information does not
character of an establishment’s produc- constitute approval by the Food and
tion or by temporary conditions in- Drug Administration of the content of
cluding, but not limited to, labor dis- the information filed, and the informa-
putes, fire, or acts of God. tion concerning processes and other
(2) Process filing. A commercial proc- data so furnished shall be considered

essor engaged in the processing of trade secrets within the meaning of 21
acidified foods shall, not later than 60 U.S.C. 331(j) and 18 U.S.C. 1905 (to the
232
extent that they qualify under those written demand during the course of a
provisions). factory inspection under section 704 of
(d) A commercial processor engaged the act by a duly authorized employee
in the processing of acidified foods of the Food and Drug Administration,
shall promptly report to the Food and a commercial processor shall permit
Drug Administration any instance of the inspection and copying by that em-
spoilage, process deviation, or con- ployee of these records to verify the pH
tamination with microorganisms, the and the adequacy of processing.
nature of which has potential health- (h) This section shall not apply to
endangering significance, where any the commercial processing of any food
lot of such food has in whole or in part processed under the continuous inspec-
entered distribution in commerce. tion of the meat and poultry inspection
(e) A commercial processor engaged program of the Food Safety and Inspec-
in the processing of acidified foods tion Service of the Department of Agri-
shall prepare and maintain files on a culture under the Federal Meat Inspec-
current procedure for use for products tion Act (34 Stat. 1256, as amended by
under the processor’s control, which 81 Stat. 584 (21 U.S.C. 601 et seq.)) and
that processor will ask the distributor the Poultry Products Inspection Act
to follow, including plans for recalling (71 Stat. 441, as amended by 82 Stat. 791
products that may be injurious to (21 U.S.C. 451 et seq.)).
health; for identifying, collecting, (i) Wherever the Commissioner finds
warehousing, and controlling products; that any State regulates the commer-
for determining the effectiveness of re-
cial processing of acidified foods under
calls; for notifying the Food and Drug
effective regulations specifying at least
Administration of any recalls; and for
the requirements of part 114 of this
implementing recall programs.
chapter, the Commissioner shall issue
(f) All plant personnel involved in
a notice stating that compliance with
acidification, pH control, heat treat-
such State regulations shall constitute
ment, or other critical factors of the
compliance with this section, if the
operation shall be under the operating
State through its regulatory agency or
supervision of a person who has at-
each processor of acidified foods in the
tended a school approved by the Com-
State files with the Food and Drug Ad-
missioner for giving instruction in
food-handling techniques, food protec- ministration the registration informa-
tion principles, personal hygiene, plant tion and the processing information
sanitation practices, pH controls, and prescribed in paragraph (c) of this sec-
critical factors in acidification, and tion.
who has satisfactorily completed the (j) Imports. (1) This section applies to
prescribed course of instruction. The any foreign commercial processor en-
Commissioner will consider students gaged in the processing of acidified
who have satisfactorily completed the foods and offering those foods for im-
required portions of the courses pre- port into the United States except
sented under § 108.35 and part 113 of this that, in lieu of providing for the
chapter before March 16, 1979, as having issuance of an emergency permit under
satisfactorily completed the prescribed paragraph (a) of this section, the Com-
course of instruction under this section missioner will request the Secretary of
and part 114 of this chapter. The Com- the Treasury to refuse admission into
missioner will not withhold approval of the United States, under section 801 of
any school qualified to give such in- the act, to any acidified foods which
struction. the Commissioner determines, after in-
(g) A commercial processor engaged vestigation, may result in the distribu-
in the processing of acidified foods tion in interstate commerce of proc-
shall prepare, review, and retain at the essed foods that may be injurious to
processing plant or other reasonably health as set forth in paragraph (a) of
accessible location for a period of 3 this section.
years from the date of manufacture, all (2) Any acidified food so refused ad-
records of processing, deviations in mission shall not be admitted until the

processing, pH, and other records speci- Commissioner determines that the
fied in part 114 of this chapter. Upon commercial processor offering the food
233
§ 108.35 21 CFR Ch. I (4–1–16 Edition)
for import has complied with the retain and hold a temporary emergency
quirements of this section and that the permit provided for under section 404 of
food is not injurious to health. To as- the Federal Food, Drug, and Cosmetic
sist the Commissioner in making this Act. Such a permit may be required
determination, a duly authorized em- whenever the Commissioner finds, after
ployee of the Food and Drug Adminis- investigation, that the commercial
tration shall be permitted to inspect processor has failed to fulfill all the re-
the commercial processor’s manufac- quirements of this section, including
turing, processing, and packing facili- registration and the filing of process
ties. information, and the mandatory por-
(k) The following information sub- tions of part 113 of this chapter. These
mitted to the Food and Drug Adminis- requirements are intended to ensure
tration under this section is not avail- safe manufacture, processing, and
able for public disclosure unless it has packing procedures and to permit the
been previously disclosed to the public Food and Drug Administration to
as defined in § 20.81 of this chapter or it verify that these procedures are being
relates to a product or ingredient that followed. Such failure shall constitute
has been abandoned and no longer rep- a prima facie basis for the immediate
resents a trade secret or confidential application of the emergency permit
commercial or financial information as control provisions of section 404 of the
defined in § 20.61 of this chapter:
act to that establishment, pursuant to
(1) Manufacturing methods or proc-
the procedures established in subpart A
esses, including quality control infor-
of this part.
mation.
(2) Production, sales, distribution, (b) The definitions in § 113.3 of this
and similar information, except that chapter are applicable when such terms
any compilation of the information ag- are used in this section.
gregated and prepared in a way that (c) Registration and process filing—(1)
does not reveal information which is Registration. A commercial processor
not available for public disclosure when first engaging in the manufac-
under this provision is available for ture, processing, or packing of ther-
public disclosure. mally processed low-acid foods in her-
(3) Quantitative or semiquantitative metically sealed containers in any
formulas. state, as defined in section 201(a)(1) of
the act, shall, not later than 10 days
[44 FR 16207, Mar. 16, 1979, as amended at 54 after first so engaging, register with
FR 24891, June 12, 1989; 61 FR 14479, Apr. 2,
1996; 66 FR 56035, Nov. 6, 2001] the Food and Drug Administration on
Form FDA 2541 (food canning establish-
§ 108.35 Thermal processing of low- ment registration) information includ-
acid foods packaged in hermetically ing (but not limited to) his name, prin-
sealed containers. cipal place of business, the location of
(a) Inadequate or improper manufac- each establishment in which such proc-
ture, processing, or packing of ther- essing is carried on, the processing
mally processed low-acid foods in her- method in terms of the type of proc-
metically sealed containers may result essing equipment employed, and a list
in the distribution in interstate com- of the low-acid foods so processed in
merce of processed foods that may be each such establishment. These forms
injurious to health. The harmful na- are available from the LACF Registra-
ture of such foods cannot be adequately tion Coordinator (HFS–618), Center for
determined after these foods have en- Food Safety and Applied Nutrition,
tered into interstate commerce. The Food and Drug Administration, 5100
Commissioner of Food and Drugs there- Paint Branch Pkwy., College Park, MD
fore finds that, in order to protect the 20740, or at any Food and Drug Admin-
public health, it may be necessary to istration district office. The completed
require any commercial processor, in form shall be submitted to the LACF
any establishment engaged in the man- Registration Coordinator (HFS–618),
ufacture, processing, or packing of Center for Food Safety and Applied Nu-
thermally processed low-acid foods in trition, Food and Drug Administration,
hermetically sealed containers, to ob- 5100 Paint Branch Pkwy., College Park,
234
MD 20740. Commercial processors pres- fice. The completed form(s) shall be

ently so engaged shall register not submitted to the LACF Registration
later than July 13, 1973. Commercial Coordinator (HFS–618), Center for Food
processors duly registered in accord- Safety and Applied Nutrition, Food and
ance with this section shall notify the Drug Administration, 5100 Paint
Food and Drug Administration not Branch Pkwy., College Park, MD 20740.
later than 90 days after such commer- (i) If all the necessary information is
cial processor ceases or discontinues not available for existing products, the
the manufacture, processing, or pack- processor shall, at the time the exist-
ing of thermally processed foods in any ing information is provided to the Food
establishment: Provided, That such no- and Drug Administration request in
tification shall not be required as to writing an extension of time for sub-
the temporary cessation necessitated
mission of such information, specifying
by the seasonal character of the par-
what additional information is to be
ticular establishment’s production or
supplied and the date by which it is to
caused by temporary conditions includ-
ing but not limited to strikes, be submitted. Within 30 working days
lockouts, fire, or acts of God. after receipt of such request the Food
(2) Process filing. A commercial proc- and Drug Administration shall either
essor engaged in the thermal proc- grant or deny such request in writing.
essing of low-acid foods packaged in (ii) If a packer intentionally makes a
hermetically sealed containers shall, change in a previously filed scheduled
not later than 60 days after registra- process by reducing the initial tem-
tion and prior to the packing of a new perature or retort temperature, reduc-
product, provide the Food and Drug ing the time of processing, or changing
Administration information as to the the product formulation, the container,
scheduled processes including but not or any other condition basic to the ade-
limited to the processing method, type quacy of scheduled process, he shall
of retort or other thermal processing prior to using such changed process ob-
equipment employed, minimum initial tain substantiation by qualified sci-
temperatures, times and temperatures entific authority as to its adequacy.
of processing, sterilizing value (Fo), or Such substantiation may be obtained
other equivalent scientific evidence of by telephone, telegram, or other media,
process adequacy, critical control fac- but must be promptly recorded,
tors affecting heat penetration, and verified in writing by the authority,
source and date of the establishment of and contained in the packer’s files for
the process, for each such low-acid food review by the Food and Drug Adminis-
in each container size: Provided, That tration. Within 30 days after first use,
the filing of such information does not the packer shall submit to the Center
constitute approval of the information for Food Safety and Applied Nutrition
by the Food and Drug Administration, (HFS–617), Food and Drug Administra-
and that information concerning proc-
tion, 5100 Paint Branch Pkwy., College
esses and other data so filed shall be
Park, MD 20740 a complete description
regarded as trade secrets within the
of the modifications made and utilized,
meaning of 21 U.S.C. 331(j) and 18
U.S.C. 1905. This information shall be together with a copy of his file record
submitted on the following forms as showing prior substantiation by a
appropriate: Form FDA 2541a (food can- qualified scientific authority as to the
ning establishment process filing for safety of the changed process. Any in-
all methods except aseptic), or Form tentional change of a previously filed
FDA 2541c (food canning establishment scheduled process or modification
process filing for aseptic systems). thereof in which the change consists
These forms are available from the solely of a higher initial temperature,
LACF Registration Coordinator (HFS– a higher retort temperature, or a
618), Center for Food Safety and Ap- longer processing time, shall not be
plied Nutrition, Food and Drug Admin- considered a change subject to this
istration, 5100 Paint Branch Pkwy., paragraph, but if that modification is

College Park, MD 20740, or at any Food thereafter to be regularly scheduled,
and Drug Administration district of- the modified process shall be promptly
235
§ 108.35 21 CFR Ch. I (4–1–16 Edition)
filed as a scheduled process, accom- tainers shall promptly report to the

panied by full information on the speci- Food and Drug Administration any in-
fied forms as provided in this para- stance wherein any lot of such food,
graph. which may be injurious to health by
(iii) Many packers employ an ‘‘oper- reason of contamination with micro-
ating’’ process in which retort opera- organisms, has in whole or in part en-
tors are instructed to use retort tem- tered distribution.
peratures and/or processing times (f) A commercial processor engaged
slightly in excess of those specified in in the thermal processing of low-acid
the scheduled process as a safety factor foods packaged in hermetically sealed
to compensate for minor fluctuations containers shall have prepared and in
in temperature or time to assure that his files a current procedure which he
the minimum times and temperatures will use for products under his control
in the scheduled process are always and which he will ask his distributor to
met. This would not constitute a modi- follow, including plans for effecting re-
fication of the scheduled process. calls of any product that may be inju-
(3) Process adherence and information. rious to health; for identifying, col-
(i) A commercial processor engaged in lecting, warehousing, and controlling
the thermal processing of low-acid the product; for determining the effec-
foods packaged in hermetically sealed tiveness of such recall; for notifying
containers in any registered establish- the Food and Drug Administration of
ment shall process each low-acid food any such recall; and for implementing
in each container size in conformity such recall program.
with at least the scheduled processes (g) All operators of retorts, thermal
and modifications filed pursuant to processing systems, aseptic processing
paragraph (c)(2) of this section. and packaging systems, or other ther-
(ii) Process information availability: mal processing systems, and container
When requested by the Food and Drug closure inspectors shall be under the
Administration in writing, a commer- operating supervision of a person who
cial processor engaged in thermal proc- has attended a school approved by the
essing of low-acid foods packaged in Commissioner for giving instruction in
hermetically sealed containers shall retort operations, aseptic processing
provide the Food and Drug Administra- and packaging systems operations or
tion with any information concerning other thermal processing systems oper-
processes and procedures which is ations, and container closure inspec-
deemed necessary by the Food and tions, and has satisfactorily completed
Drug Administration to determine the the prescribed course of instruction:
adequacy of the process: Provided, That Provided, That this requirement shall
the furnishing of such information does not apply in the State of California as
not constitute approval of the informa- listed in paragraph (j) of this section.
tion by the Food and Drug Administra- The Commissioner will not withhold
tion, and that the information con- approval of any school qualified to give
cerning processes and other data so such instruction.
furnished shall be regarded as trade se- (h) A commercial processor engaged
crets within the meaning of 21 U.S.C. in the thermal processing of low-acid
331(j) and 18 U.S.C. 1905. foods packaged in hermetically sealed
(d) A commercial processor engaged containers shall prepare, review, and
in the thermal processing of low-acid retain at the processing plant for a pe-
foods packaged in hermetically sealed riod of not less than one year, and at
containers shall promptly report to the the processing plant or other reason-
Food and Drug Administration any in- ably accessible location for an addi-
stance of spoilage or process deviation tional two years, all records of proc-
the nature of which indicates potential essing, deviations in processing, con-
health significance where any lot of tainer closure inspections, and other
such food has in whole or in part en- records specified in part 113 of this
tered distribution. chapter. If during the first year of the
(e) A commercial processor engaged three-year record retention period the

in thermal processing of low-acid foods processing plant is closed for a pro-
packaged in hermetically sealed con- longed period between seasonal packs,
236
the records may be transferred to some lations, shall be deemed to comply

other reasonably accessible location at with the requirements of part 113 of
the end of the seasonal pack. Upon this chapter.
written demand during the course of a (k) Imports. (1) This section shall
factory inspection pursuant to section apply to any foreign commercial proc-
704 of the act by a duly authorized em- essor engaged in the thermal proc-
ployee of the Food and Drug Adminis- essing of low-acid foods packaged in
tration, a commercial processor shall hermetically sealed containers and of-
permit the inspection and copying by fering such foods for import into the
such employee of these records to United States except that, in lieu of
verify the adequacy of processing, the providing for the issuance of an emer-
integrity of container closures, and the gency permit under paragraph (a) of
coding of the products. this section, the Commissioner will re-
(i) This section shall not apply to the quest the Secretary of the Treasury to
commercial processing of any food refuse admission into the United
processed under the continuous inspec- States, pursuant to section 801 of the
tion of the meat and poultry inspection act, of any such low-acid foods which
program of the Animal and Plant the Commissioner determines, after in-
Health Inspection Service of the De- vestigation, may result in the distribu-
partment of Agriculture under the Fed- tion in interstate commerce of proc-
eral Meat Inspection Act (34 Stat. 1256, essed foods that may be injurious to
as amended by 81 Stat. 584 (21 U.S.C. health as set forth in paragraph (a) of
601 et seq.)) and the Poultry Products this section.
Inspection Act (71 Stat. 441, as amend- (2) Any such food refused admission
ed by 82 Stat. 791 (21 U.S.C. 451 et seq.)). shall not be admitted until such time
(j) Compliance with State regulations. as the Commissioner may determine
(1) Wherever the Commissioner finds that the commercial processor offering
that any State regulates the commer- the food for import is in compliance
cial thermal processing of low-acid with the requirements and conditions
foods in accordance with effective reg- of this section and that such food is not
ulations specifying at least the require- injurious to health. For the purpose of
ments of part 113 of this chapter, he making such determination, the Com-
shall issue a notice stating that commissioner reserves the right for a duly
pliance with such State regulations authorized employee of the Food and
shall constitute compliance with part Drug Administration to inspect the
113 of this chapter. However, the provi- commercial processor’s manufacturing,
sions of this section shall remain appli- processing, and packing facilities.
cable to the commercial processing of (l) The following data and informa-
low-acid foods in any such State, ex- tion submitted to the Food and Drug
cept that, either the State through its Administration pursuant to this sec-
regulatory agency or each processor of tion are not available for public disclo-
low-acid foods in such State shall file sure unless they have been previously
with the Center for Food Safety and disclosed to the public as defined in
Applied Nutrition the registration in- § 20.81 of this chapter or they relate to
formation and the processing informa- a product or ingredient that has been
tion prescribed in paragraph (c) of this abandoned and they no longer rep-
section. resent a trade secret or confidential
(2) The Commissioner finds that the commercial or financial information as
regulations adopted by the State of defined in § 20.81 of this chapter:
California under the laws relating to (1) Manufacturing methods or proc-
cannery inspections governing thermal esses, including quality control infor-
processing of low-acid foods packaged mation.
in hermetically sealed containers sat- (2) Production, sales, distribution,
isfy the requirements of part 113 of this and similar data and information, ex-
chapter. cept that any compilation of such data
Accordingly, processors, who under the and information aggregated and pre-
laws relating to cannery inspections pared in a way that does not reveal
are licensed by the State of California data or information which is not avail-
and who comply with such state regu- able for public disclosure under this
237
provision is available for public disclo- not the result of environmental, agri-
sure. cultural, industrial, or other contami-
(3) Quantitative or semiquantitative nation.
formulas. (d) An added poisonous or deleterious
[42 FR 14334, Mar. 15, 1977, as amended at 42 substance is a poisonous or deleterious
FR 15673, Mar. 22, 1977; 54 FR 24891, June 12, substance that is not a naturally oc-
1989; 61 FR 14480, Apr. 2, 1996; 66 FR 56035, curring poisonous or deleterious sub-
Nov. 6, 2001] stance. When a naturally occurring
poisonous or deleterious substance is
PART 109—UNAVOIDABLE CON- increased to abnormal levels through
TAMINANTS IN FOOD FOR mishandling or other intervening acts,
HUMAN CONSUMPTION AND it is an added poisonous or deleterious
FOOD-PACKAGING MATERIAL substance to the extent of such in-
crease.
Subpart A—General Provisions (e) Food includes human food and
substances migrating to food from
Sec. food-contact articles.
109.3 Definitions and interpretations.
109.4 Establishment of tolerances, regu- § 109.4 Establishment of tolerances,
latory limits, and action levels. regulatory limits, and action levels.
109.6 Added poisonous or deleterious sub-
stances. (a) When appropriate under the cri-
109.7 Unavoidability. teria of § 109.6, a tolerance for an added
109.15 Use of polychlorinated biphenyls poisonous or deleterious substance,
(PCB’s) in establishments manufacturing which may be a food additive, may be
food-packaging materials.
109.16 Ornamental and decorative
established by regulation in subpart B
ceramicware. of this part under the provisions of sec-
tion 406 of the act. A tolerance may
Subpart B—Tolerances for Unavoidable prohibit any detectable amount of the
Poisonous or Deleterious Substances substance in food.
(b) When appropriate under the cri-
109.30 Tolerances for polychlorinated
biphenyls (PCB’s). teria of § 109.6, and under section
402(a)(1) of the act, a regulatory limit
Subpart C—Regulatory Limits for Added for an added poisonous or deleterious
Poisonous or Deleterious Substances substance, which may be a food addi-
[Reserved] tive, may be established by regulation
in subpart C of this part under the pro-
Subpart D—Naturally Occurring Poisonous visions of sections 402(a)(1) and 701(a) of
or Deleterious Substances [Reserved] the act. A regulatory limit may pro-
hibit any detectable amount of the sub-
AUTHORITY: 21 U.S.C. 321, 336, 342, 346, 346a, stance in food. The regulatory limit es-
348, 371. tablished represents the level at which
SOURCE: 42 FR 52819, Sept. 30, 1977, unless food is adulterated within the meaning
otherwise noted. of section 402(a)(1) of the act.
(c)(1) When appropriate under the cri-
Subpart A—General Provisions teria of § 109.6, an action level for an
added poisonous or deleterious sub-
§ 109.3 Definitions and interpretations. stance, which may be a food additive,
(a) Act means the Federal Food, may be established to define a level of
Drug, and Cosmetic Act. contamination at which a food may be
(b) The definitions of terms con- regarded as adulterated.
tained in section 201 of the act are ap- (2) Whenever an action level is estab-
plicable to such terms when used in lished or changed, a notice shall be
this part unless modified in this sec- published in the FEDERAL REGISTER as
tion. soon as practicable thereafter. The no-
(c) A naturally occurring poisonous or tice shall call attention to the mate-
deleterious substance is a poisonous or rial supporting the action level which

deleterious substance that is an inher- shall be on file with the Division of
ent natural constituent of a food and is Dockets Management before the notice
238
is published. The notice shall invite (3) No technological or other changes

public comment on the action level. are foreseeable in the near future that
(d) A regulation may be established might affect the appropriateness of the
in subpart D of this part to identify a tolerance established. Examples of
food containing a naturally occurring changes that might affect the appro-
poisonous or deleterious substance priateness of the tolerance include an-
which will be deemed to be adulterated ticipated improvements in good manu-
under section 402(a)(1) of the act. These facturing practice that would change
regulations do not constitute a com- the extent to which use of the sub-
plete list of such foods. stance is unavoidable and anticipated
[42 FR 52819, Sept. 30, 1977, as amended at 55 studies expected to provide significant
FR 20785, May 21, 1990] new toxicological or use data.
(c) A regulatory limit for an added
§ 109.6 Added poisonous or deleterious poisonous or deleterious substance in
substances. any food may be established when each
(a) Use of an added poisonous or dele- of the following criteria is met:
terious substance, other than a pes- (1) The substance cannot be avoided
ticide chemical, that is also a food ad- by current good manufacturing prac-
ditive, will be controlled by a regula- tices.
tion issued under section 409 of the act (2) There is no tolerance established
when possible. When such a use cannot for the substance in the particular food
be approved under the criteria of sec- under sections 406, 408, or 409 of the act.
tion 409 of the act, or when the added (3) There is insufficient information
poisonous or deleterious substance is by which a tolerance may be estab-
not a food additive, a tolerance, regu- lished for the substance under section
latory limit, or action level may be es- 406 of the act or technological changes
tablished pursuant to the criteria in appear reasonably possible that may
paragraphs (b), (c), or (d) of this sec- affect the appropriateness of a toler-
tion. Residues resulting from the use of ance. The regulatory limit established
an added poisonous or deleterious sub- represents the level at which food is
stance that is also a pesticide chemical adulterated within the meaning of sec-
will ordinarily be controlled by a toler- tion 402(a)(1) of the act.
ance established in a regulation issued (d) An action level for an added poi-
under sections 406, 408, or 409 of the act sonous or deleterious substance in any
by the U.S. Environmental Protection food may be established when the cri-
Agency (EPA). When such a regulation teria in paragraph (b) of this section
has not been issued, an action level for are met, except that technological or
an added poisonous or deleterious sub- other changes that might affect the ap-
stance that is also a pesticide chemical propriateness of the tolerance are fore-
may be established by the Food and seeable in the near future. An action
Drug Administration. The Food and level for an added poisonous or delete-
Drug Administration will request EPA rious substance in any food may be es-
to recommend such an action level pur- tablished at a level at which the Food
suant to the criteria established in and Drug Administration may regard
paragraph (d) of this section. the food as adulterated within the
(b) A tolerance for an added poi- meaning of section 402(a)(1) of the act,
sonous or deleterious substance in any without regard to the criteria in para-
food may be established when the fol- graph (b) of this section or in section
lowing criteria are met: 406 of the act. An action level will be
(1) The substance cannot be avoided withdrawn when a tolerance or regu-
by good manufacturing practice. latory limit for the same substance and
(2) The tolerance established is suffi- use has been established.
cient for the protection of the public (e) Tolerances will be established
health, taking into account the extent under authority appropriate for action
to which the presence of the substance levels (sections 306, 402(a), and 701(a) of
cannot be avoided and the other ways the act, together with section 408 or 409
in which the consumer may be affected of the act, if appropriate) as well as

by the same or related poisonous or under authority appropriate for toler-
deleterious substances. ances (sections 406 and 701 of the act).
239
§ 109.7 21 CFR Ch. I (4–1–16 Edition)
In the event the effectiveness of a tol- formulations of lubricants, coatings,

erance is stayed pursuant to section and inks. Their unique physical and
701(e)(2) of the act by the filing of an chemical properties and widespread,
objection, the order establishing the uncontrolled industrial applications
tolerance shall be deemed to be an have caused PCB’s to be a persistent
order establishing an action level until and ubiquitous contaminant in the en-
final action is taken upon such objec- vironment, causing the contamination
tion. of certain foods. In addition, incidents
[42 FR 52819, Sept. 30, 1977, as amended at 55 have occurred in which PCB’s have di-
FR 20785, May 21, 1990] rectly contaminated animal feeds as a
result of industrial accidents (leakage
§ 109.7 Unavoidability. or spillage of PCB fluids from plant
(a) Tolerances and action levels in equipment). These accidents in turn
this part are established at levels based caused the contamination of food prod-
on the unavoidability of the poisonous ucts intended for human consumption
or deleterious substance concerned and (meat, milk and eggs). Investigations
do not establish a permissible level of by the Food and Drug Administration
contamination where it is avoidable. have revealed that a significant per-
(b) Compliance with tolerances, regu- centage of paper food-packaging mate-
latory limits, and action levels does rial contains PCB’s which can migrate
not excuse failure to observe either the to the packaged food. The origin of
requirement in section 402(a)(4) of the PCB’s in such material is not fully un-
act that food may not be prepared, derstood. Reclaimed fibers containing
packed, or held under insanitary condi- carbonless copy paper (contains 3 to 5
tions or the other requirements in this percent PCB’s) have been identified as
chapter that food manufacturers must a primary source of PCB’s in paper
observe current good manufacturing products. Some virgin paper products
practices. Evidence obtained through have also been found to contain PCB’s,
factory inspection or otherwise indi- the source of which is generally attrib-
cating such a violation renders the uted to direct contamination from in-
food unlawful, even though the dustrial accidents from the use of PCB-
amounts of poisonous or deleterious containing equipment and machinery
substances are lower than the cur- in food packaging manufacturing es-
rently established tolerances, regu- tablishments. Since PCB’s are toxic
latory limits, or action levels. The chemicals, the PCB contamination of
manufacturer of food must at all times food-packaging materials as a result of
utilize quality control procedures industrial accidents, which can cause
which will reduce contamination to the the PCB contamination of food, rep-
lowest level currently feasible. resents a hazard to public health. It is
[42 FR 52819, Sept. 30, 1977, as amended at 55
therefore necessary to place certain re-
FR 20785, May 21, 1990] strictions on the industrial uses of
PCB’s in establishments manufac-
§ 109.15 Use of polychlorinated turing food-packaging materials.
biphenyls (PCB’s) in establishments (b) The following special provisions
manufacturing food-packaging ma- are necessary to preclude the acci-
terials. dental PCB contamination of food-
(a) Polychlorinated biphenyls (PCB’s) packaging materials:
represent a class of toxic industrial (1) New equipment or machinery for
chemicals manufactured and sold under manufacturing food-packaging mate-
a variety of trade names, including: rials shall not contain or use PCB’s.
Aroclor (United States); Phenoclor (2) On or before September 4, 1973, the
(France); Colphen (Germany); and management of establishments manu-
Kanaclor (Japan). PCB’s are highly sta- facturing food-packaging materials
ble, heat resistant, and nonflammable shall:
chemicals. Industrial uses of PCB’s in- (i) Have the heat exchange fluid used
clude, or did include in the past, their in existing equipment for manufac-
use as electrical transformer and ca- turing food-packaging materials sam-

pacitor fluids, heat transfer fluids, hy- pled and tested to determine whether it
draulic fluids, and plasticizers, and in contains PCB’s or verify the absence of
240
PCB’s in such formulations by other indications that they are not to be

appropriate means. On or before Sept. used for food-handling purposes.
4, 1973, any such fluid formulated with (b) Ornamental or decorative
PCB’s must to the fullest extent pos- ceramicware initially introduced or
sible commensurate with current good initially delivered for introduction into
manufacturing practices be replaced interstate commerce on or after July
with a heat exchange fluid that does 13, 1994 appears to be suitable for food
not contain PCB’s. use will be considered to be for food use
(ii) Eliminate to the fullest extent unless:
possible commensurate with current (1) It bears:
good manufacturing practices from the (i) A conspicuous stick-on label on a
establishment any other PCB-con- surface clearly visible to consumers
taining equipment, machinery and ma-
that states in legible script in letters
terials wherever there is a reasonable
at least 3.2 millimeters (0.125 inch) in
expectation that such articles could
height one of the following messages:
cause food-packaging materials to be-
‘‘Not for Food Use. May Poison Food,’’
come contaminated with PCB’s either
as a result of normal use or as a result ‘‘Not for Food Use. Glaze contains lead.
of accident, breakage, or other mishap. Food Use May Result in Lead Poi-
(iii) The toxicity and other charac- soning,’’ and ‘‘Not for Food Use—Food
teristics of fluids selected as PCB re- Consumed from this Vessel May be
placements must be adequately deter- Harmful,’’ and
mined so that the least potentially (ii) A conspicuous and legible perma-
hazardous replacement is used. In mak- nent statement of the message selected
ing this determination with respect to from paragraph (b)(1)(i) of this section
a given fluid, consideration should be molded or fired onto the exterior sur-
given to (a) its toxicity; (b) the max- face of the base or, when the
imum quantity that could be spilled ceramicware is not fired after decora-
onto a given quantity of food before it tion, permanently painted onto the ex-
would be noticed, taking into account terior surface of the base. This perma-
its color and odor; (c) possible signaling nent statement shall be in letters at
devices in the equipment to indicate a least 3.2 millimeters (0.125 inch) in
loss of fluid, etc.; and (d) its environ- height, except that if insufficient space
mental stability and tendency to sur- exists for the permanent statement in
vive and be concentrated through the letters of such height, the statement
food chain. The judgment as to wheth- shall be in the largest letters that will
er a replacement fluid is sufficiently allow it to fit on the base of the piece,
non-hazardous is to be made on an indi- provided that the letters are at least
vidual installation and operation basis. 1.6 millimeters (0.062 inch) in height; or
(c) The provisions of this section do (2) A hole is bored through the poten-
not apply to electrical transformers tial food-contact surface.
and condensers containing PCB’s in (c) In addition to steps required
sealed containers. under paragraphs (b)(1) and (b)(2) of
§ 109.16 Ornamental and decorative this section, the following optional in-
ceramicware. formation may be provided on the
ware:
(a) Lead is a toxic metal that is used (1) A further explanatory statement
as a component of glazes and decora-
concerning the decorative nature of the
tive decals on ceramics, including some
piece, such as ‘‘Decorative’’ or ‘‘For
ornamental and decorative
Decorative Purposes Only,’’ may be
ceramicware. The use of ornamental or
used; however, such additional state-
decorative ceramicware to prepare,
serve, or hold food may result in the ment shall be placed after the required
leaching of lead from the glaze or deco- statement.
ration into the food. The provisions of (2) A symbol may be used to advise
paragraph (b) of this section are nec- that a piece of ornamental or decora-
essary to ensure that ornamental or tive ceramicware is not to be used with
decorative ceramicware bear adequate food, as illustrated below.
241
§ 109.30 21 CFR Ch. I (4–1–16 Edition)
of PCB’s is present as the residue. The

temporary tolerances for residues of
PCB’s are as follows:
(1) 1.5 parts per million in milk (fat
basis).
(2) 1.5 parts per million in manufac-
tured dairy products (fat basis).
(3) 3 parts per million in poultry (fat
basis).
The circle of the above symbol should
(4) 0.3 parts per million in eggs.
be at least 2.54 centimeters (1 inch) in
(5) 0.2 parts per million in finished
diameter. The symbol may be used on
the temporary label or applied to the animal feed for food-producing animals
base of the piece in the same manner as (except the following finished animal
the permanent statement. feeds: feed concentrates, feed supple-
ments, and feed premixes).
[59 FR 1641, Jan. 12, 1994] (6) 2 parts per million in animal feed
components of animal origin, including
Subpart B—Tolerances for Un- fishmeal and other by-products of ma-
avoidable Poisonous or Dele- rine origin and in finished animal feed
terious Substances concentrates, supplements, and pre-
mixes intended for food producing ani-
§ 109.30 Tolerances for polychlorinated mals.
biphenyls (PCB’s). (7) 2 parts per million in fish and
(a) Polychlorinated biphenyls (PCB’s) shellfish (edible portion). The edible
are toxic, industrial chemicals. Be- portion of fish excludes head, scales,
cause of their widespread, uncontrolled viscera, and inedible bones.
industrial applications, PCB’s have be- (8) 0.2 parts per million in infant and
come a persistent and ubiquitous con- junior foods.
taminant in the environment. As a re- (9) 10 parts per million in paper food-
sult, certain foods and animal feeds, packaging material intended for or
principally those of animal and marine used with human food, finished animal
origin, contain PCB’s as unavoidable, feed and any components intended for
environmental contaminants. PCB’s animal feeds. The tolerance shall not
are transmitted to the food portion apply to paper food-packaging material
(meat, milk, and eggs) of food-pro- separated from the food therein by a
ducing animals ingesting PCB-con- functional barrier which is imper-
taminated animal feed. In addition, a meable to migration of PCB’s.
significant percentage of paper food-
(b) A compilation entitled ‘‘Analyt-
packaging materials contain PCB’s
ical Methodology for Polychlorinated
which may migrate to the packaged
Biphenyls, June 1979’’ for determining
food. The source of PCB’s in paper
food-packaging materials is primarily compliance with the tolerances estab-
of certain types of carbonless copy lished in this section is available from
paper (containing 3 to 5 percent PCB’s) the Division of Dockets Management
in waste paper stocks used for manu- (HFA–305), Food and Drug Administra-
facturing recycled paper. Therefore, tion, 5630 Fishers Lane, rm. 1061, Rock-
temporary tolerances for residues of ville, MD 20852.
PCB’s as unavoidable environmental or (c) A barrier is functional for pur-
industrial contaminants are estab- poses of paragraph (a)(9) of this section
lished for a sufficient period of time if the barrier limits migration of PCB’s
following the effective date of this from the packaging material to food to
paragraph to permit the elimination of a level not exceeding the migration
such contaminants at the earliest prac- which occurs under the same test con-
ticable time. For the purposes of this ditions from packaging material con-
paragraph, the term ‘‘polychlorinated taining 10 parts per million PCB with-
biphenyls (PCB’s)’’ is applicable to out the use of a barrier. A class of bar-

mixtures of chlorinated biphenyl com- rier material is functional for purposes
pounds, irrespective of which mixture of paragraph (a)(9) of this section if a
242
ER01JA93.368</GPH>
representative barrier of the class lim- College Park, MD 20740. All barriers or
its migration of PCB’s from the pack- classes of barriers shall be tested with
aging material to food to a level not the four solid food receptors specified
exceeding the migration which occurs in ‘‘Test Procedures for Determination
under the same test conditions from of PCB Permeability of Food Pack-
packaging material containing 10 parts aging, Inner-Wraps, September 1976, re-
per million PCB without the use of a vised May 1983’’, which is incorporated
barrier. Migration levels shall be deter- by reference. The availability of this
mined for purpose of this paragraph reference is given in paragraph (c) of
solely by use of testing conditions de- this section. The test results as to each
scribed in ‘‘Test Procedures for Deter- barrier shall be accompanied by (1) a
mination of PCB Permeability of Food description of the barrier’s composition
Packaging, Inner-Wraps, September adequate to enable identification; and
1976, revised May 1983’’, which is incor- (2) a specific definition of the barrier
porated by reference. Copies are avail-
by relevant technical characteristics.
able from the Division of Dockets Man-
The Center for Food Safety and Ap-
agement (HFA–305), Food and Drug Ad-
plied Nutrition shall review submitted
ministration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, or available test results promptly. Within 60 days of
for inspection at the National Archives the receipt of test results, the Director,
and Records Administration (NARA). Center for Food Safety and Applied Nu-
For information on the availability of trition, shall notify the person submit-
this material at NARA, call 202–741– ting the test results whether the tests
6030, or go to: http://www.archives.gov/ were conducted in accordance with the
federallregister/ ‘‘Analytical Methodology for Poly-
codeloflfederallregulations/ chlorinated Biphenyls; June 1979’’,
ibrllocations.html. A class of barrier which is incorporated by reference, or
material shall be deemed functional the ‘‘Test Procedures for Determina-
only if the definition of the class and tion of PCB Permeability of Food
the designation of one or more rep- Packaging, Inner-Wraps, September
resentative barriers has been approved 1976, revised May 1983’’ and whether,
by the Director, Center for Food Safety therefore, the barrier or class of bar-
and Applied Nutrition, Food and Drug riers is deemed functional within the
Administration. In the event that the meaning of paragraph (c) of this sec-
Director, Center for Food Safety and tion. The test results and any response
Applied Nutrition, does not approve a of the Food and Drug Administration
proposal made to the Center regarding shall be placed on file with the Division
the definition of a class of barrier ma- of Dockets Management, Food and
terial or the designation of representa- Drug Administration, 5630 Fishers
tive barriers, the Director shall advise Lane, rm. 1061, Rockville, MD 20852.
the person making the proposal of the
reasons for the Center’s disapproval [42 FR 52819, Sept. 30, 1977, as amended at 44
within 90 days of receipt of the pro- FR 38340, June 29, 1979; 46 FR 8459, Jan. 27,
posal. All proposals for definition of 1981; 48 FR 10811, Mar. 15, 1983; 48 FR 37021,
Aug. 16, 1983; 54 FR 24892, June 12, 1989; 59 FR
classes and determinations of the Food
14364, Mar. 28, 1994; 61 FR 14480, Apr. 2, 1996;
and Drug Administration regarding 66 FR 56035, Nov. 6, 2001]
such proposals shall be on file with the
Division of Dockets Management EFFECTIVE DATE NOTE: At 38 FR 22794, Aug.
(HFA–305), Food and Drug Administra- 24, 1973, the following appeared concerning
tion, 5630 Fishers Lane, rm. 1061, Rock- § 109.30(a)(9) (formerly 122.10(a)(9)):
ville, MD 20852. * * * § 109.30(a)(9) is hereby stayed pending
full review of the objections and requests for
(d) Any person who asserts that a
hearing. * * *
barrier or class of barriers is functional
In the interim, as stated in the final order
shall submit the results of tests con- (38 FR 18098) the Food and Drug Administra-
ducted to determine the functionality tion will enforce the temporary tolerance
of the barrier or class of barriers to level established by § 109.30(a)(9) by seizing
Center for Food Safety and Applied Nu- any paper food-packaging material shipped
trition (HFS–308), Food and Drug Ad- in interstate commerce after September 4,
ministration, 5100 Paint Branch Pkwy., 1973 containing higher than the specified
243
level of PCB’s as adulterated in violation of Food, Drug, and Cosmetic Act (the act)
sec. 402 of the act. are applicable to such terms when used
in this part. The following definitions
Subpart C—Regulatory Limits for shall also apply:
Added Poisonous or Delete- (a) Acid foods or acidified foods means
rious Substances [Reserved] foods that have an equilibrium pH of
4.6 or below.
Subpart D—Naturally Occurring (b) Adequate means that which is
Posionous or Deleterious Sub- needed to accomplish the intended pur-
stances [Reserved] pose in keeping with good public health
practice.
PART 110—CURRENT GOOD MAN- (c) Batter means a semifluid sub-
UFACTURING PRACTICE IN MAN- stance, usually composed of flour and
other ingredients, into which principal
UFACTURING, PACKING, OR
components of food are dipped or with
HOLDING HUMAN FOOD which they are coated, or which may
Subpart A—General Provisions be used directly to form bakery foods.
(d) Blanching, except for tree nuts
Sec. and peanuts, means a prepackaging
110.3 Definitions. heat treatment of foodstuffs for a suffi-
110.5 Current good manufacturing practice.
110.10 Personnel.
cient time and at a sufficient tempera-
110.19 Exclusions. ture to partially or completely inac-
tivate the naturally occurring enzymes
Subpart B—Buildings and Facilities and to effect other physical or bio-
chemical changes in the food.
110.20 Plant and grounds.
110.35 Sanitary operations. (e) Critical control point means a point
110.37 Sanitary facilities and controls. in a food process where there is a high
probability that improper control may
Subpart C—Equipment cause, allow, or contribute to a hazard
110.40 Equipment and utensils. or to filth in the final food or decompo-
sition of the final food.
Subpart D [Reserved] (f) Food means food as defined in sec-
tion 201(f) of the act and includes raw
Subpart E—Production and Process materials and ingredients.
Controls (g) Food-contact surfaces are those
110.80 Processes and controls. surfaces that contact human food and
110.93 Warehousing and distribution. those surfaces from which drainage
onto the food or onto surfaces that
Subpart F [Reserved] contact the food ordinarily occurs dur-
Subpart G—Defect Action Levels ing the normal course of operations.
‘‘Food-contact surfaces’’ includes uten-
110.110 Natural or unavoidable defects in sils and food-contact surfaces of equip-
food for human use that present no ment.
health hazard.
(h) Lot means the food produced dur-
AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. ing a period of time indicated by a spe-
264. cific code.
SOURCE: 51 FR 22475, June 19, 1986, unless (i) Microorganisms means yeasts,
otherwise noted. molds, bacteria, and viruses and in-
EFFECTIVE DATE NOTE: At 80 FR 56144, cludes, but is not limited to, species
Sept. 17, 2015, part 110 was removed, effective having public health significance. The
Sept. 17, 2018. term ‘‘undesirable microorganisms’’ in-
cludes those microorganisms that are
Subpart A—General Provisions of public health significance, that sub-
ject food to decomposition, that indi-
§ 110.3 Definitions. cate that food is contaminated with

The definitions and interpretations filth, or that otherwise may cause food
of terms in section 201 of the Federal to be adulterated within the meaning
244
of the act. Occasionally in these regu- § 110.5 Current good manufacturing

lations, FDA used the adjective ‘‘mi- practice.
crobial’’ instead of using an adjectival (a) The criteria and definitions in
phrase containing the word microorga- this part shall apply in determining
nism. whether a food is adulterated (1) within
(j) Pest refers to any objectionable the meaning of section 402(a)(3) of the
animals or insects including, but not act in that the food has been manufac-
limited to, birds, rodents, flies, and lar- tured under such conditions that it is
vae. unfit for food; or (2) within the mean-
(k) Plant means the building or facil- ing of section 402(a)(4) of the act in
ity or parts thereof, used for or in con- that the food has been prepared,
nection with the manufacturing, pack- packed, or held under insanitary condi-
aging, labeling, or holding of human tions whereby it may have become con-
food. taminated with filth, or whereby it
(l) Quality control operation means a may have been rendered injurious to
planned and systematic procedure for health. The criteria and definitions in
taking all actions necessary to prevent this part also apply in determining
food from being adulterated within the whether a food is in violation of sec-
meaning of the act. tion 361 of the Public Health Service
(m) Rework means clean, unadulter- Act (42 U.S.C. 264).
ated food that has been removed from (b) Food covered by specific current
processing for reasons other than in- good manufacturing practice regula-
sanitary conditions or that has been tions also is subject to the require-
successfully reconditioned by reproc- ments of those regulations.
essing and that is suitable for use as
food. § 110.10 Personnel.
(n) Safe-moisture level is a level of The plant management shall take all
moisture low enough to prevent the reasonable measures and precautions
growth of undesirable microorganisms to ensure the following:
in the finished product under the in- (a) Disease control. Any person who,
tended conditions of manufacturing, by medical examination or supervisory
storage, and distribution. The max- observation, is shown to have, or ap-
imum safe moisture level for a food is pears to have, an illness, open lesion,
based on its water activity (aw). An aw including boils, sores, or infected
will be considered safe for a food if ade- wounds, or any other abnormal source
quate data are available that dem- of microbial contamination by which
onstrate that the food at or below the there is a reasonable possibility of
given aw will not support the growth of food, food-contact surfaces, or food-
undesirable microorganisms. packaging materials becoming con-
(o) Sanitize means to adequately treat taminated, shall be excluded from any
food-contact surfaces by a process that operations which may be expected to
is effective in destroying vegetative result in such contamination until the
cells of microorganisms of public condition is corrected. Personnel shall
health significance, and in substan- be instructed to report such health
tially reducing numbers of other unde- conditions to their supervisors.
sirable microorganisms, but without (b) Cleanliness. All persons working in
adversely affecting the product or its direct contact with food, food-contact
safety for the consumer. surfaces, and food-packaging materials
(p) Shall is used to state mandatory shall conform to hygienic practices
requirements. while on duty to the extent necessary
(q) Should is used to state rec- to protect against contamination of
ommended or advisory procedures or food. The methods for maintaining
identify recommended equipment. cleanliness include, but are not limited
(r) Water activity (aw) is a measure of to:
the free moisture in a food and is the (1) Wearing outer garments suitable
quotient of the water vapor pressure of to the operation in a manner that pro-
the substance divided by the vapor tects against the contamination of

pressure of pure water at the same food, food-contact surfaces, or food-
temperature. packaging materials.
245
§ 110.19 21 CFR Ch. I (4–1–16 Edition)
(2) Maintaining adequate personal should receive appropriate training in

cleanliness. proper food handling techniques and
(3) Washing hands thoroughly (and food-protection principles and should
sanitizing if necessary to protect be informed of the danger of poor per-
against contamination with undesir- sonal hygiene and insanitary practices.
able microorganisms) in an adequate (d) Supervision. Responsibility for as-
hand-washing facility before starting suring compliance by all personnel
work, after each absence from the work with all requirements of this part shall
station, and at any other time when be clearly assigned to competent super-
the hands may have become soiled or visory personnel.
contaminated.
(4) Removing all unsecured jewelry [51 FR 22475, June 19, 1986, as amended at 54
FR 24892, June 12, 1989]
and other objects that might fall into
food, equipment, or containers, and re-
§ 110.19 Exclusions.
moving hand jewelry that cannot be
adequately sanitized during periods in (a) The following operations are not
which food is manipulated by hand. If subject to this part: Establishments
such hand jewelry cannot be removed, engaged solely in the harvesting, stor-
it may be covered by material which age, or distribution of one or more
can be maintained in an intact, clean, ‘‘raw agricultural commodities,’’ as de-
and sanitary condition and which effec- fined in section 201(r) of the act, which
tively protects against the contamina- are ordinarily cleaned, prepared, treat-
tion by these objects of the food, food- ed, or otherwise processed before being
contact surfaces, or food-packaging marketed to the consuming public.
materials. (b) FDA, however, will issue special
(5) Maintaining gloves, if they are regulations if it is necessary to cover
used in food handling, in an intact, these excluded operations.
clean, and sanitary condition. The
gloves should be of an impermeable Subpart B—Buildings and Facilities
material.
(6) Wearing, where appropriate, in an § 110.20 Plant and grounds.
effective manner, hair nets, headbands,
caps, beard covers, or other effective (a) Grounds. The grounds about a food
hair restraints. plant under the control of the operator
(7) Storing clothing or other personal shall be kept in a condition that will
belongings in areas other than where protect against the contamination of
food is exposed or where equipment or food. The methods for adequate main-
utensils are washed. tenance of grounds include, but are not
(8) Confining the following to areas limited to:
other than where food may be exposed (1) Properly storing equipment, re-
or where equipment or utensils are moving litter and waste, and cutting
washed: eating food, chewing gum, weeds or grass within the immediate
drinking beverages, or using tobacco. vicinity of the plant buildings or struc-
(9) Taking any other necessary pre- tures that may constitute an attract-
cautions to protect against contamina- ant, breeding place, or harborage for
tion of food, food-contact surfaces, or pests.
food-packaging materials with micro- (2) Maintaining roads, yards, and
organisms or foreign substances includ- parking lots so that they do not con-
ing, but not limited to, perspiration, stitute a source of contamination in
hair, cosmetics, tobacco, chemicals, areas where food is exposed.
and medicines applied to the skin. (3) Adequately draining areas that
(c) Education and training. Personnel may contribute contamination to food
responsible for identifying sanitation by seepage, foot-borne filth, or pro-
failures or food contamination should viding a breeding place for pests.
have a background of education or ex- (4) Operating systems for waste
perience, or a combination thereof, to treatment and disposal in an adequate
provide a level of competency nec- manner so that they do not constitute

essary for production of clean and safe a source of contamination in areas
food. Food handlers and supervisors where food is exposed.
246
If the plant grounds are bordered by ployees to perform their duties and to
grounds not under the operator’s con- protect against contaminating food or
trol and not maintained in the manner food-contact surfaces with clothing or
described in paragraph (a) (1) through personal contact.
(3) of this section, care shall be exer- (5) Provide adequate lighting in
cised in the plant by inspection, exter- hand-washing areas, dressing and lock-
mination, or other means to exclude er rooms, and toilet rooms and in all
pests, dirt, and filth that may be a areas where food is examined, proc-
source of food contamination. essed, or stored and where equipment
(b) Plant construction and design. or utensils are cleaned; and provide
Plant buildings and structures shall be safety-type light bulbs, fixtures, sky-
suitable in size, construction, and de- lights, or other glass suspended over
sign to facilitate maintenance and san- exposed food in any step of preparation
itary operations for food-manufac- or otherwise protect against food con-
turing purposes. The plant and facili- tamination in case of glass breakage.
ties shall: (6) Provide adequate ventilation or
(1) Provide sufficient space for such control equipment to minimize odors
placement of equipment and storage of and vapors (including steam and nox-
materials as is necessary for the main- ious fumes) in areas where they may
tenance of sanitary operations and the contaminate food; and locate and oper-
production of safe food. ate fans and other air-blowing equip-
(2) Permit the taking of proper pre- ment in a manner that minimizes the
cautions to reduce the potential for potential for contaminating food, food-
contamination of food, food-contact packaging materials, and food-contact
surfaces, or food-packaging materials surfaces.
with microorganisms, chemicals, filth,
(7) Provide, where necessary, ade-
or other extraneous material. The po-
quate screening or other protection
tential for contamination may be re-
against pests.
duced by adequate food safety controls
and operating practices or effective de- § 110.35 Sanitary operations.
sign, including the separation of oper-
ations in which contamination is likely (a) General maintenance. Buildings,
to occur, by one or more of the fol- fixtures, and other physical facilities
lowing means: location, time, parti- of the plant shall be maintained in a
tion, air flow, enclosed systems, or sanitary condition and shall be kept in
other effective means. repair sufficient to prevent food from
(3) Permit the taking of proper pre- becoming adulterated within the mean-
cautions to protect food in outdoor ing of the act. Cleaning and sanitizing
bulk fermentation vessels by any effec- of utensils and equipment shall be con-
tive means, including: ducted in a manner that protects
(i) Using protective coverings. against contamination of food, food-
(ii) Controlling areas over and around contact surfaces, or food-packaging
the vessels to eliminate harborages for materials.
pests. (b) Substances used in cleaning and
(iii) Checking on a regular basis for sanitizing; storage of toxic materials. (1)
pests and pest infestation. Cleaning compounds and sanitizing
(iv) Skimming the fermentation ves- agents used in cleaning and sanitizing
sels, as necessary. procedures shall be free from undesir-
(4) Be constructed in such a manner able microorganisms and shall be safe
that floors, walls, and ceilings may be and adequate under the conditions of
adequately cleaned and kept clean and use. Compliance with this requirement
kept in good repair; that drip or con- may be verified by any effective means
densate from fixtures, ducts and pipes including purchase of these substances
does not contaminate food, food-con- under a supplier’s guarantee or certifi-
tact surfaces, or food-packaging mate- cation, or examination of these sub-
rials; and that aisles or working spaces stances for contamination. Only the
are provided between equipment and following toxic materials may be used
walls and are adequately unobstructed or stored in a plant where food is proc-
and of adequate width to permit em- essed or exposed:
247
§ 110.37 21 CFR Ch. I (4–1–16 Edition)
(i) Those required to maintain clean production operation, the utensils and
and sanitary conditions; food-contact surfaces of the equipment
(ii) Those necessary for use in labora- shall be cleaned and sanitized as nec-
tory testing procedures; essary.
(iii) Those necessary for plant and (3) Non-food-contact surfaces of
equipment maintenance and operation; equipment used in the operation of
and food plants should be cleaned as fre-
(iv) Those necessary for use in the quently as necessary to protect against
plant’s operations. contamination of food.
(2) Toxic cleaning compounds, sani- (4) Single-service articles (such as
tizing agents, and pesticide chemicals utensils intended for one-time use,
shall be identified, held, and stored in a paper cups, and paper towels) should be
manner that protects against contami- stored in appropriate containers and
nation of food, food-contact surfaces, shall be handled, dispensed, used, and
or food-packaging materials. All rel- disposed of in a manner that protects
evant regulations promulgated by against contamination of food or food-
other Federal, State, and local govern- contact surfaces.
ment agencies for the application, use, (5) Sanitizing agents shall be ade-
or holding of these products should be quate and safe under conditions of use.
followed. Any facility, procedure, or machine is
(c) Pest control. No pests shall be al- acceptable for cleaning and sanitizing
lowed in any area of a food plant. equipment and utensils if it is estab-
Guard or guide dogs may be allowed in lished that the facility, procedure, or
some areas of a plant if the presence of machine will routinely render equip-
the dogs is unlikely to result in con- ment and utensils clean and provide
tamination of food, food-contact sur- adequate cleaning and sanitizing treat-
faces, or food-packaging materials. Ef- ment.
fective measures shall be taken to ex- (e) Storage and handling of cleaned
clude pests from the processing areas portable equipment and utensils. Cleaned
and to protect against the contamina- and sanitized portable equipment with
tion of food on the premises by pests. food-contact surfaces and utensils
The use of insecticides or rodenticides should be stored in a location and man-
is permitted only under precautions ner that protects food-contact surfaces
and restrictions that will protect from contamination.
against the contamination of food, [51 FR 22475, June 19, 1986, as amended at 54
food-contact surfaces, and food-pack- FR 24892, June 12, 1989]
aging materials.
(d) Sanitation of food-contact surfaces. § 110.37 Sanitary facilities and con-
All food-contact surfaces, including trols.
utensils and food-contact surfaces of Each plant shall be equipped with
equipment, shall be cleaned as fre- adequate sanitary facilities and accom-
quently as necessary to protect against modations including, but not limited
contamination of food. to:
(1) Food-contact surfaces used for (a) Water supply. The water supply
manufacturing or holding low-moisture shall be sufficient for the operations
food shall be in a dry, sanitary condi- intended and shall be derived from an
tion at the time of use. When the sur- adequate source. Any water that con-
faces are wet-cleaned, they shall, when tacts food or food-contact surfaces
necessary, be sanitized and thoroughly shall be safe and of adequate sanitary
dried before subsequent use. quality. Running water at a suitable
(2) In wet processing, when cleaning temperature, and under pressure as
is necessary to protect against the in- needed, shall be provided in all areas
troduction of microorganisms into where required for the processing of
food, all food-contact surfaces shall be food, for the cleaning of equipment,
cleaned and sanitized before use and utensils, and food-packaging materials,
after any interruption during which or for employee sanitary facilities.
the food-contact surfaces may have be- (b) Plumbing. Plumbing shall be of
come contaminated. Where equipment adequate size and design and ade-
and utensils are used in a continuous quately installed and maintained to:
248
(1) Carry sufficient quantities of structed to protect against recontami-

water to required locations throughout nation of clean, sanitized hands.
the plant. (5) Readily understandable signs di-
(2) Properly convey sewage and liquid recting employees handling unpro-
disposable waste from the plant. tected food, unprotected food-pack-
(3) Avoid constituting a source of aging materials, of food-contact sur-
contamination to food, water supplies, faces to wash and, where appropriate,
equipment, or utensils or creating an sanitize their hands before they start
unsanitary condition. work, after each absence from post of
(4) Provide adequate floor drainage in duty, and when their hands may have
all areas where floors are subject to become soiled or contaminated. These
flooding-type cleaning or where normal signs may be posted in the processing
operations release or discharge water room(s) and in all other areas where
or other liquid waste on the floor. employees may handle such food, ma-
(5) Provide that there is not backflow terials, or surfaces.
from, or cross-connection between, pip-
(6) Refuse receptacles that are con-
ing systems that discharge waste water
structed and maintained in a manner
or sewage and piping systems that
carry water for food or food manufac- that protects against contamination of
turing. food.
(c) Sewage disposal. Sewage disposal (f) Rubbish and offal disposal. Rubbish
shall be made into an adequate sewer- and any offal shall be so conveyed,
age system or disposed of through stored, and disposed of as to minimize
other adequate means. the development of odor, minimize the
(d) Toilet facilities. Each plant shall potential for the waste becoming an at-
provide its employees with adequate, tractant and harborage or breeding
readily accessible toilet facilities. place for pests, and protect against
Compliance with this requirement may contamination of food, food-contact
be accomplished by: surfaces, water supplies, and ground
(1) Maintaining the facilities in a surfaces.
sanitary condition.
(2) Keeping the facilities in good re- Subpart C—Equipment
pair at all times.
(3) Providing self-closing doors. § 110.40 Equipment and utensils.
(4) Providing doors that do not open
(a) All plant equipment and utensils
into areas where food is exposed to air-
shall be so designed and of such mate-
borne contamination, except where al-
rial and workmanship as to be ade-
ternate means have been taken to pro-
quately cleanable, and shall be prop-
tect against such contamination (such
as double doors or positive air-flow sys- erly maintained. The design, construc-
tems). tion, and use of equipment and utensils
(e) Hand-washing facilities. Hand- shall preclude the adulteration of food
washing facilities shall be adequate with lubricants, fuel, metal fragments,
and convenient and be furnished with contaminated water, or any other con-
running water at a suitable tempera- taminants. All equipment should be so
ture. Compliance with this require- installed and maintained as to facili-
ment may be accomplished by pro- tate the cleaning of the equipment and
viding: of all adjacent spaces. Food-contact
(1) Hand-washing and, where appro- surfaces shall be corrosion-resistant
priate, hand-sanitizing facilities at when in contact with food. They shall
each location in the plant where good be made of nontoxic materials and de-
sanitary practices require employees signed to withstand the environment of
to wash and/or sanitize their hands. their intended use and the action of
(2) Effective hand-cleaning and sani- food, and, if applicable, cleaning com-
tizing preparations. pounds and sanitizing agents. Food-
(3) Sanitary towel service or suitable contact surfaces shall be maintained to
drying devices. protect food from being contaminated

(4) Devices or fixtures, such as water by any source, including unlawful indi-
control valves, so designed and con- rect food additives.
249
§ 110.80 21 CFR Ch. I (4–1–16 Edition)
(b) Seams on food-contact surfaces principles. Appropriate quality control

shall be smoothly bonded or main- operations shall be employed to ensure
tained so as to minimize accumulation that food is suitable for human con-
of food particles, dirt, and organic mat- sumption and that food-packaging ma-
ter and thus minimize the opportunity terials are safe and suitable. Overall
for growth of microorganisms. sanitation of the plant shall be under
(c) Equipment that is in the manu- the supervision of one or more com-
facturing or food-handling area and petent individuals assigned responsi-
that does not come into contact with bility for this function. All reasonable
food shall be so constructed that it can precautions shall be taken to ensure
be kept in a clean condition. that production procedures do not con-
(d) Holding, conveying, and manufac- tribute contamination from any
turing systems, including gravimetric, source. Chemical, microbial, or extra-
pneumatic, closed, and automated sys-
neous-material testing procedures
tems, shall be of a design and construc-
shall be used where necessary to iden-
tion that enables them to be main-
tify sanitation failures or possible food
tained in an appropriate sanitary con-
dition. contamination. All food that has be-
(e) Each freezer and cold storage come contaminated to the extent that
compartment used to store and hold it is adulterated within the meaning of
food capable of supporting growth of the act shall be rejected, or if permis-
microorganisms shall be fitted with an sible, treated or processed to eliminate
indicating thermometer, temperature- the contamination.
measuring device, or temperature-re- (a) Raw materials and other ingredi-
cording device so installed as to show ents. (1) Raw materials and other ingre-
the temperature accurately within the dients shall be inspected and seg-
compartment, and should be fitted regated or otherwise handled as nec-
with an automatic control for regu- essary to ascertain that they are clean
lating temperature or with an auto- and suitable for processing into food
matic alarm system to indicate a sig- and shall be stored under conditions
nificant temperature change in a man- that will protect against contamina-
ual operation. tion and minimize deterioration. Raw
(f) Instruments and controls used for materials shall be washed or cleaned as
measuring, regulating, or recording necessary to remove soil or other con-
temperatures, pH, acidity, water activ- tamination. Water used for washing,
ity, or other conditions that control or rinsing, or conveying food shall be safe
prevent the growth of undesirable and of adequate sanitary quality.
microorganisms in food shall be accu- Water may be reused for washing, rins-
rate and adequately maintained, and ing, or conveying food if it does not in-
adequate in number for their des- crease the level of contamination of
ignated uses. the food. Containers and carriers of
(g) Compressed air or other gases me- raw materials should be inspected on
chanically introduced into food or used receipt to ensure that their condition
to clean food-contact surfaces or equip- has not contributed to the contamina-
ment shall be treated in such a way tion or deterioration of food.
that food is not contaminated with un- (2) Raw materials and other ingredi-
lawful indirect food additives. ents shall either not contain levels of
microorganisms that may produce food
Subpart D [Reserved] poisoning or other disease in humans,
or they shall be pasteurized or other-
Subpart E—Production and wise treated during manufacturing op-
Process Controls erations so that they no longer contain
levels that would cause the product to
§ 110.80 Processes and controls. be adulterated within the meaning of
All operations in the receiving, in- the act. Compliance with this require-
specting, transporting, segregating, ment may be verified by any effective
preparing, manufacturing, packaging, means, including purchasing raw mate-

and storing of food shall be conducted rials and other ingredients under a sup-
in accordance with adequate sanitation plier’s guarantee or certification.
250
(3) Raw materials and other ingredi- shall be taken apart for thorough
ents susceptible to contamination with cleaning.
aflatoxin or other natural toxins shall (2) All food manufacturing, including
comply with current Food and Drug packaging and storage, shall be con-
Administration regulations and action ducted under such conditions and con-
levels for poisonous or deleterious sub- trols as are necessary to minimize the
stances before these materials or ingre- potential for the growth of microorga-
dients are incorporated into finished nisms, or for the contamination of
food. Compliance with this require- food. One way to comply with this re-
ment may be accomplished by pur- quirement is careful monitoring of
chasing raw materials and other ingre- physical factors such as time, tempera-
dients under a supplier’s guarantee or ture, humidity, aw, pH, pressure, flow
certification, or may be verified by rate, and manufacturing operations
analyzing these materials and ingredi- such as freezing, dehydration, heat
ents for aflatoxins and other natural processing, acidification, and refrigera-
toxins. tion to ensure that mechanical break-
(4) Raw materials, other ingredients, downs, time delays, temperature fluc-
and rework susceptible to contamina- tuations, and other factors do not con-
tion with pests, undesirable microorga- tribute to the decomposition or con-
nisms, or extraneous material shall tamination of food.
comply with applicable Food and Drug (3) Food that can support the rapid
Administration regulations and defect growth of undesirable microorganisms,
action levels for natural or unavoidable particularly those of public health sig-
defects if a manufacturer wishes to use nificance, shall be held in a manner
the materials in manufacturing food. that prevents the food from becoming
Compliance with this requirement may adulterated within the meaning of the
be verified by any effective means, in- act. Compliance with this requirement
cluding purchasing the materials under may be accomplished by any effective
a supplier’s guarantee or certification, means, including:
or examination of these materials for (i) Maintaining refrigerated foods at
contamination. 45 °F (7.2 °C) or below as appropriate for
the particular food involved.
(5) Raw materials, other ingredients,
(ii) Maintaining frozen foods in a fro-
and rework shall be held in bulk, or in
zen state.
containers designed and constructed so
(iii) Maintaining hot foods at 140 °F
as to protect against contamination
(60 °C) or above.
and shall be held at such temperature
(iv) Heat treating acid or acidified
and relative humidity and in such a foods to destroy mesophilic microorga-
manner as to prevent the food from be- nisms when those foods are to be held
coming adulterated within the mean- in hermetically sealed containers at
ing of the act. Material scheduled for ambient temperatures.
rework shall be identified as such. (4) Measures such as sterilizing, irra-
(6) Frozen raw materials and other diating, pasteurizing, freezing, refrig-
ingredients shall be kept frozen. If erating, controlling pH or controlling
thawing is required prior to use, it aw that are taken to destroy or prevent
shall be done in a manner that pre- the growth of undesirable microorga-
vents the raw materials and other in- nisms, particularly those of public
gredients from becoming adulterated health significance, shall be adequate
within the meaning of the act. under the conditions of manufacture,
(7) Liquid or dry raw materials and handling, and distribution to prevent
other ingredients received and stored food from being adulterated within the
in bulk form shall be held in a manner meaning of the act.
that protects against contamination. (5) Work-in-process shall be handled
(b) Manufacturing operations. (1) in a manner that protects against con-
Equipment and utensils and finished tamination.
food containers shall be maintained in (6) Effective measures shall be taken
an acceptable condition through appro- to protect finished food from contami-

priate cleaning and sanitizing, as nec- nation by raw materials, other ingredi-
essary. Insofar as necessary, equipment ents, or refuse. When raw materials,
251
§ 110.80 21 CFR Ch. I (4–1–16 Edition)
other ingredients, or refuse are unpro- passing it to subsequent manufacturing

tected, they shall not be handled si- without delay. Thermophilic growth
multaneously in a receiving, loading, and contamination in blanchers should
or shipping area if that handling could be minimized by the use of adequate
result in contaminated food. Food operating temperatures and by periodic
transported by conveyor shall be pro- cleaning. Where the blanched food is
tected against contamination as nec- washed prior to filling, water used
essary. shall be safe and of adequate sanitary
(7) Equipment, containers, and uten- quality.
sils used to convey, hold, or store raw (12) Batters, breading, sauces, gra-
materials, work-in-process, rework, or vies, dressings, and other similar prep-
food shall be constructed, handled, and arations shall be treated or maintained
maintained during manufacturing or in such a manner that they are pro-
storage in a manner that protects tected against contamination. Compli-
against contamination. ance with this requirement may be ac-
(8) Effective measures shall be taken complished by any effective means, in-
to protect against the inclusion of cluding one or more of the following:
metal or other extraneous material in (i) Using ingredients free of contami-
food. Compliance with this require- nation.
ment may be accomplished by using (ii) Employing adequate heat proc-
sieves, traps, magnets, electronic esses where applicable.
metal detectors, or other suitable ef- (iii) Using adequate time and tem-
fective means. perature controls.
(9) Food, raw materials, and other in- (iv) Providing adequate physical pro-
gredients that are adulterated within tection of components from contami-
the meaning of the act shall be dis- nants that may drip, drain, or be drawn
posed of in a manner that protects into them.
against the contamination of other (v) Cooling to an adequate tempera-
food. If the adulterated food is capable ture during manufacturing.
of being reconditioned, it shall be re- (vi) Disposing of batters at appro-
conditioned using a method that has priate intervals to protect against the
been proven to be effective or it shall growth of microorganisms.
be reexamined and found not to be (13) Filling, assembling, packaging,
adulterated within the meaning of the and other operations shall be per-
act before being incorporated into formed in such a way that the food is
other food. protected against contamination. Com-
(10) Mechanical manufacturing steps pliance with this requirement may be
such as washing, peeling, trimming, accomplished by any effective means,
cutting, sorting and inspecting, mash- including:
ing, dewatering, cooling, shredding, ex- (i) Use of a quality control operation
truding, drying, whipping, defatting, in which the critical control points are
and forming shall be performed so as to identified and controlled during manu-
protect food against contamination. facturing.
Compliance with this requirement may (ii) Adequate cleaning and sanitizing
be accomplished by providing adequate of all food-contact surfaces and food
physical protection of food from con- containers.
taminants that may drip, drain, or be (iii) Using materials for food con-
drawn into the food. Protection may be tainers and food- packaging materials
provided by adequate cleaning and that are safe and suitable, as defined in
sanitizing of all food-contact surfaces, § 130.3(d) of this chapter.
and by using time and temperature (iv) Providing physical protection
controls at and between each manufac- from contamination, particularly air-
turing step. borne contamination.
(11) Heat blanching, when required in (v) Using sanitary handling proce-
the preparation of food, should be ef- dures.
fected by heating the food to the re- (14) Food such as, but not limited to,
quired temperature, holding it at this dry mixes, nuts, intermediate moisture

temperature for the required time, and food, and dehydrated food, that relies
then either rapidly cooling the food or on the control of aw for preventing the
252
growth of undesirable microorganisms Subpart G—Defect Action Levels

shall be processed to and maintained at
a safe moisture level. Compliance with § 110.110 Natural or unavoidable de-
this requirement may be accomplished fects in food for human use that
by any effective means, including em- present no health hazard.
ployment of one or more of the fol- (a) Some foods, even when produced
lowing practices: under current good manufacturing
(i) Monitoring the aw of food. practice, contain natural or unavoid-
(ii) Controlling the soluble solids- able defects that at low levels are not
water ratio in finished food. hazardous to health. The Food and
(iii) Protecting finished food from Drug Administration establishes max-
moisture pickup, by use of a moisture imum levels for these defects in foods
barrier or by other means, so that the produced under current good manufac-
aw of the food does not increase to an turing practice and uses these levels in
unsafe level. deciding whether to recommend regu-
(15) Food such as, but not limited to, latory action.
acid and acidified food, that relies prin- (b) Defect action levels are estab-
cipally on the control of pH for pre- lished for foods whenever it is nec-
venting the growth of undesirable essary and feasible to do so. These lev-
microorganisms shall be monitored and els are subject to change upon the de-
maintained at a pH of 4.6 or below. velopment of new technology or the
Compliance with this requirement may availability of new information.
be accomplished by any effective (c) Compliance with defect action
means, including employment of one or levels does not excuse violation of the
more of the following practices: requirement in section 402(a)(4) of the
(i) Monitoring the pH of raw mate- act that food not be prepared, packed,
rials, food in process, and finished food. or held under unsanitary conditions or
(ii) Controlling the amount of acid or the requirements in this part that food
acidified food added to low-acid food. manufacturers, distributors, and hold-
(16) When ice is used in contact with ers shall observe current good manu-
food, it shall be made from water that facturing practice. Evidence indicating
is safe and of adequate sanitary qual- that such a violation exists causes the
ity, and shall be used only if it has food to be adulterated within the
been manufactured in accordance with meaning of the act, even though the
current good manufacturing practice amounts of natural or unavoidable de-
as outlined in this part. fects are lower than the currently es-
(17) Food-manufacturing areas and tablished defect action levels. The
equipment used for manufacturing manufacturer, distributor, and holder
human food should not be used to man- of food shall at all times utilize quality
ufacture nonhuman food-grade animal control operations that reduce natural
feed or inedible products, unless there or unavoidable defects to the lowest
is no reasonable possibility for the con- level currently feasible.
tamination of the human food. (d) The mixing of a food containing
defects above the current defect action
[51 FR 22475, June 19, 1986, as amended at 65
FR 56479, Sept. 19, 2000]
level with another lot of food is not
permitted and renders the final food
§ 110.93 Warehousing and distribution. adulterated within the meaning of the
act, regardless of the defect level of the
Storage and transportation of fin-
final food.
ished food shall be under conditions
(e) A compilation of the current de-
that will protect food against physical,
fect action levels for natural or un-
chemical, and microbial contamination
avoidable defects in food for human use
as well as against deterioration of the
that present no health hazard may be
food and the container.
obtained upon request from the Center

for Food Safety and Applied Nutrition
Subpart F [Reserved]
253
(HFS–565), Food and Drug Administra- 111.60 What are the design requirements for
tion, 5100 Paint Branch Pkwy., College the production and process control sys-
Park, MD 20740. tem?
111.65 What are the requirements for qual-
[51 FR 22475, June 19, 1986, as amended at 61 ity control operations?
FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 111.70 What specifications must you estab-
2001] lish?
111.73 What is your responsibility for deter-
PART 111—CURRENT GOOD MAN- mining whether established specifica-
UFACTURING PRACTICE IN MAN- tions are met?
UFACTURING, PACKAGING, LA- 111.75 What must you do to determine
whether specifications are met?
BELING, OR HOLDING OPER-
111.77 What must you do if established spec-
ATIONS FOR DIETARY SUPPLE- ifications are not met?
MENTS 111.80 What representative samples must
you collect?
Subpart A—General Provisions 111.83 What are the requirements for re-
serve samples?
Sec.
111.1 Who is subject to this part? 111.87 Who conducts a material review and
111.3 What definitions apply to this part? makes a disposition decision?
111.5 Do other statutory provisions and reg- 111.90 What requirements apply to treat-
ulations apply? ments, in-process adjustments, and re-
processing when there is a deviation or
Subpart B—Personnel unanticipated occurrence or when a spec-
ification established in accordance with
111.8 What are the requirements under this § 111.70 is not met?
subpart B for written procedures?
111.95 Under this subpart E, what records
111.10 What requirements apply for pre-
venting microbial contamination from must you make and keep?
sick or infected personnel and for hygien-
ic practices? Subpart F—Production and Process Control
111.12 What personnel qualification require- System: Requirements for Quality Control
ments apply?
111.13 What supervisor requirements apply? 111.103 What are the requirements under
111.14 Under this subpart B, what records this subpart F for written procedures?
must you make and keep? 111.105 What must quality control personnel
do?
Subpart C—Physical Plant and Grounds 111.110 What quality control operations are
required for laboratory operations asso-
111.15 What sanitation requirements apply
ciated with the production and process
to your physical plant and grounds?
control system?
111.16 What are the requirements under this
subpart C for written procedures? 111.113 What quality control operations are
111.20 What design and construction re- required for a material review and dis-
quirements apply to your physical plant? position decision?
111.23 Under this subpart C, what records 111.117 What quality control operations are
must you make and keep? required for equipment, instruments, and
controls?
Subpart D—Equipment and Utensils 111.120 What quality control operations are
required for components, packaging, and
111.25 What are the requirements under this labels before use in the manufacture of a
subpart D for written procedures?
dietary supplement?
111.27 What requirements apply to the
equipment and utensils that you use? 111.123 What quality control operations are
111.30 What requirements apply to auto- required for the master manufacturing
mated, mechanical, or electronic equip- record, the batch production record, and
ment? manufacturing operations?
111.35 Under this subpart D, what records 111.127 What quality control operations are
must you make and keep? required for packaging and labeling oper-
ations?
Subpart E—Requirement to Establish a 111.130 What quality control operations are
Production and Process Control System required for returned dietary supple-
ments?
111.55 What are the requirements to imple- 111.135 What quality control operations are
ment a production and process control
required for product complaints?
system?
254
Food and Drug Administration, HHS Pt. 111
111.140 Under this subpart F, what records 111.325 Under this subpart J, what records
must you make and keep? must you make and keep?
Subpart G—Production and Process Con- Subpart K—Production and Process Control
trol System: Requirements for Compo- System: Requirements for Manufac-
nents, Packaging, and Labels and for turing Operations
Product That You Receive for Pack-
111.353 What are the requirements under
aging or Labeling as a Dietary Supple- this subpart K for written procedures?
ment 111.355 What are the design requirements
for manufacturing operations?
111.360 What are the requirements for sani-
this subpart G for written procedures?
tation?
111.155 What requirements apply to compo- 111.365 What precautions must you take to
nents of dietary supplements? prevent contamination?
111.160 What requirements apply to pack- 111.370 What requirements apply to rejected
aging and labels received? dietary supplements?
111.165 What requirements apply to a prod- 111.375 Under this subpart K, what records
uct received for packaging or labeling as must you make and keep?
a dietary supplement (and for distribu-
tion rather than for return to the sup- Subpart L—Production and Process Control
plier)? System: Requirements for Packaging
111.170 What requirements apply to rejected and Labeling Operations
components, packaging, and labels, and
to rejected products that are received for 111.403 What are the requirements under
packaging or labeling as a dietary sup- this subpart L for written procedures?
plement? 111.410 What requirements apply to pack-
111.180 Under this subpart G, what records aging and labels?
must you make and keep? 111.415 What requirements apply to filling,
assembling, packaging, labeling, and re-
Subpart H—Production and Process Con- lated operations?
111.420 What requirements apply to repack-
trol System: Requirements for the Mas-
aging and relabeling?
ter Manufacturing Record 111.425 What requirements apply to a pack-
111.205 What is the requirement to establish aged and labeled dietary supplement that
is rejected for distribution?
a master manufacturing record?
111.430 Under this subpart L, what records
111.210 What must the master manufac-
must you make and keep?
turing record include?
Subpart M—Holding and Distributing
Subpart I—Production and Process Control
System: Requirements for the Batch 111.453 What are the requirements under
Production Record this subpart M for written procedures?
111.455 What requirements apply to holding
111.255 What is the requirement to establish components, dietary supplements, pack-
a batch production record? aging, and labels?
111.260 What must the batch record include? 111.460 What requirements apply to holding
in-process material?
Subpart J—Production and Process Control 111.465 What requirements apply to holding
System: Requirements for Laboratory reserve samples of dietary supplements?
Operations 111.470 What requirements apply to distrib-
uting dietary supplements?
111.303 What are the requirements under 111.475 Under this subpart M, what records
this subpart J for written procedures? must you make and keep?
111.310 What are the requirements for the
laboratory facilities that you use? Subpart N—Returned Dietary Supplements
111.315 What are the requirements for lab- 111.503 What are the requirements under
oratory control processes? this subpart N for written procedures?
111.320 What requirements apply to labora- 111.510 What requirements apply when a re-
tory methods for testing and examina- turned dietary supplement is received?
tion? 111.515 When must a returned dietary sup-
plement be destroyed, or otherwise suit-
ably disposed of?

111.520 When may a returned dietary supple-
ment be salvaged?
255
§ 111.1 21 CFR Ch. I (4–1–16 Edition)
111.525 What requirements apply to a re- § 111.3 What definitions apply to this
turned dietary supplement that quality part?
control personnel approve for reprocess-
ing? The definitions and interpretations
111.530 When must an investigation be con- of terms in section 201 of the Federal
ducted of your manufacturing processes Food, Drug, and Cosmetic Act (the act)
and other batches? apply to such terms when used in this
111.535 Under this subpart N, what records part. For the purpose of this part, the
must you make and keep? following definitions also apply:
Actual yield means the quantity that
Subpart O—Product Complaints is actually produced at any appropriate
step of manufacture or packaging of a
this subpart O for written procedures? particular dietary supplement.
111.560 What requirements apply to the re- Batch means a specific quantity of a
view and investigation of a product com- dietary supplement that is uniform,
plaint? that is intended to meet specifications
111.570 Under this subpart O, what records for identity, purity, strength, and com-
must you make and keep? position, and that is produced during a
specified time period according to a
Subpart P—Records and Recordkeeping single manufacturing record during the
same cycle of manufacture.
111.605 What requirements apply to the
records that you make and keep?
Batch number, lot number, or control
111.610 What records must be made avail- number means any distinctive group of
able to FDA? letters, numbers, or symbols, or any
combination of them, from which the
AUTHORITY: 21 U.S.C. 321, 342, 343, 371, 374, complete history of the manufacturing,
381, 393; 42 U.S.C. 264. packaging, labeling, and/or holding of a
SOURCE: 72 FR 34942, June 25, 2007, unless batch or lot of dietary supplements can
otherwise noted. be determined.
Component means any substance in-
Subpart A—General Provisions tended for use in the manufacture of a
dietary supplement, including those
§ 111.1 Who is subject to this part? that may not appear in the finished
batch of the dietary supplement. Com-
(a) Except as provided by paragraph
ponent includes dietary ingredients (as
(b) of this section, you are subject to described in section 201(ff) of the act)
this part if you manufacture, package, and other ingredients.
label, or hold a dietary supplement, in- Contact surface means any surface
cluding: that contacts a component or dietary
(1) A dietary supplement you manu- supplement, and those surfaces from
facture but that is packaged or labeled which drainage onto the component or
by another person; and dietary supplement, or onto surfaces
(2) A dietary supplement imported or that contact the component or dietary
offered for import in any State or terri- supplement, occurs during the normal
tory of the United States, the District course of operations. Examples of con-
of Columbia, or the Commonwealth of tact surfaces include containers, uten-
Puerto Rico. sils, tables, contact surfaces of equip-
(b) The requirements pertaining to ment, and packaging.
holding dietary supplements do not Ingredient means any substance that
apply to you if you are holding those is used in the manufacture of a dietary
dietary supplements at a retail estab- supplement and that is intended to be
lishment for the sole purpose of direct present in the finished batch of the die-
retail sale to individual consumers. A tary supplement. An ingredient in-
retail establishment does not include a cludes, but is not necessarily limited
warehouse or other storage facility for to, a dietary ingredient as defined in
section 201(ff) of the act.
a retailer or a warehouse or other stor-
age facility that sells directly to indi- In-process material means any mate-
rial that is fabricated, compounded,
vidual consumers.
blended, ground, extracted, sifted,
256
sterilized, derived by chemical reac- Quality means that the dietary sup-
tion, or processed in any other way for plement consistently meets the estab-
use in the manufacture of a dietary lished specifications for identity, pu-
supplement. rity, strength, and composition, and
Lot means a batch, or a specific iden- limits on contaminants, and has been
tified portion of a batch, that is uni- manufactured, packaged, labeled, and
form and that is intended to meet spec- held under conditions to prevent adul-
ifications for identity, purity, teration under section 402(a)(1), (a)(2),
strength, and composition; or, in the (a)(3), and (a)(4) of the act.
case of a dietary supplement produced Quality control means a planned and
by continuous process, a specific iden- systematic operation or procedure for
tified amount produced in a specified ensuring the quality of a dietary sup-
unit of time or quantity in a manner
plement.
that is uniform and that is intended to
Quality control personnel means any
meet specifications for identity, pu-
rity, strength, and composition. person, persons, or group, within or
Microorganisms means yeasts, molds, outside of your organization, who you
bacteria, viruses, and other similar mi- designate to be responsible for your
croscopic organisms having public quality control operations.
health or sanitary concern. This defini- Representative sample means a sample
tion includes species that: that consists of an adequate number of
(1) May have public health signifi- units that are drawn based on rational
cance; criteria, such as random sampling, and
(2) May cause a component or dietary that are intended to ensure that the
supplement to decompose; sample accurately portrays the mate-
(3) Indicate that the component or di- rial being sampled.
etary supplement is contaminated with Reprocessing means using, in the
filth; or manufacture of a dietary supplement,
(4) Otherwise may cause the compo- clean, uncontaminated components or
nent or dietary supplement to be adul- dietary supplements that have been
terated. previously removed from manufac-
Must is used to state a requirement. turing and that have been made suit-
Pest means any objectionable insect able for use in the manufacture of a di-
or other animal including birds, ro- etary supplement.
dents, flies, mites, and larvae. Reserve sample means a representa-
Physical plant means all or any part tive sample of product that is held for
of a building or facility used for or in a designated period of time.
connection with manufacturing, pack- Sanitize means to adequately treat
aging, labeling, or holding a dietary cleaned equipment, containers, uten-
supplement.
sils, or any other cleaned contact sur-
Product complaint means any commu-
face by a process that is effective in de-
nication that contains any allegation,
stroying vegetative cells of microorga-
written, electronic, or oral, expressing
nisms of public health significance, and
concern, for any reason, with the qual-
in substantially reducing numbers of
ity of a dietary supplement, that could
be related to current good manufac- other microorganisms, but without ad-
turing practice. Examples of product versely affecting the product or its
complaints are: Foul odor, off taste, ill- safety for the consumer.
ness or injury, disintegration time, Theoretical yield means the quantity
color variation, tablet size or size vari- that would be produced at any appro-
ation, under-filled container, foreign priate step of manufacture or pack-
material in a dietary supplement con- aging of a particular dietary supple-
tainer, improper packaging, ment, based upon the quantity of com-
mislabeling, or dietary supplements ponents or packaging to be used, in the
that are superpotent, subpotent, or absence of any loss or error in actual
contain the wrong ingredient, or con- production.
tain a drug or other contaminant (e.g., Water activity (aw) is a measure of the
bacteria, pesticide, mycotoxin, glass, free moisture in a component or die-
lead). tary supplement and is the quotient of
257
§ 111.5 21 CFR Ch. I (4–1–16 Edition)
the water vapor pressure of the sub- faces, until the health condition no
stance divided by the vapor pressure of longer exists; and
pure water at the same temperature. (2) Instructing your employees to no-
We means the U.S. Food and Drug tify their supervisor(s) if they have or
Administration (FDA). if there is a reasonable possibility that
You means a person who manufac- they have a health condition described
tures, packages, labels, or holds die- in paragraph (a)(1) of this section that
tary supplements. could result in microbial contamina-
tion of any components, dietary sup-
§ 111.5 Do other statutory provisions
and regulations apply? plements, or any contact surface.
(b) Hygienic practices. If you work in
In addition to this part, you must an operation during which adulteration
comply with other applicable statutory of the component, dietary supplement,
provisions and regulations under the or contact surface could occur, you
act related to dietary supplements. For must use hygienic practices to the ex-
importers of dietary supplements and tent necessary to protect against such
dietary supplement components, the contamination of components, dietary
regulation on foreign supplier supplements, or contact surfaces.
verification programs can be found in These hygienic practices include the
subpart L of part 1 of this chapter. following:
[72 FR 34942, June 25, 2007, as amended at 80 (1) Wearing outer garments in a man-
FR 74352, Nov. 27, 2015] ner that protects against the contami-
nation of components, dietary supple-
Subpart B—Personnel ments, or any contact surface;
(2) Maintaining adequate personal
§ 111.8 What are the requirements cleanliness;
under this subpart B for written
procedures? (3) Washing hands thoroughly (and
sanitizing if necessary to protect
You must establish and follow writ- against contamination with microorga-
ten procedures for fulfilling the re- nisms) in an adequate hand-washing fa-
quirements of this subpart. cility:
§ 111.10 What requirements apply for (i) Before starting work; and
preventing microbial contamination (ii) At any time when the hands may
from sick or infected personnel and have become soiled or contaminated;
for hygienic practices? (4) Removing all unsecured jewelry
(a) Preventing microbial contamination. and other objects that might fall into
You must take measures to exclude components, dietary supplements,
from any operations any person who equipment, or packaging, and removing
might be a source of microbial con- hand jewelry that cannot be ade-
tamination, due to a health condition, quately sanitized during periods in
where such contamination may occur, which components or dietary supple-
of any material, including components, ments are manipulated by hand. If
dietary supplements, and contact sur- hand jewelry cannot be removed, it
faces used in the manufacture, pack- must be covered by material that is
aging, labeling, or holding of a dietary maintained in an intact, clean, and
supplement. Such measures include the sanitary condition and that effectively
following: protects against contamination of
(1) Excluding from working in any components, dietary supplements, or
operations that may result in contami- contact surfaces;
nation any person who, by medical ex- (5) Maintaining gloves used in han-
amination, the person’s acknowledge- dling components or dietary supple-
ment, or supervisory observation, is ments in an intact, clean, and sanitary
shown to have, or appears to have, an condition. The gloves must be of an im-
illness, infection, open lesion, or any permeable material;
other abnormal source of microbial (6) Wearing, where appropriate, in an
contamination, that could result in mi- effective manner, hair nets, caps, beard
crobial contamination of components, covers, or other effective hair re-
dietary supplements, or contact sur- straints;
258
(7) Not storing clothing or other per- (1) Written procedures for fulfilling
sonal belongings in areas where compo- the requirements of this subpart B; and
nents, dietary supplements, or any con- (2) Documentation of training, in-
tact surfaces are exposed or where concluding the date of the training, the
tact surfaces are washed; type of training, and the person(s)
(8) Not eating food, chewing gum, trained.
drinking beverages, or using tobacco
products in areas where components, Subpart C—Physical Plant and
dietary supplements, or any contact Grounds
surfaces are exposed, or where contact
surfaces are washed; and § 111.15 What sanitation requirements
(9) Taking any other precautions nec- apply to your physical plant and
essary to protect against the contami- grounds?
nation of components, dietary supple- (a) Grounds. You must keep the
ments, or contact surfaces with micro- grounds of your physical plant in a
organisms, filth, or any other extra- condition that protects against the
neous materials, including perspira- contamination of components, dietary
tion, hair, cosmetics, tobacco, chemi- supplements, or contact surfaces. The
cals, and medicines applied to the skin. methods for adequate ground mainte-
nance include:
§ 111.12 What personnel qualification (1) Properly storing equipment, re-
requirements apply? moving litter and waste, and cutting
(a) You must have qualified employ- weeds or grass within the immediate
ees who manufacture, package, label, vicinity of the physical plant so that it
or hold dietary supplements. does not attract pests, harbor pests, or
(b) You must identify who is respon- provide pests a place for breeding;
sible for your quality control oper- (2) Maintaining roads, yards, and
ations. Each person who is identified to parking lots so that they do not con-
perform quality control operations stitute a source of contamination in
must be qualified to do so and have dis- areas where components, dietary sup-
tinct and separate responsibilities re- plements, or contact surfaces are ex-
lated to performing such operations posed;
from those responsibilities that the (3) Adequately draining areas that
person otherwise has when not per- may contribute to the contamination
forming such operations. of components, dietary supplements, or
(c) Each person engaged in manufac- contact surfaces by seepage, filth or
turing, packaging, labeling, or holding, any other extraneous materials, or by
or in performing any quality control providing a breeding place for pests;
operations, must have the education, (4) Adequately operating systems for
training, or experience to perform the waste treatment and disposal so that
person’s assigned functions. they do not constitute a source of con-
tamination in areas where components,
§ 111.13 What supervisor requirements dietary supplements, or contact sur-
apply? faces are exposed; and
(a) You must assign qualified per- (5) If your plant grounds are bordered
sonnel to supervise the manufacturing, by grounds not under your control, and
packaging, labeling, or holding of die- if those other grounds are not main-
tary supplements. tained in the manner described in this
(b) Each supervisor whom you use section, you must exercise care in the
must be qualified by education, train- plant by inspection, extermination, or
ing, or experience to supervise. other means to exclude pests, dirt, and
filth or any other extraneous materials
§ 111.14 Under this subpart B, what that may be a source of contamination.
records must you make and keep? (b) Physical plant facilities. (1) You
(a) You must make and keep records must maintain your physical plant in a
required under this subpart B in ac- clean and sanitary condition; and
cordance with subpart P of this part. (2) You must maintain your physical
(b) You must make and keep the fol- plant in repair sufficient to prevent
lowing records: components, dietary supplements, or
259
§ 111.15 21 CFR Ch. I (4–1–16 Edition)
contact surfaces from becoming con- e.g., when such water contacts compo-
taminated. nents, dietary supplements, or any con-
(c) Cleaning compounds, sanitizing tact surface, must, at a minimum,
agents, pesticides, and other toxic mate- comply with applicable Federal, State,
rials. (1) You must use cleaning com- and local requirements and not con-
pounds and sanitizing agents that are taminate the dietary supplement.
free from microorganisms of public (f) Plumbing. The plumbing in your
health significance and that are safe physical plant must be of an adequate
and adequate under the conditions of size and design and be adequately in-
use. stalled and maintained to:
(2) You must not use or hold toxic (1) Carry sufficient amounts of water
materials in a physical plant in which to required locations throughout the
components, dietary supplements, or physical plant;
contact surfaces are manufactured or
(2) Properly convey sewage and liquid
exposed, unless those materials are
disposable waste from your physical
necessary as follows:
plant;
(i) To maintain clean and sanitary
conditions; (3) Avoid being a source of contami-
(ii) For use in laboratory testing pro- nation to components, dietary supple-
cedures; ments, water supplies, or any contact
(iii) For maintaining or operating the surface, or creating an unsanitary con-
physical plant or equipment; or dition;
(iv) For use in the plant’s operations. (4) Provide adequate floor drainage in
(3) You must identify and hold clean- all areas where floors are subject to
ing compounds, sanitizing agents, pes- flooding-type cleaning or where normal
ticides, pesticide chemicals, and other operations release or discharge water
toxic materials in a manner that pro- or other liquid waste on the floor; and
tects against contamination of compo- (5) Not allow backflow from, or cross
nents, dietary supplements, or contact connection between, piping systems
surfaces. that discharge waste water or sewage
(d) Pest control. (1) You must not and piping systems that carry water
allow animals or pests in any area of used for manufacturing dietary supple-
your physical plant. Guard or guide ments, for cleaning contact surfaces, or
dogs are allowed in some areas of your for use in bathrooms or hand-washing
physical plant if the presence of the facilities.
dogs will not result in contamination (g) Sewage disposal. You must dispose
of components, dietary supplements, or of sewage into an adequate sewage sys-
contact surfaces; tem or through other adequate means.
(2) You must take effective measures (h) Bathrooms. You must provide your
to exclude pests from the physical employees with adequate, readily ac-
plant and to protect against contami- cessible bathrooms. The bathrooms
nation of components, dietary supple- must be kept clean and must not be a
ments, and contact surfaces on the
potential source of contamination to
premises by pests; and
components, dietary supplements, or
(3) You must not use insecticides, fu-
contact surfaces.
migants, fungicides, or rodenticides,
unless you take precautions to protect (i) Hand-washing facilities. You must
against the contamination of compo- provide hand-washing facilities that
nents, dietary supplements, or contact are designed to ensure that an employ-
surfaces. ee’s hands are not a source of contami-
(e) Water supply. (1) You must provide nation of components, dietary supple-
water that is safe and sanitary, at suit- ments, or any contact surface, by pro-
able temperatures, and under pressure viding facilities that are adequate, con-
as needed, for all uses where water does venient, and furnish running water at a
not become a component of the dietary suitable temperature.
supplement. (j) Trash disposal. You must convey,
(2) Water that is used in a manner store, and dispose of trash to:
such that the water may become a (1) Minimize the development of
component of the dietary supplement, odors;
260
(2) Minimize the potential for the (1) Receiving, identifying, holding,
trash to attract, harbor, or become a and withholding from use, components,
breeding place for pests; dietary supplements, packaging, and
(3) Protect against contamination of labels that will be used in or during the
components, dietary supplements, any manufacturing, packaging, labeling, or
contact surface, water supplies, and holding of dietary supplements;
grounds surrounding your physical (2) Separating, as necessary, compo-
plant; and nents, dietary supplements, packaging,
(4) Control hazardous waste to pre- and labels that are to be used in manu-
vent contamination of components, di- facturing from components, dietary
etary supplements, and contact sur- supplements, packaging, or labels that
faces. are awaiting material review and dis-
(k) Sanitation supervisors. You must position decision, reprocessing, or are
assign one or more employees to super- awaiting disposal after rejection;
vise overall sanitation. Each of these (3) Separating the manufacturing,
supervisors must be qualified by edu- packaging, labeling, and holding of dif-
cation, training, or experience to de- ferent product types including dif-
velop and supervise sanitation proce- ferent types of dietary supplements
dures. and other foods, cosmetics, and phar-
maceutical products;
§ 111.16 What are the requirements (4) Performing laboratory analyses
under this subpart C for written and holding laboratory supplies and
procedures? samples;
You must establish and follow writ- (5) Cleaning and sanitizing contact
ten procedures for cleaning the phys- surfaces;
ical plant and for pest control. (6) Packaging and label operations;
and
§ 111.20 What design and construction (7) Holding components or dietary
requirements apply to your phys- supplements.
ical plant? (d) Be designed and constructed in a
Any physical plant you use in the manner that prevents contamination of
manufacture, packaging, labeling, or components, dietary supplements, or
holding of dietary supplements must: contact surfaces.
(a) Be suitable in size, construction, (1) The design and construction must
and design to facilitate maintenance, include:
cleaning, and sanitizing operations; (i) Floors, walls, and ceilings that
(b) Have adequate space for the or- can be adequately cleaned and kept
derly placement of equipment and clean and in good repair;
holding of materials as is necessary for (ii) Fixtures, ducts, and pipes that do
maintenance, cleaning, and sanitizing not contaminate components, dietary
operations and to prevent contamina- supplements, or contact surfaces by
tion and mixups of components and di- dripping or other leakage, or conden-
etary supplements during manufac- sate;
turing, packaging, labeling, or holding; (iii) Adequate ventilation or environ-
(c) Permit the use of proper pre- mental control equipment such as air-
cautions to reduce the potential for flow systems, including filters, fans,
mixups or contamination of compo- and other air-blowing equipment, that
nents, dietary supplements, or contact minimize odors and vapors (including
surfaces, with microorganisms, chemi- steam and noxious fumes) in areas
cals, filth, or other extraneous mate- where they may contaminate compo-
rial. Your physical plant must have, nents, dietary supplements, or contact
and you must use, separate or defined surfaces;
areas of adequate size or other control (iv) Equipment that controls tem-
systems, such as computerized inven- perature and humidity, when such
tory controls or automated systems of equipment is necessary to ensure the
separation, to prevent contamination quality of the dietary supplement; and
and mixups of components and dietary (v) Aisles or working spaces between
supplements during the following oper- equipment and walls that are ade-
ations: quately unobstructed and of adequate
261
§ 111.23 21 CFR Ch. I (4–1–16 Edition)
width to permit all persons to perform (c) You must make and keep records
their duties and to protect against con- that show that water, when used in a
tamination of components, dietary sup- manner such that the water may be-
plements, or contact surfaces with come a component of the dietary sup-
clothing or personal contact. plement, meets the requirements of
(2) When fans and other air-blowing § 111.15(e)(2).
equipment are used, such fans and
equipment must be located and oper- Subpart D—Equipment and
ated in a manner that minimizes the Utensils
potential for microorganisms and par-
ticulate matter to contaminate compo- § 111.25 What are the requirements
nents, dietary supplements, or contact under this subpart D for written
surfaces; procedures?
(e) Provide adequate light in: You must establish and follow writ-
(1) All areas where components or di- ten procedures for fulfilling the re-
etary supplements are examined, proc- quirements of this subpart D, including
essed, or held; written procedures for:
(2) All areas where contact surfaces (a) Calibrating instruments and con-
are cleaned; and trols that you use in manufacturing or
(3) Hand-washing areas, dressing and testing a component or dietary supple-
locker rooms, and bathrooms. ment;
(f) Use safety-type light bulbs, fix- (b) Calibrating, inspecting, and
tures, skylights, or other glass or checking automated, mechanical, and
glass-like materials when the light electronic equipment; and
bulbs, fixtures, skylights or other glass (c) Maintaining, cleaning, and sani-
or glass-like materials are suspended tizing, as necessary, all equipment,
over exposed components or dietary utensils, and any other contact sur-
supplements in any step of preparation, faces that are used to manufacture,
unless your physical plant is otherwise package, label, or hold components or
constructed in a manner that will pro- dietary supplements.
tect against contamination of compo-
nents or dietary supplements in case of § 111.27 What requirements apply to
breakage of glass or glass-like mate- the equipment and utensils that
rials. you use?
(g) Provide effective protection (a) You must use equipment and
against contamination of components utensils that are of appropriate design,
and dietary supplements in bulk fer- construction, and workmanship to en-
mentation vessels, by, for example: able them to be suitable for their in-
(1) Use of protective coverings; tended use and to be adequately
(2) Placement in areas where you can cleaned and properly maintained.
eliminate harborages for pests over and (1) Equipment and utensils include
around the vessels; the following:
(3) Placement in areas where you can (i) Equipment used to hold or convey;
check regularly for pests, pest infesta- (ii) Equipment used to measure;
tion, filth or any other extraneous ma- (iii) Equipment using compressed air
terials; and or gas;
(4) Use of skimming equipment. (iv) Equipment used to carry out
(h) Use adequate screening or other processes in closed pipes and vessels;
protection against pests, where nec- and
essary. (v) Equipment used in automated,
mechanical, or electronic systems.
§ 111.23 Under this subpart C, what (2) You must use equipment and
records must you make and keep? utensils of appropriate design and con-
(a) You must make and keep records struction so that use will not result in
required under this subpart C in ac- the contamination of components or
cordance with subpart P of this part. dietary supplements with:
(b) You must make and keep records (i) Lubricants;

of the written procedures for cleaning (ii) Fuel;
the physical plant and for pest control. (iii) Coolants;
262
(iv) Metal or glass fragments; (iii) Adequate in number for their

(v) Filth or any other extraneous ma- designated uses.
terial; (7) Compressed air or other gases you
(vi) Contaminated water; or introduce mechanically into or onto a
(vii) Any other contaminants. component, dietary supplement, or
(3) All equipment and utensils you contact surface or that you use to
use must be: clean any contact surface must be
(i) Installed and maintained to facili- treated in such a way that the compo-
tate cleaning the equipment, utensils, nent, dietary supplement, or contact
and all adjacent spaces; surface is not contaminated.
(ii) Corrosion-resistant if the equip- (b) You must calibrate instruments
ment or utensils contact components and controls you use in manufacturing
or dietary supplements; or testing a component or dietary sup-
(iii) Made of nontoxic materials; plement. You must calibrate:
(iv) Designed and constructed to (1) Before first use; and
withstand the environment in which (2) At the frequency specified in writ-
they are used, the action of compo- ing by the manufacturer of the instru-
nents or dietary supplements, and, if ment and control; or
applicable, cleaning compounds and (3) At routine intervals or as other-
sanitizing agents; and wise necessary to ensure the accuracy
(v) Maintained to protect compo- and precision of the instrument and
nents and dietary supplements from control.
being contaminated by any source. (c) You must repair or replace instru-
(4) Equipment and utensils you use ments or controls that cannot be ad-
must have seams that are smoothly justed to agree with the reference
bonded or maintained to minimize ac- standard.
cumulation of dirt, filth, organic mate- (d) You must maintain, clean, and
rial, particles of components or dietary sanitize, as necessary, all equipment,
supplements, or any other extraneous utensils, and any other contact sur-
materials or contaminants. faces used to manufacture, package,
(5) Each freezer, refrigerator, and label, or hold components or dietary
other cold storage compartment you supplements.
use to hold components or dietary sup- (1) Equipment and utensils must be
plements: taken apart as necessary for thorough
(i) Must be fitted with an indicating maintenance, cleaning, and sanitizing.
thermometer, temperature-measuring (2) You must ensure that all contact
device, or temperature-recording de- surfaces, used for manufacturing or
vice that indicates and records, or al- holding low-moisture components or
lows for recording by hand, the tem- dietary supplements, are in a dry and
perature accurately within the com- sanitary condition when in use. When
partment; and the surfaces are wet-cleaned, they
(ii) Must have an automated device must be sanitized, when necessary, and
for regulating temperature or an auto- thoroughly dried before subsequent
mated alarm system to indicate a sig- use.
nificant temperature change in a man- (3) If you use wet processing during
ual operation. manufacturing, you must clean and
(6) Instruments or controls used in sanitize all contact surfaces, as nec-
the manufacturing, packaging, label- essary, to protect against the introduc-
ing, or holding of a dietary supplement, tion of microorganisms into compo-
and instruments or controls that you nents or dietary supplements. When
use to measure, regulate, or record cleaning and sanitizing is necessary,
temperatures, hydrogen-ion concentra- you must clean and sanitize all contact
tion (pH), water activity, or other con- surfaces before use and after any inter-
ditions, to control or prevent the ruption during which the contact sur-
growth of microorganisms or other face may have become contaminated. If
contamination must be: you use contact surfaces in a contin-

(i) Accurate and precise; uous production operation or in con-
(ii) Adequately maintained; and secutive operations involving different
263
§ 111.30 21 CFR Ch. I (4–1–16 Edition)
batches of the same dietary supple- approved by quality control personnel

ment, you must adequately clean and and instituted only by authorized per-
sanitize the contact surfaces, as nec- sonnel; and
essary. (e) Establish and use appropriate con-
(4) You must clean surfaces that do trols to ensure that the equipment
not come into direct contact with com- functions in accordance with its in-
ponents or dietary supplements as fre- tended use. These controls must be ap-
quently as necessary to protect against proved by quality control personnel.
contaminating components or dietary
supplements. § 111.35 Under this subpart D, what
(5) Single-service articles (such as records must you make and keep?
utensils intended for one-time use, (a) You must make and keep records
paper cups, and paper towels) must be: required under this subpart D in ac-
(i) Stored in appropriate containers; cordance with subpart P of this part.
and (b) You must make and keep the fol-
(ii) Handled, dispensed, used, and dis- lowing records:
posed of in a manner that protects (1) Written procedures for fulfilling
against contamination of components, the requirements of this subpart, in-
dietary supplements, or any contact cluding written procedures for:
surface. (i) Calibrating instruments and con-
(6) Cleaning compounds and sani- trols that you use in manufacturing or
tizing agents must be adequate for testing a component or dietary supple-
their intended use and safe under their ment;
conditions of use; (ii) Calibrating, inspecting, and
(7) You must store cleaned and sani- checking automated, mechanical, and
tized portable equipment and utensils electronic equipment; and
that have contact surfaces in a loca- (iii) Maintaining, cleaning, and sani-
tion and manner that protects them tizing, as necessary, all equipment,
from contamination. utensils, and any other contact sur-
[72 FR 34942, June 25, 2007, as amended at 73 faces that are used to manufacture,
FR 13124, Mar. 12, 2008] package, label, or hold components or
dietary supplements;
§ 111.30 What requirements apply to (2) Documentation, in individual
automated, mechanical, or elec- equipment logs, of the date of the use,
tronic equipment? maintenance, cleaning, and sanitizing
For any automated, mechanical, or of equipment, unless such documenta-
electronic equipment that you use to tion is kept with the batch record;
manufacture, package, label, or hold a (3) Documentation of any calibration,
dietary supplement, you must: each time the calibration is performed,
(a) Design or select equipment to en- for instruments and controls that you
sure that dietary supplement specifica- use in manufacturing or testing a com-
tions are consistently met; ponent or dietary supplement. In your
(b) Determine the suitability of the documentation, you must:
equipment by ensuring that your (i) Identify the instrument or control
equipment is capable of operating sat- calibrated;
isfactorily within the operating limits (ii) Provide the date of calibration;
required by the process; (iii) Identify the reference standard
(c) Routinely calibrate, inspect, or used including the certification of ac-
check the equipment to ensure proper curacy of the known reference standard
performance. Your quality control per- and a history of recertification of accu-
sonnel must periodically review these racy;
calibrations, inspections, or checks; (iv) Identify the calibration method
(d) Establish and use appropriate used, including appropriate limits for
controls for automated, mechanical, accuracy and precision of instruments
and electronic equipment (including and controls when calibrating;
software for a computer controlled (v) Provide the calibration reading or
process) to ensure that any changes to readings found;

the manufacturing, packaging, label- (vi) Identify the recalibration meth-
ing, holding, or other operations are od used, and reading or readings found,
264
if accuracy or precision or both accu- that the dietary supplement is pack-

racy and precision limits for instru- aged and labeled as specified in the
ments and controls were not met; and master manufacturing record; and
(vii) Include the initials of the person (b) The production and in-process
who performed the calibration and any control system must include all re-
recalibration. quirements of subparts E through L of
(4) Written records of calibrations, this part and must be reviewed and ap-
inspections, and checks of automated, proved by quality control personnel.
mechanical, and electronic equipment;
(5) Backup file(s) of current software § 111.65 What are the requirements for
programs (and of outdated software quality control operations?
that is necessary to retrieve records You must implement quality control
that you are required to keep in ac- operations in your manufacturing,
cordance with subpart P of this part, packaging, labeling, and holding oper-
when current software is not able to re- ations for producing the dietary sup-
trieve such records) and of data entered plement to ensure the quality of the di-
into computer systems that you use to etary supplement and that the dietary
manufacture, package, label, or hold supplement is packaged and labeled as
dietary supplements. specified in the master manufacturing
(i) Your backup file (e.g., a hard copy record.
of data you have entered, diskettes,
tapes, microfilm, or compact disks) § 111.70 What specifications must you
must be an exact and complete record establish?
of the data you entered.
(ii) You must keep your backup soft- (a) You must establish a specification
ware programs and data secure from al- for any point, step, or stage in the
terations, inadvertent erasures, or loss; manufacturing process where control is
and necessary to ensure the quality of the
(6) Documentation of the controls dietary supplement and that the die-
that you use to ensure that equipment tary supplement is packaged and la-
functions in accordance with its in- beled as specified in the master manu-
tended use. facturing record.
(b) For each component that you use
in the manufacture of a dietary supple-
Subpart E—Requirement to Estab- ment, you must establish component
lish a Production and Process specifications as follows:
Control System (1) You must establish an identity
§ 111.55 What are the requirements to specification;
implement a production and proc- (2) You must establish component
ess control system? specifications that are necessary to en-
You must implement a system of pro- sure that specifications for the purity,
duction and process controls that cov- strength and composition of dietary
ers all stages of manufacturing, pack- supplements manufactured using the
aging, labeling, and holding of the die- components are met; and
tary supplement to ensure the quality (3) You must establish limits on
of the dietary supplement and that the those types of contamination that may
dietary supplement is packaged and la- adulterate or may lead to adulteration
beled as specified in the master manu- of the finished batch of the dietary sup-
facturing record. plement to ensure the quality of the di-
etary supplement.
§ 111.60 What are the design require- (c) For the in-process production:
ments for the production and proc- (1) You must establish in-process
ess control system? specifications for any point, step, or
(a) Your production and in-process stage in the master manufacturing
control system must be designed to en- record where control is necessary to
sure that the dietary supplement is help ensure that specifications are met
manufactured, packaged, labeled, and for the identity, purity, strength, and
held in a manner that will ensure the composition of the dietary supplements
quality of the dietary supplement and and, as necessary, for limits on those
265
§ 111.73 21 CFR Ch. I (4–1–16 Edition)
types of contamination that may adul- § 111.73 What is your responsibility for
terate or may lead to adulteration of determining whether established
the finished batch of the dietary sup- specifications are met?
plement; You must determine whether the
(2) You must provide adequate docu- specifications you establish under
mentation of your basis for why meet- § 111.70 are met.
ing the in-process specifications, in
combination with meeting component § 111.75 What must you do to deter-
specifications, will help ensure that the mine whether specifications are
specifications are met for the identity, met?
purity, strength, and composition of (a) Before you use a component, you
the dietary supplements and for limits must:
on those types of contamination that (1)(i) Conduct at least one appro-
may adulterate or may lead to adulter- priate test or examination to verify the
ation of the finished batch of the die- identity of any component that is a di-
tary supplement; and etary ingredient, unless you petition
(3) Quality control personnel must the agency under paragraph (a)(1)(ii) of
review and approve the documentation this section and the agency exempts
that you provide under paragraph (c)(2) you from such testing;
of this section. (ii) You may submit a petition, under
(d) You must establish specifications 21 CFR 10.30, to request an exemption
for dietary supplement labels (label from the testing requirements in para-
specifications) and for packaging that graph (a)(1)(i) of this section. The peti-
may come in contact with dietary sup- tion must set forth the scientific ra-
plements (packaging specifications). tionale, and must be accompanied by
the supporting data and information,
Packaging that may come into contact
for proposed alternative testing that
with dietary supplements must be safe
will demonstrate that there is no mate-
and suitable for its intended use and
rial diminution of assurance, compared
must not be reactive or absorptive or
to the assurance provided by 100 per-
otherwise affect the safety or quality
cent identity testing, of the identity of
of the dietary supplement.
the dietary ingredient before use when
(e) For each dietary supplement that the dietary ingredient is obtained from
you manufacture you must establish one or more suppliers identified in the
product specifications for the identity, petition. If FDA grants the petition,
purity, strength, and composition of you must conduct the tests and exami-
the finished batch of the dietary sup- nations for the dietary ingredient, oth-
plement, and for limits on those types erwise required under § 111.75(a)(1)(i),
of contamination that may adulterate, under the terms specified by FDA when
or that may lead to adulteration of, the petition is granted; and
the finished batch of the dietary sup- (2) Confirm the identity of other
plement to ensure the quality of the di- components and determine whether
etary supplement. other applicable component specifica-
(f) If you receive a product from a tions established in accordance with
supplier for packaging or labeling as a § 111.70(b) are met. To do so, you must
dietary supplement (and for distribu- either:
tion rather than for return to the sup- (i) Conduct appropriate tests or ex-
plier), you must establish specifica- aminations; or
tions to provide sufficient assurance (ii) Rely on a certificate of analysis
that the product you receive is ade- from the supplier of the component
quately identified and is consistent that you receive, provided that:
with your purchase order. (A) You first qualify the supplier by
(g) You must establish specifications establishing the reliability of the sup-
for the packaging and labeling of the plier’s certificate of analysis through
finished packaged and labeled dietary confirmation of the results of the sup-
supplements, including specifications plier’s tests or examinations;
that ensure that you used the specified (B) The certificate of analysis in-
packaging and that you applied the cludes a description of the test or ex-
specified label. amination method(s) used, limits of
266
the test or examinations, and actual ducted under paragraph (c)(2) of this
results of the tests or examinations; section, will ensure that your finished
(C) You maintain documentation of batch of the dietary supplement meets
how you qualified the supplier; all product specifications for identity,
(D) You periodically re-confirm the purity, strength, and composition, and
supplier’s certificate of analysis; and the limits on those types of contamina-
(E) Your quality control personnel tion that may adulterate, or that may
review and approve the documentation lead to the adulteration of, the dietary
setting forth the basis for qualification supplement; and
(and re-qualification) of any supplier. (4) Your quality control personnel
(b) You must monitor the in-process
must review and approve the docu-
points, steps, or stages where control is
mentation that you provide under
necessary to ensure the quality of the
finished batch of dietary supplement paragraph (c)(3) of this section.
to: (d)(1) You may exempt one or more
(1) Determine whether the in-process product specifications from
specifications are met; and verification requirements in paragraph
(2) Detect any deviation or unantici- (c)(1) of this section if you determine
pated occurrence that may result in a and document that the specifications
failure to meet specifications. you select under paragraph (c)(1) of
(c) For a subset of finished dietary this section for determination of com-
supplement batches that you identify pliance with specifications are not able
through a sound statistical sampling to verify that the production and proc-
plan (or for every finished batch), you ess control system is producing a die-
must verify that your finished batch of tary supplement that meets the ex-
the dietary supplement meets product empted product specification and there
specifications for identity, purity, is no scientifically valid method for
strength, composition, and for limits testing or examining such exempted
on those types of contamination that product specification at the finished
may adulterate or that may lead to batch stage. In such a case, you must
adulteration of the finished batch of document why, for example, any com-
the dietary supplement. To do so: ponent and in-process testing, exam-
(1) You must select one or more es-
ination, or monitoring, and any other
tablished specifications for identity,
information, will ensure that such ex-
purity, strength, composition, and the
empted product specification is met
limits on those types of contamination
that may adulterate or that may lead without verification through periodic
to adulteration of the dietary supple- testing of the finished batch; and
ment that, if tested or examined on the (2) Your quality control personnel
finished batches of the dietary supple- must review and approve the docu-
ment, would verify that the production mentation that you provide under
and process control system is pro- paragraph (d)(1) of this section.
ducing a dietary supplement that (e) Before you package or label a
meets all product specifications (or product that you receive for packaging
only those product specifications not or labeling as a dietary supplement
otherwise exempted from this provision (and for distribution rather than for re-
by quality control personnel under turn to the supplier), you must vis-
paragraph (d) of this section); ually examine the product and have
(2) You must conduct appropriate documentation to determine whether
tests or examinations to determine the specifications that you established
compliance with the specifications se- under § 111.70 (f) are met.
lected in paragraph (c)(1) of this sec- (f)(1) Before you use packaging, you
tion; must, at a minimum, conduct a visual
(3) You must provide adequate docu-
identification of the containers and
mentation of your basis for deter-
closures and review the supplier’s in-
mining that compliance with the speci-
fication(s) selected under paragraph voice, guarantee, or certification to de-

(c)(1) of this section, through the use of termine whether the packaging speci-
appropriate tests or examinations con- fications are met; and
267
§ 111.77 21 CFR Ch. I (4–1–16 Edition)
(2) Before you use labels, you must, (c) For specifications established
at a minimum, conduct a visual exam- under § 111.70(f) that you do not meet,
ination of the label and review the sup- quality control personnel must reject
plier’s invoice, guarantee, or certifi- the product and the product may not
cation to determine whether label be packaged or labeled for distribution
specifications are met. as a dietary supplement.
(g) You must, at a minimum, conduct
a visual examination of the packaging § 111.80 What representative samples
and labeling of the finished packaged must you collect?
and labeled dietary supplements to de- The representative samples that you
termine whether you used the specified must collect include:
packaging and applied the specified (a) Representative samples of each
label. unique lot of components, packaging,
(h)(1) You must ensure that the tests and labels that you use to determine
and examinations that you use to de- whether the components, packaging,
termine whether the specifications are and labels meet specifications estab-
met are appropriate, scientifically lished in accordance with § 111.70(b) and
valid methods. (d), and as applicable, § 111.70(a) (and,
(2) The tests and examinations that when you receive components, pack-
you use must include at least one of aging, or labels from a supplier, rep-
the following: resentative samples of each unique
(i) Gross organoleptic analysis; shipment, and of each unique lot with-
(ii) Macroscopic analysis; in each unique shipment);
(iii) Microscopic analysis; (b) Representative samples of in-
(iv) Chemical analysis; or process materials for each manufac-
(v) Other scientifically valid meth- tured batch at points, steps, or stages,
ods. in the manufacturing process as speci-
(i) You must establish corrective ac- fied in the master manufacturing
tion plans for use when an established record where control is necessary to
specification is not met. ensure the identity, purity, strength,
[72 FR 34942, June 25, 2007, as amended at 72 and composition of dietary supple-
FR 34968, June 25, 2007; 73 FR 27727, May 14, ments to determine whether the in-
2008] process materials meet specifications
established in accordance with
§ 111.77 What must you do if estab- § 111.70(c), and as applicable, § 111.70(a);
lished specifications are not met? (c) Representative samples of a sub-
(a) For specifications established set of finished batches of each dietary
under § 111.70(a), (b)(2), (b)(3), (c), (d), supplement that you manufacture,
(e), and (g) that you do not meet, qual- which you identify through a sound
ity control personnel, in accordance statistical sampling plan (or otherwise
with the requirements in subpart F of every finished batch), before releasing
this part, must reject the component, for distribution to verify that the fin-
dietary supplement, package or label ished batch of dietary supplement
unless such personnel approve a treat- meets product specifications estab-
ment, an in-process adjustment, or re- lished in accordance with § 111.70(e),
processing that will ensure the quality and as applicable, § 111.70(a);
of the finished dietary supplement and (d) Representative samples of each
that the dietary supplement is pack- unique shipment, and of each unique
aged and labeled as specified in the lot within each unique shipment, of
master manufacturing record. No fin- product that you receive for packaging
ished batch of dietary supplements or labeling as a dietary supplement
may be released for distribution unless (and for distribution rather than for re-
it complies with § 111.123(b). turn to the supplier) to determine
(b) For specifications established whether the received product meets
under § 111.70(b)(1) that you do not specifications established in accord-
meet, quality control personnel must ance with § 111.70(f), and as applicable,
reject the component and the compo- § 111.70(a); and

nent must not be used in manufac- (e) Representative samples of each
turing the dietary supplement. lot of packaged and labeled dietary
268
supplements to determine whether the suitable for use in the manufacture of

packaging and labeling of the finished a dietary supplement unless:
packaged and labeled dietary supple- (1) Quality control personnel conduct
ments meet specifications established a material review and make a disposi-
in accordance with § 111.70(g), and as tion decision to approve the reprocess-
applicable, § 111.70(a). ing, treatment, or in-process adjust-
ment; and
§ 111.83 What are the requirements for (2) The reprocessing, treatment, or
reserve samples? in-process adjustment is permitted by
(a) You must collect and hold reserve § 111.77;
samples of each lot of packaged and la- (b) You must not reprocess any die-
beled dietary supplements that you dis- tary supplement or treat or provide an
tribute. in-process adjustment to a component
(b) The reserve samples must: to make it suitable for use in the man-
(1) Be held using the same container- ufacture of a dietary supplement, un-
closure system in which the packaged less:
and labeled dietary supplement is dis- (1) Quality control personnel conduct
tributed, or if distributing dietary sup- a material review and make a disposi-
plements to be packaged and labeled, tion decision that is based on a sci-
using a container-closure system that entifically valid reason and approves
provides essentially the same charac- the reprocessing, treatment, or in-proc-
teristics to protect against contamina- ess adjustment; and
tion or deterioration as the one in (2) The reprocessing, treatment or in-
which it is distributed for packaging process adjustment is permitted by
and labeling elsewhere; § 111.77;
(2) Be identified with the batch, lot, (c) Any batch of dietary supplement
or control number; that is reprocessed, that contains com-
(3) Be retained for 1 year past the ponents that you have treated, or to
shelf life date (if shelf life dating is which you have made in-process adjust-
used), or for 2 years from the date of ments to make them suitable for use in
distribution of the last batch of dietary the manufacture of the dietary supple-
supplements associated with the re- ment must be approved by quality con-
serve sample, for use in appropriate in- trol personnel and comply with
vestigations; and § 111.123(b) before releasing for distribu-
tion.
(4) Consist of at least twice the quan-
tity necessary for all tests or examina- § 111.95 Under this subpart E, what
tions to determine whether or not the records must you make and keep?
dietary supplement meets product
(a) You must make and keep records
specifications.
required under this subpart E in ac-
§ 111.87 Who conducts a material re- cordance with subpart P of this part.
view and makes a disposition deci- (b) Under this subpart E, you must
sion? make and keep the following records:
(1) The specifications established;
Quality control personnel must con-
(2) Documentation of your qualifica-
duct all required material reviews and
tion of a supplier for the purpose of re-
make all required disposition deci-
lying on the supplier’s certificate of
sions.
analysis;
§ 111.90 What requirements apply to (3) Documentation for why meeting
treatments, in-process adjustments, in-process specifications, in combina-
and reprocessing when there is a tion with meeting component speci-
deviation or unanticipated occur- fications, helps ensure that the dietary
rence or when a specification estab- supplement meets the specifications
lished in accordance with § 111.70 is for identity, purity, strength, and com-
not met? position; and for limits on those types
(a) You must not reprocess a rejected of contamination that may adulterate
dietary supplement or treat or provide or may lead to adulteration of the fin-

an in-process adjustment to a compo- ished batch of the dietary supplement;
nent, packaging, or label to make it and
269
§ 111.103 21 CFR Ch. I (4–1–16 Edition)
(4) Documentation for why the re- (a) Approving or rejecting all proc-
sults of appropriate tests or examina- esses, specifications, written proce-
tions for the product specifications se- dures, controls, tests, and examina-
lected under § 111.75(c)(1) ensure that tions, and deviations from or modifica-
the dietary supplement meets all prod- tions to them, that may affect the
uct specifications; identity, purity, strength, or composi-
(5) Documentation for why any com- tion of a dietary supplement;
ponent and in-process testing, exam- (b) Reviewing and approving the doc-
ination, or monitoring, and any other umentation setting forth the basis for
information, will ensure that a product qualification of any supplier;
specification that is exempted under (c) Reviewing and approving the doc-
§ 111.75(d) is met without verification umentation setting forth the basis for
through periodic testing of the finished why meeting in-process specifications,
batch, including documentation that in combination with meeting compo-
the selected specifications tested or ex- nent specifications, will help ensure
amined under § 111.75 (c)(1) are not able that the identity, purity, strength, and
to verify that the production and proc- composition of the dietary supplement
ess control system is producing a die- are met;
tary supplement that meets the ex- (d) Reviewing and approving the doc-
empted product specification and there umentation setting forth the basis for
is no scientifically valid method for why the results of appropriate tests or
testing or examining such exempted examinations for each product speci-
product specification at the finished fication selected under § 111.75(c)(1) will
batch stage. ensure that the finished batch of the
(6) Documentation of FDA’s response dietary supplement meets product
to a petition submitted under specifications;
§ 111.75(a)(1)(ii) providing for an exemp- (e) Reviewing and approving the basis
tion from the provisions of and the documentation for why any
§ 111.75(a)(1)(i). product specification is exempted from
the verification requirements in
[72 FR 34942, June 25, 2007, as amended at 72
FR 34968, June 25, 2007] § 111.75(c)(1), and for why any compo-
nent and in-process testing, examina-
tion, or monitoring, or other methods
Subpart F—Production and Proc- will ensure that such exempted product
ess Control System: Require- specification is met without
ments for Quality Control verification through periodic testing of
the finished batch;
§ 111.103 What are the requirements (f) Ensuring that required representa-
under this subpart F for written
procedures? tive samples are collected;
(g) Ensuring that required reserve
You must establish and follow writ- samples are collected and held;
ten procedures for the responsibilities (h) Determining whether all speci-
of the quality control operations, in- fications established under § 111.70(a)
cluding written procedures for con- are met; and
ducting a material review and making (i) Performing other operations re-
a disposition decision, and for approv- quired under this subpart.
ing or rejecting any reprocessing.
§ 111.110 What quality control oper-
§ 111.105 What must quality control ations are required for laboratory
personnel do? operations associated with the pro-
Quality control personnel must en- duction and process control sys-
sure that your manufacturing, pack- tem?
aging, labeling, and holding operations Quality control operations for lab-
ensure the quality of the dietary sup- oratory operations associated with the
plement and that the dietary supple- production and process control system
ment is packaged and labeled as speci- must include:
fied in the master manufacturing (a) Reviewing and approving all lab-
record. To do so, quality control per- oratory control processes associated

sonnel must perform operations that with the production and process con-
include: trol system;
270
(b) Ensuring that all tests and exami- ance, document that material review
nations required under § 111.75 are con- and disposition decision.
ducted; and
(c) Reviewing and approving the re- § 111.117 What quality control oper-
sults of all tests and examinations re- ations are required for equipment,
instruments, and controls?
quired under § 111.75.
Quality control operations for equip-
§ 111.113 What quality control oper- ment, instruments, and controls must
ations are required for a material include:
review and disposition decision? (a) Reviewing and approving all proc-
(a) Quality control personnel must esses for calibrating instruments and
conduct a material review and make a controls;
disposition decision if: (b) Periodically reviewing all records
(1) A specification established in ac- for calibration of instruments and con-
cordance with § 111.70 is not met; trols;
(2) A batch deviates from the master (c) Periodically reviewing all records
manufacturing record, including when for calibrations, inspections, and
any step established in the master checks of automated, mechanical, or
manufacturing record is not completed electronic equipment; and
and including any deviation from spec- (d) Reviewing and approving controls
ifications; to ensure that automated, mechanical,
(3) There is any unanticipated occur- or electronic equipment functions in
rence during the manufacturing oper- accordance with its intended use.
ations that adulterates or may lead to
adulteration of the component, dietary § 111.120 What quality control oper-
ations are required for components,
supplement, or packaging, or could packaging, and labels before use in
lead to the use of a label not specified the manufacture of a dietary sup-
in the master manufacturing record; plement?
(4) Calibration of an instrument or
Quality control operations for com-
control suggests a problem that may
ponents, packaging, and labels before
have resulted in a failure to ensure the
use in the manufacture of a dietary
quality of a batch or batches of a die-
supplement must include:
tary supplement; or (a) Reviewing all receiving records
(5) A dietary supplement is returned. for components, packaging, and labels;
(b)(1) When there is a deviation or (b) Determining whether all compo-
unanticipated occurrence during the nents, packaging, and labels conform
production and in-process control sys- to specifications established under
tem that results in or could lead to § 111.70 (b) and (d);
adulteration of a component, dietary (c) Conducting any required material
supplement, or packaging, or could review and making any required dis-
lead to the use of a label not specified position decision;
in the master manufacturing record, (d) Approving or rejecting any treat-
quality control personnel must reject ment and in-process adjustments of
the component, dietary supplement, components, packaging, or labels to
packaging, or label unless it approves a make them suitable for use in the man-
treatment, an in-process adjustment, ufacture of a dietary supplement; and
or reprocessing to correct the applica- (e) Approving, and releasing from
ble deviation or occurrence. quarantine, all components, packaging,
(2) When a specification established and labels before they are used.
in accordance with § 111.70 is not met,
quality control personnel must reject § 111.123 What quality control oper-
the component, dietary supplement, ations are required for the master
package or label, unless quality control manufacturing record, the batch
personnel approve a treatment, an in- production record, and manufac-
process adjustment, or reprocessing, as turing operations?
permitted in § 111.77. (a) Quality control operations for the
(c) The person who conducts a mate- master manufacturing record, the
rial review and makes the disposition batch production record, and manufac-
decision must, at the time of perform- turing operations must include:
271
§ 111.127 21 CFR Ch. I (4–1–16 Edition)
(1) Reviewing and approving all mas- (a) Reviewing the results of any vis-
ter manufacturing records and all ual examination and documentation to
modifications to the master manufac- ensure that specifications established
turing records; under § 111.70(f) are met for all products
(2) Reviewing and approving all batch that you receive for packaging and la-
production-related records; beling as a dietary supplement (and for
(3) Reviewing all monitoring required distribution rather than for return to
under subpart E; the supplier);
(4) Conducting any required material (b) Approving, and releasing from
review and making any required dis- quarantine, all products that you re-
position decision; ceive for packaging or labeling as a di-
(5) Approving or rejecting any reproc- etary supplement (and for distribution
essing; rather than for return to the supplier)
(6) Determining whether all in-proc- before they are used for packaging or
ess specifications established in ac- labeling;
cordance with § 111.70(c) are met; (c) Reviewing and approving all
(7) Determining whether each fin- records for packaging and label oper-
ished batch conforms to product speci- ations;
fications established in accordance (d) Determining whether the finished
with § 111.70(e); and packaged and labeled dietary supple-
(8) Approving and releasing, or re- ment conforms to specifications estab-
jecting, each finished batch for dis- lished in accordance with § 111.70(g);
tribution, including any reprocessed (e) Conducting any required material
finished batch. review and making any required dis-
(b) Quality control personnel must position decision;
not approve and release for distribu- (f) Approving or rejecting any re-
tion: packaging of a packaged dietary sup-
(1) Any batch of dietary supplement plement;
for which any component in the batch (g) Approving or rejecting any re-
does not meet its identity specifica- labeling of a packaged and labeled die-
tion; tary supplement; and
(2) Any batch of dietary supplement, (h) Approving for release, or reject-
including any reprocessed batch, that ing, any packaged and labeled dietary
does not meet all product specifica- supplement (including a repackaged or
tions established in accordance with relabeled dietary supplement) for dis-
§ 111.70(e); tribution.
(3) Any batch of dietary supplement,
including any reprocessed batch, that § 111.130 What quality control oper-
has not been manufactured, packaged, ations are required for returned di-
etary supplements?
labeled, and held under conditions to
prevent adulteration under section Quality control operations for re-
402(a)(1), (a)(2), (a)(3), and (a)(4) of the turned dietary supplements must in-
act; and clude:
(4) Any product received from a sup- (a) Conducting any required material
plier for packaging or labeling as a die- review and making any required dis-
tary supplement (and for distribution position decision; including:
rather than for return to the supplier) (1) Determining whether tests or ex-
for which sufficient assurance is not amination are necessary to determine
provided to adequately identify the compliance with product specifications
product and to determine that the established in accordance with
product is consistent with your pur- § 111.70(e); and
chase order. (2) Reviewing the results of any tests
or examinations that are conducted to
§ 111.127 What quality control oper- determine compliance with product
ations are required for packaging specifications established in accord-
and labeling operations? ance with § 111.70(e);
Quality control operations for pack- (b) Approving or rejecting any sal-
aging and labeling operations must in- vage and redistribution of any returned
clude: dietary supplement;
272
(c) Approving or rejecting any re- ure to ensure the quality of the dietary
processing of any returned dietary sup- supplement or a failure to package and
plement; and label the dietary supplement as speci-
(d) Determining whether the reproc- fied in the master manufacturing
essed dietary supplement meets prod- record;
uct specifications and either approving (iv) Identification of the action(s)
for release, or rejecting, any returned taken to correct, and prevent a recur-
dietary supplement that is reprocessed. rence of, the deviation or the unantici-
pated occurrence;
§ 111.135 What quality control oper- (v) Explanation of what you did with
ations are required for product the component, dietary supplement,
complaints?
packaging, or label;
Quality control operations for prod- (vi) A scientifically valid reason for
uct complaints must include reviewing any reprocessing of a dietary supple-
and approving decisions about whether ment that is rejected or any treatment
to investigate a product complaint and or in-process adjustment of a compo-
reviewing and approving the findings nent that is rejected; and
and followup action of any investiga- (vii) The signature of the indi-
tion performed. vidual(s) designated to perform the
quality control operation, who con-
§ 111.140 Under this subpart F, what ducted the material review and made
records must you make and keep?
the disposition decision, and of each
(a) You must make and keep the qualified individual who provides infor-
records required under this subpart F mation relevant to that material re-
in accordance with subpart P of this view and disposition decision.
part.
(b) You must make and keep the fol- Subpart G—Production and Proc-
lowing records:
(1) Written procedures for the respon-
ess Control System: Require-
sibilities of the quality control oper- ments for Components, Pack-
ations, including written procedures aging, and Labels and for
for conducting a material review and Product That You Receive for
making a disposition decision and writ- Packaging or Labeling as a
ten procedures for approving or reject- Dietary Supplement
ing any reprocessing;
(2) Written documentation, at the § 111.153 What are the requirements
time of performance, that quality con- under this subpart G for written
trol personnel performed the review, procedures?
approval, or rejection requirements by You must establish and follow writ-
recording the following: ten procedures for fulfilling the re-
(i) Date that the review, approval, or quirements of this subpart G.
rejection was performed; and
(ii) Signature of the person per- § 111.155 What requirements apply to
forming the review, approval, or rejec- components of dietary supple-
tion; and ments?
(3) Documentation of any material (a) You must visually examine each
review and disposition decision and fol- immediate container or grouping of
lowup. Such documentation must be immediate containers in a shipment
included in the appropriate batch pro- that you receive for appropriate con-
duction record and must include: tent label, container damage, or bro-
(i) Identification of the specific devi- ken seals to determine whether the
ation or the unanticipated occurrence; container condition may have resulted
(ii) Description of your investigation in contamination or deterioration of
into the cause of the deviation from the components;
the specification or the unanticipated (b) You must visually examine the
occurrence; supplier’s invoice, guarantee, or cer-
(iii) Evaluation of whether or not the tification in a shipment you receive to

deviation or unanticipated occurrence ensure the components are consistent
has resulted in or could lead to a fail- with your purchase order;
273
§ 111.160 21 CFR Ch. I (4–1–16 Edition)
(c) You must quarantine components (c) You must quarantine packaging
before you use them in the manufac- and labels before you use them in the
ture of a dietary supplement until: manufacture of a dietary supplement
(1) You collect representative sam- until:
ples of each unique lot of components (1) You collect representative sam-
(and, for components that you receive, ples of each unique shipment, and of
of each unique shipment, and of each each unique lot within each unique
unique lot within each unique ship- shipment, of packaging and labels and,
ment); at a minimum, conduct a visual identi-
(2) Quality control personnel review fication of the immediate containers
and approve the results of any tests or and closures;
examinations conducted on compo- (2) Quality control personnel review
nents; and and approve the results of any tests or
(3) Quality control personnel approve examinations conducted on the pack-
the components for use in the manufac- aging and labels; and
ture of a dietary supplement, including (3) Quality control personnel approve
approval of any treatment (including the packaging and labels for use in the
in-process adjustments) of components manufacture of a dietary supplement
to make them suitable for use in the and release them from quarantine.
manufacture of a dietary supplement, (d)(1) You must identify each unique
and releases them from quarantine. lot within each unique shipment of
(d)(1) You must identify each unique packaging and labels in a manner that
lot within each unique shipment of allows you to trace the lot to the sup-
components that you receive and any plier, the date received, the name of
lot of components that you produce in the packaging and label, the status of
a manner that allows you to trace the the packaging and label (e.g., quar-
lot to the supplier, the date received, antined, approved, or rejected); and to
the name of the component, the status the dietary supplement that you dis-
of the component (e.g., quarantined, tributed; and
approved, or rejected); and to the die- (2) You must use this unique identi-
tary supplement that you manufac- fier whenever you record the disposi-
tured and distributed. tion of each unique lot within each
(2) You must use this unique identi- unique shipment of packaging and la-
fier whenever you record the disposi- bels.
(e) You must hold packaging and la-
tion of each unique lot within each
bels under conditions that will protect
unique shipment of components that
against contamination and deteriora-
you receive and any lot of components
tion, and avoid mixups.
that you produce.
(e) You must hold components under § 111.165 What requirements apply to a
conditions that will protect against product received for packaging or
contamination and deterioration, and labeling as a dietary supplement
avoid mixups. (and for distribution rather than
for return to the supplier)?
§ 111.160 What requirements apply to (a) You must visually examine each
packaging and labels received? immediate container or grouping of
(a) You must visually examine each immediate containers in a shipment of
immediate container or grouping of product that you receive for packaging
immediate containers in a shipment or labeling as a dietary supplement
for appropriate content label, con- (and for distribution rather than for re-
tainer damage, or broken seals to de- turn to the supplier) for appropriate
termine whether the container condi- content label, container damage, or
tion may have resulted in contamina- broken seals to determine whether the
tion or deterioration of the packaging container condition may have resulted
and labels. in contamination or deterioration of
(b) You must visually examine the the received product.
supplier’s invoice, guarantee, or cer- (b) You must visually examine the
tification in a shipment to ensure that supplier’s invoice, guarantee, or cer-

the packaging or labels are consistent tification in a shipment of the received
with your purchase order. product to ensure that the received
274
product is consistent with your pur- (b) You must make and keep the fol-
chase order. lowing records:
(c) You must quarantine the received (1) Written procedures for fulfilling
product until: the requirements of this subpart.
(1) You collect representative sam- (2) Receiving records (including
ples of each unique shipment, and of records such as certificates of analysis,
each unique lot within each unique suppliers’ invoices, and suppliers’ guar-
shipment, of received product;
antees) for components, packaging, and
(2) Quality control personnel review
and approve the documentation to de- labels and for products that you re-
termine whether the received product ceive for packaging or labeling as a di-
meets the specifications that you es- etary supplement (and for distribution
tablished under § 111.70(f); and rather than for return to the supplier);
(3) Quality control personnel approve and
the received product for packaging or (3) Documentation that the require-
labeling as a dietary supplement and ments of this subpart were met.
release the received product from quar- (i) The person who performs the re-
antine. quired operation must document, at
(d)(1) You must identify each unique the time of performance, that the re-
lot within each unique shipment of required operation was performed.
ceived product in a manner that allows (ii) The documentation must include:
you to trace the lot to the supplier, the (A) The date that the components,
date received, the name of the received
packaging, labels, or products that you
product, the status of the received
product (e.g., quarantined, approved, or receive for packaging or labeling as a
rejected), and to the product that you dietary supplement were received;
packaged or labeled and distributed as (B) The initials of the person per-
a dietary supplement. forming the required operation;
(2) You must use this unique identi- (C) The results of any tests or exami-
fier whenever you record the disposi- nations conducted on components,
tion of each unique lot within each packaging, or labels, and of any visual
unique shipment of the received prod- examination of product that you re-
uct. ceive for packaging or labeling as a di-
(e) You must hold the received prod- etary supplement; and
uct under conditions that will protect (D) Any material review and disposi-
against contamination and deterioration decision conducted on compo-
tion, and avoid mixups. nents, packaging, labels, or products
§ 111.170 What requirements apply to that you receive for packaging or la-
rejected components, packaging, beling as a dietary supplement.
and labels, and to rejected products
that are received for packaging or Subpart H—Production and Proc-
labeling as a dietary supplement?
ess Control System: Require-
You must clearly identify, hold, and
control under a quarantine system for
ments for the Master Manu-
appropriate disposition any compo- facturing Record
nent, packaging, and label, and any
product that you receive for packaging § 111.205 What is the requirement to
establish a master manufacturing
or labeling as a dietary supplement
record?
(and for distribution rather than for re-
turn to the supplier), that is rejected (a) You must prepare and follow a
and unsuitable for use in manufac- written master manufacturing record
turing, packaging, or labeling oper- for each unique formulation of dietary
ations. supplement that you manufacture, and
for each batch size, to ensure uni-
§ 111.180 Under this subpart G, what formity in the finished batch from
batch to batch.
(a) You must make and keep records (b) The master manufacturing record
required under this subpart G in ac- must:
cordance with subpart P of this part.
275
§ 111.210 21 CFR Ch. I (4–1–16 Edition)
(1) Identify specifications for the erence to the physical location of the
points, steps, or stages in the manufac- actual or representative label;
turing process where control is nec- (h) Written instructions, including
essary to ensure the quality of the die- the following:
tary supplement and that the dietary (1) Specifications for each point,
supplement is packaged and labeled as step, or stage in the manufacturing
specified in the master manufacturing process where control is necessary to
record; and ensure the quality of the dietary sup-
(2) Establish controls and procedures plement and that the dietary supple-
to ensure that each batch of dietary ment is packaged and labeled as speci-
supplement that you manufacture fied in the master manufacturing
meets the specifications identified in record;
accordance with paragraph (b)(1) of (2) Procedures for sampling and a
this section. cross-reference to procedures for tests
(c) You must make and keep master or examinations;
manufacturing records in accordance (3) Specific actions necessary to per-
with subpart P of this part. form and verify points, steps, or stages
in the manufacturing process where
§ 111.210 What must the master manu- control is necessary to ensure the qual-
facturing record include? ity of the dietary supplement and that
The master manufacturing record the dietary supplement is packaged
must include: and labeled as specified in the master
(a) The name of the dietary supple- manufacturing record.
ment to be manufactured and the (i) Such specific actions must include
strength, concentration, weight, or verifying the weight or measure of any
measure of each dietary ingredient for component and verifying the addition
each batch size; of any component; and
(b) A complete list of components to (ii) For manual operations, such spe-
be used; cific actions must include:
(c) An accurate statement of the (A) One person weighing or meas-
weight or measure of each component uring a component and another person
to be used; verifying the weight or measure; and
(d) The identity and weight or meas- (B) One person adding the component
ure of each dietary ingredient that will and another person verifying the addi-
be declared on the Supplement Facts tion.
label and the identity of each ingre- (4) Special notations and precautions
dient that will be declared on the in- to be followed; and
gredients list of the dietary supple- (5) Corrective action plans for use
ment; when a specification is not met.
(e) A statement of any intentional
overage amount of a dietary ingre- Subpart I—Production and Process
dient; Control System: Requirements
(f) A statement of theoretical yield of for the Batch Production
a manufactured dietary supplement ex- Record
pected at each point, step, or stage of
the manufacturing process where con- § 111.255 What is the requirement to
trol is needed to ensure the quality of establish a batch production
the dietary supplement, and the ex- record?
pected yield when you finish manufac- (a) You must prepare a batch produc-
turing the dietary supplement, includ- tion record every time you manufac-
ing the maximum and minimum per- ture a batch of a dietary supplement;
centages of theoretical yield beyond (b) Your batch production record
which a deviation investigation of a must include complete information re-
batch is necessary and material review lating to the production and control of
is conducted and disposition decision is each batch;
made; (c) Your batch production record

(g) A description of packaging and a must accurately follow the appropriate
representative label, or a cross-ref- master manufacturing record and you
276
must perform each step in the produc- (1) The date on which each step of the
tion of the batch; and master manufacturing record was per-
(d) You must make and keep batch formed; and
production records in accordance with (2) The initials of the persons per-
subpart P of this part. forming each step, including:
(i) The initials of the person respon-
§ 111.260 What must the batch record sible for weighing or measuring each
include? component used in the batch;
The batch production record must in- (ii) The initials of the person respon-
clude the following: sible for verifying the weight or meas-
ure of each component used in the
(a) The batch, lot, or control number:
batch;
(1) Of the finished batch of dietary
(iii) The initials of the person respon-
supplement; and sible for adding the component to the
(2) That you assign in accordance batch; and
with § 111.415(f) for the following: (iv) The initials of the person respon-
(i) Each lot of packaged and labeled sible for verifying the addition of com-
dietary supplement from the finished ponents to the batch;
batch of dietary supplement; (k) Documentation, at the time of
(ii) Each lot of dietary supplement, performance, of packaging and labeling
from the finished batch of dietary sup- operations, including:
plement, that you distribute to an- (1) The unique identifier that you as-
other person for packaging or labeling; signed to packaging and labels used,
(b) The identity of equipment and the quantity of the packaging and la-
processing lines used in producing the bels used, and, when label reconcili-
batch; ation is required, reconciliation of any
(c) The date and time of the mainte- discrepancies between issuance and use
nance, cleaning, and sanitizing of the of labels;
equipment and processing lines used in (2) An actual or representative label,
producing the batch, or a cross-ref- or a cross-reference to the physical lo-
erence to records, such as individual cation of the actual or representative
equipment logs, where this information label specified in the master manufac-
is retained; turing record; and
(d) The unique identifier that you as- (3) The results of any tests or exami-
signed to each component (or, when ap- nations conducted on packaged and la-
plicable, to a product that you receive beled dietary supplements (including
from a supplier for packaging or label- repackaged or relabeled dietary supple-
ing as a dietary supplement), pack- ments), or a cross-reference to the
aging, and label used; physical location of such results;
(e) The identity and weight or meas- (l) Documentation at the time of per-
ure of each component used; formance that quality control per-
sonnel:
(f) A statement of the actual yield
(1) Reviewed the batch production
and a statement of the percentage of
record, including:
theoretical yield at appropriate phases
(i) Review of any monitoring oper-
of processing;
ation required under subpart E of this
(g) The actual results obtained dur- part; and
ing any monitoring operation; (ii) Review of the results of any tests
(h) The results of any testing or ex- and examinations, including tests and
amination performed during the batch examinations conducted on compo-
production, or a cross-reference to such nents, in-process materials, finished
results; batches of dietary supplements, and
(i) Documentation that the finished packaged and labeled dietary supple-
dietary supplement meets specifica- ments;
tions established in accordance with (2) Approved or rejected any reproc-
§ 111.70(e) and (g); essing or repackaging; and
(j) Documentation, at the time of (3) Approved and released, or re-

performance, of the manufacture of the jected, the batch for distribution, in-
batch, including: cluding any reprocessed batch; and
277
§ 111.303 21 CFR Ch. I (4–1–16 Edition)
(4) Approved and released, or re- ment (and for distribution rather than
jected, the packaged and labeled die- for return to the supplier); and
tary supplement, including any repack- (5) Packaged and labeled dietary sup-
aged or relabeled dietary supplement. plements.
(m) Documentation at the time of (c) Use of criteria for selecting appro-
performance of any required material priate examination and testing meth-
review and disposition decision. ods;
(n) Documentation at the time of (d) Use of criteria for selecting stand-
performance of any reprocessing. ard reference materials used in per-
forming tests and examinations; and
Subpart J—Production and Proc- (e) Use of test methods and examina-
ess Control System: Require- tions in accordance with established
ments for Laboratory Oper- criteria.
ations
§ 111.320 What requirements apply to
§ 111.303 What are the requirements laboratory methods for testing and
under this subpart J for written examination?
procedures?
(a) You must verify that the labora-
You must establish and follow writ- tory examination and testing meth-
ten procedures for laboratory oper- odologies are appropriate for their in-
ations, including written procedures tended use.
for the tests and examinations that (b) You must identify and use an ap-
you conduct to determine whether
propriate scientifically valid method
specifications are met.
for each established specification for
§ 111.310 What are the requirements which testing or examination is re-
for the laboratory facilities that you quired to determine whether the speci-
use? fication is met.
You must use adequate laboratory fa-
§ 111.325 Under this subpart J, what
cilities to perform whatever testing
and examinations are necessary to de-
termine whether: (a) You must make and keep records
(a) Components that you use meet required under this subpart J in ac-
specifications; cordance with subpart P of this part.
(b) In-process specifications are met (b) You must make and keep the fol-
as specified in the master manufac- lowing records:
turing record; and (1) Written procedures for laboratory
(c) Dietary supplements that you operations, including written proce-
manufacture meet specifications. dures for the tests and examinations
that you conduct to determine whether
§ 111.315 What are the requirements
for laboratory control processes? specifications are met;
(2) Documentation that laboratory
You must establish and follow lab- methodology established in accordance
oratory control processes that are re- with this subpart J is followed.
viewed and approved by quality control
(i) The person who conducts the test-
personnel, including the following:
ing and examination must document,
(a) Use of criteria for establishing ap-
at the time of performance, that lab-
propriate specifications;
oratory methodology established in ac-
(b) Use of sampling plans for obtain-
ing representative samples, in accord- cordance with this subpart J is fol-
ance with subpart E of this part, of: lowed.
(1) Components, packaging, and la- (ii) The documentation for labora-
bels; tory tests and examinations must in-
(2) In-process materials; clude the results of the testing and ex-
(3) Finished batches of dietary sup- amination.
plements;
(4) Product that you receive for pack-
aging or labeling as a dietary supple-
278
Subpart K—Production and Proc- of microorganisms and prevent decom-

ess Control System: Require- position;
(f) Holding components and dietary
ments for Manufacturing Op- supplements that can support the rapid
erations growth of microorganisms of public
§ 111.353 What are the requirements health significance in a manner that
under this subpart K for written prevents the components and dietary
procedures? supplements from becoming adulter-
ated;
You must establish and follow writ- (g) Identifying and holding any com-
ten procedures for manufacturing oper- ponents or dietary supplements, for
ations. which a material review and disposi-
§ 111.355 What are the design require- tion decision is required, in a manner
ments for manufacturing oper- that protects components or dietary
ations? supplements that are not under a ma-
terial review against contamination
You must design or select manufac- and mixups with those that are under a
turing processes to ensure that product material review;
specifications are consistently met. (h) Performing mechanical manufac-
§ 111.360 What are the requirements turing steps (such as cutting, sorting,
for sanitation? inspecting, shredding, drying, grinding,
blending, and sifting) by any effective
You must conduct all manufacturing means to protect the dietary supple-
operations in accordance with adequate ments against contamination, by, for
sanitation principles. example:
(1) Cleaning and sanitizing contact
§ 111.365 What precautions must you
take to prevent contamination? surfaces;
(2) Using temperature controls; and
You must take all the necessary pre- (3) Using time controls.
cautions during the manufacture of a (i) Using effective measures to pro-
dietary supplement to prevent con- tect against the inclusion of metal or
tamination of components or dietary other foreign material in components
supplements. These precautions in- or dietary supplements, by, for exam-
clude: ple:
(a) Performing manufacturing oper- (1) Filters or strainers,
ations under conditions and controls (2) Traps,
that protect against the potential for (3) Magnets, or
growth of microorganisms and the po- (4) Electronic metal detectors.
tential for contamination; (j) Segregating and identifying all
(b) Washing or cleaning components containers for a specific batch of die-
that contain soil or other contami- tary supplements to identify their con-
nants; tents and, when necessary, the phase of
(c) Using water that, at a minimum, manufacturing; and
complies with the applicable Federal, (k) Identifying all processing lines
State, and local requirements and does and major equipment used during man-
not contaminate the dietary supple- ufacturing to indicate their contents,
ment when the water may become a including the name of the dietary sup-
component of the finished batch of die- plement and the specific batch or lot
tary supplement; number and, when necessary, the phase
(d) Performing chemical, micro- of manufacturing.
biological, or other testing, as nec-
essary to prevent the use of contami- § 111.370 What requirements apply to
nated components; rejected dietary supplements?
(e) Sterilizing, pasteurizing, freezing, You must clearly identify, hold, and
refrigerating, controlling hydrogen-ion control under a quarantine system for
concentration (pH), controlling humid- appropriate disposition any dietary
ity, controlling water activity (aw), or supplement that is rejected and unsuit-
using any other effective means to re- able for use in manufacturing, pack-
move, destroy, or prevent the growth aging, or labeling operations.
279
§ 111.375 21 CFR Ch. I (4–1–16 Edition)
§ 111.375 Under this subpart K, what and labeled as specified in the master
records must you make and keep? manufacturing record. You must do
(a) You must make and keep records this using any effective means, includ-
required under this subpart K in ac- ing the following:
cordance with subpart P of this part. (a) Cleaning and sanitizing all filling
(b) You must make and keep records and packaging equipment, utensils, and
of the written procedures for manufac- dietary supplement packaging, as ap-
turing operations. propriate;
(b) Protecting manufactured dietary
Subpart L—Production and Proc- supplements from contamination, par-
ess Control System: Require- ticularly airborne contamination;
ments for Packaging and La- (c) Using sanitary handling proce-
beling Operations dures;
(d) Establishing physical or spatial
§ 111.403 What are the requirements separation of packaging and label oper-
under this subpart L for written ations from operations on other compo-
procedures? nents and dietary supplements to pre-
You must establish and follow writ- vent mixups;
ten procedures for packaging and label- (e) Identifying, by any effective
ing operations. means, filled dietary supplement con-
tainers that are set aside and held in
packaging and labels? unlabeled condition for future label op-
erations, to prevent mixups;
(a) You must take necessary actions (f) Assigning a batch, lot, or control
to determine whether packaging for di-
number to:
etary supplements meets specifications
so that the condition of the packaging (1) Each lot of packaged and labeled
will ensure the quality of your dietary dietary supplement from a finished
supplements; batch of dietary supplement; and,
(b) You must control the issuance (2) Each lot of dietary supplement,
and use of packaging and labels and from a finished batch of dietary supple-
reconciliation of any issuance and use ment, that you distribute to another
discrepancies. Label reconciliation is person for packaging or labeling.
not required for cut or rolled labels if a (g) Examining a representative sam-
100-percent examination for correct la- ple of each batch of the packaged and
bels is performed by appropriate elec- labeled dietary supplement to deter-
tronic or electromechanical equipment mine whether the dietary supplement
during or after completion of finishing meets specifications established in ac-
operations; and cordance with § 111.70(g); and
(c) You must examine, before pack- (h) Suitably disposing of labels and
aging and labeling operations, pack- packaging for dietary supplements that
aging and labels for each batch of die- are obsolete or incorrect to ensure that
tary supplement to determine whether they are not used in any future pack-
the packaging and labels conform to aging and label operations.
the master manufacturing record; and
(d) You must be able to determine § 111.420 What requirements apply to
the complete manufacturing history repackaging and relabeling?
and control of the packaged and la-
beled dietary supplement through dis- (a) You may repackage or relabel die-
tribution. tary supplements only after quality
control personnel have approved such
§ 111.415 What requirements apply to repackaging or relabeling.
filling, assembling, packaging, la- (b) You must examine a representa-
beling, and related operations? tive sample of each batch of repack-
You must fill, assemble, package, aged or relabeled dietary supplements
label, and perform other related oper- to determine whether the repackaged
ations in a way that ensures the qual- or relabeled dietary supplements meet
ity of the dietary supplement and that all specifications established in accord-
the dietary supplement is packaged ance with § 111.70(g).
280
(c) Quality control personnel must protect against mixup, contamination,

approve or reject each batch of repack- and deterioration.
aged or relabeled dietary supplement (b) You must hold in-process mate-
prior to its release for distribution. rial under appropriate conditions of
temperature, humidity, and light.
§ 111.425 What requirements apply to a
packaged and labeled dietary sup- § 111.465 What requirements apply to
plement that is rejected for dis-
tribution? holding reserve samples of dietary
supplements?
You must clearly identify, hold, and
control under a quarantine system for (a) You must hold reserve samples of
appropriate disposition any packaged dietary supplements in a manner that
and labeled dietary supplement that is protects against contamination and de-
rejected for distribution. terioration. This includes:
(1) Holding the reserve samples under
§ 111.430 Under this subpart L, what conditions consistent with product la-
records must you make and keep? bels or, if no storage conditions are
(a) You must make and keep records recommended on the label, under ordi-
required under this subpart L in ac- nary storage conditions; and
cordance with subpart P of this part. (2) Using the same container-closure
(b) You must make and keep records system in which the packaged and la-
of the written procedures for packaging beled dietary supplement is distrib-
and labeling operations. uted, or if distributing dietary supple-
ments to be packaged and labeled,
Subpart M—Holding and using a container-closure system that
Distributing provides essentially the same charac-
teristics to protect against contamina-
§ 111.453 What are the requirements tion or deterioration as the one in
under this subpart for M written which you distribute the dietary sup-
procedures?
plement for packaging and labeling
You must establish and follow writ- elsewhere.
ten procedures for holding and distrib- (b) You must retain reserve samples
uting operations. for 1 year past the shelf life date (if
§ 111.455 What requirements apply to shelf life dating is used), or for 2 years
holding components, dietary sup- from the date of distribution of the last
plements, packaging, and labels? batch of dietary supplements associ-
(a) You must hold components and ated with the reserve samples, for use
dietary supplements under appropriate in appropriate investigations.
conditions of temperature, humidity,
and light so that the identity, purity, § 111.470 What requirements apply to
distributing dietary supplements?
strength, and composition of the com-
ponents and dietary supplements are You must distribute dietary supple-
not affected. ments under conditions that will pro-
(b) You must hold packaging and la- tect the dietary supplements against
bels under appropriate conditions so contamination and deterioration.
that the packaging and labels are not
adversely affected. § 111.475 Under this subpart M, what
(c) You must hold components, die- records must you make and keep?
tary supplements, packaging, and la- (a) You must make and keep records
bels under conditions that do not lead required under this subpart M in ac-
to the mixup, contamination, or dete- cordance with subpart P of this part.
rioration of components, dietary sup-
(b) You must make and keep the fol-
plements, packaging, and labels.
lowing records:
§ 111.460 What requirements apply to (1) Written procedures for holding
holding in-process material? and distributing operations; and

(a) You must identify and hold in- (2) Records of product distribution.
process material under conditions that
281
§ 111.503 21 CFR Ch. I (4–1–16 Edition)
Subpart N—Returned Dietary § 111.530 When must an investigation

Supplements be conducted of your manufac-
turing processes and other batches?
§ 111.503 What are the requirements If the reason for a dietary supple-
under this subpart N for written ment being returned implicates other
procedures? batches, you must conduct an inves-
You must establish and follow writ- tigation of your manufacturing proc-
ten procedures to fulfill the require- esses and each of those other batches
ments of this subpart. to determine compliance with speci-
fications.
§ 111.510 What requirements apply
when a returned dietary supple- § 111.535 Under this subpart N, what
ment is received? records must you make and keep?
You must identify and quarantine re- (a) You must make and keep records
turned dietary supplements until qual- required under this subpart N in ac-
cordance with subpart P of this part.
ity control personnel conduct a mate-
rial review and make a disposition de-
lowing records:
cision.
(1) Written procedures for fulfilling
§ 111.515 When must a returned die- the requirements of this subpart N.
tary supplement be destroyed, or (2) Any material review and disposi-
otherwise suitably disposed of? tion decision on a returned dietary sup-
plement;
You must destroy, or otherwise suit-
(3) The results of any testing or ex-
ably dispose of, any returned dietary
amination conducted to determine
supplement unless the outcome of a compliance with product specifications
material review and disposition deci- established under § 111.70(e); and,
sion is that quality control personnel (4) Documentation of the reevalua-
do the following: tion by quality control personnel of
(a) Approve the salvage of the re- any dietary supplement that is reproc-
turned dietary supplement for redis- essed and the determination by quality
tribution or control personnel of whether the re-
(b) Approve the returned dietary sup- processed dietary supplement meets
plement for reprocessing. product specifications established in
accordance with § 111.70(e).
§ 111.520 When may a returned dietary
supplement be salvaged?
Subpart O—Product Complaints
You may salvage a returned dietary
supplement only if quality control per- § 111.553 What are the requirements
sonnel conduct a material review and under this subpart O for written
procedures?
make a disposition decision to allow
the salvage. You must establish and follow writ-
ten procedures to fulfill the require-
§ 111.525 What requirements apply to a ments of this subpart O.
returned dietary supplement that
quality control personnel approve § 111.560 What requirements apply to
for reprocessing? the review and investigation of a
product complaint?
(a) You must ensure that any re-
turned dietary supplements that are (a) A qualified person must:
reprocessed meet all product specifica- (1) Review all product complaints to
tions established in accordance with determine whether the product com-
§ 111.70(e); and plaint involves a possible failure of a
(b) Quality control personnel must dietary supplement to meet any of its
specifications, or any other require-
approve or reject the release for dis-
ments of this part 111, including those
tribution of any returned dietary sup-

specifications and other requirements
plement that is reprocessed.
that, if not met, may result in a risk of
illness or injury; and
282
(2) Investigate any product complaint Subpart P—Records and

that involves a possible failure of a die- Recordkeeping
tary supplement to meet any of its
specifications, or any other require- § 111.605 What requirements apply to
ments of this part, including those the records that you make and
specifications and other requirements keep?
that, if not met, may result in a risk of (a) You must keep written records re-
illness or injury. quired by this part for 1 year past the
(b) Quality control personnel must shelf life date, if shelf life dating is
review and approve decisions about used, or 2 years beyond the date of dis-
whether to investigate a product com- tribution of the last batch of dietary
plaint and review and approve the find- supplements associated with those
ings and followup action of any inves- records.
tigation performed. (b) Records must be kept as original
(c) The review and investigation of records, as true copies (such as photo-
the product complaint by a qualified copies, microfilm, microfiche, or other
person, and the review by quality con- accurate reproductions of the original
trol personnel about whether to inves- records), or as electronic records.
tigate a product complaint, and the (c) All electronic records must com-
findings and followup action of any in- ply with part 11 of this chapter.
vestigation performed, must extend to
all relevant batches and records. § 111.610 What records must be made
available to FDA?
§ 111.570 Under this subpart O, what
records must you make and keep? (a) You must have all records re-
quired under this part, or copies of
(a) You must make and keep the
such records, readily available during
records required under this subpart O
the retention period for inspection and
in accordance with subpart P of this
copying by FDA when requested.
part.
(b) If you use reduction techniques,
such as microfilming, you must make
lowing records:
suitable reader and photocopying
(1) Written procedures for fulfilling equipment readily available to FDA.
the requirements of this subpart,
(2) A written record of every product
complaint that is related to good man- PART 112—STANDARDS FOR THE
ufacturing practice, GROWING, HARVESTING, PACK-
(i) The person who performs the re- ING, AND HOLDING OF
quirements of this subpart must docu- PRODUCE FOR HUMAN CON-
ment, at the time of performance, that SUMPTION
the requirement was performed.
(ii) The written record of the product Subpart A—General Provisions
complaint must include the following:
(A) The name and description of the Sec.
dietary supplement; 112.1 What food is covered by this part?
112.2 What produce is not covered by this
(B) The batch, lot, or control number part?
of the dietary supplement, if available; 112.3 What definitions apply to this part?
(C) The date the complaint was re- 112.4 Which farms are subject to the re-
ceived and the name, address, or tele- quirements of this part?
phone number of the complainant, if 112.5 Which farms are eligible for a quali-
available; fied exemption and associated modified
(D) The nature of the complaint in- requirements based on average monetary
cluding, if known, how the product was value of all food sold and direct farm
used; marketing?
112.6 What modified requirements apply to
(E) The reply to the complainant, if me if my farm is eligible for a qualified
any; and exemption in accordance with § 112.5?
(F) Findings of the investigation and 112.7 What records must I establish and
followup action taken when an inves- keep if my farm is eligible for a qualified
tigation is performed. exemption in accordance with § 112.5?
283
Subpart B—General Requirements Subpart F—Biological Soil Amendments of

Animal Origin and Human Waste
112.11 What general requirements apply to
persons who are subject to this part? 112.51 What requirements apply for deter-
112.12 Are there any alternatives to the re- mining the status of a biological soil
quirements established in this part? amendment of animal origin?
112.52 How must I handle, convey, and store
Subpart C—Personnel Qualifications and biological soil amendments of animal or-
Training igin?
112.53 What prohibitions apply regarding
112.21 What requirements apply regarding use of human waste?
qualifications and training for personnel
112.54 What treatment processes are accept-
who handle (contact) covered produce or
able for a biological soil amendment of
food contact surfaces?
animal origin that I apply in the growing
112.22 What minimum requirements apply
of covered produce?
for training personnel who conduct a
covered activity? 112.55 What microbial standards apply to
112.23 What requirements apply regarding the treatment processes in § 112.54?
supervisors? 112.56 What application requirements and
112.30 Under this subpart, what require- minimum application intervals apply to
ments apply regarding records? biological soil amendments of animal or-
igin?
Subpart D—Health and Hygiene 112.60 Under this subpart, what require-
ments apply regarding records?
112.31 What measures must I take to pre-
vent ill or infected persons from con- Subpart G–H—[Reserved]
taminating covered produce with micro-
organisms of public health significance? Subpart I—Domesticated and Wild Animals
112.32 What hygienic practices must per-
sonnel use? 112.81 How do the requirements of this sub-
112.33 What measures must I take to pre- part apply to areas where covered activi-
vent visitors from contaminating cov- ties take place?
ered produce and food contact surfaces 112.83 What requirements apply regarding
with microorganisms of public health grazing animals, working animals, and
significance? animal intrusion?
112.84 Does this regulation require covered
Subpart E—Agricultural Water farms to take actions that would con-
stitute a ‘‘taking’’ of threatened or en-
112.41 What requirements apply to the qual- dangered species; to take measures to ex-
ity of agricultural water?
clude animals from outdoor growing
112.42 What requirements apply to my agri- areas; or to destroy animal habitat or
cultural water sources, water distribu-
otherwise clear farm borders around out-
tion system, and pooling of water?
door growing areas or drainages?
112.43 What requirements apply to treating
agricultural water?
Subpart J—[Reserved]
112.44 What specific microbial quality cri-
teria apply to agricultural water used for
Subpart K—Growing, Harvesting, Packing,
certain intended uses?
112.45 What measures must I take if my ag-
and Holding Activities
ricultural water does not meet the re- 112.111 What measures must I take if I grow,
quirements of § 112.41 or § 112.44? harvest, pack or hold both covered and
112.46 How often must I test agricultural excluded produce?
water that is subject to the requirements
112.112 What measures must I take imme-
of § 112.44?
diately prior to and during harvest ac-
112.47 Who must perform the tests required
tivities?
under § 112.46 and what methods must be
used? 112.113 How must I handle harvested cov-
112.48 What measures must I take for water ered produce during covered activities?
that I use during harvest, packing, and 112.114 What requirements apply to dropped
holding activities for covered produce? covered produce?
112.49 What alternatives may I establish 112.115 What measures must I take when
and use in lieu of the requirements of packaging covered produce?
this subpart? 112.116 What measures must I take when

112.50 Under this subpart, what require- using food-packing (including food pack-
ments apply regarding records? aging) material?
284
Subpart L—Equipment, Tools, Buildings, Subpart N—Analytical Methods

and Sanitation
112.151 What methods must I use to test the
112.121 What equipment and tools are sub- quality of water to satisfy the require-
ject to the requirements of this subpart? ments of § 112.46?
112.122 What buildings are subject to the re- 112.152 What methods must I use to test the
quirements of this subpart? growing, harvesting, packing, and hold-
112.123 What requirements apply regarding ing environment for Listeria species or L.
equipment and tools subject to this sub- monocytogenes to satisfy the require-
part? ments of § 112.144(a)?
112.124 What requirements apply to instru- 112.153 What methods must I use to test
ments and controls used to measure, reg- spent sprout irrigation water (or sprouts)
ulate, or record? from each production batch of sprouts
112.125 What requirements apply to equip- for pathogens to satisfy the requirements
ment that is subject to this subpart used of § 112.144(b) and (c)?
in the transport of covered produce?
112.126 What requirements apply to my Subpart O—Records
buildings?
112.161 What general requirements apply to
112.127 What requirements apply regarding
records required under this part?
domesticated animals in and around a
112.162 Where must I store records?
fully-enclosed building?
112.163 May I use existing records to satisfy
112.128 What requirements apply regarding
the requirements of this part?
pest control in buildings?
112.164 How long must I keep records?
112.129 What requirements apply to toilet
112.165 What formats are acceptable for the
facilities?
records I keep?
112.130 What requirements apply for hand-
112.166 What requirements apply for making
washing facilities?
records available and accessible to FDA?
112.131 What must I do to control and dis-
112.167 Can records that I provide to FDA be
pose of sewage?
disclosed to persons outside of FDA?
112.132 What must I do to control and dis-
pose of trash, litter, and waste in areas Subpart P—Variances
used for covered activities?
112.133 What requirements apply to plumb- 112.171 Who may request a variance from
ing? the requirements of this part?
112.134 What must I do to control animal 112.172 How may a State, tribe, or foreign
excreta and litter from domesticated ani- country request a variance from one or
mals that are under my control? more requirements of this part?
112.140 Under this subpart, what require- 112.173 What must be included in the State-
ments apply regarding records? ment of Grounds in a petition requesting
a variance?
Subpart M—Sprouts 112.174 What information submitted in a pe-
tition requesting a variance or submitted
112.141 What commodities are subject to in comments on such a petition are pub-
this subpart? licly available?
112.142 What requirements apply to seeds or 112.175 Who responds to a petition request-
beans used to grow sprouts? ing a variance?
112.143 What measures must I take for 112.176 What process applies to a petition
growing, harvesting, packing, and hold- requesting a variance?
ing sprouts? 112.177 Can an approved variance apply to
112.144 What testing must I do during grow- any person other than those identified in
ing, harvesting, packing, and holding the petition requesting that variance?
sprouts? 112.178 Under what circumstances may FDA
112.145 What requirements apply to testing deny a petition requesting a variance?
the environment for Listeria species or L. 112.179 When does a variance approved by
monocytogenes? FDA become effective?
112.146 What actions must I take if the 112.180 Under what circumstances may FDA
growing, harvesting, packing, or holding modify or revoke an approved variance?
environment tests positive for Listeria 112.181 What procedures apply if FDA deter-
species or L. monocytogenes? mines that an approved variance should
112.147 What must I do to collect and test be modified or revoked?
samples of spent sprout irrigation water 112.182 What are the permissible types of
or sprouts for pathogens? variances that may be granted?
112.148 What actions must I take if the sam-
ples of spent sprout irrigation water or
Subpart Q—Compliance and Enforcement

sprouts test positive for a pathogen?
112.150 Under this subpart, what require- 112.192 What is the applicability and status
ments apply regarding records? of this part?
285
§ 112.1 21 CFR Ch. I (4–1–16 Edition)
112.193 What are the provisions for coordi- dos, babacos, bananas, Belgian endive,
nation of education and enforcement? blackberries, blueberries, boysen-
berries, brazil nuts, broad beans, broc-
Subpart R—Withdrawal of Qualified
coli, Brussels sprouts, burdock, cab-
Exemption
bages, Chinese cabbages (Bok Choy,
112.201 Under what circumstances can FDA mustard, and Napa), cantaloupes,
withdraw a qualified exemption in ac- carambolas, carrots, cauliflower,
cordance with the requirements of § 112.5? celeriac, celery, chayote fruit, cherries
112.202 What procedure will FDA use to
withdraw an exemption?
(sweet), chestnuts, chicory (roots and
112.203 What information must FDA include tops), citrus (such as clementine,
in an order to withdraw a qualified ex- grapefruit, lemons, limes, mandarin,
emption? oranges, tangerines, tangors, and uniq
112.204 What must I do if I receive an order fruit), cowpea beans, cress-garden, cu-
to withdraw a qualified exemption appli- cumbers, curly endive, currants, dan-
cable to my farm?
delion leaves, fennel-Florence, garlic,
112.205 Can I appeal or request a hearing on
an order to withdraw a qualified exemp- genip, gooseberries, grapes, green
tion applicable to my farm? beans, guavas, herbs (such as basil,
112.206 What is the procedure for submitting chives, cilantro, oregano, and parsley),
an appeal? honeydew, huckleberries, Jerusalem
112.207 What is the procedure for requesting artichokes, kale, kiwifruit, kohlrabi,
an informal hearing? kumquats, leek, lettuce, lychees, mac-
112.208 What requirements are applicable to
an informal hearing?
adamia nuts, mangos, other melons
112.209 Who is the presiding officer for an (such as Canary, Crenshaw and Per-
appeal and for an informal hearing? sian), mulberries, mushrooms, mustard
112.210 What is the timeframe for issuing a greens, nectarines, onions, papayas,
decision on an appeal? parsnips, passion fruit, peaches, pears,
112.211 When is an order to withdraw a peas, peas-pigeon, peppers (such as bell
qualified exemption applicable to a farm
and hot), pine nuts, pineapples, plan-
revoked?
112.213 If my qualified exemption is with- tains, plums, plumcots, quince, rad-
drawn, under what circumstances would ishes, raspberries, rhubarb, rutabagas,
FDA reinstate my qualified exemption? scallions, shallots, snow peas, soursop,
AUTHORITY: 21 U.S.C. 321, 331, 342, 350h, 371;
spinach, sprouts (such as alfalfa and
42 U.S.C. 243, 264, 271. mung bean), strawberries, summer
squash (such as patty pan, yellow and
SOURCE: 80 FR 74547, Nov. 27, 2015, unless
zucchini), sweetsop, Swiss chard, taro,
otherwise noted.
tomatoes, turmeric, turnips (roots and
tops), walnuts, watercress, water-
Subpart A—General Provisions melons, and yams; and
§ 112.1 What food is covered by this (2) Mixes of intact fruits and vegeta-
part? bles (such as fruit baskets).
(a) Unless it is excluded from this § 112.2 What produce is not covered by
part under § 112.2, food that is produce this part?
within the meaning of this part and
that is a raw agricultural commodity (a) The following produce is not cov-
(RAC) is covered by this part. This in- ered by this part:
cludes a produce RAC that is grown do- (1) Produce that is rarely consumed
mestically and a produce RAC that will raw, specifically the produce on the
be imported or offered for import in following exhaustive list: Asparagus;
any State or territory of the United beans, black; beans, great Northern;
States, the District of Columbia, or the beans, kidney; beans, lima; beans,
Commonwealth of Puerto Rico. navy; beans, pinto; beets, garden (roots
(b) For the purpose of this part and and tops); beets, sugar; cashews; cher-
subject to the exemptions and qualified ries, sour; chickpeas; cocoa beans; cof-
exemptions therein, covered produce fee beans; collards; corn, sweet; cran-
includes all of the following: berries; dates; dill (seeds and weed);
(1) Fruits and vegetables such as al- eggplants; figs; ginger; hazelnuts;
monds, apples, apricots, apriums, Arti- horseradish; lentils; okra; peanuts; pe-
chokes-globe-type, Asian pears, avoca- cans; peppermint; potatoes; pumpkins;
286
squash, winter; sweet potatoes; and (A) Will disclose in documents ac-
water chestnuts. companying the food, in accordance
(2) Produce that is produced by an in- with the practice of the trade, that the
dividual for personal consumption or food is ‘‘not processed to adequately re-
produced for consumption on the farm duce the presence of microorganisms of
or another farm under the same man- public health significance’’; and
agement; and (B) Will only sell to another entity
(3) Produce that is not a raw agricul- that agrees, in writing, it will either:
tural commodity. (1) Follow procedures (identified in a
(b) Produce is eligible for exemption written assurance) that adequately re-
from the requirements of this part (ex- duce the presence of microorganisms of
cept as noted in paragraphs (b)(1), (2), public health significance; or
and (3) of this section) under the fol- (2) Obtain a similar written assur-
lowing conditions: ance from its customer that the
(1) The produce receives commercial produce will receive commercial proc-
processing that adequately reduces the essing described in paragraph (b)(1) of
presence of microorganisms of public this section, and that there will be dis-
health significance. Examples of com- closure in documents accompanying
mercial processing that adequately re- the food, in accordance with the prac-
duces the presence of microorganisms tice of the trade, that the food is ‘‘not
of public health significance are proc- processed to adequately reduce the
essing in accordance with the require- presence of microorganisms of public
ments of part 113, 114, or 120 of this health significance’’; and
chapter, treating with a validated proc- (4) You must establish and maintain
ess to eliminate spore-forming micro- documentation of your compliance
organisms (such as processing to with applicable requirements in para-
produce tomato paste or shelf-stable graphs (b)(2) and (3) in accordance with
tomatoes), and processing such as re- the requirements of subpart O of this
fining, distilling, or otherwise manu- part, including:
facturing/processing produce into prod- (i) Documents containing disclosures
ucts such as sugar, oil, spirits, wine, required under paragraph (b)(2) of this
beer or similar products; and section; and
(2) You must disclose in documents
(ii) Annual written assurances ob-
accompanying the produce, in accord-
tained from customers required under
ance with the practice of the trade,
paragraph (b)(3) of this section; and
that the food is ‘‘not processed to ade-
quately reduce the presence of micro- (5) The requirements of this subpart
organisms of public health signifi- and subpart Q of this part apply to
cance;’’ and such produce; and
(3) You must either: (6) An entity that provides a written
(i) Annually obtain written assur- assurance under § 112.2(b)(3)(i) or (ii)
ance, subject to the requirements of must act consistently with the assur-
paragraph (b)(6) of this section, from ance and document its actions taken to
the customer that performs the com- satisfy the written assurance.
mercial processing described in para-
§ 112.3 What definitions apply to this
graph (b)(1) of this section that the part?
customer has established and is fol-
lowing procedures (identified in the (a) The definitions and interpreta-
written assurance) that adequately re- tions of terms in section 201 of the Fed-
duce the presence of microorganisms of eral Food, Drug, and Cosmetic Act
public health significance; or apply to such terms when used in this
(ii) Annually obtain written assur- part.
ance, subject to the requirements of (b) For the purpose of this part, the
paragraph (b)(6) of this section, from following definitions of very small
your customer that an entity in the business and small business also apply:
distribution chain subsequent to the (1) Very small business. For the pur-
customer will perform commercial pose of this part, your farm is a very
processing described in paragraph (b)(1) small business if it is subject to any of
of this section and that the customer: the requirements of this part and, on a
287
§ 112.3 21 CFR Ch. I (4–1–16 Edition)
rolling basis, the average annual mone- used for preventing dehydration of cov-
tary value of produce (as defined in ered produce).
paragraph (c) of this section) you sold Animal excreta means solid or liquid
during the previous 3-year period is no animal waste.
more than $250,000. Application interval means the time
(2) Small business. For the purpose of interval between application of an ag-
this part, your farm is a small business ricultural input (such as a biological
if it is subject to any of the require- soil amendment of animal origin) to a
ments of this part and, on a rolling growing area and harvest of covered
basis, the average annual monetary produce from the growing area where
value of produce (as defined in para- the agricultural input was applied.
graph (c) of this section) you sold dur- Biological soil amendment means any
ing the previous 3-year period is no soil amendment containing biological
more than $500,000; and your farm is materials such as stabilized compost,
not a very small business as provided manure, non-fecal animal byproducts,
in paragraph (b)(1) of this section. peat moss, pre-consumer vegetative
(c) For the purpose of this part, the waste, sewage sludge biosolids, table
following definitions also apply: waste, agricultural tea, or yard trim-
Adequate means that which is needed mings, alone or in combination.
to accomplish the intended purpose in Biological soil amendment of animal ori-
keeping with good public health prac- gin means a biological soil amendment
tice. which consists, in whole or in part, of
Adequately reduce microorganisms of materials of animal origin, such as ma-
public health significance means reduce nure or non-fecal animal byproducts
the presence of such microorganisms to including animal mortalities, or table
an extent sufficient to prevent illness. waste, alone or in combination. The
Agricultural tea means a water ex- term ‘‘biological soil amendment of
tract of biological materials (such as animal origin’’ does not include any
stabilized compost, manure, non-fecal form of human waste.
animal byproducts, peat moss, pre-con- Composting means a process to
sumer vegetative waste, table waste, or produce stabilized compost in which or-
yard trimmings), excluding any form of ganic material is decomposed by the
human waste, produced to transfer mi- actions of microorganisms under
crobial biomass, fine particulate or- thermophilic conditions for a des-
ganic matter, and soluble chemical ignated period of time (for example, 3
components into an aqueous phase. Ag- days) at a designated temperature (for
ricultural teas are held for longer than example, 131 °F (55 °C)), followed by a
one hour before application. Agricul- curing stage under cooler conditions.
tural teas are soil amendments for the Covered activity means growing, har-
purposes of this rule. vesting, packing, or holding covered
Agricultural tea additive means a nu- produce on a farm. Covered activity in-
trient source (such as molasses, yeast cludes manufacturing/processing of
extract, or algal powder) added to agri- covered produce on a farm, but only to
cultural tea to increase microbial bio- the extent that such activities are per-
mass. formed on raw agricultural commod-
Agricultural water means water used ities and only to the extent that such
in covered activities on covered activities are within the meaning of
produce where water is intended to, or ‘‘farm’’ as defined in this chapter. Pro-
is likely to, contact covered produce or viding, acting consistently with, and
food contact surfaces, including water documenting actions taken in compli-
used in growing activities (including ance with written assurances as de-
irrigation water applied using direct scribed in § 112.2(b) are also covered ac-
water application methods, water used tivities. This part does not apply to ac-
for preparing crop sprays, and water tivities of a facility that are subject to
used for growing sprouts) and in har- part 110 of this chapter.
vesting, packing, and holding activities Covered produce means produce that
(including water used for washing or is subject to the requirements of this
cooling harvested produce and water part in accordance with §§ 112.1 and
288
112.2. The term ‘‘covered produce’’ re- (ii) Treatment to manipulate the rip-
fers to the harvestable or harvested ening of raw agricultural commodities
part of the crop. (such as by treating produce with
Curing means the final stage of ethylene gas), and packaging and label-
composting, which is conducted after ing treated raw agricultural commod-
much of the readily metabolized bio- ities, without additional manufac-
logical material has been decomposed, turing/processing; and
at cooler temperatures than those in (iii) Packaging and labeling raw agri-
the thermophilic phase of composting, cultural commodities, when these ac-
to further reduce pathogens, promote tivities do not involve additional man-
further decomposition of cellulose and ufacturing/processing (an example of
lignin, and stabilize composition. Cur- additional manufacturing/processing is
ing may or may not involve insulation, irradiation); or
depending on environmental condi- (ii) Secondary Activities Farm. A Sec-
tions. ondary Activities Farm is an oper-
Direct water application method means ation, not located on a Primary Pro-
using agricultural water in a manner duction Farm, devoted to harvesting
whereby the water is intended to, or is (such as hulling or shelling), packing,
likely to, contact covered produce or and/or holding of raw agricultural com-
food contact surfaces during use of the modities, provided that the Primary
water. Production Farm(s) that grows, har-
Farm means: vests, and/or raises the majority of the
(i) Primary Production Farm. A Pri- raw agricultural commodities har-
mary Production Farm is an operation vested, packed, and/or held by the Sec-
under one management in one general ondary Activities Farm owns, or joint-
(but not necessarily contiguous) phys- ly owns, a majority interest in the Sec-
ical location devoted to the growing of ondary Activities Farm. A Secondary
crops, the harvesting of crops, the rais- Activities Farm may also conduct
ing of animals (including seafood), or those additional activities allowed on a
any combination of these activities. Primary Production Farm in para-
The term ‘‘farm’’ includes operations graphs (i)(B) and (C) of this definition.
that, in addition to these activities: Food means food as defined in section
(A) Pack or hold raw agricultural 201(f) of the Federal Food, Drug, and
commodities; Cosmetic Act and includes seeds and
(B) Pack or hold processed food, pro- beans used to grow sprouts.
vided that all processed food used in Food contact surfaces means those
such activities is either consumed on surfaces that contact human food and
that farm or another farm under the those surfaces from which drainage, or
same management, or is processed food other transfer, onto the food or onto
identified in paragraph (i)(C)(2)(i) of surfaces that contact the food ordi-
this definition; and narily occurs during the normal course
(C) Manufacture/process food, proof operations. ‘‘Food contact surfaces’’
vided that: includes food contact surfaces of equip-
(1) All food used in such activities is ment and tools used during harvest,
consumed on that farm or another packing and holding.
farm under the same management; or Ground water means the supply of
(2) Any manufacturing/processing of fresh water found beneath the Earth’s
food that is not consumed on that farm surface, usually in aquifers, which sup-
or another farm under the same man- ply wells and springs. Ground water
agement consists only of: does not include any water that meets
(i) Drying/dehydrating raw agricul- the definition of surface water.
tural commodities to create a distinct Growth media means material that
commodity (such as drying/dehy- acts as a substrate during the growth
drating grapes to produce raisins), and of covered produce (such as mushrooms
packaging and labeling such commod- and some sprouts) that contains, may
ities, without additional manufac- contain, or consists of components that
turing/processing (an example of addi- may include any animal waste (such as
tional manufacturing/processing is stabilized compost, manure, non-fecal
slicing); animal byproducts or table waste).
289
§ 112.3 21 CFR Ch. I (4–1–16 Edition)
Harvesting applies to farms and farm known to be, or has the potential to be,
mixed-type facilities and means activi- associated with the farm or the food.
ties that are traditionally performed Manufacturing/processing means mak-
on farms for the purpose of removing ing food from one or more ingredients,
raw agricultural commodities from the or synthesizing, preparing, treating,
place they were grown or raised and modifying or manipulating food, in-
preparing them for use as food. Har- cluding food crops or ingredients. Ex-
vesting is limited to activities per- amples of manufacturing/processing ac-
formed on raw agricultural commod- tivities include: Baking, boiling, bot-
ities, or on processed foods created by tling, canning, cooking, cooling, cut-
drying/dehydrating a raw agricultural ting, distilling, drying/dehydrating raw
commodity without additional manu- agricultural commodities to create a
facturing/processing, on a farm. Har-
distinct commodity (such as drying/de-
vesting does not include activities that
hydrating grapes to produce raisins),
transform a raw agricultural com-
evaporating, eviscerating, extracting
modity into a processed food as defined
juice, formulating, freezing, grinding,
in section 201(gg) of the Federal Food,
Drug, and Cosmetic Act. Examples of homogenizing, labeling, milling, mix-
harvesting include cutting (or other- ing, packaging (including modified at-
wise separating) the edible portion of mosphere packaging), pasteurizing,
the raw agricultural commodity from peeling, rendering, treating to manipu-
the crop plant and removing or trim- late ripening, trimming, washing, or
ming part of the raw agricultural com- waxing. For farms and farm mixed-type
modity (e.g., foliage, husks, roots or facilities, manufacturing/processing
stems). Examples of harvesting also in- does not include activities that are
clude cooling, field coring, filtering, part of harvesting, packing, or holding.
gathering, hulling, removing stems and Manure means animal excreta, alone
husks from, shelling, sifting, threshing, or in combination with litter (such as
trimming of outer leaves of, and wash- straw and feathers used for animal bed-
ing raw agricultural commodities ding) for use as a soil amendment.
grown on a farm. Microorganisms means yeasts, molds,
Hazard means any biological agent bacteria, viruses, protozoa, and micro-
that has the potential to cause illness scopic parasites and includes species
or injury in the absence of its control. having public health significance. The
Holding means storage of food and term ‘‘undesirable microorganisms’’ in-
also includes activities performed inci- cludes those microorganisms that are
dental to storage of a food (e.g., activi- of public health significance, that sub-
ties performed for the safe or effective ject food to decomposition, that indi-
storage of that food, such as fumigat- cate that food is contaminated with
ing food during storage, and drying/de- filth, or that otherwise may cause food
hydrating raw agricultural commod-
to be adulterated.
ities when the drying/dehydrating does
not create a distinct commodity (such Mixed-type facility means an estab-
as drying/dehydrating hay or alfalfa)). lishment that engages in both activi-
Holding also includes activities per- ties that are exempt from registration
formed as a practical necessity for the under section 415 of the Federal Food,
distribution of that food (such as Drug, and Cosmetic Act and activities
blending of the same raw agricultural that require the establishment to be
commodity and breaking down pallets), registered. An example of such a facil-
but does not include activities that ity is a ‘‘farm mixed-type facility,’’
transform a raw agricultural com- which is an establishment that is a
modity into a processed food as defined farm, but that also conducts activities
in section 201(gg) of the Federal Food, outside the farm definition that re-
Drug, and Cosmetic Act. Holding facili- quire the establishment to be reg-
ties could include warehouses, cold istered.
storage facilities, storage silos, grain Monitor means to conduct a planned
elevators, and liquid storage tanks. sequence of observations or measure-

Known or reasonably foreseeable haz- ments to assess whether a process,
ard means a biological hazard that is point or procedure is under control
290
and, when required, to produce an ac- the edible reproductive body of a seed
curate record of the observation or plant or tree nut (such as apple, or-
measurement. ange, and almond) such that fruit
Non-fecal animal byproduct means means the harvestable or harvested
solid waste (other than manure) that is part of a plant developed from a flower.
animal in origin (such as meat, fat, A vegetable is the edible part of an her-
dairy products, eggs, carcasses, blood baceous plant (such as cabbage or po-
meal, bone meal, fish meal, shellfish tato) or fleshy fruiting body of a fun-
waste (such as crab, shrimp, and lob- gus (such as white button or shiitake)
ster waste), fish emulsions, and offal) grown for an edible part such that veg-
and is generated by commercial, insti- etable means the harvestable or har-
tutional, or agricultural operations. vested part of any plant or fungus
Packing means placing food into a whose fruit, fleshy fruiting bodies,
container other than packaging the seeds, roots, tubers, bulbs, stems,
food and also includes activities per- leaves, or flower parts are used as food
formed incidental to packing a food and includes mushrooms, sprouts, and
(e.g., activities performed for the safe herbs (such as basil or cilantro).
or effective packing of that food (such Produce does not include food grains
as sorting, culling, grading, and weigh- meaning the small, hard fruits or seeds
ing or conveying incidental to packing of arable crops, or the crops bearing
or re-packing)), but does not include these fruits or seeds, that are primarily
activities that transform a raw agricul- grown and processed for use as meal,
tural commodity, as defined in section flour, baked goods, cereals and oils
201(r) of the Federal Food, Drug, and rather than for direct consumption as
Cosmetic Act, into a processed food as small, hard fruits or seeds (including
defined in section 201(gg) of the Federal cereal grains, pseudo cereals, oilseeds
Food, Drug, and Cosmetic Act. and other plants used in the same fash-
Pest means any objectionable ani- ion). Examples of food grains include
mals or insects, including birds, ro- barley, dent- or flint-corn, sorghum,
dents, flies, and larvae. oats, rice, rye, wheat, amaranth,
Pre-consumer vegetative waste means quinoa, buckwheat, and oilseeds (e.g.,
solid waste that is purely vegetative in cotton seed, flax seed, rapeseed, soy-
origin, not considered yard trash, and bean, and sunflower seed).
derived from commercial, institu- Production batch of sprouts means all
tional, or agricultural operations with-
sprouts that are started at the same
out coming in contact with animal
time in a single growing unit (e.g., a
products, byproducts or manure or
single drum or bin, or a single rack of
with an end user (consumer). Pre-con-
trays that are connected to each
sumer vegetative waste includes mate-
other), whether or not the sprouts are
rial generated by farms, packing
grown from a single lot of seed (includ-
houses, canning operations, wholesale
ing, for example, when multiple types
distribution centers and grocery stores;
of seeds are grown in a single growing
products that have been removed from
unit).
their packaging (such as out-of-date
juice, vegetables, condiments, and Qualified end-user, with respect to a
bread); and associated packaging that food, means the consumer of the food
is vegetative in origin (such as paper or (where the term consumer does not in-
corn-starch based products). Pre-conclude a business); or a restaurant or re-
sumer vegetative waste does not in- tail food establishment (as those terms
clude table waste, packaging that has are defined in § 1.227) that is located:
come in contact with materials (such (i) In the same State or the same In-
as meat) that are not vegetative in ori- dian reservation as the farm that pro-
gin, or any waste generated by res- duced the food; or
taurants. (ii) Not more than 275 miles from
Produce means any fruit or vegetable such farm.
(including mixes of intact fruits and Raw agricultural commodity (RAC)
vegetables) and includes mushrooms, means ‘‘raw agricultural commodity’’

sprouts (irrespective of seed source), as defined in section 201(r) of the Fed-
peanuts, tree nuts, and herbs. A fruit is eral Food, Drug, and Cosmetic Act.
291
§ 112.4 21 CFR Ch. I (4–1–16 Edition)
Sanitize means to adequately treat estuaries, etc.) and all springs, wells,
cleaned surfaces by a process that is ef- or other collectors that are directly in-
fective in destroying vegetative cells of fluenced by surface water.
microorganisms of public health sig- Table waste means any post-consumer
nificance, and in substantially reduc- food waste, irrespective of whether the
ing numbers of other undesirable source material is animal or vegetative
microorganisms, but without adversely in origin, derived from individuals, in-
affecting the product or its safety for stitutions, restaurants, retail oper-
the consumer. ations, or other sources where the food
Sewage sludge biosolids means the has been served to a consumer.
solid or semi-solid residue generated Turned composting means a process to
during the treatment of domestic sew- produce stabilized compost in which air
age in a treatment works within the is introduced into biological material
meaning of the definition of ‘‘sewage (in a pile, row, or enclosed vessel) by
sludge’’ in 40 CFR 503.9(w). turning on a regular basis. Turning is
Soil amendment means any chemical, the process of mechanically mixing bi-
biological, or physical material (such ological material that is undergoing a
as elemental fertilizers, stabilized com- composting process with the specific
post, manure, non-fecal animal byprod- intention of moving the outer, cooler
ucts, peat moss, perlite, pre-consumer sections of the material being
vegetative waste, sewage sludge bio- composted to the inner, hotter sec-
solids, table waste, agricultural tea tions.
and yard trimmings) intentionally Visitor means any person (other than
added to the soil to improve the chem- personnel) who enters your covered
ical or physical condition of soil in re- farm with your permission.
lation to plant growth or to improve Water distribution system means a sys-
the capacity of the soil to hold water. tem to carry water from its primary
The term soil amendment also includes source to its point of use, including
growth media that serve as the entire pipes, sprinklers, irrigation canals,
substrate during the growth of covered pumps, valves, storage tanks, res-
produce (such as mushrooms and some ervoirs, meters, and fittings.
sprouts). We means the U.S. Food and Drug
Spent sprout irrigation water means Administration (FDA).
water that has been used in the grow- Yard trimmings means purely vegeta-
ing of sprouts. tive matter resulting from landscaping
Stabilized compost means a stabilized maintenance or land clearing oper-
(i.e., finished) biological soil amend- ations, including materials such as tree
ment produced through a controlled and shrub trimmings, grass clippings,
composting process. palm fronds, trees, tree stumps, un-
Static composting means a process to treated lumber, untreated wooden pal-
produce stabilized compost in which air lets, and associated rocks and soils.
is introduced into biological material You, for purposes of this part, means
(in a pile (or row) that may or may not the owner, operator, or agent in charge
be covered with insulating material, or of a covered farm that is subject to
in an enclosed vessel) by a mechanism some or all of the requirements of this
that does not include turning. Exam- part.
ples of structural features for intro-
ducing air include embedded perforated § 112.4 Which farms are subject to the
pipes and a constructed permanent requirements of this part?
base that includes aeration slots. Ex- (a) Except as provided in paragraph
amples of mechanisms for introducing (b) of this section, a farm or farm
air include passive diffusion and me- mixed-type facility with an average an-
chanical means (such as blowers that nual monetary value of produce (as
suction air from the composting mate- ‘‘produce’’ is defined in § 112.3(c)) sold
rial or blow air into the composting during the previous 3-year period of
material using positive pressure). more than $25,000 (on a rolling basis),
Surface water means all water open to adjusted for inflation using 2011 as the
the atmosphere (rivers, lakes, res- baseline year for calculating the ad-
ervoirs, streams, impoundments, seas, justment, is a ‘‘covered farm’’ subject
292
to this part. Covered farms subject to (1) When a food packaging label is re-
this part must comply with all applica- quired on food that would otherwise be
ble requirements of this part when con- covered produce under the Federal
ducting a covered activity on covered Food, Drug, and Cosmetic Act or its
produce. implementing regulations, you must
(b) A farm is not a covered farm if it include prominently and conspicuously
satisfies the requirements in § 112.5 and on the food packaging label the name
we have not withdrawn the farm’s ex- and the complete business address of
emption in accordance with the re- the farm where the produce was grown.
quirements of subpart R of this part.
(2) When a food packaging label is
§ 112.5 Which farms are eligible for a not required on food that would other-
qualified exemption and associated wise be covered produce under the Fed-
modified requirements based on av- eral Food, Drug, and Cosmetic Act, you
erage monetary value of all food must prominently and conspicuously
sold and direct farm marketing? display, at the point of purchase, the
(a) A farm is eligible for a qualified name and complete business address of
exemption and associated modified re- the farm where the produce was grown,
quirements in a calendar year if: on a label, poster, sign, placard, or doc-
(1) During the previous 3-year period uments delivered contemporaneously
preceding the applicable calendar year, with the produce in the normal course
the average annual monetary value of of business, or, in the case of Internet
the food (as defined in § 112.3(c)) the sales, in an electronic notice.
farm sold directly to qualified end-
(3) The complete business address
users (as defined in § 112.3(c)) during
that you must include in accordance
such period exceeded the average an-
with the requirements of paragraph
nual monetary value of the food the
farm sold to all other buyers during (b)(1) or (2) of this section must include
that period; and the street address or post office box,
(2) The average annual monetary city, state, and zip code for domestic
value of all food (as defined in § 112.3(c)) farms, and comparable full address in-
the farm sold during the 3-year period formation for foreign farms.
preceding the applicable calendar year
was less than $500,000, adjusted for in- § 112.7 What records must I establish
and keep if my farm is eligible for a
flation.
qualified exemption in accordance
(b) For the purpose of determining with § 112.5?
whether the average annual monetary
value of all food sold during the 3-year If your farm is eligible for a qualified
period preceding the applicable cal- exemption in accordance with § 112.5:
endar year was less than $500,000, ad- (a) You must establish and keep
justed for inflation, the baseline year records required under this provision in
for calculating the adjustment for in- accordance with the requirements of
flation is 2011. subpart O of this part, except that the
requirement in § 112.161(a)(4) for a sig-
§ 112.6 What modified requirements nature or initial of the person per-
apply to me if my farm is eligible
for a qualified exemption in accord- forming the activity is not required for
ance with § 112.5? sales receipts kept in the normal
course of business. Such receipts must
(a) If your farm is eligible for a quali-
be dated as required under
fied exemption in accordance with
§ 112.161(a)(4).
§ 112.5, you are subject to the require-
ments of: (b) You must establish and keep ade-
(1) This subpart (General Provisions); quate records necessary to dem-
(2) Subpart O of this part (Records); onstrate that your farm satisfies the
(3) Subpart Q of this part (Compli- criteria for a qualified exemption that
ance and Enforcement); and are described in § 112.5, including a
(4) Subpart R of this part (With- written record reflecting that you have
drawal of Qualified Exemption). performed an annual review and

(b) In addition, you are subject to the verification of your farm’s continued
following modified requirements: eligibility for the qualified exemption.
293
§ 112.11 21 CFR Ch. I (4–1–16 Edition)
Subpart B—General Requirements Subpart C—Personnel

Qualifications and Training
§ 112.11 What general requirements
apply to persons who are subject to § 112.21 What requirements apply re-
this part? garding qualifications and training
for personnel who handle (contact)
You must take appropriate measures covered produce or food contact
to minimize the risk of serious adverse surfaces?
health consequences or death from the
use of, or exposure to, covered produce, All of the following requirements
apply regarding qualifications and
including those measures reasonably
training for personnel who handle (con-
necessary to prevent the introduction
tact) covered produce or food contact
of known or reasonably foreseeable
surfaces:
hazards into covered produce, and to
(a) All personnel (including tem-
provide reasonable assurances that the porary, part time, seasonal, and con-
produce is not adulterated under sec- tracted personnel) who handle covered
tion 402 of the Federal Food, Drug, and produce or food contact surfaces, or
Cosmetic Act on account of such haz- who are engaged in the supervision
ards. thereof, must receive adequate train-
ing, as appropriate to the person’s du-
§ 112.12 Are there any alternatives to ties, upon hiring, and periodically
the requirements established in this
part? thereafter, at least once annually.
(b) All personnel (including tem-
(a) You may establish alternatives to porary, part time, seasonal, and con-
certain specific requirements of sub- tracted personnel) who handle covered
part E of this part, as specified in produce or food contact surfaces, or
§ 112.49, provided that you satisfy the who are engaged in the supervision
requirements of paragraphs (b) and (c) thereof, must have a combination of
of this section. education, training, and experience
(b) You may establish and use an al- necessary to perform the person’s as-
ternative to any of the requirements signed duties in a manner that ensures
specified in paragraph (a) of this sec- compliance with this part.
tion, provided you have adequate sci- (c) Training must be conducted in a
entific data or information to support manner that is easily understood by
a conclusion that the alternative would personnel being trained.
provide the same level of public health (d) Training must be repeated as nec-
protection as the applicable require- essary and appropriate in light of ob-
ment established in this part, and servations or information indicating
would not increase the likelihood that that personnel are not meeting stand-
your covered produce will be adulter- ards established by FDA in subparts C
through O of this part.
ated under section 402 of the Federal
Food, Drug, and Cosmetic Act, in light § 112.22 What minimum requirements
of your covered produce, practices, and apply for training personnel who
conditions. conduct a covered activity?
(c) Scientific data and information (a) At a minimum, all personnel who
used to support an alternative to a re- handle (contact) covered produce dur-
quirement specified in paragraph (a) of ing covered activities or supervise the
this section may be developed by you, conduct of such activities must receive
available in the scientific literature, or training that includes all of the fol-
available to you through a third party. lowing:
You must establish and maintain docu- (1) Principles of food hygiene and
mentation of the scientific data and in- food safety;
formation on which you rely in accord- (2) The importance of health and per-
ance with the requirements of subpart sonal hygiene for all personnel and
O of this part. You are not required to visitors, including recognizing symp-
notify or seek prior approval from FDA toms of a health condition that is rea-
regarding your decision to establish or sonably likely to result in contamina-
use an alternative under this section. tion of covered produce or food contact
294
surfaces with microorganisms of public Subpart D—Health and Hygiene

health significance; and
(3) The standards established by FDA § 112.31 What measures must I take to
in subparts C through O of this part prevent ill or infected persons from
that are applicable to the employee’s contaminating covered produce
job responsibilities. with microorganisms of public
health significance?
(b) Persons who conduct harvest ac-
tivities for covered produce must also (a) You must take measures to pre-
receive training that includes all of the vent contamination of covered produce
following: and food contact surfaces with micro-
(1) Recognizing covered produce that organisms of public health significance
must not be harvested, including cov- from any person with an applicable
ered produce that may be contami- health condition (such as commu-
nated with known or reasonably fore- nicable illnesses that present a public
seeable hazards; health risk in the context of normal
(2) Inspecting harvest containers and work duties, infection, open lesion,
equipment to ensure that they are vomiting, or diarrhea).
functioning properly, clean, and main- (b) The measures you must take to
tained so as not to become a source of satisfy the requirements of paragraph
contamination of covered produce with (a) of this section must include all of
known or reasonably foreseeable haz- the following measures:
ards; and (1) Excluding any person from work-
(3) Correcting problems with harvest ing in any operations that may result
containers or equipment, or reporting in contamination of covered produce or
such problems to the supervisor (or food contact surfaces with microorga-
other responsible party), as appropriate nisms of public health significance
to the person’s job responsibilities. when the person (by medical examina-
(c) At least one supervisor or respon- tion, the person’s acknowledgement, or
sible party for your farm must have observation) is shown to have, or ap-
successfully completed food safety pears to have, an applicable health con-
training at least equivalent to that re- dition, until the person’s health condi-
ceived under standardized curriculum tion no longer presents a risk to public
recognized as adequate by the Food and health; and
Drug Administration. (2) Instructing personnel to notify
their supervisor(s) (or a responsible
§ 112.23 What requirements apply re- party) if they have, or if there is a rea-
garding supervisors? sonable possibility that they have an
You must assign or identify per- applicable health condition.
sonnel to supervise (or otherwise be re-
§ 112.32 What hygienic practices must
sponsible for) your operations to en-
personnel use?
sure compliance with the requirements
of this part. (a) Personnel who work in an oper-
ation in which covered produce or food
§ 112.30 Under this subpart, what re- contact surfaces are at risk of contami-
quirements apply regarding nation with known or reasonably fore-
records? seeable hazards must use hygienic
(a) You must establish and keep practices while on duty to the extent
records required under this subpart in necessary to protect against such con-
accordance with the requirements of tamination.
subpart O of this part. (b) The hygienic practices that per-
(b) You must establish and keep sonnel use to satisfy the requirements
records of training that document re- of paragraph (a) of this section when
quired training of personnel, including handling (contacting) covered produce
the date of training, topics covered, or food contact surfaces during a cov-
and the persons(s) trained. ered activity must include all of the
following practices:
295
§ 112.33 21 CFR Ch. I (4–1–16 Edition)
(1) Maintaining adequate personal ered produce and food contact surfaces
cleanliness to protect against contami- from contamination by people and take
nation of covered produce and food con- all steps reasonably necessary to en-
tact surfaces; sure that visitors comply with such
(2) Avoiding contact with animals policies and procedures.
other than working animals, and tak- (b) You must make toilet and hand-
ing appropriate steps to minimize the washing facilities accessible to visi-
likelihood of contamination of covered tors.
produce when in direct contact with
working animals;
(3) Washing hands thoroughly, in- Subpart E—Agricultural Water
cluding scrubbing with soap (or other
effective surfactant) and running water § 112.41 What requirements apply to
the quality of agricultural water?
that satisfies the requirements of
§ 112.44(a) (as applicable) for water used All agricultural water must be safe
to wash hands, and drying hands thor- and of adequate sanitary quality for its
oughly using single-service towels, san- intended use.
itary towel service, electric hand dry-
ers, or other adequate hand drying de- § 112.42 What requirements apply to
vices: my agricultural water sources,
(i) Before starting work; water distribution system, and pool-
(ii) Before putting on gloves; ing of water?
(iii) After using the toilet; (a) At the beginning of a growing sea-
(iv) Upon return to the work station son, as appropriate, but at least once
after any break or other absence from annually, you must inspect all of your
the work station; agricultural water systems, to the ex-
(v) As soon as practical after touch- tent they are under your control (in-
ing animals (including livestock and cluding water sources, water distribu-
working animals), or any waste of ani- tion systems, facilities, and equip-
mal origin; and ment), to identify conditions that are
(vi) At any other time when the reasonably likely to introduce known
hands may have become contaminated
or reasonably foreseeable hazards into
in a manner that is reasonably likely
or onto covered produce or food con-
to lead to contamination of covered
tact surfaces in light of your covered
produce with known or reasonably
foreseeable hazards; produce, practices, and conditions, in-
(4) If you choose to use gloves in han- cluding consideration of the following:
dling covered produce or food contact (1) The nature of each agricultural
surfaces, maintaining gloves in an in- water source (for example, ground
tact and sanitary condition and replac- water or surface water);
ing such gloves when no longer able to (2) The extent of your control over
do so; each agricultural water source;
(5) Removing or covering hand jew- (3) The degree of protection of each
elry that cannot be adequately cleaned agricultural water source;
and sanitized during periods in which (4) Use of adjacent and nearby land;
covered produce is manipulated by and
hand; and (5) The likelihood of introduction of
(6) Not eating, chewing gum, or using known or reasonably foreseeable haz-
tobacco products in an area used for a ards to agricultural water by another
covered activity (however, drinking user of agricultural water before the
beverages is permitted in designated water reaches your covered farm.
areas).
(b) You must adequately maintain all
§ 112.33 What measures must I take to agricultural water distribution sys-
prevent visitors from contami- tems to the extent they are under your
nating covered produce and food control as necessary and appropriate to
contact surfaces with microorga- prevent the water distribution system
nisms of public health significance? from being a source of contamination

(a) You must make visitors aware of to covered produce, food contact sur-
policies and procedures to protect cov- faces, areas used for a covered activity,
296
or water sources, including by regu- (b) You must monitor any treatment
larly inspecting and adequately storing of agricultural water at a frequency
all equipment used in the system. adequate to ensure that the treated
(c) You must adequately maintain all water is consistently safe and of ade-
agricultural water sources to the ex- quate sanitary quality for its intended
tent they are under your control (such use and/or consistently meets the rel-
as wells). Such maintenance includes evant microbial quality criteria in
regularly inspecting each source to § 112.44, as applicable.
identify any conditions that are rea-
sonably likely to introduce known or § 112.44 What specific microbial qual-
reasonably foreseeable hazards into or ity criteria apply to agricultural
onto covered produce or food contact water used for certain intended
surfaces; correcting any significant de- uses?
ficiencies (e.g., repairs to well cap, well (a) When you use agricultural water
casing, sanitary seals, piping tanks and for any one or more of these following
treatment equipment, and control of
purposes, you must ensure there is no
cross-connections); and keeping the
detectable generic Escherichia coli (E.
source free of debris, trash, domes-
ticated animals, and other possible coli) in 100 milliliters (mL) of agricul-
sources of contamination of covered tural water, and you must not use un-
produce to the extent practicable and treated surface water for any of these
appropriate under the circumstances. purposes:
(d) As necessary and appropriate, you (1) Used as sprout irrigation water;
must implement measures reasonably (2) Applied in any manner that di-
necessary to reduce the potential for rectly contacts covered produce during
contamination of covered produce with or after harvest activities (for example,
known or reasonably foreseeable haz- water that is applied to covered
ards as a result of contact of covered produce for washing or cooling activi-
produce with pooled water. For exam- ties, and water that is applied to har-
ple, such measures may include using vested crops to prevent dehydration be-
protective barriers or staking to keep fore cooling), including when used to
covered produce from touching the make ice that directly contacts cov-
ground or using an alternative irriga- ered produce during or after harvest
tion method. activities;
§ 112.43 What requirements apply to (3) Used to contact food contact sur-
treating agricultural water? faces, or to make ice that will contact
food contact surfaces; and
(a) When agricultural water is treat-
ed in accordance with § 112.45: (4) Used for washing hands during and
(1) Any method you use to treat agri- after harvest activities.
cultural water (such as with physical (b) When you use agricultural water
treatment, including using a pesticide during growing activities for covered
device as defined by the U.S. Environ- produce (other than sprouts) using a di-
mental Protection Agency (EPA); EPA- rect water application method, the fol-
registered antimicrobial pesticide lowing criteria apply (unless you estab-
product; or other suitable method) lish and use alternative criteria in ac-
must be effective to make the water cordance with § 112.49):
safe and of adequate sanitary quality (1) A geometric mean (GM) of your
for its intended use and/or meet the agricultural water samples of 126 or
relevant microbial quality criteria in less colony forming units (CFU) of ge-
§ 112.44, as applicable. neric E. coli per 100 mL of water (GM is
(2) You must deliver any treatment a measure of the central tendency of
of agricultural water in a manner to your water quality distribution); and
ensure that the treated water is con- (2) A statistical threshold value
sistently safe and of adequate sanitary (STV) of your agricultural water sam-
quality for its intended use and/or con-
ples of 410 or less CFU of generic E. coli

sistently meets the relevant microbial
per 100 mL of water (STV is a measure
quality criteria in § 112.44, as applica-
ble.
297
§ 112.45 21 CFR Ch. I (4–1–16 Edition)
of variability of your water quality dis- greater than a maximum time interval
tribution, derived as a model-based cal- of 4 consecutive days; or
culation approximating the 90th per- (B) An alternative microbial die-off
centile using the lognormal distribu- rate and any accompanying maximum
tion). time interval, in accordance with
§ 112.49; and/or
§ 112.45 What measures must I take if (ii) Applying a time interval between
my agricultural water does not harvest and end of storage using an ap-
meet the requirements of § 112.41 or
§ 112.44? propriate microbial die-off rate be-
tween harvest and end of storage, and/
(a) If you have determined or have or applying a (calculated) log reduction
reason to believe that your agricul- using appropriate microbial removal
tural water is not safe or of adequate rates during activities such as commer-
sanitary quality for its intended use as cial washing, to meet the microbial
required under § 112.41 and/or if your quality criteria in § 112.44(b) (or any al-
agricultural water does not meet the ternative microbial criteria, if applica-
microbial quality criterion for the ble), and any accompanying maximum
specified purposes as required under time interval or log reduction, pro-
§ 112.44(a), you must immediately dis- vided you have adequate supporting
continue that use(s), and before you scientific data and information;
may use the water source and/or dis- (2) Re-inspect the entire affected ag-
tribution system again for the intended ricultural water system to the extent
use(s), you must either: it is under your control, identify any
(1) Re-inspect the entire affected ag- conditions that are reasonably likely
ricultural water system to the extent to introduce known or reasonably fore-
it is under your control, identify any seeable hazards into or onto covered
conditions that are reasonably likely produce or food contact surfaces, make
to introduce known or reasonably fore- necessary changes, and take adequate
seeable hazards into or onto covered measures to determine if your changes
produce or food contact surfaces, make were effective and adequately ensure
necessary changes, and take adequate that your agricultural water meets the
measures to determine if your changes microbial quality criteria in § 112.44(b)
were effective and, as applicable, ade- (or any alternative microbial criteria,
quately ensure that your agricultural if applicable); or
water meets the microbial quality cri- (3) Treat the water in accordance
terion in § 112.44(a); or with the requirements of § 112.43.
(2) Treat the water in accordance
with the requirements of § 112.43. § 112.46 How often must I test agricul-
(b) If you have determined that your tural water that is subject to the re-
agricultural water does not meet the quirements of § 112.44?
microbial quality criteria (or any al- (a) There is no requirement to test
ternative microbial quality criteria, if any agricultural water that is subject
applicable) required under § 112.44(b), as to the requirements of § 112.44 when:
soon as practicable and no later than (1) You receive water from a Public
the following year, you must dis- Water System, as defined under the
continue that use, unless you either: Safe Drinking Water Act (SDWA) regu-
(1) Apply a time interval(s) (in days) lations, 40 CFR part 141, that furnishes
and/or a (calculated) log reduction by: water that meets the microbial re-
(i) Applying a time interval between quirements under those regulations or
last irrigation and harvest using ei- under the regulations of a State (as de-
ther: fined in 40 CFR 141.2) approved to ad-
(A) A microbial die-off rate of 0.5 log minister the SDWA public water sup-
per day to achieve a (calculated) log reply program, and you have Public
duction of your geometric mean (GM) Water System results or certificates of
and statistical threshold value (STV) compliance that demonstrate that the
to meet the microbial quality criteria water meets that requirement;

in § 112.44(b) (or any alternative micro- (2) You receive water from a public
bial criteria, if applicable), but no water supply that furnishes water that
298
meets the microbial quality require- tinues to be appropriate. You must

ment described in § 112.44(a), and you analyze:
have public water system results or (A) For an untreated surface water
certificates of compliance that dem- source, a minimum number of five
onstrate that the water meets that re- samples per year (or an alternative
quirement; or testing frequency that you establish
(3) You treat water in accordance and use, in accordance with § 112.49).
with the requirements of § 112.43. (B) For an untreated ground water
(b) Except as provided in paragraph source, a minimum of one sample per
(a) of this section, you must take the year.
following steps for each source of water (ii) The samples of agricultural water
used for purposes that are subject to must be representative of your use of
the requirements of § 112.44(b): the water and must be collected as
(1) Conduct an initial survey to de- close in time as practicable to, but
velop a microbial water quality profile prior to, harvest.
of the agricultural water source. (iii) To update the microbial water
(i) The initial survey must be con- quality profile, you must calculate re-
ducted: vised GM and STV values using your
(A) For an untreated surface water current annual survey data, combined
source, by taking a minimum total of with your most recent initial or annual
20 samples of agricultural water (or an survey data from within the previous 4
alternative testing frequency that you years, to make up a rolling data set of:
establish and use, in accordance with (A) At least 20 samples for untreated
§ 112.49) over a minimum period of 2 surface water sources; and
years, but not greater than 4 years. (B) At least 4 samples for untreated
(B) For an untreated ground water ground water sources.
source, by taking a minimum total of (iv) You must modify your water use,
four samples of agricultural water dur- as appropriate, based on the revised
ing the growing season or over a period GM and STV values in your updated
of 1 year. microbial water quality profile in ac-
(ii) The samples of agricultural water cordance with § 112.45(b).
must be representative of your use of (3) If you have determined or have
the water and must be collected as reason to believe that your microbial
close in time as practicable to, but water quality profile no longer rep-
prior to, harvest. The microbial water resents the quality of your water (for
quality profile initially consists of the example, if there are significant
geometric mean (GM) and the statis- changes in adjacent land use that are
tical threshold value (STV) of generic reasonably likely to adversely affect
Escherichia coli (E. coli) (colony forming the quality of your water source), you
units (CFU) per 100 milliliter (mL)) cal- must develop a new microbial water
culated using this data set. You must quality profile reflective of the time
determine the appropriate way(s) in period at which you believe your mi-
which the water may be used based on crobial water quality profile changed.
your microbial water quality profile in (i) To develop a new microbial water
accordance with § 112.45(b). quality profile, you must calculate new
(iii) You must update the microbial GM and STV values using your current
water quality profile annually as re- annual survey data (if taken after the
quired under paragraph (b)(2) of this time of the change), combined with
section, and otherwise required under new data, to make up a data set of:
paragraph (b)(3) of this section. (A) At least 20 samples for untreated
(2) Conduct an annual survey to up- surface water sources; and
date the microbial water quality pro- (B) At least 4 samples for untreated
file of your agricultural water. ground water sources.
(i) After the initial survey described (ii) You must modify your water use
in paragraph (b)(1)(i) of this section, based on the new GM and STV values
you must test the water annually to in your new microbial water quality
update your existing microbial water profile in accordance with § 112.45(b).

quality profile to confirm that the (c) If you use untreated ground water
way(s) in which the water is used con- for the purposes that are subject to the
299
§ 112.47 21 CFR Ch. I (4–1–16 Edition)
requirements of § 112.44(a), you must harvest, packing, and holding activi-

initially test the microbial quality of ties for covered produce (for example,
each source of the untreated ground water used for washing covered produce
water at least four times during the in dump tanks, flumes, or wash tanks,
growing season or over a period of 1 and water used for cooling covered
year, using a minimum total of four produce in hydrocoolers) for buildup of
samples collected to be representative organic material (such as soil and
of the intended use(s). Based on these plant debris).
results, you must determine whether
(c) You must maintain and monitor
the water can be used for that purpose,
the temperature of water at a tempera-
in accordance with § 112.45(a). If your
four initial sample results meet the ture that is appropriate for the com-
microbial quality criteria of § 112.44(a), modity and operation (considering the
you may test once annually thereafter, time and depth of submersion) and is
using a minimum of one sample col- adequate to minimize the potential for
lected to be representative of the in- infiltration of microorganisms of pub-
tended use(s). You must resume testing lic health significance into covered
at least four times per growing season produce.
or year if any annual test fails to meet
the microbial quality criteria in § 112.49 What alternatives may I estab-
§ 112.44(a). lish and use in lieu of the require-
ments of this subpart?
§ 112.47 Who must perform the tests Provided you satisfy the require-
required under § 112.46 and what
methods must be used? ments of § 112.12, you may establish and
use one or more of the following alter-
(a) You may meet the requirements natives:
related to agricultural water testing
(a) An alternative microbial quality
required under § 112.46 using:
(1) Test results from your agricul- criterion (or criteria) using an appro-
tural water source(s) performed by you, priate indicator of fecal contamina-
or by a person or entity acting on your tion, in lieu of the microbial quality
behalf; or criteria in § 112.44(b);
(2) Data collected by a third party or (b) An alternative microbial die-off
parties, provided the water source(s) rate and an accompanying maximum
sampled by the third party or parties time interval, in lieu of the microbial
adequately represent your agricultural die-off rate and maximum time inter-
water source(s) and all other applicable val in § 112.45(b)(1)(i);
requirements of this part are met. (c) An alternative minimum number
(b) Agricultural water samples must of samples used in the initial survey
be aseptically collected and tested for an untreated surface water source,
using a method as set forth in § 112.151. in lieu of the minimum number of sam-
§ 112.48 What measures must I take for ples required under § 112.46(b)(1)(i)(A);
water that I use during harvest, and
packing, and holding activities for (d) An alternative minimum number
covered produce? of samples used in the annual survey
(a) You must manage the water as for an untreated surface water source,
necessary, including by establishing in lieu of the minimum number of sam-
and following water-change schedules ples required under § 112.46(b)(2)(i)(A).
for re-circulated water, to maintain its
safety and adequate sanitary quality § 112.50 Under this subpart, what re-
and minimize the potential for con- quirements apply regarding
tamination of covered produce and food records?
contact surfaces with known or reason- (a) You must establish and keep
ably foreseeable hazards (for example, records required under this subpart in
hazards that may be introduced into accordance with the requirements of
the water from soil adhering to the subpart O of this part.
covered produce).
(b) You must establish and keep the
(b) You must visually monitor the
quality of water that you use during following records:
300
(1) The findings of the inspection of Subpart F—Biological Soil Amend-

your agricultural water system in ac- ments of Animal Origin and
cordance with the requirements of Human Waste
§ 112.42(a);
(2) Documentation of the results of § 112.51 What requirements apply for
all analytical tests conducted on agri- determining the status of a biologi-
cultural water for purposes of compli- cal soil amendment of animal ori-
gin?
ance with this subpart;
(3) Scientific data or information you (a) A biological soil amendment of
rely on to support the adequacy of a animal origin is treated if it has been
method used to satisfy the require- processed to completion to adequately
ments of § 112.43(a)(1) and (2); reduce microorganisms of public health
significance in accordance with the re-
(4) Documentation of the results of
quirements of § 112.54, or, in the case of
water treatment monitoring under
an agricultural tea, the biological ma-
§ 112.43(b); terials of animal origin used to make
(5) Scientific data or information you the tea have been so processed, the
rely on to support the microbial die-off water used to make the tea is not un-
or removal rate(s) that you used to de- treated surface water, and the water
termine the time interval (in days) be- used to make the tea has no detectable
tween harvest and end of storage, in- generic Escherichia coli (E. coli) in 100
cluding other activities such as com- milliliters (mL) of water.
mercial washing, as applicable, used to (b) A biological soil amendment of
achieve the calculated log reduction of animal origin is untreated if it:
generic Escherichia coli (E. coli), in ac- (1) Has not been processed to comple-
cordance with § 112.45(b)(1)(ii); tion in accordance with the require-
(6) Documentation of actions you ments of § 112.54, or in the case of an
take in accordance with § 112.45. With agricultural tea, the biological mate-
respect to any time interval or (cal- rials of animal origin used to make the
culated) log reduction applied in ac- tea have not been so processed, or the
cordance with § 112.45(b)(1)(i) and/or (ii), water used to make the tea is un-
such documentation must include the treated surface water, or the water
specific time interval or log reduction used to make the tea has detectable ge-
neric E. coli in 100 mL of water;
applied, how the time interval or log
(2) Has become contaminated after
reduction was determined, and the
treatment;
dates of corresponding activities such (3) Has been recombined with an un-
as the dates of last irrigation and har- treated biological soil amendment of
vest, the dates of harvest and end of animal origin;
storage, and/or the dates of activities (4) Is or contains a component that is
such as commercial washing); untreated waste that you know or have
(7) Annual documentation of the re- reason to believe is contaminated with
sults or certificates of compliance from a hazard or has been associated with
a public water system required under foodborne illness; or
§ 112.46(a)(1) or (2), if applicable; (5) Is an agricultural tea made with
(8) Scientific data or information you biological materials of animal origin
rely on to support any alternative that that contains an agricultural tea addi-
you establish and use in accordance tive.
with § 112.49; and
§ 112.52 How must I handle, convey,
(9) Any analytical methods you use and store biological soil amend-
in lieu of the method that is incor- ments of animal origin?
porated by reference in § 112.151(a).
(a) You must handle, convey and
store any biological soil amendment of
animal origin in a manner and location
such that it does not become a poten-
tial source of contamination to covered

produce, food contact surfaces, areas
used for a covered activity, water
301
§ 112.53 21 CFR Ch. I (4–1–16 Edition)
sources, water distribution systems, ical process (e.g., high alkaline pH), bi-
and other soil amendments. Agricul- ological process (e.g., composting), or a
tural teas that are biological soil combination of scientifically valid con-
amendments of animal origin may be trolled physical, chemical and/or bio-
used in water distribution systems pro- logical processes that has been vali-
vided that all other requirements of dated to satisfy the microbial standard
this rule are met. in § 112.55(a) for Listeria monocytogenes
(b) You must handle, convey and (L. monocytogenes), Salmonella species,
store any treated biological soil and E. coli O157:H7; or
amendment of animal origin in a man- (b) A scientifically valid controlled
ner and location that minimizes the physical, chemical, or biological proc-
risk of it becoming contaminated by an ess, or a combination of scientifically
untreated or in-process biological soil valid controlled physical, chemical,
amendment of animal origin. and/or biological processes, that has
(c) You must handle, convey, and been validated to satisfy the microbial
store any biological soil amendment of standard in § 112.55(b) for Salmonella
animal origin that you know or have species and fecal coliforms. Examples
reason to believe may have become of scientifically valid controlled bio-
contaminated as if it was untreated. logical (e.g., composting) processes
that meet the microbial standard in
§ 112.53 What prohibitions apply re-
garding use of human waste? § 112.55(b) include:
(1) Static composting that maintains
You may not use human waste for aerobic (i.e., oxygenated) conditions at
growing covered produce, except sew- a minimum of 131 °F (55 °C) for 3 con-
age sludge biosolids used in accordance secutive days and is followed by ade-
with the requirements of 40 CFR part quate curing; and
503, subpart D, or equivalent regu-
(2) Turned composting that main-
latory requirements.
tains aerobic conditions at a minimum
§ 112.54 What treatment processes are of 131 °F (55 °C) for 15 days (which do
acceptable for a biological soil not have to be consecutive), with a
amendment of animal origin that I minimum of five turnings, and is fol-
apply in the growing of covered lowed by adequate curing.
produce?
Each of the following treatment § 112.55 What microbial standards
processes are acceptable for a biologi- apply to the treatment processes in
§ 112.54?
cal soil amendment of animal origin
that you apply in the growing of cov- The following microbial standards
ered produce, provided that the result- apply to the treatment processes in
ing biological soil amendments are ap- § 112.54 as set forth in that section.
plied in accordance with the applicable (a) For L. monocytogenes, Salmonella
requirements of § 112.56: species, and E. coli O157:H7, the rel-
(a) A scientifically valid controlled evant standards in the table in this
physical process (e.g., thermal), chem- paragraph (a); or
For the microorganism— The microbial standard is—
(1) L. monocytogenes .................................................................. Not detected using a method that can detect one colony form-
ing unit (CFU) per 5 gram (or milliliter, if liquid is being sam-
pled) analytical portion.
(2) Salmonella species ................................................................ Not detected using a method that can detect three most prob-
able numbers (MPN) per 4 grams (or milliliter, if liquid is
being sampled) of total solids.
(3) E. coli O157:H7 ...................................................................... Not detected using a method that can detect 0.3 MPN per 1
gram (or milliliter, if liquid is being sampled) analytical por-
tion.
(b) Salmonella species are not de- and less than 1,000 MPN fecal coliforms
tected using a method that can detect per gram of total solids (dry weight
three MPN Salmonella species per 4 basis).
grams of total solids (dry weight basis);
302
§ 112.56 What application require- paragraph (a) in accordance with the

ments and minimum application in- application requirements specified in
tervals apply to biological soil the second column of the table in this
amendments of animal origin? paragraph (a) and the minimum appli-
(a) You must apply the biological soil cation intervals specified in the third
amendments of animal origin specified column of the table in this paragraph
in the first column of the table in this (a).
And then the
If the biological soil amendment of animal origin Then the biological soil amendment of animal or- minimum application in-
is— igin must be applied— terval is—
(1)(i) Untreated ....................................................... In a manner that does not contact covered [Reserved].
produce during application and minimizes the
potential for contact with covered produce
after application.
(ii) Untreated ........................................................... In a manner that does not contact covered 0 days.
produce during or after application.
(2) Treated by a scientifically valid controlled In a manner that minimizes the potential for con- 0 days.
physical, chemical, or biological process, or tact with covered produce during and after ap-
combination of scientifically valid controlled plication.
physical, chemical, and/or biological processes,
in accordance with the requirements of
§ 112.54(b) to meet the microbial standard in
§ 112.55(b).
(3) Treated by a scientifically valid controlled In any manner (i.e., no restrictions) ..................... 0 days.
physical, chemical, or biological process, or
combination of scientifically valid controlled
physical, chemical, or biological processes, in
accordance with the requirements of § 112.54(a)
to meet the microbial standard in § 112.55(a).
(b) [Reserved] (2) For a treated biological soil

amendment of animal origin you
§ 112.60 Under this subpart, what re- produce for your own covered farm(s),
quirements apply regarding documentation that process controls
records?
(for example, time, temperature, and
(a) You must establish and keep turnings) were achieved.
records required under this subpart in
accordance with the requirements of Subpart G–H [Reserved]
subpart O of this part.
(b) For any biological soil amend-
ment of animal origin you use, you
Subpart I—Domesticated and Wild
must establish and keep the following Animals
records: § 112.81 How do the requirements of
(1) For a treated biological soil this subpart apply to areas where
amendment of animal origin you re- covered activities take place?
ceive from a third party, documenta-
(a) The requirements of this subpart
tion (such as a Certificate of Conform-
apply when a covered activity takes
ance) at least annually that:
place in an outdoor area or a partially-
(i) The process used to treat the bio-
enclosed building and when, under the
logical soil amendment of animal ori-
circumstances, there is a reasonable
gin is a scientifically valid process that
probability that animals will contami-
has been carried out with appropriate
nate covered produce.
process monitoring; and
(b) The requirements of this subpart
(ii) The biological soil amendment of
animal origin has been handled, con- do not apply:
veyed and stored in a manner and loca- (1) When a covered activity takes
tion to minimize the risk of contami- place in a fully-enclosed building; or
nation by an untreated or in process bi- (2) To fish used in aquaculture oper-

ological soil amendment of animal ori- ations.
gin; and
303
§ 112.83 21 CFR Ch. I (4–1–16 Edition)
§ 112.83 What requirements apply re- Subpart K—Growing, Harvesting,

garding grazing animals, working Packing, and Holding Activities
animals, and animal intrusion?
(a) You must take the steps set forth § 112.111 What measures must I take if
in paragraph (b) of this section if under I grow, harvest, pack or hold both
the circumstances there is a reasonable covered and excluded produce?
probability that grazing animals, If you grow, harvest, pack or hold
working animals, or animal intrusion produce that is not covered in this part
will contaminate covered produce. (i.e., excluded produce in accordance
(b) You must: with § 112.2) and also conduct such ac-
(1) Assess the relevant areas used for tivities on covered produce, and the ex-
a covered activity for evidence of po- cluded produce is not grown, harvested,
tential contamination of covered packed or held in accordance with this
produce as needed during the growing part, you must take measures during
season (based on your covered produce; these covered activities, as applicable,
your practices and conditions; and to:
your observations and experience); and (a) Keep covered produce separate
(2) If significant evidence of potential from excluded produce (except when
contamination is found (such as obser- covered produce and excluded produce
vation of animals, animal excreta or are placed in the same container for
crop destruction), you must evaluate distribution); and
whether the covered produce can be (b) Adequately clean and sanitize, as
harvested in accordance with the re- necessary, any food contact surfaces
quirements of § 112.112 and take meas- that contact excluded produce before
ures reasonably necessary during grow- using such food contact surfaces for
ing to assist you later during harvest covered activities on covered produce.
when you must identify, and not har-
§ 112.112 What measures must I take
vest, covered produce that is reason- immediately prior to and during
ably likely to be contaminated with a harvest activities?
known or reasonably foreseeable haz-
ard. You must take all measures reason-
ably necessary to identify, and not har-
§ 112.84 Does this regulation require vest, covered produce that is reason-
covered farms to take actions that ably likely to be contaminated with a
would constitute a ‘‘taking’’ of known or reasonably foreseeable haz-
threatened or endangered species; ard, including steps to identify and not
to take measures to exclude ani- harvest covered produce that is visibly
mals from outdoor growing areas; contaminated with animal excreta. At
or to destroy animal habitat or oth- a minimum, identifying and not har-
erwise clear farm borders around
outdoor growing areas or drain- vesting covered produce that is reason-
ages? ably likely to be contaminated with
animal excreta or that is visibly con-
No. Nothing in this regulation au- taminated with animal excreta re-
thorizes the ‘‘taking’’ of threatened or quires a visual assessment of the grow-
endangered species as that term is de- ing area and all covered produce to be
fined by the Endangered Species Act harvested, regardless of the harvest
(16 U.S.C. 1531–1544) (i.e., to harass, method used.
harm, pursue, hunt, shoot, wound, kill,
trap, capture, or collect, or to attempt § 112.113 How must I handle harvested
to engage in any such conduct), in vio- covered produce during covered ac-
lation of the Endangered Species Act. tivities?
This regulation does not require cov- You must handle harvested covered
ered farms to take measures to exclude produce during covered activities in a
animals from outdoor growing areas, or manner that protects against contami-
to destroy animal habitat or otherwise nation with known or reasonably fore-
clear farm borders around outdoor seeable hazards—for example, by avoid-
growing areas or drainages. ing, to the degree practicable, contact

of cut surfaces of harvested produce
Subpart J—[Reserved] with soil.
304
§ 112.114 What requirements apply to dump tanks, flumes, and vehicles or

dropped covered produce? other equipment used for transport
You must not distribute dropped cov- that are intended to, or likely to, con-
ered produce. Dropped covered produce tact covered produce).
is covered produce that drops to the
ground before harvest. Dropped covered § 112.122 What buildings are subject to
produce does not include root crops the requirements of this subpart?
that grow underground (such as car- Buildings subject to the require-
rots), crops that grow on the ground ments of this subpart include:
(such as cantaloupe), or produce that is (a) Any fully- or partially-enclosed
intentionally dropped to the ground as building used for covered activities, in-
part of harvesting (such as almonds). cluding minimal structures that have a
roof but do not have any walls; and
when packaging covered produce? (b) Storage sheds, buildings, or other
structures used to store food contact
You must package covered produce in
surfaces (such as harvest containers
a manner that prevents the formation
and food-packing materials).
of Clostridium botulinum toxin if such
toxin is a known or reasonably foresee- § 112.123 What general requirements
able hazard (such as for mushrooms). apply regarding equipment and
tools subject to this subpart?
when using food-packing (including All of the following requirements
food packaging) material? apply regarding equipment and tools
(a) You must use food-packing mate- subject to this subpart:
rial that is adequate for its intended (a) You must use equipment and
use, which includes being: tools that are of adequate design, con-
(1) Cleanable or designed for single struction, and workmanship to enable
use; and them to be adequately cleaned and
(2) Unlikely to support growth or properly maintained; and
transfer of bacteria. (b) Equipment and tools must be:
(b) If you reuse food-packing mate- (1) Installed and maintained as to fa-
rial, you must take adequate steps to cilitate cleaning of the equipment and
ensure that food contact surfaces are of all adjacent spaces; and
clean, such as by cleaning food-packing (2) Stored and maintained to protect
containers or using a clean liner.
covered produce from being contami-
nated with known or reasonably fore-
Subpart L—Equipment, Tools, seeable hazards and to prevent the
Buildings, and Sanitation equipment and tools from attracting
and harboring pests.
§ 112.121 What equipment and tools
are subject to the requirements of (c) Seams on food contact surfaces of
this subpart? equipment and tools that you use must
be either smoothly bonded, or main-
Equipment and tools subject to the
tained to minimize accumulation of
requirements of this subpart are those
that are intended to, or likely to, con- dirt, filth, food particles, and organic
tact covered produce; and those instru- material and thus minimize the oppor-
ments or controls used to measure, reg- tunity for harborage or growth of
ulate, or record conditions to control microorganisms.
or prevent the growth of microorga- (d)(1) You must inspect, maintain,
nisms of public health significance. Ex- and clean and, when necessary and ap-
amples include knives, implements, propriate, sanitize all food contact sur-
mechanical harvesters, waxing machin- faces of equipment and tools used in
ery, cooling equipment (including covered activities as frequently as rea-
hydrocoolers), grading belts, sizing sonably necessary to protect against
equipment, palletizing equipment, and contamination of covered produce.
equipment used to store or convey har- (2) You must maintain and clean all
vested covered produce (such as con- non-food-contact surfaces of equipment
tainers, bins, food-packing material, and tools subject to this subpart used
305
§ 112.124 21 CFR Ch. I (4–1–16 Edition)
during harvesting, packing, and hold- tamination of covered produce, food

ing as frequently as reasonably nec- contact surfaces, or packing materials
essary to protect against contamina- with known or reasonably foreseeable
tion of covered produce. hazards. The potential for contamina-
(e) If you use equipment such as pal- tion must be reduced by effective de-
lets, forklifts, tractors, and vehicles sign including the separation of oper-
such that they are intended to, or like- ations in which contamination is likely
ly to, contact covered produce, you to occur, by one or more of the fol-
must do so in a manner that minimizes lowing means: Location, time, parti-
the potential for contamination of cov- tion, enclosed systems, or other effec-
ered produce or food contact surfaces tive means; and
with known or reasonably foreseeable (2) You must provide adequate drain-
hazards. age in all areas where normal oper-
§ 112.124 What requirements apply to ations release or discharge water or
instruments and controls used to other liquid waste on the ground or
measure, regulate, or record? floor of the building.
Instruments or controls you use to (b) You must implement measures to
measure, regulate, or record tempera- prevent contamination of your covered
tures, hydrogen-ion concentration produce and food contact surfaces in
(pH), sanitizer efficacy or other condi- your buildings, as appropriate, consid-
tions, in order to control or prevent ering the potential for such contamina-
the growth of microorganisms of public tion through:
health significance, must be: (1) Floors, walls, ceilings, fixtures,
(a) Accurate and precise as necessary ducts, or pipes; and
and appropriate in keeping with their (2) Drip or condensate.
purpose;
(b) Adequately maintained; and § 112.127 What requirements apply re-
(c) Adequate in number for their des- garding domesticated animals in
ignated uses. and around a fully-enclosed build-
ing?
§ 112.125 What requirements apply to (a) You must take reasonable pre-
equipment that is subject to this cautions to prevent contamination of
subpart used in the transport of
covered produce? covered produce, food contact surfaces,
and food-packing materials in fully-en-
Equipment that is subject to this closed buildings with known or reason-
subpart that you use to transport cov- ably foreseeable hazards from domes-
ered produce must be: ticated animals by:
(a) Adequately clean before use in
(1) Excluding domesticated animals
transporting covered produce; and
from fully-enclosed buildings where
(b) Adequate for use in transporting
covered produce, food contact surfaces,
covered produce.
or food-packing material is exposed; or
§ 112.126 What requirements apply to (2) Separating domesticated animals
my buildings? in a fully enclosed building from an
(a) All of the following requirements area where a covered activity is con-
apply regarding buildings: ducted on covered produce by location,
(1) Buildings must be suitable in size, time, or partition.
construction, and design to facilitate (b) Guard or guide dogs may be al-
maintenance and sanitary operations lowed in some areas of a fully enclosed
for covered activities to reduce the po- building if the presence of the dogs is
tential for contamination of covered unlikely to result in contamination of
produce or food contact surfaces with produce, food contact surfaces, or food-
known or reasonably foreseeable haz- packing materials.
ards. Buildings must:
(i) Provide sufficient space for place- § 112.128 What requirements apply re-
garding pest control in buildings?
ment of equipment and storage of ma-
terials; (a) You must take those measures

(ii) Permit proper precautions to be reasonably necessary to protect cov-
taken to reduce the potential for con- ered produce, food contact surfaces,
306
and food-packing materials from con- (b) Your hand-washing facilities must
tamination by pests in buildings, in- be furnished with:
cluding routine monitoring for pests as (1) Soap (or other effective surfac-
necessary and appropriate. tant);
(b) For fully-enclosed buildings, you (2) Running water that satisfies the
must take measures to exclude pests requirements of § 112.44(a) for water
from your buildings. used to wash hands; and
(c) For partially-enclosed buildings, (3) Adequate drying devices (such as
you must take measures to prevent single service towels, sanitary towel
pests from becoming established in service, or electric hand dryers).
your buildings (such as by use of (c) You must provide for appropriate
screens or by monitoring for the pres- disposal of waste (for example, waste
ence of pests and removing them when water and used single-service towels)
present). associated with a hand-washing facility
and take appropriate measures to pre-
§ 112.129 What requirements apply to vent waste water from a hand-washing
toilet facilities?
facility from contaminating covered
All of the following requirements produce, food contact surfaces, areas
apply to toilet facilities: used for a covered activity, agricul-
(a) You must provide personnel with tural water sources, and agricultural
adequate, readily accessible toilet fa- water distribution systems with known
cilities, including toilet facilities read- or reasonably foreseeable hazards.
ily accessible to growing areas during (d) You may not use antiseptic hand
harvesting activities. rubs as a substitute for soap (or other
(b) Your toilet facilities must be de- effective surfactant) and water.
signed, located, and maintained to:
(1) Prevent contamination of covered § 112.131 What must I do to control
produce, food contact surfaces, areas and dispose of sewage?
used for a covered activity, water All of the following requirements
sources, and water distribution sys- apply for the control and disposal of
tems with human waste; sewage:
(2) Be directly accessible for serv- (a) You must dispose of sewage into
icing, be serviced and cleaned at a fre- an adequate sewage or septic system or
quency sufficient to ensure suitability through other adequate means.
of use, and be kept supplied with toilet (b) You must maintain sewage and
paper; and septic systems in a manner that pre-
(3) Provide for the sanitary disposal vents contamination of covered
of waste and toilet paper. produce, food contact surfaces, areas
(c) During growing activities that used for a covered activity, agricul-
take place in a fully-enclosed building, tural water sources, and agricultural
and during covered harvesting, pack- water distribution systems with known
ing, or holding activities, you must or reasonably foreseeable hazards.
provide a hand-washing station in suf- (c) You must manage and dispose of
ficiently close proximity to toilet fa- leakages or spills of human waste in a
cilities to make it practical for persons manner that prevents contamination of
who use the toilet facility to wash covered produce, and prevents or mini-
their hands. mizes contamination of food contact
surfaces, areas used for a covered activ-
§ 112.130 What requirements apply for ity, agricultural water sources, or agri-
hand-washing facilities? cultural water distribution systems.
All of the following requirements (d) After a significant event (such as
apply to hand-washing facilities: flooding or an earthquake) that could
(a) You must provide personnel with negatively impact a sewage or septic
adequate, readily accessible hand- system, you must take appropriate
washing facilities during growing ac- steps to ensure that sewage and septic
tivities that take place in a fully-en- systems continue to operate in a man-

closed building, and during covered ner that does not contaminate covered
harvest, packing, or holding activities. produce, food contact surfaces, areas
307
§ 112.132 21 CFR Ch. I (4–1–16 Edition)
used for a covered activity, agricul- produce, food contact surfaces, areas
tural water sources, or agricultural used for a covered activity, agricul-
water distribution systems. tural water sources, or agricultural
water distribution systems with ani-
§ 112.132 What must I do to control mal waste, you must:
and dispose of trash, litter, and (1) Adequately control their excreta
waste in areas used for covered ac-
tivities? and litter; and
(2) Maintain a system for control of
All of the following requirements animal excreta and litter.
apply to the control and disposal of (b) [Reserved]
trash, litter, and waste in areas used
for covered activities: § 112.140 Under this subpart, what re-
(a) You must convey, store, and dis- quirements apply regarding
pose of trash, litter and waste to: records?
(1) Minimize the potential for trash, (a) You must establish and keep
litter, or waste to attract or harbor records required under this subpart in
pests; and accordance with the requirements of
(2) Protect against contamination of subpart O of this part.
covered produce, food contact surfaces, (b) You must establish and keep doc-
areas used for a covered activity, agri- umentation of the date and method of
cultural water sources, and agricul- cleaning and sanitizing of equipment
tural water distribution systems with subject to this subpart used in:
known or reasonably foreseeable haz- (1) Growing operations for sprouts;
ards. and
(b) You must adequately operate sys- (2) Covered harvesting, packing, or
tems for waste treatment and disposal holding activities.
so that they do not constitute a poten-
tial source of contamination in areas
used for a covered activity. Subpart M—Sprouts
§ 112.133 What requirements apply to § 112.141 What commodities are sub-
plumbing? ject to this subpart?
The plumbing must be of an adequate The requirements of this subpart
size and design and be adequately in- apply to growing, harvesting, packing,
stalled and maintained to: and holding of all sprouts, except soil-
(a) Distribute water under pressure or substrate-grown sprouts harvested
as needed, in sufficient quantities, in without their roots.
all areas where used for covered activi-
ties, for sanitary operations, or for seeds or beans used to grow
hand-washing and toilet facilities; sprouts?
(b) Properly convey sewage and liq-
uid disposable waste; In addition to the requirements of
(c) Avoid being a source of contami- this part, all of the following require-
nation to covered produce, food contact ments apply to seeds or beans used to
surfaces, areas used for a covered activ- grow sprouts.
ity, or agricultural water sources; and (a) You must take measures reason-
(d) Not allow backflow from, or cross ably necessary to prevent the introduc-
connection between, piping systems tion of known or reasonably foresee-
that discharge waste water or sewage able hazards into or onto seeds or
and piping systems that carry water beans that you will use for sprouting.
used for a covered activity, for sani- (b) Except as provided in paragraph
tary operations, or for use in hand- (c) of this section, if you know or have
washing facilities. reason to believe that a lot of seeds or
beans may be contaminated with a
§ 112.134 What must I do to control pathogen (either because it has been
animal excreta and litter from do- associated with foodborne illness; or
mesticated animals that are under based on microbial test results, includ-
my control? ing a positive finding of a pathogen in

(a) If you have domesticated animals, tests required under § 112.144(b)), you
to prevent contamination of covered must:
308
(1) Discontinue use of all seeds or (i) The prior treatment was con-
beans from that lot for sprout produc- ducted using a scientifically valid
tion and ensure that sprouts grown method to reduce microorganisms of
from that lot of seeds or beans do not public health significance; and
enter commerce; and (ii) The treated seeds or beans were
(2) Report the information (associa- handled and packaged following the
tion with illness and/or findings of mi- treatment in a manner that minimizes
crobial testing) to the seed grower, dis- the potential for contamination.
tributor, supplier, or other entity from
whom you received the seeds or beans. § 112.143 What measures must I take
for growing, harvesting, packing,
(c) If your reason to believe that a lot and holding sprouts?
of seeds or beans may be contaminated
was based only on microbial test re- You must take all of the following
sults: measures for growing, harvesting,
(1) You are not required to take the packing, and holding sprouts:
steps set forth in paragraph (b)(1) of (a) You must grow, harvest, pack,
this section if you treat your lot of and hold sprouts in a fully-enclosed
seeds or beans with a process that is building.
reasonably certain to achieve destruc- (b) Any food contact surfaces you use
tion or elimination in the seeds or to grow, harvest, pack, or hold sprouts
must be cleaned and sanitized before
beans of the most resistant microorga-
contact with sprouts or seeds or beans
nisms of public health significance
used to grow sprouts.
that are likely to occur in the seeds or
(c) You must conduct testing during
beans; or
growing, harvesting, packing, and hold-
(2) You are not required to take the ing sprouts, as specified in § 112.144.
steps set forth in paragraphs (b)(1) and (d) You must establish and imple-
(2) of this section if you later reason- ment a written environmental moni-
ably determine, through appropriate toring plan as specified in § 112.145.
followup actions, that the lot of seeds (e) You must take certain actions if
or beans is not the source of contami- you detect Listeria species or L.
nation (e.g., the lot of seeds or beans is monocytogenes in the growing, har-
not the source of a pathogen found in vesting, packing, or holding environ-
spent sprout irrigation water or ment, as specified in § 112.146.
sprouts). (f) You must establish and implement
(d) You must visually examine seeds a written sampling plan to test spent
and beans, and packaging used to ship sprout irrigation water or sprouts for
seeds or beans, for signs of potential pathogens as specified in § 112.147.
contamination with known or reason- (g) You must take certain actions if
ably foreseeable hazards. the samples of spent sprout irrigation
(e) You must either: water or sprouts test positive for a
(1) Treat seeds or beans that will be pathogen as specified in § 112.148.
used to grow sprouts using a scientif-
ically valid method to reduce micro- § 112.144 What testing must I do dur-
organisms of public health signifi- ing growing, harvesting, packing,
cance; or and holding sprouts?
(2) Rely on prior treatment of seeds All of the following testing must be
or beans conducted by a grower, dis- done during growing, harvesting, pack-
tributor, or supplier of the seeds or ing, and holding sprouts:
beans (whether to fulfill this require- (a) You must test the growing, har-
ment completely or for the purpose of vesting, packing, and holding environ-
considering such prior treatment when ment for Listeria species or L.
applying appropriate additional treat- monocytogenes in accordance with the
ment of the seeds or beans at the cov- requirements of § 112.145.
ered farm immediately before sprout- (b) You must either:
ing), provided that you obtain docu- (1) Test spent sprout irrigation water
mentation (such as a Certificate of from each production batch of sprouts

Conformance) from the grower, dis- for E. coli O157:H7, Salmonella species,
tributor, or supplier that: and any pathogens meeting the criteria
309
§ 112.145 21 CFR Ch. I (4–1–16 Edition)
in paragraph (c) of this section, in ac- (3) Sample collection sites; the num-
cordance with the requirements of ber and location of sampling sites must
§ 112.147; or be sufficient to determine whether
(2) If testing spent sprout irrigation measures are effective and must in-
water is not practicable (for example, clude appropriate food contact surfaces
soil-grown sprouts harvested with and non-food-contact surfaces of equip-
roots or for hydroponically grown ment, and other surfaces within the
sprouts that use very little water), test growing, harvesting, packing, and hold-
each production batch of sprouts at the ing environment.
in-process stage (i.e., while sprouts are (d) You must aseptically collect envi-
still growing) for E. coli O157:H7, Sal- ronmental samples and test them for
monella species, and any pathogens Listeria species or L. monocytogenes
meeting the criteria in paragraph (c) of
using a method as set forth in § 112.152.
this section, in accordance with the re-
(e) Your written environmental mon-
quirements of § 112.147.
(c) In addition to E. coli O157:H7 and itoring plan must include a corrective
Salmonella species, you must conduct action plan that, at a minimum, re-
tests as provided in paragraph (b) of quires you to take the actions in
this section for additional pathogens § 112.146, and details when and how you
when the following conditions are met: will accomplish those actions, if the
(1) Testing for the pathogen is rea- growing, harvesting, packing, or hold-
sonably necessary to minimize the risk ing environment tests positive for Lis-
of serious adverse health consequences teria species or L. monocytogenes.
or death from use of, or exposure to,
sprouts; and § 112.146 What actions must I take if
(2) A scientifically valid test method the growing, harvesting, packing,
or holding environment tests posi-
for the pathogen is available to detect tive for Listeria species or L.
the pathogen in spent sprout irrigation monocytogenes?
water (or sprouts).
You must, at a minimum, take the
§ 112.145 What requirements apply to following actions if you detect Listeria
testing the environment for Listeria species or L. monocytogenes in the grow-
species or L. monocytogenes? ing, harvesting, packing, or holding en-
All of the following testing require- vironment:
ments apply for the growing, har- (a) Conduct additional testing of sur-
vesting, packing, and holding environ- faces and areas surrounding the area
ment for Listeria species or L. where Listeria species or L.
monocytogenes. monocytogenes was detected to evaluate
(a) You must establish and imple- the extent of the problem, including
ment a written environmental moni- the potential for Listeria species or L.
toring plan that is designed to identify monocytogenes to have become estab-
L. monocytogenes if it is present in the lished in a niche;
growing, harvesting, packing, or hold- (b) Clean and sanitize the affected
ing environment. surfaces and surrounding areas;
(b) Your written environmental mon-
(c) Conduct additional sampling and
itoring plan must be directed to sam-
testing to determine whether the Lis-
pling and testing for either Listeria spe-
teria species or L. monocytogenes has
cies or L. monocytogenes.
(c) Your written environmental mon- been eliminated;
itoring plan must include a sampling (d) Conduct finished product testing
plan that specifies: when appropriate;
(1) What you will test collected sam- (e) Perform any other actions nec-
ples for (i.e., Listeria species or L. essary to prevent recurrence of the
monocytogenes); contamination; and
(2) How often you will collect envi- (f) Take appropriate action to pre-
ronmental samples, which must be no vent any food that is adulterated under
less than monthly, and at what point section 402 of the Federal Food, Drug,
during production you will collect the and Cosmetic Act from entering into
samples; and commerce.
310
§ 112.147 What must I do to collect and (b) Take the steps required in
test samples of spent sprout irriga- § 112.142(b) with respect to the lot of
tion water or sprouts for patho- seeds or beans used to grow the af-
gens? fected production batch of sprouts (ex-
All of the following requirements cept as allowed under § 112.142(c));
apply for collecting and testing sam- (c) Clean and sanitize the affected
ples of spent sprout irrigation water or surfaces and surrounding areas; and
sprouts for pathogens as required in (d) Perform any other actions nec-
§ 112.144(b): essary to prevent reoccurrence of the
(a) You must establish and imple- contamination.
ment a written sampling plan that
identifies the number and location of § 112.150 Under this subpart, what re-
quirements apply regarding
samples (of spent sprout irrigation records?
water or sprouts) to be collected for
each production batch of sprouts to en- (a) You must establish and keep
sure that the collected samples are rep- records required under this subpart in
resentative of the production batch accordance with the requirements of
when testing for contamination. subpart O of this part.
(b) In accordance with the written (b) You must establish and keep the
sampling plan required under para- following records:
graph (a) of this section, you must (1) Documentation of your treatment
aseptically collect samples of spent of seeds or beans to reduce microorga-
sprout irrigation water or sprouts, and nisms of public health significance in
test the collected samples for patho- the seeds or beans, at your farm; or al-
gens using a method as set forth in ternatively, documentation (such as a
§ 112.153. You must not allow the pro- Certificate of Conformance) from your
duction batch of sprouts to enter into seed supplier that seeds or beans are
commerce unless the results of the treated to reduce microorganisms of
testing of spent sprout irrigation water public health significance and are ap-
or sprouts are negative for E. coli propriately handled and packaged fol-
O157:H7, Salmonella species, and, if ap- lowing the treatment, in accordance
plicable, a pathogen meeting the cri- with the requirements of § 112.142(e);
teria in § 112.144(c). (2) Your written environmental mon-
(c) Your written sampling plan must itoring plan in accordance with the re-
include a corrective action plan that at quirements of § 112.145;
a minimum, requires you to take the (3) Your written sampling plan for
actions in § 112.148, and details when each production batch of sprouts in ac-
and how you will accomplish those accordance with the requirements of
tions, if the samples of spent sprout ir- § 112.147(a) and (c);
rigation water or sprouts test positive (4) Documentation of the results of
for E. coli O157:H7, Salmonella species, all analytical tests conducted for pur-
or a pathogen meeting the criteria in poses of compliance with this subpart;
§ 112.144(c). (5) Any analytical methods you use
in lieu of the methods that are incor-
§ 112.148 What actions must I take if porated by reference in §§ 112.152 and
the samples of spent sprout irriga- 112.153; and
tion water or sprouts test positive (6) Documentation of actions you
for a pathogen? take in accordance with §§ 112.142(b)
You must, at a minimum, take the and (c), 112.146, and 112.148.
following actions if the samples of
spent sprout irrigation water or Subpart N—Analytical Methods
sprouts test positive for E. coli O157:H7,
Salmonella species, or a pathogen meet- § 112.151 What methods must I use to
ing the criteria in § 112.144(c): test the quality of water to satisfy
(a) Take appropriate action to pre- the requirements of § 112.46?
vent any food that is adulterated under You must test the quality of water
section 402 of the Federal Food, Drug, using:

and Cosmetic Act from entering into (a) The method of analysis published
commerce; by the U.S. Environmental Protection
311
§ 112.152 21 CFR Ch. I (4–1–16 Edition)
Agency (EPA), ‘‘Method 1603: Esch- http://www.fda.gov/fsma; or at the Na-

erichia coli (E. coli) in Water by Mem- tional Archives and Records Adminis-
brane Filtration Using Modified mem- tration (NARA). For information on
brane-Thermotolerant Escherichia coli the availability of this material at
Agar (Modified mTEC), EPA–821–R–09– NARA, call 202–741–6030, or go to: http://
007),’’ December, 2009. The Director of www.archives.gov/federallregister/
the Federal Register approves this in- codeloflfederallregulation/
corporation by reference in accordance ibrllocations.html; or
with 5 U.S.C. 552(a) and 1 CFR part 51.
(b) A scientifically valid method that
You may obtain a copy from EPA, Of-
is at least equivalent to the method of
fice of Water (4303T), 1200 Pennsylvania
Avenue NW., Washington, DC 20460. analysis in § 112.152(a) in accuracy, pre-
You may inspect a copy at FDA’s Main cision, and sensitivity.
Library, 10903 New Hampshire Ave.,
§ 112.153 What methods must I use to
Bldg. 2, Third Floor, Silver Spring, MD
test spent sprout irrigation water
20993, 301–796–2039, or at the National (or sprouts) from each production
Archives and Records Administration batch of sprouts for pathogens to
(NARA). For information on the avail- satisfy the requirements of
ability of this material at NARA, call § 112.144(b) and (c)?
202–741–6030, or go to: http://
www.archives.gov/federallregister/ You must test spent sprout irrigation
codeloflfederallregulations/ water (or sprouts) from each produc-
ibrllocations.html; or tion batch for pathogens using:
(b)(1) A scientifically valid method (a) For E. coli O157:H7, Salmonella spe-
that is at least equivalent to the meth- cies:
od of analysis in § 112.151(a) in accu- (1) The method of analysis described
racy, precision, and sensitivity; or in ‘‘Testing Methodologies for E. coli
(2) For any other indicator of fecal O157:H7 and Salmonella species in Spent
contamination you may test for pursu- Sprout Irrigation Water (or Sprouts),’’
ant to § 112.49(a), a scientifically valid Version 1, October 2015, U.S. Food and
method. Drug Administration. The Director of
§ 112.152 What methods must I use to the Federal Register approves this in-
test the growing, harvesting, pack- corporation by reference in accordance
ing, and holding environment for with 5 U.S.C. 552(a) and 1 CFR part 5.
Listeria species or L. You may obtain a copy from, and/or in-
monocytogenes to satisfy the respect a copy at, the Division of
quirements of § 112.144(a)? Produce Safety, Center for Food Safety
You must test the growing, har- and Applied Nutrition (CFSAN), Food
vesting, packing, and holding environ- and Drug Administration, 5100 Paint
ment for Listeria species or L. Branch Pkwy., College Park, MD 20740,
monocytogenes using: 240–402–1600; FDA’s Main Library, 10903
(a) The method of analysis described New Hampshire Ave., Bldg. 2, Third
in ‘‘Testing Methodology for Listeria Floor, Silver Spring, MD 20993, 301–796–
species or L. monocytogenes in Environ- 2039; http://www.fda.gov/fsma; or at the
mental Samples,’’ Version 1, October
National Archives and Records Admin-
2015, U.S. Food and Drug Administra-
istration (NARA). For information on
tion. The Director of the Federal Reg-
the availability of this material at
ister approves this incorporation by
reference in accordance with 5 U.S.C. NARA, call 202–741–6030, or go to: http://
552(a) and 1 CFR part 5. You may ob- www.archives.gov/federallregister/
tain a copy from, and/or inspect a copy codeloflfederallregulation/
at, the Division of Produce Safety, ibrllocations.html; or
Center for Food Safety and Applied Nu- (2) A scientifically valid method that
trition (CFSAN), U.S. Food and Drug is at least equivalent to the method of
Administration, 5100 Paint Branch analysis in § 112.153(a)(1) in accuracy,
Pkwy., College Park, MD 20740, 240–402– precision, and sensitivity; and
1600; FDA’s Main Library, 10903 New (b) For any other pathogen(s) meet-
Hampshire Ave., Bldg. 2, Third Floor, ing the criteria in § 112.144(c), a sci-
Silver Spring, MD 20993, 301–796–2039; entifically valid method.
312
Subpart O—Records ments of this part. Existing records

may be supplemented as necessary to
§ 112.161 What general requirements include all of the required information
apply to records required under and satisfy the requirements of this
this part? part.
(a) Except as otherwise specified, all (b) The information required by this
records required under this part must: part does not need to be kept in one set
(1) Include, as applicable: of records. If existing records contain
(i) The name and location of your some of the required information, any
farm; new information required by this part
(ii) Actual values and observations may be kept either separately or com-
obtained during monitoring; bined with the existing records.
(iii) An adequate description (such as
the commodity name, or the specific § 112.164 How long must I keep
variety or brand name of a commodity, records?
and, when available, any lot number or (a)(1) You must keep records required
other identifier) of covered produce ap- by this part for at least 2 years past
plicable to the record; the date the record was created.
(iv) The location of a growing area (2) Records that a farm relies on dur-
(for example, a specific field) or other ing the 3-year period preceding the ap-
area (for example, a specific packing plicable calendar year to satisfy the
shed) applicable to the record; and criteria for a qualified exemption, in
(v) The date and time of the activity accordance with §§ 112.5 and 112.7, must
documented; be retained as long as necessary to sup-
(2) Be created at the time an activity
port the farm’s status during the appli-
is performed or observed;
cable calendar year.
(3) Be accurate, legible, and indelible;
(b) Records that relate to the general
and
adequacy of the equipment or processes
(4) Be dated, and signed or initialed
or records that relate to analyses, sam-
by the person who performed the activ-
pling, or action plans being used by a
ity documented.
farm, including the results of scientific
(b) Records required under §§ 112.7(b),
studies, tests, and evaluations, must be
112.30(b)(2), 112.50(b)(2), (4), and (6),
retained at the farm for at least 2 years
112.60(b)(2), 112.140(b)(1) and (2), and
after the use of such equipment or
112.150(b)(1), (4), and (6), must be re-
processes, or records related to anal-
viewed, dated, and signed, within a rea-
yses, sampling, or action plans, is dis-
sonable time after the records are
continued.
made, by a supervisor or responsible
party. § 112.165 What formats are acceptable
for the records I keep?
§ 112.162 Where must I store records?
(a) Offsite storage of records is per- You must keep records as:
mitted if such records can be retrieved (a) Original records;
and provided onsite within 24 hours of (b) True copies (such as photocopies,
request for official review. pictures, scanned copies, microfilm,
(b) Electronic records are considered microfiche, or other accurate reproduc-
to be onsite at your farm if they are tions of the original records); or
accessible from an onsite location at (c) Electronic records. Records that
your farm. are established or maintained to sat-
isfy the requirements of this part and
§ 112.163 May I use existing records to that meet the definition of electronic
satisfy the requirements of this records in § 11.3(b)(6) of this chapter are
part? exempt from the requirements of part
(a) Existing records (e.g., records that 11 of this chapter. Records that satisfy
are kept to comply with other Federal, the requirements of this part, but that
State, or local regulations, or for any also are required under other applica-
other reason) do not need to be dupli- ble statutory provisions or regulations,

cated if they contain all of the required remain subject to part 11 of this chap-
information and satisfy the require- ter.
313
§ 112.166 21 CFR Ch. I (4–1–16 Edition)
§ 112.166 What requirements apply for § 112.172 How may a State, tribe, or
making records available and ac- foreign country request a variance
cessible to FDA? from one or more requirements of
this part?
(a) You must have all records re-
quired under this part readily available To request a variance from one or
and accessible during the retention pe- more requirements of this part, the
riod for inspection and copying by FDA competent authority (i.e., the regu-
upon oral or written request, except latory authority for food safety) for a
that you have 24 hours to obtain State, tribe, or a foreign country must
records you keep offsite and make submit a petition under § 10.30 of this
them available and accessible to FDA chapter.
for inspection and copying. § 112.173 What must be included in the
(b) If you use electronic techniques Statement of Grounds in a petition
to keep records, or to keep true copies requesting a variance?
of records, or if you use reduction tech-
In addition to the requirements set
niques such as microfilm to keep true forth in § 10.30 of this chapter, the
copies of records, you must provide the Statement of Grounds in a petition re-
records to FDA in a format in which questing a variance must:
they are accessible and legible. (a) Provide a statement that the ap-
(c) If your farm is closed for a pro- plicable State, tribe, or foreign country
longed period, the records may be has determined that the variance is
transferred to some other reasonably necessary in light of local growing con-
accessible location but must be re- ditions and that the procedures, proc-
turned to your farm within 24 hours for esses, and practices to be followed
official review upon request. under the variance are reasonably like-
ly to ensure that the produce is not
§ 112.167 Can records that I provide to adulterated under section 402 of the
FDA be disclosed to persons outside Federal Food, Drug and Cosmetic Act
of FDA?
and to provide the same level of public
Records obtained by FDA in accord- health protection as the requirements
ance with this part are subject to the of this part;
disclosure requirements under part 20 (b) Describe with particularity the
of this chapter. variance requested, including the per-
sons to whom the variance would apply
Subpart P—Variances and the provision(s) of this part to
which the variance would apply;
§ 112.171 Who may request a variance (c) Present information dem-
from the requirements of this part? onstrating that the procedures, proc-
A State, Federally-recognized tribe esses, and practices to be followed
(or ‘‘tribe’’), or a foreign country from under the variance are reasonably like-
which food is imported into the United ly to ensure that the produce is not
adulterated under section 402 of the
States may request a variance from
Federal Food, Drug, and Cosmetic Act
one or more requirements of this part,
(21 U.S.C. 342) and to provide the same
where the State, tribe, or foreign coun-
level of public health protection as the
try determines that:
requirements of this part.
(a) The variance is necessary in light
of local growing conditions; and § 112.174 What information submitted
(b) The procedures, processes, and in a petition requesting a variance
practices to be followed under the vari- or submitted in comments on such
ance are reasonably likely to ensure a petition are publicly available?
that the produce is not adulterated We will presume that information
under section 402 of the Federal Food, submitted in a petition requesting a
Drug, and Cosmetic Act and to provide variance and comments submitted on
the same level of public health protec- such a petition, including a request
tion as the requirements of this part. that a variance be applied to its simi-
larly situated persons, does not contain
314
information exempt from public disclo- quested by a petition submitted by an-

sure under part 20 of this chapter and other State, tribe, or foreign country
will be made public as part of the dock- should also apply to similarly situated
et associated with this request. persons in its jurisdiction may request
that the variance be applied to its
§ 112.175 Who responds to a petition similarly situated persons by submit-
requesting a variance?
ting comments in accordance with
The Director or Deputy Directors of § 10.30 of this chapter. These comments
the Center for Food Safety and Applied must include the information required
Nutrition (CFSAN), or the Director, Of- in § 112.173. If FDA determines that
fice of Compliance, CFSAN, responds these comments should instead be
to a request for a variance.
treated as a separate request for a vari-
§ 112.176 What process applies to a pe- ance, FDA will notify the State, tribe,
tition requesting a variance? or foreign country that submitted
these comments that a separate re-
(a) In general, the procedures set
forth in § 10.30 of this chapter govern quest must be submitted in accordance
our response to a petition requesting a with §§ 112.172 and 112.173.
variance. (b) If we grant a petition requesting a
(b) Under § 10.30(h)(3) of this chapter, variance, in whole or in part, we may
we will publish a notice in the FEDERAL specify that the variance also applies
REGISTER, requesting information and to persons in a specific location who
views on a filed petition, including in- are similarly situated to those identi-
formation and views from persons who fied in the petition.
could be affected by the variance if the (c) If we specify that the variance
petition were to be granted (e.g., be- also applies to persons in a specific lo-
cause their farm is covered by the peti- cation who are similarly situated to
tion or as a person similarly situated those identified in the petition, we will
to persons covered by the petition). inform the applicable State, tribe, or
(c) Under § 10.30(e)(3) of this chapter, foreign country where the similarly
we will respond to the petitioner in situated persons are located of our de-
writing and will also make public a no- cision in writing and will publish a no-
tice on FDA’s Web site announcing our tice on our Web site announcing our
decision to either grant or deny the pe- decision to apply the variance to simi-
tition. larly situated persons in that par-
(1) If we grant the petition, either in
ticular location.
whole or in part, we will specify the
persons to whom the variance applies § 112.178 Under what circumstances
and the provision(s) of this part to may FDA deny a petition request-
which the variance applies. ing a variance?
(2) If we deny the petition (including
partial denials), our written response We may deny a variance request if it
to the petitioner and our public notice does not provide the information re-
announcing our decision to deny the quired under § 112.173 (including the re-
petition will explain the reason(s) for quirements of § 10.30 of this chapter), or
the denial. if we determine that the variance is
(d) We will make readily accessible not reasonably likely to ensure that
to the public, and periodically update, the produce is not adulterated under
a list of filed petitions requesting section 402 of the Federal Food, Drug
variances, including the status of each and Cosmetic Act and to provide the
petition (for example, pending, grant- same level of public health protection
ed, or denied). as the requirements of this part.
§ 112.177 Can an approved variance § 112.179 When does a variance ap-

apply to any person other than proved by FDA become effective?
those identified in the petition re-
A variance approved by FDA becomes
questing that variance?

effective on the date of our written de-
(a) A State, tribe, or a foreign coun-
cision on the petition.
try that believes that a variance re-
315
§ 112.180 21 CFR Ch. I (4–1–16 Edition)
§ 112.180 Under what circumstances eign countries under part 16 of this

may FDA modify or revoke an ap- chapter.
proved variance? (i) If FDA grants a hearing, we will
We may modify or revoke a variance provide the State, tribe, or foreign
if we determine that such variance is country with an opportunity to make
not reasonably likely to ensure that an oral submission. We will provide no-
the produce is not adulterated under tice on our Web site of the hearing, in-
section 402 of the Federal Food, Drug, cluding the time, date, and place of the
and Cosmetic Act and to provide the hearing.
same level of public health protection (ii) If more than one State, tribe, or
as the requirements of this part. foreign country requests an informal
§ 112.181 What procedures apply if hearing under part 16 of this chapter
FDA determines that an approved about our determination that a par-
variance should be modified or re- ticular variance should be modified or
voked? revoked, we may consolidate such re-
(a) We will provide the following no- quests (for example, into a single hear-
tifications: ing).
(1) We will notify a State, tribe, or a (2) We will consider written submis-
foreign country directly, in writing at sions submitted to the public docket
the address identified in its petition, if from interested parties.
we determine that a variance granted (c) We will provide notice of our final
in response to its petition should be decision as follows:
modified or revoked. Our direct, writ- (1) On the basis of the administrative
ten notification will provide the State, record, FDA will issue a written deci-
tribe, or foreign country with an oppor- sion, as provided for under part 16 of
tunity to request an informal hearing this chapter.
under part 16 of this chapter. (2) We will publish a notice of our de-
(2) We will publish a notice of our de-
cision in the FEDERAL REGISTER. The
termination that a variance should be
effective date of the decision will be
modified or revoked in the FEDERAL
the date of publication of the notice.
REGISTER. This notice will establish a
public docket so that interested parties § 112.182 What are the permissible
may submit written comments on our types of variances that may be
determination. granted?
(3) When applicable, we will:
(i) Notify in writing any States, A variance(s) may be requested for
tribes, or foreign countries where a one or more requirements in subparts
variance applies to similarly situated A through O of this part. Examples of
persons of our determination that the permissible types of variances include:
variance should be modified or re- (a) Variance from the microbial qual-
voked; ity criteria when agricultural water is
(ii) Provide those States, tribes, or used during growing activities for cov-
foreign countries with an opportunity ered produce (other than sprouts) using
to request an informal hearing under a direct water application method, es-
part 16 of this chapter; and tablished in § 112.44(b);
(iii) Include in the FEDERAL REGISTER (b) Variance from the microbial die-
notice described in paragraph (a)(2) of off rate that is used to determine the
this section public notification of our time interval between last irrigation
decision to modify or revoke the vari- and harvest, and/or the accompanying
ance granted to States, tribes, or for- maximum time interval, established in
eign countries in which similarly situ-
§ 112.45(b)(1)(i); and
ated persons are located.
(b) We will consider submissions from (c) Variance from the approach or
affected States, tribes, or foreign coun- frequency for testing water used for
tries and from other interested parties purposes that are subject to the re-
as follows: quirements of § 112.44(b), established in

(1) We will consider requests for hear- § 112.46(b).
ings by affected States, tribes, or for-
316
Subpart Q—Compliance and outbreak based on conduct or condi-

Enforcement tions associated with your farm that
are material to the safety of the food
§ 112.192 What is the applicability and that would otherwise be covered
status of this part? produce grown, harvested, packed or
(a) The failure to comply with the re- held at your farm.
quirements of this part, issued under (b) Before FDA issues an order to
section 419 of the Federal Food, Drug, withdraw your qualified exemption,
and Cosmetic Act, is a prohibited act FDA:
under section 301(vv) of the Federal (1) May consider one or more other
Food, Drug, and Cosmetic Act. actions to protect the public health
(b) The criteria and definitions in and prevent or mitigate a foodborne
this part apply in determining whether illness outbreak, including a warning
a food is: letter, recall, administrative deten-
(1) Adulterated within the meaning
tion, refusal of food offered for import,
of:
seizure, and injunction;
(i) Section 402(a)(3) of the Federal
Food, Drug, and Cosmetic Act in that (2) Must notify the owner, operator,
the food has been grown, harvested, or agent in charge of the farm, in writ-
packed, or held under such conditions ing, of circumstances that may lead
that it is unfit for food; or FDA to withdraw the exemption, and
(ii) Section 402(a)(4) of the Federal provide an opportunity for the owner,
Food, Drug, and Cosmetic Act in that operator, or agent in charge of the
the food has been prepared, packed, or farm to respond in writing, within 15
held under insanitary conditions calendar days of the date of receipt of
whereby it may have become contami- the notification, to FDA’s notification;
nated with filth, or whereby it may and
have been rendered injurious to health; (3) Must consider the actions taken
or by the farm to address the cir-
(2) In violation of section 361 of the cumstances that may lead FDA to
Public Health Service Act (42 U.S.C. withdraw the exemption.
264).
§ 112.202 What procedure will FDA use
§ 112.193 What are the provisions for to withdraw an exemption?
coordination of education and en-
forcement? (a) An FDA District Director in
Under section 419(b)(2)(A) of the Fed- whose district the farm is located (or,
eral Food, Drug, and Cosmetic Act, in the case of a foreign farm, the Direc-
FDA coordinates education and en- tor of the Office of Compliance in the
forcement activities by State, terri- Center for Food Safety and Applied Nu-
torial, tribal, and local officials by trition), or an FDA official senior to ei-
helping develop education, training, ther such Director, must approve an
and enforcement approaches. order to withdraw the exemption be-
fore the order is issued.
Subpart R—Withdrawal of (b) Any officer or qualified employee
Qualified Exemption of FDA may issue an order to withdraw
the exemption after it has been ap-
§ 112.201 Under what circumstances proved in accordance with paragraph
can FDA withdraw a qualified ex- (a) of this section.
emption in accordance with the re-
quirements of § 112.5? (c) FDA must issue an order to with-
draw the exemption to the owner, oper-
(a) We may withdraw your qualified ator, or agent in charge of the farm.
exemption under § 112.5:
(d) FDA must issue an order to with-
(1) In the event of an active inves-
tigation of a foodborne illness outbreak draw the exemption in writing, signed
that is directly linked to your farm; or and dated by the officer or qualified
(2) If we determine that it is nec- employee of FDA who is issuing the

essary to protect the public health and order.
prevent or mitigate a foodborne illness
317
§ 112.203 21 CFR Ch. I (4–1–16 Edition)
§ 112.203 What information must FDA (i) The name and the title of the FDA
include in an order to withdraw a representative who approved the order.
qualified exemption?
An order to withdraw a qualified ex- § 112.204 What must I do if I receive an
order to withdraw a qualified ex-
emption applicable to a farm under emption applicable to my farm?
§ 112.5 must include the following infor-
mation: The owner, operator, or agent in
(a) The date of the order; charge of a farm that receives an order
(b) The name, address and location of to withdraw a qualified exemption ap-
the farm; plicable to that farm under § 112.5 must
(c) A brief, general statement of the either:
reasons for the order, including infor- (a) Comply with applicable require-
mation relevant to one or both of the ments of this part within 120 calendar
following circumstances that leads days of the date from receipt of the
FDA to issue the order: order or, if operations have ceased and
(1) An active investigation of a will not resume within 120 calendar
foodborne illness outbreak that is di- days, before the beginning of oper-
rectly linked to the farm; or ations in the next growing season, or
(2) Conduct or conditions associated within a reasonable timeframe, agreed
with a farm that are material to the to by FDA, based on a written jus-
safety of the food that would otherwise tification, submitted to FDA, for a
be covered produce grown, harvested, timeframe that exceeds 120 calendar
packed and held at such farm. days from the date of receipt of the
(d) A statement that the farm must order; or
either: (b) Appeal the order within 15 cal-
(1) Comply with subparts B through O endar days of the date of receipt of the
of this part on the date that is 120 cal- order in accordance with the require-
endar days from the date of receipt of ments of § 112.206.
the order, or within a reasonable time-
frame, agreed to by FDA, based on a § 112.205 Can I appeal or request a
written justification, submitted to hearing on an order to withdraw a
FDA, for a timeframe that exceeds 120 qualified exemption applicable to
my farm?
calendar days from the date of receipt
of the order; or (a) Submission of an appeal, includ-
(2) Appeal the order within 15 cal- ing submission of a request for an in-
endar days of the date of receipt of the formal hearing, will not operate to
order in accordance with the require- delay or stay any administrative ac-
ments of § 112.206. tion, including enforcement action by
(e) A statement that a farm may re- FDA, unless the Commissioner of Food
quest that FDA reinstate an exemption and Drugs, as a matter of discretion,
that was withdrawn by following the determines that delay or a stay is in
procedures in § 112.213; the public interest.
(f) The text of section 419(f) of the (b) If the owner, operator, or agent in
Federal Food, Drug, and Cosmetic Act charge of the farm appeals the order,
and of this subpart; and FDA confirms the order:
(g) A statement that any informal (1) The owner, operator, or agent in
hearing on an appeal of the order must charge of the farm must comply with
be conducted as a regulatory hearing applicable requirements of this part
under part 16 of this chapter, with cer- within 120 calendar days from the date
tain exceptions described in § 112.208; of receipt of the order, or, if operations
(h) The mailing address, telephone have ceased and will not resume within
number, email address, and facsimile 120 calendar days, before the beginning
number of the FDA district office and of operations in the next growing sea-
the name of the FDA District Director son, or within a reasonable timeframe,
in whose district the farm is located agreed to by FDA, based on a written
(or for foreign farms, the same infor- justification, submitted to FDA, for a
mation for the Director of the Office of timeframe that exceeds 120 calendar
Compliance in the Center for Food days from the date of receipt of the
Safety and Applied Nutrition); and order; and
318
(2) The owner, operator, or agent in § 112.208 What requirements are appli-
charge of the farm is no longer subject cable to an informal hearing?
to the modified requirements in §§ 112.6 If the owner, operator, or agent in
and 112.7. charge of the farm requests an infor-
mal hearing, and FDA grants the re-
§ 112.206 What is the procedure for
quest:
submitting an appeal?
(a) The hearing will be held within 15
(a) To appeal an order to withdraw a calendar days after the date the appeal
qualified exemption applicable to a is filed or, if applicable, within a time-
farm under § 112.5, the owner, operator, frame agreed upon in writing by the
or agent in charge of the farm must: owner, operator, or agent in charge of
(1) Submit the appeal in writing to the farm and FDA.
the FDA District Director in whose dis- (b) The presiding officer may require
trict the farm is located (or in the case that a hearing conducted under this
of a foreign farm, the Director of the subpart be completed within 1 calendar
Office of Compliance in the Center for day, as appropriate.
Food Safety and Applied Nutrition), at (c) FDA must conduct the hearing in
the mailing address, email address, or accordance with part 16 of this chapter,
facsimile number identified in the except that:
order within 15 calendar days of the (1) The order withdrawing an exemp-
date of receipt of the order; and tion under § 112.5, rather than the no-
(2) Respond with particularity to the tice under § 16.22(a) of this chapter, pro-
facts and issues contained in the order, vides notice of the opportunity for a
including any supporting documenta- hearing under this section and is part
tion upon which the owner, operator or of the administrative record of the reg-
agent in charge of the farm relies. ulatory hearing under § 16.80(a) of this
(b) In a written appeal of the order chapter.
withdrawing an exemption provided (2) A request for a hearing under this
under § 112.5, the owner, operator, or subpart must be addressed to the FDA
agent in charge of the farm may in- District Director (or, in the case of a
clude a written request for an informal foreign farm, the Director of the Office
hearing as provided in § 112.207. of Compliance in the Center for Food
Safety and Applied Nutrition) as pro-
§ 112.207 What is the procedure for re- vided in the order withdrawing an ex-
questing an informal hearing? emption.
(a) If the owner, operator, or agent in (3) Section 112.209, rather than
charge of the farm appeals the order, § 16.42(a) of this chapter, describes the
FDA employees who preside at hear-
the owner, operator, or agent in charge
ings under this subpart.
of the farm:
(4) Section 16.60(e) and (f) of this
(1) May request an informal hearing;
chapter does not apply to a hearing
and
under this subpart. The presiding offi-
(2) Must submit any request for an cer must prepare a written report of
informal hearing together with its the hearing. All written material pre-
written appeal submitted in accordance sented at the hearing will be attached
with § 112.206 within 15 calendar days of to the report. The presiding officer
the date of receipt of the order. must include as part of the report of
(b) A request for an informal hearing the hearing a finding on the credibility
may be denied, in whole or in part, if of witnesses (other than expert wit-
the presiding officer determines that nesses) whenever credibility is a mate-
no genuine and substantial issue of ma- rial issue, and must include a proposed
terial fact has been raised by the mate- decision, with a statement of reasons.
rial submitted. If the presiding officer The hearing participant may review
determines that a hearing is not justi- and comment on the presiding officer’s
fied, a written notice of the determina- report within 2 calendar days of
tion will be given to the owner, oper- issuance of the report. The presiding
ator, or agent in charge of the farm ex- officer will then issue the final deci-
plaining the reason for the denial. sion.
319
§ 112.209 21 CFR Ch. I (4–1–16 Edition)
(5) Section 16.80(a)(4) of this chapter participants to review and submit com-
does not apply to a regulatory hearing ments on the report of the hearing
under this subpart. The presiding offi- under § 112.208(c)(4), and must issue a
cer’s report of the hearing and any final decision within 10 calendar days
comments on the report by the hearing after the hearing is held; or
participant under § 112.208(c)(4) are part (2) If FDA denies the request for a
of the administrative record. hearing, the presiding officer must
(6) No party shall have the right, issue a final decision on the appeal
under § 16.119 of this chapter to petition confirming or revoking the withdrawal
the Commissioner of Food and Drugs within 10 calendar days after the date
for reconsideration or a stay of the pre- the appeal is filed.
siding officer’s final decision.
(7) If FDA grants a request for an in- § 112.211 When is an order to with-
formal hearing on an appeal of an order draw a qualified exemption applica-
withdrawing an exemption, the hearing ble to a farm revoked?
must be conducted as a regulatory An order to withdraw a qualified ex-
hearing under a regulation in accord- emption applicable to a farm under
ance with part 16 of this chapter, ex- § 112.5 is revoked if:
cept that § 16.95(b) does not apply to a (a) The owner, operator, or agent in
hearing under this subpart. With re- charge of the farm appeals the order
spect to a regulatory hearing under and requests an informal hearing, FDA
this subpart, the administrative record grants the request for an informal
of the hearing specified in §§ 16.80(a)(1), hearing, and the presiding officer does
(2), (3), and (5) of this chapter and not confirm the order within the 10 cal-
112.208(c)(5) constitutes the exclusive endar days after the hearing, or issues
record for the presiding officer’s final a decision revoking the order within
decision. For purposes of judicial re- that time; or
view under § 10.45 of this chapter, the (b) The owner, operator, or agent in
record of the administrative pro- charge of the farm appeals the order
ceeding consists of the record of the and requests an informal hearing, FDA
hearing and the presiding officer’s final denies the request for an informal
decision. hearing, and FDA does not confirm the
order within the 10 calendar days after
§ 112.209 Who is the presiding officer the appeal is filed, or issues a decision
for an appeal and for an informal revoking the order within that time; or
hearing?
(c) The owner, operator, or agent in
The presiding officer for an appeal, charge of the farm appeals the order
and for an informal hearing, must be without requesting an informal hear-
an FDA Regional Food and Drug Direc- ing, and FDA does not confirm the
tor or another FDA official senior to order within the 10 calendar days after
an FDA District Director. the appeal is filed, or issues a decision
revoking the order within that time.
§ 112.210 What is the timeframe for (d) Confirmation of a withdrawal
issuing a decision on an appeal?
order by the presiding officer is consid-
(a) If the owner, operator, or agent in ered a final Agency action for purposes
charge of a farm appeals the order of 5 U.S.C. 702.
without requesting a hearing, the pre-
siding officer must issue a written re- § 112.213 If my qualified exemption is
port that includes a final decision con- withdrawn, under what cir-
firming or revoking the withdrawal by cumstances would FDA reinstate
the 10th calendar day after the appeal my qualified exemption?
is filed. (a) If the FDA District Director in
(b) If the owner, operator, or agent in whose district your farm is located (or,
charge of a farm appeals the order and in the case of a foreign farm, the Direc-
requests an informal hearing: tor of the Office of Compliance in the
(1) If FDA grants the request for a Center for Food Safety and Applied Nu-
hearing and the hearing is held, the trition) determines that the farm has
presiding officer must provide a 2 cal- adequately resolved any problems with
endar day opportunity for the hearing the conduct and conditions that are
320
material to the safety of the food pro- PART 113—THERMALLY PROCESSED

duced or harvested at such farm, and LOW-ACID FOODS PACKAGED
that continued withdrawal of the ex- IN HERMETICALLY SEALED CON-
emption is not necessary to protect the TAINERS
public health or prevent or mitigate a
foodborne illness outbreak, the FDA Subpart A—General Provisions
District Director in whose district your
farm is located (or, in the case of a for- Sec.
eign farm, the Director of the Office of 113.3 Definitions.
Compliance in the Center for Food 113.5 Current good manufacturing practice.
113.10 Personnel.
Safety and Applied Nutrition) will, on
his own initiative or at the request of Subpart B [Reserved]
a farm, reinstate the qualified exemp-
tion. Subpart C—Equipment
(b) You may ask FDA to reinstate a
113.40 Equipment and procedures.
qualified exemption that has been
withdrawn under the procedures of this Subpart D—Control of Components, Food
subpart as follows: Product Containers, Closures, and In-
(1) Submit a request, in writing, to Process Material
the FDA District Director in whose dis-
trict your farm is located (or, in the 113.60 Containers.
case of a foreign farm, the Director of Subpart E—Production and Process
the Office of Compliance in the Center Controls
for Food Safety and Applied Nutrition);
and 113.81 Product preparation.
(2) Present, in writing, data and in- 113.83 Establishing scheduled processes.
113.87 Operations in the thermal processing
formation to demonstrate that you
room.
have adequately resolved any problems 113.89 Deviations in processing, venting, or
with the conduct and conditions that control of critical factors.
produced and harvested at your farm, Subpart F—Records and Reports
such that continued withdrawal of the
113.100 Processing and production records.
exemption is not necessary to protect
the public health and prevent or miti- AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C.
264.
gate a foodborne illness outbreak.
(c) If your qualified exemption was SOURCE: 44 FR 16215, Mar. 16, 1979, unless
withdrawn under § 112.201(a)(1) and FDA otherwise noted.
later determines, after finishing the
active investigation of a foodborne ill- Subpart A—General Provisions
ness outbreak, that the outbreak is not
directly linked to your farm, FDA will § 113.3 Definitions.
reinstate your qualified exemption For the purposes of this part, the fol-
under § 112.5, and FDA will notify you lowing definitions apply:
in writing that your exempt status has (a) Aseptic processing and packaging
been reinstated. means the filling of a commercially
(d) If your qualified exemption was sterilized cooled product into pre-
withdrawn under § 112.201(a)(1) and (2) sterilized containers, followed by asep-
and FDA later determines, after fin- tic hermetical sealing, with a
ishing the active investigation of a presterilized closure, in an atmosphere
foodborne illness outbreak, that the free of microorganisms.
outbreak is not directly linked to your (b) Bleeders means openings used to
remove air that enters with steam
farm, FDA will inform you of this find-
from retorts and steam chambers and
ing, and you may ask FDA to reinstate
to promote circulation of steam in
your qualified exemption under § 112.5, such retorts and steam chambers.
in accordance with the requirements of Bleeders may serve as a means of re-
paragraph (b) of this section. moving condensate.
321
§ 113.3 21 CFR Ch. I (4–1–16 Edition)
(c) Come-up-time means the time (h) Headspace, gross is the vertical
which elapses between the introduction distance between the level of the prod-
of steam into the closed retort and the uct (generally the liquid surface) in an
time when the retort reaches the re- upright rigid container and the top
quired processing temperature. edge of the container (the top of the
(d) Commercial processor includes any double seam of a can or the top edge of
person engaged in commercial, custom, a glass jar).
or institutional (church, school, penal, (i) Headspace, net of a container is the
or other organization) processing of vertical distance between the level of
food, including pet food. Persons en- the product (generally the liquid sur-
gaged in the production of foods that face) in the upright rigid container and
are to be used in market or consumer the inside surface of the lid.
tests are also included. (j) Hermetically sealed container means
(e) Commercial sterility: (1) ‘‘Commer- a container that is designed and in-
cial sterility’’ of thermally processed tended to be secure against the entry
food means the condition achieved— of microorganisms and thereby to
(i) By the application of heat which maintain the commercial sterility of
renders the food free of— its contents after processing.
(a) Microorganisms capable of repro- (k) Incubation means the holding of a
ducing in the food under normal non- sample(s) at a specified temperature
refrigerated conditions of storage and for a specified period of time for the
distribution; and purpose of permitting or stimulating
(b) Viable microorganisms (including the growth of microorganisms.
spores) of public health significance; or (l) Initial temperature means the aver-
(ii) By the control of water activity age temperature of the contents of the
and the application of heat, which ren- coldest container to be processed at the
ders the food free of microorganisms time the thermal processing cycle be-
capable of reproducing in the food gins, as determined after thorough stir-
under normal nonrefrigerated condi- ring or shaking of the filled and sealed
tions of storage and distribution. container.
(2) ‘‘Commercial sterility’’ of equip- (m) Lot means that amount of a prod-
ment and containers used for aseptic uct produced during a period of time
processing and packaging of food indicated by a specific code.
means the condition achieved by appli-
(n) Low-acid foods means any foods,
cation of heat, chemical sterilant(s), or
other than alcoholic beverages, with a
other appropriate treatment that ren-
finished equilibrium pH greater than
ders the equipment and containers free
4.6 and a water activity (aw) greater
of viable microorganisms having public
than 0.85. Tomatoes and tomato prod-
health significance, as well as micro-
organisms of nonhealth significance, ucts having a finished equilibrium pH
capable of reproducing in the food less than 4.7 are not classed as low-acid
under normal nonrefrigerated condi- foods.
tions of storage and distribution. (o) Minimum thermal process means
(f) Critical factor means any property, the application of heat to food, either
characteristic, condition, aspect, or before or after sealing in a hermeti-
other parameter, variation of which cally sealed container, for a period of
may affect the scheduled process and time and at a temperature scientif-
the attainment of commercial ste- ically determined to be adequate to en-
rility. sure destruction of microorganisms of
(g) Flame sterilizer means an appa- public health significance.
ratus in which hermetically sealed con- (p) Operating process means the proc-
tainers are agitated at atmospheric ess selected by the processor that
pressure, by either continuous, dis- equals or exceeds the minimum re-
continuous, or reciprocating move- quirements set forth in the scheduled
ment, with impinging gas flames to process.
achieve sterilization temperatures. A (q) Retort means any closed vessel or

holding period in a heated section may other equipment used for the thermal
follow the initial heating period. processing of foods.
322
(r) Scheduled process means the proc- appropriate to the preservation tech-
ess selected by the processor as ade- nology involved and who has been iden-
quate under the conditions of manufac- tified by that school as having satisfac-
ture for a given product to achieve torily completed the prescribed course
commercial sterility. This process may of instruction. This person shall super-
be in excess of that necessary to ensure vise only in those areas for which a
destruction of microorganisms of pub- school approved by the Commissioner
lic health significance, and shall be at identifies the person as having satisfac-
least equivalent to the process estab- torily completed training.
lished by a competent processing au-
thority to achieve commercial ste- Subpart B [Reserved]
rility.
(s) Shall is used to state mandatory Subpart C—Equipment
requirements.
(t) Should is used to state rec- § 113.40 Equipment and procedures.
ommended or advisory procedures or to (a) Equipment and procedures for pres-
identify recommended equipment. sure processing in steam in still retorts—
(u) Vacuum-packed products means (1) Temperature-indicating device. Each
those products that are sealed in a con- retort shall be equipped with at least
tainer under the vacuum specified in one temperature-indicating device that
the scheduled process, the maintenance accurately indicates the temperature
of which vacuum is critical to the ade- during processing. Each temperature-
quacy of the scheduled process. indicating device shall have a sensor
(v) Vents means openings through the and a display. Each temperature-indi-
retort shell, controlled by gate, plug cating device and each reference device
cock, or other adequate valves used for that is maintained by the processor
the elimination of air during the vent- shall be tested for accuracy against a
ing period. reference device for which the accuracy
(w) Water activity (aw) is a measure of is traceable to a National Institute of
the free moisture in a product and is Standards and Technology (NIST), or
the quotient of the water vapor pres- other national metrology institute,
sure of the substance divided by the standard reference device by appro-
vapor pressure of pure water at the priate standard procedures, upon in-
same temperature. stallation and at least once a year
thereafter, or more frequently if nec-
§ 113.5 Current good manufacturing
practice. essary, to ensure accuracy during proc-
essing. Each temperature-indicating
The criteria in §§ 113.10, 113.40, 113.60, device and each reference device that is
113.81, 113.83, 113.87, 113.89, and 113.100 maintained by the processor shall have
shall apply in determining whether the a tag, seal, or other means of identity.
facilities, methods, practices, and con- (i) The design of the temperature-in-
trols used by the commercial processor dicating device shall ensure that the
in the manufacture, processing, or accuracy of the device is not affected
packing of low-acid foods in hermeti- by electromagnetic interference and
cally sealed containers are operated or environmental conditions.
administered in a manner adequate to (ii) Records of the accuracy of the
protect the public health. temperature-indicating device and of a
reference device that is maintained by
§ 113.10 Personnel. the processor shall be established and
The operators of processing systems, maintained in accordance with
retorts, aseptic processing and pack- § 113.100(c) and (d).
aging systems and product formulating (iii) A temperature-indicating device
systems (including systems wherein that is defective or cannot be adjusted
water activity is used in conjunction to the accurate calibrated reference de-
with thermal processing) and container vice shall be repaired before further
closure inspectors shall be under the use or replaced.
operating supervision of a person who (iv) A temperature-indicating device

has attended a school approved by the shall be accurate to 1 °F (0.5 °C). The
Commissioner for giving instruction temperature range of a mercury-in-
323
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
glass thermometer shall not exceed 17 parameters of the process time and
°F per inch (4 °C per centimeter) of process temperature have been met.
graduated scale. A mercury-in-glass (ii) Digital recordings. Temperature-
thermometer that has a divided mer- recording devices, such as data loggers,
cury column shall be considered defec- that record numbers or create other
tive. digital records may be used. Such a de-
(v) Each temperature-indicating device shall record the temperature at in-
vice shall be installed where it can be tervals that will assure that the pa-
accurately and easily read. The tem- rameters of the process time and proc-
perature-indicating device sensor shall ess temperature have been met.
be installed either within the retort (iii) Adjustments. The temperature-re-
shell or in external wells attached to cording device shall be adjusted with
the retort. External wells or pipes shall sufficient frequency to ensure agree-
be connected to the retort through at ment as nearly as possible with, but to
least a 3⁄4-inch (2 centimeters) diameter be in no event higher than, the tem-
opening and equipped with a 1⁄16-inch perature-indicating device during proc-
(1.5 millimeters) or larger bleeder open- essing. A means of preventing unau-
ing so located as to provide a full flow thorized changes in adjustment shall
of steam past the length of the tem- be provided. A lock or a notice from
perature-indicating device sensor. The management posted at or near the tem-
bleeders for external wells shall emit perature-recording device that provides
steam continuously during the entire a warning that only authorized persons
processing period. The temperature-in- are permitted to make adjustments is a
dicating device—not the temperature satisfactory means of preventing unau-
recording device—shall be the ref- thorized changes.
erence instrument for indicating the
(iv) Temperature controller. The tem-
processing temperature.
perature-recording device may be com-
(2) Temperature-recording device. Each
bined with the steam controller and
retort shall have an accurate tempera-
may be a recorder-controller.
ture-recording device. Each tempera-
ture-recording device shall have a sen- (3) Pressure gages. Each retort should
sor and a mechanism for recording be equipped with a pressure gage that
temperatures to a permanent record, is accurate to 2 pounds per square inch
such as a temperature-recording chart. (13.8 kilopascals) or less.
The temperature-recording device sen- (4) Steam controller. Each retort shall
sor shall be installed either within the be equipped with an automatic steam
retort shell or in a well attached to the controller to maintain the retort tem-
shell. Each temperature-recording de- perature. This may be a recorder-con-
vice sensor well shall have a 1⁄16-inch troller when combined with a tempera-
(1.5 millimeters) or larger bleeder that ture-recording device. The steam con-
emits steam continuously during the troller may be air-operated and actu-
processing period. ated by a temperature sensor posi-
(i) Analog or graphical recordings. tioned near the temperature-indicating
Temperature-recording devices that device in the retort. Air-operated tem-
create analog or graphical recordings perature controllers should have ade-
may be used. Temperature-recording quate filter systems to ensure a supply
devices that record to charts shall be of clean, dry air. A steam controller ac-
used only with the appropriate chart. tivated by the steam pressure of the re-
Each chart shall have a working scale tort is acceptable if it is carefully
of not more than 55 °F per inch (12 °C maintained mechanically so that it op-
per centimeter) within a range of 20 °F erates satisfactorily.
(10 °C) of the process temperature. (5) Steam inlet. The steam inlet to
Chart graduations shall not exceed 2 °F each still retort shall be large enough
(1 °C) within a range of 10 °F (5 °C) of to provide sufficient steam for proper
the process temperature. Temperature- operation of the retort. Steam may
recording devices that create enter either the top portion or the bot-
multipoint plottings of temperature tom portion of the retort but, in any

readings shall record the temperature case, shall enter the portion of the re-
at intervals that will assure that the tort opposite the vent; for example,
324
steam inlet in bottom portion and vent for holding containers shall be made of
in top portion. strap iron, adequately perforated sheet
(6) Crate supports. A bottom crate metal, or other suitable material.
support shall be used in vertical still When perforated sheet metal is used for
retorts. Baffle plates shall not be used the bottoms, the perforations should be
in the bottom of still retorts. approximately the equivalent of 1-inch
(7) Steam spreaders. Steam spreaders (2.5 centimeters) holes on 2-inch (5.1
are continuations of the steam inlet centimeters) centers. If dividers are
line inside the retort. Horizontal still used between the layers of containers,
retorts shall be equipped with steam they should be perforated as stated in
spreaders that extend the length of the this paragraph. The positioning of con-
retort. For steam spreaders along the tainers in the retort, when specified in
bottom of the retort, the perforations the scheduled process, shall be in ac-
should be along the top 90° of the pipe, cordance with that process.
that is, within 45° on either side of the (10) Air valves. Retorts using air for
top center. Horizontal still retorts over pressure cooling shall be equipped with
30 feet (9.1 meters) long should have a suitable valve to prevent air leakage
two steam inlets connected to the into the retort during processing.
spreader. In vertical still retorts, the
(11) Water valves. Retorts using water
steam spreaders, if used, should be per-
for cooling shall be equipped with a
forated along the center line of the
suitable valve to prevent leakage of
pipe facing the interior of the retort or
water into the retort during proc-
along the sides of the pipe. The number
essing.
of perforations should be such that the
total cross-sectional area of the per- (12) Vents. Vents shall be installed in
forations is equal to 1.5 to 2 times the such a way that air is removed from
cross-sectional area of the smallest re- the retort before timing of the process
striction in the steam inlet line. is started. Vents shall be controlled by
(8) Bleeders. Bleeders, except those for gate, plug cock, or other adequate type
temperature-indicating device wells, valves which shall be fully open to per-
shall be 1/8-inch (3 millimeters) or larg- mit rapid discharge of air from the re-
er and shall be wide open during the tort during the venting period. Vents
entire process, including the come-up shall not be connected directly to a
time. For horizontal still retorts, closed drain system. If the overflow is
bleeders shall be located within ap- used as a vent, there shall be an atmos-
proximately 1 foot (30.5 centimeters) of pheric break in the line before it con-
the outermost locations of containers nects to a closed drain. The vent shall
at each end along the top of the retort. be located in that portion of the retort
Additional bleeders shall be located opposite the steam inlet; for example,
not more than 8 feet (2.4 meters) apart steam inlet in bottom portion and vent
along the top. Bleeders may be in- in top portion. Where a retort manifold
stalled at positions other than those connects several vent pipes from a sin-
specified in this paragraph, as long as gle still retort, it shall be controlled by
there is evidence in the form of heat a gate, plug cock, or other adequate
distribution data that they accomplish type of valve. The retort manifold shall
adequate removal of air and circula- be of a size that the cross-sectional
tion of steam within the retort. area of the pipe is larger than the total
Vertical retorts shall have at least one cross-sectional area of all connecting
bleeder opening located in that portion vents. The discharge shall not be di-
of the retort opposite the steam inlet. rectly connected to a closed drain
In retorts having top steam inlet and without an atmospheric break in the
bottom venting, a bleeder shall be in- line. A manifold header connecting
stalled in the bottom of the retort to vents or manifolds from several still
remove condensate. All bleeders shall retorts shall lead to the atmosphere.
be arranged so that the operator can The manifold header shall not be con-
observe that they are functioning prop- trolled by a valve and shall be of a size
erly. that the cross-sectional area is at least

(9) Stacking equipment and position of equal to the total cross-sectional area
containers. Crates, trays, gondolas, etc., of all connecting retort manifold pipes
325
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
from all retorts venting simulta- without divider plates are given in
neously. Timing of the process shall paragraphs (a)(12)(i)(A) through
not begin until the retort has been (a)(12)(i)(D) and (a)(12)(ii)(A) and
properly vented and the processing (a)(12)(ii)(B) of this section.
temperature has been reached. Some (i) Venting horizontal retorts. (A) Vent-
typical installations and operating pro- ing through multiple 1-inch (2.5 centi-
cedures reflecting the requirements of meters) vents discharging directly to
this section for venting still retorts atmosphere.
(1) Specifications. One 1-inch (2.5 cen- (2) Venting method. Vent valves
timeters) vent for every 5 feet (1.5 me- should be wide open for at least 5 min-
ters) of retort length equipped with a utes and to at least 225 °F (107 °C), or at
gate or plug cock valve and discharging least 7 minutes and to at least 220 °F
to atmosphere; end vents not more (104.5 °C).
than 2.5 feet (76 centimeters) from ends (B) Venting through multiple 1-inch
of retort. (2.5 centimeters) vents discharging
through a manifold to atmosphere.
326
ER03MR11.000</GPH>
(1) Specifications. One 1-inch (2.5 cen- 15 feet (4.6 meters) and over in length,
timeters) vent for every 5 feet (1.5 me- 3 inches (7.6 centimeters).
ters) of retort length; and vents not (2) Venting method. Manifold vent
over 2.5 feet (76 centimeters) from ends gate or plug cock valve should be wide
of retort. Size of manifold—for retorts open for at least 6 minutes and to at
less than 15 feet (4.6 meters) in length, least 225 °F (107 °C), or for at least 8
2.5 inches (6.4 centimeters); for retorts minutes and to at least 220 °F (104.5 °C).
(C) Venting through water spreaders.
ER03MR11.002</GPH>
(1) Size of vent and vent valve. For re- length, 2 inches (5.1 centimeters); for
torts less than 15 feet (4.6 meters) in
327
ER03MR11.001</GPH>
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
retorts 15 feet (4.6 meters) and over in (3) Venting method. Water spreader
length, 2.5 inches (6.4 centimeters). vent gate or plug cock valve should be
(2) Size of water spreader. For retorts wide open for at least 5 minutes and to
less than 15 feet (4.6 meters) in length, at least 225 °F (107 °C), or for at least 7
1.5 inches (3.8 centimeters); for retorts minutes and to at least 220 °F (104.5 °C).
15 feet (4.6 meters) and over in length, (D) Venting through a single 2.5-inch
2 inches (5.1 centimeters). The number (6.4 centimeters) top vent (for retorts
of holes should be such that their total not exceeding 15 feet (4.6 meters) in
cross-sectional area is approximately
length).
equal to the cross-sectional area of the
vent pipe inlet.
(1) Specifications. A 2.5-inch (6.4 centi- least 4 minutes and to at least 220 °F
meters) vent equipped with a 2.5-inch (104.5 °C).
(6.4 centimeters) gate or plug cock (ii) Venting vertical retorts. (A) Vent-
valve and located within 2 feet (61 cen- ing through a 1.5-inch (3.8 centimeters)
timeters) of the center of the retort. overflow.
(2) Venting method. Vent gate or plug
cock valve should be wide open for at
328
ER03MR11.003</GPH>
(1) Specifications. A 1.5-inch (3.8 centi- (2) Venting method. Vent gate or plug
meters) overflow pipe equipped with a cock valve should be wide open for at
1.5-inch (3.8 centimeters) gate or plug least 4 minutes and to at least 218 °F
cock valve and with not more than 6 (103.5 °C), or for at least 5 minutes and
feet (1.8 meters) of 1.5-inch (3.8 centi- to at least 215 °F (102 °C).
meters) pipe beyond the valve before (B) Venting through a single 1-inch
break to the atmosphere or to a mani- (2.5 centimeters) side or top vent.
fold header.
329
ER03MR11.004</GPH>
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
(1) Specifications. A 1-inch (2.5 centi- essing record at intervals of sufficient

meters) vent in lid or top side, frequency to ensure that the factors
equipped with a 1-inch (2.5 centimeters) are within the limits specified in the
gate or plug cock valve and discharging scheduled process.
directly into the atmosphere or to a (i) When maximum fill-in or drained
manifold header. weight is specified in the scheduled
(2) Venting method. Vent gate or plug process, it shall be measured and re-
cock valve should be wide open for at corded at intervals of sufficient fre-
least 5 minutes and to at least 230 °F
quency to ensure that the weight of the
(110 °C), or for at least 7 minutes and to
at least 220 °F (104.5 °C). product does not exceed the maximum
(iii) Other procedures. Other installa- for the given container size specified in
tions and operating procedures that de- the scheduled process.
viate from the requirements in para- (ii) Closing machine vacuum in vacu-
graph (a)(12) of this section may be um-packed products shall be observed
used if there is evidence in the form of and recorded at intervals of sufficient
heat distribution data, which shall be frequency to ensure that the vacuum is
kept on file, that they accomplish ade- as specified in the scheduled process.
quate venting of air. (iii) Such measurements and record-
(13) Critical factors. Critical factors ings should be made at intervals not to
specified in the scheduled process shall exceed 15 minutes.
be measured and recorded on the proc-
330
ER03MR11.005</GPH>
(iv) When the product style results in izontal and vertical retorts, the tem-
stratification or layering of the pri- perature-indicating device sensor shall
mary product in the containers, the po- be inserted directly into the retort
sitioning of containers in the retort shell or in a separate well or sleeve at-
shall be according to the scheduled tached to the retort. The temperature-
process. indicating device sensor shall be lo-
(b) Equipment and procedures for pres- cated so that it is beneath the surface
sure processing in water in still retorts— of the water throughout the process
(1) Temperature-indicating device. Each and where there is adequate circulation
retort shall be equipped with at least to ensure accurate temperature meas-
one temperature-indicating device that urement. On horizontal retorts, the
accurately indicates the temperature
temperature-indicating device sensor
during processing. Each temperature-
should be located in the side at the
indicating device shall have a sensor
and a display. Each temperature-indi- center of the retort. The temperature-
cating device and each reference device indicating device—not the tempera-
that is maintained by the processor ture-recording device—shall be the ref-
shall be tested for accuracy against a erence instrument for indicating the
reference device for which the accuracy processing temperature.
is traceable to a National Institute of (2) Temperature-recording device. Each
Standards and Technology (NIST), or retort shall have an accurate tempera-
other national metrology institute, ture-recording device. Each tempera-
standard reference device by appro- ture-recording device shall have a sen-
priate standard procedures, upon in- sor and a mechanism for recording
stallation and at least once a year temperatures to a permanent record,
thereafter, or more frequently if nec- such as a temperature-recording chart.
essary, to ensure accuracy during proc- (i) Analog or graphical recordings.
essing. Each temperature-indicating Temperature-recording devices that
device and each reference device that is create analog or graphical recordings
maintained by the processor shall have may be used. Temperature-recording
a tag, seal, or other means of identity. devices that record to charts shall be
(i) The design of the temperature-in- used only with the appropriate chart.
dicating device shall ensure that the
Each chart shall have a working scale
accuracy of the device is not affected
of not more than 55 °F per inch (12 °C
by electromagnetic interference and
per centimeter) within a range of 20 °F
environmental conditions.
(ii) Records of the accuracy of the (10 °C) of the process temperature.
temperature-indicating device and of a Chart graduations shall not exceed 2 °F
reference device that is maintained by (1 °C) within a range of 10 °F (5 °C) of
the processor shall be established and the process temperature. Temperature-
maintained in accordance with recording devices that create
§ 113.100(c) and (d). multipoint plottings of temperature
(iii) A temperature-indicating device readings shall record the temperature
that is defective or cannot be adjusted at intervals that will assure that the
to the accurate calibrated reference de- parameters of the process time and
vice shall be repaired before further process temperature have been met.
use or replaced. (ii) Digital recordings. Temperature-
(iv) A temperature-indicating device recording devices, such as data loggers,
shall be accurate to 1 °F (0.5 °C). The that record numbers or create other
temperature range of a mercury-in- digital records may be used. Such a de-
glass thermometer shall not exceed 17 vice shall record the temperature at in-
°F per inch (4 °C per centimeter) of tervals that will assure that the pa-
graduated scale. A mercury-in-glass rameters of the process time and proc-
thermometer that has a divided mer- ess temperature have been met.
cury column shall be considered defec-
(iii) Adjustments. The temperature-re-
tive.
cording device shall be adjusted with

(v) Each temperature-indicating de-
vice shall be installed where it can be sufficient frequency to ensure agree-
accurately and easily read. In both hor- ment as nearly as possible with, but to
331
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
be in no event higher than, the tem- (5) Steam introduction. Steam shall be
perature-indicating device during proc- distributed in the bottom of the retort
essing. A means of preventing unau- in a manner adequate to provide uni-
thorized changes in adjustment shall form heat distribution throughout the
be provided. A lock or a notice from retort. In vertical retorts, uniform
management posted at or near the tem- steam distribution can be achieved by
perature-recording device that provides any of several methods. In horizontal
a warning that only authorized persons retorts, the steam distributor shall run
are permitted to make adjustments is a the length of the bottom of the retort
satisfactory means of preventing unau- with perforations distributed uni-
thorized changes. formly along the upper part of the pipe.
(iv) Temperature controller. The tem- (6) Crate supports. A bottom crate
perature-recording device may be com- support shall be used in vertical still
bined with the steam controller and retorts. Baffle plates shall not be used
may be a combination recorder-con- in the bottom of the retort. Centering
troller. For a vertical retort equipped guides should be installed so as to en-
with a combination recorder-con- sure that there is about a 1.5-inch (3.8
troller, the temperature recorder-con- centimeters) clearance between the
troller sensor shall be located at the side wall of the crate and the retort
bottom of the retort below the lowest wall.
crate rest in such a position that the (7) Stacking equipment and position of
steam does not strike it directly. For a containers. Crates, trays, gondolas, etc.,
horizontal retort equipped with a com- for holding containers shall be made of
bination recorder-controller, the tem- strap iron, adequately perforated sheet
perature recorder-controller sensor metal, or other suitable material.
shall be located between the water sur- When perforated sheet metal is used for
face and the horizontal plane passing the bottoms, the perforations should be
through the center of the retort so that approximately the equivalent of 1-inch
there is no opportunity for direct (2.5 centimeters) holes on 2-inch (5.1
steam impingement on the sensor. For centimeters) centers. If divider plates
all still retort systems that pressure are used between the layers of con-
process in water and are equipped with tainers, they should be perforated as
combination recorder-controllers, the stated in this paragraph. The posi-
temperature recorder-controller sen- tioning of containers in the retort,
sors shall be located where the re- when specified in the scheduled proc-
corded temperature is an accurate ess, shall be in accordance with that
measurement of the scheduled process process. Dividers, racks, trays, or other
temperature and is not affected by the means of positioning of flexible con-
heating media. tainers shall be designed and employed
(3) Pressure gages. (i) Each retort to ensure even circulation of heating
should be equipped with a pressure medium around all containers in the
gage that is accurate to 2 pounds per retort.
square inch (13.8 kilopascals) or less. (8) Drain valve. A nonclogging, water-
(ii) Each retort should have an ad- tight valve shall be used. A screen shall
justable pressure relief or control valve be installed or other suitable means
of a capacity sufficient to prevent an shall be used on all drain openings to
undesired increase in retort pressure prevent clogging.
when the water valve is wide open and (9) Air supply and controls. In both
should be installed in the overflow line. horizontal and vertical still retorts for
(4) Steam controller. Each retort shall pressure processing in water, a means
be equipped with an automatic steam shall be provided for introducing com-
controller to maintain the retort tem- pressed air at the proper pressure and
perature. The steam controller may be rate. The proper pressure shall be con-
combined with a temperature-record- trolled by an automatic pressure con-
ing device and, thus, may be a com- trol unit. A check valve shall be pro-
bination recorder-controller. Air-oper- vided in the air supply line to prevent
ated temperature controllers should water from entering the system. Air or
have adequate filter systems to ensure water circulation shall be maintained
a supply of clean, dry air. continuously during the come-up time
332
and during processing and cooling peri- lating system. The pump shall be de-
ods. The adequacy of the air or water signed to provide proper flow on start-
circulation for uniform heat distribu- up and during operation, such as with a
tion within the retort shall be estab- bleeder or other suitable means to re-
lished in accordance with procedures move air during startup and with an
recognized by a competent processing appropriate device or design to prevent
authority and records shall be kept on pump cavitation during operation. The
file. If air is used to promote circula- pump shall be equipped with a sig-
tion, it shall be introduced into the naling device to warn the operator
steam line at a point between the re- when it is not running. Alternative
tort and the steam control valve at the methods for circulation of water in the
bottom of the retort. retort may be used when established by
(10) Water level indicator. There shall a competent authority as adequate for
be a means of determining the water even heat distribution.
level in the retort during operation, (12) Cooling water supply. In vertical
e.g., by using a sensor, gage, water retorts, the cooling water should be in-
glass, or petcock(s). Water shall cover troduced at the top of the retort be-
the top layer of containers during the
tween the water and container levels.
entire come-up time and processing pe-
In horizontal retorts the cooling water
riods and should cover the top layer of
should be introduced into the suction
containers during the cooling periods.
side of the pump. A check valve should
The operator shall check and record
the water level at intervals sufficient be included in the cooling water line.
to ensure its adequacy. (13) Retort headspace. The headspace
(11) Water circulation. When a water necessary to control the air pressure
circulating system is used for heat dis- should be maintained between the
tribution, it shall be installed in such a water level and the top of the retort
manner that water will be drawn from shell.
the bottom of the retort through a suc- (14) Vertical and horizontal still retorts.
tion manifold and discharged through a Vertical and horizontal still retorts
spreader which extends the length of should follow the arrangements in the
the top of the retort. The holes in the diagrams in this paragraph. Other in-
water spreader shall be uniformly dis- stallation and operating procedures
tributed and should have an aggregate that deviate from these arrangements
area not greater than the cross-sec- may be used, as long as there is evi-
tional area of the outlet line from the dence in the form of heat distribution
pump. The suction outlets shall be pro- data or other suitable information,
tected with nonclogging screens or which shall be kept on file, which dem-
other suitable means shall be used to onstrates that the heat distribution is
keep debris from entering the circu- adequate.
333
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
LEGEND FOR VERTICAL AND HORIZONTAL C—Temperature control.

D—Overflow line.
STILL RETORTS
E1—Drain line.
A—Water line. E2—Screens.
B—Steam line. F—Check valves.
334
ER03MR11.006</GPH>
G—Line from hot water storage. device shall have a sensor and a dis-
H—Suction line and manifold. play. Each temperature-indicating de-
I—Circulating pump. vice and each reference device that is
J—Petcocks.
K—Recirculating line. maintained by the processor shall be
L—Steam distributor. tested for accuracy against a reference
M—Temperature-controller sensor. device for which the accuracy is trace-
N—Temperature-indicating device sensor. able to a National Institute of Stand-
O—Water spreader. ards and Technology (NIST), or other
P—Safety valve. national metrology institute, standard
Q—Vent valve for steam processing.
R—Pressure gage.
reference device by appropriate stand-
S—Inlet air control. ard procedures, upon installation and
T—Pressure control. at least once a year thereafter, or more
U—Air line. frequently if necessary, to ensure accu-
V—To pressure control instrument. racy during processing. Each tempera-
W—To temperature control instrument. ture-indicating device and each ref-
X—Wing nuts. erence device that is maintained by the
Y1—Crate support.
Y2—Crate guides. processor shall have a tag, seal, or
Z—Constant flow orifice valve. other means of identity.
Z1—Constant flow orifice valve used during (i) The design of the temperature-in-
come-up. dicating device shall ensure that the
Z2—Constant flow orifice valve used during accuracy of the device is not affected
cook. by electromagnetic interference and
(15) Critical factors. Critical factors environmental conditions.
specified in the scheduled process shall (ii) Records of the accuracy of the
be measured and recorded on the proc- temperature-indicating device and of a
essing record at intervals of sufficient reference device that is maintained by
frequency to ensure that the factors the processor shall be established and
are within the limits specified in the maintained in accordance with
scheduled process. § 113.100(c) and (d).
(i) When maximum fill-in or drained (iii) A temperature-indicating device
weight is specified in the scheduled that is defective or cannot be adjusted
process, it shall be measured and re- to the accurate calibrated reference de-
corded at intervals of sufficient fre- vice shall be repaired before further
quency to ensure that the weight of the use or replaced.
product does not exceed the maximum (iv) A temperature-indicating device
for the given container size specified in shall be accurate to 1 °F (0.5 °C). The
the scheduled process. temperature range of a mercury-in-
(ii) Closing machine vacuum in vacu- glass thermometer shall not exceed 17
um-packed products shall be observed °F per inch (4 °C per centimeter) of
and recorded at intervals of sufficient graduated scale. A mercury-in-glass
frequency to ensure that the vacuum is thermometer that has a divided mer-
as specified in the scheduled process. cury column shall be considered defec-
(iii) Such measurements and record- tive.
ings should be made at intervals not to (v) Each temperature-indicating de-
exceed 15 minutes. vice shall be installed where it can be
(iv) When the product style results in accurately and easily read. The tem-
stratification or layering of the pri- perature-indicating device sensor shall
mary product in the containers, the po- be installed either within the retort
sitioning of containers in the retort shell or in external wells attached to
shall be according to the scheduled the retort. External wells or pipes shall
process. be connected to the retort through at
(c) Equipment and procedures for pres- least a 3⁄4-inch (2 centimeters) diameter
sure processing in steam in continuous opening and equipped with a 1⁄16-inch
agitating retorts—(1) Temperature-indi- (1.5 millimeters) or larger bleeder open-
cating device. Each retort shall be ing so located as to provide a full flow
equipped with at least one tempera- of steam past the length of the tem-
ture-indicating device that accurately perature-indicating device sensor. The

indicates the temperature during proc- bleeders for external wells shall emit
essing. Each temperature-indicating steam continuously during the entire
335
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
processing period. The temperature-in- are permitted to make adjustments is a

dicating device—not the temperature- satisfactory means of preventing unau-
recording device—shall be the ref- thorized changes.
erence instrument for indicating the (iv) Temperature controller. The tem-
processing temperature. perature-recording device may be com-
(2) Temperature-recording device. Each bined with the steam controller and
retort shall have an accurate tempera- may be a recorder-controller.
ture-recording device. Each tempera- (3) Pressure gages. Each retort should
ture-recording device shall have a sen- be equipped with a pressure gage that
sor and a mechanism for recording is accurate to 2 pounds per square inch
temperatures to a permanent record, (13.8 kilopascals) or less.
such as a temperature-recording chart. (4) Steam controller. Each retort shall
The temperature-recording device sen- be equipped with an automatic steam
sor shall be installed either within the controller to maintain the retort tem-
retort shell or in a well attached to the perature. This may be a recorder-con-
shell. Each temperature-recording de- troller when combined with a tempera-
vice sensor well shall have a 1⁄16-inch ture-recording device. A steam con-
(1.5 millimeters) or larger bleeder that troller activated by the steam pressure
emits steam continuously during the of the retort is acceptable if it is care-
processing period. fully maintained mechanically so that
(i) Analog or graphical recordings. it operates satisfactorily. Air-operated
Temperature-recording devices that temperature controllers should have
create analog or graphical recordings adequate filter systems to ensure a
may be used. Temperature-recording supply of clean, dry air.
devices that record to charts shall be (5) Bleeders. Bleeders, except those for
used only with the appropriate chart. temperature-indicating device wells,
Each chart shall have a working scale shall be 1⁄8-inch (3 millimeters) or larg-
of not more than 55 °F per inch (12 °C er and shall be wide open during the
per centimeter) within a range of 20 °F entire process, including the come-up
(10 °C) of the process temperature. time. Bleeders shall be located within
Chart graduations shall not exceed 2 °F approximately 1 foot (30.5 centimeters)
(1 °C) within a range of 10 °F (5 °C) of of the outermost location of containers
the process temperature. Temperature- at each end along the top of the retort.
recording devices that create Additional bleeders shall be located
multipoint plottings of temperature not more than 8 feet (2.4 meters) apart
readings shall record the temperature along the top of the retort. All bleeders
at intervals that will assure that the shall be arranged so that the operator
parameters of the process time and can observe that they are functioning
process temperature have been met. properly. The condensate bleeder shall
(ii) Digital recordings. Temperature- be checked with sufficient frequency to
recording devices, such as data loggers, ensure adequate removal of condensate
that record numbers or create other or shall be equipped with an automatic
digital records may be used. Such a de- alarm system(s) that would serve as a
vice shall record the temperature at in- continuous monitor of condensate-
tervals that will assure that the pa- bleeder functioning. Visual checks
rameters of the process time and proc- should be done at intervals of not more
ess temperature have been met. than 15 minutes. A record of such
(iii) Adjustments. The temperature-re- checks should be kept to show that the
cording device shall be adjusted with bleeder is functioning properly.
sufficient frequency to ensure agree- (6) Venting and condensate removal.
ment as nearly as possible with, but to Vents shall be located in that portion
be in no event higher than, the tem- of the retort opposite the steam inlet.
perature-indicating device during proc- Air shall be removed before processing
essing. A means of preventing unau- is started. Heat distribution data or
thorized changes in adjustment shall documentary proof from the manufac-
be provided. A lock or a notice from turer or from a competent processing
management posted at or near the tem- authority, demonstrating that ade-

perature-recording device that provides quate venting is achieved, shall be kept
a warning that only authorized persons on file. At the time steam is turned on,
336
the drain should be opened for a time records required in this chapter. If the
sufficient to remove steam condensate alternative procedure of prompt cool-
from the retort, and provision shall be ing is followed, the subsequent han-
made for continuing drainage of con- dling methods used for the containers
densate during the retort operation. in the retort at the time of stopping
The condensate bleeder in the bottom and cooling shall be entered on the pro-
of the shell serves as an indicator of duction records.
continuous condensate removal. (9) Temperature drop. If the tempera-
(7) Retort speed timing. The rotational ture of the continuous retort drops
speed of the retort shall be specified in below the temperature specified in the
the scheduled process. The speed shall scheduled process while containers are
be adjusted and recorded when the rein the retort, the retort reel shall be
tort is started, at any time a speed stopped promptly. An automatic device
change is made, and at intervals of suf- should be used to stop the reel when
ficient frequency to ensure that the re- the temperature drops below the speci-
tort speed is maintained as specified in fied process temperature. Before the
the scheduled process. These adjust- reel is restarted, all containers in the
ments and recordings should be made retort shall be given a complete sched-
every 4 hours or less. Alternatively, a uled still retort process if the tempera-
recording tachometer may be used to ture drop was 10 °F (5 °C) or more below
provide a continuous record of the the specified temperature, or alter-
speed. A means of preventing unau- natively, container entry to the retort
thorized speed changes on retorts shall shall be stopped and the reel restarted
be provided. A lock or a notice from to empty the retort. The discharged
management posted at or near the containers shall be either reprocessed,
speed adjustment device that provides repacked and reprocessed, or discarded.
a warning that only authorized persons Both the time at which the reel
are permitted to make adjustments is a stopped and the time the retort was
satisfactory means of preventing unau- used for a still retort process, if so
thorized changes. used, shall be indicated on the tem-
(8) Emergency stops. If a retort jams perature-recording device record and
or breaks down during processing oper- entered on the other production
ations, necessitating cooling the retort records required in this chapter. If the
for repairs, the retort shall be operated alternative procedure of emptying the
in such a way that ensures that the retort is followed, the subsequent han-
product is commercially sterile, or the dling methods used for the containers
retort is to be cooled promptly and all in the retort at the time of the tem-
containers either reprocessed, repacked perature drop shall be entered on the
and reprocessed, or discarded. When op- production records. If the temperature
erated as a still retort, all containers drop was less than 10 °F (5 °C), a sched-
shall be given a full still retort process uled authorized emergency still process
before the retort is cooled. If, in such approved by a qualified person(s) hav-
an emergency, a scheduled still process ing expert knowledge of thermal proc-
or another process established to en- essing requirements may be used before
sure commercial sterility is to be used, restarting the retort reel. Alter-
it shall be made readily available to natively, container entry to the retort
the retort operator. shall be stopped and an authorized
(i) Any containers in the retort in- emergency agitating process may be
take valve or in transfer valves be- used before container entry to the re-
tween cooker shells of a continuous retort is restarted. When emergency pro-
tort at the time of breakdown shall ei- cedures are used, no containers may
ther be reprocessed, repacked and re- enter the retort and the process and
processed, or discarded. procedures used shall be noted on the
(ii) Both the time at which the reel production records.
stopped and the time the retort was (10) Critical factors. Critical factors
used for a still retort process, if so specified in the scheduled process shall
used, shall be indicated on the tem- be measured and recorded on the proc-
perature-recording device record and essing record at intervals of sufficient
entered on the other production frequency to ensure that the factors
337
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
are within the limits specified in the frequently if necessary, to ensure accu-
scheduled process. The minimum racy during processing. Each tempera-
headspace of containers, if specified in ture-indicating device and each ref-
the scheduled process, shall be meas- erence device that is maintained by the
ured and recorded at intervals of suffi- processor shall have a tag, seal, or
cient frequency to ensure that the other means of identity.
headspace is as specified in the sched- (i) The design of the temperature-in-
uled process. The headspace of solder- dicating device shall ensure that the
tipped, lapseam (vent hole) cans may accuracy of the device is not affected
be measured by net weight determina- by electromagnetic interference and
tions. The headspace of double seamed environmental conditions.
cans may also be measured by net (ii) Records of the accuracy of the
weight determinations for homogenous temperature-indicating device and of a
liquids, taking into account the spe- reference device that is maintained by
cific can end profile and other factors the processor shall be established and
which affect the headspace, if proof of maintained in accordance with
the accuracy of such measurements is § 113.100(c) and (d).
maintained and the procedure and re- (iii) A temperature-indicating device
sultant headspace is in accordance that is defective or cannot be adjusted
with the scheduled process. When the to the accurate calibrated reference de-
product consistency is specified in the vice shall be repaired before further
scheduled process, the consistency of use or replaced.
the product shall be determined by ob- (iv) A temperature-indicating device
jective measurements on the product shall be accurate to 1 °F (0.5 °C). The
taken from the filler before processing temperature range of a mercury-in-
and recorded at intervals of sufficient glass thermometer shall not exceed 17
frequency to ensure that the consist- °F per inch (4 °C per centimeter) of
ency is as specified in the scheduled graduated scale. A mercury-in-glass
process. Minimum closing machine thermometer that has a divided mer-
vacuum in vacuum-packed products, cury column shall be considered defec-
maximum fill-in or drained weight, tive.
minimum net weight, and percent sol- (v) Each temperature-indicating de-
ids shall be as specified in the sched- vice shall be installed where it can be
uled process for all products when devi- accurately and easily read. The tem-
ations from such specifications may af- perature-indicating device sensor shall
fect the scheduled process. All meas- be installed either within the retort
urements and recordings of critical fac- shell or in external wells attached to
tors should be made at intervals not to the retort. External wells or pipes shall
exceed 15 minutes. be connected to the retort through at
(d) Equipment and procedures for pres- least a 3⁄4-inch (2 centimeters) diameter
sure processing in steam in discontinuous opening and equipped with a 1⁄16-inch
agitating retorts—(1) Temperature-indi- (1.5 millimeters) or larger bleeder open-
cating device. Each retort shall be ing so located as to provide a full flow
equipped with at least one tempera- of steam past the length of the tem-
ture-indicating device that accurately perature-indicating device sensor. The
indicates the temperature during proc- bleeders for external wells shall emit
essing. Each temperature-indicating steam continuously during the entire
device shall have a sensor and a dis- processing period. The temperature-in-
play. Each temperature-indicating de- dicating device—not the temperature-
vice and each reference device that is recording device—shall be the ref-
maintained by the processor shall be erence instrument for indicating the
tested for accuracy against a reference processing temperature.
device for which the accuracy is trace- (2) Temperature-recording device. Each
able to a National Institute of Stand- retort shall have an accurate tempera-
ards and Technology (NIST), or other ture-recording device. Each tempera-
national metrology institute, standard ture-recording device shall have a sen-
reference device by appropriate stand- sor and a mechanism for recording

ard procedures, upon installation and temperatures to a permanent record,
at least once a year thereafter, or more such as a temperature-recording chart.
338
The temperature-recording device sen- (4) Steam controller. Each retort shall
sor shall be installed either within the be equipped with an automatic steam
retort shell or in a well attached to the controller to maintain the retort tem-
shell. Each temperature-recording de- perature. This may be a recorder-con-
vice sensor well shall have a 1⁄16-inch troller when combined with a tempera-
(1.5 millimeters) or larger bleeder that ture-recording device. A steam con-
emits steam continuously during the troller activated by the steam pressure
processing period. of the retort is acceptable if it is me-
(i) Analog or graphical recordings. chanically maintained so that it oper-
Temperature-recording devices that ates satisfactorily. Air-operated tem-
create analog or graphical recordings perature controllers should have ade-
may be used. Temperature-recording quate filter systems to ensure a supply
devices that record to charts shall be of clean, dry air.
used only with the appropriate chart. (5) Bleeders. Bleeders, except those for
Each chart shall have a working scale temperature-indicating device wells,
of not more than 55 °F per inch (12 °C shall be 1⁄8-inch (3 millimeters) or larg-
per centimeter) within a range of 20 °F er and shall be wide open during the
(10 °C) of the process temperature. entire process, including the come-up
Chart graduations shall not exceed 2 °F time. Bleeders shall be located within
(1 °C) within a range of 10 °F (5 °C) of approximately 1 foot (30.5 centimeters)
the process temperature. Temperature- of the outermost location of con-
recording devices that create tainers, at each end along the top of
multipoint plottings of temperature the retort; additional bleeders shall be
readings shall record the temperature located not more than 8 feet (2.4 me-
at intervals that will assure that the ters) apart along the top. Bleeders may
parameters of the process time and be installed at positions other than
process temperature have been met. those specified in this paragraph, as
(ii) Digital recordings. Temperature- long as there is evidence in the form of
recording devices, such as data loggers, heat distribution data that they ac-
that record numbers or create other complish adequate removal of air and
digital records may be used. Such a de- circulation of heat within the retort.
vice shall record the temperature at in- In retorts having top steam inlet and
tervals that will assure that the pa- bottom venting, a bleeder shall be in-
rameters of the process time and proc- stalled in the bottom of the retort to
ess temperature have been met. remove condensate. All bleeders shall
(iii) Adjustments. The temperature-re- be arranged in a way that enables the
cording device shall be adjusted with operator to observe that they are func-
sufficient frequency to ensure agree- tioning properly.
ment as nearly as possible with, but to (6) Venting and condensate removal.
be in no event higher than, the tem- The air in each retort shall be removed
perature-indicating device during proc- before processing is started. Heat dis-
essing. A means of preventing unau- tribution data or documentary proof
thorized changes in adjustment shall from the manufacturer or from a com-
be provided. A lock or a notice from petent processing authority, dem-
management posted at or near the tem- onstrating that adequate venting is
perature-recording device that provides achieved, shall be kept on file. At the
a warning that only authorized persons time steam is turned on, the drain
are permitted to make adjustments is a should be opened for a time sufficient
satisfactory means of preventing unau- to remove steam condensate from the
thorized changes. retort and provision should be made for
(iv) Temperature controller. The tem- continuing drainage of condensate dur-
perature-recording device may be coming the retort operation.
bined with the steam controller and (7) Retort speed timing. The rotational
may be a recorder-controller. speed of the retort shall be specified in
(3) Pressure gages. Each retort should the scheduled process. The speed shall
be equipped with a pressure gage that be adjusted, as necessary, to ensure

is accurate to 2 pounds per square inch that the speed is as specified in the
(13.8 kilopascals) or less. scheduled process. The rotational speed
339
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
as well as the process time shall be re- maintained by the processor shall be
corded for each retort load processed. tested for accuracy against a reference
Alternatively, a recording tachometer device for which the accuracy is trace-
may be used to provide a continuous able to a National Institute of Stand-
record of the speed. A means of pre- ards and Technology (NIST), or other
venting unauthorized speed changes on national metrology institute, standard
retorts shall be provided. A lock or a reference device by appropriate stand-
notice from management posted at or ard procedures, upon installation and
near the speed-adjustment device that at least once a year thereafter, or more
provides a warning that only author- frequently if necessary, to ensure accu-
ized persons are permitted to make ad- racy during processing. Each tempera-
justments is a satisfactory means of ture-indicating device and each ref-
preventing unauthorized changes. erence device that is maintained by the
(8) Critical factors. Critical factors processor shall have a tag, seal, or
specified in the scheduled process shall
other means of identity.
(i) The design of the temperature-in-
essing record at intervals of sufficient
frequency to ensure that the factors dicating device shall ensure that the
are within the limits specified in the accuracy of the device is not affected
scheduled process. The minimum by electromagnetic interference and
headspace of containers in each retort environmental conditions.
load to be processed, if specified in the (ii) Records of the accuracy of the
scheduled process, shall be measured temperature-indicating device and of a
and recorded at intervals of sufficient reference device that is maintained by
frequency to ensure that the headspace the processor shall be established and
is as specified in the scheduled process. maintained in accordance with
The headspace of solder-tipped, lap § 113.100(c) and (d).
seam (vent hole) cans may be measured (iii) A temperature-indicating device
by net weight determinations. When that is defective or cannot be adjusted
the product consistency is specified in to the accurate calibrated reference de-
the scheduled process, the consistency vice shall be repaired before further
of the product shall be determined by use or replaced.
objective measurements on the product (iv) A temperature-indicating device
taken from the filler before processing shall be accurate to 1 °F (0.5 °C). The
and recorded at intervals of sufficient temperature range of a mercury-in-
frequency to ensure that the consist- glass thermometer shall not exceed 17
ency is as specified in the scheduled °F per inch (4 °C per centimeter) of
process. Minimum closing machine graduated scale. A mercury-in-glass
vacuum in vacuum-packed products,
thermometer that has a divided mer-
maximum fill-in or drained weight,
cury column shall be considered defec-
minimum net weight, and percent sol-
tive.
ids shall be as specified in the sched-
uled process for all products for which (v) Each temperature-indicating de-
deviations from such specifications vice shall be installed where it can be
may affect the scheduled process. All accurately and easily read. In both hor-
measurements and recordings of crit- izontal and vertical retorts, the tem-
ical factors should be made at intervals perature-indicating device sensor shall
not to exceed 15 minutes. be inserted directly into the retort
(e) Equipment and procedures for pres- shell or in a separate well or sleeve at-
sure processing in water in discontinuous tached to the retort. The temperature-
agitating retorts—(1) Temperature-indi- indicating device sensor shall be lo-
cating device. Each retort shall be cated so that it is beneath the surface
equipped with at least one tempera- of the water throughout the process
ture-indicating device that accurately and where there is adequate circulation
indicates the temperature during proc- to ensure accurate temperature meas-
essing. Each temperature-indicating urement. On horizontal retorts, the
device shall have a sensor and a dis- temperature-indicating device sensor

play. Each temperature-indicating de- should be located in the side at the
vice and each reference device that is center of the retort. The temperature-
340
indicating device—not the tempera- bined with the steam controller and
ture-recording device—shall be the ref- may be a recorder-controller. Air-oper-
erence instrument for indicating the ated temperature controllers should
processing temperature. have adequate filter systems to ensure
(2) Temperature-recording device. Each a supply of clean, dry air.
retort shall have an accurate tempera- (3) Pressure gages. Each retort should
ture-recording device. Each tempera- be equipped with a pressure gage that
ture-recording device shall have a sen- is accurate to 2 pounds per square inch
sor and a mechanism for recording (13.8 kilopascals) or less.
temperatures to a permanent record, (4) Steam controller. Each retort shall
such as a temperature-recording chart. be equipped with an automatic steam
The temperature-recording device sen- controller to maintain the retort tem-
sor shall be installed either within the perature. This may be a recorder-con-
retort shell or in a well attached to the troller when combined with a tempera-
shell. ture-recording device. Air-operated
(i) Analog or graphical recordings. temperature controllers should have
Temperature-recording devices that adequate filter systems to ensure a
create analog or graphical recordings supply of clean, dry air.
may be used. Temperature-recording (5) Retort speed timing. The rotational
devices that record to charts shall be speed of the retort shall be specified in
used only with the appropriate chart. the scheduled process. The speed shall
Each chart shall have a working scale be adjusted, as necessary, to ensure
of not more than 55 °F per inch (12 °C that the speed is as specified in the
per centimeter) within a range of 20 °F scheduled process. The rotational speed
(10 °C) of the process temperature. as well as the process time shall be re-
Chart graduations shall not exceed 2 °F corded for each retort load processed.
(1 °C) within a range of 10 °F (5 °C) of Alternatively, a recording tachometer
the process temperature. Temperature- may be used to provide a continuous
recording devices that create record of the speed. A means of pre-
multipoint plottings of temperature venting unauthorized speed changes
readings shall record the temperature shall be provided. A lock or a notice
at intervals that will assure that the from management posted at or near
parameters of the process time and the speed adjustment device that pro-
process temperature have been met. vides a warning that only authorized
(ii) Digital recordings. Temperature- persons are permitted to make adjust-
recording devices, such as data loggers, ment is a satisfactory means of pre-
that record numbers or create other venting unauthorized changes.
digital records may be used. Such a de- (6) Air supply and controls. When air is
vice shall record the temperature at in- used to provide overpressure:
tervals that will assure that the pa- (i) A means shall be provided for in-
rameters of the process time and proc- troducing compressed air at the proper
ess temperature have been met. pressure and rate. The proper pressure
(iii) Adjustments. The temperature-re- shall be controlled by an automatic
cording device shall be adjusted with pressure control unit. A check valve
sufficient frequency to ensure agree- shall be provided in the air supply line
ment as nearly as possible with, but to to prevent water from entering the sys-
be in no event higher than, the tem- tem.
perature-indicating device during proc- (ii) A water level indicator, e.g., sen-
essing. A means of preventing unau- sor, gage, water glass, or petcock(s),
thorized changes in adjustment shall shall be used for determining the water
be provided. A lock or a notice from level in the retort during operation.
management posted at or near the tem- Water shall cover the top layer of con-
perature-recording device that provides tainers during the entire come-up time
a warning that only authorized persons and processing periods and should also
are permitted to make adjustments is a cover the top layer of containers dur-
satisfactory means of preventing unau- ing the cooling periods. The operator
thorized changes. shall check and record the water level

(iv) Temperature controller. The tem- at intervals sufficient to ensure its
perature-recording device may be com- adequacy.
341
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
(7) Water circulation. When a water ing machine vacuum in vacuum-packed

circulating system is used for heat dis- products, maximum fill-in or drained
tribution, it shall be installed in such a weight, minimum net weight, and per-
manner that water will be drawn from cent solids shall be as specified in the
the bottom of the retort through a suc- scheduled process for all products when
tion manifold and discharged through a deviations from such specifications
spreader which extends the length of may affect the scheduled process. All
the top of the retort. The holes in the measurements and recordings of crit-
water spreader shall be uniformly dis- ical factors should be made at intervals
tributed and should have an aggregate not to exceed 15 minutes.
area not greater than the cross-sec- (f) Equipment and procedures for pres-
tional area of the outlet line from the sure processing in steam in hydrostatic re-
pump. The suction outlets shall be pro-
torts—(1) Temperature-indicating device.
tected with nonclogging screens or
Each retort shall be equipped with at
other suitable means shall be used to
least one temperature-indicating de-
keep debris from entering the circu-
vice that accurately indicates the tem-
lating system. The pump shall be de-
signed to provide proper flow on start- perature during processing. Each tem-
up and during operation, such as with a perature-indicating device shall have a
bleeder or other suitable means to re- sensor and a display. Each tempera-
move air during startup and with an ture-indicating device and each ref-
appropriate device or design to prevent erence device that is maintained by the
pump cavitation during operation. The processor shall be tested for accuracy
pump shall be equipped with a sig- against a reference device for which
naling device to warn the operator the accuracy is traceable to a National
when it is not running. Alternative Institute of Standards and Technology
methods for circulation of water in the (NIST), or other national metrology in-
retort may be used when established by stitute, standard reference device by
a competent authority as adequate for appropriate standard procedures, upon
even heat distribution. installation and at least once a year
(8) Drain valve. A nonclogging, water- thereafter, or more frequently if nec-
tight valve shall be used. A screen shall essary, to ensure accuracy during proc-
be installed or other suitable means essing. Each temperature-indicating
shall be used on all drain openings to device and each reference device that is
prevent clogging. maintained by the processor shall have
(9) Critical factors. Critical factors a tag, seal, or other means of identity.
specified in the scheduled process shall (i) The design of the temperature-in-
be measured and recorded on the proc- dicating device shall ensure that the
essing record at intervals of sufficient accuracy of the device is not affected
frequency to ensure that the factors by electromagnetic interference and
are within the limits specified in the environmental conditions.
scheduled process. The minimum
(ii) Records of the accuracy of the
headspace of containers, if specified in
temperature-indicating device and of a
the scheduled process, shall be meas-
ured and recorded at intervals of suffi- reference device that is maintained by
cient frequency to ensure that the the processor shall be established and
headspace is as specified in the sched- maintained in accordance with
uled process. The headspace of solder- § 113.100(c) and (d).
tipped, lap seam (vent hole) cans may (iii) A temperature-indicating device
be measured by net weight determina- that is defective or cannot be adjusted
tions. When the product consistency is to the accurate calibrated reference de-
specified in the scheduled process, the vice shall be repaired before further
consistency of the product shall be de- use or replaced.
termined by objective measurements (iv) A temperature-indicating device
on the product taken from the filler be- shall be accurate to 1 °F (0.5 °C). The
fore processing and recorded at inter- temperature range of a mercury-in-
vals of sufficient frequency to ensure glass thermometer shall not exceed 17

that the consistency is as specified in °F per inch (4 °C per centimeter) of
the scheduled process. Minimum clos- graduated scale. A mercury-in-glass
342
thermometer that has a divided mer- parameters of the process time and
cury column shall be considered defec- process temperature have been met.
tive. (ii) Digital recordings. Temperature-
(v) Each temperature-indicating de- recording devices, such as data loggers,
vice shall be installed where it can be that record numbers or create other
accurately and easily read. The tem- digital recordings may be used. Such a
perature-indicating device sensor shall device shall record the temperature at
be located in the steam dome near the intervals that will assure that the pa-
steam-water interface. When the sched- rameters of the process time and proc-
uled process specifies maintenance of ess temperature have been met.
particular temperatures in the hydro- (iii) Adjustments. The temperature-re-
static water legs, a temperature-indi- cording device shall be adjusted with
cating device sensor shall be located in sufficient frequency to ensure agree-
each hydrostatic water leg in a posi- ment as nearly as possible with, but to
tion near the bottom temperature-re- be in no event higher than, the tem-
cording device sensor. The tempera- perature-indicating device during proc-
ture-indicating device—not the tem- essing. A means of preventing unau-
perature-recording device—shall be the thorized changes in adjustment shall
reference instrument for indicating the be provided. A lock or a notice from
processing temperature. management posted at or near the tem-
perature-recording device that provides
(2) Temperature-recording device. Each
a warning that only authorized persons
retort shall have an accurate tempera-
are permitted to make adjustments is a
ture-recording device. Each tempera-
satisfactory means of preventing unau-
ture-recording device shall have a sen-
thorized changes.
sor and a mechanism for recording (iv) Temperature controller. The tem-
temperatures to a permanent record, perature-recording device may be com-
such as a temperature-recording chart. bined with the steam controller and
The temperature-recording device sen- may be a recorder-controller.
sor shall be installed either within the (3) Pressure gages. Each retort should
steam dome or in a well attached to be equipped with a pressure gage that
the dome. Each temperature-recording is accurate to 2 pounds per square inch
device sensor well shall have a 1⁄16-inch (13.8 kilopascals) or less.
(1.5 millimeters) or larger bleeder that (4) Recording of temperatures. Tem-
emits steam continuously during the peratures indicated by the tempera-
processing period. Additional temperature-indicating device or devices shall
ture-recording device sensors shall be be entered on a suitable form during
installed in the hydrostatic water legs processing operations. Temperatures
in situations where the scheduled proc- shall be recorded by an accurate tem-
ess specifies maintenance of particular perature-recording device or devices at
temperatures in the hydrostatic water the following points:
legs. (i) In the steam chamber between the
(i) Analog or graphical recordings. steam-water interface and the lowest
Temperature-recording devices that container position.
create analog or graphical recordings (ii) Near the top and the bottom of
may be used. Temperature-recording each hydrostatic water leg if the sched-
devices that record to charts shall be uled process specifies maintenance of
used only with the appropriate chart. particular temperatures in the legs.
Each chart shall have a working scale (5) Steam controller. Each retort shall
of not more than 55 °F per inch (12 °C be equipped with an automatic steam
per centimeter) within a range of 20 °F controller to maintain the retort tem-
(10 °C) of the process temperature. perature. This may be a recorder-con-
Chart graduations shall not exceed 2 °F troller when combined with a tempera-
(1 °C) within a range of 10 °F (5 °C) of ture-recording device. A steam con-
the process temperature. Temperature- troller activated by the steam pressure
recording devices that create of the retort is acceptable if it is care-
multipoint plottings of temperature fully mechanically maintained so that

readings shall record the temperature it operates satisfactorily. Air-operated
at intervals that will assure that the temperature controllers should have
343
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
adequate filter systems to ensure a (iii) Such measurements and record-

supply of clean, dry air. ings should be made at intervals not to
(6) Venting. Before the start of proc- exceed 15 minutes.
essing operations, the retort steam (g) Aseptic processing and packaging
chamber or chambers shall be vented systems—(1) Product sterilizer—(i) Equip-
to ensure removal of air. ment—(A) Temperature-indicating device.
(7) Bleeders. Bleeder openings 1⁄4-inch Each product sterilizer shall be
(6 millimeters) or larger shall be lo- equipped with at least one tempera-
cated at the top of the steam chamber ture-indicating device that accurately
or chambers opposite the point of indicates the temperature during proc-
essing. Each temperature-indicating
steam entry. Bleeders shall be wide
device shall have a sensor and a dis-
open and shall emit steam continu-
play. Each temperature-indicating de-
ously during the entire process, includ-
vice and each reference device that is
ing the come-up time. All bleeders
maintained by the processor shall be
shall be arranged in such a way that tested for accuracy against a reference
the operator can observe that they are device for which the accuracy is trace-
functioning properly. able to a National Institute of Stand-
(8) Retort speed. The speed of the con- ards and Technology (NIST), or other
tainer-conveyor chain shall be speci- national metrology institute, standard
fied in the scheduled process and shall reference device by appropriate stand-
be determined and recorded at the ard procedures, upon installation and
start of processing and at intervals of at least once a year thereafter, or more
sufficient frequency to ensure that the frequently if necessary, to ensure accu-
retort speed is maintained as specified. racy during processing. Each tempera-
The speed should be determined and re- ture-indicating device and each ref-
corded every 4 hours. An automatic de- erence device that is maintained by the
vice should be used to stop the chain processor shall have a tag, seal, or
when the temperature drops below that other means of identity.
specified in the scheduled process. A (1) The design of the temperature-in-
means of preventing unauthorized dicating device shall ensure that the
speed changes shall be provided. A lock accuracy of the device is not affected
or a notice from management posted at by electromagnetic interference and
or near the speed-adjusting device that environmental conditions.
provides a warning that only author- (2) Records of the accuracy of the
ized persons are permitted to make ad- temperature-indicating device and of a
justments is a satisfactory means of reference device that is maintained by
preventing unauthorized changes. the processor shall be established and
maintained in accordance with
(9) Critical factors. Critical factors
§ 113.100(c) and (d).
specified in the scheduled process shall
(3) A temperature-indicating device
that is defective or cannot be adjusted
essing record at intervals of sufficient
to the accurate calibrated reference de-
frequency to ensure that the factors
vice shall be repaired before further
are within the limits specified in the use or replaced.
scheduled process. (4) A temperature-indicating device
(i) When maximum fill-in or drained shall be accurate to 1 °F (0.5 °C). The
weight is specified in the scheduled temperature range of a mercury-in-
process, it shall be measured and re- glass thermometer shall not exceed 17
corded at intervals of sufficient fre- °F per inch (4 °C per centimeter) of
quency to ensure that the weight of the graduated scale. A mercury-in-glass
product does not exceed the maximum thermometer that has a divided mer-
for the given container size specified in cury column shall be considered defec-
the scheduled process. tive.
(ii) Closing machine vacuum in vacu- (5) Each temperature-indicating de-
um-packed products shall be observed vice shall be installed where it can be
and recorded at intervals of sufficient accurately and easily read. The tem-
frequency to ensure that the vacuum is perature-indicating device—not the
as specified in the scheduled process. temperature-recording device—shall be
344
the reference instrument for indicating satisfactory means of preventing unau-

the processing temperature. thorized changes.
(B) Temperature-recording device. Each (C) Temperature controller. An accu-
product sterilizer shall have an accurate temperature controller shall be in-
rate temperature-recording device. stalled and capable of ensuring that
Each temperature-recording device the desired product sterilization tem-
shall have a sensor and a mechanism perature is maintained. Air-operated
for recording temperatures to a perma- temperature controllers should have
nent record, such as a temperature-re- adequate filter systems to ensure a
cording chart. A temperature-recording supply of clean, dry air.
device sensor shall be installed in the (D) Product-to-product regenerators.
product at the holding-tube outlet be- When a product-to-product regenerator
tween the holding tube and the inlet to is used to heat the cold unsterilized
the cooler. Additional temperature-re- product entering the sterilizer by
cording device sensors shall be located means of a heat exchange system, it
at each point where temperature is shall be designed, operated, and con-
specified as a critical factor in the trolled so that the pressure of the
scheduled process. sterilized product in the regenerator is
(1) Analog or graphical recordings. greater than the pressure of any
Temperature-recording devices that unsterilized product in the regenerator
create analog or graphical recordings to ensure that any leakage in the re-
may be used. Temperature-recording generator is from the sterilized product
devices that record to charts shall be into the unsterilized product.
used only with the appropriate chart. (E) Differential pressure recorder-con-
Each chart shall have a working scale troller. When a product-to-product re-
of not more than 55 °F per inch (12 °C generator is used, it shall be equipped
per centimeter) within a range of 20 °F with an accurate differential pressure
(10 °C) of the desired product steriliza- recorder-controller. The differential
tion temperature. Chart graduations pressure recorder-controller shall be
shall not exceed 2 °F (1 °C) within a accurate to within 2 pounds per square
range of 10 °F (5 °C) of the process tem- inch (13.8 kilopascals). One pressure
perature. Temperature-recording de- sensor shall be installed at the steri-
vices that create multipoint plottings lized product regenerator outlet and
of temperature readings shall record the other pressure sensor shall be in-
the temperature at intervals that will stalled at the unsterilized product re-
assure that the parameters of the proc- generator inlet. The sensor and re-
ess time and process temperature have corder of the differential pressure re-
been met. corder-controller shall be tested for ac-
(2) Digital recordings. Temperature-re- curacy against an accurate reference
cording devices, such as data loggers, device upon installation and at least
that record numbers or create other once every 3 months of operation
digital recordings may be used. Such a thereafter, or more frequently if nec-
device shall record the temperature at essary, to ensure its accuracy.
intervals that will assure that the pa- (1) Analog or graphical recordings. Dif-
rameters of the process time and proc- ferential pressure recorder-controllers
ess temperature have been met. that create analog or graphical record-
(3) Adjustments. The temperature-re- ings may be used. Differential pressure
cording device shall be adjusted with recorder-controllers that record to
sufficient frequency to ensure agree- charts shall be used only with the ap-
ment as nearly as possible with, but to propriate chart. The scale divisions of
be in no event higher than, the tem- the chart shall not exceed 2 pounds per
perature-indicating device during proc- square inch (13.8 kilopascals) on a
essing. A means of preventing unau- working scale of not more than 20
thorized changes in adjustment shall pounds per square inch per inch of
be provided. A lock or a notice from scale (55 kilopascals per centimeter).
management posted at or near the tem- (2) Digital recordings. Differential
perature-recording device that provides pressure recorder-controllers, such as

a warning that only authorized persons data loggers, that record numbers or
are permitted to make adjustments is a create other digital recordings may be
345
§ 113.40 21 CFR Ch. I (4–1–16 Edition)
used. Such differential pressure re- seals or other effective barriers at the
corder-controllers shall record the dif- potential access points. Appropriate
ferential pressure at intervals that will means should be provided to permit the
assure that the minimum differential operator to monitor the performance of
pressure is maintained. the seals or barriers during operations.
(F) Flow control. A flow control de- (ii) Operation—(A) Startup. Before the
vice shall be located upstream from the start of aseptic processing operations
holding tube and shall be operated to the product sterilizer and all product-
maintain the required rate of product contact surfaces downstream shall be
flow. A means of preventing unauthor- brought to a condition of commercial
ized flow adjustments shall be pro- sterility.
vided. A lock or a notice from manage- (B) Temperature drop in product-steri-
ment posted at or near the flow con- lizing holding tube. When product tem-
trolling device that provides a warning perature in the holding tube drops
that only authorized persons are per- below the temperature specified in the
mitted to make adjustments is a satis- scheduled process, product flow should
factory means of preventing unauthor- be diverted away from the filler or
ized changes. aseptic surge tank by means of a flow-
(G) Product holding tube. The product- diversion system. If for any reason
sterilizing holding tube shall be de- product subjected to a temperature
signed to give continuous holding of drop below the scheduled process is
every particle of food for at least the filled into containers, the product shall
minimum holding time specified in the
be segregated from product that re-
scheduled process. The holding tube
ceived the scheduled process. The proc-
shall be designed so that no portion of
essing deviation shall be handled in ac-
the tube between the product inlet and
cordance with § 113.89. The product
the product outlet can be heated, and
holding tube and any further system
it must be sloped upward at least 1⁄4-
portions affected shall be returned to a
inch per foot (2.1 centimeters per
condition of commercial sterility be-
meter).
fore product flow is resumed to the
(H) Flow-diversion systems. If a proc-
filler or to the aseptic surge tank.
essor elects to install a flow-diversion
system, it should be installed in the (C) Loss of proper pressures in the re-
product piping located between the generator. When a regenerator is used,
product cooler and the product filler or the product may lose sterility when-
aseptic surge tank and should be de- ever the pressure of sterilized product
signed to divert flow away from the in the regenerator is less than 1 pound
filler or aseptic surge tank automati- per square inch (6.9 kilopascals) greater
cally. Controls and/or warning systems than the pressure of unsterilized prod-
should be designed and installed with uct in the regenerator. In this case,
necessary sensors and actuators to op- product flow should be diverted away
erate whenever the sterilizing tempera- from the filler or aseptic surge tank by
ture in the holding tube or pressure dif- means of the flow-diversion system. If
ferential in the product regenerator for any reason the product is filled into
drops below specified limits. Flow-di- containers, the product shall be seg-
version systems should be designed and regated from product that received the
operated in accordance with rec- scheduled process. The processing devi-
ommendations of an aseptic processing ation shall be handled in accordance
and packaging authority. with § 113.89. Product flow to the filler
(I) Equipment downstream from the or to the aseptic surge tank shall not
holding tube. Product coolers, aseptic be resumed until the cause of the im-
surge tanks, or any other equipment proper pressure relationships in the re-
downstream from the holding tube, generator has been corrected and the
with rotating or reciprocating shafts, affected system(s) has been returned to
valve stems, instrument connections, a condition of commercial sterility.
or other such points, are subject to po- (D) Loss of sterile air pressure or other
tential entry of microorganisms into protection level in the aseptic surge tank.
the product. Such locations in the sys- When an aseptic surge tank is used,
tem should be equipped with steam conditions of commercial sterility may
346
be lost when the sterile air over- factory means of preventing unauthor-
pressure or other means of protection ized changes.
drops below the scheduled process (ii) Operation—(A) Startup. Before the
value. Product flow to and/or from the start of packaging operations, both the
aseptic surge tank shall not be re- container and closure sterilizing sys-
sumed until the potentially contami- tem and the product filling and closing
nated product in the tank is removed, system shall be brought to a condition
and the aseptic surge tank has been re- of commercial sterility.
turned to a condition of commercial (B) Loss of sterility. A system shall be
sterility. provided to stop packaging operations,
(E) Records. Readings at the following or alternatively to ensure segregation
points shall be observed and recorded of any product packaged when the
at the start of aseptic packaging oper- packaging conditions fall below sched-
ations and at intervals of sufficient fre- uled processes. Compliance with this
quency to ensure that these values are requirement may be accomplished by
as specified in the scheduled process: diverting product away from the filler,
Temperature-indicating device in hold- by preventing containers from entering
ing tube outlet; temperature-recording the filler, or by other suitable means.
device in holding tube outlet; differen- In the event product is packaged under
tial pressure recorder-controller, if a conditions below those specified in the
product-to-product regenerator is used; scheduled process, all such product
product flow rate as established by the shall be segregated from product that
flow control device or as determined by received the scheduled process. The
filling and closing rates and, if an asep- processing deviation shall be handled
tic surge tank is used, sterile air pres- in accordance with § 113.89. In the event
sure or other protection means; and of loss of sterility, the system(s) shall
proper performance of steam seals or be returned to a condition of commer-
other similar devices. The measure-
cial sterility before resuming pack-
ments and recordings should be made
aging operations.
at intervals not to exceed 1 hour.
(C) Records. Observations and meas-
(2) Container sterilizing, filling, and
closing operation—(i) Equipment—(A) Re- urements of operating conditions shall
cording device. The container and clo- be made and recorded at intervals of
sure sterilization system and product sufficient frequency to ensure that
filling and closing system shall be in- commercial sterility of the food prod-
strumented to demonstrate that the re- uct is being achieved; such measure-
quired sterilization is being accom- ments shall include the sterilization
plished continuously. Recording de- media flow rates, temperatures, the
vices shall be used to record, when ap- container and closure rates (if applica-
plicable, the sterilization media flow ble) through the sterilizing system, and
rates, temperature, concentration, or the sterilization conditions if a batch
other factors. When a batch system is system is used for container steriliza-
used for container sterilization, the tion. The measurements and recordings
sterilization conditions shall be re- should be made at intervals not to ex-
corded. ceed 1 hour.
(B) Timing method(s). A method(s) (3) Incubation. Incubation tests
shall be used either to give the reten- should be conducted on a representa-
tion time of containers, and closures if tive sample of containers of product
applicable, in the sterilizing environ- from each code; records of the test re-
ment specified in the scheduled proc- sults should be maintained.
ess, or to control the sterilization cycle (4) Critical factors. Critical factors
at the rate specified in the scheduled specified in the scheduled process shall
process. A means of preventing unau- be measured and recorded on the proc-
thorized speed changes must be pro- essing record at intervals of sufficient
vided. A lock or a notice from manage- frequency to ensure that the factors
ment posted at or near the speed ad- are within the limits specified in the
justing device that provides a warning scheduled process. Such measurements

that only authorized persons are per- and recordings should be done at inter-
mitted to make adjustments is a satis- vals not to exceed 15 minutes.
347
§ 113.60 21 CFR Ch. I (4–1–16 Edition)
(h) Equipment and procedures for flame specified in the scheduled process shall
sterilizers. The container conveyor be measured with instruments having
speed shall be specified in the sched- the accuracy and dependability ade-
uled process. The container conveyor quate to ensure that the requirements
speed shall be measured and recorded of the scheduled process are met. All
at the start of operations and at inter- measurements shall be made and re-
vals of sufficient frequency to ensure corded at intervals of sufficient fre-
that the conveyor speed is as specified quency to ensure that the critical fac-
in the scheduled process. Such meas- tors are within the limits specified in
urements and recordings should be the scheduled process.
done at 1-hour intervals. Alternatively, (j) Other systems. All systems, wheth-
a recording tachometer may be used to er or not specifically mentioned in this
provide a continuous record of the part, for the thermal processing of low-
speed. A means of preventing changes acid foods in hermetically sealed con-
in flame intensity and unauthorized tainers shall conform to the applicable
speed changes on the conveyor shall be requirements of this part and the
provided. A lock or a notice from man- methods and controls used for the man-
agement posted at or near the speed ufacture, processing, and packing of
adjusting device that provides a warn- these foods shall be as established in
ing that only authorized persons are the scheduled process. These systems
permitted to make adjustments is a shall be operated or administered in a
satisfactory means of preventing unau- manner adequate to ensure that com-
thorized changes. The surface tempera- mercial sterility is achieved. Critical
ture of at least one container from factors specified in the scheduled proc-
each conveyor channel shall be meas- ess shall be measured and recorded at
ured and recorded at the entry and at intervals of sufficient frequency to en-
the end of the holding period at inter- sure that the critical factors are within
vals of sufficient frequency to ensure the limits specified in the scheduled
that the temperatures specified in the process.
scheduled process are maintained. Such [76 FR 11906, Mar. 3, 2011; 76 FR 81363, Dec. 28,
measurements and recordings should 2011]
be done at intervals not to exceed 15
minutes.
(1) Process interruption. In the event Subpart D—Control of Compo-
of process interruption wherein the nents, Food Product Con-
temperature of the product may have tainers, Closures, and In-Proc-
dropped, an authorized, scheduled ess Materials
emergency plan approved by a qualified
person having expert knowledge of the § 113.60 Containers.
process requirements may be used. (a) Closures. Regular observations
(2) Critical factors. Critical factors shall be maintained during production
specified in the scheduled process shall runs for gross closure defects. Any such
be measured and recorded on the proc- defects shall be recorded and corrective
essing record at intervals of sufficient action taken and recorded. At intervals
frequency to ensure that the factors of sufficient frequency to ensure proper
are within the limits specified in the closure, the operator, closure super-
scheduled process. visor, or other qualified container clo-
(i) Equipment and procedures for ther- sure inspection person shall visually
mal processing of foods wherein critical examine either the top seam of a can
factors such as water activity are used in randomly selected from each seaming
conjunction with thermal processing. The head or the closure of any other type of
methods and controls used for the man- container being used and shall record
ufacture, processing, and packing of the observations made. For double-
such foods shall be as established in seam cans, each can should be exam-
the scheduled process and shall be op- ined for cutover or sharpness, skidding
erated or administered in a manner or deadheading, false seam, droop at
adequate to ensure that the product is the crossover or lap, and condition of
safe. The time and temperature of inside of countersink wall for evidence
processing and other critical factors of broken chuck. Such measurements
348
and recordings should be made at inter- down examinations shall be recorded

vals not to exceed 30 minutes. Addi- and the corrective action taken, if any,
tional visual closure inspections shall shall be noted.
be made immediately following a jam (i) Required and optional can seam
in a closing machine, after closing ma- measurements:
chine adjustment, or after startup of a (a) Micrometer measurement system:
machine following a prolonged shut- Required Optional
down. All pertinent observations shall
be recorded. When irregularities are Cover hook Overlap (by calculation).
Body hook Countersink.
found, the corrective action shall be re- Width (length, height)
corded. Tightness (observation for wrinkle)
(1) Teardown examinations for dou- Thickness
ble-seam cans shall be performed by a
qualified individual and the results (b) Seam scope or projector:
therefrom shall be recorded at inter- Required Optional
vals of sufficient frequency on enough
containers from each seaming station Body hook Width (length, height).
Overlap Cover hook.
to ensure maintenance of seam integ- Tightness (observation for wrinkle) Countersink.
rity. Such examinations and recordings Thickness by micrometer
should be made at intervals not to ex-
ceed 4 hours. The results of the tear- (c) Can double seam terminology:
349
§ 113.60 21 CFR Ch. I (4–1–16 Edition)
(1) ‘‘Crossover’’: The portion of a dou- (2) ‘‘Cutover’’: A fracture, sharp bend,
ble seam at the lap. or break in the metal at the top of the
inside portion of the double seam.
350
ER01JA93.376</GPH>
(3) ‘‘Deadhead’’: A seam which is in- ibly perforated or otherwise marked, if

complete due to chuck spinning in the the label is securely affixed to the
countersink. product container. The required identi-
(4) ‘‘Droop’’: Smooth projection of fication shall identify in code the es-
double seam below bottom of normal tablishment where packed, the product
seam. contained therein, the year packed, the
(5) ‘‘False seam’’: A small seam day packed, and the period during
breakdown where the cover hook and which packed. The packing period code
the body hook are not overlapped. shall be changed with sufficient fre-
(6) ‘‘Lap’’: Two thicknesses of mate- quency to enable ready identification
rial bonded together. of lots during their sale and distribu-
(ii) Two measurements at different tion. Codes may be changed on the
locations, excluding the side seam, basis of one of the following: intervals
shall be made for each double seam of 4 to 5 hours; personnel shift changes;
characteristic if a seam scope or seam or batches, as long as the containers
projector is used. When a micrometer that constitute the batch do not extend
is used, three measurements shall be over a period of more than one per-
made at points approximately 120° sonnel shift.
apart, excluding the side seam. (d) Postprocess handling. Container
(iii) Overlap length can be calculated handling equipment used in handling
by the following formula: filled containers shall be designed, con-
structed, and operated to preserve the
The theoretical overlap length = CH + can seam or other container closure in-
BH + T ¥ W, where tegrity. Container handling equipment,
CH = cover hook including automated and non-auto-
BH = body hook mated equipment, shall be checked
T = cover thickness, and with sufficient frequency and repaired
W = seam width (height, length)
or replaced as necessary to prevent
(2) For glass containers with vacuum damage to containers and container
closures, capper efficiency must be closures. When cans are handled on
checked by a measurement of the cold belt conveyors, the conveyors should
water vacuum. This shall be done be- be constructed to minimize contact by
fore actual filling operations, and the the belt with the double seam, i.e., cans
results shall be recorded. should not be rolled on the double
(3) For closures other than double seam. All worn and frayed belting, can
seams and glass containers, appro- retarders, cushions, etc. should be re-
priate detailed inspections and tests placed with new nonporous material.
shall be conducted by qualified per- All tracks and belts that come into
sonnel at intervals of sufficient fre- contact with the can seams should be
quency to ensure proper closing ma- thoroughly scrubbed and sanitized at
chine performance and consistently re- intervals of sufficient frequency to
liable hermetic seal production. avoid product contamination.
Records of such tests shall be main-
tained. FR 11922, Mar. 3, 2011]
(b) Cooling water. Container cooling
water shall be chlorinated or otherwise
sanitized as necessary for cooling ca- Subpart E—Production and
nals and for recirculated water sup- Process Controls
plies. There should be a measurable re-
sidual of the sanitizer employed at the § 113.81 Product preparation.
water discharge point of the container (a) Before using raw materials and
cooler. ingredients susceptible to micro-
(c) Coding. Each hermetically sealed biological contamination, the proc-
container of low-acid processed food essor shall ensure that those materials
shall be marked with an identifying and ingredients are suitable for use in
code that shall be permanently visible processing low-acid food. Compliance
to the naked eye. When the container with this requirement may be accom-
does not permit the code to be em- plished by receiving the raw materials
bossed or inked, the label may be leg- and ingredients under a supplier’s
351
§ 113.83 21 CFR Ch. I (4–1–16 Edition)
guarantee that they are suitable for the food free of microorganisms capa-
use, by examining them for their ble of reproducing in the food under
microbiological condition, or by other normal nonrefrigerated conditions of
acceptable means. storage and distribution.
(b) Blanching by heat, when required
in the preparation of food for canning, § 113.83 Establishing scheduled proc-
should be effected by heating the food esses.
to the required temperature, holding it Scheduled processes for low-acid
at this temperature for the required foods shall be established by qualified
time, and then either rapidly cooling persons having expert knowledge of
the food or passing it to subsequent thermal processing requirements for
processing without delay. low-acid foods in hermetically sealed
Thermophilic growth and contamina- containers and having adequate facili-
tion in blanchers should be minimized ties for making such determinations.
by the use of adequate operating tem- The type, range, and combination of
peratures and by cleaning. If the variations encountered in commercial
blanched food product is washed before
production shall be adequately pro-
filling, potable water should be used.
vided for in establishing the scheduled
(c) The filling of containers, either
process. Variations include those that
mechanically or by hand, shall be con-
occur due to seasonal or growing fluc-
trolled so as to ensure that the filling
tuations, variety differences, supplier
requirements specified in the scheduled
process are met. processes, reprocessing, and mixing a
(d) The exhausting of containers for batch of processed product with the
the removal of air shall be controlled same unprocessed product before it is
so as to meet the conditions for which processed. Critical factors, e.g., min-
the process was designed. Compliance imum headspace, consistency, max-
with the requirement may be accom- imum fill-in or drained weight, aw, etc.,
plished by heat exhausting, mechanical that may affect the scheduled process,
exhausting, hot brining, or steam in- shall be specified in the scheduled proc-
jection. ess. Acceptable scientific methods of
(e) When the maintenance of pH establishing heat sterilization proc-
(above 4.6) of a normally low-acid food esses shall include, when necessary,
is a basis for a scheduled process, there but shall not be limited to, the use of
shall be careful supervision to ensure microbial thermal death time data,
that the equilibrium pH of the finished process calculations based on product
product meets that of the scheduled heat penetration data, and inoculated
process. The methodology described in packs. Calculation shall be performed
§ 114.90 of this chapter should be used. according to procedures recognized by
(f) When the scheduled process sets competent processing authorities. If in-
forth critical factors to prevent the cubation tests are necessary for proc-
growth of microorganisms not de- ess confirmation, they shall include
stroyed by the thermal process, the containers from test trials and from
factors shall be carefully controlled to actual commercial production runs
ensure that the limits established in during the period of instituting the
the scheduled process are not exceeded. process. The incubation tests for con-
When normally low-acid foods require firmation of the scheduled processes
sufficient solute to permit safe proc- should include the containers from the
essing at low temperatures, such as in test trials and a number of containers
boiling water, there shall be careful su- from each of four or more actual com-
pervision to ensure that the equi- mercial production runs. The number
librium water activity (aw) of the fin- of containers from actual commercial
ished product meets that of the sched- production runs should be determined
uled process. The scheduled thermal on the basis of recognized scientific
processes for foods having an aw great- methods to be of a size sufficient to en-
er than 0.85 and less than the aw that sure the adequacy of the process. Com-
would allow the growth of spores of plete records covering all aspects of
microorganisms of public health sig- the establishment of the process and
nificance shall be sufficient to render associated incubation tests shall be
352
prepared and shall be permanently re- mine the initial temperature shall be
tained by the person or organization tested for accuracy against a reference
making the determination. device for which the accuracy is trace-
[76 FR 11922, Mar. 3, 2011]
able to a National Institute of Stand-
ards and Technology (NIST), or other
§ 113.87 Operations in the thermal national metrology institute, standard
processing room. reference device, by appropriate stand-
(a) Operating processes and retort ard procedures, with sufficient fre-
venting procedures to be used for each quency to ensure that initial tempera-
product and container size being ture measurements are accurate.
packed shall either be posted in a con- Records of the accuracy of the tem-
spicuous place near the processing perature-indicating device and of a ref-
equipment or be made readily available erence device that is maintained by the
to the retort or processing system op- processor shall be established and
erator and any duly authorized em- maintained in accordance with
ployee of the Food and Drug Adminis- § 113.100(c) and (d).
tration. Scheduled processes must be (d) Timing devices used in recording
made readily available to the super- thermal process time information shall
visor and any duly authorized em- be accurate to the extent needed to en-
ployee of the Food and Drug Adminis- sure that the processing time and vent-
tration. ing time specified in the scheduled
(b) A system for product traffic con- process are achieved. Pocket or wrist
trol in the retort room shall be estab- watches are not considered satisfactory
lished to prevent unretorted product for timing purposes. Digital clocks
from bypassing the retort process. may be used if the operating process
Each retort basket, truck, car, or crate and the venting schedule have a 1-
used to hold containers in a retort, or minute or greater safety factor over
one or more containers therein, shall, the scheduled process.
if it contains any retorted food prod- (e) Clock times on temperature-re-
uct, be plainly and conspicuously cording device records shall reasonably
marked with a heat-sensitive indicator, correspond to the time of day on the
or by other effective means that will processing records to provide correla-
indicate visually, to thermal proc- tion of these records.
essing personnel, those units that have (f) The steam supply to the thermal
been retorted. A visual check shall be processing system shall be adequate to
performed to determine whether or not the extent needed to ensure that suffi-
the appropriate change has occurred in cient steam pressure is maintained
the heat-sensitive indicator as a result during thermal processing, regardless
of retorting for all retort baskets, of other demands of steam by the
trucks, cars, or crates, to ensure that plant.
each unit of product has been retorted. (g) If mufflers are used on bleeders or
A record of these checks should be vent systems, evidence that the bleed-
made. ers or vents are operated in a manner
(c) The initial temperature of the that does not significantly impede the
contents of the containers to be proc- removal of air shall be kept on file.
essed shall be accurately determined This evidence may be in the form of
and recorded with sufficient frequency heat distribution data or other satis-
to ensure that the temperature of the factory evidence such as a letter from
product is no lower than the minimum the manufacturer, the designer, or a
initial temperature specified in the competent processing authority.
scheduled process. For those operations [44 FR 16215, Mar. 16, 1979, as amended at 76
that use water during the filling of the FR 11923, Mar. 3, 2011]
retort or during processing, provision
shall be made to ensure that the water § 113.89 Deviations in processing, vent-
will not, before the start of each ther- ing, or control of critical factors.
mal process, lower the initial tempera- Whenever any process is less than the
ture of the product below that specified scheduled process or when critical fac-
in the scheduled process. The tempera- tors are out of control for any low-acid
ture-indicating device used to deter- food or container system as disclosed
353
§ 113.100 21 CFR Ch. I (4–1–16 Edition)
from records by processor check or oth- cating device and temperature-record-

erwise, the commerical processor of ing device readings, and other appro-
that low-acid food shall either fully re- priate processing data. Closing ma-
process that portion of the production chine vacuum in vacuum-packed prod-
involved, keeping full records of the re- ucts, maximum fill-in or drained
processing conditions or, alternatively, weight, or other critical factors speci-
must set aside that portion of the prod- fied in the scheduled process shall also
uct involved for further evaluation as be recorded. In addition, the following
to any potential public health signifi- records shall be maintained:
cance. Such evaluation shall be made (1) Still retorts. Time steam on; time
by a competent processing authority temperature up to processing tempera-
and shall be in accordance with proce- ture; time steam off; venting time and
dures recognized by competent proc- temperature to which vented.
essing authorities as being adequate to (2) Agitating retorts. Functioning of
detect any potential hazard to public condensate bleeder; retort speed; and,
health. Unless this evaluation dem- when specified in the scheduled proc-
onstrates that the product had been ess, headspace, consistency, maximum
given a thermal process that rendered drained weight, minimum net weight,
it free of microorganisms of potential and percent solids.
public health significance, the product (3) Hydrostatic retorts. The tempera-
set aside shall be either fully reproc- ture in the steam chamber between the
essed to render it commercially sterile steam-water interface and the lowest
or destroyed. A record shall be made of container position; speed of the con-
the evaluation procedures used and the tainer conveyor chain; and, when the
results. Either upon completion of full scheduled process specifies mainte-
reprocessing and the attainment of nance of particular temperatures in the
commerical sterility or after the deter- hydrostatic water legs, the tempera-
mination that no significant potential tures near the top and the bottom of
for public health hazard exists, that each hydrostatic water leg.
portion of the product involved may be (4) Aseptic processing and packaging
shipped in normal distribution. Other- systems. Product temperature in the
wise, the portion of the product in- holding tube outlet as indicated by the
volved shall be destroyed. All process temperature-indicating device and the
deviations involving a failure to satisfy temperature-recording device; differen-
the minimum requirements of the tial pressure as indicated by the dif-
scheduled process, including emer- ferential pressure recorder-controller,
gencies arising from a jam or break- if a product-to-product regenerator is
down of a continuous agitating retort used; product flow rate, as determined
necessitating cooling the retort for re- by the flow controlling device or by
pairs, shall be recorded and made the filling and closing rates; sterilization
subject of a separate file (or a log iden- media flow rate or temperature or
tifying the appropriate data) detailing both; retention time of containers, and
those deviations and the actions taken. closures when applicable, in the steri-
lizing environment; and, when a batch
Subpart F—Records and Reports system is used for container and/or clo-
sure sterilization, sterilization cycle
§ 113.100 Processing and production times and temperatures.
records. (5) Flame sterilizers. Container con-
(a) Processing and production infor- veyor speed; surface temperature at
mation shall be entered at the time it the beginning and at the end of the
is observed by the retort or processing holding period; nature of container.
system operator, or other designated (6) Food preservation methods wherein
person, on forms that include the prod- critical factors such as water activity are
uct, the code number, the date, the reused in conjunction with thermal proc-
tort or processing system number, the essing. Product formulation and sched-
size of container, the approximate uled processes used, including the ther-
number of containers per coding inter- mal process, its associated critical fac-
val, the initial temperature, the actual tors, as well as other critical factors,
processing time, the temperature-indi- and results of aw determinations.
354
(7) Other systems. Critical factors (5) The date and results of each accu-
specified in the formulation of the racy test, including the amount of cali-
product or in the scheduled process. bration adjustment; and
(b) Temperature-recording device (6) The date on or before which the
records shall be identified by date, re- next accuracy test must be performed.
tort number, and other data as nec- (d) Records of the accuracy of a ref-
essary, so they can be correlated with erence device maintained by the proc-
the record of lots processed. Each entry essor shall include:
on the processing and production (1) A reference to the tag, seal, or
records shall be made by the retort or other means of identity used by the
processing system operator, or other processor to identify the reference de-
designated person, at the time the spe- vice;
cific retort or processing system condi- (2) The name of the manufacturer of
tion or operation occurs, and this re- the reference device;
tort or processing system operator or (3) The identity of the equipment and
other designated person shall sign or reference to procedures used for the ac-
initial each record form. Not later than curacy test and to adjust or calibrate
1 working day after the actual process, the reference device or, if an outside
and before shipment or release for dis- facility is used to conduct the accuracy
tribution, a representative of plant test for the reference device, a guar-
management who is qualified by suit- antee, certificate of accuracy, certifi-
able training or experience shall review cate of calibration, or other document
all processing and production records from the facility that includes a state-
for completeness and to ensure that ment or other documentation regard-
the product received the scheduled ing the traceability of the accuracy to
process. The records, including tem- a NIST or other national metrology in-
stitute standard;
perature-recording device records,
shall be signed or initialed and dated (4) The identity of the person or facil-
by the reviewer. ity that performed the accuracy test
and adjusted or calibrated the ref-
(c) Records of the accuracy of a tem-
erence device;
perature-indicating device shall in-
(5) The date and results of each accu-
clude:
racy test, including the amount of cali-
(1) A reference to the tag, seal, or bration adjustment; and
other means of identity used by the
(6) The date on or before which the
processor to identify the temperature- next accuracy test must be performed.
indicating device;
(e) Records of all container closure
(2) The name of the manufacturer of examinations shall specify the product
the temperature-indicating device; code, the date and time of container
(3) The identity of the reference de- closure inspections, the measurements
vice, equipment, and procedures used obtained, and all corrective actions
for the accuracy test and to adjust the taken. Records shall be signed or ini-
temperature-indicating device or, if an tialed by the container closure inspec-
outside facility is used to conduct the tor and reviewed by management with
accuracy test for the temperature-indi- sufficient frequency to ensure that the
cating device, a guarantee, certificate containers are hermetically sealed.
of accuracy, certificate of calibration, The records shall be signed or initialed
or other document from the facility and dated by the reviewer.
that includes a statement or other doc- (f) Records shall be maintained to
umentation regarding the traceability identify the initial distribution of the
of the accuracy to a National Institute finished product to facilitate, when
of Standards and Technology (NIST) or necessary, the segregation of specific
other national metrology institute food lots that may have become con-
standard; taminated or otherwise rendered unfit
(4) The identity of the person or facil- for their intended use.
ity that performed the accuracy test (g) Copies of all records provided for
and adjusted or calibrated the tempera- in this part, except those required
ture-indicating device; under § 113.83 establishing scheduled
355
processes, shall be retained at the proc- singly or in any combination. They

essing plant for a period of not less have a water activity (aw) greater than
than 1 year from the date of manufac- 0.85 and have a finished equilibrium pH
ture, and at the processing plant or of 4.6 or below. These foods may be
other reasonably accessible location called, or may purport to be, ‘‘pickles’’
for an additional 2 years. If, during the or ‘‘pickled lll.’’ Carbonated bev-
first year of the 3-year record-retention erages, jams, jellies, preserves, acid
period, the processing plant is closed foods (including such foods as stand-
for a prolonged period between sea- ardized and nonstandardized food
sonal packs, the records may be trans- dressings and condiment sauces) that
ferred to some other reasonably acces-
contain small amounts of low-acid
sible location at the end of the sea-
food(s) and have a resultant finished
sonal pack.
(h) Records of this part may be main- equilibrium pH that does not signifi-
tained electronically, provided they cantly differ from that of the predomi-
are in compliance with part 11 of this nant acid or acid food, and foods that
chapter. are stored, distributed, and retailed
under refrigeration are excluded from
the coverage of this part.
FR 11923, Mar. 3, 2011]
(c) Lot means the product produced
during a period indicated by a specific
PART 114—ACIDIFIED FOODS code.
Subpart A—General Provisions (d) Low-acid foods means any foods,
other than alcoholic beverages, with a
Sec. finished equilibrium pH greater than
114.3 Definitions. 4.6 and a water activity (aw) greater
114.5 Current good manufacturing practices.
114.10 Personnel. than 0.85. Tomatoes and tomato prod-
ucts having a finished equilibrium pH
Subparts B–D [Reserved] less than 4.7 are not classed as low-acid
foods.
Subpart E—Production and Process (e) Scheduled process means the proc-
Controls ess selected by a processor as adequate
114.80 Processes and controls. for use under the conditions of manu-
114.83 Establishing scheduled processes. facture for a food in achieving and
114.89 Deviations from scheduled proce- maintaining a food that will not per-
dures.
mit the growth of microorganisms hav-
114.90 Methodology.
ing public health significance. It in-
Subpart F—Records and Reports cludes control of pH and other critical
factors equivalent to the process estab-
114.100 Records.
lished by a competent processing au-
AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. thority.
264. (f) Shall is used to state mandatory
SOURCE: 44 FR 16235, Mar. 16, 1979, unless requirements.
otherwise noted. (g) Should is used to state rec-
ommended or advisory procedures or to
Subpart A—General Provisions identify recommended equipment.
(h) Water activity (aw) is a measure of
§ 114.3 Definitions.
the free moisture in a product and is
For the purposes of this part, the fol- the quotient of the water vapor pres-
lowing definitions apply. sure of the substance divided by the
(a) Acid foods means foods that have vapor pressure of pure water at the
a natural pH of 4.6 or below.
same temperature.
(b) Acidified foods means low-acid
foods to which acid(s) or acid food(s) [44 FR 16235, Mar. 16, 1979, as amended at 61
are added; these foods include, but are FR 14245, Apr. 1, 1996]
not limited to, beans, cucumbers, cab-

bage, artichokes, cauliflower, pud-
dings, peppers, tropical fruits, and fish,
356
§ 114.5 Current good manufacturing designated in the scheduled process and

practice. maintained in all finished foods. Manu-
The criteria in §§ 114.10, 114.80, 114.83, facturing shall be in accordance with
114.89, and 114.100, as well as the cri- the scheduled process. Acidified foods
teria in parts 110 and 117 of this chap- shall be thermally processed to an ex-
ter, apply in determining whether an tent that is sufficient to destroy the
article of acidified food is adulterated: vegetative cells of microorganisms of
(a) Within the meaning of section public health significance and those of
402(a)(3) of the Federal Food, Drug, and nonhealth significance capable of re-
Cosmetic Act in that it has been manu- producing in the food under the condi-
factured under such conditions that it tions in which the food is stored, dis-
is unfit for food; or tributed, retailed and held by the user.
(b) Within the meaning of section Permitted preservatives may be used
402(a)(4) of the Federal Food, Drug, and to inhibit reproduction of microorga-
Cosmetic Act in that it has been pre- nisms of nonhealth significance (in lieu
pared, packed, or held under insanitary of thermal processing).
conditions whereby it may have be- (2) Sufficient control, including fre-
come contaminated with filth, or quent testing and recording of results,
whereby it may have been rendered in- shall be exercised so that the finished
jurious to health. equilibrium pH values for acidified
foods are not higher than 4.6. Measure-
[80 FR 56144, Sept. 17, 2015]
ment of acidity of foods in-process may
§ 114.10 Personnel. be made by potentiometric methods,
titratable acidity, or colorimetric
All operators of processing and pack- methods. If the finished equilibrium pH
aging systems shall be under the oper- of the food is above 4.0, the measure-
ating supervisions of a person who has ment of the finished equilibrium pH
attended a school approved by the
shall be by a potentiometric method,
Commissioner for giving instruction in
and the in-process measurements by ti-
food-handling techniques, food-protec-
tration or colorimetry shall be related
tion principles, personal hygiene and
to the finished equilibrium pH. If the
plant sanitation practices, pH controls
finished equilibrium pH is 4.0 or below,
and critical factors in acidification,
then the measurement of acidity of the
and who has been identified by that
final product may be made by any suit-
school as having satisfactorily com-
able method. Special care should be
pleted the prescribed course of instruc-
taken when food ingredients have been
tion. The Commissioner will consider
subjected to lye, lime, or similar high
students who have satisfactorily com-
pH materials.
pleted the required portions of the
(3) Procedures for acidification to at-
courses presented under § 108.35 and
tain acceptable equilibrium pH levels
part 113 of this chapter before March
in the final food include, but are not
16, 1979, to be in compliance with the
limited to, the following:
requirement of this section.
(i) Blanching of the food ingredients
in acidified aqueous solutions.
Subparts B–D [Reserved] (ii) Immersion of the blanched food
in acid solutions. Although immersion
Subpart E—Production and of food in an acid solution is a satisfac-
Process Controls tory method for acidification, care
must be taken to ensure that the acid
§ 114.80 Processes and controls. concentration is properly maintained.
(a) Processing operations. The manu- (iii) Direct batch acidification, which
facturer shall employ appropriate qual- can be achieved by adding a known
ity control procedures to ensure that amount of an acid solution to a speci-
finished foods do not present a health fied amount of food during acidifica-
hazard. tion.
(1) Acidified foods shall be so manu- (iv) Direct addition of a predeter-
factured, processed, and packaged that mined amount of acid to individual

a finished equilibrium pH value of 4.6 containers during production. Liquid
or lower is achieved within the time acids are generally more effective than
357
§ 114.83 21 CFR Ch. I (4–1–16 Edition)
solid or pelleted acids. Care must be of this chapter; or (c) set aside that
taken to ensure that the proper portion of the food involved for further
amount of acid is added to each con- evaluation as to any potential public
tainer. health significance. The evaluation
(v) Addition of acid foods to low-acid shall be made by a competent proc-
foods in controlled proportions to con- essing authority and shall be in accord-
form to specific formulations. ance with procedures recognized by
(4) Testing and examinations of con- competent processing authorities as
tainers shall occur often enough to en- being adequate to detect any potential
sure that the container suitably pro- hazard to public health. Unless the
tects the food from leakage or con- evaluation demonstrates that the food
tamination. has undergone a process that has ren-
(b) Coding. Each container or product dered it safe, the food set aside shall ei-
shall be marked with an identifying ther be fully reprocessed to render it
code permanently visible to the naked safe, or be destroyed. A record shall be
eye. If the container does not permit made of the procedures used in the
the code to be embossed or inked, the evaluation and the results. Either upon
label may be legibly perforated or oth- completion of full reprocessing and the
erwise marked, as long as the label is attainment of a safe food, or after the
securely affixed to the product con- determination that no significant po-
tainer. The required identification tential for public health hazard exists,
shall specify in code the establishment that portion of the food involved may
where the product was packed, the be shipped in normal distribution. Oth-
product contained therein, and the erwise, the portion of the food involved
year, day, and period during which it shall be destroyed.
was packed. The packing period code
shall be changed often enough to en- § 114.90 Methodology.
able ready identification of lots during Methods that may be used to deter-
their sale and distribution. Codes may mine pH or acidity for acidified foods
be changed periodically on one of the include, but are not limited to, the fol-
following bases: intervals of 4 to 5 lowing:
hours; personnel shift changes; or (a) Potentiometric method for the deter-
batches, as long as the containers con- mination of pH—(1) Principles. The term
stituting the batch do not represent ‘‘pH’’ is used to designate the intensity
those processed during more than one or degree of acidity. The value of pH,
personnel shift. the logarithm of the reciprocal of the
hydrogen ion concentration in solu-
§ 114.83 Establishing scheduled proc- tion, is determined by measuring the
esses. difference in potential between two
The scheduled process shall be estab- electrodes immersed in a sample solu-
lished by a qualified person who has ex- tion. A suitable system consists of a
pert knowledge acquired through ap- potentiometer, a glass electrode, and a
propriate training and experience in reference electrode. A precise pH deter-
the acidification and processing of mination can be made by making an
acidified foods. electromotive force (emf) measurement
of a standard buffer solution whose pH
§ 114.89 Deviations from scheduled is known, and then comparing that
processes. measurement to an emf measurement
Whenever any process operation devi- of a sample of the solution to be tested.
ates from the scheduled process for any (2) Instruments. The primary instru-
acidified food and/or the equilibrium ment for use in pH determination is
pH of the finished product is higher the pH meter or potentiometer. For
than 4.6, the commercial processor of most work, an instrument with a di-
the acidified food shall either: (a) Fully rect-reading pH scale is necessary. Bat-
reprocess that portion of the food by a tery and line-operated instruments are
process established by a competent available commercially. If the line
processing authority as adequate to en- voltage is unstable, line-operated in-

sure a safe product; (b) thermally proc- struments should be fitted with voltage
ess it as a low-acid food under part 113 regulators to eliminate drifting of
358
meter-scale readings. Batteries should automatic temperature compensator

be checked frequently to ensure proper may be used.
operation of battery operated instru- (iii) Accuracy. The accuracy of most
ments. An instrument using an ex- pH meters is stated to be approxi-
panded unit scale or a digital readout mately 0.1 pH unit, and reproducibility
system is preferred since it allows is usually ±0.05 pH unit or less. Some
more precise measurements. meters permit the expansion of any pH
(3) Electrodes. The typical pH meter is unit range to cover the entire scale and
equipped with a glass membrane elec- have an accuracy of approximately
trode and a reference electrode or a ±0.01 pH unit and a reproducibility of
single probe combination electrode. ±0.005 pH units.
Various types of electrodes designed (4) General procedure for determining
for specific uses are available. The pH. When operating an instrument, the
most commonly used reference elec- operator should use the manufacturer’s
trode is the calomel electrode, which instructions and should observe the fol-
incorporates a salt bridge filled with lowing techniques for pH determina-
saturated potassium chloride solution. tions:
(i) Care and use of electrodes. Calomel (i) Switch the instrument on and
electrodes should be kept filled with allow the electronic components to
saturated potassium chloride solution warm up and stabilize before pro-
or other solution specified by the man- ceeding.
ufacturer because they may become (ii) Standardize the instrument and
damaged if they are allowed to dry out. electrodes with commercially prepared
For best results, electrodes should be standard 4.0 pH buffer or with freshly
soaked in buffer solution, distilled or prepared 0.05 molar potassium acid
deionized water, or other liquid speci- phthalate buffer solution prepared as
fied by the manufacturer for several outlined in ‘‘Official Methods of Anal-
hours before using and kept ready by ysis of the Association of Official Ana-
storing with tips immersed in distilled lytical Chemists’’ (AOAC), 13th Ed.
water or in buffer solution used for (1980), section 50.007(c), under ‘‘Buffer
standardization. Electrodes should be Solutions for Calibration of pH Equip-
rinsed with water before immersing in ment—Official Final Action,’’ which is
the standard buffers and rinsed with incorporated by reference. Copies may
water or the solution to be measured be obtained from the AOAC INTER-
next between sample determinations. A NATIONAL, 481 North Frederick Ave.,
lag in meter response may indicate suite 500, Gaithersburg, MD 20877, or
aging effects or fouling of the elec- may be examined at the National Ar-
trodes, and cleaning and rejuvenation chives and Records Administration
of the electrodes may be necessary and (NARA). For information on the avail-
may be accomplished by placing the ability of this material at NARA, call
electrodes in 0.1 molar sodium hydrox- 202–741–6030, or go to: http://
ide solution for 1 minute and then www.archives.gov/federallregister/
transferring them to 0.1 molar hydro- codeloflfederallregulations/
chloric acid solution for 1 minute. The ibrllocations.html. Note the tempera-
cycle should be repeated two times, ture of the buffer solution and set the
ending with the electrodes in the acid temperature compensator control at
solution. The electrodes should then be the observed temperature (room tem-
thoroughly rinsed with water and blot- perature is near 25 °C).
ted with soft tissue before proceeding (iii) Rinse the electrodes with water
with the standardization. and blot, but do not wipe, with soft tis-
(ii) Temperature. To obtain accurate sue.
results, a uniform temperature should (iv) Immerse the tips in the buffer so-
be maintained for the electrodes, the lution and take the pH reading, allow-
standard buffer solutions, and the sam- ing about 1 minute for the meter to
ples. Tests should be made at a tem- stabilize. Adjust the standardization
perature between 20° and 30 °C, the op- control so that the meter reading cor-
timum being 25 °C. Any temperature responds to the pH of the known buffer
determinations made without meter (for example, 4.0) for the temperature
compensation may affect pH values. An observed. Rinse the electrodes with
359
§ 114.90 21 CFR Ch. I (4–1–16 Edition)
water and blot with soft tissue. Repeat the temperature of the buffer solution
procedure with fresh portions of buffer used for the standardization.
solution until the instrument remains (ii) Rinse and blot the electrodes. Im-
in balance on two successive trials. To merse the electrodes in the sample and
check the operation of the pH meter, take the pH reading, allowing 1 minute
check the pH reading using another for the meter to stabilize. Rinse and
standard buffer such as one having a blot the electrodes and repeat on a
pH of 7.0, or check it with freshly pre- fresh portion of sample. Oil and grease
pared 0.025 molar phosphate solution from the samples may coat the elec-
prepared as outlined in the AOAC, 13th trodes; therefore, it is advisable to
Ed. (1980), section 50.007(e), which is in- clean and standardize the instrument
corporated by reference. The avail- frequently. When oily samples cause
ability of this incorporation by ref- fouling problems, it may become nec-
erence is given in paragraph (a)(4)(ii) of essary to rinse the electrodes with
this section. Expanded scale pH meters ethyl ether.
may be checked with pH 3.0 or pH 5.0 (iii) Determine two pH values on the
standard buffers. Buffers and instru- well-mixed sample. These readings
ments can be further checked by com- should agree with one another to indi-
parison with values obtained with a cate that the sample is homogeneous.
second properly standardized instru- Report values to the nearest 0.05 pH
ment. unit.
(v) Indicating electrodes may be (6) Preparation of samples. Some food
checked for proper operation by first products may consist of a mixture of
using an acid buffer and then a base liquid and solid components that differ
buffer. First standardize the electrodes in acidity. Other food products may be
using a pH 4.0 buffer at or near 25 °C. semisolid in character. The following
Standardization control should be ad- are examples of preparation procedures
justed so that the meter reads exactly for pH testing for each of these cat-
4.0. Electrodes should be rinsed with egories:
water, then blotted and immersed in a (i) Liquid and solid component mix-
pH 9.18 borax buffer prepared as out- tures. Drain the contents of the con-
lined in the AOAC, 13th Ed. (1980), sec- tainer for 2 minutes on a U.S. standard
tion 50.007(f), which is incorporated by No. 8 sieve (preferably stainless steel)
reference. The availability of this in- inclined at a 17- to 20-degree angle.
corporation by reference is given in Record weight of the liquid and solid
paragraph (a)(4)(ii) of this section. The portions and retain each portion sepa-
pH reading should be within ±0.3 units rately.
of the 9.18 value. (a) If the liquid contains sufficient
(vi) The pH meter can be tested for oil to cause electrode fouling, separate
proper operation by shorting the glass the layers with a separatory funnel and
and reference electrode inputs, thereby retain the aqueous layer. The oil layer
reducing the voltage to zero. In some may be discarded. Adjust the tempera-
meters this shorting is done by switch- ture of the aqueous layer to 25 °C and
ing the instrument to standby, and in determine its pH.
other instruments by use of a shorting (b) Remove the drained solids from
strap. With the instrument shorted the sieve, blend to a uniform paste, ad-
out, standardization control should be just the temperature of the paste to 25
turned from one extreme to another. °C and determine its pH.
This operation should produce a deflec- (c) Mix aliquots of solid and liquid
tion greater than ±1.5 pH unit from fractions in the same ratio as found in
center scale. the original container and blend to a
(5) Determining pH on samples. (i) Ad- uniform consistency. Adjust the tem-
just the temperature of the sample to perature of the blend to 25 °C and de-
room temperature (25 °C), and set the termine the equilibriated pH. Alter-
temperature compensator control to natively, blend the entire contents of
the observed temperature. With some the container to a uniform paste, ad-
expanded scale instruments, the sam- just the temperature of the paste to 25
ple temperature must be the same as °C, and determine the equilibriated pH.
360
(ii) Marinated oil products. Separate (b) Colorimetric methods for the deter-
the oil from the solid product. Blend mination of pH. This method may be
the solid in a blender to a paste con- used in lieu of the potentiometric
sistency; it may become necessary to method if the pH is 4.0 or lower.
add a small amount of distilled water (1) Principle. The colorimetric method
to some samples to facilitate the for pH involves the use of indicator
blending. A small amount of added dyes in solutions that gradually change
water will not alter the pH of most color over limited pH ranges. An indi-
food products, but caution must be ex- cator that has the greatest color
ercised concerning poorly buffered change at approximately the pH of the
foods. No more than 20 milliliters of sample being tested is selected. The pH
distilled water should be added to each is determined by the color of the indi-
100 grams of product. Determine the pH
cator when exposed to the sample
by immersing electrodes in the pre-
under test.
pared paste after adjusting the tem-
(2) Indicator solutions. Most indicator
perature to 25 °C.
solutions are prepared as a 0.04 percent
(iii) Semisolid products. Food products
solution of the indicator dye in alco-
of a semisolid consistency, such as pud-
dings, potato salad, etc., may be blend- hol. In testing, a few drops of indicator
ed to a paste consistency, and the pH solution are added to 10-milliliter por-
may be determined on the prepared tions of the sample solution. Colors
paste. If more fluidity is required, 10 to should be compared using a bright
20 milliliters of distilled water may be background. Approximate determina-
added to 100 grams of product. Adjust tions can be made on white porcelain
the temperature of the prepared paste spot plates, the test colors being com-
to 25 °C and determine its pH. pared thereon with a set of color stand-
(iv) Special product mixtures. For spe- ards. More accurate colorimetric tests
cial product mixtures such as anti- can be made using a comparator block
pasto, pour off the oil, blend the re- fitted with sets of tubes of standard in-
maining product to a paste, and deter- dicator solutions of known pH.
mine the pH of the blended paste. If (3) Indicator paper. A paper tape
more fluidity is required, add 10 to 20 treated with indicator dye is dipped
milliliters of distilled water to each 100 into the sample solution. Depending
grams of product and blend. Adjust the upon the pH of the solution, the tape
temperature of the prepared paste to 25 will change color and an approximate
°C and determine its pH. pH can be determined by comparison
(7) Process pH determination. Obtain with a standard color chart.
sample portions of material for pH de- (c) Titratable acidity. Acceptable
termination. methods for determining titratable
(i) For process liquids, adjust the acidity are described in the AOAC, 13th
temperature of the liquid to 25 °C and Ed. (1980), section 22.060, under ‘‘Ti-
determine the pH by immersing the tratable Acidity—Official Final Ac-
electrodes in the liquid. tion,’’ for ‘‘Indicator Method,’’ and sec-
(ii) Drain solid materials on a sieve tion 22.061 for ‘‘Glass Electrode Meth-
and blend to a workable paste. Adjust od—Official Final Action,’’ which is in-
the temperature of the prepared paste corporated by reference. The avail-
to 25 °C and determine its pH. ability of this incorporation by ref-
(iii) If enough solid materials are erence is given in paragraph (a)(4)(ii) of
available to make a paste, blend rep- this section. The procedure for pre-
resentative aliquots of liquid and solid paring and standardizing the sodium
materials to a workable paste. Adjust hydroxide solution is described in the
the temperature of the prepared paste AOAC, 13th Ed. (1980), sections 50.032–
to 25 °C and determine the equilibrated 50.035, under ‘‘Sodium Hydroxide—Offi-
pH. Alternatively, blend the entire con-
cial Final Action’’ by the ‘‘Standard
tents of the container to a uniform
paste, adjust the temperature of the

paste to 25 °C, and determine the
equilibrated pH.
361
§ 114.100 21 CFR Ch. I (4–1–16 Edition)
Potassium Hydroxide Phthalate Meth- PART 115—SHELL EGGS

od,’’ which is also incorporated by ref-
erence and available as set forth in
paragraph (a)(4)(ii) of this section. AUTHORITY: 21 U.S.C. 342, 371; 42 U.S.C. 243,
264, 271.
FR 11822, Mar. 19, 1982; 49 FR 5609, Feb. 14, § 115.50 Refrigeration of shell eggs
1984; 54 FR 24892, June 12, 1989; 63 FR 14035, held for retail distribution.
Mar. 24, 1998]
(a) For purposes of this section a
‘‘retail establishment’’ is an operation
Subpart F—Records and Reports that stores, prepares, packages, serves,
vends, or otherwise provides food for
§ 114.100 Records.
human consumption directly to con-
(a) Records shall be maintained of ex- sumers.
aminations of raw materials, pack- (b) Except as provided in paragraph
aging materials, and finished products, (c) of this section, all shell eggs,
and of suppliers’ guarantees or certifi- whether in intrastate or interstate
cations that verify compliance with commerce, held for retail distribution:
Food and Drug Administration regula- (1) Shall promptly be placed under re-
tions and guidance documents or ac- frigeration as specified in paragraph
tion levels. (b)(2) of this section upon receipt at a
(b) Processing and production records retail establishment, except that, when
showing adherence to scheduled proc- short delays are unavoidable, the eggs
esses, including records of pH measure- shall be placed under refrigeration, as
ments and other critical factors in- soon as reasonably possible; and
tended to ensure a safe product, shall (2) Shall be stored and displayed
be maintained and shall contain suffi- under refrigeration at an ambient tem-
cient additional information such as perature not greater than 7.2 °C (45 °F)
product code, date, container size, and while held at a retail establishment.
product, to permit a public health haz- (c) Shell eggs that have been specifi-
ard evaluation of the processes applied cally processed to destroy all viable
to each lot, batch, or other portion of Salmonella shall be exempt from the re-
production. quirements of paragraph (b) of this sec-
(c) All departures from scheduled tion.
processes having a possible bearing on (d) Under sections 311 and 361 of the
public health or the safety of the food Public Health Service Act (PHS Act),
shall be noted and the affected portion any State or locality that is willing
of the product identified; these depar- and able to assist the agency in the en-
tures shall be recorded and made the forcement of paragraph (b) of this sec-
subject of a separate file (or log identi- tion, and is authorized to inspect or
fying the appropriate data) delineating regulate retail establishments, may, in
them, the action taken to rectify them, its own jurisdiction, enforce paragraph
and the disposition of the portion of (b) of this section through inspections
the product involved. under paragraph (f) of this section and
(d) Records shall be maintained iden- through administrative enforcement
tifying initial distribution of the fin- remedies identified in paragraph (e) of
ished product to facilitate, when nec- this section until FDA notifies the
essary, the segregation of specific food State or locality in writing that such
lots that may have become contami- assistance is no longer needed. When
nated or otherwise unfit for their in- providing assistance under paragraph
tended use. (e) of this section, a State or locality
(e) Copies of all records provided for may follow the hearing procedures set
in paragraphs (b), (c), and (d) of this out in paragraphs (e)(2)(iii) through
section shall be retained at the proc- (e)(2)(iv) of this section, substituting,
essing plant or other reasonably acces- where necessary, appropriate State or
sible location for a period of 3 years local officials for designated FDA offi-
from the date of manufacture. cials or may utilize State or local hear-
[44 FR 16235, Mar. 16, 1979, as amended at 65 ing procedures if such procedures sat-
FR 56479, Sept. 19, 2000] isfy due process.
362
(e) This section is established under (E) Identification or description of

authority of both the Federal Food, the eggs;
Drug, and Cosmetic Act (the act) and (F) The order number;
the PHS Act. Under the act, the agency (G) The date of the order;
can enforce the food adulteration pro- (H) The text of this entire section;
visions under 21 U.S.C. 331, 332, 333, and (I) A statement that the order may
334. However, 42 U.S.C. 264 provides for be appealed by written appeal or by re-
the issuance of implementing enforce- questing an informal hearing;
ment regulations; therefore, FDA has (J) The name and phone number of
established the following administra- the person issuing the order; and
tive enforcement procedures for the di- (K) The location and telephone num-
version or destruction of shell eggs and ber of the office or agency and the
for informal hearings under the PHS name of its director.
Act: (iii) Approval of District Director. An
(1) Upon finding that any shell eggs order, before issuance, shall be ap-
have been held in violation of this sec- proved by the Food and Drug Adminis-
tion, an authorized FDA representative tration (FDA) District Director in
or a State or local representative in ac- whose district the shell eggs are lo-
cordance with paragraph (d) of this sec- cated. If prior written approval is not
tion may order such eggs to be di- feasible, prior oral approval shall be
verted, under the supervision of said obtained and confirmed by written
representative, for processing in ac- memorandum as soon as possible.
cordance with the Egg Products Inspec- (iv) Labeling or marking of shell eggs
tion Act (EPIA) (21 U.S.C. 1031 et seq.) under order. An FDA, State, or local
or destroyed by or under the super- agency representative issuing an order
vision of an officer or employee of the under paragraph (e)(1) of this section
FDA, or, if applicable, of the State or shall label or mark the shell eggs with
locality in accordance with the fol- official tags that include the following
lowing procedures: information:
(i) Order for diversion or destruction. (A) A statement that the shell eggs
Any district office of FDA or any State are detained in accordance with regula-
or local agency acting under paragraph tions issued under section 361(a) of the
(d) of this section, upon finding shell PHS Act (42 U.S.C. 264(a)).
eggs held in violation of this section, (B) A statement that the shell eggs
may serve upon the person in whose shall not be sold, distributed or other-
possession such eggs are found a writ- wise disposed of or moved except, after
ten order that such eggs be diverted, notifying the issuing entity in writing,
under the supervision of an officer or to:
employee of the issuing entity, for (1) Divert them for processing in ac-
processing in accordance with the cordance with the EPIA or destroy
EPIA (21 U.S.C. 1031 et seq.) or de- them; or
stroyed by or under the supervision of (2) Move them to an another location
said district office, within 10-working for holding pending appeal.
days from the date of receipt of the (C) A statement that the violation of
order. the order or the removal or alteration
(ii) Issuance of order. The order shall of the tag is punishable by fine or im-
include the following information: prisonment or both (section 368 of the
(A) A statement that the shell eggs PHS Act, 42 U.S.C. 271).
identified in the order are subject to di- (D) The order number and the date of
version for processing in accordance the order, and the name of the govern-
with the EPIA or destruction; ment representative who issued the
(B) A detailed description of the facts order.
that justify the issuance of the order; (v) Sale or other disposition of shell eggs
(C) The location of the eggs; under order. After service of the order,
(D) A statement that these eggs shall the person in possession of the shell
not be sold, distributed, or otherwise eggs that are the subject of the order
disposed of or moved except as pro- shall not sell, distribute, or otherwise

vided in paragraph (e)(1)(v) of this sec- dispose of or move any eggs subject to
tion; the order unless and until the notice is
363
§ 115.50 21 CFR Ch. I (4–1–16 Edition)
withdrawn after an appeal except, after (A) The FDA Regional Food and Drug
notifying FDA’s district office or, if ap- Director may direct that the hearing
plicable, the State or local agency in be conducted in any suitable manner
writing, to: permitted by law and this section. The
(A) Divert or destroy them as speci- FDA Regional Food and Drug Director
fied in paragraph (e)(1)(i) of this sec- has the power to take such actions and
tion; or make such rulings as are necessary or
(B) Move them to another location appropriate to maintain order and to
for holding pending appeal. conduct an informal fair, expeditious,
(2) The person on whom the order for and impartial hearing, and to enforce
diversion or destruction is served may the requirements concerning the con-
either comply with the order or appeal duct of hearings.
the order to the FDA Regional Food (B) Employees of FDA will first give
and Drug Director in accordance with a full and complete statement of the
the following procedures: action which is the subject of the hear-
ing, together with the information and
(i) Appeal of a detention order. Any ap-
reasons supporting it, and may present
peal shall be submitted in writing to
oral or written information relevant to
FDA’s District Director in whose dis-
the hearing. The party requesting the
trict the shell eggs are located within
hearing may then present oral or writ-
5-working days of the issuance of the
ten information relevant to the hear-
order. If the appeal includes a request
ing. All parties may conduct reason-
for an informal hearing, the hearing
able examination of any person (except
shall be held within 5-working days
for the presiding officer and counsel for
after the appeal is filed or, if requested the parties) who makes any statement
by the appellant, at a later date, which on the matter at the hearing.
shall not be later than 20-calendar days (C) The hearing shall be informal in
after the issuance of the order. The nature, and the rules of evidence do not
order may also be appealed within the apply. No motions or objections relat-
same period of 5-working days by any ing to the admissibility of information
other person having an ownership or and views will be made or considered,
proprietary interest in such shell eggs. but any party may comment upon or
The appellant of an order shall state rebut any information and views pre-
the ownership or proprietary interest sented by another party.
the appellant has in the shell eggs. (D) The party requesting the hearing
(ii) Summary decision. A request for a may have the hearing transcribed, at
hearing may be denied, in whole or in the party’s expense, in which case a
part and at any time after a request for copy of the transcript is to be fur-
a hearing has been submitted, if the nished to FDA. Any transcript of the
FDA Regional Food and Drug Director hearing will be included with the FDA
or his or her designee determines that Regional Food and Drug Director’s re-
no genuine and substantial issue of fact port of the hearing.
has been raised by the material sub- (E) The FDA Regional Food and Drug
mitted in connection with the hearing Director shall prepare a written report
or from matters officially noticed. If of the hearing. All written material
the FDA Regional Food and Drug Di- presented at the hearing will be at-
rector determines that a hearing is not tached to the report. Whenever time
justified, written notice of the deter- permits, the FDA Regional Food and
mination will be given to the parties Drug Director may give the parties the
explaining the reason for denial. opportunity to review and comment on
(iii) Informal hearing. Appearance by the report of the hearing.
any appellant at the hearing may be by (F) The FDA Regional Food and Drug
mail or in person, with or without Director shall include as part of the re-
counsel. The informal hearing shall be port of the hearing a finding on the
conducted by the FDA Regional Food credibility of witnesses (other than ex-
and Drug Director or his designee, and pert witnesses) whenever credibility is
a written summary of the proceedings a material issue, and shall include a

shall be prepared by the FDA Regional recommended decision, with a state-
Food and Drug Director. ment of reasons.
364
(iv) Written appeal. If the appellant such eggs and the equipment in which
appeals the detention order but does shell eggs are held and any records re-
not request a hearing, the FDA Re- lating to such equipment or eggs, as
gional Food and Drug Director shall may be necessary in the judgement of
render a decision on the appeal affirm- such representatives to determine com-
ing or revoking the detention within 5- pliance with the provisions of this sec-
working days after the receipt of the tion. Inspections may be made with or
appeal. without notice and will ordinarily be
(v) Regional Food and Drug Director made during regular business hours.
decision. If, based on the evidence pre- (g) Preemption. No State or local gov-
sented at the hearing or by the appel- erning entity shall establish or con-
lant in a written appeal, the Regional tinue in effect any law, rule, regula-
Food and Drug Director finds that the tion, or other requirement allowing re-
shell eggs were held in violation of this frigeration of unpasteurized shell eggs
section, he shall affirm the order that at retail establishments at any tem-
they be diverted, under the supervision perature greater than 7.2 °C (45 °F).
of an officer or employee of the FDA
[65 FR 76112, Dec. 5, 2000]
for processing under the EPIA or de-
stroyed by or under the supervision of
an officer or employee of the FDA; oth- PART 117—CURRENT GOOD MAN-
erwise, the Regional Food and Drug Di- UFACTURING PRACTICE, HAZARD
rector shall issue a written notice that ANALYSIS, AND RISK–BASED PRE-
the prior order is withdrawn. If the Re- VENTIVE CONTROLS FOR HUMAN
gional Food and Drug Director affirms FOOD
the order he shall order that the diver-
sion or destruction be accomplished Subpart A—General Provisions
within 10-working days from the date
of the issuance of his decision. The Re- Sec.
gional Food and Drug Director’s deci- 117.1 Applicability and status.
sion shall be accompanied by a state- 117.3 Definitions.
ment of the reasons for the decision. 117.4 Qualifications of individuals who man-
The decision of the Regional Food and ufacture, process, pack, or hold food.
Drug Director shall constitute final 117.5 Exemptions.
117.7 Applicability of subparts C, D, and G
agency action, reviewable in the
of this part to a facility solely engaged
courts. in the storage of unexposed packaged
(vi) No appeal. If there is no appeal of food.
the order and the person in possession 117.8 Applicability of subpart B of this part
of the shell eggs that are subject to the to the off-farm packing and holding of
order fails to divert or destroy them raw agricultural commodities
within 10-working days, or if the de- 117.9 Records required for this subpart.
mand is affirmed by the Regional Food
and Drug Director after an appeal and Subpart B—Current Good Manufacturing
the person in possession of such eggs Practice
fails to divert or destroy them within 117.10 Personnel.
10-working days, FDA’s district office 117.20 Plant and grounds.
or appropriate State or local agency 117.35 Sanitary operations.
may designate an officer or employee 117.37 Sanitary facilities and controls.
to divert or destroy such eggs. It shall 117.40 Equipment and utensils.
be unlawful to prevent or to attempt to 117.80 Processes and controls.
prevent such diversion or destruction 117.93 Warehousing and distribution.
of the shell eggs by the designated offi- 117.95 Holding and distribution of human
cer or employee. food by-products for use as animal food.
(f) Inspection. Persons engaged in re- 117.110 Defect action levels.
tail distribution of shell eggs shall per-
Subpart C—Hazard Analysis and Risk-
mit authorized representatives of FDA
Based Preventive Controls
to make at any reasonable time such
inspection of the retail establishment 117.126 Food safety plan.

in which shell eggs are being held, in- 117.130 Hazard analysis.
cluding inspection and sampling of 117.135 Preventive controls.
365
§ 117.1 21 CFR Ch. I (4–1–16 Edition)
117.136 Circumstances in which the owner, 117.310 Additional requirements applying to
operator, or agent in charge of a manu- the food safety plan.
facturing/processing facility is not re- 117.315 Requirements for record retention.
quired to implement a preventive con- 117.320 Requirements for official review.
trol. 117.325 Public disclosure.
117.137 Provision of assurances required 117.330 Use of existing records.
under § 117.136(a)(2), (3), and (4). 117.335 Special requirements applicable to a
117.139 Recall plan. written assurance.
117.140 Preventive control management
components. Subpart G—Supply-Chain Program
117.145 Monitoring.
117.150 Corrective actions and corrections. 117.405 Requirement to establish and imple-
117.155 Verification. ment a supply-chain program.
117.160 Validation. 117.410 General requirements applicable to a
117.165 Verification of implementation and supply-chain program.
effectiveness. 117.415 Responsibilities of the receiving fa-
117.170 Reanalysis. cility.
117.180 Requirements applicable to a pre- 117.420 Using approved suppliers.
ventive controls qualified individual and 117.425 Determining appropriate supplier
a qualified auditor. verification activities (including deter-
117.190 Implementation records required for mining the frequency of conducting the
this subpart. activity).
117.430 Conducting supplier verification ac-
Subpart D—Modified Requirements tivities for raw materials and other in-
gredients.
117.201 Modified requirements that apply to 117.435 Onsite audit.
a qualified facility. 117.475 Records documenting the supply-
117.206 Modified requirements that apply to chain program.
a facility solely engaged in the storage of AUTHORITY: 21 U.S.C. 331, 342, 343, 350d note,
unexposed packaged food. 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
Subpart E—Withdrawal of a Qualified SOURCE: 80 FR 56145, Sept. 17, 2015, unless
Facility Exemption otherwise noted.
117.251 Circumstances that may lead FDA Subpart A—General Provisions

to withdraw a qualified facility exemp-
tion. § 117.1 Applicability and status.
117.254 Issuance of an order to withdraw a
qualified facility exemption. (a) The criteria and definitions in
117.257 Contents of an order to withdraw a this part apply in determining whether
qualified facility exemption. a food is:
117.260 Compliance with, or appeal of, an (1) Adulterated within the meaning
order to withdraw a qualified facility ex- of:
emption.
117.264 Procedure for submitting an appeal.
(i) Section 402(a)(3) of the Federal
117.267 Procedure for requesting an informal Food, Drug, and Cosmetic Act in that
hearing. the food has been manufactured under
117.270 Requirements applicable to an infor- such conditions that it is unfit for
mal hearing. food; or
117.274 Presiding officer for an appeal and (ii) Section 402(a)(4) of the Federal
for an informal hearing. Food, Drug, and Cosmetic Act in that
117.277 Timeframe for issuing a decision on the food has been prepared, packed, or
an appeal.
117.280 Revocation of an order to withdraw
held under insanitary conditions
a qualified facility exemption. whereby it may have become contami-
117.284 Final agency action. nated with filth, or whereby it may
117.287 Reinstatement of a qualified facility have been rendered injurious to health;
exemption that was withdrawn. and
(2) In violation of section 361 of the
Subpart F—Requirements Applying to Public Health Service Act (42 U.S.C.
Records That Must Be Established and 264).
Maintained (b) The operation of a facility that
117.301 Records subject to the requirements manufactures, processes, packs, or
of this subpart. holds food for sale in the United States

117.305 General requirements applying to if the owner, operator, or agent in
records. charge of such facility is required to
366
comply with, and is not in compliance without other actions associated with
with, section 418 of the Federal Food, a corrective action procedure (such as
Drug, and Cosmetic Act or subpart C, actions to reduce the likelihood that
D, E, F, or G of this part is a prohibited the problem will recur, evaluate all af-
act under section 301(uu) of the Federal fected food for safety, and prevent af-
Food, Drug, and Cosmetic Act. fected food from entering commerce).
(c) Food covered by specific current Critical control point means a point,
good manufacturing practice regula- step, or procedure in a food process at
tions also is subject to the require- which control can be applied and is es-
ments of those regulations. sential to prevent or eliminate a food
[80 FR 56145, Sept. 17, 2015, as amended at 81 safety hazard or reduce such hazard to
FR 3715, Jan. 22, 2015] an acceptable level.
Defect action level means a level of a
§ 117.3 Definitions. non-hazardous, naturally occurring,
The definitions and interpretations unavoidable defect at which FDA may
of terms in section 201 of the Federal regard a food product ‘‘adulterated’’
Food, Drug, and Cosmetic Act apply to and subject to enforcement action
such terms when used in this part. The under section 402(a)(3) of the Federal
following definitions also apply: Food, Drug, and Cosmetic Act.
Acid foods or acidified foods means Environmental pathogen means a
foods that have an equilibrium pH of pathogen capable of surviving and per-
4.6 or below. sisting within the manufacturing, proc-
Adequate means that which is needed essing, packing, or holding environ-
to accomplish the intended purpose in ment such that food may be contami-
keeping with good public health prac- nated and may result in foodborne ill-
tice. ness if that food is consumed without
Affiliate means any facility that con- treatment to significantly minimize
trols, is controlled by, or is under com- the environmental pathogen. Examples
mon control with another facility. of environmental pathogens for the
Allergen cross-contact means the unin- purposes of this part include Listeria
tentional incorporation of a food aller- monocytogenes and Salmonella spp. but
gen into a food. do not include the spores of pathogenic
Audit means the systematic, inde- sporeforming bacteria.
pendent, and documented examination
Facility means a domestic facility or
(through observation, investigation,
a foreign facility that is required to
records review, discussions with em-
register under section 415 of the Fed-
ployees of the audited entity, and, as
eral Food, Drug, and Cosmetic Act, in
appropriate, sampling and laboratory
accordance with the requirements of
analysis) to assess an audited entity’s
part 1, subpart H of this chapter.
food safety processes and procedures.
Batter means a semifluid substance, Farm means farm as defined in § 1.227
usually composed of flour and other in- of this chapter.
gredients, into which principal compo- FDA means the Food and Drug Ad-
nents of food are dipped or with which ministration.
they are coated, or which may be used Food means food as defined in section
directly to form bakery foods. 201(f) of the Federal Food, Drug, and
Blanching, except for tree nuts and Cosmetic Act and includes raw mate-
peanuts, means a prepackaging heat rials and ingredients.
treatment of foodstuffs for an adequate Food allergen means a major food al-
time and at an adequate temperature lergen as defined in section 201(qq) of
to partially or completely inactivate the Federal Food, Drug, and Cosmetic
the naturally occurring enzymes and to Act.
effect other physical or biochemical Food-contact surfaces are those sur-
changes in the food. faces that contact human food and
Calendar day means every day shown those surfaces from which drainage, or
on the calendar. other transfer, onto the food or onto
Correction means an action to iden- surfaces that contact the food ordi-
tify and correct a problem that oc- narily occurs during the normal course
curred during the production of food, of operations. ‘‘Food-contact surfaces’’
367
§ 117.3 21 CFR Ch. I (4–1–16 Edition)
includes utensils and food-contact sur- injury if the hazard were to occur and
faces of equipment. the probability that the hazard will
Full-time equivalent employee is a term occur in the absence of preventive con-
used to represent the number of em- trols), establish one or more preventive
ployees of a business entity for the pur- controls to significantly minimize or
pose of determining whether the busi- prevent the hazard in a food and com-
ness qualifies for the small business ex- ponents to manage those controls (such
emption. The number of full-time as monitoring, corrections or correc-
equivalent employees is determined by tive actions, verification, and records)
dividing the total number of hours of as appropriate to the food, the facility,
salary or wages paid directly to em- and the nature of the preventive con-
ployees of the business entity and of all trol and its role in the facility’s food
of its affiliates and subsidiaries by the safety system.
number of hours of work in 1 year, 2,080 Holding means storage of food and
hours (i.e., 40 hours × 52 weeks). If the also includes activities performed inci-
result is not a whole number, round dental to storage of a food (e.g., activi-
down to the next lowest whole number. ties performed for the safe or effective
Harvesting applies to farms and farm storage of that food, such as fumigat-
mixed-type facilities and means activi- ing food during storage, and drying/de-
ties that are traditionally performed hydrating raw agricultural commod-
on farms for the purpose of removing ities when the drying/dehydrating does
raw agricultural commodities from the not create a distinct commodity (such
place they were grown or raised and as drying/dehydrating hay or alfalfa)).
preparing them for use as food. Har- Holding also includes activities per-
vesting is limited to activities performed as a practical necessity for the
formed on raw agricultural commod- distribution of that food (such as
ities, or on processed foods created by blending of the same raw agricultural
drying/dehydrating a raw agricultural commodity and breaking down pallets),
commodity without additional manu- but does not include activities that
facturing/processing, on a farm. Har- transform a raw agricultural com-
vesting does not include activities that modity into a processed food as defined
transform a raw agricultural com- in section 201(gg) of the Federal Food,
modity into a processed food as defined Drug, and Cosmetic Act. Holding facili-
in section 201(gg) of the Federal Food, ties could include warehouses, cold
Drug, and Cosmetic Act. Examples of storage facilities, storage silos, grain
harvesting include cutting (or other- elevators, and liquid storage tanks.
wise separating) the edible portion of Known or reasonably foreseeable haz-
the raw agricultural commodity from ard means a biological, chemical (in-
the crop plant and removing or trim- cluding radiological), or physical haz-
ming part of the raw agricultural com- ard that is known to be, or has the po-
modity (e.g., foliage, husks, roots or tential to be, associated with the facil-
stems). Examples of harvesting also in- ity or the food.
clude cooling, field coring, filtering, Lot means the food produced during a
gathering, hulling, shelling, sifting, period of time and identified by an es-
threshing, trimming of outer leaves of, tablishment’s specific code.
and washing raw agricultural commod- Manufacturing/processing means mak-
ities grown on a farm. ing food from one or more ingredients,
Hazard means any biological, chem- or synthesizing, preparing, treating,
ical (including radiological), or phys- modifying or manipulating food, in-
ical agent that has the potential to cluding food crops or ingredients. Ex-
cause illness or injury. amples of manufacturing/processing ac-
Hazard requiring a preventive control tivities include: Baking, boiling, bot-
means a known or reasonably foresee- tling, canning, cooking, cooling, cut-
able hazard for which a person knowl- ting, distilling, drying/dehydrating raw
edgeable about the safe manufacturing, agricultural commodities to create a
processing, packing, or holding of food distinct commodity (such as drying/de-
would, based on the outcome of a haz- hydrating grapes to produce raisins),

ard analysis (which includes an assess- evaporating, eviscerating, extracting
ment of the severity of the illness or juice, formulating, freezing, grinding,
368
homogenizing, irradiating, labeling, essing, packing, or holding of human

milling, mixing, packaging (including food.
modified atmosphere packaging), pas- Preventive controls means those risk-
teurizing, peeling, rendering, treating based, reasonably appropriate proce-
to manipulate ripening, trimming, dures, practices, and processes that a
washing, or waxing. For farms and person knowledgeable about the safe
farm mixed-type facilities, manufac- manufacturing, processing, packing, or
turing/processing does not include ac- holding of food would employ to sig-
tivities that are part of harvesting, nificantly minimize or prevent the haz-
packing, or holding. ards identified under the hazard anal-
Microorganisms means yeasts, molds, ysis that are consistent with the cur-
bacteria, viruses, protozoa, and micro- rent scientific understanding of safe
scopic parasites and includes species food manufacturing, processing, pack-
that are pathogens. The term ‘‘unde- ing, or holding at the time of the anal-
sirable microorganisms’’ includes those ysis.
microorganisms that are pathogens, Preventive controls qualified individual
that subject food to decomposition, means a qualified individual who has
that indicate that food is contaminated successfully completed training in the
with filth, or that otherwise may cause development and application of risk-
food to be adulterated. based preventive controls at least
Mixed-type facility means an estab- equivalent to that received under a
lishment that engages in both activi- standardized curriculum recognized as
ties that are exempt from registration adequate by FDA or is otherwise quali-
under section 415 of the Federal Food, fied through job experience to develop
Drug, and Cosmetic Act and activities and apply a food safety system.
that require the establishment to be Qualified auditor means a person who
registered. An example of such a facil- is a qualified individual as defined in
ity is a ‘‘farm mixed-type facility,’’ this part and has technical expertise
which is an establishment that is a obtained through education, training,
farm, but also conducts activities out- or experience (or a combination there-
side the farm definition that require of) necessary to perform the auditing
the establishment to be registered. function as required by § 117.180(c)(2).
Monitor means to conduct a planned Examples of potential qualified audi-
sequence of observations or measure- tors include:
ments to assess whether control meas-
(1) A government employee, includ-
ures are operating as intended.
ing a foreign government employee;
Packing means placing food into a
and
container other than packaging the
(2) An audit agent of a certification
food and also includes re-packing and
body that is accredited in accordance
activities performed incidental to
with regulations in part 1, subpart M of
packing or re-packing a food (e.g., ac-
this chapter.
tivities performed for the safe or effec-
tive packing or re-packing of that food Qualified end-user, with respect to a
(such as sorting, culling, grading, and food, means the consumer of the food
weighing or conveying incidental to (where the term consumer does not in-
packing or re-packing)), but does not clude a business); or a restaurant or re-
include activities that transform a raw tail food establishment (as those terms
agricultural commodity into a proc- are defined in § 1.227 of this chapter)
essed food as defined in section 201(gg) that:
of the Federal Food, Drug, and Cos- (1) Is located:
metic Act. (i) In the same State or the same In-
Pathogen means a microorganism of dian reservation as the qualified facil-
public health significance. ity that sold the food to such res-
Pest refers to any objectionable ani- taurant or establishment; or
mals or insects including birds, ro- (ii) Not more than 275 miles from
dents, flies, and larvae. such facility; and
Plant means the building or structure (2) Is purchasing the food for sale di-
or parts thereof, used for or in connec- rectly to consumers at such restaurant
tion with the manufacturing, proc- or retail food establishment.
369
§ 117.3 21 CFR Ch. I (4–1–16 Edition)
Qualified facility means (when includ- cessfully reconditioned by reprocessing

ing the sales by any subsidiary; affil- and that is suitable for use as food.
iate; or subsidiaries or affiliates, col- Safe-moisture level is a level of mois-
lectively, of any entity of which the fa- ture low enough to prevent the growth
cility is a subsidiary or affiliate) a fa- of undesirable microorganisms in the
cility that is a very small business as finished product under the intended
defined in this part, or a facility to conditions of manufacturing, proc-
which both of the following apply: essing, packing, and holding. The safe
(1) During the 3-year period preceding moisture level for a food is related to
the applicable calendar year, the aver- its water activity (aw). An aw will be
age annual monetary value of the food considered safe for a food if adequate
manufactured, processed, packed or data are available that demonstrate
held at such facility that is sold di- that the food at or below the given aw
rectly to qualified end-users (as defined will not support the growth of undesir-
in this part) during such period exceed- able microorganisms.
ed the average annual monetary value Sanitize means to adequately treat
of the food sold by such facility to all cleaned surfaces by a process that is ef-
other purchasers; and fective in destroying vegetative cells of
(2) The average annual monetary pathogens, and in substantially reduc-
value of all food sold during the 3-year ing numbers of other undesirable
period preceding the applicable cal- microorganisms, but without adversely
endar year was less than $500,000, ad- affecting the product or its safety for
justed for inflation. the consumer.
Qualified facility exemption means an
Significantly minimize means to reduce
exemption applicable to a qualified fa-
to an acceptable level, including to
cility under § 117.5(a).
eliminate.
Qualified individual means a person
Small business means, for purposes of
who has the education, training, or ex-
this part, a business (including any
perience (or a combination thereof)
subsidiaries and affiliates) employing
necessary to manufacture, process,
fewer than 500 full-time equivalent em-
pack, or hold clean and safe food as ap-
ployees.
propriate to the individual’s assigned
duties. A qualified individual may be, Subsidiary means any company which
but is not required to be, an employee is owned or controlled directly or indi-
of the establishment. rectly by another company.
Quality control operation means a Supplier means the establishment
planned and systematic procedure for that manufactures/processes the food,
taking all actions necessary to prevent raises the animal, or grows the food
food from being adulterated. that is provided to a receiving facility
Raw agricultural commodity has the without further manufacturing/proc-
meaning given in section 201(r) of the essing by another establishment, ex-
Federal Food, Drug, and Cosmetic Act. cept for further manufacturing/proc-
Ready-to-eat food (RTE food) means essing that consists solely of the addi-
any food that is normally eaten in its tion of labeling or similar activity of a
raw state or any other food, including de minimis nature.
a processed food, for which it is reason- Supply-chain-applied control means a
ably foreseeable that the food will be preventive control for a hazard in a
eaten without further processing that raw material or other ingredient when
would significantly minimize biologi- the hazard in the raw material or other
cal hazards. ingredient is controlled before its re-
Receiving facility means a facility ceipt.
that is subject to subparts C and G of Unexposed packaged food means pack-
this part and that manufactures/proc- aged food that is not exposed to the en-
esses a raw material or other ingre- vironment.
dient that it receives from a supplier. Validation means obtaining and eval-
Rework means clean, unadulterated uating scientific and technical evi-
food that has been removed from proc- dence that a control measure, combina-
essing for reasons other than insani- tion of control measures, or the food
tary conditions or that has been suc- safety plan as a whole, when properly
370
implemented, is capable of effectively (2) The owner, operator, or agent in

controlling the identified hazards. charge of a facility must ensure that
Verification means the application of all individuals who manufacture, proc-
methods, procedures, tests and other ess, pack, or hold food subject to sub-
evaluations, in addition to monitoring, part C, D, E, F, or G of this part are
to determine whether a control meas- qualified to perform their assigned du-
ure or combination of control measures ties.
is or has been operating as intended (b) Qualifications of all individuals en-
and to establish the validity of the food gaged in manufacturing, processing,
safety plan. packing, or holding food. Each indi-
Very small business means, for pur- vidual engaged in manufacturing, proc-
poses of this part, a business (including essing, packing, or holding food (in-
any subsidiaries and affiliates) aver- cluding temporary and seasonal per-
aging less than $1,000,000, adjusted for sonnel) or in the supervision thereof
inflation, per year, during the 3-year must:
period preceding the applicable cal- (1) Be a qualified individual as that
endar year in sales of human food plus term is defined in § 117.3—i.e., have the
the market value of human food manu- education, training, or experience (or a
factured, processed, packed, or held combination thereof) necessary to
without sale (e.g., held for a fee). manufacture, process, pack, or hold
Water activity (aw) is a measure of the clean and safe food as appropriate to
free moisture in a food and is the the individual’s assigned duties; and
quotient of the water vapor pressure of (2) Receive training in the principles
the substance divided by the vapor of food hygiene and food safety, includ-
pressure of pure water at the same ing the importance of employee health
temperature. and personal hygiene, as appropriate to
Written procedures for receiving raw the food, the facility and the individ-
materials and other ingredients means ual’s assigned duties.
written procedures to ensure that raw (c) Additional qualifications of super-
materials and other ingredients are re- visory personnel. Responsibility for en-
ceived only from suppliers approved by suring compliance by individuals with
the receiving facility (or, when nec- the requirements of this part must be
essary and appropriate, on a temporary clearly assigned to supervisory per-
basis from unapproved suppliers whose sonnel who have the education, train-
raw materials or other ingredients are ing, or experience (or a combination
subjected to adequate verification ac- thereof) necessary to supervise the pro-
tivities before acceptance for use). duction of clean and safe food.
You means, for purposes of this part, (d) Records. Records that document
the owner, operator, or agent in charge training required by paragraph (b)(2) of
of a facility. this section must be established and
maintained.
FR 3715, Jan. 22, 2015] § 117.5 Exemptions.
EFFECTIVE DATE NOTE: At 80 FR 56145, (a) Except as provided by subpart E
Sept. 17, 2015, § 117.3 was added, effective Nov. of this part, subparts C and G of this
16, 2015, except for paragraph (2) of the defi-
nition of ‘‘qualified auditor’’. FDA will pub-
part do not apply to a qualified facil-
lish a document in the FEDERAL REGISTER ity. Qualified facilities are subject to
announcing the effective date for this para- the modified requirements in § 117.201.
graph. (b) Subparts C and G of this part do
not apply with respect to activities
§ 117.4 Qualifications of individuals that are subject to part 123 of this
who manufacture, process, pack, or chapter (Fish and Fishery Products) at
hold food. a facility if you are required to comply
(a) Applicability. (1) The management with, and are in compliance with, part
of an establishment must ensure that 123 of this chapter with respect to such
all individuals who manufacture, proc- activities.
ess, pack, or hold food subject to sub- (c) Subparts C and G of this part do
parts B and F of this part are qualified not apply with respect to activities
to perform their assigned duties. that are subject to part 120 of this
371
§ 117.5 21 CFR Ch. I (4–1–16 Edition)
chapter (Hazard Analysis and Critical of this part and therefore do not need
Control Point (HACCP) Systems) at a to be specified in the exemption.
facility if you are required to comply (2) For the purposes of paragraphs
with, and are in compliance with, part (g)(3) and (h)(3) of this section, the fol-
120 of this chapter with respect to such lowing terms describe the foods associ-
activities. ated with the activity/food combina-
(d)(1) Subparts C and G of this part tions. Several foods that are fruits or
do not apply with respect to activities vegetables are separately considered
that are subject to part 113 of this for the purposes of these activity/food
chapter (Thermally Processed Low- combinations (i.e., coffee beans, cocoa
Acid Foods Packaged in Hermetically beans, fresh herbs, peanuts, sugarcane,
Sealed Containers) at a facility if you sugar beets, tree nuts, seeds for direct
are required to comply with, and are in consumption) to appropriately address
compliance with, part 113 of this chap- specific hazards associated with these
ter with respect to such activities. foods and/or processing activities con-
(2) The exemption in paragraph (d)(1) ducted on these foods.
of this section is applicable only with (i) Dried/dehydrated fruit and vegetable
respect to the microbiological hazards products includes only those processed
that are regulated under part 113 of food products such as raisins and dried
this chapter. legumes made without additional man-
ufacturing/processing beyond drying/
(e) Subparts C and G do not apply to
dehydrating, packaging, and/or label-
any facility with regard to the manu-
ing.
facturing, processing, packaging, or
(ii) Other fruit and vegetable products
holding of a dietary supplement that is
includes those processed food products
in compliance with the requirements of
that have undergone one or more of the
part 111 of this chapter (Current Good
following processes: acidification, boil-
Manufacturing Practice in Manufac-
ing, canning, coating with things other
turing, Packaging, Labeling, or Hold-
than wax/oil/resin, cooking, cutting,
ing Operations for Dietary Supple-
chopping, grinding, peeling, shredding,
ments) and section 761 of the Federal
slicing, or trimming. Examples include
Food, Drug, and Cosmetic Act (Serious flours made from legumes (such as
Adverse Event Reporting for Dietary chickpea flour), pickles, and snack
Supplements). chips made from potatoes or plantains.
(f) Subparts C and G of this part do Examples also include dried fruit and
not apply to activities of a facility that vegetable products made with addi-
are subject to section 419 of the Federal tional manufacturing/processing (such
Food, Drug, and Cosmetic Act (Stand- as dried apple slices; pitted, dried
ards for Produce Safety). plums, cherries, and apricots; and
(g)(1) The exemption in paragraph sulfited raisins). This category does
(g)(3) of this section applies to packing not include dried/dehydrated fruit and
or holding of processed foods on a farm vegetable products made without addi-
mixed-type facility, except for proc- tional manufacturing/processing as de-
essed foods produced by drying/dehy- scribed in paragraph (g)(2)(i) of this
drating raw agricultural commodities section. This category also does not in-
to create a distinct commodity (such clude products that require time/tem-
as drying/dehydrating grapes to perature control for safety (such as
produce raisins, and drying/dehy- fresh-cut fruits and vegetables).
drating fresh herbs to produce dried (iii) Peanut and tree nut products in-
herbs), and packaging and labeling cludes processed food products such as
such commodities, without additional roasted peanuts and tree nuts, sea-
manufacturing/processing (such as soned peanuts and tree nuts, and pea-
chopping and slicing), the packing and nut and tree nut flours.
holding of which are within the ‘‘farm’’ (iv) Processed seeds for direct consump-
definition in § 1.227 of this chapter. Ac- tion include processed food products
tivities that are within the ‘‘farm’’ def- such as roasted pumpkin seeds, roasted
inition, when conducted on a farm sunflower seeds, and roasted flax seeds.
mixed-type facility, are not subject to (v) Dried/dehydrated herb and spice
the requirements of subparts C and G products includes only processed food
372
products such as dried intact herbs (including weighing or conveying inci-

made without additional manufac- dental to packing or re-packing); sort-
turing/processing beyond drying/dehy- ing, culling, or grading incidental to
drating, packaging, and/or labeling. packing or storing; and storing (ambi-
(vi) Other herb and spice products in- ent, cold and controlled atmosphere)
cludes those processed food products of:
such as chopped fresh herbs, chopped or (i) Baked goods (e.g., bread and cook-
ground dried herbs (including tea), ies);
herbal extracts (e.g., essential oils, ex- (ii) Candy (e.g., hard candy, fudge,
tracts containing more than 20 percent maple candy, maple cream, nut
ethanol, extracts containing more than brittles, taffy, and toffee);
35 percent glycerin), dried herb- or (iii) Cocoa beans (roasted);
spice-infused honey, and dried herb- or (iv) Cocoa products;
spice-infused oils and/or vinegars. This (v) Coffee beans (roasted);
category does not include dried/dehy- (vi) Game meat jerky;
drated herb and spice products made (vii) Gums, latexes, and resins that
without additional manufacturing/ are processed foods;
processing beyond drying/dehydrating, (viii) Honey (pasteurized);
packaging, and/or labeling as described (ix) Jams, jellies, and preserves;
in paragraph (g)(2)(v) of this section. (x) Milled grain products (e.g., flour,
This category also does not include bran, and corn meal);
products that require time/temperature (xi) Molasses and treacle;
control for safety, such as fresh herb- (xii) Oils (e.g., olive oil and sunflower
infused oils. seed oil);
(vii) Grains include barley, dent- or (xiii) Other fruit and vegetable prod-
flint-corn, sorghum, oats, rice, rye, ucts (e.g., flours made from legumes;
wheat, amaranth, quinoa, buckwheat pitted, dried fruits; sliced, dried apples;
and oilseeds for oil extraction (such as snack chips);
cotton seed, flax seed, rapeseed, soy- (xiv) Other grain products (e.g., dried
beans, and sunflower seed). pasta, oat flakes, and popcorn);
(viii) Milled grain products include (xv) Other herb and spice products
processed food products such as flour, (e.g., chopped or ground dried herbs,
bran, and corn meal. herbal extracts);
(ix) Baked goods include processed (xvi) Peanut and tree nut products
food products such as breads, brownies, (e.g., roasted peanuts and tree nut
cakes, cookies, and crackers. This cat- flours);
egory does not include products that (xvii) Processed seeds for direct con-
require time/temperature control for sumption (e.g., roasted pumpkin seeds);
safety, such as cream-filled pastries. (xviii) Soft drinks and carbonated
(x) Other grain products include proc- water;
essed food products such as dried ce- (xix) Sugar;
real, dried pasta, oat flakes, and pop- (xx) Syrups (e.g., maple syrup and
corn. This category does not include agave syrup);
milled grain products as described in (xxi) Trail mix and granola;
paragraph (g)(2)(viii) of this section or (xxii) Vinegar; and
baked goods as described in paragraph (xxiii) Any other processed food that
(g)(2)(ix) of this section. does not require time/temperature con-
(3) Subparts C and G of this part do trol for safety (e..g., vitamins, min-
not apply to on-farm packing or hold- erals, and dietary ingredients (e.g.,
ing of food by a small or very small bone meal) in powdered, granular, or
business, and § 117.201 does not apply to other solid form).
on-farm packing or holding of food by a (h)(1) The exemption in paragraph
very small business, if the only pack- (h)(3) of this section applies to manu-
ing and holding activities subject to facturing/processing of foods on a farm
section 418 of the Federal Food, Drug, mixed-type facility, except for manu-
and Cosmetic Act that the business facturing/processing that is within the
conducts are the following low-risk ‘‘farm’’ definition in § 1.227 of this chap-
packing or holding activity/food com- ter. Drying/dehydrating raw agricul-
binations—i.e., packing (or re-packing) tural commodities to create a distinct
373
§ 117.5 21 CFR Ch. I (4–1–16 Edition)
commodity (such as drying/dehy- tree nut products (e.g., chopping roast-

drating grapes to produce raisins, and ed peanuts);
drying/dehydrating fresh herbs to (iii) Coating dried/dehydrated fruit
produce dried herbs), and packaging and vegetable products (e.g., coating
and labeling such commodities, with- raisins with chocolate), other fruit and
out additional manufacturing/proc- vegetable products except for non-
essing (such as chopping and slicing), dried, non-intact fruits and vegetables
are within the ‘‘farm’’ definition in (e.g., coating dried plum pieces, dried
§ 1.227 of this chapter. In addition, pitted cherries, and dried pitted apri-
treatment to manipulate ripening of cots with chocolate are low-risk activ-
raw agricultural commodities (such as ity/food combinations but coating ap-
by treating produce with ethylene gas), ples on a stick with caramel is not a
and packaging and labeling the treated low-risk activity/food combination),
raw agricultural commodities, without other grain products (e.g., adding car-
additional manufacturing/processing, amel to popcorn or adding seasonings
is within the ‘‘farm’’ definition. In ad- to popcorn provided that the
dition, coating intact fruits and vege- seasonings have been treated to signifi-
tables with wax, oil, or resin used for cantly minimize pathogens, peanuts
the purpose of storage or transpor- and tree nuts (e.g., adding seasonings
tation is within the ‘‘farm’’ definition. provided that the seasonings have been
Activities that are within the ‘‘farm’’ treated to significantly minimize
definition, when conducted on a farm pathogens), and peanut and tree nut
mixed-type facility, are not subject to products (e.g., adding seasonings pro-
the requirements of subparts C and G vided that the seasonings have been
of this part and therefore do not need treated to significantly minimize
to be specified in the exemption. pathogens));
(2) The terms in paragraph (g)(2) of (iv) Drying/dehydrating (that in-
this section describe certain foods asso- cludes additional manufacturing or is
ciated with the activity/food combina- performed on processed foods) other
tions in paragraph (h)(3) of this sec- fruit and vegetable products with pH
tion. less than 4.2 (e.g., drying cut fruit and
(3) Subparts C and G of this part do vegetables with pH less than 4.2), and
not apply to on-farm manufacturing/ other herb and spice products (e.g., dry-
processing activities conducted by a ing chopped fresh herbs, including tea);
small or very small business for dis- (v) Extracting (including by pressing,
tribution into commerce, and § 117.201 by distilling, and by solvent extrac-
does not apply to on-farm manufac- tion) dried/dehydrated herb and spice
turing/processing activities conducted products (e.g., dried mint), fresh herbs
by a very small business for distribu- (e.g., fresh mint), fruits and vegetables
tion into commerce, if the only manu- (e.g., olives, avocados), grains (e.g., oil-
facturing/processing activities subject seeds), and other herb and spice prod-
to section 418 of the Federal Food, ucts (e.g., chopped fresh mint, chopped
Drug, and Cosmetic Act that the busi- dried mint);
ness conducts are the following low- (vi) Freezing acid fruits and vegeta-
risk manufacturing/processing activ- bles with pH less than 4.2 and other
ity/food combinations: fruit and vegetable products with pH
(i) Boiling gums, latexes, and resins; less than 4.2 (e.g., cut fruits and vegeta-
(ii) Chopping, coring, cutting, peel- bles);
ing, pitting, shredding, and slicing acid (vii) Grinding/cracking/crushing/mill-
fruits and vegetables that have a pH ing baked goods (e.g., crackers), cocoa
less than 4.2 (e.g., cutting lemons and beans (roasted), coffee beans (roasted),
limes), baked goods (e.g., slicing bread), dried/dehydrated fruit and vegetable
dried/dehydrated fruit and vegetable products (e.g., raisins and dried leg-
products (e.g., pitting dried plums), umes), dried/dehydrated herb and spice
dried herbs and other spices (e.g., chop- products (e.g., intact dried basil),
ping intact, dried basil), game meat grains (e.g., oats, rice, rye, wheat),
jerky, gums/latexes/resins, other grain other fruit and vegetable products (e.g.,
products (e.g., shredding dried cereal), dried, pitted dates), other grain prod-
peanuts and tree nuts, and peanut and ucts (e.g., dried cereal), other herb and
374
spice products (e.g., chopped dried (xiii) Making jams, jellies, and pre-
herbs), peanuts and tree nuts, and pea- serves from acid fruits and vegetables
nut and tree nut products (e.g., roasted with a pH of 4.6 or below;
peanuts); (xiv) Making molasses and treacle
(viii) Labeling baked goods that do from sugar beets and sugarcane;
not contain food allergens, candy that (xv) Making oat flakes from grains;
does not contain food allergens, cocoa (xvi) Making popcorn from grains;
beans (roasted), cocoa products that do (xvii) Making snack chips from fruits
not contain food allergens), coffee and vegetables (e.g., making plantain
beans (roasted), game meat jerky, and potato chips);
gums/latexes/resins that are processed (xviii) Making soft drinks and car-
foods, honey (pasteurized), jams/jellies/ bonated water from sugar, syrups, and
preserves, milled grain products that water;
do not contain food allergens (e.g., corn (xix) Making sugars and syrups from
meal) or that are single-ingredient fruits and vegetables (e.g., dates),
foods (e.g., wheat flour, wheat bran), grains (e.g., rice, sorghum), other grain
molasses and treacle, oils, other fruit products (e.g., malted grains such as
and vegetable products that do not barley), saps (e.g., agave, birch, maple,
contain food allergens (e.g., snack chips palm), sugar beets, and sugarcane;
made from potatoes or plantains), (xx) Making trail mix and granola
other grain products that do not con- from cocoa products (e.g., chocolate),
tain food allergens (e.g., popcorn), dried/dehydrated fruit and vegetable
other herb and spice products (e.g., products (e.g., raisins), other fruit and
chopped or ground dried herbs), peanut vegetable products (e.g., chopped dried
or tree nut products, (provided that fruits), other grain products (e.g., oat
they are single-ingredient, or are in flakes), peanut and tree nut products,
forms in which the consumer can rea- and processed seeds for direct consump-
sonably be expected to recognize the tion, provided that peanuts, tree nuts,
food allergen(s) without label declara- and processed seeds are treated to sig-
tion, or both (e.g., roasted or seasoned nificantly minimize pathogens;
whole nuts, single-ingredient peanut or (xxi) Making vinegar from fruits and
tree nut flours)), processed seeds for di- vegetables, other fruit and vegetable
rect consumption, soft drinks and car- products (e.g., fruit wines, apple cider),
bonated water, sugar, syrups, trail mix and other grain products (e.g., malt);
and granola (other than those con- (xxii) Mixing baked goods (e.g., types
taining milk chocolate and provided of cookies), candy (e.g., varieties of
that peanuts and/or tree nuts are in taffy), cocoa beans (roasted), coffee
forms in which the consumer can rea- beans (roasted), dried/dehydrated fruit
sonably be expected to recognize the and vegetable products (e.g., dried blue-
food allergen(s) without label declara- berries, dried currants, and raisins),
tion), vinegar, and any other processed dried/dehydrated herb and spice prod-
food that does not require time/tem- ucts (e.g., dried, intact basil and dried,
perature control for safety and that intact oregano), honey (pasteurized),
milled grain products (e.g., flour, bran,
does not contain food allergens (e.g., vi-
and corn meal), other fruit and vege-
tamins, minerals, and dietary ingredi-
table products (e.g., dried, sliced apples
ents (e.g., bone meal) in powdered,
and dried, sliced peaches), other grain
granular, or other solid form);
products (e.g., different types of dried
(ix) Making baked goods from milled pasta), other herb and spice products
grain products (e.g., breads and cook- (e.g., chopped or ground dried herbs,
ies); dried herb- or spice-infused honey, and
(x) Making candy from peanuts and dried herb- or spice-infused oils and/or
tree nuts (e.g., nut brittles), sugar/syr- vinegars), peanut and tree nut prod-
ups (e.g., taffy, toffee), and saps (e.g., ucts, sugar, syrups, vinegar, and any
maple candy, maple cream); other processed food that does not re-
(xi) Making cocoa products from quire time/temperature control for

roasted cocoa beans; safety (e.g., vitamins, minerals, and di-
(xii) Making dried pasta from grains; etary ingredients (e.g., bone meal) in
375
§ 117.5 21 CFR Ch. I (4–1–16 Edition)
powdered, granular, or other solid ity because it is engaged in manufac-

form); turing, processing, packing, or holding
(xxiii) Packaging baked goods (e.g., one or more alcoholic beverages.
bread and cookies), candy, cocoa beans (2) Subparts C and G of this part do
(roasted), cocoa products, coffee beans not apply with respect to food that is
(roasted), game meat jerky, gums/ not an alcoholic beverage at a facility
latexes/resins that are processed foods, described in paragraph (i)(1) of this sec-
honey (pasteurized), jams/jellies/pre- tion, provided such food:
serves, milled grain products (e.g., (i) Is in prepackaged form that pre-
flour, bran, corn meal), molasses and vents any direct human contact with
treacle, oils, other fruit and vegetable such food; and
products (e.g., pitted, dried fruits; (ii) Constitutes not more than 5 per-
sliced, dried apples; snack chips), other cent of the overall sales of the facility,
grain products (e.g., popcorn), other as determined by the Secretary of the
herb and spice products (e.g., chopped Treasury.
or ground dried herbs), peanut and tree (j) Subparts C and G of this part do
nut products, processed seeds for direct not apply to facilities that are solely
consumption, soft drinks and carbon- engaged in the storage of raw agricul-
ated water, sugar, syrups, trail mix and tural commodities (other than fruits
granola, vinegar, and any other proc- and vegetables) intended for further
essed food that does not require time/ distribution or processing.
temperature control for safety (e.g., vi- (k)(1) Except as provided by para-
tamins, minerals, and dietary ingredi- graph (k)(2) of this section, subpart B
ents (e.g., bone meal) in powdered, of this part does not apply to any of
granular, or other solid form); the following:
(xxiv) Pasteurizing honey; (i) ‘‘Farms’’ (as defined in § 1.227 of
(xxv) Roasting and toasting baked this chapter);
goods (e.g., toasting bread for crou- (ii) Fishing vessels that are not sub-
tons); ject to the registration requirements of
(xxvi) Salting other grain products part 1, subpart H of this chapter in ac-
(e.g., soy nuts), peanut and tree nut cordance with § 1.226(f) of this chapter;
products, and processed seeds for direct (iii) Establishments solely engaged in
consumption; and the holding and/or transportation of
(xxvii) Sifting milled grain products one or more raw agricultural commod-
(e.g., flour, bran, corn meal), other ities;
fruit and vegetable products (e.g., (iv) Activities of ‘‘farm mixed-type
chickpea flour), and peanut and tree facilities’’ (as defined in § 1.227 of this
nut products (e.g., peanut flour, almond chapter) that fall within the definition
flour). of ‘‘farm’’; or
(i)(1) Subparts C and G of this part do (v) Establishments solely engaged in
not apply with respect to alcoholic bev- hulling, shelling, drying, packing, and/
erages at a facility that meets the fol- or holding nuts (without additional
lowing two conditions: manufacturing/processing, such as
(i) Under the Federal Alcohol Admin- roasting nuts).
istration Act (27 U.S.C. 201 et seq.) or (2) If a ‘‘farm’’ or ‘‘farm mixed-type
chapter 51 of subtitle E of the Internal facility’’ dries/dehydrates raw agricul-
Revenue Code of 1986 (26 U.S.C. 5001 et tural commodities that are produce as
seq.) the facility is required to obtain a defined in part 112 of this chapter to
permit from, register with, or obtain create a distinct commodity, subpart B
approval of a notice or application of this part applies to the packaging,
from the Secretary of the Treasury as packing, and holding of the dried com-
a condition of doing business in the modities. Compliance with this re-
United States, or is a foreign facility of quirement may be achieved by com-
a type that would require such a per- plying with subpart B of this part or
mit, registration, or approval if it were with the applicable requirements for
a domestic facility; and packing and holding in part 112 of this
(ii) Under section 415 of the Federal chapter.

Food, Drug, and Cosmetic Act the fa- [80 FR 56145, Sept. 17, 2015, as amended at 81
cility is required to register as a facil- FR 3716, Jan. 22, 2015]
376
§ 117.7 Applicability of subparts C, D, (a) Disease control. Any person who,

and G of this part to a facility solely by medical examination or supervisory
engaged in the storage of unex- observation, is shown to have, or ap-
posed packaged food. pears to have, an illness, open lesion,
(a) Applicability of subparts C and G. including boils, sores, or infected
Subparts C and G of this part do not wounds, or any other abnormal source
apply to a facility solely engaged in of microbial contamination by which
the storage of unexposed packaged there is a reasonable possibility of
food. food, food-contact surfaces, or food-
(b) Applicability of subpart D. A facil- packaging materials becoming con-
ity solely engaged in the storage of un- taminated, must be excluded from any
exposed packaged food, including unex- operations which may be expected to
posed packaged food that requires result in such contamination until the
time/temperature control to signifi- condition is corrected, unless condi-
cantly minimize or prevent the growth tions such as open lesions, boils, and
of, or toxin production by, pathogens is infected wounds are adequately cov-
subject to the modified requirements ered (e.g., by an impermeable cover).
in § 117.206 for any unexposed packaged Personnel must be instructed to report
food that requires time/temperature such health conditions to their super-
control to significantly minimize or visors.
prevent the growth of, or toxin produc- (b) Cleanliness. All persons working in
tion by, pathogens. direct contact with food, food-contact
surfaces, and food-packaging materials
§ 117.8 Applicability of subpart B of must conform to hygienic practices
this part to the off-farm packing
and holding of raw agricultural while on duty to the extent necessary
commodities. to protect against allergen cross-con-
tact and against contamination of
Except as provided by § 117.5(k)(1), food. The methods for maintaining
subpart B of this part applies to the cleanliness include:
off-farm packaging, packing, and hold-
(1) Wearing outer garments suitable
ing of raw agricultural commodities.
to the operation in a manner that pro-
Compliance with this requirement for
tects against allergen cross-contact
raw agricultural commodities that are
and against the contamination of food,
produce as defined in part 112 of this
food-contact surfaces, or food-pack-
chapter may be achieved by complying
with subpart B of this part or with the aging materials.
applicable requirements for packing (2) Maintaining adequate personal
and holding in part 112 of this chapter. cleanliness.
(3) Washing hands thoroughly (and
[81 FR 3956, Jan. 25, 2016] sanitizing if necessary to protect
against contamination with undesir-
§ 117.9 Records required for this sub-
part. able microorganisms) in an adequate
hand-washing facility before starting
(a) Records that document training work, after each absence from the work
required by § 117.4(b)(2) must be estab- station, and at any other time when
lished and maintained. the hands may have become soiled or
(b) The records that must be estab- contaminated.
lished and maintained are subject to (4) Removing all unsecured jewelry
the requirements of subpart F of this and other objects that might fall into
part. food, equipment, or containers, and re-
moving hand jewelry that cannot be
Subpart B—Current Good adequately sanitized during periods in
Manufacturing Practice which food is manipulated by hand. If
such hand jewelry cannot be removed,
§ 117.10 Personnel. it may be covered by material which
The management of the establish- can be maintained in an intact, clean,
ment must take reasonable measures and sanitary condition and which effec-
and precautions to ensure the fol- tively protects against the contamina-
lowing: tion by these objects of the food, food-
377
§ 117.20 21 CFR Ch. I (4–1–16 Edition)
contact surfaces, or food-packaging be exercised in the plant by inspection,

materials. extermination, or other means to ex-
(5) Maintaining gloves, if they are clude pests, dirt, and filth that may be
used in food handling, in an intact, a source of food contamination.
clean, and sanitary condition. (b) Plant construction and design. The
(6) Wearing, where appropriate, in an plant must be suitable in size, con-
effective manner, hair nets, headbands, struction, and design to facilitate
caps, beard covers, or other effective maintenance and sanitary operations
hair restraints. for food-production purposes (i.e., man-
(7) Storing clothing or other personal ufacturing, processing, packing, and
belongings in areas other than where holding). The plant must:
food is exposed or where equipment or (1) Provide adequate space for such
utensils are washed. placement of equipment and storage of
(8) Confining the following to areas materials as is necessary for mainte-
other than where food may be exposed nance, sanitary operations, and the
or where equipment or utensils are production of safe food.
washed: eating food, chewing gum, (2) Permit the taking of adequate
drinking beverages, or using tobacco. precautions to reduce the potential for
(9) Taking any other necessary pre- allergen cross-contact and for contami-
cautions to protect against allergen nation of food, food-contact surfaces,
cross-contact and against contamina- or food-packaging materials with
tion of food, food-contact surfaces, or microorganisms, chemicals, filth, and
food-packaging materials with micro- other extraneous material. The poten-
organisms or foreign substances (in- tial for allergen cross-contact and for
cluding perspiration, hair, cosmetics, contamination may be reduced by ade-
tobacco, chemicals, and medicines ap- quate food safety controls and oper-
plied to the skin). ating practices or effective design, in-
cluding the separation of operations in
§ 117.20 Plant and grounds. which allergen cross-contact and con-
(a) Grounds. The grounds about a food tamination are likely to occur, by one
plant under the control of the operator or more of the following means: loca-
must be kept in a condition that will tion, time, partition, air flow systems,
protect against the contamination of dust control systems, enclosed sys-
food. The methods for adequate main- tems, or other effective means.
tenance of grounds must include: (3) Permit the taking of adequate
(1) Properly storing equipment, re- precautions to protect food in installed
moving litter and waste, and cutting outdoor bulk vessels by any effective
weeds or grass within the immediate means, including:
vicinity of the plant that may con- (i) Using protective coverings.
stitute an attractant, breeding place, (ii) Controlling areas over and around
or harborage for pests. the vessels to eliminate harborages for
(2) Maintaining roads, yards, and pests.
parking lots so that they do not con- (iii) Checking on a regular basis for
stitute a source of contamination in pests and pest infestation.
areas where food is exposed. (iv) Skimming fermentation vessels,
(3) Adequately draining areas that as necessary.
may contribute contamination to food (4) Be constructed in such a manner
by seepage, foot-borne filth, or pro- that floors, walls, and ceilings may be
viding a breeding place for pests. adequately cleaned and kept clean and
(4) Operating systems for waste kept in good repair; that drip or con-
treatment and disposal in an adequate densate from fixtures, ducts and pipes
manner so that they do not constitute does not contaminate food, food-con-
a source of contamination in areas tact surfaces, or food-packaging mate-
where food is exposed. rials; and that aisles or working spaces
(5) If the plant grounds are bordered are provided between equipment and
by grounds not under the operator’s walls and are adequately unobstructed
control and not maintained in the and of adequate width to permit em-
manner described in paragraphs (a)(1) ployees to perform their duties and to
through (4) of this section, care must protect against contaminating food,
378
food-contact surfaces, or food-pack- (i) Those required to maintain clean

aging materials with clothing or per- and sanitary conditions;
sonal contact. (ii) Those necessary for use in labora-
(5) Provide adequate lighting in tory testing procedures;
hand-washing areas, dressing and lock- (iii) Those necessary for plant and
er rooms, and toilet rooms and in all equipment maintenance and operation;
areas where food is examined, manu- and
factured, processed, packed, or held (iv) Those necessary for use in the
and where equipment or utensils are plant’s operations.
cleaned; and provide shatter-resistant (2) Toxic cleaning compounds, sani-
light bulbs, fixtures, skylights, or tizing agents, and pesticide chemicals
other glass suspended over exposed must be identified, held, and stored in
food in any step of preparation or oth- a manner that protects against con-
erwise protect against food contamina- tamination of food, food-contact sur-
tion in case of glass breakage. faces, or food-packaging materials.
(6) Provide adequate ventilation or (c) Pest control. Pests must not be al-
control equipment to minimize dust, lowed in any area of a food plant.
odors and vapors (including steam and Guard, guide, or pest-detecting dogs
noxious fumes) in areas where they may be allowed in some areas of a
may cause allergen cross-contact or plant if the presence of the dogs is un-
contaminate food; and locate and oper- likely to result in contamination of
ate fans and other air-blowing equip- food, food-contact surfaces, or food-
ment in a manner that minimizes the packaging materials. Effective meas-
potential for allergen cross-contact and ures must be taken to exclude pests
for contaminating food, food-packaging from the manufacturing, processing,
materials, and food-contact surfaces. packing, and holding areas and to pro-
(7) Provide, where necessary, ade- tect against the contamination of food
quate screening or other protection on the premises by pests. The use of
against pests. pesticides to control pests in the plant
is permitted only under precautions
§ 117.35 Sanitary operations. and restrictions that will protect
(a) General maintenance. Buildings, against the contamination of food,
fixtures, and other physical facilities food-contact surfaces, and food-pack-
of the plant must be maintained in a aging materials.
clean and sanitary condition and must (d) Sanitation of food-contact surfaces.
be kept in repair adequate to prevent All food-contact surfaces, including
food from becoming adulterated. Clean- utensils and food-contact surfaces of
ing and sanitizing of utensils and equipment, must be cleaned as fre-
equipment must be conducted in a quently as necessary to protect against
manner that protects against allergen allergen cross-contact and against con-
cross-contact and against contamina- tamination of food.
tion of food, food-contact surfaces, or (1) Food-contact surfaces used for
food-packaging materials. manufacturing/processing, packing, or
(b) Substances used in cleaning and holding low-moisture food must be in a
sanitizing; storage of toxic materials. (1) clean, dry, sanitary condition before
Cleaning compounds and sanitizing use. When the surfaces are wet-cleaned,
agents used in cleaning and sanitizing they must, when necessary, be sani-
procedures must be free from undesir- tized and thoroughly dried before sub-
able microorganisms and must be safe sequent use.
and adequate under the conditions of (2) In wet processing, when cleaning
use. Compliance with this requirement is necessary to protect against allergen
must be verified by any effective cross-contact or the introduction of
means, including purchase of these sub- microorganisms into food, all food-con-
stances under a letter of guarantee or tact surfaces must be cleaned and sani-
certification or examination of these tized before use and after any interrup-
substances for contamination. Only the tion during which the food-contact sur-
following toxic materials may be used faces may have become contaminated.
or stored in a plant where food is proc- Where equipment and utensils are used
essed or exposed: in a continuous production operation,
379
§ 117.37 21 CFR Ch. I (4–1–16 Edition)
the utensils and food-contact surfaces equipment, or utensils or creating an

of the equipment must be cleaned and unsanitary condition.
sanitized as necessary. (4) Provide adequate floor drainage in
(3) Single-service articles (such as all areas where floors are subject to
utensils intended for one-time use, flooding-type cleaning or where normal
paper cups, and paper towels) must be operations release or discharge water
stored, handled, and disposed of in a or other liquid waste on the floor.
manner that protects against allergen (5) Provide that there is not backflow
cross-contact and against contamina- from, or cross-connection between, pip-
tion of food, food-contact surfaces, or ing systems that discharge waste water
food-packaging materials. or sewage and piping systems that
(e) Sanitation of non-food-contact sur- carry water for food or food manufac-
faces. Non-food-contact surfaces of turing.
equipment used in the operation of a (c) Sewage disposal. Sewage must be
food plant must be cleaned in a manner disposed of into an adequate sewerage
and as frequently as necessary to pro- system or disposed of through other
tect against allergen cross-contact and adequate means.
against contamination of food, food- (d) Toilet facilities. Each plant must
contact surfaces, and food-packaging provide employees with adequate, read-
materials. ily accessible toilet facilities. Toilet
(f) Storage and handling of cleaned facilities must be kept clean and must
portable equipment and utensils. Cleaned not be a potential source of contamina-
and sanitized portable equipment with tion of food, food-contact surfaces, or
food-contact surfaces and utensils food-packaging materials.
(e) Hand-washing facilities. Each plant
must be stored in a location and man-
must provide hand-washing facilities
ner that protects food-contact surfaces
designed to ensure that an employee’s
from allergen cross-contact and from
hands are not a source of contamina-
contamination.
tion of food, food-contact surfaces, or
§ 117.37 Sanitary facilities and con- food-packaging materials, by providing
trols. facilities that are adequate, conven-
ient, and furnish running water at a
Each plant must be equipped with suitable temperature.
adequate sanitary facilities and accom- (f) Rubbish and offal disposal. Rubbish
modations including: and any offal must be so conveyed,
(a) Water supply. The water supply stored, and disposed of as to minimize
must be adequate for the operations in- the development of odor, minimize the
tended and must be derived from an potential for the waste becoming an at-
adequate source. Any water that con- tractant and harborage or breeding
tacts food, food-contact surfaces, or place for pests, and protect against
food-packaging materials must be safe contamination of food, food-contact
and of adequate sanitary quality. Run- surfaces, food-packaging materials,
ning water at a suitable temperature, water supplies, and ground surfaces.
and under pressure as needed, must be
provided in all areas where required for § 117.40 Equipment and utensils.
the processing of food, for the cleaning (a)(1) All plant equipment and uten-
of equipment, utensils, and food-pack- sils used in manufacturing, processing,
aging materials, or for employee sani- packing, or holding food must be so de-
tary facilities. signed and of such material and work-
(b) Plumbing. Plumbing must be of manship as to be adequately cleanable,
adequate size and design and ade- and must be adequately maintained to
quately installed and maintained to: protect against allergen cross-contact
(1) Carry adequate quantities of and contamination.
water to required locations throughout (2) Equipment and utensils must be
the plant. designed, constructed, and used appro-
(2) Properly convey sewage and liquid priately to avoid the adulteration of
disposable waste from the plant. food with lubricants, fuel, metal frag-
(3) Avoid constituting a source of ments, contaminated water, or any
contamination to food, water supplies, other contaminants.
380
(3) Equipment must be installed so as to clean food-contact surfaces or equip-

to facilitate the cleaning and mainte- ment must be treated in such a way
nance of the equipment and of adjacent that food is not contaminated with un-
spaces. lawful indirect food additives.
(4) Food-contact surfaces must be
corrosion-resistant when in contact § 117.80 Processes and controls.
with food. (a) General. (1) All operations in the
(5) Food-contact surfaces must be manufacturing, processing, packing,
made of nontoxic materials and de- and holding of food (including oper-
signed to withstand the environment of ations directed to receiving, inspect-
their intended use and the action of ing, transporting, and segregating)
food, and, if applicable, cleaning com- must be conducted in accordance with
pounds, sanitizing agents, and cleaning adequate sanitation principles.
procedures.
(2) Appropriate quality control oper-
(6) Food-contact surfaces must be
ations must be employed to ensure
maintained to protect food from aller-
that food is suitable for human con-
gen cross-contact and from being con-
sumption and that food-packaging ma-
taminated by any source, including un-
terials are safe and suitable.
lawful indirect food additives.
(b) Seams on food-contact surfaces (3) Overall sanitation of the plant
must be smoothly bonded or main- must be under the supervision of one or
tained so as to minimize accumulation more competent individuals assigned
of food particles, dirt, and organic mat- responsibility for this function.
ter and thus minimize the opportunity (4) Adequate precautions must be
for growth of microorganisms and al- taken to ensure that production proce-
lergen cross-contact. dures do not contribute to allergen
(c) Equipment that is in areas where cross-contact and to contamination
food is manufactured, processed, from any source.
packed, or held and that does not come (5) Chemical, microbial, or extra-
into contact with food must be so con- neous-material testing procedures
structed that it can be kept in a clean must be used where necessary to iden-
and sanitary condition. tify sanitation failures or possible al-
(d) Holding, conveying, and manufac- lergen cross-contact and food contami-
turing systems, including gravimetric, nation.
pneumatic, closed, and automated sys- (6) All food that has become contami-
tems, must be of a design and construc- nated to the extent that it is adulter-
tion that enables them to be main- ated must be rejected, or if appro-
tained in an appropriate clean and san- priate, treated or processed to elimi-
itary condition. nate the contamination.
(e) Each freezer and cold storage (b) Raw materials and other ingredi-
compartment used to store and hold ents. (1) Raw materials and other ingre-
food capable of supporting growth of dients must be inspected and seg-
microorganisms must be fitted with an regated or otherwise handled as nec-
indicating thermometer, temperature- essary to ascertain that they are clean
measuring device, or temperature-re- and suitable for processing into food
cording device so installed as to show and must be stored under conditions
the temperature accurately within the that will protect against allergen
compartment. cross-contact and against contamina-
(f) Instruments and controls used for tion and minimize deterioration. Raw
measuring, regulating, or recording materials must be washed or cleaned as
temperatures, pH, acidity, water activ- necessary to remove soil or other con-
ity, or other conditions that control or tamination. Water used for washing,
prevent the growth of undesirable rinsing, or conveying food must be safe
microorganisms in food must be accu- and of adequate sanitary quality.
rate and precise and adequately main- Water may be reused for washing, rins-
tained, and adequate in number for ing, or conveying food if it does not
their designated uses. cause allergen cross-contact or in-

(g) Compressed air or other gases me- crease the level of contamination of
chanically introduced into food or used the food.
381
§ 117.80 21 CFR Ch. I (4–1–16 Edition)
(2) Raw materials and other ingredi- (2) All food manufacturing, proc-
ents must either not contain levels of essing, packing, and holding must be
microorganisms that may render the conducted under such conditions and
food injurious to the health of humans, controls as are necessary to minimize
or they must be pasteurized or other- the potential for the growth of micro-
wise treated during manufacturing op- organisms, allergen cross-contact, con-
erations so that they no longer contain tamination of food, and deterioration
levels that would cause the product to of food.
be adulterated. (3) Food that can support the rapid
(3) Raw materials and other ingredi- growth of undesirable microorganisms
ents susceptible to contamination with must be held at temperatures that will
aflatoxin or other natural toxins must prevent the food from becoming adul-
comply with FDA regulations for poi- terated during manufacturing, proc-
sonous or deleterious substances before essing, packing, and holding.
these raw materials or other ingredi- (4) Measures such as sterilizing, irra-
ents are incorporated into finished diating, pasteurizing, cooking, freez-
food. ing, refrigerating, controlling pH, or
(4) Raw materials, other ingredients, controlling aw that are taken to de-
and rework susceptible to contamina- stroy or prevent the growth of undesir-
tion with pests, undesirable microorga- able microorganisms must be adequate
nisms, or extraneous material must under the conditions of manufacture,
comply with applicable FDA regula- handling, and distribution to prevent
tions for natural or unavoidable defects food from being adulterated.
if a manufacturer wishes to use the
(5) Work-in-process and rework must
materials in manufacturing food.
be handled in a manner that protects
(5) Raw materials, other ingredients,
against allergen cross-contact, con-
and rework must be held in bulk, or in
tamination, and growth of undesirable
containers designed and constructed so
microorganisms.
as to protect against allergen cross-
contact and against contamination and (6) Effective measures must be taken
must be held at such temperature and to protect finished food from allergen
relative humidity and in such a man- cross-contact and from contamination
ner as to prevent the food from becom- by raw materials, other ingredients, or
ing adulterated. Material scheduled for refuse. When raw materials, other in-
rework must be identified as such. gredients, or refuse are unprotected,
(6) Frozen raw materials and other they must not be handled simulta-
ingredients must be kept frozen. If neously in a receiving, loading, or ship-
thawing is required prior to use, it ping area if that handling could result
must be done in a manner that pre- in allergen cross-contact or contami-
vents the raw materials and other in- nated food. Food transported by con-
gredients from becoming adulterated. veyor must be protected against aller-
(7) Liquid or dry raw materials and gen cross-contact and against contami-
other ingredients received and stored nation as necessary.
in bulk form must be held in a manner (7) Equipment, containers, and uten-
that protects against allergen cross- sils used to convey, hold, or store raw
contact and against contamination. materials and other ingredients, work-
(8) Raw materials and other ingredi- in-process, rework, or other food must
ents that are food allergens, and re- be constructed, handled, and main-
work that contains food allergens, tained during manufacturing, proc-
must be identified and held in a man- essing, packing, and holding in a man-
ner that prevents allergen cross-con- ner that protects against allergen
tact. cross-contact and against contamina-
(c) Manufacturing operations. (1) tion.
Equipment and utensils and food con- (8) Adequate measures must be taken
tainers must be maintained in an ade- to protect against the inclusion of
quate condition through appropriate metal or other extraneous material in
cleaning and sanitizing, as necessary. food.

Insofar as necessary, equipment must (9) Food, raw materials, and other in-
be taken apart for thorough cleaning. gredients that are adulterated:
382
(i) Must be disposed of in a manner must be processed to and maintained

that protects against the contamina- at a safe moisture level.
tion of other food; or (15) Food, such as acid and acidified
(ii) If the adulterated food is capable food, that relies principally on the con-
of being reconditioned, it must be: trol of pH for preventing the growth of
(A) Reconditioned (if appropriate) undesirable microorganisms must be
using a method that has been proven to monitored and maintained at a pH of
be effective; or 4.6 or below.
(B) Reconditioned (if appropriate) (16) When ice is used in contact with
and reexamined and subsequently food, it must be made from water that
found not to be adulterated within the is safe and of adequate sanitary quality
meaning of the Federal Food, Drug, in accordance with § 117.37(a), and must
and Cosmetic Act before being incor- be used only if it has been manufac-
porated into other food. tured in accordance with current good
(10) Steps such as washing, peeling, manufacturing practice as outlined in
trimming, cutting, sorting and inspect- this part.
ing, mashing, dewatering, cooling,
shredding, extruding, drying, whipping, § 117.93 Warehousing and distribution.
defatting, and forming must be per- Storage and transportation of food
formed so as to protect food against al- must be under conditions that will pro-
lergen cross-contact and against con- tect against allergen cross-contact and
tamination. Food must be protected against biological, chemical (including
from contaminants that may drip, radiological), and physical contamina-
drain, or be drawn into the food. tion of food, as well as against deterio-
(11) Heat blanching, when required in ration of the food and the container.
the preparation of food capable of sup-
porting microbial growth, must be ef- § 117.95 Holding and distribution of
fected by heating the food to the re- human food by-products for use as
quired temperature, holding it at this animal food.
temperature for the required time, and (a) Human food by-products held for
then either rapidly cooling the food or distribution as animal food without ad-
passing it to subsequent manufacturing ditional manufacturing or processing
without delay. Growth and contamina- by the human food processor, as identi-
tion by thermophilic microorganisms fied in § 507.12 of this chapter, must be
in blanchers must be minimized by the held under conditions that will protect
use of adequate operating temperatures against contamination, including the
and by periodic cleaning and sanitizing following:
as necessary. (1) Containers and equipment used to
(12) Batters, breading, sauces, gra- convey or hold human food by-products
vies, dressings, dipping solutions, and for use as animal food before distribu-
other similar preparations that are tion must be designed, constructed of
held and used repeatedly over time appropriate material, cleaned as nec-
must be treated or maintained in such essary, and maintained to protect
a manner that they are protected against the contamination of human
against allergen cross-contact and food by-products for use as animal
against contamination, and mini- food;
mizing the potential for the growth of (2) Human food by-products for use as
undesirable microorganisms. animal food held for distribution must
(13) Filling, assembling, packaging, be held in a way to protect against con-
and other operations must be per- tamination from sources such as trash;
formed in such a way that the food is and
protected against allergen cross-con- (3) During holding, human food by-
tact, contamination and growth of un- products for use as animal food must
desirable microorganisms. be accurately identified.
(14) Food, such as dry mixes, nuts, in- (b) Labeling that identifies the by-
termediate moisture food, and dehy- product by the common or usual name
drated food, that relies principally on must be affixed to or accompany

the control of aw for preventing the human food by-products for use as ani-
growth of undesirable microorganisms mal food when distributed.
383
§ 117.110 21 CFR Ch. I (4–1–16 Edition)
(c) Shipping containers (e.g., totes, ventive controls as required by

drums, and tubs) and bulk vehicles § 117.145(a)(1);
used to distribute human food by-prod- (6) The written corrective action pro-
ucts for use as animal food must be ex- cedures as required by § 117.150(a)(1);
amined prior to use to protect against and
contamination of the human food by- (7) The written verification proce-
products for use as animal food from dures as required by § 117.165(b).
the container or vehicle when the facil- (c) Records. The food safety plan re-
ity is responsible for transporting the quired by this section is a record that
human food by-products for use as ani- is subject to the requirements of sub-
mal food itself or arranges with a third part F of this part.
party to transport the human food by-
products for use as animal food. § 117.130 Hazard analysis.
[80 FR 56337, Sept. 17, 2015] (a) Requirement for a hazard analysis.
(1) You must conduct a hazard analysis
§ 117.110 Defect action levels. to identify and evaluate, based on expe-
(a) The manufacturer, processor, rience, illness data, scientific reports,
packer, and holder of food must at all and other information, known or rea-
times utilize quality control operations sonably foreseeable hazards for each
that reduce natural or unavoidable de- type of food manufactured, processed,
fects to the lowest level currently fea- packed, or held at your facility to de-
sible. termine whether there are any hazards
(b) The mixing of a food containing requiring a preventive control.
defects at levels that render that food (2) The hazard analysis must be writ-
adulterated with another lot of food is ten regardless of its outcome.
not permitted and renders the final (b) Hazard identification. The hazard
food adulterated, regardless of the de- identification must consider:
fect level of the final food. For exam- (1) Known or reasonably foreseeable
ples of defect action levels that may hazards that include:
render food adulterated, see the Defect (i) Biological hazards, including
Levels Handbook, which is accessible microbiological hazards such as
athttp://www.fda.gov/pchfrule and parasites, environmental pathogens,
athttp://www.fda.gov. and other pathogens;
(ii) Chemical hazards, including radi-
Subpart C—Hazard Analysis and ological hazards, substances such as
Risk-Based Preventive Controls pesticide and drug residues, natural
toxins, decomposition, unapproved food
§ 117.126 Food safety plan. or color additives, and food allergens;
(a) Requirement for a food safety plan. and
(1) You must prepare, or have prepared, (iii) Physical hazards (such as stones,
and implement a written food safety glass, and metal fragments); and
plan. (2) Known or reasonably foreseeable
(2) The food safety plan must be pre- hazards that may be present in the
pared, or its preparation overseen, by food for any of the following reasons:
one or more preventive controls quali- (i) The hazard occurs naturally;
fied individuals. (ii) The hazard may be unintention-
(b) Contents of a food safety plan. The ally introduced; or
written food safety plan must include: (iii) The hazard may be intentionally
(1) The written hazard analysis as re- introduced for purposes of economic
quired by § 117.130(a)(2); gain.
(2) The written preventive controls as (c) Hazard evaluation. (1)(i) The haz-
required by § 117.135(b); ard analysis must include an evalua-
(3) The written supply-chain program tion of the hazards identified in para-
as required by subpart G of this part; graph (b) of this section to assess the
(4) The written recall plan as re- severity of the illness or injury if the
quired by § 117.139(a); and hazard were to occur and the prob-

(5) The written procedures for moni- ability that the hazard will occur in
toring the implementation of the pre- the absence of preventive controls.
384
(ii) The hazard evaluation required (1) Process controls. Process controls
by paragraph (c)(1)(i) of this section include procedures, practices, and proc-
must include an evaluation of environ- esses to ensure the control of param-
mental pathogens whenever a ready-to- eters during operations such as heat
eat food is exposed to the environment processing, acidifying, irradiating, and
prior to packaging and the packaged refrigerating foods. Process controls
food does not receive a treatment or must include, as appropriate to the na-
otherwise include a control measure ture of the applicable control and its
(such as a formulation lethal to the role in the facility’s food safety sys-
pathogen) that would significantly tem:
minimize the pathogen. (i) Parameters associated with the
(2) The hazard evaluation must con- control of the hazard; and
sider the effect of the following on the (ii) The maximum or minimum
safety of the finished food for the in- value, or combination of values, to
tended consumer: which any biological, chemical, or
(i) The formulation of the food; physical parameter must be controlled
(ii) The condition, function, and de- to significantly minimize or prevent a
sign of the facility and equipment; hazard requiring a process control.
(iii) Raw materials and other ingredi- (2) Food allergen controls. Food aller-
ents; gen controls include procedures, prac-
(iv) Transportation practices; tices, and processes to control food al-
(v) Manufacturing/processing proce- lergens. Food allergen controls must
dures; include those procedures, practices,
(vi) Packaging activities and labeling and processes employed for:
activities; (i) Ensuring protection of food from
(vii) Storage and distribution; allergen cross-contact, including dur-
(viii) Intended or reasonably foresee- ing storage, handling, and use; and
able use; (ii) Labeling the finished food, in-
(ix) Sanitation, including employee cluding ensuring that the finished food
hygiene; and is not misbranded under section 403(w)
(x) Any other relevant factors, such of the Federal Food, Drug, and Cos-
as the temporal (e.g., weather-related) metic Act.
nature of some hazards (e.g., levels of (3) Sanitation controls. Sanitation con-
some natural toxins). trols include procedures, practices, and
processes to ensure that the facility is
§ 117.135 Preventive controls. maintained in a sanitary condition
(a)(1) You must identify and imple- adequate to significantly minimize or
ment preventive controls to provide as- prevent hazards such as environmental
surances that any hazards requiring a pathogens, biological hazards due to
preventive control will be significantly employee handling, and food allergen
minimized or prevented and the food hazards. Sanitation controls must in-
manufactured, processed, packed, or clude, as appropriate to the facility
held by your facility will not be adul- and the food, procedures, practices, and
terated under section 402 of the Federal processes for the:
Food, Drug, and Cosmetic Act or mis- (i) Cleanliness of food-contact sur-
branded under section 403(w) of the faces, including food-contact surfaces
Federal Food, Drug, and Cosmetic Act. of utensils and equipment;
(2) Preventive controls required by (ii) Prevention of allergen cross-con-
paragraph (a)(1) of this section include: tact and cross-contamination from in-
(i) Controls at critical control points sanitary objects and from personnel to
(CCPs), if there are any CCPs; and food, food packaging material, and
(ii) Controls, other than those at other food-contact surfaces and from
CCPs, that are also appropriate for raw product to processed product.
food safety. (4) Supply-chain controls. Supply-
(b) Preventive controls must be writ- chain controls include the supply-chain
ten. program as required by subpart G of
(c) Preventive controls include, as this part.

appropriate to the facility and the (5) Recall plan. Recall plan as re-
food: quired by § 117.139.
385
§ 117.136 21 CFR Ch. I (4–1–16 Edition)
(6) Other controls. Preventive controls manufacturing, processing, or pre-

include any other procedures, prac- paring the food in accordance with ap-
tices, and processes necessary to sat- plicable food safety requirements.
isfy the requirements of paragraph (a) (4) You rely on your customer to pro-
of this section. Examples of other con- vide assurance that the food will be
trols include hygiene training and processed to control the identified haz-
other current good manufacturing ard by an entity in the distribution
practices. chain subsequent to the customer and
you:
§ 117.136 Circumstances in which the
owner, operator, or agent in charge (i) Disclose in documents accom-
of a manufacturing/processing facil- panying the food, in accordance with
ity is not required to implement a the practice of the trade, that the food
preventive control. is ‘‘not processed to control [identified
(a) Circumstances. If you are a manu- hazard]’’; and
facturer/processor, you are not re- (ii) Annually obtain from your cus-
quired to implement a preventive con- tomer written assurance, subject to the
trol when you identify a hazard requir- requirements of § 117.137, that your cus-
ing a preventive control (identified tomer:
hazard) and any of the following cir- (A) Will disclose in documents ac-
cumstances apply: companying the food, in accordance
(1) You determine and document that with the practice of the trade, that the
the type of food (e.g., raw agricultural food is ‘‘not processed to control [iden-
commodities such as cocoa beans, cof- tified hazard]’’; and
fee beans, and grains) could not be con- (B) Will only sell to another entity
sumed without application of an appro- that agrees, in writing, it will:
priate control. (1) Follow procedures (identified in a
(2) You rely on your customer who is written assurance) that will signifi-
subject to the requirements for hazard cantly minimize or prevent the identi-
analysis and risk-based preventive con- fied hazard (if the entity is subject to
trols in this subpart to ensure that the the requirements for hazard analysis
identified hazard will be significantly and risk-based preventive controls in
minimized or prevented and you: this subpart) or manufacture, process,
(i) Disclose in documents accom- or prepare the food in accordance with
panying the food, in accordance with applicable food safety requirements (if
the practice of the trade, that the food the entity is not subject to the require-
is ‘‘not processed to control [identified ments for hazard analysis and risk-
hazard]’’; and based preventive controls in this sub-
(ii) Annually obtain from your cus-
part); or
tomer written assurance, subject to the
requirements of § 117.137, that the cus- (2) Obtain a similar written assur-
tomer has established and is following ance from the entity’s customer, sub-
procedures (identified in the written ject to the requirements of § 117.137, as
assurance) that will significantly mini- in paragraphs (a)(4)(ii)(A) and (B) of
mize or prevent the identified hazard. this section, as appropriate; or
(3) You rely on your customer who is (5) You have established, docu-
not subject to the requirements for mented, and implemented a system
hazard analysis and risk-based preven- that ensures control, at a subsequent
tive controls in this subpart to provide distribution step, of the hazards in the
assurance it is manufacturing, proc- food you distribute and you document
essing, or preparing the food in accord- the implementation of that system.
ance with applicable food safety re- (b) Records. You must document any
quirements and you: circumstance, specified in paragraph
(i) Disclose in documents accom- (a) of this section, that applies to you,
panying the food, in accordance with including:
the practice of the trade, that the food (1) A determination, in accordance
is ‘‘not processed to control [identified with paragraph (a) of this section, that
hazard]’’; and the type of food could not be consumed

(ii) Annually obtain from your cus- without application of an appropriate
tomer written assurance that it is control;
386
(2) The annual written assurance control management components as

from your customer in accordance with appropriate to ensure the effectiveness
paragraph (a)(2) of this section; of the preventive controls, taking into
(3) The annual written assurance account the nature of the preventive
from your customer in accordance with control and its role in the facility’s
paragraph (a)(3) of this section; food safety system:
(4) The annual written assurance (1) Monitoring in accordance with
from your customer in accordance with § 117.145;
paragraph (a)(4) of this section; and (2) Corrective actions and corrections
(5) Your system, in accordance with in accordance with § 117.150; and
paragraph (a)(5) of this section, that (3) Verification in accordance with
ensures control, at a subsequent dis- § 117.155.
tribution step, of the hazards in the (b) The supply-chain program estab-
food you distribute. lished in subpart G of this part is sub-
[80 FR 56145, Sept. 17, 2015, as amended at 81 ject to the following preventive control
FR 3716, Jan. 22, 2015] management components as appro-
priate to ensure the effectiveness of the
§ 117.137 Provision of assurances re- supply-chain program, taking into ac-
quired under § 117.136(a)(2), (3), and count the nature of the hazard con-
(4).
trolled before receipt of the raw mate-
A facility that provides a written as- rial or other ingredient:
surance under § 117.136(a)(2), (3), or (4) (1) Corrective actions and corrections
must act consistently with the assur- in accordance with § 117.150, taking into
ance and document its actions taken to account the nature of any supplier non-
satisfy the written assurance. conformance;
(2) Review of records in accordance
§ 117.139 Recall plan.
with § 117.165(a)(4); and
For food with a hazard requiring a (3) Reanalysis in accordance with
preventive control: § 117.170.
(a) You must establish a written re- (c) The recall plan established in
call plan for the food. § 117.139 is not subject to the require-
(b) The written recall plan must in- ments of paragraph (a) of this section.
clude procedures that describe the
steps to be taken, and assign responsi- § 117.145 Monitoring.
bility for taking those steps, to per-
form the following actions as appro- As appropriate to the nature of the
priate to the facility: preventive control and its role in the
(1) Directly notify the direct con- facility’s food safety system:
signees of the food being recalled, in- (a) Written procedures. You must es-
cluding how to return or dispose of the tablish and implement written proce-
affected food; dures, including the frequency with
(2) Notify the public about any haz- which they are to be performed, for
ard presented by the food when appro- monitoring the preventive control; and
priate to protect public health; (b) Monitoring. You must monitor the
(3) Conduct effectiveness checks to preventive controls with adequate fre-
verify that the recall is carried out; quency to provide assurance that they
and are consistently performed.
(4) Appropriately dispose of recalled (c) Records. (1) Requirement to docu-
food—e.g., through reprocessing, re- ment monitoring. You must document
working, diverting to a use that does the monitoring of preventive controls
not present a safety concern, or de- in accordance with this section in
stroying the food. records that are subject to verification
in accordance with § 117.155(a)(2) and
§ 117.140 Preventive control manage- records review in accordance with
ment components. § 117.165(a)(4)(i).
(a) Except as provided by paragraphs (2) Exception records. (i) Records of re-
(b) and (c) of this section, the preven- frigeration temperature during storage
tive controls required under § 117.135 of food that requires time/temperature
are subject to the following preventive control to significantly minimize or
387
§ 117.150 21 CFR Ch. I (4–1–16 Edition)
prevent the growth of, or toxin produc- quirements of paragraphs (b)(2) of this
tion by, pathogens may be affirmative section if any of the following cir-
records demonstrating temperature is cumstances apply:
controlled or exception records dem- (i) A preventive control is not prop-
onstrating loss of temperature control. erly implemented and a corrective ac-
(ii) Exception records may be ade- tion procedure has not been estab-
quate in circumstances other than lished;
monitoring of refrigeration tempera-
(ii) A preventive control, combina-
ture.
tion of preventive controls, or the food
[80 FR 56145, Sept. 17, 2015, as amended at 81 safety plan as a whole is found to be in-
FR 3716, Jan. 22, 2015] effective; or
§ 117.150 Corrective actions and cor- (iii) A review of records in accord-
rections. ance with § 117.165(a)(4) finds that the
records are not complete, the activities
(a) Corrective action procedures. As ap-
propriate to the nature of the hazard conducted did not occur in accordance
and the nature of the preventive con- with the food safety plan, or appro-
trol, except as provided by paragraph priate decisions were not made about
(c) of this section: corrective actions.
(1) You must establish and imple- (2) If any of the circumstances listed
ment written corrective action proce- in paragraph (b)(1) of this section
dures that must be taken if preventive apply, you must:
controls are not properly implemented, (i) Take corrective action to identify
including procedures to address, as ap- and correct the problem, reduce the
propriate: likelihood that the problem will recur,
(i) The presence of a pathogen or ap- evaluate all affected food for safety,
propriate indicator organism in a and, as necessary, prevent affected food
ready-to-eat product detected as a re- from entering commerce as would be
sult of product testing conducted in ac- done following a corrective action pro-
cordance with § 117.165(a)(2); and cedure under paragraphs (a)(2)(i)
(ii) The presence of an environmental through (iv) of this section; and
pathogen or appropriate indicator or-
(ii) When appropriate, reanalyze the
ganism detected through the environ-
food safety plan in accordance with
mental monitoring conducted in ac-
cordance with § 117.165(a)(3). § 117.170 to determine whether modi-
(2) The corrective action procedures fication of the food safety plan is re-
must describe the steps to be taken to quired.
ensure that: (c) Corrections. You do not need to
(i) Appropriate action is taken to comply with the requirements of para-
identify and correct a problem that has graphs (a) and (b) of this section if:
occurred with implementation of a pre- (1) You take action, in a timely man-
ventive control; ner, to identify and correct conditions
(ii) Appropriate action is taken, when and practices that are not consistent
necessary, to reduce the likelihood with the food allergen controls in
that the problem will recur; § 117.135(c)(2)(i) or the sanitation con-
(iii) All affected food is evaluated for trols in § 117.135(c)(3)(i) or (ii); or
safety; and (2) You take action, in a timely man-
(iv) All affected food is prevented ner, to identify and correct a minor
from entering into commerce, if you and isolated problem that does not di-
cannot ensure that the affected food is
rectly impact product safety.
not adulterated under section 402 of the
(d) Records. All corrective actions
Federal Food, Drug, and Cosmetic Act
or misbranded under section 403(w) of (and, when appropriate, corrections)
the Federal Food, Drug, and Cosmetic taken in accordance with this section
Act. must be documented in records. These
(b) Corrective action in the event of an records are subject to verification in
unanticipated food safety problem. (1) Ex- accordance with § 117.155(a)(3) and
cept as provided by paragraph (c) of records review in accordance with
this section, you are subject to the re- § 117.165(a)(4)(i).
388
§ 117.155 Verification. mented, will effectively control the

hazards; and
(a) Verification activities. Verification
(iii) Whenever a reanalysis of the
activities must include, as appropriate
food safety plan reveals the need to do
to the nature of the preventive control
so;
and its role in the facility’s food safety
(2) Must include obtaining and evalu-
system:
ating scientific and technical evidence
(1) Validation in accordance with
(or, when such evidence is not available
§ 117.160.
or is inadequate, conducting studies) to
(2) Verification that monitoring is
determine whether the preventive con-
being conducted as required by § 117.140
trols, when properly implemented, will
(and in accordance with § 117.145).
effectively control the hazards; and
(3) Verification that appropriate de- (c) You do not need to validate:
cisions about corrective actions are (1) The food allergen controls in
being made as required by § 117.140 (and § 117.135(c)(2);
in accordance with § 117.150). (2) The sanitation controls in
(4) Verification of implementation § 117.135(c)(3);
and effectiveness in accordance with (3) The recall plan in § 117.139;
§ 117.165; and (4) The supply-chain program in sub-
(5) Reanalysis in accordance with part G of this part; and
§ 117.170. (5) Other preventive controls, if the
(b) Documentation. All verification preventive controls qualified individual
activities conducted in accordance prepares (or oversees the preparation
with this section must be documented of) a written justification that valida-
in records. tion is not applicable based on factors
such as the nature of the hazard, and
§ 117.160 Validation.
the nature of the preventive control
(a) You must validate that the pre- and its role in the facility’s food safety
ventive controls identified and imple- system.
mented in accordance with § 117.135 are
adequate to control the hazard as ap- § 117.165 Verification of implementa-
propriate to the nature of the prevention and effectiveness.
tive control and its role in the facili- (a) Verification activities. You must
ty’s food safety system. verify that the preventive controls are
(b) The validation of the preventive consistently implemented and are ef-
controls: fectively and significantly minimizing
(1) Must be performed (or overseen) or preventing the hazards. To do so you
by a preventive controls qualified indi- must conduct activities that include
vidual: the following, as appropriate to the fa-
(i)(A) Prior to implementation of the cility, the food, and the nature of the
food safety plan; or preventive control and its role in the
(B) When necessary to demonstrate facility’s food safety system:
the control measures can be imple- (1) Calibration of process monitoring
mented as designed: instruments and verification instru-
(1) Within 90 calendar days after pro- ments (or checking them for accuracy);
duction of the applicable food first be- (2) Product testing, for a pathogen
gins; or (or appropriate indicator organism) or
(2) Within a reasonable timeframe, other hazard;
provided that the preventive controls (3) Environmental monitoring, for an
qualified individual prepares (or over- environmental pathogen or for an ap-
sees the preparation of) a written jus- propriate indicator organism, if con-
tification for a timeframe that exceeds tamination of a ready-to-eat food with
90 calendar days after production of the an environmental pathogen is a hazard
applicable food first begins; requiring a preventive control, by col-
(ii) Whenever a change to a control lecting and testing environmental sam-
measure or combination of control ples; and
measures could impact whether the (4) Review of the following records
control measure or combination of con- within the specified timeframes, by (or
trol measures, when properly imple- under the oversight of) a preventive
389
§ 117.170 21 CFR Ch. I (4–1–16 Edition)
controls qualified individual, to ensure tion. Procedures for environmental

that the records are complete, the ac- monitoring must:
tivities reflected in the records oc- (i) Be scientifically valid;
curred in accordance with the food (ii) Identify the test microorga-
safety plan, the preventive controls are nism(s);
effective, and appropriate decisions (iii) Identify the locations from
were made about corrective actions: which samples will be collected and the
(i) Records of monitoring and correc- number of sites to be tested during rou-
tive action records within 7 working tine environmental monitoring. The
days after the records are created or number and location of sampling sites
within a reasonable timeframe, pro- must be adequate to determine wheth-
vided that the preventive controls er preventive controls are effective;
qualified individual prepares (or over-
(iv) Identify the timing and fre-
sees the preparation of) a written jus-
quency for collecting and testing sam-
tification for a timeframe that exceeds
7 working days; and ples. The timing and frequency for col-
(ii) Records of calibration, testing lecting and testing samples must be
(e.g., product testing, environmental adequate to determine whether preven-
monitoring), supplier and supply-chain tive controls are effective;
verification activities, and other (v) Identify the test(s) conducted, in-
verification activities within a reason- cluding the analytical method(s) used;
able time after the records are created; (vi) Identify the laboratory con-
and ducting the testing; and
(5) Other activities appropriate for (vii) Include the corrective action
verification of implementation and ef- procedures required by § 117.150(a)(1).
fectiveness.
(b) Written procedures. As appropriate § 117.170 Reanalysis.
to the facility, the food, the nature of (a) You must conduct a reanalysis of
the preventive control, and the role of the food safety plan as a whole at least
the preventive control in the facility’s once every 3 years;
food safety system, you must establish (b) You must conduct a reanalysis of
and implement written procedures for the food safety plan as a whole, or the
the following activities: applicable portion of the food safety
(1) The method and frequency of cali- plan:
brating process monitoring instru- (1) Whenever a significant change in
ments and verification instruments (or
the activities conducted at your facil-
checking them for accuracy) as re-
ity creates a reasonable potential for a
quired by paragraph (a)(1) of this sec-
new hazard or creates a significant in-
tion.
crease in a previously identified haz-
(2) Product testing as required by
ard;
paragraph (a)(2) of this section. Proce-
dures for product testing must: (2) Whenever you become aware of
(i) Be scientifically valid; new information about potential haz-
(ii) Identify the test microorga- ards associated with the food;
nism(s) or other analyte(s); (3) Whenever appropriate after an un-
(iii) Specify the procedures for iden- anticipated food safety problem in ac-
tifying samples, including their rela- cordance with § 117.150(b); and
tionship to specific lots of product; (4) Whenever you find that a preven-
(iv) Include the procedures for sam- tive control, combination of preventive
pling, including the number of samples controls, or the food safety plan as a
and the sampling frequency; whole is ineffective.
(v) Identify the test(s) conducted, in- (c) You must complete the reanalysis
cluding the analytical method(s) used; required by paragraphs (a) and (b) of
(vi) Identify the laboratory con- this section and validate, as appro-
ducting the testing; and priate to the nature of the preventive
(vii) Include the corrective action control and its role in the facility’s
procedures required by § 117.150(a)(1). food safety system, any additional pre-

(3) Environmental monitoring as re- ventive controls needed to address the
quired by paragraph (a)(3) of this sec- hazard identified:
390
(1) Before any change in activities to the nature of the preventive control
(including any change in preventive and its role in the facility’s food safety
control) at the facility is operative; or system, in a timeframe that exceeds
(2) When necessary to demonstrate the first 90 calendar days of production
the control measures can be imple- of the applicable food.
mented as designed: (b) A qualified auditor must conduct
(i) Within 90 calendar days after pro- an onsite audit (§ 117.435(a)).
duction of the applicable food first be- (c)(1) To be a preventive controls
gins; or qualified individual, the individual
(ii) Within a reasonable timeframe, must have successfully completed
provided that the preventive controls training in the development and appli-
qualified individual prepares (or over- cation of risk-based preventive con-
sees the preparation of) a written jus- trols at least equivalent to that re-
tification for a timeframe that exceeds ceived under a standardized curriculum
90-calendar days after production of recognized as adequate by FDA or be
the applicable food first begins. otherwise qualified through job experi-
(d) You must revise the written food ence to develop and apply a food safety
safety plan if a significant change in system. Job experience may qualify an
the activities conducted at your facil- individual to perform these functions if
ity creates a reasonable potential for a such experience has provided an indi-
new hazard or a significant increase in vidual with knowledge at least equiva-
a previously identified hazard or docu- lent to that provided through the
ment the basis for the conclusion that standardized curriculum. This indi-
no revisions are needed. vidual may be, but is not required to
(e) A preventive controls qualified in- be, an employee of the facility.
dividual must perform (or oversee) the (2) To be a qualified auditor, a quali-
reanalysis. fied individual must have technical ex-
(f) You must conduct a reanalysis of pertise obtained through education,
the food safety plan when FDA deter- training, or experience (or a combina-
mines it is necessary to respond to new tion thereof) necessary to perform the
hazards and developments in scientific auditing function.
understanding. (d) All applicable training in the de-
velopment and application of risk-
§ 117.180 Requirements applicable to a
preventive controls qualified indi- based preventive controls must be doc-
vidual and a qualified auditor. umented in records, including the date
of the training, the type of training,
(a) One or more preventive controls and the person(s) trained.
qualified individuals must do or over-
see the following: § 117.190 Implementation records re-
(1) Preparation of the food safety quired for this subpart.
plan (§ 117.126(a)(2));
(a) You must establish and maintain
(2) Validation of the preventive con-
the following records documenting im-
trols (§ 117.160(b)(1));
plementation of the food safety plan:
(3) Written justification for valida-
(1) Documentation, as required by
tion to be performed in a timeframe
§ 117.136(b), of the basis for not estab-
that exceeds the first 90 calendar days
lishing a preventive control in accord-
of production of the applicable food;
ance with § 117.136(a);
(4) Determination that validation is
not required (§ 117.160(c)(5)); (2) Records that document the moni-
(5) Review of records (§ 117.165(a)(4)); toring of preventive controls;
(6) Written justification for review of (3) Records that document corrective
records of monitoring and corrective actions;
actions within a timeframe that ex- (4) Records that document
ceeds 7 working days; verification, including, as applicable,
(7) Reanalysis of the food safety plan those related to:
(§ 117.170(d)); and (i) Validation;
(8) Determination that reanalysis can (ii) Verification of monitoring;

be completed, and additional preven- (iii) Verification of corrective ac-
tive controls validated, as appropriate tions;
391
§ 117.201 21 CFR Ch. I (4–1–16 Edition)
(iv) Calibration of process moni- ies, copy centers, schools, and Internet
toring and verification instruments; cafes. FDA encourages electronic sub-
(v) Product testing; mission.
(vi) Environmental monitoring; (2) Submission by mail. (i) You must
(vii) Records review; and use Form FDA 3942a. You may obtain a
(viii) Reanalysis; copy of this form by any of the fol-
(5) Records that document the sup- lowing mechanisms:
ply-chain program; and
(A) Download it from http://
(6) Records that document applicable
training for the preventive controls www.fda.gov/pchfrule;
qualified individual and the qualified (B) Write to the U.S. Food and Drug
auditor. Administration (HFS–681), 5100 Paint
(b) The records that you must estab- Branch Pkwy., College Park, MD 20740;
lish and maintain are subject to the re- or
quirements of subpart F of this part. (C) Request a copy of this form by
phone at 1–800–216–7331 or 301–575–0156.
Subpart D—Modified (ii) Send a paper Form FDA 3942a to
Requirements the U.S. Food and Drug Administration
(HFS–681), 5100 Paint Branch Pkwy.,
§ 117.201 Modified requirements that College Park, MD 20740. We recommend
apply to a qualified facility. that you submit a paper copy only if
(a) Attestations to be submitted. A your facility does not have reasonable
qualified facility must submit the fol- access to the Internet.
lowing attestations to FDA: (c) Frequency of determination of status
(1) An attestation that the facility is and submission. (1) A facility must de-
a qualified facility as defined in § 117.3. termine and document its status as a
For the purpose of determining wheth- qualified facility on an annual basis no
er a facility satisfies the definition of later than July 1 of each calendar year.
qualified facility, the baseline year for (2) The attestations required by para-
calculating the adjustment for infla-
graph (a) of this section must be:
tion is 2011; and
(2)(i) An attestation that you have (i) Submitted to FDA initially:
identified the potential hazards associ- (A) By December 17, 2018, for a facil-
ated with the food being produced, are ity that begins manufacturing, proc-
implementing preventive controls to essing, packing, or holding food before
address the hazards, and are moni- September 17, 2018;
toring the performance of the preven- (B) Before beginning operations, for a
tive controls to ensure that such con- facility that begins manufacturing,
trols are effective; or processing, packing, or holding food
(ii) An attestation that the facility is after September 17, 2018; or
in compliance with State, local, coun- (C) By July 31 of the applicable cal-
ty, tribal, or other applicable non-Fed- endar year, when the status of a facil-
eral food safety law, including relevant ity changes from ‘‘not a qualified facil-
laws and regulations of foreign coun- ity’’ to ‘‘qualified facility’’ based on
tries, including an attestation based on the annual determination required by
licenses, inspection reports, certifi- paragraph (c)(1) of this section; and
cates, permits, credentials, certifi-
(ii) Beginning in 2020, submitted to
cation by an appropriate agency (such
FDA every 2 years during the period
as a State department of agriculture),
beginning on October 1 and ending on
or other evidence of oversight.
(b) Procedure for submission. The at- December 31.
testations required by paragraph (a) of (3) When the status of a facility
this section must be submitted to FDA changes from ‘‘qualified facility’’ to
by one of the following means: ‘‘not a qualified facility’’ based on the
(1) Electronic submission. To submit annual determination required by para-
electronically, go to http://www.fda.gov/ graph (c)(1) of this section, the facility
furls and follow the instructions. This must notify FDA of that change in sta-
Web site is available from wherever the tus using Form 3942a by July 31 of the
Internet is accessible, including librar- applicable calendar year.
392
(d) Timeframe for compliance with sub- duction by pathogens, the facility must
parts C and G of this part when the facil- conduct the following activities as ap-
ity status changes to ‘‘not a qualified fa- propriate to ensure the effectiveness of
cility.’’ When the status of a facility the temperature controls:
changes from ‘‘qualified facility’’ to (1) Establish and implement tempera-
‘‘not a qualified facility,’’ the facility ture controls adequate to significantly
must comply with subparts C and G of minimize or prevent the growth of, or
this part no later than December 31 of toxin production by, pathogens;
the applicable calendar year unless (2) Monitor the temperature controls
otherwise agreed to by FDA and the fa- with adequate frequency to provide as-
cility. surance that the temperature controls
(e) Notification to consumers. A quali- are consistently performed;
fied facility that does not submit attes- (3) If there is a loss of temperature
tations under paragraph (a)(2)(i) of this control that may impact the safety of
section must provide notification to such refrigerated packaged food, take
consumers as to the name and com- appropriate corrective actions to:
plete business address of the facility (i) Correct the problem and reduce
where the food was manufactured or the likelihood that the problem will
processed (including the street address recur;
or P.O. box, city, state, and zip code for (ii) Evaluate all affected food for
domestic facilities, and comparable full safety; and
address information for foreign facili-
(iii) Prevent the food from entering
ties), as follows:
commerce, if you cannot ensure the af-
(1) If a food packaging label is re-
fected food is not adulterated under
quired, the notification required by
section 402 of the Federal Food, Drug,
paragraph (e) of this section must ap-
and Cosmetic Act;
pear prominently and conspicuously on
the label of the food. (4) Verify that temperature controls
(2) If a food packaging label is not re- are consistently implemented by:
quired, the notification required by (i) Calibrating temperature moni-
paragraph (e) of this section must ap- toring and recording devices (or check-
pear prominently and conspicuously, at ing them for accuracy);
the point of purchase, on a label, post- (ii) Reviewing records of calibration
er, sign, placard, or documents deliv- within a reasonable time after the
ered contemporaneously with the food records are created; and
in the normal course of business, or in (iii) Reviewing records of monitoring
an electronic notice, in the case of and corrective actions taken to correct
Internet sales. a problem with the control of tempera-
(f) Records. (1) A qualified facility ture within 7 working days after the
must maintain those records relied records are created or within a reason-
upon to support the attestations that able timeframe, provided that the pre-
are required by paragraph (a) of this ventive controls qualified individual
section. prepares (or oversees the preparation
(2) The records that a qualified facil- of) a written justification for a time-
ity must maintain are subject to the frame that exceeds 7 working days;
requirements of subpart F of this part. (5) Establish and maintain the fol-
lowing records:
FR 3716, Jan. 22, 2015] (i) Records (whether affirmative
records demonstrating temperature is
§ 117.206 Modified requirements that controlled or exception records dem-
apply to a facility solely engaged in onstrating loss of temperature control)
the storage of unexposed packaged documenting the monitoring of tem-
food. perature controls for any such refrig-
(a) If a facility that is solely engaged erated packaged food;
in the storage of unexposed packaged (ii) Records of corrective actions
food stores any such refrigerated pack- taken when there is a loss of tempera-
aged food that requires time/temperature control that may impact the safe-
ture control to significantly minimize ty of any such refrigerated packaged
or prevent the growth of, or toxin pro- food; and
393
§ 117.251 21 CFR Ch. I (4–1–16 Edition)
(iii) Records documenting Compliance in the Center for Food

verification activities. Safety and Applied Nutrition), or an
(b) The records that a facility must FDA official senior to either such Di-
establish and maintain under para- rector, must approve an order to with-
graph (a)(5) of this section are subject draw the exemption before the order is
to the requirements of subpart F of issued.
this part. (b) Any officer or qualified employee
of FDA may issue an order to withdraw
Subpart E—Withdrawal of a the exemption after it has been ap-
Qualified Facility Exemption proved in accordance with paragraph
(a) of this section.
§ 117.251 Circumstances that may lead
FDA to withdraw a qualified facil- (c) FDA must issue an order to with-
ity exemption. draw the exemption to the owner, oper-
ator, or agent in charge of the facility.
(a) FDA may withdraw a qualified fa-
cility exemption under § 117.5(a): (d) FDA must issue an order to with-
(1) In the event of an active inves- draw the exemption in writing, signed
tigation of a foodborne illness outbreak and dated by the officer or qualified
that is directly linked to the qualified employee of FDA who is issuing the
facility; or order.
(2) If FDA determines that it is nec-
essary to protect the public health and § 117.257 Contents of an order to with-
prevent or mitigate a foodborne illness draw a qualified facility exemption.
outbreak based on conditions or con- An order to withdraw a qualified fa-
duct associated with the qualified facility exemption under § 117.5(a) must
cility that are material to the safety of include the following information:
the food manufactured, processed, (a) The date of the order;
packed, or held at such facility. (b) The name, address, and location
(b) Before FDA issues an order to of the qualified facility;
withdraw a qualified facility exemp-
(c) A brief, general statement of the
tion, FDA:
reasons for the order, including infor-
(1) May consider one or more other
actions to protect the public health or mation relevant to one or both of the
mitigate a foodborne illness outbreak, following circumstances that leads
including a warning letter, recall, ad- FDA to issue the order:
ministrative detention, suspension of (1) An active investigation of a
registration, refusal of food offered for foodborne illness outbreak that is di-
import, seizure, and injunction; rectly linked to the facility; or
(2) Must notify the owner, operator, (2) Conditions or conduct associated
or agent in charge of the facility, in with a qualified facility that are mate-
writing, of circumstances that may rial to the safety of the food manufac-
lead FDA to withdraw the exemption, tured, processed, packed, or held at
and provide an opportunity for the such facility.
owner, operator, or agent in charge of (d) A statement that the facility
the facility to respond in writing, with- must either:
in 15 calendar days of the date of re- (1) Comply with subparts C and G of
ceipt of the notification, to FDA’s noti- this part on the date that is 120 cal-
fication; and
endar days after the date of receipt of
(3) Must consider the actions taken
the order, or within a reasonable time-
by the facility to address the cir-
frame, agreed to by FDA, based on a
cumstances that may lead FDA to
withdraw the exemption. written justification, submitted to
FDA, for a timeframe that exceeds 120
§ 117.254 Issuance of an order to with- calendar days from the date of receipt
draw a qualified facility exemption. of the order; or
(a) An FDA District Director in (2) Appeal the order within 15 cal-
whose district the qualified facility is endar days of the date of receipt of the
located (or, in the case of a foreign fa- order in accordance with the require-
cility, the Director of the Office of ments of § 117.264.
394
(e) A statement that a facility may calendar days of the date of receipt of
request that FDA reinstate an exemp- the order, or within a reasonable time-
tion that was withdrawn by following frame, agreed to by FDA, based on a
the procedures in § 117.287; written justification, submitted to
(f) The text of section 418(l) of the FDA, for a timeframe that exceeds 120
Federal Food, Drug, and Cosmetic Act calendar days from the date of receipt
and of this subpart; of the order; and
(g) A statement that any informal (2) You are no longer subject to the
hearing on an appeal of the order must modified requirements in § 117.201.
be conducted as a regulatory hearing
under part 16 of this chapter, with cer- § 117.264 Procedure for submitting an
tain exceptions described in § 117.270; appeal.
(h) The mailing address, telephone
(a) To appeal an order to withdraw a
number, email address, and facsimile
qualified facility exemption, you must:
number of the FDA district office and
the name of the FDA District Director (1) Submit the appeal in writing to
in whose district the facility is located the FDA District Director in whose dis-
(or, in the case of a foreign facility, the trict the facility is located (or, in the
same information for the Director of case of a foreign facility, the Director
the Office of Compliance in the Center of the Office of Compliance in the Cen-
for Food Safety and Applied Nutrition); ter for Food Safety and Applied Nutri-
and tion), at the mailing address, email ad-
(i) The name and the title of the FDA dress, or facsimile number identified in
representative who approved the order. the order within 15 calendar days of the
date of receipt of confirmation of the
[80 FR 56145, Sept. 17, 2015, as amended at 81 order; and
FR 3716, Jan. 22, 2015]
(2) Respond with particularity to the
§ 117.260 Compliance with, or appeal facts and issues contained in the order,
of, an order to withdraw a qualified including any supporting documenta-
facility exemption. tion upon which you rely.
(a) If you receive an order under (b) In a written appeal of the order
§ 117.254 to withdraw a qualified facility withdrawing an exemption provided
exemption, you must either: under § 117.5(a), you may include a
(1) Comply with applicable require- written request for an informal hearing
ments of this part within 120 calendar as provided in § 117.267.
days of the date of receipt of the order, [80 FR 56145, Sept. 17, 2015, as amended at 81
or within a reasonable timeframe, FR 3716, Jan. 22, 2015]
agreed to by FDA, based on a written
justification, submitted to FDA, for a § 117.267 Procedure for requesting an
timeframe that exceeds 120 calendar informal hearing.
days from the date of receipt of the
(a) If you appeal the order, you:
order; or
(2) Appeal the order within 15 cal- (1) May request an informal hearing;
endar days of the date of receipt of the and
order in accordance with the require- (2) Must submit any request for an
ments of § 117.264. informal hearing together with your
(b) Submission of an appeal, includ- written appeal submitted in accordance
ing submission of a request for an in- with § 117.264 within 15 calendar days of
formal hearing, will not operate to the date of receipt of the order.
delay or stay any administrative ac- (b) A request for an informal hearing
tion, including enforcement action by may be denied, in whole or in part, if
FDA, unless the Commissioner of Food the presiding officer determines that
and Drugs, as a matter of discretion, no genuine and substantial issue of ma-
determines that delay or a stay is in terial fact has been raised by the mate-
the public interest. rial submitted. If the presiding officer
(c) If you appeal the order, and FDA determines that a hearing is not justi-
confirms the order: fied, written notice of the determina-

(1) You must comply with applicable tion will be given to you explaining the
requirements of this part within 120 reason for the denial.
395
§ 117.270 21 CFR Ch. I (4–1–16 Edition)
§ 117.270 Requirements applicable to comments on the report by the hearing

an informal hearing. participant under § 117.270(c)(4) are part
If you request an informal hearing, of the administrative record.
and FDA grants the request: (6) No party shall have the right,
(a) The hearing will be held within 15 under § 16.119 of this chapter to petition
calendar days after the date the appeal the Commissioner of Food and Drugs
is filed or, if applicable, within a time- for reconsideration or a stay of the pre-
frame agreed upon in writing by you siding officer’s final decision.
and FDA. (7) If FDA grants a request for an in-
(b) The presiding officer may require formal hearing on an appeal of an order
that a hearing conducted under this withdrawing an exemption, the hearing
subpart be completed within 1-calendar must be conducted as a regulatory
day, as appropriate. hearing under a regulation in accord-
(c) FDA must conduct the hearing in ance with part 16 of this chapter, ex-
accordance with part 16 of this chapter, cept that § 16.95(b) of this chapter does
except that: not apply to a hearing under this sub-
(1) The order withdrawing an exemp- part. With respect to a regulatory
tion under §§ 117.254 and 117.257, rather hearing under this subpart, the admin-
than the notice under § 16.22(a) of this istrative record of the hearing specified
chapter, provides notice of opportunity in §§ 16.80(a)(1) through (3) and (a)(5) of
for a hearing under this section and is this chapter and 117.270(c)(5) con-
part of the administrative record of the stitutes the exclusive record for the
regulatory hearing under § 16.80(a) of presiding officer’s final decision. For
this chapter. purposes of judicial review under § 10.45
(2) A request for a hearing under this of this chapter, the record of the ad-
subpart must be addressed to the FDA ministrative proceeding consists of the
District Director (or, in the case of a record of the hearing and the presiding
foreign facility, the Director of the Of- officer’s final decision.
fice of Compliance in the Center for
Food Safety and Applied Nutrition) as § 117.274 Presiding officer for an ap-
provided in the order withdrawing an peal and for an informal hearing.
exemption. The presiding officer for an appeal,
(3) Section 117.274, rather than and for an informal hearing, must be
§ 16.42(a) of this chapter, describes the an FDA Regional Food and Drug Direc-
FDA employees who preside at hear- tor or another FDA official senior to
ings under this subpart. an FDA District Director.
(4) Section 16.60(e) and (f) of this
chapter does not apply to a hearing § 117.277 Timeframe for issuing a deci-
under this subpart. The presiding offi- sion on an appeal.
cer must prepare a written report of (a) If you appeal the order without
the hearing. All written material pre- requesting a hearing, the presiding offi-
sented at the hearing will be attached cer must issue a written report that in-
to the report. The presiding officer cludes a final decision confirming or
must include as part of the report of revoking the withdrawal by the 10th
the hearing a finding on the credibility calendar day after the appeal is filed.
of witnesses (other than expert wit- (b) If you appeal the order and re-
nesses) whenever credibility is a mate- quest an informal hearing:
rial issue, and must include a proposed (1) If FDA grants the request for a
decision, with a statement of reasons. hearing and the hearing is held, the
The hearing participant may review presiding officer must provide a 2-cal-
and comment on the presiding officer’s endar day opportunity for the hearing
report within 2-calendar days of participants to review and submit com-
issuance of the report. The presiding ments on the report of the hearing
officer will then issue the final deci- under § 117.270(c)(4), and must issue a
sion. final decision within 10-calendar days
(5) Section 16.80(a)(4) of this chapter after the hearing is held; or
does not apply to a regulatory hearing (2) If FDA denies the request for a
under this subpart. The presiding offi- hearing, the presiding officer must
cer’s report of the hearing and any issue a final decision on the appeal
396
confirming or revoking the withdrawal on the request of a facility, reinstate

within 10 calendar days after the date the exemption.
the appeal is filed. (b) You may ask FDA to reinstate an
exemption that has been withdrawn
§ 117.280 Revocation of an order to under the procedures of this subpart as
withdraw a qualified facility ex-
emption. follows:
(1) Submit a request, in writing, to
An order to withdraw a qualified fa- the FDA District Director in whose dis-
cility exemption is revoked if: trict your facility is located (or, in the
(a) You appeal the order and request case of a foreign facility, the Director
an informal hearing, FDA grants the of the Office of Compliance in the Cen-
request for an informal hearing, and
ter for Food Safety and Applied Nutri-
the presiding officer does not confirm
tion); and
the order within the 10-calendar days
after the hearing, or issues a decision (2) Present data and information to
revoking the order within that time; or demonstrate that you have adequately
(b) You appeal the order and request resolved any problems with the condi-
an informal hearing, FDA denies the tions and conduct that are material to
request for an informal hearing, and the safety of the food manufactured,
FDA does not confirm the order within processed, packed, or held at your fa-
the 10-calendar days after the appeal is cility, such that continued withdrawal
filed, or issues a decision revoking the of the exemption is not necessary to
order within that time; or protect public health and prevent or
(c) You appeal the order without re- mitigate a foodborne illness outbreak.
questing an informal hearing, and FDA (c) If your exemption was withdrawn
does not confirm the order within the under § 117.251(a)(1) and FDA later de-
10-calendar days after the appeal is termines, after finishing the active in-
filed, or issues a decision revoking the vestigation of a foodborne illness out-
order within that time. break, that the outbreak is not di-
rectly linked to your facility, FDA will
§ 117.284 Final agency action. reinstate your exemption under
Confirmation of a withdrawal order § 117.5(a), and FDA will notify you in
by the presiding officer is considered a writing that your exempt status has
final agency action for purposes of 5 been reinstated.
U.S.C. 702. (d) If your exemption was withdrawn
under both § 117.251(a)(1) and (2) and
§ 117.287 Reinstatement of a qualified FDA later determines, after finishing
facility exemption that was with- the active investigation of a foodborne
drawn. illness outbreak, that the outbreak is
(a) If the FDA District Director in not directly linked to your facility,
whose district your facility is located FDA will inform you of this finding,
(or, in the case of a foreign facility, the and you may ask FDA to reinstate
Director of the Office of Compliance in your exemption under § 117.5(a) in ac-
the Center for Food Safety and Applied cordance with the requirements of
Nutrition) determines that a facility paragraph (b) of this section.
has adequately resolved any problems
with the conditions and conduct that Subpart F—Requirements Apply-
manufactured, processed, packed, or
ing to Records That Must Be
held at the facility and that continued Established and Maintained
withdrawal of the exemption is not
§ 117.301 Records subject to the re-
necessary to protect public health and quirements of this subpart.
prevent or mitigate a foodborne illness
outbreak, the FDA District Director in (a) Except as provided by paragraphs
whose district your facility is located (b) and (c) of this section, all records
(or, in the case of a foreign facility, the required by this part are subject to all
Director of the Office of Compliance in requirements of this subpart.

the Center for Food Safety and Applied (b) The requirements of § 117.310 apply
Nutrition) will, on his own initiative or only to the written food safety plan.
397
§ 117.305 21 CFR Ch. I (4–1–16 Edition)
(c) The requirements of § 117.305(b), (2) Records that a facility relies on

(d), (e), and (f) do not apply to the during the 3-year period preceding the
records required by § 117.201. applicable calendar year to support its
status as a qualified facility must be
§ 117.305 General requirements apply- retained at the facility as long as nec-
ing to records. essary to support the status of a facil-
Records must: ity as a qualified facility during the
(a) Be kept as original records, true applicable calendar year.
copies (such as photocopies, pictures, (b) Records that relate to the general
scanned copies, microfilm, microfiche, adequacy of the equipment or processes
or other accurate reproductions of the being used by a facility, including the
original records), or electronic records; results of scientific studies and evalua-
(b) Contain the actual values and ob- tions, must be retained by the facility
servations obtained during monitoring for at least 2 years after their use is
and, as appropriate, during verification discontinued (e.g., because the facility
activities; has updated the written food safety
(c) Be accurate, indelible, and legible; plan (§ 117.126) or records that docu-
(d) Be created concurrently with per- ment validation of the written food
formance of the activity documented; safety plan (§ 117.155(b)));
(c) Except for the food safety plan,
(e) Be as detailed as necessary to pro-
offsite storage of records is permitted
vide history of work performed; and
if such records can be retrieved and
(f) Include:
provided onsite within 24 hours of re-
(1) Information adequate to identify quest for official review. The food safe-
the plant or facility (e.g., the name, ty plan must remain onsite. Electronic
and when necessary, the location of the records are considered to be onsite if
plant or facility); they are accessible from an onsite loca-
(2) The date and, when appropriate, tion.
the time of the activity documented; (d) If the plant or facility is closed
(3) The signature or initials of the for a prolonged period, the food safety
person performing the activity; and plan may be transferred to some other
(4) Where appropriate, the identity of reasonably accessible location but
the product and the lot code, if any. must be returned to the plant or facil-
(g) Records that are established or ity within 24 hours for official review
maintained to satisfy the requirements upon request.
of this part and that meet the defini-
tion of electronic records in § 11.3(b)(6) § 117.320 Requirements for official re-
of this chapter are exempt from the review.
quirements of part 11 of this chapter. All records required by this part
Records that satisfy the requirements must be made promptly available to a
of this part, but that also are required duly authorized representative of the
under other applicable statutory provi- Secretary of Health and Human Serv-
sions or regulations, remain subject to ices for official review and copying
part 11 of this chapter. upon oral or written request.
§ 117.310 Additional requirements ap- § 117.325 Public disclosure.
plying to the food safety plan.
Records obtained by FDA in accord-
The owner, operator, or agent in ance with this part are subject to the
charge of the facility must sign and disclosure requirements under part 20
date the food safety plan: of this chapter.
(a) Upon initial completion; and
(b) Upon any modification. § 117.330 Use of existing records.
(a) Existing records (e.g., records that
§ 117.315 Requirements for record re- are kept to comply with other Federal,
tention. State, or local regulations, or for any
(a)(1) All records required by this other reason) do not need to be dupli-
part must be retained at the plant or cated if they contain all of the required
facility for at least 2 years after the information and satisfy the require-
date they were prepared. ments of this subpart. Existing records
398
may be supplemented as necessary to quirements under part 1, subpart L of

include all of the required information this chapter, and has documentation of
and satisfy the requirements of this verification activities conducted under
subpart. § 1.506(e) of this chapter (which provides
(b) The information required by this assurance that the hazards requiring a
part does not need to be kept in one set supply-chain-applied control for the
of records. If existing records contain raw material or other ingredient have
some of the required information, any been significantly minimized or pre-
new information required by this part vented) need not conduct supplier
may be kept either separately or com- verification activities for that raw ma-
bined with the existing records. terial or other ingredient.
§ 117.335 Special requirements appli- (3) The requirements in this subpart
cable to a written assurance. do not apply to food that is supplied for
research or evaluation use, provided
(a) Any written assurance required that such food:
by this part must contain the following
(i) Is not intended for retail sale and
elements:
(1) Effective date; is not sold or distributed to the public;
(2) Printed names and signatures of (ii) Is labeled with the statement
authorized officials; ‘‘Food for research or evaluation use’’;
(3) The applicable assurance under: (iii) Is supplied in a small quantity
(i) Section 117.136(a)(2); that is consistent with a research,
(ii) Section 117.136(a)(3); analysis, or quality assurance purpose,
(iii) Section 117.136(a)(4); the food is used only for this purpose,
(iv) Section 117.430(c)(2); and any unused quantity is properly
(v) Section 117.430(d)(2); or disposed of; and
(vi) Section 117.430(e)(2); (iv) Is accompanied with documents,
(b) A written assurance required in accordance with the practice of the
under § 117.136(a)(2), (3), or (4) must in- trade, stating that the food will be
clude: used for research or evaluation pur-
(1) Acknowledgement that the facil- poses and cannot be sold or distributed
ity that provides the written assurance to the public.
assumes legal responsibility to act con- (b) The supply-chain program must
sistently with the assurance and docu- be written.
ment its actions taken to satisfy the
(c) When a supply-chain-applied con-
written assurance; and
trol is applied by an entity other than
(2) Provision that if the assurance is
the receiving facility’s supplier (e.g.,
terminated in writing by either entity,
when a non-supplier applies controls to
responsibility for compliance with the
applicable provisions of this part re- certain produce (i.e., produce covered
verts to the manufacturer/processor as by part 112 of this chapter), because
of the date of termination. growing, harvesting, and packing ac-
tivities are under different manage-
ment), the receiving facility must:
Subpart G—Supply-Chain (1) Verify the supply-chain-applied
Program control; or
§ 117.405 Requirement to establish and (2) Obtain documentation of an ap-
implement a supply-chain program. propriate verification activity from an-
(a)(1) Except as provided by para- other entity, review and assess the en-
graphs (a)(2) and (3) of this section, the tity’s applicable documentation, and
receiving facility must establish and document that review and assessment.
implement a risk-based supply-chain [80 FR 56145, Sept. 17, 2015; 81 FR 3956, Jan.
program for those raw materials and 25, 2016]
other ingredients for which the receiv-
EFFECTIVE DATE NOTE: At 80 FR 56145,
ing facility has identified a hazard re- Sept. 17, 2015, § 117.405 was added, effective
quiring a supply-chain-applied control. Nov. 16, 2015, except for paragraphs (a)(2).
(2) A receiving facility that is an im- FDA will publish a document in the FEDERAL
porter, is in compliance with the for- REGISTER announcing the effective date for
eign supplier verification program re- these paragraphs.
399
§ 117.410 21 CFR Ch. I (4–1–16 Edition)
§ 117.410 General requirements appli- (iii) Supplier performance, including:

cable to a supply-chain program. (A) The supplier’s procedures, proc-
(a) The supply-chain program must esses, and practices related to the safe-
include: ty of the raw material and other ingre-
(1) Using approved suppliers as re- dients;
quired by § 117.420; (B) Applicable FDA food safety regu-
(2) Determining appropriate supplier lations and information relevant to the
verification activities (including deter- supplier’s compliance with those regu-
mining the frequency of conducting the lations, including an FDA warning let-
activity) as required by § 117.425; ter or import alert relating to the safe-
(3) Conducting supplier verification ty of food and other FDA compliance
activities as required by §§ 117.430 and actions related to food safety (or, when
117.435; applicable, relevant laws and regula-
(4) Documenting supplier verification tions of a country whose food safety
activities as required by § 117.475; and system FDA has officially recognized
(5) When applicable, verifying a sup- as comparable or has determined to be
ply-chain-applied control applied by an equivalent to that of the United
entity other than the receiving facili- States, and information relevant to the
ty’s supplier and documenting that supplier’s compliance with those laws
verification as required by § 117.475, or and regulations); and
obtaining documentation of an appro- (C) The supplier’s food safety history
priate verification activity from an- relevant to the raw materials or other
other entity, reviewing and assessing ingredients that the receiving facility
that documentation, and documenting receives from the supplier, including
the review and assessment as required available information about results
by § 117.475. from testing raw materials or other in-
(b) The following are appropriate sup- gredients for hazards, audit results re-
plier verification activities for raw ma- lating to the safety of the food, and re-
terials and other ingredients: sponsiveness of the supplier in cor-
(1) Onsite audits; recting problems; and
(2) Sampling and testing of the raw (iv) Any other factors as appropriate
material or other ingredient; and necessary, such as storage and
(3) Review of the supplier’s relevant transportation practices.
food safety records; and (2) Considering supplier performance
(4) Other appropriate supplier can be limited to the supplier’s compli-
verification activities based on sup- ance history as required by paragraph
plier performance and the risk associ- (d)(1)(iii)(B) of this section, if the sup-
ated with the raw material or other in- plier is:
gredient. (i) A qualified facility as defined by
(c) The supply-chain program must § 117.3;
provide assurance that a hazard requir- (ii) A farm that grows produce and is
ing a supply-chain-applied control has not a covered farm under part 112 of
been significantly minimized or pre- this chapter in accordance with
vented. § 112.4(a), or in accordance with
(d)(1) Except as provided by para- §§ 112.4(b) and 112.5; or
graph (d)(2) of this section, in approv- (iii) A shell egg producer that is not
ing suppliers and determining the ap- subject to the requirements of part 118
propriate supplier verification activi- of this chapter because it has less than
ties and the frequency with which they 3,000 laying hens.
are conducted, the following must be (e) If the owner, operator, or agent in
considered: charge of a receiving facility deter-
(i) The hazard analysis of the food, mines through auditing, verification
including the nature of the hazard con- testing, document review, relevant
trolled before receipt of the raw mate- consumer, customer or other com-
rial or other ingredient, applicable to plaints, or otherwise that the supplier
the raw material and other ingredients; is not controlling hazards that the re-
(ii) The entity or entities that will be ceiving facility has identified as re-
applying controls for the hazards requiring a supply-chain-applied control,
quiring a supply-chain-applied control; the receiving facility must take and
400
document prompt action in accordance (3) A review by its supplier of that

with § 117.150 to ensure that raw mate- supplier’s own relevant food safety
rials or other ingredients from the sup- records; or
plier do not cause food that is manu- (4) The conduct by its supplier of
factured or processed by the receiving other appropriate supplier verification
facility to be adulterated under section activities for that supplier within the
402 of the Federal Food, Drug, and Cos- meaning of § 117.410(b)(4).
metic Act or misbranded under section (c) The requirements of this section
403(w) of the Federal Food, Drug, and do not prohibit a receiving facility
Cosmetic Act. from relying on an audit provided by
§ 117.415 Responsibilities of the receiv- its supplier when the audit of the sup-
ing facility. plier was conducted by a third-party
qualified auditor in accordance with
(a)(1) The receiving facility must ap- §§ 117.430(f) and 117.435.
prove suppliers.
(2) Except as provided by paragraphs § 117.420 Using approved suppliers.
(a)(3) and (4) of this section, the receiv-
(a) Approval of suppliers. The receiv-
ing facility must determine and con-
duct appropriate supplier verification ing facility must approve suppliers in
activities, and satisfy all documenta- accordance with the requirements of
tion requirements of this subpart. § 117.410(d), and document that ap-
(3) An entity other than the receiving proval, before receiving raw materials
facility may do any of the following, and other ingredients received from
provided that the receiving facility re- those suppliers;
views and assesses the entity’s applica- (b) Written procedures for receiving raw
ble documentation, and documents materials and other ingredients. (1) Writ-
that review and assessment: ten procedures for receiving raw mate-
(i) Establish written procedures for rials and other ingredients must be es-
receiving raw materials and other in- tablished and followed;
gredients by the entity; (2) The written procedures for receiv-
(ii) Document that written proce- ing raw materials and other ingredi-
dures for receiving raw materials and ents must ensure that raw materials
other ingredients are being followed by and other ingredients are received only
the entity; and from approved suppliers (or, when nec-
(iii) Determine, conduct, or both de- essary and appropriate, on a temporary
termine and conduct the appropriate basis from unapproved suppliers whose
supplier verification activities, with raw materials or other ingredients are
appropriate documentation. subjected to adequate verification ac-
(4) The supplier may conduct and tivities before acceptance for use); and
document sampling and testing of raw (3) Use of the written procedures for
materials and other ingredients, for receiving raw materials and other in-
the hazard controlled by the supplier, gredients must be documented.
as a supplier verification activity for a
particular lot of product and provide § 117.425 Determining appropriate
such documentation to the receiving supplier verification activities (in-
facility, provided that the receiving fa- cluding determining the frequency
cility reviews and assesses that docu- of conducting the activity).
mentation, and documents that review Appropriate supplier verification ac-
and assessment. tivities (including the frequency of
(b) For the purposes of this subpart, a conducting the activity) must be deter-
receiving facility may not accept any mined in accordance with the require-
of the following as a supplier ments of § 117.410(d).
verification activity:
(1) A determination by its supplier of § 117.430 Conducting supplier
the appropriate supplier verification verification activities for raw mate-
activities for that supplier; rials and other ingredients.

(2) An audit conducted by its sup- (a) Except as provided by paragraph
plier; (c), (d), or (e) of this section, one or
401
§ 117.430 21 CFR Ch. I (4–1–16 Edition)
more of the supplier verification ac- (ii) A statement that the facility is
tivities specified in § 117.410(b), as de- in compliance with State, local, coun-
termined under § 117.410(d), must be ty, tribal, or other applicable non-Fed-
conducted for each supplier before eral food safety law, including relevant
using the raw material or other ingre- laws and regulations of foreign coun-
dient from that supplier and periodi- tries.
cally thereafter. (d) If a supplier is a farm that grows
(b)(1) Except as provided by para- produce and is not a covered farm
graph (b)(2) of this section, when a haz- under part 112 of this chapter in ac-
ard in a raw material or other ingre- cordance with § 112.4(a), or in accord-
dient will be controlled by the supplier ance with §§ 112.4(b) and 112.5, the re-
and is one for which there is a reason- ceiving facility does not need to com-
able probability that exposure to the ply with paragraphs (a) and (b) of this
hazard will result in serious adverse section for produce that the receiving
health consequences or death to hu- facility receives from the farm as a raw
mans: material or other ingredient if the re-
(i) The appropriate supplier ceiving facility:
verification activity is an onsite audit (1) Obtains written assurance that
of the supplier; and the raw material or other ingredient
(ii) The audit must be conducted be- provided by the supplier is not subject
fore using the raw material or other in- to part 112 of this chapter in accord-
gredient from the supplier and at least ance with § 112.4(a), or in accordance
annually thereafter. with §§ 112.4(b) and 112.5:
(2) The requirements of paragraph (i) Before first approving the supplier
(b)(1) of this section do not apply if for an applicable calendar year; and
there is a written determination that (ii) On an annual basis thereafter, by
other verification activities and/or less December 31 of each calendar year, for
frequent onsite auditing of the supplier the following calendar year; and
provide adequate assurance that the (2) Obtains written assurance, at
hazards are controlled. least every 2 years, that the farm ac-
(c) If a supplier is a qualified facility knowledges that its food is subject to
as defined by § 117.3, the receiving facil- section 402 of the Federal Food, Drug,
ity does not need to comply with para- and Cosmetic Act (or, when applicable,
graphs (a) and (b) of this section if the that its food is subject to relevant laws
receiving facility: and regulations of a country whose
(1) Obtains written assurance that food safety system FDA has officially
the supplier is a qualified facility as recognized as comparable or has deter-
defined by § 117.3: mined to be equivalent to that of the
(i) Before first approving the supplier United States).
for an applicable calendar year; and (e) If a supplier is a shell egg pro-
(ii) On an annual basis thereafter, by ducer that is not subject to the re-
December 31 of each calendar year, for quirements of part 118 of this chapter
the following calendar year; and because it has less than 3,000 laying
(2) Obtains written assurance, at hens, the receiving facility does not
least every 2 years, that the supplier is need to comply with paragraphs (a) and
producing the raw material or other in- (b) of this section if the receiving facil-
gredient in compliance with applicable ity:
FDA food safety regulations (or, when (1) Obtains written assurance that
applicable, relevant laws and regula- the shell eggs produced by the supplier
tions of a country whose food safety are not subject to part 118 because the
system FDA has officially recognized shell egg producer has less than 3,000
as comparable or has determined to be laying hens:
equivalent to that of the United (i) Before first approving the supplier
States). The written assurance must for an applicable calendar year; and
include either: (ii) On an annual basis thereafter, by
(i) A brief description of the preven- December 31 of each calendar year, for
tive controls that the supplier is imple- the following calendar year; and
menting to control the applicable haz- (2) Obtains written assurance, at
ard in the food; or least every 2 years, that the shell egg
402
producer acknowledges that its food is whose food safety system FDA has offi-
subject to section 402 of the Federal cially recognized as comparable or de-
Food, Drug, and Cosmetic Act (or, termined to be equivalent, the food
when applicable, that its food is sub- that is the subject of the onsite audit
ject to relevant laws and regulations of must be within the scope of the official
a country whose food safety system recognition or equivalence determina-
FDA has officially recognized as com- tion, and the foreign supplier must be
parable or has determined to be equiva- in, and under the regulatory oversight
lent to that of the United States). of, such country.
(f) There must not be any financial (d) If the onsite audit is solely con-
conflicts of interests that influence the ducted to meet the requirements of
results of the verification activities this subpart by an audit agent of a cer-
listed in § 117.410(b) and payment must tification body that is accredited in ac-
not be related to the results of the ac-
cordance with regulations in part 1,
tivity.
subpart M of this chapter, the audit is
§ 117.435 Onsite audit. not subject to the requirements in
those regulations.
(a) An onsite audit of a supplier must
be performed by a qualified auditor. EFFECTIVE DATE NOTE: At 80 FR 56145,
(b) If the raw material or other ingre- Sept. 17, 2015, § 117.435 was added, effective
dient at the supplier is subject to one Nov. 16, 2015, except for paragraph (d). FDA
or more FDA food safety regulations, will publish a document in the FEDERAL REG-
ISTER announcing the effective date for this
an onsite audit must consider such reg-
paragraph.
ulations and include a review of the
supplier’s written plan (e.g., Hazard § 117.475 Records documenting the
Analysis and Critical Control Point supply-chain program.
(HACCP) plan or other food safety
plan), if any, and its implementation, (a) The records documenting the sup-
for the hazard being controlled (or, ply-chain program are subject to the
when applicable, an onsite audit may requirements of subpart F of this part.
consider relevant laws and regulations (b) The receiving facility must re-
of a country whose food safety system view the records listed in paragraph (c)
FDA has officially recognized as com- of this section in accordance with
parable or has determined to be equiva- § 117.165(a)(4).
lent to that of the United States). (c) The receiving facility must docu-
(c)(1) The following may be sub- ment the following in records as appli-
stituted for an onsite audit, provided cable to its supply-chain program:
that the inspection was conducted (1) The written supply-chain pro-
within 1 year of the date that the on- gram;
site audit would have been required to (2) Documentation that a receiving
be conducted: facility that is an importer is in com-
(i) The written results of an appro- pliance with the foreign supplier
priate inspection of the supplier for verification program requirements
compliance with applicable FDA food under part 1, subpart L of this chapter,
safety regulations by FDA, by rep- including documentation of
resentatives of other Federal Agencies verification activities conducted under
(such as the United States Department
§ 1.506(e) of this chapter;
of Agriculture), or by representatives
(3) Documentation of the approval of
of State, local, tribal, or territorial
agencies; or a supplier;
(ii) For a foreign supplier, the writ- (4) Written procedures for receiving
ten results of an inspection by FDA or raw materials and other ingredients;
the food safety authority of a country (5) Documentation demonstrating use
whose food safety system FDA has offi- of the written procedures for receiving
cially recognized as comparable or has raw materials and other ingredients;
determined to be equivalent to that of (6) Documentation of the determina-
the United States. tion of the appropriate supplier

(2) For inspections conducted by the verification activities for raw mate-
food safety authority of a country rials and other ingredients;
403
§ 117.475 21 CFR Ch. I (4–1–16 Edition)
(7) Documentation of the conduct of in a raw material or other ingredient

an onsite audit. This documentation will be controlled by the supplier and is
must include: one for which there is a reasonable
(i) The name of the supplier subject probability that exposure to the hazard
to the onsite audit; will result in serious adverse health
(ii) Documentation of audit proce- consequences or death to humans;
dures; (12) The following documentation of
(iii) The dates the audit was con- an alternative verification activity for
ducted; a supplier that is a qualified facility:
(iv) The conclusions of the audit; (i) The written assurance that the
(v) Corrective actions taken in re- supplier is a qualified facility as de-
sponse to significant deficiencies iden- fined by § 117.3, before approving the
tified during the audit; and supplier and on an annual basis there-
(vi) Documentation that the audit after; and
was conducted by a qualified auditor; (ii) The written assurance that the
(8) Documentation of sampling and supplier is producing the raw material
testing conducted as a supplier or other ingredient in compliance with
verification activity. This documenta- applicable FDA food safety regulations
tion must include: (or, when applicable, relevant laws and
(i) Identification of the raw material regulations of a country whose food
or other ingredient tested (including
safety system FDA has officially recog-
lot number, as appropriate) and the
nized as comparable or has determined
number of samples tested;
to be equivalent to that of the United
(ii) Identification of the test(s) con-
States);
ducted, including the analytical meth-
od(s) used; (13) The following documentation of
(iii) The date(s) on which the test(s) an alternative verification activity for
were conducted and the date of the re- a supplier that is a farm that supplies
port; a raw material or other ingredient and
(iv) The results of the testing; is not a covered farm under part 112 of
(v) Corrective actions taken in re- this chapter:
sponse to detection of hazards; and (i) The written assurance that sup-
(vi) Information identifying the lab- plier is not a covered farm under part
oratory conducting the testing; 112 of this chapter in accordance with
(9) Documentation of the review of § 112.4(a), or in accordance with
the supplier’s relevant food safety §§ 112.4(b) and 112.5, before approving
records. This documentation must in- the supplier and on an annual basis
clude: thereafter; and
(i) The name of the supplier whose (ii) The written assurance that the
records were reviewed; farm acknowledges that its food is sub-
(ii) The date(s) of review; ject to section 402 of the Federal Food,
(iii) The general nature of the records Drug, and Cosmetic Act (or, when ap-
reviewed; plicable, that its food is subject to rel-
(iv) The conclusions of the review; evant laws and regulations of a coun-
and try whose food safety system FDA has
(v) Corrective actions taken in re- officially recognized as comparable or
sponse to significant deficiencies iden- has determined to be equivalent to
tified during the review; that of the United States);
(10) Documentation of other appro- (14) The following documentation of
priate supplier verification activities an alternative verification activity for
based on the supplier performance and a supplier that is a shell egg producer
the risk associated with the raw mate- that is not subject to the requirements
rial or other ingredient; established in part 118 of this chapter
(11) Documentation of any deter- because it has less than 3,000 laying
mination that verification activities hens:
other than an onsite audit, and/or less (i) The written assurance that the
frequent onsite auditing of a supplier, shell eggs provided by the supplier are
provide adequate assurance that the not subject to part 118 of this chapter
hazards are controlled when a hazard because the supplier has less than 3,000
404
laying hens, before approving the sup- (v) Applicable documentation, from
plier and on an annual basis thereafter; an entity other than the receiving fa-
and cility, of verification activities when a
(ii) The written assurance that the supply-chain-applied control is applied
shell egg producer acknowledges that by an entity other than the receiving
its food is subject to section 402 of the facility’s supplier.
Federal Food, Drug, and Cosmetic Act EFFECTIVE DATE NOTE: At 80 FR 56145,
(or, when applicable, that its food is Sept. 17, 2015, § 117.475 was added, effective
subject to relevant laws and regula- Nov. 16, 2015, except for paragraphs (c)(2).
tions of a country whose safety system FDA will publish a document in the FEDERAL
FDA has officially recognized as com- REGISTER announcing the effective date for
parable or has determined to be equiva- these paragraphs.
lent to that of the United States);
(15) The written results of an appro- PART 118—PRODUCTION, STOR-
priate inspection of the supplier for AGE, AND TRANSPORTATION OF
compliance with applicable FDA food SHELL EGGS
safety regulations by FDA, by rep-
resentatives of other Federal Agencies Sec.
(such as the United States Department 118.1 Persons covered by the requirements
of Agriculture), or by representatives in this part.
from State, local, tribal, or territorial 118.3 Definitions.
agencies, or the food safety authority 118.4 Salmonella Enteritidis (SE) prevention
of another country when the results of measures.
118.5 Environmental testing for Salmonella
such an inspection is substituted for an Enteritidis (SE).
onsite audit; 118.6 Egg testing for Salmonella Enteritidis
(16) Documentation of actions taken (SE).
with respect to supplier non-conform- 118.7 Sampling methodology for Salmonella
ance; Enteritidis (SE).
(17) Documentation of verification of 118.8 Testing methodology for Salmonella
a supply-chain-applied control applied Enteritidis (SE).
118.9 Administration of the Salmonella
by an entity other than the receiving Enteritidis (SE) prevention plan.
facility’s supplier; and 118.10 Recordkeeping requirements for the
(18) When applicable, documentation Salmonella Enteritidis (SE) prevention
of the receiving facility’s review and plan.
assessment of: 118.11 Registration requirements for shell
(i) Applicable documentation from an egg producers covered by the require-
entity other than the receiving facility ments of this part.
that written procedures for receiving 118.12 Enforcement and compliance.
raw materials and other ingredients AUTHORITY: 21 U.S.C. 321, 331–334, 342, 371,
are being followed; 381, 393; 42 U.S.C. 243, 264, 271.
(ii) Applicable documentation, from SOURCE: 74 FR 33095, July 9, 2009, unless
an entity other than the receiving fa- otherwise noted.
cility, of the determination of the ap-
propriate supplier verification activi- § 118.1 Persons covered by the require-
ties for raw materials and other ingre- ments in this part.
dients; (a) If you are a shell egg producer
(iii) Applicable documentation, from with 3,000 or more laying hens at a par-
an entity other than the receiving fa- ticular farm that does not sell all of
cility, of conducting the appropriate your eggs directly to consumers and
supplier verification activities for raw that produces shell eggs for the table
materials and other ingredients; market, you are covered by some or all
(iv) Applicable documentation, from of the requirements in this part, as fol-
its supplier, of: lows:
(A) The results of sampling and test- (1) If any of your eggs that are pro-
ing conducted by the supplier; or duced at a particular farm do not re-
(B) The results of an audit conducted ceive a treatment as defined in § 118.3,
by a third-party qualified auditor in you must comply with all of the re-
accordance with §§ 117.430(f) and 117.435; quirements of this part for egg produc-
and tion on that farm.
405
§ 118.3 21 CFR Ch. I (4–1–16 Edition)
(2) If all of your eggs that are pro- and the time that the hen is perma-
duced at the particular farm receive a nently taken out of production.
treatment as defined in § 118.3, you Molting means a life stage during
must comply only with the refrigera- which hens stop laying eggs and shed
tion requirements in § 118.4(e) for pro- their feathers.
duction of eggs on that farm and with Pest means any objectionable animal
the registration requirements in including, but not limited to, rodents,
§ 118.11. flies, and larvae.
(b) If you transport or hold shell eggs Positive flock means a flock that has
for shell egg processing or egg products had an egg test that was positive for
facilities, you must comply with the SE. A flock is considered positive until
refrigeration requirements in § 118.4(e). that flock meets the egg testing re-
This section applies only to eggs from quirements in § 118.6(c) to return to
farms with 3,000 or more laying hens. table egg production.
Positive poultry house means a poultry
§ 118.3 Definitions. house from which there has been an en-
The definitions and interpretations vironmental test that was positive for
of terms in section 201 of the Federal SE at any time during the life of a
Food, Drug, and Cosmetic Act (the group in the poultry house until that
FFDCA) (21 U.S.C. 321) are applicable house is cleaned and disinfected ac-
to such terms when used in this part, cording to § 118.4(d).
except where they are redefined in this Poultry house means a building, other
part. The following definitions also structure, or separate section within a
apply: structure used to house poultry. For
structures comprising more than one
Biosecurity means a program, includ-
section containing poultry, each sec-
ing the limiting of visitors on the farm
tion that is separated from the other
and in poultry houses, maintaining
sections is considered a separate house.
personnel and equipment practices that
Producer means a person who owns
will protect against cross contamina-
and/or operates a poultry house con-
tion from one poultry house to an-
taining laying hens which produce
other, preventing stray poultry, wild
shell eggs for human consumption.
birds, cats, and other animals from en-
Shell egg (or egg) means the egg of
tering poultry houses, and not allowing
the domesticated chicken.
employees to keep birds at home, to
Shell egg processing facility means a
ensure that there is no introduction or
facility that processes (e.g., washes,
transfer of Salmonella Enteritidis (SE)
grades, packs) shell eggs for the table
onto a farm or among poultry houses.
egg market.
Egg products facility means a USDA-
Treatment (or treated) means a tech-
inspected egg products plant where liq-
nology or process that achieves at least
uid, frozen, and/or dried egg products
a 5-log destruction of SE for shell eggs,
are produced.
or the processing of egg products in ac-
Farm means all poultry houses and cordance with the Egg Products Inspec-
grounds immediately surrounding the tion Act.
poultry houses covered under a single
biosecurity program. § 118.4 Salmonella Enteritidis (SE) pre-
Flock means all laying hens within vention measures.
one poultry house. You must follow the SE prevention
Group means all laying hens of the measures set forth in this section. In
same age within one poultry house. addition, you must have and imple-
Induced molting means molting that ment a written SE prevention plan
is artificially initiated. that is specific to each farm where you
Laying cycle means the period of time produce eggs and that includes, at a
that a hen begins to produce eggs until minimum, the following SE prevention
it undergoes induced molting or is per- measures:
manently taken out of production and (a) Pullets. You must procure pullets
the period of time that a hen produces that are SE monitored or raise pullets
eggs between successive induced molt- under SE monitored conditions. ‘‘SE
ing periods or between induced molting monitored’’ means the pullets are
406
raised under SE control conditions (1) Monitor for rodents by visual in-
that prevent SE, including: spection and mechanical traps or
(1) Procurement of chicks. Chicks are glueboards or another appropriate
procured from SE-monitored breeder monitoring method and, when moni-
flocks that meet the National Poultry toring indicates unacceptable rodent
Improvement Plan’s standards for activity within a poultry house, use ap-
‘‘U.S. S. Enteritidis Clean’’ status (9 propriate methods to achieve satisfac-
CFR 145.23(d)) or equivalent standard; tory rodent control;
(2) Environmental testing. (i) The pul- (2) Monitor for flies by spot cards,
let environment is tested for SE when Scudder grills, or sticky traps or an-
pullets are 14 to 16 weeks of age; other appropriate monitoring method
(ii) If the environmental test re- and, when monitoring indicates unac-
quired in paragraph (a)(2)(i) of this sec- ceptable fly activity within a poultry
tion is negative, you do not need to house, use appropriate methods to
perform any additional testing of those achieve satisfactory fly control.
birds or their environment until the (3) Remove debris within a poultry
environmental test at 40 to 45 weeks of house and vegetation and debris out-
age specified in § 118.5(a); and side a poultry house that may provide
(iii) If the environmental test re- harborage for pests.
quired in paragraph (a)(2)(i) of this sec- (d) Cleaning and disinfection. You
tion is positive, you must begin egg must clean and disinfect the poultry
testing, as specified in § 118.6, within 2 house according to these procedures be-
weeks of the start of egg laying. fore new laying hens are added to the
(3) Cleaning and disinfection. If the en- house, if you have had an environ-
vironmental test required in paragraph mental test or an egg test that was
(a)(2) of this section is positive, the positive for SE at any point during the
pullet environment is cleaned and dis- life of a flock that was housed in the
infected, to include: poultry house prior to depopulation. As
(i) Removal of all visible manure; part of the cleaning and disinfection
(ii) Dry cleaning the positive pullet procedures, you must:
house to remove dust, feathers, and old (1) Remove all visible manure;
feed; and (2) Dry clean the positive poultry
(iii) Following cleaning, disinfection house to remove dust, feathers, and old
of the positive pullet house with spray, feed; and
aerosol, fumigation, or another appro- (3) Following cleaning, disinfect the
priate disinfection method. positive poultry house with spray, aer-
(b) Biosecurity. As part of this pro- osol, fumigation, or another appro-
gram, you must take steps to ensure priate disinfection method.
that there is no introduction or trans- (e) Refrigeration. You must hold and
fer of SE into or among poultry houses. transport eggs at or below 45 °F ambi-
Among such biosecurity measures you ent temperature beginning 36 hours
must, at a minimum: after time of lay. If the eggs are to be
(1) Limit visitors on the farm and in processed as table eggs and are not
the poultry houses; processed for the ultimate consumer
(2) Maintain practices that will pro- within 36 hours from the time of lay
tect against cross contamination when and, therefore, are held and trans-
equipment is moved among poultry ported as required at or below 45 °F
houses; ambient temperature, then you may
(3) Maintain practices that will pro- then hold them at room temperature
tect against cross contamination when for no more than 36 hours just prior to
persons move between poultry houses; processing to allow an equilibration
(4) Prevent stray poultry, wild birds, step to temper the eggs.
cats, and other animals from entering
poultry houses; and § 118.5 Environmental testing for Sal-
(5) Not allow employees to keep birds monella Enteritidis (SE).
at home. (a) Environmental testing when laying

(c) Rodents, flies, and other pest con- hens are 40 to 45 weeks of age. As one in-
trol. As part of this program, you must: dicator of the effectiveness of your SE
407
§ 118.6 21 CFR Ch. I (4–1–16 Edition)
prevention plan, you must perform en- (ii) Begin egg testing (described in
vironmental testing for SE (as de- § 118.6), unless you divert eggs to treat-
scribed in §§ 118.7 and 118.8) in a poultry ment as defined in § 118.3 for the life of
house when any group of laying hens the flock in that poultry house. Re-
constituting the flock within the poul- sults of egg testing, when conducted,
try house is 40 to 45 weeks of age. must be available within 10-calendar
(1) If an environmental test at 40 to days of receiving notification of the
45 weeks is negative and your laying positive environmental test.
hens do not undergo induced molting,
then you do not need to perform any § 118.6 Egg testing for Salmonella
additional environmental testing with- Enteritidis (SE).
in that poultry house, unless the poul- (a)(1) If the environmental test for
try house contains more than one pullets at 14 to 16 weeks of age required
group of laying hens. If the poultry by § 118.4(a) is positive, you must divert
house contains more than one group of eggs to treatment (defined in § 118.3) for
laying hens, then you must perform en- the life of any flock or conduct egg
vironmental testing on the poultry testing within 2 weeks of the start of
house when each group of laying hens egg laying, as specified in paragraphs
is 40 to 45 weeks of age. (b) through (e) of this section.
(2) If the environmental test at 40 to (2) If you have an SE-positive envi-
45 weeks is positive, then you must: ronmental test at any time during the
(i) Review and make any necessary life of a flock, you must divert eggs to
adjustments to your SE prevention treatment (defined in § 118.3) for the
plan to ensure that all measures are life of the flock in that positive poultry
being properly implemented and house or conduct egg testing as speci-
(ii) Begin egg testing (described in fied in paragraphs (b) through (e) of
§ 118.6), unless you divert eggs to treat- this section.
ment as defined in § 118.3 for the life of (b) Eggs must be sampled as de-
the flock in that poultry house. Re- scribed in § 118.7 and tested using meth-
sults of egg testing must be obtained odology as described in § 118.8.
within 10-calendar days of receiving no- (c) You must conduct four egg tests,
tification of the positive environ- using sampling and methodology in
mental test. §§ 118.7 and 118.8, on the flock in the
(b) Environmental testing after an in- positive poultry house at 2-week inter-
duced molting period. If you induce a vals. If all four tests are negative for
molt in a flock or a group in a flock, SE, you are not required to do further
you must perform environmental test- egg testing.
ing for SE in the poultry house at 4 to (d) If any of the four egg tests is posi-
6 weeks after the end of any molting tive for SE, you must divert, upon re-
process. ceiving notification of an SE-positive
(1) If an environmental test at 4 to 6 egg test, all eggs from that flock to
weeks after the end of the molting treatment (defined in § 118.3) until the
process is negative and none of your conditions of paragraph (c) of this sec-
laying hens in that poultry house is tion are met.
molted again, then you do not need to (e) If you have a positive egg test in
perform any additional environmental a flock and divert eggs from that flock
testing in that poultry house. Each and later meet the negative test result
time a flock or group within the flock requirements described in paragraph
is molted, you must perform environ- (c) of this section and return to table
mental testing in the poultry house at egg production, you must conduct one
4 to 6 weeks after the end of the molt- egg test per month on that flock, using
ing process. sampling and methodology in §§ 118.7
(2) If the environmental test at 4 to 6 and 118.8, for the life of the flock.
weeks after the end of a molting proc- (1) If all the monthly egg tests in
ess is positive, then you must: paragraph (e) of this section are nega-
(i) Review and make any necessary tive for SE, you may continue to sup-
adjustments to your SE prevention ply eggs to the table market.

plan to ensure that all measures are (2) If any of the monthly egg tests in
being properly implemented; and paragraph (e) of this section is positive
408
for SE, you must divert eggs from the pling and Detection of Salmonella Web
positive flock to treatment for the life site is located at http://www.fda.gov/
of the flock or until the conditions of Food/ScienceResearch/
paragraph (c) of this section are met. LaboratoryMethods/ucm114716.htm, cur-
(f) If you are diverting eggs, the pal- rent as of June 26, 2009. The Director of
let, case, or other shipping container the Federal Register approves the in-
must be labeled and all documents ac- corporation by reference of ‘‘Environ-
companying the shipment must con- mental Sampling and Detection of Sal-
tain the following statement: ‘‘Federal monella in Poultry Houses,’’ April 2008,
law requires that these eggs must be in accordance with 5 U.S.C. 552(a) and 1
treated to achieve at least a 5-log de- CFR part 51. FDA will request approval
struction of Salmonella Enteritidis or to incorporate by reference any up-
processed as egg products in accord- dates to this Web site. FDA will change
ance with the Egg Products Inspection the date of the Web site in this para-
Act, 21 CFR 118.6(f).’’ The statement graph with each update. You may ob-
must be legible and conspicuous. tain a copy from Division of Microbi-
ology (HFS–710), Center for Food Safe-
§ 118.7 Sampling methodology for Sal- ty and Applied Nutrition, Food and
monella Enteritidis (SE). Drug Administration, 5100 Paint
(a) Environmental sampling. An envi- Branch Pkwy., College Park, MD 20740,
ronmental test must be done for each 301–436–2364, or you may examine a
poultry house in accordance with § 118.5 copy at the Food and Drug Administra-
(a) and (b). Within each poultry house, tion’s Main Library, 10903 New Hamp-
you must sample the environment shire Ave., Bldg. 2, Third Floor, Silver
using a sampling plan appropriate to Spring, MD 20993, 301–796–2039, or at the
the poultry house layout. National Archives and Records Admin-
(b) Egg sampling. When you conduct istration (NARA). For information on
an egg test required under § 118.6, you the availability of this material at
must collect and test the following NARA, call 202–741–6030, or go to: http://
number of eggs from the positive poul- www.archives.gov/federallregister/
try house: codeloflfederallregulation/
(1) To meet the egg testing require- ibrllocations.html.
ments of § 118.6(c), you must collect and (b) Testing of egg samples for SE. Test-
deliver for testing a minimum of 1,000 ing to detect SE in egg samples must
intact eggs representative of a day’s be conducted according to Chapter 5 of
production. The 1,000-egg sample must FDA’s Bacteriological Analytical Man-
be tested according to § 118.8. You must ual (BAM), December 2007 Edition, or
collect and test four 1,000-egg samples an equivalent method in accuracy, pre-
at 2-week intervals for a total of 4,000 cision, and sensitivity in detecting SE.
eggs. Chapter 5 of FDA’s Bacteriological An-
(2) To meet the monthly egg testing alytical Manual, December 2007 Edi-
requirement of § 118.6(e), you must col- tion, is located at http://www.fda.gov/
lect and deliver for testing a minimum Food/ScienceResearch/
of 1,000 intact eggs representative of a LaboratoryMethods/
day’s production per month for the life BacteriologicalAnalyticalManualBAM/
of the flock. Eggs must be tested ac- ucm070149.htm, current as of June 26,
cording to § 118.8. 2009. The method is incorporated by
reference in accordance with 5 U.S.C.
§ 118.8 Testing methodology for Sal- 552(a) and 1 CFR part 51. FDA will re-
monella Enteritidis (SE). quest approval to incorporate by ref-
(a) Testing of environmental samples for erence any updates to this Web site.
SE. Testing to detect SE in environ- FDA will change the date of the Web
mental samples must be conducted by site in this paragraph with each up-
the method entitled ‘‘Environmental date. You may obtain a copy from Divi-
Sampling and Detection of Salmonella sion of Microbiology (HFS–710), Center
in Poultry Houses,’’ April 2008, or an for Food Safety and Applied Nutrition,
equivalent method in accuracy, preci- Food and Drug Administration, 5100

sion, and sensitivity in detecting SE. Paint Branch Pkwy., College Park, MD
The April 2008 Environmental Sam- 20740, 301–436–2364, or you may examine
409
§ 118.9 21 CFR Ch. I (4–1–16 Edition)
a copy at the Food and Drug Adminis- (2) Documentation that pullets were
tration’s Main Library, 10903 New ‘‘SE monitored’’ or were raised under
Hampshire Ave., Bldg. 2, Third Floor, ‘‘SE monitored’’ conditions, including
Silver Spring, MD 20993, 301–796–2039, or environmental testing records for pul-
at the National Archives and Records lets, as required by § 118.4(a)(2);
Administration (NARA). For informa- (3) Records documenting compliance
tion on the availability of this mate- with the SE prevention measures, as
rial at NARA, call 202–741–6030, or go follows:
to: http://www.archives.gov/ (i) Biosecurity measures;
federallregister/ (ii) Rodent and other pest control
codeloflfederallregulation/ measures;
ibrllocations.html. (iii) Cleaning and disinfection proce-
dures performed at depopulation, when
[74 FR 33095, July 9, 2009, as amended at 81 applicable;
FR 5590, Feb. 3, 2016]
(iv) Refrigeration requirements;
§ 118.9 Administration of the Sal- (v) Environmental and egg sampling
monella Enteritidis (SE) prevention procedures, when applicable, performed
plan. under § 118.7;
(vi) Results of SE testing, when ap-
You must have one or more super- plicable, performed under § 118.8 as re-
visory personnel, who do not have to be quired in §§ 118.4(a)(2), 118.5, and 118.6;
on-site employees, to be responsible for (vii) Diversion of eggs, if applicable,
ensuring compliance with each farm’s as required in § 118.6; and
SE prevention plan. This person must (viii) Eggs at a particular farm being
have successfully completed training given a treatment as defined in § 118.3,
on SE prevention measures for egg pro- if you are a producer complying with
duction that is equivalent to that re- the requirements of this section as de-
ceived under a standardized curriculum scribed in § 118.1(a)(2).
recognized by the Food and Drug Ad- (4) Records of review and of modifica-
ministration or must be otherwise tions of the SE prevention plan and
qualified through job experience to ad- corrective actions taken.
minister the SE prevention measures. (b) General requirements for records
Job experience will qualify this person maintained by shell egg producers. All
to perform these functions if it has pro- records required by § 118.10(a) must in-
vided knowledge at least equivalent to clude:
that provided through the standardized (1) Your name and the location of
curriculum. This person is responsible your farm,
for: (2) The date and time of the activity
(a) Development and implementation that the record reflects,
of an SE prevention plan that is appro- (3) The signature or initials of the
priate for your specific farm and meets person performing the operation or cre-
the requirements of § 118.4; ating the record. The written SE pre-
(b) Reassessing and modifying the SE vention plan must be dated and carry
prevention plan as necessary to ensure the signature(s) (not initials) of the
that the requirements in § 118.4 are person(s) who administers the plan as
met; and described in § 118.9, and
(c) Review of records created under (4) Data and information reflecting
§ 118.10. This person does not need to compliance activities must be entered
have performed the monitoring or cre- on records at the time the activity is
ated the records. performed or observed, and the records
must contain the actual values ob-
§ 118.10 Recordkeeping requirements served, if applicable.
for the Salmonella Enteritidis (SE) (c) Length of time records must be re-
prevention plan.
tained. You must retain all records re-
(a) Records: You must maintain the quired by this part at your place of
following records documenting your SE business, unless stored offsite under
prevention measures: § 118.10(d), for 1 year after the flock to

(1) A written SE prevention plan re- which they pertain has been taken per-
quired by § 118.4; manently out of production.
410
(d) Offsite storage of records. You may of the methods described in paragraph
store the records required by this part, (b)(1) of this section, an individual au-
except for the written SE prevention thorized by the owner or operator of a
plan, offsite. You must be able to re- farm, such as an agent in charge, may
trieve and provide the records at your register by mail or fax.
place of business within 24 hours of re- (i) You must register using FDA
quest for official review. Electronic Form No. 3733. You may obtain a copy
records are considered to be onsite if of this form by writing to the U.S.
they are accessible from an onsite loca- Food and Drug Administration, 5600
tion. Fishers Lane (HFS–681), Rockville, MD
(e) Official review of records. You must 20857, or by requesting the form by
have all records required by this part phone at 1–800–216–7331 or 301–575–0156.
available for official review and copy- (ii) When you receive the form, you
ing at reasonable times. must fill it out completely and legibly
(f) Public disclosure of records. Records and either mail it to the address in
required by this part are subject to the paragraph (b)(2)(i) of this section or fax
disclosure requirements under part 20 it to the number on the form.
of this chapter. (iii) If any required information on
the form is incomplete or illegible
§ 118.11 Registration requirements for when FDA receives it, FDA will return
shell egg producers covered by the the form to you for revision, provided
requirements of this part. that your mailing address or fax num-
(a) Shell egg producers covered under ber is legible and valid. When returning
§ 118.1(a) are required to register their a registration form for revision, FDA
farms with FDA within 30 days of be- will use the means by which the form
coming an egg producer or, if already was received by the agency (i.e., by
an egg producer, by each farm’s appli- mail or fax).
cable compliance date. (iv) FDA will enter complete and leg-
(b) Shell egg producers may register ible mailed and faxed registration sub-
their farms by any of the following missions into its registration system,
means: along with CD–ROM submissions, as
(1) Electronic registration. To register soon as practicable, in the order FDA
electronically, you must register at receives them.
http://www.access.fda.gov, which will be (v) FDA will then mail to the address
available for registration 24 hours a or fax to the fax number on the reg-
day, 7 days a week beginning May 10, istration form a copy of the registra-
2010. This Web site is available from tion as entered, confirmation of reg-
wherever the Internet is accessible, in- istration, and your registration num-
cluding libraries, copy centers, schools, ber. When responding to a registration
and Internet cafes. submission, FDA will use the means by
(i) An individual authorized by the which the registration was received by
owner or operator of a farm, such as an the agency (i.e., by mail or fax).
agent in charge, may also register a (vi) If any information you pre-
farm electronically. viously submitted was incorrect at the
(ii) FDA strongly encourages elec- time of submission, you must imme-
tronic registration for the benefit of diately update your facility’s registra-
both FDA and the registrant. tion. If any information you previously
(iii) Once you complete your elec- submitted that was correct at the time
tronic registration, FDA will auto- of submission subsequently changes,
matically provide you with an elec- you must update your facility’s reg-
tronic confirmation of registration and istration within 60 calendar days.
a permanent registration number. (vii) Your facility is considered reg-
(iv) You will be considered registered istered once FDA enters your facility’s
once FDA electronically transmits registration data into the registration
your confirmation and registration system and the system generates a reg-
number. istration number.
(2) Registration by mail or by fax. If, (3) Registration by CD–ROM for mul-
for example, you do not have reason- tiple submissions. If, for example, you do
able access to the Internet through any not have reasonable access to the
411
§ 118.12 21 CFR Ch. I (4–1–16 Edition)
Internet through any of the methods system and the system generates a reg-
provided under paragraph (b)(1) of this istration number.
section, you may register by CD–ROM. (c) No registration fee is required.
(i) Registrants submitting their reg- (d) You must submit all registration
istrations in CD–ROM format must use information in the English language.
ISO 9660 (CD–R or CD–RW) data format. All information must be submitted
(ii) These files must be submitted on using the Latin (Roman) alphabet.
a portable document format (PDF) ren- (e) Each registrant must submit the
dition of the registration form (FDA following information through one of
Form No. 3733) and be accompanied by the methods described in paragraph (b)
one signed copy of the certification of this section:
statement that appears on the registra- (1) The name, full address, and phone
tion form. number of the farm; and
(2) The average or usual number of
(iii) Each submission on the CD–ROM
layers of each house and number of
must contain the same preferred mail-
poultry houses on the farm.
ing address in the appropriate block on
(3) A statement in which the shell
FDA Form No. 3733.
egg producer certifies that the infor-
(iv) A CD–ROM may contain registra- mation submitted is true and accurate.
tions for as many facilities as needed If the individual submitting the form is
up to the CD–ROM’s capacity. not the shell egg producer in charge of
(v) The registration on the CD–ROM the farm, the registration must also in-
for each separate facility must have a clude a statement in which the indi-
unique file name up to 32 characters vidual certifies that the information
long, the first part of which may be submitted is true and accurate, cer-
used to identify the parent company. tifies that he/she is authorized to sub-
(vi) You must mail the CD–ROM to mit registration, and identifies by
the U.S. Food and Drug Administra- name, address, and telephone number,
tion, 5600 Fishers Lane (HFS–681), the individual who authorized submis-
Rockville, MD 20857. sion of the registration. Each registra-
(vii) If FDA receives a CD–ROM that tion must include the name of the indi-
does not comply with these specifica- vidual registering the farm submitting
tions, it will return the CD–ROM to the the registration, and the individual’s
submitter unprocessed. signature (for paper and CD–ROM op-
(viii) FDA will enter CD–ROM sub- tions).
missions that comply with these speci- (f) Registered egg producers must
fications into its registration system, submit an update to a registration
along with the complete and legible within 60-calendar days of any change
mailed and faxed submissions, as soon to any of the information previously
as practicable, in the order FDA re- submitted by any of the means as pro-
ceives them. vided in § 118.11(b).
(ix) For each facility on the CD– (g) Registered egg producers must no-
ROM, FDA will mail to the preferred tify FDA within 120 days of ceasing egg
mailing address a copy of the registra- production by completing sections 1b,
tion(s) as entered, confirmation of reg- 1c, and 2 of Form 3733. This notifica-
istration, and each facility’s assigned tion is not required if you are a sea-
registration number. sonal egg producer or you temporarily
(x) If any information you previously cease operation due to labor disputes,
submitted was incorrect at the time of fire, natural disasters, or other tem-
submission, you must immediately up- porary conditions.
date your facility’s registration. If any [74 FR 33095, July 9, 2009, as amended at 75
information you previously submitted FR 18751, Apr. 13, 2010]
that was correct at the time of submis-
sion subsequently changes, you must § 118.12 Enforcement and compliance.
update your facility’s registration (a) Authority. This part is established
within 60 calendar days. under authority of the Public Health
(xi) Your facility is considered reg- Service Act (the PHS Act). Under the
istered once FDA enters your facility’s FFDCA, the Food and Drug Adminis-
registration data into the registration tration (FDA) can enforce the food
412
adulteration provisions under 21 U.S.C. (B) A detailed description of the facts

331 through 334 and 342. Under the PHS that justify the issuance of the order;
Act (42 U.S.C. 264), FDA has the au- (C) The location of the eggs;
thority to make and enforce regula- (D) A statement that these eggs must
tions for the control of communicable not be sold, distributed, or otherwise
diseases. FDA has established the fol- disposed of or moved except as pro-
lowing administrative enforcement vided in paragraph (a)(1)(iv) of this sec-
procedures for the diversion or destruction;
tion of shell eggs and for informal
(E) Identification or description of
hearings under the PHS Act:
the eggs;
(1) Upon a finding that any shell eggs
have been produced or held in violation (F) The order number;
of this part, an authorized FDA rep- (G) The date of the order;
resentative or a State or local rep- (H) The text of this entire section;
resentative in accordance with para- (I) A statement that the order may
graph (c) of this section may order be appealed by written appeal or by re-
such eggs to be diverted, under the su- questing an informal hearing;
pervision of said representative, for (J) The name and phone number of
processing in accordance with the Egg the person issuing the order; and
Products Inspection Act (EPIA) (21 (K) The location and telephone num-
U.S.C. 1031 et seq.) or by a treatment ber of the office or agency issuing the
that achieves at least a 5-log destruc- order and the name of its Director.
tion of SE or destroyed by or under the (ii) Approval of District Director. An
supervision of an officer or employee of order, before issuance, must be ap-
FDA, or, if applicable, of the State or
proved by FDA’s District Director or
locality in accordance with the fol-
the Acting District Director. If prior
lowing procedures:
(i) Order for diversion or destruction written approval is not feasible, prior
under the PHS Act. Any district office oral approval must be obtained and
of FDA or any State or locality acting confirmed by written memorandum as
under paragraph (c) of this section, soon as possible.
upon finding shell eggs that have been (iii) Labeling or marking of shell eggs
produced or held in violation of this under order. An FDA, State, or local
regulation, may serve a written order representative issuing an order under
upon the person in whose possession paragraph (a)(1)(i) of this section must
the eggs are found requiring that the label or mark the shell eggs with offi-
eggs be diverted, under the supervision cial tags that include the following in-
of an officer or employee of the issuing formation:
entity, for processing in accordance (A) A statement that the shell eggs
with the EPIA (21 U.S.C. 1031 et seq.) or are detained in accordance with regula-
by a treatment that achieves at least a tions issued under section 361(a) of the
5-log destruction of SE or destroyed by PHS Act (42 U.S.C. 264(a)).
or under the supervision of the issuing (B) A statement that the shell eggs
entity, within 10-working days from must not be sold, distributed or other-
the date of receipt of the order, unless, wise disposed of or moved except, after
under paragraph (a)(2)(iii) of this sec- notifying the issuing entity in writing,
tion, a hearing is held, in which case
to:
the eggs must be diverted or destroyed
(1) Divert them for processing in ac-
consistent with the decision of the Re-
gional Food and Drug Director under cordance with the EPIA or by a treat-
paragraph (a)(2)(v) of this section. The ment that achieves at least a 5-log de-
order must include the following infor- struction of SE or destroy them or
mation: (2) Move them to another location for
(A) A statement that the shell eggs holding pending appeal.
identified in the order are subject to di- (C) A statement that the violation of
version for processing in accordance the order or the removal or alteration
with the EPIA or by a treatment that of the tag is punishable by fine or im-
achieves at least a 5-log destruction of prisonment or both (section 368 of the
SE or destruction; PHS Act (42 U.S.C. 271)).
413
§ 118.12 21 CFR Ch. I (4–1–16 Edition)
(D) The order number and the date of will be given to the parties explaining
the order, and the name of the govern- the reason for denial.
ment representative who issued the (iii) Informal hearing. Appearance by
order. any appellant at the hearing may be by
(iv) Sale or other disposition of shell mail or in person, with or without
eggs under order. After service of the counsel. The informal hearing must be
order, the person in possession of the conducted by the Regional Food and
shell eggs that are the subject of the Drug Director or his designee, and a
order must not sell, distribute, or oth- written summary of the proceedings
erwise dispose of or move any eggs sub- must be prepared by the Regional Food
ject to the order unless and until re- and Drug Director.
ceiving a notice that the order is with- (A) The Regional Food and Drug Di-
drawn after an appeal except, after no- rector may direct that the hearing be
tifying FDA’s district office or, if ap- conducted in any suitable manner per-
plicable, the State or local representa- mitted by law and by this section. The
tive, in writing, to: Regional Food and Drug Director has
(A) Divert or destroy them as speci- the power to take such actions and
fied in paragraph (a)(1)(i) of this sec- make such rulings as are necessary or
tion, or appropriate to maintain order and to
(B) Move them to another location conduct an informal, fair, expeditious,
for holding pending appeal. and impartial hearing, and to enforce
(2) The person on whom the order for the requirements concerning the con-
diversion or destruction is served may duct of hearings.
either comply with the order or appeal (B) Employees of FDA will first give
the order to the Regional Food and a full and complete statement of the
Drug Director in accordance with the action that is the subject of the hear-
following procedures: ing, together with the information and
(i) Appeal of a detention order. Any ap- reasons supporting it, and may present
peal must be submitted in writing to oral or written information relevant to
FDA’s District Director in whose dis- the hearing. The party requesting the
trict the shell eggs are located within hearing may then present oral or writ-
5-working days of the issuance of the ten information relevant to the hear-
order. If the appeal includes a request ing. All parties may conduct reason-
for an informal hearing, the hearing able examination of any person (except
must be held within 5-working days for the presiding officer and counsel for
after the appeal is filed or, if requested the parties) who makes any statement
by the appellant, at a later date, which on the matter at the hearing.
must not be later than 20-calendar days (C) The hearing shall be informal in
after the issuance of the order. The nature, and the rules of evidence do not
order may also be appealed within the apply. No motions or objections relat-
same period of 5-working days by any ing to the admissibility of information
other person having an ownership or and views will be made or considered,
proprietary interest in such shell eggs. but any party may comment upon or
The appellant of an order must state rebut any information and views pre-
the ownership or proprietary interest sented by another party.
the appellant has in the shell eggs. (D) The party requesting the hearing
(ii) Summary decision. A request for a may have the hearing transcribed, at
hearing may be denied, in whole or in the party’s expense, in which case a
part and at any time after a request for copy of the transcript is to be fur-
a hearing has been submitted, if the nished to FDA. Any transcript of the
Regional Food and Drug Director or his hearing will be included with the Re-
or her designee determines that no gen- gional Food and Drug Director’s report
uine and substantial issue of fact has of the hearing.
been raised by the material submitted (E) The Regional Food and Drug Di-
in connection with the hearing or from rector must prepare a written report of
matters officially noticed. If the Re- the hearing. All written material pre-
gional Food and Drug Director deter- sented at the hearing will be attached
mines that a hearing is not justified, to the report. Whenever time permits,
written notice of the determination the Regional Food and Drug Director
414
may give the parties the opportunity employee to divert or destroy such
to review and comment on the report eggs. It shall be unlawful to prevent or
of the hearing. to attempt to prevent such diversion or
(F) The Regional Food and Drug Di- destruction of the shell eggs by the
rector must include as part of the re- designated officer or employee.
port of the hearing a finding on the (b) Inspection. Persons engaged in
credibility of witnesses (other than ex- production of shell eggs must permit
pert witnesses) whenever credibility is authorized representatives of FDA to
a material issue, and must include a make, at any reasonable time, an in-
recommended decision, with a state- spection of the egg production estab-
ment of reasons. lishment in which shell eggs are being
(iv) Written appeal. If the appellant produced. Such inspection includes the
appeals the detention order but does inspection and sampling of shell eggs
not request a hearing, the Regional and the environment, the equipment
Food and Drug Director must render a related to production of shell eggs, the
decision on the appeal affirming or re- equipment in which shell eggs are held,
voking the detention order within 5- and examination and copying of any
working days after the receipt of the records relating to such equipment or
appeal. eggs, as may be necessary in the judg-
(v) Regional Food and Drug Director ment of such representatives to deter-
decision. If, based on the evidence pre- mine compliance with the provisions of
sented at the hearing or by the appel- this section. Inspections may be made
lant in a written appeal, the Regional
with or without notice and will ordi-
Food and Drug Director finds that the
narily be made during regular business
shell eggs were produced or held in vio-
hours.
lation of this section, he must affirm
the order that they be diverted, under (c) State and local cooperation. Under
the supervision of an officer or em- sections 311 and 361 of the Public
ployee of FDA for processing under the Health Service Act, any State or local-
EPIA or by a treatment that achieves ity that is willing and able to assist
at least a 5-log destruction of SE or de- the agency in the enforcement of
stroyed by or under the supervision of §§ 118.4 through 118.10, and is authorized
an officer or employee of FDA; other- to inspect or regulate egg production
wise, the Regional Food and Drug Di- establishments, may, in its own juris-
rector must issue a written notice that diction, enforce §§ 118.4 through 118.10
the prior order is withdrawn. If the Re- through inspections under paragraph
gional Food and Drug Director affirms (b) of this section and through adminis-
the order, he must order that the diver- trative enforcement remedies specified
sion or destruction be accomplished in paragraph (a) of this section unless
within 10-working days from the date FDA notifies the State or locality in
of the issuance of his decision. The Re- writing that such assistance is no
gional Food and Drug Director’s deci- longer needed. A state or locality may
sion must be accompanied by a state- substitute, where necessary, appro-
ment of the reasons for the decision. priate State or local officials for des-
The decision of the Regional Food and ignated FDA officials in this section.
Drug Director constitutes final agency When providing assistance under para-
action, subject to judicial review. graph (a) of this section, a State or lo-
(vi) No appeal. If there is no appeal of cality may follow the hearing proce-
the order and the person in possession dures set out in paragraphs (a)(2)(iii)
of the shell eggs that are subject to the through (a)(2)(v) of this section, or may
order fails to divert or destroy them utilize comparable State or local hear-
within 10-working days, or if the de- ing procedures if such procedures sat-
mand is affirmed by the Regional Food isfy due process.
and Drug Director after an appeal and (d) Preemption. No State or local gov-
the person in possession of such eggs erning entity shall establish, or con-
fails to divert or destroy them within tinue in effect any law, rule, regula-
10-working days, FDA’s district office tion, or other requirement regarding

or, if applicable, the State or local rep- prevention of SE in shell eggs during
resentative may designate an officer or production, storage, or transportation
415
that is less stringent than those re- Subpart A—General Provisions

quired by this part.
§ 120.1 Applicability.
PART 119—DIETARY SUPPLEMENTS (a) Any juice sold as such or used as
THAT PRESENT A SIGNIFICANT OR an ingredient in beverages shall be
UNREASONABLE RISK processed in accordance with the re-
quirements of this part. Juice means
the aqueous liquid expressed or ex-
AUTHORITY: 21 U.S.C. 321, 342, 343, 371. tracted from one or more fruits or
vegetables, purees of the edible por-
§ 119.1 Dietary supplements con- tions of one or more fruits or vegeta-
taining ephedrine alkaloids. bles, or any concentrates of such liquid
Dietary supplements containing or puree. The requirements of this part
ephedrine alkaloids present an unrea- shall apply to any juice regardless of
sonable risk of illness or injury under whether the juice, or any of its ingredi-
conditions of use recommended or sug- ents, is or has been shipped in inter-
gested in the labeling, or if no condi- state commerce (as defined in section
tions of use are recommended or sug- 201(b) of the Federal Food, Drug, and
gested in the labeling, under ordinary Cosmetic Act, 21 U.S.C. 321(b)). Raw ag-
conditions of use. Therefore, dietary ricultural ingredients of juice are not
supplements containing ephedrine subject to the requirements of this
alkaloids are adulterated under section part. Processors should apply existing
402(f)(1)(A) of the Federal Food, Drug, agency guidance to minimize microbial
and Cosmetic Act. food safety hazards for fresh fruits and
vegetables in handling raw agricultural
[69 FR 6853, Feb. 11, 2004] products.
(b) The regulations in this part shall
PART 120—HAZARD ANALYSIS AND be effective January 22, 2002. However,
CRITICAL CONTROL POINT by its terms, this part is not binding on
(HACCP) SYSTEMS small and very small businesses until
the dates listed in paragraphs (b)(1) and
Subpart A—General Provisions (b)(2) of this section.
(1) For small businesses employing
Sec. fewer than 500 persons the regulations
120.1 Applicability. in this part are binding on January 21,
120.3 Definitions. 2003.
120.5 Current good manufacturing practice. (2) For very small businesses that
120.6 Sanitation standard operating proce- have either total annual sales of less
dures. than $500,000, or if their total annual
120.7 Hazard analysis. sales are greater than $500,000 but their
120.8 Hazard Analysis and Critical Control total food sales are less than $50,000; or
Point (HACCP) plan.
the person claiming this exemption
120.9 Legal basis.
employed fewer than an average of 100
120.10 Corrective actions.
full-time equivalent employees and
120.11 Verification and validation.
120.12 Records.
fewer than 100,000 units of juice were
120.13 Training. sold in the United States, the regula-
120.14 Application of requirements to im- tions are binding on January 20, 2004.
ported products.
§ 120.3 Definitions.
Subpart B—Pathogen Reduction The definitions of terms in section
201 of the Federal Food, Drug, and Cos-
120.20 General. metic Act, § 101.9(j)(18)(vi) of this chap-
120.24 Process controls.
ter, and parts 110 and 117 of this chap-
120.25 Process verification for certain proc-
essors.
ter are applicable to such terms when
used in this part, except that the defi-
AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348, nitions and terms in parts 110 and 117
371, 374, 379e, 381, 393; 42 U.S.C. 241, 242l, 264. do not govern such terms where such
SOURCE: 66 FR 6197, Jan. 19, 2001, unless terms are redefined in this part and ex-
otherwise noted. cept that the terms facility, hazard,
416
and manufacturing/processing in parts (2) For purposes of this part, proc-

110 and 117 do not govern such terms essing does not include:
where used in this part. The following (i) Harvesting, picking, or trans-
definitions shall also apply: porting raw agricultural ingredients of
(a) Cleaned means washed with water juice products, without otherwise en-
of adequate sanitary quality. gaging in processing; and
(b) Control means to prevent, elimi- (ii) The operation of a retail estab-
nate, or reduce. lishment.
(c) Control measure means any action (k) Processor means any person en-
or activity to prevent, reduce to ac- gaged in commercial, custom, or insti-
ceptable levels, or eliminate a hazard. tutional processing of juice products,
(d) Critical control point means a either in the United States or in a for-
point, step, or procedure in a food proc- eign country, including any person en-
ess at which a control measure can be gaged in the processing of juice prod-
applied and at which control is essen- ucts that are intended for use in mar-
tial to reduce an identified food hazard ket or consumer tests.
to an acceptable level. (l) Retail establishment is an operation
(e) Critical limit means the maximum that provides juice directly to the con-
or minimum value to which a physical, sumers and does not include an estab-
biological, or chemical parameter must lishment that sells or distributes juice
be controlled at a critical control point to other business entities as well as di-
to prevent, eliminate, or reduce to an rectly to consumers. ‘‘Provides’’ in-
acceptable level the occurrence of the cludes storing, preparing, packaging,
identified food hazard. serving, and vending.
(f) Culled means separation of dam- (m) Shall is used to state mandatory
aged fruit from undamaged fruit. For requirements.
processors of citrus juices using treat- (n) Shelf-stable product means a prod-
ments to fruit surfaces to comply with uct that is hermetically sealed and,
§ 120.24, culled means undamaged, tree- when stored at room temperature,
picked fruit that is U.S. Department of should not demonstrate any microbial
Agriculture choice or higher quality. growth.
(g) Food hazard means any biological, (o) Should is used to state rec-
chemical, or physical agent that is rea- ommended or advisory procedures or to
sonably likely to cause illness or in- identify recommended equipment.
(p) Validation means that element of
jury in the absence of its control.
verification focused on collecting and
(h) Importer means either the U.S.
evaluating scientific and technical in-
owner or consignee at the time of entry
formation to determine whether the
of a food product into the United
HACCP plan, when properly imple-
States, or the U.S. agent or representa-
mented, will effectively control the
tive of the foreign owner or consignee
identified food hazards.
at the time of entry into the United (q) Verification means those activi-
States. The importer is responsible for ties, other than monitoring, that es-
ensuring that goods being offered for tablish the validity of the HACCP plan
entry into the United States are in and that the system is operating ac-
compliance with all applicable laws. cording to the plan.
For the purposes of this definition, the
importer is ordinarily not the custom [66 FR 6197, Jan. 19, 2001, as amended at 80
house broker, the freight forwarder, FR 56167, Sept. 17, 2015]
the carrier, or the steamship represent-
§ 120.5 Current good manufacturing
ative. practice.
(i) Monitor means to conduct a
planned sequence of observations or Except as provided by § 117.5(c), parts
measurements to assess whether a 110 and 117 of this chapter apply in de-
process, point, or procedure is under termining whether the facilities, meth-
control and to produce an accurate ods, practices, and controls used to
record for use in verification. process juice are safe, and whether the
(j)(1) Processing means activities that food has been processed under sanitary
are directly related to the production conditions.
of juice products. [80 FR 56167, Sept. 17, 2015]
417
§ 120.6 21 CFR Ch. I (4–1–16 Edition)
§ 120.6 Sanitation standard operating (d) Relationship to Hazard Analysis

procedures. and Critical Control Point (HACCP) plan.
(a) Sanitation controls. Each processor Sanitation standard operating proce-
shall have and implement a sanitation dure controls may be included in the
standard operating procedure (SSOP) HACCP plan required under § 120.8(b).
that addresses sanitation conditions However, to the extent that they are
and practices before, during, and after implemented in accordance with this
processing. The SSOP shall address: section, they need not be included in
the HACCP plan.
(1) Safety of the water that comes
into contact with food or food contact [66 FR 6197, Jan. 19, 2001, as amended at 80
surfaces or that is used in the manufac- FR 56167, Sept. 17, 2015]
ture of ice;
(2) Condition and cleanliness of food § 120.7 Hazard analysis.
contact surfaces, including utensils, (a) Each processor shall develop, or
gloves, and outer garments; have developed for it, a written hazard
(3) Prevention of cross contamination analysis to determine whether there
from insanitary objects to food, food are food hazards that are reasonably
packaging material, and other food likely to occur for each type of juice
contact surfaces, including utensils, processed by that processor and to
gloves, and outer garments, and from identify control measures that the
raw product to processed product; processor can apply to control those
(4) Maintenance of hand washing, hazards. The written hazard analysis
hand sanitizing, and toilet facilities; shall consist of at least the following:
(5) Protection of food, food packaging (1) Identification of food hazards;
material, and food contact surfaces (2) An evaluation of each food hazard
from adulteration with lubricants, fuel, identified to determine if the hazard is
pesticides, cleaning compounds, sani- reasonably likely to occur and thus,
tizing agents, condensate, and other constitutes a food hazard that must be
chemical, physical, and biological con- addressed in the HACCP plan. A food
taminants; hazard that is reasonably likely to
(6) Proper labeling, storage, and use occur is one for which a prudent proc-
of toxic compounds; essor would establish controls because
(7) Control of employee health condi- experience, illness data, scientific re-
tions that could result in the micro- ports, or other information provide a
biological contamination of food, food basis to conclude that there is a rea-
packaging materials, and food contact sonable possibility that, in the absence
surfaces; and of those controls, the food hazard will
(8) Exclusion of pests from the food occur in the particular type of product
plant. being processed. This evaluation shall
(b) Monitoring. The processor shall include an assessment of the severity
monitor the conditions and practices of the illness or injury if the food haz-
during processing with sufficient fre- ard occurs;
quency to ensure, at a minimum, con- (3) Identification of the control meas-
formance with those conditions and ures that the processor can apply to
practices specified in part 110 of this control the food hazards identified as
chapter and in subpart B of part 117 of reasonably likely to occur in paragraph
this chapter that are appropriate both (a)(2) of this section;
to the plant and to the food being proc- (4) Review of the current process to
essed. Each processor shall correct, in determine whether modifications are
a timely manner, those conditions and necessary; and
practices that are not met. (5) Identification of critical control
(c) Records. Each processor shall points.
maintain SSOP records that, at a min- (b) The hazard analysis shall include
imum, document the monitoring and food hazards that can be introduced
corrections prescribed by paragraph (b) both within and outside the processing
of this section. These records are sub- plant environment, including food haz-
ject to the recordkeeping requirements ards that can occur before, during, and
of § 120.12. after harvest. The hazard analysis shall
418
be developed by an individual or indi- types of juice products together, or

viduals who have been trained in ac- group types of production methods to-
cordance with § 120.13 and shall be sub- gether, if the food hazards, critical con-
ject to the recordkeeping requirements trol points, critical limits, and proce-
of § 120.12. dures required to be identified and per-
(c) In evaluating what food hazards formed by paragraph (b) of this section
are reasonably likely to occur, consid- are essentially identical, provided that
eration should be given, at a minimum, any required features of the plan that
to the following: are unique to a specific product or
(1) Microbiological contamination; method are clearly delineated in the
(2) Parasites; plan and are observed in practice.
(3) Chemical contamination; (b) The contents of the HACCP plan.
(4) Unlawful pesticides residues; The HACCP plan shall, at a minimum:
(5) Decomposition in food where a (1) List all food hazards that are rea-
food hazard has been associated with sonably likely to occur as identified in
decomposition; accordance with § 120.7, and that thus
(6) Natural toxins; must be controlled for each type of
(7) Unapproved use of food or color product;
additives; (2) List the critical control points for
(8) Presence of undeclared ingredi- each of the identified food hazards that
ents that may be allergens; and is reasonably likely to occur, including
(9) Physical hazards. as appropriate:
(d) Processors should evaluate prod-
(i) Critical control points designed to
uct ingredients, processing procedures,
control food hazards that are reason-
packaging, storage, and intended use;
ably likely to occur and could be intro-
facility and equipment function and
duced inside the processing plant envi-
design; and plant sanitation, including
ronment; and
employee hygiene, to determine the po-
(ii) Critical control points designed
tential effect of each on the safety of
to control food hazards introduced out-
the finished food for the intended con-
side the processing plant environment,
sumer.
including food hazards that occur be-
(e) HACCP plans for juice need not
fore, during, and after harvest;
address the food hazards associated
with microorganisms and microbial (3) List the critical limits that shall
toxins that are controlled by the re- be met at each of the critical control
quirements of part 113 or part 114 of points;
this chapter. A HACCP plan for such (4) List the procedures, and the fre-
juice shall address any other food haz- quency with which they are to be per-
ards that are reasonably likely to formed, that will be used to monitor
occur. each of the critical control points to
ensure compliance with the critical
§ 120.8 Hazard Analysis and Critical limits;
Control Point (HACCP) plan. (5) Include any corrective action
(a) HACCP plan. Each processor shall plans that have been developed in ac-
have and implement a written HACCP cordance with § 120.10(a), and that are
plan whenever a hazard analysis re- to be followed in response to deviations
veals one or more food hazards that are from critical limits at critical control
reasonably likely to occur during proc- points;
essing, as described in § 120.7. The (6) List the validation and
HACCP plan shall be developed by an verification procedures, and the fre-
individual or individuals who have quency with which they are to be per-
been trained in accordance with § 120.13 formed, that the processor will use in
and shall be subject to the record- accordance with § 120.11; and
keeping requirements of § 120.12. A (7) Provide for a recordkeeping sys-
HACCP plan shall be specific to: tem that documents the monitoring of
(1) Each location where juice is proc- the critical control points in accord-
essed by that processor; and ance with § 120.12. The records shall
(2) Each type of juice processed by contain the actual values and observa-
the processor. The plan may group tions obtained during monitoring.
419
§ 120.9 21 CFR Ch. I (4–1–16 Edition)
(c) Sanitation. Sanitation controls fected product for distribution. The re-
may be included in the HACCP plan. view shall be performed by an indi-
However, to the extent that they are vidual or individuals who have ade-
monitored in accordance with § 120.6, quate training or experience to perform
they are not required to be included in such review;
the HACCP plan. (3) Take corrective action, when nec-
essary, with respect to the affected
§ 120.9 Legal basis. product to ensure that no product en-
Failure of a processor to have and to ters commerce that is either injurious
implement a Hazard Analysis and Crit- to health or is otherwise adulterated as
ical Control Point (HACCP) system a result of the deviation;
that complies with §§ 120.6, 120.7, and (4) Take corrective action, when nec-
120.8, or otherwise to operate in accord- essary, to correct the cause of the devi-
ance with the requirements of this ation; and
part, shall render the juice products of (5) Perform or obtain timely
that processor adulterated under sec- verification in accordance with § 120.11,
tion 402(a)(4) of the Federal Food, by an individual or individuals who
Drug, and Cosmetic Act. Whether a have been trained in accordance with
processor’s actions are consistent with § 120.13, to determine whether modifica-
ensuring the safety of juice will be de- tion of the HACCP plan is required to
termined through an evaluation of the reduce the risk of recurrence of the de-
processor’s overall implementation of viation, and to modify the HACCP plan
its HACCP system. as necessary.
(c) All corrective actions taken in ac-
§ 120.10 Corrective actions. cordance with this section shall be
Whenever a deviation from a critical fully documented in records that are
limit occurs, a processor shall take subject to verification in accordance
corrective action by following the pro- with § 120.11(a)(1)(iv)(B) and the record-
cedures set forth in paragraph (a) or keeping requirements of § 120.12.
paragraph (b) of this section.
(a) Processors may develop written § 120.11 Verification and validation.
corrective action plans, which become (a) Verification. Each processor shall
part of their HACCP plans in accord- verify that the Hazard Analysis and
ance with § 120.8(b)(5), by which proc- Critical Control Point (HACCP) system
essors predetermine the corrective ac- is being implemented according to de-
tions that they will take whenever sign.
there is a deviation from a critical (1) Verification activities shall in-
limit. A corrective action plan that is clude:
appropriate for a particular deviation (i) A review of any consumer com-
is one that describes the steps to be plaints that have been received by the
taken and assigns responsibility for processor to determine whether such
taking those steps, to ensure that: complaints relate to the performance
(1) No product enters commerce that of the HACCP plan or reveal previously
is either injurious to health or is other- unidentified critical control points;
wise adulterated as a result of the devi- (ii) The calibration of process moni-
ation; and toring instruments;
(2) The cause of the deviation is cor- (iii) At the option of the processor,
rected. the performance of periodic end-prod-
(b) When a deviation from a critical uct or in-process testing; except that
limit occurs, and the processor does processors of citrus juice that rely in
not have a corrective action plan that whole or in part on surface treatment
is appropriate for that deviation, the of fruit shall perform end-product test-
processor shall: ing in accordance with § 120.25.
(1) Segregate and hold the affected (iv) A review, including signing and
product, at least until the require- dating, by an individual who has been
ments of paragraphs (b)(2) and (b)(3) of trained in accordance with § 120.13, of
this section are met; the records that document:

(2) Perform or obtain a review to de- (A) The monitoring of critical con-
termine the acceptability of the af- trol points. The purpose of this review
420
shall be, at a minimum, to ensure that product distribution systems; or the in-
the records are complete and to verify tended use or consumers of the finished
that the records document values that product. The validation shall be per-
are within the critical limits. This re- formed by an individual or individuals
view shall occur within 1 week (7 days) who have been trained in accordance
of the day that the records are made; with § 120.13 and shall be subject to the
(B) The taking of corrective actions. recordkeeping requirements of § 120.12.
The purpose of this review shall be, at The HACCP plan shall be modified im-
a minimum, to ensure that the records mediately whenever a validation re-
are complete and to verify that appro- veals that the plan is no longer ade-
priate corrective actions were taken in quate to fully meet the requirements of
accordance with § 120.10. This review this part.
shall occur within 1 week (7 days) of (c) Validation of the hazard analysis.
the day that the records are made; and Whenever a juice processor has no
(C) The calibrating of any process HACCP plan because a hazard analysis
monitoring instruments used at crit- has revealed no food hazards that are
ical control points and the performance reasonably likely to occur, the proc-
of any periodic end-product or in-processor shall reassess the adequacy of
ess testing that is part of the proc- that hazard analysis whenever there
essor’s verification activities. The pur- are any changes in the process that
pose of these reviews shall be, at a min- could reasonably affect whether a food
imum, to ensure that the records are hazard exists. Such changes may in-
complete and that these activities oc- clude changes in the following: Raw
curred in accordance with the proc- materials or source of raw materials;
essor’s written procedures. These re- product formulation; processing meth-
views shall occur within a reasonable ods or systems, including computers
time after the records are made; and and their software; packaging; finished
(v) The following of procedures in product distribution systems; or the in-
§ 120.10 whenever any verification pro- tended use or intended consumers of
cedure, including the review of con- the finished product. The validation of
sumer complaints, establishes the need the hazard analysis shall be performed
to take a corrective action; and by an individual or individuals who
(vi) Additional process verification if have been trained in accordance with
required by § 120.25. § 120.13, and, records documenting the
(2) Records that document the cali- validation shall be subject to the rec-
bration of process monitoring instru- ordkeeping requirements of § 120.12.
ments, in accordance with paragraph
(a)(1)(iv)(B) of this section, and the per- § 120.12 Records.
formance of any periodic end-product (a) Required records. Each processor
and in-process testing, in accordance shall maintain the following records
with paragraph (a)(1)(iv)(C) of this sec- documenting the processor’s Hazard
tion, are subject to the recordkeeping Analysis and Critical Control Point
requirements of § 120.12. (HACCP) system:
(b) Validation of the HACCP plan. (1) Records documenting the imple-
Each processor shall validate that the mentation of the sanitation standard
HACCP plan is adequate to control operating procedures (SSOP’s) (see
food hazards that are reasonably likely § 120.6);
to occur; this validation shall occur at (2) The written hazard analysis re-
least once within 12 months after im- quired by § 120.7;
plementation and at least annually (3) The written HACCP plan required
thereafter or whenever any changes in by § 120.8;
the process occur that could affect the (4) Records documenting the ongoing
hazard analysis or alter the HACCP application of the HACCP plan that in-
plan in any way. Such changes may include:
clude changes in the following: Raw (i) Monitoring of critical control
materials or source of raw materials; points and their critical limits, includ-
product formulation; processing meth- ing the recording of actual times, tem-
ods or systems, including computers peratures, or other measurements, as
and their software; packaging; finished prescribed in the HACCP plan; and
421
§ 120.13 21 CFR Ch. I (4–1–16 Edition)
(ii) Corrective actions, including all the monitoring occurred, if such

actions taken in response to a devi- records can be retrieved and provided
ation; and onsite within 24 hours of request for of-
(5) Records documenting verification ficial review. Electronic records are
of the HACCP system and validation of considered to be onsite if they are ac-
the HACCP plan or hazard analysis, as cessible from an onsite location and
appropriate. comply with paragraph (g) of this sec-
(b) General requirements. All records tion.
required by this part shall include: (3) If the processing facility is closed
(1) The name of the processor or im- for a prolonged period between sea-
porter and the location of the processor sonal packs, the records may be trans-
or importer, if the processor or im- ferred to some other reasonably acces-
porter has more than one location; sible location at the end of the sea-
(2) The date and time of the activity sonal pack but shall be immediately
that the record reflects, except that returned to the processing facility for
records required by paragraphs (a)(2), official review upon request.
(a)(3), and (a)(5) of this section need not (e) Official review. All records re-
include the time; quired by this part shall be available
(3) The signature or initials of the for review and copying at reasonable
person performing the operation or cre- times.
ating the record; and (f) Public disclosure. (1) All records re-
(4) Where appropriate, the identity of quired by this part are not available
the product and the production code, if for public disclosure unless they have
any. Processing and other information been previously disclosed to the public,
shall be entered on records at the time as defined in § 20.81 of this chapter, or
that it is observed. The records shall unless they relate to a product or in-
contain the actual values and observa- gredient that has been abandoned and
tions obtained during monitoring. no longer represent a trade secret or
(c) Documentation. (1) The records in confidential commercial or financial
paragraphs (a)(2) and (a)(3) of this sec- information as defined in § 20.61 of this
tion shall be signed and dated by the chapter.
most responsible individual onsite at (2) Records required to be maintained
the processing facility or by a higher by this part are subject to disclosure to
level official of the processor. These the extent that they are otherwise pub-
signatures shall signify that these licly available, or that disclosure could
records have been accepted by the firm. not reasonably be expected to cause a
(2) The records in paragraphs (a)(2) competitive hardship, such as generic
and (a)(3) of this section shall be signed type HACCP plans that reflect stand-
and dated: ard industry practices.
(i) Upon initial acceptance; (g) Records maintained on computers.
(ii) Upon any modification; and The maintenance of computerized
(iii) Upon verification and validation records, in accordance with part 11 of
in accordance with § 120.11. this chapter, is acceptable.
(d) Record retention. (1) All records re-
quired by this part shall be retained at § 120.13 Training.
the processing facility or at the im- (a) Only an individual who has met
porter’s place of business in the United the requirements of paragraph (b) of
States for, in the case of perishable or this section shall be responsible for the
refrigerated juices, at least 1 year after following functions:
the date that such products were pre- (1) Developing the hazard analysis,
pared, and for, in the case of frozen, including delineating control meas-
preserved, or shelf stable products, 2 ures, as required by § 120.7.
years or the shelf life of the product, (2) Developing a Hazard Analysis and
whichever is greater, after the date Critical Control Point (HACCP) plan
that the products were prepared. that is appropriate for a specific proc-
(2) Offsite storage of processing essor, in order to meet the require-
records required by paragraphs (a)(1) ments of § 120.8;

and (a)(4) of this section is permitted (3) Verifying and modifying the
after 6 months following the date that HACCP plan in accordance with the
422
corrective action procedures specified were processed under controls that

in § 120.10(b)(5) and the validation ac- meet the requirements of this part.
tivities specified in §§ 120.11(b) and (c); These steps may include any of the fol-
and 120.7; lowing:
(4) Performing the record review re- (A) Obtaining from the foreign proc-
quired by § 120.11(a)(1)(iv). essor the Hazard Analysis and Critical
(b) The individual performing the Control Point (HACCP) plan and pre-
functions listed in paragraph (a) of this requisite program of the standard oper-
section shall have successfully com- ating procedure records required by
pleted training in the application of this part that relate to the specific lot
HACCP principles to juice processing of food being offered for import;
at least equivalent to that received (B) Obtaining either a continuing or
under standardized curriculum recog- lot specific certificate from an appro-
nized as adequate by the Food and priate foreign government inspection
Drug Administration, or shall be other- authority or competent third party
wise qualified through job experience certifying that the imported food has
to perform these functions. Job experi- been processed in accordance with the
ence may qualify an individual to per- requirements of this part;
form these functions if such experience (C) Regularly inspecting the foreign
has provided knowledge at least equiv- processor’s facilities to ensure that the
alent to that provided through the imported food is being processed in ac-
standardized curriculum. The trained cordance with the requirements of this
individual need not be an employee of part;
the processor. (D) Maintaining on file a copy, in
English, of the foreign processor’s haz-
§ 120.14 Application of requirements to ard analysis and HACCP plan, and a
imported products. written guarantee from the foreign
This section sets forth specific re- processor that the imported food is
quirements for imported juice. processed in accordance with the re-
(a) Importer requirements. Every im- quirements of this part;
porter of juice shall either: (E) Periodically testing the imported
(1) Obtain the juice from a country food, and maintaining on file a copy, in
that has an active memorandum of un- English, of a written guarantee from
derstanding (MOU) or similar agree- the foreign processor that the imported
ment with the Food and Drug Adminis- food is processed in accordance with
tration, that covers the food and docu- the requirements of this part; or
ments the equivalency or compliance (F) Other such verification measures
of the inspection system of the foreign as appropriate that provide an equiva-
country with the U.S. system, accu- lent level of assurance of compliance
rately reflects the relationship be- with the requirements of this part.
tween the signing parties, and is func- (b) Competent third party. An importer
tioning and enforceable in its entirety; may hire a competent third party to
or assist with or perform any or all of the
(2) Have and implement written pro- verification activities specified in para-
cedures for ensuring that the juice that graph (a)(2) of this section, including
such importer receives for import into writing the importer’s verification pro-
the United States was processed in ac- cedures on the importer’s behalf.
cordance with the requirements of this (c) Records. The importer shall main-
part. The procedures shall provide, at a tain records, in English, that document
minimum: the performance and results of the af-
(i) Product specifications that are de- firmative steps specified in paragraph
signed to ensure that the juice is not (a)(2)(ii) of this section. These records
adulterated under section 402 of the shall be subject to the applicable provi-
Federal Food, Drug, and Cosmetic Act sions of § 120.12.
because it may be injurious to health (d) Determination of compliance. The
or because it may have been processed importer shall provide evidence that
under insanitary conditions; and all juice offered for entry into the
(ii) Affirmative steps to ensure that United States has been processed under
the products being offered for entry conditions that comply with this part.
423
§ 120.20 21 CFR Ch. I (4–1–16 Edition)
If assurances do not exist that an im- of this section and perform final prod-
ported juice has been processed under uct packaging within a single produc-
conditions that are equivalent to those tion facility operating under current
required of domestic processors under good manufacturing practices. Proc-
this part, the product will appear to be essors claiming an exemption under
adulterated and will be denied entry. paragraph (a)(1) or (a)(2) of this section
shall also process and perform final
Subpart B—Pathogen Reduction product packaging of all juice subject
to the claimed exemption within a sin-
§ 120.20 General. gle production facility operating under
This subpart augments subpart A of current good manufacturing practices.
this part by setting forth specific re-
quirements for process controls. § 120.25 Process verification for cer-
tain processors.
§ 120.24 Process controls. Each juice processor that relies on
(a) In order to meet the requirements treatments that do not come into di-
of subpart A of this part, processors of rect contact with all parts of the juice
juice products shall include in their to achieve the requirements of § 120.24
Hazard Analysis and Critical Control shall analyze the finished product for
Point (HACCP) plans control measures biotype I Escherichia coli as follows:
that will consistently produce, at a (a) One 20 milliliter (mL) sample
minimum, a 5 log (i.e., 105) reduction, (consisting of two 10 mL subsamples)
for a period at least as long as the shelf for each 1,000 gallons of juice produced
life of the product when stored under shall be sampled each production day.
normal and moderate abuse conditions, If less than 1,000 gallons of juice is pro-
in the pertinent microorganism. For duced per day, the sample must be
the purposes of this regulation, the taken for each 1,000 gallons produced
‘‘pertinent microorganism’’ is the most but not less than once every 5 working
resistant microorganism of public days that the facility is producing that
health significance that is likely to juice. Each subsample shall be taken
occur in the juice. The following juice
by randomly selecting a package of
processors are exempt from this para-
juice ready for distribution to con-
graph:
sumers.
(1) A juice processor that is subject
to the requirements of part 113 or part (b) If the facility is producing more
114 of this chapter; and than one type of juice covered by this
(2) A juice processor using a single section, processors shall take subsam-
thermal processing step sufficient to ples according to paragraph (a) of this
achieve shelf-stability of the juice or a section for each of the covered juice
thermal concentration process that in- products produced.
cludes thermal treatment of all ingre- (c) Processors shall analyze each sub-
dients, provided that the processor in- sample for the presence of E. coli by the
cludes a copy of the thermal process method entitled ‘‘Analysis for Esch-
used to achieve shelf-stability or con- erichia coli in Citrus Juices—Modifica-
centration in its written hazard anal- tion of AOAC Official Method 992.30’’ or
ysis required by § 120.7. another method that is at least equiva-
(b) All juice processors shall meet lent to this method in terms of accu-
the requirements of paragraph (a) of racy, precision, and sensitivity in de-
this section through treatments that tecting E. coli. This method is designed
are applied directly to the juice, except to detect the presence or absence of E.
that citrus juice processors may use coli in a 20 mL sample of juice (con-
treatments to fruit surfaces, provided sisting of two 10 mL subsamples). The
that the 5-log reduction process begins method is as follows:
after culling and cleaning as defined in (1) Sample size. Total-20 mL of juice;
§ 120.3(a) and (f) and the reduction is ac- perform analysis using two 10 mL
complished within a single production aliquots.
facility. (2) Media. Universal Preenrichment

(c) All juice processors shall meet the Broth (Difco, Detroit, MI), EC Broth
requirements of paragraphs (a) and (b) (various manufacturers).
424
(3) Method. ColiComplete (AOAC Offi- sive to determine that there are no
cial Method 992.30—modified). trends towards loss of control;
(4) Procedure. Perform the following (i) If the conditions and practices are
procedure two times: not being met, correct those that do
(i) Aseptically inoculate 10 mL of not conform to the HACCP plan; or
juice into 90 mL of Universal (ii) If the conditions and practices
Preenrichment Broth (Difco) and incu- are being met, the processor shall vali-
bate at 35 °C for 18 to 24 hours. date the HACCP plan in relation to the
(ii) Next day, transfer 1 mL of 5-log reduction standard; and
preenriched sample into 10 mL of EC (3) Take corrective action as set
Broth, without durham gas vials. After forth in § 120.10. Corrective actions
inoculation, aseptically add a shall include ensuring no product en-
ColiComplete SSD disc into each tube. ters commerce that is injurious to
(iii) Incubate at 44.5 °C for 18 to 24 health as set forth in § 120.10(a)(1).
hours.
(iv) Examine the tubes under PART 123—FISH AND FISHERY
longwave ultra violet light (366 nm). PRODUCTS
Fluorescent tubes indicate presence of
E. coli. Subpart A—General Provisions
(v) MUG positive and negative con-
trols should be used as reference in in- Sec.
terpreting fluorescence reactions. Use 123.3 Definitions.
an E. coli for positive control and 2 neg- 123.5 Current good manufacturing practice.
ative controls—a MUG negative strain 123.6 Hazard analysis and Hazard Analysis
Critical Control Point (HACCP) plan.
and an uninoculated tube media. 123.7 Corrective actions.
(d) If either 10 mL subsample is posi- 123.8 Verification.
tive for E. coli, the 20 mL sample is re- 123.9 Records.
corded as positive and the processor 123.10 Training.
shall: 123.11 Sanitation control procedures.
(1) Review monitoring records for the 123.12 Special requirements for imported
control measures to attain the 5-log re- products.
duction standard and correct those
Subpart B—Smoked and Smoke-Flavored
conditions and practices that are not
Fishery Products
met. In addition, the processor may
choose to test the sample for the pres- 123.15 General.
ence of pathogens of concern. 123.16 Process controls.
(2) If the review of monitoring
records or the additional testing indi- Subpart C—Raw Molluscan Shellfish
cates that the 5-log reduction standard 123.20 General.
was not achieved (e.g., a sample is 123.28 Source controls.
found to be positive for the presence of
AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348,
a pathogen or a deviation in the proc-
371, 374, 379e, 381, 393; 42 U.S.C. 241, 241l, 264.
ess or its delivery is identified), the
processor shall take corrective action SOURCE: 60 FR 65197, Dec. 18, 1995, unless
as set forth in § 120.10. otherwise noted.
(e) If two samples in a series of seven
tests are positive for E. coli, the control Subpart A—General Provisions
measures to attain the 5-log reduction
standard shall be deemed to be inad- § 123.3 Definitions.
equate and the processor shall imme- The definitions and interpretations
diately: of terms in section 201 of the Federal
(1) Until corrective actions are com- Food, Drug, and Cosmetic Act (the act)
pleted, use an alternative process or and in parts 110 and 117 of this chapter
processes that achieve the 5-log reduc- are applicable to such terms when used
tion after the juice has been expressed; in this part, except that the definitions
(2) Perform a review of the moni- and terms in parts 110 and 117 do not
toring records for control measures to govern such terms where such terms
attain the 5-log reduction standard. are redefined in this part and except
The review shall be sufficiently exten- that the terms facility, hazard, and
425
§ 123.3 21 CFR Ch. I (4–1–16 Edition)
manufacturing/processing in parts 110 (i) Preventive measure means physical,

and 117 do not govern such terms where chemical, or other factors that can be
used in this part. The following defini- used to control an identified food safe-
tions shall also apply: ty hazard.
(a) Certification number means a (j) Process-monitoring instrument
unique combination of letters and means an instrument or device used to
numbers assigned by a shellfish control indicate conditions during processing
authority to a molluscan shellfish at a critical control point.
processor. (k)(1) Processing means, with respect
(b) Critical control point means a to fish or fishery products: Handling,
point, step, or procedure in a food proc- storing, preparing, heading, evis-
ess at which control can be applied, cerating, shucking, freezing, changing
and a food safety hazard can as a result into different market forms, manufac-
be prevented, eliminated, or reduced to turing, preserving, packing, labeling,
acceptable levels. dockside unloading, or holding.
(c) Critical limit means the maximum (2) The regulations in this part do
or minimum value to which a physical, not apply to:
biological, or chemical parameter must (i) Harvesting or transporting fish or
be controlled at a critical control point fishery products, without otherwise en-
to prevent, eliminate, or reduce to an gaging in processing.
acceptable level the occurrence of the (ii) Practices such as heading, evis-
identified food safety hazard. cerating, or freezing intended solely to
(d) Fish means fresh or saltwater prepare a fish for holding on board a
finfish, crustaceans, other forms of harvest vessel.
aquatic animal life (including, but not (iii) The operation of a retail estab-
limited to, alligator, frog, aquatic tur- lishment.
tle, jellyfish, sea cucumber, and sea ur- (l) Processor means any person en-
chin and the roe of such animals) other gaged in commercial, custom, or insti-
than birds or mammals, and all mol- tutional processing of fish or fishery
lusks, where such animal life is in- products, either in the United States or
tended for human consumption. in a foreign country. A processing in-
(e) Fishery product means any human cludes any person engaged in the pro-
food product in which fish is a charac- duction of foods that are to be used in
terizing ingredient. market or consumer tests.
(f) Food safety hazard means any bio- (m) Scombroid toxin-forming species
logical, chemical, or physical property means tuna, bluefish, mahi mahi, and
that may cause a food to be unsafe for other species, whether or not in the
human consumption. family Scombridae, in which signifi-
(g) Importer means either the U.S. cant levels of histamine may be pro-
owner or consignee at the time of entry duced in the fish flesh by
into the United States, or the U.S. decarboxylation of free histidine as a
agent or representative of the foreign result of exposure of the fish after cap-
owner or consignee at the time of entry ture to temperatures that permit the
into the United States, who is respon- growth of mesophilic bacteria.
sible for ensuring that goods being of- (n) Shall is used to state mandatory
fered for entry into the United States requirements.
are in compliance with all laws affect- (o) Shellfish control authority means a
ing the importation. For the purposes Federal, State, or foreign agency, or
of this definition, ordinarily the im- sovereign tribal government, legally
porter is not the custom house broker, responsible for the administration of a
the freight forwarder, the carrier, or program that includes activities such
the steamship representative. as classification of molluscan shellfish
(h) Molluscan shellfish means any edi- growing areas, enforcement of
ble species of fresh or frozen oysters, molluscan shellfish harvesting con-
clams, mussels, or scallops, or edible trols, and certification of molluscan
portions of such species, except when shellfish processors.

the product consists entirely of the (p) Shellstock means raw, in-shell
shucked adductor muscle. molluscan shellfish.
426
(q) Should is used to state rec- dent processor would establish controls
ommended or advisory procedures or to because experience, illness data, sci-
identify recommended equipment. entific reports, or other information
(r) Shucked shellfish means molluscan provide a basis to conclude that there
shellfish that have one or both shells is a reasonable possibility that it will
removed. occur in the particular type of fish or
(s) Smoked or smoke-flavored fishery fishery product being processed in the
products means the finished food pre- absence of those controls.
pared by: (b) The HACCP plan. Every processor
(1) Treating fish with salt (sodium shall have and implement a written
chloride), and HACCP plan whenever a hazard anal-
(2) Subjecting it to the direct action ysis reveals one or more food safety
of smoke from burning wood, sawdust, hazards that are reasonably likely to
or similar material and/or imparting to occur, as described in paragraph (a) of
it the flavor of smoke by a means such this section. A HACCP plan shall be
as immersing it in a solution of wood specific to:
smoke. (1) Each location where fish and fish-
(t) Tag means a record of harvesting ery products are processed by that
information attached to a container of processor; and
shellstock by the harvester or proc- (2) Each kind of fish and fishery prod-
essor. uct processed by the processor. The
[60 FR 65197, Dec. 18, 1995, as amended at 80 plan may group kinds of fish and fish-
FR 56167, Sept. 17, 2015] ery products together, or group kinds
of production methods together, if the
§ 123.5 Current good manufacturing food safety hazards, critical control
practice. points, critical limits, and procedures
(a) Except as provided by § 117.5(b), required to be identified and performed
parts 110 and 117 of this chapter apply in paragraph (c) of this section are
in determining whether the facilities, identical for all fish and fishery prod-
methods, practices, and controls used ucts so grouped or for all production
to process fish and fishery products are methods so grouped.
safe, and whether these products have (c) The contents of the HACCP plan.
been processed under sanitary condi- The HACCP plan shall, at a minimum:
tions. (1) List the food safety hazards that
(b) The purpose of this part is to set are reasonably likely to occur, as iden-
forth requirements specific to the proc- tified in accordance with paragraph (a)
essing of fish and fishery products. of this section, and that thus must be
[60 FR 65197, Dec. 18, 1995, as amended at 80 controlled for each fish and fishery
FR 56167, Sept. 17, 2015] product. Consideration should be given
to whether any food safety hazards are
§ 123.6 Hazard analysis and Hazard reasonably likely to occur as a result
Analysis Critical Control Point of the following:
(HACCP) plan. (i) Natural toxins;
(a) Hazard analysis. Every processor (ii) Microbiological contamination;
shall conduct, or have conducted for it, (iii) Chemical contamination;
a hazard analysis to determine whether (iv) Pesticides;
there are food safety hazards that are (v) Drug residues;
reasonably likely to occur for each (vi) Decomposition in scombroid
kind of fish and fishery product proc- toxin-forming species or in any other
essed by that processor and to identify species where a food safety hazard has
the preventive measures that the proc- been associated with decomposition;
essor can apply to control those haz- (vii) Parasites, where the processor
ards. Such food safety hazards can be has knowledge or has reason to know
introduced both within and outside the that the parasite-containing fish or
processing plant environment, includ- fishery product will be consumed with-
ing food safety hazards that can occur out a process sufficient to kill the
before, during, and after harvest. A parasites, or where the processor rep-
food safety hazard that is reasonably resents, labels, or intends for the prod-
likely to occur is one for which a pru- uct to be so consumed;
427
§ 123.7 21 CFR Ch. I (4–1–16 Edition)
(viii) Unapproved use of direct or in- tion of Clostridium botulinum toxin in

direct food or color additives; and the finished, hermetically sealed con-
(ix) Physical hazards; tainer, nor list the controls to prevent
(2) List the critical control points for that food safety hazard. A HACCP plan
each of the identified food safety haz- for such fish and fishery products shall
ards, including as appropriate: address any other food safety hazards
(i) Critical control points designed to that are reasonably likely to occur.
control food safety hazards that could (f) Sanitation. Sanitation controls
be introduced in the processing plant may be included in the HACCP plan.
environment; and However, to the extent that they are
(ii) Critical control points designed monitored in accordance with § 123.11(b)
to control food safety hazards intro- they need not be included in the
duced outside the processing plant en- HACCP plan, and vice versa.
vironment, including food safety haz- (g) Legal basis. Failure of a processor
ards that occur before, during, and to have and implement a HACCP plan
after harvest; that complies with this section when-
(3) List the critical limits that must ever a HACCP plan is necessary, other-
be met at each of the critical control wise operate in accordance with the re-
points; quirements of this part, shall render
(4) List the procedures, and frequency the fish or fishery products of that
thereof, that will be used to monitor processor adulterated under section
each of the critical control points to 402(a)(4) of the act. Whether a proc-
ensure compliance with the critical essor’s actions are consistent with en-
limits; suring the safety of food will be deter-
(5) Include any corrective action mined through an evaluation of the
plans that have been developed in ac- processors overall implementation of
cordance with § 123.7(b), to be followed its HACCP plan, if one is required.
in response to deviations from critical
limits at critical control points; § 123.7 Corrective actions.
(6) List the verification procedures,
(a) Whenever a deviation from a crit-
and frequency thereof, that the proc-
ical limit occurs, a processor shall take
essor will use in accordance with
corrective action either by:
§ 123.8(a);
(1) Following a corrective action plan
(7) Provide for a recordkeeping sys-
that is appropriate for the particular
tem that documents the monitoring of
deviation, or
the critical control points. The records
shall contain the actual values and ob- (2) Following the procedures in para-
servations obtained during monitoring. graph (c) of this section.
(d) Signing and dating the HACCP (b) Processors may develop written
plan. (1) The HACCP plan shall be corrective action plans, which become
signed and dated, either by the most part of their HACCP plans in accord-
responsible individual onsite at the ance with § 123.6(c)(5), by which they
processing facility or by a higher level predetermine the corrective actions
official of the processor. This signature that they will take whenever there is a
shall signify that the HACCP plan has deviation from a critical limit. A cor-
been accepted for implementation by rective action plan that is appropriate
the firm. for a particular deviation is one that
(2) The HACCP plan shall be dated describes the steps to be taken and as-
and signed: signs responsibility for taking those
(i) Upon initial acceptance; steps, to ensure that:
(ii) Upon any modification; and (1) No product enters commerce that
(iii) Upon verification of the plan in is either injurious to health or is other-
accordance with § 123.8(a)(1). wise adulterated as a result of the devi-
(e) Products subject to other regula- ation; and
tions. For fish and fishery products (2) The cause of the deviation is cor-
that are subject to the requirements of rected.
part 113 or 114 of this chapter, the (c) When a deviation from a critical
HACCP plan need not list the food safe- limit occurs and the processor does not
ty hazard associated with the forma- have a corrective action plan that is
428
appropriate for that deviation, the uct. The reassessment shall be per-
processor shall: formed by an individual or individuals
(1) Segregate and hold the affected who have been trained in accordance
product, at least until the require- with § 123.10. The HACCP plan shall be
ments of paragraphs (c)(2) and (c)(3) of modified immediately whenever a reas-
this section are met; sessment reveals that the plan is no
(2) Perform or obtain a review to de- longer adequate to fully meet the re-
termine the acceptability of the af- quirements of § 123.6(c).
fected product for distribution. The re- (2) Ongoing verification activities. On-
view shall be performed by an indi- going verification activities including:
vidual or individuals who have ade-
(i) A review of any consumer com-
quate training or experience to perform
plaints that have been received by the
such a review. Adequate training may
processor to determine whether they
or may not include training in accord-
ance with § 123.10; relate to the performance of critical
(3) Take corrective action, when nec- control points or reveal the existence
essary, with respect to the affected of unidentified critical control points;
product to ensure that no product en- (ii) The calibration of process-moni-
ters commerce that is either injurious toring instruments; and,
to health or is otherwise adulterated as (iii) At the option of the processor,
a result of the deviation; the performing of periodic end-product
(4) Take corrective action, when nec- or in-process testing.
essary, to correct the cause of the devi- (3) Records review. A review, including
ation; signing and dating, by an individual
(5) Perform or obtain timely reassess- who has been trained in accordance
ment by an individual or individuals with § 123.10, of the records that docu-
who have been trained in accordance ment:
with § 123.10, to determine whether the (i) The monitoring of critical control
HACCP plan needs to be modified to re- points. The purpose of this review shall
duce the risk of recurrence of the devi- be, at a minimum, to ensure that the
ation, and modify the HACCP plan as records are complete and to verify that
necessary. they document values that are within
(d) All corrective actions taken in ac- the critical limits. This review shall
cordance with this section shall be occur within 1 week of the day that the
fully documented in records that are records are made;
subject to verification in accordance
(ii) The taking of corrective actions.
with § 123.8(a)(3)(ii) and the record-
The purpose of this review shall be, at
keeping requirements of § 123.9.
a minimum, to ensure that the records
§ 123.8 Verification. are complete and to verify that appro-
priate corrective actions were taken in
(a) Overall verification. Every proc-
accordance with § 123.7. This review
essor shall verify that the HACCP plan
shall occur within 1 week of the day
is adequate to control food safety haz-
that the records are made; and
ards that are reasonably likely to
occur, and that the plan is being effec- (iii) The calibrating of any process
tively implemented. Verification shall control instruments used at critical
include, at a minimum: control points and the performing of
(1) Reassessment of the HACCP plan. A any periodic end-product or in-process
reassessment of the adequacy of the testing that is part of the processor’s
HACCP plan whenever any changes verification activities. The purpose of
occur that could affect the hazard anal- these reviews shall be, at a minimum,
ysis or alter the HACCP plan in any to ensure that the records are com-
way or at least annually. Such changes plete, and that these activities oc-
may include changes in the following: curred in accordance with the proc-
Raw materials or source of raw mate- essor’s written procedures. These re-
rials, product formulation, processing views shall occur within a reasonable
methods or systems, finished product time after the records are made.
distribution systems, or the intended (b) Corrective actions. Processors shall
use or consumers of the finished prod- immediately follow the procedures in
429
§ 123.9 21 CFR Ch. I (4–1–16 Edition)
§ 123.7 whenever any verification proce- (2) Records that relate to the general
dure, including the review of a con- adequacy of equipment or processes
sumer complaint, reveals the need to being used by a processor, including
take a corrective action. the results of scientific studies and
(c) Reassessment of the hazard analysis. evaluations, shall be retained at the
Whenever a processor does not have a processing facility or the importer’s
HACCP plan because a hazard analysis place of business in the United States
has revealed no food safety hazards for at least 2 years after their applica-
that are reasonably likely to occur, the bility to the product being produced at
processor shall reassess the adequacy the facility.
of that hazard analysis whenever there (3) If the processing facility is closed
are any changes that could reasonably for a prolonged period between sea-
affect whether a food safety hazard sonal packs, or if record storage capac-
now exists. Such changes may include,
ity is limited on a processing vessel or
but are not limited to changes in: Raw
at a remote processing site, the records
materials or source of raw materials,
may be transferred to some other rea-
product formulation, processing meth-
ods or systems, finished product dis- sonably accessible location at the end
tribution systems, or the intended use of the seasonal pack but shall be imme-
or consumers of the finished product. diately returned for official review
The reassessment shall be performed upon demand.
by an individual or individuals who (c) Official review. All records re-
have been trained in accordance with quired by this part and all plans and
§ 123.10. procedures required by this part shall
(d) Recordkeeping. The calibration of be available for official review and
process-monitoring instruments, and copying at reasonable times.
the performing of any periodic end- (d) Public disclosure. (1) Subject to the
product and in-process testing, in ac- limitations in paragraph (d)(2) of this
cordance with paragraphs (a)(2)(ii) section, all plans and records required
through (iii) of this section shall be by this part are not available for public
documented in records that are subject disclosure unless they have been pre-
to the recordkeeping requirements of viously disclosed to the public as de-
§ 123.9. fined in § 20.81 of this chapter or they
relate to a product or ingredient that
§ 123.9 Records.
has been abandoned and they no longer
(a) General requirements. All records represent a trade secret or confidential
required by this part shall include: commercial or financial information as
(1) The name and location of the defined in § 20.61 of this chapter.
processor or importer; (2) However, these records and plans
(2) The date and time of the activity may be subject to disclosure to the ex-
that the record reflects; tent that they are otherwise publicly
(3) The signature or initials of the available, or that disclosure could not
person performing the operation; and reasonably be expected to cause a com-
(4) Where appropriate, the identity of petitive hardship, such as generic-type
the product and the production code, if HACCP plans that reflect standard in-
any. Processing and other information dustry practices.
shall be entered on records at the time (e) Tags. Tags as defined in § 123.3(t)
that it is observed. are not subject to the requirements of
(b) Record retention. (1) All records re- this section unless they are used to ful-
quired by this part shall be retained at fill the requirements of § 123.28(c).
the processing facility or importer’s (f) Records maintained on computers.
place of business in the United States
The maintenance of records on com-
for at least 1 year after the date they
puters is acceptable, provided that ap-
were prepared in the case of refrig-
erated products and for at least 2 years propriate controls are implemented to
after the date they were prepared in ensure the integrity of the electronic
the case of frozen, preserved, or shelf- data and signatures.
stable products.
430
§ 123.10 Training. (1) Safety of the water that comes

At a minimum, the following func- into contact with food or food contact
tions shall be performed by an indi- surfaces, or is used in the manufacture
vidual who has successfully completed of ice;
training in the application of HACCP (2) Condition and cleanliness of food
principles to fish and fishery product contact surfaces, including utensils,
processing at least equivalent to that gloves, and outer garments;
received under standardized cur- (3) Prevention of cross-contamina-
riculum recognized as adequate by the tion from insanitary objects to food,
U.S. Food and Drug Administration or food packaging material, and other
who is otherwise qualified through job food contact surfaces, including uten-
experience to perform these functions. sils, gloves, and outer garments, and
Job experience will qualify an indi- from raw product to cooked product;
vidual to perform these functions if it (4) Maintenance of hand washing,
has provided knowledge at least equiv- hand sanitizing, and toilet facilities;
alent to that provided through the (5) Protection of food, food packaging
standardized curriculum. material, and food contact surfaces
(a) Developing a HACCP plan, which from adulteration with lubricants, fuel,
could include adapting a model or ge- pesticides, cleaning compounds, sani-
neric-type HACCP plan, that is appro- tizing agents, condensate, and other
priate for a specific processor, in order chemical, physical, and biological con-
to meet the requirements of § 123.6(b); taminants;
(b) Reassessing and modifying the
(6) Proper labeling, storage, and use
HACCP plan in accordance with the
of toxic compounds;
corrective action procedures specified
in § 123.7(c)(5), the HACCP plan in ac- (7) Control of employee health condi-
cordance with the verification activi- tions that could result in the micro-
ties specified in § 123.8(a)(1), and the biological contamination of food, food
hazard analysis in accordance with the packaging materials, and food contact
verification activities specified in surfaces; and
§ 123.8(c); and (8) Exclusion of pests from the food
(c) Performing the record review re- plant.
quired by § 123.8(a)(3); The trained indi- The processor shall correct in a time-
vidual need not be an employee of the ly manner, those conditions and prac-
processor. tices that are not met.
(c) Sanitation control records. Each
§ 123.11 Sanitation control procedures. processor shall maintain sanitation
(a) Sanitation SOP. Each processor control records that, at a minimum,
should have and implement a written document the monitoring and correc-
sanitation standard operating proce- tions prescribed by paragraph (b) of
dure (herein referred to as SSOP) or this section. These records are subject
similar document that is specific to to the requirements of § 123.9.
each location where fish and fishery (d) Relationship to HACCP plan. Sani-
products are produced. The SSOP tation controls may be included in the
should specify how the processor will HACCP plan, required by § 123.6(b).
meet those sanitation conditions and However, to the extent that they are
practices that are to be monitored in monitored in accordance with para-
accordance with paragraph (b) of this graph (b) of this section they need not
section. be included in the HACCP plan, and
(b) Sanitation monitoring. Each proc- vice versa.
essor shall monitor the conditions and
practices during processing with suffi- [60 FR 65197, Dec. 18, 1995, as amended at 80
cient frequency to ensure, at a min- FR 56167, Sept. 17, 2015]
imum, conformance with those condi-
tions and practices specified in part 110 § 123.12 Special requirements for im-
ported products.
of this chapter and in subpart B of part
117 of this chapter that are both appro- This section sets forth specific re-
priate to the plant and the food being quirements for imported fish and fish-
processed and relate to the following: ery products.
431
§ 123.15 21 CFR Ch. I (4–1–16 Edition)
(a) Importer verification. Every im- (E) Periodically testing the imported
porter of fish or fishery products shall fish or fishery product, and maintain-
either: ing on file a copy, in English, of a writ-
(1) Obtain the fish or fishery product ten guarantee from the foreign proc-
from a country that has an active essor that the imported fish or fishery
memorandum of understanding (MOU) product is processed in accordance with
or similar agreement with the Food the requirements of this part or,
and Drug Administration, that covers (F) Other such verification measures
the fish or fishery product and docu- as appropriate that provide an equiva-
ments the equivalency or compliance lent level of assurance of compliance
of the inspection system of the foreign with the requirements of this part.
country with the U.S. system, accu- (b) Competent third party. An importer
rately reflects the current situation be- may hire a competent third party to
tween the signing parties, and is func- assist with or perform any or all of the
tioning and enforceable in its entirety; verification activities specified in para-
or graph (a)(2) of this section, including
(2) Have and implement written writing the importer’s verification pro-
verification procedures for ensuring cedures on the importer’s behalf.
that the fish and fishery products that (c) Records. The importer shall main-
they offer for import into the United tain records, in English, that document
States were processed in accordance the performance and results of the af-
with the requirements of this part. The firmative steps specified in paragraph
procedures shall list at a minimum: (a)(2)(ii) of this section. These records
(i) Product specifications that are de- shall be subject to the applicable provi-
signed to ensure that the product is not sions of § 123.9.
adulterated under section 402 of the (d) Determination of compliance. There
Federal Food, Drug, and Cosmetic Act must be evidence that all fish and fish-
because it may be injurious to health ery products offered for entry into the
or have been processed under insani- United States have been processed
tary conditions, and, under conditions that comply with this
(ii) Affirmative steps that may in- part. If assurances do not exist that the
clude any of the following: imported fish or fishery product has
been processed under conditions that
(A) Obtaining from the foreign proc-
are equivalent to those required of do-
essor the HACCP and sanitation moni-
mestic processors under this part, the
toring records required by this part
product will appear to be adulterated
that relate to the specific lot of fish or
and will be denied entry.
fishery products being offered for im-
port;
(B) Obtaining either a continuing or Subpart B—Smoked and Smoke-
lot-by-lot certificate from an appro- Flavored Fishery Products
priate foreign government inspection
authority or competent third party § 123.15 General.
certifying that the imported fish or This subpart augments subpart A of
fishery product is or was processed in this part by setting forth specific re-
accordance with the requirements of quirements for processing smoked and
this part; smoke-flavored fishery products.
(C) Regularly inspecting the foreign
processor’s facilities to ensure that the § 123.16 Process controls.
imported fish or fishery product is In order to meet the requirements of
being processed in accordance with the subpart A of this part, processors of
requirements of this part; smoked and smoke-flavored fishery
(D) Maintaining on file a copy, in products, except those subject to the
English, of the foreign processor’s requirements of part 113 or 114 of this
HACCP plan, and a written guarantee chapter, shall include in their HACCP
from the foreign processor that the im- plans how they are controlling the food
ported fish or fishery product is proc- safety hazard associated with the for-
essed in accordance with the require- mation of toxin by Clostridium botu-
ments of the part; linum for at least as long as the shelf
432
life of the product under normal and quirements of this section. These
moderate abuse conditions. records shall document:
(1) The date of harvest;
Subpart C—Raw Molluscan (2) The location of harvest by State
Shellfish and site;
(3) The quantity and type of shellfish;
§ 123.20 General. (4) The date of receipt by the proc-
This subpart augments subpart A of essor; and
this part by setting forth specific re- (5) The name of the harvester, the
quirements for processing fresh or fro- name or registration number of the
zen molluscan shellfish, where such harvester’s vessel, or an identification
processing does not include a treat- number issued to the harvester by the
ment that ensures the destruction of shellfish control authority.
vegetative cells of microorganisms of (d) To meet the requirements of para-
public health concern. graph (b) of this section, processors
who receive shucked molluscan shell-
§ 123.28 Source controls. fish shall accept only containers of
(a) In order to meet the requirements shucked molluscan shellfish that bear
of subpart A of this part as they apply a label that complies with § 1240.60(c) of
to microbiological contamination, this chapter. Processors shall maintain
chemical contamination, natural tox- records that document that all shucked
ins, and related food safety hazards, molluscan shellfish have met the re-
processors shall include in their quirements of this section. These
HACCP plans how they are controlling records shall document:
the origin of the molluscan shellfish (1) The date of receipt;
they process to ensure that the condi- (2) The quantity and type of shellfish;
tions of paragraphs (b), (c), and (d) of and
this section are met. (3) The name and certification num-
(b) Processors shall only process ber of the packer or repacker of the
molluscan shellfish harvested from product.
growing waters approved for harvesting
by a shellfish control authority. In the PART 129—PROCESSING AND BOT-
case of molluscan shellfish harvested TLING OF BOTTLED DRINKING
from U.S. Federal waters, the require- WATER
ments of this paragraph will be met so
long as the shellfish have not been har- Subpart A—General Provisions
vested from waters that have been
closed to harvesting by an agency of Sec.
the Federal government. 129.1 Current good manufacturing practice.
(c) To meet the requirements of para- 129.3 Definitions.
graph (b) of this section, processors
who receive shellstock shall accept Subpart B—Buildings and Facilities
only shellstock from a harvester that 129.20 Plant construction and design.
is in compliance with such licensure 129.35 Sanitary facilities.
requirements as may apply to the har- 129.37 Sanitary operations.
vesting of molluscan shellfish or from
a processor that is certified by a shell- Subpart C—Equipment
fish control authority, and that has a
129.40 Equipment and procedures.
tag affixed to each container of
shellstock. The tag shall bear, at a Subpart D [Reserved]
minimum, the information required in
§ 1240.60(b) of this chapter. In place of Subpart E—Production and Process
the tag, bulk shellstock shipments may Controls
be accompanied by a bill of lading or
129.80 Processes and controls.
similar shipping document that con-
tains the information required in AUTHORITY: 21 U.S.C. 342, 348, 371, 374; 42
§ 1240.60(b) of this chapter. Processors U.S.C. 264.

shall maintain records that document SOURCE: 42 FR 14355, Mar. 15, 1977, unless
that all shellstock have met the re- otherwise noted.
433
§ 129.1 21 CFR Ch. I (4–1–16 Edition)
Subpart A—General Provisions utilized in the transporting, proc-

essing, storing, and packaging of bot-
§ 129.1 Current good manufacturing tled drinking water, which are free of
practice. substances which may render the water
The applicable criteria in parts 110 injurious to health or which may ad-
and 117 of this chapter, as well as the versely affect the flavor, color, odor, or
criteria in §§ 129.20, 129.35, 129.37, 129.40, bacteriological quality of the water.
and 129.80 shall apply in determining (f) Operations water means water
whether the facilities, methods, prac- which is delivered under pressure to a
tices, and controls used in the proc- plant for container washing, hand
essing, bottling, holding, and shipping washing, plant and equipment cleanup
of bottled drinking water are in con- and for other sanitary purposes.
formance with or are operated or ad- (g) Primary container means the im-
ministered in conformity with good mediate container in which the product
water is packaged.
manufacturing practice to assure that
(h) Product water means processed
bottled drinking water is safe and that
water used by a plant for bottled drink-
it has been processed, bottled, held,
ing water.
and transported under sanitary condi-
(i) Shall and should. ‘‘Shall’’ refers to
tions.
mandatory requirements and ‘‘should’’
[80 FR 56167, Sept. 17, 2015] refers to recommended or advisory pro-
cedures or equipment.
§ 129.3 Definitions. (j) Shipping case means a container in
For the purposes of this part, the fol- which one or more primary containers
lowing definitions apply: of the product are held.
(a) Approved source when used in ref- (k) Single-service container means a
erence to a plant’s product water or op- container intended for one time usage
erations water means a source of water only.
and the water therefrom, whether it be (l) Unit package means a standard
from a spring, artesian well, drilled commercial package of bottled drink-
well, municipal water supply, or any ing water, which may consist of one or
other source, that has been inspected more containers.
and the water sampled, analyzed, and [42 FR 14355, Mar. 6, 1977, as amended at 44
found to be of a safe and sanitary qual- FR 12175, Mar. 6, 1979]
ity according to applicable laws and
regulations of State and local govern- Subpart B—Buildings and Facilities
ment agencies having jurisdiction. The
presence in the plant of current certifi- § 129.20 Plant construction and design.
cates or notifications of approval from (a) The bottling room shall be sepa-
the government agency or agencies rated from other plant operations or
having jurisdiction constitutes ap- storage areas by tight walls, ceilings,
proval of the source and the water sup- and self-closing doors to protect
ply. against contamination. Conveyor open-
(b) Bottled drinking water means all ings shall not exceed the size required
water which is sealed in bottles, pack- to permit passage of containers.
ages, or other containers and offered (b) If processing operations are con-
for sale for human consumption, in- ducted in other than a sealed system
cluding bottled mineral water. under pressure, adequate protection
(c) Lot means a collection of primary shall be provided to preclude contami-
containers or unit packages of the nation of the water and the system.
same size, type, and style produced (c) Adequate ventilation shall be pro-
under conditions as nearly uniform as vided to minimize condensation in
possible and designated by a common processing rooms, bottling rooms, and
container code or marking. in container washing and sanitizing
(d) Multiservice containers means con- areas.
tainers intended for use more than one (d) The washing and sanitizing of
time. containers for bottled drinking water

(e) Nontoxic materials means mate- shall be performed in an enclosed room.
rials for product water contact surfaces The washing and sanitizing operation
434
shall be positioned within the room so water by paragraph (a)(1) of this sec-
as to minimize any possible post-sani- tion. Before a bottler can use source
tizing contamination of the containers water from a source that has tested
before they enter the bottling room. positive for E. coli, the bottler must
(e) Rooms in which product water is take appropriate measures to rectify or
handled, processed, or held or in which otherwise eliminate the cause of E. coli
containers, utensils, or equipment are contamination of that source in a man-
washed or held shall not open directly ner sufficient to prevent its reoccur-
into any room used for domestic house- rence. A source previously found to
hold purposes. contain E. coli will be considered nega-
tive for E. coli after five samples col-
§ 129.35 Sanitary facilities. lected over a 24-hour period from the
Each plant shall provide adequate same sampling site that originally
sanitary facilities including, but not tested positive for E. coli are tested and
limited to, the following: found to be E. coli negative. Records of
(a) Product water and operations approval of the source water by govern-
water—(1) Product water. The product ment agencies having jurisdiction,
water supply for each plant shall be records of sampling and analyses for
from an approved source properly lo- which the plant is responsible, and
cated, protected, and operated and records describing corrective measures
shall be easily accessible, adequate, taken in response to a finding of E. coli
and of a safe, sanitary quality which are to be maintained on file at the
shall be in conformance at all times plant.
with the applicable laws and regula- (ii) Test and sample methods shall be
tions of the government agency or those recognized and approved by the
agencies having jurisdiction. government agency or agencies having
(2) Operations water. If different from jurisdiction over the approval of the
the product water supply, the oper- water source, and shall be consistent
ations water supply shall be obtained with the minimum requirements set
from an approved source properly lo- forth in § 165.110(b) of this chapter.
cated, protected, and operated and
(iii) Analysis of the sample may be
shall be easily accessible, adequate,
performed for the plant by competent
and of a safe, sanitary quality which
commercial laboratories (e.g., Environ-
shall be in conformance at all times
mental Protection Agency (EPA) and
with the applicable laws and regula-
State-certified laboratories).
tions of the government agency or
agencies having jurisdiction. (4) Source water testing exemptions. (i)
(3) Product water and operations water Firms that use a public water system
from approved sources. (i) Samples of for source water may substitute public
source water from each source in use water system testing results, or certifi-
by the plant are to be taken and ana- cates showing full compliance with all
lyzed by the plant as often as nec- provisions of EPA National Primary
essary, but at a minimum frequency of and Secondary Drinking Water Regula-
once each year for chemical contami- tions pertaining to chemical contami-
nants and once every 4 years for radio- nants (40 CFR parts 141 and 143), for the
logical contaminants. Additionally, testing requirements of § 129.35(a)(3).
source water obtained from other than (ii) Firms that do not use a public
a public water system is to be sampled water system as the source of their
and analyzed for total coliform at least water may reduce the frequency of
once each week. If any coliform orga- their testing of that source, as well as
nisms are detected, follow-up testing the number of chemical contaminants
must be conducted to determine wheth- for which they test the source water, if
er any of the coliform organisms are they can document that such reduction
Escherichia coli. This sampling is in ad- is consistent with a State-issued waiv-
dition to any performed by government er under EPA regulations (40 CFR parts
agencies having jurisdiction. Source 141 and 143).
water found to contain E. coli is not (iii) Firms that do not use a public
considered water of a safe, sanitary water system as the source of their
quality as required for use in bottled water and whose source water has not
435
§ 129.37 21 CFR Ch. I (4–1–16 Edition)
been treated with a chlorine-based dis- tion, scale, residue, or oxidation shall
infectant or ozone do not have to test be immediately remedied by adequate
their source water for the residual dis- cleaning and sanitizing of that product
infectants and DBP’s listed in water-contact surface prior to use.
§ 165.110(b)(4)(iii)(H) of this chapter. (b) After cleaning, all multiservice
Firms that do not use a public water containers, utensils, and disassembled
system as the source of their water but piping and equipment shall be trans-
whose source water has been treated ported and stored in such a manner as
with a chlorine-based disinfectant or to assure drainage and shall be pro-
ozone must test their source water for tected from contamination.
the residual disinfectants and the (c) Single-service containers and caps
DBP’s listed in § 165.110(b)(4)(iii)(H) or seals shall be purchased and stored
that are likely to result from such in sanitary closures and kept clean
treatment. therein in a clean, dry place until used.
(iv) The finished bottled water must Prior to use they shall be examined,
comply with bottled water quality and as necessary, washed, rinsed, and
standards (§ 165.110(b) of this chapter) sanitized and shall be handled in a san-
and section 402(a)(1) and (a)(3) of the itary manner.
Federal Food, Drug, and Cosmetic Act (d) Filling, capping, closing, sealing,
dealing with adulterated foods. and packaging of containers shall be
(b) Air under pressure. Whenever air done in a sanitary manner so as to pre-
under pressure is directed at product clude contamination of the bottled
water or a product water-contact sur- drinking water.
face, it shall be free of oil, dust, rust,
excessive moisture, and extraneous ma- Subpart C—Equipment
terials; shall not affect the bacterio-
logical quality of the water; and should § 129.40 Equipment and procedures.
not adversely affect the flavor, color,
(a) Suitability. (1) All plant equipment
or odor of the water.
and utensils shall be suitable for their
(c) Locker and lunchrooms. When em-
intended use. This includes all collec-
ployee locker and lunchrooms are pro-
tion and storage tanks, piping, fittings,
vided, they shall be separate from
connections, bottle washers, fillers,
plant operations and storage areas and
cappers, and other equipment which
shall be equipped with self-closing
may be used to store, handle, process,
doors. The rooms shall be maintained
package, or transport product water.
in a clean and sanitary condition and
(2) All product water contact surfaces
refuse containers should be provided.
shall be constructed of nontoxic and
Packaging or wrapping material or
nonabsorbant material which can be
other processing supplies shall not be
adequately cleaned and sanitized and is
stored in locker or lunchrooms.
in compliance with section 409 of the
[42 FR 14355, Mar. 15, 1977, as amended at 44 act.
FR 12175, Mar. 6, 1979; 60 FR 57123, Nov. 13, (b) Design. Storage tanks shall be of
1995; 66 FR 16865, Mar. 28, 2001; 74 FR 25664, the type that can be closed to exclude
May 29, 2009]
all foreign matter and shall be ade-
§ 129.37 Sanitary operations. quately vented.
(a) The product water-contact sur-
faces of all multiservice containers, Subpart D [Reserved]
utensils, pipes, and equipment used in
the transportation, processing, han- Subpart E—Production and
dling, and storage of product water Process Controls
shall be clean and adequately sanitized.
All product water-contact surfaces § 129.80 Processes and controls.
shall be inspected by plant personnel as (a) Treatment of product water. All
often as necessary to maintain the san- treatment of product water by distilla-
itary condition of such surfaces and to tion, ion-exchanging, filtration, ultra-
assure they are kept free of scale, evi- violet treatment, reverse osmosis,
dence of oxidation, and other residue. carbonation, mineral addition, or any
The presence of any unsanitary condi- other process shall be done in a manner
436
so as to be effective in accomplishing or hot water, shall be adequate to ef-

its intended purpose and in accordance fect sanitization of the intended prod-
with section 409 of the Federal Food, uct water-contact surfaces and any
Drug, and Cosmetic Act. All such proc- other critical area. The plant should
esses shall be performed in and by maintain a record of the intensity of
equipment and with substances which the sanitizing agent and the time dura-
will not adulterate the bottled product. tion that the agent was in contact with
A record of the type and date of phys- the surface being sanitized. The fol-
ical inspections of such equipment, lowing times and intensities shall be
conditions found, and the performance considered a minimum:
and effectiveness of such equipment (1) Steam in enclosed system: At
shall be maintained by the plant. Prod- least 170 °F for at least 15 minutes or at
uct water samples shall be taken after least 200 °F for at least 5 minutes.
processing and prior to bottling by the (2) Hot water in enclosed system: At
plant and analyzed as often as is nec- least 170 °F for at least 15 minutes or at
essary to assure uniformity and effec- least 200 °F for at least 5 minutes.
tiveness of the processes performed by (3) Chemical sanitizers shall be
the plant. The methods of analysis equivalent in bactericidal action to a 2-
shall be those approved by the govern- minute exposure of 50 parts per million
ment agency or agencies having juris- of available chlorine at 57 °F when used
diction. as an immersion or circulating solu-
(b) Containers. (1) Multiservice pri- tion. Chemical sanitizers applied as a
mary containers shall be adequately spray or fog shall have as a minimum
cleaned, sanitized, and inspected just 100 parts per million of available chlo-
prior to being filled, capped, and rine at 57 °F or its equivalent in bac-
sealed. Containers found to be unsani- tericidal action.
tary or defective by the inspection (4) 0.1 part per million ozone water
shall be reprocessed or discarded. All solution in an enclosed system for at
multiservice primary containers shall least 5 minutes.
be washed, rinsed, and sanitized by me- (5) When containers are sanitized
chanical washers or by any other meth- using a substance other than one pro-
od giving adequate sanitary results. vided for in § 178.1010 of this chapter,
Mechanical washers shall be inspected such substance shall be removed from
as often as is necessary to assure ade- the surface of the container by a rins-
quate performance. Records of physical ing procedure. The final rinse, prior to
maintenance, inspections and condi- filling the container with product
tions found, and performance of the water, shall be performed with a dis-
mechanical washer shall be maintained infected water rinse free of pathogenic
by the plant. bacteria or by an additional sanitizing
(2) Multiservice shipping cases shall procedure equivalent in bactericidal
be maintained in such condition as to action to that required in paragraph
assure they will not contaminate the (d)(3) of this section.
primary container or the product (e) Unit package production code. Each
water. Adequate dry or wet cleaning unit package from a batch or segment
procedures shall be performed as often of a continuous production run of bot-
as necessary to maintain the cases in tled drinking water shall be identified
satisfactory condition. by a production code. The production
(c) Cleaning and sanitizing solutions. code shall identify a particular batch
Cleaning and sanitizing solutions uti- or segment of a continuous production
lized by the plant shall be sampled and run and the day produced. The plant
tested by the plant as often as is nec- shall record and maintain information
essary to assure adequate performance as to the kind of product, volume pro-
in the cleaning and sanitizing oper- duced, date produced, lot code used,
ations. Records of these tests shall be and the distribution of the finished
maintained by the plant. product to wholesale and retail outlets.
(d) Sanitizing operations. Sanitizing (f) Filling, capping, or sealing. During
operations, including those performed the process of filling, capping or seal-

by chemical means or by any other ing either single-service or multi-
means such as circulation of live steam service containers, the performance of
437
the filler, capper or sealer shall be sample(s) consists of primary con-

monitored and the filled containers tainers of product of unit packages of
visually or electronically inspected to product.
assure they are sound, properly capped (3) Analyze such samples by methods
or sealed, and coded and labeled. Con- approved by the government agency or
tainers which are not satisfactory shall agencies having jurisdiction. The plant
be reprocessed or rejected. Only shall maintain records of date of sam-
nontoxic containers and closures shall pling, type of product sampled, produc-
be used. All containers and closures tion code, and results of the analysis.
shall be sampled and inspected to as- (h) Record retention. All records re-
certain that they are free from con- quired by §§ 129.1, 129.20, 129.35, 129.37,
tamination. At least once each 3 129.40, and 129.80 shall be maintained at
months, a bacteriological swab and/or the plant for not less than 2 years.
rinse count should be made from at Plants shall also retain, on file at the
least four containers and closures se- plant, current certificates or notifica-
lected just prior to filling and sealing. tions of approval issued by the govern-
No more than one of the four samples ment agency or agencies approving the
may exceed more than one bacteria per plant’s source and supply of product
milliliter of capacity or one colony per water and operations water. All re-
square centimeter of surface area. All quired documents shall be available for
samples shall be free of coliform orga- official review at reasonable times.
nisms. The procedure and apparatus for
these bacteriological tests shall be in [42 FR 14355, Mar. 15, 1977, as amended at 44
conformance with those recognized by FR 12175, Mar. 6, 1979; 60 FR 57124, Nov. 13,
1995; 74 FR 25665, May 29, 2009]
the government agency or agencies
having jurisdiction. Tests shall be per-
formed either by qualified plant per- PART 130—FOOD STANDARDS:
sonnel or a competent commercial lab- GENERAL
oratory.
(g) Compliance procedures. A quality Subpart A—General Provisions
standard for bottled drinking water is
established in § 165.110(b) of this chap- Sec.
ter. To assure that the plant’s produc- 130.3 Definitions and interpretations.
tion of bottled drinking water complies 130.5 Procedure for establishing a food
standard.
with the applicable standards, laws,
130.6 Review of Codex Alimentarius food
and regulations of the government standards.
agency or agencies having jurisdiction, 130.8 Conformity to definitions and stand-
the plant will analyze product samples ards of identity.
as follows: 130.9 Sulfites in standardized food.
(1) For bacteriological purposes, take 130.10 Requirements for foods named by use
and analyze at least once a week for of a nutrient content claim and a stand-
total coliform a representative sample ardized term.
from a batch or segment of a contin- 130.11 Label designations of ingredients for
uous production run for each type of standardized foods.
bottled drinking water produced during 130.12 General methods for water capacity
a day’s production. The representative and fill of containers.
sample shall consist of primary con- 130.14 General statements of substandard
tainers of product or unit packages of quality and substandard fill of container.
product. If any coliform organisms are 130.17 Temporary permits for interstate
shipment of experimental packs of food
detected, follow-up testing must be varying from the requirements of defini-
conducted to determine whether any of tions and standards of identity.
the coliform organisms are E. coli.
(2) For chemical, physical, and radio- Subpart B—Food Additives in Standardized
logical purposes, take and analyze at Foods
least annually a representative sample
from a batch or segment of a contin- 130.20 Food additives proposed for use in
uous production run for each type of foods for which definitions and standards
of identity are established.
bottled drinking water produced during
a day’s production. The representtive AUTHORITY: 21 U.S.C. 321, 336, 341, 343, 371.
438
Subpart A—General Provisions listed in accordance with the require-

ments of part 101 of this chapter, ex-
§ 130.3 Definitions and interpretations. cept that where a definition and stand-
(a) The definitions and interpreta- ard of identity has specific labeling
tions of terms contained in section 201 provisions for optional ingredients, op-
of the act shall be applicable also to tional ingredients may be declared in
such terms when used in regulations accordance with those provisions.
promulgated under the act. [42 FR 14357, Mar. 15, 1977, as amended at 58
(b) If a regulation prescribing a defi- FR 2876, Jan. 6, 1993]
nition and standard of identity for a
food has been promulgated under sec- § 130.5 Procedure for establishing a
tion 401 of the act and the name there- food standard.
in specified for the food is used in any (a) The procedure for establishing a
other regulation under section 401 or food standard under section 401 of the
any other provision of the act, such act shall be governed by part 10 of this
name means the food which conforms chapter.
to such definition and standard, except (b) Any petition for a food standard
as otherwise specifically provided in shall show that the proposal, if adopt-
such other regulation. ed, would promote honesty and fair
(c) No provision of any regulation dealing in the interest of consumers.
prescribing a definition and standard of (c) Any petition for a food standard
identity or standard of quality or fill of shall assert that the petitioner com-
container under section 401 of the act mits himself to substantiate the infor-
shall be construed as in any way affect- mation in the petition by evidence in a
ing the concurrent applicability of the public hearing, if such a hearing be-
general provisions of the act and the comes necessary.
regulations thereunder relating to (d) If a petitioner fails to appear, or
adulteration and misbranding. For ex- to substantiate the information in his
ample, all regulations under section 401 petition, at a public hearing on the
contemplate that the food and all arti- matter, the Commissioner may either
cles used as components or ingredients (1) withdraw the regulation and termi-
thereof shall not be poisonous or dele- nate the proceeding or (2) if he con-
terious and shall be clean, sound, and cludes that it is in accordance with the
fit for food. A provision in such regula- requirements of section 401 of the act,
tions for the use of coloring or fla- continue the proceeding and introduce
voring does not authorize such use evidence to substantiate such informa-
under circumstances or in a manner tion.
whereby damage or inferiority is con-
cealed or whereby the food is made to [42 FR 14357, Mar. 15, 1977, as amended at 42
appear better or of greater value than FR 15673, Mar. 22, 1977]
it is.
(d) Safe and suitable means that the § 130.6 Review of Codex Alimentarius
food standards.
ingredient:
(1) Performs an appropriate function (a) All food standards adopted by the
in the food in which it is used. Codex Alimentarius Commission will
(2) Is used at a level no higher than be reviewed by the Food and Drug Ad-
necessary to achieve its intended pur- ministration and will be accepted with-
pose in that food. out change, accepted with change, or
(3) Is not a food additive or color ad- not accepted.
ditive as defined in section 201 (s) or (t) (b) Review of Codex standards will be
of the Federal Food, Drug, and Cos- accomplished in one of the following
metic Act as used in that food, or is a three ways:
food additive or color additive as so de- (1) Any interested person may peti-
fined and is used in conformity with tion the Commissioner to adopt a
regulations established pursuant to Codex standard, with or without
section 409 or 721 of the act. change, by proposing a new standard or
(e) Section 403(i) of the act requires an appropriate amendment of an exist-

the listing of all ingredients in standing standard, pursuant to section 401 of
ardized foods. All ingredients must be the act. Any such petition shall specify
439
§ 130.8 21 CFR Ch. I (4–1–16 Edition)
any deviations from the Codex stand- definition and standard of identity
ard, and the reasons for any such devi- therefor:
ations. The Commissioner shall publish (a) If it contains an ingredient for
such a petition in the FEDERAL REG- which no provision is made in such def-
ISTER as a proposal, with an oppor- inition and standard, unless such ingre-
tunity for comment, if reasonable dient is an incidental additive intro-
grounds are provided in the petition. duced at a nonfunctional and insignifi-
Any published proposal shall state any cant level as a result of its deliberate
deviations from the Codex standard and purposeful addition to another in-
and the stated reasons therefor. gredient permitted by the terms of the
(2) The Commissioner may on his applicable standard and the presence of
own initiative propose by publication such incidental additive in
in the FEDERAL REGISTER the adoption unstandardized foods has been exempt-
of a Codex standard, with or without ed from label declaration as provided
change, through a new standard or an in § 101.100 of this chapter.
appropriate amendment to an existing (b) If it fails to contain any one or
standard, pursuant to section 401 of the more ingredients required by such defi-
act. Any such proposal shall specify nition and standard;
any deviations from the Codex stand- (c) If the quantity of any ingredient
ard, and the reasons for any such devi- or component fails to conform to the
ations.
limitation, if any, prescribed therefor
(3) Any Codex standard not handled
by such definition and standard.
under paragraph (b) (1) or (2) of this
section may be published in the FED- § 130.9 Sulfites in standardized food.
ERAL REGISTER for review and informal
comment. Interested persons shall be (a) Any standardized food that con-
requested to comment on the desir- tains a sulfiting agent or combination
ability and need for the standard, on of sulfiting agents that is functional
the specific provisions of the standard, and provided for in the applicable
on additional or different provisions standard or that is present in the fin-
that should be included in the stand- ished food at a detectable level is mis-
ard, and on any other pertinent points. branded unless the presence of the
After reviewing all such comments, the sulfiting agent or agents is declared on
Commissioner either shall publish a the label of the food. A detectable
proposal to establish a food standard amount of sulfiting agent is 10 parts
pursuant to section 401 of the act cov- per million or more of the sulfite in the
ering the food involved, or shall pub- finished food. The level of sulfite in the
lish a notice terminating consideration finished food will be determined using
of such a standard. sections 20.123 through 20.125, ‘‘Sulfu-
(c) All interested persons are encour- rous Acid (Total) in Food Modified
aged to confer with different interest Monier-Williams Method Final Action’’
groups (consumers, industry, the aca- in ‘‘Official Methods of Analysis of the
demic community, professional organi- Association of Official Analytical
zations, and others) in formulating pe- Chemists,’’ 14th ed. (1984), which is in-
titions or comments pursuant to para- corporated by reference in accordance
graph (b) of this section. All such peti- with 5 U.S.C. 552(a) and 1 CFR part 51,
tions or comments are requested to in- and the refinements of the ‘‘Total Sul-
clude a statement of any meetings and furous Acid’’ procedure in the ‘‘Monier-
discussions that have been held with Williams Procedure (with Modifica-
other interest groups. Appropriate tions) for Sulfites in Foods,’’ which is
weight will be given by the Commis- appendix A to part 101 of this chapter.
sioner to petitions or comments that A copy of sections 20.123 through 20.125
reflect a consensus of different interest of the ‘‘Official Methods of Analysis of
groups. the Association of Official Analytical
Chemists’’ is available from AOAC
§ 130.8 Conformity to definitions and INTERNATIONAL, 481 North Frederick
standards of identity. Ave., suite 500, Gaithersburg, MD 20877

In the following conditions, among , or available for at the National Ar-
others, a food does not conform to the chives and Records Administration
440
(NARA). For information on the avail- the standard of identity (e.g., moisture
ability of this material at NARA, call content, food solids content require-
202–741–6030, or go to: http:// ments, or processing conditions) are
www.archives.gov/federallregister/ permitted in order that the substitute
codeloflfederallregulations/ food possesses performance character-
ibrllocations.html. istics similar to those of the standard-
(b) Any standardized food that, as a ized food. Deviations from ingredient
result of actions that are consistent and noningredient provisions of the
with current good manufacturing prac- standard must be the minimum nec-
tice, contains an indirectly added essary to qualify for the nutrient con-
sulfiting agent that has no functional tent claim while maintaining similar
effect in the food and that would, in performance characteristics as the
the absence of § 101.100(a)(4) of this standardized food, or the food will be
chapter, be considered to be an inci- deemed to be adulterated under section
dental additive for purposes of § 130.8, 402(b) of the act. The performance char-
conforms to the applicable definition acteristics (e.g., physical properties,
and standard of identity if the presence flavor characteristics, functional prop-
of the sulfiting agent is declared on the erties, shelf life) of the food shall be
label of the food. similar to those of the standardized
[58 FR 2876, Jan. 6, 1993, as amended at 63 FR food as produced under parts 131
14035, Mar. 24, 1998] through 169 of this chapter, except that
if there is a significant difference in
§ 130.10 Requirements for foods named performance characteristics that mate-
by use of a nutrient content claim rially limits the uses of the food com-
and a standardized term. pared to the uses of the standardized
(a) Description. The foods prescribed food, the label shall include a state-
by this general definition and standard ment informing the consumer of such
of identity are those foods that sub- difference (e.g., if appropriate, ‘‘not
stitute (see § 101.13(d) of this chapter) recommended for cooking’’). Such
for a standardized food defined in parts statement shall comply with the re-
131 through 169 of this chapter and that quirements of § 101.13(d) of this chapter.
use the name of that standardized food The modified product shall perform at
in their statement of identity but that least one of the principal functions of
do not comply with the standard of the standardized product substantially
identity because of a deviation that is as well as the standardized product.
described by an expressed nutrient con- (d) Other ingredients. (1) Ingredients
tent claim that has been defined by used in the product shall be those in-
FDA regulation. The nutrient content gredients provided for by the standard
claim shall comply with the require- as defined in parts 131 through 169 of
ments of § 101.13 of this chapter and this chapter and in paragraph (b) of
with the requirements of the regula- this section, except that safe and suit-
tions in part 101 of this chapter that able ingredients may be used to im-
define the particular nutrient content prove texture, add flavor, prevent syn-
claim that is used. The food shall com- eresis, extend shelf life, improve ap-
ply with the relevant standard in all pearance, or add sweetness so that the
other respects except as provided in product is not inferior in performance
paragraphs (b), (c), and (d) of this sec- characteristics to the standardized
tion. food defined in parts 131 through 169 of
(b) Nutrient addition. Nutrients shall this chapter.
be added to the food to restore nutrient (2) An ingredient or component of an
levels so that the product is not nutri- ingredient that is specifically required
tionally inferior, as defined in by the standard (i.e., a mandatory in-
§ 101.3(e)(4) of this chapter, to the gredient) as defined in parts 131
standardized food as defined in parts through 169 of this chapter, shall not be
131 through 169 of this chapter. The ad- replaced or exchanged with a similar
dition of nutrients shall be reflected in ingredient from another source unless
the ingredient statement. the standard, as defined in parts 131

(c) Performance characteristics. Devi- through 169 of this chapter, provides
ations from noningredient provisions of for the addition of such ingredient
441
§ 130.11 21 CFR Ch. I (4–1–16 Edition)
(e.g., vegetable oil shall not replace ents such as spices, flavorings, color-
milkfat in light sour cream). ings, emulsifiers, flavor enhancers, sta-
(3) An ingredient or component of an bilizers, preservatives, and sweeteners
ingredient that is specifically prohib- be declared in a specified manner on
ited by the standard as defined in parts the label wherever the name of the
131 through 169 of this chapter, shall standardized food appears on the label
not be added to a substitute food under so conspicuously as to be easily seen
this section. under customary conditions of pur-
(4) An ingredient that is specifically chase. Such requirements shall apply
required by the standard as defined in to a manufacturer, packer, or dis-
parts 131 through 169 of this chapter, tributor of a standardized food only if
shall be present in the product in a sig- the words or statements on the label of
nificant amount. A significant amount the standardized food significantly dif-
of an ingredient or component of an in- ferentiate between two or more foods
gredient is at least that amount that is that comply with the same standard by
required to achieve the technical effect describing the optional forms or vari-
of that ingredient in the food. eties, the packing medium, or signifi-
(5) Water and fat analogs may be cant characterizing ingredients present
added to replace fat and calories in ac- in the food.
cordance with § 130.10(c), (d)(1), and
(d)(2). [58 FR 2876, Jan. 6, 1993]
(e) Nomenclature. The name of a sub-
§ 130.12 General methods for water ca-
stitute food that complies with all pacity and fill of containers.
parts of this regulation is the appro-
priate expressed nutrient content For the purposes of regulations pro-
claim and the applicable standardized mulgated under section 401 of the act:
term. (a) The term general method for water
(f) Label declaration. (1) Each of the capacity of containers means the fol-
ingredients used in the food shall be de- lowing method:
clared on the label as required by the (1) In the case of a container with lid
applicable sections of part 101 of this attached by double seam, cut out the
chapter and part 130. lid without removing or altering the
(2) Ingredients not provided for, and height of the double seam.
ingredients used in excess of those lev- (2) Wash, dry, and weigh the empty
els provided for, by the standard as de- container.
fined in parts 131 through 169 of this (3) Fill the container with distilled
chapter, shall be identified as such water at 68 °F to 3⁄16 inch vertical dis-
with an asterisk in the ingredient tance below the top level of the con-
statement, except that ingredients tainer, and weigh the container thus
added to restore nutrients to the prod- filled.
uct as required in paragraph (b) of this (4) Subtract the weight found in
section shall not be identified with an paragraph (a)(2) of this section from
asterisk. The statement the weight found in paragraph (a)(3) of
‘‘*Ingredient(s) not in regular lll’’ this section. The difference shall be
(fill in name of the traditional stand- considered to be the weight of water re-
ardized food) or ‘‘*Ingredient(s) in ex- quired to fill the container.
cess of amount permitted in regular In the case of a container with lid at-
lll’’ (fill in name of the traditional tached otherwise than by double seam,
standardized food) or both as appro- remove the lid and proceed as directed
priate shall immediately follow the in- in paragraphs (a) (2) to (4) of this sec-
gredient statement in the same type tion, except that under paragraph (a)(3)
size. of this section, fill the container to the
[58 FR 2446, Jan. 6, 1993] level of the top thereof.
(b) The term general method for fill of
§ 130.11 Label designations of ingredi- containers means the following method:
ents for standardized foods. (1) In the case of a container with lid
Some definitions and standards of attached by double seam, cut out the
identity for foods set forth below re- lid without removing or altering the
quire that designated optional ingredi- height of the double seam.
442
(2) Measure the vertical distance statement is enclosed within lines, not
from the top level of the container to less than 6 points in width, forming a
the top level of the food. rectangle. Such statement, with en-
(3) Remove the food from the con- closing lines, is on a strongly con-
tainer; wash, dry, and weigh the contrasting, uniform background, and is so
tainer. placed as to be easily seen when the
(4) Fill the container with water to name of the food or any pictorial rep-
3⁄16 inch vertical distance below the top
resentation thereof is viewed, wherever
level of the container. Record the tem- such name or representation appears so
perature of the water, weigh the con- conspicuously as to be easily seen
tainer thus filled, and determine the under customary conditions of pur-
weight of the water by subtracting the chase.
weight of the container found in para- (b) The term general statement of sub-
graph (b)(3) of this section. standard fill means the statement
(5) Maintaining the water at the tem- ‘‘Below Standard in Fill’’ printed in
perature recorded in paragraph (b)(4) of Cheltenham bold condensed caps. If the
this section, draw off water from the quantity of the contents of the con-
container as filled in paragraph (b)(4) tainer is less than 1 pound, the state-
of this section to the level of the food ment is in 12-point type; if such quan-
found in paragraph (b)(2) of this sec- tity is 1 pound or more, the statement
tion, weigh the container with remain- is in 14-point type. Such statement is
ing water, and determine the weight of enclosed within lines, not less than 6
the remaining water by subtracting the points in width, forming a rectangle;
weight of the container found in para- but if the statement specified in para-
graph (b)(3) of this section. graph (a) of this section is also used,
(6) Divide the weight of water found both statements (one following the
in paragraph (b)(5) of this section by other) may be enclosed within the
the weight of water found in paragraph same rectangle. Such statement or
(b)(4) of this section, and multiply by statements, with enclosing lines, are
100. The result shall be considered to be on a strongly contrasting, uniform
the percent of the total capacity of the background, and are so placed as to be
container occupied by the food. easily seen when the name of the food
or any pictorial representation thereof
In the case of a container with lid at-
is viewed, wherever such name or rep-
tached otherwise than by double seam, resentation appears so conspicuously
remove the lid and proceed as directed as to be easily seen under customary
in paragraphs (b) (2) to (6) of this sec- conditions of purchase.
tion, except that under paragraph (b)(4)
of this section, fill the container to the § 130.17 Temporary permits for inter-
level of the top thereof. state shipment of experimental
packs of food varying from the re-
§ 130.14 General statements of sub- quirements of definitions and
standard quality and substandard standards of identity.
fill of container.
(a) The Food and Drug Administra-
For the purposes of regulations pro- tion recognizes that before petitions to
mulgated under section 401 of the act: amend food standards can be sub-
(a) The term general statement of submitted, appropriate investigations of
standard quality means the statement potential advances in food technology
‘‘Below Standard in Quality Good sometimes require tests in interstate
Food—Not High Grade’’ printed in two markets of the advantages to and ac-
lines of Cheltenham bold condensed ceptance by consumers of experimental
caps. The words ‘‘Below Standard in packs of food varying from applicable
Quality’’ constitute the first line, and definitions and standards of identity
the second immediately follows. If the prescribed under section 401 of the act.
quantity of the contents of the con- (b) It is the purpose of the Food and
tainer is less than 1 pound, the type of Drug Administration to permit such
the first line is 12-point, and of the sec- tests when it can be ascertained that
ond, 8-point. If such quantity is 1 pound the sole purpose of the tests is to ob-
or more, the type of the first line is 14- tain data necessary for reasonable
point, and of the second, 10-point. Such grounds in support of a petition to
443
§ 130.17 21 CFR Ch. I (4–1–16 Edition)
amend food standards, that the tests (5) The basis upon which the food so
are necessary to the completion or con- varying is believed to be wholesome
clusiveness of an otherwise adequate and nondeleterious.
investigation, and that the interests of (6) The amount of any new ingredient
consumers are adequately safeguarded; to be added; the amount of any ingre-
permits for such tests shall normally dient, required by the standard, to be
be for a period not to exceed 15 months. eliminated; any change of concentra-
The Food and Drug Administration, or tion not contemplated by the standard;
good cause shown by the applicant, or any change in name that would
may provide for a longer test market more appropriately describe the new
period. The Food and Drug Administra- product under test. If such new ingre-
tion will therefore refrain from recom- dient is not a commonly known food
mending regulatory proceedings under ingredient, a description of its prop-
the act on the charge that a food does erties and basis for concluding that it
is not a deleterious substance.
not conform to an applicable standard,
(7) The purpose of effecting the vari-
if the person who introduces or causes
ation.
the introduction of the food into inter-
(8) A statement of how the variation
state commerce holds an effective per- is of potential advantage to consumers.
mit from the Food and Drug Adminis- The statement shall include the rea-
tration providing specifically for those sons why the applicant does not con-
variations in respect to which the food sider the data obtained in any prior in-
fails to conform to the applicable defi- vestigations which may have been con-
nition and standard of identity. The ducted sufficient to support a petition
test period will begin on the date the to amend the standard.
person holding an effective permit (9) The proposed label (or an accurate
from the Food and Drug Administra- draft) to be used on the food to be mar-
tion introduces or causes the introduc- ket tested. The label shall conform in
tion of the food covered by the permit all respects to the general require-
into interstate commerce but not later ments of the act and shall provide a
than 3 months after notice of the means whereby the consumer can dis-
issuance of the permit is published in tinguish between the food being tested
the FEDERAL REGISTER. The Food and and such food complying with the
Drug Administration shall be notified standard.
in writing of the date on which the test (10) The period during which the ap-
period begins as soon as it is deter- plicant desires to introduce such food
mined. into interstate commerce, with a state-
(c) Any person desiring a permit may ment of the reasons supporting the
file with the Team Leader, Conven- need for such period. If a period longer
tional Foods Team, Division of Stand- than 15 months is requested, a detailed
ards and Labeling Regulations, Office explanation of why a 15-month period
of Nutritional Products, Labeling and is inadequate shall be provided.
Dietary Supplements, Center for Food (11) The probable amount of such
Safety and Applied Nutrition (HFS– food that will be distributed. The
amount distributed should be limited
822), 5100 Paint Branch Pkwy., College
to the smallest number of units reason-
Park, MD 20740, a written application
ably required for a bona fide market
in triplicate containing as part thereof
test. Justification for the amount re-
the following:
quested shall be included.
(1) Name and address of the appli- (12) The areas of distribution.
cant. (13) The address at which such food
(2) A statement of whether or not the will be manufactured.
applicant is regularly engaged in pro- (14) A statement of whether or not
ducing the food involved. such food has been or is to be distrib-
(3) A reference to the applicable defi- uted in the State in which it was man-
nition and standard of identity (citing ufactured.
applicable section of regulations). (15) If it has not been or is not to be

(4) A full description of the proposed so distributed, a statement showing
variation from the standard. why.
444
(16) If it has been or is to be so dis- shall be accompanied by a petition to

tributed, a statement of why it is amend the affected food standard. If
deemed necessary to distribute such the Food and Drug Administration con-
food in other States. cludes that it will be in the interest of
(d) The Food and Drug Administra- consumers to issue an extension of the
tion may require the applicant to fur- time period for the market test, a no-
nish samples of the food varying from tice will be published in the FEDERAL
the standard and to furnish such addi- REGISTER stating that fact. The notice
tional information as may be deemed will include an invitation to all inter-
necessary for action on the application. ested persons to participate in the mar-
(e) If the Food and Drug Administra- ket test under the same conditions
tion concludes that the variation may
that applied to the initial permit hold-
be advantageous to consumers and will
er, including labeling and the amount
not result in failure of the food to con-
form to any provision of the act except to be distributed, except that the des-
section 403(g), a permit shall be issued ignated area of distribution shall not
to the applicant for interstate ship- apply. The extended market test period
ment of such food. The terms and con- shall not begin prior to the publication
ditions of the permit shall be those set of a notice in the FEDERAL REGISTER
forth in the application with such granting the extension and shall termi-
modifications, restrictions, or quali- nate either on the effective date of an
fications as the Food and Drug Admin- affirmative order ruling on the pro-
istration may deem necessary and posal or 30 days after a negative order
state in the permit. ruling on the proposal, whichever the
(f) The terms and conditions of the case may be. Any interested person
permit may be modified at the discre- who accepts the invitation to partici-
tion of the Food and Drug Administra- pate in the extended market test shall
tion or upon application of the per- notify the Food and Drug Administra-
mittee during the effective period of tion in writing of that fact, the amount
the permit. to be distributed, and the area of dis-
(g) The Food and Drug Administra- tribution; and along with such notifica-
tion may revoke a permit for cause, tion, he shall submit the labeling under
which shall include but not be limited which the food is to be distributed.
to the following:
(j) Notice of the granting or revoca-
(1) That the permittee has introduced
tion of any permit shall be published in
a food into interstate commerce con-
trary to the terms and conditions of the FEDERAL REGISTER.
the permit. (k) All applications for a temporary
(2) That the application for a permit permit, applications for an extension of
contains an untrue statement of a ma- a temporary permit, and related
terial fact. records are available for public disclo-
(3) That the need therefor no longer sure when the notice of a permit or ex-
exists. tension thereof is published in the FED-
(h) During the period within which ERAL REGISTER. Such disclosure shall
any permit is effective, it shall be be in accordance with the rules estab-
deemed to be included within the terms lished in part 20 of this chapter.
of any guaranty or undertaking other- (l) Any person who contests denial,
wise effective pursuant to the provi- modification, or revocation of a tem-
sions of section 303(c) of the act. porary permit shall have an oppor-
(i) If an application is made for an tunity for a regulatory hearing before
extension of the permit, it shall be ac- the Food and Drug Administration pur-
companied by a description of experi- suant to part 16 of this chapter.
ments conducted under the permit,
tentative conclusions reached, and rea- [42 FR 14357, Mar. 15, 1977, as amended at 42
sons why further experimental ship- FR 15673, Mar. 22, 1977; 46 FR 37500, July 21,
ments are considered necessary. The 1981; 54 FR 24892, June 12, 1989; 59 FR 15051,
application for an extension shall be Mar. 31, 1994; 66 FR 17359, Mar. 30, 2001; 66 FR
56035, Nov. 6, 2001]
filed not later than 3 months prior to
the expiration date of the permit and
445
§ 130.20 21 CFR Ch. I (4–1–16 Edition)
Subpart B—Food Additives in 131.130 Evaporated milk.

131.147 Dry whole milk.
Standardized Foods 131.149 Dry cream.
131.150 Heavy cream.
§ 130.20 Food additives proposed for 131.155 Light cream.
use in foods for which definitions 131.157 Light whipping cream.
and standards of identity are estab- 131.160 Sour cream.
lished. 131.162 Acidified sour cream.
(a) Where a petition is received for 131.170 Eggnog.
the issuance or amendment of a regula- 131.180 Half-and-half.
tion establishing a definition and 131.200 Yogurt.
standard of identity for a food under 131.203 Lowfat yogurt.
131.206 Nonfat yogurt.
section 401 of the act, which proposes
the inclusion of a food additive in such AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371,
definition and standard of identity, the 379e.
provisions of the regulations in part 171 SOURCE: 42 FR 14360, Mar. 15, 1977, unless
of this chapter shall apply with respect otherwise noted.
to the information that must be sub- EDITORIAL NOTE: Nomenclature changes to
mitted with respect to the food addi- part 131 appear at 63 FR 14035, Mar. 24, 1998.
tive. Since section 409(b)(5) of the act
requires that the Commissioner publish
notice of a petition for the establish-
ment of a food additive regulation § 131.3 Definitions.
within 30 days after filing, notice of a
petition relating to a definition and (a) Cream means the liquid milk prod-
standard of identity shall also be pub- uct high in fat separated from milk,
lished within that time limitation if it which may have been adjusted by add-
includes a request, so designated, for ing thereto: Milk, concentrated milk,
the establishment of a regulation per- dry whole milk, skim milk, con-
taining to a food additive. centrated skim milk, or nonfat dry
(b) If a petition for a definition and milk. Cream contains not less than 18
standard of identity contains a pro- percent milkfat.
posal for a food additive regulation, (b) Pasteurized when used to describe
and the petitioner fails to designate it a dairy product means that every par-
as such, the Commissioner, upon deter- ticle of such product shall have been
mining that the petition includes a heated in properly operated equipment
proposal for a food additive regulation, to one of the temperatures specified in
shall so notify the petitioner and shall the table of this paragraph and held
thereafter proceed in accordance with continuously at or above that tempera-
the regulations in part 171 of this chap- ture for the specified time (or other
ter. time/temperature relationship which
has been demonstrated to be equivalent
thereto in microbial destruction):
PART 131—MILK AND CREAM
Temperature Time
145 °F 1 ..................................................... 30 minutes
Sec. 161 °F 1 ..................................................... 15 seconds
131.3 Definitions. 191 °F ....................................................... 1 second
204 °F ....................................................... 0.05 second
131.25 Whipped cream products containing 212 °F ....................................................... 0.01 second
flavoring or sweetening.
1 If the dairy ingredient has a fat content of 10 percent or
more, or if it contains added sweeteners, the specified tem-
Subpart B—Requirements for Specific perature shall be increased by 5 °F.
Standardized Milk and Cream
(c) Ultra-pasteurized when used to de-
131.110 Milk. scribe a dairy product means that such
131.111 Acidified milk. product shall have been thermally
131.112 Cultured milk.
processed at or above 280 °F for at least
131.115 Concentrated milk.
131.120 Sweetened condensed milk. 2 seconds, either before or after pack-
131.125 Nonfat dry milk. aging, so as to produce a product which

131.127 Nonfat dry milk fortified with vita- has an extended shelf life under refrig-
mins A and D. erated conditions.
446
§ 131.25 Whipped cream products con- (d) Methods of analysis. Referenced

taining flavoring or sweetening. methods are from ‘‘Official Methods of
The unqualified name ‘‘whipped Analysis of the Association of Official
cream’’ should not be applied to any Analytical Chemists,’’ 13th Ed. (1980),
product other than one made by whip- which is incorporated by reference.
ping the cream that complies with the Copies may be obtained from the AOAC
standards of identity for whipping INTERNATIONAL, 481 North Frederick
cream (§§ 131.150 and 131.157 of this Ave., suite 500, Gaithersburg, MD 20877,
chapter). If flavoring and/or sweetening or may be examined at the National
is added, the resulting product is a fla- Archives and Records Administration
vored and/or sweetened whipped cream, (NARA). For information on the avail-
and should be so identified. ability of this material at NARA, call
202–741–6030, or go to: http://
Subpart B—Requirements for Spe- codeloflfederallregulations/
cific Standardized Milk and ibrllocations.html.
Cream (1) Milkfat content—‘‘Fat, Roese-
Gottlieb Method—Official Final Ac-
§ 131.110 Milk.
tion,’’ section 16.059.
(a) Description. Milk is the lacteal se- (2) Milk solids not fat content—Cal-
cretion, practically free from colos- culated by subtracting the milk fat
trum, obtained by the complete milk- content from the total solids content
ing of one or more healthy cows. Milk as determined by the method ‘‘Total
that is in final package form for bev- Solids, Method I—Official Final Ac-
erage use shall have been pasteurized tion,’’ section 16.032.
or ultrapasteurized, and shall contain (3) Vitamin D content—‘‘Vitamin D—
not less than 81⁄4 percent milk solids Official Final Action,’’ sections 43.195–
not fat and not less than 31⁄4 percent 43.208.
milkfat. Milk may have been adjusted
(e) Nomenclature. The name of the
by separating part of the milkfat
food is ‘‘milk’’. The name of the food
therefrom, or by adding thereto cream,
concentrated milk, dry whole milk, shall be accompanied on the label by a
skim milk, concentrated skim milk, or declaration indicating the presence of
nonfat dry milk. Milk may be homog- any characterizing flavoring, as speci-
enized. fied in § 101.22 of this chapter.
(b) Vitamin addition (Optional). (1) If (1) The following terms shall accom-
added, vitamin A shall be present in pany the name of the food wherever it
such quantity that each quart of the appears on the principal display panel
food contains not less than 2000 Inter- or panels of the label in letters not less
national Units thereof within limits of than one-half the height of the letters
good manufacturing practice. used in such name:
(2) If added, vitamin D shall be (i) If vitamins are added, the phrase
present in such quantity that each ‘‘vitamin A’’ or ‘‘vitamin A added’’, or
quart of the food contains 400 Inter- ‘‘vitamin D’’ or ‘‘vitamin D added’’, or
national Units thereof within limits of ‘‘vitamin A and D’’ or ‘‘vitamins A and
good manufacturing practice. D added’’, as is appropriate. The word
(c) Optional ingredients. The following ‘‘vitamin’’ may be abbreviated ‘‘vit.’’.
safe and suitable ingredients may be (ii) The word ‘‘ultra-pasteurized’’ if
used: the food has been ultra-pasteurized.
(1) Carriers for vitamins A and D. (2) The following terms may appear
(2) Characterizing flavoring ingredi- on the label:
ents (with or without coloring, nutri- (i) The word ‘‘pasteurized’’ if the food
tive sweetener, emulsifiers, and stabi- has been pasteurized.
lizers) as follows: (ii) The word ‘‘homogenized’’ if the
(i) Fruit and fruit juice (including food has been homogenized.
concentrated fruit and fruit juice). (f) Label declaration. Each of the in-
(ii) Natural and artificial food gredients used in the food shall be de-
flavorings. clared on the label as required by the
447
§ 131.111 21 CFR Ch. I (4–1–16 Edition)
applicable sections of parts 101 and 130 lactalbumins, lactoglobulins, or whey

of this chapter. modified by partial or complete re-
[42 FR 14360, Mar. 15, 1977, as amended at 47 moval of lactose and/or minerals, to in-
FR 11822, Mar. 19, 1982; 49 FR 10090, Mar. 19, crease the nonfat solids content of the
1984; 54 FR 24892, June 12, 1989; 58 FR 2890, food: Provided, That the ratio of pro-
Jan. 6, 1993] tein to total nonfat solids of the food,
and the protein efficiency ratio of all
§ 131.111 Acidified milk. protein present, shall not be decreased
(a) Description. Acidified milk is the as a result of adding such ingredients.
food produced by souring one or more (2) Nutritive carbohydrate sweet-
of the optional dairy ingredients speci- eners. Sugar (sucrose), beet or cane; in-
fied in pargaph (c) of this section with vert sugar (in paste or sirup form);
one or more of the acidifying ingredi- brown sugar; refiner’s sirup; molasses
ents specified in paragraph (d) of this (other than blackstrap); high fructose
section, with or without the addition of corn sirup; fructose; fructose sirup;
characterizing microbial organisms. maltose; maltose sirup, dried maltose
One or more of the other optional in- sirup; malt extract, dried malt extract;
gredients specified in paragraphs (b) malt sirup, dried malt sirup; honey;
and (e) of this section may also be maple sugar; or any of the sweeteners
added. When one or more of the ingre- listed in part 168 of this chapter, except
dients specified in paragraph (e)(1) of table sirup.
this section are used, they shall be in- (3) Flavoring ingredients.
cluded in the souring process. All in- (4) Color additives that do not impart
gredients used are safe and suitable. a color simulalting that of milkfat or
Acidified milk contains not less than butterfat.
3.25 percent milkfat and not less than (5) Stabilizers.
8.25 percent milk solids not fat and has
(6) Butterfat or milkfat, which may
a titratable acidity of not less than 0.5
or may not contain color additives, in
percent, expressed as lactic acid. The
the form of flakes or granules.
food may be homogenized and shall be
(7) Aroma- and flavor-producing mi-
pasteurized or ultra-pasteurized prior
crobial culture.
to the addition of the microbial culture
and, when applicable, the addition of (8) Salt.
flakes or granules of butterfat or (9) Citric acid, in a maximum amount
milkfat. of 0.15 percent by weight of the milk
(b) Vitamin addition (optional). (1) If used, or an equivalent amount of so-
added, vitamin A shall be present in dium citrate, as a flavor precursor.
such quantity that each 946 milliliters (f) Methods of analysis. The following
(quart) of the food contains not less referenced methods of analysis are
than 2,000 International Units thereof, from ‘‘Official Methods of Analysis of
within limits of good manufacturing the Association of Official Analytical
practice. Chemists,’’ 13th Ed. (1980), which is in-
(2) If added, vitamin D shall be corporated by reference. Copies are
present in such quantity that each 946 available from the AOAC INTER-
milliliters (quart) of the food contains NATIONAL, 481 North Frederick Ave.,
400 International Units thereof, within suite 500, Gaithersburg, MD 20877, or
limits of good manufacturing practice. available for inspection at the National
(c) Optional dairy ingredients. Cream, Archives and Records Administration
milk, partially skimmed milk, or skim (NARA). For information on the avail-
milk, used alone or in combination. ability of this material at NARA, call
(d) Optional acidifying ingredients. 202–741–6030, or go to: http://
Acetic acid, adipic acid, citric acid, fu- www.archives.gov/federallregister/
maric acid, glucono-delta- lactone, hy- codeloflfederallregulations/
drochloric acid, lactic acid, malic acid, ibrllocations.html.
phosphoric acid, succinic acid, and tar- (1) Milkfat content—As determined
taric acid. by the method prescribed in section
(e) Other optional ingredients. (1) Con- 16.059, ‘‘Roese-Gottlieb Method (Ref-
centrated skim milk, nonfat dry milk, erence Method) (11)—Official Final Ac-
buttermilk, whey, lactose, tion,’’ under the heading ‘‘Fat.’’
448
(2) Milk solids not fat content—Cal- applicable sections of parts 101 and 130
culated by subtracting the milkfat con- of this chapter.
tent from the total solids content as [46 FR 9934, Jan. 30, 1981, as amended at 47
determined by the method prescribed FR 11822, Mar. 19, 1982; 47 FR 41523, Sept. 21,
in section 16.032, ‘‘Method I—Official 1982; 48 FR 24869, June 3, 1983; 54 FR 24892,
Final Action,’’ under the heading June 12, 1989; 58 FR 2890, Jan. 6, 1993]
‘‘Total Solids.’’
§ 131.112 Cultured milk.
(3) Titratable acidity—As determined
by the method prescribed in section (a) Description. Cultured milk is the
16.023, ‘‘Acidity (2)—Official Final Ac- food produced by culturing one or more
tion,’’ or by an equivalent potentio- of the optional dairy ingredients speci-
metric method. fied in paragraph (c) of this section
with characterizing microbial orga-
(g) Nomenclature. The name of the
nisms. One or more of the other op-
food is ‘‘acidified milk’’. The full name tional ingredients specified in para-
of the food shall appear on the prin- graphs (b) and (d) of this section may
cipal display panel of the label in type also be added. When one or more of the
of uniform size, style, and color. The ingredients specified in paragraph
name of the food shall be accompanied (d)(1) of this section are used, they
by a declaration indicating the pres- shall be included in the culturing proc-
ence of any characterizing flavoring as ess. All ingredients used are safe and
specified in § 101.22 of this chapter, and suitable. Cultured milk contains not
may be accompanied by a declaration less than 3.25 percent milkfat and not
such as a traditional name of the food less than 8.25 percent milk solids not
or the generic name of the organisms fat and has a titratable acidity of not
used, thereby indicating the presence less than 0.5 percent, expressed as lac-
of the characterizing microbial orga- tic acid. The food may be homogenized
nisms or ingredients when used, e.g., and shall be pasteurized or ultra-pas-
‘‘acidified kefir milk’’, ‘‘acidified aci- teurized prior to the addition to the
dophilus milk’’, or when characterizing microbial culture, and when applicable,
ingredients such as those in paragraphs the addition of flakes or granules of
(e) (6), (7), (8), and (9) of this section are butterfat or milkfat.
used, the food may be named ‘‘acidified (b) Vitamin addition (optional). (1) If
added, vitamin A shall be present in
buttermilk’’.
such quantity that each 946 milliliters
(1) The following terms shall accom-
(quart) of the food contains not less
pany the name of the food wherever it than 2,000 International Units thereof,
appears on the principal display panel within limits of good manufacturing
or panels of the label in letters not less practice.
than one-half of the height of the let- (2) If added, vitamin D shall be
ters used in such name: present in such quantity that each 946
(i) The phrase ‘‘vitamin A’’ or ‘‘vita- milliliters (quart) of the food contains
min A added’’, or ‘‘vitamin D’’ or ‘‘vi- 400 International Units thereof, within
tamin D added’’, or ‘‘vitamins A and D limits of good manufacturing practice.
added’’, as appropriate. The word ‘‘vi- (c) Optional dairy ingredients. Cream,
tamin’’ may be abbreviated ‘‘vit.’’. milk, partially skimmed milk, or skim
(ii) The word ‘‘sweetened’’ if nutri- milk, used alone or in combination.
tive carbohydrate sweetener is added (d) Other optional ingredients. (1) Con-
without the addition of characterizing centrated skim milk, nonfat dry milk,
flavoring. buttermilk, whey, lactose, lactalbum-
(2) The term ‘‘homogenized’’ may ap- ins, lactoglobulins, or whey modified
pear on the label if the dairy ingredi- by partial or complete removal of lac-
tose and/or minerals, to increase the
ents used are homogenized.
nonfat solids content of the food: Pro-
(h) Label declaration. Each of the in- vided, That the ratio of protein to total
gredients used in the food shall be de- nonfat solids of the food, and the pro-
clared on the label as required by the tein efficiency ratio of all protein
present, shall not be decreased as a re-
sult of adding such ingredients.
449
§ 131.115 21 CFR Ch. I (4–1–16 Edition)
(2) Nutritive carbohydrate sweet- tion,’’ or by an equivalent potentio-

eners. Sugar (sucrose), beet or cane; in- metric method.
vert sugar (in paste or sirup form); (f) Nomenclature. The name of the
brown sugar; refiner’s sirup; molasses food is ‘‘cultured milk’’. The full name
(other than blackstrap); high fructose of the food shall appear on the prin-
corn sirup; fructose; fructose sirup; cipal display panel in type of uniform
maltose; maltose sirup, dried maltose size, style, and color. The name of the
sirup; malt extract, dried malt extract; food shall be accompanied by a declara-
malt sirup, dried malt sirup; honey; tion indicating the presence of any
maple sugar; or any of the sweeteners characterizing flavoring as specified in
listed in part 168 of this chapter, except § 101.22 of this chapter, and may be ac-
table sirup. companied by a declaration such as a
(3) Flavoring ingredients. traditional name of the food or the ge-
(4) Color additives that do not impart neric name of the organisms used,
a color simulating that of milkfat or thereby indicating the presence of the
butterfat. characterizing microbial organisms or
(5) Stabilizers. ingredients, e.g., ‘‘kefir cultured
(6) Butterfat or milkfat, which may milk’’, ‘‘acidophilus cultured milk’’, or
or may not contain color additives, in when characterizing ingredients such
the form of flakes or granules. as those in paragraphs (d) (6), (7), (8),
and (9) of this section, and lactic acid-
(7) Aroma- and flavor-producing mi-
producing organisms are used the food
crobial culture.
may be named ‘‘cultured buttermilk’’.
(8) Salt. (1) The following terms shall accom-
(9) Citric acid, in a maximum amount pany the name of the food wherever it
of 0.15 percent by weight of the milk appears on the principal display panel
used, or an equivalent amount of so- or panels of the label in letters not less
dium citrate, as a flavor precursor. than one-half of the height of the let-
(e) Methods of analysis. The following ters used in such name:
referenced methods of analysis are (i) The phrase ‘‘vitamin A’’ or ‘‘vita-
from ‘‘Official Methods of Analysis of min A added’’, or ‘‘vitamin D’’ or ‘‘vi-
the Association of Official Analytical tamin D added’’, or ‘‘vitamin A and D
Chemists,’’ 13th Ed. (1980), which is in- added’’, as appropriate. The word ‘‘vi-
corporated by reference. Copies may be tamin’’ may be abbreviated ‘‘vit.’’.
obtained from the AOAC INTER- (ii) The word ‘‘sweetened’’ if nutri-
NATIONAL, 481 North Frederick Ave., tive carbohydrate sweetener is added
suite 500, Gaithersburg, MD 20877, or without the addition of characterizing
available for inspection at the National flavoring.
Archives and Records Administration (2) The term ‘‘homogenized’’ may ap-
(NARA). For information on the avail- pear on the label if the dairy ingredi-
ability of this material at NARA, call ents used are homogenized.
202–741–6030, or go to: http:// (g) Label declaration. Each of the in-
www.archives.gov/federallregister/ gredients used in the food shall be de-
codeloflfederallregulations/ clared on the label as required by the
ibrllocations.html. applicable sections of parts 101 and 130
(1) Milkfat content—section 16.059, of this chapter.
‘‘Roese-Gottlieb Method (Reference [46 FR 9934, Jan. 30, 1981, as amended at 47
Method) (11)—Official Final Action,’’ FR 11822, Mar. 19, 1982; 47 FR 41523, Sept. 21,
under the heading ‘‘Fat.’’ 1982; 48 FR 24869, June 3, 1983; 54 FR 24892,
(2) Milk solids not fat content—Cal- June 12, 1989; 58 FR 2890, Jan. 6, 1993]
culated by subtracting the milkfat con-
tent from the total solids content as § 131.115 Concentrated milk.
determined by the method prescribed (a) Description. Concentrated milk is
in section 16.032, ‘‘Method I—Official the liquid food obtained by partial re-
Final Action,’’ under the heading moval of water from milk. The milkfat
‘‘Total Solids.’’ and total milk solids contents of the
(3) Titratable acidity—As determined food are not less than 7.5 and 25.5 per-
by the methods prescribed in section cent, respectively. It is pasteurized,
16.023 ‘‘Acidity (2)—Official Final Ac- but is not processed by heat so as to
450
prevent spoilage. It may be homog- (f) Label declaration. Each of the in-
enized. gredients used in the food shall be de-
(b) Vitamin addition (Optional). If clared on the label as required by the
added, vitamin D shall be present in applicable sections of parts 101 and 130
such quantity that each fluid ounce of of this chapter.
the food contains 25 International [42 FR 14360, Mar. 15, 1977, as amended at 47
Units thereof, within limits of good FR 11822, Mar. 19, 1982; 48 FR 13024, Mar. 29,
manufacturing practice. 1983; 49 FR 10090, Mar. 19, 1984; 54 FR 24892,
(c) Optional ingredients. The following June 12, 1989; 58 FR 2890, Jan. 6, 1993]
safe and suitable optional ingredients
may be used: § 131.120 Sweetened condensed milk.
(1) Carrier for vitamin D. (a) Description. Sweetened condensed
(2) Characterizing flavoring ingredi- milk is the food obtained by partial re-
ents, with or without coloring, as fol- moval of water only from a mixture of
lows: milk and safe and suitable nutritive
(i) Fruit and fruit juice, including carbohydrate sweeteners. The finished
concentrated fruit and fruit juice. food contains not less than 8 percent
(ii) Natural and artificial food fla- by weight of milkfat, and not less than
voring. 28 percent by weight of total milk sol-
ids. The quantity of nutritive carbo-
(d) Methods of analysis. Referenced
hydrate sweetener used is sufficient to
methods are from ‘‘Official Methods of
prevent spoilage. The food is pasteur-
Analysis of the Association of Official
ized and may be homogenized.
Analytical Chemists,’’ 13th Ed. (1980),
(b) Optional ingredients. The following
which is incorporated by reference.
safe and suitable characterizing fla-
Copies may be obtained from the AOAC
voring ingredients, with or without
INTERNATIONAL, 481 North Frederick
coloring and nutritive carbohydrate
Ave., suite 500, Gaithersburg, MD 20877,
sweeteners, may be used:
or may be examined at the National (1) Fruit and fruit juice, including
Archives and Records Administration concentrated fruit and fruit juice.
(NARA). For information on the avail- (2) Natural and artificial food fla-
ability of this material at NARA, call voring.
202–741–6030, or go to: http:// (c) Methods of analysis. The milkfat
www.archives.gov/federallregister/ content is determined by the method
codeloflfederallregulations/ prescribed in ‘‘Official Methods of
ibrllocations.html. Analysis of the Association of Official
(1) Milkfat content—‘‘Fat—Official Analytical Chemists,’’ 13th Ed. (1980),
Final Action,’’ section 16.172. section 16.185, under ‘‘Fat—Official
(2) Total milk solids—‘‘Total Solids— Final Action,’’ which is incorporated
Official Final Action,’’ section 16.169. by reference. Copies may be obtained
(3) Vitamin D content—‘‘Vitamin D from the AOAC INTERNATIONAL, 481
in Milk—Official Final Action,’’ sec- North Frederick Ave., suite 500, Gai-
tions 43.195–43.208. thersburg, MD 20877, or may be exam-
(e) Nomenclature. The name of the ined at the National Archives and
food is ‘‘Concentrated milk’’ or alter- Records Administration (NARA). For
natively ‘‘Condensed milk’’. If the food information on the availability of this
contains added vitamin D, the phrase material at NARA, call 202–741–6030, or
‘‘vitamin D’’ or ‘‘vitamin D added’’ go to: http://www.archives.gov/
shall accompany the name of the food federallregister/
wherever it appears on the principal codeloflfederallregulations/
display panel or panels of the label in ibrllocations.html.
letters not less than one-half the (d) Nomenclature. The name of the
height of the letters used in such name. food is ‘‘Sweetened condensed milk.’’
The word ‘‘homogenized’’ may appear The word ‘‘homogenized’’ may appear
on the label if the food has been ho- on the label if the food has been ho-
mogenized. The name of the food shall mogenized. The name of the food shall
include a declaration of the presence of include a declaration of the presence of

any characterizing flavoring, as speci- any characterizing flavoring, as speci-
fied in § 101.22 of this chapter. fied in § 101.22 of this chapter.
451
§ 131.125 21 CFR Ch. I (4–1–16 Edition)
(e) Label declaration. Each of the in- practice. The name of the food shall in-
gredients used in the food shall be de- clude a declaration of the presence of
clared on the label as required by the any characterizing flavoring, as speci-
applicable sections of parts 101 and 130 fied in § 101.22 of this chapter.
of this chapter. (e) Label declaration. Each of the in-
[43 FR 21670, May 19, 1978, as amended at 47 gredients used in the food shall be de-
FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, clared on the label as required by the
1984; 54 FR 24892, June 12, 1989; 58 FR 2890, applicable sections of parts 101 and 130
Jan. 6, 1993] of this chapter.
§ 131.125 Nonfat dry milk. [42 FR 14360, Mar. 15, 1977, as amended at 43
FR 19836, May 9, 1978; 47 FR 11823, Mar. 19,
(a) Description. Nonfat dry milk is the 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892,
product obtained by removal of water June 12, 1989; 58 FR 2890, Jan. 6, 1993]
only from pasteurized skim milk. It
contains not more than 5 percent by § 131.127 Nonfat dry milk fortified
weight of moisture, and not more than with vitamins A and D.
11⁄2 percent by weight of milkfat unless (a) Description. Nonfat dry milk for-
otherwise indicated. tified with vitamins A and D conforms
(b) Optional ingredients. Safe and suit- to the standard of identity for nonfat
able characterizing flavoring ingredi- dry milk, except that vitamins A and D
ents (with or without coloring and nu- are added as prescribed by paragraph
tritive carbohydrate sweetener) as fol- (b) of this section.
lows: (b) Vitamin addition. (1) Vitamin A is
(1) Fruit and fruit juice, including added in such quantity that, when pre-
concentrated fruit and fruit juice. pared according to label directions,
(2) Natural and artificial food each quart of the reconstituted product
flavorings. contains 2000 International Units
(c) Methods of analysis. The following thereof.
referenced methods of analysis are
(2) Vitamin D is added in such quan-
from ‘‘Official Methods of Analysis of
tity that, when prepared according to
the Association of Official Analytical
label directions, each quart of the re-
Chemists,’’ 13th Ed. (1980), which is in-
constituted product contains 400 Inter-
corporated by reference. Copies may be
national Units thereof.
obtained from the AOAC INTER-
(3) The requirements of this para-
NATIONAL, 481 North Frederick Ave.,
graph will be deemed to have been met
suite 500, Gaithersburg, MD 20877, or
if reasonable overages, within limits of
may be examined at the National Ar-
good manufacturing practice, are
chives and Records Administration
present to ensure that the required lev-
(NARA). For information on the avail-
els of vitamins are maintained
ability of this material at NARA, call
throughout the expected shelf life of
202–741–6030, or go to: http://
the food under customary conditions of
distribution.
ibrllocations.html. (c) Optional ingredients. The following
(1) Milkfat content—‘‘Fat in Dried safe and suitable optional ingredients
Milk—Official Final Action,’’ sections may be used:
16.199–16.200. (1) Carriers for vitamins A and D.
(2) Moisture content—‘‘Moisture—Of- (2) Characterizing flavoring ingredi-
ficial Final Action,’’ section 16.192. ents, with or without coloring and nu-
(d) Nomenclature. The name of the tritive carbohydrate sweetener, as fol-
food is ‘‘Nonfat dry milk’’. If the fat lows:
content is over 11⁄2 percent by weight, (i) Fruit and fruit juice, including
the name of the food on the principal concentrated fruit and fruit juice.
display panel or panels shall be accom- (ii) Natural and artificial food
panied by the statement ‘‘Contains l% flavorings.
milkfat’’, the blank to be filled in with (d) Methods of analysis. The following
the percentage to the nearest one- referenced methods of analysis are

tenth of 1 percent of fat contained, from ‘‘Official Methods of Analysis of
within limits of good manufacturing the Association of Official Analytical
452
Chemists,’’ 13th Ed. (1980), which is in- tainer and so processed by heat, either
corporated by reference. Copies may be before or after sealing, as to prevent
obtained from the AOAC INTER- spoilage.
NATIONAL, 481 North Frederick Ave., (b) Vitamin addition. (1) Vitamin D
suite 500, Gaithersburg, MD 20877, or shall be present in such quantity that
may be examined at the National Ar- each fluid ounce of the food contains 25
chives and Records Administration International Units thereof within lim-
(NARA). For information on the avail- its of good manufacturing practice.
ability of this material at NARA, call (2) Addition of vitamin A is optional,
202–741–6030, or go to: http:// If added, vitamin A shall be present in
www.archives.gov/federallregister/ such quantity that each fluid ounce of
codeloflfederallregulations/ the food contains not less than 125
ibrllocations.html. International Units thereof within lim-
(1) Milkfat content—‘‘Fat in Dried its of good maufacturing practice.
Milk—Official Final Action,’’ sections (c) Optional ingredients. The following
16.199–16.200. safe and suitable ingredients may be
(2) Moisture content—‘‘Moisture—Of- used:
ficial Final Action,’’ section 16.192. (1) Carriers for vitamins A and D.
(3) Vitamin D content—‘‘Vitamin D— (2) Emulsifiers.
Official Final Action,’’ sections 43.195– (3) Stabilizers, with or without
43.208. dioctyl sodium sulfosuccinate (when
(e) Nomenclature. The name of the permitted by and complying with the
food is ‘‘Nonfat dry milk fortified with provisions of § 172.810 of this chapter) as
vitamins A and D’’. If the fat content is a solubilizing agent.
over 11⁄2 percent by weight, the name of (4) Characterizing flavoring ingredi-
the food on the principal display panel ents, with or without coloring and nu-
or panels shall be accompanied by the tritive carbohydrate sweeteners, as fol-
statement ‘‘Contains l% milkfat’’, the lows:
blank to be filled in to the nearest one- (i) Fruit and fruit juice, including
tenth of 1 percent with the percentage concentrated fruit and fruit juice.
of fat contained within limits of good (ii) Natural and artificial food fla-
manufacturing practice. The name of voring.
the food shall include a declaration of (d) Methods of analysis. The following
the presence of any characterizing fla- referenced methods of analysis are
voring, as specified in § 101.22 of this from ‘‘Official Methods of Analysis of
chapter. the Association of Official Analytical
(f) Label declaration. Each of the in- Chemists,’’ 13th Ed. (1980), which is in-
gredients used in the food shall be de- corporated by reference. Copies may be
clared on the label as required by the obtained from the AOAC INTER-
applicable sections of parts 101 and 130 NATIONAL, 481 North Frederick Ave.,
of this chapter. suite 500, Gaithersburg, MD 20877, or
[42 FR 14360, Mar. 15, 1977, as amended at 43 may be examined at the National Ar-
FR 19836, May 9, 1978; 43 FR 29769, July 11, chives and Records Administration
1978; 43 FR 36622, Aug. 18, 1978; 47 FR 11823, (NARA). For information on the avail-
Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR ability of this material at NARA, call
24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993] 202–741–6030, or go to: http://
§ 131.130 Evaporated milk. codeloflfederallregulations/
(a) Description. Evaporated milk is ibrllocations.html.
the liquid food obtained by partial re- (1) Milkfat content—‘‘Fat—Official
moval of water only from milk. It con- Final Action,’’ section 16.172.
tains not less than 6.5 percent by (2) Total milk solids—‘‘Total Solids—
weight of milkfat, not less than 16.5 Official Final Action,’’ section 16.169.
percent by weight of milk solids not (3) Vitamin D content—‘‘Vitamin D
fat, and not less than 23 percent by in Milk—Official Final Action,’’ sec-
weight of total milk solids. Evaporated tions 43.195–43.208.
milk contains added vitamin D as pre- (e) Nomenclature. The name of the
scribed by paragraph (b) of this section. food is ‘‘Evaporated milk.’’ The phrase
It is homogenized. It is sealed in a con- ‘‘vitamin D’’ or ‘‘vitamin D added’’, or
453
§ 131.147 21 CFR Ch. I (4–1–16 Edition)
‘‘vitamins A and D’’ or ‘‘vitamins A ages, within limits of good manufac-

and D added’’, as is appropriate, shall turing practice, are present to ensure
immediately precede or follow the that the required levels of vitamins are
name of the food wherever it appears maintained throughout the expected
on the principal display panel or panels shelf life of the food under customary
of the label in letters not less than one- conditions of distribution.
half the height of the letters used in (c) Optional ingredients. The following
such name. The name of the food shall safe and suitable optional ingredients
include a declaration of a the presence may be used:
of any characterizing flavoring, as (1) Carriers for vitamins A and D.
specified in § 101.22 of this chapter. (2) Emulsifiers.
(f) Label declaration. Each of the in- (3) Stabilizers.
gredients used in the food shall be de-
(4) Anticaking agents.
clared on the label as required by the
(5) Antioxidants.
applicable sections of parts 101 and 130
of this chapter. (6) Characterizing flavoring ingredi-
ents (with or without coloring and nu-
[43 FR 21670, May 19, 1978, as amended at 47 tritive carbohydrate sweetener) as fol-
FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, lows:
1984; 54 FR 24892, June 12, 1989; 58 FR 2890,
Jan. 6, 1993; 59 FR 17691, Apr. 14, 1994]
(i) Fruit and fruit juice, including
concentrated fruit and fruit juice.
§ 131.147 Dry whole milk. (ii) Natural and artificial food fla-
(a) Description. Dry whole milk is the voring.
product obtained by removal of water (d) Methods of analysis. The following
only from pasteurized milk, as defined referenced methods of analysis are
in § 131.110(a), which may have been ho- from ‘‘Official Methods of Analysis of
mogenized. Alternatively, dry whole the Association of Official Analytical
milk may be obtained by blending Chemists,’’ 13th Ed. (1980), which is in-
fluid, condensed, or dried nonfat milk corporated by reference. Copies may be
with liquid or dried cream or with obtained from the AOAC INTER-
fluid, condensed, or dried milk, as ap- NATIONAL, 481 North Frederick Ave.,
propriate, provided the resulting dry suite 500, Gaithersburg, MD 20877, or
whole milk is equivalent in composi- may be examined at the National Ar-
tion to that obtained by the method chives and Records Administration
described in the first sentence of this (NARA). For information on the avail-
paragraph. It contains the lactose, ability of this material at NARA, call
milk proteins, milkfat, and milk min- 202–741–6030, or go to: http://
erals in the same relative proportions www.archives.gov/federallregister/
as the milk from which it was made. It codeloflfederallregulations/
contains not less than 26 percent but ibrllocations.html.
less than 40 percent by weight of (1) Milkfat content—‘‘Fat in Dried
milkfat on an as is basis. It contains Milk—Official Final Action,’’ sections
not more than 5 percent by weight of 16.199–16.200.
moisture on a milk solids not fat basis. (2) Moisture content—‘‘Moisture—Of-
(b) Vitamin addition. (1) Addition of ficial Final Action,’’ section 16.192.
vitamin A is optional. If added, vita- (3) Vitamin D content—‘‘Vitamin D—
min A shall be present in such quantity Official Final Action,’’ sections 43.195–
that, when prepared according to label 43.208.
directions, each quart of the reconsti- (e) Nomenclature. The name of the
tuted product shall contain not less food is ‘‘Dry whole milk.’’ The name of
than 2,000 International Units thereof. the food shall appear on the principal
(2) Addition of vitamin D is optional. display panel of the label in type of
If added, vitamin D shall be present in uniform size, style, and color. The
such quantity that, when prepared ac- name of the food shall be accompanied
cording to label directions, each quart by a declaration indicating the pres-
of the reconstituted product shall con- ence of any characterizing flavoring as
tain 400 International Units thereof. specified in § 101.22 of this chapter. The
(3) The requirements of this para- following phrases in type size not less
graph will be met if reasonable over- than one-half the height of the type
454
size used in such name shall accom- (c) Methods of analysis. The following
pany the name of the food wherever it referenced methods of analysis are
appears on the principal display panel from ‘‘Official Methods of Analysis of
or panels. the Association of Official Analytical
(1) The phrase ‘‘Contains l% Chemists,’’ 13th Ed. (1980), which is in-
milkfat’’, the blank to be filled in with corporated by reference. Copies may be
the whole number closest to the actual obtained from the AOAC INTER-
fat content of the food. NATIONAL, 481 North Frederick Ave.,
(2) If vitamins are ‘‘added’’, the suite 500, Gaithersburg, MD 20877, or
phrase ‘‘vitamin A’’, or ‘‘vitamin A may be examined at the National Ar-
added’’, or ‘‘vitamin D’’, or ‘‘vitamin D chives and Records Administration
added’’, or ‘‘vitamins A and D’’, or ‘‘vi- (NARA). For information on the avail-
tamins A and D added’’, as appropriate. ability of this material at NARA, call
The word ‘‘vitamin’’ may be abbre- 202–741–6030, or go to: http://
viated ‘‘vit.’’ www.archives.gov/federallregister/
(f) Label declaration. Each of the in- codeloflfederallregulations/
gredients used in the food shall be de- ibrllocations.html.
clared on the label as required by the (1) Milkfat content—‘‘Fat in Dried
applicable sections of parts 101 and 130 Milk—Official Final Action,’’ sections
of this chapter. 16.199–16.200.
[43 FR 19836, May 9, 1978, as amended at 47
(2) Moisture content—‘‘Moisture—Of-
FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, ficial Final Action,’’ section 16.192.
1984; 54 FR 24893, June 12, 1989; 58 FR 2891, (d) Nomenclature. The name of the
Jan. 6, 1993] food is ‘‘Dry cream.’’ The name of the
food shall appear on the principal dis-
§ 131.149 Dry cream. play panel of the label in type of uni-
(a) Description. Dry cream is the prod- form size, style, and color. The name of
uct obtained by removal of water only the food shall be accompanied by a dec-
from pasteurized milk or cream or a laration indicating the presence of any
mixture thereof, which may have been characterizing flavoring as specified in
homogenized. Alternatively, dry cream § 101.22 of this chapter. The following
may be obtained by blending dry milks terms shall accompany the name of the
as defined in §§ 131.125(a) and 131.147(a) food wherever it appears on the prin-
with dry cream as appropriate: Pro- cipal display panel or panels of the
vided, That the resulting product is label, in letters not less than one-half
equivalent in composition to that ob- of the height of the letters used in such
tained by the method described in the name:
first sentence of this paragraph. It con- (1) The phrase ‘‘Contains l%
tains not less than 40 percent but less milkfat’’, the blank to be filled in with
than 75 percent by weight of milkfat on the whole number closest to the actual
an as is basis. It contains not more fat content of the food.
than 5 percent by weight of moisture (2) The word ‘‘sweetened’’ if no char-
on a milk solids not fat basis. acterizing flavoring ingredients are
(b) Optional ingredients. The following used but nutritive carbohydrate sweet-
safe and suitable optional ingredients ener is added.
may be used: (e) Label declaration. Each of the in-
(1) Emulsifiers. gredients used in the food shall be de-
(2) Stabilizers. clared on the label as required by the
(3) Anticaking agents. applicable sections of parts 101 and 130
(4) Antioxidants. of this chapter.
(5) Nutritive carbohydrate sweet- [43 FR 19836, May 9, 1978, as amended at 44
eners. FR 3965, Jan. 19, 1979; 47 FR 11824, Mar. 19,
(6) Characterizing flavoring ingredi- 1982; 48 FR 13024, Mar. 29, 1983; 49 FR 10092,
ents, with or without coloring, as fol- Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR
lows: 2891, Jan. 6, 1993; 61 FR 59002, Nov. 20, 1996]
(i) Fruit and fruit juice, including
concentrated fruit and fruit juice. § 131.150 Heavy cream.

(ii) Natural and artificial food fla- (a) Description. Heavy cream is cream
voring. which contains not less than 36 percent
455
§ 131.155 21 CFR Ch. I (4–1–16 Edition)
milkfat. It is pasteurized or ultra-pas- (e) Label declaration. Each of the in-

teurized, and may be homogenized. gredients used in the food shall be de-
(b) Optional ingredients. The following clared on the label as required by the
safe and suitable optional ingredients applicable sections of parts 101 and 130
may be used: of this chapter.
(1) Emulsifiers. [42 FR 14360, Mar. 15, 1977, as amended at 47
(2) Stabilizers. FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19,
(3) Nutritive sweeteners. 1984; 54 FR 24893, June 12, 1989; 58 FR 2891,
(4) Characterizing flavoring ingredi- Jan. 6, 1993]
ents (with or without coloring) as fol-
§ 131.155 Light cream.
lows:
(i) Fruit and fruit juice (including (a) Description. Light cream is cream
concentrated fruit and fruit juice). which contains not less than 18 percent
(ii) Natural and artificial food fla- but less than 30 percent milkfat. It is
voring. pasteurized or ultra-pasteurized, and
(c) Methods of analysis. The milkfat may be homogenized.
content is determined by the method
safe and suitable ingredients may be
prescribed in ‘‘Official Methods of
used:
Analysis of the Association of Official
(1) Stabilizers.
Analytical Chemists,’’ 13th Ed. (1980),
(2) Emulsifiers.
sections 16.156 and 16.059, under ‘‘Fat,
(3) Nutritive sweeteners.
Roese-Gottlieb Method—Official Final
(4) Characterizing flavoring ingredi-
Action,’’ which is incorporated by ref-
erence. Copies may be obtained from
lows:
the AOAC INTERNATIONAL, 481 North (i) Fruit and fruit juice (including
Frederick Ave., suite 500, Gaithersburg, concentrated fruit and fruit juice).
MD 20877, or may be examined at the (ii) Natural and artificial food fla-
National Archives and Records Admin- voring.
istration (NARA). For information on (c) Methods of analysis. The milkfat
the availability of this material at content is determined by the method
NARA, call 202–741–6030, or go to: http:// prescribed in ‘‘Official Methods of
www.archives.gov/federallregister/ Analysis of the Association of Official
codeloflfederallregulations/ Analytical Chemists,’’ 13th Ed. (1980),
ibrllocations.html. sections 16.156 and 16.059, under ‘‘Fat,
(d) Nomenclature. (1) The name of the Roese-Gottlieb Method—Official Final
food is ‘‘Heavy cream’’ or alternatively Action,’’ which is incorporated by ref-
‘‘Heavy whipping cream’’. The name of erence. Copies may be obtained from
the food shall be accompanied on the the AOAC INTERNATIONAL, 481 North
label by a declaration indicating the Frederick Ave., suite 500, Gaithersburg,
presence of any characterizing fla- MD 20877, or may be examined at the
voring, as specified in § 101.22 of this National Archives and Records Admin-
chapter. The following terms shall ac- istration (NARA). For information on
company the name of the food wher- the availability of this material at
ever it appears on the principal display NARA, call 202–741–6030, or go to: http://
panel or panels of the label in letters www.archives.gov/federallregister/
not less than one-half the height of the codeloflfederallregulations/
letters used in such name: ibrllocations.html.
(i) The word ‘‘ultra-pasteurized’’ if (d) Nomenclature. The name of the
the food has been ultra-pasteurized. food is ‘‘Light cream’’, or alternatively
(ii) The word ‘‘sweetened’’ if no char- ‘‘Coffee cream’’ or ‘‘Table cream’’. The
acterizing flavoring ingredients are name of the food shall be accompanied
used, but nutritive sweetener is added. on the label by a declaration indicating
(2) The following terms may appear the presence of any characterizing fla-
on the label: voring, as specified in § 101.22 of this
(i) The word ‘‘pasteurized’’ if the food chapter.
has been pasteurized. (1) The following terms shall accom-

(ii) The word ‘‘homogenized’’ if the pany the name of the food wherever it
food has been homogenized. appears on the principal display panel
456
or panels of the label in letters not less www.archives.gov/federallregister/

than one-half the height of the letters codeloflfederallregulations/
used in such name: ibrllocations.html.
(i) The word ‘‘ultra-pasteurized’’ if (d) Nomenclature. The name of the
the food has been ultra-pasteurized. food is ‘‘Light whipping cream’’ or al-
(ii) The word ‘‘sweetened’’ if no char- ternatively ‘‘Whipping cream’’. The
acterizing flavoring ingredients are name of the food shall be accompanied
used, but nutritive sweetener is added. on the label by a declaration indicating
(2) The following terms may appear the presence of any characterizing fla-
on the label: voring, as specified in § 101.22 of this
(i) The word ‘‘pasteurized’’ if the food chapter.
has been pasteurized. (1) The following terms shall accom-
(ii) The word ‘‘homogenized’’ if the pany the name of the food wherever it
food has been homogenized. appears on the principal display panel
(e) Label declaration. Each of the in- or panels of the label in letters not less
gredients used in the food shall be de- than one-half the height of the letters
clared on the label as required by the used in such name:
applicable sections of parts 101 and 130 (i) The word ‘‘ultra-pasteurized’’ if
of this chapter. the food has been ultra-pasteurized.
(ii) The word ‘‘sweetened’’ if no char-
FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 1, acterizing flavoring ingredients are
1984; 54 FR 24893, June 12, 1989; 58 FR 2891, used, but nutritive sweetener is added.
Jan. 6, 1993] (2) The following terms may appear
on the label:
§ 131.157 Light whipping cream. (i) The word ‘‘pasteurized’’ if the food
(a) Description. Light whipping cream has been pasteurized.
is cream which contains not less than (ii) The word ‘‘homogenized’’ if the
30 percent but less than 36 percent food has been homogenized.
milkfat. It is pasteurized or ultra-pas- (e) Label declaration. Each of the in-
teurized, and may be homogenized. gredients used in the food shall be de-
(b) Optional ingredients. The following clared on the label as required by the
safe and suitable optional ingredients applicable sections of parts 101 and 130
may be used: of this chapter.
lows: § 131.160 Sour cream.
(i) Fruit and fruit juice (including (a) Description. Sour cream results
concentrated fruit and fruit juice). from the souring, by lactic acid pro-
(ii) Natural and artificial food fla- ducing bacteria, of pasteurized cream.
voring. Sour cream contains not less than 18
(c) Methods of analysis. The milkfat percent milkfat; except that when the
content is determined by the method food is characterized by the addition of
prescribed in ‘‘Official Methods of nutritive sweeteners or bulky flavoring
Analysis of the Association of Official ingredients, the weight of the milkfat
Analytical Chemists,’’ 13th Ed. (1980), is not less than 18 percent of the re-
sections 16.156 and 16.059, under ‘‘Fat, mainder obtained by subtracting the
Roese-Gottlieb Method—Official Final weight of such optional ingredients
Action,’’ which is incorporated by ref- from the weight of the food; but in no
erence. Copies may be obtained from case does the food contain less than
the AOAC INTERNATIONAL, 481 North 14.4 percent milkfat. Sour cream has a
Frederick Ave., suite 500, Gaithersburg, titratable acidity of not less than 0.5
MD 20877, or may be examined at the percent, calculated as lactic acid.
National Archives and Records Admin- (b) Optional ingredients. (1) Safe and
istration (NARA). For information on suitable ingredients that improve tex-

the availability of this material at ture, prevent syneresis, or extend the
NARA, call 202–741–6030, or go to: http:// shelf life of the product.
457
§ 131.162 21 CFR Ch. I (4–1–16 Edition)
(2) Sodium citrate in an amount not applicable sections of parts 101 and 130
more than 0.1 percent may be added of this chapter.
prior to culturing as a flavor precursor. [42 FR 14360, Mar. 15, 1977, as amended at 47
(3) Rennet. FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19,
(4) Safe and suitable nutritive sweet- 1984; 54 FR 24893, June 12, 1989; 58 FR 2891,
eners. Jan. 6, 1993]
(5) Salt.
§ 131.162 Acidified sour cream.
(6) Flavoring ingredients, with or
without safe and suitable coloring, as (a) Description. Acidified sour cream
follows: results from the souring of pasteurized
(i) Fruit and fruit juice (including cream with safe and suitable acidifiers,
concentrated fruit and fruit juice). with or without addition of lactic acid
(ii) Safe and suitable natural and ar- producing bacteria. Acidified sour
tificial food flavoring. cream contains not less than 18 percent
milkfat; except that when the food is
(c) Methods of analysis. Referenced
characterized by the addition of nutri-
methods in paragraph (c) (1) and (2) of
tive sweeteners or bulky flavoring in-
this section are from ‘‘Official Methods gredients, the weight of milkfat is not
of Analysis of the Association of Offi- less than 18 percent of the remainder
cial Analytical Chemists,’’ 13th Ed. obtained by subtracting the weight of
(1980), which is incorporated by ref- such optional ingredients from the
erence. Copies may be obtained from weight of the food; but in no case does
the AOAC INTERNATIONAL, 481 North the food contain less than 14.4 percent
Frederick Ave., suite 500, Gaithersburg, milkfat. Acidified sour cream has a ti-
MD 20877, or may be examined at the tratable acidity of not less than 0.5 per-
National Archives and Records Admin- cent, calculated as lactic acid.
istration (NARA). For information on (b) Optional ingredients. (1) Safe and
the availability of this material at suitable ingredients that improve tex-
NARA, call 202–741–6030, or go to: http:// ture, prevent syneresis, or extend the
www.archives.gov/federallregister/ shelf life of the product.
codeloflfederallregulations/ (2) Rennet.
ibrllocations.html. (3) Safe and suitable nutritive sweet-
(1) Milkfat content—‘‘Fat—Official eners.
Final Action,’’ section 16.172. (4) Salt.
(2) Titratable acidity—‘‘Acidity—Of- (5) Flavoring ingredients, with or
ficial Final Action,’’ section 16.023. without safe and suitable coloring, as
(d) Nomenclature. The name of the follows:
food is ‘‘Sour cream’’ or alternatively (i) Fruit and fruit juice, including
‘‘Cultured sour cream’’. The full name concentrated fruit and fruit juice.
of the food shall appear on the prin- (ii) Safe and suitable natural and ar-
cipal display panel of the label in type tificial food flavoring.
of uniform size, style, and color. The (c) Methods of analysis. Referenced
name of the food shall be accompanied methods in paragraphs (c) (1) and (2) of
by a declaration indicating the pres- this section are from ‘‘Official Methods
ence of any flavoring that character- of Analysis of the Association of Offi-
izes the product, as specified in § 101.22 cial Analytical Chemists,’’ 13th Ed.
of this chapter. If nutritive sweetener (1980), which is incorporated by ref-
erence. Copies may be obtained from
in an amount sufficient to characterize
the AOAC INTERNATIONAL, 481 North
the food is added without addition of
Frederick Ave., suite 500, Gaithersburg,
characterizing flavoring, the name of MD 20877, or may be examined at the
the food shall be preceded by the word National Archives and Records Admin-
‘‘sweetened’’. istration (NARA). For information on
(e) Label declaration. Each of the in- the availability of this material at
gredients used in the food shall be de- NARA, call 202–741–6030, or go to: http://
clared on the label as required by the www.archives.gov/federallregister/

ibrllocations.html.
458
(1) Milkfat content—‘‘Fat—Official whole eggs, dried whole eggs, or any

Final Action,’’ section 16.172. one or more of the foregoing ingredi-
(2) Titratable acidity—‘‘Acidity—Of- ents with liquid egg white or frozen egg
ficial Final Action,’’ section 16.023. white.
(d) Nomenclature. The name of the (d) Nutritive carbohydrate sweeteners.
food is ‘‘Acidified sour cream’’. The full Sugar (sucrose), beet or cane; invert
name of the food shall appear on the sugar (in paste or sirup form); brown
principal display panel of the label in sugar; refiner’s sirup; molasses (other
type of uniform size, style, and color. than blackstrap); high fructose corn
The name of the food shall be accom- sirup; fructose; fructose sirup; maltose;
panied by a declaration indicating the maltose sirup, dried maltose sirup;
presence of any flavoring that charac- malt extract, dried malt extract; malt
terizes the product, as specified in sirup, dried malt sirup; honey; maple
§ 101.22 of this chapter. If nutritive sugar; or any of the sweeteners listed
sweetener in an amount sufficient to in part 168 of this chapter, except table
characterize the food is added without sirup.
addition of characterizing flavoring, (e) Other optional ingredients. (1) Con-
the name of the food shall be preceded centrated skim milk, nonfat dry milk,
by the word ‘‘sweetened’’. buttermilk, whey, lactose,
(e) Label declaration. Each of the in- lactalbumins, lactoglobulins, or whey
gredients used in the food shall be de- modified by partial or complete re-
clared on the label as required by the moval of lactose and/or minerals, to in-
applicable sections of parts 101 and 130 crease the nonfat solids content of the
of this chapter. food: Provided, That the ratio of pro-
[42 FR 14360, Mar. 15, 1977, as amended at 47 tein to total nonfat solids of the food,
FR 11825, Mar. 19, 1982; 49 FR 10092, Mar. 19, and the protein efficiency ratio of all
1984; 54 FR 24893, June 12, 1989; 58 FR 2891, protein present shall not be decreased
Jan. 6, 1993] as a result of adding such ingredients.
(2) Salt.
§ 131.170 Eggnog. (3) Flavoring ingredients.
(a) Description. Eggnog is the food (4) Color additives that do not impart
containing one or more of the optional a color simulating that of egg yolk,
dairy ingredients specified in para- milkfat, or butterfat.
graph (b), one or more of the optional (5) Stabilizers.
egg yolk-containing ingredients speci- (f) Methods of analysis. The following
fied in paragraph (c) of this section, referenced methods of analysis are
and one or more of the optional nutri- from ‘‘Official Methods of Analysis of
tive carbohydrate sweeteners specified the Association of Official Analytical
in paragraph (d) of this section. One or Chemists,’’ 13th Ed. (1980), which is in-
more of the optional ingredients speci- corporated by reference. Copies are
fied in paragraph (e) of this section available from the AOAC INTER-
may also be added. All ingredients used NATIONAL, 481 North Frederick Ave.,
are safe and suitable. Eggnog contains suite 500, Gaithersburg, MD 20877, or
not less than 6 percent milkfat and not available for inspection at the National
less than 8.25 percent milk solids not Archives and Records Administration
fat. The egg yolk solids content is not (NARA). For information on the avail-
less than 1 percent by weight of the fin- ability of this material at NARA, call
ished food. The food shall be pasteur- 202–741–6030, or go to: http://
ized or ultra-pasteurized and may be www.archives.gov/federallregister/
homogenized. Flavoring ingredients codeloflfederallregulations/
and color additives may be added after ibrllocations.html.
the food is pasteurized or ultra-pas- (1) Milkfat content—As determined
teurized. by the method prescribed in section
(b) Optional dairy ingredients. Cream, 16.059, ‘‘Roese-Gottlieb Method (Ref-
milk, partially skimmed milk, or skim erence Method) (11)—Official Final Ac-
milk, used alone or in combination. tion,’’ under the heading ‘‘Fat.’’
(c) Egg yolk-containing ingredients. (2) Milk solids not fat content—Cal-
Liquid egg yolk, frozen egg yolk, dried culated by subtracting the milkfat con-
egg yolk, liquid whole eggs, frozen tent from the total solids content as
459
§ 131.180 21 CFR Ch. I (4–1–16 Edition)
determined by the method prescribed Final Action,’’ which is incorporated

in section 16.032, ‘‘Method I—Official by reference. Copies may be obtained
Final Action,’’ under the heading from the AOAC INTERNATIONAL, 481
‘‘Total Solids.’’ North Frederick Ave., suite 500, Gai-
(g) Nomenclature. The name of the thersburg, MD 20877, at the National
food is ‘‘eggnog’’. The name of the food Archives and Records Administration
shall be accompanied by a declaration (NARA). For information on the avail-
indicating the presence of any charac- ability of this material at NARA, call
terizing flavoring as specified in § 101.22 202–741–6030, or go to: http://
of this chapter. If the food is ultra-pas- www.archives.gov/federallregister/
teurized, the phrase ‘‘ultra-pasteur- codeloflfederallregulations/
ized’’ shall accompany the name of the ibrllocations.html.
food wherever it appears on the label in (d) Nomenclature. The name of the
letters not less than one-half of the food is ‘‘Half-and-half’’. The name of
height of the letters used in the name. the food shall be accompanied on the
The following terms may accompany label by a declaration indicating the
the name of the food on the label: presence of any characterizing fla-
(1) The word ‘‘pasteurized’’ if the food voring, as specified in § 101.22 of this
has been pasteurized. chapter.
(2) The word ‘‘homogenized’’ if the (1) The following terms shall accom-
food has been homogenized. pany the name of the food wherever it
(h) Label declaration. Each of the in- appears on the principal display panel
gredients used in the food shall be de- or panels of the label in letters not less
clared on the label as required by the than one-half the height of the letters
applicable sections of parts 101 and 130 used in such name:
of this chapter. (i) The word ‘‘ultra-pasteurized’’ if
[46 FR 9938, Jan. 30, 1981, as amended at 47 the food has been ultra-pasteurized.
FR 11825, Mar. 19, 1982; 47 FR 41524, Sept. 21, (ii) The word ‘‘sweetened’’ if no char-
1982; 47 FR 49638, Nov. 2, 1982; 48 FR 24869, acterizing flavor ingredients are used,
June 3, 1983; 54 FR 24893, June 12, 1989; 58 FR but nutritive sweetener is added.
2891, Jan. 6, 1993]
(2) The following terms may appear
§ 131.180 Half-and-half. on the label:
(i) The word ‘‘pasteurized’’ if the food
(a) Description. Half-and-half is the has been pasteurized.
food consisting of a mixture of milk
(ii) The word ‘‘homogenized’’ if the
and cream which contains not less than
food has been homogenized.
10.5 percent but less than 18 percent
(e) Label declaration. Each of the in-
milkfat. It is pasteurized or ultra-pas-
teurized, and may be homogenized.
safe and suitable optional ingredients
of this chapter.
may be used:
lows: § 131.200 Yogurt.
(i) Fruit and fruit juice (including (a) Description. Yogurt is the food
concentrated fruit and fruit juice). produced by culturing one or more of
(ii) Natural and artificial food fla- the optional dairy ingredients specified
voring. in paragraph (c) of this section with a
(c) Methods of analysis. The milkfat characterizing bacterial culture that
content is determined by the method contains the lactic acid-producing bac-
prescribed in ‘‘Official Methods of teria, Lactobacillus bulgaricus and Strep-
Analysis of the Association of Official tococcus thermophilus. One or more of
Analytical Chemists,’’ 13th Ed. (1980), the other optional ingredients specified
in sections 16.156 and 16.059, under in paragraphs (b) and (d) of this section
‘‘Fat, Roese-Gottlieb Method—Official may also be added. When one or more
460
of the ingredients specified in para- listed in part 168 of this chapter, except
graph (d)(1) of this section are used, table sirup.
they shall be included in the culturing (3) Flavoring ingredients.
process. All ingredients used are safe (4) Color additives.
and suitable. Yogurt, before the addi- (5) Stabilizers.
tion of bulky flavors, contains not less (e) Methods of analysis. The following
than 3.25 percent milkfat and not less referenced methods of analysis are
than 8.25 percent milk solids not fat, from ‘‘Official Methods of Analysis of
and has a titratable acidity of not less the Association of Official Analytical
than 0.9 percent, expressed as lactic Chemists,’’ 13th Ed. (1980), which is in-
acid. The food may be homogenized and corporated by reference. Copies are
shall be pasteurized or ultra-pasteur- available from the AOAC INTER-
ized prior to the addition of the bac- NATIONAL, 481 North Frederick Ave.,
terial culture. Flavoring ingredients suite 500, Gaithersburg, MD 20877, or
may be added after pasteurization or
available for inspection at the National
ultra-pasteurization. To extend the
Archives and Records Administration
shelf life of the food, yogurt may be
(NARA). For information on the avail-
heat treated after culturing is com-
ability of this material at NARA, call
pleted, to destroy viable microorga-
202–741–6030, or go to: http://
nisms.
(b) Vitamin addition (optional). (1) If codeloflfederallregulations/
added, vitamin A shall be present in
ibrllocations.html.
such quantity that each 946 milliliters
(1) Milkfat content—As determined
(quart) of the food contains not less
by the method prescribed in section
than 2,000 International Units thereof,
16.059 ‘‘Roese-Gottlieb Method (Ref-
within limits of current good manufac-
erence Method) (11)—Official Final Ac-
turing practice.
tion,’’ under the heading ‘‘Fat.’’
(2) If added, vitamin D shall be
present in such quantity that each 946 (2) Milk solids not fat content—Cal-
milliliters (quart) of the food contains culated by subtracting the milkfat con-
400 International Units thereof, within tent from the total solids content as
limits of current good manufacturing determined by the method prescribed
practice. in section 16.032, ‘‘Method I—Official
Final Action,’’ under the heading
(c) Optional dairy ingredients. Cream,
‘‘Total Solids.’’
milk, partially skimmed milk, or skim
milk, used alone or in combination. (3) Titratable acidity—As determined
(d) Other optional ingredients. (1) Con- by the method prescribed in section
centrated skim milk, nonfat dry milk, 16.023, ‘‘Acidity (2)—Official Final Ac-
buttermilk, whey, lactose, lactalbum- tion,’’ or by an equivalent potentio-
ins, lactoglobulins, or whey modified metric method.
by partial or complete removal of lac- (f) Nomenclature. The name of the
tose and/or minerals, to increase the food is ‘‘yogurt’’. The name of the food
nonfat solids content of the food: Pro- shall be accompanied by a declaration
vided, That the ratio of protein to total indicating the presence of any charac-
nonfat solids of the food, and the pro- terizing flavoring as specified in § 101.22
tein efficiency ratio of all protein of this chapter.
present shall not be decreased as a re- (1) The following terms shall accom-
sult of adding such ingredients. pany the name of the food wherever it
(2) Nutritive carbohydrate sweet- appears on the principal display panel
eners. Sugar (sucrose), beet or cane; in- or panels of the label in letters not less
vert sugar (in paste or sirup form); than one-half of the height of the let-
brown sugar; refiner’s sirup; molasses ters used in such name:
(other than blackstrap); high fructose (i) The word ‘‘sweetened’’ if nutritive
corn sirup; fructose; fructose sirup; carbohydrate sweetener is added with-
maltose; maltose sirup, dried maltose out the addition of characterizing fla-
sirup; malt extract, dried malt extract; vor.

malt sirup, dried malt sirup; honey; (ii) The parenthetical phrase ‘‘(heat-
maple sugar; or any of the sweeteners treated after culturing)’’ shall follow
461
§ 131.203 21 CFR Ch. I (4–1–16 Edition)
the name of the food if the dairy ingre- within limits of current good manufac-
dients have been heat-treated after culturing practice.
turing. (2) If added, vitamin D shall be
(iii) The phrase ‘‘vitamin A’’ or ‘‘vi- present in such quantity that each 946
tamin A added’’, or ‘‘vitamin D’’ or milliliters (quart) of the food contains
‘‘vitamin D added’’, or ‘‘vitamins A and 400 International Units thereof, within
D added’’, as appropriate. The word limits of current good manufacturing
‘‘vitamin’’ may be abbreviated ‘‘vit’’. practice.
(2) The term ‘‘homogenized’’ may ap-
(c) Optional dairy ingredients. Cream,
pear on the label if the dairy ingredi-
milk, partially skimmed milk, or skim
ents used are homogenized.
(g) Label declaration. Each of the in- milk, used alone or in combination.
gredients used in the food shall be de- (d) Other optional ingredients. (1) Con-
clared on the label as required by the centrated skim milk, nonfat dry milk,
applicable sections of parts 101 and 130 buttermilk, whey, lactose, lactalbum-
of this chapter. ins, lactoglobulins, or whey modified
by partial or complete removal of lac-
tose and/or minerals, to increase the
FR 11825, Mar. 19, 1982; 47 FR 41524, Sept. 21,
1982; 48 FR 24869, June 3, 1983; 54 FR 24893, nonfat solids content of the food: Pro-
June 12, 1989; 58 FR 2891, Jan. 6, 1993] vided, That the ratio of protein to total
nonfat solids of the food, and the pro-
§ 131.203 Lowfat yogurt. tein efficiency ratio of all protein
(a) Description. Lowfat yogurt is the present shall not be decreased as a re-
food produced by culturing one or more sult of adding such ingredients.
of the optional dairy ingredients speci- (2) Nutritive carbohydrate sweet-
fied in paragraph (c) of this section eners. Sugar (sucrose), beet or cane; in-
with a characterizing bacterial culture vert sugar (in paste or sirup form);
that contains the lactic acid-producing brown sugar; refiner’s sirup; molasses
bacteria, Lactobacillus bulgaricus and (other than blackstrap); high fructose
Streptococcus thermophilus. One or more corn sirup; fructose; fructose sirup;
of the other optional ingredients speci- maltose, maltose sirup, dried maltose
fied in paragraphs (b) and (d) of this sirup; malt extract, dried malt extract;
section may also be added. When one or malt sirup, dried malt sirup; honey;
more of the ingredients specified in maple sugar; or any of the sweeteners
paragraph (d)(1) of this section are listed in part 168 of this chapter, except
used, they shall be included in the cul- table sirup.
turing process. All ingredients used are (3) Flavoring ingredients.
safe and suitable. Lowfat yogurt, be- (4) Color additives.
fore the addition of bulky flavors, con- (5) Stabilizers.
tains not less than 0.5 percent nor more
(e) Methods of analysis. The following
than 2 percent milkfat and not less
referenced methods of analysis are
than 8.25 percent milk solids not fat,
from ‘‘Official Methods of Analysis of
and has a titratable acidity of not less
than 0.9 percent, expressed as lactic the Association of Official Analytical
acid. The food may be homogenized and Chemists,’’ 13th Ed. (1980), which is in-
shall be pasteurized or ultra-pasteur- corporated by reference. Copies are
ized prior to the addition of the bac- available from the AOAC INTER-
terial culture. Flavoring ingredients NATIONAL, 481 North Frederick Ave.,
may be added after pasteurization or suite 500, Gaithersburg, MD 20877 or
ultra-pasteurization. To extend the available for inspection at the National
shelf life of the food, lowfat yogurt Archives and Records Administration
may be heat treated after culturing is (NARA). For information on the avail-
completed, to destroy viable micro- ability of this material at NARA, call
organisms. 202–741–6030, or go to: http://
(b) Vitamin addition (optional). (1) If www.archives.gov/federallregister/
added, vitamin A shall be present in codeloflfederallregulations/
such quantity that each 946 milliliters ibrllocations.html.

(quart) of the food contains not less (1) Milkfat content—As determined
than 2,000 International Units thereof, by the method prescribed in section
462
16.059 ‘‘Roese-Gottlieb Method (Ref- applicable sections of parts 101 and 130
erence Method) (11)—Official Final Ac- of this chapter.
(2) Milk solids not fat content—Cal- FR 11825, Mar. 19, 1982; 47 FR 41524, Sept. 21,
culated by subtracting the milkfat con- 1982; 48 FR 24869, June 3, 1983; 54 FR 24893,
tent from the total solids content as June 12, 1989; 58 FR 2891, Jan. 6, 1993]
determined by the method prescribed
in section 16.032, ‘‘Method I—Official § 131.206 Nonfat yogurt.
Final Action,’’ under the heading (a) Description. Nonfat yogurt is the
‘‘Total Solids.’’ food produced by culturing one or more
(3) Titratable acidity—As determined of the optional dairy ingredients speci-
by the method prescribed in section fied in paragraph (c) of this section
16.023, ‘‘Acidity (2)—Official Final Ac- with a characterizing bacterial culture
tion,’’ or by an equivalent potentio- that contains the lactic acid-producing
metric method. bacteria, Lactobacillus bulgaricus and
(f) Nomenclature. The name of the Streptococcus thermophilus. One or more
food is ‘‘lowfat yogurt’’. The full name of the other optional ingredients speci-
of the food shall appear on the prin- fied in paragraphs (b) and (d) of this
cipal display panel of the label in type section may also be added. When one or
of uniform size, style, and color. The more of the ingredients specified in
name of the food shall be accompanied paragraph (d)(1) of this section are
by a declaration indicating the pres- used, they shall be included in the cul-
turing process. All ingredients used are
ence of any characterizing flavoring as
safe and suitable. Nonfat yogurt, before
specified in § 101.22 of this chapter.
the addition of bulky flavors, contains
(1) The following terms shall accom- less than 0.5 percent milkfat and not
pany the name of the food wherever it less than 8.25 percent milk solids not
appears on the principal display panel fat, and has a titratable acidity of not
or panels of the label in letters not less less than 0.9 percent, expressed as lac-
than one-half of the height of the let- tic acid. The food may be homogenized
ters used in such name. and shall be pasteurized or ultra-pas-
(i) The phrase ‘‘l% milkfat’’, the teurized prior to the addition of the
blank to be filled in with the fraction bacterial culture. Flavoring ingredi-
1⁄2 or multiple thereof closest to the ac- ents may be added after pasteurization
tual fat content of the food. or ultra-pasteurization. To extend the
(ii) The word ‘‘sweetened’’ if nutri- shelf life of the food, nonfat yogurt
tive carbohydrate sweetener is added may be heat treated after culturing is
without the addition of characterizing completed, to destroy viable micro-
flavoring. organisms.
(iii) The parenthetical phrase ‘‘(heat- (b) Vitamin addition (optional). (1) If
treated after culturing)’’ shall follow added, vitamin A shall be present in
the name of the food if the dairy ingre- such quantity that each 946 milliliters
dients have been heat-treated after cul- (quart) of the food contains not less
turing. than 2,000 International Units thereof,
within limits of good manufacturing
(iv) The phrase ‘‘vitamin A’’ or ‘‘vi-
practice.
tamin A added’’, or ‘‘vitamin D’’ or
(2) If added, vitamin D shall be
‘‘vitamin D added’’, or ‘‘vitamins A and
present in such quantity that each 946
D added’’, as appropriate. The word milliliters (quart) of the food contains
‘‘vitamin’’ may be abbreviated ‘‘vit’’. 400 International Units thereof, within
(2) The term ‘‘homogenized’’ may ap- limits of good manufacturing practice.
pear on the label if the dairy ingredi- (c) Optional dairy ingredients. Cream,
ents used are homogenized. milk, partially skimmed milk, or skim
(g) Label declaration. Each of the in- milk, used alone or in combination.
gredients used in the food shall be de- (d) Other optional ingredients. (1) Con-
clared on the label as required by the centrated skim milk, nonfat dry milk,
buttermilk, whey, lactose,
lactalbumins, lactoglobulins, or whey
463
modified by partial or complete re- of the food shall appear on the prin-
moval of lactose and/or minerals, to in- cipal display panel of the label in type
crease the nonfat solids content of the of uniform size, style, and color. The
food: Provided, That the ratio of pro- name of the food shall be accompanied
tein to total nonfat solids of the food, by a declaration indicating the pres-
and the protein efficiency ratio of all ence of any characterizing flavoring as
protein present shall not be decreased specified in § 101.22 of this chapter.
as a result of adding such ingredients. (1) The following terms shall accom-
(2) Nutritive carbohydrate sweet- pany the name of the food wherever it
eners. Sugar (sucrose), beet or cane; in- appears on the principal display panel
vert sugar (in paste or sirup form); or panels of the label in letters not less
brown sugar; refiner’s sirup; molasses than one-half of the height of the let-
(other than blackstrap); high fructose ters used in such name:
corn sirup; fructose; fructose sirup; (i) The word ‘‘sweetened’’ if nutritive
maltose; maltose sirup, dried maltose carbohydrate sweetener is added with-
sirup; malt extract, dired malt extract; out the addition of characterizing fla-
malt sirup, dried malt sirup; honey; voring.
maple sugar; or any of the sweeteners (ii) The parenthetical phrase ‘‘(heat-
listed in part 168 of this chapter, except treated after culturing)’’ shall follow
table sirup. the name of the food if the dairy ingre-
(3) Flavoring ingredients. dients have been heat-treated after cul-
(4) Color additives. turing.
(5) Stabilizers. (iii) The phrase ‘‘vitamin A’’ or ‘‘vi-
(e) Methods of analysis. The following tamin A added’’, or ‘‘vitamin D’’ or
referenced methods of analysis are ‘‘vitamin D added’’, or ‘‘vitamins A and
from ‘‘Official Methods of Analysis of D added’’, as appropriate. The word
the Association of Official Analytical ‘‘vitamin’’ may be abbreviated ‘‘vit’’.
Chemists,’’ 13th Ed. (1980), which is in- (2) The term ‘‘homogenized’’ may ap-
corporated by reference. Copies are pear on the label if the dairy ingredi-
available from the AOAC INTER- ents used are homogenized.
NATIONAL, 481 North Frederick Ave., (g) Label declaration. Each of the in-
suite 500, Gaithersburg, MD 20877, or gredients used in the food shall be de-
available for inspection at the National clared on the label as required by the
Archives and Records Administration applicable sections of parts 101 and 130
(NARA). For information on the avail- of this chapter.
ability of this material at NARA, call [46 FR 9940, Jan. 30, 1981, as amended at 47
202–741–6030, or go to: http:// FR 11825, Mar. 19, 1982; 47 FR 41524, Sept. 21,
www.archives.gov/federallregister/ 1982; 48 FR 24869, June 3, 1983; 54 FR 24893,
codeloflfederallregulations/ June 12, 1989; 58 FR 2891, Jan. 6, 1993]
ibrllocations.html.
(1) Milkfat content—As determined PART 133—CHEESES AND RELATED
by the method prescribed in section CHEESE PRODUCTS
16.059, ‘‘Roese-Gottlieb Method (Ref-
erence Method) (11)—Official Final Ac- Subpart A—General Provisions
(2) Milk solids not fat content—Cal- Sec.
culated by subtracting the milkfat con- 133.3 Definitions.
133.5 Methods of analysis.
tent from the total solids content as 133.10 Notice to manufacturers, packers,
determined by the method prescribed and distributors of pasteurized blended
in section 16.032, ‘‘Method I—Official cheese, pasteurized process cheese,
Final Action,’’ under the heading cheese food, cheese spread, and related
‘‘Total Solids.’’ foods.
(3) Titratable acidity—As determined
by the method prescribed in section Subpart B—Requirements for Specific
16.023, ‘‘Acidity (2)—Official Final Ac- Standardized Cheese and Related
tion,’’ or by an equivalent potentio- Products
metric method. 133.102 Asiago fresh and asiago soft cheese.

(f) Nomenclature. The name of the 133.103 Asiago medium cheese.
food is ‘‘nonfat yogurt’’. The full name 133.104 Asiago old cheese.
464
133.106 Blue cheese. 133.180 Pasteurized process cheese spread
133.108 Brick cheese. with fruits, vegetables, or meats.
133.109 Brick cheese for manufacturing. 133.181 Provolone cheese.
133.111 Caciocavallo siciliano cheese. 133.182 Soft ripened cheeses.
133.113 Cheddar cheese. 133.183 Romano cheese.
133.114 Cheddar cheese for manufacturing.
133.184 Roquefort cheese, sheep’s milk blue-
133.116 Low sodium cheddar cheese.
mold, and blue-mold cheese from sheep’s
133.118 Colby cheese.
milk.
133.119 Colby cheese for manufacturing.
133.121 Low sodium colby cheese. 133.185 Samsoe cheese.
133.123 Cold-pack and club cheese. 133.186 Sap sago cheese.
133.124 Cold-pack cheese food. 133.187 Semisoft cheeses.
133.125 Cold-pack cheese food with fruits, 133.188 Semisoft part-skim cheeses.
vegetables, or meats. 133.189 Skim milk cheese for manufac-
133.127 Cook cheese, koch kaese. turing.
133.128 Cottage cheese. 133.190 Spiced cheeses.
133.129 Dry curd cottage cheese. 133.191 Part-skim spiced cheeses.
133.133 Cream cheese. 133.193 Spiced, flavored standardized
133.134 Cream cheese with other foods. cheeses.
133.136 Washed curd and soaked curd cheese. 133.195 Swiss and emmentaler cheese.
133.137 Washed curd cheese for manufac-
133.196 Swiss cheese for manufacturing.
turing.
133.138 Edam cheese. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371,
133.140 Gammelost cheese. 379e.
133.141 Gorgonzola cheese.
133.142 Gouda cheese.
133.144 Granular and stirred curd cheese. Subpart A—General Provisions
133.145 Granular cheese for manufacturing.
133.146 Grated cheeses. § 133.3 Definitions.
133.147 Grated American cheese food.
(a) Milk means the lacteal secretion,
133.148 Hard grating cheeses.
133.149 Gruyere cheese. practically free from colostrum, ob-
133.150 Hard cheeses. tained by the complete milking of one
133.152 Limburger cheese. or more healthy cows, which may be
133.153 Monterey cheese and monterey jack clarified and may be adjusted by sepa-
cheese. rating part of the fat therefrom; con-
133.154 High-moisture jack cheese. centrated milk, reconstituted milk,
133.155 Mozzarella cheese and scamorza and dry whole milk. Water, in a suffi-
cheese.
133.156 Low-moisture mozzarella and
cient quantity to reconstitute con-
scamorza cheese. centrated and dry forms, may be added.
133.157 Part-skim mozzarella and scamorza (b) Nonfat milk means skim milk,
cheese. concentrated skim milk, reconstituted
133.158 Low-moisture part-skim mozzarella skim milk, and nonfat dry milk. Water,
and scamorza cheese. in a sufficient quantity to reconstitute
133.160 Muenster and munster cheese. concentrated and dry forms, may be
133.161 Muenster and munster cheese for
manufacturing.
added.
133.162 Neufchatel cheese. (c) Cream means cream, reconstituted
133.164 Nuworld cheese. cream, dry cream, and plastic cream.
133.165 Parmesan and reggiano cheese. Water, in a sufficient quantity to re-
133.167 Pasteurized blended cheese. constitute concentrated and dry forms,
133.168 Pasteurized blended cheese with may be added.
fruits, vegetables, or meats.
133.169 Pasteurized process cheese.
(d) Pasteurized when used to describe
133.170 Pasteurized process cheese with a dairy ingredient means that every
fruits, vegetables, or meats. particle of such ingredient shall have
133.171 Pasteurized process pimento cheese. been heated in properly operated equip-
133.173 Pasteurized process cheese food. ment to one of the temperatures speci-
133.174 Pasteurized process cheese food with fied in the table of this paragraph and
fruits, vegetables, or meats. held continuously at or above that
133.175 Pasteurized cheese spread.
temperature for the specified time (or
133.176 Pasteurized cheese spread with
fruits, vegetables, or meats. other time/temperature relationship
133.178 Pasteurized neufchatel cheese spread which has been demonstrated to be

with other foods. equivalent thereto in microbial de-
133.179 Pasteurized process cheese spread. struction):
465
§ 133.5 21 CFR Ch. I (4–1–16 Edition)
Temperature Time § 133.10 Notice to manufacturers,

packers, and distributors of pas-
145 °F1 ................................................................ 30 min.
teurized blended cheese, pasteur-
161 °F1 ................................................................ 15 s.
191 °F .................................................................. 1 s.
ized process cheese, cheese food,
204 °F .................................................................. 0.05 s.
cheese spread, and related foods.
212 °F .................................................................. 0.01 s. (a) Definitions and standards of iden-
1 If
the dairy ingredient has a fat content of 10 percent or tity have recently been promulgated
more, the specified temperature shall be increased by 5 °F. under the authority of the Federal
(e) Ultrapasteurized when used to de- Food, Drug, and Cosmetic Act for a
scribe a dairy ingredient means that number of foods made in part from
such ingredient shall have been ther- cheese, including pasteurized process
mally processed at or above 280 °F for cheese; pasteurized process cheese with
at least 2 seconds. fruits, vegetables, or meats; pasteur-
ized blended cheese; pasteurized proc-
[48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18, ess cheese food; pasteurized process
1983]
cheese spread, and related foods. These
§ 133.5 Methods of analysis. standards prescribe the name for each
such food. The act requires that this
Moisture, milkfat, and phosphatase name appear on the label. Many of
levels in cheeses will be determined by these names consist of several words.
the following methods of analysis from In the past it has been the practice of
‘‘Official Methods of Analysis of the some manufacturers to subordinate the
Association of Official Analytical words ‘‘pasteurized,’’ ‘‘blended,’’
Chemists,’’ 13th ed., 1980, which is in- ‘‘process,’’ ‘‘food,’’ and ‘‘spread’’ to
corporated by reference (copies are give undue prominence to the word
available from the AOAC INTER- ‘‘cheese’’ and to words naming the va-
NATIONAL, 481 North Frederick Ave., riety of cheese involved.
suite 500, Gaithersburg, MD 20877, or (b) When placing the names of these
available for inspection at the National foods on labels so as to comply with
Archives and Records Administration the requirements of section 403 (a), (f),
(NARA). For information on the avail- and (g) of the act, all the words form-
ability of this material at NARA, call ing the name specified by a definition
202–741–6030, or go to: http:// and standard of identity should be
www.archives.gov/federallregister/ given equal prominence. This can read-
codeloflfederallregulations/ ily be accomplished by printing the
ibrllocations.html): specified name of the food in letters of
(a) Moisture content—section 16.233 the same size, color, and style of type,
‘‘Method I (52)—Official Final Action’’, and with the same background.
under the heading ‘‘Moisture’’. (c) Where the names of optional in-
(b) Milkfat content—section 16.255 gredients are required to appear on the
‘‘Fat (60)—Official Final Action’’. label, the designations of all such in-
(c) Phenol equivalent value—section gredients should be given equal promi-
16.275 ‘‘Reagents’’, section 16.276 nence. The names of the optional ingre-
‘‘Sampling’’, and section 16.277 ‘‘Deter- dients should appear prominently and
mination’’, under the heading ‘‘Resid- conspicuously but should not be dis-
ual Phosphatase (27) Official Final Ac- played with greater prominence than
tion’’. the name of the food. The word ‘‘con-
(d) Milkfat in solids (fat on a dry tains’’ may precede the names of the
basis)—Subtract the percent of mois- optional ingredients, and when so used
ture found from 100; divide the remain- will not be considered as intervening
der into the percent milkfat found. The printed matter between name of food
quotient, multiplied by 100, shall be and name of optional ingredients re-
considered to be the percent of milkfat quired to be placed on the label.
contained in the solids. (d) Where a manufacturer elects to
[48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18, include a label statement of fat and
1983, as amended at 54 FR 24893, June 12, 1989; moisture content, the declaration
63 FR 14035, Mar. 24, 1998] should be on the basis of the food as
466
marketed. A fat declaration on a mois- cheese may be added during the proce-
ture-free basis is likely to be mis- dure in such quantity that the weight
leading, and should not be used in la- of the solids of such preparation is not
beling. more than 0.1 percent of the weight of
the milk used.
Subpart B—Requirements for Spe- (c)(1) For the purposes of this sec-
cific Standardized Cheese tion, the word ‘‘milk’’ means cow’s
and Related Products milk, which may be adjusted by sepa-
rating part of the fat therefrom or by
§ 133.102 Asiago fresh and asiago soft adding thereto one or more of the fol-
cheese. lowing: Cream, skim milk, con-
(a) Asiago fresh cheese, asiago soft centrated skim milk, nonfat dry milk,
cheese, is the food prepared from milk water in a quantity sufficient to recon-
and other ingredients specified in this stitute any concentrated skim milk or
section, by the procedure set forth in nonfat dry milk used.
paragraph (b) of this section, or by an- (2) Such milk may be bleached by the
other procedure which produces a fin- use of benzoyl peroxide or a mixture of
ished cheese having the same physical benzoyl peroxide with potassium alum,
and chemical properties as the cheese calcium sulfate, and magnesium car-
produced when the procedure set forth bonate; but the weight of the benzoyl
in paragraph (b) of this section is used. peroxide is not more than 0.002 percent
It contains not more than 45 percent of of the weight of the milk bleached, and
moisture, and its solids contain not the weight of the potassium alum, cal-
less than 50 percent of milkfat, as de-
cium sulfate, and magnesium car-
termined by the methods prescribed in
bonate, singly or combined, is not more
§ 133.5 (a), (b), and (d). It is cured for
than six times the weight of the ben-
not less than 60 days.
(b) Milk which may be pasteurized or zoyl peroxide used. If milk is bleached
clarified or both, and which may be in this manner, sufficient vitamin A is
warmed, is subjected to the action of added to the curd to compensate for
harmless lactic-acid producing bac- the vitamin A or its precursors de-
teria, present in such milk or added stroyed in the bleaching process, and
thereto. Harmless artificial blue or artificial coloring is not used.
green coloring in a quantity which neu- (d) Safe and suitable antimycotic
tralizes any natural yellow coloring in agent(s), the cumulative levels of
the curd may be added. Sufficient which shall not exceed current good
rennet, or other safe and suitable milk- manufacturing practice, may be added
clotting enzyme that produces equiva- to the surface of the cheese.
lent curd formation, or both, with or (e) Label declaration. Each of the in-
without purified calcium chloride in a gredients used in the food shall be de-
quantity not more than 0.02 percent clared on the label as required by the
(calculated as anhydrous calcium chlo- applicable sections of parts 101 and 130
ride) of the weight of the milk, is added of this chapter, except that enzymes of
to set the milk to a semisolid mass. animal, plant, or microbial origin may
The mass is cut, stirred, and heated to be declared as ‘‘enzymes’’.
promote and regulate separation of the
whey from the curd. The whey is [42 FR 14366, Mar. 15, 1977, as amended at 48
drained off. When the curd is suffi- FR 49013, Oct. 24, 1983; 49 FR 10093, Mar. 19,
1984; 58 FR 2891, Jan. 6, 1993]
ciently firm it is removed from the
kettle or vat, further drained for a § 133.103 Asiago medium cheese.
short time, packed into hoops, and
pressed. The pressed curd is salted in Asiago medium cheese conforms to
brine and cured in a well-ventilated the definition and standard of identity
room. During curing the surface of the and is subject to the requirements for
cheese is occasionally rubbed with a label statement of ingredients pre-
vegetable oil. A harmless preparation scribed by § 133.102 for asiago fresh
of enzymes of animal or plant origin cheese, except that it contains not

capable of aiding in the curing or de- more than 35 percent moisture, its sol-
velopment of flavor of asiago fresh ids contain not less than 45 percent of
467
§ 133.104 21 CFR Ch. I (4–1–16 Edition)
milkfat, and it is cured for not less the surface of the cheese may be
than 6 months. scraped to remove surface growth of
[58 FR 2892, Jan. 6, 1993]
undesirable microorganisms.
Antimycotics may be applied to the
§ 133.104 Asiago old cheese. surface of the whole cheese. One or
more of the other optional ingredients
Asiago old cheese conforms to the
specified in paragraph (b)(3) of this sec-
definition and standard of identity and
tion may be added during the proce-
is subject to the requirements for label
dure.
statement of ingredients prescribed by
§ 133.102 for asiago fresh cheese, except
that it contains not more than 32 per-
used:
cent moisture, its solids contain not
(1) Dairy ingredients. Milk, nonfat
less than 42 percent of milk fat, and it
milk, or cream, as defined in § 133.3,
is cured for not less than 1 year.
used alone or in combination.
[58 FR 2892, Jan. 6, 1993] (2) Clotting enzymes. Rennet and/or
other clotting enzymes of animal,
§ 133.106 Blue cheese. plant, or microbial origin.
(a) Description. (1) Blue cheese is the (3) Other optional ingredients. (i) Blue
food prepared by the procedure set or green color in an amount to neu-
forth in paragraph (a)(2), of this sec- tralize the natural yellow color of the
tion, or by any other procedure which curd.
produces a finished cheese having the (ii) Calcium chloride in an amount
same physical and chemical properties. not more than 0.02 percent (calculated
It is characterized by the presence of as anhydrous calcium chloride) of the
bluish-green mold, Penicillium roque- weight of the dairy ingredients, used as
fortii, throughout the cheese. The min- a coagulation aid.
imum milkfat content is 50 percent by (iii) Enzymes of animal, plant, or mi-
weight of the solids and the maximum crobial origin, used in curing or flavor
moisture content is 46 percent by development.
weight, as determined by the methods (iv) Antimycotic agents, applied to
described in § 133.5. The dairy ingredi- the surface of slices or cuts in con-
ents used may be pasteurized. Blue sumer-sized packages or to the surface
cheese is at least 60 days old. of the bulk cheese during curing.
(2) One or more of the dairy ingredi- (v) Benzoyl peroxide or a mixture of
ents specified in paragraph (b)(1) of benzoyl peroxide with potassium alum,
this section may be homogenized, calcium sulfate, and magnesium car-
bleached, warmed, and is subjected to bonate used to bleach the dairy ingre-
the action of a lactic acid-producing dients. The weight of the benzoyl per-
bacterial culture. One or more of the oxide is not more than 0.002 percent of
clotting enzymes specified in para- the weight of the milk being bleached,
graph (b)(2) of this section is added to and the weight of the potassium alum,
set the dairy ingredients to a semisolid calcium sulfate, and magnesium car-
mass. The mass is cut into smaller por- bonate, singly or combined, is not more
tions and allowed to stand for a time. than six times the weight of the ben-
The mixed curd and whey is placed in zoyl peroxide used. If milk is bleached
forms permitting further drainage. in this manner, vitamin A is added to
While the curd is being placed in forms, the curd in such quantity as to com-
spores of the mold Penicillium roque- pensate for the vitamin A or its precur-
fortii are added. The forms are turned sors destroyed in the bleaching process,
several times during drainage. When and artificial coloring is not used.
sufficiently drained, the shaped curd is (vi) Vegetable fats or oils, which may
removed from the forms and salted be hydrogenated, used as a coating for
with dry salt or brine. Perforations are the rind.
then made in the shaped curd, and it is (c) Nomenclature. The name of the
held at a temperature of approximately food is ‘‘blue cheese.’’
50 °F. at 90 to 95 percent relative hu- (d) Label declaration. Each of the in-
midity, until the characteristic mold gredients used in the food shall be de-
growth has developed. During storage clared on the label as required by the
468
applicable sections of parts 101 and 130 istics of brick cheese. One or more of
of this chapter, except that: the other optional ingredients specified
(1) Enzymes of animal, plant, or mi- in paragraph (b)(3) of this section may
crobial origin may be declared as ‘‘en- be added during the procedure.
zymes’’; and (b) Optional ingredients. The following
(2) The dairy ingredients may be de- safe and suitable ingredients may be
clared, in descending order of predomi- used:
nance, by the use of the terms ‘‘milkfat (1) Dairy ingredients. Milk, nonfat
and nonfat milk’’ or ‘‘nonfat milk and
milkfat’’, as appropriate.
[48 FR 2742, Jan. 21, 1983, as amended at 54 (2) Clotting enzymes. Rennet and/or
FR 32052, Aug. 4, 1989; 58 FR 2892, Jan. 6, 1993] other clotting enzymes of animal,
§ 133.108 Brick cheese. plant, or microbial origin.
(3) Other optional ingredients. (i)
(a) Description. (1) Brick cheese is the Coloring.
food prepared from dairy ingredients
(ii) Calcium chloride in an amount
and other ingredients specified in this
section by the procedure set forth in not more than 0.02 percent (calculated
paragraph (a)(3) of this section, or by as anhydrous calcium chloride) of the
any other procedure which produces a weight of the dairy ingredients, used as
finished cheese having the same phys- a coagulation aid.
ical and chemical properties. The min- (iii) Enzymes of animal, plant, or mi-
imum milkfat content is 50 percent by crobial origin, used in curing or flavor
weight of the solids and the maximum development.
moisture content is 44 percent by (iv) Antimycotic agents, the cumu-
weight, as determined by the methods lative level of which shall not exceed
described in § 133.5. If the dairy ingredi- current good manufacturing practice,
ents used are not pasteurized, the may be added to the surface of the
cheese is cured at a temperature of not cheese.
less than 35 °F for at least 60 days. (c) Nomenclature. The name of the
(2) If pasteurized dairy ingredients food is ‘‘brick cheese’’.
are used, the phenol equivalent value (d) Label declaration. Each of the in-
of 0.25 gram of brick cheese is not more gredients used in the food shall be de-
than 5 micrograms as determined by clared on the label as required by the
the method described in § 133.5. applicable sections of parts 101 and 130
(3) One or more of the dairy ingredi-
of this chapter, except that:
ents specified in paragraph (b)(1) of
this section is brought to a tempera- (1) Enzymes of animal, plant, or mi-
ture of about 88 °F and subjected to the crobial origin may be declared as ‘‘en-
action of a lactic acid-producing bac- zymes’’; and
terial culutre. One or more of the clot- (2) The dairy ingredients may be de-
ting enzymes specified in paragraph clared, in descending order of predomi-
(b)(2) of this section is added to set the nance, by the use of the terms ‘‘milkfat
dairy ingredients to a semisolid mass. and nonfat milk’’ or ‘‘nonfat milk and
The mass is cut into cubes with sides milkfat’’, as appropriate.
approximately 3⁄8 inch long, and stirred [54 FR 32052, Aug. 4, 1989; 54 FR 35756, Aug. 29,
and heated so that the temperature 1989, as amended at 58 FR 2892, Jan. 6, 1993;
rises slowly to about 96 °F. The stirring 58 FR 17105, Apr. 1, 1993]
is continued until the curd is suffi-
ciently firm. Part of the whey is then § 133.109 Brick cheese for manufac-
removed, and the mixture diluted with turing.
water or salt brine to control the acid- Brick cheese for manufacturing con-
ity. The curd is transferred to forms, forms to the definition and standard of
and drained. During drainage it is identity for brick cheese prescribed by
pressed and turned. After drainage the § 133.108, except that the dairy ingredi-
curd is salted, and the biological curing
ents are not pasteurized and curing is
agents characteristic of brick cheese

not required.
are applied to the surface. The cheese
is then cured to develop the character- [54 FR 32053, Aug. 4, 1989]
469
§ 133.111 21 CFR Ch. I (4–1–16 Edition)
§ 133.111 Caciocavallo siciliano cheese. solids of such preparation is not more

(a) Caciocavallo siciliano cheese is than 0.1 percent of the weight of the
the food prepared from cow’s milk or milk used.
sheep’s milk or goat’s milk or mixtures (c)(1) For the purposes of this sec-
of two or all of these and other ingredi- tion, the word ‘‘milk’’ means cow’s
ents specified in this section, by the milk or goat’s milk or sheep’s milk or
procedure set forth in paragraph (b) of mixtures of two or all of these. Such
this section, or by another procedure milk may be adjusted by separating
which produces a finished cheese hav- part of the fat therefrom or (in the case
ing the same physical and chemical of cow’s milk) by adding one or more of
properties as the cheese produced when the following: Cream, skim milk, con-
the procedure set forth in paragraph (b) centrated skim milk, nonfat dry milk;
of this section is used. It has a stringy (in the case of goat’s milk) the cor-
texture, and is made in oblong shapes. responding products from goat’s milk;
It contains not more than 40 percent of (in the case of sheep’s milk) the cor-
moisture, and its solids contain not responding products from sheep’s milk;
less than 42 percent milkfat as deter- water in a quantity sufficient to recon-
mined by the methods prescribed in stitute any such concentrated or dried
§ 133.5 (a), (b), and (d). It is cured for products used.
not less than 90 days at a temperature (2) Such milk may be bleached by the
of not less than 35 °F. use of benzoyl peroxide or a mixture of
(b) Milk, which may be pasteurized or benzoyl peroxide with potassium alum,
clarified or both, and which may be calcium sulfate, and magnesium car-
warmed, is subjected to the action of bonate; but the weight of the benzoyl
harmless lactic-acid-producing bac- peroxide is not more than 0.002 percent
teria, present in such milk or added of the weight of the milk bleached, and
thereto. Harmless artificial blue or the weight of the potassium alum, cal-
green coloring in a quantity which neu- cium sulfate, and magnesium car-
tralizes any natural yellow coloring in bonate, singly or combined, is not more
the curd may be added. Sufficient than six times the weight of the ben-
rennet, rennet paste, extract of rennet zoyl peroxide used. If milk is bleached
paste, or other safe and suitable milk- in this manner, sufficient vitamin A is
clotting enzyme that produces equiva- added to the curd to compensate for
lent curd formation, singly or in any the vitamin A or its precursors de-
combination (with or without purified stroyed in the bleaching process, and
calcium chloride in a quantity not artificial coloring is not used.
more than 0.02 percent, calculated as (d) Safe and suitable antimycotic
anhydrous calcium chloride, of the agent(s), the cumulative levels of
weight of the milk) is added to set the which shall not exceed current good
milk to a semisolid mass. The mass is manufacturing practice, may be added
cut, stirred, and heated so as to pro- to the cheese during the kneading and
mote and regulate the separation of stretching process and/or applied to the
whey from curd. The whey is drained surface of the cheese.
off, and the curd is removed to another (e) When caciocavallo siciliano
vat containing hot whey, in which it is cheese is made solely from cow’s milk,
soaked for several hours. This whey is the name of such cheese is
withdrawn, the curd is allowed to mat, ‘‘Caciocavallo siciliano cheese’’. When
and is cut into blocks. These are made from sheep’s milk or goat’s milk
washed in hot whey until the desired or mixtures of these, or one or both of
elasticity is obtained. The curd is re- these with cow’s milk, the name is fol-
moved from the vat, drained, pressed lowed by the words ‘‘made from
into oblong forms, dried, and salted in lll’’, the blank being filled in with
brine, and cured. It may be paraffined. the name or names of the milks used,
A harmless preparation of enzymes of in order of predominance by weight.
animal or plant origin capable of aid- (f) Label declaration. Each of the in-
ing in the curing or development of fla- gredients used in the food shall be de-
vor of caciocavallo siciliano cheese clared on the label as required by the

may be added during the procedure, in applicable sections of parts 101 and 130
such quantity that the weight of the of this chapter, except that enzymes of
470
animal, plant, or microbial origin may (b) Optional ingredients. The following
be declared as ‘‘enzymes’’. safe and suitable ingredients may be
used:
FR 39102, Aug. 2, 1977; 48 FR 49013, Oct. 24,
1983; 49 FR 10093, Mar. 19, 1984; 58 FR 2892,
Jan. 6, 1993] used alone or in combination.
(2) Clotting enzymes. Rennet and/or
§ 133.113 Cheddar cheese. other clotting enzymes of animal,
plant, or microbial origin.
(a) Description. (1) Cheddar cheese is (3) Other optional ingredients. (i)
the food prepared by the procedure set Coloring.
forth in paragraph (a)(3) of this section, (ii) Calcium chloride in an amount
or by any other procedure which pro- not more than 0.02 percent (calculated
duces a finished cheese having the as anhydrous calcium chloride) of the
same physical and chemical properties. weight of the dairy ingredients, used as
The minimum milkfat content is 50 a coagulation aid.
percent by weight of the solids, and the (iii) Enzymes of animal, plant, or mi-
maximum moisture content is 39 per- crobial orgin, used in curing or flavor
cent by weight, as determined by the development.
methods described in § 133.5. If the (iv) Antimycotic agents, applied to
dairy ingredients used are not pasteur- the surface of slices or cuts in con-
ized, the cheese is cured at a tempera- sumer-sized packages.
ture of not less than 35 °F for at least (v) Hydrogen peroxide, followed by a
60 days. sufficient quantity of catalase prepara-
(2) If pasteurized dairy ingredients tion to eliminate the hydrogen per-
are used, the phenol equivalent value oxide. The weight of the hydrogen per-
of 0.25 gram of cheddar cheese is not oxide shall not exceed 0.05 percent of
more than 3 micrograms as determined the weight of the milk and the weight
by the method described in § 133.5. of the catalase shall not exceed 20 parts
(3) One or more of the dairy ingredi- per million of the weight of the milk
ents specified in paragraph (b)(1) of treated.
this section may be warmed, treated (c) Nomenclature. The name of the
with hydrogen peroxide/catalase, and is food is ‘‘cheddar cheese’’.
subjected to the action of a lactic acid- (d) Label declaration. Each of the in-
producing bacterial culture. One or gredients used in the food shall be de-
more of the clotting enzymes specified
in paragraph (b)(2) of this section is
added to set the dairy ingredients to a
(1) Enzymes of animal, plant, or mi-
semisolid mass. The mass is so cut,
crobial origin may be declared as ‘‘en-
stirred, and heated with continued stir- zymes’’; and
ring, as to promote and regulate the (2) The dairy ingredients may be de-
separation of whey and curd. The whey clared, in descending order or predomi-
is drained off, and the curd is matted nance, by the use of the terms ‘‘milkfat
into a cohesive mass. The mass is cut and nonfat milk’’ or ‘‘nonfat milk and
into slabs, which are so piled and han- milkfat’’, as appropriate.
dled as to promote the drainage of
whey and the development of acidity. [48 FR 2743, Jan. 21, 1983; 48 FR 11426, Mar. 18,
The slabs are then cut into pieces, 1983, as amended at 58 FR 2892, Jan. 6, 1993]
which may be rinsed by sprinkling or § 133.114 Cheddar cheese for manufac-
pouring water over them, with free and turing.
continuous drainage; but the duration
of such rinsing is so limited that only Cheddar cheese for manufacturing
the whey on the surface of such pieces conforms to the definition and stand-
is removed. The curd is salted, stirred, ard of identity prescribed for cheddar
further drained, and pressed into cheese by § 133.113, except that the milk
forms. One or more of the other op- is not pasteurized, curing is not re-
tional ingredients specified in para- quired, and the provisions of paragraph

graph (b)(3) of this section may be (b)(3)(iv) of that section do not apply.
added during the procedure. [48 FR 2743, Jan. 21, 1983]
471
§ 133.116 21 CFR Ch. I (4–1–16 Edition)
§ 133.116 Low sodium cheddar cheese. rified calcium chloride in a quantity

not more than 0.02 percent (calculated
Low sodium cheddar cheese is the
as anhydrous calcium chloride) of the
food prepared from the same ingredi-
weight of the milk, is added to set the
ents and in the same manner pre-
milk to a semisolid mass. The mass is
scribed in § 133.113 for cheddar cheese
so cut, stirred, and heated with contin-
and complies with all the provisions of
ued stirring, as to promote and regu-
§ 133.113, including the requirements for
late the separation of whey and curd. A
label statement of ingredients, except
part of the whey is drained off, and the
that:
curd is cooled by adding water, the
(a) It contains not more than 96 mil-
stirring being continued so as to pre-
ligrams of sodium per pound of finished
vent the pieces of curd from matting.
food.
The curd is drained, salted, stirred, fur-
(b) The name of the food is ‘‘low so-
ther drained, and pressed into forms. A
dium cheddar cheese’’. The letters in
harmless preparation of enzymes of
the words ‘‘low sodium’’ shall be of the
animal or plant origin capable of aid-
same size and style of type as the let-
ing in the curing or development of fla-
ters in the words ‘‘cheddar cheese’’,
vor of colby cheese may be added dur-
wherever such words appear on the
ing the procedure, in such quantity
label.
that the weight of the solids of such
(c) If a salt substitute is used, the
preparation is not more than 0.1 per-
label shall bear the statement ‘‘lll
cent of the weight of the milk used.
added as a salt substitute’’, the blank
(c) For the purposes of this section:
being filled in with the common name
(1) The word ‘‘milk’’ means cow’s
or names of the ingredient or ingredi-
milk, which may be adjusted by sepa-
ents used as a salt substitute.
rating part of the fat therefrom or by
(d) Low sodium cheddar cheese is
adding thereto one or more of the fol-
subject to § 105.69 of this chapter.
lowing: Cream, skim milk, con-
[48 FR 2743, Jan. 21, 1983] centrated skim milk, nonfat dry milk,
water, in a quantity sufficient to re-
§ 133.118 Colby cheese. constitute any concentrated skim milk
(a) Colby cheese is the food prepared or nonfat dry milk used.
from milk and other ingredients speci- (2) Milk shall be deemed to have been
fied in this section, by the procedure pasteurized if it has been held at a tem-
set forth in paragraph (b) of this sec- perature of not less than 143 °F for a
tion, or by another procedure which period of not less than 30 minutes, or
produces a finished cheese having the for a time and at a temperature equiva-
same physical and chemical properties lent thereto in phosphatase destruc-
as the cheese produced when the proce- tion. Colby cheese shall be deemed not
dure set forth in paragraph (b) of this to have been made from pasteurized
section is used. It contains not more milk if 0.25 gram shows a phenol equiv-
than 40 percent of moisture, and its alent of more than 3 micrograms when
solids contain not less than 50 percent tested by the method prescribed in
of milkfat, as determined by the meth- § 133.5(c).
ods prescribed in § 133.5 (a), (b), and (d). (3) During the cheesemaking process
If the milk used is not pasteurized, the the milk may be treated with hydrogen
cheese so made is cured at a tempera- peroxide/catalase as provided in
ture of not less than 35 °F for not less § 133.113(a)(3).
than 60 days. (d)(1) Colby cheese in the form of
(b) Milk, which may be pasteurized or slices or cuts may have added to it a
clarified or both, and which may be clear aqueous solution prepared by con-
warmed, is subjected to the action of densing or precipitating wood smoke in
harmless lactic-acid-producing bac- water.
teria, present in such milk or added (2) Colby cheese in the form of slices
thereto. Harmless artificial coloring or cuts in consumer-sized packages
may be added. Sufficient rennet, or may contain an optional mold-inhib-
other safe and suitable milk-clotting iting ingredient consisting of sorbic

enzyme that produces equivalent curd acid, potassium sorbate, sodium sor-
formation, or both, with or without pu- bate, or any combination of two or
472
more of these, in an amount not to ex- § 133.121 Low sodium colby cheese.
ceed 0.3 percent by weight calculated
Low sodium colby cheese is the food
as sorbic acid.
prepared from the same ingredients
(e)(1) If colby cheese has added to it and in the same manner prescribed in
a clear aqueous solution prepared by § 133.118 for colby cheese and complies
condensing or precipitating wood with all the provisions of § 133.118, in-
smoke in water as provided in para- cluding the requirements for label
graph (d)(1) of this section, the name of statement of ingredients, except that:
the food is immediately followed by (a) Salt is not used. Any safe and
the words ‘‘with added smoke fla- suitable ingredient or combination of
voring’’ with all words in this phrase of ingredients that contains no sodium
the same type size, style, and color and that is recognized as a salt sub-
without intervening written, printed, stitute may be used.
or graphic matter. (b) Sodium sorbate is not used.
(2) If colby cheese in sliced or cut (c) It contains not more than 96 mil-
form contains an optional mold-inhib- ligrams of sodium per pound of finished
iting ingredient as specified in para- food.
graph (d)(2) of this section, the label (d) The name of the food is ‘‘low so-
shall bear the statement ‘‘lll added dium colby cheese’’. The letters in the
to retard mold growth’’ or ‘‘lll words ‘‘low sodium’’ shall be of the
added as a preservative’’, the blank same size and style of type as the let-
being filled in with the common name ters in the words ‘‘colby cheese’’, wher-
or names of the mold-inhibiting ingre- ever such words appear on the label.
dient or ingredients used. (e) If a salt substitute as provided for
(3) Wherever the name of the food ap- in paragraph (a) of this section is used,
pears on the label so conspicuously as the label shall bear the statement
to be easily seen under customary con- ‘‘lll added as a salt substitute’’, the
ditions of purchase, the statement blank being filled in with the common
specified in paragraph (e)(2) of this sec- name or names of the ingredient or in-
tion, showing the optional ingredient gredients used as a salt substitute.
used, shall immediately and conspicu- (f) Low sodium colby cheese is sub-
ously precede or follow such name, ject to § 105.69 of this chapter.
without intervening written, printed,
or graphic matter except for the state- [42 FR 14366, Mar. 15, 1977, as amended at 58
FR 2892, Jan. 6, 1993]
ment ‘‘with added smoke flavoring,’’ as
set forth in paragraph (e)(1) of this sec- § 133.123 Cold-pack and club cheese.
tion.
(f) Each of the ingredients used in the (a)(1) Cold-pack cheese, club cheese,
food shall be declared on the label as is the food prepared by comminuting,
required by the applicable sections of without the aid of heat, one or more
parts 101 and 130 of this chapter, except cheeses of the same or two or more va-
that enzymes of animal, plant, or mi- rieties, except cream cheese, neuf-
chatel cheese, cottage cheese, lowfat
crobial origin may be declared as ‘‘en-
cottage cheese, cottage cheese dry
zymes’’.
curd, hard grating cheese, semisoft
[42 FR 14366, Mar. 15, 1977, as amended at 49 part-skim cheese, part-skim spiced
FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, cheese and skim milk cheese for manu-
1993] facturing, into a homogeneous plastic
mass. One or more of the optional in-
§ 133.119 Colby cheese for manufac- gredients designated in paragraph (c) of
turing. this section may be used.
Colby cheese for manufacturing con- (2) All cheeses used in a cold-pack
forms to the definition and standard of cheese are made from pasteurized milk
identity prescribed for colby cheese by or are held for not less than 60 days at
§ 133.118, except that the milk is not a temperature of not less than 35 °F be-
pasteurized, curing is not required, and fore being comminuted.

the provisions of paragraph (d) of that (3)(i) The moisture content of a cold-
section do not apply. pack cheese made from a single variety
473
§ 133.123 21 CFR Ch. I (4–1–16 Edition)
of cheese is not more than the max- the weight of limburger cheese is not
imum moisture content prescribed by less than 5 percent of the total weight
the definition and standard of identity, of both. The weight of each variety of
if any there be, for the variety of cheese in a cold-pack cheese made from
cheese used. If there is no applicable three or more varieties of cheese is not
definition and standard of identity, or less than 15 percent of the total weight
if such standard contains no provision of all, except that the weight of blue
as to maximum moisture content, no cheese, nuworld cheese, roquefort
water is used in the preparation of the cheese, or gorgonzola cheese is not less
cold-pack cheese. than 5 percent of the total weight of
(ii) The fat content of the solids of a all, and the weight of limburger cheese
cold-pack cheese made from a single is not less than 3 percent of the total
variety of cheese is not less than the weight of all. These limits do not apply
minimum prescribed by the definition to the quantity of cheddar cheese,
and standard of identity, if any there washed curd cheese, colby cheese, and
be, for the variety of cheese used, but granular cheese in mixtures which are
in no case is less than 47 percent, ex- designated as ‘‘American cheese’’ as
cept that the fat content of the solids prescribed in paragraph (d)(2) of this
of cold-pack swiss cheese is not less section. Such mixtures are considered
than 43 percent, and the fat content of as one variety of cheese for the purpose
the solids of cold-pack gruyere cheese of this paragraph (a)(6).
is not less than 45 percent. (b) Cold-pack cheese may be smoked,
(4)(i) The moisture content of a cold- or the cheese or cheeses from which it
pack cheese made from two or more va- is made may be smoked, before
rieties of cheese is not more than the comminuting and mixing, or it may
arithmetical average of the maximum contain substances prepared by con-
moisture contents prescribed by the densing or precipitating wood smoke.
definitions and standards of identity, if
(c) The optional ingredients referred
any there be, for the varieties of cheese
to in paragraph (a) of this section are:
used, but in no case is the moisture
(1) An acidifying agent consisting of
content more than 42 percent, except
one or any mixture of two or more of
that the moisture content of a cold-
the following: A vinegar, lactic acid,
pack cheese made from two or more of
citric acid, acetic acid, and phosphoric
the varieties cheddar cheese, washed
acid, in such quantity that the pH of
curd cheese, colby cheese, and granular
the finished cold-pack cheese is not
cheese is not more than 39 percent.
below 4.5. For the purposes of this sec-
(ii) The fat content of the solids of a
tion vinegar is considered to be acetic
cold-pack cheese made from two or
acid.
more varieties of cheese is not less
than the arithmetical average of the (2) Water.
minimum percent of fat prescribed by (3) Salt.
the definitions and standards of iden- (4) Harmless artificial coloring.
tity, if any there be, for the varieties of (5) Spices or flavorings, other than
cheese used, but in no case is less than any which singly or in combination
47 percent, except that the fat content with other ingredients simulate the
of the solids of a cold-pack cheese flavor of a cheese of any age or variety.
made from swiss cheese and gruyere (6) Cold-pack cheese in consumer-
cheese is not less than 45 percent. sized packages may contain an op-
(5) Moisture and fat are determined tional mold-inhibiting ingredient con-
by the methods prescribed in § 133.5(a), sisting of sorbic acid, potassium sor-
(b), and (d). bate, sodium sorbate, or any combina-
(6) The weight of each variety of tion of two or more of these, in an
cheese in a cold-pack cheese made from amount not to exceed 0.3 percent by
two varieties of cheese is not less than weight, calculated as sorbic acid or
25 percent of the total weight of both, consisting of not more than 0.3 percent
except that the weight of blue cheese, by weight of sodium propionate, cal-
nuworld cheese, roquefort cheese, or cium propionate, or a combination of

gorgonzola cheese is not less than 10 sodium propionate and calcium propio-
percent of the total weight of both, and nate.
474
(d)(1) The name of a cold-pack cheese colby cheese, granular cheese, or any
for which a definition and standard of mixture of two or more of these, such
identity is prescribed by this section is cheese or such mixture may be des-
‘‘Cold-pack lll cheese’’, ‘‘lll cold- ignated as ‘‘American cheese’’.
pack cheese’’ or ‘‘lll club cheese’’, [42 FR 14366, Mar. 15, 1977, as amended at 49
the blanks being filled in with the FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6,
name or names of the varieties of 1993]
cheese used, in order of predominance
by weight. § 133.124 Cold-pack cheese food.
(2) If the cold-pack cheese is made of (a)(1) Cold-pack cheese food is the
cheddar cheese, washed curd cheese, food prepared by comminuting and
colby cheese, or granular cheese or any mixing, without the aid of heat, one or
mixture of two or more of these, it may more of the optional cheese ingredients
be designated ‘‘Cold-pack American prescribed in paragraph (c) of this sec-
cheese’’; or when cheddar cheese, tion with one or more of the optional
washed curd cheese, colby cheese, dairy ingredients prescribed in para-
granular cheese, or any mixture of two graph (d) of this section, into a homo-
or more of these is combined with geneous plastic mass. One or more of
other varieties of cheese in the cheese the optional ingredients specified in
ingredient any of such cheeses or such paragraph (e) of this section may be
mixture may be designated as ‘‘Amer- used.
ican cheese’’. (2) All cheeses used in a cold-pack
(3) The full name of the food shall ap- cheese food are made from pasteurized
pear on the principal display panel of milk, or are held for not less than 60
the label in type of uniform size, style, days at a temperature of not less than
and color. Wherever any word or state- 35 °F before being comminuted.
ment emphasizing the name of any in- (3) The moisture content of a cold-
gredient appears on the label (other pack cheese food is not more than 44
than in an ingredient statement as percent, and the fat content is not less
specified in paragraph (f) of this sec- than 23 percent.
tion) so conspicuously as to be easily (4) Moisture and fat are determined
seen under customary conditions of by the methods prescribed in § 133.5 (a),
purchase, the full name of the food (b), and (d), except that in determining
shall immediately and conspicuously moisture the loss in weight which oc-
precede or follow such word or state- curs in drying for 5 hours, under the
ment in type of at least the same size conditions prescribed in such method,
as the type used in such word or state- is taken as the weight of moisture.
ment. (5) The weight of the cheese ingre-
(e) The name of the food shall include dient prescribed by paragraph (a)(1) of
a declaration of any flavoring, includ- this section constitutes not less than 51
ing smoke and substances prepared by percent of the weight of the finished
condensing or precipitating wood cold-pack cheese food.
smoke, that characterizes the product (6) The weight of each variety of
as specified in § 101.22 of this chapter cheese in the cold-pack cheese food
and a declaration of any spice that made with two varieties of cheese is
characterizes the product. not less than 25 percent of the total
(f) Each of the ingredients used in the weight of both, except that the weight
food shall be declared on the label as of blue cheese, nuworld cheese, roque-
required by the applicable sections of fort cheese, gorgonzola cheese, or lim-
parts 101 and 130 of this chapter, except burger cheese is not less than 10 per-
that cheddar cheese, washed curd cent of the total weight of both. The
cheese, colby cheese, granular cheese, weight of each variety of cheese in the
or any mixture of two or more of these, cold-pack cheese food made with three
may be designated as ‘‘American or more varieties of cheese is not less
cheese’’. than 15 percent of the total weight of
(1) Artificial coloring need not be de- all, except that the weight of blue
clared. cheese, nuworld cheese, roquefort

(2) If the cheese ingredient contains cheese, gorgonzola cheese, or limburger
cheddar cheese, washed curd cheese, cheese is not less than 5 percent of the
475
§ 133.124 21 CFR Ch. I (4–1–16 Edition)
total weight of all. These limits do not (6) A sweetening agent consisting of
apply to the quantity of cheddar one or any mixture of two or more of
cheese, washed curd cheese, colby the following: Sugar, dextrose, corn
cheese, and granular cheese in mix- sugar, corn sirup, corn sirup solids,
tures which are designated as ‘‘Amer- glucose sirup, glucose sirup solids,
ican cheese’’ as prescribed in paragraph maltose, malt sirup, and hydrolyzed
(h)(5) of this section. Such mixtures are lactose, in a quantity necessary for
considered as one variety of cheese for seasoning.
the purposes of this paragraph (a)(6). (7) Cold-pack cheese food in con-
(b) Cold-pack cheese food may be sumer-sized packages may contain an
smoked, or the cheese or cheeses from optional mold-inhibiting ingredient
which it is made may be smoked, be- consisting of sorbic acid, potassium
fore comminuting and mixing, or it sorbate, sodium sorbate, or any com-
may contain substances prepared by bination of two or more of these, in an
condensing or precipitating wood amount not to exceed 0.3 percent by
smoke. weight, calculated as sorbic acid or
(c) The optional cheese ingredients consisting of not more than 0.3 percent
referred to in paragraph (a) of this sec- by weight of sodium propionate, cal-
tion are: One or more cheeses of the cium propionate, or a combination of
same or two or more varieties, except sodium propionate and calcium propio-
that cream cheese, neufchatel cheese, nate.
cottage cheese, creamed cottage (8) In the preparation of cold-pack
cheese, cook cheese, and skim-milk cheese food, guar gum or xanthan gum,
cheese for manufacturing are not used, or both, may be used, but the total
and except that semisoft part-skim quantity of such ingredient or com-
cheese, part-skim spiced cheese, and bination is not to exceed 0.3 percent of
hard grating cheese may not be used, the weight of the finished food. When
alone or in combination with each one or both such optional ingredients
other, as the cheese ingredient. is used, dioctyl sodium sulfosuccinate
complying with the requirements of
(d) The optional dairy ingredients re-
§ 172.810 of this chapter may be used in
ferred to in paragraph (a) of this sec-
a quantity not in excess of 0.5 percent
tion are: Cream, milk, skim milk, but-
by weight of such ingredient or ingredi-
termilk, cheese whey, any of the fore-
ents.
going from which part of the water has
(f) The name of the food is ‘‘cold-
been removed, anhydrous milkfat, de-
pack cheese food’’. The full name of the
hydrated cream, skim milk cheese for
food shall appear on the principal dis-
manufacturing, and albumin from
play panel of the label in type of uni-
cheese whey. All optional dairy ingre-
form size, style, and color. Wherever
dients used in cold-pack cheese food
any word or statement emphasizing the
are pasteurized or made from products
name of (other than in an ingredient
that have been pasteurized.
statement any ingredient appears on
(e) The other optional ingredients re- the label as specified in paragraph (h)
ferred to in paragraph (a) of this sec- of this section) so conspicuously as to
tion are: be easily seen under customary condi-
(1) An acidifying agent consisting of tions of purchase, the full name of the
one or any mixture of two or more of food shall immediately and conspicu-
the following: A vinegar, lactic acid, ously precede or follow such word or
citric acid, acetic acid, and phosphoric statement in type of at least the same
acid, in such quantity that the pH of size as the type used in such word or
the finished cold-pack cheese food is statement.
not below 4.5. (g) The name of the food shall include
(2) Water. a declaration of any flavoring, includ-
(3) Salt. ing smoke and substances prepared by
(4) Harmless artificial coloring. condensing or precipitating wood
(5) Spices or flavorings, other than smoke, that characterizes the product
any which singly or in combination as specified in § 101.22 of this chapter

with other ingredients simulate the and a declaration of any spice that
flavor of cheese of any age or variety. characterizes the product.
476
(h) Each of the ingredients used in than 3 micrograms as determined by

the food shall be declared on the label the method described in § 133.5.
as required by the applicable sections (3) One or more of the dairy ingredi-
of parts 101 and 130 of this chapter, ex- ents specified in paragraph (b)(1) of
cept that cheddar cheese, washed curd this section may be warmed and is sub-
cheese, colby cheese, granular cheese, jected to the action of a lactic acid-
or any mixture of two or more of these, producing bacterial culture. One or
may be designated as ‘‘American more of the clotting enzymes specified
cheese’’. in paragraph (b)(2) of this section is
[42 FR 14366, Mar. 15, 1977, as amended at 49 added to set the dairy ingredients to a
FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, semisolid mass. The mass is cut,
1993] stirred, and heated with continued stir-
ring, so as to separate the curd and
§ 133.125 Cold-pack cheese food with whey. The whey is drained from the
fruits, vegetables, or meats. curd and the curd is cured for 2 or 3
(a) Cold-pack cheese food with fruits, days. It is then heated to a tempera-
vegetables, or meats or mixtures of ture of not less than 180 °F until the
these is the food which conforms to the hot curd will drop from a ladle with a
definition and standard of identity, and consistency like that of honey. The hot
is subject to the requirements for label cheese is filled into packages and
declaration of ingredients, prescribed cooled. One or more of the other op-
for cold pack cheese food by § 133.124, tional ingredients specified in para-
except that: graph (b)(3) of this section may be
(1) Its milk fat content is not less added during the procedure.
than 22 percent. (b) Optional ingredients. The following
(2) It contains one or any mixture of safe and suitable ingredients may be
two or more of the following: Any prop- used:
erly prepared fresh, cooked, canned, or (1) Dairy ingredients. Nonfat milk as
dried vegetable; any properly prepared defined in § 133.3.
cooked or canned meat. (2) Clotting enzymes. Rennet and/or
(3) When the added fruits, vegetables, other clotting enzymes of animal,
or meats contain fat, the method pre- plant, or microbial origin.
scribed for the determination of fat by (3) Other optional ingredients. (i) Cal-
§ 133.5(b) and (d) is not applicable. cium chloride in an amount not more
(b) The name of a cold-pack cheese than 0.02 percent (calculated as anhy-
food with fruits, vegetables or meats is drous calcium chloride) of the weight
‘‘Cold-pack cheese food with lll’’, of the dairy ingredients, used as a co-
the blank being filled in with the com- agulation aid.
mon or usual name or names of the (ii) Culture of white mold.
fruits, vegetables, or meats used, in (iii) Pasteurized cream.
order of predominance by weight. (iv) Caraway seed.
(v) Salt.
FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, (c) Nomenclature. The name of the
1993] food is ‘‘cook cheese’’ or, alternatively,
‘‘koch kaese’’.
§ 133.127 Cook cheese, koch kaese. (d) Label declaration. Each of the in-
(a) Description. (1) Cook cheese, koch gredients used in the food shall be de-
kaese, is the food prepared by the pro- clared on the label as required by the
cedure set forth in paragraph (a)(3) of applicable sections of parts 101 and 130,
this section or by any other procedure except that enzymes of animal, plant,
which produces a finished cheese hav- or microbial origin may be declared as
ing the same physical and chemical ‘‘enzymes’’.
properties. The maximum moisture [54 FR 32053, Aug. 4, 1989, as amended at 55
content is 80 percent by weight, as de- FR 51409, Dec. 14, 1990; 58 FR 2892, Jan. 6,
termined by the method described in 1993]
§ 133.5. The dairy ingredients used may
be pasteurized. § 133.128 Cottage cheese.

(2) The phenol equivalent value of (a) Cottage cheese is the soft uncured
0.25 gram of cook cheese is not more cheese prepared by mixing cottage
477
§ 133.129 21 CFR Ch. I (4–1–16 Edition)
cheese dry curd with a creaming mix- as required by the applicable sections
ture as provided in paragraph (b) of of parts 101 and 130 of this chapter, ex-
this section. The milkfat content is not cept that milk-clotting enzymes may
less than 4 percent by weight of the fin- be declared by the word ‘‘enzymes’’.
ished food, within limits of good manu- [42 FR 14366, Mar. 15, 1977, as amended at 58
facturing practice. The finished food FR 2892, Jan. 6, 1993]
contains not more than 80 percent of
moisture, as determined by the method § 133.129 Dry curd cottage cheese.
prescribed in § 133.129(a). (a) Cottage cheese dry curd is the
(b) The creaming mixture is prepared soft uncured cheese prepared by the
from safe and suitable ingredients in- procedure set forth in paragraph (b) of
cluding, but not limited to, milk or this section. The finished food contains
substances derived from milk. Any in- less than 0.5 percent milkfat. It con-
gredients used that are not derived tains not more than 80 percent of mois-
from milk shall serve a useful function ture, as determined by the method pre-
other than building the total solids scribed in § 133.5(a).
content of the finished food, and shall (b)(1) One or more of the dairy ingre-
be used in a quantity not greater than dients specified in paragraph (b)(2) of
is reasonably required to accomplish this section is pasteurized; calcium
their intended effect. The creaming chloride may be added in a quantity of
mixture shall be pasteurized; however, not more than 0.02 percent (calculated
heat labile ingredients, such as bac- as anhydrous calcium chloride) of the
terial starters, may be added following weight of the mix; thereafter one of the
pasteurization. following methods is employed:
(c) The name of the food consists of (i) Harmless lactic-acid-producing
the following two phrases which shall bacteria, with or without rennet and/or
appear together: other safe and suitable milk-clotting
(1) The words ‘‘cottage cheese’’ which enzyme that produces equivalent curd
shall appear in type of the same size formation, are added and it is held
and style. until it becomes coagulated. The co-
(2) The statement ‘‘not less than l agulated mass may be cut; it may be
percent milkfat’’ or ‘‘l percent warmed; it may be stirred; it is then
milkfat minimum’’, the blank being drained. The curd may be washed with
filled in with the whole number that is water and further drained; it may be
closest to, but does not exceed, the ac- pressed, chilled, worked, seasoned with
tual fat content of the product. This salt; or
statement of fat content shall appear (ii) Food grade phosphoric acid, lac-
in letters not less than one-half of the tic acid, citric acid, or hydrochloric
height of the letters in the phrase spec- acid, with or without rennet and/or
ified in paragraph (c)(1) of this section, other safe and suitable milk-clotting
but in no case less than one-eighth of enzyme that produces equivalent curd
an inch in height. formation, is added in such amount as
(d) When the optional process de- to reach a pH of between 4.5 and 4.7; co-
scribed in § 133.129(b)(1) (ii) or (iii) is agulation to a firm curd is achieved
used to make the cottage cheese dry while heating to a maximum of 120 °F
curd used in cottage cheese, the label without agitation during a continuous
shall bear the statement ‘‘Directly set’’ process. The coagulated mass may be
or ‘‘Curd set by direct acidification’’. cut; it may be warmed; it may be
Wherever the name of the food appears stirred; it is then drained. The curd is
on the label so conspicuously as to be washed with water, stirred, and further
seen under customary conditions of drained. It may be pressed, chilled,
purchase, the statement specified in worked, seasoned with salt.
this paragraph, showing the optional (iii) Food grade acids as provided in
process used, shall immediately and paragraph (b)(1)(ii) of this section, D-
conspicuously precede or follow such Glucono-delta-lactone with or without
name without intervening written, rennet, and/or other safe and suitable
printed, or graphic matter. milk clotting enzyme that produces

(e) Each of the ingredients used in equivalent curd formation, are added in
the food shall be declared on the label such amounts as to reach a final pH
478
value in the range of 4.5–4.8, and it is cept that milk-clotting enzymes may
held until it becomes coagulated. The be declared by the word ‘‘enzymes’’.
coagulated mass may be cut; it may be
warmed; it may be stirred; it is then FR 11826, Mar. 19, 1982; 49 FR 10093, Mar. 19,
drained. The curd is then washed with 1984; 58 FR 2892, Jan. 6, 1993]
water, and further drained. It may be
pressed, chilled, worked, and seasoned § 133.133 Cream cheese.
with salt. (a) Description. (1) Cream cheese is
(2) The dairy ingredients referred to the soft, uncured cheese prepared by
in paragraph (b)(1) of this section are the procedure set forth in paragraph
sweet skim milk, concentrated skim (a)(2) of this section, or by any other
milk, and nonfat dry milk. If con- procedure which produces a finished
centrated skim milk or nonfat dry cheese having the same physical and
milk is used, water may be added in a chemical properties. The minimum
quantity not in excess of that removed milkfat content is 33 percent by weight
when the skim milk was concentrated of the finished food, and the maximum
or dried. moisture content is 55 percent by
(3) For the purposes of this section weight, as determined by the methods
the term ‘‘skim milk’’ means the milk described in § 133.5. The dairy ingredi-
of cows from which the milk fat has ents used are pasteurized.
been separated, and ‘‘concentrated (2) One or more of the dairy ingredi-
skim milk’’ means skim milk from ents specified in paragraph (b)(1) of
which a portion of the water has been this section may be homogenized and is
removed by evaporation. subjected to the action of lactic acid-
(c) The name of the food consists of producing bacterial culture. One or
the following two phrases which shall more of the clotting enzymes specified
appear together: in paragraph (b)(2) of this section is
added to coagulate the dairy ingredi-
(1) The words ‘‘cottage cheese dry
ents. The coagulated mass may be
curd’’ or alternatively ‘‘dry curd cot-
warmed and stirred and it is drained.
tage cheese’’ which shall all appear in
The moisture content may be adjusted
type of the same size and style. with one or more of the optional ingre-
(2) The words ‘‘less than 1⁄2% dients specified in paragraph (b)(3)(ii)
milkfat’’ which shall all appear in let- of this section. The curd may be
ters not less than one-half of the pressed, chilled, and worked and it may
height of the letters in the phrase spec- be heated until it becomes fluid. It may
ified in paragraph (c)(1) of this section, then be homogenized or otherwise
but in no case less than one-eighth of mixed. One or more of the optional
an inch in height. dairy ingredients specified in para-
(d) When either of the optional proc- graph (b)(1) and the other optional in-
esses described in paragraph (b)(1) (ii) gredients specified in paragraph (b)(3)
or (iii) of this section is used to make of this section may be added during the
cottage cheese dry curd, the label shall procedure.
bear the statement ‘‘Directly set’’ or (b) Optional ingredients. The following
‘‘Curd set by direct acidification’’. safe and suitable ingredients may be
Wherever the name of the food appears used:
on the label so conspicuously as to be (1) Dairy ingredients. Milk, nonfat
seen under customary conditions of milk, or cream, as defined in § 133.3,
purchase, the statement specified in used alone or in combination.
this paragraph, showing the optional (2) Clotting enzymes. Rennet and/or
process used, shall immediately and other clotting enzymes of animal,
conspicuously precede or follow such plant, or microbial origin.
name without intervening written, (3) Other optional ingredients. (i) Salt.
printed, or graphic matter. (ii) Cheese whey, concentrated cheese
(e) Each of the ingredients used in whey, dried cheese whey, or reconsti-
the food shall be declared on the label tuted cheese whey prepared by addition
as required by the applicable sections of water to concentrated cheese whey
of parts 101 and 130 of this chapter, ex- or dried cheese whey.
479
§ 133.134 21 CFR Ch. I (4–1–16 Edition)
(iii) Stabilizers, in a total amount addition of dioctyl sodium sulfo-

not to exceed 0.5 percent of the weight succinate in a maximum amount of 0.5
of the finished food, with or without percent of the weight of the sta-
the addition of dioctyl sodium sulfo- bilizer(s) used.
succinate in a maximum amount of 0.5 (ii) Coloring.
percent of the weight of the sta- (c) Nomenclature. The name of the
bilizer(s) used. food is ‘‘cream cheese with lll’’ or,
(c) Nomenclature. The name of the alternatively, ‘‘cream cheese and
food is ‘‘cream cheese’’. lll’’, the blank being filled in with
(d) Label declaration. Each of the in- the name of the foods used in order of
gredients used in the food shall be de- predominance by weight.
clared on the label as required by the (d) Label declaration. Each of the in-
applicable sections of parts 101 and 130 gredients used in the food shall be de-
of this chapter, except that: clared on the label as required by the
(1) Enzymes of animal, plant, or mi- applicable sections of parts 101 and 130
crobial original may be declared as of this chapter, except that:
‘‘enzymes’’; and (1) Enzymes of animal, plant, or mi-
(2) The dairy ingredients may be de- crobial origin may be declared as ‘‘en-
clared, in descending order of predomi- zymes’’; and
nance, by the use of the terms ‘‘milkfat (2) The dairy ingredients may be de-
and nonfat milk’’ or ‘‘nonfat milk and clared, in descending order of predomi-
milkfat’’, as appropriate. nance, by the use of the terms ‘‘milkfat
FR 2892, Jan. 6, 1993] milkfat’’, as appropriate.
§ 133.134 Cream cheese with other FR 2893, Jan. 6, 1993]
foods.
(a) Description. Cream cheese with § 133.136 Washed curd and soaked
other foods is the class of foods pre- curd cheese.
pared by mixing, with or without the (a) Description. (1) Washed curd,
aid of heat, cream cheese with one or a soaked curd cheese is the food prepared
mixture of two or more types of foods by the procedure set forth in paragraph
(except other cheeses) listed in para- (a)(3) of this section or by any other
graph (b)(1) of this section, in an procedure which produces a finished
amount sufficient to differentiate the cheese having the same physical and
mixture from cream cheese. One or chemical properties. The minimum
more of the other optional ingredients milkfat content is 50 percent by weight
in paragraph (b)(2) of this section may of the solids and the maximum mois-
be used. The maximum moisture con- ture content is 42 percent by weight, as
tent of the mixture is 60 percent by determined by the methods described
weight. The minimum milkfat is 33 in § 133.5. If the dairy ingredients used
percent by weight of the cream cheese are not pasteurized, the cheese is cured
and in no case less than 27 percent of at a temperature of not less than 35 °F
the finished food. The moisture and fat for at least 60 days.
contents will be determined by the (2) If pasteurized dairy ingredients
methods described in § 133.5, except are used, the phenol equivalent value
that the method for determination of of 0.25 gram of washed curd cheese is
fat content is not applicable when the not more than 3 micrograms as deter-
added food contains fat. mined by the method described in
(b) Optional ingredients. The following § 133.5.
safe and suitable optional ingredients (3) One or more of the dairy ingredi-
may be used: ents specified in paragraph (b)(1) of
(1) Foods. Properly prepared fresh, this section may be warmed, treated
cooked, canned, or dried fruits or vege- with hydrogen peroxide/catalase, and is
tables; cooked or canned meats, rel- subjected to the action of a lactic acid-
ishes, pickles, or other suitable foods. producing bacterial culture. One or
(2) Other optional ingredients. (i) Sta- more of the clotting enzymes specified
bilizers, in a total amount not to ex- in paragraph (b)(2) of this section is
ceed 0.8 percent, with or without the added to set the dairy ingredients to a
480
semisolid mass. The mass is so cut, (1) Enzymes of animal, plant or mi-
stirred, and heated with continued stir- crobial origin may be declared as ‘‘en-
ring, as to promote and regulate the zymes’’; and
separation of whey and curd. The whey (2) The dairy ingredients may be de-
is drained off, and the curd is matted clared, in descending order of predomi-
into a cohesive mass. The mass is cut nance, by the use of the terms ‘‘milkfat
into slabs, which are so piled and han- and nonfat milk’’ or ‘‘nonfat milk and
dled as to promote the drainage of milkfat’’, as appropriate.
whey and the development of acidity.
The slabs are then cut into pieces, [54 FR 32054, Aug. 4, 1989, as amended at 58
cooled in water, and soaked therein FR 2893, Jan. 6, 1993]
until the whey is partly extracted and
water is absorbed. The curd is drained, § 133.137 Washed curd cheese for man-
salted, stirred, and pressed into forms. ufacturing.
One or more of the other optional in- Washed curd cheese for manufac-
gredients specified in paragraph (b)(3) turing conforms to the definition and
of this section may be added during the standard of identity prescribed for
procedure. washed curd cheese by § 133.136, except
(b) Optional ingredients. The following that the dairy ingredients are not pas-
safe and suitable ingredients may be teurized and curing is not required.
used:
(1) Dairy ingredients. Milk, nonfat [54 FR 32054, Aug. 4, 1989]
used alone or in combination. § 133.138 Edam cheese.
(2) Clotting enzymes. Rennet and/or (a) Description. (1) Edam cheese is the
other clotting enzymes of animal, food prepared by the procedure set
plant, or microbial origin. forth in paragraph (a)(3) of this section
(3) Other optional ingredients. (i) or by any other procedure which pro-
Coloring. duces a finished cheese having the
(ii) Calcium chloride in an amount same physical and chemical properties.
not more than 0.02 percent (calculated The minimum milkfat content is 40
as anhydrous calcium chloride) of the percent by weight of the solids and the
weight of the dairy ingredients, used as maximum moisture content is 45 per-
a coagulation aid.
cent by weight, as determined by the
(iii) Enzymes of animal, plant, or mi-
methods described in § 133.5. If the
crobial origin, used in curing or flavor
development. dairy ingredients used are not
(iv) Antimycotic agents, the cumu- pasturized, the cheese is cured at a
lative levels of which shall not exceed temperature of not less than than 35 °F
current good manufacturing practice, for at least 60 days.
may be added to the surface of the (2) If pasteurized dairy ingredients
cheese. are used, the phenol equivalent value
(v) Hydrogen peroxide, followed by a of 0.25 gram of edam cheese is not more
sufficient quantity of catalase prepara- than 3 micrograms, as determined by
tion to eliminate the hydrogen per- the method described in § 133.5.
oxide. The weight of the hydrogen per- (3) One or more of the dairy ingredi-
oxide shall not exceed 0.05 percent of ents specified in paragraph (b)(1) of
the weight of the dairy ingredients and this section may be warmed and is sub-
the weight of the catalase shall not jected to the action of a lactic acid-
exeed 20 parts per million of the weight producing bacterial culture. One or
of dairy ingredients treated. more of the clotting enzymes specified
(c) Nomenclature. The name of the in paragraph (b)(2) of this section is
food is ‘‘washed curd cheese’’ or, alter- added to set the dairy ingredients to a
natively, ‘‘soaked curd cheese’’. semisolid mass. After coagulation the
(d) Label declaration. Each of the in-
mass is cut into small cube-shaped
pieces with sides approximately three-

eighths-inch long. The mass is stirred
481
§ 133.140 21 CFR Ch. I (4–1–16 Edition)
and heated to about 90 °F. and so han- § 133.140 Gammelost cheese.

dled by further stirring, heating, dilu- (a) Description. (1) Gammelost cheese
tion with water or salt brine, and salt- is the food prepared from nonfat milk,
ing as to promote and regulate the sep- as defined in § 133.3, by the procedure
aration of curd and whey. When the de- set forth in paragraph (a)(2) of this sec-
sired curd is obtained, it is transferred tion, or by any other procedure which
to forms permitting drainage of whey. produces a finished cheese having the
During drainage the curd is pressed and same physical and chemical properties.
turned. After drainage the curd is re- The maximum moisture content is 52
moved from the forms and is salted and percent by weight, as determined by
cured. One or more of the other op- the methods described in § 133.5.
tional ingredients specified in para- (2) The dairy ingredients are sub-
graph (b)(3) of this section may be jected to the action of a lactic acid-
added during the procedures. producing bacterial culture. The devel-
(b) Optional ingredients. The following opment of acidity is continued until
safe and suitable ingredients may be the dairy ingredients coagulate to a
used: semisolid mass. The mass is stirred and
(1) Dairy ingredients. Milk, nonfat heated until a temperature of about 145
milk, or cream, as defined in § 133.3, °F is reached, and is held at that tem-
perature for at least 30 minutes. The
whey is drained off and the curd re-
moved and placed in forms and pressed.
other clotting enzymes of animal, The shaped curd is placed in whey and
plant, or microbial origin. heated for 3 or 4 hours, and may again
(3) Other optional ingredients. (i) be pressed. It is then stored under con-
Coloring. ditions suitable for curing.
(ii) Calcium chloride in an amount (b) Nomenclature. The name of the
not more than 0.02 percent (calculated food is ‘‘gammelost cheese’’.
as anhydrous calcium chloride) of the (c) Label declaration. Each of the in-
weight of the dairy ingredients, used as gredients used in the food shall be de-
a coagulation aid. clared on the label as required by the
(iii) Enzymes of animal, plant, or mi- applicable sections of parts 101 and 130
crobial origin, used in curing or flavor of this chapter.
development. [54 FR 32054, Aug. 4, 1989, as amended at 58
(iv) Antimycotic agents, the cumu- FR 2893, Jan. 6, 1993]
lative levels of which shall not exceed
current good manufacturing practice, § 133.141 Gorgonzola cheese.
may be added to the surface of the (a) Description. (1) Gorgonzola cheese
cheese. is the food prepared by the procedure
(c) Nomenclature. The name of the set forth in paragraph (a)(2) of this sec-
food is ‘‘edam cheese.’’ tion or by any other procedure which
(d) Label declaration. Each of the in- produces a finished cheese having the
gredients used in the food shall be de- same physical and chemical properties.
clared on the label as required by the It is characterized by the presence of
applicable sections of parts 101 and 130 bluish-green mold, Penicillium roque-
of this chapter, except that: fortii, throughout the cheese. The min-
(1) Enzymes of animal, plant, or mi- imum milkfat content is 50 percent by
crobial origin may be declared as ‘‘en- weight of the solids and the maximum
zymes’’; and moisture content is 42 percent by
weight, as determined by the methods
(2) The dairy ingredients may be de-
described in § 133.5. The dairy ingredi-
clared, in descending order of predomi-
ents used may be pasteurized. Gorgon-
nance, by the use of the terms ‘‘milkfat zola cheese is at least 90 days old.
and nonfat milk’’ or ‘‘nonfat milk and (2) One or more of the dairy ingredi-
milkfat,’’ as appropriate. ents specified in paragraph (b)(1) of
[48 FR 2743, Jan. 21, 1983; 48 FR 11426, Mar. 18, this section may be warmed and is sub-
1983, as amended at 55 FR 6795, Feb. 27, 1990; jected to the action of a lactic acid-
58 FR 2893, Jan. 6, 1993] producing bacterial culture. One or
482
more of the clotting enzymes specified the weight of the dairy ingredients
in paragraph (b)(2) of this section is being bleached, and the weight of the
added to set the dairy ingredients to a potassium alum, calcium sulfate, and
semisolid mass. The mass is cut into magnesium carbonate, singly or com-
smaller portions and allowed to stand bined, is not more than six times the
for a time. The mixed curd and whey is weight of the benzoyl peroxide used. If
placed into forms permitting further the dairy ingredients are bleached in
drainage. While being placed in forms, this manner, vitamin A is added to the
spores of the mold Penicillium roque- curd in such quantity as to compensate
fortii are added. The forms are turned for the vitamin A or its precursors de-
several times during drainage. When stroyed in the bleaching process, and
sufficiently drained, the shaped curd is artificial coloring is not used.
removed from the forms and salted (vi) Vegetable fats or oil which may
with dry salt or brine. Perforations are be hydrogenated, used as a coating for
then made in the shaped curd and it is the rind.
held at a temperature of approximately (c) Nomenclature. The name of the
50 °F at 90 to 95 percent relative humid- food is ‘‘gorgonzola cheese’’.
ity, until the characteristic mold (d) Label declaration. Each of the in-
growth has developed. During storage, gredients used in the food shall be de-
the surface of the cheese may be clared on the label as required by the
scraped to remove surface growth of applicable sections of parts 101 and 130
undesirable microorganisms. One or of this chapter, except that:
more of the other optional ingredients (1) Enzymes of animal, plant, or mi-
specified in paragraph (b)(3) of this sec- crobial origin may be declared as ‘‘en-
tion may be added during the proce- zymes’’; and
dure. (2) The dairy ingredients may be de-
(b) Optional ingredients. The following clared, in descending order of predomi-
safe and suitable ingredients may be nance, by the use of the terms ‘‘milkfat
used: and nonfat milk’’ or ‘‘nonfat milk and
(1) Dairy ingredients. Milk, nonfat milkfat’’, as appropriate; ‘‘milkfat
milk, or cream, as defined in § 133.3, or from goat’s milk and nonfat goat’s
corresponding products of goat origin, milk’’, etc.
(2) Clotting enzymes. Rennet and/or FR 2893, Jan. 6, 1993]
plant, or microbial origin. § 133.142 Gouda cheese.
(3) Other optional ingredients. (i) Blue
Gouda cheese conforms to the defini-
or green color in an amount to neu-
tion and standard of identity and com-
tralize the natural yellow color of the
plies with the requirements for label
curd.
declaration of ingredients prescribed
for edam cheese by § 133.138, except that
the minimum milkfat content is 46 per-
as anhydrous calcium chloride) of the
cent by weight of the solids, as deter-
weight of the dairy ingredients, used as
mined by the methods described in
a coagulation aid.
§ 133.5 and the maximum moisture con-
tent is 45 percent by weight.
development. [48 FR 2744, Jan. 21, 1983]
(iv) Antimycotic agents, the cumu-
lative levels of which shall not exceed § 133.144 Granular and stirred curd
current good manufacturing practice, cheese.
may be added to the surface of the (a) Description. (1) Granular cheese,
cheese. stirred curd cheese is the food prepared
(v) Benzoyl peroxide, or a mixture of by the procedure set forth in paragraph
benzoyl peroxide with potassium alum, (a)(3) of this section or by any other
calcium sulfate, and magnesium car- procedure which produces a finished
bonate used to bleach the dairy ingre- cheese having the same physical and
dients. The weight of the benzoyl per- chemical properties. The minimum
oxide is not more than 0.002 percent of milkfat content is 50 percent by weight
483
§ 133.145 21 CFR Ch. I (4–1–16 Edition)
of the solids and the maximum mois- (v) Hydrogen peroxide, followed by a
ture content is 39 percent by weight as sufficient quantity of catalase prepara-
determined by the methods described tion to eliminate the hydrogen per-
in § 133.5. If the dairy ingredients used oxide. The weight of the hydrogen per-
are not pasteurized, the cheese is cured oxide shall not exceed 0.05 percent of
at a temperature of not less than 35 °F the weight of the dairy ingredients and
for at least 60 days. the weight of the catalase shall not ex-
(2) If pasteurized dairy ingredients ceed 20 parts per million of the weight
are used, the phenol equivalent value of the dairy ingredients treated.
of 0.25 gram of granular cheese is not (c) Nomenclature. The name of the
more than 3 micrograms as determined food is ‘‘granular cheese’’ or, alter-
by the method described in § 133.5. natively, ‘‘stirred curd cheese’’.
(3) One or more of the dairy ingredi- (d) Label declaration. Each of the in-
ents specified in paragraph (b)(1) of gredients used in the food shall be de-
this section may be warmed, treated clared on the label as required by the
with hydrogen peroxide/catalase, and is applicable sections of parts 101 and 130
subjected to the action of a lactic acid- of this chapter, except that:
producing bacterial culture. One or (1) Enzymes of animal, plant, or mi-
more of the clotting enzymes specified crobial origin may be declared as ‘‘en-
in paragraph (b)(2) of this section is zymes’’; and
added to set the dairy ingredients to a (2) The dairy ingredients may be de-
semisolid mass. The mass is so cut, clared, in descending order of predomi-
stirred, and heated with continued stir- nance, by the use of the terms ‘‘milkfat
ring, as to promote and regulate the and nonfat milk’’ or ‘‘nonfat milk and
separation of whey and curd. A part of milkfat’’, as appropriate.
the whey is drained off. The curd is [54 FR 32055, Aug. 4, 1989, as amended at 58
then alternately stirred and drained to FR 2893, Jan. 6, 1993]
prevent matting and to remove whey
from curd. The curd is then salted, § 133.145 Granular cheese for manu-
stirred, drained, and pressed into facturing.
forms. One or more of the other op- Granular cheese for manufacturing
tional ingredients specified in para- conforms to the definition and stand-
graph (b)(3) of this section may be ard of identity prescribed for granular
added during the procedure. cheese by § 133.144, except that the
(b) Optional ingredients. The following dairy ingredients are not pasteurized
safe and suitable ingredients may be and curing is not required.
used: [54 FR 32056, Aug. 4, 1989]
milk, or cream, as defined in § 133.3, § 133.146 Grated cheeses.
used alone or in combination. (a) Description. Grated cheeses is the
(2) Clotting enzymes. Rennet and/or class of foods prepared by grinding,
other clotting enzymes of animal, grating, shredding, or otherwise
plant, or microbial origin. comminuting cheese of one variety or a
(3) Other optional ingredients. (i) mixture of two or more varieties. The
Coloring. cheese varieties that may be used are
(ii) Calcium chloride in an amount those for which there are definitions
not more than 0.02 percent (calculated and standards of identity, except that
as anhydrous calcium chloride) by cream cheese, neufchatel cheese, cot-
weight of the dairy ingredients, used as tage cheese, creamed cottage cheese,
a coagulation aid. cook cheese, and skim milk cheese for
(iii) Enzymes of animal, plant, or mi- manufacturing may not be used. All
crobial origin, used in curing or flavor cheese ingredients used are either
development. made from pasteurized milk or held at
(iv) Antimycotic agents, the cumu- a temperature of not less than 35 °F for
lative levels of which shall not exceed at least 60 days. Moisture may be re-
current good manufacturing practice, moved from the cheese ingredients in

may be added to the surface of the the manufacture of the finished food,
cheese. but no moisture is added. One or more
484
of the optional ingredients specified in (ii) If only parmesan and romano

paragraph (c) of this section may be cheeses are used and each is present at
used. a level of not less than 25 percent by
(b) Composition. (1) Each cheese ingre- weight of the finished food, the name of
dient used is present at a minimum the food is ‘‘grated lll and lll
level of 2 percent of the weight of the cheese’’, the blanks being filled with
finished food. the names ‘‘parmesan’’ and ‘‘romano’’
(2) When one variety of cheese is in order of predominance by weight.
used, the minimum milkfat content of The name ‘‘reggiano’’ may be used for
the food is not more than 1 percent ‘‘parmesan’’.
lower than the minimum prescribed by (iii) If a mixture of cheese varieties
the standard of identity for that (not including parmesan or romano) is
cheese. used and each variety is present at a
(3) When two or more varieties of level of not less than 25 percent of the
cheese are used, the minimum milkfat weight of the finished food, the name of
content is not more than 1 percent the food is ‘‘grated lll cheese’’, the
below the arithmetical average of the blank being filled in with the names of
minimum fat content percentages pre- the varieties in order of predominance
scribed by the standards of identity for by weight.
the varieties of cheese used, and in no (iv) If a mixture of cheese varieties in
case is the milkfat content less than 31 which one or more varieties (not in-
percent. cluding parmesan or romano) are each
(4) Milkfat and moisture contents are present at a level of not less than 25
determined by the methods described percent by weight of the finished food,
in § 133.5. and one or more other varieties (which
(c) Optional ingredients. The following may include parmesan and romano
safe and suitable ingredients may be cheese) are each present at a level of
used: not less than 2 percent but in the ag-
(1) Antimycotics. gregate not more than 10 percent of the
(2) Anticaking agents. weight of the finished food, the name of
(3) Spices. the food is ‘‘grated lll cheese with
(4) Flavorings other than those other grated cheese’’ or ‘‘grated lll
which, singly or in combination with cheese with other grated cheeses’’, as
other ingredients, simulate the flavor appropriate, the blank being filled in
of cheese of any age or variety. with the name or names of those
(d) Nomenclature. (1) The name of the cheese varieties present at levels of not
food is ‘‘grated cheese’’ or ‘‘grated less than 25 percent by weight of the
cheeses’’, as appropriate. The name of finished food in order of predominance,
the food shall be accompanied by a dec- in letters not more than twice as high
laration of the specific variety of as the letters in the phrase ‘‘with other
cheese(s) used in the food and by a dec- grated cheese(s)’’.
laration indicating the presence of any (4) The following terms may be used
added spice or flavoring. in place of ‘‘grated’’ to describe alter-
(2) Any cheese varietal names used in native forms of cheese:
the name of the food are those speci- (i) ‘‘Shredded’’, if the particles of
fied by applicable standards of iden- cheese are in the form of cylinders,
tity, except that the designation shreds, or strings.
‘‘American cheese’’ may be used for (ii) ‘‘Chipped’’ or ‘‘chopped’’, if the
cheddar, washed curd, colby, or granu- particles of cheese are in the form of
lar cheese or for any mixture of these chips.
cheeses. (e) Label declaration. Each of the in-
(3) The following terms may be used gredients used in the food shall be de-
in place of the name of the food to declared on the label as required by the
scribe specific types of grated cheese: applicable sections of parts 101 and 130
(i) If only one variety of cheese is of this chapter, except that:
used, the name of the food is ‘‘grated (1) Enzymes of animal, plant, or mi-
lll cheese’’, the name of the cheese crobial origin may be declared as ‘‘en-
filling the blank. zymes’’; and
485
§ 133.147 21 CFR Ch. I (4–1–16 Edition)
(2) The dairy ingredients may be de- spicuously as to be easily seen under
clared, in descending order of predomi- customary conditions of purchase, the
nance, by the use of the terms ‘‘milkfat full name of the food shall immediately
and nonfat milk’’ or ‘‘nonfat milk and and conspicuously precede or follow
milkfat’’, ‘‘milkfat from goat’s milk such word or statement in type of at
and nonfat goat’s milk’’, ‘‘milkfat from least the same size as the type used in
sheep’s milk and nonfat sheep’s milk’’, such word or statement.
etc., as appropriate. (e) Each of the ingredients used in
the food shall be declared on the label
[54 FR 32056, Aug. 4, 1989; 54 FR 35756, Aug. 29,
1989, as amended at 58 FR 2893, Jan. 6, 1993] as required by the applicable sections
of parts 101 and 130 of this chapter, ex-
§ 133.147 Grated American cheese cept that cheddar cheese, washed curd
food. cheese, colby cheese, granular cheese,
(a)(1) Grated American cheese food is or any mixture of two or more of these
the food prepared by mixing, with or may be designated ‘‘American cheese’’.
without the aid of heat, one or more of [42 FR 14366, Mar. 15, 1977, as amended at 49
the optional cheese ingredients pre- FR 10094, Mar. 19, 1984; 58 FR 2893, Jan. 6,
scribed in paragraph (b) of this section 1993]
with one or more of the optional ingre-
§ 133.148 Hard grating cheeses.
dients prescribed in paragraph (c) of
this section, into a uniformly blended, (a) The cheeses for which definitions
partially dehydrated, powdered, or and standards of identity are pre-
granular mixture. scribed by this section are hard grating
(2) Grated American cheese food con- cheeses for which specifically applica-
tains not less than 23 percent of ble definitions and standards of iden-
milkfat, as determined by the method tity are not prescribed by other sec-
prescribed in § 133.5(b). tions of this part. They are made from
(b) The optional cheese ingredients milk and the other ingredients speci-
referred to in paragraph (a) of this sec- fied in this section, by the procedure
tion are cheddar cheese, washed curd set forth in paragraph (b) of this sec-
cheese, colby cheese, and granular tion. They contain not more than 34
cheese. percent of moisture, and their solids
(c) The other optional ingredients re- contain not less than 32 percent of
ferred to in paragraph (a) of this sec- milkfat, as determined by the methods
tion are: prescribed in § 133.5 (a), (b), and (d).
(1) Nonfat dry milk. Hard grating cheeses are cured for not
(2) Dried whey. less than 6 months.
(3) An emulsifying agent consisting (b) Milk, which may be pasteurized or
of one or any mixture of two or more of clarified or both, and which may be
the emulsifying ingredients named in warmed, is subjected to the action of
§ 133.173(e)(1), in such quantity that the harmless lactic-acid-producing bac-
weight of the solids thereof is not more teria or other harmless flavor-pro-
than 3 percent of the weight of the ducing bacteria, present in such milk
grated American cheese food. or added thereto. Sufficient rennet,
(4) An acidifying agent consisting of rennet paste, extract of rennet paste,
one or more of the acid-reacting ingre- or other safe and suitable milk-clot-
dients named in § 133.173(e)(2). ting enzyme that produces equivalent
(5) Salt. curd formation, singly or in any com-
(6) Artificial coloring. bination (with or without purified cal-
(d) The name of the food is ‘‘Grated cium chloride in a quantity not more
American cheese food’’. The full name than 0.02 percent, calculated as anhy-
of the food shall appear on the prin- drous calcium chloride, of the weight
cipal display panel of the label in type of the milk) is added to set the milk to
of uniform size, style, and color. Wher- a semisolid mass. Harmless artificial
ever any word or statement empha- coloring may be added. The mass is cut
sizing the name of any ingredient ap- into small particles, stirred, and heat-
pears on the label (other than in an ined. The curd is separated from the
gredient statement as specified in whey, drained, shaped into forms,
paragraph (e) of this section) so con- pressed, salted, and cured. The rind
486
may be colored or rubbed with vege- ingredient shall be declared in order of

table oil or both. A harmless prepara- predominance by weight; and
tion of enzymes of animal or plant ori- (2) Enzymes of the animal, plant, or
gin capable of aiding in the curing or microbial origin may be declared as
development of flavor of hard grating ‘‘enzymes’’.
cheese may be added during the proce- [42 FR 14366, Mar. 15, 1977, as amended at 48
dure, in such quantity that the weight FR 49013, Oct. 24, 1983; 49 FR 10094, Mar. 19,
of the solids of such preparation is not 1984; 58 FR 2893, Jan. 6, 1993]
more than 0.1 percent of the weight of
the milk used. § 133.149 Gruyere cheese.
(c) For the purposes of this section, (a) Description. (1) Gruyere cheese is
the word ‘‘milk’’ means cow’s milk or the food prepared by the procedure set
goat’s milk or sheep’s milk or mixtures forth in paragraph (a)(3) of this section
of two or all of these. Such milk may or by any other procedure which pro-
be adjusted by separating part of the duces a finished cheese having the
fat therefrom or (in the case of cow’s same physical and chemical properties.
milk) by adding one or more of the fol- It contains small holes or eyes. It has
lowing: Cream, skim milk, con- a mild flavor, due in part to the growth
centrated skim milk, nonfat dry milk; of surface-curing agents. The minimum
(in the case of goat’s milk) the cor- milkfat content is 45 percent by weight
responding products from goat’s milk; of the solids and the maximum mois-
(in the case of sheep’s milk) the cor- ture content is 39 percent by weight, as
responding products from sheep’s milk; determined by the methods described
water in a quantity sufficient to recon- in § 133.5. The dairy ingredients used
stitute any such concentrated or dried may be pasteurized. The cheese is at
products used. least 90 days old.
(d) Safe and suitable antimycotic (2) If pasteurized dairy ingredients
agent(s), the cumulative levels of are used, the phenol equivalent value
which shall not exceed current good of 0.25 gram of gruyere cheese is not
manufacturing practice, may be added more than 3 micrograms as determined
to the surface of the cheese. by the method described in § 133.5.
(e) The name of each hard grating (3) One or more of the dairy ingredi-
cheese for which a definition and ents specified in paragraph (b)(1) of
standard of identity is prescribed by this section may be warmed and is sub-
this section is ‘‘Hard grating cheese’’, jected to the action of lactic acid-pro-
preceded or followed by: ducing and propionic acid-producing
(1) The specific common or usual bacterial cultures. One or more of the
name of such hard grating cheese, if clotting enzymes specified in para-
any such name has become generally graph (b)(2) of this section is added to
recognized therefor; or set the dairy ingredients to a semisolid
(2) If no such specific common or mass. The mass is cut into particles
usual name has become generally rec- similar in size to wheat kernels. For
ognized therefor, an arbitrary or fan- about 30 minutes the particles are al-
ciful name that is not false or mis- ternately stirred and allowed to settle.
leading in any particular. The temperature is raised to about 126
(3) When milk other than cow’s milk °F. Stirring is continued until the curd
is used, in whole or in part, the state- becomes firm. The curd is transferred
ment ‘‘made from lll’’, the blank to hoops or forms, and pressed until
being filled in with the name or names the desired shape and firmness are ob-
of the milk used, in order of predomi- tained. The cheese is surface-salted
nance by weight. while held at a temperature of 48° to 54
(f) Label declaration. Each of the in- °F for a few days. It is soaked for 1 day
gredients used in the food shall be de- in a saturated salt solution. It is then
clared on the label as required by the held for 3 weeks in a salting cellar and
applicable sections of parts 101 and 130 wiped every 2 days with brine cloth to
of this chapter, except that: insure growth of biological curing
(1) When milk other than cow’s milk agents on the rind. It is then removed
is used, in whole or in part, the com- to a heating room and held at progres-
mon or usual name of each such milk sively higher temperatures, finally
487
§ 133.150 21 CFR Ch. I (4–1–16 Edition)
reaching 65 °F with a relative humidity tain not more than 39 percent of mois-
of 85 to 90 percent, for several weeks, ture, and their solids contain not less
during which time small holes, or so- than 50 percent of milkfat, as deter-
called eyes, form. The cheese is then mined by the methods prescribed in
stored at a lower temperature for fur- § 133.5 (a), (b), and (d). If the milk used
ther curing. One or more of the other is not pasteurized, the cheese so made
optional ingredients specified in para- is cured at a temperature of not less
graph (b)(3) of this section may be than 35 °F for not less than 60 days.
added during the procedure. (b) Milk, which may be pasteurized or
(b) Optional ingredients. The following clarified or both, and which may be
safe and suitable ingredients may be warmed, is subjected to the action of
used: harmless lactic-acid-producing bac-
(1) Dairy ingredients. Milk, nonfat teria, with or without other harmless
milk, or cream, as defined in § 133.3, flavor-producing bacteria, present in
used alone or in combination. such milk or added thereto. Harmless
(2) Clotting enzymes. Rennet and/or artificial coloring may be added. Suffi-
other clotting enzymes of animal, cient rennet, rennet paste, extract of
plant, or microbial origin. rennet paste, or other safe and suitable
(3) Other optional ingredients. (i) Cal- milk-clotting enzyme that produces
cium chloride in an amount not more equivalent curd formation, singly or in
than 0.02 percent (calculated as anhy- any combination (with or without puri-
drous calcium chloride) of the weight fied calcium chloride in a quantity not
of the dairy ingredients, used as a co- more than 0.02 percent, calculated as
agulation aid. anhydrous calcium chloride, of the
(ii) Enzymes of animal, plant, or mi- weight of the milk) is added to set the
crobial origin, used in curing or flavor milk to a semisolid mass. The mass is
development. cut into small particles, stirred, and
(iii) Antimycotic agents, applied to heated. The curd is separated from the
the surface of slices or cuts in con- whey, drained, and shaped into forms,
sumer-sized packages. and may be pressed. The curd is salted
(c) Nomenclature. The name of the at some stage of the manufacturing
food is ‘‘gruyere cheese’’. process. The shaped curd may be cured.
(d) Label declaration. Each of the in- The rind may be coated with paraffin
gredients used in the food shall be de- or rubbed with vegetable oil. A harm-
clared on the label as required by the less preparation of enzymes of animal
applicable sections of parts 101 and 130 or plant origin capable of aiding in the
of this chapter, except that: curing or development of flavor of hard
(1) Enzymes of animal, plant, or mi- cheese may be added during the proce-
crobial origin may be declared as ‘‘en- dure, in such quantity that the weight
zymes’’; and of the solids of such preparation is not
(2) The dairy ingredients may be de- more than 0.1 percent of the weight of
clared, in descending order of predomi- the milk used. Harmless flavor-pro-
nance, by the use of the terms ‘‘milkfat ducing microorganisms may be added,
and nonfat milk’’ or ‘‘nonfat milk and and curing may be conducted under
milkfat’’, as appropriate. suitable conditions for the develop-
[48 FR 2744, Jan. 21, 1983; 48 FR 11426, Mar. 18, ment of biological curing agents.
1983, as amended at 58 FR 2893, Jan. 6, 1993] (c) For the purposes of this section:
(1) The word ‘‘milk’’ means cow’s
§ 133.150 Hard cheeses. milk or goat’s milk or sheep’s milk or
(a) The cheeses for which definitions mixtures of two or all of these. Such
and standards of identity are pre- milk may be adjusted by separating
scribed by this section are hard cheeses part of the fat therefrom, or (in the
for which specifically applicable defini- case of cow’s milk) by adding one or
tions and standards of identity are not more of the following: Cream, skim
prescribed by other sections of this milk, concentrated skim milk, nonfat
part. They are made from milk and the dry milk; (in the case of goat’s milk)
other ingredients specified in this sec- the corresponding products from goat’s
tion, by the procedure set forth in milk; (in the case of sheep’s milk) the
paragraph (b) of this section. They con- corresponding products from sheep’s
488
milk; water in a quantity sufficient to § 133.152 Limburger cheese.

reconstitute any concentrated or dried (a) Description. (1) Limburger cheese
products used. is the food prepared by one of the pro-
(2) Milk shall be deemed to have been cedures set forth in paragraph (a)(3) of
pasteurized if it has been held at a tem- this section, or by any other procedure
perature of not less than 143 °F for a which produces a finished cheese hav-
period of not less than 30 minutes, or ing the same physical and chemical
for a time and at a temperature equiva- properties. The minimum milkfat con-
lent thereto in phosphatase destruc- tent is 50 percent by weight of the sol-
tion. A hard cheese shall be deemed not ids and the maximum moisture content
to have been made from pasteurized is 50 percent by weight, as determined
milk if 0.25 gram shows a phenol equiv- by the methods described in § 133.5. If
alent of more than 3 micrograms when the dairy ingredients used are not pas-
tested by the method prescribed in teurized, the cheese is cured at a tem-
§ 133.5(c). perature of not less than 35 °F for at
least 60 days.
(d) Safe and suitable antimycotic
(2) If pasteurized dairy ingredients
agent(s), the cumulative levels of are used, the phenol equivalent value
which shall not exceed current good of 0.25 gram of limburger cheese is not
manufacturing practice, may be added more than 4 micrograms as determined
to the surface of the cheese. by the method described in § 133.5.
(e) The name of each hard cheese for (3) One of the following procedures
which a definition and standard of may be followed for producing lim-
identity is prescribed by this section is burger cheese:
‘‘Hard cheese’’, preceded or followed (i) One or more of the dairy ingredi-
by: ents, unpasteurized, specified in para-
(1) The specific common or unusual graph (b)(1) of this section is warmed
name of such hard cheese, if any such to about 92 °F and subjected to the ac-
name has become generally recognized tion of a lactic acid-producing bac-
therefor; or terial culture. One or more of the clot-
ting enzymes specified in paragraph
(2) If no such specific common or
(b)(2) of this section is added to set the
usual name has become generally rec-
dairy ingredients to a semisolid mass.
ognized, therefor, an arbitrary or fan- The mass is cut into cubes with sides
ciful name that is not false or mis- approximately one-half inch long.
leading in any particular. After a few minutes the mass is stirred
(3) When milk other than cow’s milk and heated, gradually raising the tem-
is used, in whole or in part, the state- perature to 96° to 98 °F. The curd is
ment ‘‘made from lll’’, the blank then allowed to settle, most of the
being filled in with the name or names whey is drained off, and the remaining
of the milk used, in order of predomi- curd and whey dipped into molds. Dur-
nance by weight. ing drainage the curd may be pressed.
(f) Label declaration. Each of the in- It is turned at regular intervals. After
gredients used in the food shall be de- drainage the curd is cut into pieces of
clared on the label as required by the desired size and dry-salted at intervals
applicable sections of parts 101 and 130 for 24 to 48 hours. The cheese is then
of this chapter, except that: cured with frequent applications of a
(1) When milk other than cow’s milk weak brine solution to the surface,
is used, in whole or in part, the com- until the proper growth of surface-cur-
mon or usual name of each such milk ing organisms is obtained. It is then
ingredient shall be declared in order of wrapped and held in storage for devel-
opment of as much additional flavor as
predominance by weight; and
is desired. One or more of the other op-
(2) Enzymes of animal, plant, or mi-
tional ingredients specified in para-
crobial origin may be declared as ‘‘en- graph (b)(3) of this section may be
zymes’’. added during the procedure.
[42 FR 14366, Mar. 15, 1977, as amended at 48 (ii) One or more of the dairy ingredi-
FR 49013, Oct. 24, 1983; 49 FR 10094, Mar. 19, ents specified in paragraph (b)(1) of
1984; 58 FR 2893, Jan. 6, 1993] this section is pasteurized, brought to
489
§ 133.153 21 CFR Ch. I (4–1–16 Edition)
a temperature of 89° to 90 °F. after pas- ical and chemical properties. The min-
teurization, and is subjected to the ac- imum milkfat content is 50 percent by
tion of a lactic acid-producing bac- weight of the solids, and the maximum
terial culture. The procedure is then moisture content is 44 percent by
the same as in paragraph (a)(3)(i) of weight, as determined by the methods
this section, except that heating is to described in § 133.5. The dairy ingredi-
94 °F. After most of the whey is drained ents used are pasteurized.
off, salt brine at a temperature of 66° to (2) The phenol equivalent of 0.25 gram
70 °F is added, so that the pH of the of monterey cheese is not more than 3
curd is about 4.8. The mixed curd, micrograms, as determined by the
whey, and brine is dipped into molds, method described in § 133.5.
and the remaining procedure specified (3) One or more of the dairy ingredi-
in paragraph (a)(3)(i) of this section is ents specified in paragraph (b)(1) of
followed. this section is subjected to the action
(b) Optional ingredients. The following of a lactic acid-producing bacterial cul-
safe and suitable ingredients may be ture. One or more of the clotting en-
used: zymes specified in paragraph (b)(2) of
(1) Dairy ingredients. Milk, nonfat this section is added to set the dairy
ingredients to a semisolid mass. The
mass is so cut, stirred, and heated with
continued stirring, as to promote and
regulate the separation of whey and
plant, or microbial origin.
curd. Part of the whey is drained off,
(3) Other optional ingredients. (i)
and water or salt brine may be added.
Coloring.
The curd is drained and placed in a
muslin or sheeting cloth, formed into a
ball, and pressed; or the curd is placed
as anhydrous calcium chloride) by
in a cheese hoop and pressed. Later,
weight of the dairy ingredients, used as
the cloth bandage is removed, and the
a coagulation aid.
(iii) Enzymes of animal, plant, or mi- cheese may be covered with a suitable
crobial origin, used in curing or flavor coating. One or more of the other op-
development. tional ingredients specified in para-
(c) Nomenclature. The name of the graph (b)(3) of this section may be
food is ‘‘limburger cheese’’. added during the procedure.
(d) Label declaration. Each of the in- (b) Optional ingredients. The following
gredients used in the food shall be de- safe and suitable ingredients may be
clared on the label as required by the used:
applicable sections of parts 101 and 130 (1) Dairy ingredients. Milk, nonfat
of this chapter, except that: milk, or cream, as defined in § 133.3,
(1) Enzymes of animal, plant, or mi- used alone or in combination.
crobial origin may be declared as ‘‘en- (2) Clotting enzymes. Rennet and/or
zymes’’; and other clotting enzymes of animal,
(2) The dairy ingredients may be de- plant, or microbial origin.
clared, in descending order of predomi- (3) Other optional ingredients. (i) Cal-
nance, by the use of the terms ‘‘milkfat cium chloride in an amount not more
and nonfat milk’’ or ‘‘nonfat milk and than 0.02 percent (calculated as anhy-
milkfat’’, as appropriate. drous calcium chloride) by weight of
[48 FR 2744, Jan. 21, 1983; 48 FR 11426, Mar. 18,
the dairy ingredients, used as a coagu-
1983, as amended at 58 FR 2893, Jan. 6, 1993] lation aid.
(ii) Enzymes of animal, plant, or mi-
§ 133.153 Monterey cheese and mon- crobial origin, used in curing or flavor
terey jack cheese. development.
(a) Description. (1) Monterey cheese, (iii) Salt.
monterey jack cheese is the food pre- (iv) Antimycotic agents, the cumu-
pared by the procedure set forth in lative levels of which shall not exceed
paragraph (a)(3) of this section, or by current good manufacturing practice,

any other procedure which produces a may be added to the surface of the
finished cheese having the same phys- cheese.
490
(v) Vegetable oil, with or without this section is warmed to approxi-

rice flour sprinkled on the surface, mately 88 °F (31.1 °C) and subjected to
used as a coating for the rind. the action of a lactic acid-producing
(c) Nomenclature. The name of the bacterial culture. One or more of the
food is ‘‘monterey cheese’’ or alter- clotting enzymes specified in para-
natively, ‘‘monterey jack cheese’’. graph (b)(2) of this section is added to
(d) Label declaration. Each of the in- set the dairy ingredients to a semisolid
gredients used in the food shall be de- mass. The mass is cut, and it may be
clared on the label as required by the stirred to facilitate separation of whey
applicable sections of parts 101 and 130 from the curd. The whey is drained,
of this chapter, except that: and the curd may be washed with cold
(1) Enzymes of animal, plant, or mi- water and the water drained off. The
crobial origin may be declared as ‘‘en- curd may be collected in bundles for
zymes’’, and further drainage and for ripening. The
(2) The dairy ingredients may be de- curd may be iced, it may be held under
clared, in descending order of predomi-
refrigeration, and it may be permitted
nance, by the use of the terms ‘‘milkfat
to warm to room temperature and
ripen further. The curd may be cut. It
milkfat’’, as appropriate.
is immersed in hot water or heated
[54 FR 32056, Aug. 4, 1989, as amended at 58 with steam and is kneaded and
FR 2893, Jan. 6, 1993] stretched until smooth and free of
lumps. It is then cut and molded. The
§ 133.154 High-moisture jack cheese.
molded curd is firmed by immersion in
High-moisture jack cheese conforms cold water and drained. One or more of
to the definition and standard of iden- the other optional ingredients specified
tity and is subject to the requirement in paragraph (b)(3) of this section may
for label statement of ingredients pre- be added during the procedure.
scribed for monterey cheese by § 133.153, (b) Optional ingredients. The following
except that its moisture content is safe and suitable ingredients may be
more than 44 percent but less than 50 used:
percent.
(1) Dairy ingredients. Cow’s milk, non-
[58 FR 2893, Jan. 6, 1993] fat milk, or cream, as defined in § 133.3,
or the corresponding products of water
§ 133.155 Mozzarella cheese and buffalo origin, except that cow’s milk
scamorza cheese.
products are not combined with water
(a) Description. (1) Mozzarella cheese, buffalo products.
scamorza cheese is the food prepared (2) Clotting enzymes. Rennet and/or
from dairy ingredients and other ingre- other clotting enzymes of animal,
dients specified in this section by the plant, or microbial origin.
procedure set forth in paragraph (a)(3) (3) Other optional ingredients. (i) Vin-
of this section, or by any other proce- egar.
dure which produces a finished cheese
(ii) Coloring to mask any natural yel-
having the same physical and chemical
low color in the curd.
properties. It may be molded into var-
ious shapes. The minimum milkfat (iii) Salt.
content is 45 percent by weight of the (iv) Antimycotics, the cumulative
solids, and the moisture content is levels of which shall not exceed current
more than 52 percent but not more good manufacturing practice, may be
than 60 percent by weight as deter- added to the cheese during the knead-
mined by the methods described in ing and stretching process and/or ap-
§ 133.5. The dairy ingredients are pas- plied to the surface of the cheese.
teurized. (c) Nomenclature. The name of the
(2) The phenol equivalent value of food is ‘‘mozzarella cheese’’ or, alter-
0.25 gram of mozzarella cheese is not natively, ‘‘scamorza cheese’’. When the
more than 3 micrograms as determined food is made with water buffalo milk,
by the method described in § 133.5. the name of the food is accompanied by

(3) One or more of the dairy ingredi- the phrase ‘‘made with water buffalo
ents specified in paragraph (b)(1) of milk’’.
491
§ 133.156 21 CFR Ch. I (4–1–16 Edition)
(d) Label declaration. Each of the in- curd may be collected in bundles for
gredients used in the food shall be de- further drainage and for ripening. The
clared on the label as required by the curd may be iced, it may be held under
applicable sections of parts 101 and 130 refrigeration, and it may be permitted
of this chapter, except that: to warm to room temperature and
(1) Enzymes of animal, plant, or mi- ripen further. The curd may be cut. It
crobial origin may be declared as ‘‘en- is immersed in hot water or heated
zymes’’; and with steam and is kneaded and
(2) The dairy ingredients may be de- stretched until smooth and free of
clared, in descending order of predomi- lumps. It is then cut and molded. In
nance, by the use of the terms ‘‘milkfat molding, the curd is kept sufficiently
and nonfat milk’’ or ‘‘nonfat milk and warm to cause proper sealing of the
milkfat’’, ‘‘milkfat from water buffalo surface. The molded curd is firmed by
milk and nonfat buffalo milk’’ or immersion in cold water and drained.
‘‘nonfat water buffalo milk and milkfat One or more of the other optional in-
from water buffalo milk,’’ as appro- gredients specified in paragraph (b)(3)
priate. of this section may be added during the
[53 FR 3743, Feb. 9, 1988, as amended at 58 FR procedure.
2893, Jan. 6, 1993] (b) Optional ingredients. The following
§ 133.156 Low-moisture mozzarella and used:
scamorza cheese. (1) Dairy ingredients. Cow’s milk, non-
(a) Description. (1) Low-moisture moz- fat milk, or cream, as defined in § 133.3,
zarella cheese, low-moisture scamorza or the corresponding products of water
cheese is the food prepared from dairy buffalo origin, except that cow’s milk
ingredients and other ingredients spec- products are not combined with water
ified in this section by the procedure buffalo products.
set forth in paragraph (a)(3) of this sec- (2) Clotting enzymes. Rennet and/or
tion, or by any other procedure which clotting enzymes of animal, plant, or
produces a finished cheese having the microbial origin.
same physical and chemical properties. (3) Other optional ingredients. (i) Vin-
It may be molded into various shapes. egar.
The minimum milkfat content is 45 (ii) Coloring to mask any natural yel-
percent by weight of the solids and the low color in the curd.
moisture content is more than 45 per- (iii) Salt.
cent but not more than 52 percent by (iv) Calcium chloride in an amount
weight as determined by the methods not more than 0.02 percent (calculated
described in § 133.5. The dairy ingredi- as anhydrous calcium chloride) of the
ents are pasteurized. weight of the dairy ingredients, used as
(2) The phenol equivalent value of a coagulation aid.
0.25 gram of low-moisture mozzarella (v) Antimycotics, the cumulative lev-
cheese is not more than 3 micrograms els of which shall not exceed current
as determined by the method described good manufacturing practices, may be
in § 133.5. added to the cheese during the knead-
(3) One or more of the dairy ingredi- ing and stretching process and/or ap-
ents specified in paragraph (b)(1) of plied to the surface of the cheese.
this section may be warmed and is sub- (c) Nomenclature. The names of the
jected to the action of a lactic acid- food is ‘‘low-moisture mozzarella
producing bacterial culture. One or cheese’’ or, alternatively, ‘‘low-mois-
more of the clotting enzymes specified ture scamorza cheese’’. When the food
in paragraph (b)(2) of this action is is made with water buffalo milk, the
added to set the dairy ingredients to a name of the food is accompanied by the
semisolid mass. The mass is cut, phrase ‘‘made with water buffalo
stirred, and allowed to stand. It may be milk’’.
reheated and again stirred. The whey is (d) Label declaration. Each of the in-
drained and the curd may be cut and gredients used in the food shall be de-
piled to promote further separation of clared on the label as required by the

whey. It may be washed with cold applicable sections of parts 101 and 130
water and the water drained off. The of this chapter, except that:
492
(1) Enzymes of animal, plant, or mi- of the solids and the maximum mois-
crobial origin may be declared as ‘‘en- ture content is 46 percent by weight, as
zymes’’; and determined by the methods decribed in
(2) The dairy ingredients may be de- § 133.5. The dairy ingredients used are
clared, in descending order of predomi- pasteurized.
nance, by the use of the terms ‘‘milkfat (2) The phenol equivalent of 0.25 gram
and nonfat milk’’ or ‘‘nonfat milk and of muenster cheese is not more than 3
milkfat’’, ‘‘milkfat from water buffalo micrograms, as determined by the
milk and nonfat water buffalo milk’’ or methods described in § 133.5.
‘‘nonfat water buffalo) The dairy ingre- (3) One or more of the dairy ingredi-
dients may be declared, in descending ents specified in paragraph (b)(1) of
order of predominance, by the use of this section may be warmed and is sub-
the terms ‘‘milkfat and nonfat milk’’ jected to the action of a harmless lac-
or ‘‘nonfat milk and milkfat’’, tic acid-producing bacterial culture.
‘‘milkfat from water buffalo milk and One or more of the clotting enzymes
nonfat water buffalo milk’’ or ‘‘nonfat specified in paragraph (b)(2) of this sec-
water buffalo milk and milkfat from tion is added to set the dairy ingredi-
water buffalo milk’’, as appropriate. ents to a semisolid mass. After coagu-
[53 FR 3743, Feb. 9, 1988, as amended at 58 FR lation the mass is divided into small
2893, Jan. 6, 1993] portions, stirred, and heated, with or
without dilution with water or salt
§ 133.157 Part-skim mozzarella and brine, so as to promote and regulate
scamorza cheese. the separation of whey and curd. The
Part-skim mozzarella cheese, part- curd is transferred to forms permitting
skim scamorza cheese conforms to the drainage of the whey. During drainage
definition and standard of identity as the curd may be pressed and turned.
prescribed for mozzarella cheese by After drainage the curd is removed
§ 133.155, except that its milk fat con- from the forms and is salted. One or
tent, calculated on the solids basis, is more of the other optional ingredients
less than 45 percent but not less than 30 specified in paragraph (b)(3) of this sec-
percent. tion may be added during the proce-
dure.
§ 133.158 Low-moisture part-skim moz- (b) Optional ingredients. The following
zarella and scamorza cheese. safe and suitable ingredients may be
Low-moisture part-skim mozzarella used:
cheese and low-moisture part-skim (1) Dairy ingredients. Milk, nonfat
scamorza cheese conform to the defini- milk, or cream, as defined in § 133.3,
tion and standard of identity and com- used alone or in combination.
ply with the requirements for label (2) Clotting enzymes. Rennet and/or
declaration of ingredients prescribed other clotting enzymes of animal,
for low-moisture mozzarella cheese and plant, or microbial origin.
low-moisture scamorza cheese by (3) Other optional ingredients. (i)
§ 133.156, except that their milkfat con- Coloring.
tent, calculated on the solids basis, is (ii) Calcium chloride in an amount
less than 45 percent but not less than 30 not more than 0.02 percent (calculated
percent. as anhydrous calcium chloride) of the
[58 FR 2894, Jan. 6, 1993] weight of the dairy ingredients, used as
a coagulation aid.
§ 133.160 Muenster and munster (iii) Enzymes of animal, plant, or mi-
cheese. crobial origin used in curing or flavor
(a) Description. (1) Muenster cheese, development.
munster cheese, is the food prepared by (iv) Antimycotic agents, the cumu-
the procedure set forth in paragraph lative levels of which shall not exceed
(a)(3) of this section or by any other current good manufacturing practice,
procedure which produces a finished may be added to the surface of the
cheese having the same physical and cheese.

chemical properties. The minimum (v) Vegetable oil, used as a coating
milkfat content is 50 percent by weight for the rind.
493
§ 133.161 21 CFR Ch. I (4–1–16 Edition)
(c) Nomenclature. The name of the comes fluid. It may then be homog-
food is ‘‘muenster cheese’’ or, alter- enized or otherwise mixed. One or more
natively, ‘‘munster cheese’’. of the dairy ingredients specified in
(d) Label declaration. Each of the in- paragraph (b)(1) of this section or the
gredients used in the food shall be de- other optional ingredients specified in
clared on the label as required by the paragraph (b)(3) of this section may be
applicable sections of parts 101 and 130 added during the procedure.
of this chapter, except that: (b) Optional ingredients. The following
(1) Enzymes of animal, plant, or mi- safe and suitable ingredients may be
crobial origin may be declared as ‘‘en- used:
zymes’’; and (1) Dairy ingredients. Milk, nonfat
(2) The dairy ingredients may be de- milk, or cream, as defined in § 133.3.
clared, in descending order of predomi- (2) Clotting enzymes. Rennet and/or
nance, by the use of the terms ‘‘milkfat other clotting enzymes of animal,
and nonfat milk’’ or ‘‘nonfat milk and plant, or microbial origin.
milkfat’’, as appropriate. (3) Other optional ingredients. (i) Salt.
(ii) Cheese whey, concentrated cheese
[54 FR 32057, Aug. 4, 1989; 54 FR 35756, Aug. 29, whey, dried cheese whey, or reconsti-
1989, as amended at 58 FR 2894, Jan. 6, 1993] tuted cheese whey prepared by addition
§ 133.161 Muenster and munster of water to concentrated cheese whey
cheese for manufacturing. or dried cheese whey.
(iii) Stabilizers, in a total amount
Muenster cheese for manufacturing not to exceed 0.5 percent of the weight
conforms to the definition and stand- of the finished food, with or without
ard of identity for muenster cheese pre- the addition of dioctyl sodium sulfo-
scribed by § 133.160, except that the succinate in a maximum amount of 0.5
dairy ingredients are not pasteurized. percent of the weight of the sta-
[54 FR 32057, Aug. 4, 1989] bilizer(s) used.
(c) Nomenclature. The name of the
§ 133.162 Neufchatel cheese. food is ‘‘neufchatel cheese’’.
(a) Description. (1) Neufchatel cheese (d) Label declaration. Each of the in-
is the soft uncured cheese prepared by gredients used in the food shall be de-
the procedure set forth in paragraph clared on the label as required by the
(a)(2) of this section or by any other applicable sections of parts 101 and 130
procedure which produces a finished of this chapter, except that:
cheese having the same physical and (1) Enzymes of animal, plant, or mi-
chemical properties. The milkfat con- crobial origin may be declared as ‘‘en-
tent is not less than 20 percent but less zymes’’; and
than 33 percent by weight of the fin- (2) The dairy ingredients may be de-
ished food and the maximum moisture clared, in descending order of predomi-
content is 65 percent by weight, as de- nance, by use of the terms ‘‘milkfat
termined by the methods described in and nonfat milk’’ or ‘‘nonfat milk and
§ 133.5. The dairy ingredients used are milkfat’’, as appropriate.
pasteurized. [54 FR 32057, Aug. 4, 1989, as amended at 58
(2) One or more of the dairy ingredi- FR 2894, Jan. 6, 1993]
ents specified in paragraph (b)(1) of
this section is subjected to the action § 133.164 Nuworld cheese.
of a harmless lactic acid-producing (a) Description. (1) Nuworld cheese is
bacterial culture, with or without one the food prepared by the procedure set
or more of the clotting enzymes speci- forth in paragraph (a)(2) of this section
fied in paragraph (b)(2) of this section. or by any other procedure which pro-
The mixture is held until the dairy in- duces a finished cheese having the
gredients coagulate. The coagulated same physical and chemical properties.
mass may be warmed and stirred and it It is characterized by the presence of
is drained. The moisture content may creamy-white mold, a white mutant of
be adjusted with one of the optional in- Penicillium roquefortii, throughout the
gredients in paragraph (b)(3)(ii) of this cheese. The minimum milkfat content

section. The curd may be pressed, is 50 percent by weight of the solids
chilled, worked, and heated until it be- and the maximum moisture content is
494
46 percent by weight, as determined by (d) Label declaration. Each of the in-

the methods described in § 133.5. The gredients used in the food shall be de-
dairy ingredients used may be pasteur- clared on the label as required by the
ized. Nuworld cheese is at least 60 days applicable sections of parts 101 and 130
old. of this chapter, except that:
(2) One or more of the dairy ingredi- (1) Enzymes of animal, plant, or mi-
ents specified in paragraph (b)(1) of crobial origin may be declared as ‘‘en-
this section may be warmed and is sub- zymes’’; and
jected to the action of a lactic acid- (2) The dairy ingredients may be de-
producing bacterial culture. One or clared, in descending order of predomi-
more of the clotting enzymes specified nance, by the use of the terms ‘‘milkfat
in paragraph (b)(2) of this section is and nonfat milk’’ or ‘‘nonfat milk and
added to set the dairy ingredients to a milkfat’’, as appropriate.
semisolid mass. The mass is cut into [54 FR 32058, Aug. 4, 1989, as amended at 58
smaller portions and allowed to stand FR 2894, Jan. 6, 1993]
for a time. The mixed curd and whey is
placed into forms permitting further § 133.165 Parmesan and reggiano
drainage. While being placed in forms, cheese.
spores of a white mutant of the mold (a) Parmesan cheese, reggiano
Penicillium roquefortii are added. The cheese, is the food prepared from milk
forms are turned several times during and other ingredients specified in this
drainage. When sufficiently drained, section, by the procedure set forth in
the shaped curd is removed from the paragraph (b) of this section, or by an-
forms and salted with dry salt or brine. other procedure which produces a fin-
Perforations are then made in the ished cheese having the same physical
shaped curd and it is held at a tempera- and chemical properties as the cheese
ture of approximately 50 °F at 90 to 95 produced when the procedure set forth
percent relative humidity, until the in paragraph (b) of this section is used.
characteristic mold growth has devel- It is characterized by a granular tex-
oped. During storage, the surface of the ture and a hard and brittle rind. It
cheese may be scraped to remove sur- grates readily. It contains not more
face growth of undesirable microorga- than 32 percent of moisture, and its
nisms. One or more of the other op- solids contain not less than 32 percent
tional ingredients specified in para- of milkfat, as determined by the meth-
graph (b)(3) of this section may be ods prescribed in § 133.5 (a), (b), and (d).
added during the procedure. It is cured for not less than 10 months.
(b) Optional ingredients. The following (b) Milk, which may be pasteurized or
safe and suitable ingredients may be clarified or both, and which may be
used: warmed, is subjected to the action of
(1) Dairy ingredients. Milk, nonfat harmless lactic-acid-producing bac-
milk, or cream, as defined in § 133.3, teria, present in such milk or added
used alone or in combination. thereto. Sufficient rennet, or other safe
(2) Clotting enzymes. Rennet and/or and suitable milk-clotting enzyme that
other clotting enzymes of animal, produces equivalent curd formation, or
plant, or microbial origin. both, with or without purified calcium
(3) Other optional ingredients. (i) Blue chloride in a quantity not more than
or green color in an amount to neu- 0.02 percent (calculated as anhydrous
tralize the natural yellow color of the calcium chloride) of the weight of the
curd. milk, is added to set the milk to a
(ii) Calcium chloride in an amount semisolid mass. Harmless artificial
not more than 0.02 percent (calculated coloring may be added. The mass is cut
as anhydrous calcium chloride) of the into pieces no larger than wheat ker-
weight of the dairy ingredients, used as nels, heated, and stirred until the tem-
a coagulation aid. perature reaches between 115 °F and 125
(iii) Enzymes of animal, plant, or mi- °F. The curd is allowed to settle and is
crobial origin, used in curing or flavor then removed from the kettle or vat,
development. drained for a short time, placed in

(c) Nomenclature. The name of the hoops, and pressed. The pressed curd is
food is ‘‘nuworld cheese’’. removed and salted in brine, or dry-
495
§ 133.167 21 CFR Ch. I (4–1–16 Edition)
salted. The cheese is cured in a cool, scribed for pasteurized process cheese
ventilated room. The rind of the cheese by § 133.169, except that:
may be coated or colored. A harmless (a) In mixtures of two or more
preparation of enzymes of animal or cheeses, cream cheese or neufchatel
plant origin capable of aiding in the cheese may be used.
curing or development of flavor of par- (b) None of the ingredients prescribed
mesan cheese may be added during the or permitted for pasteurized process
procedure, in such quantity that the
cheese by § 133.169 (c) and (d)(1) is used.
weight of the solids of such preparation
is not more than 0.1 percent of the (c) In case of mixtures of two or more
weight of the milk used. cheeses containing cream cheese or
(c)(1) For the purposes of this sec- neufchatel cheese, the moisture con-
tion, the word ‘‘milk’’ means cow’s tent is not more than the arithmetical
milk, which may be adjusted by sepa- average of the maximum moisture con-
rating part of the fat therefrom or by tents prescribed by the definitions and
adding thereto one or more of the fol- standards of identity for the varieties
lowing: Cream, skim milk, con- of cheeses blended, for which such lim-
centrated skim milk, nonfat dry milk, its have been prescribed.
water in a quantity sufficient to recon- (d) The word ‘‘process’’ is replaced by
stitute any concentrated skim milk or the word ‘‘blended’’ in the name pre-
nonfat dry milk used. scribed by § 133.169(e).
(2) Such milk may be bleached by the
use of benzoyl peroxide or a mixture of [42 FR 14366, Mar. 15, 1977, as amended at 58
benzoyl peroxide with potassium alum, FR 2894, Jan. 6, 1993]
calcium sulfate, and magnesium car-
bonate; but the weight of the benzoyl § 133.168 Pasteurized blended cheese
with fruits, vegetables, or meats.
peroxide is not more than 0.002 percent
of the weight of the milk bleached, and (a) Pasteurized blended cheese with
the weight of the potassium alum, cal- fruits, vegetables, or meats, or mix-
cium sulfate, and magnesium car- tures of these is the food which con-
bonate, singly or combined, is not more forms to the definition and standard of
than six times the weight of the ben- identity, and is subject to the require-
zoyl peroxide used. If milk is bleached ments for label statement of ingredi-
in this manner, sufficient vitamin A is ents, prescribed for pasteurized blended
added to the curd to compensate for cheese by § 133.167, except that:
the vitamin A or its precursors de- (1) Its moisture content may be 1 per-
stroyed in the bleaching process, and cent more, and the milk fat content of
artificial coloring is not used. its solids may be 1 percent less, than
(d) Safe and suitable antimycotic the limits prescribed by § 133.167 for
agent(s), the cumulative levels of
moisture and milk fat in the cor-
which shall not exceed current good
responding pasteurized blended cheese.
manufacturing practice may be added
to the surface of the cheese. (2) It contains one or any mixture of
(e) Label declaration. Each of the in- two or more of the following: Any prop-
gredients used in the food shall be de- erly prepared cooked, canned, or dried
clared on the label as required by the fruit; any properly prepared cooked,
applicable sections of parts 101 and 130 canned, or dried vegetable; any prop-
of this chapter, except that enzymes of erly prepared cooked or canned meat.
animal, plant, or microbial origin may (3) When the added fruits, vegetables,
be declared as ‘‘enzymes’’. or meats contain fat, the method pre-
scribed for the determination of fat by
FR 49014, Oct. 24, 1983; 49 FR 10095, Mar. 19, § 133.5(b) is not applicable.
1984; 58 FR 2894, Jan. 6, 1993] (b) The name of a pasteurized blended
cheese with fruits, vegetables, or meats
§ 133.167 Pasteurized blended cheese. is the name prescribed by § 133.167 for
Pasteurized blended cheese conforms the applicable pasteurized blended
to the definition and standard of iden- cheese, followed by the term ‘‘with
tity, and is subject to the requirements lll’’, the blank being filled in with
for label statement of ingredients, pre- the common or usual name or names of
496
the fruits, vegetables, or meats used, in ids of pasteurized process swiss cheese
order of predominance by weight. is not less than 43 percent, and the fat
content of the solids of pasteurized
FR 10095, Mar. 19, 1977; 58 FR 2894, Jan. 6, process gruyere cheese is not less than
1993] 45 percent.
(4)(i) The moisture content of a pas-
§ 133.169 Pasteurized process cheese. teurized process cheese made from two
(a)(1) Pasteurized process cheese is or more varieties of cheese is not more
the food prepared by comminuting and than 1 percent greater than the arith-
mixing, with the aid of heat, one or metical average of the maximum mois-
more cheeses of the same or two or ture contents prescribed by the defini-
more varieties, except cream cheese, tions and standards of identity, if any
neufchatel cheese, cottage cheese, there be, for the varieties of cheese
lowfat cottage cheese, cottage cheese used; but in no case is the moisture
dry curd, cook cheese, hard grating content more than 43 percent, except
cheese, semisoft part-skim cheese, that the moisture content of a pasteur-
part-skim spiced cheese, and skim milk ized process cheese made from two or
cheese for manufacturing with an more of the varieties cheddar cheese,
emulsifying agent prescribed by para- washed curd cheese, colby cheese, and
graph (c) of this section into a homo- granular cheese is not more than 40
geneous plastic mass. One or more of percent, and the moisture content of a
the optional ingredients designated in mixture of swiss cheese and gruyere
paragraph (d) of this section may be cheese is not more than 44 percent.
used. (ii) The fat content of the solids of a
(2) During its preparation, pasteur- pasteurized process cheese made from
ized process cheese is heated for not two or more varieties of cheese is not
less than 30 seconds at a temperature less than the arithmetical average of
of not less than 150 °F. When tested for the minimum fat contents prescribed
phosphatase by the method prescribed by the definitions and standards of
in § 133.5(c), the phenol equivalent of identity, if any there be, for the vari-
0.25 gram of pasteurized process cheese eties of cheese used, but in no case is
is not more than 3 micrograms. less than 47 percent, except that the fat
(3)(i) The moisture content of a pas- content of the solids of a pasteurized
teurized process cheese made from a process gruyere cheese made from a
single variety of cheese is not more mixture of swiss cheese and gruyere
than 1 percent greater than the max- cheese is not less than 45 percent.
imum moisture content prescribed by (5) Moisture and fat are determined
the definition and standard of identity, by the methods prescribed in § 133.5(a),
if any there be, for the variety of (b), and (d).
cheese used; but in no case is more (6) The weight of each variety of
than 43 percent, except that the mois- cheese in a pasteurized process cheese
ture content of pasteurized process made from two varieties of cheese is
washed curd cheese or pasteurized not less than 25 percent of the total
process colby cheese is not more than weight of both, except that the weight
40 percent; the moisture content of pas- of blue cheese, nuworld cheese, roque-
teurized process swiss cheese or pas- fort cheese, or gorgonzola cheese is not
teurized process gruyere cheese is not less than 10 percent of the total weight
more than 44 percent; and the moisture of both, and the weight of limburger
content of pasteurized process lim- cheese is not less than 5 percent of the
burger cheese is not more than 51 per- total weight of both. The weight of
cent. each variety of cheese in a pasteurized
(ii) The fat content of the solids of a process cheese made from three or
pasteurized process cheese made from a more varieties of cheese is not less
single variety of cheese is not less than than 15 percent of the total weight of
the minimum prescribed by the defini- all, except that the weight of blue
tion and standard of identity, if any cheese, nuworld cheese, roquefort
there be, for the variety of cheese used, cheese, or gorgonzola cheese is not less
but in no case is less than 47 percent; than 5 percent of the total weight of
except that the fat content of the sol- all, and the weight of limburger cheese
497
§ 133.169 21 CFR Ch. I (4–1–16 Edition)
is not less than 3 percent of the total therefrom is less than 5 percent of the
weight of all. These limits do not apply weight of the pasteurized process
to the quantity of cheddar cheese, cheese.
washed curd cheese, colby cheese and (3) Water.
granular cheese in mixtures which are (4) Salt.
designated as ‘‘American cheese’’ as (5) Harmless artificial coloring.
prescribed in paragraph (e)(2)(ii) of this (6) Spices or flavorings, other than
section. Such mixtures are considered any which singly or in combination
as one variety of cheese for the pur- with other ingredients simulate the
poses of this paragraph (a)(6). flavor of a cheese of any age or variety.
(7) For the purposes of this section, (7) Pasteurized process cheese in the
cheddar cheese for manufacturing, form of slices or cuts in consumer-sized
washed curd cheese for manufacturing, packages may contain an optional
colby cheese for manufacturing, granu- mold-inhibiting ingredient consisting
lar cheese for manufacturing, brick of not more than 0.2 percent by weight
cheese for manufacturing, muenster of sorbic acid, potassium sorbate, so-
cheese for manufacturing, and swiss dium sorbate, or any combination of
cheese for manufacturing are consid- two or more of these, or consisting of
ered as cheddar cheese, washed curd not more than 0.3 percent by weight of
cheese, colby cheese, granular cheese, sodium propionate, calcium propio-
brick cheese, muenster cheese, and nate, or a combination of sodium pro-
swiss cheese, respectively. pionate and calcium propionate.
(b) Pasteurized process cheese may be (8) Pasteurized process cheese in the
smoked, or the cheese or cheeses from form of slices or cuts in consumer-sized
which it is made may be smoked, be- packages may contain lecithin as an
fore comminuting and mixing, or it optional anti-sticking agent in an
may contain substances prepared by amount not to exceed 0.03 percent by
condensing or precipitating wood weight of the finished product.
smoke. (9) Safe and suitable enzyme modified
(c) The emulsifying agent referred to cheese.
in paragraph (a) of this section is one (e) The name of a pasteurized process
or any mixture of two or more of the cheese for which a definition and
following: Monosodium phosphate, di- standard of identity is prescribed by
sodium phosphate, dipotassium phos- this section is as follows:
phate, trisodium phosphate, sodium (1) In case it is made from a single
metaphosphate (sodium variety of cheese, its name is ‘‘Pas-
hexametaphosphate), sodium acid teurized process lll cheese’’, the
pyrophosphate, tetrasodium blank being filled in with the name of
pyrophosphate, sodium aluminum the variety of cheese used.
phosphate, sodium citrate, potassium (2) In case it is made from two or
citrate, calcium citrate, sodium tar- more varieties of cheese, its name is
trate, and sodium potassium tartrate, ‘‘Pasteurized process lll and lll
in such quantity that the weight of the cheese’’, or ‘‘Pasteurized process lll
solids of such emulsifying agent is not blended with lll cheese’’, or ‘‘Pas-
more than 3 percent of the weight of teurized process blend of lll and
the pasteurized process cheese. lll cheese’’, the blanks being filled
(d) The optional ingredients referred in with the names of the varieties of
to in paragraph (a) of this section are: cheeses used, in order of predominance
(1) An acidifying agent consisting of by weight; except that:
one or any mixture of two or more of (i) In case it is made from gruyere
the following: A vinegar, lactic acid, cheese and swiss cheese, and the weight
citric acid, acetic acid, and phosphoric of gruyere cheese is not less than 25
acid, in such quantity that the pH of percent of the weight of both, it may
the pasteurized process cheese is not be designated ‘‘Pasteurized process
below 5.3. gruyere cheese’’; and
(2) Cream, anhydrous milkfat, dehy- (ii) In case it is made of cheddar
drated cream, or any combination of cheese, washed curd cheese, colby

two or more of these, in such quantity cheese, or granular cheese or any mix-
that the weight of the fat derived ture of two or more of these, it may be
498
designated ‘‘Pasteurized process Amer- (1) Its moisture content may be 1 per-
ican cheese’’; or when cheddar cheese, cent more, and the milk fat content of
washed curd cheese, colby cheese, its solids may be 1 percent less than
granular cheese, or any mixture of two the limits prescribed by § 133.169 for
or more of these is combined with moisture and fat in the corresponding
other varieties of cheese in the cheese pasteurized process cheese.
ingredient, any of such cheeses or such (2) It contains one or any mixture of
mixture may be designated as ‘‘Amer- two or more of the following: Any prop-
ican cheese’’. erly prepared cooked, canned, or dried
The full name of the food shall appear fruit; any properly prepared cooked,
on the principal display panel of the canned, or dried vegetable; any prop-
label in type of uniform size, style, and erly prepared cooked or canned meat.
color. Wherever any word or statement (3) When the added fruits, vegetables,
emphasizing the name of any ingre- or meats contain fat, the method pre-
dient appears on the label (other than scribed for the determination of fat by
in an ingredient statement as specified § 133.5(b) is not applicable.
in paragraph (g) of this section) so con- (b) The name of a pasteurized process
spicuously as to be easily seen under cheese with fruits, vegetables, or meats
customary conditions of purchase, the is the name prescribed by § 133.169 for
full name of the food shall immediately the applicable pasteurized process
and conspicuously precede or follow cheese, followed by the term ‘‘with
such word or statement in type of at lll’’, the blank being filled in with
least the same size as the type used in the common or usual name or names of
such word or statement. the fruits, vegetables, or meats used, in
(f) The name of the food shall include order of predominance by weight.
a declaration of any flavoring, includ- [42 FR 14366, Mar. 15, 1977, as amended at 49
ing smoke and substances prepared by FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6,
condensing or precipitating wood 1993]
smoke, that characterizes the product
as specified in § 101.22 of this chapter § 133.171 Pasteurized process pimento
and a declaration of any spice that cheese.
characterizes the product. Pasteurized process pimento cheese
(g) Each of the ingredients used in is the food which conforms to the defi-
the food shall be declared on the label nition and standard of identity for pas-
as required by the applicable sections teurized process cheese with fruits,
of parts 101 and 130 of this chapter, ex- vegetables, or meats, and is subject to
cept that cheddar cheese, washed curd the requirement for label statement of
cheese, colby cheese, granular cheese, ingredients, except that:
or any mixture of two or more of these (a) Its moisture content is not more
may be designated as ‘‘American than 41 percent, and the fat content of
cheese’’. its solids is not less than 49 percent.
[42 FR 14366, Mar. 15, 1977, as amended at 49 (b) The cheese ingredient is cheddar
FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, cheese, washed curd cheese, colby
1993] cheese, granular cheese or any mixture
of two or more of these in any propor-
§ 133.170 Pasteurized process cheese tion.
with fruits, vegetables, or meats. (c) For the purposes of this section,
(a) Unless a definition and standard cheddar cheese for manufacturing,
of identity specifically applicable is es- washed curd cheese for manufacturing,
tablished by another section of this colby cheese for manufacturing, and
part, a pasteurized process cheese with granular cheese for manufacturing
fruits, vegetables, or meats, or mix- shall be considered as cheddar cheese,
tures of these is a food which conforms washed curd cheese, colby cheese, and
to the definition and standard of iden- granular cheese, respectively.
tity, and is subject to the requirements (d) The only fruit, vegetable, or meat
for label statement of ingredients, pre- ingredient is pimentos in such quantity

scribed for pasteurized process cheese that the weight of the solids thereof is
by § 133.169, except that: not less than 0.2 percent of the weight
499
§ 133.173 21 CFR Ch. I (4–1–16 Edition)
of the finished pasteurized process pi- is not less than 15 percent of the total
mento cheese. weight of all, except that the weight of
(e) The optional ingredients des- blue cheese, nuworld cheese, roquefort
ignated in § 133.169(b) and (d)(6) are not cheese, gorgonzola cheese, or limburger
used. cheese is not less than 5 percent of the
[42 FR 14366, Mar. 15, 1977, as amended at 58 total weight of all. These limits do not
FR 2894, Jan. 6, 1993] apply to the quantity of cheddar
cheese, washed curd cheese, colby
§ 133.173 Pasteurized process cheese cheese, and granular cheese in mix-
food. tures which are designated as ‘‘Amer-
(a)(1) A pasteurized process cheese ican cheese’’ as prescribed in paragraph
food is the food prepared by (h)(5) of this section. Such mixtures are
comminuting and mixing, with the aid considered as one variety of cheese for
of heat, one or more of the optional the purposes of this subparagraph.
cheese ingredients prescribed in para- (7) For the purposes of this section,
graph (c) of this section, with one or cheddar cheese for manufacturing,
more of the optional dairy ingredients washed curd cheese for manufacturing,
prescribed in paragraph (d) of this sec- colby cheese for manufacturing, granu-
tion, into a homogeneous plastic mass. lar cheese for manufacturing, brick
One or more of the optional ingredients cheese for manufacturing, muenster
specified in paragraph (e) of this sec- cheese for manufacturing, and swiss
tion may be used. cheese for manufacturing are consid-
(2) During its preparation, a pasteur- ered as cheddar cheese, washed curd
ized process cheese food is heated for cheese, colby cheese, granular cheese,
not less than 30 seconds, at a tempera- brick cheese, muenster cheese, and
ture of not less than 150 °F. When test- swiss cheese, respectively.
ed for phosphatase by the method pre- (b) Pasteurized process cheese food
scribed in § 133.5(c), the phenol equiva- may be smoked, or the cheese or
lent of 0.25 gram of pasteurized process cheeses from which it is made may be
cheese food is not more than 3 smoked, before comminuting and mix-
micrograms. ing, or it may contain substances pre-
(3) The moisture content of a pas- pared by condensing or precipitating
teurized process cheese food is not wood smoke.
more than 44 percent, and the fat con- (c) The optional cheese ingredients
tent is not less than 23 percent. referred to in paragraph (a) of this sec-
(4) Moisture and fat are determined tion are one or more cheeses of the
by the methods prescribed in § 133.5(a) same or two or more varieties, except
and (b), except that in determining cream cheese, neufchatel cheese, cot-
moisture the loss in weight which oc- tage cheese, creamed cottage cheese,
curs in drying for 5 hours, under the cook cheese, and skim-milk cheese for
conditions prescribed in such method, manufacturing, and except that hard
is taken as the weight of the moisture. grating cheese, semisoft part skim
(5) The weight of the cheese ingre- cheese, and part-skim spiced cheese are
dient prescribed by paragraph (a)(1) of not used alone or in combination with
this section constitutes not less than 51 each other as the cheese ingredient.
percent of the weight of the finished (d) The optional dairy ingredients re-
pasteurized process cheese food. ferred to in paragraph (a) of this sec-
(6) The weight of each variety of tion are cream, milk, skim milk, but-
cheese in a pasteurized process cheese termilk, cheese whey, any of the fore-
food made with two varieties of cheese going from which part of the water has
is not less than 25 percent of the total been removed, anhydrous milkfat, de-
weight of both, except that the weight hydrated cream, albumin from cheese
of blue cheese, nuworld cheese, roque- whey, and skim milk cheese for manu-
fort cheese, gorgonzola cheese, or lim- facturing.
burger cheese is not less than 10 per- (e) The other optional ingredients re-
cent of the total weight of both. The ferred to in paragraph (a) of this sec-
weight of each variety of cheese in a tion are:

pasteurized process cheese food made (1) An emulsifying agent consisting
with three or more varieties of cheese of one or any mixture of two or more of
500
the following: Monosodium phosphate, customary conditions of purchase, the

disodium phosphate, dipotassium phos- full name of the food shall immediately
phate, trisodium phosphate, sodium and conspicuously precede or follow
metaphosphate (sodium hexametaphos- such word or statement in type of at
phate), sodium acid pyrophosphate, least the same size as the type used in
tetrasodium pyrophosphate, sodium such word or statement.
aluminum phosphate, sodium citrate, (g) The name of the food shall include
potassium citrate, calcium citrate, so- a declaration of any flavoring, includ-
dium tartrate, and sodium potassium ing smoke and substances prepared by
tartrate, in such quantity that the condensing or precipitating wood
weight of the solids of such emulsifying smoke, that characterizes the product
agent is not more than 3 percent of the as specified in § 101.22 of this chapter
weight of the pasteurized process and a declaration of any spice that
cheese food. characterizes the product.
(2) An acidifying agent consisting of (h) Each of the ingredients used in
one or any mixture of two or more of the food shall be declared on the label
the following: A vinegar, lactic acid, as required by the applicable sections
citric acid, acetic acid, and phosphoric of parts 101 and 130 of this chapter, ex-
acid in such quantity that the pH of cept that cheddar cheese, washed curd
the pasteurized process cheese food is cheese, colby cheese, granular cheese,
not below 5.0. or any mixture of two or more of these
(3) Water. may be designated as ‘‘American
(4) Salt. cheese’’.
(5) Harmless artificial coloring. [42 FR 14366, Mar. 15, 1977, as amended at 49
(6) Spices or flavorings other than FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6,
any which singly or in combination 1993]
with other ingredients simulate the
flavor of cheese of any age or variety. § 133.174 Pasteurized process cheese
(7) Pasteurized process cheese food in food with fruits, vegetables, or
the form of slices or cuts in consumer- meats.
sized packages may contain an op- (a) Pasteurized process cheese food
tional mold-inhibiting ingredient con- with fruits, vegetables, or meats, or
sisting of not more than 0.2 percent by mixtures of these is the food which
weight of sorbic acid, potassium sor- conforms to the definition and stand-
bate, sodium sorbate, or any combina- ard of identity, and is subject to the re-
tion of two or more of these, or con- quirements for label statement of in-
sisting of not more than 0.3 percent by gredients, prescribed for pasteurized
weight of sodium propionate, calcium process cheese food by § 133.173, except
propionate, or a combination of sodium that:
propionate and calcium propionate. (1) Its milk fat content is not less
(8) Pasteurized process cheese food in than 22 percent.
the form of slices or cuts in consumer- (2) It contains one or any mixture of
sized packages may contain lecithin as two or more of the following: Any prop-
an optional anti-sticking agent in an erly prepared cooked, canned, or dried
amount not to exceed 0.03 percent by fruit; any properly prepared cooked,
weight of the finished product. canned, or dried vegetable; any prop-
(9) Safe and suitable enzyme modified erly prepared cooked or canned meat.
cheese. (3) When the added fruits, vegetables,
(f) The name of the food is ‘‘Pasteur- or meats contain fat, the method pre-
ized process cheese food’’. The full scribed for the determination of fat by
name of the food shall appear on the § 133.5(b) is not applicable.
principal display panel of the label in (b) The name of a pasteurized process
type of uniform size, style, and color. cheese food with fruits, vegetables, or
Wherever any word or statement em- meats is ‘‘Pasteurized process cheese
phasizing the name of any ingredient food with lll’’, the blank being filled
appears on the label (other than in an in with the common or usual name or
ingredient statement as specified in names of the fruits, vegetables, or

paragraph (h) of this section) so con- meats used, in order of predominance
spicuously as to be easily seen under by weight.
501
§ 133.175 21 CFR Ch. I (4–1–16 Edition)
(c) If the only vegetable ingredient is § 133.178 Pasteurized neufchatel

pimento, and no meat or fruit ingre- cheese spread with other foods.
dient is used, the weight of the solids (a)(1) Pasteurized neufchatel cheese
of such pimentos is not less than 0.2 spread with other foods is the class of
percent of the weight of the finished foods each of which is prepared by mix-
food. The name of this food is ‘‘Pi- ing, with the aid of heat, neufchatel
mento pasteurized process cheese food’’ cheese with one or a mixture of two or
or ‘‘Pasteurized process pimento cheese more properly prepared foods (except
food’’. other cheeses), such as fresh, cooked,
canned, or dried fruits or vegetables;
[42 FR 14366, Mar. 15, 1977, as amended at 49 cooked or canned meats; relishes, pick-
FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, les or other foods suitable for blending
1993]
with neufchatel cheese. It may contain
one or any mixture of two or more of
§ 133.175 Pasteurized cheese spread.
the optional ingredients named in
Pasteurized cheese spread is the food paragraph (b) of this section. The
which conforms to the definition and amount of the added food or foods must
standard of identity, and is subject to be sufficient to so differentiate the
the requirements for label statement of blend that it does not simulate neuf-
ingredients, prescribed for pasteurized chatel cheese. It is spreadable at 70 °F.
process cheese spread by § 133.179, ex- (2) During its preparation the mix-
cept that no emulsifying agent as pre- ture is heated for not less than 30 sec-
scribed by § 133.179(e) is used. onds at a temperature of not less than
150 °F. When tested for phosphatase by
[58 FR 2894, Jan. 6, 1993] the method prescribed in § 133.5(c), the
phenol equivalent of 0.25 gram of such
§ 133.176 Pasteurized cheese spread food is not more than 3 micrograms.
with fruits, vegetables, or meats. (3)(i) No water other than that con-
(a) Pasteurized cheese spread with tained in the ingredients used is added
fruits, vegetables, or meats, or mix- to this food, but the moisture content
tures of these is a food which conforms in no case is more than 65 percent.
to the definition and standard of iden- (ii) The milk fat is not less than 20
tity, and is subject to the requirements percent by weight of the finished food.
for label statement of ingredients, pre- (b) The optional ingredients referred
scribed for pasteurized cheese spread to in paragraph (a) of this section are:
by § 133.175, except that: (1)(i) One or any mixture of two or
more of the following: Gum karaya,
(1) It contains one or any mixture of
gum tragacanth, carob bean gum, gela-
two or more of the following: Any prop-
tin, algin (sodium alginate), propylene
erly prepared cooked, canned, or dried glycol alginate, guar gum, sodium
fruit; any properly prepared cooked, carboxymethylcellulose (cellulose
canned, or dried vegetable; any prop- gum), carrageenan, oat gum, or xan-
erly prepared cooked or canned meat. than gum. The total quantity of any
(2) When the added fruits, vegetables, such substances, including that con-
or meats contain fat, the method pre- tained in the neufchatel cheese, is not
scribed for the determination of fat by more than 0.8 percent by weight of the
§ 133.5(b) is not applicable. finished food.
(b) The name of a pasteurized cheese (ii) When one or more of the optional
spread with fruits, vegetables, or meats ingredients in paragraph (b)(1)(i) of
is ‘‘Pasteurized cheese spread with this section are used, dioctyl sodium
lll’’, the blank being filled in with sulfosuccinate complying with the re-
the name or names of the fruits, vege- quirements of § 172.810 of this chapter
tables, or meats used, in order of pre- may be used in a quantity not in excess
dominance by weight. of 0.5 percent by weight of such ingre-
dients.
[42 FR 14366, Mar. 15, 1977, as amended at 49 (2) Artificial coloring, unless such ad-
FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, dition conceals damage or inferiority
1993] or makes the finished food appear bet-
ter or of greater value than it is.
502
(3) An acidifying agent consisting of without one or more of the optional in-
one or a mixture of two or more of the gredients prescribed by paragraph (f) of
following: A vinegar, acetic acid, lactic this section, into a homogeneous plas-
acid, citric acid, phosphoric acid. tic mass, which is spreadable at 70 °F.
(4) A sweetening agent consisting of (2) During its preparation, a pasteur-
one or a mixture of two or more of the ized process cheese spread is heated for
following: Sugar, dextrose, corn sirup, not less than 30 seconds at a tempera-
corn sirup solids, glucose sirup, glucose ture of not less than 150 °F. When test-
sirup solids, maltose, malt sirup, ed for phosphatase by the method pre-
hydrolyzed lactose. scribed in § 133.5(c), the phenol equiva-
(5) Cream, milk, skim milk, butter- lent of 0.25 gram of pasteurized process
milk, cheese whey, any of the foregoing cheese spread is not more than 3
from which part of the water has been micrograms.
removed, anhydrous milkfat, dehy- (3) The moisture content of a pas-
drated cream, and albumin from cheese teurized process cheese spread is more
whey. than 44 percent but not more than 60
(c) The name of the food is ‘‘pasteur- percent, and the milk fat content is
ized Neufchatel cheese spread with not less than 20 percent.
lll’’ or ‘‘pasteurized Neufchatel (4) Moisture and fat are determined
cheese spread and lll’’, the blank by the methods prescribed in § 133.5(a)
being filled in with the common names and (b), except that in determining
of the foods added, in order of predomi- moisture the loss in weight which oc-
nance by weight. The full name of the curs in drying for 5 hours, under the
food shall appear on the principal dis- conditions prescribed in such method,
play panel of the label in type of uni- is taken as the weight of the moisture.
form size, style, and color. Wherever (5) The weight of the cheese ingre-
any word or statement emphasizing the dient referred to in paragraph (a)(1) of
name of any ingredient appears on the this section constitutes not less than 51
label (other than in an ingredient percent of the weight of the pasteur-
statement as specified in paragraph (d) ized process cheese spread.
of this section) so conspicuously as to (6) The weight of each variety of
be easily seen under customary condi- cheese in a pasteurized process cheese
tions of purchase, the full name of the spread made with two varieties of
food shall immediately and conspicu- cheese is not less than 25 percent of the
ously precede or follow such word or total weight of both, except that the
statement in type of at least the same weight of blue cheese, nuworld cheese,
size as the type used in such word or roquefort cheese, gorgonzola cheese, or
statement. limburger cheese is not less than 10
(d) Each of the ingredients used in percent of the total weight of both. The
the food shall be declared on the label weight of each variety of cheese in a
as required by the applicable sections pasteurized process cheese spread made
of parts 101 and 130 of this chapter. with three or more varieties of cheese
[42 FR 14366, Mar. 15, 1977, as amended at 49 is not less than 15 percent of the total
FR 10095, Mar. 19, 1984; 58 FR 2894, Jan. 6, weight of all, except that the weight of
1993] blue cheese, nuworld cheese, roquefort
cheese, gorgonzola cheese, or limburger
§ 133.179 Pasteurized process cheese cheese is not less than 5 percent of the
spread. total weight of all. These limits do not
(a)(1) Pasteurized process cheese apply to the quantity of cheddar
spread is the food prepared by cheese, washed curd cheese, colby
comminuting and mixing, with the aid cheese, and granular cheese in mix-
of heat, one or more of the optional tures which are designated as ‘‘Amer-
cheese ingredients prescribed in para- ican cheese’’ as prescribed in paragraph
graph (c) of this section, with or with- (i)(5) of this section. Such mixtures are
out one or more of the optional dairy considered as one variety of cheese for
ingredients prescribed in paragraph (d) the purposes of this paragraph (a)(6).
of this section, with one or more of the (7) For the purposes of this section,
emulsifying agents prescribed in para- cheddar cheese for manufacturing,
graph (e) of this section, and with or washed curd cheese for manufacturing,
503
§ 133.179 21 CFR Ch. I (4–1–16 Edition)
colby cheese for manufacturing, granu- (1)(i) One or any mixture of two or
lar cheese for manufacturing, brick more of the following: Carob bean gum,
cheese for manufacturing, muenster gum karaya, gum tragacanth, guar
cheese for manufacturing, and swiss gum, gelatin, sodium carboxymethyl-
cheese for manufacturing are consid- cellulose (cellulose gum), carrageenan,
ered as cheddar cheese, washed curd oat gum, algin (sodium alginate), pro-
cheese, colby cheese, granular cheese, pylene glycol alginate, or xanthan
brick cheese, muenster cheese, and gum. The total weight of such sub-
swiss cheese, respectively. stances is not more than 0.8 percent of
(b) Pasteurized process cheese spread the weight of the finished food.
may be smoked, or the cheese or (ii) When one or more of the optional
cheeses from which it is made may be ingredients in paragraph (f)(1)(i) of this
smoked, before comminuting and mix- section are used, dioctyl sodium sulfo-
ing, or it may contain substances pre- succinate complying with the require-
pared by condensing or precipitating ments of § 172.810 of this chapter may
wood smoke. be used in a quantity not in excess of
(c) The optional cheese ingredients 0.5 percent by weight of such ingredi-
referred to in paragraph (a) of this sec- ents.
tion are one or more cheeses of the (2) An acidifying agent consisting of
same or two or more varieties, except one or any mixture of two or more of
that skim-milk cheese for manufac- the following: A vinegar, lactic acid,
turing may not be used, and except citric acid, acetic acid, and phosphoric
that cream cheese, neufchatel cheese, acid, in such quantity that the pH of
cottage cheese, creamed cottage the pasteurized process cheese spread is
cheese, cook cheese, hard grating not below 4.0.
cheese, semisoft part-skim cheese, and (3) A sweetening agent consisting of
part-skim spiced cheese are not used, one or any mixture of two or more of
the following: Sugar, dextrose, corn
alone or in combination with each
sugar, corn sirup, corn sirup solids,
other, as the cheese ingredient.
glucose sirup, glucose sirup solids,
(d) The optional dairy ingredients re-
maltose, malt sirup, and hydrolyzed
ferred to in paragraph (a) of this sec- lactose, in a quantity necessary for
tion are cream, milk, skim milk, but- seasoning.
termilk, cheese whey, any of the fore- (4) Water.
going from which part of the water has (5) Salt.
been removed, anhydrous milkfat, de- (6) Harmless artificial coloring.
hydrated cream, albumin from cheese (7) Spices or flavorings other than
whey, and skim milk cheese for manu- any which singly or in combination
facturing. with other ingredients simulates the
(e) The emulsifying agents prescribed flavor of a cheese of any age or variety.
in paragraph (a) of this section are one (8) Pasteurized process cheese spread
or any mixture of two or more of the in consumer-sized packages may con-
following: Monosodium phosphate, di- tain an optional mold-inhibiting ingre-
sodium phosphate, dipotassium phos- dient consisting of sorbic acid, potas-
phate, trisodium phosphate, sodium sium sorbate, sodium sorbate, or any
metaphosphate (sodium hexametaphos- combination of two or more of these, in
phate), sodium acid pyrophosphate, an amount not to exceed 0.2 percent by
tetrasodium pyrophosphate, sodium weight, calculated as sorbic acid or
aluminum phosphate, sodium citrate, consisting of not more than 0.3 percent
potassium citrate, calcium citrate, so- by weight of sodium propionate, cal-
dium tartrate, and sodium potassium cium propionate, or a combination of
tartrate, in such quantity that the sodium propionate and calcium propio-
weight of the solids of such emulsifying nate.
agent is not more than 3 percent of the (9) Pasteurized process cheese spread
weight of the pasteurized process in consumer-sized packages may con-
cheese spread. tain lecithin as an optional anti-stick-
(f) The other optional ingredients re- ing agent in an amount not to exceed
ferred to in paragraph (a) of this sec- 0.03 percent by weight of the finished
tion are: product.
504
(10) Safe and suitable enzyme modi- canned, or dried vegetable; any prop-
fied cheese. erly prepared cooked or canned meat.
(11) Nisin preparation in an amount (2) When the added fruits, vegetables,
which results in not more than 250 or meats contain fat, the method pre-
parts per million nisin in the food. scribed for the determination of fat by
(g) The name of the food is ‘‘pasteur- § 133.5(b) is not applicable.
ized process cheese spread’’. The full (b) The name of a pasteurized process
name of the food shall appear on the cheese spread with fruits, vegetables,
principal display panel of the label in or meats is ‘‘Pasteurized process cheese
type of uniform size, style, and color. spread with lll’’, the blank being
Wherever any word or statement em- filled in with the name or names of the
phasizing the name of any ingredient fruits, vegetables, or meats used, in
appears on the label (other than in an order of predominance by weight.
ingredient statement as specified in [42 FR 14366, Mar. 15, 1977, as amended at 49
paragraph (i) of this section) so con- FR 10095, Mar. 19, 1984; 58 FR 2895, Jan. 6,
spicuously as to be easily seen under 1993]
customary conditions of purchase, the
full name of the food shall immediately § 133.181 Provolone cheese.
and conspicuously precede or follow (a) Description. (1) Provolone, a pasta
such word or statement in type of at filata or stretched curd-type cheese, is
least the same size as the type used in the food prepared by the procedure set
such word or statement. forth in paragraph (a)(3) of this section,
(h) The name of the food shall in- or by any other method which produces
clude a declaration of any flavoring, a finished cheese having the same
including smoke and substances pre- physical and chemical properties. It
pared by condensing or precipitating has a stringy texture. The minimum
wood smoke, that characterizes the milkfat content is 45 percent by weight
product as specified in § 101.22 of this of the solids, as determined by the
chapter and a declaration of any spice methods described in § 133.5 and the
that characterizes the product. maximum moisture content is 45 per-
(i) Each of the ingredients used in the cent by weight. If the dairy ingredients
food shall be declared on the label as used are not pasteurized, the cheese is
required by the applicable sections of cured at a temperature of not less than
parts 101 and 130 of this chapter, except 35 °F for at least 60 days.
that cheddar cheese, washed curd (2) If pasteurized dairy ingredients
cheese, colby cheese, granular cheese, are used, the phenol equivalent value
or any mixture of two or more of these of 0.25 gram of provolone cheese is not
may be designated as ‘‘American more than 3 micrograms as determined
cheese’’. by the method described in § 133.5.
(3) One or more of the dairy ingredi-
FR 10095, Mar. 19, 1984; 54 FR 6121, Feb. 8, ents specified in paragraph (b)(1) of
1989; 54 FR 22741, May 26, 1989; 58 FR 2895, this section may be bleached, warmed,
Jan. 6, 1993] and is subjected to the action of a lac-
tic acid-producing bacterial culture.
§ 133.180 Pasteurized process cheese One or more of the clotting enzymes
spread with fruits, vegetables, or specified in paragraph (b)(2) of this sec-
meats. tion is added to set the dairy ingredi-
(a) Pasteurized process cheese spread ents to a semisolid mass. The mass is
with fruits, vegetables, or meats, or cut, stirred, and heated so as to pro-
mixtures of these is a food which con- mote and regulate the separation of
forms to the definition and standard of whey from the curd. The whey is
identity, and is subject to the require- drained off, and the curd is matted and
ments for label statement of ingredi- cut, immersed in hot water, and knead-
ents, prescribed for pasteurized process ed and stretched until it is smooth and
cheese spread by § 133.179, except that: free from lumps. Antimycotics may be
(1) It contains one or any mixture of added to the curd during the kneading
two or more of the following: Any prop- and stretching process. Then it is cut
erly prepared cooked, canned, or dried and molded. During the molding the
fruit; any properly prepared cooked, curd is kept sufficiently warm to cause
505
§ 133.182 21 CFR Ch. I (4–1–16 Edition)
proper sealing of the surface. The (2) One of the following terms, in let-
molded curd is then firmed by immer- ters not less than one-half the height
sion in cold water, salted in brine, and of the letters used in the name of the
dried. It is given some additional cur- food, shall accompany the name of the
ing. Provolone cheese may be smoked, food wherever it appears on the prin-
and one or more of the other optional cipal display panel or panels:
ingredients specified in paragraph (i) ‘‘Smoked’’ if the food has been
(b)(3) of this section may be added dur- smoked.
ing the procedure. (ii) ‘‘Not smoked’’ if the food has not
(b) Optional ingredients. The following been smoked.
safe and suitable ingredients may be (d) Label declaration. Each of the in-
used: gredients used in the food shall be de-
(1) Dairy ingredients. Milk, nonfat clared on the label as required by the
milk, or cream, as defined in § 133.3, applicable sections of parts 101 and 130
used alone or in combination. of this chapter, except that:
(2) Clotting enzymes. Rennet and/or (1) Enzymes of animal, plant, or mi-
other clotting enzymes of animal, crobial origin may be declared as ‘‘en-
plant, or microbial origin. zymes’’; and
(3) Other optional ingredients. (i) Blue (2) The dairy ingredients may be de-
or green color in an amount to neu- clared, in descending order of predomi-
tralize the natural yellow color of the nance, by the use of the terms ‘‘milkfat
curd. and nonfat milk’’ or ‘‘nonfat milk and
(ii) Calcium chloride in an amount milkfat’’, as appropriate.
as anhydrous calcium chloride) by [48 FR 2745, Jan. 21, 1983, as amended at 48
weight of the dairy ingredients, used as FR 49014, Oct. 24, 1983; 58 FR 2895, Jan. 6,
a coagulation aid. 1993]
§ 133.182 Soft ripened cheeses.
development. (a) The cheeses for which definitions
(iv) Safe and suitable antimycotic and standards of identity are pre-
agent(s), the cumulative levels of scribed by this section are soft ripened
which shall not exceed current good cheeses for which specifically applica-
manufacturing practice, may be added ble definitions and standards of iden-
to the cheese during the kneading and tity are not prescribed by other sec-
stretching process and/or applied to the tions of this part. They are made from
surface of the cheese. milk and other ingredients specified in
(v) Benzoyl peroxide or a mixture of this section, by the procedure set forth
benzoyl peroxide with potassium alum, in paragraph (b) of this section. Their
calcium sulfate, and magnesium car- solids contain not less than 50 percent
bonate used to bleach the dairy ingre- of milkfat, as determined by the meth-
dients. The weight of the benzoyl per- ods prescribed in § 133.5(a), (b), and (d).
oxide is not more than 0.002 percent of If the milk used is not pasteurized, the
the weight of the milk being bleached, cheese so made is cured at a tempera-
and the weight of the potassium alum, ture of not less than 35 °F for not less
calcium sulfate, and magnesium car- than 60 days.
bonate, singly or combined, is not more (b) Milk, which may be pasteurized or
than six times the weight of the ben- clarified or both, and which may be
zoyl peroxide used. If milk is bleached warmed, is subjected to the action of
in this manner, vitamin A is added to harmless lactic-acid-producing bac-
the curd in such quantity as to com- teria or other harmless flavor-pro-
pensate for the vitamin A or its precur- ducing bacteria, present in such milk
sors destroyed in the bleaching process, or added thereto. Sufficient rennet,
and artificial coloring is not used. rennet paste, extract of rennet paste,
(c) Nomenclature. (1) The name of the or other safe and suitable milk-clot-
food is ‘‘provolone cheese’’. The name ting enzyme that produces equivalent
of the food may include the common curd formation, singly or in any com-
name of the shape of the cheese, such bination (with or without purified cal-
as ‘‘salami provolone’’. cium chloride in a quantity not more
506
than 0.02 percent, calculated as anhy- such name has become generally recog-
drous calcium chloride, of the weight nized therefor; or
of the milk) is added to set the milk to (2) If no such specific common or
a semisolid mass. Harmless artificial usual name has become generally rec-
coloring may be added. After coagula- ognized therefor, an arbitrary or fan-
tion the mass is so treated as to pro- ciful name which is not false or mis-
mote and regulate the separation of leading in any particular.
whey and curd. Such treatment may (e) When milk other than cow’s milk
include one or more of the following: is used in whole or in part, the name of
Cutting, stirring, heating, dilution the cheese includes the statement
with water or brine. The whey, or part ‘‘made from lll’’, the blank being
of it, is drained off, and the curd is col- filled in with the name or names of the
lected and shaped. It may be placed in milk used, in order of predominance by
forms, and may be pressed. Harmless weight.
flavor-producing microorganisms may (f) Each of the ingredients used in the
be added. It is cured under conditions food shall be declared on the label as
suitable for development of biological required by the applicable sections of
curing agents on the surface of the parts 101 and 130 of this chapter.
cheese, and the curing is conducted so [42 FR 14366, Mar. 15, 1977, as amended at 49
that the cheese cures from the surface FR 10095, Mar. 19, 1984; 58 FR 2895, Jan. 6,
toward the center. Salt may be added 1993]
during the procedure. A harmless prep-
aration of enzymes of animal or plant § 133.183 Romano cheese.
origin capable of aiding in the curing (a) Romano cheese is the food pre-
or development of flavor of soft ripened pared from cow’s milk or sheep’s milk
cheeses may be added, in such quantity or goat’s milk or mixtures of two or all
that the weight of the solids of such of these and other ingredients specified
preparation is not more than 0.1 per- in this section, by the procedure set
cent of the weight of the milk used. forth in paragraph (b) of this section,
(c) For the purposes of this section: or by another procedure which pro-
(1) The word ‘‘milk’’ means cow’s duces a finished cheese having the
milk or goat’s milk or sheep’s milk or same physical and chemical properties
mixtures of two or all of these. Such as the cheese produced when the proce-
milk may be adjusted by separating dure set forth in paragraph (b) of this
part of the fat therefrom or (in the case section is used. It grates readily, and
of cow’s milk) by adding one or more of has a granular texture and a hard and
the following: Cream, skim milk, con- brittle rind. It contains not more than
centrated skim milk, nonfat dry milk; 34 percent of moisture, and its solids
(in the case of goat’s milk) the cor- contain not less than 38 percent of
responding products from goat’s milk; milkfat, as determined by the methods
(in the case of sheep’s milk) the cor- prescribed in § 133.5(a), (b), and (d). It is
responding products from sheep’s milk; cured for not less than 5 months.
water, in a quantity sufficient to re- (b) Milk, which may be pasteurized or
constitute any such concentrated or clarified or both, and which may be
dried products used. warmed, is subjected to the action of
(2) Milk shall be deemed to have been harmless lactic-acid-producing bac-
pasteurized if it has been held at a tem- teria present in such milk or added
perature of not less than 143 °F for a thereto. Harmless artificial blue or
period of not less than 30 minutes, or green coloring in a quantity which neu-
for a time and at a temperature equiva- tralizes any natural yellow coloring in
lent thereto in phosphatase destruc- the curd may be added. Rennet, rennet
tion. paste, extract of rennet paste, or other
(d) The name of each soft ripened safe and suitable milk-clotting enzyme
cheese for which a definition and that produces equivalent curd forma-
standard of identity is prescribed by tion, singly or in any combination
this section is ‘‘Soft ripened cheese’’, (with or without purified calcium chlo-
preceded or followed by: ride in a quantity not more than 0.02

(1) The specific common or usual percent, calculated as anhydrous cal-
name of such soft ripened cheese, if any cium chloride, of the weight of the
507
§ 133.184 21 CFR Ch. I (4–1–16 Edition)
milk) is added to set the milk to be a (d) Safe and suitable antimycotic
semisolid mass. The mass is cut into agent(s), the cumulative levels of
particles no larger than corn kernels, which shall not exceed current good
stirred, and heated to a temperature of manufacturing practice, may be added
about 120 °F. The curd is allowed to to the surface of the cheese.
settle to the bottom of the kettle or (e) When romano cheese is made sole-
vat, and is then removed and drained ly from cow’s milk, the name of such
for a short time, packed in forms or cheese is ‘‘Romano cheese made from
hoops, and pressed. The pressed curd is cow’s milk’’, and may be preceded by
salted by immersing in brine for about the word ‘‘Vaccino’’ (or ‘‘Vacchino’’);
24 hours and is then removed from the when made solely from sheep’s milk,
brine and the surface allowed to dry. It the name is ‘‘Romano cheese made
is then alternately rubbed with salt from sheep’s milk’’, and may be pre-
and washed at intervals. It may be per- ceded by the word ‘‘Pecorino’’; when
forated with needles. It is finally made solely from goat’s milk, the
drycured. During curing it is turned name is ‘‘Romano cheese made from
and scraped. The surface may be goat’s milk’’, and may be preceded by
rubbed with vegetable oil. A harmless the word ‘‘Caprino’’; and when a mix-
preparation of enzymes of animal or ture of two or all of the milks specified
plant origin capable of aiding in the in this section is used, the name of the
curing or development of flavor of ro- cheese is ‘‘Romano cheese made from
mano cheese may be added during the lll’’, the blank being filled in with
procedure, in such quantity that the the names of the milks used, in order
weight of the solids of such preparation of predominance by weight.
is not more than 0.1 percent of the (f) Label declaration. Each of the in-
weight of the milk used. gredients used in the food shall be de-
(c)(1) For the purposes of this sec- clared on the label as required by the
tion, the word ‘‘milk’’ means cow’s applicable sections of parts 101 and 130
milk or goat’s milk or sheep’s milk or of this chapter, except that:
mixtures of two or all of these. Such (1) When milk other than cow’s milk
milk may be adjusted by separating is used, in whole or in part, the com-
part of the fat therefrom or (in the case mon or usual name of each such milk
of cow’s milk) by adding one or more of ingredient shall be declared in order of
the following: Cream, skim milk, con- predominance by weight; and
centrated skim milk, nonfat dry milk; (2) Enzymes of animal, plant, or mi-
(in the case of goat’s milk) the cor- crobial origin may be declared as ‘‘en-
responding products from goat’s milk; zymes’’.
(in the case of sheep’s milk) the cor- [42 FR 14366, Mar. 15, 1977, as amended at 48
responding products from sheep’s milk; FR 49014, Oct. 24, 1983; 49 FR 10095, Mar. 19,
water in a quantity sufficient to recon- 1984; 58 FR 2895, Jan. 6, 1993]
stitute any such concentrated or dried
products used. § 133.184 Roquefort cheese, sheep’s
(2) Such milk may be bleached by the milk blue-mold, and blue-mold
use of benzoyl peroxide or a mixture of cheese from sheep’s milk.
benzoyl peroxide with potassium alum, (a) Description. (1) Roquefort cheese,
calcium sulfate, and magnesium car- sheep’s milk blue-mold cheese, blue-
bonate; but the weight of the benzoyl mold cheese from sheep’s milk, is the
peroxide is not more than 0.002 percent food prepared by the procedure set
of the weight of the milk bleached, and forth in paragraph (a)(2) of this section
the weight of the potassium alum, cal- or by any other procedure which pro-
cium, sulfate, and magnesium car- duces a finished cheese having the
bonate, singly or combined, is not more same physical and chemical properties.
than six times the weight of the ben- It is characterized by the presence of
zoyl peroxide used. If milk is bleached bluish-green mold, Penicillium roque-
in this manner, sufficient vitamin A is fortii, throughout the cheese. The min-
added to the curd to compensate for imum milkfat content is 50 percent by
the vitamin A or its precursors de- weight of the solids and the maximum
stroyed in the bleaching process, and moisture content is 45 percent by
artificial coloring is not used. weight, as determined by the methods
508
described in § 133.5. The dairy ingredi- (1) Enzymes of animal, plant, or mi-
ents used may be pasteurized. Roque- crobial origin may be declared as ‘‘en-
fort cheese is at least 60 days old. zymes’’; and
(2) One or more of the dairy ingredi- (2) The dairy ingredients may be de-
ents specified in paragraph (b)(1) of clared, in descending order of predomi-
this section may be warmed and is sub- nance, by the use of the terms ‘‘milkfat
jected to the action of a lactic acid- from sheep’s milk and nonfat sheep’s
producing bacterial culture. One or milk’’ or ‘‘nonfat sheep’s milk and
more of the clotting enzymes specified milkfat from sheep’s milk’’, as appro-
in paragraph (b)(2) of this section is priate.
added to set the dairy ingredients to a
semisolid mass. The mass is cut into FR 2895, Jan. 6, 1993]
smaller portions and allowed to stand
for a time. The mixed curd and whey is § 133.185 Samsoe cheese.
placed into forms permitting further
drainage. While being placed in forms, (a) Description. (1) Samsoe cheese is
spores of the mold Penicillium the food prepared by the procedure set
roquefortii are added. The forms are forth in paragraph (a)(3) of this section
or by any other procedure which pro-
turned several times during drainage.
duces a finished cheese having the
When sufficiently drained, the shaped
same physical and chemical properties.
curd is removed from the forms and
It has a small amount of eye formation
salted with dry salt or brine. Perfora-
of approximately uniform size of about
tions are then made in the shaped curd
five-sixteenths inch (8 millimeters).
and it is held at a temperature of ap-
The minimum milkfat content is 45
proximately 50 °F at 90 to 95 percent
percent by weight of the solids and the
relative humidity, until the char-
maximum moisture content is 41 per-
acteristic mold growth has developed.
cent by weight, as determined by the
During storage, the surface of the
methods described in § 133.5. The dairy
cheese may be scraped to remove sur- ingredients used may be pasteurized.
face growth of undesirable microorga- Samsoe cheese is cured at not less than
nisms. One or more of the other op- 35 °F for at least 60 days.
tional ingredients specified in para-
(2) If pasteurized dairy ingredients
graph (b)(3) of this section may be
are used, the phenol equivalent value
added during the procedure.
of 0.25 gram of samsoe cheese is not
(b) Operational ingredients. The fol- more than 3 micrograms as determined
lowing safe and suitable ingredients by the method described in § 133.5.
may be used: (3) One or more of the dairy ingredi-
(1) Dairy ingredients. Forms of milk, ents specified in paragraph (b)(1) of
nonfat milk, or cream, as defined in this section may be warmed and is sub-
§ 133.3, of sheep origin, used alone or in jected to the action of a lactic acid-
combination. producing bacterial culture. One or
(2) Clotting enzymes. Rennet and/or more of the clotting enzymes specified
other clotting enzymes of animal, in paragraph (b)(2) of this section is
plant, or microbial origin. added to set the dairy ingredients to a
(3) Other optional ingredients. En- semisolid mass. After coagulation the
zymes of animal, plant, or microbial mass is cut into small cube-shaped
origin, used in curing or flavor develop- pieces with sides approximately three-
ment. eighths inch (1 centimeter). The mass
(c) Nomenclature. The name of the is stirred and heated to about 102 °F,
food is ‘‘roquefort cheese’’, or alter- and so handled by further stirring,
natively, ‘‘sheep’s milk blue-mold heating, dilution with water, and salt-
cheese’’ or ‘‘blue-mold cheese from ing as to promote and regulate the sep-
sheep’s milk. aration of curd and whey. When the de-
(d) Label declaration. Each of the in- sired curd is obtained, it is transferred
gredients used in the food shall be de- to forms permitting drainage of whey.
clared on the label as required by the During drainage, the curd is pressed.
applicable sections of parts 101 and 130 After drainage, the curd is removed
of this chapter, except that: from the forms and is further salted by
509
§ 133.186 21 CFR Ch. I (4–1–16 Edition)
immersing in a concentrated salt solu- maximum moisture content is 38 per-

tion for about 3 days. The curd is then cent by weight, as determined by the
cured at a temperature of from 60° to 70 method described in § 133.5. Sap sago
°F for 3 to 5 weeks to obtain the desired cheese is not less than 5 months old.
eye formation. Further curing is con- (2) One or more of the dairy ingredi-
ducted at a lower temperature. One or ents specified in paragraph (b)(1) of
more of the other optional ingredients this section is allowed to become sour,
specified in paragraph (b)(3) of this sec- and is heated to boiling temperature,
tion may be added during the proce- with stirring. Sufficient sour whey is
dure. added to precipitate the casein. The
(b) Optional ingredients. The following curd is removed, spread out in boxes,
safe and suitable ingredients may be and pressed, and while under pressure
used: is allowed to drain and ferment. It is
(1) Dairy ingredients. Milk, nonfat ripened for not less than 5 weeks. The
milk, or cream, as defined in § 133.3, ripened curd is dried and ground; salt
used alone or in combination. and dried clover of the species Melilotus
(2) Clotting enzymes. Rennet and/or coerulea are added. The mixture is
other clotting enzymes of animal, shaped into truncated cones and rip-
plant, or microbial origin. ened. The optional ingredient in para-
(3) Other optional ingredients. (i) graph (b)(2) of this section may be
Coloring. added during this procedure.
(ii) Calcium chloride in an amount (b) Optional ingredients. The following
not more than 0.02 percent (calculated safe and suitable ingredients may be
as anhydrous calcium chloride) by used:
weight of the dairy ingredients, used as (1) Dairy ingredients. Nonfat milk, as
a coagulation aid. defined in § 133.3.
(2) Other optional ingredients. Butter-
milk.
development.
(iv) Antimycotic agents, applied to (c) Nonmenclature. The name of the
the surface of slices or cuts in con- food is ‘‘sap sago cheese’’.
sumer-sized packages. (d) Label declaration. Each of the in-
(c) Nomenclature. The name of the gredients used in the food shall be de-
food is ‘‘samsoe cheese’’. clared on the label as required by the
(d) Label declaration. Each of the in- applicable sections of parts 101 and 130
gredients used in the food shall be de- of this chapter.
clared on the label as required by the [54 FR 32058, Aug. 4, 1989, as amended at 58
applicable sections of parts 101 and 130 FR 2895, Jan. 6, 1993]
(1) Enzymes of animal, plant, or mi- § 133.187 Semisoft cheeses.
crobial origin may be declared as ‘‘en- (a) The cheeses for which definitions
zymes’’; and and standards of identity are pre-
(2) The dairy ingredients may be described by this section are semisoft
clared, in descending order of predomi- cheeses for which specifically applica-
nance, by the use of the terms ‘‘milkfat ble definitions and standards of iden-
and nonfat milk’’ or ‘‘nonfat milk and tity are not prescribed by other sec-
milkfat’’, as appropriate. tions of this part. They are made from
[48 FR 2745, Jan. 21, 1983; 48 FR 11426, Mar. 18, milk and other ingredients specified in
1983, as amended at 58 FR 2895, Jan. 6, 1993] this section, by the procedure set forth
in paragraph (b) of this section. They
§ 133.186 Sap sago cheese. contain more than 39 percent, but not
(a) Description. (1) Sap sago cheese is more than 50 percent, of moisture, and
the food prepared by the procedure set their solids contain not less than 50
forth in paragraph (a)(2) of this section percent of milkfat, as determined by
or by any other procedure which pro- the methods prescribed in § 133.5 (a),
duces a finished cheese having the (b), and (d). If the milk used is not pas-
same physical and chemical properties. teurized, the cheese so made is cured at
The cheese is pale green in color and a temperature of not less than 35 °F for
has the shape of a truncated cone. The not less than 60 days.
510
(b) Milk, which may be pasteurized or for a time and at a temperature equiva-
clarified or both, and which may be lent thereto in phosphatase destruc-
warmed, is subjected to the action of tion. A semisoft cheese shall be deemed
harmless lactic-acid-producing bac- not to have been made from pasteur-
teria or other harmless flavor-pro- ized milk if 0.25 gram shows a phenol
ducing bacteria, present in such milk equivalent of more than 5 micrograms
or added thereto. Sufficient rennet, when tested by the method prescribed
rennet paste, extract of rennet paste, in § 133.5(c).
or other safe and suitable milk-clot- (d) Semisoft cheeses in the form of
ting enzyme that produces equivalent slices or cuts in consumer-sized pack-
curd formation, singly or in any com- ages may contain an optional mold-in-
bination (with or without purified cal- hibiting ingredient consisting of sorbic
cium chloride in a quantity not more acid, potassium sorbate, sodium sor-
than 0.02 percent, calculated as anhy- bate, or any combination of two or
drous calcium chloride, of the weight more of these, in an amount not to ex-
of the milk) is added to set the milk to ceed 0.3 percent by weight, calculated
a semisolid mass. Harmless artificial as sorbic acid.
coloring may be added. After coagula- (e) The name of each semisoft cheese
tion the mass is so treated as to pro- for which a definition and standard of
mote and regulate the separation of identity is prescribed by this section is
whey and curd. Such treatment may ‘‘Semisoft cheese’’, preceded or fol-
include one or more of the following: lowed by:
cutting, stirring, heating, dilution with
(1) The specific common or usual
water or brine. The whey, or part of it,
name of such semisoft cheese, if any
is drained off, and the curd is collected
such name has become generally recog-
and shaped. It may be placed in forms,
nized therefor; or
and may be pressed. Harmless flavor-
producing microorganisms may be (2) If no such specific common or
added. It may be cured in a manner to usual name has become generally rec-
promote the growth of biological cur- ognized therefor, an arbitrary or fan-
ing agents. Salt may be added during ciful name which is not false or mis-
the procedure. A harmless preparation leading in any particular.
of enzymes of animal or plant origin (f)(1) When milk other than cow’s
capable of aiding in the curing or de- milk is used in whole or in part, the
velopment of flavor of semisoft cheese name of the cheese includes the state-
may be added, in such quantity that ment ‘‘made from lll’’, the blank
the weight of the solids of such prepa- being filled in with the name or names
ration is not more than 0.1 percent of of the milk used, in order of predomi-
the weight of the milk used. nance by weight.
(c) For the purposes of this section: (2) If semisoft cheese in sliced or cut
(1) The word ‘‘milk’’ means cow’s form contains an optional mold-inhib-
milk or goat’s milk or sheep’s milk or iting ingredient as specified in para-
mixtures of two or all of these. Such graph (d) of this section, the label shall
milk may be adjusted by separating bear the statement ‘‘lll added to re-
part of the fat therefrom, or (in the tard mold growth’’ or ‘‘lll added as
case of cow’s milk) by adding one or a preservative’’, the blank being filled
more of the following: Cream, skim in with the common name or names of
milk, concentrated skim milk, nonfat the mold-inhibiting ingredient or in-
dry milk; (in the case of goat’s milk) gredients used.
the corresponding products from goat’s (3) Wherever the name of the food ap-
milk; (in the case of sheep’s milk) the pears on the label so conspicuously as
corresponding products from sheep’s to be easily seen under customary con-
milk; water in a quantity sufficient to ditions of purchase, the words and
reconstitute any concentrated or dried statements prescribed by this section,
products used. showing the optional ingredient used,
(2) Milk shall be deemed to have been shall immediately and conspicuously
pasteurized if it has been held at a tem- precede or follow such name, without
perature of not less than 143 °F for a intervening written, printed, or graph-
period of not less than 30 minutes, or ic matter.
511
§ 133.188 21 CFR Ch. I (4–1–16 Edition)
(g) Label declaration. Each of the in- to promote the growth of biological
gredients used in the food shall be de- curing agents. Salt may be added dur-
clared on the label as required by the ing the procedure. A harmless prepara-
applicable sections of parts 101 and 130 tion of enzymes of animal or plant ori-
of this chapter. gin capable of aiding in the curing or
[42 FR 14366, Mar. 15, 1977, as amended at 49 development of flavor of semisoft part-
FR 10096, Mar. 19, 1984; 58 FR 2895, Jan. 6, skim cheese may be added in such
1993] quantity that the weight of the solids
of such preparation is not more than
§ 133.188 Semisoft part-skim cheeses. 0.1 percent of the weight of the milk
(a) The cheeses for which definitions used.
and standards of identity are pre- (c) For the purposes of this section:
scribed by this section are semisoft (1) The word ‘‘milk’’ means cow’s
part-skim cheeses for which specifi- milk or goat’s milk or sheep’s milk or
cally applicable definitions and stand- mixtures of two or all of these. Such
ards of identity are not prescribed by
milk may be adjusted by separating
other sections of this part. They are
part of the fat therefrom or (in the case
made from partly skimmed milk and
other ingredients specified in this sec- of cow’s milk) by adding one or more of
tion, by the procedure set forth in the following: Cream, skim milk, con-
paragraph (b) of this section. They concentrated skim milk, nonfat dry milk;
tain not more than 50 percent of mois- (in the case of goat’s milk) the cor-
ture, and their solids contain not less responding products from goat’s milk;
than 45 percent, but less than 50 per- (in the case of sheep’s milk) the cor-
cent, of milkfat, as determined by the responding products from sheep’s milk;
methods set forth in § 133.5 (a), (b), and water in a quantity sufficient to recon-
(d). If the milk used is not pasteurized, stitute any such concentrated or dried
the cheese so made is cured at a tem- products used.
perature of not less than 35 °F, for not (2) Milk shall be deemed to have been
less than 60 days. pasteurized if it has been held at a tem-
(b) Milk, which may be pasteurized or perature of not less than 143 °F for a
clarified or both, and which may be period of not less than 30 minutes, or
warmed, is subjected to the action of for a time and at a temperature equiva-
harmless lactic-acid-producing bac- lent thereto in phosphatase destruc-
teria or other harmless flavor-pro- tion. A semisoft part-skim cheese shall
ducing bacteria, present in such milk be deemed not to have been made from
or added thereto. Sufficient rennet, pasteurized milk if 0.25 gram shows a
rennet paste, extract of rennet paste, phenol equivalent of more than 5
or other safe and suitable milk-clot- micrograms when tested by the method
ting enzyme that produces equivalent prescribed in § 133.5(c).
curd formation singly or in any com-
(d) Semisoft part-skim cheeses in the
bination (with or without purified cal-
form of slices or cuts in consumer-sized
cium chloride in a quantity not more
packages may contain an optional
than 0.02 percent, calculated as anhy-
drous calcium chloride, of the weight mold-inhibiting ingredient consisting
of the milk) is added to set the milk to of sorbic acid, potassium sorbate, so-
a semisolid mass. Harmless artificial dium sorbate, or any combination of
coloring may be added. After coagula- two or more of these, in an amount not
tion the mass is so treated as to pro- to exceed 0.3 percent by weight, cal-
mote and regulate the separation of culated as sorbic acid.
whey and curd. Such treatment may (e) The name of each semisoft part-
include one or more of the following: skim cheese for which a definition and
Cutting, stirring, heating, dilution standard of identity is prescribed by
with water or brine. The whey, or part this section is ‘‘Semisoft part-skim
of it, is drained off, and the curd is col- cheese,’’ preceded or followed by:
lected and shaped. It may be placed in (1) The specific common or usual
forms, and it may be pressed. Harmless name of such semisoft cheese, if any
flavor-producing microorganisms may such name has become generally recog-
be added. It may be cured in a manner nized therefor; or
512
(2) If no such specific common or (b) Skim milk or the optional dairy
usual name has become generally rec- ingredients specified in paragraph (c)
ognized therefor, an arbitrary or fan- of this section, which may be pasteur-
ciful name which is not false or mis- ized, and which may be warmed, are
leading in any particular. subjected to the action of harmless lac-
(f)(1) When milk other than cow’s tic-acid-producing bacteria, present in
milk is used in whole or in part, the such milk or added thereto. Harmless
name of the cheese includes the state- artificial coloring may be added. Suffi-
ment ‘‘made from lll’’, the blank cient rennet, or other safe and suitable
being filled in with the name or names milk-clotting enzyme that produces
of the milk used, in order of predomi- equivalent curd formation, or both,
nance by weight. with or without purified calcium chlo-
(2) If semi-soft part-skim cheese in ride in a quantity not more than 0.02
sliced or cut form contains an optional percent (calculated as anhydrous cal-
mold-inhibiting ingredient as specified cium chloride) of the weight of the
in paragraph (d) of this section, the skim milk, is added to set the skim
label shall bear the statement ‘‘lll milk to a semisolid mass. The mass is
added to retard mold growth’’ or so cut, stirred, and heated with contin-
‘‘lll added as a preservative’’, the ued stirring, as to promote and regu-
blank being filled in with the common late the separation of whey and curd.
name or names of the mold-inhibiting The whey is drained off, and the curd is
ingredient or ingredients used. matted into a cohesive mass. Proteins
(3) Wherever the name of the food ap- from the whey may be incorporated.
pears on the label so conspicuously as The mass is cut into slabs which are so
to be easily seen under customary con- piled and handled as to promote the
ditions of purchase, the words and drainage of whey and the development
statements prescribed by this section,
of acidity. The slabs are then cut into
showing the optional ingredient used,
pieces, which may be rinsed by pouring
shall immediately and conspicuously
or sprinkling water over them, with
precede or follow such name, without
free and continuous drainage; but the
intervening written, printed, or graph-

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Title 21—Food and

CHAPTER I—Food and Drug Administration, Department of

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION

114 Acidified foods ......................................................... 356

PART 100—GENERAL (b) Definitions. (1) Act means the Fed-

the requirement of the preemptive Fed- A. Action Requested

Subpart F—Misbranding for Subpart G—Specific Administra-

or to further reduce the size of the (d) Individual serving-sized packages

of a food described in this section shall Subpart C—Specific Nutrition Labeling

to accommodate the necessary infor- requirement of this section other than

lithographed onto the surface of the taurants, institutions, and on board

type-size requirements of this para- (iii) The statement of ingredients re-

be considered to be a necessary part of or usual name regulation pursuant to

usual name is established by regulation tary’’ may be deleted and replaced by

or an appropriately descriptive term Acts by the U.S. Department of Agri-

or oils is partially hydrogenated, the used in the product. Such ingredients

the ingredient statement, in order of present, such as ‘‘or’’, ‘‘and/or’’, or

common or usual name in the manner rather than ‘‘flos’’);

Authorized official of a vending ma- of an actual Nutrition Facts label that

duction of the Nutrition Facts label on lowing manner:

ground at least as contrasting as the chine operator that is not otherwise

may be the amount in ounces that generated by further division by 2 or 3.

amount to serving size in paragraph (vii) As provided for in § 101.9(h)(1),

quantity in parenthesis (fluids in milli- clared by different manufacturers, FDA

cup prepared)). units, the number of servings shall be

mation on the label and in labeling of www.archives.gov/federallregister/

(ii) ‘‘Trans fat’’ or ‘‘Trans’’: A state-

one that meets the criteria in number of grams of total carbohydrate

be declared voluntarily except that sugar alcohol is present in the food.

serving, as determined in paragraph use by infants and the protein quality

RDI for protein for children less than 4 food; or

the ingredient statement. The declara- Biotin, 300 micrograms

Vitamin B6, 2.0 milligrams

and ‘‘Calories from fat’’ to allow clear as specified in paragraph (c)(7)(ii) of

food in more than insignificant a lot. Unless a particular method of

small size is contained in a gift pack- the provisions of this section.

allows a declaration of ‘‘less than 1 agement of a disease or condition for

administered enterally under the su- tion labeling in accordance with

labeling contains all nutrition infor- label information on the information

there is no packaging, the form in Sections Affected, which appears in the

extracts, and food colors. (2) FDA calculated the reference

food customarily consumed per eating (ii) Serving sizes recommended in

Cereals, dry instant .................................................................... 15 g ........................ l cup (l g)

priate to their specific product using the procedures in 21 CFR 101.9(b).

Breakfast cereals, ready-to-eat weighing 20 g or 30 g ........................ l cup(s) (l g)

Fats and Oils:

Mayonnaise, sandwich spreads, mayonnaise-type 15 g ........................ l tbsp (l g)

kles for cookies, cake decorations. measurable by tsp (l g)

Dietary supplements .................................................... The maximum l tablet(s), l capsule(s), l packet(s),

other sauces for dipping (e.g., mustard sauce,

small pieces (e.g., cut corn, green

Olives 11 ........................................................................ 15 g ........................ l piece(s) (l g); l tbsp(s) (l g) for

priate or are more likely to promote graphic and socioeconomic characteris-

100 calories.’’ lar to, and that it is not nutritionally

as defined in § 101.13(l), a main dish closure statement shall be no less than

value is representative of the food (A) A claim on the principal display

and in the regulations in subpart D of quirements of § 101.13.

requirement, if a definition for use of ments of paragraphs (d)(2)(vi) or

which is not required by or under au- quirements of this paragraph (c)(2), if

(3) If any article of labeling (other (iii) Products of a net quantity of

juice. section until FDA notifies the State or

or on its container or wrapper, or on or usual name or may state ‘‘All flavor

Only such notes or such flavor ingre-