CFR Title 21 - 2012

Title 21
Food and Drugs

Parts 170 to 199
Revised as of April 1, 2012
Containing a codification of documents

of general applicability and future effect
As of April 1, 2012
Published by the Office of the Federal Register

National Archives and Records Administration
as a Special Edition of the Federal Register
erowe on DSK2VPTVN1PROD with CFR
VerDate Mar<15>2010 10:14 May 14, 2012 Jkt 226069 PO 00000 Frm 00001 Fmt 8091 Sfmt 8091 Y:\SGML\226069.XXX 226069
U.S. GOVERNMENT OFFICIAL EDITION NOTICE
Legal Status and Use of Seals and Logos

The seal of the National Archives and Records Administration
(NARA) authenticates the Code of Federal Regulations (CFR) as
the official codification of Federal regulations established under
the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the
contents of the CFR, a special edition of the Federal Register, shall
be judicially noticed. The CFR is prima facie evidence of the origi-
nal documents published in the Federal Register (44 U.S.C. 1510).
It is prohibited to use NARA’s official seal and the stylized Code
of Federal Regulations logo on any republication of this material
without the express, written permission of the Archivist of the
United States or the Archivist’s designee. Any person using
NARA’s official seals and logos in a manner inconsistent with the
provisions of 36 CFR part 1200 is subject to the penalties specified
in 18 U.S.C. 506, 701, and 1017.
Use of ISBN Prefix

This is the Official U.S. Government edition of this publication
and is herein identified to certify its authenticity. Use of the 0–16
ISBN prefix is for U.S. Government Printing Office Official Edi-
tions only. The Superintendent of Documents of the U.S. Govern-
ment Printing Office requests that any reprinted edition clearly be
labeled as a copy of the authentic work with a new ISBN.
U.S. GOVERNMENT PRINTING OFFICE
U.S. Superintendent of Documents • Washington, DC 20402–0001

e:\seals\archives.ai</GPH> e:\seals\gpologo.eps</GPH>
http://bookstore.gpo.gov
Phone: toll-free (866) 512-1800; DC area (202) 512-1800
Table of Contents
Page
Explanation ................................................................................................ v
Title 21:
Chapter I—Food and Drug Administration, Department of Health

and Human Services (Continued) ................................................. 3
Finding Aids:
Table of CFR Titles and Chapters ....................................................... 607
Alphabetical List of Agencies Appearing in the CFR ......................... 627
List of CFR Sections Affected ............................................................. 637

iii
Cite this Code: CFR
To cite the regulations in

this volume use title,
part and section num-
ber. Thus, 21 CFR 170.3
refers to title 21, part
170, section 3.
iv
Explanation
The Code of Federal Regulations is a codification of the general and permanent
rules published in the Federal Register by the Executive departments and agen-
cies of the Federal Government. The Code is divided into 50 titles which represent
broad areas subject to Federal regulation. Each title is divided into chapters
which usually bear the name of the issuing agency. Each chapter is further sub-
divided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued
on a quarterly basis approximately as follows:
Title 1 through Title 16..............................................................as of January 1
Title 17 through Title 27 .................................................................as of April 1
Title 28 through Title 41 ..................................................................as of July 1
Title 42 through Title 50 .............................................................as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially noticed (44
U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text
of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual issues
of the Federal Register. These two publications must be used together to deter-
mine the latest version of any given rule.
To determine whether a Code volume has been amended since its revision date
(in this case, April 1, 2012), consult the ‘‘List of CFR Sections Affected (LSA),’’
which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which
appears in the Reader Aids section of the daily Federal Register. These two lists
will identify the Federal Register page number of the latest amendment of any
given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal Reg-
ister since the last revision of that volume of the Code. Source citations for
the regulations are referred to by volume number and page number of the Federal
Register and date of publication. Publication dates and effective dates are usu-
ally not the same and care must be exercised by the user in determining the
actual effective date. In instances where the effective date is beyond the cut-
off date for the Code a note has been inserted to reflect the future effective
date. In those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be inserted following
the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies
to display an OMB control number with their information collection request.
Many agencies have begun publishing numerous OMB control numbers as amend-
ments to existing regulations in the CFR. These OMB numbers are placed as
close as possible to the applicable recordkeeping or reporting requirements.
OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on the cover
of each volume are not carried. Code users may find the text of provisions in
effect on a given date in the past by using the appropriate numerical list of
sections affected. For the period before January 1, 2001, consult either the List
of CFR Sections Affected, 1949–1963, 1964–1972, 1973–1985, or 1986–2000, published
in eleven separate volumes. For the period beginning January 1, 2001, a ‘‘List
of CFR Sections Affected’’ is published at the end of each CFR volume.
‘‘[RESERVED]’’ TERMINOLOGY
The term ‘‘[Reserved]’’ is used as a place holder within the Code of Federal
Regulations. An agency may add regulatory information at a ‘‘[Reserved]’’ loca-
tion at any time. Occasionally ‘‘[Reserved]’’ is used editorially to indicate that
a portion of the CFR was left vacant and not accidentally dropped due to a print-
ing or computer error.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was established
by statute and allows Federal agencies to meet the requirement to publish regu-
lations in the Federal Register by referring to materials already published else-
where. For an incorporation to be valid, the Director of the Federal Register
must approve it. The legal effect of incorporation by reference is that the mate-
rial is treated as if it were published in full in the Federal Register (5 U.S.C.
552(a)). This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the Federal Register
will approve an incorporation by reference only when the requirements of 1 CFR
part 51 are met. Some of the elements on which approval is based are:
(a) The incorporation will substantially reduce the volume of material pub-
lished in the Federal Register.
(b) The matter incorporated is in fact available to the extent necessary to
afford fairness and uniformity in the administrative process.
(c) The incorporating document is drafted and submitted for publication in
accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If you have any
problem locating or obtaining a copy of material listed as an approved incorpora-
tion by reference, please contact the agency that issued the regulation containing
that incorporation. If, after contacting the agency, you find the material is not
available, please notify the Director of the Federal Register, National Archives
and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or
call 202-741-6010.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a separate
volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS.
This volume contains the Parallel Table of Authorities and Rules. A list of CFR
titles, chapters, subchapters, and parts and an alphabetical list of agencies pub-
lishing in the CFR are also included in this volume.

An index to the text of ‘‘Title 3—The President’’ is carried within that volume.
vi
The Federal Register Index is issued monthly in cumulative form. This index
is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg-
ister.
A List of CFR Sections Affected (LSA) is published monthly, keyed to the
revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing in the
Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this volume,
contact the issuing agency. The issuing agency’s name appears at the top of
odd-numbered pages.
For inquiries concerning CFR reference assistance, call 202–741–6000 or write
to the Director, Office of the Federal Register, National Archives and Records
Administration, 8601 Adelphi Road, College Park, MD 20740-6001 or e-mail
fedreg.info@nara.gov.
SALES
The Government Printing Office (GPO) processes all sales and distribution of
the CFR. For payment by credit card, call toll-free, 866-512-1800, or DC area, 202-
512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2104, 24 hours
a day. For payment by check, write to: US Government Printing Office – New
Orders, P.O. Box 979050, St. Louis, MO 63197-9000.
ELECTRONIC SERVICES
The full text of the Code of Federal Regulations, the LSA (List of CFR Sections
Affected), The United States Government Manual, the Federal Register, Public
Laws, Public Papers of the Presidents of the United States, Compilation of Presi-
dential Documents and the Privacy Act Compilation are available in electronic
format via www.ofr.gov. For more information, contact the GPO Customer Con-
tact Center, U.S. Government Printing Office. Phone 202-512-1800, or 866-512-1800
(toll-free). E-mail, gpo@custhelp.com.
The Office of the Federal Register also offers a free service on the National
Archives and Records Administration’s (NARA) World Wide Web site for public
law numbers, Federal Register finding aids, and related information. Connect
to NARA’s web site at www.archives.gov/federal-register.
MICHAEL L. WHITE,
Acting Director,
Office of the Federal Register.
April 1, 2012.
vii
THIS TITLE
Title 21—FOOD AND DRUGS is composed of nine volumes. The parts in these
volumes are arranged in the following order: Parts 1–99, 100–169, 170–199, 200–299,
300–499, 500–599, 600–799, 800–1299 and 1300 to end. The first eight volumes, con-
taining parts 1–1299, comprise Chapter I—Food and Drug Administration, Depart-
ment of Health and Human Services. The ninth volume, containing part 1300 to
end, includes Chapter II—Drug Enforcement Administration, Department of Jus-
tice, and Chapter III—Office of National Drug Control Policy. The contents of
these volumes represent all current regulations codified under this title of the
CFR as of April 1, 2012.
For this volume, Susannah C. Hurley was Chief Editor. The Code of Federal
Regulations publication program is under the direction of Michael L. White, as-
sisted by Ann Worley.
ix
Title 21—Food and
Drugs
(This book contains parts 170 to 199)
Part
CHAPTER I—Food and Drug Administration, Department of

Health and Human Services (Continued) ........................... 170
CHAPTER I—FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF HEALTH
AND HUMAN SERVICES (CONTINUED)
(Parts 170 to 199)
EDITORIAL NOTE: Nomenclature changes to chapter I appear at 59 FR 14366, Mar. 28, 1994,
and 69 FR 18803, Apr. 9, 2004.
SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED)
Part Page
170 Food additives ......................................................... 5
171 Food additive petitions ........................................... 24
172 Food additives permitted for direct addition to
food for human consumption ................................ 30
173 Secondary direct food additives permitted in food
for human consumption ....................................... 122
174 Indirect food additives: General .............................. 155
175 Indirect food additives: Adhesives and components
of coatings ............................................................ 156
176 Indirect food additives: Paper and paperboard com-
ponents ................................................................. 199
177 Indirect food additives: Polymers ........................... 238
178 Indirect food additives: Adjuvants, production
aids, and sanitizers ............................................... 362
179 Irradiation in the production, processing and han-
dling of food ......................................................... 456
180 Food additives permitted in food or in contact
with food on an interim basis pending additional
study .................................................................... 462
181 Prior-sanctioned food ingredients ........................... 467
182 Substances generally recognized as safe ................. 472
184 Direct food substances affirmed as generally recog-
nized as safe ......................................................... 485
186 Indirect food substances affirmed as generally rec-
ognized as safe ...................................................... 590
189 Substances prohibited from use in human food ...... 595

190 Dietary supplements ............................................... 602
3
21 CFR Ch. I (4–1–12 Edition)
Part Page
191–199 [Reserved]
SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
(CONTINUED)
PART 170—FOOD ADDITIVES 170.106 Notification for a food contact sub-

stance formulation (NFCSF).
Subpart A—General Provisions AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348,
371.
Sec.
170.3 Definitions. SOURCE: 42 FR 14483, Mar. 15, 1977, unless
170.6 Opinion letters on food additive sta- otherwise noted.
tus. EDITORIAL NOTE: Nomenclature changes to
170.10 Food additives in standardized foods. part 170 appear at 66 FR 56035, Nov. 6, 2001
170.15 Adoption of regulation on initiative and 69 FR 13717, Mar. 24, 2004.
of Commissioner.
170.17 Exemption for investigational use
and procedure for obtaining authoriza- Subpart A—General Provisions
tion to market edible products from ex-
perimental animals. § 170.3 Definitions.
170.18 Tolerances for related food additives. For the purposes of this subchapter,
170.19 Pesticide chemicals in processed the following definitions apply:
foods. (a) Secretary means the Secretary of
Health and Human Services.
Subpart B—Food Additive Safety
(b) Department means the Department
170.20 General principles for evaluating the of Health and Human Services.
safety of food additives. (c) Commissioner means the Commis-
170.22 Safety factors to be considered. sioner of Food and Drugs.
170.30 Eligibility for classification as gen- (d) As used in this part, the term act
erally recognized as safe (GRAS).
means the Federal Food, Drug, and
170.35 Affirmation of generally recognized
as safe (GRAS) status. Cosmetic Act approved June 25, 1936, 52
170.38 Determination of food additive sta- Stat. 1040 et seq., as amended (21 U.S.C.
tus. 301–392).
170.39 Threshold of regulation for sub- (e)(1) Food additives includes all sub-
stances used in food-contact articles. stances not exempted by section 201(s)
of the act, the intended use of which
Subpart C—Specific Administrative Rulings results or may reasonably be expected
and Decisions to result, directly or indirectly, either
170.45 Fluorine-containing compounds. in their becoming a component of food
170.50 Glycine (aminoacetic acid) in food for or otherwise affecting the characteris-
human consumption. tics of food. A material used in the pro-
170.60 Nitrites and/or nitrates in curing pre- duction of containers and packages is
mixes. subject to the definition if it may rea-
Subpart D—Premarket Notifications sonably be expected to become a com-
ponent, or to affect the characteristics,
170.100 Submission of a premarket notifica- directly or indirectly, of food packed in
tion for a food contact substance (FCN) the container. ‘‘Affecting the charac-
to the Food and Drug Administration teristics of food’’ does not include such
(FDA). physical effects, as protecting contents
170.101 Information in a premarket notifica-
tion for a food contact substance (FCN). of packages, preserving shape, and pre-
170.102 Confidentiality of information in a venting moisture loss. If there is no
premarket notification for a food contact migration of a packaging component
substance (FCN). from the package to the food, it does
170.103 Withdrawal without prejudice of a not become a component of the food
premarket notification for a food contact and thus is not a food additive. A sub-
substance (FCN). stance that does not become a compo-
170.104 Action on a premarket notification
nent of food, but that is used, for exam-
for a food contact substance (FCN).
170.105 The Food and Drug Administration’s ple, in preparing an ingredient of the
food to give a different flavor, texture,
(FDA’s) determination that a premarket

notification for a food contact substance or other characteristic in the food,
(FCN) is no longer effective. may be a food additive.
§ 170.3 21 CFR Ch. I (4–1–12 Edition)
(2) Uses of food additives not requiring (j) The term nonperishable processed
a listing regulation. Use of a substance food means any processed food not sub-
in a food contact article (e.g., food- ject to rapid decay or deterioration
packaging or food-processing equip- that would render it unfit for consump-
ment) whereby the substance migrates, tion. Examples are flour, sugar, cere-
or may reasonably be expected to mi- als, packaged cookies, and crackers.
grate, into food at such levels that the Not included are hermetically sealed
use has been exempted from regulation foods or manufactured dairy products
as a food additive under § 170.39, and and other processed foods requiring re-
food contact substances used in accord- frigeration.
ance with a notification submitted (k) General recognition of safety shall
under section 409(h) of the act that is be determined in accordance with
effective. § 170.30.
(3) A food contact substance is any sub- (l) Prior sanction means an explicit
stance that is intended for use as a approval granted with respect to use of
component of materials used in manu- a substance in food prior to September
facturing, packing, packaging, trans- 6, 1958, by the Food and Drug Adminis-
porting, or holding food if such use is tration or the United States Depart-
not intended to have any technical ef- ment of Agriculture pursuant to the
fect in such food. Federal Food, Drug, and Cosmetic Act,
(f) Common use in food means a sub- the Poultry Products Inspection Act,
stantial history of consumption of a or the Meat Inspection Act.
substance for food use by a significant (m) Food includes human food, sub-
number of consumers. stances migrating to food from food-
(g) The word substance in the defini- contact articles, pet food, and animal
tion of the term ‘‘food additive’’ in- feed.
cludes a food or food component con- (n) The following general food cat-
sisting of one or more ingredients. egories are established to group spe-
(h) Scientific procedures include those cific related foods together for the pur-
human, animal, analytical, and other pose of establishing tolerances or limi-
scientific studies, whether published or tations for the use of direct human
unpublished, appropriate to establish food ingredients. Individual food prod-
the safety of a substance. ucts will be included within these cat-
(i) Safe or safety means that there is egories according to the detailed clas-
a reasonable certainty in the minds of sifications lists contained in Exhibit
competent scientists that the sub- 33B of the report of the National Acad-
stance is not harmful under the in- emy of Sciences/National Research
tended conditions of use. It is impos- Council report, ‘‘A Comprehensive Sur-
sible in the present state of scientific vey of Industry on the Use of Food
knowledge to establish with complete Chemicals Generally Recognized as
certainty the absolute harmlessness of Safe’’ (September 1972), which is incor-
the use of any substance. Safety may porated by reference. Copies are avail-
be determined by scientific procedures able from the National Technical Infor-
or by general recognition of safety. In mation Service (NTIS), 5285 Port Royal
determining safety, the following fac- Rd., Springfield, VA 22161, or at the Na-
tors shall be considered: tional Archives and Records Adminis-
(1) The probable consumption of the tration (NARA). For information on
substance and of any substance formed the availability of this material at
in or on food because of its use. NARA, call 202–741–6030, or go to: http://
(2) The cumulative effect of the sub- www.archives.gov/federallregister/
stance in the diet, taking into account codeloflfederallregulations/
any chemically or pharmacologically ibrllocations.html.
related substance or substances in such (1) Baked goods and baking mixes, in-
diet. cluding all ready-to-eat and ready-to-
(3) Safety factors which, in the opin- bake products, flours, and mixes re-
ion of experts qualified by scientific quiring preparation before serving.
training and experience to evaluate the (2) Beverages, alcoholic, including
safety of food and food ingredients, are malt beverages, wines, distilled liq-
generally recognized as appropriate. uors, and cocktail mix.
Food and Drug Administration, HHS § 170.3
(3) Beverages and beverage bases, (18) Fresh poultry, including only
nonalcoholic, including only special or fresh or home-frozen poultry and game
spiced teas, soft drinks, coffee sub- birds and home-prepared fresh poultry-
stitutes, and fruit and vegetable fla- containing dishes, salads, appetizers, or
vored gelatin drinks. sandwich spreads made therefrom.
(4) Breakfast cereals, including (19) Fresh vegetables, tomatoes, and
ready-to-eat and instant and regular potatoes, including only fresh and
hot cereals. home-prepared vegetables.
(5) Cheeses, including curd and whey (20) Frozen dairy desserts and mixes,
cheeses, cream, natural, grating, proc- including ice cream, ice milks, sher-
essed, spread, dip, and miscellaneous bets, and other frozen dairy desserts
cheeses. and specialties.
(6) Chewing gum, including all forms. (21) Fruit and water ices, including
(7) Coffee and tea, including regular, all frozen fruit and water ices.
decaffeinated, and instant types. (22) Gelatins, puddings, and fillings,
(8) Condiments and relishes, includ- including flavored gelatin desserts,
ing plain seasoning sauces and spreads, puddings, custards, parfaits, pie fill-
olives, pickles, and relishes, but not ings, and gelatin base salads.
spices or herbs. (23) Grain products and pastas, in-
(9) Confections and frostings, includ- cluding macaroni and noodle products,
ing candy and flavored frostings, rice dishes, and frozen multicourse
marshmallows, baking chocolate, and meals, without meat or vegetables.
brown, lump, rock, maple, powdered, (24) Gravies and sauces, including all
and raw sugars.
meat sauces and gravies, and tomato,
(10) Dairy product analogs, including milk, buttery, and specialty sauces.
nondairy milk, frozen or liquid cream-
(25) Hard candy and cough drops, in-
ers, coffee whiteners, toppings, and
cluding all hard type candies.
other nondairy products.
(26) Herbs, seeds, spices, seasonings,
(11) Egg products, including liquid,
frozen, or dried eggs, and egg dishes blends, extracts, and flavorings, includ-
made therefrom, i.e., egg roll, egg foo ing all natural and artificial spices,
young, egg salad, and frozen multi- blends, and flavors.
course egg meals, but not fresh eggs. (27) Jams and jellies, home-prepared,
(12) Fats and oils, including mar- including only home-prepared jams,
garine, dressings for salads, butter, jellies, fruit butters, preserves, and
salad oils, shortenings and cooking sweet spreads.
oils. (28) Jams and jellies, commercial, in-
(13) Fish products, including all pre- cluding only commercially processed
pared main dishes, salads, appetizers, jams, jellies, fruit butters, preserves,
frozen multicourse meals, and spreads and sweet spreads.
containing fish, shellfish, and other (29) Meat products, including all
aquatic animals, but not fresh fish. meats and meat containing dishes, sal-
(14) Fresh eggs, including cooked ads, appetizers, frozen multicourse
eggs and egg dishes made only from meat meals, and sandwich ingredients
fresh shell eggs. prepared by commercial processing or
(15) Fresh fish, including only fresh using commercially processed meats
and frozen fish, shellfish, and other with home preparation.
aquatic animals. (30) Milk, whole and skim, including
(16) Fresh fruits and fruit juices, in- only whole, lowfat, and skim fluid
cluding only raw fruits, citrus, melons, milks.
and berries, and home-prepared ‘‘ades’’ (31) Milk products, including flavored
and punches made therefrom. milks and milk drinks, dry milks, top-
(17) Fresh meats, including only fresh pings, snack dips, spreads, weight con-
or home-frozen beef or veal, pork, lamb trol milk beverages, and other milk or-
or mutton and home-prepared fresh igin products.
meat-containing dishes, salads, appe- (32) Nuts and nut products, including
tizers, or sandwich spreads made there- whole or shelled tree nuts, peanuts, co-
from. conut, and nut and peanut spreads.
§ 170.3 21 CFR Ch. I (4–1–12 Edition)
(33) Plant protein products, including Copies are available from the National
the National Academy of Sciences/Na- Technical Information Service (NTIS),
tional Research Council ‘‘reconstituted 5285 Port Royal Rd., Springfield, VA
vegetable protein’’ category, and meat, 22161, or at the National Archives and
poultry, and fish substitutes, analogs, Records Administration (NARA). For
and extender products made from plant information on the availability of this
proteins. material at NARA, call 202–741–6030, or
(34) Poultry products, including all go to: http://www.archives.gov/
poultry and poultry-containing dishes, federallregister/
salads, appetizers, frozen multicourse codeloflfederallregulations/
poultry meals, and sandwich ingredi- ibrllocations.html.
ents prepared by commercial proc- (1) Anticaking agents and free-flow
essing or using commercially processed agents: Substances added to finely pow-
poultry with home preparation. dered or crystalline food products to
(35) Processed fruits and fruit juices, prevent caking, lumping, or agglomer-
including all commercially processed ation.
fruits, citrus, berries, and mixtures; (2) Antimicrobial agents: Substances
salads, juices and juice punches, con- used to preserve food by preventing
centrates, dilutions, ‘‘ades’’, and drink growth of microorganisms and subse-
substitutes made therefrom. quent spoilage, including fungistats,
(36) Processed vegetables and vege- mold and rope inhibitors, and the ef-
table juices, including all commer- fects listed by the National Academy of
cially processed vegetables, vegetable Sciences/National Research Council
dishes, frozen multicourse vegetable under ‘‘preservatives.’’
meals, and vegetable juices and blends. (3) Antioxidants: Substances used to
(37) Snack foods, including chips, preserve food by retarding deteriora-
pretzels, and other novelty snacks. tion, rancidity, or discoloration due to
(38) Soft candy, including candy bars, oxidation.
chocolates, fudge, mints, and other (4) Colors and coloring adjuncts: Sub-
chewy or nougat candies. stances used to impart, preserve, or en-
(39) Soups, home-prepared, including hance the color or shading of a food, in-
meat, fish, poultry, vegetable, and cluding color stabilizers, color fixa-
combination home-prepared soups. tives, color-retention agents, etc.
(40) Soups and soup mixes, including (5) Curing and pickling agents: Sub-
commercially prepared meat, fish, stances imparting a unique flavor and/
poultry, vegetable, and combination or color to a food, usually producing an
soups and soup mixes. increase in shelf life stability.
(41) Sugar, white, granulated, includ- (6) Dough strengtheners: Substances
ing only white granulated sugar. used to modify starch and gluten,
(42) Sugar substitutes, including thereby producing a more stable dough,
granulated, liquid, and tablet sugar including the applicable effects listed
substitutes. by the National Academy of Sciences/
(43) Sweet sauces, toppings, and syr- National Research Council under
ups, including chocolate, berry, fruit, ‘‘dough conditioner.’’
corn syrup, and maple sweet sauces and (7) Drying agents: Substances with
toppings. moisture-absorbing ability, used to
(o) The following terms describe the maintain an environment of low mois-
physical or technical functional effects ture.
for which direct human food ingredi- (8) Emulsifiers and emulsifier salts:
ents may be added to foods. They are Substances which modify surface ten-
adopted from the National Academy of sion in the component phase of an
Sciences/National Research Council na- emulsion to establish a uniform disper-
tional survey of food industries, re- sion or emulsion.
ported to the Food and Drug Adminis- (9) Enzymes: Enzymes used to im-
tration under the contract title ‘‘A prove food processing and the quality
Comprehensive Survey of Industry on of the finished food.
the Use of Food Chemicals Generally (10) Firming agents: Substances added
Recognized as Safe’’ (September 1972), to precipitate residual pectin, thus

which is incorporated by reference. strengthening the supporting tissue
and preventing its collapse during (23) pH control agents: Substances

processing. added to change or maintain active
(11) Flavor enhancers: Substances acidity or basicity, including buffers,
added to supplement, enhance, or mod- acids, alkalies, and neutralizing
ify the original taste and/or aroma of a agents.
food, without imparting a char- (24) Processing aids: Substances used
acteristic taste or aroma of its own. as manufacturing aids to enhance the
(12) Flavoring agents and adjuvants: appeal or utility of a food or food com-
Substances added to impart or help im- ponent, including clarifying agents,
part a taste or aroma in food. clouding agents, catalysts, flocculents,
(13) Flour treating agents: Substances filter aids, and crystallization inhibi-
added to milled flour, at the mill, to tors, etc.
improve its color and/or baking quali- (25) Propellants, aerating agents, and
ties, including bleaching and maturing gases: Gases used to supply force to
agents. expel a product or used to reduce the
(14) Formulation aids: Substances used amount of oxygen in contact with the
to promote or produce a desired phys- food in packaging.
ical state or texture in food, including (26) Sequestrants: Substances which
carriers, binders, fillers, plasticizers, combine with polyvalent metal ions to
film-formers, and tableting aids, etc. form a soluble metal complex, to im-
(15) Fumigants: Volatile substances prove the quality and stability of prod-
used for controlling insects or pests. ucts.
(16) Humectants: Hygroscopic sub- (27) Solvents and vehicles: Substances
stances incorporated in food to pro- used to extract or dissolve another sub-
mote retention of moisture, including stance.
moisture-retention agents and anti- (28) Stabilizers and thickeners: Sub-
dusting agents. stances used to produce viscous solu-
(17) Leavening agents: Substances tions or dispersions, to impart body,
used to produce or stimulate produc- improve consistency, or stabilize emul-
tion of carbon dioxide in baked goods sions, including suspending and body-
to impart a light texture, including ing agents, setting agents, jellying
yeast, yeast foods, and calcium salts agents, and bulking agents, etc.
listed by the National Academy of
(29) Surface-active agents: Substances
Sciences/National Research Council
used to modify surface properties of
under ‘‘dough conditioners.’’
liquid food components for a variety of
(18) Lubricants and release agents: Sub-
effects, other than emulsifiers, but in-
stances added to food contact surfaces
cluding solubilizing agents,
to prevent ingredients and finished
dispersants, detergents, wetting
products from sticking to them.
agents, rehydration enhancers, whip-
(19) Non-nutritive sweeteners: Sub-
ping agents, foaming agents, and de-
stances having less than 2 percent of
foaming agents, etc.
the caloric value of sucrose per equiva-
lent unit of sweetening capacity. (30) Surface-finishing agents: Sub-
stances used to increase palatability,
(20) Nutrient supplements: Substances
which are necessary for the body’s nu- preserve gloss, and inhibit discolora-
tritional and metabolic processes. tion of foods, including glazes, polishes,
waxes, and protective coatings.
(21) Nutritive sweeteners: Substances
having greater than 2 percent of the ca- (31) Synergists: Substances used to act
loric value of sucrose per equivalent or react with another food ingredient
unit of sweetening capacity. to produce a total effect different or
(22) Oxidizing and reducing agents: greater than the sum of the effects pro-
Substances which chemically oxidize duced by the individual ingredients.
or reduce another food ingredient, (32) Texturizers: Substances which af-
thereby producing a more stable prod- fect the appearance or feel of the food.
uct, including the applicable effect list- [42 FR 14483, Mar. 15, 1977, as amended at 47
ed by the National Academy of
FR 11835, Mar. 19, 1982; 53 FR 16546, May 10,

Sciences/National Research Council 1988; 54 FR 24896, June 12, 1989; 60 FR 36595,
under ‘‘dough conditioners.’’ July 17, 1995; 67 FR 35729, May 21, 2002]
§ 170.6 21 CFR Ch. I (4–1–12 Edition)
§ 170.6 Opinion letters on food addi- Drug Administration are hereby re-
tive status. voked.
(e) The prior opinions of the kind de-
(a) Over the years the Food and Drug
scribed in paragraph (c) of this section
Administration has given informal
will be replaced by qualified and cur-
written opinions to inquiries as to the
rent opinions if the recipient of each
safety of articles intended for use as
such letter forwards a copy of each to
components of, or in contact with,
the Department of Health and Human
food. Prior to the enactment of the
Services, Food and Drug Administra-
Food Additives Amendment of 1958
tion, Center for Food Safety and Ap-
(Pub. L. 85–929; Sept. 6, 1958), these
plied Nutrition, 5100 Paint Branch
opinions were given pursuant to sec-
Pkwy., College Park, MD 20740, along
tion 402(a)(1) of the Federal Food, with a copy of his letter of inquiry, on
Drug, and Cosmetic Act, which reads in or before July 23, 1970.
part: ‘‘A food shall be deemed to be (f) This section does not apply to food
adulterated if it bears or contains any additive status opinion letters per-
poisonous or deleterious substance taining to articles that were considered
which may render it injurious to by the Food and Drug Administration
health’’. to be food additives nor to articles in-
(b) Since enactment of the Food Ad- cluded in regulations in parts 170
ditives Amendment, the Food and Drug through 189 of this chapter if the arti-
Administration has advised such in- cles are used in accordance with the re-
quirers that an article: quirements of such regulations.
(1) Is a food additive within the
[42 FR 14483, Mar. 15, 1977, as amended at 54
meaning of section 201(s) of the act; or
FR 24896, June 12, 1989]
(2) Is generally recognized as safe
(GRAS); or § 170.10 Food additives in standard-
(3) Has prior sanction or approval ized foods.
under that amendment; or (a) The inclusion of food ingredients
(4) Is not a food additive under the in parts 170 through 189 of this chapter
conditions of intended use. does not imply that these ingredients
(c) In the interest of the public may be used in standardized foods un-
health, such articles which have been less they are recognized as optional in-
considered in the past by the Food and gredients in applicable food standards.
Drug Administration to be safe under Where a petition is received for the
the provisions of section 402(a)(1), or to issuance or amendment of a regulation
be generally recognized as safe for establishing a definition and standard
their intended use, or to have prior of identity for a food under section 401
sanction or approval, or not to be food of the Act, which proposes the inclu-
additives under the conditions of in- sion of a food additive in such defini-
tended use, must be reexamined in the tion and standard of identity, the pro-
light of current scientific information visions of the regulations in this part
and current principles for evaluating shall apply with respect to the infor-
the safety of food additives if their use mation that must be submitted with
is to be continued. respect to the food additive. Since sec-
(d) Because of the time span in- tion 409(b)(5) of the Act requires that
volved, copies of many of the letters in the Secretary publish notice of a peti-
which the Food and Drug Administra- tion for the establishment of a food-ad-
tion has expressed an informal opinion ditive regulation within 30 days after
concerning the status of such articles filing, notice of a petition relating to a
may no longer be in the file of the Food definition and standard of identity
and Drug Administration. In the ab- shall also be published within that
sence of information concerning the time limitation if it includes a request,
names and uses made of all the articles so designated, for the establishment of
referred to in such letters, their safety a regulation pertaining to a food addi-
of use cannot be reexamined. For this tive.
reason all food additive status opinions (b) If a petition for a definition and
of the kind described in paragraph (c) standard of identity contains a pro-

of this section given by the Food and posal for a food-additive regulation,
10
and the petitioner fails to designate it (b) If intended for use in animals
as such, the Commissioner, upon deter- other than laboratory research animals
mining that the petition includes a and if the edible products of the ani-
proposal for a food-additive regulation, mals are to be marketed as food, per-
shall so notify the petitioner and shall mission for the marketing of the edible
thereafter proceed in accordance with products as food has been requested by
the regulations in this part. the sponsor, and authorization has
(c) A regulation will not be issued al- been granted by the Food and Drug Ad-
lowing the use of a food additive in a ministration in accordance with § 511.1
food for which a definition and stand- of this chapter or by the Department of
ard of identity is established, unless its Agriculture in accordance with 9 CFR
issuance is in conformity with section 309.17, and it bears a label which states
401 of the Act or with the terms of a prominently, in addition to the other
temporary permit issued under § 130.17 information required by the Act, the
of this chapter. When the contemplated warning:
use of such additive complies with the Caution. Contains a new food additive for
terms of a temporary permit, the food use only in investigational animals. Not for
additive regulation will be conditioned use in humans.
on such compliance and will expire Edible products of investigational animals
with the expiration of the temporary are not to be used for food unless authoriza-
permit. tion has been granted by the U.S. Food and
Drug Administration or by the U.S. Depart-
§ 170.15 Adoption of regulation on ini- ment of Agriculture.
tiative of Commissioner. (c) If intended for nonclinical labora-
(a) The Commissioner upon his own tory studies in food-producing animals,
initiative may propose the issuance of the study is conducted in compliance
a regulation prescribing, with respect with the regulations set forth in part 58
to any particular use of a food additive, of this chapter.
the conditions under which such addi- [42 FR 14483, Mar. 15, 1977, as amended at 43
tive may be safely used. Notice of such FR 60021, Dec. 22, 1978]
proposal shall be published in the FED-
ERAL REGISTER and shall state the rea- § 170.18 Tolerances for related food ad-
sons for the proposal. ditives.
(b) Action upon a proposal made by (a) Food additives that cause similar
the Commissioner shall proceed as pro- or related pharmacological effects will
vided in part 10 of this chapter. be regarded as a class, and in the ab-
[42 FR 14486, Mar. 15, 1977, as amended at 42 sence of evidence to the contrary, as
FR 15673, Mar. 22, 1977] having additive toxic effects and will
be considered as related food additives.
§ 170.17 Exemption for investigational (b) Tolerances established for such
use and procedure for obtaining au- related food additives may limit the
thorization to market edible prod- amount of a common component that
ucts from experimental animals. may be present, or may limit the
A food additive or food containing a amount of biological activity (such as
food additive intended for investiga- cholinesterase inhibition) that may be
tional use by qualified experts shall be present or may limit the total amount
exempt from the requirements of sec- of related food additives that may be
tion 409 of the Act under the following present.
conditions: (c) Where food additives from two or
(a) If intended for investigational use more chemicals in the same class are
in vitro or in laboratory research ani- present in or on a food, the tolerance
mals, it bears a label which states for the total of such additives shall be
prominently, in addition to the other the same as that for the additive hav-
information required by the act, the ing the lowest numerical tolerance in
warning: this class, unless there are available
Caution. Contains a new food additive for methods that permit quantitative de-
termination of the amount of each food
investigational use only in laboratory re-

search animals or for tests in vitro. Not for additive present or unless it is shown
use in humans. that a higher tolerance is reasonably
11
§ 170.19 21 CFR Ch. I (4–1–12 Edition)
required for the combined additives to by the regulations in this part. Food
accomplish the physical or technical that is itself ready to eat, and which
effect for which such combined addi- contains a higher residue than allowed
tives are intended and that the higher for the raw agricultural commodity,
tolerance will be safe. may not be legalized by blending or
(d) Where residues from two or more mixing with other foods to reduce the
additives in the same class are present residue in the mixed food below the tol-
in or on a food and there are available erance prescribed for the raw agricul-
methods that permit quantitative de- tural commodity.
termination of each residue, the quan-
tity of combined residues that are Subpart B—Food Additive Safety
within the tolerance may be deter-
mined as follows: § 170.20 General principles for evalu-
(1) Determine the quantity of each ating the safety of food additives.
residue present.
(2) Divide the quantity of each res- (a) In reaching a decision on any pe-
idue by the tolerance that would apply tition filed under section 409 of the
if it occurred alone, and multiply by Act, the Commissioner will give full
100 to determine the percentage of the consideration to the specific biological
permitted amount of residue present. properties of the compound and the
(3) Add the percentages so obtained adequacy of the methods employed to
for all residues present. demonstrate safety for the proposed
(4) The sum of the percentage shall use, and the Commissioner will be
not exceed 100 percent. guided by the principles and procedures
for establishing the safety of food addi-
§ 170.19 Pesticide chemicals in proc- tives stated in current publications of
essed foods. the National Academy of Sciences-Na-
When pesticide chemical residues tional Research Council. A petition
occur in processed foods due to the use will not be denied, however, by reason
of raw agricultural commodities that of the petitioner’s having followed pro-
bore or contained a pesticide chemical cedures other than those outlined in
in conformity with an exemption the publications of the National Acad-
granted or a tolerance prescribed under emy of Sciences-National Research
section 408 of the Act, the processed Council if, from available evidence, the
food will not be regarded as adulter- Commissioner finds that the proce-
ated so long as good manufacturing dures used give results as reliable as,
practice has been followed in removing or more reliable than, those reasonably
any residue from the raw agricultural to be expected from the use of the out-
commodity in the processing (such as lined procedures. In reaching a deci-
by peeling or washing) and so long as sion, the Commissioner will give due
the concentration of the residue in the weight to the anticipated levels and
processed food when ready to eat is not patterns of consumption of the additive
greater than the tolerance prescribed specified or reasonably inferrable. For
for the raw agricultural commodity. the purposes of this section, the prin-
But when the concentration of residue ciples for evaluating safety of additives
in the processed food when ready to eat set forth in the abovementioned publi-
is higher than the tolerance prescribed cations will apply to any substance
for the raw agricultural commodity, that may properly be classified as a
the processed food is adulterated unless food additive as defined in section
the higher concentration is permitted 201(s) of the Act.
by a tolerance obtained under section (b) Upon written request describing
409 of the Act. For example, if fruit the proposed use of an additive and the
bearing a residue of 7 parts per million proposed experiments to determine its
of DDT permitted on the raw agricul- safety, the Commissioner will advise a
tural commodity is dried and a residue person who wishes to establish the
in excess of 7 parts per million of DDT safety of a food additive whether he be-
results on the dried fruit, the dehy- lieves the experiments planned will
drated fruit is adulterated unless the yield data adequate for an evaluation
higher tolerance for DDT is authorized of the safety of the additive.
12
§ 170.22 Safety factors to be consid- generally available data and informa-

ered. tion. An ingredient not in common use
In accordance with section in food prior to January 1, 1958, may
409(c)(5)(C) of the Act, the following achieve general recognition of safety
safety factors will be applied in deter- only through scientific procedures.
mining whether the proposed use of a (2) A substance used in food prior to
food additive will be safe: Except where January 1, 1958, may be generally rec-
evidence is submitted which justifies ognized as safe through experience
use of a different safety factor, a safety based on its common use in food when
factor in applying animal experimen- that use occurred exclusively or pri-
tation data to man of 100 to 1, will be marily outside of the United States if
used; that is, a food additive for use by the information about the experience
man will not be granted a tolerance establishes that the use of the sub-
that will exceed 1⁄100th of the maximum stance is safe within the meaning of
amount demonstrated to be without the act (see § 170.3(i)). Common use in
harm to experimental animals. food prior to January 1, 1958, that oc-
curred outside of the United States
§ 170.30 Eligibility for classification as shall be documented by published or
generally recognized as safe other information and shall be corrobo-
(GRAS). rated by information from a second,
(a) General recognition of safety may independent source that confirms the
be based only on the views of experts history and circumstances of use of the
qualified by scientific training and ex- substance. The information used to
perience to evaluate the safety of sub- document and to corroborate the his-
stances directly or indirectly added to tory and circumstances of use of the
food. The basis of such views may be ei- substance must be generally available;
ther (1) scientific procedures or (2) in that is, it must be widely available in
the case of a substance used in food the country in which the history of use
prior to January 1, 1958, through expe- has occurred and readily available to
rience based on common use in food. interested qualified experts in this
General recognition of safety requires country. Persons claiming GRAS sta-
common knowledge about the sub- tus for a substance based on its com-
stance throughout the scientific common use in food outside of the United
munity knowledgeable about the safety States should obtain FDA concurrence
of substances directly or indirectly that the use of the substance is GRAS.
added to food. (d) The food ingredients listed as
(b) General recognition of safety GRAS in part 182 of this chapter or af-
based upon scientific procedures shall firmed as GRAS in part 184 or § 186.1 of
require the same quantity and quality this chapter do not include all sub-
of scientific evidence as is required to stances that are generally recognized
obtain approval of a food additive regu- as safe for their intended use in food.
lation for the ingredient. General rec- Because of the large number of sub-
ognition of safety through scientific stances the intended use of which re-
procedures shall ordinarily be based sults or may reasonably be expected to
upon published studies which may be result, directly or indirectly, in their
corroborated by unpublished studies becoming a component or otherwise af-
and other data and information. fecting the characteristics of food, it is
(c)(1) General recognition of safety impracticable to list all such sub-
through experience based on common stances that are GRAS. A food ingre-
use in food prior to January 1, 1958, dient of natural biological origin that
may be determined without the quan- has been widely consumed for its nutri-
tity or quality of scientific procedures ent properties in the United States
required for approval of a food additive prior to January 1, 1958, without known
regulation. General recognition of safe- detrimental effects, which is subject
ty through experience based on com- only to conventional processing as
mon use in food prior to January 1, practiced prior to January 1, 1958, and
1958, shall be based solely on food use for which no known safety hazard ex-
of the substance prior to January 1, ists, will ordinarily be regarded as

1958, and shall ordinarily be based upon GRAS without specific inclusion in
13
§ 170.30 21 CFR Ch. I (4–1–12 Edition)
part 182, part 184 or § 186.1 of this chap- (6) Substances of natural biological
ter. origin intended for consumption for
(e) Food ingredients were listed as other than their nutrient properties.
GRAS in part 182 of this chapter during (g) A food ingredient that is not
1958–1962 without a detailed scientific GRAS or subject to a prior sanction re-
review of all available data and infor- quires a food additive regulation pro-
mation relating to their safety. Begin- mulgated under section 409 of the act
ning in 1969, the Food and Drug Admin- before it may be directly or indirectly
istration has undertaken a systematic added to food.
review of the status of all ingredients (h) A food ingredient that is listed as
used in food on the determination that GRAS in part 182 of this chapter or af-
they are GRAS or subject to a prior firmed as GRAS in part 184 or § 186.1 of
sanction. All determinations of GRAS this chapter shall be regarded as GRAS
status or food additive status or prior only if, in addition to all the require-
sanction status pursuant to this review ments in the applicable regulation, it
shall be handled pursuant to §§ 170.35, also meets all of the following require-
170.38, and 180.1 of this chapter. Affir- ments:
mation of GRAS status shall be an- (1) It complies with any applicable
nounced in part 184 or § 186.1 of this food grade specifications of the Food
chapter. Chemicals Codex, 2d Ed. (1972), or, if
(f) The status of the following food
specifically indicated in the GRAS af-
ingredients will be reviewed and af-
firmation regulation, the Food Chemi-
firmed as GRAS or determined to be a
cals Codex, 3d Ed. (1981), which are in-
food additive or subject to a prior sanc-
corporated by reference, except that
tion pursuant to § 170.35, § 170.38, or
any substance used as a component of
§ 180.1 of this chapter:
articles that contact food and affirmed
(1) Any substance of natural biologi-
as GRAS in § 186.1 of this chapter shall
cal origin that has been widely con-
comply with the specifications therein,
sumed for its nutrient properties in the
or in the absence of such specifications,
United States prior to January 1, 1958,
shall be of a purity suitable for its in-
without known detrimental effect, for
which no health hazard is known, and tended use. Copies may be obtained
which has been modified by processes from the National Academy Press, 2101
first introduced into commercial use Constitution Ave. NW., Washington,
after January 1, 1958, which may rea- DC 20418, or at the National Archives
sonably be expected significantly to and Records Administration (NARA).
alter the composition of the substance. For information on the availability of
(2) Any substance of natural biologi- this material at NARA, call 202–741–
cal origin that has been widely con- 6030, or go to: http://www.archives.gov/
sumed for its nutrient properties in the federallregister/
United States prior to January 1, 1958, codeloflfederallregulations/
without known detrimental effect, for ibrllocations.html.
which no health hazard is known, that (2) It performs an appropriate func-
has had significant alteration of com- tion in the food or food-contact article
position by breeding or selection after in which it is used.
January 1, 1958, where the change may (3) It is used at a level no higher than
be reasonably expected to alter the nu- necessary to achieve its intended pur-
tritive value or the concentration of pose in that food or, if used as a compo-
toxic constituents. nent of a food-contact article, at a
(3) Distillates, isolates, extracts, and level no higher than necessary to
concentration of extracts of GRAS sub- achieve its intended purpose in that ar-
stances. ticle.
(4) Reaction products of GRAS sub- (i) If a substance is affirmed as GRAS
stances. in part 184 or § 186.1 of this chapter with
(5) Substances not of a natural bio- no limitation other than good manu-
logical origin, including those for facturing practice, it shall be regarded
which evidence is offered that they are as GRAS if its conditions of use are not
identical to a GRAS counterpart of significantly different from those re-

natural biological origin. ported in the regulation as the basis on
14
which the GRAS status of the sub- uses, and any limitations proposed for
stance was affirmed. If the conditions purposes other than safety.
of use are significantly different, such (2) The FEDERAL REGISTER notice will
use of the substance may not be GRAS. allow a period of 60 days during which
In such a case a manufacturer may not any interested person may review the
rely on the regulation as authorizing data and information and/or file com-
the use but must independently estab- ments with the Division of Dockets
lish that the use is GRAS or must use Management. Copies of all comments
the substance in accordance with a received shall be made available for ex-
food additive regulation. amination in the Division of Dockets
(j) If an ingredient is affirmed as Management’s office.
GRAS in part 184 or § 186.1 of this chap- (3) The Commissioner will evaluate
ter with specific limitation(s), it may all comments received. If he concludes
be used in food only within such limi- that there is convincing evidence that
tation(s) (including the category of the substance is GRAS as described in
food(s), the functional use(s) of the in- § 170.30, he will publish a notice in the
gredient, and the level(s) of use). Any FEDERAL REGISTER listing the sub-
use of such an ingredient not in full stance as GRAS in part 182, part 184, or
compliance with each such established part 186 of this chapter, as appropriate.
limitation shall require a food additive (4) If, after evaluation of the com-
regulation. ments, the Commissioner concludes
(k) Pursuant to § 170.35, a food ingre- that there is a lack of convincing evi-
dient may be affirmed as GRAS in part dence that the substance is GRAS and
184 or § 186.1 of this chapter for a spe- that it should be considered a food ad-
cific use(s) without a general evalua- ditive subject to section 409 of the Act,
tion of use of the ingredient. In addi- he shall publish a notice thereof in the
tion to the use(s) specified in the regu- FEDERAL REGISTER in accordance with
lation, other uses of such an ingredient § 170.38.
may also be GRAS. Any affirmation of (c)(1) Persons seeking the affirmation
GRAS status for a specific use(s), with- of GRAS status of substances as pro-
out a general evaluation of use of the vided in § 170.30(e), except those subject
ingredient, is subject to reconsider- to the NAS/NRC GRAS list survey (36
ation upon such evaluation. FR 20546; October 23, 1971), shall submit
(l) New information may at any time a petition for GRAS affirmation pursu-
require reconsideration of the GRAS ant to part 10 of this chapter. Such pe-
status of a food ingredient. Any change tition shall contain information to es-
in part 182, part 184, or § 186.1 of this tablish that the GRAS criteria as set
chapter shall be accomplished pursuant forth in § 170.30 (b) or (c) have been met,
to § 170.38. in the following form:
[42 FR 14483, Mar. 15, 1977, as amended at 49 (i) Description of the substance, in-
FR 5610, Feb. 14, 1984; 53 FR 16546, May 10, cluding:
1988] (a) Common or usual name.
§ 170.35 Affirmation of generally recog- (b) Chemical name.
nized as safe (GRAS) status. (c) Chemical Abstract Service (CAS)
registry number.
(a) The Commissioner, either on his
initiative or on the petition of an in- (d) Empirical formula.
terested person, may affirm the GRAS (e) Structural formula.
status of substances that directly or (f) Specifications for food grade ma-
indirectly become components of food. terial, including arsenic and heavy
(b)(1) If the Commissioner proposes metals. (Recommendation for any
on his own initiative that a substance change in the Food Chemicals Codex
is entitled to affirmation as GRAS, he monograph should be included where
will place all of the data and informa- applicable.)
tion on which he relies on public file in (g) Quantitative compositions.
the office of the Division of Dockets (h) Manufacturing process (excluding
Management and will publish in the any trade secrets).
FEDERAL REGISTER a notice giving the (ii) Use of the substance, including:
name of the substance, its proposed (a) Date when use began.
15
§ 170.35 21 CFR Ch. I (4–1–12 Edition)
(b) Information and reports or other ing the name of the substance, its pro-
data on past uses in food. posed use, and any limitations pro-
(c) Foods in which used, and levels of posed for reasons other than safety. A
use in such foods, and for what pur- copy of the notice will be mailed to the
poses. petitioner at the time the original is
(iii) Methods for detecting the sub- sent to the FEDERAL REGISTER.
stance in food, including: (3)(i) If intended uses of the sub-
(a) References to qualitative and stance include uses in meat, meat food
quantitative methods for determining product, or poultry product subject to
the substance(s) in food, including the regulation by the U.S. Department of
type of analytical procedures used. Agriculture (USDA) under the Poultry
(b) Sensitivity and reproducibility of Products Inspection Act (PPIA) (21
such method(s). U.S.C. 451 et seq.) or Federal Meat In-
(iv) Information to establish the safe- spection Act (FMIA) (21 U.S.C. 601 et
ty and functionality of the substance seq.), FDA shall, upon filing of the peti-
in food. Published scientific literature, tion, forward a copy of the petition or
evidence that the substance is identical relevant portions thereof to the Food
to a GRAS counterpart of natural bio- Safety and Inspection Service, USDA,
logical origin, and other data may be for simultaneous review under the
submitted to support safety. Any ad- PPIA and FMIA.
verse information or consumer com- (ii) FDA will ask USDA to advise
plaints shall be included. Complete bib- whether the proposed meat and poultry
liographic references shall be provided uses comply with the FMIA and PPIA
where a copy of the article is not pro- or, if not, whether use of the substance
vided. would be permitted in products under
(v) A statement signed by the person USDA jurisdiction under specified con-
responsible for the petition that to the ditions or restrictions.
best of his knowledge it is a represent- (4) The notice of filing in the FED-
ative and balanced submission that in- ERAL REGISTER will allow a period of 60
cludes unfavorable information, as well days during which any interested per-
as favorable information, known to son may review the petition and/or file
him pertinent to the evaluation of the comments with the Division of Dockets
safety and functionality of the sub- Management. Copies of all comments
stance. received shall be made available for ex-
(vi) If nonclinical laboratory studies amination in the Division of Dockets
are involved, additional information Management’s office.
and data submitted in support of filed (5) The Commissioner will evaluate
petitions shall include, with respect to the petition and all available informa-
each nonclinical study, either a state- tion including all comments received.
ment that the study was conducted in If the petition and such information
compliance with the requirements set provide convincing evidence that the
forth in part 58 of this chapter, or, if substance is GRAS as described in
the study was not conducted in compli- § 170.30 he will publish an order in the
ance with such regulations, a brief FEDERAL REGISTER listing the sub-
statement of the reason for the non- stance as GRAS in part 182, part 184, or
compliance. part 186 of this chapter, as appropriate.
(vii) [Reserved] (6) If, after evaluation of the petition
(viii) A claim for categorical exclu- and all available information, the Com-
sion under § 25.30 or § 25.32 of this chap- missioner concludes that there is a
ter or an environmental assessment lack of convincing evidence that the
under § 25.40 of this chapter. substance is GRAS and that it should
(2) Within 30 days after the date of be considered a food additive subject to
filing the petition, the Commissioner section 409 of the Act, he shall publish
will place the petition on public file in a notice thereof in the FEDERAL REG-
the office of the Division of Dockets ISTER in accordance with § 170.38.
Management and will publish a notice (7) The notice of filing in the FED-
of filing in the FEDERAL REGISTER giv- ERAL REGISTER will request submission
ing the name of the petitioner and a of proof of any applicable prior sanc-
brief description of the petition includ- tion for use of the ingredient under
16
conditions different from those pro- (3) The Commissioner will evaluate
posed to be determined to be GRAS. all comments received. If he concludes
The failure of any person to come for- that there is a lack of convincing evi-
ward with proof of such an applicable dence that the substance is GRAS or is
prior sanction in response to the notice otherwise exempt from the definition
of filing will constitute a waiver of the of a food additive in section 201(s) of
right to assert or rely on such sanction the Act, he will publish a notice there-
at any later time. The notice of filing of in the FEDERAL REGISTER. If he con-
will also constitute a proposal to estab- cludes that there is convincing evi-
lish a regulation under part 181 of this dence that the substance is GRAS, he
chapter, incorporating the same provi- will publish an order in the FEDERAL
sions, in the event that such a regula- REGISTER listing the substance as
tion is determined to be appropriate as GRAS in part 182, part 184, or part 186
a result of submission of proof of such of this chapter, as appropriate.
an applicable prior sanction in re- (c) A FEDERAL REGISTER notice deter-
sponse to the notice of filing. mining that a substance is a food addi-
(Information collection requirements were tive shall provide for the use of the ad-
approved by the Office of Management and ditive in food or food contact surfaces
Budget under control number 0910–0132) as follows:
(1) It may promulgate a food additive
FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, regulation governing use of the addi-
1985; 53 FR 16547, May 10, 1988; 62 FR 40599, tive.
July 29, 1997; 65 FR 51762, Aug. 25, 2000] (2) It may promulgate an interim
food additive regulation governing use
§ 170.38 Determination of food addi- of the additive.
tive status. (3) It may require discontinuation of
(a) The Commissioner may, in ac- the use of the additive.
cordance with § 170.35(b)(4) or (c)(5), (4) It may adopt any combination of
publish a notice in the FEDERAL REG- the above three approaches for dif-
ISTER determining that a substance is ferent uses or levels of use of the addi-
not GRAS and is a food additive sub- tive.
ject to section 409 of the Act. (d) If the Commissioner of Food and
(b)(1) The Commissioner, on his own Drugs is aware of any prior sanction
initiative or on the petition of any infor use of the substance, he will con-
terested person, pursuant to part 10 of currently propose a separate regulation
this chapter, may issue a notice in the covering such use of the ingredient
FEDERAL REGISTER proposing to deter- under part 181 of this chapter. If the
mine that a substance is not GRAS and Commissioner is unaware of any such
is a food additive subject to section 409 applicable prior sanction, the proposed
of the Act. Any petition shall include regulation will so state and will re-
all relevant data and information of quire any person who intends to assert
the type described in § 171.130(b). The or rely on such sanction to submit
Commissioner will place all of the data proof of its existence. Any regulation
and information on which he relies on promulgated pursuant to this section
public file in the office of the Division constitutes a determination that ex-
of Dockets Management and will included uses would result in adultera-
clude in the FEDERAL REGISTER notice tion of the food in violation of section
the name of the substance, its known 402 of the Act, and the failure of any
uses, and a summary of the basis for person to come forward with proof of
the determination. such an applicable prior sanction in re-
(2) The FEDERAL REGISTER notice will sponse to the proposal will constitute a
allow a period of 60 days during which waiver of the right to assert or rely on
any interested person may review the such sanction at any later time. The
data and information and/or file com- notice will also constitute a proposal
ments with the Division of Dockets to establish a regulation under part 181
Management. Copies of all comments of this chapter, incorporating the same
shall be made available for examina- provisions, in the event that such a
tion in the Division of Dockets Man- regulation is determined to be appro-

agement’s office. priate as a result of submission of proof
17
§ 170.39 21 CFR Ch. I (4–1–12 Edition)
of such an applicable prior sanction in the Food and Drug Administration’s

response to the proposal. files or from other appropriate sources;
[42 FR 14488, Mar. 15, 1977, as amended at 42 (3) The substance has no technical ef-
FR 15673, Mar. 22, 1977; 54 FR 24896, June 12, fect in or on the food to which it mi-
1989] grates; and
(4) The substance use has no signifi-
§ 170.39 Threshold of regulation for cant adverse impact on the environ-
substances used in food-contact ar-
ticles. ment.
(b) Notwithstanding paragraph (a) of
(a) A substance used in a food-con- this section, the Food and Drug Admin-
tact article (e.g., food-packaging or
istration reserves the right to decline
food-processing equipment) that mi-
to grant an exemption in those cases in
grates, or that may be expected to mi-
which available information estab-
grate, into food will be exempted from
regulation as a food additive because it lishes that the proposed use may pose a
becomes a component of food at levels public health risk. The reasons for the
that are below the threshold of regula- agency’s decision to decline to grant an
tion if: exemption will be explained in the
(1) The substance has not been shown Food and Drug Administration’s re-
to be a carcinogen in humans or ani- sponse to the requestor.
mals, and there is no reason, based on (c) A request for the Food and Drug
the chemical structure of the sub- Administration to exempt a use of a
stance, to suspect that the substance is substance from regulation as a food ad-
a carcinogen. The substance must also ditive shall include three copies of the
not contain a carcinogenic impurity or, following information (If part of the
if it does, must not contain a carcino- submitted material is in a foreign lan-
genic impurity with a TD50 value based guage, it must be accompanied by an
on chronic feeding studies reported in English translation verified to be com-
the scientific literature or otherwise plete and accurate in accordance with
available to the Food and Drug Admin- § 10.20(c)(2) of this chapter):
istration of less than 6.25 milligrams (1) The chemical composition of the
per kilogram bodyweight per day (The substance for which the request is
TD50, for the purposes of this section, is made, including, whenever possible,
the feeding dose that causes cancer in the name of the chemical in accord-
50 percent of the test animals when ance with current Chemical Abstract
corrected for tumors found in control Service (CAS) nomenclature guidelines
animals. If more than one TD50 value and a CAS registry number, if avail-
has been reported in the scientific lit- able;
erature for a substance, the Food and (2) Detailed information on the con-
Drug Administration will use the low- ditions of use of the substance (e.g.,
est appropriate TD50 value in its re-
temperature, type of food with which
view.);
the substance will come into contact,
(2) The substance presents no other
the duration of the contact, and wheth-
health or safety concerns because:
er the food-contact article will be for
(i) The use in question has been
shown to result in or may be expected repeated or single use applications);
to result in dietary concentrations at (3) A clear statement as to whether
or below 0.5 parts per billion, cor- the request for exemption from regula-
responding to dietary exposure levels tion as a food additive is based on the
at or below 1.5 micrograms/person/day fact that the use of the substance in
(based on a diet of 1,500 grams of solid the food-contact article results in a di-
food and 1,500 grams of liquid food per etary concentration at or below 0.5
person per day); or parts per billion, or on the fact that it
(ii) The substance is currently regu- involves the use of a regulated direct
lated for direct addition into food, and food additive for which the dietary ex-
the dietary exposure to the substance posure is at or below 1 percent of the
resulting from the proposed use is at or acceptable dietary intake (ADI);
below 1 percent of the acceptable daily (4) Data that will enable the Food
intake as determined by safety data in and Drug Administration to estimate
18
the daily dietary concentration result- posed use of the substance. The request
ing from the proposed use of the sub- should contain either a claim for cat-
stance. These data should be in the egorical exclusion as specified in § 25.32
form of: of this chapter or an environmental as-
(i) Validated migration data obtained sessment as specified in § 25.40 of this
under worst-case (time/temperature) chapter.
intended use conditions utilizing ap- (d) Data to be reviewed under this
propriate food simulating solvents; section shall be submitted to the Food
(ii) Information on the amount of the and Drug Administration’s Office of
substance used in the manufacture of Premarket Approval (HFS–200), 5100
the food-contact article; or Paint Branch Pkwy., College Park, MD
(iii) Information on the residual level 20740.
of the substance in the food-contact ar- (e) The Food and Drug Administra-
ticle. For repeat-use articles, an esti- tion will inform the requestor by letter
mate of the amount of food that con- whether the specific food-contact ap-
tacts a specific unit of surface area
plication is exempt from regulation as
over the lifetime of the article should
a food additive or not. Although a sub-
also be provided. (In cases where data
stance that migrates to food at a level
are provided only in the form of manu-
that results in a dietary concentration
facturing use levels or residual levels
at or below the threshold of regulation
of the substance present in the food-
contact article, the Food and Drug Ad- will not be the subject of a regulation
ministration will calculate a worst- published in the FEDERAL REGISTER
case dietary concentration level as- and will not appear in the Code of Fed-
suming 100 percent migration.) A de- eral Regulations, the Food and Drug
tailed description of the analytical Administration will maintain a list of
method used to quantify the substance substances exempted from regulation
should also be submitted along with as food additives under this section on
data used to validate the detection display at the Division of Dockets
limit. Management. This list will include the
(iv) In cases where there is no detect- name of the company that made the re-
able migration into food or food quest, the chemical name of the sub-
simulants, or when no residual level of stance, the specific use for which it has
a substance is detected in the food-con- received an exemption from regulation
tact article by a suitable analytical as a food additive, and any appropriate
method, the Food and Drug Adminis- limitations on its use. The list will not
tration will, for the purposes of esti- include any trade names. This list will
mating the dietary concentration, con- enable interested persons to see the
sider the validated detection limit of types of uses of food-contact materials
the method used to analyze for the sub- being exempted under the regulation.
stance. Interested persons may also obtain a
(5) The results of an analysis of exist- copy of the list of exempted substances
ing toxicological information on the by contacting the Food and Drug Ad-
substance and its impurities. This in- ministration’s Office of Premarket Ap-
formation on the substance is needed proval (HFS–200), 5100 Paint Branch
to show whether an animal carcinogen Pkwy., College Park, MD 20740. For ac-
bioassay has been carried out, or tions requiring an environmental as-
whether there is some other basis for sessment, the agency’s finding of no
suspecting that the substance is a car- significant impact and the evidence
cinogen or potent toxin. This type of supporting that finding, contained in
information on the impurities is need- the petitioner’s environmental assess-
ed to show whether any of them are ment, also will be available for public
carcinogenic, and, if carcinogenic, inspection at the Division of Dockets
whether their TD50 values are greater Management in accordance with
than 6.25 milligrams per kilogram § 25.51(b)(2) of this chapter. Requests for
bodyweight per day in accordance with copies of releasable information con-
paragraph (a)(1) of this section. tained in submissions requesting ex-
(6) Information on the environmental emptions from the food additive regu-
impact that would result from the pro- lations will be handled in accordance
19
§ 170.45 21 CFR Ch. I (4–1–12 Edition)
with the Food and Drug Administra- and Drug Administration plans to no-
tion’s Freedom of Information Act pro- tify other manufacturers by means of a
cedures, as described in part 20 of this notice published in the FEDERAL REG-
chapter. In particular, data and infor- ISTER of its decision to revoke an ex-
mation that fall within the definitions emption issued for a specific use of a
of a trade secret or confidential com- substance in a food contact article.
mercial or financial information are (h) Guidance documents to assist re-
not available for public disclosure in questors in the preparation of submis-
accordance with § 20.61(c) of this chap- sions seeking exemptions from the food
ter. additive regulations are available from
(f) If the request for an exemption the Food and Drug Administration’s
from regulation as a food additive is Office of Premarket Approval (HFS–
not granted, the requestor may submit 200), 5100 Paint Branch Pkwy., College
a petition to the Food and Drug Ad- Park, MD 20740. Interested persons are
ministration for reconsideration of the encouraged to obtain specific guidance
decision in accordance with the provi- from the Food and Drug Administra-
sions of § 10.33 of this chapter. tion on the appropriate protocols to be
(g) If the Food and Drug Administra- used for obtaining migration data, on
tion receives significant new informa- the validation of the analytical meth-
tion that raises questions about the di- ods used to quantify migration levels,
etary concentration or the safety of a on the procedures used to relate migra-
substance that the agency has exempt- tion data to dietary exposures, and on
ed from regulation, the Food and Drug any other issue not specifically covered
Administration may reevaluate the in the Food and Drug Administration’s
substance. If the Food and Drug Ad- guidance documents.
ministration tentatively concludes
that the information that is available [60 FR 36595, July 17, 1995, as amended at 62
about the substance no longer supports FR 40599, July 29, 1997; 65 FR 56479, Sept. 19,
an exemption for the use of the food- 2000]
contact material from the food addi-
tive regulations, the agency will notify Subpart C—Specific Administra-
any persons that requested an exemp- tive Rulings and Decisions
tion for the substance of its tentative
decision. The requestors will be given § 170.45 Fluorine-containing com-
an opportunity to show why the use of pounds.
the substance should not be regulated The Commissioner of Food and Drugs
under the food additive provisions of has concluded that it is in the interest
the act. If the requestors fail to ade- of the public health to limit the addi-
quately respond to the new evidence, tion of fluorine compounds to foods (a)
the agency will notify them that fur- to that resulting from the fluoridation
ther use of the substance in question of public water supplies, (b) to that re-
for the particular use will require a sulting from the fluoridation of bottled
food additive regulation. This notifica- water within the limitation established
tion will be placed on public display at in § 165.110(d) of this chapter, and (c) to
the Division of Dockets Management that authorized by regulations (40 CFR
as part of the file of uses of substances part 180) under section 408 of the Act.
exempted from regulation as food addi-
tives. The Food and Drug Administra- [42 FR 14483, Mar. 15, 1977, as amended at 72
tion recognizes that manufacturers FR 10357 Mar. 8, 2007]
other than those that actually made a
request for exemption may also be § 170.50 Glycine (aminoacetic acid) in
using exempted substances in food-con- food for human consumption.
tact articles under conditions of use (a) Heretofore, the Food and Drug
(e.g., use levels, temperature, type of Administration has expressed the opin-
food contacted, etc.) that are similar to ion in trade correspondence that gly-
those for which the exemption was cine is generally recognized as safe for
issued. Because only requestors will be certain technical effects in human food
notified as part of the revocation proc- when used in accordance with good
ess described in this section, the Food manufacturing practice; however:
20
(1) Reports in scientific literature in- taining such food additives, is required
dicate that adverse effects were found to establish safety.
in cases where high levels of glycine (b) Nitrites and/or nitrates, when
were administered in diets of experi- packaged separately from flavoring
mental animals. and seasoning in curing premixes, may
(2) Current usage information indi- continue to be used under prior sanc-
cates that the daily dietary intake of tions in the commercial curing of meat
glycine by humans may be substan- and meat products and poultry prod-
tially increasing due to changing use ucts and in accordance with the provi-
patterns in food technology. sions of §§ 172.170 and 172.175 of this
Therefore, the Food and Drug Adminis- chapter that apply to meat curing
tration no longer regards glycine and preparations for the home curing of
its salts as generally recognized as safe meat and meat products, including
for use in human food and all out- poultry and wild game. To assure safe
standing letters expressing sanction for use of such ingredients the labeling of
such use are rescinded. the premixes shall bear instructions to
(b) The Commissioner of Food and the user that such separately packaged
Drugs concludes that by May 8, 1971, ingredients are not to be combined
manufacturers: until just prior to use. Encapsulating
(1) Shall reformulate food products or coating some or all of the ingredi-
for human use to eliminate added gly- ents does not constitute separate pack-
cine and its salts; or aging.
(2) Shall bring such products into
compliance with an authorizing food Subpart D—Premarket
additive regulation. A food additive pe- Notifications
tition supported by toxicity data is re-
quired to show that any proposed level SOURCE: 67 FR 35729, May 21, 2002, unless
of glycine or its salts added to foods for otherwise noted.
human consumption will be safe.
(c) The status of glycine as generally § 170.100 Submission of a premarket
recognized as safe for use in animal notification for a food contact sub-
feed, as prescribed in § 582.5049 of this stance (FCN) to the Food and Drug
chapter, remains unchanged because Administration (FDA).
the additive is considered an essential (a) An FCN is effective for the food
nutrient in certain animal feeds and is contact substance manufactured or
safe for such use under conditions of prepared by the manufacturer or sup-
good feeding practice. plier identified in the FCN submission.
If another manufacturer or supplier
§ 170.60 Nitrites and/or nitrates in cur- wishes to market the same food con-
ing premixes. tact substance for the same use, that
(a) Nitrites and/or nitrates are food manufacturer or supplier must also
additives when combined in curing pre- submit an FCN to FDA.
mixes with spices and/or other fla- (1) An FCN must contain all of the
voring or seasoning ingredients that information described in § 170.101.
contain or constitute a source of sec- (2) An FCN may incorporate by ref-
ondary or tertiary amines, including erence any information in FDA’s files
but not limited to essential oils, diso- provided that the manufacturer or sup-
dium inosinate, disodium guanylate, plier is authorized to reference the in-
hydrolysates of animal or plant origin formation. The FCN must include in-
(such as hydrolyzed vegetable protein), formation establishing that the manu-
oleoresins of spices, soy products, and facturer or supplier is authorized to
spice extractives. Such food additives reference information in FDA’s files.
may be used only after the establish- (3) Any material submitted in or ref-
ment of an authorizing food additive erenced by an FCN that is in a foreign
regulation. A food additive petition language must be accompanied by an
submitted pursuant to §§ 171.1 and English translation verified to be com-
171.100 of this chapter, supported by plete and accurate.
data demonstrating that nitrosamines (b) FDA may choose not to accept an
are not formed in curing premixes con- FCN for either of the following:
21
§ 170.101 21 CFR Ch. I (4–1–12 Edition)
(1) A use of a food contact substance (b) All data and other information
that is the subject of a regulation in that form the basis of the determina-
parts 173 through 189 of this chapter; or tion that the food contact substance is
(2) A use of a food contact substance safe under the intended conditions of
that is the subject of an exemption use. Data must include primary bio-
under the threshold of regulation proc- logical data and chemical data.
ess described in § 170.39. (c) A good laboratory practice state-
(c) A petition must be submitted ment for each nonclinical laboratory
under § 171.1 of this chapter to author- study, as defined under § 58.3(d) of this
ize the safe use of a food contact subchapter, that is submitted as part of
stance in either of the following cir- the FCN, in the form of either:
cumstances, unless FDA agrees to ac- (1) A signed statement that the study
cept an FCN for the proposed use. was conducted in compliance with the
(1) The use of the food contact sub- good laboratory practice regulations
stance increases the cumulative die- under part 58 of this chapter; or
tary concentration to a certain level. (2) A brief signed statement listing
For a substance that is a biocide (e.g., the reason(s) that the study was not
it is intended to exert microbial tox- conducted in compliance with part 58
icity), this level is equal to or greater of this chapter.
than 200 parts per billion in the daily (3) Data from any study conducted
diet (0.6 milligram (mg)/person/day). after 1978 but not conducted in compli-
For a substance that is not a biocide, ance with part 58 of this chapter must
this level is equal to or greater than 1 be validated by an independent third
part per million in the daily diet (3 mg/ party prior to submission to the Food
person/day); or and Drug Administration (FDA), and
(2) There exists a bioassay on the the report and signed certification of
food contact substance, FDA has not the validating party must be submitted
reviewed the bioassay, and the bio- as part of the notification.
assay is not clearly negative for car- (d) Information to address FDA’s re-
cinogenic effects. sponsibility under the National Envi-
(d) A manufacturer or supplier for ronmental Policy Act, in the form of
which a notification is effective must either:
keep a current address on file with (1) A claim of categorical exclusion
FDA. under § 25.30 or § 25.32 of this chapter; or
(1) The current address may be either (2) An environmental assessment
the manufacturer’s (or supplier’s) ad- complying with § 25.40 of this chapter.
dress or the address of the manufactur- (e) A completed and signed FDA
er’s (or supplier’s) agent. Form No. 3480.
(2) FDA will deliver correspondence
to the manufacturer’s or supplier’s cur- § 170.102 Confidentiality of informa-
rent address. tion in a premarket notification for
a food contact substance (FCN).
§ 170.101 Information in a premarket (a) During the 120-day period of the
notification for a food contact sub- Food and Drug Administration (FDA)
stance (FCN).
review of an FCN, FDA will not dis-
An FCN must contain the following: close publicly any information in that
(a) A comprehensive discussion of the FCN.
basis for the manufacturer’s or sup- (b) FDA will not disclose publicly the
plier’s determination that the use of information in an FCN that is with-
the food contact substance is safe. This drawn prior to the completion of FDA’s
discussion must: review.
(1) Discuss all information and data (c) Once FDA completes its review of
submitted in the notification; and an FCN, the agency will make its con-
(2) Address any information and data clusion about the FCN publicly avail-
that may appear to be inconsistent able. For example, if FDA objects to a
with the determination that the pro- notification 90 days after the date of
posed use of the food contact substance receipt, the agency would make avail-
is safe. able its objection at that time.
22
(d) By submitting an FCN to FDA, ing to the FCN or FDA has issued an
the manufacturer or supplier waives objection letter.
any claim to confidentiality of the in-
formation required to adequately de- § 170.104 Action on a premarket notifi-
scribe the food contact substance and cation for a food contact substance
(FCN).
the intended conditions of use that are
the subject of that FCN. (a) If the Food and Drug Administra-
(e) The following data and information (FDA) does not object to an FCN
tion in an FCN are available for public within the 120-day period for FDA re-
disclosure, unless extraordinary cir- view, the FCN becomes effective.
cumstances are shown, on the 121st day (b) If an FCN is complete when re-
after receipt of the notification by ceived, the 120-day review period begins
FDA, except that no data or informa- on the date FDA receives the FCN.
tion are available for public disclosure (1) If any element required under
if the FCN is withdrawn under § 170.103. § 170.101 is missing from an FCN, then
(1) All safety and functionality data FDA will not accept that FCN and FDA
and information submitted with or in- will send an FCN nonacceptance letter
corporated by reference into the notifi- to the manufacturer or supplier. If the
cation. Safety and functionality data manufacturer or supplier submits the
include all studies and tests of a food missing information before FDA sends
contact substance on animals and hu- an FCN nonacceptance letter, the 120-
mans and all studies and tests on a day review period begins on the date of
food contact substance for establishing receipt of the missing information.
identity, stability, purity, potency, (2) If FDA accepts an FCN, then FDA
will acknowledge in writing its receipt
performance, and usefulness.
of that FCN.
(2) A protocol for a test or study, un-
(c) Objection to an FCN:
less it is exempt from disclosure under
(1) If FDA objects to an FCN, then
§ 20.61 of this chapter.
FDA will send an FCN objection letter.
(3) A list of all ingredients contained
The date of the letter will be the date
in a food contact substance, excluding of FDA’s objection for purposes of sec-
information that is exempt from dis- tion 409(h)(2)(A) of the act.
closure under § 20.61 of this chapter. (2) If FDA objects to an FCN within
Where applicable, an ingredient list the 120-day period for FDA review, the
will be identified as incomplete. FCN will not become effective.
(4) An assay method or other analyt- (3) FDA may object to an FCN if any
ical method, unless it serves no regu- part of FDA’s 120-day review occurs
latory or compliance purpose and is ex- during a period when this program is
empt from disclosure under § 20.61 of not funded as required in section
this chapter. 409(h)(5) of the act.
(5) All correspondence and written (d) If FDA and a manufacturer or
summaries of oral discussions relating supplier agree that the notifier may
to the notification, except information submit a food additive petition pro-
that is exempt for disclosure under posing the approval of the food contact
§ 20.61 of this chapter. substance for the use in the manufac-
(6) All other information not subject turer’s or supplier’s FCN, FDA will
to an exemption from disclosure under consider that FCN to be withdrawn by
subpart D of part 20 of this chapter. the manufacturer or supplier on the
date the petition is received by FDA.
§ 170.103 Withdrawal without preju-
dice of a premarket notification for § 170.105 The Food and Drug Adminis-
a food contact substance (FCN). tration’s (FDA’s) determination that
A manufacturer or supplier may a premarket notification for a food
withdraw an FCN without prejudice to contact substance (FCN) is no
a future submission to the Food and longer effective.
Drug Administration (FDA) if FDA has (a) If data or other information avail-
not completed review of the FCN. For able to FDA, including data not sub-
the purpose of this section, FDA’s re- mitted by the manufacturer or sup-
view is completed when FDA has al- plier, demonstrate that the intended
lowed 120 days to pass without object- use of the food contact substance is no
23
§ 170.106 21 CFR Ch. I (4–1–12 Edition)
longer safe, FDA may determine that PART 171—FOOD ADDITIVE

the authorizing FCN is no longer effec- PETITIONS
tive.
(b) If FDA determines that an FCN is Subpart A—General Provisions
no longer effective, FDA will inform
the manufacturer or supplier in writing Sec.
171.1 Petitions.
of the basis for that determination. 171.6 Amendment of petition.
FDA will give the manufacturer or sup- 171.7 Withdrawal of petition without preju-
plier an opportunity to show why the dice.
FCN should continue to be effective 171.8 Threshold of regulation for substances
and will specify the time that the man- used in food-contact articles.
ufacturer or supplier will have to re-
Subpart B—Administrative Actions on
spond.
Applications
(c) If the manufacturer or supplier
fails to respond adequately to the safe- 171.100 Regulation based on petition.
ty concerns regarding the notified use, 171.102 Effective date of regulation.
FDA will publish a notice of its deter- 171.110 Procedure for objections and hear-
ings.
mination that the FCN is no longer ef- 171.130 Procedure for amending and repeal-
fective. FDA will publish this notice in ing tolerances or exemptions from toler-
the FEDERAL REGISTER, stating that a ances.
detailed summary of the basis for AUTHORITY: 21 U.S.C. 321, 342, 348, 371.
FDA’s determination that the FCN is
no longer effective has been placed on SOURCE: 42 FR 14489, Mar. 15, 1977, unless
otherwise noted.
public display and that copies are
available upon request. The date that
the notice publishes in the FEDERAL Subpart A—General Provisions
REGISTER is the date on which the noti- § 171.1 Petitions.
fication is no longer effective.
(d) FDA’s determination that an FCN (a) Petitions to be filed with the
is no longer effective is final agency Commissioner under the provisions of
section 409(b) of the Federal Food,
action subject to judicial review.
Drug, and Cosmetic Act (the act) shall
§ 170.106 Notification for a food con- be submitted in triplicate (quadru-
tact substance formulation plicate, if intended uses include use in
(NFCSF). meat, meat food product, or poultry
product). If any part of the material
(a) In order for the Food and Drug submitted is in a foreign language, it
Administration (FDA) to accept an shall be accompanied by an accurate
NFCSF, any food additive that is a and complete English translation. The
component of the formulation must be petition shall state petitioner’s post of-
authorized for its intended use in that fice address to which published notices
NFCSF. or orders issued or objections filed pur-
(b) FDA may publish a notice in the suant to section 409 of the Act may be
FEDERAL REGISTER stating that the sent.
agency has insufficient resources to re- (b) Pertinent information may be in-
view NFCSFs. From the date that this corporated in, and will be considered as
notice publishes in the FEDERAL REG- part of, a petition on the basis of spe-
ISTER, FDA will no longer accept cific reference to such information sub-
NFCSFs. mitted to and retained in the files of
(c) An NFCSF must contain the fol- the Food and Drug Administration.
lowing: However, any reference to unpublished
(1) A completed and signed FDA information furnished by a person
other than the applicant will not be
Form No. 3479; and
considered unless use of such informa-
(2) Any additional documentation re-
tion is authorized in a written state-
quired to establish that each compo- ment signed by the person who sub-
nent of the formulation already may be mitted it. Any reference to published
marketed legally for its intended use. information offered in support of a food
24
additive petition should be accom- be followed by a complete quantitative

panied by reprints or photostatic cop- statement of composition. Reasonable alter-
ies of such references. natives for any listed substance may be spec-
ified.
(c) Petitions shall include the fol- If the petitioner does not himself perform
lowing data and be submitted in the all the manufacturing, processing, and pack-
following form: ing operations for a food additive, the peti-
tion shall identify each person who will per-
(Date)
form a part of such operations and designate
Name of petitioner lllllllllllll
the part.
Post-office address lllllllllllll
The petition shall include stability data,
Date lllllllllllllllllllll
and, if the data indicate that it is needed to
Name of food additive and proposed use ll
insure the identity, strength, quality, or pu-
llllllllllllllllllllllll
rity of the additive, the expiration date that
Office of Food Additive Safety (HFS–200), will be employed.
Center for Food Safety and Applied Nutri- B. The amount of the food additive pro-
tion, Food and Drug Administration, 5100 posed for use and the purposes for which it is
Paint Branch Pkwy., College Park, MD 20740. proposed, together with all directions, rec-
ommendations, and suggestions regarding
DEAR SIRS: the proposed use, as well as specimens of the
The undersigned, lllll submits this labeling proposed for the food additive and
petition pursuant to section 409(b)(1) of the any labeling that will be required by applica-
Federal Food, Drug, and Cosmetic Act with ble provisions of the Federal Food, Drug, and
respect to lllll Cosmetic Act on the finished food by reason
(Name of the food additive and proposed use) of the use of the food additive. If the additive
results or may reasonably be expected to re-
Attached hereto, in triplicate (quadru- sult from the use of packaging material, the
plicate, if intended uses include use in meat, petitioner shall show how this may occur
meat food product, or poultry product), and and what residues may reasonably be antici-
constituting a part of this petition are the pated.
following: (Typewritten or other draft-labeling copy
A. The name and all pertinent information will be accepted for consideration of the pe-
concerning the food additive, including tition, provided a statement is made that
chemical identity and composition of the final printed labeling identical in content to
food additive, its physical, chemical, and bi- the draft copy will be submitted as soon as
ological properties, and specifications pre- available and prior to the marketing of the
scribing the minimum content of the desired food additive.)
component(s) and identifying and limiting (If the food additive is one for which a tol-
the reaction byproducts and other impuri- erance limitation is required to assure its
ties. Where such information is not avail- safety, the level of use proposed should be no
able, a statement as to the reasons why it is higher than the amount reasonably required
not should be submitted. to accomplish the intended physical or other
When the chemical identity and composi- technical effect, even though the safety data
tion of the food additive is not known, the may support a higher tolerance.)
petition shall contain information in suffi- C. Data establishing that the food additive
cient detail to permit evaluation regarding will have the intended physical or other
the method of manufacture and the analyt- technical effect or that it may reasonably be
ical controls used during the various stages expected to become a component, or to affect
of manufacturing, processing, or packing of the characteristics, directly or indirectly, of
the food additive which are relied upon to es- food and the amount necessary to accom-
tablish that it is a substance of reproducible plish this. These data should include infor-
composition. Alternative methods and con- mation in sufficient detail to permit evalua-
trols and variations in methods and controls tion with control data.
within reasonable limits that do not affect D. A description of practicable methods to
the characteristics of the substance or the determine the amount of the food additive in
reliability of the controls may be specified. the raw, processed, and/or finished food and
If the food additive is a mixture of chemi- of any substance formed in or on such food
cals, the petition shall supply a list of all because of its use. The test proposed shall be
substances used in the synthesis, extraction, one that can be used for food-control pur-
or other method of preparation, regardless of poses and that can be applied with consistent
whether they undergo chemical change in results by any properly equipped and trained
the process. Each substance should be identi- laboratory personnel.
fied by its common English name and com- E. Full reports of investigations made with
plete chemical name, using structural for- respect to the safety of the food additive.
mulas when necessary for specific identifica- (A petition may be regarded as incomplete
tion. If any proprietary preparation is used unless it includes full reports of adequate
as a component, the proprietary name should tests reasonably applicable to show whether
25
§ 171.1 21 CFR Ch. I (4–1–12 Edition)
or not the food additive will be safe for its tioner. Nothing herein shall prevent
intended use. The reports ordinarily should reference to published data.
include detailed data derived from appro- (g) A petition shall be retained but
priate animal and other biological experi-
shall not be filed if any of the data pre-
ments in which the methods used and the re-
sults obtained are clearly set forth. The peti- scribed by section 409(b) of the Act are
tion shall not omit without explanation any lacking or are not set forth so as to be
reports of investigations that would bias an readily understood.
evaluation of the safety of the food additive.) (h)(1) The following data and infor-
F. Proposed tolerances for the food addi- mation in a food additive petition are
tive, if tolerances are required in order to in- available for public disclosure, unless
sure its safety. A petitioner may include a extraordinary circumstances are
proposed regulation.
G. If submitting petition to modify an ex-
shown, after the notice of filing of the
isting regulation issued pursuant to section petition is published in the FEDERAL
409(c)(1)(A) of the Act, full information on REGISTER or, if the petition is not
each proposed change that is to be made in promptly filed because of deficiencies
the original regulation must be submitted. in it, after the petitioner is informed
The petition may omit statements made in that it will not be filed because of the
the original petition concerning which no deficiencies involved:
change is proposed. A supplemental petition (i) All safety and functionality data
must be submitted for any change beyond
the variations provided for in the original
and information submitted with or in-
petition and the regulation issued on the corporated by reference in the petition.
basis of the original petition. (ii) A protocol for a test or study, un-
H. The petitioner is required to submit ei- less it is shown to fall within the ex-
ther a claim for categorical exclusion under emption established for trade secrets
§ 25.30 or 25.32 of this chapter or an environ- and confidential commercial informa-
mental assessment under § 25.40 of this chap- tion in § 20.61 of this chapter.
ter. (iii) Adverse reaction reports, prod-
Yours very truly, uct experience reports, consumer com-
Petitioner llllllllllllllllll plaints, and other similar data and in-
By llllllllllllllllllllll formation, after deletion of:
(Indicate authority)
(a) Names and any information that
(d) The petitioner will be notified of would identify the person using the
the date on which his petition is filed; product.
and an incomplete petition, or one that (b) Names and any information that
has not been submitted in triplicate, would identify any third party involved
will usually be retained but not filed as with the report, such as a physician or
a petition under section 409 of the Act. hospital or other institution.
The petitioner will be notified in what (iv) A list of all ingredients contained
respects his petition is incomplete. in a food additive, whether or not it is
(e) The petition must be signed by in descending order of predominance. A
the petitioner or by his attorney or particular ingredient or group of ingre-
agent, or (if a corporation) by an au- dients shall be deleted from any such
thorized official. list prior to public disclosure if it is
(f) The data specified under the sev- shown to fall within the exemption es-
eral lettered headings should be sub- tablished in § 20.61 of this chapter, and
mitted on separate sheets or sets of a notation shall be made that any such
sheets, suitably identified. If such data ingredient list is incomplete.
have already been submitted with an (v) An assay method or other analyt-
earlier application, the present peti- ical method, unless it serves no regu-
tion may incorporate it by specific ref- latory or compliance purpose and is
erence to the earlier. If part of the data shown to fall within the exemption es-
have been submitted by the manufac- tablished in § 20.61 of this chapter.
turer of the food additive as a master (2) The following data and informa-
file, the petitioner may refer to the tion in a food additive petition are not
master file if and to the extent he ob- available for public disclosure unless
tains the manufacturer’s written per- they have been previously disclosed to
mission to do so. The manufacturer the public as defined in § 20.81 of this
may authorize specific reference to the chapter or they relate to a product or

data without disclosure to the peti- ingredient that has been abandoned
26
and they no longer represent a trade tioner does not wish to supplement or
secret or confidential commercial or fi- explain the petition and requests in
nancial information as defined in § 20.61 writing that it be filed as submitted,
of this chapter: the petition shall be filed and the peti-
(i) Manufacturing methods or proc- tioner so notified.
esses, including quality control proce- (iii) Notwithstanding paragraph
dures. (i)(1)(ii) of this section, the petition
(ii) Production, sales, distribution, shall not be filed if the Food and Drug
and similar data and information, ex- Administration determines that the
cept that any compilation of such data use identified in the petition should be
and information aggregated and pre- the subject of an FCN under section
pared in a way that does not reveal 409(h) of the act rather than a petition.
data or information which is not avail- (2) The Commissioner will publish in
able for public disclosure under this the FEDERAL REGISTER within 30 days
provision is available for public disclo- from the date of filing of such petition,
sure. a notice of the filing, the name of the
(iii) Quantitative or semiquantita- petitioner, and a brief description of
tive formulas. the proposal in general terms. In the
(3) All correspondence and written case of a food additive which becomes a
summaries of oral discussions relating component of food by migration from
to a food additive petition are avail- packaging material, the notice shall
able for public disclosure in accordance include the name of the migratory sub-
with the provisions of part 20 of this stance, and where it is different from
chapter when the food additive regula- that of one of the original components,
tion is published in the FEDERAL REG- the name of the parent component, the
ISTER. maximum quantity of the migratory
(4) For purposes of this regulation, substance that is proposed for use in
safety and functionality data include food, and the physical or other tech-
all studies and tests of a food additive nical effect which the migratory sub-
on animals and humans and all studies stance or its parent component is in-
and tests on a food additive for iden- tended to have in the packaging mate-
tity, stability, purity, potency, per- rial. A copy of the notice will be
formance, and usefulness. mailed to the petitioner when the
(i)(1)(i) Within 15 days after receipt, original is forwarded to the FEDERAL
the Food and Drug Administration will REGISTER for publication.
notify the petitioner of the acceptance (j) The Commissioner may request a
or nonacceptance of a petition, and if full description of the methods used in,
not accepted, the reasons therefor. If and the facilities and controls used for,
accepted, the petitioner will be sent a the production of the food additive, or
letter stating this and the date of the a sample of the food additive, articles
letter shall become the date of filing used as components thereof, or of the
for the purposes of section 409(b)(5) of food in which the additive is proposed
the act. In cases in which the Food and to be used, at any time while a petition
Drug Administration agrees that a pre- is under consideration. The Commis-
market notification for a food contact sioner shall specify in the request for a
substance (Food Contact Notification sample of the food additive, or articles
(FCN)) submitted under section 409(h) used as components thereof, or of the
of the act may be converted to a peti- food in or on which the additive is pro-
tion, the withdrawal date for the FCN posed to be used, a quantity deemed
will be deemed the date of receipt for adequate to permit tests of analytical
the petition. methods to determine quantities of the
(ii) If the petitioner desires, he may food additive present in foods for which
supplement a deficient petition after it is intended to be used or adequate
being notified regarding deficiencies. If for any study or investigation reason-
the supplementary material or expla- ably required with respect to the safety
nation of the petition is deemed ac- of the food additive or the physical or
ceptable, the petitioner shall be noti- technical effect it produces. The date
fied. The date of such notification be- used for computing the 90-day limit for
comes the date of filing. If the peti- the purposes of section 409(c)(2) of the
27
§ 171.6 21 CFR Ch. I (4–1–12 Edition)
Act shall be moved forward 1 day for USDA jurisdiction under specified con-
each day after the mailing date of the ditions or restrictions.
request taken by the petitioner to sub-
mit the sample. If the information or FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27,
sample is requested a reasonable time 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26,
in advance of the 180 days, but is not 1985; 62 FR 40599, July 29, 1997; 65 FR 51763,
submitted within such 180 days after Aug. 25, 2000; 67 FR 35731, May 21, 2002; 72 FR
filing of the petition, the petition will 10357, Mar. 8, 2007]
be considered withdrawn without prej-
udice. § 171.6 Amendment of petition.
(k) If nonclinical laboratory studies After a petition has been filed, the
are involved, petitions filed with the petitioner may submit additional in-
Commissioner under section 409(b) of formation or data in support thereof.
the act shall include, with respect to In such cases, if the Commissioner de-
each nonclinical study contained in the termines that the additional informa-
petition, either a statement that the tion or data amount to a substantive
study has been, or will be, conducted in amendment, the petition as amended
compliance with the good laboratory will be given a new filing date, and the
practice regulations as set forth in part time limitation will begin to run anew.
58 of this chapter, or, if any such study If nonclinical laboratory studies are in-
was not conducted in compliance with volved, additional information and
such regulations, a brief statement of data submitted in support of filed peti-
the reason for the noncompliance. tions shall include, with respect to
(l) [Reserved] each nonclinical study, either a state-
(m) If clinical investigations involv- ment that the study was conducted in
ing human subjects are involved, peti- compliance with the requirements set
tions filed with the Commissioner forth in part 58 of this chapter, or, if
under section 409(b) of the Act shall in- the study was not conducted in compli-
clude statements regarding each such ance with such regulations, a brief
clinical investigation relied upon in statement of the reason for the non-
the petition that it either was con- compliance.
ducted in compliance with the require- [50 FR 7492, Feb. 22, 1985, as amended at 50
ments for institutional review set forth 16668, Apr. 26, 1985]
in part 56 of this chapter, or was not
subject to such requirements in accord- § 171.7 Withdrawal of petition without
ance with § 56.104 or § 56.105, and that it prejudice.
was conducted in compliance with the (a) In some cases the Commissioner
requirements for informed consent set will notify the petitioner that the peti-
forth in part 50 of this chapter. tion, while technically complete, is in-
(n)(1) If intended uses of the food ad- adequate to justify the establishment
ditive include uses in meat, meat food of a regulation or the regulation re-
product, or poultry product subject to quested by petitioner. This may be due
regulation by the U.S. Department of to the fact that the data are not suffi-
Agriculture (USDA) under the Poultry ciently clear or complete. In such
Products Inspection Act (PPIA) (21 cases, the petitioner may withdraw the
U.S.C. 451 et seq.) or the Federal Meat petition pending its clarification or the
Inspection Act (FMIA) (21 U.S.C. 601 et obtaining of additional data. This with-
seq.), FDA shall, upon filing of the peti- drawal will be without prejudice to a
tion, forward a copy of the petition or future filing. Upon refiling, the time
relevant portions thereof to the Food limitation will begin to run anew from
Safety and Inspection Service, USDA, the date of refiling.
for simultaneous review under the (b) At any time before the order pro-
PPIA and FMIA. vided for in § 171.100(a) has been for-
(2) FDA will ask USDA to advise warded to the FEDERAL REGISTER for
whether the proposed meat and poultry publication, the petitioner may with-
uses comply with the FMIA and PPIA, draw the petition without prejudice to
or if not, whether use of the substance a future filing. Upon refiling the time
would be permitted in products under limitation will begin to run anew.
28
(c) Any petitioner who has a food ad- the petitioner of such order and the
ditive petition pending before the agen- reasons for such action; or by order
cy and who subsequently submits a deny the petition, and shall notify the
premarket notification for a food con- petitioner of such order and of the rea-
tact substance (FCN) for a use or uses sons for such action.
described in such petition shall be (b) The regulation shall describe the
deemed to have withdrawn the petition conditions under which the substance
for such use or uses without prejudice may be safely used in any meat prod-
to a future filing on the date the FCN uct, meat food product, or poultry
is received by the Food and Drug Ad- product subject to the Federal Meat In-
ministration. spection Act (FMIA) (21 U.S.C. 601 et
seq.) or the Poultry Products Inspec-
tion Act (PPIA) (21 U.S.C. 451 et seq.).
FR 35731, May 21, 2002]
(c) If the Commissioner determines
§ 171.8 Threshold of regulation for that additional time is needed to study
substances used in food-contact ar- and investigate the petition, he shall
ticles. by written notice to the petitioner ex-
Substances used in food-contact arti- tend the 90-day period for not more
cles (e.g., food-packaging or food-proc- than 180 days after the filing of the pe-
essing equipment) that migrate or that tition.
may be expected to migrate into food [42 FR 14489, Mar. 15, 1977, as amended at 65
at negligible levels may be reviewed FR 51763, Aug. 25, 2000]
under § 170.39 of this chapter. The Food
and Drug Administration will exempt § 171.102 Effective date of regulation.
substances whose uses it determines A regulation published in accordance
meet the criteria in § 170.39 of this with § 171.100(a) shall become effective
chapter from regulation as food addi- upon publication in the FEDERAL REG-
tives and, therefore, a food additive pe- ISTER.
tition will not be required for the ex-
empted use. § 171.110 Procedure for objections and
hearings.
[60 FR 36596, July 17, 1995]
Objections and hearings relating to
food additive regulations under section
Subpart B—Administrative Actions 409 (c), (d), or (h) of the Act shall be
on Applications governed by part 12 of this chapter.
§ 171.100 Regulation based on petition. [42 FR 14491, Mar. 15, 1977, as amended at 42
FR 15674, Mar. 22, 1977]
(a) The Commissioner will forward
for publication in the FEDERAL REG- § 171.130 Procedure for amending and
ISTER, within 90 days after filing of the repealing tolerances or exemptions
petition (or within 180 days if the time from tolerances.
is extended as provided for in section (a) The Commissioner, on his own
409(c)(2) of the Act), a regulation pre- initiative or on the petition of any in-
scribing the conditions under which terested person, pursuant to part 10 of
the food additive may be safely used this chapter, may propose the issuance
(including, but not limited to, speci- of a regulation amending or repealing a
fications as to the particular food or regulation pertaining to a food additive
classes of food in or on which such ad- or granting or repealing an exception
ditive may be used, the maximum for such additive.
quantity that may be used or per- (b) Any such petition shall include an
mitted to remain in or on such food, assertion of facts, supported by data,
the manner in which such additive may showing that new information exists
be added to or used in or on such food, with respect to the food additive or
and any directions or other labeling or that new uses have been developed or
packaging requirements for such addi- old uses abandoned, that new data are
tive deemed necessary by him to assure available as to toxicity of the chem-
the safety of such use), and prior to the ical, or that experience with the exist-
forwarding of the order to the FEDERAL ing regulation or exemption may jus-
REGISTER for publication shall notify tify its amendment or repeal. New data
29
Pt. 172 21 CFR Ch. I (4–1–12 Edition)
shall be furnished in the form specified Subpart D—Special Dietary and Nutritional
in §§ 171.1 and 171.100 for submitting pe- Additives
titions.
172.310 Aluminum nicotinate.
[42 FR 14491, Mar. 15, 1977, as amended at 42 172.315 Nicotinamide-ascorbic acid complex.
FR 15674, Mar. 22, 1977] 172.320 Amino acids.
172.325 Bakers yeast protein.
172.330 Calcium pantothenate, calcium chlo-
PART 172—FOOD ADDITIVES PER- ride double salt.
MITTED FOR DIRECT ADDITION TO 172.335 D-Pantothenamide.
FOOD FOR HUMAN CONSUMP- 172.340 Fish protein isolate.
172.345 Folic acid (folacin).
TION 172.350 Fumaric acid and salts of fumaric
acid.
Subpart A—General Provisions 172.365 Kelp.
172.370 Iron-choline citrate complex.
Sec. 172.372 N-Acetyl-L-methionine.
172.5 General provisions for direct food ad- 172.375 Potassium iodide.
ditives. 172.379 Vitamin D2.
172.380 Vitamin D3.
Subpart B—Food Preservatives 172.385 Whole fish protein concentrate.
172.395 Xylitol.
172.105 Anoxomer. 172.399 Zinc methionine sulfate.
172.110 BHA.
172.115 BHT. Subpart E—Anticaking Agents
172.120 Calcium disodium EDTA. 172.410 Calcium silicate.
172.130 Dehydroacetic acid. 172.430 Iron ammonium citrate.
172.133 Dimethyl dicarbonate. 172.480 Silicon dioxide.
172.135 Disodium EDTA. 172.490 Yellow prussiate of soda.
172.140 Ethoxyquin.
172.145 Heptylparaben. Subpart F—Flavoring Agents and Related
172.150 4-Hydroxymethyl-2,6-di-tert-butyl- Substances
phenol.
172.510 Natural flavoring substances and
172.155 Natamycin (pimaricin). natural substances used in conjunction
172.160 Potassium nitrate. with flavors.
172.165 Quaternary ammonium chloride 172.515 Synthetic flavoring substances and
combination. adjuvants.
172.167 Silver nitrate and hydrogen peroxide 172.520 Cocoa with dioctyl sodium sulfo-
solution. succinate for manufacturing.
172.170 Sodium nitrate. 172.530 Disodium guanylate.
172.175 Sodium nitrite. 172.535 Disodium inosinate.
172.177 Sodium nitrite used in processing 172.540 DL-Alanine.
smoked chub. 172.560 Modified hop extract.
172.180 Stannous chloride. 172.575 Quinine.
172.185 TBHQ. 172.580 Safrole-free extract of sassafras.
172.585 Sugar beet extract flavor base.
172.190 THBP.
172.590 Yeast-malt sprout extract.
Subpart C—Coatings, Films and Related Subpart G—Gums, Chewing Gum Bases
Substances and Related Substances
172.210 Coatings on fresh citrus fruit. 172.610 Arabinogalactan.
172.215 Coumarone-indene resin. 172.615 Chewing gum base.
172.225 Methyl and ethyl esters of fatty 172.620 Carrageenan.
acids produced from edible fats and oils. 172.623 Carrageenan with polysorbate 80.
172.230 Microcapsules for flavoring sub- 172.626 Salts of carrageenan.
stances. 172.655 Furcelleran.
172.235 Morpholine. 172.660 Salts of furcelleran.
172.250 Petroleum naphtha. 172.665 Gellan gum.
172.255 Polyacrylamide. 172.695 Xanthan gum.
172.260 Oxidized polyethylene.
Subpart H—Other Specific Usage Additives
172.270 Sulfated butyl oleate.
172.275 Synthetic paraffin and succinic de- 172.710 Adjuvants for pesticide use dilu-
rivatives. tions.
172.280 Terpene resin. 172.712 1,3–Butylene glycol.
30
172.715 Calcium lignosulfonate. 172.863 Salts of fatty acids.
172.720 Calcium lactobionate. 172.864 Synthetic fatty alcohols.
172.723 Epoxidized soybean oil. 172.866 Synthetic glycerin produced by the
172.725 Gibberellic acid and its potassium hydrogenolysis of carbohydrates.
salt. 172.867 Olestra.
172.730 Potassium bromate. 172.868 Ethyl cellulose.
172.735 Glycerol ester of rosin. 172.869 Sucrose oligoesters.
172.736 Glycerides and polyglycides of hy- 172.870 Hydroxypropyl cellulose.
drogenated vegetable oils. 172.872 Methyl ethyl cellulose.
172.755 Stearyl monoglyceridyl citrate. 172.874 Hydroxypropyl methylcellulose.
172.765 Succistearin (stearoyl propylene gly- 172.876 Castor oil.
col hydrogen succinate). 172.878 White mineral oil.
172.770 Ethylene oxide polymer. 172.880 Petrolatum.
172.775 Methacrylic acid-divinylbenzene co-
172.882 Synthetic isoparaffinic petroleum
polymer.
hydrocarbons.
172.780 Acacia (gum arabic).
172.884 Odorless light petroleum hydro-
172.785 Listeria-specific bacteriophage prepa-
carbons.
ration.
172.886 Petroleum wax.
Subpart I—Multipurpose Additives 172.888 Synthetic petroleum wax.
172.890 Rice bran wax.
172.800 Acesulfame potassium. 172.892 Food starch-modified.
172.802 Acetone peroxides. 172.894 Modified cottonseed products in-
172.804 Aspartame. tended for human consumption.
172.806 Azodicarbonamide. 172.896 Dried yeasts.
172.808 Copolymer condensates of ethylene 172.898 Bakers yeast glycan.
oxide and propylene oxide.
AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371,
172.809 Curdlan.
172.810 Dioctyl sodium sulfosuccinate. 379e.
172.811 Glyceryl tristearate. SOURCE: 42 FR 14491, Mar. 15, 1977, unless
172.812 Glycine. otherwise noted.
172.814 Hydroxylated lecithin.
172.816 Methyl glucoside-coconut oil ester. EDITORIAL NOTE: Nomenclature changes to
172.818 Oxystearin. part 172 appear at 61 FR 14482, Apr. 2, 1996, 66
172.820 Polyethylene gylcol (mean molec- FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27,
ular weight 200–9,500). 2001, 68 FR 15355, Mar. 31, 2003, 70 FR 40880,
172.822 Sodium lauryl sulfate. July 15, 2005, 70 FR 67651, Nov. 8, 2005, and 70
172.824 Sodium mono- and dimethyl naph- FR 72074, Dec. 1, 2005.
thalene sulfonates.
172.826 Sodium stearyl fumarate. Subpart A—General Provisions
172.828 Acetylated monoglycerides.
172.829 Neotame. § 172.5 General provisions for direct
172.830 Succinylated monoglycerides. food additives.
172.831 Sucralose.
172.832 Monoglyceride citrate. (a) Regulations prescribing condi-
172.833 Sucrose acetate isobutyrate (SAIB). tions under which food additive sub-
172.834 Ethoxylated mono- and diglycerides. stances may be safely used predicate
172.836 Polysorbate 60. usage under conditions of good manu-
172.838 Polysorbate 65.
172.840 Polysorbate 80. facturing practice. For the purposes of
172.841 Polydextrose. this part, good manufacturing practice
172.842 Sorbitan monostearate. shall be defined to include the fol-
172.844 Calcium stearoyl-2-lactylate. lowing restrictions.
172.846 Sodium stearoyl lactylate. (1) The quantity of the substance
172.848 Lactylic esters of fatty acids. added to food does not exceed the
172.850 Lactylated fatty acid esters of glyc-
erol and propylene glycol.
amount reasonably required to accom-
172.852 Glyceryl-lacto esters of fatty acids. plish its intended physical, nutritive,
172.854 Polyglycerol esters of fatty acids. or other technical effect in food.
172.856 Propylene glycol mono- and diesters (2) Any substance intended for use in
of fats and fatty acids. or on food is of appropriate food grade
172.858 Propylene glycol alginate. and is prepared and handled as a food
172.859 Sucrose fatty acid esters. ingredient.
172.860 Fatty acids.
172.861 Cocoa butter substitute from coco- (b) The existence of a regulation pre-
scribing safe conditions of use for a
nut oil, palm kernel oil, or both oils.

172.862 Oleic acid derived from tall oil fatty food additive shall not be construed to
acids. relieve the use of the substance from
31
§ 172.105 21 CFR Ch. I (4–1–12 Edition)
compliance with any other provision of www.archives.gov/federallregister/

the Act. codeloflfederallregulations/
(c) The existence of any regulation ibrllocations.html.
prescribing safe conditions of use for a (3) Phenol content: Not less than 3.2
nutrient substance does not constitute milliequivalent/gram and not more
a finding that the substance is useful than 3.8 milliequivalent/gram as deter-
or required as a supplement to the diet mined by a method entitled ‘‘Total
of humans. Phenols,’’ 1982, which is incorporated
by reference. Copies are available from
Subpart B—Food Preservatives the Center for Food Safety and Applied
Nutrition (HFS–200), Food and Drug
§ 172.105 Anoxomer. Administration, 5100 Paint Branch
Anoxomer as identified in this sec- Pkwy., College Park, MD 20740, or at
tion may be safely used in accordance the National Archives and Records Ad-
with the following conditions: ministration (NARA). For information
(a) Anoxomer is 1,4-benzenediol, 2- on the availability of this material at
(1,1-dimethylethyl)-polymer with NARA, call 202–741–6030, or go to: http://
diethenylbenzene, 4-(1,1-dimethyl- www.archives.gov/federallregister/
ethyl)phenol, 4- methoxyphenol, 4,4′-(1- codeloflfederallregulations/
methylethylidene)bis(phenol) and 4- ibrllocations.html.
methylphenol (CAS Reg. No. 60837–57–2) (4) Heavy metals as lead (as Pb), not
prepared by condensation polymeriza- more than 10 parts per million. Arsenic
tion of divinylbenzene (m- and p-) with (as As), not more than 3 parts per mil-
tert-butylhydroquinone, tert-butyl- lion. Mercury (as Hg), not more than 1
phenol, hydroxyanisole, p-cresol and part per million.
4,4′-isopropylidenediphenol. (c) Anoxomer may be safely used as
(b) The polymeric antioxidant meets an antioxidant in food at a level of not
the following specifications: more than 5,000 parts per million based
(1) Polymer, not less than 98.0 per- on fat and oil content of the food.
cent as determined by an ultraviolet [48 FR 18798, Apr. 26, 1983, as amended at 54
method entitled ‘‘Ultraviolet Assay, FR 24896, June 12, 1989]
‘‘1982, which is incorporated by ref-
erence. Copies are available from the § 172.110 BHA.
Center for Food Safety and Applied Nu- The food additive BHA (butylated hy-
trition (HFS–200), Food and Drug Ad- droxyanisole) alone or in combination
ministration, 5100 Paint Branch Pkwy., with other antioxidants permitted in
College Park, MD 20740, or at the Na- food for human consumption in this
tional Archives and Records Adminis- subpart B may be safely used in or on
tration (NARA). For information on specified foods, as follows:
the availability of this material at (a) The BHA meets the following
NARA, call 202–741–6030, or go to: http:// specification:
www.archives.gov/federallregister/
codeloflfederallregulations/ Assay (total BHA), 98.5 percent minimum.
ibrllocations.html. Melting point 48 °C minimum.
(2) Molecular weight: Total mono- (b) The BHA is used alone or in com-
mers, dimers and trimers below 500 not bination with BHT, as an antioxidant
more than 1 percent as determined by a in foods, as follows:
method entitled ‘‘Low Molecular
Weight Anoxomer Analysis,’’ 1982, Limitations
(total BHA
which is incorporated by reference. Food and BHT)
Copies are available from the Center parts per
million
for Food Safety and Applied Nutrition
(HFS–200), Food and Drug Administra- Dehydrated potato shreds ................................... 50
Active dry yeast ................................................... 1 1,000
tion, 5100 Paint Branch Pkwy., College Beverages and desserts prepared from dry
Park, MD 20740, or at the National Ar- mixes ................................................................ 12
chives and Records Administration Dry breakfast cereals .......................................... 50

Dry diced glazed fruit .......................................... 1 32
(NARA). For information on the avail-
Dry mixes for beverages and desserts ............... 1 90

ability of this material at NARA, call Emulsion stabilizers for shortenings .................... 200
202–741–6030, or go to: http:// Potato flakes ........................................................ 50
32
Limitations § 172.120 Calcium disodium EDTA.

(total BHA
Food and BHT) The food additive calcium disodium
parts per
million EDTA (calcium disodium ethylene-
diaminetetraacetate) may be safely
Potato granules ................................................... 10 used in designated foods for the pur-
Sweet potato flakes ............................................. 50
poses and in accordance with the condi-
1 BHA only. tions prescribed, as follows:
(c) To assure safe use of the additive: (a) The additive contains a minimum
(1) The label of any market package of 99 percent by weight of either the di-
of the additive shall bear, in addition hydrate C10H12O8N2CaNa2·2H2O or the
to the other information required by trihydrate C10H12O8N2CaNa2·3H2O, or
the Act, the name of the additive. any mixture of the two.
(2) When the additive is marketed in (b) It is used or intended for use as
a suitable carrier, in addition to meet- follows:
ing the requirement of paragraph (c)(1) (1) Alone, in the following foods at
of this section, the label shall declare not to exceed the levels prescribed, cal-
the percentage of the additive in the culated as the anhydrous compound:
mixture.
Limita-
(3) The label or labeling of dry mixes tion
for beverages and desserts shall bear Food (parts Use
per mil-
adequate directions for use to provide lion)
that beverages and desserts prepared
from the dry mixes contain no more Cabbage, pickled .......... 220 Promote color, flavor,
and texture retention.
than 2 parts per million BHA. Canned carbonated soft 33 Promote flavor reten-
drinks. tion.
§ 172.115 BHT. Canned white potatoes 110 Promote color retention.
Clams (cooked canned) 340 Promote color retention.
The food additive BHT (butylated hy- Crabmeat (cooked 275 Retard struvite forma-
droxytoluene), alone or in combination canned). tion; promote color
with other antioxidants permitted in retention.
Cucumbers pickled ....... 220 Promote color, flavor,
this subpart B may be safely used in or and texture retention.
on specified foods, as follows: Distilled alcoholic bev- 25 Promote stability of
(a) The BHT meets the following erages. color, flavor, and/or
specification: Assay (total BHT) 99 per- product clarity.
Dressings, nonstandard- 75 Preservative.
cent minimum. ized.
(b) The BHT is used alone or in com- Dried lima beans 310 Promote color retention.
bination with BHA, as an antioxidant (cooked canned).
Egg product that is 1 200 Preservative.
in foods, as follows:
hard-cooked and con-
Limitations sists, in a cylindrical
(total BHA shape, of egg white
Food and BHT) with an inner core of
parts per egg yolk.
million Fermented malt bev- 25 Antigushing agent.
erages.
Dehydrated potato shreds ................................... 50 French dressing ............ 75 Preservative.
Dry breakfast cereals .......................................... 50 Legumes (all cooked 365 Promote color retention.
Emulsion stabilizers for shortenings .................... 200 canned, other than
Potato flakes ........................................................ 50 dried lima beans, pink
Potato granules ................................................... 10 beans, and red
Sweetpotato flakes .............................................. 50 beans).
Mayonnaise .................. 75 Do.
(c) To assure safe use of the additive: Mushrooms (cooked 200 Promote color retention.
(1) The label of any market package canned).
Oleomargarine .............. 75 Preservative.
of the additive shall bear, in addition Pecan pie filling ............ 100 Promote color retention.
to the other information required by Pink beans (cooked 165 Promote color retention.
the Act, the name of the additive. canned).
Potato salad .................. 100 Preservative.
(2) When the additive is marketed in Processed dry pinto 800 Promote color retention.
a suitable carrier, in addition to meet- beans.
ing the requirement of paragraph (c)(1) Red beans (cooked 165 Promote color retention.
of this section, the label shall declare canned).
Salad dressing .............. 75 Preservative.

the percentage of the additive in the Sandwich spread .......... 100 Do.
mixture. Sauces .......................... 75 Do.
33
§ 172.130 21 CFR Ch. I (4–1–12 Edition)
Limita- Sodium salt of dehydroacetic acid: Assay,

tion minimum 98 percent (dry basis).
Food (parts Use
per mil- (b) It is used or intended for use as a
lion)
preservative for cut or peeled squash,
Shrimp (cooked 250 Retard struvite forma- and is so used that no more than 65
canned). tion; promote color
retention. parts per million expressed as dehydro-
Spice extractives in 60 Promote color and fla- acetic acid remains in or on the pre-
soluble carriers. vor retention. pared squash.
Spreads, artificially col- 100 Promote color retention.
ored and lemon-fla- (c) The label or labeling of any pack-
vored or orange-fla- age of the additive intended for use in
vored. food shall bear adequate directions for
1 By weight of egg yolk portion. use to insure compliance with this sec-
(2) With disodium EDTA (disodium tion.
ethylenediaminetetraacetate) in the
§ 172.133 Dimethyl dicarbonate.
following foods at not to exceed, in
combination, the levels prescribed, cal- Dimethyl dicarbonate (CAS Reg. No.
culated as anhydrous C10H12O8N2CaNa2: 4525–33–1) may be safely used in food in
accordance with the following pre-
Limita-
tion scribed conditions:
Food (parts Use (a) The additive meets the following
per mil-
lion) specifications:
(1) The additive has a purity of not
Dressings, nonstandardized .... 75 Preservative.
French dressing ...................... 75 Do. less than 99.8 percent as determined by
Mayonnaise ............................. 75 Do. the following titration method:
Salad dressing ........................ 75 Do.
Sandwich spread ..................... 100 Do. PRINCIPLES OF METHOD
Sauces .................................... 75 Do.
Dimethyl dicarbonate (DMDC) is mixed
(c) To assure safe use of the additive: with excess diisobutylamine with which it
(1) The label and labeling of the addi- reacts quantitatively. The excess amine is
backtitrated with acid.
tive container shall bear, in addition to
the other information required by the APPARATUS
Act, the name of the additive.
(2) The label or labeling of the addi- 250-milliliter (mL) Beaker
tive container shall bear adequate use 100-mL Graduate cylinder
directions to provide a final food prod- 25-mL Pipette
10-mL Burette (automatic, eg., Metrohm bu-
uct that complies with the limitations
rette)
provided in paragraph (b) of this sec-
Stirrer
tion.
Device for potentiometric titration
(d) In the standardized foods listed in
Reference electrode
paragraph (b) of this section, the addi- Glass electrode
tives are used only in compliance with
the applicable standards of identity for REAGENTS
such foods.
Acetone, analytical-grade
[42 FR 14491, Mar. 15, 1977, as amended at 48 Solution of 1 N diisobutylamine in chloro-
FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, benzene, distilled
1993; 60 FR 33710, June 29, 1995; 65 FR 48379, 1 N Acetic Acid
Aug. 8, 2000]
PROCEDURE
§ 172.130 Dehydroacetic acid.
Accurately weigh in about 2 grams of the
The food additive dehydroacetic acid sample (W) and dissolve in 100 mL acetone.
and/or its sodium salt may be safely Add accurately 25 mL of the 1 N diisobutyl-
used in accordance with the following amine solution by pipette and allow to stand
prescribed conditions: for 5 minutes. Subsequently, titrate the re-
(a) The food additive meets the fol- action mixture potentiometrically with 1 N
lowing specifications: hydrochloric acid (consumption=a mL) while
stirring. For determining the blank con-

Dehydroacetic acid: Melting point, 109 °C–111 sumption, carry out the analysis without a
°C; assay, minimum 98 percent (dry basis). sample (consumption=b mL).
34
CALCULATION cent, in an amount not to exceed 250
parts per million.
( b − a ) × 13.4 (c) To ensure the safe use of the food
= % DMDC additive, the label of the package con-
W taining the additive shall bear, in addi-
NOTE: For adding the diisobutylamine so- tion to other information required by
lution, always use the same pipette and wait the Federal Food, Drug, and Cosmetic
for a further three drops to fall when the Act:
flow has stopped. (1) The name of the additive ‘‘di-
(2) The additive contains not more methyl dicarbonate.’’
than 2,000 ppm (0.2 percent) dimethyl (2) The intended use of the additive.
carbonate as determined by a method (3) Adequate directions for use to en-
entitled ‘‘Gas Chromatography Method sure compliance with this section.
for Dimethyl Carbonate Impurity in [53 FR 41329, Oct. 21, 1988, as amended at 58
Dimethyl Dicarbonate,’’ which is incor- FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994;
porated by reference in accordance 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29,
with 5 U.S.C. 552(a). Copies are avail- 1996; 66 FR 13653, Mar. 7, 2001]
able from the Center for Food Safety
and Applied Nutrition (HFS–200), 5100 § 172.135 Disodium EDTA.
Paint Branch Pkwy., College Park, MD The food additive disodium EDTA
20740, or at the National Archives and (disodium ethylenediaminetetraace-
Records Administration (NARA). For tate) may be safely used in designated
information on the availability of this foods for the purposes and in accord-
material at NARA, call 202–741–6030, or ance with the following prescribed con-
go to: http://www.archives.gov/ ditions:
federallregister/ (a) The additive contains a minimum
codeloflfederallregulations/ of 99 percent disodium ethylenedia-
ibrllocations.html. minetetraacetate dihydrate
(b) The additive is used or intended (C10H14O8N2Na2·2H2O).
for use as a microbial control agent in (b) It is used or intended for use as
the following beverages under normal follows:
circumstances of bottling, canning, or (1) Alone, in the following foods at
other forms of final packaging, where not to exceed the levels prescribed, cal-
the viable microbial load has been re- culated as anhydrous calcium disodium
duced to 500 microorganisms per milli- EDTA:
liter or less by current good manufac-
Limita-
turing practices such as heat treat- tion
ment, filtration, or other technologies Food (parts Use
per mil-
prior to the use of dimethyl dicar- lion)
bonate:
Aqueous multivitamin prep- 150 With iron salts as a
(1) In wine, dealcoholized wine, and arations. stabilizer for vita-
low alcohol wine in an amount not to min B 12 in liquid
exceed 200 parts per million. multivitamin prep-
arations.
(2) In ready-to-drink teas in an Canned black-eyed peas .... 145 Promote color re-
amount not to exceed 250 parts per mil- tention.
lion. Canned kidney beans ......... 165 Preservative.
Canned strawberry pie filling 500 Promote color re-
(3) In carbonated or noncarbonated, tention.
nonjuice-containing (less than or equal Cooked sausage ................. 36 As a cure accel-
to 1 percent juice), flavored or erator with so-
dium ascorbate
unflavored beverages containing added or ascorbic acid.
electrolytes (5–20 milliequivalents/liter Dressings, nonstandardized 75 Preservative.
sodium ion (Na+) and 3–7 milli- French dressing .................. 75 Do.
Frozen white potatoes in- 100 Promote color re-
equivalents/liter potassium ion (K+)) in cluding cut potatoes. tention.
an amount not to exceed 250 parts per Gefilte fish balls or patties in 1 50 Inhibit discoloration.
million. packing medium.
Legumes (all cooked 165 Promote color re-
(4) In carbonated, dilute beverages
canned, other than black- tention.

containing juice, fruit flavor, or both, eyed peas).
with juice content not to exceed 50 per- Mayonnaise ......................... 75 Preservative.
35
ER10MR99.023</GPH>
§ 172.140 21 CFR Ch. I (4–1–12 Edition)
Limita- § 172.140 Ethoxyquin.

tion
Food (parts Use (a) Ethoxyquin (1,2-dihydro-6-ethoxy-
per mil-
lion) 2,2,4-trimethylquinoline) may be safely
2 315
used as an antioxidant for preservation
Ready-to-eat cereal prod- Promote color re-
ucts containing dried ba- tention. of color in the production of chili pow-
nanas. der, paprika, and ground chili at levels
Salad dressing .................... 75 Preservative. not in excess of 100 parts per million.
Sandwich spread ................. 100 Do.
Sauces ................................ 75 Do.
(b) In order to provide for the safe
1 Based on total weight of finished product including packing
use of the additive in feed prepared in
medium. accordance with §§ 573.380 and 573.400 of
2 In dried banana component of cereal product.
this chapter, tolerances are established
(2) With calcium disodium EDTA for residues of ethoxyquin in or on edi-
(calcium disodium ethylenediamine- ble products of animals as follows:
tetraacetate; calcium disodium 5 parts per million in or on the uncooked fat
(ethylenedinitrilo) tetraacetate), in the of meat from animals except poultry.
following foods at not to exceed, in 3 parts per million in or on the uncooked
combination, the levels prescribed, cal- liver and fat of poultry.
culated as anhydrous C10H12O8N2CaNa2: 0.5 part per million in or on the uncooked
muscle meat of animals.
Limita- 0.5 part per million in poultry eggs.
tion
Food (parts Use Zero in milk.
per mil-
lion)
§ 172.145 Heptylparaben.
Dressings, nonstandardized 75 Preservative. (a) The food additive heptylparaben
French dressing .................. 75 Do.
Mayonnaise ......................... 75 Do. is the chemical n-heptyl p-hydroxy-
Salad dressing .................... 75 Do. benzoate.
Sandwich spread ................. 100 Do. (b) It may be safely used to inhibit
Sauces ................................ 75 Do. microbiological spoilage in accordance
with the following prescribed condi-
(3) Alone, as a sequestrant in the tions:
nonnutritive sweeteners that are listed
(1) In fermented malt beverages in
in § 180.37 of this chapter and that, in
amounts not to exceed 12 parts per mil-
addition, are designed for aqueous solu-
tion: Provided, That the amount of the lion.
additive, calculated as anhydrous cal- (2) In noncarbonated soft drinks and
cium disodium EDTA, does not exceed fruit-based beverages in amounts not
0.1 percent by weight of the dry non- to exceed 20 parts per million, when
nutritive sweetener. standards of identity established under
(c) To assure the safe use of the addi- section 401 of the Act (21 U.S.C. 341) do
tive: not preclude such use.
(1) The label and labeling of the addi-
tive container shall bear, in addition to § 172.150 4-Hydroxymethyl-2,6-di-tert-
butylphenol.
the other information required by the
act, the name of the additive. The food additive 4-hydroxymethyl-
(2) The label or labeling of the addi- 2,6-di-tert-butylphenol may be safely
tive container shall bear adequate use used in food in accordance with the fol-
directions to provide a final food prod- lowing prescribed conditions:
uct that complies with the limitations (a) The additive has a solidification
provided in paragraph (b) of this sec- point of 140 °C–141 °C.
tion. (b) The additive is used as an anti-
(d) In the standardized foods listed in oxidant alone or in combination with
paragraphs (b) (1) and (2) of this section other permitted antioxidants.
the additives are used only in compli- (c) The total amount of all anti-
ance with the applicable standards of oxidants added to such food shall not
identity for such foods. exceed 0.02 percent of the oil or fat con-
[42 FR 14491, Mar. 15, 1977, as amended at 65 tent of the food, including the essential
FR 48379, Aug. 8, 2000] (volatile) oil content of the food.
36
§ 172.155 Natamycin (pimaricin). § 172.165 Quaternary ammonium chlo-

ride combination.
(a) Natamycin (CAS Reg. No. 7681–93–
8), also known as pimaricin, is a pol- The food additive, quaternary ammo-
yene macrolide antimycotic substance nium chloride combination, may be
possessing an empirical formula of safely used in food in accordance with
C33H47NO13 and a molecular weight of the following conditions:
665.7. (a) The additive contains the fol-
(b) The additive shall conform to the lowing compounds: n-dodecyl dimethyl
following specifications: benzyl ammonium chloride (CAS Reg.
No. 139–07–1); n-dodecyl dimethyl ethyl-
Purity: 97 percent ±2 percent on an anhy- benzyl ammonium chloride (CAS Reg.
drous basis. No. 27479–28–3); n-hexadecyl dimethyl
Arsenic: Not more than 1 part per million. benzyl ammonium chloride (CAS Reg.
Heavy metals (as Pb): Not more than 20 parts No. 122–18–9); n-octadecyl dimethyl
per million. benzyl ammonium chloride (CAS Reg.
(c) The additive may be applied on No. 122–19–0); n-tetradecyl dimethyl
cheese, as an antimycotic, in amounts benzyl ammonium chloride (CAS Reg.
not to exceed 20 milligrams per kilo- No. 139–08–2); n-tetradecyl dimethyl
gram (20 parts per million) in the fin- ethylbenzyl ammonium chloride (CAS
ished product as determined by Inter- Reg. No. 27479–29–4).
national Dairy Federation (IDF) Stand- (b) The additive meets the following
ard 140A:1992, ‘‘Cheese and Cheese specifications: pH (5 percent active so-
Rind-Determination of Natamycin Con- lution) 7.0–8.0; total amines, maximum
tent-Method by Molecular Absorption 1 percent as combined free amines and
Spectrometry and by High-Perform- amine hydrochlorides.
ance Liquid Chromatography,’’ which (c) The additive is used as an anti-
is incorporated by reference. The Di- microbial agent, as defined in
rector of the Office of the Federal Reg- § 170.3(o)(2) of this chapter, in raw sugar
ister approves this incorporation by cane juice. It is added prior to clari-
reference in accordance with 5 U.S.C. fication when further processing of the
552(a) and 1 CFR part 51. Copies are sugar cane juice must be delayed.
available from the Division of Product (d) The additive is applied to the
Policy (HFS–206), Center for Food Safe- sugar juice in the following quantities,
ty and Applied Nutrition, Food and based on the weight of the raw cane:
Drug Administration, 5100 Paint Parts per
Component
Branch Pkwy., College Park, MD 20740, million
or may be examined at the Center for n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0
Food Safety and Applied Nutrition’s n-Dodecyl dimethyl ethylbenzyl ammonium
Library, 5100 Paint Branch Pkwy., Col- chloride ........................................................... 3.4–13.5
lege Park, MD 20740, or at the National n-Hexadecyl dimethyl benzyl ammonium chlo-
ride ................................................................. 1.5–6.0
Archives and Records Administration n-Octadecyl dimethyl benzyl ammonium chlo-
(NARA). For information on the avail- ride ................................................................. 0.25–1.0
ability of this material at NARA, call n-Tetradecyl dimethyl benzyl ammonium chlo-
ride ................................................................. 3.0–12.0
202–741–6030, or go to: http://
n-Tetradecyl dimethyl ethylbenzyl ammonium
www.archives.gov/federallregister/ chloride ........................................................... 1.6–6.5
codeloflfederallregulations/
ibrllocations.html.
[50 FR 3890, Jan. 29, 1985]
[47 FR 26823, June 22, 1982, as amended at 50
FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, § 172.167 Silver nitrate and hydrogen
1998; 66 FR 13847, Mar. 8, 2001] peroxide solution.
An aqueous solution containing a
§ 172.160 Potassium nitrate. mixture of silver nitrate and hydrogen
The food additive potassium nitrate peroxide may be safely used in accord-
may be safely used as a curing agent in ance with the following prescribed con-
the processing of cod roe, in an amount ditions:
not to exceed 200 parts per million of (a) The additive is used as an anti-
the finished roe. microbial agent in bottled water.
37
§ 172.170 21 CFR Ch. I (4–1–12 Edition)
(b) Hydrogen peroxide meets the at the National Archives and Records
specifications of the ‘‘Food Chemicals Administration (NARA). For informa-
Codex,’’ 6th ed. (2008), pp. 463 and 464, tion on the availability of this mate-
which is incorporated by reference. The rial at NARA, call 202–741–6030 or go to:
Director of the Federal Register ap- http://www.archives.gov/federallregister/
proves this incorporation by reference codelofl federallregulations/
in accordance with 5 U.S.C. 552(a) and 1 ibrllocations.html.
CFR part 51. You may obtain copies (e) Substances generally recognized
from the United States Pharmacopeial as safe in or on food may be used to
Convention, 12601 Twinbrook Pkwy., stabilize the additive to ensure that
Rockville, MD 20852 (Internet address the additive will perform its intended
http://www.usp.org). Copies may be ex- technical effect.
amined at the Center for Food Safety (f) The additive may not be added to
and Applied Nutrition’s Library, Food bottled water that has been filtered or
and Drug Administration, 5100 Paint is intended to be filtered through a sil-
Branch Pkwy., College Park, MD 20740, ver-containing water filter.
301–436–2163, or at the National Ar-
(g) Bottled water must meet the
chives and Records Administration
quality standards for bottled water in
§ 165.110(b)(2) through (b)(5) of this
ability of this material at NARA, call
chapter, including the limits specified
202–741–6030 or go to: http://
for total silver and nitrate, unless the
water bears a label statement of sub-
standard quality, as provided for under
ibrllocations.html.
§ 165.110(c) of this chapter.
(c) The amount of silver added will
not exceed 17 micrograms per kilogram [74 FR 11478, Mar. 18, 2009]
in the treated bottled water, and the
amount of hydrogen peroxide will not § 172.170 Sodium nitrate.
exceed 23 milligrams per kilogram in The food additive sodium nitrate
the treated bottled water. Analyses for may be safely used in or on specified
silver and hydrogen peroxide shall be foods in accordance with the following
conducted on samples of treated bot- prescribed conditions:
tled water at the site of bottling, using
(a) It is used or intended for use as
samples of the water intended for
follows:
treatment for the blank determination.
(d)(1) The amount of silver in the (1) As a preservative and color fixa-
treated bottled water is determined tive, with or without sodium nitrite, in
using the method for silver designated smoked, cured sablefish, smoked, cured
in 21 CFR 165.110(b)(4)(iii)(G)(2)(i). salmon, and smoked, cured shad, so
(2) The amount of hydrogen peroxide that the level of sodium nitrate does
in the treated bottled water is deter- not exceed 500 parts per million and the
mined using a Hydrogen Peroxide Test level of sodium nitrite does not exceed
Kit from the HACH Co., or equivalent. 200 parts per million in the finished
The manual from the Hydrogen Per- product.
oxide Test Kit, Model HYP–1, Catalog (2) As a preservative and color fixa-
Number 22917–00, 1991, is incorporated tive, with or without sodium nitrite, in
by reference. The Director of the Fed- meat-curing preparations for the home
eral Register approves this incorpora- curing of meat and meat products (in-
tion by reference in accordance with 5 cluding poultry and wild game), with
U.S.C. 552(a) and 1 CFR part 51. You directions for use which limit the
may obtain copies of the test kit man- amount of sodium nitrate to not more
ual from the HACH Co., P.O. Box 389, than 500 parts per million in the fin-
Loveland CO, 80359 (1–800–227–4224), ished meat product and the amount of
Model HYP–1, Catalog Number 22917–00. sodium nitrite to not more than 200
Copies may be examined at the Center parts per million in the finished meat
for Food Safety and Applied Nutri- product.
tion’s Library, Food and Drug Admin- (b) To assure safe use of the additive,
istration, 5100 Paint Branch Pkwy., in addition to the other information re-
College Park, MD 20740, 301–436–2163, or quired by the Act:
38
(1) The label of the additive or of a (ii) A statement of the concentration

mixture containing the additive shall of the additive in any mixture.
bear: (2) If in a retail package intended for
(i) The name of the additive. household use, the label and labeling of
(ii) A statement of the concentration the additive, or of a mixture con-
of the additive in any mixture. taining the additive, shall bear ade-
(2) If in a retail package intended for quate directions for use to provide a
household use, the label and labeling of final food product which complies with
the additive, or of a mixture con- the limitations prescribed in paragraph
taining the additive, shall bear ade- (a) of this section.
quate directions for use to provide a (3) If in a retail package intended for
final food product that complies with household use, the label of the addi-
the limitations prescribed in paragraph tive, or of a mixture containing the ad-
(a) of this section. ditive, shall bear the statement ‘‘Keep
(3) If in a retail package intended for out of the reach of children’’.
household use, the label of the additive
or of a mixture containing the addi- § 172.177 Sodium nitrite used in proc-
tive, shall bear the statement ‘‘Keep essing smoked chub.
out of the reach of children’’. The food additive sodium nitrite may
be safely used in combination with salt
§ 172.175 Sodium nitrite. (NaCl) to aid in inhibiting the out-
The food additive sodium nitrite may growth and toxin formation from Clos-
be safely used in or on specified foods tridium botulinum type E in the com-
in accordance with the following pre- mercial processing of smoked chub in
scribed conditions: accordance with the following pre-
(a) It is used or intended for use as scribed conditions:
follows: (a) All fish in smoking establish-
(1) As a color fixative in smoked ments shall be clean and wholesome
cured tunafish products so that the and shall be expeditiously processed,
level of sodium nitrite does not exceed packed, and stored under adequate san-
10 parts per million (0.001 percent) in itary conditions in accordance with
the finished product. good manufacturing practice.
(2) As a preservative and color fixa- (b) The brining procedure is con-
tive, with or without sodium nitrate, trolled in such a manner that the
in smoked, cured sablefish, smoked, water phase portion of the edible por-
cured salmon, and smoked, cured shad tion of the finished smoked product has
so that the level of sodium nitrite does a salt (NaCl) content of not less than
not exceed 200 parts per million and the 3.5 percent, as measured in the loin
level of sodium nitrate does not exceed muscle, and the sodium nitrite content
500 parts per million in the finished of the edible portion of the finished
product. smoked product is not less than 100
(3) As a preservative and color fixa- parts per million and not greater than
tive, with sodium nitrate, in meat-cur- 200 parts per million, as measured in
ing preparations for the home curing of the loin muscle.
meat and meat products (including (c) Smoked chub shall be heated by a
poultry and wild game), with directions controlled heat process which provides
for use which limit the amount of so- a monitoring system positioned in as
dium nitrite to not more than 200 parts many strategic locations in the smoke-
per million in the finished meat prod- house as necessary to assure a contin-
uct, and the amount of sodium nitrate uous temperature throughout each fish
to not more than 500 parts per million of at least 160 °F for a minimum of 30
in the finished meat product. minutes.
(b) To assure safe use of the additive, (d) The finished product shall be
in addition to the other information re- cooled to a temperature of 50 °F or
quired by the Act: below within 3 hours after smoking and
(1) The label of the additive or of a further cooled to a temperature of 38 °F
mixture containing the additive shall or below within 12 hours after smoking.
bear: A temperature of 38 °F or below shall

(i) The name of the additive. be maintained during all subsequent
39
§ 172.180 21 CFR Ch. I (4–1–12 Edition)
storage and distribution. All shipping exceed 0.02 percent of the oil or fat con-
containers, retail packages, and ship- tent of the food, including the essential
ping records shall indicate with appro- (volatile) oil content of the food.
priate notice the perishable nature of
the product and specify that the prod- § 172.190 THBP.
uct shall be held under refrigeration (38 The food additive THBP (2,4,5-tri-
°F or below) until consumed. hydroxybutyrophenone) may be safely
(e) To assure safe use of the additive: used in food in accordance with the fol-
(1) The label and labeling of the addi- lowing prescribed conditions:
tive container shall bear, in addition to (a) The food additive has a melting
the other information required by the point of 149 °C–153 °C.
Act, the name of the additive. (b) It is used as an antioxidant alone
(2) The label or labeling of the addi- or in combination with other permitted
tive container shall bear adequate di- antioxidants.
rections to assure use in compliance (c) The total antioxidant content of a
with the provisions of this section. food containing the additive will not
§ 172.180 Stannous chloride. exceed 0.02 percent of the oil or fat con-
tent of the food, including the essential
The food additive stannous chloride (volatile) oil content of the food.
may be safely used for color retention
in asparagus packed in glass, with lids
lined with an inert material, in an Subpart C—Coatings, Films and
amount not to exceed 20 parts per mil- Related Substances
lion calculated as tin (Sn).
§ 172.210 Coatings on fresh citrus fruit.
§ 172.185 TBHQ. Coatings may be applied to fresh cit-
The food additive TBHQ, which is the rus fruit for protection of the fruit in
chemical 2-(1,1-dimethylethyl)-1,4-benz- accordance with the following condi-
enediol (Chemical Abstracts Service tions:
Registry Number 1948–33–0), also known (a) The coating is applied in the min-
as tertiary butylhydroquinone, may be imum amount required to accomplish
safely used in food in accordance with the intended effect.
the following prescribed conditions: (b) The coating may be formulated
(a) The food additive has a melting from the following components, each
point of 126.5 °C–128.5 °C. used in the minimum quantity required
(b) It is used as an antioxidant alone to accomplish the intended effect:
or in combination with BHA and/or (1) Substances generally recognized
BHT. as safe for the purpose or previously
(c) The total antioxidant content of a sanctioned for the purpose.
food containing the additive will not (2) One or more of the following:
Component Limitations
Fatty acids ............................................................ Complying with § 172.860.

Oleic acid derived from tall oil fatty acids ............ Complying with § 172.862.
Partially hydrogenated rosin ................................ Catalytically hydrogenated to a maximum refractive index of 1.5012 at 100
°C. Color of WG or paler.
Pentaerythritol ester of maleic anhydride-modi- Acid number of 134–145; drop-softening point of 127 °C–173 °C; saponifica-
fied wood rosin. tion number of less than 280; and a color of M or paler.
Do .................................................................. Acid number of 176–186; drop-softening point of 110 °C–118 °C; saponifica-
tion number of less than 280; and a color of M or paler.
Polyethylene glycol .............................................. Complying with § 172.820. As a defoamer and dispersing adjuvant.
Polyhydric alcohol diesters of oxidatively refined Complying with § 178.3770 of this chapter and having a dropping point of 77
(Gersthofen process) montan wax acids. to 83 °C (170.6 to 181.4 °F), as determined by ASTM Method D566–76
(Reapproved 1982), ‘‘Standard Test Method for Dropping Point of Lubri-
cating Grease,’’ which is incorporated by reference (Copies are available
from the American Society for Testing and Materials, 100 Barr Harbor Dr.,
West Conshohocken, Philadelphia, PA 19428-2959, or at the National Ar-
chives and Records Administration (NARA). For information on the avail-
ability of this material at NARA, call 202–741–6030, or go to: http://
www.archives.gov/federallregister/codeloflfederallregulations/
ibrllocations.html.) using as a solvent xylene-ethyl alcohol in a 2:1 ratio

instead of toluene-ethyl alcohol in a 2:1 ratio.
Sodium lauryl sulfate ............................................ Complying with § 172.822. As a film former.
40
Wood rosin ........................................................... Color of K or paler.
(3) In lieu of the components listed in the following copolymer and one or
paragraph (b) (2) and (4) of this section, more of the listed adjuvants.
Vinyl chloride-vinylidene chloride copolymer ....... As an aqueous dispersion containing a minimum of 75 percent water when
applied.
Polyethylene glycol .............................................. Complying with § 172.820. As a defoamer and dispersing adjuvant.
Polyvinylpyrrolidone .............................................. As an adjuvant.
Potassium persulfate ............................................ Do.
Propylene glycol alginate ..................................... Do.
Sodium decylbenzenesulfonate ........................... Do.
(4) In lieu of the components listed in the following rosin derivative and ei-
paragraph (b) (2) and (3) of this section, ther or both of the listed adjuvants:
Calcium salt of partially dimerized rosin .............. Having a maximum drop-softening point of 197 °C and a color of H or paler.
It is prepared by reaction with not more than 7 parts hydrated lime per 100
parts of partially dimerized rosin. The partially dimerized rosin is rosin that
has been dimerized by sulfuric acid catalyst to a drop-softening point of 95
°C to 105 °C and a color of WG or paler.
Petroleum naphtha ............................................... As adjuvant. Complying with § 172.250.
Sperm oil .............................................................. As adjuvant.
[42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51 FR 2693, Jan. 21, 1986;
52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1, 1996]
§ 172.215 Coumarone-indene resin. Barr Harbor Dr., West Conshohocken,

The food additive coumarone-indene Philadelphia, PA 19428-2959, or may be
resin may be safely used on grapefruit, examined at the National Archives and
lemons, limes, oranges, tangelos, and Records Administration (NARA). For
tangerines in accordance with the fol- information on the availability of this
lowing prescribed conditions: material at NARA, call 202–741–6030, or
(a) The food additive is manufactured go to: http://www.archives.gov/
by the polymerization of a crude, federallregister/
heavy coal-tar solvent naphtha meet- codeloflfederallregulations/
ing the following specifications: ibrllocations.html.
(1) It is a mixture of indene, indan (2) Refractive index (n25/D) 1.63–1.64.
(hydrindene), substituted benzenes, and (c) It is used or intended for use as a
related compounds. protective coating for grapefruit, lem-
(2) It contains no more than 0.25 per- ons, limes, oranges, tangelos, and tan-
cent tar bases. gerines whereby the maximum amount
(3) 95 percent distills in the range 167 of the resin remaining on the fruit does
°C–184 °C. not exceed 200 parts per million on a
(b) The food additive meets the fol- fresh-weight basis.
lowing specifications: (d) To assure safe use of the additive:
(1) Softening point, ring and ball: 126 (1) The label of the market package
°C minimum as determined by ASTM or any intermediate premix of the ad-
method E28–67 (Reapproved 1982), ditive shall bear, in addition to the
‘‘Standard Test Method for Softening other information required by the act:
Point by Ring-and-Ball Apparatus,’’ (i) The name of the additive, cou-
which is incorporated by reference. marone-indene resin.
Copies may be obtained from the Amer- (ii) A statement of the concentration
ican Society for Testing Materials, 100 of the additive therein.
41
§ 172.225 21 CFR Ch. I (4–1–12 Edition)
(2) The label or accompanying label- Arabinogalactan—Complying with § 172.610;

ing shall bear adequate directions that, as adjuvant.
if followed, will result in a finished Silicon dioxide—Complying with § 172.480; as
adjuvant.
food not in conflict with the require-
ments of this section. (3) In lieu of the components listed in
paragraph (a)(2) of this section, the fol-
FR 10103, Mar. 19, 1984] lowing components:
§ 172.225 Methyl and ethyl esters of COMPONENT AND LIMITATIONS

fatty acids produced from edible Glutaraldehyde—As cross-linking agent for
fats and oils. insolubilizing a coacervate of gum arabic
Methyl esters and ethyl esters of and gelatin.
fatty acids produced from edible fats n-Octyl alcohol—As a defoamer.
and oils may be safely used in food, (4) In lieu of the components listed in
subject to the following prescribed con- paragraphs (a)(2) and (3) of this section,
ditions: the following component:
(a) The additive consists of a mixture
of either methyl or ethyl esters of COMPONENT AND LIMITATIONS
fatty acids produced from edible fats
and oils and meets the following speci- Petroleum wax—Complying with § 172.886.
Not to exceed 50 percent by combined
fications:
weight of the microcapsule and spice-fla-
(1) Not less than 90 percent methyl or voring substance.
ethyl esters of fatty acids.
(2) Not more than 1.5 percent unsa- (b) The microcapsules produced from
ponifiable matter. the components listed in paragraphs (a)
(b) The additive is used or intended (1), (2), and (3) of this section may be
for use at the level not to exceed 3 per- used for encapsulating authorized fla-
cent by weight in an aqueous emulsion voring oils for use, in accordance with
in dehydrating grapes to produce rai- good manufacturing practice, in foods
sins, whereby the residue of the addi- for which standards of identity estab-
tive on the raisins does not exceed 200 lished under section 401 of the Act do
parts per million. not preclude such use, except that
microcapsules formulated from compo-
[57 FR 12711, Apr. 13, 1992] nents listed in paragraph (a)(2) of this
section may be used only for encap-
§ 172.230 Microcapsules for flavoring sulating lemon oil, distilled lime oil,
substances.
orange oil, peppermint oil, and spear-
Microcapsules may be safely used for mint oil for use in dry mixes for pud-
encapsulating discrete particles of fla- dings and gelatin desserts.
voring substances that are generally (c) The microcapsules produced from
recognized as safe for their intended the components listed in paragraphs (a)
use or are regulated under this part, in (1) and (4) of this section may be used
accordance with the following condi- only for encapsulating authorized
tions: spice-flavoring substances for use, in
(a) The microcapsules may be formu- accordance with good manufacturing
lated from the following components, practice, in frozen pizzas which are to
each used in the minimum quantity re- be further processed by heat. Such piz-
quired to accomplish the intended ef- zas shall bear labels or labeling includ-
fect: ing adequate directions for use to en-
(1) Substances generally recognized sure heating to temperatures which
as safe for the purpose. will melt the wax to release the spice-
(2) One or more of the following com- flavoring substances.
ponents:
[45 FR 48123, July 18, 1980]
COMPONENT AND LIMITATIONS
§ 172.235 Morpholine.
Succinylated gelatin—Not to exceed 15 per-
Morpholine may be safely used as a
cent by combined weight of the microcap-

sule and flavoring oil. Succinic acid con- component of food, subject to the fol-
tent of the gelatin is 4.5 to 5.5 percent. lowing restrictions.
42
(a) It is used as the salt(s) of one or APPARATUS

more of the fatty acids meeting the re- Separatory funnels. 250-milliliter, and 2,000-
quirements of § 172.860, as a component milliliter capacity, equipped with tetra-
of protective coatings applied to fresh fluoroethylene polymer stopcocks.
fruits and vegetables. Erlenmeyer flask. 125-milliliter with 24/40
standard taper neck.
(b) It is used at a level not in excess Evaporation flask. 250-milliliter capacity
of that reasonably required to produce all-glass flask equipped with 24/40 standard
its intended effect. taper stopper having inlet and outlet tubes
to permit passage of nitrogen across the sur-
§ 172.250 Petroleum naphtha. face of the container liquid to be evaporated.
Condenser. 24/40 joints, fitted with drying
Petroleum naphtha may be safely tube, length optional.
used in food in accordance with the fol- Spectrophotometric cells. Fused quartz cells,
lowing conditions: optical path length in the range of 5,000 cen-
(a) The additive is a mixture of liquid timeters ±0.005 centimeter; also for checking
spectrophotometer performance only, optical
hydrocarbons, essentially paraffinic path length in the range 1,000 centimeter
and naphthenic in nature obtained ±0.005 centimeter. With distilled water in the
from petroleum, cells, determine any absorbance difference.
(b) The additive is refined to meet Spectrophotometer. Spectral range 250–400
the following specifications when sub- mμ with spectral slit width of 2 mμ or less;
under instrument operating conditions for
jected to the procedures described in these absorbance measurements, the spectro-
this paragraph. photometer shall also meet the following
(1) Boiling-point range: 175 °F–300 °F. performance requirements:
(2) Nonvolatile residue: 0.002 gram Absorbance repeatability, ±0.01 at 0.4 absorb-
per 100 milliliters maximum. ance.
(3) Ultraviolet absorbance limits, as Absorbance accuracy, 1 ±0.05 at 0.4 absorb-
follows: ance.
Wavelength repeatability, ±0.2 millimicron.
Maximum Wavelength accuracy, ±1.0 millimicron.
absorb-
ance per Ultraviolet lamp. Long wavelength (3400–
Wavelength (milli-microns) 3800A°).
centimeter
optical
pathlength REAGENTS
280–289 ............................................................... 0.15 Isooctane (2,2,4-trimethylpentane). Use 180

290–299 ............................................................... .13 milliliters in a 250-milliliter Erlenmeyer
300–359 ............................................................... .08 flask, add 1 milliliter of purified n-hexa-
360–400 ............................................................... .02 decane, insert the head assembly, allow ni-
trogen gas to flow into the inlet tube and
connect the outlet tube to a solvent trap and
ANALYTICAL SPECIFICATION FOR PETROLEUM vacuum line in such a way as to prevent any
NAPHTHA back flow of condensate into the flask. The
GENERAL INSTRUCTIONS
1 As determined by procedure using potas-
All glassware should be scrupulously sium chromate for reference standard and
cleaned to remove all organic matter such as described in National Bureau of Standards
oil, grease, detergent residues, etc. Examine Circular 484, Spectrophotometry, U.S. De-
all glassware, including stoppers and stop- partment of Commerce, (1949). The accuracy
cocks, under ultraviolet light to detect any is to be determined by comparison with the
residual fluorescent contamination. As a pre- standard values at 290, 345, and 400 milli-
cautionary measure, it is recommended prac- microns. The procedure is incorporated by
tice to rinse all glassware with purified iso- reference. Copies of the material incor-
octane immediately before use. No grease is porated by reference are available from the
to be used on stopcocks or joints. Great care Center for Food Safety and Applied Nutri-
to avoid contamination of petroleum naph- tion (HFS–200), Food and Drug Administra-
tha samples in handling and to assure ab- tion, 5100 Paint Branch Pkwy., College Park,
sence of any extraneous material arising MD 20740, or available for inspection at the
National Archives and Records Administra-
from inadequate packaging is essential. Be-
tion (NARA). For information on the avail-
cause some of the polynuclear hydrocarbons
ability of this material at NARA, call 202–
sought in this test are very susceptible to
741–6030, or go to: http://www.archives.gov/

photo-oxidation, the entire procedure is to federallregister/codeloflfederallregulations/
be carried out under subdued light. ibrllocations.html.
43
§ 172.250 21 CFR Ch. I (4–1–12 Edition)
contents of the flask are evaporated on a tube into the flask, mix until the sodium
steam bath until 1 milliliter of residue re- borohydride is dissolved, and allow to stand
mains. Dissolve the 1 milliliter of hexa- for 30 minutes at room temperature, with
decane residue in isooctane and make up to intermittent swirling. At the end of this
25 milliliters. Determine the absorbance in a time, disconnect the flask and evaporate the
5-centimeter path length cell compared to methyl alcohol on the steam bath under ni-
isooctane as reference. The absorbance trogen until sodium borohydride begins to
should not exceed 0.01 per centimeter path drop out of solution. Remove the flask and
length between 280–400 mμ. If necessary, iso- let it cool.
octane may be purified by passage through a Add 6 milliliters of isooctane to the flask
column of activated silica gel (Grade 12, Da- and swirl to wash the crystalline slurry.
vidson Chemical Co., Baltimore, Md., or Carefully transfer the isooctane extract to a
equivalent) or by distillation. 250-milliliter separatory funnel. Dissolve the
Methyl alcohol, A.C.S. reagent grade. Use 10 crystals in the flask with about 25 milliliters
milliliters and proceed as with isooctane. of distilled water and pour this also into the
The absorbance per centimeter of path separatory funnel. Adjust the water volume
length should be 0.00 between 280–400 mμ. in the separatory funnel to about 100 milli-
Methyl alcohol may be purified by simple liters and shake for 1 minute. After separa-
distillation or by refluxing in the presence of tion of the layers, draw off the aqueous layer
potassium hydroxide (10 grams/2 liters) and into a second 250-milliliter separatory fun-
zinc dust (25 grams/2 liters) for 3 hours fol- nel. Transfer the hydrocarbon layer in the
lowed by distillation. first funnel to a 25-milliliter volumetric
n-Hexadecane, 99 percent olefin-free. Dilute flask.
1.0 milliliter of n-hexadecane to 25 milliliters Carefully wash the Erlenmeyer flask with
with isooctane and determine the absorbance an additional 6 milliliters of isooctane, swirl,
in a 5-centimeter cell compared to isooctane and transfer to the second separatory funnel.
as reference between 280–400 mμ. The absorb- Shake the funnel for 1 minute. After separa-
ance per centimeter path length shall not ex- tion of the layers, draw off the aqueous layer
ceed 0.00 in this range. Purify, if necessary, into the first separatory funnel. Transfer the
by percolation through activated silica gel isooctane in the second funnel to the volu-
or by distillation. metric flask. Again wash the Erlenmeyer
Sodium borohydride. 98 percent. flask with an additional 6 milliliters of iso-
Water. All distilled water must be ex- octane, swirl, and transfer to the first sepa-
tracted with isooctane before use. A series of ratory funnel. Shake the funnel for 1 minute.
three successive extracts of 1.5 liters of dis- After separation of the layers, draw off the
tilled water with 100-milliliter portions of aqueous layer and discard. Transfer the iso-
isooctane is satisfactory. octane layer to the volumetric flask and ad-
just the volume to 25 milliliters of isooctane.
PROCEDURE Mix the contents well, then transfer to the
Determination of ultraviolet absorbance. Add first separatory funnel and wash twice with
a 25-milliliter aliquot of the hydrocarbon 50-milliliter portions of distilled water. Dis-
solvent together with 1 milliliter of hexa- card the aqueous layers after each wash.
decane to the 125-milliliter Erlenmeyer Determine the ultraviolet absorbance of
flask. While flushing with nitrogen, evapo- the isooctane extract in 5-centimeter path
rate to 1 milliliter on a steam bath. Nitrogen length cells compared to isooctane as ref-
is admitted through a 8±1-milliliter outer-di- erence between 280–400 mμ. Determine a rea-
ameter tube, drawn out into a 2±1-centimeter gent blank concurrently with the sample,
long and 1±0.5-millimeter inner-diameter using 25 milliliters of purified isooctane in-
capillary tip. This is positioned so that the stead of a solvent sample and measuring the
capillary tip extends 4 centimeters into the ultraviolet absorbance of the blank between
flask. The nitrogen flow rate is such that the 280–400mμ.
surface of the liquid is barely disturbed. The reagent blank absorbance should not
After the volume is reduced to that of the 1 exceed 0.04 per centimeter path length be-
milliliter of hexadecane, the flask is left on tween 280–289 mμ; 0.020 between 290–359 mμ;
the steam bath for 10 more minutes before and 0.010 between 360–400 mμ.
removing. Add 10 milliliters of purified iso- Determination of boiling-point range. Use
octane to the flask and reevaporate the solu- ASTM method D86–82, ‘‘Standard Method for
tion to a 1-milliliter volume in the same Distillation of Petroleum Products,’’ which
manner as described above, except do not is incorporated by reference. Copies may be
heat for an added 10 minutes. Repeat this op- obtained from the American Society for
eration twice more. Let the flask cool. Testing Materials, 100 Barr Harbor Dr., West
Add 10 milliliters of methyl alcohol and Conshohocken, Philadelphia, PA 19428-2959,
about 0.3 gram of sodium borohydride. (Mini- or may be examined at the National Ar-
mize exposure of the borohydride to the at- chives and Records Administration (NARA).
mosphere; a measuring dipper may be used.) For information on the availability of this
Immediately fit a water-cooled condenser material at NARA, call 202–741–6030, or go to:
equipped with a 24/40 joint and with a drying http://www.archives.gov/federallregister/
44
codeloflfederallregulations/ scribed in item 2.3 of the table in
ibrllocations.html. § 177.1520(c) of this chapter. The
Determination of nonvolatile residue. For hy- oxidized polyethylene has a minimum
drocarbons boiling below 121 °C, determine
the nonvolatile residue by ASTM method
number average molecular weight of
D1353–78, ‘‘Standard Test Method for Non- 1,200, as determined by high tempera-
volatile Matter in Volatile Solvents for Use ture vapor pressure osmometry; con-
in Paint, Varnish, Lacquer, and Related tains a maximum of 5 percent by
Products;’’ for those boiling above 121 °C, use weight of total oxygen; and has an acid
ASTM method D381–80, ‘‘Standard Test value of 9 to 19.
Method for Existent Gum in Fuels by Jet (b) The additive is used or intended
Evaporation,’’ which methods are incor-
porated by reference. Copies may be obtained for use as a protective coating or com-
from the American Society for Testing Ma- ponent of protective coatings for fresh
terials, 100 Barr Harbor Dr., West avocados, bananas, beets, coconuts,
Conshohocken, Philadelphia, PA 19428-2959, eggplant, garlic, grapefruit, lemons,
or may be examined at the National Ar- limes, mango, muskmelons, onions, or-
chives and Records Administration (NARA). anges, papaya, peas (in pods), pine-
For information on the availability of this apple, plantain, pumpkin, rutabaga,
material at NARA, call 202–741–6030, or go to:
squash (acorn), sweetpotatoes, tan-
http://www.archives.gov/federallregister/
codeloflfederallregulations/ gerines, turnips, watermelon, Brazil
ibrllocations.html. nuts, chestnuts, filberts, hazelnuts, pe-
cans, and walnuts (all nuts in shells).
(c) Petroleum naphtha containing (c) The additive is used in accordance
antioxidants shall meet the specified with good manufacturing practice and
ultraviolet absorbance limits after cor- in an amount not to exceed that re-
rection for any absorbance due to the quired to produce the intended effect.
antioxidants. Petroleum naphtha may
contain antioxidants authorized for use § 172.270 Sulfated butyl oleate.
in food in an amount not to exceed
that reasonably required to accomplish Sulfate butyl oleate may be safely
the intended effect or to exceed any used in food, subject to the following
prescribed limitations. prescribed conditions:
(d) Petroleum naphtha is used or in- (a) The additive is prepared by sul-
tended for use as a solvent in protec- fation, using concentrated sulfuric
tive coatings on fresh citrus fruit in acid, of a mixture of butyl esters pro-
compliance with § 172.210. duced by transesterification of an edi-
ble vegetable oil using 1-butanol. Fol-
[42 FR 14491, Mar. 15, 1977, as amended at 47 lowing sulfation, the reaction mixture
FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, is washed with water and neutralized
1984; 54 FR 24896, June 12, 1989]
with aqueous sodium or potassium hy-
§ 172.255 Polyacrylamide. droxide. Prior to sulfation, the butyl
oleate reaction mixture meets the fol-
Polyacrylamide containing not more lowing specifications:
than 0.2 percent of acrylamide mon- (1) Not less than 90 percent butyl ole-
omer may be safely used as a film ate.
former in the imprinting of soft-shell
(2) Not more than 1.5 percent unsa-
gelatin capsules when the amount used
ponifiable matter.
is not in excess of the minimum re-
(b) The additive is used or intended
quired to produce the intended effect.
for use at a level not to exceed 2 per-
§ 172.260 Oxidized polyethylene. cent by weight in an aqueous emulsion
in dehydrating grapes to produce rai-
Oxidized polyethylene may be safely sins, whereby the residue of the addi-
used as a component of food, subject to tive on the raisins does not exceed 100
the following restrictions: parts per million.
(a) Oxidized polyethylene is the basic
resin produced by the mild air oxida- [57 FR 12711, Apr. 13, 1992]
tion of polyethylene. The polyethylene
used in the oxidation process conforms § 172.275 Synthetic paraffin and suc-
to the density, maximum n-hexane ex- cinic derivatives.
tractable fraction, and maximum xy- Synthetic paraffin and succinic de-
lene soluble fraction specifications pre- rivatives identified in this section may
45
§ 172.280 21 CFR Ch. I (4–1–12 Edition)
be safely used as a component of food, federallregister/

subject to the following restrictions: codeloflfederallregulations/
(a) The additive is prepared with 50 ibrllocations.html.
percent Fischer-Tropsch process syn- (b) It is used or intended for use as
thetic paraffin, meeting the definition follows:
and specifications of § 172.615, and 50 (1) As a moisture barrier on soft gela-
percent of such synthetic paraffin to tin capsules in an amount not to ex-
which is bonded succinic anhydride and ceed 0.07 percent of the weight of the
succinic acid derivatives of isopropyl capsule.
alcohol, polyethylene glycol, and poly- (2) As a moisture barrier on powders
propylene glycol. It consists of a mix- of ascorbic acid or its salts in an
ture of the Fischer-Tropsch process amount not to exceed 7 percent of the
paraffin (alkane), alkyl succinic anhy- weight of the powder.
dride, alkyl succinic anhydride iso- [42 FR 14491, Mar. 15, 1977, as amended at 49
propyl half ester, dialkyl succinic an- FR 10104, Mar. 19, 1984]
hydride polyethylene glycol half ester,
and dialkyl succinic anhydride poly- Subpart D—Special Dietary and
propylene glycol half ester, where the
alkane (alkyl) has a chain length of 30–
Nutritional Additives
70 carbon atoms and the polyethylene § 172.310 Aluminum nicotinate.
and polypropylene glycols have molec-
Aluminum nicotinate may be safely
ular weights of 600 and 260, respec-
used as a source of niacin in foods for
tively.
special dietary use. A statement of the
(b) The additive meets the following
concentration of the additive, ex-
specifications: Molecular weight, 880–
pressed as niacin, shall appear on the
930; melting point, 215°–217 °F; acid
label of the food additive container or
number, 43–47; and saponification num-
on that of any intermediate premix
ber, 75–78.
prepared therefrom.
(c) It is used or intended for use as a
protective coating or component of § 172.315 Nicotinamide-ascorbic acid
protective coatings for fresh grape- complex.
fruit, lemons, limes, muskmelons, or- Nicotinamide-ascorbic acid complex
anges, sweetpotatoes, and tangerines. may be safely used in accordance with
(d) It is used in an amount not to ex-
the following prescribed conditions:
ceed that required to produce the in- (a) The additive is the product of the
tended effect. controlled reaction between ascorbic
§ 172.280 Terpene resin. acid and nicotinamide, melting in the
range 141 °C to 145 °C.
The food additive terpene resin may (b) It is used as a source of ascorbic
be safely used in accordance with the acid and nicotinamide in multivitamin
following prescribed conditions: preparations.
(a) The food additive is the beta-
pinene polymer obtained by polym- § 172.320 Amino acids.
erizing terpene hydrocarbons derived The food additive amino acids may
from wood. It has a softening point of be safely used as nutrients added to
112 °C–118 °C, as determined by ASTM foods in accordance with the following
method E28–67 (Reapproved 1982), conditions:
‘‘Standard Test Method for Softening (a) The food additive consists of one
Point By Ring-and-Ball Apparatus,’’ or more of the following individual
which is incorporated by reference. amino acids in the free, hydrated or an-
Copies may be obtained from the Amer- hydrous form or as the hydrochloride,
ican Society for Testing Materials, 100 sodium or potassium salts:
Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be L-Alanine
examined at the National Archives and L-Arginine
L-Asparagine
Records Administration (NARA). For L-Aspartic acid
information on the availability of this
L-Cysteine
material at NARA, call 202–741–6030, or L-Cystine
go to: http://www.archives.gov/ L-Glutamic acid
46
L-Glutamine Records Administration (NARA). For
Aminoacetic acid (glycine) information on the availability of this
L-Histidine material at NARA, call 202–741–6030, or
L-Isoleucine
L-Leucine
go to: http://www.archives.gov/
L-Lysine federallregister/
DL-Methionine (not for infant foods) codeloflfederallregulations/
L-Methionine ibrllocations.html.) for the following:
L-Phenylalanine
L-Proline L-Asparagine
L-Serine L-Aspartic acid
L-Threonine L-Glutamine
L-Tryptophan L-Histidine
L-Tyrosine (c) The additive(s) is used or intended
L-Valine for use to significantly improve the bi-
(b) The food additive meets the fol- ological quality of the total protein in
lowing specifications: a food containing naturally occurring
(1) As found in ‘‘Food Chemicals primarily-intact protein that is consid-
Codex,’’ National Academy of Sciences/ ered a significant dietary protein
National Research Council (NAS/NRC), source, provided that:
3d Ed. (1981), which is incorporated by (1) A reasonable daily adult intake of
reference (Copies may be obtained from the finished food furnishes at least 6.5
the National Academy Press, 2101 Con- grams of naturally occurring primarily
stitution Ave. NW., Washington, DC intact protein (based upon 10 percent of
20418, or may be examined at the Na- the daily allowance for the ‘‘reference’’
tional Archives and Records Adminis- adult male recommended by the Na-
tration (NARA). For information on tional Academy of Sciences in ‘‘Rec-
the availability of this material at ommended Dietary Allowances,’’ NAS
NARA, call 202–741–6030, or go to: http:// Publication No. 1694, 7th Ed. (1968),
www.archives.gov/federallregister/ which is incorporated by reference.
codeloflfederallregulations/ Copies are available from the Center
ibrllocations.html.) for the following: for Food Safety and Applied Nutrition
(HFS–200), Food and Drug Administra-
L-Alanine tion, 5100 Paint Branch Pkwy., College
L-Arginine Park, MD 20740, or available for inspec-
L-Arginine Monohydrochloride
L-Cysteine Monohydrochloride
tion at the National Archives and
L-Cystine Records Administration (NARA). For
Aminoacetic acid (glycine) information on the availability of this
L-Leucine material at NARA, call 202–741–6030, or
DL-Methionine go to: http://www.archives.gov/
L-Methionine federallregister/
L-Tryptophan codeloflfederallregulations/
L-Phenylalanine ibrllocations.html.
L-Proline
L-Serine
(2) The additive(s) results in a pro-
L-Threonine tein efficiency ratio (PER) of protein
Glutamic Acid Hydrochloride in the finished ready-to-eat food equiv-
L-Isoleucine alent to casein as determined by the
L-Lysine Monohydrochloride method specified in paragraph (d) of
Monopotassium L-glutamate this section.
L-Tyrosine (3) Each amino acid (or combination
L-Valine
of the minimum number necessary to
(2) As found in ‘‘Specifications and achieve a statistically significant in-
Criteria for Biochemical Compounds,’’ crease) added results in a statistically
NAS/NRC Publication, 3rd Ed. (1972), significant increase in the PER as de-
which is incorporated by reference termined by the method described in
(Copies are available from the Center paragraph (d) of this section. The min-
for Food Safety and Applied Nutrition imum amount of the amino acid(s) to
(HFS–200), Food and Drug Administra- achieve the desired effect must be used
tion, 5100 Paint Branch Pkwy., College and the increase in PER over the pri-
Park, MD 20740, or available for inspec- marily-intact naturally occurring pro-

tion at the National Archives and tein in the food must be substantiated
47
§ 172.325 21 CFR Ch. I (4–1–12 Edition)
as a statistically significant difference make such records available upon re-

with at least a probability (P) value of quest at all reasonable hours by any of-
less than 0.05. ficer or employee of the Food and Drug
(4) The amount of the additive added Administration, or any other officer or
for nutritive purposes plus the amount employee acting on behalf of the Sec-
naturally present in free and combined retary of Health and Human Services
(as protein) form does not exceed the and shall permit such officer or em-
following levels of amino acids ex- ployee to conduct such inventories of
pressed as percent by weight of the raw and finished materials on hand as
total protein of the finished food: he deems necessary and otherwise to
check the correctness of such records.
Percent by
weight of (e) To assure safe use of the additive,
total pro- the label and labeling of the additive
tein (ex-
pressed as and any premix thereof shall bear, in
free amino addition to the other information re-
acid)
quired by the Act, the following:
L-Alanine .............................................................. 6.1 (1) The name of the amino acid(s)
L-Arginine ............................................................ 6.6 contained therein including the spe-
L-Aspartic acid (including L-asparagine) ............. 7.0
L-Cystine (including L-cysteine) .......................... 2.3
cific optical and chemical form.
L-Glutamic acid (including L-glutamine) .............. 12.4 (2) The amounts of each amino acid
Aminoacetic acid (glycine) ................................... 3.5 contained in any mixture.
L-Histidine ............................................................ 2.4
L-Isoleucine ......................................................... 6.6
(3) Adequate directions for use to
L-Leucine ............................................................. 8.8 provide a finished food meeting the
L-Lysine ............................................................... 6.4 limitations prescribed by paragraph (c)
L- and DL-Methionine .......................................... 3.1 of this section.
L-Phenylalanine ................................................... 5.8
L-Proline .............................................................. 4.2 (f) The food additive amino acids
L-Serine ............................................................... 8.4 added as nutrients to special dietary
L-Threonine ......................................................... 5.0 foods that are intended for use solely
L-Tryptophan ....................................................... 1.6
L-Tyrosine ............................................................ 4.3
under medical supervision to meet nu-
L-Valine ................................................................ 7.4 tritional requirements in specific med-
ical conditions and comply with the re-
(d) Compliance with the limitations quirements of part 105 of this chapter
concerning PER under paragraph (c) of are exempt from the limitations in
this section shall be determined by the paragraphs (c) and (d) of this section
method described in sections 43.212– and may be used in such foods at levels
43.216, ‘‘Official Methods of Analysis of not to exceed good manufacturing
the Association of Official Analytical practices.
Chemists,’’ 13th Ed. (1980), which is in- [42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct.
corporated by reference. Copies may be 28, 1977, as amended at 47 FR 11836, Mar. 19,
obtained from the AOAC INTER- 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897,
NATIONAL, 481 North Frederick Ave., June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR
suite 500, Gaithersburg, MD 20877, or 14480, Apr. 2, 1996]
may be examined at the National Ar-
chives and Records Administration § 172.325 Bakers yeast protein.
(NARA). For information on the avail- Bakers yeast protein may be safely
ability of this material at NARA, call used in food in accordance with the fol-
202–741–6030, or go to: http:// lowing conditions:
www.archives.gov/federallregister/ (a) Bakers yeast protein is the insol-
codeloflfederallregulations/ uble proteinaceous material remaining
ibrllocations.html. Each manufacturer after the mechanical rupture of yeast
or person employing the additive(s) cells of Saccharomyces cerevisiae and re-
under the provisions of this section moval of whole cell walls by cen-
shall keep and maintain throughout trifugation and separation of soluble
the period of his use of the additive(s) cellular materials.
and for a minimum of 3 years there- (b) The additive meets the following
after, records of the tests required by specifications on a dry weight basis:
this paragraph and other records re- (1) Zinc salts less than 500 parts per
quired to assure effectiveness and com- million (ppm) as zinc.

pliance with this regulation and shall (2) Nucleic acid less than 2 percent.
48
(3) Less than 0.3 ppm arsenic, 0.1 ppm (1) The additive shall consist prin-
cadmium, 0.4 ppm lead, 0.05 ppm mer- cipally of dried fish protein prepared
cury, and 0.3 ppm selenium. from the edible portions of fish after
(c) The viable microbial content of removal of the heads, fins, tails, bones,
the finished ingredient is: scales, viscera, and intestinal contents.
(1) Less than 10,000 organisms/gram (2) The additive shall be derived only
by aerobic plate count. from species of bony fish that are gen-
(2) Less than 10 yeasts and molds/ erally recognized by qualified sci-
gram. entists as safe for human consumption
(3) Negative for Salmonella, E. coli, and that can be processed as prescribed
coagulase positive Staphylococci, Clos- to meet the required specifications.
tridium perfringens, Clostridium botu- (3) Only wholesome fresh fish other-
linum, or any other recognized micro- wise suitable for human consumption
bial pathogen or any harmful microbial may be used. The fish shall be handled
toxin. expeditiously under sanitary condi-
(d) The ingredient is used in food as tions. These conditions shall be in ac-
a nutrient supplement as defined in cordance with recognized good manu-
§ 170.3(o)(20) of this chapter. facturing practice for fish to be used as
human food.
§ 172.330 Calcium pantothenate, cal- (4) The additive shall be prepared by
cium chloride double salt. extraction with hexane and food-grade
ethanol to remove fat and moisture.
The food additive calcium chloride Solvent residues shall be reduced by
double salt of calcium pantothenate drying.
may be safely used in foods for special (b) The food additive meets the fol-
dietary uses in accordance with good lowing specifications: (Where methods
manufacturing practice and under the of determination are specified, they are
following prescribed conditions: Association of Official Analytical
(a) The food additive is of the d (dex- Chemists Methods, 13th ed., 1980, which
trorotatory) or the dl (racemic) form. are incorporated by reference). 1
(b) To assure safe use of the additive, (1) Protein content, as N × 6.25, shall
the label and labeling of the food addi- not be less than 90 percent by weight of
tive container, or that of any inter- the final product, as determined by the
mediate premixes prepared therefrom, method described in section 2.057, Im-
shall bear, in addition to the other in- proved Kjeldahl Method for Nitrate-
formation required by the Act, the fol- Free Samples (20)—Official Final Ac-
lowing: tion.
(1) The name of the additive ‘‘cal- (2) Moisture content shall not be
cium chloride double salt of d-calcium more than 10 percent by weight of the
pantothenate’’ or ‘‘calcium chloride final product, as determined by the
double salt of dl-calcium panto- method described in section 24.003, Air
thenate’’, whichever is appropriate. Drying (1)—Official First Action.
(2) A statement of the appropriate (3) Fat content shall not be more
concentration of the additive, ex- than 0.5 percent by weight of the final
pressed as pantothenic acid. product, as determined by the method
described in section 24.005, Crude Fat
§ 172.335 D-Pantothenamide. or Ether Extract—Official Final Ac-
The food additive D-pantothenamide tion.
as a source of pantothenic acid activ- (4) Solvent residues in the final prod-
ity, may be safely used in foods for spe- uct shall not be more than 5 parts per
cial dietary use in an amount not in
excess of that reasonably required to 1 Copies are available from: AOAC INTER-
produce its intended effect. NATIONAL, 481 North Frederick Ave., suite
500, Gaithersburg, MD 20877, or examined at
§ 172.340 Fish protein isolate. the National Archives and Records Adminis-
tration (NARA). For information on the
(a) The food additive fish protein iso- availability of this material at NARA, call
late may be safely used as a food sup-
202–741–6030, or go to: http://www.archives.gov/

plement in accordance with the fol- federallregister/codeloflfederallregulations/
lowing prescribed conditions: ibrllocations.html.
49
§ 172.345 21 CFR Ch. I (4–1–12 Edition)
million of hexane and 3.5 percent eth- the Orphan Drug Act (21 U.S.C.
anol by weight. 360ee(b)(3)), at levels not to exceed the
[46 FR 38072, July 24, 1981, as amended at 47 amount necessary to meet the distinc-
FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, tive nutritional requirements of the
1989] disease or condition for which the food
is formulated.
§ 172.345 Folic acid (folacin). (g) Folic acid may be added to food
Folic acid (CAS Reg. No. 59–30–3), for special dietary use at levels not to
also known as folacin or folate, may be exceed the amount necessary to meet
safely used in food as a nutrient in ac- the special dietary needs for which the
cordance with the following prescribed food is formulated.
conditions: (h) Folic acid may be added to foods
(a) Folic acid is the chemical N-[4-
represented as meal-replacement prod-
[[(2-amino-1,4-dihydro-4-oxo-6-pteri-
ucts, in amounts not to exceed:
dinyl)methyl]amino]benzoyl]-L-glu-
tamic acid. (1) Four hundred μg per serving if the
(b) Folic acid meets the specifica- food is a meal-replacement that is rep-
tions of the ‘‘Food Chemicals Codex,’’ resented for use once per day; or
4th ed. (1996), pp. 157–158, which is in- (2) Two hundred μg per serving if the
corporated by reference in accordance food is a meal-replacement that is rep-
with 5 U.S.C. 552(a) and 1 CFR part 51. resented for use more than once per
Copies are available from the National day.
Academy Press, Box 285, 2101 Constitu-
[61 FR 8807, Mar. 5, 1996, as amended at 61 FR
tion Ave. NW., Washington, DC 20055 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999]
(Internet address http://www.nap.edu),
or may be examined at the Center for § 172.350 Fumaric acid and salts of fu-
Food Safety and Applied Nutrition’s maric acid.
Library, Food and Drug Administra-
tion, 5100 Paint Branch Pkwy., College Fumaric acid and its calcium, fer-
Park, MD 20740, or at the National Ar- rous, magnesium, potassium, and so-
chives and Records Administration dium salts may be safely used in food
(NARA). For information on the avail- in accordance with the following pre-
ability of this material at NARA, call scribed conditions:
202–741–6030, or go to: http:// (a) The additives meet the following
www.archives.gov/federallregister/ specifications:
codeloflfederallregulations/ (1) Fumaric acid contains a minimum
ibrllocations.html. of 99.5 percent by weight of fumaric
(c) Folic acid may be added to foods acid, calculated on the anhydrous
subject to a standard of identity estab- basis.
lished under section 401 of the Federal (2) The calcium, magnesium, potas-
Food, Drug, and Cosmetic Act (the act) sium, and sodium salts contain a min-
when the standard of identity specifi- imum of 99 percent by weight of the re-
cally provides for the addition of folic spective salt, calculated on the anhy-
acid.
drous basis. Ferrous fumarate contains
(d) Folic acid may be added, at levels
a minimum of 31.3 percent total iron
not to exceed 400 micrograms (μg) per
serving, to breakfast cereals, as defined and not more than 2 percent ferric
under § 170.3(n)(4) of this chapter, and iron.
to corn grits at a level such that each (b) With the exception of ferrous fu-
pound of corn grits contains not more marate, fumaric acid and the named
than 1.0 milligram of folic acid. salts are used singly or in combination
(e) Folic acid may be added to infant in food at a level not in excess of the
formula in accordance with section amount reasonably required to accom-
412(i)(1) of the act or with regulations plish the intended effect.
issued under section 412(i)(2) of the act (c) Ferrous fumarate is used as a
which are codified in § 107.100 of this source of iron in foods for special die-
chapter.
tary use, when the use is consistent

(f) Folic acid may be added to a med- with good nutrition practice.
ical food, as defined in section 5(b)(3) of
50
§ 172.365 Kelp. tate; 50 ppm ethyl alcohol; 10 ppm

Kelp may be safely added to a food as methyl alcohol; and 10 ppm acetone,
a source of the essential mineral io- when used as processing solvents.
dine, provided the maximum intake of (c) The additive is used or intended
the food as may be consumed during a for use as a source of L-methionine to
period of one day, or as directed for use improve significantly the biological
in the case of a dietary supplement, quality of the total protein in a food
will not result in daily ingestion of the containing naturally occurring pri-
additive so as to provide a total marily intact vegetable protein that is
amount of iodine in excess of 225 considered a significant dietary protein
micrograms for foods labeled without source, provided that:
reference to age or physiological state; (1) A reasonable daily adult intake of
and when age or the conditions of preg- the finished food furnishes at least 6.5
nancy or lactation are specified, in ex- grams of naturally occurring primarily
cess of 45 micrograms for infants, 105 intact vegetable protein.
micrograms for children under 4 years (2) The additive results in a protein
of age, 225 micrograms for adults and efficiency ratio (PER) of protein in the
children 4 or more years of age, and 300 finished ready-to-eat food equivalent
micrograms for pregnant or lactating to casein as determined by the method
women. The food additive kelp is the specified in paragraph (d) of this sec-
dehydrated, ground product prepared tion.
from Macrocystis pyrifera, Laminaria (3) The use of the additive results in
digitata, Laminaria saccharina, and Lam- a statistically significant increase in
inaria cloustoni. the PER as determined by the method
described in paragraph (d) of this sec-
§ 172.370 Iron-choline citrate complex. tion. The minimum amount of the ad-
Iron-choline citrate complex made by ditive to achieve the desired effect
reacting approximately equimolecular must be used, and the increase in PER
quantities of ferric hydroxide, choline, over the primarily intact naturally oc-
and citric acid may be safely used as a curring vegetable protein in the food
source of iron in foods for special die- must be substantiated as a statis-
tary use. tically significant difference with at
least a probability (P) value of less
§ 172.372 N-Acetyl-L-methionine. than 0.05.
The food additive N-acetyl-L-methio- (4) The amount of the additive added
nine may be safely added to food (ex- for nutritive purpose shall not exceed
cept infant foods and foods containing the level that will provide a total of 3.1
added nitrites/nitrates) as a source of percent L- and DL-methionine (ex-
L-methionine for use as a nutrient in pressed as the free amino acid) by
accordance with the following condi- weight of the total protein of the fin-
tions: ished food, including the amount natu-
(a) N-Acetyl-L-methionine (Chemical rally present in free and combined (as
Abstracts Service Registry No. 65–82–7) protein) form.
is the derivative of the amino acid me- (5) The additive shall not be added to
thionine formed by addition of an ace- infant foods or to foods containing
tyl group to the alpha-amino group of added nitrites/nitrates.
methionine. It may be in the free, hy- (d) Compliance with the limitations
drated or anhydrous form, or as the so- concerning PER under paragraph (c) of
dium or potassium salts. the section shall be determined by the
(b) The additive meets the following method described in sections 43.212–
specifications: 43.216, ‘‘Official Methods of Analysis of
(1) Purity assay, on a dry basis: Min- the Association of Official Analytical
imum 99 percent. Chemists,’’ 13th Ed. (1980), which is in-
(2) Residue on ignition: Maximum 0.1 corporated by reference. Copies may be
percent. obtained from the AOAC INTER-
(3) Specific optical rotation NATIONAL, 481 North Frederick Ave.,
[alpha]20D: Between ¥19° and ¥23°. suite 500, Gaithersburg, MD 20877, or
(4) The additive may contain residues may be examined at the National Ar-
of not more than 500 ppm ethyl ace- chives and Records Administration
51
§ 172.375 21 CFR Ch. I (4–1–12 Edition)
(NARA). For information on the avail- (a) Potassium iodide may be safely
ability of this material at NARA, call added to a food as a source of the es-
202–741–6030, or go to: http:// sential mineral iodine, provided the
www.archives.gov/federallregister/ maximum intake of the food as may be
codeloflfederallregulations/ consumed during a period of one day,
ibrllocations.html. Each manufacturer or as directed for use in the case of a
or person employing the additive under dietary supplement, will not result in
the provisions of this section shall daily ingestion of the additive so as to
keep and maintain throughout the pe- provide a total amount of iodine in ex-
riod of use of the additive and for a cess of 225 micrograms for foods labeled
minimum of 3 years thereafter, records without reference to age or physio-
of the tests required by this paragraph logical state; and when age or the con-
and other records required to assure ef- ditions of pregnancy or lactation are
fectiveness and compliance with this specified, in excess of 45 micrograms
regulation. Those records shall be for infants, 105 micrograms for children
made available upon request at all rea- under 4 years of age, 225 micrograms
sonable hours by any officer or em- for adults and children 4 or more years
ployee acting on behalf of the Sec- of age, and 300 micrograms for preg-
retary of Health and Human Services. nant or lactating women.
Those officers or employees shall be (b) To assure safe use of the additive,
permitted to conduct inventories of in addition to the other information re-
raw and finished materials on hand as quired by the Act, the label of the addi-
are deemed necessary to verify the tive shall bear:
records. (1) The name of the additive.
(e) To assure safe use of the additive, (2) A statement of the concentration
the label and labeling of the additive of the additive in any mixture.
and any premix thereof shall bear, in
addition to the other information re- § 172.379 Vitamin D2.
quired by the Act, the following:
(1) The name of the additive con- Vitamin D2 may be used safely in
tained therein. foods as a nutrient supplement defined
under § 170.3(o)(20) of this chapter in ac-
(2) The amounts of additive and each
cordance with the following prescribed
amino acid contained in any mixture.
conditions:
(3) Adequate directions for use to
(a) Vitamin D2, also known as
provide a finished food meeting the
ergocalciferol, is the chemical 9,10-
limitations prescribed by paragraph (c)
seco(5Z,7E,22E)-5,7,10(19),22-
of this section.
ergostatetraen-3-ol. Vitamin D2 is pro-
(f) When the food additive is added as
duced by ultraviolet irradiation of er-
a nutrient to special dietary foods that
gosterol isolated from yeast and is pu-
are intended for use solely under med-
rified by crystallization.
ical supervision to meet nutritional re-
quirements in specific medical condi- (b) Vitamin D2 meets the specifica-
tions and these foods comply with the tions of the Food Chemicals Codex, 6th
requirements of part 105 of this chap- ed. (2008), pp. 1013 and 1014, which is in-
ter, the food additive is exempt from corporated by reference. The Director
the limitations in paragraphs (c)(1) of the Federal Register approves this
through (4) and (d) of this section and incorporation by reference in accord-
may be used in those foods at levels ance with 5 U.S.C 552(a) and 1 CFR part
not to exceed good manufacturing 51. You may obtain a copy from the
practices. United States Pharmacopeial Conven-
tion, 12601 Twinbrook Pkwy., Rock-
[43 FR 27784, June 27, 1978, as amended at 46 ville, MD 20852 (Internet address: http://
FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, www.usp.org). You may inspect a copy
1984; 54 FR 24897, June 12, 1989] at the Center for Food Safety and Ap-
plied Nutrition’s Library, Food and
§ 172.375 Potassium iodide. Drug Administration, 5100 Paint
The food additive potassium iodide Branch Pkwy., College Park, MD 20740,
may be safely used in accordance with 301–436–1071, or at the National Ar-

the following prescribed conditions: chives and Records Administration
52
(NARA). For information on the avail- codeloflfederallregulations/

ability of this material at NARA, call ibrllocations.html.
202–741–6030, or go to: http:// (c) The additive may be used as fol-
www.archives.gov/federallregister/ lows:
Category of Food Maximum Levels in Food (as Served)
Soy beverages 50 International Units (IU)/100 grams (g)
Soy beverage products 89 IU/100 g
Soy-based butter substitute spreads 330 IU/100 g
Soy-based cheese substitutes and soy-based cheese substitute 270 IU/100 g

products
[74 FR 11022, Mar. 16, 2009] fined under § 170.3(n)(35) of this chapter)
that are fortified with greater than or
§ 172.380 Vitamin D3. equal to 33 percent of the reference
Vitamin D3 may be used safely in daily intake (RDI) of calcium per 240
foods as a nutrient supplement defined mL, excluding fruit juices that are spe-
under § 170.3(o)(20) of this chapter in ac- cially formulated or processed for in-
cordance with the following prescribed fants.
conditions: (2) At levels not to exceed 100 IU per
(a) Vitamin D3, also known as chole- 240 mL in fruit juice drinks (as defined
calciferol, is the chemical 9,10- under § 170.3(n)(35) of this chapter) that
seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. are fortified with greater than or equal
Vitamin D3 occurs in and is isolated to 10 percent of the RDI of calcium per
from fish liver oils. It also is manufac-
240 mL, excluding fruit juice drinks
tured by ultraviolet irradiation of 7-de-
that are specially formulated or proc-
hydrocholesterol produced from choles-
essed for infants.
terol and is purified by crystallization.
(b) Vitamin D3 meets the specifica- (3) At levels not to exceed 140 IU per
tions of the Food Chemicals Codex, 5th 240 mL (prepared beverage) in soy-pro-
ed. (2004), pp. 498–499, which is incor- tein based meal replacement beverages
porated by reference. The Director of (powder or liquid) that are represented
the Office of the Federal Register ap- for special dietary use in reducing or
proves this incorporation by reference maintaining body weight in accordance
in accordance with 5 U.S.C. 552(a) and 1 with § 105.66 of this chapter.
CFR part 51. You may obtain copies (4) At levels not to exceed 100 IU per
from the National Academy Press, 500 40 grams in meal replacement bars or
Fifth St. NW., Washington, DC 20001 other-type bars that are represented
(Internet address http://www.nap.edu). for special dietary use in reducing or
Copies may be examined at the Center maintaining body weight in accordance
for Food Safety and Applied Nutri- with § 105.66 of this chapter.
tion’s Library, Food and Drug Admin- (5) At levels not to exceed 81 IU per 30
istration, 5100 Paint Branch Pkwy., grams in cheese and cheese products as
College Park, MD 20740, or at the Na- defined under § 170.3(n)(5) of this chap-
tional Archives and Records Adminis- ter, excluding cottage cheese, ricotta
tration (NARA). For information on cheese, and hard grating cheeses such
the availability of this material at
as Parmesan and Romano as defined in
NARA, call 202–741–6030, or go to: http://
§§ 133.165 and 133.183 of this chapter, and
codeloflfederallregulations/ those defined by standard of identity in
ibrllocations.html. § 133.148 of this chapter.
(c) The additive may be used as fol- [68 FR 9003, Feb. 27, 2003, as amended at 70
lows: FR 36025, June 22, 2005; 70 FR 37257, June 29,
(1) At levels not to exceed 100 Inter- 2005; 70 FR 69438, Nov. 16, 2005]
national Units (IU) per 240 milliliters

(mL) in 100 percent fruit juices (as de-
53
§ 172.385 21 CFR Ch. I (4–1–12 Edition)
§ 172.385 Whole fish protein con- scribed in section 24.003 of the AOAC.
centrate. See paragraph (c)(1) of this section for
The food additive whole fish protein availability of the material incor-
concentrate may be safely used as a porated by reference.
food supplement in accordance with (3) Fat content shall not exceed 0.5
the following prescribed conditions: percent by weight of the final product,
(a) The additive is derived from as determined by the method described
whole, wholesome hake and hakelike in section 24.005 of the AOAC. See para-
fish, herring of the genera Clupea, men- graph (c)(1) of the this section for
haden, and anchovy of the species En- availability of the material incor-
graulis mordax, handled expeditiously porated by reference.
and under sanitary conditions in ac- (4) The additive may contain residues
cordance with good manufacturing of isopropyl alcohol and ethylene di-
practices recognized as proper for fish chloride not in excess of 250 parts per
that are used in other forms for human million and 5 parts per million, respec-
food. tively, when used as solvents in the ex-
(b) The additive consists essentially traction process.
of a dried fish protein processed from (5) Microwave radiation meeting the
the whole fish without removal of requirements of § 179.30 of this chapter
heads, fins, tails, viscera, or intestinal may be used to reduce residues of the
contents. It is prepared by solvent ex- solvents used in the extraction process.
traction of fat and moisture with iso- (6) The additive shall contain not in
propyl alcohol or with ethylene dichlo- excess of 100 parts per million fluorides
ride followed by isopropyl alcohol, ex- (expressed as F).
cept that the additive derived from (7) The additive shall be free of Esch-
herring, menhaden and anchovy is pre- erichia coli and pathogenic organisms,
pared by solvent extraction with iso- including Salmonella, and shall have a
propyl alcohol alone. Solvent residues total bacterial plate count of not more
are reduced by conventional heat dry- than 10,000 per gram.
ing and/or microwave radiation and
(8) The additive shall have no more
there is a partial removal of bone.
than a faint characteristic fish odor
(c) The food additive meets the fol-
and taste.
lowing specifications:
(1) Protein content (N × 6.25) shall (d) When the additive is used or in-
not be less than 75 percent by weight of tended for use in the household as a
the final product, as determined by the protein supplement in food for regular
method described in section 2.057 in consumption by children up to 8 years
‘‘Official Methods of Analysis of the of age, the amount of the additive from
Association of Official Analytical this source shall not exceed 20 grams
Chemists’’ (AOAC), 13th Ed. (1980). Pro- per day (about one heaping table-
tein quality shall not be less than 100, spoon).
as determined by the method described (e) When the additive is used as a
in sections 43.212–43.216 of the AOAC. protein supplement in manufactured
The 13th Ed. is incorporated by ref- food, the total fluoride content (ex-
erence, and copies may be obtained pressed as F) of the finished food shall
from the AOAC INTERNATIONAL, 481 not exceed 8 ppm based on the dry
North Frederick Ave., suite 500, Gai- weight of the food product.
thersburg, MD 20877, or may be exam- (f) To assure safe use of the additive,
ined at the National Archives and in addition to the other information re-
Records Administration (NARA). For quired by the Act:
information on the availability of this (1) The label of consumer-sized or
material at NARA, call 202–741–6030, or bulk containers of the additive shall
go to: http://www.archives.gov/ bear the name ‘‘whole fish protein con-
federallregister/ centrate’’.
codeloflfederallregulations/ (2) The label or labeling of containers
ibrllocations.html. of the additive shall bear adequate di-
(2) Moisture content shall not exceed rections for use to comply with the
10 percent by weight of the final prod- limitations prescribed by paragraphs

uct, as determined by the method de- (d) and (e) of this section.
54
(3) Labels of manufactured foods con- (a) The additive is the chemical
taining the additive shall bear, in the green ferric ammonium citrate.
ingredient statement, the name of the (b) The additive is used, or intended
additive, ‘‘whole fish protein con- for use as an anticaking agent in salt
centrate’’ in the proper order of de- for human consumption so that the
creasing predominance in the finished level of iron ammonium citrate does
food. not exceed 25 parts per million (0.0025
percent) in the finished salt.
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12,
(c) To assure safe use of the additive
1989] the label or labeling of the additive
shall bear, in addition to the other in-
§ 172.395 Xylitol. formation required by the Act:
(1) The name of the additive.
Xylitol may be safely used in foods
(2) Adequate directions to provide a
for special dietary uses, provided the
final product that complies with the
amount used is not greater than that
limitations prescribed in paragraph (b)
required to produce its intended effect.
of this section.
§ 172.399 Zinc methionine sulfate.
§ 172.480 Silicon dioxide.
Zinc methionine sulfate, CAS Reg.
The food additive silicon dioxide may
No. 56329–42–1, may be safely used in
be safely used in food in accordance
with the following conditions:
scribed conditions:
(a) The food additive is manufactured
(a) The additive is the product of the
by vapor phase hydrolysis or by other
reaction between equimolar amounts of
means whereby the particle size is such
zinc sulfate and DL-methionine in puri-
as to accomplish the intended effect.
fied water.
(b) It is used as an anticaking agent,
subject to the following conditions:
specifications:
(1) It is used in only those foods in
Zinc content—19 to 22 percent. which the additive has been dem-
C5H11NO2S ‘‘DL-methionine’’—46 to 50 per- onstrated to have an anticaking effect.
cent. (2) It is used in an amount not in ex-
Cadmium—not more than 0.05 part per mil- cess of that reasonably required to
lion.
produce its intended effect.
(c) The additive is used in tablet form (3) [Reserved]
as a source of dietary zinc. (4) It is used in an amount not to ex-
ceed 2 percent by weight of the food.
[46 FR 58297, Dec. 1, 1981]
(c) It is used or intended for use as a
stabilizer in the production of beer, and
Subpart E—Anticaking Agents is removed from the beer by filtration
prior to final processing.
§ 172.410 Calcium silicate. (d) It is used or intended for use as an
Calcium silicate, including synthetic adsorbent for dl-a-tocopheryl acetate
calcium silicate, may be safely used in and pantothenyl alcohol in tableted
food in accordance with the following foods for special dietary use, in an
prescribed conditions: amount not greater than that required
(a) It is used as an anticaking agent to accomplish the intended physical or
in food in an amount not in excess of technical effect.
that reasonably required to produce its
intended effect. § 172.490 Yellow prussiate of soda.
(b) It will not exceed 2 percent by (a) The food additive yellow prussiate
weight of the food, except that it may of soda (sodium ferrocyanide decahy-
be present up to 5 percent by weight of drate; Na4Fe(CN)6·10H2O contains a
baking powder. minimum of 99 percent by weight of so-
dium ferrocyanide decahydrate.
§ 172.430 Iron ammonium citrate. (b) The additive is used or intended
Iron ammonium citrate may be safe- for use as an anticaking agent in salt
ly used in food in accordance with the and as an adjuvant in the production of

following prescribed conditions: dendritic crystals of salt in an amount
55
§ 172.510 21 CFR Ch. I (4–1–12 Edition)
needed to produce its intended effect (a) They are used in the minimum
but not in excess of 13 parts per million quantity required to produce their in-
calculated as anhydrous sodium ferro- tended physical or technical effect and
cyanide. in accordance with all the principles of
[42 FR 14491, Mar. 15, 1977, as amended at 58 good manufacturing practice.
FR 17098, Apr. 1, 1993] (b) In the appropriate forms (plant
parts, fluid and solid extracts, con-
Subpart F—Flavoring Agents and centrates, absolutes, oils, gums, bal-
Related Substances sams, resins, oleoresins, waxes, and dis-
tillates) they consist of one or more of
§ 172.510 Natural flavoring substances the following, used alone or in com-
and natural substances used in con- bination with flavoring substances and
junction with flavors.
adjuvants generally recognized as safe
Natural flavoring substances and in food, previously sanctioned for such
natural adjuvants may be safely used use, or regulated in any section of this
in food in accordance with the fol- part.
lowing conditions.
Common name Scientific name Limitations
Aloe ................................................................ Aloe perryi Baker, A. barbadensis Mill., A. ferox Mill.,

and hybrids of this sp. with A. africana Mill. and A.
spicata Baker.
Althea root and flowers .................................. Althea officinalis L.
Amyris (West Indian sandalwood) ................. Amyris balsamifera L.
Angola weed .................................................. Roccella fuciformis Ach .............................................. In alcoholic beverages
only
Arnica flowers ................................................. Arnica montana L., A. fulgens Pursh, A. sororia Do.
Greene, or A. cordifolia Hooker.
Artemisia (wormwood) .................................... Artemisia spp .............................................................. Finished food thujone
free 1
Artichoke leaves ............................................. Cynara scolymus L ..................................................... In alcoholic beverages
only
Benzoin resin ................................................. Styrax benzoin Dryander, S. paralleloneurus Per-
kins, S. tonkinensis (Pierre) Craib ex Hartwich, or
other spp. of the Section Anthostyrax of the genus
Styrax.
Blackberry bark .............................................. Rubus, Section Eubatus.
Boldus (boldo) leaves .................................... Peumus boldus Mol .................................................... Do.
Boronia flowers .............................................. Boronia megastigma Nees.
Bryonia root .................................................... Bryonia alba L., or B. diocia Jacq .............................. Do.
Buchu leaves .................................................. Barosma betulina Bartl. et Wendl., B. crenulata (L.)
Hook. or B. serratifolia Willd.
Buckbean leaves ............................................ Menyanthes trifoliata L ............................................... Do.
Cajeput ........................................................... Melaleuca leucadendron L. and other Melaleuca spp.
Calumba root .................................................. Jateorhiza palmata (Lam.) Miers ................................ Do.
Camphor tree ................................................. Cinnamomum camphora (L.) Nees et Eberm ............ Safrole free
Cascara sagrada ............................................ Rhamnus purshiana DC.
Cassie flowers ................................................ Acacia farnesiana (L.) Willd.
Castor oil ........................................................ Ricinus communis L.
Catechu, black ............................................... Acacia catechu Willd.
Cedar, white (aborvitae), leaves and twigs ... Thuja occidentalis L .................................................... Finished food thujone
free 1
Centuary ......................................................... Centaurium umbellatum Gilib ..................................... In alcoholic beverages
only
Cherry pits ...................................................... Prunus avium L. or P. cerasus L ............................... Not to exceed 25 p.p.m.
prussic acid
Cherry-laurel leaves ....................................... Prunus laurocerasus L ............................................... Do.
Chestnut leaves ............................................. Castanea dentata (Marsh.) Borkh.
Chirata ............................................................ Swertia chirata Buch.-Ham ......................................... In alcoholic beverages
only
Cinchona, red, bark ........................................ Cinchona succirubra Pav. or its hybrids .................... In beverages only; not
more than 83 p.p.m.
total cinchona alkaloids
in finished beverage
Cinchona, yellow, bark ................................... Cinchona ledgeriana Moens, C. calisaya Wedd., or Do.
hybrids of these with other spp. of Cinchona..
Copaiba .......................................................... South American spp. of Copaifera L.
Cork, oak ........................................................ Quercus suber L., or Q. occidentalis F. Gay ............. In alcoholic beverages
only
Costmary ........................................................ Chrysanthemum balsamita L ...................................... Do.
56
Costus root ..................................................... Saussurea lappa Clarke.

Cubeb ............................................................. Piper cubeba L. f.
Currant, black, buds and leaves .................... Ribes nigrum L.
Damiana leaves .............................................. Turnera diffusa Willd.
Davana ........................................................... Artemisia pallens Wall.
Dill, Indian ...................................................... Anethum sowa Roxb. (Peucedanum graveolens
Benth et Hook., Anethum graveolens L.).
Dittany (fraxinella) roots ................................. Dictamnus albus L ...................................................... Do.
Dittany of Crete .............................................. Origanum dictamnus L.
Dragon’s blood (dracorubin) ........................... Daemonorops spp.
Elder tree leaves ............................................ Sambucus nigra L ...................................................... In alcoholic beverages
only; not to exceed 25
p.p.m. prussic acid in
the flavor
Elecampane rhizome and roots ..................... Inula helenium L ......................................................... In alcoholic beverages
only
Elemi .............................................................. Canarium commune L. or C. luzonicum Miq.
Erigeron .......................................................... Erigeron canadensis L.
Eucalyptus globulus leaves ............................ Eucalyptus globulus Labill.
Fir (‘‘pine’’) needles and twigs ....................... Abies sibirica Ledeb., A. alba Mill., A. sachalinesis
Masters or A. mayriana Miyabe et Kudo.
Fir, balsam, needles and twigs ...................... Abies balsamea (L.) Mill.
Galanga, greater ............................................ Alpinia galanga Willd .................................................. Do.
Galbanum ....................................................... Ferula galbaniflua Boiss. et Buhse and other Ferula
spp.
Gambir (catechu, pale) .................................. Uncaria gambir Roxb.
Genet flowers ................................................. Spartium junceum L.
Gentian rhizome and roots ............................ Gentiana lutea L.
Gentian, stemless ........................................... Gentiana acaulis L ...................................................... Do.
Germander, chamaedrys ................................ Teucrium chamaedrys L ............................................. Do.
Germander, golden ........................................ Teucrium polium L ...................................................... Do.
Guaiac ............................................................ Guaiacum officinale L., G. santum L., Bulnesia
sarmienti Lor.
Guarana ......................................................... Paullinia cupana HBK.
Haw, black, bark ............................................ Viburnum prunifolium L.
Hemlock needles and twigs ........................... Tsuga canadensis (L.) Carr. or T. heterophylla (Raf.)
Sarg.
Hyacinth flowers ............................................. Hyacinthus orientalis L.
Iceland moss .................................................. Cetraria islandica Ach ................................................ Do.
Imperatoria ..................................................... Peucedanum ostruthium (L.). Koch (Imperatoria
ostruthium L.).
Iva ................................................................... Achillea moschata Jacq .............................................. Do.
Labdanum ...................................................... Cistus spp.
Lemon-verbena .............................................. Lippia citriodora HBK .................................................. Do.
Linaloe wood .................................................. Bursera delpechiana Poiss. and other Bursera spp.
Linden leaves ................................................. Tillia spp ..................................................................... Do.
Lovage ............................................................ Levisticum officinale Koch.
Lungmoss (lungwort) ...................................... Sticta pulmonacea Ach.
Maidenhair fern .............................................. Adiantum capillus-veneris L ....................................... Do.
Maple, mountain ............................................. Acer spicatum Lam.
Mimosa (black wattle) flowers ........................ Acacia decurrens Willd. var. dealbata.
Mullein flowers ................................................ Verbascum phlomoides L. or V. thapsiforme Schrad Do.
Myrrh .............................................................. Commiphora molmol Engl., C. abyssinica (Berg)
Engl., or other Commiphora spp.
Myrtle leaves .................................................. Myrtus communis L .................................................... Do.
Oak, English, wood ........................................ Quercus robur L ......................................................... Do.
Oak, white, chips ............................................ Quercus alba L.
Oak moss ....................................................... Evernia prunastri (L.) Ach., E. furfuracea (L.) Mann, Finished food thujone
and other lichens. free 1
Olibanum ........................................................ Boswellia carteri Birdw. and other Boswellia spp.
Opopanax (bisabolmyrrh) ............................... Opopanax chironium Koch (true opopanax) of
Commiphora erythraea Engl. var. Llabrescens.
Orris root ........................................................ Iris germanica L. (including its variety florentina
Dykes) and I. pallida Lam.
Pansy ............................................................. Viola tricolor L ............................................................. In alcoholic beverages
only
Passion flower ................................................ Passiflora incarnata L.
Patchouly ........................................................ Pogostemon cablin Benth. and P. heyneanus Benth.
Peach leaves .................................................. Prunus persica (L.) Batsch ......................................... In alcoholic beverages
only; not to exceed 25
p.p.m. prussic acid in
the flavor
Pennyroyal, American .................................... Hedeoma pulegioides (L.) Pers.
Pennyroyal, European .................................... Mentha pulegium L.
57
§ 172.510 21 CFR Ch. I (4–1–12 Edition)
Pine, dwarf, needles and twigs ...................... Pinus mugo Turra var. pumilio (Haenke) Zenari.
Pine, Scotch, needles and twigs .................... Pinus sylvestris L.
Pine, white, bark ............................................ Pinus strobus L ........................................................... In alcoholic beverages
only
Pine, white oil ................................................. Pinus palustris Mill., and other Pinus spp.
Poplar buds .................................................... Populus balsamifera L. (P. tacamahacca Mill.), P. Do.
candicans Ait., or P. nigra L.
Quassia .......................................................... Picrasma excelsa (Sw.) Planch, or Quassia amara L.
Quebracho bark ............................................. Aspidosperma quebracho-blanco Schlecht, or Schinopsis lorentzii
(Quebrachia lorentzii (Griseb)). (Griseb.) Engl.
Quillaia (soapbark) ......................................... Quillaja saponaria Mol.
Red saunders (red sandalwood) .................... Pterocarpus san alinus L ............................................ In alcoholic beverages
only
Rhatany root ................................................... Krameria triandra Ruiz et Pav. or K. argentea Mart.
Rhubarb, garden root ..................................... Rheum rhaponticum L ................................................ Do.
Rhubarb root .................................................. Rheum officinale Baill., R. palmatum L., or other
spp. (excepting R. rhaponticum L.) or hybrids of
Rheum grown in China.
Roselle ........................................................... Hibiscus sabdariffa L .................................................. Do.
Rosin (colophony) .......................................... Pinus palustris Mill., and other Pinus spp .................. Do.
St. Johnswort leaves, flowers, and caulis ...... Hypericum perforatum L ............................................. Hypericin-free alcohol dis-
tillate form only; in alco-
holic beverages only
Sandalwood, white (yellow, or East Indian) ... Santalum album L.
Sandarac ........................................................ Tetraclinis articulata (Vahl.), Mast .............................. In alcoholic beverages
only
Sarsaparilla ..................................................... Smilax aristolochiaefolia Mill., (Mexican sarsaparilla),
S. regelii Killip et Morton (Honduras sarsaparilla),
S. febrifuga Kunth (Ecuadorean sarsaparilla), or
undetermined Smilax spp. (Ecuadorean or Central
American sarsaparilla).
Sassafras leaves ............................................ Sassafras albidum (Nutt.) Nees ................................. Safrole free
Senna, Alexandria .......................................... Cassia acutifolia Delile.
Serpentaria (Virginia snakeroot) .................... Aristolochia serpentaria L ........................................... In alcoholic beverages
only
Simaruba bark ................................................ Simaruba amara Aubl ................................................. Do.
Snakeroot, Canadian (wild ginger) ................ Asarum canadense L.
Spruce needles and twigs .............................. Picea glauca (Moench) Voss or P. mariana (Mill.)
BSP.
Storax (styrax) ................................................ Liquidambar orientalis Mill. or L. styraciflua L.
Tagetes (marigold) ......................................... Tagetes patula L., T. erecta L., or T. minuta L. (T. As oil only
glandulifera Schrank).
Tansy .............................................................. Tanacetum vulgare L .................................................. In alcoholic beverages
only; finished alcoholic
beverage thujone free 1
Thistle, blessed (holy thistle) .......................... Onicus benedictus L ................................................... In alcoholic beverages
only
Thymus capitatus (Spanish ‘‘origanum’’) ....... Thymus capitatus Hoffmg. et Link.
Tolu ................................................................ Myroxylon balsamum (L.) Harms.
Turpentine ...................................................... Pinus palustris Mill. and other Pinus spp. which yield
terpene oils exclusively.
Valerian rhizome and roots ............................ Valeriana officinalis L.
Veronica ......................................................... Veronica officinalis L .................................................. Do.
Vervain, European ......................................... Verbena officinalis L ................................................... Do.
Vetiver ............................................................ Vetiveria zizanioides Stapf ......................................... Do.
Violet, Swiss ................................................... Viola calcarata L.
Walnut husks (hulls), leaves, and green nuts Juglans nigra L. or J. regia L.
Woodruff, sweet ............................................. Asperula odorata L ..................................................... In alcoholic beverages
only
Yarrow ............................................................ Achillea millefolium L .................................................. In beverages only; fin-
ished beverage thujone
free 1
Yerba santa .................................................... Eriodictyon californicum (Hook, et Arn.) Torr.
Yucca, Joshua-tree ........................................ Yucca brevifolia Engelm.
Yucca, Mohave .............................................. Yucca schidigera Roezl ex Ortgies (Y. mohavensis
Sarg.).
1 As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of
the ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by ref-
erence. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of
this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/codeloflfederallregulations/
ibrllocations.html.
58
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49 FR 10104, Mar. 19, 1984;
54 FR 24897, June 12, 1989; 69 FR 24511, May 4, 2004; 72 FR 10357, Mar. 8, 2007]
§ 172.515 Synthetic flavoring sub- Amyl heptanoate.

stances and adjuvants. Amyl hexanoate.
Amyl octanoate.
Synthetic flavoring substances and Anisole; methoxybenzene.
adjuvants may be safely used in food in Anisyl acetate.
accordance with the following condi- Anisyl alcohol; p-methoxybenzyl alcohol.
tions. Anisyl butyrate
(a) They are used in the minimum Anisyl formate.
Anisyl phenylacetate.
quantity required to produce their in- Anisyl propionate.
tended effect, and otherwise in accord- Beechwood creosote.
ance with all the principles of good Benzaldehyde dimethyl acetal.
manufacturing practice. Benzaldehyde glyceryl acetal; 2-phenyl-m-di-
(b) They consist of one or more of the oxan-5-ol.
following, used alone or in combination Benzaldehyde propylene glycol acetal; 4-
with flavoring substances and adju- methyl-2-phenyl-m-dioxolane.
Benzenethiol; thiophenol.
vants generally recognized as safe in Benzoin; 2-hydroxy-2-phenylacetophenone.
food, prior-sanctioned for such use, or Benzophenone; diphenylketone.
regulated by an appropriate section in Benzyl acetate.
this part. Benzyl acetoacetate.
Benzyl alcohol.
Acetal; acetaldehyde diethyl acetal. Benzyl benzoate.
Acetaldehyde phenethyl propyl acetal. Benzyl butyl ether.
Acetanisole; 4′-methoxyacetophenone. Benzyl butyrate.
Acetophenone; methyl phenyl ketone. Benzyl cinnamate.
Allyl anthranilate. Benzyl 2,3–dimethylcrotonate; benzyl methyl
Allyl butyrate. tiglate.
Allyl cinnamate. Benzyl disulfide; dibenzyl disulfide.
Allyl cyclohexaneacetate. Benzyl ethyl ether.
Allyl cyclohexanebutyrate. Benzyl formate.
Allyl cyclohexanehexanoate. 3-Benzyl-4-heptanone; benzyl dipropyl ke-
Allyl cyclohexaneproprionate. tone.
Allyl cyclohexanevalerate. Benzyl isobutyrate.
Allyl disulfide. Benzyl isovalerate.
Allyl 2-ethylbutyrate. Benzyl mercaptan; a-toluenethiol.
Allyl hexanoate; allyl caproate. Benzyl methoxyethyl acetal; acetaldehyde
Allyl a-ionone; 1-(2,6,6-trimethyl-2-cyclo-hex- benzyl b-methoxyethyl acetal.
ene-1-yl)-1,6-heptadiene-3-one. Benzyl phenylacetate.
Allyl isothiocyanate; mustard oil. Benzyl propionate.
Allyl isovalerate. Benzyl salicylate.
Allyl mercaptan; 2-propene-1-thiol. Birch tar oil.
Allyl nonanoate. Borneol; d-camphanol.
Allyl octanoate. Bornyl acetate.
Allyl phenoxyacetate. Bornyl formate.
Allyl phenylacetate. Bornyl isovalerate.
Allyl propionate. Bornyl valerate.
Allyl sorbate; allyl 2,4-hexadienoate. b-Bourbonene; 1,2,3,3a,3bb,4,5,6,6ab,6ba-deca-
Allyl sulfide. hydro-la-isopropyl-3aa-methyl-6-meth-
Allyl tiglate; allyl trans-2-methyl-2- ylene-cyclobuta [1,2:3,4] dicyclopentene.
butenoate. 2-Butanol.
Allyl 10-undecenoate. 2-Butanone; methyl ethyl ketone.
Ammonium isovalerate. Butter acids.
Ammonium sulfide. Butter esters.
Amyl alcohol; pentyl alcohol. Butyl acetate.
Amyl butyrate. Butyl acetoacetate.
a-Amylcinnamaldehyde. Butyl alcohol; 1-butanol.
a-Amylcinnamaldehyde dimethyl acetal. Butyl anthranilate.
a-Amylcinnamyl acetate. Butyl butyrate.
a-Amylcinnamyl alcohol. Butyl butyryllactate; lactic acid, butyl
a-Amylcinnamyl formate. ester, butyrate.

a-Amylcinnamyl isovalerate. a-Butylcinnamaldehyde.
Amyl formate. Butyl cinnamate.
59
§ 172.515 21 CFR Ch. I (4–1–12 Edition)
Butyl 2-decenoate. Citronellyl valerate.
Butyl ethyl malonate. p-Cresol.
Butyl formate. Cuminaldehyde; cuminal; p-isopropyl benz-
Butyl heptanoate. aldehyde.
Butyl hexanoate. Cyclohexaneacetic acid.
Butyl p-hydroxybenzoate. Cyclohexaneethyl acetate.
Butyl isobutyrate. Cyclohexyl acetate.
Butyl isovalerate. Cyclohexyl anthranilate.
Butyl lactate. Cyclohexyl butyrate.
Butyl laurate. Cyclohexyl cinnamate.
Butyl levulinate. Cyclohexyl formate.
Butyl phenylacetate. Cyclohexyl isovalerate.
Butyl propionate. Cyclohexyl propionate.
Butyl stearate. p-Cymene.
Butyl sulfide. g-Decalactone; 4-hydroxy-decanoic acid, g-
Butyl 10-undecenoate. lactone.
Butyl valerate. g-Decalactone; 5-hydroxy-decanoic acid, d-
Butyraldehyde. lactone.
Cadinene. Decanal dimethyl acetal.
Camphene; 2,2-dimethyl-3-methylene- 1-Decanol; decylic alcohol.
norbornane. 2-Decenal.
d-Camphor. 3-Decen-2-one; heptylidene acetone.
Carvacrol; 2-p-cymenol. Decyl actate.
Carvacryl ethyl ether; 2-ethoxy-p-cymene. Decyl butyrate.
Carveol; p-mentha-6,8-dien-2-ol. Decyl propionate.
4-Carvomenthenol; 1-p-menthen-4-ol; 4- Dibenzyl ether.
terpinenol. 4,4-Dibutyl-g-butyrolactone; 4,4-dibutyl-4-hy-
cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2- droxy-butyric acid, g-lactone.
one. Dibutyl sebacate.
Carvyl acetate. Diethyl malate.
Carvyl propionate. Diethyl malonate; ethyl malonate.
b-Caryophyllene. Diethyl sebacate.
Caryophyllene alcohol. Diethyl succinate.
Caryophyllene alcohol acetate. Diethyl tartrate.
b-Caryophyllene oxide; 4-12,12-trimethyl-9- 2,5-Diethyltetrahydrofuran.
methylene-5-oxatricylo [8.2.0.0 4,6] dode- Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl-
cane. 3-isopropenylcyclohexanol.
Cedarwood oil alcohols. Dihydrocarvone.
Cedarwood oil terpenes. Dihydrocarvyl acetate.
1,4-Cineole. m-Dimethoxybenzene.
Cinnamaldehyde ethylene glycol acetal. p-Dimethoxybenzene; dimethyl hydro-
Cinnamic acid. quinone.
Cinnamyl acetate. 2,4-Dimethylacetophenone.
Cinnamyl alcohol; 3-phenyl-2-propen-1-ol. a,a-Dimethylbenzyl isobutyrate; phenyldi-
Cinnamyl benzoate. methylcarbinyl isobutyrate.
Cinnamyl butyrate. 2,6-Dimethyl-5-heptenal.
Cinnamyl cinnamate. 2,6-Dimethyl octanal; isodecylaldehyde.
Cinnamyl formate. 3,7-Dimethyl-1-octanol; tetrahydrogeraniol.
Cinnamyl isobutyrate. a,a-Dimethylphenethyl acetate; benzyl-
Cinnamyl isovalerate. propyl acetate; benzyldimethylcarbinyl ac-
Cinnamyl phenylacetate. etate.
Cinnamyl propionate. a,a-Dimethylphenethyl alcohol; dimethyl-
Citral diethyl acetal; 3,7-dimethyl-2,6-octa- benzyl carbinol.
dienal diethyl acetal. a,a-Dimethylphenethyl butyrate; benzyl-
Citral dimethyl acetal; 3,7-dimethyl-2,6-octa- dimethylcarbinyl butyrate.
dienal dimethyl acetal. a,a-Dimethylphenethyl formate; benzyldi-
Citral propylene glycol acetal. methylcarbinyl formate.
Citronellal; 3,7-dimethyl-6-octenal; rhodinal. Dimethyl succinate.
Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit- 1,3-Diphenyl-2-propanone; dibenzyl ketone.
ronellol. delta-Dodecalactone; 5-hydroxydodecanoic
Citronelloxyacetaldehyde. acid, deltalactone.
Citronellyl acetate. g-Dodecalactone; 4-hydroxydodecanoic acid g-
Citronellyl butyrate. lactone.
Citronellyl formate. 2-Dodecenal.
Citronellyl isobutyrate. Estragole.

Citronellyl phenylacetate. r-Ethoxybenzaldehyde.
Citronellyl propionate. Ethyl acetoacetate.
60
Ethyl 2-acetyl-3-phenylpropionate; ethyl- Formic acid
benzyl acetoacetate. (2-Furyl)-2-propanone; furyl acetone.
Ethyl aconitate, mixed esters. 1-Furyl-2-propanone; furyl acetone.
Ethyl acrylate. Fusel oil, refined (mixed amyl alcohols).
Ethyl r-anisate. Geranyl acetoacetate; trans-3,7-dimethyl-2, 6-
Ethyl anthranilate. octadien-1-yl acetoacetate.
Ethyl benzoate. Geranyl acetone; 6,10-dimethyl-5,9-
Ethyl benzoylacetate. undecadien-2-one.
a-Ethylbenzyl butyrate; a-phenylpropyl bu- Geranyl benzoate.
tyrate. Geranyl butyrate.
Ethyl brassylate; tridecanedioic acid cyclic Geranyl formate.
ethylene glycol diester; cyclo 1,13-ethyl- Geranyl hexanoate
enedioxytridecan-1,13-dione. Geranyl isobutyrate.
2-Ethylbutyl acetate. Geranyl isovalerate.
2-Ethylbutyraldehyde. Geranyl phenylacetate.
2-Ethylbutyric acid. Geranyl propionate.
Ethyl cinnamate. Glucose pentaacetate.
Ethyl crotonate; trans-2-butenoic acid ethyl- Guaiacol; μ-methoxyphenol.
ester. Guaiacyl acetate; μ-methoxyphenyl acetate.
Ethyl cyclohexanepropionate. Guaiacyl phenylacetate.
Ethyl decanoate. Guaiene; 1,4-dimethyl-7-isopropenyl-D9,10-
2-Ethylfuran. octahydroazulene.
Ethyl 2-furanpropionate. Guaiol acetate; 1,4-dimethyl-7-(a-hydroxy-
4-Ethylguaiacol; 4-ethyl-2-methoxyphenol. isopropyl)-d9,10-octahydroazulene acetate.
Ethyl heptanoate. g-Heptalactone; 4-hydroxyheptanoic acid, g-
2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein. lactone.
Ethyl hexanoate. Heptanal; enanthaldehyde.
Ethyl isobutyrate. Heptanal dimethyl acetal.
Ethyl isovalerate. Heptanal 1,2-glyceryl acetal.
Ethyl lactate. 2,3-Heptanedione; acetyl valeryl.
Ethyl laurate. 3-Heptanol.
Ethyl levulinate. 2-Heptanone; methyl amyl ketone.
Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4- 3-Heptanone; ethyl butyl ketone.
one. 4-Heptanone; dipropyl ketone.
Ethyl 2-methylbutyrate. cis-4-Heptenal; cis-4-hepten-1-al.
Ethyl myristate. Heptyl acetate.
Ethyl nitrite. Heptyl alcohol; enanthic alcohol.
Ethyl nonanoate. Heptyl butyrate.
Ethyl 2-nonynoate; ethyl octyne carbonate. Heptyl cinnamate.
Ethyl octanoate. Heptyl formate.
Ethyl oleate. Heptyl isobutyrate.
Ethyl phenylacetate. Heptyl octanoate.
Ethyl 4-phenylbutyrate. 1-Hexadecanol; cetyl alcohol.
Ethyl 3-phenylglycidate. w-6-Hexadecenlactone; 16-hydroxy-6-
Ethyl 3-phenylpropionate; ethyl hydro- hexadecenoic acid, w-lactone;
cinnamate. ambrettolide.
Ethyl propionate. g-Hexalactone; 4-hydroxyhexanoic acid, g-lac-
Ethyl pyruvate. tone; tonkalide.
Ethyl salicylate. Hexanal; caproic aldehyde.
Ethyl sorbate; ethyl 2,4-hexadienoate. 2,3-Hexanedione; acetyl butyryl.
Ethyl tiglate; ethyl trans-2-methyl-2- Hexanoic acid; caproic acid.
butenoate. 2-Hexenal.
Ethyl undecanoate. 2-Hexen-1-ol.
Ethyl 10-undecenoate. 3-Hexen-1-ol; leaf alcohol.
Ethyl valerate. 2-Hexen-1-yl acetate.
Eucalyptol; 1,8-epoxy-p-menthane; cineole. 3-Hexenyl isovalerate.
Eugenyl acetate. 3-Hexenyl 2-methylbutyrate.
Eugenyl benzoate. 3-Hexenyl phenylacetate; cis-3-hexenyl phen-
Eugenyl formate. ylacetate.
Eugenyl methyl ether; 4-allylveratrole; Hexyl acetate.
methyl eugenol. 2-Hexyl-4-acetoxytetrahydrofuran.
Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien- Hexyl alcohol.
1-ol. Hexyl butyrate.
d-Fenchone; d-1,3,3-trimethyl-2-nor- a-Hexylcinnamaldehyde.
bornanone. Hexyl formate.

Fenchyl alcohol; 1,3,3-trimethyl-2-nor- Hexyl hexanoate.
bornanol. 2-Hexylidene cyclopentanone.
61
§ 172.515 21 CFR Ch. I (4–1–12 Edition)
Hexyl isovalerate. a-Isobutylphenethyl alcohol; isobutyl benzyl
Hexyl 2-methylbutyrate. carbinol; 4-methyl-1-phenyl-2-pentanol.
Hexyl octanoate. Isobutyl phenylacetate.
Hexyl phenylacetate; n-hexyl phenylacetate. Isobutyl propionate.
Hexyl propionate. Isobutyl salicylate.
Hydroxycitronellal; 3,7-dimethyl-7-hydroxy- 2-Isobutylthiazole.
octanal. Isobutyraldehyde.
Hydroxycitronellal diethyl acetal. Isobutyric acid.
Hydroxycitronellal dimethyl acetal. Isoeugenol; 2-methoxy-4-propenylphenol.
Hydroxycitronellol; 3,7-dimethyl-1,7- Isoeugenyl acetate.
octanediol. Isoeugenyl benzyl ether; benzyl isoeugenol.
N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl-
pelargonyl vanillylamide. anisole; ethyl isoeugenol.
5-Hydroxy-4-octanone; butyroin. Isoeugenyl formate.
4-(p-Hydroxyphenyl)-2-butanone; p-hydroxy- Isoeugenyl methyl ether; 4-propenyl-
benzyl acetone. veratrole; methyl isoeugenol.
Indole. Isoeugenyl phenylacetate.
a-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- Isojasmone; mixture of 2-hexylidenecyclo-
yl)-3-buten-2-one. pentanone and 2-hexyl-2-cyclopenten-1-one.
b-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- a-Isomethylionone; 4-(2,6,6-trimethyl-2-
yl)-3-buten-2-one. cyclohexen-1-yl)-3-methyl-3-buten-2-one;
a-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- methyl g-ionone.
1-yl)-3-buten-2-one; 6-methylionone. Isopropyl acetate.
Isoamyl acetate. r-Isopropylacetophenone.
Isoamyl acetoacetate. Isopropyl alcohol; isopropanol.
Isopropyl benzoate.
Isoamyl alcohol; isopentyl alcohol; 3-methyl-
r-Isopropylbenzyl alcohol; cuminic alcohol;
1-butanol.
r-cymen-7-ol.
Isoamyl benzoate.
Isopropyl butyrate.
Isoamyl butyrate.
Isopropyl cinnamate.
Isoamyl cinnamate.
Isopropyl formate.
Isoamyl formate. Isopropyl hexanoate.
Isoamyl 2-furanbutyrate; a-isoamyl furfuryl- Isopropyl isobutyrate.
propionate. Isopropyl isovalerate.
Isoamyl 2-furanpropionate; a-isoamyl fur- r-Isopropylphenylacetaldehyde; r-cymen-7-
furylacetate. carboxaldehyde.
Isoamyl hexanoate. Isopropyl phenylacetate.
Isoamyl isobutyrate. 3-(r-Isopropylphenyl)-propionaldehyde; r-iso-
Isoamyl isovalerate. propylhydrocinnamaldehyde; cuminyl ac-
Isoamyl laurate. etaldehyde.
Isoamyl-2-methylbutyrate; isopentyl-2- Isopropyl propionate.
methylbutyrate. Isopulegol; p-menth-8-en-3-ol.
Isoamyl nonanoate. Isopulegone; p-menth-8-en-3-one.
Isoamyl octanoate. Isopulegyl acetate.
Isoamyl phenylacetate. Isoquinoline.
Isoamyl propionate. Isovaleric acid.
Isoamyl pyruvate. cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclo-
Isoamyl salicylate. penten-1-one.
Isoborneol. Lauric aldehyde; dodecanal.
Isobornyl acetate. Lauryl acetate.
Isobornyl formate. Lauryl alcohol; 1-dodecanol.
Isobornyl isovalerate. Lepidine; 4-methylquinoline.
Isobornyl propionate. Levulinic acid.
Isobutyl acetate. Linalool oxide; cis- and trans-2-vinyl-2-meth-
Isobutyl acetoacetate. yl-5-(1′-hydroxy-1′-methylethyl) tetra-
Isobutyl alcohol. hydrofuran.
Isobutyl angelate; isobutyl cis-2-methyl-2- Linalyl anthranilate; 3,7-dimethyl-1,6-
butenoate. octadien-3-yl anthranilate.
Isobutyl anthranilate. Linalyl benzoate.
Isobutyl benzoate. Linalyl butyrate.
Isobutyl butyrate. Linalyl cinnamate.
Isobutyl cinnamate. Linalyl formate.
Isobutyl formate. Linalyl hexanoate.
Isobutyl 2-furanpropionate. Linalyl isobutyrate.
Isobutyl heptanoate. Linalyl isovalerate.

Isobutyl hexanoate. Linalyl octanoate.
Isobutyl isobutyrate. Linalyl propionate.
62
Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one. Methyl-5-hepten-2-ol.
Menthadienol; p-mentha-1,8(10)-dien-9-ol. 6-Methyl-5-hepten-2-one.
p-Mentha-1,8-dien-7-ol; perillyl alcohol. Methyl hexanoate.
Menthadienyl acetate; p-mentha-1,8(10)-dien- Methyl 2-hexanoate.
9-yl acetate. Methyl p-hydroxybenzoate; methylparaben.
p-Menth-3-en-1-ol. Methyl a-ionone; 5-(2,6,6-trimethyl-2-cyclo-
1-p-Menthen-–9-yl acetate; p-menth-1-en-9-yl hexen-1-yl)-4-penten-3-one.
acetate. Methyl b-ionone; 5-(2,6,6-trimethyl-1-cyclo-
Menthol; 2-isopropyl-5-methylcyclohexanol. hexen-1-yl)-4-penten-3-one.
Menthone; p-menthan-3-one. Methyl D-ionone; 5-(2,6,6-trimethyl-3-cyclo-
Menthyl acetate; p-menth-3-yl acetate. hexen-1-yl-)-4-penten-3-one.
Menthyl isovalerate; p-menth-3-yl iso- Methyl isobutyrate.
valerate. 2-Methyl-3-(p-isopropylphenyl)-propionalde-
o-Methoxybenzaldehyde. hyde; a-methyl-p-isopropylhydro-
p-Methoxybenzaldehyde; p-anisaldehyde. cinnamaldehyde; cyclamen aldehyde.
o-Methoxycinnamaldehyde. Methyl isovalerate.
2-Methoxy-4-methylphenol; 4-methyl- Methyl laurate.
guaiacol; 2-methoxy-p-cresol. Methyl mercaptan; methanethiol.
4-(p-Methoxyphenyl)-2-butanone; anisyl ace- Methyl o-methoxybenzoate.
tone. Methyl N-methylanthranilate; dimethyl an-
1-(4-Methoxyphenyl)-4-methyl-1-penten-3- thranilate.
one; methoxystyryl isopropyl ketone. Methyl 2-methylbutyrate.
1-(p-Methoxyphenyl)-1-penten-3-one; a- Methyl-3-methylthiopropionate.
methylanisylidene acetone; ethone. Methyl 4-methylvalerate.
1-(p-Methoxyphenyl)-2-propanone; Methyl myristate.
anisylmethyl ketone; anisic ketone. Methyl b-naphthyl ketone; 2′-acetonaph-
2-Methoxy-4-vinylphenol; p-vinylguaiacol. thone.
Methyl acetate. Methyl nonanoate.
4′-Methylacetophenone; p-methylaceto- Methyl 2-nonenoate.
phenone; methyl p-tolyl ketone. Methyl 2-nonynoate; methyloctyne car-
2-Methylallyl butyrate; 2-methyl-2-propenl- bonate.
yl butyrate. 2-Methyloctanal; methyl hexyl acetaldehyde.
Methyl anisate. Methyl octanoate.
o-Methylanisole; o-cresyl methyl ether. Methyl 2-octynoate; methyl heptine car-
p-Methylanisole; p-cresyl methyl ether; p- bonate.
methoxytoluene. 4-Methyl-2,3-pentanedione; acetyl iso-
Methyl benzoate. butyryl.
Methylbenzyl acetate, mixed o-,m-,p-. 4-Methyl-2-pentanone; methyl isobutyl ke-
a-Methylbenzyl acetate; styralyl acetate. tone.
a-Methylbenzyl alcohol; styralyl alcohol. b-Methylphenethyl alcohol; hydratropyl al-
a-Methylbenzyl butyrate; styralyl butyrate. cohol.
a-Methylbenzyl isobutyrate; styralyl iso- Methyl phenylacetate.
butyrate. 3-Methyl-4-phenyl-3-butene-2-one.
a-Methylbenzyl formate; styralyl formate. 2-Methyl-4-phenyl-2-butyl acetate; dimethyl-
a-Methylbenzyl propionate; styralyl propio- phenylethyl carbinyl acetate.
nate. 2-Methyl-4-phenyl-2-butyl isobutyrate;
2-Methyl-3-buten-2-ol. dimethylphenyl ethylcarbinyl isobutyrate.
2-Methylbutyl isovalerate. 3-Methyl-2-phenylbutyraldehyde; a-isopropyl
Methyl p-tert-butylphenylacetate. phenylacetaldehyde.
2-Methylbutyraldehyde; methyl ethyl acetal- Methyl 4-phenylbutyrate.
dehyde. 4-Methyl-1-phenyl-2-pentanone; benzyl iso-
3-Methylbutyraldehyde; isovaleraldehyde. butyl ketone.
Methyl butyrate. Methyl 3-phenylpropionate; methyl hydro-
2-Methylbutyric acid. cinnamate.
a-Methylcinnamaldehyde. Methyl propionate.
p-Methylcinnamaldehyde. 3-Methyl-5-propyl-2-cyclohexen-1-one.
Methyl cinnamate. Methyl sulfide.
2-Methyl-1,3-cyclohexadiene. 3-Methylthiopropionaldehyde; methional.
Methylcyclopentenolone; 3-methylcyclopen- 2-Methyl-3-tolylpropionaldehyde, mixed o-,
tane-1,2-dione. m-, p-.
Methyl disulfide; dimethyl disulfide. 2-Methylundecanal; methyl nonyl acetal-
Methyl ester of rosin, partially hydrogenated dehyde.
(as defined in § 172.615); methyl Methyl 9-undecenoate.
dihydroabietate. Methyl 2-undecynoate; methyl decyne car-
Methyl heptanoate. bonate.

2-Methylheptanoic acid. Methyl valerate.
6-Methyl-3,5-heptadien-2-one. 2-Methylvaleric acid.
63
§ 172.515 21 CFR Ch. I (4–1–12 Edition)
Myrcene; 7-methyl-3-methylene-1,6-octa- Phenethyl anthranilate.
diene. Phenethyl benzoate.
Myristaldehyde; tetradecanal. Phenethyl butyrate.
d-Neomenthol; 2-isopropyl-5-methylcyclo- Phenethyl cinnamate.
hexanol. Phenethyl formate.
Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol. Phenethyl isobutyrate.
Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien- Phenethyl isovalerate.
3-ol. Phenethyl 2-methylbutyrate.
Neryl acetate. Phenethyl phenylacetate.
Neryl butyrate. Phenethyl propionate.
Neryl formate. Phenethyl salicylate.
Neryl isobutyrate. Phenethyl senecioate; phenethyl 3,3-di-
Neryl isovalerate. methylacrylate.
Neryl propionate. Phenethyl tiglate.
2,6-Nonadien-1-ol. Phenoxyacetic acid.
g-Nonalactone; 4-hydroxynonanoic acid, g- 2-Phenoxyethyl isobutyrate.
lactone; aldehyde C–18. Phenylacetaldehyde; a-toluic aldehyde.
Nonanal; pelargonic aldehyde. Phenylacetaldehyde 2,3-butylene glycol ace-
1,3-Nonanediol acetate, mixed esters. tal.
Nonanoic acid; pelargonic acid. Phenylacetaldehyde dimethyl acetal.
2-Nonanone; methylheptyl ketone. Phenylacetaldehyde glyceryl acetal.
3-Nonanon-1-yl acetate; 1-hydroxy-3- Phenylacetic acid; a-toluic acid.
nonanone acetate. 4-Phenyl-2-butanol; phenylethyl methyl car-
Nonyl acetate. binol.
Nonyl alcohol; 1-nonanol. 4-Phenyl-3-buten-2-ol; methyl styryl car-
Nonyl octanoate. binol.
Nonyl isovalerate. 4-Phenyl-3-buten-2-one.
Nootkatone; 5,6-dimethyl-8-isopropenyl- 4-Phenyl-2-butyl acetate; phenylethyl meth-
bicyclo[4,4,0]-dec-1-en-3-one. yl carbinyl acetate.
Ocimene; trans-b-ocimene; 3,7-dimethyl-1,3,6- 1-Phenyl-3-methyl-3-pentanol; phenylethyl
octatriene. methyl ethyl carbinol.
g-Octalactone; 4-hydroxyoctanoic acid, g-lac- 1-Phenyl-1-propanol; phenylethyl carbinol.
tone. 3-Phenyl-1-propanol; hydrocinnamyl alcohol.
Octanal; caprylaldehyde. 2-Phenylpropionaldehyde; hydratropalde-
Octanal dimethyl acetal. hyde.
1-Octanol; octyl alcohol. 3-Phenylpropionaldehyde; hydrocinnamal-
2-Octanol. dehyde.
3-Octanol. 2-Phenylpropionalde-hyde dimethyl acetal;
2-Octanone; methyl hexyl ketone. hydratropic aldehyde dimethyl acetal.
3-Octanone; ethyl amyl ketone. 3-Phenylpropionic acid; hydrocinnamic acid.
3-Octanon-1-ol. 3-Phenylpropyl acetate.
1-Octen-3-ol; amyl vinyl carbinol. 2-Phenylpropyl butyrate.
1-Octen-3-yl acetate. 3-Phenylpropyl cinnamate.
Octyl acetate. 3-Phenylpropyl formate.
3-Octyl acetate. 3-Phenylpropyl hexanoate.
Octyl butyrate. 2-Phenylpropyl isobutyrate.
Octyl formate. 3-Phenylpropyl isobutyrate.
Octyl heptanoate. 3-Phenylpropyl isovalerate.
Octyl isobutyrate. 3-Phenylpropyl propionate.
Octyl isovalerate. 2-(3-Phenylpropyl)-tetrahydrofuran.
Octyl octanoate. a-Pinene; 2-pinene.
Octyl phenylacetate. b-Pinene; 2(10)-pinene.
Octyl propionate. Pine tar oil.
w-Pentadecalactone; 15-hydroxypentadeca- Pinocarveol; 2(10)-pinen-3-ol.
noic acid, w-lactone; pentadecanolide; an- Piperidine.
gelica lactone. Piperine.
2,3-Pentanedione; acetyl propionyl. d-Piperitone; p-menth-1-en-3-one.
2-Pentanone; methyl propyl ketone. Piperitenone; p-mentha-1,4(8)-dien-3-one.
4-Pentenoic acid. Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)-
1-Penten-3-ol. en-3-one.
Perillaldehyde; 4-isopropenyl-1-cyclohexene- Piperonyl acetate; heliotropyl acetate.
1-carboxaldehyde;p-mentha-1,8-dien-7-al. Piperonyl isobutyrate.
Perillyl acetate; p-mentha-1,8-dien-7-yl ace- Polylimonene.
tate. Polysorbate 20; polyoxyethylene (20) sorbitan
a-Phellandrene; r-mentha-1,5-diene. monolaurate.

Phenethyl acetate. Polysorbate 60; polyoxyethylene (20) sorbitan
Phenethyl alcohol; b-phenylethyl alcohol. monostereate.
64
Polysorbate 80; polyoxyethylene (20) sorbitan Tetramethyl ethylcyclohexenone; mixture of
monooleate. 5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1-
Potassium acetate. one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclo-
Propenylguaethol; 6-ethoxy-m-anol. hexen-1-one.
Propionaldehyde. 2-Thienyl mercaptan; 2-thienylthiol.
Propyl acetate. Thymol.
Propyl alcohol; 1-propanol. Tolualdehyde glyceryl acetal, mixed o, m, p.
p-Propyl anisole; dihydroanethole. Tolualdehydes, mixed o, m, p.
Propyl benzoate. p-Tolylacetaldehyde.
Propyl butyrate. o-Tolyl acetate; o-cresyl acetate.
Propyl cinnamate. p-Tolyl acetate; p-cresyl acetate.
Propyl disulfide. 4-(p-Tolyl)-2-butanone; p-methylbenzylace-
Propyl formate. tone.
Propyl 2-furanacrylate. p-Tolyl isobutyrate.
Propyl heptanoate. p-Tolyl laurate.
Propyl hexanoate. p-Tolyl phenylacetate.
Propyl p-hydroxybenzoate; propylparaben. 2-(p-Tolyl)-propionaldehyde; p-methylhydra-
3-Propylidenephthalide. tropic aldehyde.
Propyl isobutyrate. Tributyl acetylcitrate.
Propyl isovalerate. 2-Tridecenal.
Propyl mercaptan. 2,3-Undecadione; acetyl nonyryl.
a-Propylphenethyl alcohol. g-Undecalactone; 4-hydroxyundecanoic acid
Propyl phenylacetate. g-lactone; peach aldehyde; aldehyde C–14.
Propyl propionate. Undecenal.
Pulegone; p-menth-4(8)-en-3-one. 2-Undecanone; methyl nonyl ketone.
Pyridine. 9-Undecenal; undecenoic aldehyde.
Pyroligneous acid extract. 10-Undecenal.
Pyruvaldehyde. Undecen-1-ol; undecylenic alcohol.
Pyruvic acid. 10-Undecen-1-yl acetate.
Rhodinol; 3,7-dimethyl-7-octen-1-ol; l- Undecyl alcohol.
citronellol. Valeraldehyde; pentanal.
Rhodinyl acetate. Valeric acid; pentanoic acid.
Rhodinyl butyrate. Vanillin acetate; acetyl vanillin.
Rhodinyl formate. Veratraldehyde.
Rhodinyl isobutyrate. Verbenol; 2-pinen-4-ol.
Rhodinyl isovalerate. Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2-
Rhodinyl phenylacetate. butanone.
Rhodinyl propionate. (c) D-Decalactone and D-
Rum ether; ethyl oxyhydrate. dodecalactone when used separately or
Salicylaldehyde.
in combination in oleomargarine are
Santalol, a and b.
Santalyl acetate. used at levels not to exceed 10 parts per
Santalyl phenylacetate. million and 20 parts per million, re-
Skatole. spectively, in accordance with § 166.110
Sorbitan monostearate. of this chapter.
Styrene. (d) BHA (butylated hydroxyanisole)
Sucrose octaacetate. may be used as an antioxidant in fla-
a-Terpinene. voring substances whereby the additive
g-Terpinene.
does not exceed 0.5 percent of the es-
a-Terpineol; p-menth-1-en-8-ol.
b-Terpineol. sential (volatile) oil content of the fla-
Terpinolene; p-menth-1,4(8)-diene. voring substance.
Terpinyl acetate. [42 FR 14491, Mar. 15, 1977, as amended at 42
Terpinyl anthranilate. FR 23148, May 6, 1977; 43 FR 19843, May 9,
Terpinyl butyrate. 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810,
Terpinyl cinnamate. June 25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR
Terpinyl formate. 51907, Nov. 15, 1983; 49 FR 5747, Feb. 15, 1984;
Terpinyl isobutyrate. 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21,
Terpinyl isovalerate. 1989; 61 FR 14245, Apr. 1, 1996; 69 FR 24511,
Terpinyl propionate. May 4, 2004]
Tetrahydrofurfuryl acetate.
Tetrahydrofurfuryl alcohol. § 172.520 Cocoa with dioctyl sodium
Tetrahydrofurfuryl butyrate. sulfosuccinate for manufacturing.
Tetrahydrofurfuryl propionate.
The food additive ‘‘cocoa with dioctyl
Tetrahydro-pseudo-ionone; 6,10-dimethyl-9-
undecen-2-one. sodium sulfosuccinate for manufac-
Tetrahydrolinalool; 3,7-dimethyloctan-3-ol. turing,’’ conforming to § 163.117 of this
65
§ 172.530 21 CFR Ch. I (4–1–12 Edition)
chapter and § 172.810, is used or in- (i) A solution of the food additive sol-
tended for use as a flavoring substance ids is made up in approximately 0.012 n
in dry beverage mixes whereby the alkaline methyl alcohol (6 milliliters
amount of dioctyl sodium sulfo- of 1 n sodium hydroxide diluted to 500
succinate does not exceed 75 parts per milliliters with methyl alcohol) to
million of the finished beverage. The show an absorbance at 253 millimicrons
labeling of the dry beverage mix shall of 0.6 to 0.9 per centimeter. (This ab-
bear adequate directions to assure use sorbance is obtained by approximately
in compliance with this section. 0.03 milligram solids permilliliter.) The
ultraviolet absorption spectrum of this
§ 172.530 Disodium guanylate. solution exhibits the following charac-
Disodium guanylate may be safely teristics: An absorption peak at 253
used as a flavor enhancer in foods, at a millimicrons; no absorption peak at 325
level not in excess of that reasonably to 330 millimicrons; the absorbance at
required to produce the intended effect. 268 millimicrons does not exceed the
absorbance at 272 millimicrons.
§ 172.535 Disodium inosinate. (ii) The boron content of the food ad-
The food additive disodium inosinate ditive does not exceed 310 parts per
may be safely used in food in accord- million (0.0310 percent), calculated as
ance with the following prescribed con- boron.
ditions: (2) The additive is manufactured
(a) The food additive is the disodium from hops by a sequence of extractions
salt of inosinic acid, manufactured and and fractionations, using benzene, light
purified so as to contain no more than petroleum spirits, and methyl alcohol
150 parts per million of soluble barium as solvents, followed by isomerization
in the compound disodium inosinate by potassium carbonate treatment.
with seven and one-half molecules of Residues of solvents in the modified
water of crystallization. hop extract shall not exceed 1.0 part
(b) The food additive is used as a fla- per million of benzene, 1.0 part per mil-
voring adjuvant in food. lion of light petroleum spirits, and 250
parts per million of methyl alcohol.
§ 172.540 DL-Alanine. The light petroleum spirits and ben-
DL-Alanine (a racemic mixture of D- zene solvents shall comply with the
and L-alanine; CAS Reg. No. 302–72–7) specifications in § 172.250 except that
may be safely used as a flavor enhancer the boiling point range for light petro-
for sweeteners in pickling mixtures at leum spirits is 150 °F–300 °F.
a level not to exceed 1 percent of the (3) The additive is manufactured
pickling spice that is added to the from hops by a sequence of extractions
pickling brine. and fractionations, using methylene
chloride, hexane, and methyl alcohol as
[56 FR 6968, Feb. 21, 1991] solvents, followed by isomerization by
sodium hydroxide treatment. Residues
§ 172.560 Modified hop extract. of the solvents in the modified hop ex-
The food additive modified hop extract shall not exceed 5 parts per mil-
tract may be safely used in beer in ac- lion of methylene chloride, 25 parts per
cordance with the following prescribed million of hexane, and 100 parts per
conditions: million of methyl alcohol.
(a) The food additive is used or in- (4) The additive is manufactured
tended for use as a flavoring agent in from hops by a sequence of extractions
the brewing of beer. and fractionations, using benzene, light
(b) The food additive is manufactured petroleum spirits, methyl alcohol, n-
by one of the following processes: butyl alcohol, and ethyl acetate as sol-
(1) The additive is manufactured vents, followed by isomerization by po-
from a hexane extract of hops by si- tassium carbonate treatment. Residues
multaneous isomerization and selec- of solvents in the modified hop extract
tive reduction in an alkaline aqueous shall not exceed 1.0 part per million of
medium with sodium borohydride, benzene, 1.0 part per million of light
whereby the additive meets the fol- petroleum spirits, 50 parts per million
lowing specifications: of methyl alcohol, 50 parts per million
66
of n-butyl alcohol, and 1 part per mil- residue limitations as prescribed in

lion of ethyl acetate. The light petro- paragraph (b)(5) of this section, and a
leum spirits and benzene solvents shall boron content level not in excess of 300
comply with the specifications in parts per million (0.0300 percent), cal-
§ 172.250 except that the boiling point culated as boron.
range for light petroleum spirits is 150 (8) The additive is manufactured
°F to 300 °F. from hops as a nonisomerizable non-
(5) The additive is manufactured volatile hop resin by an initial extrac-
from hops by an initial extraction and tion and fractionation using one or
fractionation using one or more of the more of the solvents listed in para-
following solvents: Ethylene dichlo- graph (b)(5) of this section followed by
ride, hexane, isopropyl alcohol, methyl a sequence of aqueous extractions and
alcohol, methylene chloride, trichloro- removal of nonaqueous solvents to less
ethylene, and water; followed by than 0.5 percent. The additive is added
isomerization by calcium chloride or to the wort before or during cooking in
magnesium chloride treatment in the manufacture of beer.
ethylene dichloride, methylene chlo-
ride, or trichloroethylene and a further § 172.575 Quinine.
sequence of extractions and fraction- Quinine, as the hydrochloride salt or
ations using one or more of the sol- sulfate salt, may be safely used in food
vents set forth in this paragraph. Resi- in accordance with the following condi-
dues of the solvents in the modified tions:
hop extract shall not exceed 125 parts
Uses Limitations
per million of hexane; 150 parts per mil-
lion of ethylene dichloride, methylene In carbonated bev- Not to exceed 83 parts per million, as
chloride, or trichloroethylene; or 250 erages as a flavor. quinine. Label shall bear a promi-
nent declaration of the presence of
parts per million of isopropyl alcohol quinine either by the use of the
or methyl alcohol. word ‘‘quinine’’ in the name of the
(6) The additive is manufactured article or through a separate dec-
from hops by an initial extraction and laration.
fractionation using one or more of the
solvents listed in paragraph (b)(5) of § 172.580 Safrole-free extract of sas-
this section followed by: Hydro- safras.
genation using palladium as a catalyst The food additive safrole-free extract
in methyl alcohol, ethyl alcohol, or of sassafras may be safely used in ac-
isopropyl alcohol acidified with hydro- cordance with the following prescribed
chloric or sulfuric acid; oxidation with conditions:
peracetic acid; isomerization by cal- (a) The additive is the aqueous ex-
cium chloride or magnesium chloride tract obtained from the root bark of
treatment in ethylene dichloride, the plant Sassafras albidum (Nuttall)
methylene chloride, or trichloro- Nees (Fam. Lauraceae).
ethylene (alternatively, the hydro- (b) It is obtained by extracting the
genation and isomerization steps may bark with dilute alcohol, first concen-
be performed in reverse order); and a trating the alcoholic solution by vacu-
further sequence of extractions and um distillation, then diluting the con-
fractionations using one or more of the centrate with water and discarding the
solvents listed in paragraph (b)(5) of oily fraction.
this section. The additive shall meet (c) The purified aqueous extract is
the residue limitations as prescribed in safrole-free.
paragraph (b)(5) of this section. (d) It is used as a flavoring in food.
(7) The additive is manufactured
from hops as set forth in paragraph § 172.585 Sugar beet extract flavor
(b)(6) of this section followed by reduc- base.
tion with sodium borohydride in aque- Sugar beet extract flavor base may
ous alkaline methyl alcohol, and a se- be safely used in food in accordance
quence of extractions and fraction- with the provisions of this section.
ations using one or more of the sol- (a) Sugar beet extract flavor base is
vents listed in paragraph (b)(5) of this the concentrated residue of soluble

section. The additive shall meet the sugar beet extractives from which
67
§ 172.590 21 CFR Ch. I (4–1–12 Edition)
sugar and glutamic acid have been re- (a) The additive is produced by par-
covered, and which has been subjected tial hydrolysis of yeast extract (de-
to ion exchange to minimize the con- rived from Saccharomyces cereviseae,
centration of naturally occurring trace Saccharomyces fragilis, or Candida utilis)
minerals. using the sprout portion of malt barley
(b) It is used as a flavor in food. as the source of enzymes. The additive
contains a maximum of 6 percent 5′ nu-
§ 172.590 Yeast-malt sprout extract. cleotides by weight.
Yeast-malt sprout extract, as de- (b) The additive may be used as a fla-
scribed in this section, may be safely vor enhancer in food at a level not in
used in food in accordance with the fol- excess of that reasonably required to
lowing prescribed conditions: produce the intended effect.
Subpart G—Gums, Chewing Gum Bases and Related Substances

§ 172.610 Arabinogalactan.
Arabinogalactan may be safely used in food in accordance with the following
conditions:
(a) Arabinogalactan is a polysaccharide extracted by water from Western larch
wood, having galactose units and arabinose units in the approximate ratio of six
to one.
(b) It is used in the following foods in the minimum quantity required to
produce its intended effect as an emulsifier, stabilizer, binder, or bodying agent:
Essential oils, nonnutritive sweeteners, flavor bases, nonstandardized dressings,
and pudding mixes.
§ 172.615 Chewing gum base.

The food additive chewing gum base may be safely used in the manufacture of
chewing gum in accordance with the following prescribed conditions:
(a) The food additive consists of one or more of the following substances that
meet the specifications and limitations prescribed in this paragraph, used in
amounts not to exceed those required to produce the intended physical or other
technical effect.
MASTICATORY SUBSTANCES
NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN
Family Genus and species
Sapotaceae:
Chicle ............................................................ Manilkara zapotilla Gilly and Manilkara chicle Gilly.
Chiquibul ....................................................... Manilkara zapotilla Gilly.
Crown gum .................................................... Manilkara zapotilla Gilly and Manilkara chicle Gilly.
Gutta hang kang ........................................... Palaquium leiocarpum Boerl. and Palaquium oblongifolium Burck.
Massaranduba balata (and the solvent-free Manilkara huberi (Ducke) Chevalier.
resin extract of Massaranduba balata).
Massaranduba chocolate .............................. Manilkara solimoesensis Gilly.
Nispero .......................................................... Manilkara zapotilla Gilly and Manilkara chicle Gilly.
Rosidinha (rosadinha) ................................... Micropholis (also known as Sideroxylon) spp.
Venezuelan chicle ......................................... Manilkara williamsii Standley and related spp.
Apocynaceae:
Jelutong ......................................................... Dyera costulata Hook, F. and Dyera lowii Hook, F.
Leche caspi (sorva) ...................................... Couma macrocarpa Barb. Rodr.
Pendare ......................................................... Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg.
Perillo ............................................................ Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg.
Moraceae:
Leche de vaca .............................................. Brosimum utile (H.B.K.) Pittier and Poulsenia spp.; also Lacmellea standleyi
(Woodson), Monachino (Apocynaceae).
Niger gutta .................................................... Ficus platyphylla Del.
Tunu (tuno) ................................................... Castilla fallax Cook.
Euphorbiaceae:
Chilte ............................................................. Cnidoscolus (also known as Jatropha) elasticus Lundell and Cnidoscolus
tepiquensis (Cost. and Gall.) McVaugh.
68
MASTICATORY SUBSTANCES—Continued
Natural rubber (smoked sheet and latex sol- Hevea brasiliensis.

ids).
Synthetic Specifications
Butadiene-styrene rubber .............................. Basic polymer.

Isobutylene-isoprene copolymer (butyl rub- Do.
ber).
Paraffin ................................................................. Synthesized by Fischer-Tropsch process from carbon monoxide and hydro-
gen which are catalytically converted to a mixture of paraffin hydrocarbon.
Lower molecular weight fractions are removed by distillation. The residue is
hydrogenated and further treated by percolation through activated charcoal.
The product has a congealing point of 93°–99 °C as determined by ASTM
method D938–71 (Reapproved 1981), ‘‘Standard Test Method for Con-
gealing Point of Petroleum Waxes, Including Petrolatum,’’ a maximum oil
content of 0.5 percent as determined by ASTM method D721–56T, ‘‘Ten-
tative Method of Test for Oil Content of Petroleum Waxes,’’ and an absorp-
tivity of less than 0.01 at 290 millimicrons in decahydronaphthalene at 88
°C as determined by ASTM method D2008–80, ‘‘Standard Test Method for
Ultraviolet Absorbance and Absorptivity of Petroleum Products,’’ which are
incorporated by reference. Copies may be obtained from the American So-
ciety for Testing Materials, 100 Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be examined at the National Ar-
chives and Records Administration (NARA). For information on the avail-
ability of this material at NARA, call 202–741–6030, or go to: http://
www.archives.gov/federallregister/codeloflfederallregulations/
ibrllocations.html.
Petroleum wax .............................................. Complying with § 172.886.
Petroleum wax synthetic ............................... Complying with § 172.888.
Polyethylene .................................................. Molecular weight 2,000–21,000.
Polyisobutylene ............................................. Minimum molecular weight 37,000 (Flory).
Polyvinyl acetate ........................................... Molecular weight, minimum 2,000.
PLASTICIZING MATERIALS (SOFTENERS)
Glycerol ester of partially dimerized rosin ........... Having an acid number of 3–8, a minimum drop-softening point of 109 °C,
and a color of M or paler.
Glycerol ester of partially hydrogenated gum or Having an acid number of 3–10, a minimum drop-softening point of 79 °C,
wood rosin. and a color of N or paler.
Glycerol ester of polymerized rosin ..................... Having an acid number of 3–12, a minimum melting-point of 80 °C, and a
color of M or paler.
Glycerol ester of gum rosin .................................. Having an acid number of 5–9, a minimum drop-softening point of 88 °C, and
a color of N or paler. The ester is purified by steam stripping.
Glycerol ester of tall oil rosin ............................... Having an acid number of 2–12, a softening point (ring and ball) of 80°–88
°C, and a color of N or paler. The ester is purified by steam stripping.
Glycerol ester of wood rosin ................................ Having an acid number of 3–9, a drop-softening point of 88 °C–96 °C, and a
color of N or paler. The ester is purified by steam stripping.
Lanolin ..................................................................
Methyl ester of rosin, partially hydrogenated ....... Having an acid number of 4–8, a refractive index of 1.5170–1.5205 at 20 °C,
and a viscosity of 23–66 poises at 25 °C. The ester is purified by steam
stripping.
Pentaerythritol ester of partially hydrogenated Having an acid number of 7–18, a minimum drop-softening point of 102 °C,
gum or wood rosin. and a color of K or paler.
Pentaerythritol ester of gum or wood rosin ......... Having an acid number of 6–16, a minimum drop-softening point of 109 °C,
and a color of M or paler.
Rice bran wax ...................................................... Complying with § 172.890.
Stearic acid .......................................................... Complying with § 172.860.
Sodium and potassium stearates ........................ Complying with § 172.863.
TERPENE RESINS
Synthetic resin ...................................................... Consisting of polymers of apinene, bpinene, and/or dipentene; acid value
less than 5, saponification number less than 5, and color less than 4 on the
Gardner scale as measured in 50 percent mineral spirit solution.
Natural resin ......................................................... Consisting of polymers of a-pinene; softening point minimum 155 °C, deter-
mined by U.S.P. closed-capillary method, United States Pharmacopeia XX

(1980) (page 961).
69
§ 172.620 21 CFR Ch. I (4–1–12 Edition)
MASTICATORY SUBSTANCES—Continued
ANTIOXIDANTS
Butylated hydroxyanisole ..................................... Not to exceed antioxidant content of 0.1% when used alone or in any com-
bination.
Butylated hydroxytoluene ..................................... Do.
Propyl gallate ....................................................... Do.
MISCELLANEOUS
Sodium sulfate .....................................................

Sodium sulfide ...................................................... Reaction-control agent in synthetic polymer production.
(b) In addition to the substances list- (1) It is a sulfated polysaccharide the

ed in paragraph (a) of this section, dominant hexose units of which are ga-
chewing gum base may also include lactose and anhydrogalactose.
substances generally recognized as safe (2) Range of sulfate content: 20 per-
in food. cent to 40 percent on a dry-weight
(c) To assure safe use of the additive, basis.
in addition to the other information re- (c) The food additive is used or in-
quired by the act, the label and label- tended for use in the amount necessary
ing of the food additive shall bear the for an emulsifier, stabilizer, or thick-
name of the additive, ‘‘chewing gum ener in foods, except for those stand-
base.’’ As used in this paragraph, the ardized foods that do not provide for
term ‘‘chewing gum base’’ means the such use.
manufactured or partially manufac- (d) To assure safe use of the additive,
tured nonnutritive masticatory sub- the label and labeling of the additive
stance comprised of one or more of the shall bear the name of the additive,
ingredients named and so defined in carrageenan.
paragraph (a) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 45 § 172.623 Carrageenan with poly-
FR 56051, Aug. 22, 1980; 49 FR 5747, Feb. 15, sorbate 80.
1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, Carrageenan otherwise meeting the
July 23, 2001; 66 FR 53711, Oct. 24, 2001]
definition and specifications of § 172.620
§ 172.620 Carrageenan. (a) and (b) and salts of carrageenan
otherwise meeting the definition of
The food additive carrageenan may § 172.626(a) may be safely produced with
be safely used in food in accordance the use of polysorbate 80 meeting the
with the following prescribed condi- specifications and requirements of
tions: § 172.840 (a) and (b) in accordance with
(a) The food additive is the refined the following prescribed conditions:
hydrocolloid prepared by aqueous ex- (a) The polysorbate 80 is used only to
traction from the following members of facilitate separation of sheeted carra-
the families Gigartinaceae and Solier- geenan and salts of carrageenan from
iaceae of the class Rodophyceae (red drying rolls.
seaweed): (b) The carrageenan and salts of car-
Chondrus crispus. rageenan contain not more than 5 per-
Chondrus ocellatus. cent by weight of polysorbate 80, and
Eucheuma cottonii. the final food containing the additives
Eucheuma spinosum. contains polysorbate 80 in an amount
Gigartina acicularis. not to exceed 500 parts per million.
Gigartina pistillata. (c) The carrageenan and salts of car-
Gigartina radula.
rageenan so produced are used only in
Gigartina stellata.
producing foods in gel form and only
(b) The food additive conforms to the for the purposes defined in §§ 172.620(c)
following conditions: and 172.626(b), respectively.
70
(d) The carrageenan and salts of car- (2) Range of sulfate content: 8 per-
rageenan so produced are not used in cent to 19 percent, on a dry-weight
foods for which standards of identity basis.
exist unless the standards provide for (c) The food additive is used or in-
the use of carrageenan, or salts of car- tended for use in the amount necessary
rageenan, combined with polysorbate for an emulsifier, stabilizer, or thick-
80. ener in foods, except for those stand-
(e) The carrageenan and salts of car- ardized foods that do not provide for
rageenan produced in accordance with such use.
this section, and foods containing the (d) To assure safe use of the additive,
same, in addition to the other require- the label and labeling of the additive
ments of the Act, are labeled to show shall bear the name of the additive,
the presence of polysorbate 80, and the furcelleran.
label or labeling of the carrageenan § 172.660 Salts of furcelleran.
and salts of carrageenan so produced
bear adequate directions for use. The food additive salts of furcelleran
may be safely used in food in accord-
§ 172.626 Salts of carrageenan. ance with the following prescribed con-
ditions:
The food additive salts of carra- (a) The food additive consists of fur-
geenan may be safely used in food in celleran, meeting the provisions of
accordance with the following pre- § 172.655, modified by increasing the
scribed conditions: concentration of one of the naturally
(a) The food additive consists of car- occurring salts (ammonium, calcium,
rageenan, meeting the provisions of potassium, or sodium) of furcelleran to
§ 172.620, modified by increasing the the level that it is the dominant salt in
concentration of one of the naturally the additive.
occurring salts (ammonium, calcium, (b) The food additive is used or in-
potassium, or sodium) of carrageenan tended for use in the amount necessary
to the level that it is the dominant salt for an emulsifier, stabilizer, or thick-
in the additive. ener in foods, except for those stand-
(b) The food additive is used or in- ardized foods that do not provide for
tended for use in the amount necessary such use.
for an emulsifier, stabilizer, or thick- (c) To assure safe use of the additive,
ener in foods, except for those stand- the label and labeling of the additive
ardized foods that do not provide for shall bear the name of the salt of fur-
such use. celleran that dominates the mixture by
(c) To assure safe use of the additive, reason of the modification, e.g., ‘‘so-
the label and labeling of the additive dium furcelleran’’, ‘‘potassium furcel-
shall bear the name of the salt of car- leran’’, etc.
rageenan that dominates the mixture § 172.665 Gellan gum.
by reason of the modification, e.g.,
‘‘sodium carrageenan’’, ‘‘potassium The food additive gellan gum may be
carrageenan’’, etc. safely used in food in accordance with
§ 172.655 Furcelleran. (a) The additive is a high molecular
weight polysaccharide gum produced
The food additive furcelleran may be from Pseudomonas elodea by a pure cul-
safely used in food in accordance with ture fermentation process and purified
the following prescribed conditions: by recovery with isopropyl alcohol. It
(a) The food additive is the refined is composed of tetrasaccharide repeat
hydrocolloid prepared by aqueous ex- units, each containing one molecule of
traction of furcellaria fastigiata of the rhamnose and glucuronic acid, and two
class Rodophyceae (red seaweed). molecules of glucose. The glucuronic
(b) The food additive conforms to the acid is neutralized to a mixed potas-
following: sium, sodium, calcium, and magnesium
(1) It is a sulfated polysaccharide the salt. The polysaccharide may contain
dominant hexose units of which are ga- acyl (glyceryl and acetyl) groups as the
lactose and anhydrogalactose. O-glycosidically linked esters.
71
§ 172.695 21 CFR Ch. I (4–1–12 Edition)
(b) The strain of P. elodea is non- used in foods where standards of iden-
pathogenic and nontoxic in man and tity established under section 401 of
animals. the Federal Food, Drug, and Cosmetic
(c) The additive is produced by a Act do not preclude such use.
process that renders it free of viable (f) To assure safe use of the additive:
cells of P. elodea. (1) The label of its container shall
(d) The additive meets the following bear, in addition to other information
specifications: required by the Federal Food, Drug,
(1) Positive for gellan gum when sub- and Cosmetic Act, the name of the ad-
jected to the following identification ditive and the designation ‘‘food
tests: grade’’.
(i) A 1-percent solution is made by (2) The label or labeling of the food
hydrating 1 gram of gellan gum in 99 additive container shall bear adequate
milliliters of distilled water. The mix- directions for use.
ture is stirred for about 2 hours, using [55 FR 39614, Sept. 28, 1990, as amended at 57
a motorized stirrer and a propeller- FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12,
type stirring blade. A small amount of 1999]
the above solution is drawn into a wide
bore pipet and transferred into a solu- § 172.695 Xanthan gum.
tion of 10-percent calcium chloride. A The food additive xanthan gum may
tough worm-like gel will form in- be safely used in food in accordance
stantly. with the following prescribed condi-
(ii) To the 1-percent distilled water tions:
solution prepared for identification (a) The additive is a polysaccharide
test (i), 0.50 gram of sodium chloride is gum derived from Xanthomonas
added. The solution is heated to 80 °C campestris by a pure-culture fermenta-
with stirring, held at 80 °C for 1 tion process and purified by recovery
minute, and allowed to cool to room with isopropyl alcohol. It contains D-
temperature without stirring. A firm glucose, D-mannose, and D-glucuronic
gel will form. acid as the dominant hexose units and
(2) Residual isopropyl alcohol (IPA) is manufactured as the sodium, potas-
not to exceed 0.075 percent as deter- sium, or calcium salt.
mined by the procedure described in (b) The strain of Xanthomonas
the Xanthan Gum monograph, the campestris is nonpathogenic and
‘‘Food Chemicals Codex,’’ 4th ed. (1996), nontoxic in man or other animals.
pp. 437–438, which is incorporated by (c) The additive is produced by a
reference in accordance with 5 U.S.C. process that renders it free of viable
552(a) and 1 CFR part 51. Copies are cells of Xanthomonas campestris.
available from the National Academy (d) The additive meets the following
Press, Box 285, 2101 Constitution Ave. specifications:
NW., Washington, DC 20055 (Internet (1) Residual isopropyl alcohol not to
address http://www.nap.edu), or may be exceed 750 parts per million.
examined at the Center for Food Safety (2) An aqueous solution containing 1
and Applied Nutrition’s Library, Food percent of the additive and 1 percent of
and Drug Administration, 5100 Paint potassium chloride stirred for 2 hours
Branch Pkwy., College Park, MD 20740, has a minimum viscosity of 600 centi-
or at the National Archives and poises at 75 °F, as determined by
Records Administration (NARA). For Brookfield Viscometer, Model LVF (or
information on the availability of this equivalent), using a No. 3 spindle at 60
material at NARA, call 202–741–6030, or r.p.m., and the ratio of viscosities at 75
go to: http://www.archives.gov/ °F and 150 °F is in the range of 1.02 to
federallregister/ 1.45.
codeloflfederallregulations/ (3) Positive for xanthan gum when
ibrllocations.html. subjected to the following procedure:
(e) The additive is used or intended
for use in accordance with current good LOCUST BEAN GUM GEL TEST
manufacturing practice as a stabilizer
Blend on a weighing paper or in a weighing

and thickener as defined in § 170.3(o)(28) pan 1.0 gram of powdered locust bean gum
of this chapter. The additive may be with 1.0 gram of the powdered polysaccharide
72
to be tested. Add the blend slowly (approxi- Compare the results with a curve of the op-
mately 1⁄2 minute) at the point of maximum tical density versus concentration of an au-
agitation to a stirred solution of 200 milli- thentic sample of pyruvic acid that has been
liters of distilled water previously heated to run through the procedure starting with the
80 °C in a 400-milliliter beaker. Continue me- preparation of the hydrazone.
chanical stirring until the mixture is in solu- Record the percent by weight of pyruvic
tion, but stir for a minimum time of 30 min- acid in the test polysaccharide. Note ‘‘posi-
utes. Do not allow the water temperature to tive’’ for xanthan gum if the sample contains
drop below 60 °C. more than 1.5 percent of pyruvic acid and
Set the beaker and its contents aside to ‘‘negative’’ for xanthan gum if the sample
cool in the absence of agitation. Allow a contains less than 1.5 percent of pyruvic acid
minimum time of 2 hours for cooling. Exam- by weight.
ine the cooled beaker contents for a firm (e) The additive is used or intended
rubbery gel formation after the temperature for use in accordance with good manu-
drops below 40 °C.
facturing practice as a stabilizer, emul-
In the event that a gel is obtained, make
up a 1 percent solution of the polysaccharide
sifier, thickener, suspending agent,
to be tested in 200 milliliters of distilled bodying agent, or foam enhancer in
water previously heated to 80 °C (omit the lo- foods for which standards of identity
cust bean gum). Allow the solution to cool established under section 401 of the Act
without agitation as before. Formation of a do not preclude such use.
gel on cooling indicates that the sample is a (f) To assure safe use of the additive:
gelling polysaccharide and not xanthan gum. (1) The label of its container shall
Record the sample as ‘‘positive’’ for xan- bear, in addition to other information
than gum if a firm, rubbery gel forms in the required by the Act, the name of the
presence of locust bean gum but not in its additive and the designation ‘‘food
absence. Record the sample as ‘‘negative’’ for
xanthan gum if no gel forms or if a soft or
grade’’.
brittle gel forms both with locust bean gum (2) The label or labeling of the food
and in a 1 percent solution of the sample additive container shall bear adequate
(containing no locust bean gum). directions for use.
(4) Positive for xanthan gum when
subjected to the following procedure:
Subpart H—Other Specific Usage
Additives
PYRUVIC ACID TEST § 172.710 Adjuvants for pesticide use
Pipet 10 milliliters of an 0.6 percent solu- dilutions.
tion of the polysaccharide in distilled water The following surfactants and related
(60 milligrams of water-soluble gum) into a adjuvants may be safely added to pes-
50-milliliter flask equipped with a standard ticide use dilutions by a grower or ap-
taper glass joint. Pipet in 20 milliliters of 1N
hydrochloric acid. Weigh the flask. Reflux
plicant prior to application to the
the mixture for 3 hours. Take precautions to growing crop:
avoid loss of vapor during the refluxing. Cool n-Alkyl (C8-C18) amine acetate, where the
the solution to room temperature. Add dis- alkyl groups (C8-C18) are derived from coco-
tilled water to make up any weight loss from nut oil, as a surfactant in emulsifier blends
the flask contents. at levels not in excess of 5 percent by weight
Pipet 1 milliliter of a 2,4-dinitrophenyl- of the emulsifier blends that are added to
hydrazine reagent (0.5 percent in 2N hydro- herbicides for application to corn and sor-
chloric acid) into a 30-milliliter separatory ghum.
funnel followed by a 2-milliliter aliquot (4 Di-n-alkyl (C8-C18) dimethyl ammonium
milligrams of water-soluble gum) of the chloride, where the alkyl groups (C8-C18) are
polysaccharide hydrolyzate. Mix and allow derived from coconut oil, as surfactants in
the reaction mixture to stand at room tem- emulsifier blends at levels not in excess of 5
perature for 5 minutes. Extract the mixture percent by weight of emulsifier blends that
with 5 milliliters of ethyl acetate. Discard are added to herbicides for application to
the aqueous layer. corn or sorghum.
Extract the hydrazone from the ethyl ace- Diethanolamide condensate based on a
tate with three 5 milliliter portions of 10 per- mixture of saturated and unsaturated soy-
cent sodium carbonate solution. Dilute the bean oil fatty acids (C16-C18) as a surfactant
combined sodium carbonate extracts to 100 in emulsifier blends that are added to the
milliliters with additional 10 percent sodium herbicide atrazine for application to corn.
carbonate in a 10-milliliter volumetric flask. Diethanolamide condensate based on

Measure the optical density of the sodium stripped coconut fatty acids (C10 C18) as a
carbonate solution at 375 millimicrons. surfactant in emulsifier blends that are
73
§ 172.712 21 CFR Ch. I (4–1–12 Edition)
added to the herbicide atrazine for applica- tional Archives and Records Adminis-
tion to corn. tration (NARA). For information on
a-(p-Dodecylphenyl)-omega-hydroxypoly the availability of this material at
(oxyethylene) produced by the condensation
of 1 mole of dodecylphenol (dodecyl group is
a proplyene tetramer isomer) with an aver-
age of 4–14 or 30–70 moles of ethylene oxide; codeloflfederallregulations/
if a blend of products is used, the average ibrllocations.html.
number of moles of ethylene oxide reacted to (c) It is used in the manufacture of
produce any product that is a component of sausage casings as a formulation aid as
the blend shall be in the range of 4–14 or 30– defined in § 170.3(o)(14) of this chapter
70. and as a processing aid as defined in
Ethylene dichloride. § 170.3(o)(24) of this chapter.
Polyglyceryl phthalate ester of coconut oil
fatty acids. [62 FR 26228, May 13, 1997]
a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-
omega-hydroxypoly(oxyethylene) produced § 172.715 Calcium lignosulfonate.
by the condensation of 1 mole of p-(1,1,3,3- Calcium lignosulfonate may be safely
tetramethylbutyl) phenol with an average of
used in or on food, subject to the provi-
4–14 or 30–70 moles of ethylene oxide; if a
blend of products is used, the average num- sions of this section.
ber of moles of ethylene oxide reacted to (a) Calcium lignosulfonate consists of
produce any product that is a component of sulfonated lignin, primarily as calcium
the blend shall be in the range of 4–14 or 30– and sodium salts.
70. (b) It is used in an amount not to ex-
a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- ceed that reasonably required to ac-
omega-hydroxypoly(oxyethylene) produced complish the intended physical or tech-
by the condensation of 1 mole of p-(1,1,3,3- nical effect when added as a dispersing
tetramethylbutyl) phenol with 1 mole of agent and stabilizer in pesticides for
ethylene oxide.
Sodium acrylate and acrylamide copoly-
preharvest or postharvest application
mer with a minimum average molecular to bananas.
weight of 10,000,000 in which 30 percent of the
polymer is comprised of acrylate units and 70 § 172.720 Calcium lactobionate.
percent acrylamide units, for use as a drift The food additive calcium
control agent in herbicide formulations ap- lactobionate may be safely used in food
plied to crops at a level not to exceed 0.5 in accordance with the following pre-
ounces of the additive per acre. scribed conditions:
§ 172.712 1,3-Butylene glycol. (a) The food additive is the calcium
salt of lactobionic acid (4-(b,D-
The food additive 1,3-butylene glycol galactosido)-D-gluconic acid) produced
(CAS Reg. No. 107–88–0) may be safely by the oxidation of lactose.
used in food in accordance with the fol- (b) It is used or intended for use as a
lowing prescribed conditions: firming agent in dry pudding mixes at
(a) It is prepared by the aldol con- a level not greater than that required
densation of acetaldehyde followed by to accomplish the intended effect.
catalytic hydrogenation.
(b) The food additive shall conform § 172.723 Epoxidized soybean oil.
to the identity and specifications listed Epoxidized soybean oil may be safely
in the monograph entitled ‘‘1,3-Butyl- used in accordance with the following
ene Glycol’’ in the Food Chemicals prescribed conditions:
Codex, 4th ed. (1996), p. 52, which is in- (a) The additive is prepared by react-
corporated by reference in accordance ing soybean oil in toluene with hydro-
with 5 U.S.C. 552(a) and 1 CFR part 51. gen peroxide and formic acid.
Copies are available from the Office of (b) It meets the following specifica-
Premarket Approval, Center for Food tions:
Safety and Applied Nutrition, 5100 (1) Epoxidized soybean oil contains
Paint Branch Pkwy., College Park, MD oxirane oxygen, between 7.0 and 8.0 per-
20740, or may be examined at the Cen- cent, as determined by the American
ter for Food Safety and Applied Nutri- Oil Chemists’ Society (A.O.C.S.) meth-
tion’s Library, Food and Drug Admin- od Cd 9–57, ‘‘Oxirane Oxygen,’’ re-
istration, 5100 Paint Branch Pkwy., approved 1989, which is incorporated by

College Park, MD 20740, or at the Na- reference in accordance with 5 U.S.C
74
552(a) and 1 CFR part 51. Copies are § 172.725 Gibberellic acid and its po-
available from the American Oil Chem- tassium salt.
ists’ Society, P. O. Box 3489, Cham- The food additives gibberellic acid
paign, IL 61826–3489, or may be exam- and its potassium salt may be used in
ined at the Division of Petition Control the malting of barley in accordance
(HFS–215), Center for Food Safety and with the following prescribed condi-
Applied Nutrition, Food and Drug Ad- tions:
ministration, 1110 Vermont Ave. NW., (a) The additives meet the following
suite 1200, Washington, DC, or at the specifications:
National Archives and Records Admin- (1) The gibberellic acid is produced
istration (NARA). For information on by deep-culture fermentation of a suit-
the availability of this material at able nutrient medium by a strain of
NARA, call 202–741–6030, or go to: http:// Fusarium moniliforme or a selection of
www.archives.gov/federallregister/ this culture.
codeloflfederallregulations/ (2) The gibberellic acid produced is of
ibrllocations.html. 80 percent purity or better.
(2) The maximum iodine value is 3.0, (3) The empirical formula of
as determined by A.O.C.S. method Cd gibberellic acid is represented by
1–25, ‘‘Iodine Value of Fats and Oils C19H22O6.
Wijs Method,’’ revised 1993, which is in- (4) Potassium gibberellate is the po-
corporated by reference in accordance tassium salt of the specified gibberellic
with 5 U.S.C. 552(a) and 1 CFR part 51. acid.
The availability of this incorporation (5) The potassium gibberellate is of 80
by reference is given in paragraph percent purity or better.
(b)(1) of this section. (6) The gibberellic acid or potassium
gibberellate may be diluted with sub-
(3) The heavy metals (as Pb) content
stances generally recognized as safe in
cannot be more than 10 parts per mil-
foods or with salts of fatty acids con-
lion, as determined by the ‘‘Heavy Met- forming to § 172.863.
als Test,’’ of the ‘‘Food Chemicals (b) They are used or intended for use
Codex,’’ 4th ed. (1996), pp. 760–761, Meth- in the malting of barley under condi-
od II (with a 2-gram sample and 20 tions whereby the amount of either or
microgram of lead ion in the control), both additives present in the malt is
which is incorporated by reference in not in excess of 2 parts per million ex-
accordance with 5 U.S.C. 552(a) and 1 pressed as gibberellic acid, and the
CFR part 51. Copies are available from treated malt is to be used in the pro-
the National Academy Press, Box 285, duction of fermented malt beverages or
2101 Constitution Ave. NW., Wash- distilled spirits only, whereby the fin-
ington, DC 20055 (Internet address ished distilled spirits contain none and
http://www.nap.edu), or may be exam- the finished malt beverage contains
ined at the Center for Food Safety and not more than 0.5 part per million of
Applied Nutrition’s Library, Food and gibberellic acid.
Drug Administration, 5100 Paint (c) To insure the safe use of the food
Branch Pkwy., College Park, MD 20740, additives the label of the package shall
or at the National Archives and bear, in addition to the other informa-
Records Administration (NARA). For tion required by the Act:
information on the availability of this (1) The name of the additive,
material at NARA, call 202–741–6030, or ‘‘gibberellic acid’’ or ‘‘potassium
go to: http://www.archives.gov/ gibberellate’’, whichever is appro-
federallregister/ priate.
codeloflfederallregulations/ (2) An accurate statement of the con-
ibrllocations.html. centration of the additive contained in
the package.
(c) The additive is used as a halogen
(3) Adequate use directions to provide
stabilizer in brominated soybean oil at
not more than 2 parts per million of
a level not to exceed 1 percent.
gibberellic acid in the finished malt.
[60 FR 32903, June 26, 1995, as amended at 64 (4) Adequate labeling directions to
FR 1759, Jan. 12, 1999] provide that the final malt is properly
75
§ 172.730 21 CFR Ch. I (4–1–12 Edition)
labeled as described in paragraph (d) of beverages only’’, or ‘‘Distiller’s Malt—

this section. To be used in the production of dis-
(d) To insure the safe use of the addi- tilled spirits only’’, whichever is the
tive the label of the treated malt shall case.
bear, in addition to the other informa-
tion required by the Act, the state- § 172.735 Glycerol ester of rosin.
ments: Glycerol ester of wood rosin, gum
(1) ‘‘Contains not more than 2 parts rosin, or tall oil rosin may be safely
per million lll’’, the blank being used in food in accordance with the fol-
filled in with the words ‘‘gibberellic lowing prescribed conditions:
acid’’ or ‘‘potassium gibberellate’’,
(a) It has an acid number of 3 to 9, a
whichever is appropriate; and
(2) ‘‘Brewer’s malt—To be used in the drop-softening point of 88 to 96 °C; and
production of fermented malt bev- a color of N or paler as determined in
erages only’’ or ‘‘Distiller’s malt—To accordance with Official Naval Stores
be used in the production of distilled Standards of the United States. It is
spirits only’’, whichever is appropriate. purified by countercurrent steam dis-
tillation or steam stripping.
§ 172.730 Potassium bromate. (b) It is used to adjust the density of
The food additive potassium bromate citrus oils used in the preparation of
may be safely used in the malting of beverages whereby the amount of the
barley under the following prescribed additive does not exceed 100 parts per
conditions: million of the finished beverage.
(a)(1) It is used or intended for use in [42 FR 14491, Mar. 15, 1977, as amended at 70
the malting of barley under conditions FR 15758, Mar. 29, 2005; 72 FR 46896, Aug. 22,
whereby the amount of the additive 2007]
present in the malt from the treatment
does not exceed 75 parts per million of § 172.736 Glycerides and polyglycides
bromate (calculated as Br), and the of hydrogenated vegetable oils.
treated malt is used only in the pro- The food additive glycerides and
duction of fermented malt beverages or polyglycides of hydrogenated vegetable
distilled spirits. oils may be safely used in food in ac-
(2) The total residue of inorganic bro- cordance with the following prescribed
mides in fermented malt beverages, re- conditions:
sulting from the use of the treated
(a) The additive is manufactured by
malt plus additional residues of inor-
heating a mixture of hydrogenated oils
ganic bromides that may be present
from uses in accordance with other reg- of vegetable origin and polyethylene
ulations in this chapter promulgated glycol in the presence of an alkaline
under sections 408 and/or 409 of the act, catalyst followed by neutralization
does not exceed 25 parts per million of with any acid that is approved or is
bromide (calculated as Br). No toler- generally recognized as safe for this
ance is established for bromide in dis- use to yield the finished product.
tilled spirits because there is evidence (b) The additive consists of a mixture
that inorganic bromides do not pass of mono-, di- and tri-glycerides and
over in the distillation process. polyethylene glycol mono- and di-
(b) To assure safe use of the additive, esters of fatty acids (polyglycides) of
the label or labeling of the food addi- hydrogenated vegetable oils and meets
tive shall bear, in addition to the other the following specifications:
information required by the Act, the (1) Total ester content, greater than
following: 90 percent as determined by a method
(1) The name of the additive. entitled ‘‘Determination of Esterified
(2) Adequate directions for use. Glycerides and Polyoxyethylene
(c) To assure safe use of the additive, Glycols,’’ approved November 16, 2001,
the label or labeling of the treated printed by Gattefosse S.A.S., and in-
malt shall bear, in addition to other incorporated by reference. The Director
formation required by the Act, the of the Office of the Federal Register
statement, ‘‘Brewer’s Malt—To be used approves this incorporation by ref-

in the production of fermented malt erence in accordance with 5 U.S.C.
76
552(a) and 1 CFR part 51. You may ob- www.archives.gov/federallregister/

tain a copy from the Office of Food Ad- codeloflfederallregulations/
ditive Safety, 5100 Paint Branch Pkwy., ibrllocations.html.
College Park, MD 20740 or you may ex- (4) 1,4-Dioxane, not greater than 10
amine a copy at the Center for Food milligrams per kilogram (mg/kg), and
Safety and Applied Nutrition’s Li- ethylene oxide, not greater than 1 mg/
brary, Food and Drug Administration, kg, as determined by a gas
5100 Paint Branch Pkwy., College Park, chromatographic method entitled
MD 20740, or at the National Archives ‘‘Determination of Ethylene Oxide and
and Records Administration (NARA). 1,4-Dioxane by Headspace Gas Chroma-
For information on the availability of tography,’’ approved November 5, 1998,
this material at NARA, call 202–741– printed by Gattefosse S.A.S., and in-
6030, or go to http://www.archives.gov/ corporated by reference in accordance
federallregister/ with 5 U.S.C. 552(a) and 1 CFR part 51;
codeloflfederallregulations/ see paragraph (b)(1) of this section for
ibrllocations.html. availability of the incorporation by
(2) Acid value, not greater than 2, reference.
and hydroxyl value, not greater than 56 (c) The additive is used or intended
as determined by the methods entitled for use as an excipient in dietary sup-
‘‘Acid Value,’’ p. 934 and ‘‘Hydroxyl plement tablets, capsules, and liquid
Value,’’ p. 936, respectively, in the formulations that are intended for in-
Food Chemicals Codex, 5th ed., effec- gestion in daily quantities measured in
tive January 1, 2004, and incorporated drops or similar small units of meas-
by reference in accordance with 5 ure.
U.S.C. 552(a) and 1 CFR part 51. Copies
[71 FR 12620, Mar. 13, 2006]
are available from the National Acad-
emies Press, 500 Fifth St. NW., Wash- § 172.755 Stearyl monoglyceridyl cit-
ington, DC 20055 (Internet address rate.
http://www.nap.edu), or may be exam-
ined at the Center for Food Safety and The food additive stearyl
Applied Nutrition’s Library, 5100 Paint monoglyceridyl citrate may be safely
Branch Pkwy., College Park, MD 20740, used in food in accordance with the fol-
or at the National Archives and lowing provisions:
Records Administration (NARA). For (a) The additive is prepared by con-
information on the availability of this trolled chemical reaction of the fol-
material at NARA, call 202–741–6030, or lowing:
go to http://www.archives.gov/ Reactant Limitations
federallregister/
codeloflfederallregulations/ Citric acid ......................
Monoglycerides of fatty Prepared by the glycerolysis of ed-
ibrllocations.html.
acids. ible fats and oils or derived from
(3) Lead, not greater than 0.1 mg/kg fatty acids conforming with
as determined by the American Oil § 172.860.
Chemists’ Society (A.O.C.S.) method Stearyl alcohol .............. Derived from fatty acids con-
forming with § 172.860, or de-
Ca 18c–91, ‘‘Determination of Lead by rived synthetically in conformity
Direct Graphite Furnace Atomic Ab- with § 172.864.
sorption Spectrophotometry,’’ updated
1995, and incorporated by reference in (b) The additive stearyl
accordance with 5 U.S.C. 552(a) and 1 monoglyceridyl citrate, produced as
CFR part 51. Copies are available from described under paragraph (a) of this
American Oil Chemists’ Society, P. O. section, meets the following specifica-
Box 3489, Champaign, IL 61826–3489, or tions:
may be examined in the library at the
Acid number 40 to 52.
Center for Food Safety and Applied Nu-
Total citric acid 15 to 18 percent.
trition, 5100 Paint Branch Pkwy., Col-
Saponification number 215–255.
lege Park, MD 20740, or at the National
Archives and Records Administration (c) The additive is used or intended
(NARA). For information on the avail- for use as an emulsion stabilizer in or
ability of this material at NARA, call with shortenings containing emulsi-

202–741–6030, or go to http:// fiers.
77
§ 172.765 21 CFR Ch. I (4–1–12 Edition)
§ 172.765 Succistearin (stearoyl pro- (c) The additive is used as a carrier of

pylene glycol hydrogen succinate). vitamin B12 in foods for special dietary
use.
The food additive succistearin (ste-
aroyl propylene glycol hydrogen succi- § 172.780 Acacia (gum arabic).
nate) may be safely used in food in ac-
The food additive may be safely used
in food in accordance with the fol-
conditions:
lowing prescribed conditions:
(a) The additive is the reaction prod- (a) Acacia (gum arabic) is the dried
uct of succinic anhydride, fully hydro- gummy exudate from stems and
genated vegetable oil (predominantly branches of trees of various species of
C16 or C18 fatty acid chain length), and the genus Acacia, family Leguminosae.
propylene glycol. (b) The ingredient meets the speci-
(b) The additive meets the following fications of the ‘‘Food Chemicals
specifications: Codex,’’ 5th Ed. (2004), pp. 210 and 211,
Acid number 50–150. which is incorporated by reference. The
Hydroxyl number 15–50. Director of the Office of the Federal
Succinated ester content 45–75 percent. Register approves this incorporation
by reference in accordance with 5
(c) The additive is used or intended U.S.C. 552(a) and 1 CFR part 51. You
for use as an emulsifier in or with may obtain copies from the National
shortenings and edible oils intended for Academies Press, 500 Fifth St. NW.,
use in cakes, cake mixes, fillings, Washington, DC 20001 (Internet ad-
icings, pastries, and toppings, in ac- dress: http://www.nap.edu). Copies may
cordance with good manufacturing be examined at the Center for Food
practice. Safety and Applied Nutrition’s Li-
brary, Food and Drug Administration,
§ 172.770 Ethylene oxide polymer. 5100 Paint Branch Pkwy., College Park,
The polymer of ethylene oxide may MD 20740, or at the National Archives
be safely used as a foam stabilizer in and Records Administration (NARA).
fermented malt beverages in accord- For information on the availability of
ance with the following conditions. this material at NARA, call 202–741–
6030, or go to: http://www.archives.gov/
(a) It is the polymer of ethylene
federallregister/
oxide having a minimum viscosity of codeloflfederalregulations/
1,500 centipoises in a 1 percent aqueous ibrllocations.html.
solution at 25 °C. (c) The ingredient is used as a thick-
(b) It is used at a level not to exceed ener, emulsifier, or stabilizer in alco-
300 parts per million by weight of the holic beverages at a use level not to ex-
fermented malt beverage. ceed 20 percent in the final beverage.
(c) The label of the additive bears di-
[70 FR 8034, Feb. 17, 2005]
rections for use to insure compliance
with paragraph (b) of this section. § 172.785 Listeria-specific
bacteriophage preparation.
§ 172.775 Methacrylic acid-
divinylbenzene copolymer. The additive may be safely used as an
antimicrobial agent specific for Listeria
Methacrylic acid-divinylbenzene co- monocytogenes (L. monocytogenes) in ac-
polymer may be safely used in food in cordance with the following conditions:
accordance with the following pre- (a) Identity. (1) The additive consists
scribed conditions: of a mixture of equal proportions of six
(a) The additive is produced by the different individually purified lytic-
polymerization of methacrylic acid and type (lacking lysogenic activity)
divinylbenzene. The divinylbenzene bacteriophages (phages) specific
functions as a cross-linking agent and against L. monocytogenes.
constitutes a minimum of 4 percent of (2) Each phage is deposited at, and
the polymer. assigned an identifying code by, a sci-
(b) Aqueous extractives from the ad- entifically-recognized culture collec-
ditive do not exceed 2 percent (dry tion center, and is made available to
basis) after 24 hours at 25 °C. FDA upon request.
78
(3) The additive is produced from one than 5 hemolytic units (HU)/ml. The
or more cell cultures of L. analytical method for determining
monocytogenes in a safe and suitable nu- LLO entitled ‘‘Quantitation of
trient medium. Listeriolysin O Levels in LMP–102TM,’’
(b) Specifications.(1) The additive dated September 27, 2004, and printed
achieves a positive lytic result (OD600 ≤ by Intralytix, Inc., is incorporated by
0.06) when tested against any of the fol- reference. Copies are available at loca-
lowing L. monocytogenes isolates avail- tions cited in paragraph (b)(1) of this
able from American Type Culture Col- section.
lection (ATCC): ATCC 35152 (serogroup (5) The additive is negative for L.
1/2a), ATCC 19118 (serogroup 4b), and
monocytogenes. The modified version of
ATCC 15313 (serogroup 1/2b). The ana-
the U.S. Department of Agriculture’s
lytical method for determining the po-
tency of the additive entitled ‘‘Deter- method for determining L.
mination of Potency of LMP–102TM,’’ monocytogenes entitled ‘‘LMP–102TM
dated October 9, 2003, and printed by Listeria monocytogenes Sterility Test-
Intralytix, Inc., is incorporated by ref- ing,’’ dated May 24, 2004, and printed by
erence. The Director of the Office of Intralytix, Inc., is incorporated by ref-
the Federal Register approves this in- erence. Copies are available at loca-
corporation by reference in accordance tions cited in paragraph (b)(1) of this
with 5 U.S.C. 552(a) and 1 CFR part 51. section.
You may obtain a copy from the Office (6) The additive is negative for gram-
of Food Additive Safety (HFS–200), positive and gram-negative bacteria
Center for Food Safety and Applied Nu- capable of growing in commonly used
trition, Food and Drug Administration, microbiological media (e.g., Luria-
5100 Paint Branch Pkwy., College Park, Bertani (LB) medium), including Esch-
MD 20740, or you may examine a copy erichia coli, Salmonella species and
at the Center for Food Safety and Ap- coagulase-positive Staphylococci, as de-
plied Nutrition’s Library, 5100 Paint termined by the ‘‘Method to Determine
Branch Pkwy., College Park, MD 20740, Microbial Contamination,’’ dated July
or at the National Archives and 11, 2003, and printed by Intralytix, Inc.,
Records Administration (NARA). For is incorporated by reference. Copies are
information on the availability of this
available at locations cited in para-
material at NARA, call 202–741–6030, or
graph (b)(1) of this section.
federallregister/ (7) Total organic carbon (TOC) is less
codeloflfederallregulations/ than or equal to 36 mg/kg. The analyt-
ibrllocations.html. ical method for determining TOC enti-
(2) The mean phage titer of each tled ‘‘Determination of Total Organic
monophage in the additive is 1 × 109 Carbon by Automated Analyzer,’’ dated
plaque forming units (PFU)/ml. The an- March 30, 2001, and printed by
alytical method for determining phage Intralytix, Inc., is incorporated by ref-
titer entitled ‘‘Method to Determine erence. Copies are available at loca-
Lytic Activity/Phage Titer,’’ dated No- tions cited in paragraph (b)(1) of this
vember 6, 2001, and printed by section.
Intralytix, Inc., is incorporated by ref- (c) Conditions of use. The additive is
erence. Copies are available at loca- used in accordance with current good
tions cited in paragraph (b)(1) of this manufacturing practice to control L.
section. monocytogenes by direct application to
(3) The phages present in the prepara- meat and poultry products that comply
tion must not contain a functional por- with the ready-to-eat definition in 9
tion of any of the toxin-encoding se- CFR 430.1. Current good manufacturing
quences described in 40 CFR 725.421(d). practice is consistent with direct spray
No sequences derived from genes en- application of the additive at a rate of
coding bacterial 16S ribosomal RNA
approximately 1 mL of the additive per
are present in the complete genomic
500 cm2 product surface area.
sequence of the phages.
(4) L. monocytogenes toxin, [71 FR 47731, Aug. 18, 2006]

listeriolysin O (LLO), is not greater
79
§ 172.800 21 CFR Ch. I (4–1–12 Edition)
Subpart I—Multipurpose Additives uses, it shall be labeled in compliance

with part 105 of this chapter.
§ 172.800 Acesulfame potassium. [53 FR 28382, July 28, 1988, as amended at 57
Acesulfame potassium (CAS Reg. No. FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545,
55589–62–3), also known as acesulfame Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR
36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003]
K, may be safely used as a general-pur-
pose sweetener and flavor enhancer in § 172.802 Acetone peroxides.
foods generally, except in meat and
The food additive acetone peroxides
poultry, in accordance with current
may be safely used in flour, and in
good manufacturing practice and in an
bread and rolls where standards of
amount not to exceed that reasonably identity do not preclude its use, in ac-
required to accomplish the intended cordance with the following prescribed
technical effect in foods for which conditions:
standards of identity established under (a) The additive is a mixture of
section 401 of the Federal Food, Drug, monomeric and linear dimeric acetone
and Cosmetic Act do not preclude such peroxide, with minor proportions of
use, under the following conditions: higher polymers, manufactured by re-
(a) Acesulfame potassium is the po- action of hydrogen peroxide and ace-
tassium salt of 6-methyl-1,2,3- tone.
oxathiazine-4(3H)-one-2,2-dioxide. (b) The additive may be mixed with
(b) The additive meets the following an edible carrier to give a concentra-
specifications: tion of: (1) 3 grams to 10 grams of hy-
(1) Purity is not less than 99 percent drogen peroxide equivalent per 100
on a dry basis. The purity shall be de- grams of the additive, plus carrier, for
termined by a method titled use in flour maturing and bleaching; or
‘‘Acesulfame Potassium Assay,’’ which (2) approximately 0.75 gram of hydro-
is incorporated by reference. Copies are gen peroxide equivalent per 100 grams
available from the Center for Food of the additive, plus carrier, for use in
Safety and Applied Nutrition (HFS– dough conditioning.
200), Food and Drug Administration, (c) It is used or intended for use: (1)
5100 Paint Branch Pkwy., College Park, In maturing and bleaching of flour in a
MD 20740, or available for inspection at quantity not more than sufficient for
the National Archives and Records Ad- such effect; and (2) as a dough-condi-
ministration (NARA). For information tioning agent in bread and roll produc-
on the availability of this material at tion at not to exceed the quantity of
NARA, call 202–741–6030, or go to: http:// hydrogen peroxide equivalent nec-
www.archives.gov/federallregister/ essary for the artificial maturing ef-
codeloflfederallregulations/ fect.
(d) To insure safe use of the additive,
ibrllocations.html.
the label of the food additive container
(2) Fluoride content is not more than and any intermediate premix thereof
30 parts per million, as determined by shall bear, in addition to the other in-
method III of the Fluoride Limit Test formation required by the act:
of the Food Chemicals Codex, 3d Ed. (1) The name of the additive, ‘‘ace-
(1981), p. 511, which is incorporated by tone peroxides’’.
reference. Copies are available from (2) The concentration of the additive
the National Academy Press, 2101 Con- expressed in hydrogen peroxide equiva-
stitution Ave. NW., Washington, DC lents per 100 grams.
20418, or available for inspection at the (3) Adequate use directions to provide
National Archives and Records Admin- a final product that complies with the
istration (NARA). For information on limitations prescribed in paragraph (c)
the availability of this material at of this section.
www.archives.gov/federallregister/ § 172.804 Aspartame.
codeloflfederallregulations/ The food additive aspartame may be
ibrllocations.html. safely used in food in accordance with
(c) If the food containing the additive good manufacturing practice as a

is represented to be for special dietary sweetening agent and a flavor enhancer
80
in foods for which standards of identity and Drug Administration, 5100 Paint
established under section 401 of the act Branch Pkwy., College Park, MD 20740,
do not preclude such use under the fol- and at the National Archives and
lowing conditions: Records Administration (NARA). For
(a) Aspartame is the chemical 1- information on the availability of this
methyl N-L-a-aspartyl-L-phenylalanine material at NARA, call 202–741–6030, or
(C14H18N2O5). go to: http://www.archives.gov/
(b) The additive meets the specifica- federallregister/
tions of the ‘‘Food Chemicals Codex,’’ codeloflfederallregulations/
3d Ed. (1981) pp. 28–29 and First Supple- ibrllocations.html.
ment p. 5, which is incorporated by ref-
(d) To assure safe use of the additive,
erence in accordance with 5 U.S.C.
in addition to the other information re-
552(a). Copies are available from the
National Academy Press, 2101 Constitu- quired by the Act:
tion Ave. NW., Washington, DC 20418, (1) The principal display panel of any
or may be examined at the Center for intermediate mix of the additive for
Food Safety and Applied Nutrition’s manufacturing purposes shall bear a
Library, Food And Drug Administra- statement of the concentration of the
tion, 5100 Paint Branch Pkwy., College additive contained therein;
Park, MD 20740, or at the National Ar- (2) The label of any food containing
chives and Records Administration the additive shall bear, either on the
(NARA). For information on the avail- principal display panel or on the infor-
ability of this material at NARA, call mation panel, the following statement:
202–741–6030, or go to: http://
www.archives.gov/federallregister/ PHENYLKETONURICS: CONTAINS
codeloflfederallregulations/ PHENYLALANINE
ibrllocations.html.
(c)(1) When aspartame is used as a The statement shall appear in the la-
sugar substitute tablet for sweetening beling prominently and conspicuously
hot beverages, including coffee and tea, as compared to other words, state-
L-leucine may be used as a lubricant in ments, designs or devices and in bold
the manufacture of such tablets at a type and on clear contrasting back-
level not to exceed 3.5 percent of the ground in order to render it likely to
weight of the tablet. be read and understood by the ordinary
(2) When aspartame is used in baked individual under customary conditions
goods and baking mixes, the amount of of purchase and use.
the additive is not to exceed 0.5 percent (3) When the additive is used in a
by weight of ready-to-bake products or sugar substitute for table use, its label
of finished formulations prior to bak- shall bear instructions not to use in
ing. Generally recognized as safe cooking or baking.
(GRAS) ingredients or food additives (4) Packages of the dry, free-flowing
approved for use in baked goods shall additive shall prominently display the
be used in combination with aspartame sweetening equivalence in teaspoons of
to ensure its functionality as a sweet- sugar.
ener in the final baked product. The
(e) If the food containing the additive
level of aspartame used in these prod-
purports to be or is represented for spe-
ucts is determined by an analytical
method entitled ‘‘Analytical Method cial dietary uses, it shall be labeled in
for the Determination of Aspartame compliance with part 105 of this chap-
and Diketopiperazine in Baked Goods ter.
and Baking Mixes,’’ October 8, 1992, [39 FR 27319, July 26, 1974]
which was developed by the Nutrasweet
Co. Copies are available from the Office EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 172.804, see the List of CFR
of Premarket Approval (HFS–200), Cen-
Sections Affected, which appears in the
ter for Food Safety and Applied Nutri- Finding Aids section of the printed volume
tion, 5100 Paint Branch Pkwy., College and at www.fdsys.gov.
Park, MD 20740, or are available for in-
spection at the Center for Food Safety

and Applied Nutrition’s Library, Food
81
§ 172.806 21 CFR Ch. I (4–1–12 Edition)
§ 172.806 Azodicarbonamide. minimum cloud point of 9 °C–12 °C in 10

percent aqueous solution.
The food additive azodicarbonamide
(4) a-Hydro-omega-hydroxy-poly(ox-
may be safely used in food in accord-
yethylene) poly (oxypropylene)-(51–57
ance with the following prescribed con-
moles) poly(oxyethylene) block copoly-
ditions:
mer, having an average molecular
(a) It is used or intended for use: weight of 14,000 and a cloud point above
(1) As an aging and bleaching ingre- 100 °C in 1 percent aqueous solution.
dient in cereal flour in an amount not (b) The additive is used or intended
to exceed 2.05 grams per 100 pounds of for use as follows:
flour (0.0045 percent; 45 parts per mil- (1) The additive identified in para-
lion). graph (a)(1) of this section is used in
(2) As a dough conditioner in bread practice as a solubilizing and stabi-
baking in a total amount not to exceed lizing agent in flavor concentrates
0.0045 percent (45 parts per million) by (containing authorized flavoring oils)
weight of the flour used, including any for use in foods for which standards of
quantity of azodicarbonamide added to identity established under section 401
flour in accordance with paragraph of the Act do not preclude such use,
(a)(1) of this section. provided that the weight of the addi-
(b) To assure safe use of the additive: tive does not exceed the weight of the
(1) The label and labeling of the addi- flavoring oils in the flavor concentrate.
tive and any intermediate premix pre- (2) The additive identified in para-
pared therefrom shall bear, in addition graph (a)(2) of this section is used as a
to the other information required by processing aid and wetting agent in
the Act, the following: combination with dioctyl sodium sulfo-
(i) The name of the additive. succinate for fumaric acid as pre-
(ii) A statement of the concentration scribed in § 172.810.
or the strength of the additive in any (3) The additive identified in para-
intermediate premixes. graph (a)(3) of this section is used:
(2) The label or labeling of the food (i) As a surfactant and defoaming
additive shall also bear adequate direc- agent, at levels not to exceed 0.05 per-
tions for use. cent by weight, in scald baths for poul-
try defeathering, followed by potable
§ 172.808 Copolymer condensates of water rinse. The temperatures of the
ethylene oxide and propylene oxide. scald baths shall be not less than 125
Copolymer condensates of ethylene °F.
oxide and propylene oxide may be safe- (ii) As a foam control and rinse adju-
ly used in food under the following pre- vant in hog dehairing machines at a
scribed conditions: use level of not more than 5 grams per
(a) The additive consists of one of the hog.
following: (4) The additive identified in para-
(1) a-Hydro-omega-hydroxy-poly (oxy- graph (a)(4) of this section is used as a
ethylene) poly(oxypropylene)-(55–61 dough conditioner in yeast-leavened
moles)poly(oxyethylene) block copoly- bakery products for which standards of
mer, having a molecular weight range identity established under section 401
of 9,760–13,200 and a cloud point above of the Act do not preclude such use,
100 °C in 1 percent aqueous solution. provided that the amount of the addi-
(2) a-Hydro-omega-hydroxy-poly (oxy- tive dose not exceed 0.5 percent by
ethylene)poly(oxypropylene)-(53–59 weight of the flour used.
moles)poly(oxyethylene)(14–16 moles) [42 FR 14491, Mar. 15, 1977, as amended at 46
block copolymer, having a molecular FR 57476, Nov. 24, 1981]
weight range of 3,500–4,125 and a cloud
point of 9 °C–12 °C in 10 percent aqueous § 172.809 Curdlan.
solution. Curdlan may be safely used in ac-
(3) a-Hydro-omega-hydroxy-poly(ox- cordance with the following conditions:
yethylene)/poly(oxypropylene) (min- (a) Curdlan is a high molecular
imum 15 moles)/poly(oxyethylene) weight polymer of glucose (b-1,3-
block copolymer, having a minimum glucan; CAS Reg. No. 54724–00–4) pro-
average molecular weight of 1900 and a duced by pure culture fermentation
82
from the nonpathogenic and section 401 of the act do not preclude
nontoxicogenic bacterium Alcaligenes such use.
faecalis var. myxogenes. [61 FR 65941, Dec. 16, 1996]
(b) Curdlan meets the following spec-
ifications when it is tested according § 172.810 Dioctyl sodium sulfosuc-
to the methods described or referenced cinate.
in the document entitled ‘‘Analytical The food additive dioctyl sodium
Methods for Specification Tests for sulfosuccinate, which meets the speci-
Curdlan,’’ by Takeda Chemical Indus- fications of the Food Chemicals Codex,
tries, Ltd., 12–10 Nihonbashi, 2–Chome, 3d Ed. (1981), pp. 102–104, which is incor-
Chuo-ku, Tokyo, 103, Japan, 1996, which porated by reference (Copies may be
is incorporated by reference in accord- obtained from the National Academy
ance with 5 U.S.C. 552(a) and 1 CFR Press, 2101 Constitution Ave. NW.,
part 51. Copies are available from the Washington, DC 20418, or may be exam-
Division of Petition Control (HFS–215), ined at the National Archives and
Center for Food Safety and Applied Nu- Records Administration (NARA). For
trition, Food and Drug Administration, information on the availability of this
5100 Paint Branch Pkwy., College Park, material at NARA, call 202–741–6030, or
MD 20740, or may be examined at the go to: http://www.archives.gov/
Center for Food Safety and Applied Nu- federallregister/
trition’s Library, Food and Drug Ad- codeloflfederallregulations/
ministration, 5100 Paint Branch Pkwy., ibrllocations.html.), may be safely used
College Park, MD 20740, or at the Na- in food in accordance with the fol-
tional Archives and Records Adminis- lowing prescribed conditions:
tration (NARA). For information on (a) As a wetting agent in the fol-
the availability of this material at lowing fumaric acid-acidulated foods:
NARA, call 202–741–6030, or go to: http:// Dry gelatin dessert, dry beverage base,
www.archives.gov/federallregister/ and fruit juice drinks, when standards
codeloflfederallregulations/ of identity do not preclude such use.
ibrllocations.html. The labeling of the dry gelatin dessert
(1) Positive for curdlan. and dry beverage base shall bear ade-
(2) Assay for curdlan (calculated as quate directions for use, and the addi-
anhydrous glucose), not less than 80 tive shall be used in such an amount
percent. that the finished gelatin dessert will
(3) pH of 1 percent aqueous suspen- contain not in excess of 15 parts per
sion, 6.0–7.5. million of the additive and the finished
(4) Lead, not more than 0.5 mg/kg. beverage or fruit juice drink will con-
(5) Heavy metals (as Pb), not more tain not in excess of 10 parts per mil-
than 0.002 percent. lion of the additive.
(b) As a processing aid in sugar fac-
(6) Total nitrogen, not more than 0.2
tories in the production of unrefined
percent.
cane sugar, in an amount not in excess
(7) Loss on drying, not more than 10 of 0.5 part per million of the additive
percent. per percentage point of sucrose in the
(8) Residue on ignition, not more juice, syrup, or massecuite being proc-
than 6 percent. essed, and so used that the final molas-
(9) Gel strength of 2 percent aqueous ses will contain no more than 25 parts
suspension, not less than 600×103 dyne per million of the additive.
per square centimeter. (c) As a solubilizing agent on gums
(10) Aerobic plate count, not more and hydrophilic colloids to be used in
than 103 per gram. food as stabilizing and thickening
(11) Coliform bacteria, not more than agents, when standards of identity do
3 per gram. not preclude such use. The additive is
(c) Curdlan is used or intended for used in an amount not to exceed 0.5
use in accordance with good manufac- percent by weight of the gums or hy-
turing practice as a formulation aid, drophilic colloids.
processing aid, stabilizer and thick- (d) As an emulsifying agent for cocoa
ener, and texturizer in foods for which fat in noncarbonated beverages con-
standards of identity established under taining cocoa, whereby the amount of
83
§ 172.811 21 CFR Ch. I (4–1–12 Edition)
the additive does not exceed 25 parts Uses Limitations

per million of the finished beverage.
1. As a crystallization accel- Not to exceed 1 percent of
(e) As a dispersing agent in ‘‘cocoa erator in cocoa products, in the combined weight of
with dioctyl sodium sulfosuccinate for imitation chocolate, and in the formulation.
manufacturing’’ that conforms to the compound coatings.
2. As a formulation aid as de- Not to exceed 0.5 percent.
provisions of § 163.117 of this chapter fined in § 170.3(o)(14) of this
and the use limitations prescribed in chapter, lubricant and release
§ 172.520, in an amount not to exceed 0.4 agent as defined in
percent by weight thereof. § 170.3(o)(18) of this chapter,
and surface-finishing agent as
(f) As a processing aid and wetting defined in § 170.3(o)(30) of
agent in combination with a-hydro- this chapter in food.
omega -hydroxy - poly(oxyethylene) - 3. As a formulation aid as de- Not to exceed 3.0 percent
fined in § 170.3(o)(14) of this of the combined weight
poly-(oxypropylene) (53–59 moles) chapter in confections. of the formulation.
poly(oxyethylene) (14–16 moles) block 4. As a formulation aid as de- Not to exceed 1.0 percent
copolymer, having a molecular weight fined in § 170.3(o)(14) of this of the combined weight
range of 3,500–4,125 and a cloud point of chapter in fats and oils as de- of the formulation.
fined in § 170.3 (n)(12) of this
9 °C–12 °C in 10 percent aqueous solu- chapter.
tion, for fumaric acid used in fumaric 5. As a winterization and frac- Not to exceed 0.5 percent
acid-acidulated dry beverage base and tionation aid in fat and oil by weight of the proc-
in fumaric acid-acidulated fruit juice processing. essed fat or oil.
drinks, when standards of identity do
not preclude such use. The labeling of (d) To assure safe use of the additive:
the dry beverage base shall bear ade- (1) In addition to the other informa-
quate directions for use, and the addition required by the act, the label or
tives shall be used in such an amount labeling of the additive shall bear the
that the finished beverage or fruit juice name of the additive.
drink will contain not in excess of a (2) The label of the additive shall
total of 10 parts per million of the bear adequate directions to provide a
dioctyl sodium sulfosuccinate-block final product that complies with the
copolymer combination. limitations prescribed in paragraph (c)
of this section.
FR 10105, Mar. 19, 1984] [53 FR 21632, June 9, 1988, as amended at 59
FR 24924, May 13, 1994]
§ 172.811 Glyceryl tristearate.
The food additive glyceryl tristearate § 172.812 Glycine.
may be safely used in food in accord- The food additive glycine may be
ance with the following prescribed con- safely used for technological purposes
ditions: in food in accordance with the fol-
(a) The food additive (CAS Reg. No. lowing prescribed conditions:
555–43–1) is prepared by reacting stearic (a) The additive complies with the
acid with glycerol in the presence of a specifications of the ‘‘Food Chemicals
suitable catalyst. Codex,’’ 3d Ed. (1981), p. 140, which is in-
(b) The food additive meets the fol- corporated by reference. Copies may be
lowing specifications: obtained from the National Academy
Acid number: Not to exceed 1.0. Press, 2101 Constitution Ave. NW.,
Iodine number: Not to exceed 1.0. Washington, DC 20418, or may be exam-
Saponification number: 186–192. ined at the National Archives and
Hydroxyl number: Not to exceed 5.0. Records Administration (NARA). For
Free glycerol content: Not to exceed 0.5 per- information on the availability of this
cent. material at NARA, call 202–741–6030, or
Unsaponifiable matter: Not to exceed 0.5 per-
cent.
Melting point (Class II): 69 °C–73 °C.
federallregister/
(c) The additive is used or intended ibrllocations.html.
for use as follows when standards of

identity established under section 401 for use as follows:
of the Act do not preclude such use:
84
Uses Limitations § 172.816 Methyl glucoside-coconut oil

ester.
As a masking agent for the Not to exceed 0.2 percent in
bitter aftertaste of sac- the finished beverage. Methyl glucoside-coconut oil ester
charin used in manufac- may be safely used in food in accord-
tured beverages and bev-
erage bases.
ance with the following conditions:
As a stabilizer in mono- and Not to exceed 0.02 percent of (a) It is the methyl glucoside-coconut
diglycerides prepared by the mono- and oil ester having the following specifica-
the glycerolysis of edible diglycerides. tions:
fats or oils.
Acid number: 10–20
(c) To assure safe use of the additive, Hydroxyl number: 200–300
pH (5% aqueous): 4.8–5.0
in addition to the other information re- Saponification number: 178–190
quired by the Act:
(1) The labeling of the additive shall (b) It is used or intended for use as
bear adequate directions for use of the follows:
additive in compliance with the provi- (1) As an aid in crystallization of su-
sions of this section. crose and dextrose at a level not to ex-
ceed the minimum quantity required to
(2) The labeling of beverage bases
produce its intended effect.
containing the additive shall bear ade- (2) As a surfactant in molasses at a
quate directions for use to provide that level not to exceed 320 parts per million
beverages prepared therefrom shall in the molasses.
contain no more than 0.2 percent gly-
cine. § 172.818 Oxystearin.
[42 FR 14491, Mar. 15, 1977, as amended at 49 The food additive oxystearin may be
FR 10105, Mar. 19, 1984] safely used in foods, when such use is
not precluded by standards of identity
§ 172.814 Hydroxylated lecithin. in accordance with the following condi-
The food additive hydroxylated tions:
(a) The additive is a mixture of the
lecithin may be safely used as an emul-
glycerides of partially oxidized stearic
sifier in foods in accordance with the
and other fatty acids obtained by heat-
following conditions:
ing hydrogenated cottonseed or soy-
(a) The additive is obtained by the bean oil under controlled conditions, in
treatment of lecithin in one of the fol- the presence of air and a suitable cata-
lowing ways, under controlled condi- lyst which is not a food additive as so
tions whereby the separated fatty acid defined. The resultant product meets
fraction of the resultant product has the following specifications:
an acetyl value of 30 to 38:
Acid number: Maximum 15.
(1) With hydrogen peroxide, benzoyl Iodine number: Maximum 15.
peroxide, lactic acid, and sodium hy- Saponification number: 225–240.
droxide. Hydroxyl number: 30–45.
(2) With hydrogen peroxide, acetic Unsaponifiable material: Maximum 0.8 per-
acid, and sodium hydroxide. cent.
Refractive index (butyro): 60±1 at 48 °C.
(b) It is used or intended for use, in
accordance with good manufacturing (b) It is used or intended for use as a
practice, as an emulsifier in foods, ex- crystallization inhibitor in vegetable
cept for those standardized foods that oils and as a release agent in vegetable
do not provide for such use. oils and vegetable shortenings, where-
(c) To assure safe use of the additive, by the additive does not exceed 0.125
the label of the food additive container percent of the combined weight of the
oil or shortening.
shall bear, in addition to the other in-
(c) To insure safe use of the additive,
formation required by the Act:
the label and labeling of the additive
(1) The name of the additive, container shall bear, in addition to the
‘‘hydroxylated lecithin’’. other information required by the Act:
(2) Adequate directions for its use. (1) The name of the additive.
(2) Adequate directions to provide an

oil or shortening that complies with
85
§ 172.820 21 CFR Ch. I (4–1–12 Edition)
the limitations prescribed in paragraph SX850, or equivalent) 12 percent in H2O by

(b) of this section. weight on 60–80 mesh nonacid washed diato-
maceous earth (Chromosorb W. Johns-Man-
§ 172.820 Polyethylene glycol (mean ville, or equivalent).
molecular weight 200–9,500). REAGENTS AND MATERIALS
Polyethylene glycol identified in this Carrier gas, nitrogen: Commercial grade in
section may be safely used in food in cylinder equipped with reducing regulator to
accordance with the following pre- provide 50 p.s.i.g. to the gas chromatograph.
scribed conditions: Ethylene glycol: Commercial grade. Purify
(a) Identity. (1) The additive is an ad- if necessary, by distillation.
dition polymer of ethylene oxide and Diethylene glycol: Commercial grade. Pu-
water with a mean molecular weight of rify, if necessary, by distillation.
200 to 9,500. Glycol standards: Prepare
chromatographic standards by dissolving
(2) It contains no more than 0.2 per- known amounts of ethylene glycol and
cent total by weight of ethylene and diethylene glycol in water. Suitable con-
diethylene glycols when tested by the centrations for standardization range from 1
analytical methods prescribed in para- to 6 milligrams of each component per milli-
graph (b) of this section. liter (for example 10 milligrams diluted to
(b) Analytical method. (1) The analyt- volume in a 10-milliliter volumetric flask is
ical method prescribed in the National equivalent to 1 milligram per milliliter).
Formulary XV (1980), page 1244, for pol- STANDARDIZATION
yethylene glycol 400 shall be used to
determine the total ethylene and Inject a 2-microliter aliquot of the glycol
standard into the gas chromatograph em-
diethylene glycol content of poly- ploying the conditions described above.
ethylene glycols having mean molec- Measure the net peak heights for the ethyl-
ular weights of 450 or higher. ene glycol and for the diethylene glycol.
(2) The following analytical method Record the values as follows:
shall be used to determine the total A=Peak height in millimeters of the ethyl-
ethylene and diethylene glycol content ene glycol peak.
of polyethylene glycols having mean B=milligrams of ethylene glycol per milli-
molecular weights below 450. liter of standard solution.
C=Peak height in millimeters of the
diethylene glycol peak.
ANALYTICAL METHOD D=Milligrams of diethylene glycol per mil-
ETHYLENE GLYCOL AND DIETHYLENE GLYCOL
liliter of standard solution.
CONTENT OF POLYETHYLENE GLYCOLS PROCEDURE
The analytical method for determining Weigh approximately 4 grams of poly-
ethylene glycol and diethylene glycol is as ethylene glycol sample accurately into a 10-
follows: milliliter volumetric flask. Dilute to volume
APPARATUS
with water. Mix the solution thoroughly and
inject a 2-microliter aliquot into the gas
Gas chromatograph with hydrogen flame chromatograph. Measure the heights, in mil-
ionization detector (Varian Aerograph 600 D limeters, of the ethylene glycol peak and of
or equivalent). The following conditions the diethylene glycol peak and record as E
shall be employed with the Varian and F, respectively.
Aerograph 600 D gas chromatograph:
Column temperature: 165 °C. Percent ethylene glycol=(E×B)/(A×sample
Inlet temperature: 260 °C. weight in grams)
Carrier gas (nitrogen) flow rate: 70 milli- Percent diethylene glycol=(F×D)/(C×sample
liters per minute. weight in grams)
Hydrogen and air flow to burner: Optimize
to give maximum sensitivity. (c) Uses. It may be used, except in
Sample size: 2 microliters. milk or preparations intended for addi-
Elution time: Ethylene glycol: 2.0 minutes. tion to milk, as follows:
Diethylene glycol: 6.5 minutes. (1) As a coating, binder, plasticizing
Recorder: ¥0.5 to +1.05 millivolt, full span, agent, and/or lubricant in tablets used
1 second full response time.
for food.
Syringe: 10-microliter (Hamilton 710 N or
equivalent). (2) As an adjuvant to improve flavor
Chromatograph column: 5 feet × 1⁄8 inch. and as a bodying agent in nonnutritive
I.D. stainless steel tube packed with sorbitol sweeteners identified in § 180.37 of this
(Mathieson-Coleman-Bell 2768 Sorbitol chapter.
86
(3) As an adjuvant in dispersing vita- step is followed by a conventional re-

min and/or mineral preparations. fining process that includes alkali neu-
(4) As a coating on sodium nitrite to tralization and deodorization of the
inhibit hygroscopic properties. fats and oils.
(d) Limitations. (1) It is used in an (c) To insure the safe use of the addi-
amount not greater than that required tive, the label of the food additive con-
to produce the intended physical or tainer shall bear, in addition to the
technical effect. other information required by the Act:
(2) A tolerance of zero is established (1) The name of the additive, sodium
for residues of polyethylene glycol in lauryl sulfate.
milk.
(2) Adequate use directions to provide
[42 FR 14491, Mar. 15, 1977, as amended at 49 a final product that complies with the
FR 10105, Mar. 19, 1984] limitations prescribed in paragraph (b)
of this section.
§ 172.822 Sodium lauryl sulfate.
The food additive sodium lauryl sul- [42 FR 14491, Mar. 15, 1977, as amended at 43
fate may be safely used in food in ac- FR 18668, May 2, 1978]
cordance with the following conditions:
§ 172.824 Sodium mono- and dimethyl
(a) The additive meets the following
naphthalene sulfonates.
specifications:
(1) It is a mixture of sodium alkyl The food additive sodium mono- and
sulfates consisting chiefly of sodium dimethyl naphthalene sulfonates may
lauryl sulfate [CH2(CH2)10CH2OSO2Na]. be safely used in accordance with the
(2) It has a minimum content of 90 following prescribed conditions:
percent sodium alkyl sulfates. (a) The additive has a molecular
(b) It is used or intended for use: weight range of 245–260.
(1) As an emulsifier in or with egg (b) The additive is used or intended
whites whereby the additive does not for use:
exceed the following limits: (1) In the crystallization of sodium
Egg white solids, 1,000 parts per million. carbonate in an amount not to exceed
Frozen egg whites, 125 parts per million. 250 parts per million of the sodium car-
Liquid egg whites, 125 parts per million. bonate. Such sodium carbonate is used
(2) As a whipping agent at a level not or intended for use in potable water
to exceed 0.5 percent by weight of gela- systems to reduce hardness and aid in
tine used in the preparation of marsh- sedimentation and coagulation by rais-
mallows. ing the pH for the efficient utilization
(3) As a surfactant in: of other coagulation materials.
(i) Fumaric acid-acidulated dry bev- (2) As an anticaking agent in sodium
erage base whereby the additive does nitrite at a level not in excess of 0.1
not exceed 25 parts per million of the percent by weight thereof for author-
finished beverage and such beverage ized uses in cured fish and meat.
base is not for use in a food for which (c) In addition to the general labeling
a standard of identity established requirements of the Act:
under section 401 of the Act precludes (1) Sodium carbonate produced in ac-
such use. cordance with paragraph (b)(1) of this
(ii) Fumaric acid-acidulated fruit section shall be labeled to show the
juice drinks whereby the additive does presence of the additive and its label or
not exceed 25 parts per million of the labeling shall bear adequate directions
finished fruit juice drink and it is not for use.
used in a fruit juice drink for which a
(2) Sodium nitrite produced in ac-
standard of identity established under
cordance with paragraph (b)(2) of this
section 401 of the Act precludes such
section shall bear the labeling required
use.
by § 172.175 and a statement declaring
(4) As a wetting agent at a level not
the presence of sodium mono- and di-
to exceed 10 parts per million in the
partition of high and low melting frac- methyl naphthalene sulfonates.
tions of crude vegetable oils and ani- [42 FR 14491, Mar. 15, 1977, as amended at 63
mal fats, provided that the partition FR 7069, Feb. 12, 1998]
87
§ 172.826 21 CFR Ch. I (4–1–12 Edition)
§ 172.826 Sodium stearyl fumarate. essing, food-packing, or food-storage

Sodium stearyl fumarate may be equipment.
safely used in food in accordance with [42 FR 14491, Mar. 15, 1977, as amended at 50
the following conditions: FR 3508, Jan. 25, 1985]
(a) It contains not less than 99 per-
cent sodium stearyl fumarate cal- § 172.829 Neotame.
culated on the anhydrous basis, and (a) Neotame is the chemical N-[N-
not more than 0.25 percent sodium ste- (3,3-dimethylbutyl)-L-a-aspartyl]-L-
aryl maleate. phenylalanine-1-methyl ester (CAS
Reg. No. 165450–17–9).
for use:
(1) As a dough conditioner in yeast- (b) Neotame meets the following
leavened bakery products in an amount specifications when it is tested accord-
not to exceed 0.5 percent by weight of ing to the methods described or ref-
the flour used. erenced in the document entitled
(2) As a conditioning agent in dehy- ‘‘Specifications and Analytical Meth-
drated potatoes in an amount not to ods for Neotame’’ dated April 3, 2001,
exceed 1 percent by weight thereof. by the NutraSweet Co., 699 North
(3) As a stabilizing agent in Wheeling Rd., Mount Prospect, IL
nonyeast-leavened bakery products in 60056. The Director of the Office of the
an amount not to exceed 1 percent by Federal Register has approved the in-
weight of the flour used. corporation by reference of this mate-
(4) As a conditioning agent in proc- rial in accordance with 5 U.S.C. 552(a)
essed cereals for cooking in an amount and 1 CFR part 51. Copies are available
not to exceed 1 percent by weight of from the Office of Food Additive Safety
the dry cereal, except for foods for (HFS–200), Center for Food Safety and
which standards of identity preclude Applied Nutrition, 5100 Paint Branch
such use. Pkwy., College Park, MD 20740. Copies
(5) As a conditioning agent in starch- may be examined at the Center for
thickened or flour-thickened foods in Food Safety and Applied Nutrition’s
an amount not to exceed 0.2 percent by Library, 5100 Paint Branch Pkwy., rm.
weight of the food. 1C–100, College Park, MD 20740, or at
the National Archives and Records Ad-
§ 172.828 Acetylated monoglycerides. ministration (NARA). For information
The food additive acetylated on the availability of this material at
monoglycerides may be safely used in NARA, call 202–741–6030, or go to: http://
or on food in accordance with the fol- www.archives.gov/federallregister/
lowing prescribed conditions: codeloflfederallregulations/
(a) The additive is manufactured by: ibrllocations.html.
(1) The interesterification of edible (1) Assay for neotame, not less than
fats with triacetin and in the presence 97.0 percent and not more than 102.0
of catalytic agents that are not food percent on a dry basis.
additives or are authorized by regula- (2) Free dipeptide acid (N-[N-(3,3-
tion, followed by a molecular distilla- dimethylbutyl)-L-a-aspartyl]-L-
tion or by steam stripping; or phenylalanine), not more than 1.5 per-
(2) The direct acetylation of edible cent.
monoglycerides with acetic anhydride (3) Other related substances, not
without the use of catalyst or molec-
more than 2.0 percent.
ular distillation, and with the removal
(4) Lead, not more than 2.0 milli-
by vacuum distillation, if necessary, of
grams per kilogram.
the acetic acid, acetic anhydride, and
triacetin. (5) Water, not more than 5.0 percent.
(b) The food additive has a Reichert- (6) Residue on ignition, not more
Meissl value of 75–200 and an acid value than 0.2 percent
of less than 6. (7) Specific rotation, determined at
(c) The food additive is used at a 20 °C [a]D: ¥40.0° to 43.4° calculated on
level not in excess of the amount rea- a dry basis.
sonably required to produce its in- (c) The food additive neotame may be
tended effect in food, or in food-proc- safely used as a sweetening agent and
88
flavor enhancer in foods generally, ex- (b) The additive meets the specifica-
cept in meat and poultry, in accord- tions of the ‘‘Food Chemicals Codex,’’
ance with current good manufacturing 4th ed. (1996), pp. 398–400, which is in-
practice, in an amount not to exceed corporated by reference in accordance
that reasonably required to accomplish with 5 U.S.C. 552(a) and 1 CFR part 51.
the intended technical effect, in foods Copies are available from the Division
for which standards of identity estab- of Product Policy (HFS–206), Center for
lished under section 401 of the Federal Food Safety and Applied Nutrition,
Food, Drug, and Cosmetic Act do not Food and Drug Administration, 5100
preclude such use. Paint Branch Pkwy., College Park, MD
(d) When neotame is used as a sugar 20740, or may be examined at the Cen-
substitute tablet, L-leucine may be ter for Food Safety and Applied Nutri-
used as a lubricant in the manufacture tion’s Library, 5100 Paint Branch
of tablets at a level not to exceed 3.5 Pkwy., College Park, MD 20740, or at
percent of the weight of the tablet. the National Archives and Records Ad-
(e) If the food containing the additive ministration (NARA). For information
purports to be or is represented to be on the availability of this material at
for special dietary use, it shall be la- NARA, call 202–741–6030, or go to: http://
beled in compliance with part 105 of www.archives.gov/federallregister/
this chapter. codeloflfederallregulations/
[67 FR 45310, July 9, 2002] ibrllocations.html.
(c) The additive may be used as a
§ 172.830 Succinylated monoglycerides. sweetener in foods generally, in accord-
The food additive succinylated ance with current good manufacturing
monoglycerides may be safely used in practice in an amount not to exceed
food in accordance with the following that reasonably required to accomplish
prescribed conditions: the intended effect.
(a) The additive is a mixture of semi- (d) If the food containing the additive
and neutral succinic acid esters of purports to be or is represented to be
mono- and diglycerides produced by the for special dietary use, it shall be la-
succinylation of a product obtained by beled in compliance with part 105 of
the glycerolysis of edible fats and oils, this chapter.
or by the direct esterification of glyc- [63 FR 16433, Apr. 3, 1998, as amended at 64
erol with edible fat-forming fatty FR 43909, Aug. 12, 1999]
acids.
(b) The additive meets the following § 172.832 Monoglyceride citrate.
specifications:
A food additive that is a mixture of
Succinic acid content: 14.8%–25.6% glyceryl monooleate and its citric acid
Melting point: 50 °C–60 °C. monoester manufactured by the reac-
Acid number: 70–120 tion of glyceryl monooleate with citric
(c) The additive is used or intended acid under controlled conditions may
for use in the following foods: be safely used as a synergist and solu-
(1) As an emulsifier in liquid and bilizer for antioxidants in oils and fats,
plastic shortenings at a level not to ex- when used in accordance with the con-
ceed 3 percent by weight of the short- ditions prescribed in this section.
ening. (a) The food additive meets the fol-
(2) As a dough conditioner in bread lowing specifications:
baking, when such use is permitted by
Acid number, 70–100.
an appropriate food standard, at a level
Total citric acid (free and combined), 14 per-
not to exceed 0.5 percent by weight of cent–17 percent.
the flour used.
(b) It is used, or intended for use, in
§ 172.831 Sucralose. antioxidant formulations for addition
(a) Sucralose is the chemical 1,6- to oils and fats whereby the additive
dichloro-1,6-dideoxy-b-D- does not exceed 200 parts per million of
fructofuranosyl-4-chloro-4-deoxy-a-D- the combined weight of the oil or fat
galactopyranoside (CAS Reg. No. 56038– and the additive.

13–2). (c) To assure safe use of the additive:
89
§ 172.833 21 CFR Ch. I (4–1–12 Edition)
(1) The container label shall bear, in codeloflfederallregulations/

addition to the other information re- ibrllocations.html.
quired by the Act, the name of the ad- (3) Acid value: Not to exceed 0.20 de-
ditive. termined using 50 grams of sample by
(2) The label or accompanying label- the ‘‘Guide to Specifications for Gen-
ing shall bear adequate directions for eral Notices, General Analytical Tech-
the use of the additive which, if fol- niques, Identification Tests, Test Solu-
lowed, will result in a food that com- tions, and Other Reference Materials,’’
plies with the requirements of this sec- in the ‘‘Compendium of Food Additive
tion. Specifications, Addendum 4, FAO Food
and Nutrition Paper 5, Revision 2,’’ p.
§ 172.833 Sucrose acetate isobutyrate 189 (1991), which is incorporated by ref-
(SAIB). erence; see paragraph (b)(2) of this sec-
Sucrose acetate isobutyrate may be tion for availability of the incorpora-
safely used in foods in accordance with tion by reference.
the following prescribed conditions: (4) Lead: Not to exceed 1.0 milli-
(a) Sucrose acetate isobutyrate (CAS grams/kilogram determined by the
Reg. No. 27216–37–1), or SAIB, is the ‘‘Atomic Absorption
chemical alpha-D-glucopyranoside, O- Spectrophotometric Graphite Furnace
acetyl-tris-O-(2-methyl-1-oxopropyl)- Method, Method I,’’ in the ‘‘Food
beta-D-fructofuranosyl, acetate tris(2- Chemicals Codex,’’ 4th ed. (1996), pp. 763
methyl propanoate). and 764, with an attached modification
(b) SAIB, a pale, straw-colored liquid, to the sample digestion section in Ap-
meets the following specifications: (1) pendix III.B (July 1996), which is incor-
Assay: Not less than 98.8 percent and porated by reference. Copies are avail-
not more than 101.9 percent, based on able from the National Academy Press,
the following formula: 2101 Constitution Ave. NW., Box 285,
Washington, DC 20055 (Internet http://
Assay = ((SV 0.10586) ÷ 56.1) × 100 www.nap.edu), or may be examined at
the Center for Food Safety and Applied
Where SV = Saponification value
Nutrition’s Library, 5100 Paint Branch
(2) Saponification value: 524–540 de- Pkwy., College Park, MD 20740, or at
termined using 1 gram of sample by the the National Archives and Records Ad-
‘‘Guide to Specifications for General ministration (NARA). For information
Notices, General Analytical Tech- on the availability of this material at
niques, Identification Tests, Test Solu- NARA, call 202–741–6030, or go to: http://
tions, and Other Reference Materials,’’ www.archives.gov/federallregister/
in the ‘‘Compendium of Food Additive codeloflfederallregulations/
Specifications, Addendum 4, Food and ibrllocations.html.
Agriculture Organization of the United (5) Triacetin: Not to exceed 0.10 per-
Nations (FAO), Food and Nutrition cent determined by gas chroma-
Paper 5, Revision 2’’ (1991), pp. 203 and tography as described in the ‘‘Guide to
204, which is incorporated by reference, Specifications for General Notices,
in accordance with 5 U.S.C. 552(a) and 1 General Analytical Techniques, Identi-
CFR part 51. Copies are available from fication Tests, Test Solutions, and
the Office of Premarket Approval, Cen- Other Reference Materials,’’ in the
ter for Food Safety and Applied Nutri- ‘‘Compendium of Food Additive Speci-
tion (HFS–200), Food and Drug Admin- fications, Addendum 4, FAO Food and
istration, 5100 Paint Branch Pkwy., Nutrition Paper 5, Revision 2,’’ (1991),
College Park, MD 20740, or may be ex- pp. 13–26, which is incorporated by ref-
amined at the Center for Food Safety erence; see paragraph (b)(2) of this sec-
and Applied Nutrition’s Library, 5100 tion for availability of the incorpora-
Paint Branch Pkwy., College Park, MD tion by reference.
20740, or at the National Archives and (c) The food additive is used as a sta-
Records Administration (NARA). For bilizer (as defined in § 170.3(o)(28) of this
information on the availability of this chapter) of emulsions of flavoring oils
material at NARA, call 202–741–6030, or in nonalcoholic beverages.
go to: http://www.archives.gov/ (d) The total SAIB content of a bev-

federallregister/ erage containing the additive does not
90
exceed 300 milligrams/kilogram of the (d) When the name ‘‘polyglycerate

finished beverage. 60’’ is used in labeling it shall be fol-
lowed by either ‘‘polyoxyethylene (20)
[64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9,
1999]
mono-and diglycerides of fatty acids’’
or ‘‘ethoxylated mono- and
§ 172.834 Ethoxylated mono- and diglycerides’’ in parentheses.
diglycerides. [42 FR 14491, Mar. 15, 1977, as amended at 42
The food additive ethoxylated mono- FR 37973, July 26, 1977; 50 FR 49536, Dec. 3,
and diglycerides (polyoxyethylene (20) 1985]
mono- and diglycerides of fatty acids)
§ 172.836 Polysorbate 60.
(polyglycerate 60) may be safely used
in food in accordance with the fol- The food additive polysorbate 60
lowing prescribed conditions: (polyoxyethylene (20) sorbitan mono-
(a) The food additive is manufactured stearate) which is a mixture of
by: polyoxyethylene ethers of mixed par-
(1) Glycerolysis of edible fats pri- tial stearic and palmitic acid esters of
marily composed of stearic, palmitic, sorbitol anhydrides and related com-
and myristic acids; or pounds, may be safely used in food in
(2) Direct esterification of glycerol accordance with the following pre-
with a mixture of primarily stearic, scribed conditions:
palmitic, and myristic acids; (a) The food additive is manufactured
by reacting stearic acid (usually con-
to yield a product with less than 0.3 taining associated fatty acids, chiefly
acid number and less than 0.2 percent palmitic) with sorbitol to yield a prod-
water, which is then reacted with uct with a maximum acid number of 10
ethylene oxide. and a maximum water content of 0.2
(b) The additive meets the following percent, which is then reacted with
specifications: ethylene oxide.
(b) The food additive meets the fol-
Saponification number, 65–75.
Acid number, 0–2.
Hydroxyl number, 65–80. Saponification number 45–55.
Oxyethylene content, 60.5–65.0 percent. Acid number 0–2.
Hydroxyl number 81–96.
(c) The additive is used or intended Oxyethylene content 65 percent–69.5 percent.
for use in the following foods when
standards of identity established under (c) It is used or intended for use as
section 401 of the Act do not preclude follows:
such use: (1) As an emulsifier in whipped edible
oil topping with or without one or a
Use Limitations combination of the following:
(i) Sorbitan monostearate;
1. As an emulsifier in pan-re- Not to exceed levels required
lease agents for and as a to produce the intended ef-
(ii) Polysorbate 65;
dough conditioner in yeast- fects, total not to exceed (iii) Polysorbate 80;
leavened bakery products. 0.5 percent by weight of
the flour used. whereby the maximum amount of the
2. As an emulsifier in cakes Not to exceed 0.5 percent by additive or additives used does not ex-
and cake mixes. weight of the dry ingredi- ceed 0.4 percent of the weight of the
ents.
finished whipped edible oil topping; ex-
3. As an emulsifier in Not to exceed 0.45 percent
whipped vegetable oil top- by weight of the finished cept that a combination of the additive
pings and topping mixes. whipped vegetable oil top- with sorbitan monostearate may be
pings. used in excess of 0.4 percent, provided
4. As an emulsifier in icings Not to exceed 0.5 percent by
and icing mixes. weight of the finished
that the amount of the additive does
icings. not exceed 0.77 percent and the amount
5. As an emulsifier in frozen Not to exceed 0.2 percent by of sorbitan monostearate does not ex-
desserts. weight of the finished fro- ceed 0.27 percent of the weight of the
zen desserts.
6. As an emulsifier in edible Not to exceed 0.4 percent by
finished whipped edible oil topping.
vegetable fat-water emul- weight of the finished vege- (2) As an emulsifier in cakes and cake
sions intended for use as table fat-water emulsions. mixes, with or without one or a com-
substitutes for milk or bination of the following:

cream in beverage coffee.
(i) Polysorbate 65.
91
§ 172.836 21 CFR Ch. I (4–1–12 Edition)
(ii) Sorbitan monostearate. (7) As an emulsifier in nonstandard-

ized dressings whereby the maximum
When used alone, the maximum
amount of the additive does not exceed
amount of polysorbate 60 shall not ex-
0.3 percent of the weight of the finished
ceed 0.46 percent of the cake or cake
dressings.
mix, on a dry-weight basis. When used
(8) As an emulsifier, alone or in com-
with polysorbate 65 and/or sorbitan
bination with polysorbate 80, in
monostearate, it shall not exceed 0.46
shortenings and edible oils intended for
percent, nor shall the polysorbate 65
use in foods as follows, when standards
exceed 0.32 percent or the sorbitan of identity established under section
monostearate exceed 0.61 percent, and 401 of the act do not preclude such use:
no combination of these emulsifiers (i) It is used alone in an amount not
shall exceed 0.66 percent of the cake or to exceed 1 percent of the weight of the
cake mix, all calculated on a dry- finished shortening or oil.
weight basis. (ii) It is used with polysorbate 80 in
(3) As an emulsifier, alone or in com- any combination providing no more
bination with sorbitan monostearate, than 1 percent of polysorbate 60 and no
in nonstandardized confectionery coat- more than 1 percent of polysorbate 80,
ings and standardized cacao products provided that the total combination
specified in §§ 163.123, 163.130, 163.135, does not exceed 1 percent of the fin-
163.140, 163.145, and 163.150 of this chap- ished shortening or oil.
ter, as follows: (iii) The 1–percent limitation speci-
(i) It is used alone in an amount not fied in paragraph (c)(8) (i) and (ii) of
to exceed 0.5 percent of the weight of this section may be exceeded in premix
the finished nonstandardized confec- concentrates of shortening or edible oil
tionery coating or standardized cacao if the labeling complies with the re-
product. quirements of paragraph (d) of this sec-
(ii) It is used with sorbitan mono- tion.
stearate in any combination of up to (9) As an emulsifier in solid-state, ed-
0.5 percent of polysorbate 60 and up to ible vegetable fat-water emulsions in-
1 percent of sorbitan monostearate: tended for use as substitutes for milk
Provided, That the total combination or cream in beverage coffee, with or
does not exceed 1 percent of the weight without one or a combination of the
of the finished nonstandardized confec- following:
tionery coating or standardized cacao (i) Polysorbate 65.
product. (ii) Sorbitan monostearate.
(4) [Reserved]
(5) As an emulsifier in cake icings The maximum amount of the additive
and cake fillings, with or without one or additives shall not exceed 0.4 per-
or a combination of the following: cent by weight of the finished edible
vegetable fat-water emulsion.
(i) Polysorbate 65.
(10) As a foaming agent in non-
(ii) Sorbitan monostearate.
alcoholic mixes, to be added to alco-
When used alone, the maximum holic beverages in the preparation of
amount of polysorbate 60 shall not ex- mixed alcoholic drinks, at a level not
ceed 0.46 percent of the weight of the to exceed 4.5 percent by weight of the
cake icings and cake fillings. When nonalcoholic mix.
used with polysorbate 65 and/or sorbi- (11) As a dough conditioner in yeast-
tan monostearate, it shall not exceed leavened bakery products in an amount
0.46 percent, nor shall the polysorbate not to exceed 0.5 percent by weight of
65 exceed 0.32 percent or the sorbitan the flour used.
monostearate exceed 0.7 percent, and (12) As an emulsifier, alone or in
no combination of these emulsifiers combination with sorbitan monostea-
shall exceed 1 percent of the weight of rate, in the minimum quantity re-
the cake icing or cake filling. quired to accomplish the intended ef-
(6) To impart greater opacity to fect, in formulations of white mineral
sugar-type confection coatings where- oil conforming with § 172.878 and/or pe-
by the maximum amount of the addi- troleum wax conforming with § 172.886
tive does not exceed 0.2 percent of the for use as protective coatings on raw
weight of the finished sugar coating. fruits and vegetables.
92
(13) As a dispersing agent in artifi- tristearate), which is a mixture of

cially sweetened gelatin desserts and in polyoxyethylene ethers of mixed ste-
artificially sweetened gelatin dessert aric acid esters of sorbitol anhydrides
mixes, whereby the amount of the addi- and related compounds, may be safely
tive does not exceed 0.5 percent on a used in food in accordance with the fol-
dry-weight basis. lowing prescribed conditions:
(14) As an emulsifier in chocolate fla- (a) The food additive is manufactured
vored syrups, whereby the maximum by reacting stearic acid (usually con-
amount of the additive does not exceed taining associated fatty acids, chiefly
0.05 percent in the finished product. palmitic) with sorbitol to yield a prod-
(15) As a surfactant and wetting uct with a maximum acid number of 15
agent for natural and artificial colors and a maximum water content of 0.2
in food as follows: percent, which is then reacted with
(i) In powdered soft drink mixes in an ethylene oxide.
amount not to exceed 4.5 percent by (b) The food additive meets the fol-
weight of the mix. lowing specifications:
(ii) In sugar-based gelatin dessert Saponification number 88–98.
mixes in an amount not to exceed 0.5 Acid number 0–2.
percent by weight of the mix. Hydroxyl number 44–60.
(iii) In artificially sweetened gelatin Oxyethylene content 46 percent–50 percent.
dessert mixes in an amount not to ex- (c) The additive is used, or intended
ceed 3.6 percent by weight of the mix. for use, as follows:
(iv) In sugar-based pudding mixes in (1) As an emulsifier in ice cream, fro-
an amount not to exceed 0.5 percent by zen custard, ice milk, fruit sherbet and
weight of the mix. nonstandardized frozen desserts when
(v) In artificially sweetened pudding used alone or in combination with
mixes in an amount not to exceed 0.5 polysorbate 80, whereby the maximum
percent by weight of the mix. amount of the additives, alone or in
(16) As an emulsifier in ice cream, combination, does not exceed 0.1 per-
frozen custard, fruit sherbet, and non- cent of the finished frozen dessert.
standardized frozen desserts when used (2) As an emulsifier in cakes and cake
alone or in combination with poly- mixes, with or without one or a com-
sorbate 65 and/or polysorbate 80, where- bination of the following:
by the maximum amount of the addi- (i) Sorbitan monostearate.
tives, alone or in combination, does not (ii) Polysorbate 60.
exceed 0.1 percent of the finished frozen
dessert. When used alone, the maximum
(d) To assure safe use of the additive, amount of polysorbate 65 shall not ex-
in addition to the other information re- ceed 0.32 percent of the cake or cake
quired by the Act: mix, on a dry-weight basis. When used
(1) The label of the additive and any with sorbitan monostearate and/or
intermediate premixes shall bear: polysorbate 60, it shall not exceed 0.32
(i) The name of the additive. percent, nor shall the sorbitan mono-
(ii) A statement of the concentration stearate exceed 0.61 percent or the
or strength of the additive in any in- polysorbate 60 exceed 0.46 percent, and
termediate premixes. no combination of these emulsifiers
(2) The label or labeling shall bear shall exceed 0.66 percent of the cake or
adequate directions to provide a final cake mix, all calculated on a dry-
product that complies with the limita- weight basis.
tions prescribed in paragraph (c) of this (3) As an emulsifier in whipped edible
section. oil topping with or without one or a
combination of the following:
[42 FR 14491, Mar. 15, 1977, as amended at 43 (i) Sorbitan monostearate;
FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5,
1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976,
(ii) Polysorbate 60;
Oct. 28, 1999] (iii) Polysorbate 80;
whereby the maximum amount of the
§ 172.838 Polysorbate 65. additive or additives used does not ex-
The food additive polysorbate 65 ceed 0.4 percent of the weight of the
(polyoxyethylene (20) sorbitan finished whipped edible oil topping.
93
§ 172.840 21 CFR Ch. I (4–1–12 Edition)
(4) As an emulsifier in solid-state, ed- sorbitol to yield a product with a max-

ible vegetable fat-water emulsions in- imum acid number of 7.5 and a max-
tended for use as substitutes for milk imum water content of 0.5 percent,
or cream in beverage coffee, with or which is then reacted with ethylene
without one or a combination of the oxide.
following: (b) The food additive meets the fol-
(i) Sorbitan monostearate. lowing specifications:
(ii) Polysorbate 60. Saponification number 45–55.
The maximum amount of the additive Acid number 0–2.
or additives shall not exceed 0.4 per- Hydroxyl number 65–80.
Oxyethylene content 65 percent–69.5 percent.
cent by weight of the finished edible
vegetable fat-water emulsion. (c) The additive is used or intended
(5) As an emulsifier in cake icings for use as follows:
and cake fillings, with or without one (1) An emulsifier in ice cream, frozen
or a combination of the following: custard, ice milk, fruit sherbet, and
(i) Sorbitan monostearate. nonstandardized frozen desserts, when
(ii) Polysorbate 60. used alone or in combination with
polysorbate 65 whereby the maximum
amount of the additives, alone or in
amount of polysorbate 65 shall not ex-
combination, does not exceed 0.1 per-
ceed 0.32 percent of the weight of the
cent of the finished frozen dessert.
cake icing or cake filling. When used
(2) In yeast-defoamer formulations
with sorbitan monostearate and/or
polysorbate 60, it shall not exceed 0.32
additive does not exceed 4 percent of
percent, nor shall the sorbitan mono-
the finished yeast defoamer and the
stearate exceed 0.7 percent or the poly-
maximum amount of the additive in
sorbate 60 exceed 0.46 percent, and no the yeast from such use does not ex-
combination of these emulsifiers shall ceed 4 parts per million.
exceed 1 percent of the weight of the (3) As a solubilizing and dispersing
cake icing or cake filling. agent in pickles and pickle products,
(d) To assure safe use of the additive, whereby the maximum amount of the
in addition to the other information re- additive does not exceed 500 parts per
quired by the Act: million.
(1) The label of the additive and any (4) As a solubilizing and dispersing
intermediate premixes shall bear: agent in:
(i) The name of the additive. (i) Vitamin-mineral preparations
(ii) A statement of the concentration containing calcium caseinate in the ab-
or strength of the additive in any in- sence of fat-soluble vitamins, whereby
termediate premixes. the maximum intake of polysorbate 80
(2) The label or labeling shall bear shall not exceed 175 milligrams from
adequate directions to provide a final the recommended daily dose of the
product that complies with the limita- preparations.
tions prescribed in paragraph (c) of this (ii) Fat-soluble vitamins in vitamin
section. and vitamin-mineral preparations con-
[42 FR 14491, Mar. 15, 1977, as amended at 43 taining no calcium caseinate, whereby
FR 2871, Jan. 20, 1978] the maximum intake of polysorbate 80
shall not exceed 300 milligrams from
§ 172.840 Polysorbate 80. the recommended daily dose of the
The food additive polysorbate 80 preparations.
(polyoxyethylene (20) sorbitan (iii) In vitamin-mineral preparations
monooleate), which is a mixture of containing both calcium caseinate and
polyoxyethylene ethers of mixed par- fat-soluble vitamins, whereby the max-
tial oleic acid esters of sorbitol anhy- imum intake of polysorbate 80 shall
drides and related compounds, may be not exceed 475 milligrams from the rec-
safely used in food in accordance with ommended daily dose of the prepara-
the following prescribed conditions: tions.
(a) The food additive is manufactured (5) As a surfactant in the production
by reacting oleic acid (usually con- of coarse crystal sodium chloride

taining associated fatty acids) with whereby the maximum amount of the
94
additive in the finished sodium chlo- prior to application of such dilutions to

ride does not exceed 10 parts per mil- the growing crop. Residues resulting
lion. from such use are exempt from the re-
(6) In special dietary foods, as an quirement of a tolerance. When so used
emulsifier for edible fats and oils, with or intended for use, the additive shall
directions for use which provide for the be exempt from the requirements of
ingestion of not more than 360 milli- paragraph (d)(1) of this section.
grams of polysorbate 80 per day. (13) As a defoaming agent in the prep-
(7) As a solubilizing and dispersing aration of the creaming mixture for
agent for dill oil in canned spiced green cottage cheese and lowfat cottage
beans, not to exceed 30 parts per mil- cheese, as identified in §§ 133.128 and
lion. 133.131 of this chapter, respectively,
(8) As an emulsifier, alone or in com- whereby the amount of the additive
bination with polysorbate 60, in does not exceed .008 percent by weight
shortenings and edible oils intended for of the finished products.
use in foods as follows, when standards (14) As a surfactant and wetting
of identity established under section agent for natural and artificial colors
401 of the act do not preclude such use: for use in barbecue sauce where the
(i) It is used alone in an amount not level of the additive does not exceed
to exceed 1 percent of the weight of the 0.005 percent by weight of the barbecue
finished shortening or oil. sauce.
(ii) It is used with polysorbate 60 in (d) To assure safe use of the additive,
any combination providing no more in addition to the other information re-
than 1 percent of polysorbate 80 and no quired by the Act:
more than 1 percent of polysorbate 60, (1) The label of the additive and any
provided that the total combination intermediate premixes shall bear:
does not exceed 1 percent of the fin- (i) The name of the additive.
ished shortening or oil. (ii) A statement of the concentration
(iii) The 1–percent limitation speci- or strength of the additive in any in-
fied in paragraph (c)(8) (i) and (ii) of termediate premixes.
this section may be exceeded in premix (2) The label or labeling shall bear
concentrates of shortening or edible oil adequate directions to provide a final
if the labeling complies with the re- product that complies with the limita-
quirements of paragraph (d) of this sections prescribed in paragraph (c) of this
tion. section.
(9) As an emulsifier in whipped edible
oil topping with or without one or a FR 2871, Jan. 20, 1978; 45 FR 58835, Sept. 5,
combination of the following: 1980; 46 FR 8466, Jan. 27, 1981]
(i) Sorbitan monostearate;
(ii) Polysorbate 60; § 172.841 Polydextrose.
(iii) Polysorbate 65; Polydextrose as identified in this sec-
whereby the maximum amount of the tion may be safely used in food in ac-
additive or additives used does not ex- cordance with the following prescribed
ceed 0.4 percent of the weight of the conditions:
finished whipped edible oil topping. (a)(1) Polydextrose (CAS Reg. No.
(10) It is used as a wetting agent in 68424–04–4) is a partially metabolizable
scald water for poultry defeathering, water-soluble polymer prepared by the
followed by potable water rinse. The condensation of a melt which consists
concentration of the additive in the either of approximately 89 percent D-
scald water does not exceed 0.0175 per- glucose, 10 percent sorbitol, and 1 per-
cent. cent citric acid or of approximately 90
(11) As a dispersing agent in gelatin percent D-glucose, 10 percent sorbitol,
desserts and in gelatin dessert mixes, and 0.1 percent phosphoric acid, on a
whereby the amount of the additive weight basis.
does not exceed 0.082 percent on a dry- (2) Polydextrose may be partially
weight basis. neutralized with potassium hydroxide,
(12) As an adjuvant added to herbi- or partially reduced by transition
cide use and plant-growth regulator metal catalytic hydrogenation in aque-

use dilutions by a grower or applicator ous solution.
95
§ 172.842 21 CFR Ch. I (4–1–12 Edition)
(b) The additive meets the specifica- food in accordance with the following
tions of the ‘‘Food Chemicals Codex,’’ prescribed conditions:
5th ed. (January 1, 2004), pp. 336–339, (a) The food additive is manufactured
and the First Supplement to the 5th by reacting stearic acid (usually con-
Edition of the Food Chemicals Codex taining associated fatty acids, chiefly
(March 1, 2006), p. 37, which are incor- palmitic) with sorbitol to yield essen-
porated by reference. The Director of tially a mixture of esters.
the Office of the Federal Register ap- (b) The food additive meets the fol-
proves this incorporation by reference lowing specifications:
in accordance with 5 U.S.C. 552(a) and 1 Saponification number, 147–157
CFR part 51. You may obtain a copy Acid number, 5–10
from The National Academies Press, Hydroxyl number, 235–260
500 Fifth St. NW., Washington, DC 20001 (c) It is used or intended for use,
(Internet address http://www.nap.edu). alone or in combination with poly-
You may inspect a copy at the Center sorbate 60 as follows:
for Food Safety and Applied Nutri- (1) As an emulsifier in whipped edible
tion’s Library, Food and Drug Admin- oil topping with or without one or a
istration, 5100 Paint Branch Pkwy., combination of the following:
College Park, MD 20740, or at the Na- (i) Polysorbate 60;
tional Archives and Records Adminis- (ii) Polysorbate 65;
tration (NARA). For information on (iii) Polysorbate 80;
additive or additives used does not ex-
www.archives.gov/federal-register/cfr/ibr-
ceed 0.4 percent of the weight of the
locations.html.
finished whipped edible oil topping; ex-
(c) When standards of identity estab- cept that a combination of the additive
lished under section 401 of the act do with polysorbate 60 may be used in ex-
not preclude such use, polydextrose cess of 0.4 percent: Provided, That the
may be used in accordance with cur- amount of the additive does not exceed
rent good manufacturing practices as a 0.27 percent and the amount of poly-
bulking agent, formulation aid, humec- sorbate 60 does not exceed 0.77 percent
tant, and texturizer in all foods, except of the weight of the finished whipped
meat and poultry, baby food, and in- edible oil topping.
fant formula. (2) As an emulsifier in cakes and cake
(d) If the food containing the additive mixes, with or without one or a com-
purports to be or is represented for spe- bination of the following:
cial dietary uses, it shall be labeled in (i) Polysorbate 65.
compliance with part 105 of this chap- (ii) Polysorbate 60.
ter. When used alone, the maximum
(e) The label and labeling of food a amount of sorbitan monostearate shall
single serving of which would be ex- not exceed 0.61 percent of the cake or
pected to exceed 15 grams of the addi- cake mix, on a dry-weight basis. When
tive shall bear the statement: ‘‘Sen- used with polysorbate 65 and/or poly-
sitive individuals may experience a sorbate 60, it shall not exceed 0.61 per-
laxative effect from excessive con- cent, nor shall the polysorbate 65 ex-
sumption of this product’’. ceed 0.32 percent or the polysorbate 60
[46 FR 30081, June 5, 1981, as amended at 59 exceed 0.46 percent, and no combina-
FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, tion of the emulsifiers shall exceed 0.66
1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, percent of the weight of the cake or
June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR cake mix, calculated on a dry-weight
64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000; basis.
72 FR 46564, Aug. 21, 2007] (3) As an emulsifier, alone or in com-
bination with polysorbate 60 in non-
§ 172.842 Sorbitan monostearate. standardized confectionery coatings
The food additive sorbitan monostea- and standardized cacao products speci-
rate, which is a mixture of partial ste- fied in §§ 163.123, 163.130, 163.135, 163.140,
aric and palmitic acid esters of sorbitol 163.145, and 163.150 of this chapter, as
anhydrides, may be safely used in or on follows:
96
(i) It is used alone in an amount not (1) The label of the additive and any
to exceed 1 percent of the weight of the intermediate premixes shall bear:
finished nonstandardized confectionery (i) The name of the additive.
coating or standardized cacao product. (ii) A statement of the concentration
(ii) It is used with polysorbate 60 in or strength of the additive in any in-
any combination of up to 1 percent sor- termediate premixes.
bitan monostearate and up to 0.5 per- (2) The label or labeling shall bear
cent polysorbate 60 provided that the adequate directions to provide a final
total combination does not exceed 1 product that complies with the limita-
percent of the weight of the finished tions prescribed in paragraph (c) of this
nonstandardized confectionery coating section.
or standardized cacao product. [42 FR 14491, Mar. 15, 1977, as amended at 43
(4) As an emulsifier in cake icings FR 2871, Jan. 20, 1978]
and cake fillings, with or without one
or a combination of the following: § 172.844 Calcium stearoyl-2-lactylate.
(i) Polysorbate 65. The food additive calcium stearoyl-2-
(ii) Polysorbate 60. lactylate may be safely used in or on
food in accordance with the following
prescribed conditions:
amount of sorbitan monostearate shall
(a) The additive, which is a mixture
not exceed 0.7 percent of the weight of
of calcium salts of stearoyl lactylic
the cake icing or cake filling. When
acids and minor proportions of other
used with polysorbate 65 and/or poly-
calcium salts of related acids, is manu-
sorbate 60, it shall not exceed 0.7 per-
factured by the reaction of stearic acid
cent, nor shall the polysorbate 65 ex-
and lactic acid and conversion to the
ceed 0.32 percent or the polysorbate 60
calcium salts.
exceed 0.46 percent, and no combina-
tion of these emulsifiers shall exceed 1
specifications:
percent of the weight of the cake icing
or cake filling. Acid number, 50–86.
(5) As an emulsifier in solid-state, ed- Calcium content, 4.2–5.2 percent.
ible vegetable fat-water emulsions in- Lactic acid content, 32–38 percent.
Ester number, 125–164.
tended for use as substitutes for milk
or cream in beverage coffee, with or (c) It is used or intended for use as
without one or a combination of the follows:
following: (1) As a dough conditioner in yeast-
(i) Polysorbate 60. leavened bakery products and prepared
(ii) Polysorbate 65. mixes for yeast-leavened bakery prod-
ucts in an amount not to exceed 0.5
The maximum amount of the additive part for each 100 parts by weight of
or additives shall not exceed 0.4 per- flour used.
cent by weight of the finished edible (2) As a whipping agent in:
vegetable fat-water emulsion. (i) Liquid and frozen egg white at a
(6) It is used alone as a rehydration level not to exceed 0.05 percent.
aid in the production of active dry (ii) Dried egg white at a level not to
yeast in an amount not to exceed 1 per- exceed 0.5 percent.
cent by weight of the dry yeast. (iii) Whipped vegetable oil topping at
(7) As an emulsifier, alone or in com- a level not to exceed 0.3 percent of the
bination with polysorbate 60, in the weight of the finished whipped vege-
minimum quantity required to accom- table oil topping.
plish the intended effect, in formula- (3) As a conditioning agent in dehy-
tions of white mineral oil conforming drated potatoes in an amount not to
with § 172.878 and/or petroleum wax exceed 0.5 percent by weight thereof.
conforming with § 172.886 for use as pro- (d) To assure safe use of the additive:
tective coatings on raw fruits and vege- (1) The label and labeling of the food
tables. additive and any intermediate premix
(d) To assure safe use of the additive, prepared therefrom shall bear, in addi-
in addition to the other information re- tion to the other information required
quired by the Act: by the act, the following:
97
§ 172.846 21 CFR Ch. I (4–1–12 Edition)
(i) The name of the additive. (4) As a formulation aid, processing

(ii) A statement of the concentration aid, or surface-active agent in dehy-
or strength of the additive in any in- drated potatoes, in an amount not to
termediate premixes. exceed 0.5 percent of the dry weight of
(2) The label or labeling of the food the food.
additive shall also bear adequate direc- (5) As an emulsifier, stabilizer, or
tions of use to provide a finished food texturizer in snack dips, at a level not
that complies with the limitations pre- to exceed 0.2 percent by weight of the
scribed in paragraph (c) of this section. finished product.
(6) As an emulsifier, stabilizer, or
§ 172.846 Sodium stearoyl lactylate. texturizer in cheese substitutes and
The food additive sodium stearoyl imitations and cheese product sub-
lactylate (CAS Reg. No. 25–383–997) may stitutes and imitations, at a level not
be safely used in food in accordance to exceed 0.2 percent by weight of the
with the following prescribed condi- finished food.
tions: (7) As an emulsifier, stabilizer, or
(a) The additive, which is a mixture texturizer in sauces or gravies, and the
of sodium salts of stearoyl lactylic products containing the same, in an
acids and minor proportions of sodium amount not to exceed 0.25 percent by
salts of related acids, is manufactured weight of the finished food.
by the reaction of stearic acid and lac- (8) In prepared mixes for each of the
tic acid and conversion to the sodium foods listed in paragraphs (c) (1)
salts. through (7) of this section, provided the
(b) The additive meets the specifica- additive is used only as specified in
tions of the ‘‘Food Chemicals Codex,’’ each of those paragraphs.
3d Ed. (1981), pp. 300–301, which is incor- (9) As an emulsifier, stabilizer, or
porated by reference. Copies may be texturizer in cream liqueur drinks, at a
obtained from the National Academy level not to exceed 0.5 percent by
Press, 2101 Constitution Ave. NW., weight of the finished product.
Washington, DC 20418, or may be exam- [45 FR 51767, Aug. 5, 1980, as amended at 49
ined at the National Archives and FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3,
Records Administration (NARA). For 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan.
information on the availability of this 27, 1986; 65 FR 60859, Oct. 13, 2000]
§ 172.848 Lactylic esters of fatty acids.
federallregister/ Lactylic esters of fatty acids may be
codeloflfederallregulations/ safely used in food in accordance with
ibrllocations.html. the following prescribed conditions:
(c) It is used or intended for use as (a) They are prepared from lactic
follows when standards of identity es- acid and fatty acids meeting the re-
tablished under section 401 of the Act quirements of § 172.860(b) and/or oleic
do not preclude such use: acid derived from tall oil fatty acids
(1) As a dough strengthener, emulsi- meeting the requirements of § 172.862.
fier, or processing aid in baked prod- (b) They are used as emulsifiers, plas-
ucts, pancakes, and waffles, in an ticizers, or surface-active agents in the
amount not to exceed 0.5 part for each following foods, when standards of
100 parts by weight of flour used. identity do not preclude their use:
(2) As a surface-active agent, emulsi- Foods Limitations
fier, or stabilizer in icings, fillings,
puddings, and toppings, at a level not Bakery mixes ................................
Baked products .............................
to exceed 0.2 percent by weight of the Cake icings, fillings, and toppings
finished food. Dehydrated fruits and vegetables
(3) As an emulsifier or stabilizer in Dehydrated fruit and vegetable
juices.
liquid and solid edible fat-water emul- Edible vegetable fat-water emul- As substitutes for milk or
sions intended for use as substitutes sions. cream in beverage cof-
for milk or cream in beverage coffee, at fee.
a level not to exceed 0.3 percent by Frozen desserts ............................
Liquid shortening .......................... For household use.

weight of the finished edible fat-water Pancake mixes .............................
emulsion. Precooked instant rice ..................
98
Foods Limitations (a) They are prepared from corn oil,

cottonseed oil, lard, palm oil from
Pudding mixes ..............................
fruit, peanut oil, safflower oil, sesame
oil, soybean oil, and tallow and the
(c) They are used in an amount not
fatty acids derived from these sub-
greater than required to produce the
stances (hydrogenated and nonhydro-
intended physical or technical effect,
genated) meeting the requirements of
and they may be used with shortening
§ 172.860(b) and/or oleic acid derived
and edible fats and oils when such are
from tall oil fatty acids meeting the
required in the foods identified in para-
requirements of § 172.862.
graph (b) of this section.
(b) They are used as emulsifiers in
§ 172.850 Lactylated fatty acid esters food, in amounts not greater than that
of glycerol and propylene glycol. required to produce the intended phys-
ical or technical effect.
The food additive lactylated fatty (c) Polyglycerol esters of a mixture
acid esters of glycerol and propylene of stearic, oleic, and coconut fatty
glycol may be safely used in food in ac- acids are used as a cloud inhibitor in
cordance with the following prescribed vegetable and salad oils when use is
conditions: not precluded by standards of identity.
(a) The additive is a mixture of esters The fatty acids used in the production
produced by the lactylation of a prod- of the polyglycerol esters meet the re-
uct obtained by reacting edible fats or quirements of § 172.860(b), and the
oils with propylene glycol. polyglycerol esters are used at a level
(b) The additive meets the following not in excess of the amount required to
specifications: Water insoluble com- perform its cloud-inhibiting effect.
bined lactic acid, 14–18 percent; and Oleic acid derived from tall oil fatty
acid number, 12 maximum. acids conforming with § 172.862 may be
(c) It is used in amounts not in excess used as a substitute for or together
of that reasonably required to produce with the oleic acid permitted by this
the intended physical effect as an paragraph.
emulsifier, plasticizer, or surface-ac- (d) Polyglycerol esters of butter oil
tive agent in food. fatty acids are used as emulsifiers in
combination with other approved emul-
§ 172.852 Glyceryl-lacto esters of fatty sifiers in dry, whipped topping base.
acids.
The fatty acids used in the production
Glyceryl-lacto esters of fatty acids of the polyglycerol esters meet the re-
(the lactic acid esters of mono- and quirements of § 172.860(b), and the
diglycerides) may be safely used in polyglycerol esters are used at a level
food in accordance with the following not in excess of the amount required to
prescribed conditions: perform their emulsifying effect.
(a) They are manufactured from glyc-
erin, lactic acid, and fatty acids con- § 172.856 Propylene glycol mono- and
forming with § 172.860 and/or oleic acid diesters of fats and fatty acids.
derived from tall oil fatty acids con- Propylene glycol mono- and diesters
forming with § 172.862 and/or edible fats of fats and fatty acids may be safely
and oils. used in food, subject to the following
(b) They are used in amounts not in prescribed conditions:
excess of those reasonably required to (a) They are produced from edible
accomplish their intended physical or fats and/or fatty acids in compliance
technical effect as emulsifiers and plas- with § 172.860 and/or oleic acid derived
ticizers in food. from tall oil fatty acids in compliance
with § 172.862.
§ 172.854 Polyglycerol esters of fatty (b) They are used in food in amounts
acids. not in excess of that reasonably re-
Polyglycerol esters of fatty acids, up quired to produce their intended effect.
to and including the decaglycerol
esters, may be safely used in food in ac- § 172.858 Propylene glycol alginate.
cordance with the following prescribed The food additive propylene glycol
conditions: alginate (CAS Reg. No. 9005–37–2) may
99
§ 172.859 21 CFR Ch. I (4–1–12 Edition)
be used as an emulsifier, flavoring ad- at a level not to exceed 0.6 percent by

juvant, formulation aid, stabilizer, sur- weight of the finished product.
factant, or thickener in foods in ac- (9) As a flavoring adjunct or adjuvant
cordance with the following prescribed in seasonings and flavors at a level not
conditions: to exceed 1.7 percent by weight of the
(a) The additive meets the specifica- finished product.
tions of the Food Chemicals Codex, 3d (10) As an emulsifier, flavoring adju-
Ed. (1981), p. 256, which is incorporated vant, formulation aid, stabilizer or
by reference (Copies are available from thickener, or surface active agent in
the National Academy Press, 2101 Con- other foods, where applicable, at a
stitution Ave. NW., Washington, DC level not to exceed 0.3 percent by
20418, or available for inspection at the weight of the finished product.
National Archives and Records Admin- (c) To ensure safe use of the additive,
istration (NARA). For information on the label of the food additive container
the availability of this material at shall bear, in addition to the other in-
NARA, call 202–741–6030, or go to: http:// formation required by the act:
www.archives.gov/federallregister/ (1) The name of the additive, ‘‘pro-
codeloflfederallregulations/ pylene glycol alginate’’ or ‘‘propylene
ibrllocations.html.), and the additional glycol ester of alginic acid’’.
specification that it shall have up to 85 (2) Adequate directions for use.
percent of the carboxylic acid groups [47 FR 29950, July 9, 1982]
esterified with the remaining groups
either free or neutralized. § 172.859 Sucrose fatty acid esters.
(b) The additive is used or intended Sucrose fatty acid esters identified in
for use in the following foods as defined this section may be safely used in ac-
in § 170.3(n) of this chapter, when stand- cordance with the following prescribed
ards of identity established under sec- conditions:
tion 401 of the act do not preclude such (a) Sucrose fatty acid esters are the
use: mono-, di-, and tri-esters of sucrose
(1) As a stabilizer in frozen dairy des- with fatty acids and are derived from
serts, in fruit and water ices, and in sucrose and edible tallow or hydro-
confections and frostings at a level not genated edible tallow or edible vege-
to exceed 0.5 percent by weight of the table oils. The only solvents which
finished product. may be used in the preparation of su-
(2) As an emulsifier, flavoring adju- crose fatty acid esters are those gen-
vant, stabilizer, or thickener in baked erally recognized as safe in food or reg-
goods at a level not to exceed 0.5 per- ulated for such use by an appropriate
cent by weight of the finished product. section in this part. Ethyl acetate or
(3) As an emulsifier, stabilizer, or methyl ethyl ketone or dimethyl sulf-
thickener in cheeses at a level not to oxide and isobutyl alcohol (2-methyl-1-
exceed 0.9 percent by weight of the fin- propanol) may be used in the prepara-
ished product. tion of sucrose fatty acid esters.
(4) As an emulsifier, stabilizer, or (b) Sucrose fatty acid esters meet the
thickener in fats and oils at a level not following specifications:
to exceed 1.1 percent by weight of the (1) The total content of mono-, di-,
finished product. and tri-esters is not less than 80 per-
(5) As an emulsifier, stabilizer, or cent as determined by a method title
thickener in gelatins and puddings at a ‘‘Sucrose Fatty Acid Esters, Method of
level not to exceed 0.6 percent by Assay,’’ which is incorporated by ref-
weight of the finished product. erence. Copies are available from the
(6) As a stabilizer or thickener in gra- Center for Food Safety and Applied Nu-
vies and in sweet sauces at a level not trition (HFS–200), Food and Drug Ad-
to exceed 0.5 percent by weight of the ministration, 5100 Paint Branch Pkwy.,
finished product. College Park, MD 20740, or available for
(7) As a stabilizer in jams and jellies inspection at the National Archives
at a level not to exceed 0.4 percent by and Records Administration (NARA).
weight of the finished product. For information on the availability of
(8) As an emulsifier, stabilizer, or this material at NARA, call 202–741–

thickener in condiments and relishes 6030, or go to: http://www.archives.gov/
100
federallregister/ tled ‘‘Determination of Dimethyl Sulf-

codeloflfederallregulations/ oxide,’’ which is incorporated by ref-
ibrllocations.html. erence. Copies are available from the
(2) The free sucrose content is not Center for Food Safety and Applied Nu-
more than 5 percent as determined by trition (HFS–200), Food and Drug Ad-
Test S.2 in the method titled ‘‘Sucrose ministration, 5100 Paint Branch Pkwy.,
Fatty Acid Esters, Method of Assay,’’ College Park, MD 20740, or available for
which is incorporated by reference. The inspection at the National Archives
availability of this incorporation by and Records Administration (NARA).
reference is given in paragraph (b)(1) of For information on the availability of
this section. this material at NARA, call 202–741–
(3) The acid value is not more than 6. 6030, or go to: http://www.archives.gov/
(4) The residue on ignition (sulfated federallregister/
ash) is not more than 2 percent. codeloflfederallregulations/
(5) The total ethyl acetate content is ibrllocations.html.
not more than 350 parts per million as (11) The total isobuytl alcohol (2-
determined by a method titled ‘‘Deter- methyl-1-propanol) content is not more
mination of Ethyl Acetate,’’ which is than 10 parts per million as determined
incorporated by reference. Copies are by a method entitled ‘‘Determination
available from the Center for Food of Isobutyl Alcohol,’’ which is incor-
Safety and Applied Nutrition (HFS– porated by reference. Copies are avail-
200), Food and Drug Administration, able from the Center for Food Safety
5100 Paint Branch Pkwy., College Park, and Applied Nutrition (HFS–200), Food
MD 20740, or available for inspection at and Drug Administration, 5100 Paint
the National Archives and Records Ad- Branch Pkwy., College Park, MD 20740,
ministration (NARA). For information or available for inspection at the Na-
on the availability of this material at tional Archives and Records Adminis-
NARA, call 202–741–6030, or go to: http:// tration (NARA). For information on
www.archives.gov/federallregister/ the availability of this material at
codeloflfederallregulations/ NARA, call 202–741–6030, or go to: http://
ibrllocations.html. www.archives.gov/federallregister/
(6) Arsenic is not more than 3 parts codeloflfederallregulations/
per million. ibrllocations.html.
(7) Total heavy metal content (as Pb) (c) Sucrose fatty acid esters may be
is not more than 50 parts per million. used as follows when standards of iden-
(8) Lead is not more than 10 parts per tity established under section 401 of
million. the Federal Food, Drug, and Cosmetic
(9) The total content of methyl ethyl Act do not preclude such use:
ketone or of methanol shall not be (1) As emulsifiers as defined in
more than 10 parts per million as deter- § 170.3(o)(8) of this chapter, or as stabi-
mined by a method titled ‘‘Methyl lizers as defined in § 170.3(o)(28) of this
Ethyl Ketone Test; Methyl Alcohol chapter, in baked goods and baking
Test,’’ which is incorporated by ref- mixes as defined in § 170.3(n)(1) of this
erence. Copies are available from the chapter, in chewing gum as defined in
Center for Food Safety and Applied Nu- § 170.3(n)(6) of this chapter, in coffee
trition (HFS–200), Food and Drug Ad- and tea beverages with added dairy in-
ministration, 5100 Paint Branch Pkwy., gredients and/or dairy product ana-
College Park, MD 20740, or available for logues, in confections and frostings as
inspection at the National Archives defined in § 170.3(n)(9) of this chapter,
and Records Administration (NARA). in dairy product analogues as defined
For information on the availability of in § 170.3(n)(10) of this chapter, in frozen
this material at NARA, call 202–741– dairy desserts and mixes as defined in
6030, or go to: http://www.archives.gov/ § 170.3(n)(20) of this chapter, and in
federallregister/ whipped milk products.
codeloflfederallregulations/ (2) As texturizers as defined in
ibrllocations.html. § 170.3(o)(32) of this chapter in biscuit
(10) The total dimethyl sulfoxide con- mixes, in chewing gum as defined in
tent is not more than 2 parts per mil- § 170.3(n)(6) of this chapter, in confec-
lion as determined by a method enti- tions and frostings as defined in
101
§ 172.860 21 CFR Ch. I (4–1–12 Edition)
§ 170.3(n)(9) of this chapter, and in the 13th Ed. (1980) of the ‘‘Official
surimi-based fabricated seafood prod- Methods of Analysis of the Association
ucts. of Official Analytical Chemists,’’ which
(3) As components of protective coat- is incorporated by reference. Copies are
ings applied to fresh apples, avocados, available from the AOAC INTER-
bananas, banana plantains, limes, mel- NATIONAL, 481 North Frederick Ave.,
ons (honeydew and cantaloupe), pa- suite 500, Gaithersburg, MD 20877, or
paya, peaches, pears, pineapples, and available for inspection at the National
plums to retard ripening and spoiling. Archives and Records Administration
(d) Sucrose fatty acid esters are used (NARA). For information on the avail-
in accordance with current good manu- ability of this material at NARA, call
facturing practice and in an amount 202–741–6030, or go to: http://
not to exceed that reasonably required www.archives.gov/federallregister/
to accomplish the intended effect. codeloflfederallregulations/
[47 FR 55475, Dec. 10, 1982, as amended at 48 ibrllocations.html.
FR 38226, Aug. 23, 1983; 52 FR 10883, Apr. 6, (2) Chick-edema factor shall be deter-
1987; 53 FR 22294, 22297, June 15, 1988; 54 FR mined by the bioassay method de-
24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995] scribed in ‘‘Official Methods of Anal-
ysis of the Association of Official Ana-
§ 172.860 Fatty acids.
lytical Chemists,’’ 13th Ed. (1980), sec-
The food additive fatty acids may be tions 28.127–28.130, which is incor-
safely used in food and in the manufac- porated by reference. Copies may be
ture of food components in accordance obtained from the AOAC INTER-
with the following prescribed condi- NATIONAL, 481 North Frederick Ave.,
tions: suite 500, Gaithersburg, MD 20877, or
(a) The food additive consists of one may be examined at the National Ar-
or any mixture of the following chives and Records Administration
straight-chain monobasic carboxylic (NARA). For information on the avail-
acids and their associated fatty acids ability of this material at NARA, call
manufactured from fats and oils de- 202–741–6030, or go to: http://
rived from edible sources: Capric acid, www.archives.gov/federallregister/
caprylic acid, lauric acid, myristic codeloflfederallregulations/
acid, oleic acid, palmitic acid, and ste- ibrllocations.html.
aric acid. (3) The gas chromatographic-electron
(b) The food additive meets the fol-
capture method for testing fatty acids
for chick-edema shall be the method
(1) Unsaponifiable matter does not
described in the ‘‘Journal of the Asso-
exceed 2 percent.
ciation of Official Analytical Chem-
(2) It is free of chick-edema factor:
ists,’’ Volume 50 (No. 1), pages 216–218
(i) As evidenced during the bioassay
(1967), or the modified method using a
method for determining the chick-
edema factor as prescribed in para- sulfuric acid clean-up procedure, as de-
graph (c)(2) of this section; or scribed in the ‘‘Journal of the Associa-
(ii) As evidenced by the absence of tion of the Offical Analytical Chem-
chromatographic peaks with a reten- ists,’’ Volume 51 (No. 2), pages 489–490
tion time relative to aldrin (RA) be- (1968), which are incorporated by ref-
tween 10 and 25, using the gas erence. See paragraph (c)(2) of this sec-
chromatographic-electron capture tion for availability of these ref-
method prescribed in paragraph (c)(3) erences.
of this section. If chromatographic (d) It is used or intended for use as
peaks are found with RA values be- follows:
tween 10 and 25, the food additive shall (1) In foods as a lubricant, binder,
meet the requirements of the bioassay and as a defoaming agent in accordance
method prescribed in paragraph (c)(2) with good manufacturing practice.
of this section for determining chick- (2) As a component in the manufac-
edema factor. ture of other food-grade additives.
(c) For the purposes of this section: (e) To assure safe use of the additive,
(1) Unsaponifiable matter shall be de- the label and labeling of the additive
termined by the method described in and any premix thereof shall bear, in
102
addition to the other information re- used in food and as a component in the
quired by the act, the following: manufacture of food-grade additives in
(1) The common or usual name of the accordance with the following pre-
acid or acids contained therein. scribed conditions:
(2) The words ‘‘food grade,’’ in jux- (a) The additive consists of purified
taposition with and equally as promi- oleic acid separated from refined tall
nent as the name of the acid. oil fatty acids.
[42 FR 14491, Mar. 15, 1977, as amended at 47 (b) The additive meets the following
FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, specifications:
1984; 54 FR 24897, June 12, 1989] (1) Specifications for oleic acid pre-
scribed in the ‘‘Food Chemicals
§ 172.861 Cocoa butter substitute from Codex.’’ 3d Ed. (1981), pp. 207–208, which
coconut oil, palm kernel oil, or both
oils. is incorporated by reference, except
that titer (solidification point) shall
The food additive, cocoa butter sub- not exceed 13.5 °C and unsaponifiable
stitute from coconut oil, palm kernel matter shall not exceed 0.5 percent.
oil, or both oils, may be safely used in Copies of the material incorporated by
food in accordance with the following reference may be obtained from the
conditions: National Academy Press, 2101 Constitu-
(a) Cocoa butter substitute from co- tion Ave. NW., Washington, DC 20418,
conut oil, palm kernel oil (CAS Reg. or may be examined at the National
No. 85665–33–4), or both oils is a mixture Archives and Records Administration
of triglycerides. It is manufactured by (NARA). For information on the avail-
esterification of glycerol with food- ability of this material at NARA, call
grade fatty acids (complying with 202–741–6030, or go to: http://
§ 172.860) derived from edible coconut www.archives.gov/federallregister/
oil, edible palm kernel oil, or both oils. codeloflfederallregulations/
(b) The ingredient meets the fol- ibrllocations.html.
(2) The resin acid content does not
Acid number: Not to exceed 0.5. exceed 0.01 as determined by ASTM
Saponification number: 220 to 260. method D1240–82, ‘‘Standard Test Meth-
Iodine number: Not to exceed 3. od for Rosin Acids in Fatty Acids,’’
Melting range: 30 to 44 °C. which is incorporated by reference.
(c) The ingredient is used or intended Copies may be obtained from the Amer-
for use as follows: ican Society for Testing Materials, 100
(1) As coating material for sugar, Barr Harbor Dr., West Conshohocken,
table salt, vitamins, citric acid, suc- Philadelphia, PA 19428-2959, or may be
cinic acid, and spices; and examined at the National Archives and
(2) In compound coatings, cocoa Records Administration (NARA). For
creams, cocoa-based sweets, toffees, information on the availability of this
caramel masses, and chewing sweets as material at NARA, call 202–741–6030, or
defined in § 170.3 (n)(9) and (n)(38) of go to: http://www.archives.gov/
this chapter, except that the ingredient federallregister/
may not be used in a standardized food codeloflfederallregulations/
unless permitted by the standard of ibrllocations.html.
identity. (3) The requirements for absence of
(d) The ingredient is used in accord- chick-edema factor as prescribed in
ance with current good manufacturing § 172.860.
practice and in an amount not to ex- (c) It is used or intended for use as
ceed that reasonably required to ac- follows:
complish the intended effect. (1) In foods as a lubricant, binder,
[56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, and defoaming agent in accordance
1992] with good manufacturing practice.
(2) As a component in the manufac-
§ 172.862 Oleic acid derived from tall ture of other food-grade additives.
oil fatty acids. (d) To assure safe use of the additive,
The food additive oleic acid derived the label and labeling of the additive
from tall oil fatty acids may be safely and any premix thereof shall bear, in
103
§ 172.863 21 CFR Ch. I (4–1–12 Edition)
addition to the other information re- (i) Hexyl, octyl, decyl, lauryl, and
quired by the Act, the following: myristyl alcohols contain not less than
(1) The common or usual name of the 99 percent of total alcohols and not less
acid. than 96 percent of straight chain alco-
(2) The words ‘‘food grade’’ in jux- hols. Any nonalcoholic impurities are
taposition with and equally as promi- primarily paraffins.
nent as the name of the acid. (ii) Cetyl and stearyl alcohols con-
[42 FR 14491, Mar. 15, 1977, as amended at 49 tain not less than 98 percent of total
FR 10105, Mar. 19, 1984] alcohols and not less than 94 percent of
straight chain alcohols. Any non-
§ 172.863 Salts of fatty acids. alcoholic impurities are primarily
The food additive salts of fatty acids paraffins.
may be safely used in food and in the (iii) The synthetic fatty alcohols con-
manufacture of food components in ac- tain no more than 0.1 weight percent of
cordance with the following prescribed total diols as determined by a method
conditions: available upon request from the Com-
(a) The additive consists of one or missioner of Food and Drugs.
any mixture of two or more of the alu- (2) Hexyl, octyl, and decyl; manufac-
minum, calcium, magnesium, potas- tured by fractional distillation of alco-
sium, and sodium salts of the fatty hols obtained by a sequence of oxida-
acids conforming with § 172.860 and/or tion, hydrolysis, and catalytic hydro-
oleic acid derived from tall oil fatty genation (catalyst consists of copper,
acids conforming with § 172.862. chromium, and nickel) of organo-alu-
(b) The food additive is used or in- minums generated by the controlled re-
tended for use as a binder, emulsifier, action of low molecular weight
and anticaking agent in food in accord-
trialkylaluminum with purified ethyl-
ance with good manufacturing prac-
ene (minimum 99 percent by volume
tice.
C2H4), and utilizing an external coolant
(c) To assure safe use of the additive,
such that these alcohols meet the spec-
and any premix thereof shall bear, in ifications prescribed in paragraph (a)(1)
addition to the other information re- (i) and (iii) of this section.
quired by the Act, the following: (3) n-Octyl; manufactured by the
(1) The common or usual name of the hydrodimerization of 1,3-butadiene, fol-
fatty acid salt or salts contained there- lowed by catalytic hydrogenation of
in. the resulting dienol, and distillation to
(2) The words ‘‘food grade,’’ in jux- produce n-octyl alcohol with a min-
taposition with and equally as promi- imum purity of 99 percent. The analyt-
nent as the name of the salt. ical method for n-octyl alcohol entitled
‘‘Test Method [Normal-octanol]’’ dated
§ 172.864 Synthetic fatty alcohols. October 2003, and printed by Kuraray
Synthetic fatty alcohols may be safe- Co., Ltd., is incorporated by reference.
ly used in food and in the synthesis of The Director of the Office of the Fed-
food components in accordance with eral Register approves this incorpora-
the following prescribed conditions: tion by reference in accordance with 5
(a) The food additive consists of any U.S.C. 552(a) and 1 CFR part 51. You
one of the following fatty alcohols: may obtain a copy from the Office of
(1) Hexyl, octyl, decyl, lauryl, Food Additive Safety, 5100 Paint
myristyl, cetyl, and stearyl; manufac- Branch Pkwy., College Park, MD 20740,
tured by fractional distillation of alco- or you may examine a copy at the Cen-
hols obtained by a sequence of oxida- ter for Food Safety and Applied Nutri-
tion and hydrolysis of organo-alu- tion’s Library, Food and Drug Admin-
minums generated by the controlled re- istration, 5100 Paint Branch Pkwy.,
action of low molecular weight College Park, MD 20740, or at the Na-
trialkylaluminum with purified ethyl- tional Archives and Records Adminis-
ene (minimum 99 percent by volume tration (NARA). For information on
C2H4), and utilizing the hydrocarbon the availability of this material at
solvent as defined in paragraph (b) of NARA, call 202–741–6030, or go to http://

this section, such that: www.archives.gov/federallregister/
104
codeloflfederallregulations/ vent samples in handling and to assure ab-

ibrllocations.html. sence of any extraneous material arising
(b) The hydrocarbon solvent used in from inadequate packaging is essential. Be-
cause some of the polynuclear hydrocarbons
the process described in paragraph sought in this test are very susceptible to
(a)(1) of this section is a mixture of liq- photo-oxidation, the entire procedure is to
uid hydrocarbons essentially paraffinic be carried out under subdued light.
in nature, derived from petroleum and
refined to meet the specifications de- APPARATUS
scribed in paragraph (b)(1) of this sec- Chromatographic tube. 450 millimeters in
tion when subjected to the procedures length (packing section), inside diameter 19
described in paragraph (b) (2) and (3) of millimeters ±1 millimeter, equipped with a
this section. wad of clean Pyrex brand filtering wool (Cor-
ning Glass Works Catalog No. 3950 or equiva-
(1) The hydrocarbon solvent meets
lent). The tube shall contain a 250-milliliter
the following specifications: reservoir and a 2-millimeter tetrafluoro-
(i) Boiling-point range: 175 °C–275 °C. ethylene polymer stopcock at the opposite
(ii) Ultraviolet absorbance limits as end. Overall length of the tube is 670 milli-
follows: meters.
Stainless steel rod. 2 feet in length, 2 to 4
Maximum millimeters in diameter.
absorb-
ance per Vacuum oven. Similar to Labline No. 3610
Wavelength (millicrons) but modified as follows: A copper tube one-
centimeter
optical fourth inch in diameter and 13 inches in
path length
length is bent to a right angle at the 4-inch
280–289 ............................................................... 0.15 point and plugged at the opposite end; eight
290–299 ............................................................... .12 copper tubes one-eighth inch in diameter and
300–359 ............................................................... .05 5 inches in length are silver soldered in
360–400 ............................................................... .02 drilled holes (one-eighth inch in diameter) to
the one-fourth-inch tube, one on each side at
(2) Use ASTM method D86–82, the 5-, 7.5-, 10- and 12.5-inch points; the one-
‘‘Standard Method for Distillation of eighth-inch copper tubes are bent to conform
Petroleum Products,’’ which is incor- with the inner periphery of the oven.
Beakers. 250-milliliter and 500-milliliter ca-
porated by reference, to determine
pacity.
boiling point range. Copies of the ma- Graduated cylinders. 25-milliliter, 50-milli-
terial incorporated by reference may liter, and 150-milliliter capacity.
be obtained from the American Society Tuberculin syringe. 1-milliliter capacity,
for Testing Materials, 100 Barr Harbor with 3-inch, 22-gauge needle.
Dr., West Conshohocken, Philadelphia, Volumetric flask. 5-milliliter capacity.
PA 19428-2959, or may be examined at Spectrophotometric cells. Fused quartz
the National Archives and Records Ad- ground glass stoppered cells, optical path
length in the range of 1.000 centimeter ±0.005
ministration (NARA). For information centimeter. With distilled water in the cells,
on the availability of this material at determine any absorbance difference.
NARA, call 202–741–6030, or go to: http:// Spectrophotometer. Spectral range 250 milli-
www.archives.gov/federallregister/ microns—400 millimicrons with spectral slit
codeloflfederallregulations/ width of 2 millimicrons or less: under instru-
ibrllocations.html. ment operating conditions for these absorb-
(3) The analytical method for deter- ance measurements, the spectrophotometer
mining ultraviolet absorbance limits is shall also meet the following performance
requirements:
as follows: Absorbance repeatability, ±0.01 at 0.4 ab-
sorbance.
GENERAL INSTRUCTIONS Absorbance accuracy, 1 ±0.05 at 0.4 absorb-
All glassware should be scrupulously ance.
cleaned to remove all organic matter such as
oil, grease, detergent residues, etc. Examine 1 As determined by using potassium chro-
all glassware, including stoppers and stop- mate for reference standard and described in
cocks, under ultraviolet light to detect any National Bureau of Standards Circular 484,
residual fluorescent contamination. As a pre- Spectrophotometry, U.S. Department of
cautionary measure, it is recommended prac- Commerce, (1949). The accuracy is to be de-
tice to rinse all glassware with purified iso- termined by comparison with the standard
octane immediately before use. No grease is values at 290, 345, and 400 millimicrons. Cir-
to be used on stopcocks or joints. Great care cular 484 is incorporated by reference. Copies
to avoid contamination of hydrocarbon sol- Continued
105
§ 172.864 21 CFR Ch. I (4–1–12 Edition)
Wavelength repeatability, ±0.2 milliequivalent). Use 20 milliliters for test. If nec-
micron. essary, 1,2-dichloroethane may be purified by
Wavelength accuracy, ±1.0 millimicron. distillation.
Nitrogen cylinder. Water-pumped or equiva- Eluting mixtures:
lent purity nitrogen in cylinder equipped 1. 10 percent 1,2-dichloroethane in hexane.
with regulator and valve to control flow at 5 Pipet 100 milliliters of 1,2-dichloroethane
p.s.i.g. into a 1-liter glass-stoppered volumetric
flask and adjust to volume with hexane, with
REAGENTS AND MATERIALS mixing.
Organic solvents. All solvents used through- 2. 40 percent benzene in hexane. Pipet 400
out the procedure shall meet the specifica- milliliters of benzene into a 1-liter glass-
tions and tests described in this specifica- stoppered volumetric flask and adjust to vol-
tion. The isooctane, benzene, hexane, and 1,2- ume with hexane, with mixing.
dichloroethane designated in the list fol- n-Hexadecane, 99 percent olefin-free. Dilute
lowing this paragraph shall pass the fol- 1.0 milliliter of n-hexadecane to 5 milliliters
lowing test: with isooctane and determine the absorbance
To the specified quantity of solvent in a in a 1-centimeter cell compared to isooctane
250-milliliter beaker, add 1 milliliter of puri- as reference between 280 mμ-400mμ. The ab-
fied n-hexadecane and evaporate in the vacu- sorbance per centimeter path length shall
um oven under a stream of nitrogen. Dis- not exceed 0.00 in this range. If necessary, n-
continue evaporation when not over 1 milli- hexadecane may be purified by percolation
liter of residue remains. (To the residue from through activated silica gel or by distilla-
benzene add a 5-milliliter portion of purified tion.
isooctane, reevaporate, and repeat once to Silica gel, 28–200 mesh (Grade 12, Davison
insure complete removal of benzene.) Chemical Co., Baltimore, Md., or equivalent).
Dissolve the 1 milliliter of hexadecane res- Activate as follows: Weigh about 900 grams
idue in isooctane and make to 5 milliliters into a 1-gallon bottle, add 100 milliliters of
volume. Determine the absorbance in the 1- de-ionized water, seal the bottle and shake
centimeter path length cells compared to and roll at intervals for 1 hour. Allow to
isooctane as reference. The absorbance of the equilibrate overnight in the sealed bottle.
solution of the solvent residue shall not ex- Activate the gel at 150 °C for 16 hours, in a
ceed 0.02 per centimeter path length between 2-inch × 7-inch × 12-inch porcelain pan loose-
280 and 300 mμ and shall not exceed 0.01 per ly covered with aluminum foil, cool in a
centimeter path length between 300 and 400 dessicator, transfer to a bottle and seal.
mμ.
Isooctane (2,2,4-trimethylpentane). Use 10 PROCEDURE
milliliters for the test described in the pre- Determination of ultraviolet absorbance. Be-
ceding paragraph. If necessary, isooctane fore proceeding with the analysis of a sample
may be purified by passage through a column determine the absorbance in a 1-centimeter
of activated silica gel (Grade 12, Davison path cell for the reagent blank by carrying
Chemical Co., Baltimore, Md., or equiva- out the procedure without a sample. Record
lent). the absorbance in the wavelength range of
Benzene, spectro grade (Burdick and Jackson 280 to 400 millimicrons. Typical reagent
Laboratories, Inc., Muskegon, Mich., or equiva- blank absorbance in this range should not
lent). Use 80 milliliters for the test. If nec- exceed 0.04 in the 280 to 299 millimicron
essary, benzene may be purified by distilla- range, 0.02 in the 300 to 359 millimicron
tion or otherwise. range, and 0.01 in the 360 to 400 millimicron
Hexane, spectro grade (Burdick and Jackson range. If the characteristic benzene peaks in
Laboratories, Inc., Muskegon, Mich., or equiva- the 250 to 260 millimicron region are present,
lent). Use 650 milliliters for the test. If nec- remove the benzene by the procedure de-
essary, hexane may be purified by distilla- scribed above under ‘‘Reagents and Mate-
tion or otherwise. rials,’’ ‘‘Organic Solvents,’’ and record ab-
1,2-Dichloroethane, spectro grade (Matheson, sorbance again.
Coleman, and Bell, East Rutherford, N.J., or Transfer 50 grams of silica gel to the
chromatographic tube for sample analysis.
are available from the Center for Food Safe- Raise and drop the column on a semisoft,
ty and Applied Nutrition (HFS–200), Food clean surface for about 1 minute to settle the
and Drug Administration, 5100 Paint Branch gel. Pour 100 milliliters of hexane into the
Pkwy., College Park, MD 20740, or available column with the stopcock open and allow to
for inspection at the National Archives and drain to about one-half inch above the gel.
Records Administration (NARA). For infor- Turn off the stopcock and allow the column
mation on the availability of this material to cool for 30 minutes. After cooling, vibrate
at NARA, call 202–741–6030, or go to: http:// the column to eliminate air and stir the top
www.archives.gov/federallregister/ 1 to 2 inches with a small diameter stainless

codeloflfederallregulations/ steel rod. Take care not to get the gel above
ibrllocations.html. the liquid and onto the sides of the column.
106
Weigh out 40 grams ±0.1 gram of the hydro- cohols used as intermediates in the
carbon solvent sample into a 250-milliliter synthesis of food additives and other
beaker, add 50 milliliters of hexane, and pour substances permitted in food.
the solution into the column. Rinse the
beaker with 50 milliliters of hexane and add [42 FR 14491, Mar. 15, 1977, as amended at 47
this to the column. Allow the hexane sample FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19,
solution to elute into a 500-milliliter beaker 1984; 54 FR 24897, June 12, 1989; 70 FR 72908,
until the solution is about one-half inch Dec. 8, 2005]
above the gel. Rinse the column three times
with 50-milliliter portions of hexane. Allow § 172.866 Synthetic glycerin produced
each hexane rinse to separately elute to by the hydrogenolysis of carbo-
about one-half inch above the gel. Replace hydrates.
the eluate beaker (discard the hexane eluate)
with a 250-milliliter beaker. Add two sepa- Synthetic glycerin produced by the
rate 25-milliliter portions of 10 percent 1,2- hydrogenolysis of carbohydrates may
dichloroethane and allow each to separately be safely used in food, subject to the
elute as before. Finally, add 150 milliliters of
provisions of this section:
10 percent 1,2-dichloroethane for a total of
200 milliliters. When the final 10 percent 1,2- (a) It shall contain not in excess of
dichloroethane fraction is about one-half 0.2 percent by weight of a mixture of
inch above the top of the gel bed, replace the butanetriols.
receiving beaker (discard the 1,2- (b) It is used or intended for use in an
dichloroethane eluate) with a 250-milliliter amount not to exceed that reasonably
beaker containing 1 milliliter of hexadecane.
Adjust the elution rate to 2 to 3 milliliters
required to produce its intended effect.
per minute, add two 25-milliliter portions of
40 percent benzene and allow each to sepa- § 172.867 Olestra.
rately elute as before to within about one- Olestra, as identified in this section,
half inch of the gel bed. Finally, add 150 mil- may be safely used in accordance with
liliters of 40 percent benzene for a total of 200
milliliters. Evaporate the benzene in the
the following conditions:
oven with vacuum and sufficient nitrogen (a) Olestra is a mixture of octa-,
flow to just ripple the top of the benzene so- hepta-, and hexa-esters of sucrose with
lution. When the benzene is removed (as de- fatty acids derived from edible fats and
termined by a constant volume of hexa- oils or fatty acid sources that are gen-
decane) add 5 milliliters of isooctane and erally recognized as safe or approved
evaporate. Repeat once to insure complete for use as food ingredients. The chain
removal of benzene. Remove the beaker and
cover with aluminum foil (previously rinsed
lengths of the fatty acids are no less
with hexane) until cool. than 12 carbon atoms.
Quantitatively transfer the hexadecane (b) Olestra meets the specifications
residue to a 5-milliliter volumetric flask and of the Food Chemicals Codex, 4th edi-
dilute to volume with isooctane. Determine tion, 1st supplement (1997), pp. 33–35,
the absorbance of the solution in 1-centi- which is incorporated by reference. The
meter path length cells between 280 and 400 Director of the Office of the Federal
millimicrons using isooctane as a reference.
Correct the absorbance values for any ab-
Register approves this incorporation
sorbance derived from reagents as deter- by reference in accordance with 5
mined by carrying out the procedure without U.S.C. 552(a) and 1 CFR part 51. You
a sample. If the corrected absorbance does may obtain copies from the National
not exceed the limits prescribed in para- Academy Press, 2101 Constitution Ave.
graph (b)(1)(ii) of this section, the sample NW., Washington, DC 20418 (Internet
meets the ultraviolet absorbance specifica- address http://www.nap.edu). Copies
tions for hydrocarbon solvent. may be examined at the Center for
(c) Synthetic fatty alcohols may be Food Safety and Applied Nutrition’s
used as follows: Library, Food and Drug Administra-
(1) As substitutes for the cor- tion, 5100 Paint Branch Pkwy., College
responding naturally derived fatty al- Park, MD 20740, or at the National Ar-
cohols permitted in food by existing chives and Records Administration
regulations in this part or part 173 of (NARA). For information on the avail-
this chapter provided that the use is in ability of this material at NARA, call
compliance with any prescribed limita- 202–741–6030, or go to: http://
tions. www.archives.gov/federallregister/
(2) As substitutes for the cor- codeloflfederallregulations/

responding naturally derived fatty al- ibrllocations.html.
107
§ 172.868 21 CFR Ch. I (4–1–12 Edition)
(c) Olestra may be used in place of taining on an anhydrous basis not more
fats and oils in prepackaged ready-to- than 2.6 ethoxy groups per
eat savory (i.e., salty or piquant but anhydroglucose unit.
not sweet) snacks and prepackaged, (b) It is used or intended for use as
unpopped popcorn kernels that are follows:
ready-to-heat. In such foods, the addi- (1) As a binder and filler in dry vita-
tive may be used in place of fats and min preparations.
oils for frying or baking, in dough con- (2) As a component of protective
ditioners, in sprays, in filling ingredi- coatings for vitamin and mineral tab-
ents, or in flavors. lets.
(d) To compensate for any inter- (3) As a fixative in flavoring com-
ference with absorption of fat soluble pounds.
vitamins, the following vitamins shall
be added to foods containing olestra: § 172.869 Sucrose oligoesters.
1.9 milligrams alpha-tocopherol equiva-
lents per gram olestra; 51 retinol Sucrose oligoesters, as identified in
equivalents per gram olestra (as this section, may be safely used in ac-
retinyl acetate or retinyl palmitate); 12 cordance with the following conditions:
IU vitamin D per gram olestra; and 8 μg (a) Sucrose oligoesters consist of
vitamin K1 per gram olestra. mixtures of sucrose fatty acid esters
(e)(1) Vitamins A, D, E, and K present with an average degree of
in foods as a result of the requirement esterification ranging from four to
in paragraph (d) of this section shall be seven. It is produced by
declared in the listing of ingredients. interesterification of sucrose with
Such vitamins shall not be considered methyl esters of fatty acids derived
in determining nutrient content for the from edible fats and oils (including hy-
nutritional label or for any nutrient drogenated fats and oils). The only sol-
claims, express or implied. vents which may be used in the prepa-
(i) An asterisk shall follow vitamins ration of sucrose oligoesters are di-
A, D, E, and K in the listing of ingredi- methyl sulfoxide, isobutyl alcohol, and
ents; those solvents generally recognized as
(ii) The asterisk shall appear as a su- safe in food.
perscript following each vitamin; (b) Sucrose oligoesters meet the spec-
(iii) Immediately following the ingre- ifications in the methods listed in the
dient list an asterisk and statement, table in this paragraph. The methods
‘‘Dietarily insignificant’’ shall appear cited for determining compliance with
prominently and conspicuously as spec- each specification are incorporated by
ified in § 101.2(c) of this chapter; reference, in accordance with 5 U.S.C.
(2) Olestra shall not be considered as 552(a) and 1 CFR part 51. Copies of the
a source of fat or calories for purposes methods may be examined at the Cen-
of §§ 101.9 and 101.13 of this chapter. ter for Food Safety and Applied Nutri-
[61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, tion’s Library, room 1C–100, 5100 Paint
1996, as amended at 68 FR 46402, Aug. 5, 2003; Branch Pkwy., College Park, MD 20740,
69 FR 29432, May 24, 2004] or at the National Archives and
Records Administration (NARA). For
§ 172.868 Ethyl cellulose. information on the availability of this
The food additive ethyl cellulose may material at NARA, call 202–741–6030, or
be safely used in food in accordance go to: http://www.archives.gov/
with the following prescribed condi- federallregister/
tions: codeloflfederallregulations/
(a) The food additive is a cellulose ibrllocations.html. Copies of the meth-
ether containing ethoxy (OC2H5) groups ods are available from the sources list-
attached by an ether linkage and con- ed in the table in this paragraph:
108
Specification Limit Method Cited Source for Obtaining Method
(1) Sucrose esters .................. Not less than 90% .................. ‘‘Method for Analyzing the Pu- Office of Food Additive Safe-
rity of Sucrose Fatty Acid ty, Center for Food Safety
Esters,’’ issued by and Applied Nutrition (HFS–
Mitsubishi Chemical Corp., 200), Food and Drug Ad-
June 17, 1998. ministration, 5100 Paint
Branch Pkwy., College
Park, MD 20740.
(2) Mono-, di-, and tri-esters ... Not more than 45% ................ ‘‘Method for Measuring the Do.
Ester Distribution of Su-
crose Oligoesters,’’ issued
by Mitsubishi Chemical
Corp., June 17, 1998.
(3) Tetra-, penta-, hexa-, and Not less than 50% .................. Do. Do.
hepta-esters.
(4) Octa-esters ........................ Not more than 40% ................ Do. Do.
(5) Free Sucrose ..................... Not more than 0.5% ............... ‘‘Free Sucrose Method,’’ Do.
issued by Mitsubishi Chem-
ical Corp., June 17, 1998.
(6) Acid Value ......................... Not more than 4.0 .................. ‘‘Acid Value,’’ Appendix VII, National Academy Press,
Method I (Commercial Fatty 2101 Constitution Ave. NW,
Acids), in the Food Chemi- Washington, DC 20418
cals Codex, 4th ed. (1996), (Internet: http://
p. 820. www.nap.edu).
(7) Residue on Ignition ........... Not more than 0.7% ............... ‘‘Residue on Ignition, Appen- Do.
dix IIC, Method I, in the
Food Chemicals Codex, 4th
ed. (1996), pp. 751–752,
(using a 1-gram sample).
(8) Residual Methanol ............. Not more than 10 milligrams/ Method listed in the mono- Do.
kilogram. graph for ‘‘Sucrose Fatty
Acid Esters’’ in the First
Supplement to the 4th ed.
of the Food Chemicals
Codex (1997), pp. 44–45.
(9) Residual Dimethyl Sulf- Not more than 2.0 milligrams/ Do. Do.
oxide. kilogram.
(10) Residual Isobutyl Alcohol Not more than 10 milligrams/ Do. Do.
kilogram.
(11) Lead ................................. Not more than 1.0 milligram/ ‘‘Atomic Absorption Do.
kilogram. Spectrophotometric Graph-
ite Furnace Method,’’ Meth-
od I, in the Food Chemicals
Codex, 4th ed. (1996), pp.
763–765.
(c) The additive is used as an emulsi- § 172.870 Hydroxypropyl cellulose.

fier (as defined in § 170.3(o)(8) of this The food additive hydroxypropyl cel-
chapter) or stabilizer (as defined in lulose may be safely used in food, ex-
§ 170.3(o)(28) of this chapter) in choco- cept standardized foods that do not
late and in butter-substitute spreads, provide for such use, in accordance
at a level not to exceed 2.0 percent; ex- with the following prescribed condi-
cept that the additive may not be used tions:
in a standardized food unless permitted (a) The additive consists of one of the
by the standard of identity. following:
(1) A cellulose ether containing pro-
[68 FR 50072, Aug. 20, 2003]
pylene glycol groups attached by an
ether linkage that contains, on an an-

hydrous basis, not more than 4.6
109
§ 172.872 21 CFR Ch. I (4–1–12 Edition)
hydroxypropyl groups per (2) The viscosity of an aqueous solu-

anhydroglucose unit. The additive has tion, 2.5 grams of the material in 100
a minimum viscosity of 10 centipoises milliliters of water, at 20 °C, is 20 to 60
for a 10 percent by weight aqueous so- centipoises.
lution at 25 degrees C. (3) The ash content on a dry basis has
(2) A cellulose ether containing pro- a maximum of 0.6 percent.
pylene glycol groups attached by an (c) The food additive is used as an
ether linkage having a hydroxypropoxy aerating, emulsifying, and foaming
(OC3H6OH) content of 5 to 16 percent agent, in an amount not in excess of
weight in weight (w/w) on an anhydrous that reasonably required to produce its
basis, i.e., 0.1 to 0.4 hydroxypropyl intended effect.
groups per anhydroglucose unit. The
common name for this form of the ad- § 172.874 Hydroxypropyl
ditive is low substituted hydroxypropyl methylcellulose.
cellulose. The food additive hydroxypropyl
(b) The additive is used or intended methylcellulose (CAS Reg. No. 9004–65–
for use as follows: 3) may be safely used in food, except in
(1) The additive identified in para- standardized foods which do not pro-
graph (a)(1) of this section is used or
vide for such use if:
intended for use as an emulsifier, film
(a) The additive complies with the
former, protective colloid, stabilizer,
definition and specifications prescribed
suspending agent, or thickener in food,
in the National Formulary, 12th edi-
in accordance with good manufacturing
practice. The additive also may be used tion.
as a binder in dietary supplements, in (b) It is used or intended for use as an
accordance with good manufacturing emulsifier, film former, protective col-
practice. loid, stabilizer, suspending agent, or
(2) The additive identified in para- thickener, in accordance with good
graph (a)(2) of this section is used or manufacturing practice.
intended for use as a binder and dis- (c) To insure safe use of the additive,
integrator in tablets or wafers con- the container of the additive, in addi-
taining dietary supplements of vita- tion to being labeled as required by the
mins and/or minerals. The additive is general provisions of the act, shall be
used in accordance with good manufac- accompanied by labeling which con-
turing practice. tains adequate directions for use to
provide a final product that complies
[46 FR 50065, Oct. 9, 1981, as amended at 76 FR with the limitations prescribed in para-
41689, July 15, 2011] graph (b) of this section.
§ 172.872 Methyl ethyl cellulose. [42 FR 14491, Mar. 15, 1977, as amended at 47
The food additive methyl ethyl cel- FR 38273, Aug. 31, 1982]
lulose may be safely used in food in ac-
§ 172.876 Castor oil.
conditions. The food additive castor oil may be
(a) The additive is a cellulose ether safely used in accordance with the fol-
having the general formula lowing conditions:
[C6H(10-x-y)O5(CH3)x(C2H5)y]n, where x is (a) The additive meets the specifica-
the number of methyl groups and y is tions of the United States Pharma-
the number of ethyl groups. The aver- copeia XX (1980).
age value of x is 0.3 and the average (b) The additive is used or intended
value of y is 0.7. for use as follows:
specifications: Use and Limitations
(1) The methoxy content shall be not Hard candy production—As a release agent
less than 3.5 percent and not more than and antisticking agent, not to exceed 500
6.5 percent, calculated as OCH3, and the parts per million in hard candy.
ethoxy content shall be not less than Vitamin and mineral tablets—As a compo-
14.5 percent and not more than 19 per- nent of protective coatings.
cent, calculated as OC2H5, both meas- [42 FR 14491, Mar. 15, 1977, as amended at 49
ured on the dry sample. FR 10105, Mar. 19, 1984]
110
§ 172.878 White mineral oil. any absorbance due to added anti-

oxidants. Copies of the material incor-
White mineral oil may be safely used
porated by reference are available from
in food in accordance with the fol-
lowing conditions: Nutrition (HFS–200), Food and Drug
(a) White mineral oil is a mixture of Administration, 5100 Paint Branch
liquid hydrocarbons, essentially par- Pkwy., College Park, MD 20740, or
affinic and naphthenic in nature ob- available for inspection at the National
tained from petroleum. It is refined to Archives and Records Administration
meet the following specifications: (NARA). For information on the avail-
(1) It meets the test requirements of ability of this material at NARA, call
the United States Pharmacopeia XX 202–741–6030, or go to: http://
(1980) for readily carbonizable sub- www.archives.gov/federallregister/
stances (page 532). codeloflfederallregulations/
(2) It meets the test requirements of ibrllocations.html.
U.S.P. XVII for sulfur compounds (page (b) White mineral oil may contain
400). any antioxidant permitted in food by
(3) It meets the specifications pre- regulations issued in accordance with
scribed in the ‘‘Journal of the Associa- section 409 of the Act, in an amount
tion of Official Analytical Chemists,’’ not greater than that required to
Volume 45, page 66 (1962), which is in- produce its intended effect.
corporated by reference, after correc- (c) White mineral oil is used or in-
tion of the ultraviolet absorbance for tended for use as follows:
Limitation (inclusive of all petroleum hydro-
Use carbons that may be used in combination
with white mineral oil)
1. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab-
taining concentrates of flavoring, spices, condiments, and nutrients intended for let.
addition to food, excluding confectionery.
2. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab-
taining food for special dietary use. let.
3. As a float on fermentation fluids in the manufacture of vinegar and wine to pre- In an amount not to exceed good manu-
vent or retard access of air, evaporation, and wild yeast contamination during facturing practice.
fermentation.
4. As a defoamer in food ............................................................................................. In accordance with § 173.340 of this chap-
ter.
5. In bakery products, as a release agent and lubricant ............................................. Not to exceed 0.15% of bakery products.
6. In dehydrated fruits and vegetables, as a release agent ........................................ Not to exceed 0.02% of dehydrated fruits
and vegetables.
7. In egg white solids, as a release agent .................................................................. Not to exceed 0.1% of egg white solids.
8. On raw fruits and vegetables, as a protective coating ............................................ In an amount not to exceed good manu-
facturing practice.
9. In frozen meat, as a component of hot-melt coating .............................................. Not to exceed 0.095% of meat.
10. As a protective float on brine used in the curing of pickles .................................. In an amount not to exceed good manu-
facturing practice.
11. In molding starch used in the manufacture of confectionery ................................ Not to exceed 0.3 percent in the molding
starch.
12. As a release agent, binder, and lubricant in the manufacture of yeast ................ Not to exceed 0.15 percent of yeast.
13. As an antidusting agent in sorbic acid for food use .............................................. Not to exceed 0.25 percent in the sorbic
acid.
14. As release agent and as sealing and polishing agent in the manufacture of Not to exceed 0.2 percent of confectionery.
confectionery.
15. As a dust control agent for wheat, corn, soybean, barley, rice, rye, oats, and Applied at a level of no more than 0.02
sorghum. percent by weight of grain.
16. As a dust control agent for rice ............................................................................. ISO 100 oil viscosity (100 centistokes (cSt)
at 100 °F) applied at a level of no more
than 0.08 percent by weight of the rice
grain.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47 FR 11838, Mar. 19, 1982;
48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 63 FR 66014,
Dec. 1, 1998]
111
§ 172.880 21 CFR Ch. I (4–1–12 Edition)
§ 172.880 Petrolatum. subjected to the analytical procedure

described in § 172.886(b):
Petrolatum may be safely used in
food, subject to the provisions of this Ultraviolet absorbance per centimeter
section. path length:
(a) Petrolatum complies with the Millimicrons Maximum
specifications set forth in the United
280–289 ............................................................... 0.25
States Pharmacopeia XX (1980) for 290–299 ............................................................... .20
white petrolatum or in the National 300–359 ............................................................... .14
Formulary XV (1980) for petrolatum. 360–400 ............................................................... .04
(b) Petrolatum meets the following
ultraviolet absorbance limits when (c) Petrolatum is used or intended for
use as follows:
Limitation (inclusive of all petroleum hydrocarbons
Use that may be used in combination with petrolatum)
In bakery products; as release agent and lubricant ................................... With white mineral oil, not to exceed 0.15 percent of
bakery product.
In confectionery; as release agent and as sealing and polishing agent ... Not to exceed 0.2 percent of confectionery.
In dehydrated fruits and vegetables; as release agent .............................. Not to exceed 0.02 percent of dehydrated fruits and
vegetables.
In egg white solids; as release agent ........................................................ Not to exceed 0.1 percent of egg white solids.
On raw fruits and vegetables; as protective coating .................................. In an amount not to exceed good manufacturing prac-
tice.
In beet sugar and yeast; as defoaming agent ........................................... As prescribed in § 173.340 of this chapter.
(d) Petrolatum may contain any 320–329 millimicrons—0.08 maximum.

antioxidant permitted in food by regu- 330–350 millimicrons—0.05 maximum.
lations issued in accordance with sec- Nonvolatile residual: 0.002 gram per 100
tion 409 of the Act, in an amount not milliliters maximum.
greater than that required to produce Synthetic isoparaffinic petroleum hydro-
carbons containing antioxidants shall meet
its intended effect.
the specified ultraviolet absorbance limits
[42 FR 14491, Mar. 15, 1977, as amended at 49 after correction for any absorbance due to
FR 10105, Mar. 19, 1984] the antioxidants. The ultraviolet absorbance
shall be determined by the procedure de-
§ 172.882 Synthetic isoparaffinic petro- scribed for application of mineral oil, dis-
leum hydrocarbons. regarding the last sentence of the procedure,
under ‘‘Specifications’’ on page 66 of the
Synthetic isoparaffinic petroleum ‘‘Journal of the Association of Official Ana-
hydrocarbons may be safely used in lytical Chemists,’’ Volume 45 (February
food, in accordance with the following 1962), which is incorporated by reference.
conditions: Copies are available from the Center for
(a) They are produced by synthesis Food Safety and Applied Nutrition (HFS–
from petroleum gases and consist of a 200), Food and Drug Administration, 5100
mixture of liquid hydrocarbons meet- Paint Branch Pkwy., College Park, MD 20740,
ing the following specifications: or available for inspection at the National
Archives and Records Administration
Boiling point 93–260 °C as determined by (NARA). For information on the availability
ASTM method D86–82, ‘‘Standard Method for of this material at NARA, call 202–741–6030,
Distillation of Petroleum Products,’’ which or go to: http://www.archives.gov/
is incorporated by reference. Copies may be federallregister/codeloflfederallregulations/
obtained from the American Society for ibrllocations.html. For hydrocarbons boiling
Testing Materials, 100 Barr Harbor Dr., West below 250 °F, the nonvolatile residue shall be
Conshohocken, Philadelphia, PA 19428-2959, determined by ASTM method D1353–78,
or may be examined at the National Ar- ‘‘Standard Test Method for Nonvolatile Mat-
chives and Records Administration (NARA). ter in Volatile Solvents for Use in Paint,
For information on the availability of this Varnish, Lacquer, and Related Products;’’
material at NARA, call 202–741–6030, or go to: for those boiling above 121 °C, ASTM method
http://www.archives.gov/federallregister/ D381–80, ‘‘Standard Test Method for Existent
codeloflfederallregulations/ Gum in Fuels by Jet Evaporation’’ shall be
ibrllocations.html. used. These methods are incorporated by ref-

Ultraviolet absorbance: erence. Copies may be obtained from the
260–319 millimicrons—1.5 maximum. American Society for Testing Materials, 100
112
Barr Harbor Dr., West Conshohocken, Phila- § 178.3620(b)(1)(ii) of this chapter, as fol-
delphia, PA 19428-2959, or may be examined lows:
at the National Archives and Records Ad-
ministration (NARA). For information on Maximum
the availability of this material at NARA, absorb-
call 202–741–6030, or go to: http:// ance per
Wavelength mμ centimeter
www.archives.gov/federallregister/ optical
codeloflfederallregulations/ pathlength
ibrllocations.html.
280–289 ............................................................... 4.0
(b) Isoparaffinic petroleum hydro- 290–299 ............................................................... 3.3
carbons may contain antioxidants au- 300–329 ............................................................... 2.3
thorized for use in food in an amount 330–360 ............................................................... .8
not to exceed that reasonably required
to accomplish the intended technical (c) The additive is used as follows:
effect nor to exceed any prescribed lim- Use Limitations
itations.
(c) Synthetic isoparaffinic petroleum As a coating on shell eggs ........... In an amount not to ex-
hydrocarbons are used or intended for ceed good manufac-
turing practice.
use as follows: As a defoamer in processing beet Complying with
sugar and yeast. § 173.340 of this chap-
Uses Limitations
ter.
1. In the froth-flotation cleaning of In an amount not to ex- As a float on fermentation fluids in In an amount not to ex-
vegetables. ceed good manufac- the manufacture of vinegar and ceed good manufac-
turing practice. wine to prevent or retard ac- turing practice.
2. As a component of insecticide Do. cess of air, evaporation, and
formulations for use on proc- wild yeast contamination during
essed foods. fermentation.
3. As a component of coatings on Do. In the froth-flotation cleaning of Do.
fruits and vegetables. vegetables.
4. As a coating on shell eggs ....... Do. As a component of insecticide for- Do.
5. As a float on fermentation Do. mulations used in compliance
fluids in the manufacture of vin- with regulations issued in parts
egar and wine and on brine 170 through 189 of this chapter.
used in curing pickles, to pre-
vent or retard access of air,
evaporation, and contamination § 172.886 Petroleum wax.
with wild organisms during fer-
mentation. Petroleum wax may be safely used in
or on food, in accordance with the fol-
[42 FR 14491, Mar. 15, 1977, as amended at 47 lowing conditions:
FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, (a) Petroleum wax is a mixture of
1984; 54 FR 24897, June 12, 1989] solid hydrocarbons, paraffinic in na-
ture, derived from petroleum, and re-
§ 172.884 Odorless light petroleum hy- fined to meet the specifications pre-
drocarbons.
scribed by this section.
Odorless light petroleum hydro- (b) Petroleum wax meets the fol-
carbons may be safely used in food, in lowing ultraviolet absorbance limits
accordance with the following pre- when subjected to the analytical proce-
scribed conditions: dure described in this paragraph.
(a) The additive is a mixture of liquid
hydrocarbons derived from petroleum Maximum
or synthesized from petroleum gases. ultraviolet
absorb-
The additive is chiefly paraffinic, ance per
isoparaffinic, or naphthenic in nature. centimeter
path length
specifications: 280–289 millimicrons ........................................... 0.15
(1) Odor is faint and not kerosenic. 290–299 millimicrons ........................................... 0.12
(2) Initial boiling point is 300 °F min- 300–359 millimicrons ........................................... 0.08
360–400 millimicrons ........................................... 0.02
imum.
(3) Final boiling point is 650 °F max-
imum.
(4) Ultraviolet absorbance limits de-

termined by method specified in
113
§ 172.886 21 CFR Ch. I (4–1–12 Edition)
ANALYTICAL SPECIFICATION FOR PETROLEUM Vigreaux vacuum-jacketed condenser (or
WAX equivalent) about 45 centimeters in length
and distilling head with separable cold finger
GENERAL INSTRUCTIONS condenser. Use of tetrafluoroethylene poly-
Because of the sensitivity of the test, the mer sleeves on the glass joints will prevent
possibility of errors arising from contamina- freezing. Do not use grease on stopcocks or
tion is great. It is of the greatest importance joints.
that all glassware be scrupulously cleaned to Spectrophotometric cells. Fused quartz cells,
remove all organic matter such as oil, optical path length in the range of 5.000 cen-
grease, detergent residues, etc. Examine all timeters ±0.005 centimeter; also for checking
glassware, including stoppers and stopcocks, spectrophotometer performance only, optical
under ultraviolet light to detect any residual path length in the range 1.000 centimeter
fluorescent contamination. As a pre- ±0.005 centimeter. With distilled water in the
cautionary measure it is recommended prac- cells, determine any absorbance differences.
tice to rinse all glassware with purified iso- Spectrophotometer. Spectral range 250 milli-
octane immediately before use. No grease is microns–400 millimicrons with spectral slit
to be used on stopcocks or joints. Great care width of 2 millimicrons or less, under instru-
to avoid contamination of wax samples in ment operating conditions for these absorb-
handling and to assure absence of any extra- ance measurements, the spectrophotometer
neous material arising from inadequate shall also meet the following performance
packaging is essential. Because some of the requirements:
polynuclear hydrocarbons sought in this test Absorbance repeatability, ±0.01 at 0.4 ab-
are very susceptible to photo-oxidation, the sorbance.
entire procedure is to be carried out under Absorbance accuracy, 1 ±0.05 at 0.4 absorb-
subdued light. ance.
Wavelength repeatability, ±0.2 milli-
APPARATUS micron.
Wavelength accuracy, ±1.0 millimicron.
Separatory funnels. 250–milliliter, 500–milli- Nitrogen cylinder. Water-pumped or equiva-
liter, 1,000–milliliter, and preferably 2,000– lent purity nitrogen in cylinder equipped
milliliter capacity, equipped with tetra- with regulator and valve to control flow at 5
fluoroethylene polymer stopcocks. p.s.i.g.
Reservoir. 500–milliliter capacity, equipped
with a 24/40 standard taper male fitting at REAGENTS AND MATERIALS
the bottom and a suitable ball-joint at the
Organic solvents. All solvents used through-
top for connecting to the nitrogen supply.
out the procedure shall meet the specifica-
The male fitting should be equipped with
tions and tests described in this specifica-
glass hooks.
tion. The isooctane, benzene, acetone, and
Chromatographic tube. 180 millimeters in
methyl alcohol designated in the list fol-
length, inside diameter to be 15.7 millimeters
lowing this paragraph shall pass the fol-
±0.1 millimeter, equipped with a coarse, frit-
lowing test:
ted-glass disc, a tetrafluoroethylene polymer
To the specified quantity of solvent in a
stopcock, and a female 24/40 standard tapered
250–milliliter Erlenmeyer flask, add 1 milli-
fitting at the opposite end. (Overall length of
liter of purified n-hexadecane and evaporate
the column with the female joint is 235 milli-
on the steam bath under a stream of nitro-
meters.) The female fitting should be
gen (a) loose aluminum foil jacket around
equipped with glass hooks.
Disc. Tetrafluoroethylene polymer 2–inch
diameter disc approximately 3⁄16–inch thick 1 As determined by using potassium chro-
with a hole bored in the center to closely fit mate for reference standard and described in
the stem of the chromatographic tube. National Bureau of Standards Circular 484,
Heating jacket. Conical, for 500–milliliter Spectrophotometry, U.S. Department of
separatory funnel. (Used with variable trans- Commerce, (1949). The accuracy is to be de-
former heat control.) termined by comparison with the standard
Suction flask. 250–milliliter or 500–milliliter values at 290, 345, and 400 millimicrons. Cir-
filter flask. cular 484 is incorporated by reference. Copies
Condenser. 24/40 joints, fitted with a drying are available from the Center for Food Safe-
tube, length optional. ty and Applied Nutrition (HFS–200), Food
Evaporation flask (optional). 250–milliliter and Drug Administration, 5100 Paint Branch
or 500–milliliter capacity all-glass flask Pkwy., College Park, MD 20740, or available
equipped with standard taper stopper having for inspection at the National Archives and
inlet and outlet tubes to permit passage of Records Administration (NARA). For infor-
nitrogen across the surface of contained liq- mation on the availability of this material
uid to be evaporated. at NARA, call 202–741–6030, or go to: http://
Vacuum distillation assembly. All glass (for www.archives.gov/federallregister/

purification of dimethyl sulfoxide); 2–liter codeloflfederallregulations/
distillation flask with heating mantle; ibrllocations.html.
114
the flask will speed evaporation). Dis- milliliters of distilled water in a 500–milli-
continue evaporation when not over 1 milliliter separatory funnel, mix and allow to
liter of residue remains. (To the residue from cool for 5–10 minutes. Add 40 milliliters of
benzene add a 10–milliliter portion of puri- isooctane to the solution and extract by
fied isooctane, reevaporate, and repeat once shaking the funnel vigorously for 2 minutes.
to insure complete removal of benzene.) Draw off the lower aqueous layer into a sec-
Alternatively, the evaporation time can be ond 500–milliliter separatory funnel and re-
reduced by using the optional evaporation peat the extraction with 40 milliliters of iso-
flask. In this case the solvent and n-hexa- octane. Draw off and discard the aqueous
decane are placed in the flask on the steam layer. Wash each of the 40–milliliter extrac-
bath, the tube assembly is inserted, and a tives three times with 50–milliliter portions
stream of nitrogen is fed through the inlet of distilled water. Shaking time for each
tube while the outlet tube is connected to a wash is 1 minute. Discard the aqueous lay-
solvent trap and vacuum line in such a way ers. Filter the first extractive through anhy-
as to prevent any flow-back of condensate drous sodium sulfate prewashed with iso-
into the flask. octane (see Sodium sulfate under ‘‘Reagents
Dissolve the 1 milliliter of hexadecane res- and Materials’’ for preparation of filter), into
idue in isooctane and make to 25 milliliters a 250–milliliter Erlenmeyer flask, or option-
volume. Determine the absorbance in the 5– ally into the evaporating flask. Wash the
centimeter path length cells compared to first separatory funnel with the second 40–
isooctane as reference. The absorbance of the milliliter isooctane extractive, and pass
solution of the solvent residue (except for through the sodium sulfate into the flask.
methyl alcohol) shall not exceed 0.01 per cen- Then wash the second and first separatory
timeter path length between 280 and 400 mμ. funnels successively with a 10–milliliter por-
For methyl alcohol this absorbance value tion of isooctane, and pass the solvent
shall be 0.00. through the sodium sulfate into the flask.
Isooctane (2,2,4–trimethylpentane). Use 180 Add 1 milliliter of n-hexadecane and evapo-
milliliters for the test described in the pre- rate the isooctane on the steam bath under
ceding paragraph. Purify, if necessary, by nitrogen. Discontinue evaporation when not
passage through a column of activated silica over 1 milliliter of residue remains. To the
gel (Grade 12, Davison Chemical Company, residue, add a 10–milliliter portion of iso-
Baltimore, Maryland, or equivalent) about 90 octane and reevaporate to 1 milliliter of
centimeters in length and 5 centimeters to 8 hexadecane. Again, add 10 milliliters of iso-
centimeters in diameter. octane to the residue and evaporate to 1 mil-
Benzene, A.C.S. reagent grade. Use 150 milli- liliter of hexadecane to insure complete re-
liters for the test. Purify, if necessary, by moval of all volatile materials. Dissolve the
distillation or otherwise. 1 milliliter of hexadecane in isooctane and
Acetone, A.C.S. reagent grade. Use 200 milli- make to 25–milliliter volume. Determine the
liters for the test. Purify, if necessary, by reference. The absorbance of the solution
distillation. should not exceed 0.02 per centimeter path
Eluting mixtures: length in the 280 mμ–400 mμ range. (NOTE.
1. 10 percent benzene in isooctane. Pipet 50 Difficulty in meeting this absorbance speci-
milliliters of benzene into a 500–milliliter fication may be due to organic impurities in
glass-stoppered volumetric flask and adjust the distilled water. Repetition of the test
to volume with isooctane, with mixing. omitting the dimethyl sulfoxide will disclose
2. 20 percent benzene in isooctane. Pipet 50 their presence. If necessary to meet the spec-
milliliters of benzene into a 250–milliliter ification, purify the water by redistillation,
glass-stoppered volumetric flask, and adjust passage through an ion-exchange resin, or
to volume with isooctane, with mixing. otherwise.)
3. Acetone-benzene-water mixture. Add 20 Purify, if necessary, by the following pro-
milliliters of water to 380 milliliters of ace- cedure: To 1,500 milliliters of dimethyl sulf-
tone and 200 milliliters of benzene, and mix. oxide in a 2–liter glass-stoppered flask, add
n-Hexadecane, 99 percent olefin-free. Dilute 6.0 milliliters of phosphoric acid and 50
1.0 milliliter of n-hexadecane to 25 milliliters grams of Norit A (decolorizing carbon, alka-
with isooctane and determine the absorbance line) or equivalent. Stopper the flask, and
in a 5–centimeter cell compared to isooctane with the use of a magnetic stirrer (tetra-
as reference point between 280 mμ–400 mμ. fluoroethylene polymer coated bar) stir the
The absorbance per centimeter path length solvent for 15 minutes. Filter the dimethyl
shall not exceed 0.00 in this range. Purify, if sulfoxide through four thicknesses of fluted
necessary, by percolation through activated paper (18.5 centimeters, Schleicher &
silica gel or by distillation. Schuell, No. 597, or equivalent). If the initial
Methyl alcohol, A.C.S. reagent grade. Use filtrate contains carbon fines, refilter
10.0 milliliters of methyl alcohol. Purify, if through the same filter until a clear filtrate
necessary, by distillation. is obtained. Protect the sulfoxide from air
Dimethyl sulfoxide. Pure grade, clear, and moisture during this operation by cov-
water-white, m.p. 18° minimum. Dilute 120 ering the solvent in the funnel and collection
milliliters of dimethyl sulfoxide with 240 flask with a layer of isooctane. Transfer the
115
§ 172.886 21 CFR Ch. I (4–1–12 Edition)
filtrate to a 2–liter separatory funnel and per centimeter path length between 280 mμ
draw off the dimethyl sulfoxide into the 2– and 400 mμ when tested as prescribed under
liter distillation flask of the vacuum dis- ‘‘Organic solvents.’’ Usually three portions
tillation assembly and distill at approxi- of wash solvent are sufficient.
mately 3–millimeter Hg pressure or less. Dis- Before proceeding with analysis of a sam-
card the first 200–milliliter fraction of the ple, determine the absorbance in a 5–centi-
distillate and replace the distillate collec- meter path cell between 250 mμ and 400 mμ
tion flask with a clean one. Continue the dis- for the reagent blank by carrying out the
tillation until approximately 1 liter of the procedure, without a wax sample, at room
sulfoxide has been collected. temperature, recording the spectra after the
At completion of the distillation, the rea- extraction stage and after the complete pro-
gent should be stored in glass-stoppered bot- cedure as prescribed. The absorbance per
tles since it is very hygroscopic and will centimeter path length following the extrac-
react with some metal containers in the tion stage should not exceed 0.040 in the
presence of air. wavelength range from 280 mμ to 400 mμ; the
Phosphoric acid. 85 percent A.C.S. reagent absorbance per centimeter path length fol-
grade. lowing the complete procedure should not
Sodium borohydride. 98 percent. exceed 0.070 in the wavelength range from 280
Magnesium oxide (Sea Sorb 43, Food Machin- mμ to 299 mμ, inclusive, nor 0.045 in the
ery Company, Westvaco Division, distributed by wavelength range from 300 mμ to 400 mμ. If in
chemical supply firms, or equivalent). Place 100 either spectrum the characteristic benzene
grams of the magnesium oxide in a large peaks in the 250 mμ–260 mμ region are
beaker, add 700 milliliters of distilled water present, remove the benzene by the proce-
to make a thin slurry, and heat on a steam
dure under ‘‘Organic solvents’’ and record
bath for 30 minutes with intermittent stir-
absorbance again.
ring. Stir well initially to insure that all the
absorbent is completely wetted. Using a Place 300 milliliters of dimethyl sulfoxide
Buchner funnel and a filter paper (Schleicher in a 1–liter separatory funnel and add 75 mil-
& Schuell No. 597, or equivalent) of suitable liliters of phosphoric acid. Mix the contents
diameter, filter with suction. Continue suc- of the funnel and allow to stand for 10 min-
tion until water no longer drips from the utes. (The reaction between the sulfoxide
funnel. Transfer the absorbent to a glass and the acid is exothermic. Release pressure
trough lined with aluminum foil (free from after mixing, then keep funnel stoppered.)
rolling oil). Break up the magnesia with a Add 150 milliliters of isooctane and shake to
clean spatula and spread out the absorbent preequilibrate the solvents. Draw off the in-
on the aluminum foil in a layer about 1 cen- dividual layers and store in glass-stoppered
timeter to 2 centimeters thick. Dry for 24 flasks.
hours at 160 °C ±1 °C. Pulverize the magnesia Place a representative 1–kilogram sample
with mortar and pestle. Sieve the pulverized of wax, or if this amount is not available, the
absorbent between 60–180 mesh. Use the mag- entire sample, in a beaker of a capacity
nesia retained on the 180–mesh sieve. about three times the volume of the sample
Celite 545. Johns-Manville Company, diato- and heat with occasional stirring on a steam
maceous earth, or equivalent. bath until the wax is completely melted and
Magnesium oxide-Celite 545 mixture (2+ 1) by homogeneous. Weigh four 25–gram ±0.2 gram
weight. Place the magnesium oxide (60–180 portions of the melted wax in separate 100–
mesh) and the Celite 545 in 2 to 1 propor- milliliter beakers. Reserve three of the por-
tions, respectively, by weight in a glass- tions for later replicate analyses as nec-
stoppered flask large enough for adequate essary. Pour one weighed portion imme-
mixing. Shake vigorously for 10 minutes. diately after remelting (on the steam bath)
Transfer the mixture to a glass trough lined into a 500–milliliter separatory funnel con-
with aluminum foil (free from rolling oil) taining 100 milliliters of the preequilibrated
and spread it out on a layer about 1 centi- sulfoxide-phosphoric acid mixture that has
meter to 2 centimeters thick. Reheat the been heated in the heating jacket at a tem-
mixture at 160 °C ±1 °C for 2 hours, and store perature just high enough to keep the wax
in a tightly closed flask. melted. (NOTE: In preheating the sulfoxide-
Sodium sulfate, anhydrous, A.C.S. reagent acid mixture, remove the stopper of the sepa-
grade, preferably in granular form. For each ratory funnel at intervals to release the
bottle of sodium sulfate reagent used, estab- pressure.)
lish as follows the necessary sodium sulfate Promptly complete the transfer of the
prewash to provide such filters required in sample to the funnel in the jacket with por-
the method: Place approximately 35 grams of tions of the preequilibrated isooctane, warm-
anhydrous sodium sulfate in a 30–milliliter ing the beaker, if necessary, and using a
coarse, fritted-glass funnel or in a 65–milli- total volume of just 50 milliliters of the sol-
meter filter funnel with glass wool plug; vent. If the wax comes out of solution during
wash with successive 15–milliliter portions of these operations, let the stoppered funnel re-
the indicated solvent until a 15–milliliter main in the jacket until the wax redissolves.
portion of the wash shows 0.00 absorbance (Remove stopper from the funnel at intervals
116
to release pressure.) When the wax is in solu- to lose none of the solution in filling the
tion, remove the funnel from the jacket and sample cell). Correct the absorbance values
shake it vigorously for 2 minutes. Set up for any absorbance derived from reagents as
three 250–milliliter separatory funnels with determined by carrying out the procedure
each containing 30 milliliters of without a wax sample. If the corrected ab-
preequilibrated isooctane. After separation sorbance does not exceed the limits pre-
of the liquid phases, allow to cool until the scribed in this paragraph (b), the wax meets
main portion of the wax-isooctane solution the ultraviolet absorbance specifications. If
begins to show a precipitate. Gently swirl the corrected absorbance per centimeter
the funnel when precipitation first occurs on path length exceeds the limits prescribed in
the inside surface of the funnel to accelerate this paragraph (b), proceed as follows:
this process. Carefully draw off the lower Quantitatively transfer the isooctane solu-
layer, filter it slowly through a thin layer of tion to a 125–milliliter flask equipped with
glass wool fitted loosely in a filter funnel 24/40 joint and evaporate the isooctane on
into the first 250–milliliter separatory fun- the steam bath under a stream of nitrogen to
nel, and wash in tandem with the 30–milli- a volume of 1 milliliter of hexadecane. Add
liter portions of isooctane contained in the 10 milliliters of methyl alcohol and approxi-
250–milliliter separatory funnels. Shaking mately 0.3 gram of sodium borohydride.
time for each wash is 1 minute. Repeat the (Minimize exposure of the borohydride to the
extraction operation with two additional atmosphere. A measuring dipper may be
portions of the sulfoxide-acid mixture, re- used.) Immediately fit a water-cooled con-
placing the funnel in the jacket after each denser equipped with a 24/40 joint and with a
extraction to keep the wax in solution and drying tube into the flask, mix until the
washing each extractive in tandem through borohydride is dissolved, and allow to stand
the same three portions of isooctane. for 30 minutes at room temperature, with
Collect the successive extractives (300 mil- intermittent swirling. At the end of this pe-
liliters total) in a separatory funnel (pref- riod, disconnect the flask and evaporate the
erably 2–liter), containing 480 milliliters of methyl alcohol on the steam bath under ni-
distilled water, mix, and allow to cool for a trogen until the sodium borohydride begins
few minutes after the last extractive has to come out of the solution. Then add 10 mil-
been added. Add 80 milliliters of isooctane to liliters of isooctane and evaporate to a vol-
the solution and extract by shaking the fun- ume of about 2–3 milliliters. Again, add 10
nel vigorously for 2 minutes. Draw off the milliliters of isooctane and concentrate to a
lower aqueous layer into a second separatory volume of approximately 5 milliliters. Swirl
funnel (preferably 2–liter) and repeat the ex- the flask repeatedly to assure adequate
traction with 80 milliliters of isooctane. washing of the sodium borohydride residues.
Draw off and discard the aqueous layer. Fit the tetrafluoroethylene polymer disc
Wash each of the 80–milliliter extractives on the upper part of the stem of the
three times with 100–milliliter portions of chromatographic tube, then place the tube
distilled water. Shaking time for each wash with the disc on the suction flask and apply
is 1 minute. Discard the aqueous layers. Fil- the vacuum (approximately 135 millimeters
ter the first extractive through anhydrous Hg pressure). Weight out 14 grams of the 2:1
sodium sulfate prewashed with isooctane (see magnesium oxide-Celite 545 mixture and
Sodium Sulfate under ‘‘Reagents and Mate- pour the adsorbent mixture into the
rials’’ for preparation of filter) into a 250– chromatographic tube in approximately 3–
milliliter Erlenmeyer flask (or optionally centimeter layers. After the addition of each
into the evaporation flask). Wash the first layer, level off the top of the adsorbent with
separatory funnel with the second 80–milli- a flat glass rod or metal plunger by pressing
liter isooctane extractive and pass through down firmly until the adsorbent is well
the sodium sulfate. Then wash the second packed. Loosen the topmost few millimeters
and first separatory funnels successively of each adsorbent layer with the end of a
with a 20–milliliter portion of isooctane and metal rod before the addition of the next
pass the solvent through the sodium sulfate layer. Continue packing in this manner until
into the flask. Add 1 milliliter of n-hexa- all the 14 grams of the adsorbent is added to
decane and evaporate the isooctane on the the tube. Level off the top of the adsorbent
steam bath under nitrogen. Discontinue by pressing down firmly with a flat glass rod
evaporation when not over 1 milliliter of res- or metal plunger to make the depth of the
idue remains. To the residue, add a 10–milli- adsorbent bed approximately 12.5 centi-
liter portion of isooctane, reevaporate to 1 meters in depth. Turn off the vacuum and re-
milliliter of hexadecane, and repeat this op- move the suction flask. Fit the 500–milliliter
eration once. reservoir onto the top of the
Quantitatively transfer the residue with chromatographic column and prewet the col-
isooctane to a 25–milliliter volumetric flask, umn by passing 100 milliliters of isooctane
make to volume, and mix. Determine the ab- through the column. Adjust the nitrogen
sorbance of the solution in the 5–centimeter pressure so that the rate of descent of the
path length cells compared to isooctane as isooctane coming off of the column is be-
reference between 280 mμ–400 mμ (take care tween 2–3 milliliters per minute. Discontinue
117
§ 172.886 21 CFR Ch. I (4–1–12 Edition)
pressure just before the last of the isooctane to volume in isooctane in a 25–milliliter vol-
reaches the level of the adsorbent. (CAUTION: umetric flask. Record the absorbance again.
Do not allow the liquid level to recede below If the corrected absorbance does not exceed
the adsorbent level at any time.) Remove the the limits prescribed in this paragraph (b),
reservoir and decant the 5–milliliter iso- the wax meets the ultraviolet absorbance
octane concentrate solution onto the column specifications.
and with slight pressure again allow the liq-
uid level to recede to barely above the ad- (c) Petroleum wax may contain one
sorbent level. Rapidly complete the transfer or more of the following adjuvants in
similarly with two 5–milliliter portions of amounts not greater than that re-
isooctane, swirling the flask repeatedly each quired to produce their intended effect:
time to assure adequate washing of the res- (1) Antioxidants permitted in food by
idue. Just before the final 5–milliliter wash
reaches the top of the adsorbent, add 100 mil-
regulations issued in accordance with
liliters of isooctane to the reservoir and con- section 409 of the act.
tinue the percolation at the 2–3 milliliter per (2) Poly(alkylacrylate) (CAS Reg. No.
minute rate. Just before the last of the iso- 27029–57–8), made from long chain (C16-
octane reaches the adsorbent level, add 100 C22) alcohols and acrylic acid, or
milliliters of 10 percent benzene in isooctane poly(alkylmethacrylate) (CAS Reg. No.
to the reservoir and continue the percolation 179529–36–3), made from long chain (C18-
at the aforementioned rate. Just before the
solvent mixture reaches adsorbent level, add
C22) methacrylate esters, having:
25 milliliters of 20 percent benzene in iso- (i) A number average molecular
octane to the reservoir and continue the per- weight between 40,000 and 100,000;
colation at 2–3 milliliters per minute until (ii) A weight average molecular
all this solvent mixture has been removed weight (MWw) to number average mo-
from the column. Discard all the elution sol- lecular weight (MWn) ratio (MWw/MWn)
vents collected up to this point. Add 300 mil- of not less than 3; and
liliters of the acetone-benzene-water mixture
to the reservoir and percolate through the (iii) Unreacted alkylacrylate or
column to elute the polynuclear compounds. alkylmethacrylate monomer content
Collect the eluate in a clean 1–liter sepa- not in excess of 14 percent, as deter-
ratory funnel. Allow the column to drain mined by a method entitled ‘‘Method
until most of the solvent mixture is re- for Determining Weight-Average and
moved. Wash the eluate three times with Number-Average Molecular Weight and
300–milliliter portions of distilled water, for Determining Alkylacrylate Mon-
shaking well for each wash. (The addition of
small amounts of sodium chloride facilitates omer Content of Poly(alkylacrylate)
separation.) Discard the aqueous layer after used as Processing Aid in Manufacture
each wash. After the final separation, filter of Petroleum Wax,’’ which is incor-
the residual benzene through anhydrous so- porated by reference in accordance
dium sulfate prewashed with benzene (see So- with 5 U.S.C. 552(a) and 1 CFR part 51.
dium sulfate under ‘‘Reagents and Materials’’ Copies are available from the Office of
for preparation of filter) into a 250–milliliter Premarket Approval (HFS–200), Center
Erlenmeyer flask (or optionally into the
evaporation flask). Wash the separatory fun-
for Food Safety and Applied Nutrition,
nel with two additional 20–milliliter portions Food and Drug Administration, 5100
of benzene which are also filtered through Paint Branch Pkwy., College Park, MD
the sodium sulfate. Add 1 milliliter of n- 20740, or may be examined at the Cen-
hexadecane and completely remove the ben- ter for Food Safety and Applied Nutri-
zene by evaporation under nitrogen, using tion’s Library, Food and Drug Admin-
the special procedure to eliminate benzene istration, 5100 Paint Branch Pkwy.,
as previously described under ‘‘Organic Sol-
College Park, MD 20740 or at the Na-
vents.’’ Quantitatively transfer the residue
with isooctane to a 25–milliliter volumetric tional Archives and Records Adminis-
flask and adjust to volume. Determine the tration (NARA). For information on
absorbance of the solution in the 5–centi- the availability of this material at
meter path length cells compared to iso- NARA, call 202–741–6030, or go to: http://
octane as reference between 250 mμ–400 mμ. www.archives.gov/federallregister/
Correct for any absorbance derived from the codeloflfederallregulations/
reagents as determined by carrying out the ibrllocations.html. Petroleum wax shall
procedure without a wax sample. If either
contain not more than 1,050 parts per
spectrum shows the characteristic benzene
peaks in the 250 mμ–260 mμ region, evaporate million of poly(alkylacrylate) or
poly(alkylmethacrylate) residues as
the solution to remove benzene by the proce-

dure under ‘‘Organic Solvents.’’ Dissolve the determined by a method entitled
residue, transfer quantitatively, and adjust ‘‘Method for Determining Residual
118
Level of Poly(alkylacrylate) in Petro- Use Limitations

leum Wax,’’ which is incorporated by
On cheese and raw fruits and In an amount not to exceed
reference. Copies are available from vegetables as a protective good manufacturing prac-
the addresses cited in this paragraph. coating. tice.
(d) Petroleum wax is used or intended As a defoamer in food ........... In accordance with § 173.340
of this chapter.
for use as follows:
Use Limitations [42 FR 14491, Mar. 15, 1977, as amended at 59
In chewing gum base, as a mas- In an amount not to ex- FR 10986, Mar. 9, 1994]
ticatory substance. ceed good manufac-
turing practice. § 172.890 Rice bran wax.
On cheese and raw fruits and Do.
vegetables as a protective coat- Rice bran wax may be safely used in
ing. food in accordance with the following
As a defoamer in food .................. In accordance with conditions:
§ 173.340 of this chap-
ter.
(a) It is the refined wax obtained
As a component of microcapsules In accordance with from rice bran and meets the following
for spice-flavoring substances. § 172.230 of this chap- specifications:
ter.
Melting point 75 °C to 80 °C.
Free fatty acids, maximum 10 percent.
[42 FR 14491, Mar. 15, 1977, as amended at 45 Iodine number, maximum 20.
FR 48123, July 18, 1980; 47 FR 11838, Mar. 19, Saponification number 75 to 120.
1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544,
May 30, 1986; 54 FR 24897, June 12, 1989; 64 FR (b) It is used or intended for use as
44122, Aug. 13, 1999] follows:
§ 172.888 Synthetic petroleum wax. Food Limitation in food Use
Synthetic petroleum wax may be Candy ............................. 50 p.p.m ............ Coating.
safely used in or on foods in accordance Fresh fruits and fresh ......do ................ Do.
with the following conditions: vegetables.
Chewing gum ................. 21⁄2 pct ............... Plasticizing
(a) Synthetic petroleum wax is a material.
mixture of solid hydrocarbons, par-
affinic in nature, prepared by either
catalytic polymerization of ethylene or § 172.892 Food starch-modified.
copolymerization of ethylene with lin- Food starch-modified as described in
ear (C3 to C12) alpha-olefins, and refined this section may be safely used in food.
to meet the specifications prescribed in The quantity of any substance em-
this section. ployed to effect such modification shall
(b) Synthetic petroleum wax meets not exceed the amount reasonably re-
the ultraviolet absorbance limits of quired to accomplish the intended
§ 172.886(b) when subjected to the ana- physical or technical effect, nor exceed
lytical procedure described therein. any limitation prescribed. To insure
(c) Synthetic petroleum wax has a safe use of the food starch-modified,
number average molecular weight of the label of the food additive container
not less than 500 nor greater than 1,200 shall bear the name of the additive
as determined by vapor pressure os- ‘‘food starch-modified’’ in addition to
mometry. other information required by the Act.
(d) Synthetic petroleum wax may Food starch may be modified by treat-
contain any antioxidant permitted in ment prescribed as follows:
food by regulations issued in accord- (a) Food starch may be acid-modified
ance with section 409 of the act, in an by treatment with hydrochloric acid or
amount not greater than that required sulfuric acid or both.
to produce its intended effect. (b) Food starch may be bleached by
(e) Synthetic petroleum wax is used treatment with one or more of the fol-
or intended for use as follows: lowing:
Use Limitations Limitations
In chewing gum base, as a In accordance with § 172.615 Active oxygen obtained from hy-
masticatory substance. in an amount not to exceed drogen peroxide and/or per-

good manufacturing prac- acetic acid, not to exceed 0.45
tice. percent of active oxygen.
119
§ 172.892 21 CFR Ch. I (4–1–12 Edition)
Limitations Limitations
Ammonium persulfate, not to ex- Vinyl acetate ................................. Acetyl groups in food
ceed 0.075 percent and sulfur starch-modified not to
dioxide, not to exceed 0.05 per- exceed 2.5 percent.
cent.
Chlorine, as calcium hypochlorite, The finished food starch-
not to exceed 0.036 percent of modified is limited to
(e) Food starch may be etherified by
dry starch. use only as a compo- treatment with one of the following:
nent of batter for com-
mercially processed Limitations
foods.
Chlorine, as sodium hypochlorite, Acrolein, not to exceed 0.6 per-
not to exceed 0.0082 pound of cent.
chlorine per pound of dry starch. Epichlorohydrin, not to exceed
Potassium permanganate, not to Residual manganese 0.3 percent.
exceed 0.2 percent. (calculated as Mn), not Epichlorohydrin, not to exceed Residual propylene
to exceed 50 parts per 0.1 percent, and propylene chlorohydrin not more
million in food starch- oxide, not to exceed 10 per- than 5 parts per million
modified. cent, added in combination or in food starch-modified.
Sodium chlorite, not to exceed 0.5 in any sequence.
percent. Epichlorohydrin, not to exceed Do.
0.1 percent, followed by pro-
pylene oxide, not to exceed 25
(c) Food starch may be oxidized by percent.
treatment with chlorine, as sodium hy- Propylene oxide, not to exceed Do.
pochlorite, not to exceed 0.055 pound of 25 percent.
chlorine per pound of dry starch.
(d) Food starch may be esterified by (f) Food starch may be esterified and
treatment with one of the following: etherified by treatment with one of the
following:
Limitations
Limitations
Acetic anhydride ........................... Acetyl groups in food
starch-modified not to Acrolein, not to exceed 0.6 per- Acetyl groups in food
exceed 2.5 percent. cent and vinyl acetate, not to starch-modified not to
Adipic anhydride, not to exceed Do. exceed 7.5 percent. exceed 2.5 percent.
0.12 percent, and acetic anhy- Epichlorohydrin, not to exceed 0.3 Acetyl groups in food
dride. percent, and acetic anhydride. starch-modified not to
Monosodium orthophosphate ....... Residual phosphate in exceed 2.5 percent.
food starch-modified Epichlorohydrin, not to exceed 0.3
not to exceed 0.4 per- percent, and succinic anhy-
cent calculated as dride, not to exceed 4 percent.
phosphorus. Phosphorus oxychloride, not to Residual propylene
1–Octenyl succinic anhydride, not exceed 0.1 percent, and pro- chlorohydrin not more
to exceed 3 percent. pylene oxide, not to exceed 10 than 5 parts per million
1–Octenyl succinic anhydride, not percent. in food starch-modi-
to exceed 2 percent, and alu- fied.
minum sulfate, not to exceed 2
percent. (g) Food starch may be modified by
1-Octenyl succinic anhydride, not Limited to use as a sta-
to exceed 3 percent, followed bilizer or emulsifier in
treatment with one of the following:
by treatment with a beta-amy- beverages and bev-
Limitations
lase enzyme that is either an erage bases as de-
approved food additive of is fined in § 170.3(n)(3) of Chlorine, as sodium hypochlorite, Residual propylene
generally recognized as safe. this chapter. not to exceed 0.055 pound of chlorohydrin not more
Phosphorus oxychloride, not to
chlorine per pound of dry than 5 parts per million
exceed 0.1 percent.
starch; 0.45 percent of active in food starch-modi-
Phosphorus oxychloride, not to Acetyl groups in food
oxygen obtained from hydrogen fied.
exceed 0.1 percent, followed by starch-modified not to
peroxide; and propylene oxide,
either acetic anhydride, not to exceed 2.5 percent.
not to exceed 25 percent.
exceed 8 percent, or vinyl ace- Sodium hydroxide, not to exceed
tate, not to exceed 7.5 percent. 1 percent.
Sodium trimetaphosphate ............. Residual phosphate in
food starch-modified
not to exceed 0.04 (h) Food starch may be modified by a
percent, calculated as combination of the treatments pre-
phosphorus.
Sodium tripolyphosphate and so- Residual phosphate in
scribed by paragraphs (a), (b), and/or (i)
dium trimetaphosphate. food starch-modified of this section and any one of the
not to exceed 0.4 per- treatments prescribed by paragraph (c),
cent calculated as (d), (e), (f), or (g) of this section, sub-
phosphorus.
Succinic anhydride, not to exceed ject to any limitations prescribed by
4 percent. the paragraphs named.
120
(i) Food starch may be modified by mation required by the act, the name
treatment with the following enzymes: of the additive as follows:
(1) The additive identified in para-
Enzyme Limitations
graph (a)(1) of this section as ‘‘par-
Alpha-amylase (E.C. 3.2.1.1) ....... The enzyme must be tially defatted, cooked cottonseed
generally recognized flour’’.
as safe or approved as
a food additive for this
purpose. The resulting graph (a)(2) of this section as ‘‘defatted
nonsweet nutritive sac- cottonseed flour’’.
charide polymer has a (3) The additive identified in para-
dextrose equivalent of
less than 20. graph (a)(3) of this section as ‘‘roasted
Beta-amylase (E.C. 3.2.1.2). glandless cottonseed kernels’’.
Glucoamylase (E.C. 3.2.1.3). (4) The additive identified in para-
Isoamylase (E.C. 3.2.1.68).
Pullulanase (E.C. 3.2.1.41).
graph (a)(4) of this section as ‘‘raw
glandless cottonseed kernels for use in
cooked hard candy’’.
(d) The Food and Drug Administra-
FR 11697, Mar. 21, 1978; 46 FR 32015, June 19,
1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100, tion and the Environmental Protection
Apr. 19, 1993; 66 FR 17509, Apr. 2, 2001] Agency have determined that glandless
cottonseed kernels permitted for use
§ 172.894 Modified cottonseed products by this section are a distinct com-
intended for human consumption. modity from glanded cottonseed.
The food additive modified cotton-
§ 172.896 Dried yeasts.
seed products may be used for human
consumption in accordance with the Dried yeast (Saccharomyces cerevisiae
following prescribed conditions: and Saccharomyces fragilis) and dried
(a) The additive is derived from: torula yeast (Candida utilis) may be
(1) Decorticated, partially defatted, safely used in food provided the total
cooked, ground cottonseed kernels; or folic acid content of the yeast does not
(2) Decorticated, ground cottonseed exceed 0.04 milligram per gram of yeast
kernels, in a process that utilizes n- (approximately 0.008 milligram of
hexane as an extracting solvent in such pteroyglutamic acid per gram of
a way that no more than 60 parts per yeast).
million of n-hexane residues and less
than 1 percent fat by weight remain in § 172.898 Bakers yeast glycan.
the finished product; or Bakers yeast glycan may be safely
(3) Glandless cottonseed kernels used in food in accordance with the fol-
roasted to attain a temperature of not lowing conditions:
less than 250 °F in the kernel for not (a) Bakers yeast glycan is the
less than 5 minutes for use as a snack comminuted, washed, pasteurized, and
food, or in baked goods, or in soft dried cell walls of the yeast, Saccharo-
candy; or myces cerevisiae. It is composed prin-
(4) Raw glandless cottonseed kernels cipally of long chain carbohydrates,
may be used in hard candy where the not less than 85 percent on a dry solids
kernel temperature during cooking basis. The carbohydrate is composed of
will exceed 250 °F for not less than 5 glycan and mannan units in approxi-
minutes. mately a 2:1 ratio.
(b) The additive is prepared to meet (b) The additive meets the following
the following specifications: specifications on a dry weight basis:
(1) Free gossypol content not to ex- Less than 0.4 part per million (ppm) ar-
ceed 450 parts per million. senic, 0.13 ppm cadmium, 0.2 ppm lead,
(2) It contains no added arsenic com- 0.05 ppm mercury, 0.09 ppm selenium,
pound and therefore may not exceed a and 10 ppm zinc.
maximum natural background level of (c) The viable microbial content of
0.2 part per million total arsenic, cal- the finished ingredient is:
culated as As. (1) Less than 10,000 organisms/gram
(c) To assure safe use of the additive, by aerobic plate count.
the label of the food additive container (2) Less than 10 yeasts and molds/
shall bear, in addition to other infor- gram.
121
(3) Negative for Salmonella, E. coli, 173.45 Polymaleic acid and its sodium salt.
coagulase positive Staphylococci, Clos- 173.50 Polyvinylpolypyrrolidone.
tridium perfringens, Clostridium botu- 173.55 Polyvinylpyrrolidone.
173.60 Dimethylamine-epichlorohydrin co-
linum, or any other recognized micro-
polymer.
bial pathogen or any harmful microbial 173.65 Divinylbenzene copolymer.
toxin. 173.70 Chloromethylated aminated styrene-
(d) The additive is used or intended divinylbenzene resin.
for use in the following foods when 173.73 Sodium polyacrylate.
standards of identity established under 173.75 Sorbitan monooleate.
section 401 of the Act do not preclude
such use: Subpart B—Enzyme Preparations and
Microorganisms
Use Limitations
173.110 Amyloglucosidase derived from
(1) In salad dressings as an emul- Not to exceed a con- Rhizopus niveus.
sifier and emulsifier salt as de- centration of 5 percent 173.115 Alpha-acetolactate decarboxylase (a-
fined in § 170.3(o)(8) of this of the finished salad ALDC) enzyme preparation derived from
chapter, stabilizer and thickener dressing.
as defined in § 170.3(o)(28) of
a recombinant Bacillus subtilis.
this chapter, or texturizer as de- 173.120 Carbohydrase and cellulase derived
fined in § 170.3(o)(32) of this from Aspergillus niger.
chapter. 173.130 Carbohydrase derived from Rhizopus
(2) In frozen dessert analogs as a In an amount not to ex- oryzae.
stabilizer and thickener as de- ceed good manufac- 173.135 Catalase derived from Microccocus
fined in § 170.3(o)(28) of this turing practice. lysodeikticus.
chapter, or texturizer as defined
in § 170.3(o)(32) of this chapter.
173.140 Esterase-lipase derived from Mucor
(3) In sour cream analogs as a Do. miehei.
stabilizer and thickener as de- 173.145 Alpha-Galactosidase derived from
fined in § 170.3(o)(28) of this Mortierella vinaceae var. raffinoseutilizer.
chapter, or texturizer as defined 173.150 Milk-clotting enzymes, microbial.
in § 170.3(o)(32) of this chapter. 173.160 Candida guilliermondii.
(4) In cheese spread analogs as Do.
173.165 Candida lipolytica.
a stabilizer and thickener as de-
fined in § 170.3(o)(28) of this 173.170 Aminoglycoside 3′-phosphotrans-
chapter, or texturizer as defined ferase II.
(5) In cheese-flavored and sour Do. Subpart C—Solvents, Lubricants, Release
cream-flavored snack dips as a Agents and Related Substances
stabilizer and thickener as de-
fined in § 170.3(o)(28) of this 173.210 Acetone.
chapter, or texturizer as defined
173.220 1,3–Butylene glycol.
173.228 Ethyl acetate.
173.230 Ethylene dichloride.
(e) The label and labeling of the in- 173.240 Isopropyl alcohol.
gredient shall bear adequate directions 173.250 Methyl alcohol residues.
to assure that use of the ingredient 173.255 Methylene chloride.
complies with this regulation. 173.270 Hexane.
173.275 Hydrogenated sperm oil.
173.280 Solvent extraction process for citric
FR 58836, Sept. 5, 1980]
acid.
173.290 Trichloroethylene.
PART 173—SECONDARY DIRECT
FOOD ADDITIVES PERMITTED IN Subpart D—Specific Usage Additives
FOOD FOR HUMAN CONSUMP- 173.300 Chlorine dioxide.
TION 173.310 Boiler water additives.
173.315 Chemicals used in washing or to as-
Subpart A—Polymer Substances and sist in the peeling of fruits and vegeta-
Polymer Adjuvants for Food Treatment bles.
173.320 Chemicals for controlling micro-
Sec. organisms in cane-sugar and beet-sugar
173.5 Acrylate-acrylamide resins. mills.
173.10 Modified polyacrylamide resin. 173.322 Chemicals used in delinting cotton-
173.20 Ion-exchange membranes. seed.
173.21 Perfluorinated ion exchange mem- 173.325 Acidified sodium chlorite solutions.
branes. 173.340 Defoaming agents.

173.25 Ion-exchange resins. 173.342 Chlorofluorocarbon 113 and
173.40 Molecular sieve resins. perfluorohexane.
122
173.345 Chloropentafluoroethane. the juice or 10 parts per million by
173.350 Combustion product gas. weight of the liquor or the corn starch
173.355 Dichlorodifluoromethane. hydrolyzate.
173.356 Hydrogen peroxide.
173.357 Materials used as fixing agents in
the immobilization of enzyme prepara- graph (a)(2) of this section is used to
tions. control organic and mineral scale in
173.360 Octafluorocyclobutane. beet sugar juice and liquor or cane
173.368 Ozone. sugar juice and liquor in an amount
173.370 Peroxyacids. not to exceed 2.5 parts per million by
173.375 Cetylpyridinium chloride. weight of the juice or liquor.
173.385 Sodium methyl sulfate.
173.395 Trifluoromethane sulfonic acid. [42 FR 14526, Mar. 15, 1977, as amended at 46
173.400 Dimethyldialkylammonium chlo- FR 30494, June 9, 1981]
ride.
§ 173.10 Modified polyacrylamide
AUTHORITY: 21 U.S.C. 321, 342, 348.
resin.
SOURCE: 42 FR 14526, Mar. 15, 1977, unless
Modified polyacrylamide resin may
otherwise noted.
EDITORIAL NOTE: Nomenclature changes to with the following prescribed condi-
part 173 appear at 61 FR 14482, Apr. 2, 1996, 66 tions:
FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. (a) The modified polyacrylamide
27, 2001.
resin is produced by the copolymeriza-
tion of acrylamide with not more than
Subpart A—Polymer Substances 5–mole percent b-methacrylyloxyethy-
and Polymer Adjuvants for ltrimethylammonium methyl sulfate.
Food Treatment (b) The modified polyacrylamide
resin contains not more than 0.05 per-
§ 173.5 Acrylate-acrylamide resins. cent residual acrylamide.
Acrylate-acrylamide resins may be (c) The modified polyacrylamide
safely used in food under the following resin is used as a flocculent in the clar-
prescribed conditions: ification of beet or cane sugar juice in
(a) The additive consists of one of the an amount not exceeding 5 parts per
following: million by weight of the juice.
(1) Acrylamide-acrylic acid resin (d) To assure safe use of the additive,
(hydrolyzed polyacrylamide) is pro- the label and labeling of the additive
duced by the polymerization of acryl- shall bear, in addition to the other in-
amide with partial hydrolysis, or by formation required by the act, ade-
copolymerization of acrylamide and quate directions to assure use in com-
acrylic acid, with the greater part of pliance with paragraph (c) of this sec-
the polymer being composed of acryl- tion.
amide units.
(2) Sodium polyacrylate-acrylamide § 173.20 Ion-exchange membranes.
resin is produced by the polymerization Ion-exchange membranes may be
and subsequent hydrolysis of acrylo- safely used in the processing of food
nitrile in a sodium silicate-sodium hy- under the following prescribed condi-
droxide aqueous solution, with the tions:
greater part of the polymer being com- (a) The ion-exchange membrane is
posed of acrylate units. prepared by subjecting a polyethylene
(b) The additive contains not more base conforming to § 177.1520 of this
than 0.05 percent of residual monomer chapter to polymerization with styrene
calculated as acrylamide. until the polystyrene phase of the base
(c) The additive is used or intended is not less than 16 percent nor more
for use as follows: than 30 percent by weight. The base is
(1) The additive identified in para- then modified by reaction with
graph (a) (1) of this section is used as a chloromethyl methyl ether, and by
flocculent in the clarification of beet subsequent amination with trimethyl-
sugar juice and liquor or cane sugar amine, dimethylamine, diethylene-
juice and liquor or corn starch triamine, or dimethylethanolamine.
hydrolyzate in an amount not to ex- (b) The ion-exchange membrane is

ceed 5 parts per million by weight of manufactured so as to comply with the
123
§ 173.21 21 CFR Ch. I (4–1–12 Edition)
following extraction limitations when tary manner in accordance with cur-

subjected to the described procedure: rent good manufacturing practice so as
Separate square-foot samples of mem- to prevent microbial adulteration of
brane weighing approximately 14 grams food.
each are cut into small pieces and (4) To assure their safe use,
refluxed for 4 hours in 150 cubic centi- perfluorinated ionomer membranes
meters of the following solvents: Dis- shall be thoroughly cleaned prior to
tilled water, 5 percent acetic acid, and their first use in accordance with cur-
50 percent alcohol. Extraction from rent good manufacturing practice.
each sample will not exceed 0.4 percent [59 FR 15623, Apr. 4, 1994]
by weight of sample.
(c) The ion-exchange membrane will § 173.25 Ion-exchange resins.
be used in the production of grapefruit Ion-exchange resins may be safely
juice to adjust the ratio of citric acid used in the treatment of food under the
to total solids of the grapefruit juice following prescribed conditions:
produced. (a) The ion-exchange resins are pre-
pared in appropriate physical form, and
§ 173.21 Perfluorinated ion exchange
membranes. consist of one or more of the following:
(1) Sulfonated copolymer of styrene
Substances identified in paragraph and divinylbenzene.
(a) of this section may be safely used as (2) Sulfonated anthracite coal meet-
ion exchange membranes intended for ing the requirements of ASTM method
use in the treatment of bulk quantities D388–38, Class I, Group 2, ‘‘Standard
of liquid food under the following pre- Specifications for Classification of Coal
scribed conditions: by Rank,’’ which is incorporated by
(a) Identity. The membrane is a co- reference. Copies are available from
polymer of ethanesulfonyl fluoride, 2- University Microfilms International,
[1-[difluoro-[(trifluoro- 300 N. Zeeb Rd., Ann Arbor, MI 48106, or
ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- available for inspection at the National
ethoxy]-1,1,2,2,-tetrafluoro-, with tetra- Archives and Records Administration
fluoroethylene that has been subse- (NARA). For information on the avail-
quently treated to hydrolyze the ability of this material at NARA, call
sulfonyl fluoride group to the sulfonic 202–741–6030, or go to: http://
acid. The Chemical Abstracts Service www.archives.gov/federallregister/
name of this polymer is ethanesulfonic codeloflfederallregulations/
acid, 2-[1-[difluoro-[(trifluoro- ibrllocations.html.
ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- (3) Sulfite-modified cross-linked phe-
ethoxy]-1,1,2,2,-tetrafluoro-, polymer nol-formaldehyde, with modification
with tetrafluoroethane (CAS Reg. No. resulting in sulfonic acid groups on
31175–20–9). side chains.
(b) Optional adjuvant substances. The (4) Methacrylic acid-divinylbenzene
basic polymer identified in paragraph copolymer.
(a) of this section may contain optional (5) Cross-linked polystyrene, first
adjuvant substances required in the chloromethylated then aminated with
production of such basic polymer. trimethylamine, dimethylamine, di-
These optional adjuvant substances ethylenetriamine, or dimethylethanol-
may include substances used in accord- amine.
ance with § 174.5 of this chapter. (6) Diethylenetriamine, triethylene-
(c) Conditions of use. (1) tetramine, or tetraethylenepentamine
Perfluorinated ion exchange mem- cross-linked with epichlorohydrin.
branes described in paragraph (a) of (7) Cross-linked phenol-formaldehyde
this section may be used in contact activated with one or both of the fol-
with all types of liquid foods at tem- lowing: Triethylene tetramine and
peratures not exceeding 70° (158 °F). tetraethylenepentamine.
(2) Maximum thickness of the copoly- (8) Reaction resin of formaldehyde,
mer membrane is 0.007 inch (0.017 centi- acetone, and tetraethylenepentamine.
meter). (9) Completely hydrolyzed copoly-
(3) Perfluorinated ion exchange mem- mers of methyl acrylate and

branes shall be maintained in a sani- divinylbenzene.
124
(10) Completely hydrolyzed with chloromethane; CAS Reg. No.

terpolymers of methyl acrylate, 68036–99–7].
divinylbenzene, and acrylonitrile. (20) Regenerated cellulose, cross-
(11) Sulfonated terpolymers of sty- linked and alkylated with epichloro-
rene, divinylbenzene, and acrylonitrile hydrin and propylene oxide, then sulfo-
or methyl acrylate. nated whereby the amount of epi-
(12) Methyl acrylate-divinylbenzene chlorohydrin plus propylene oxide em-
copolymer containing not less than 2 ployed does not exceed 250 percent by
percent by weight of divinylbenzene, weight of the starting quantity of cel-
aminolyzed with dimethylaminopro- lulose.
pylamine. (b) Ion-exchange resins are used in
(13) Methyl acrylate-divinylbenzene the purification of foods, including po-
copolymer containing not less than 3.5 table water, to remove undesirable ions
percent by weight of divinylbenzene, or to replace less desirable ions with
aminolyzed with dimethylaminopro- one or more of the following: bicarbon-
pylamine. ate, calcium, carbonate, chloride, hy-
drogen, hydroxyl, magnesium, potas-
(14) Epichlorohydrin cross-linked
sium, sodium, and sulfate except that:
with ammonia.
The ion-exchange resin identified in
(15) Sulfonated tetrapolymer of sty- paragraph (a)(12) of this section is used
rene, divinylbenzene, acrylonitrile, and only in accordance with paragraph
methyl acrylate derived from a mix- (b)(1) of this section, the ion-exchange
ture of monomers containing not more resin identified in paragraph (a)(13) of
than a total of 2 percent by weight of this section is used only in accordance
acrylonitrile and methyl acrylate. with paragraph (b)(2) of this section,
(16) Methyl acrylate-divinylbenzene- the resin identified in paragraph (a)(16)
diethylene glycol divinyl ether of this section is used only in accord-
terpolymer containing not less than 3.5 ance with paragraph (b)(1) or (b)(2) of
percent by weight of divinylbenzene this section, the ion-exchange resin
and not more than 0.6 percent by identified in paragraph (a)(17) of this
weight of diethylene glycol divinyl section is used only in accordance with
ether, aminolyzed with dimethyl- paragraph (b)(3) of this section, the
aminopropylamine. ion-exchange resin identified in para-
(17) Styrene-divinylbenzene cross- graph (a)(18) of this section is used only
linked copolymer, first in accordance with paragraph (b)(4) of
chloromethylated then aminated with this section, and the ion-exchange
dimethylamine and oxidized with hy- resin identified in paragraph (a)(20) of
drogen peroxide whereby the resin con- this section is used only in accordance
tains not more than 15 percent by with paragraphs (b)(5) and (d) of this
weight of vinyl N,N-dimethylbenzyl- section.
amine-N-oxide and not more than 6.5 (1) The ion-exchange resins identified
percent by weight of nitrogen. in paragraphs (a) (12) and (16) of this
(18) Methyl acrylate-divinylbenzene- section are used to treat water for use
diethylene glycol divinyl ether in the manufacture of distilled alco-
terpolymer containing not less than 7 holic beverages, subject to the fol-
percent by weight of divinylbenzene lowing conditions:
and not more than 2.3 percent by (i) The water is subjected to treat-
weight of diethylene glycol divinyl ment through a mixed bed consisting of
ether, aminolyzed with dimethyl- one of the resins identified in para-
aminopropylamine and quaternized graph (a) (12) or (16) of this section and
with methyl chloride. one of the strongly acidic cation-ex-
(19) Epichlorohydrin cross-linked change resins in the hydrogen form
with ammonia and then quaternized identified in paragraphs (a) (1), (2), and
with methyl chloride to contain not (11) of this section; or
more than 18 percent strong base ca- (ii) The water is first subjected to
pacity by weight of total exchange ca- one of the resins identified in para-
pacity [Chemical Abstracts Service graph (a) (12) or (16) of this section and
name: Oxirane (chloromethyl)-, poly- is subsequently subjected to treatment

mer with ammonia, reaction product through a bed of activated carbon or
125
§ 173.25 21 CFR Ch. I (4–1–12 Edition)
one of the strongly acidic cation-ex- through the bed is not less than 0.5 gal-
change resins in the hydrogen form lon per cubic foot per minute; or
identified in paragraphs (a) (1), (2), and (B) Extracts of the resin will be found
(11) of this section. to contain no more than 1 milligram/
(iii) The temperature of the water kilogram dimethylaminopropylamine
passing through the resin beds identi- in each of the food simulants, distilled
fied in paragraphs (b)(1) (i) and (ii) of water and 10 percent ethanol, when,
this section is maintained at 30 °C or following washing and pretreatment of
less, and the flow rate of the water the resin in accordance with
passing through the beds is not less § 173.25(c)(1), the resin is subjected to
than 2 gallons per cubic foot per the following test under conditions
minute. simulating the actual temperature and
(iv) The ion-exchange resins identi- flow rate of use: ‘‘The Determination of
fied in paragraph (a) (12) or (16) of this 3-Dimethylaminopropylamine in Food
section are exempted from the require- Simulating Extracts of Ion Exchange
ments of paragraph (c)(4) of this sec- Resins,’’ February 4, 1998, which is in-
tion, but the strongly acidic cation-ex- corporated by reference in accordance
change resins referred to in paragraphs with 5 U.S.C. 552(a) and 1 CFR part 51.
(b)(1) (i) and (ii) of this section used in Copies are available from the Division
the process meet the requirements of of Petition Control (HFS–215), Center
paragraph (c)(4) of this section, except for Food Safety and Applied Nutrition,
for the exemption described in para- Food and Drug Administration, 5100
graph (d) of this section. Paint Branch Pkwy., College Park, MD
(2) The ion-exchange resins identified 20740, or may be examined at the Cen-
in paragraphs (a) (13) and (16) of this ter for Food Safety and Applied Nutri-
section are used to treat water and tion’s Library, 5100 Paint Branch
aqueous food only of the types identi- Pkwy., College Park, MD 20740, or at
fied under Categories I, II, and VI-B in the National Archives and Records Ad-
table 1 of § 176.170(c) of this chapter: ministration (NARA). For information
Provided, That the temperature of the on the availability of this material at
water or food passing through the resin NARA, call 202–741–6030, or go to: http://
beds is maintained at 50 °C or less and www.archives.gov/federallregister/
the flow rate of the water or food pass- codeloflfederallregulations/
ing through the beds is not less than 0.5 ibrllocations.html.
gallon per cubic foot per minute. (3) The ion-exchange resin identified
(i) The ion-exchange resin identified in paragraph (a)(17) of this section is
in paragraph (a)(13) of this section is used only for industrial application to
used to treat water and aqueous food treat bulk quantities of aqueous food,
only of the types identified under cat- including potable water, or for treat-
egories I, II, and VI-B in Table 1 of ment of municipal water supplies, sub-
§ 176.170(c) of this chapter: Provided, ject to the condition that the tempera-
That the temperature of the water or ture of the food or water passing
food passing through the resin bed is through the resin bed is maintained at
maintained at 50 °C or less and the flow 25 °C or less and the flow rate of the
rate of the water or food passing food or water passing through the bed
through the bed is not less than 0.5 gal- is not less than 2 gallons per cubic foot
lon per cubic foot per minute. per minute.
(ii) The ion-exchange resin identified (4) The ion-exchange resin identified
in paragraph (a)(16) of this section is in paragraph (a)(18) of this section is
used to treat water and aqueous food used to treat aqueous sugar solutions
only of the types identified under cat- subject to the condition that the tem-
egories I, II, and VI-B in Table 1 of perature of the sugar solution passing
§ 176.170(c) of this chapter, Provided, through the resin bed is maintained at
that either: 82 °C (179.6 °F) or less and the flow rate
(A) The temperature of the water or of the sugar solution passing through
food passing through the resin bed is the bed is not less than 46.8 liters per
maintained at 50 °C or less and the flow cubic meter (0.35 gallon per cubic foot)
rate of the water or food passing of resin bed volume per minute.
126
(5) The ion-exchange resin identified from each solvent is discarded, then
in paragraph (a)(20) of this section is the next 2 liters are used to determine
limited to use in aqueous process organic extractives. The 2-liter sample
streams for the isolation and purifi- is carefully evaporated to constant
cation of protein concentrates and iso- weight at 105 °C; this is total extrac-
lates under the following conditions: tives. This residue is fired in a muffle
(i) For resins that comply with the furnace at 850 °C to constant weight;
requirements in paragraph (d)(2)(i) of this is ash. Total extractives, minus
this section, the pH range for the resin ash equals the organic extractives. If
shall be no less than 3.5 and no more the organic extractives are greater
than 9, and the temperatures of water than 1 part per million of the solvent
and food passing through the resin bed used, a blank should be run on the sol-
shall not exceed 25 °C. vent and a correction should be made
(ii) For resins that comply with the by subtracting the total extractives ob-
requirements in paragraph (d)(2)(ii) of tained with the blank from the total
this section, the pH range for the resin extractives obtained in the resin test.
shall be no less than 2 and no more The solvents used are to be made as
than 10, and the temperatures of water follows:
and food passing through the resin Distilled water (de-ionized water is distilled).
shall not exceed 50 °C. 15 percent ethyl alcohol made by mixing 15
(c) To insure safe use of ion-exchange volumes of absolute ethyl alcohol A.C.S.
resins, each ion-exchange resin will be: reagent grade, with 85 volumes of distilled
(1) Subjected to pre-use treatment by de-ionized water.
the manufacturer and/or the user in ac- 5 percent acetic acid made by mixing 5 parts
by weight of A.C.S. reagent grade glacial
cordance with the manufacturer’s di-
acetic acid with 95 parts by weight of dis-
rections prescribed on the label or la- tilled de-ionized water.
beling accompanying the resins, to
guarantee a food-grade purity of ion- In addition to the organic extractives
exchange resins, in accordance with limitation prescribed in this para-
good manufacturing practice. graph, the ion-exchange resin identi-
(2) Accompanied by label or labeling fied in paragraph (a)(17) of this section,
to include directions for use consistent when extracted with each of the named
with the intended functional purpose of solvents, distilled water, 50 percent al-
the resin. cohol, and 5 percent acetic acid, will be
(3) Used in compliance with the label found to result in not more than 7
or labeling required by paragraph (c)(2) parts per million of nitrogen extrac-
of this section. tives (calculated as nitrogen) when the
(4) Found to result in no more than 1 resin in the free-base form is subjected
part per million of organic extractives to the following test immediately be-
obtained with each of the named sol- fore each use: Using a separate 1–inch
vents, distilled water, 15 percent alco- diameter glass ion-exchange column
hol, and 5 percent acetic acid when, for each solvent, prepare each column
having been washed and otherwise using 100 milliliters of ready to use ion-
treated in accordance with the manu- exchange resin that is to be tested.
facturer’s directions for preparing With the bottom outlet closed, fill each
them for use with food, the ion-ex- ion-exchange column with one of the
change resin is subjected to the fol- three solvents at a temperature of 25 °C
lowing test: Using a separate ion-ex- until the solvent level is even with the
change column for each solvent, pre- top of the resin bed. Seal each column
pare columns using 50 milliliters of the at the top and bottom and store in a
ready to use ion-exchange resin that is vertical position at a temperature of 25
to be tested. While maintaining the °C. After 96 hours, open the top of each
highest temperature that will be en- column, drain the solvent into a collec-
countered in use pass through these tion vessel, and analyze each drained
beds at the rate of 350–450 milliliters solvent and a solvent blank for nitro-
per hour the three test solvents dis- gen by a standard micro-Kjeldahl
tilled water, 15 percent (by volume) method.
ethyl alcohol, and 5 percent (by weight) (d)(1) The ion-exchange resins identi-
acetic acid. The first liter of effluent fied in paragraphs (a)(1), (a)(2), (a)(11),
127
§ 173.40 21 CFR Ch. I (4–1–12 Edition)
and (a)(15) of this section are exempted sanitary manner in accordance with
from the acetic acid extraction re- good manufacturing practice so as to
quirement of paragraph (c)(4) of this prevent microbial build-up on the bed
section. and adulteration of the product.
(2) The ion-exchange resin identified
in paragraph (a)(20) of this section § 173.45 Polymaleic acid and its so-
shall comply either with: dium salt.
(i) The extraction requirement in Polymaleic acid (CAS Reg. No. 26099–
paragraph (c)(4) of this section by using 09–2) and its sodium salt (CAS Reg. No.
dilute sulfuric acid, pH 3.5 as a sub-
70247–90–4) may be safely used in food
stitute for acetic acid; or
in accordance with the following pre-
(ii) The extraction requirement in
paragraph (c)(4) of this section by using scribed conditions:
reagent grade hydrochloric acid, di- (a) The additives have a weight-aver-
luted to pH 2, as a substitute for acetic age molecular weight in the range of
acid. The resin shall be found to result 540 to 850 and a number-average molec-
in no more than 25 parts per million of ular weight in the range of 520 to 650,
organic extractives obtained with each calculated as the acid. Molecular
of the following solvents: Distilled weights shall be determined by a meth-
water; 15 percent alcohol; and hydro- od entitled ‘‘Determination of Molec-
chloric acid, pH 2. Blanks should be run ular Weight Distribution of
for each of the solvents, and correc- Poly(Maleic) Acid,’’ March 17, 1992, pro-
tions should be made by subtracting duced by Ciba-Geigy, Inc., Seven Sky-
the total extractives obtained with the line Dr., Hawthorne, NY 10532–2188,
blank from the total extractives ob- which is incorporated by reference in
tained in the resin test. accordance with 5 U.S.C. 552(a) and 1
(e) Acrylonitrile copolymers identi- CFR part 51. Copies are available from
fied in this section shall comply with the Division of Product Policy, Center
the provisions of § 180.22 of this chap- for Food Safety and Applied Nutrition
ter. (HFS–205), Food and Drug Administra-
[42 FR 14526, Mar. 15, 1977, as amended at 46 tion, 5100 Paint Branch Pkwy., College
FR 40181, Aug. 7, 1981; 46 FR 57033, Nov. 20, Park, MD 20740, or are available for in-
1981; 49 FR 28830, July 17, 1984; 56 FR 16268, spection at the Center for Food Safety
Apr. 22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR
14609, Mar. 26, 1999; 64 FR 56173, Oct. 18, 1999]
and Applied Nutrition’s Library, 5100
Paint Branch Pkwy., College Park, MD
§ 173.40 Molecular sieve resins. 20740, or at the National Archives and
Molecular sieve resins may be safely Records Administration (NARA). For
used in the processing of food under the information on the availability of this
following prescribed conditions: material at NARA, call 202–741–6030, or
(a) The molecular sieve resins consist go to: http://www.archives.gov/
of purified dextran having an average federallregister/
molecular weight of 40,000, cross-linked codeloflfederallregulations/
with epichlorohydrin in a ratio of 1 ibrllocations.html.
part of dextran to 10 parts of (b) The additives may be used, indi-
epichlorohydrin, to give a stable three vidually or together, in the processing
dimensional structure. The resins have of beet sugar juice and liquor or of cane
a pore size of 2.0 to 3.0 milliliters per sugar juice and liquor to control min-
gram of dry resin (expressed in terms eral scale.
of water regain), and a particle size of (c) The additives are to be used so
10 to 300 microns. that the amount of either or both addi-
(b) The molecular sieve resins are tives does not exceed 4 parts per mil-
thoroughly washed with potable water lion (calculated as the acid) by weight
prior to their first use in contact with of the beet or cane sugar juice or liquor
food.
process stream.
(c) Molecular sieve resins are used as
the gel filtration media in the final pu-
[51 FR 5315, Feb. 13, 1986, as amended at 61

rification of partially delactosed whey. FR 386, Jan. 5, 1996]
The gel bed shall be maintained in a
128
§ 173.50 Polyvinylpolypyrrolidone. § 173.55 Polyvinylpyrrolidone.

The food additive polyvinylpoly- The food additive polyvinylpyrroli-
pyrrolidone may be safely used in ac- done may be safely used in accordance
cordance with the following prescribed with the following prescribed condi-
conditions: tions:
(a) The additive is a homopolymer of (a) The additive is a polymer of puri-
purified vinylpyrrolidone catalytically fied vinylpyrrolidone catalytically pro-
produced under conditions producing
duced, having an average molecular
polymerization and cross-linking such
that an insoluble polymer is produced. weight of 40,000 and a maximum
(b) The food additive is so processed unsaturation of 1 percent, calculated as
that when the finished polymer is the monomer, except that the
refluxed for 3 hours with water, 5 per- polyvinylpyrrolidone used in beer is
cent acetic acid, and 50 percent alco- that having an average molecular
hol, no more than 50 parts per million weight of 360,000 and a maximum
of extractables is obtained with each unsaturation of 1 percent, calculated as
solvent. the monomer.
(c) It is used or intended for use as a (b) The additive is used or intended
clarifying agent in beverages and vin- for use in foods as follows:
egar, followed by removal with filtra-
tion.
Food Limitations
Beer ......................................................................... As a clarifying agent, at a residual level not to exceed 10 parts per million.
Flavor concentrates in tablet form .......................... As a tableting adjuvent in an amount not to exceed good manufacturing
practice.
Nonnutritive sweeteners in concentrated liquid As a stabilizer, bodying agent, and dispersant, in an amount not to exceed
form. good manufacturing practice.
Nonnutritive sweeteners in tablet form ................... As a tableting adjuvant in an amount not to exceed good manufacturing
practice.
Vitamin and mineral concentrates in liquid form .... As a stabilizer, bodying agent, and dispersant, in an amount not to exceed
good manufacturing practice.
Vitamin and mineral concentrates in tablet form .... As a tableting adjuvant in an amount not to exceed good manufacturing
practice.
Vinegar .................................................................... As a clarifying agent, at a residual level not to exceed 40 parts per million.
Wine ........................................................................ As a clarifying agent, at a residual level not to exceed 60 parts per million.
§ 173.60 Dimethylamine- imum viscosity of 175 centipoises at 25

epichlorohydrin copolymer. °C as determined by LVT-series Brook-
field viscometer using a No. 2 spindle
Dimethylamine-epichlorohydrin co-
at 60 RPM (or by another equivalent
polymer (CAS Reg. No. 25988–97–0) may
method).
(3) The additive contains not more
than 1,000 parts per million of 1,3-
tions:
dichloro-2-propanol and not more than
(a) The food additive is produced by 10 parts per million epichlorohydrin.
copolymerization of dimethylamine The epichlorohydrin and 1,3-dichloro-2-
and epichlorohydrin in which not more propanol content is determined by an
than 5 mole-percent of dimethylamine analytical method entitled ‘‘The Deter-
may be replaced by an equimolar mination of Epichlorohydrin and 1,3-
amount of ethylenediamine, and in Dichloro-2-Propanol in Dimethyl-
which the mole ratio of total amine to amine-Epichlorohydrin Copolymer,’’
epichlorohydrin is approximately 1:1. which is incorporated by reference.
(b) The additive meets the following Copies are available from the Center
specifications: for Food Safety and Applied Nutrition
(1) The nitrogen content of the co- (HFS–200), Food and Drug Administra-
polymer is 9.4 to 10.8 weight percent on tion, 5100 Paint Branch Pkwy., College
a dry basis. Park, MD 20740, or available for inspec-
(2) A 50-percent-by-weight aqueous tion at the National Archives and

solution of the copolymer has a min- Records Administration (NARA). For
129
§ 173.65 21 CFR Ch. I (4–1–12 Edition)
information on the availability of this this material at NARA, call 202–741–

material at NARA, call 202–741–6030, or 6030, or go to: http://www.archives.gov/
go to: http://www.archives.gov/ federallregister/
federallregister/ codeloflfederallregulations/
codeloflfederallregulations/ ibrllocations.html. The copolymer is
ibrllocations.html. then treated with water according to
(4) Heavy metals (as Pb), 2 parts per the manufacturer’s recommendation to
million maximum. remove the extraction solvent to guar-
(5) Arsenic (as As), 2 parts per million antee a food-grade purity of the resin
maximum. at the time of use, in accordance with
(c) The food additive is used as a de- current good manufacturing practice.
colorizing agent and/or flocculant in (c) The temperature of the aqueous
the clarification of refinery sugar liq- food stream contacting the polymer is
uors and juices. It is added only at the maintained at 79.4 °C (175 °F) or less.
defecation/clarification stage of sugar (d) The copolymer may be used in
liquor refining at a concentration not contact with food only of Types I, II,
to exceed 150 parts per million of co- and VI-B (excluding carbonated bev-
polymer by weight of sugar solids. erages) described in table 1 of para-
(d) To assure safe use of the additive, graph (c) of § 176.170 of this chapter.
shall bear, in addition to other infor- [50 FR 61, Jan. 2, 1985]
mation required by the Act, adequate
directions to assure use in compliance § 173.70 Chloromethylated aminated
with paragraph (c) of this section. styrene-divinylbenzene resin.
[48 FR 37614, Aug. 19, 1983, as amended at 54 Chloromethylated aminated styrene-
FR 24897, June 12, 1989] divinylbenzene copolymer (CAS Reg.
No. 60177–39–1) may be safely used in
§ 173.65 Divinylbenzene copolymer. food in accordance with the following
Divinylbenzene copolymer may be prescribed conditions:
used for the removal of organic sub- (a) The additive is an aqueous disper-
stances from aqueous foods under the sion of styrene-divinylbenzene copoly-
following prescribed conditions: mers, first chloromethylated then
(a) The copolymer is prepared in ap- aminated with trimethylamine, having
propriate physical form and is derived an average particle size of not more
by the polymerization of a grade of than 2.0 microns.
divinylbenzene which comprises at (b) The additive shall contain no
least 79 weight-percent divinylbenzene, more than 3.0 percent nonvolatile,
15 to 20 weight-percent ethylvinyl- soluble extractives when tested as fol-
benzene, and no more than 4 weight- lows: One hundred grams of the addi-
percent nonpolymerizable impurities. tive is centrifuged at 17,000 r/min for 2
(b) In accordance with the manufac- hours. The resulting clear supernatant
turer’s directions, the copolymer de- is removed from the compacted solids
scribed in paragraph (a) of this section and concentrated to approximately 10
is subjected to pre-use extraction with grams on a steam bath. The 10-gram
a water soluble alcohol until the level sample is again centrifuged at 17,000 r/
of divinylbenzene in the extract is less min for 2 hours to remove any residual
than 50 parts per billion as determined insoluble material. The supernatant
by a method titled, ‘‘The Determina- from the second centrifugation is then
tion of Divinylbenzene in Alcohol Ex- removed from any compacted solids
tracts of Amberlite XAD–4,’’ which is and dried to constant residual weight
incorporated by reference. Copies of using a steam bath. The percent non-
this method are available from the volatile solubles is obtained by divid-
Center for Food Safety and Applied Nu- ing the weight of the dried residue by
trition (HFS–200), Food and Drug Ad- the weight of the solids in the original
ministration, 5100 Paint Branch Pkwy., resin dispersion.
College Park, MD 20740, or available for (c) The additive is used as a decol-
inspection at the National Archives orizing and clarification agent for
and Records Administration (NARA). treatment of refinery sugar liquors and

For information on the availability of juices at levels not to exceed 500 parts
130
of additive solids per million parts of (c) The additive is used or intended
sugar solids. for use as follows:
[50 FR 29209, July 18, 1985] (1) As an emulsifier in polymer dis-
persions that are used in the clarifica-
§ 173.73 Sodium polyacrylate. tion of cane or beet sugar juice or liq-
Sodium polyacrylate (CAS Reg. No. uor in an amount not to exceed 7.5 per-
9003–04–7) may be safely used in food in cent by weight in the final polymer dis-
accordance with the following pre- persion.
scribed conditions: (2) The additive is used in an amount
(a) The additive is produced by the not to exceed 0.70 part per million in
polymerization of acrylic acid and sub- sugar juice and 1.4 parts per million in
sequent hydrolysis of the polyacrylic sugar liquor.
acid with an aqueous sodium hydroxide [51 FR 11720, Apr. 7, 1986]
solution. As determined by a method
entitled ‘‘Determination of Weight Av-
erage and Number Average Molecular Subpart B—Enzyme Preparations
Weight of Sodium Polyacrylate,’’ and Microorganisms
which is incorporated by reference in
§ 173.110 Amyloglucosidase derived
accordance with 5 U.S.C. 552(a), the ad-
from Rhizopus niveus.
ditive has—
(1) A weight average molecular Amyloglucosidase enzyme product,
weight of 2,000 to 2,300; and consisting of enzyme derived from
(2) A weight average molecular Rhizopus niveus, and diatomaceous sili-
weight to number average molecular ca as a carrier, may be safely used in
weight ratio of not more than 1.3. Cop- food in accordance with the following
ies of the method are available from conditions:
the Center for Food Safety and Applied (a) Rhizopus niveus is classified as fol-
Nutrition (HFS–200), Food and Drug lows: Class, Phycomycetes; order,
Administration, 5100 Paint Branch Mucorales; family, Mucoraceae; genus,
Pkwy., College Park, MD 20740, or Rhizopus; species, niveus.
available for inspection at the National (b) The strain of Rhizopus niveus is
Archives and Records Administration nonpathogenic and nontoxic in man or
(NARA). For information on the avail- other animals.
ability of this material at NARA, call (c) The enzyme is produced by a proc-
202–741–6030, or go to: http:// ess which completely removes the or-
www.archives.gov/federallregister/ ganism Rhizopus niveus from the
codeloflfederallregulations/ amyloglucosidase.
ibrllocations.html. (d) The additive is used or intended
(b) The additive is used to control for use for degrading gelatinized starch
mineral scale during the evaporation of into constituent sugars, in the produc-
beet sugar juice or cane sugar juice in tion of distilled spirits and vinegar.
the production of sugar in an amount (e) The additive is used at a level not
not to exceed 3.6 parts per million by to exceed 0.1 percent by weight of the
weight of the raw juice. gelatinized starch.
[53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9,
1988] § 173.115 Alpha-acetolactate
decarboxylase (α-ALDC) enzyme
§ 173.75 Sorbitan monooleate. preparation derived from a recom-
binant Bacillus subtilis.
Sorbitan monooleate may be safely
used in accordance with the following The food additive alpha-acetolactate
prescribed conditions: decarboxylase (a-ALDC) enzyme prepa-
(a) The additive is produced by the ration, may be safely used in accord-
esterification of sorbitol with commer- ance with the following conditions:
cial oleic acid. (a) The food additive is the enzyme
(b) It meets the following specifica- preparation derived from a modified
tions: Bacillus subtilis strain that contains the
(1) Saponification number, 145–160. gene coding for a-ALDC from Bacillus
(2) Hydroxyl number, 193–210. brevis.
131
§ 173.120 21 CFR Ch. I (4–1–12 Edition)
(b)(1) The manufacturer produces the carbohydrase and cellulase enzyme

additive from a pure culture fermenta- product.
tion of a strain of Bacillus subtilis that (d) The additive is used or intended
is nonpathogenic and nontoxigenic in for use as follows:
man or other animals. (1) For removal of visceral mass (bel-
(2) The manufacturer may stabilize lies) in clam processing.
the enzyme preparation with (2) As an aid in the removal of the
glutaraldehyde or with other suitable shell from the edible tissue in shrimp
approved food additives or generally processing.
recognized as safe substances. (e) The additive is used in an amount
(3) The enzyme preparation must not in excess of the minimum required
meet the general and additional re- to produce its intended effect.
quirements for enzyme preparations in
the Food Chemicals Codex, 4th ed., 1996, § 173.130 Carbohydrase derived from
pp. 133–134, which is incorporated by Rhizopus oryzae.
reference. The Director of the Office of
the Federal Register approves this in- Carbohydrase from Rhizopus oryzae
corporation by reference in accordance may be safely used in the production of
with 5 U.S.C. 552(a) and 1 CFR part 51. dextrose from starch in accordance
Copies may be obtained from the Na- with the following prescribed condi-
tional Academy Press, 2101 Constitu- tions:
tion Ave. NW., Washington, DC 20055, (a) Rhizopus oryzae is classified as fol-
or may be examined at the Center for lows: Class, Phycomycetes; order,
Food Safety and Applied Nutrition, Mucorales; family, Mucoraceae; genus,
5100 Paint Branch Pkwy., College Park, Rhizopus; species, Rhizopus oryzae.
MD 20740, or at the National Archives (b) The strain of Rhizopus oryzae is
and Records Administration (NARA). nonpathogenic and nontoxic.
For information on the availability of (c) The carbohydrase is produced
this material at NARA, call 202–741– under controlled conditions to main-
6030, or go to: http://www.archives.gov/ tain nonpathogenicity and nontoxicity,
federallregister/ including the absence of aflatoxin.
codeloflfederallregulations/ (d) The carbohydrase is produced by a
ibrllocations.html. process which completely removes the
(c) The additive is used in an amount organism Rhizopus oryzae from the
not in excess of the minimum required carbohydrase product.
to produce its intended effect as a proc- (e) The carbohydrase is maintained
essing aid in the production of alco- under refrigeration from production to
holic malt beverages and distilled liq- use and is labeled to include the neces-
uors. sity of refrigerated storage.
[66 FR 27022, May 16, 2001]
§ 173.135 Catalase derived from Micro-
§ 173.120 Carbohydrase and cellulase coccus lysodeikticus.
derived from Aspergillus niger. Bacterial catalase derived from
Carbohydrase and cellulase enzyme Micrococcus lysodeikticus by a pure cul-
preparation derived from Aspergillus ture fermentation process may be safe-
niger may be safely used in food in ac- ly used in destroying and removing hy-
cordance with the following prescribed drogen peroxide used in the manufac-
conditions: ture of cheese, in accordance with the
(a) Aspergillus niger is classified as following conditions.
follows: Class, Deuteromycetes; order, (a) The organism Micrococcus
Moniliales; family, Moniliaceae; genus, lysodeikticus from which the bacterial
Aspergillus; species, niger. catalase is to be derived is dem-
(b) The strain of Aspergillus niger is onstrated to be nontoxic and nonpatho-
nonpathogenic and nontoxic in man or genic.
other animals. (b) The organism Micrococcus
(c) The additive is produced by a lysodeikticus is removed from the bac-
process that completely removes the terial catalase prior to use of the bac-
organism Aspergillus niger from the terial catalase.
132
(c) The bacterial catalase is used in var. raffinoseutilizer which produces the
an amount not in excess of the min- enzyme.
imum required to produce its intended (b) The nonpathogenic microorga-
effect. nism matches American Type Culture
Collection (ATCC) No. 20034, 1 and is
§ 173.140 Esterase-lipase derived from classified as follows:
Mucor miehei.
Class: Phycomycetes.
Esterase-lipase enzyme, consisting of Order: Mucorales.
enzyme derived from Mucor miehei var. Family: Mortierellaceae.
Cooney et Emerson by a pure culture fer- Genus: Mortierella.
mentation process, with maltodextrin Species: vinaceae.
Variety: raffinoseutilizer.
or sweet whey as a carrier, may be
safely used in food in accordance with (c) The additive is used or intended
the following conditions: for use in the production of sugar (su-
(a) Mucor miehei var. Cooney et Emer- crose) from sugar beets by addition as
son is classified as follows: Class, mycelial pellets to the molasses to in-
Phycomycetes; subclass, Zygomycetes; crease the yield of sucrose, followed by
order, Mucorales; family, Mucoraceae; removal of the spent mycelial pellets
genus, Mucor; species, miehei; variety by filtration.
Cooney et Emerson. (d) The enzyme removal is such that
(b) The strain of Mucor miehei var. there are no enzyme or mycelial resi-
Cooney et Emerson is nonpathogenic and dues remaining in the finished sucrose.
nontoxic in man or other animals. [42 FR 14526, Mar. 15, 1977, as amended at 54
(c) The enzyme is produced by a proc- FR 24897, June 12, 1989]
ess which completely removes the or-
ganism Mucor miehei var. Cooney et § 173.150 Milk-clotting enzymes, micro-
Emerson from the esterase-lipase. bial.
(d) The enzyme is used as a flavor Milk-clotting enzyme produced by
enhancer as defined in § 170.3(o)(12). pure-culture fermentation process may
(e) The enzyme is used at levels not be safely used in the production of
to exceed current good manufacturing cheese in accordance with the fol-
practice in the following food cat- lowing prescribed conditions:
egories: cheeses as defined in (a) Milk-clotting enzyme is derived
§ 170.3(n)(5) of this chapter; fat and oils from one of the following organisms by
as defined in § 170.(3)(n)(12) of this chap- a pure-culture fermentation process:
ter; and milk products as defined in (1) Endothia parasitica classified as
§ 170.(3)(n)(31) of this chapter. Use of follows: Class, Ascomycetes; order,
this food ingredient is limited to Sphaeriales; family, Diaporthacesae;
nonstandarized foods and those foods genus, Endothia; species, parasitica.
for which the relevant standards of (2) Bacillus cereus classified as fol-
identity permit such use. lows: Class, Schizomycetes; order,
(f) The enzyme is used in the min- Eubacteriales; family, Bacillaceae;
imum amount required to produce its genus, Bacillus; species, cereus
limited technical effect. (Frankland and Frankland).
(3) Mucor pusillus Lindt classified as
[47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, follows: Class, Phycomycetes; subclass,
1983] Zygomycetes; order, Mucorales; fam-
ily, Mucoraceae; genus, Mucor; species,
§ 173.145 Alpha-Galactosidase derived pusillus; variety, Lindt.
from Mortierella vinaceae var. (4) Mucor miehei Cooney et Emerson
raffinoseutilizer.
classified as follows: Class,
The food additive alpha-galactosidase Phycomycetes; subclass, Zygomycetes;
and parent mycelial microorganism order, Mucorales; family, Mucoraceae;
Mortierella vinaceae var. raffinoseutilizer genus, Mucor; species, miehei; variety,
may be safely used in food in accord- Cooney et Emerson.
ance with the following conditions:
(a) The food additive is the enzyme
1 Available from: American Type Culture

alpha-galactosidase and the mycelia of Collection, 12301 Parklawn Drive, Rockville,
the microorganism Mortierella vinaceae MD 20852.
133
§ 173.160 21 CFR Ch. I (4–1–12 Edition)
(5) Aspergillus oryzae modified by re- standard description for Candida

combinant deoxyribonucleic (DNA) guilliermondii variety guilliermondii list-
techniques to contain the gene coding ed in ‘‘The Yeasts—A Toxonomic
for aspartic proteinase from Study;’’ 2d Ed. (1970), by Jacomina
Rhizomucor miehei var. Cooney et Emer- Lodder, which is incorporated by ref-
son as defined in paragraph (a)(4) of erence. Copies are available from the
this section, and classified as follows: Center for Food Safety and Applied Nu-
Class, Blastodeuteromycetes trition (HFS–200), Food and Drug Ad-
(Hyphomycetes); order, Phialidales ministration, 5100 Paint Branch Pkwy.,
(Moniliales); genus, Aspergillus; species College Park, MD 20740, or available for
oryzae. inspection at the National Archives
(b) The strains of organism identified and Records Administration (NARA).
in paragraph (a) of this section are For information on the availability of
nonpathogenic and nontoxic in man or this material at NARA, call 202–741–
other animals. 6030, or go to: http://www.archives.gov/
(c) The additive is produced by a federallregister/
process that completely removes the codeloflfederallregulations/
generating organism from the milk- ibrllocations.html.
clotting enzyme product. (c)(1) The additive is used or intended
(d) The additive is used in an amount for use as a pure culture in the fer-
not in excess of the minimum required mentation process for the production
to produce its intended effect in the of citric acid using an acceptable aque-
production of those cheeses for which ous carbohydrate substrate.
it is permitted by standards of identity (2) The organism Candida
established pursuant to section 401 of quilliermondii is made nonviable and is
the Act. completely removed from the citric
[42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. acid during the recovery and purifi-
28, 1977, as amended at 62 FR 59284, Nov. 3, cation process.
1997] (d) The additive is so used that the
citric acid produced conforms to the
§ 173.160 Candida guilliermondii. specifications of the ‘‘Food Chemicals
The food additive Candida Codex,’’ 3d Ed. (1981), under ‘‘Citric
guilliermondii may be safely used as the acid,’’ pp. 86–87, which is incorporated
organism for fermentation production by reference. Copies may be obtained
of citric acid in accordance with the from the National Academy Press, 2101
following conditions: Constitution Ave. NW., Washington,
(a) The food additive is the enzyme DC 20418, or may be examined at the
system of the viable organism Candida National Archives and Records Admin-
guilliermondii and its concomitant me- istration (NARA). For information on
tabolites produced during the fer- the availability of this material at
mentation process. NARA, call 202–741–6030, or go to: http://
(b)(1) The nonpathogenic and www.archives.gov/federallregister/
nontoxicogenic organism descending codeloflfederallregulations/
from strain, American Type Culture ibrllocations.html.
Collection (ATCC) No. 20474, 1 is classi- [42 FR 14526, Mar. 15, 1977, as amended at 47
fied as follows: FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19,
Class: Deuteromycetes. 1984; 54 FR 24897, June 12, 1989]
Order: Moniliales.
Family: Cryptococcaceae. § 173.165 Candida lipolytica.
Genus: Candida. The food additive Candida lipolytica
Species: guilliermondii. may be safely used as the organism for
Variety: guilliermondii. fermentation production of citric acid
(2) The toxonomic characteristics of in accordance with the following condi-
the reference culture strain ATCC No. tions:
20474 agree in the essentials with the (a) The food additive is the enzyme
system of the organism Candida
lipolytica and its concimitant metabo-
1 Available from: American Type Culture
Collection, 12301 Parklawn Drive, Rockville, lites produced during the fermentation
MD 20852. process.
134
(b)(1) The nonpathogenic organism is ANALYTICAL PROCEDURE FOR CITRIC ACID

classified as follows:
Class: Deuteromycetes.
Because of the sensitivity of the test, the
Order: Moniliales. possibility of errors arising from contamina-
Family: Cryptococcaceae. tion is great. It is of the greatest importance
Genus: Candida. that all glassware be scrupulously cleaned to
Species: lipolytica. remove all organic matter such as oil,
grease, detergent residues, etc. Examine all
(2) The taxonomic characteristics of glassware including stoppers and stopcocks,
the culture agree in essential with the under ultraviolet light to detect any residual
standard description for Candida fluorescent contamination. As a pre-
lipolytica variety lipolytica listed in cautionary measure it is recommended prac-
‘‘The Yeasts—A Toxonomic Study,’’ 2d tice to rinse all glassware with purified iso-
Ed. (1970), by Jacomina Lodder, which octane immediately before use. No grease is
to be used on stopcocks or joints. Great care
is incorporated by reference. Copies are
to avoid contamination of citric acid sam-
available from the Center for Food ples in handling is essential to assure ab-
Safety and Applied Nutrition (HFS– sence of any extraneous material arising
200), Food and Drug Administration, from inadequate packaging. Because some of
5100 Paint Branch Pkwy., College Park, the polynuclear hydrocarbons sought in this
MD 20740, or available for inspection at test are very susceptible to photo-oxidation,
the National Archives and Records Ad- the entire procedure is to be carried out
under subdued light.
ministration (NARA). For information
on the availability of this material at APPARATUS
1. Aluminum foil, oil free.
2. Separatory funnels, 500-milliliter capac-
codeloflfederallregulations/ ity, equipped with tetrafluoroethylene poly-
ibrllocations.html. mer stopcocks.
(c) The additive is used or intended 3. Chromatographic tubes: (a) 80-milli-
for use as a pure culture in the fer- meter ID × 900-millimeter length equipped
mentation process for the production with tetrafluoroethylene polymer stopcock
of citric acid from purified normal and course fritted disk; (b) 18-millimeter ID
alkanes. × 300-millimeter length equipped with tetra-
fluoroethylene polymer stopcock.
(d) The additive is so used that the 4. Rotary vacuum evaporator, Buchi or
citric acid produced conforms to the equivalent.
specifications of the ‘‘Food Chemicals 5. Spectrophotometer—Spectral range 250–
Codex,’’ 3d Ed. (1981), pp. 86–87, which is 400 nanometers with spectral slit width of 2
incorporated by reference. Copies may nanometers or less; under instrument oper-
be obtained from the National Acad- ating conditions for these absorbance meas-
emy Press, 2101 Constitution Ave. NW., urements, the spectrophotometer shall also
meet the following performance require-
Washington, DC 20418, or may be exam-
ments:
ined at the National Archives and Absorbance repeatability, ±0.01 at 0.4 ab-
Records Administration (NARA). For sorbance.
information on the availability of this Wavelength repeatability, ±0.2 nanometer.
material at NARA, call 202–741–6030, or Wavelength accuracy, ±1.0 nanometer.
go to: http://www.archives.gov/ The spectrophotometer is equipped with
federallregister/ matched 1 centimeter path length quartz
codeloflfederallregulations/ microcuvettes with 0.5-milliliter volume ca-
ibrllocations.html. The additive meets pacity.
the following ultraviolet absorbance 6. Vacuum oven, minimum inside dimen-
limits when subjected to the analytical sions: 200 mm × 200 mm × 300 mm deep.
procedure described in this paragraph: REAGENTS AND MATERIALS
Ultraviolet absorbance per centimeter path Maximum Organic solvents. All solvents used through-
length out the procedure shall meet the specifica-
tions and tests described in this specifica-
280 to 289 millimicrons ....................................... 0.25
tion. The methyl alcohol, isooctane, benzene,
290 to 299 millimicrons ....................................... 0.20
hexane and 1,2-dichloroethane designated in

300 to 359 millimicrons ....................................... 0.13
360 to 400 millimicrons ....................................... 0.03
the list following this paragraph shall pass
the following test:
135
§ 173.165 21 CFR Ch. I (4–1–12 Edition)
The specified quantity of solvent is added wash with an additional 6 liters of purified
to a 250-milliliter round bottom flask con- water and wash with 3,600 milliliters of puri-
taining 0.5 milliliter of purified n-hexa- fied methyl alcohol at a relatively slow rate.
decane and evaporated on the rotary evapo- Drain all of the solvents and transfer the
rator at 45 °C to constant volume. Six milli- silica gel to an aluminum foil-lined drying
liters of purified isooctane are added to this dish. Place foil over the top of the dish. Acti-
residue and evaporated under the same con- vate in a vacuum oven at low vacuum (ap-
ditions as above for 5 minutes. Determine proximately 750 millimeters Mercury or 27
the absorbance of the residue compared to inches of Mercury below atmospheric pres-
purified n-hexadecane as reference. The ab- sure) at 173° to 177 °C for at least 20 hours.
sorbance of the solution of the solvent res- Cool under vacuum and store in an amber
idue shall not exceed 0.03 per centimeter bottle.
path length between 280 and 299 nanometers Sodium sulfate, anhydrous, A.C.S. reagent
and 0.01 per centimeter path length between grade. This reagent should be washed with
300 and 400 nanometers. purified isooctane. Check the purity of this
Methyl alcohol, A.C.S. reagent grade. Use 100 reagent as described in § 172.886 of this chap-
milliliters for the test described in the pre- ter.
ceding paragraph. If necessary, methyl alco- Water, purified. All water used must meet
hol may be purified by distillation through a the specifications of the following test:
Virgreaux column discarding the first and Extract 600 milliliters of water with 50 mil-
last ten percent of the distillate or other- liliters of purified isooctane. Add 1 milliliter
wise. of purified n-hexadecane to the isooctane ex-
Benzene, spectrograde (Burdick and Jackson tract and evaporate the resulting solution to
Laboratories, Inc., Muskegon, Mich., or equiva- 1 milliliter. The absorbance of this residue
lent). Use 80 milliliters for the test. If nec- shall not exceed 0.02 per centimeter path
essary, benzene may be purified by distilla- length between 300–400 nanometers and 0.03
tion or otherwise. per centimeter path length between 280–299
Isooctane (2,2,4-trimethylpentane). Use 100 nanometers. If necessary, water may be puri-
milliliters for the test. If necessary, iso- fied by distillation, extraction with purified
octane may be purified by passage through a organic solvents, treatment with an absorb-
column of activated silica gel, distillation or ent (e.g., activated carbon) followed by fil-
otherwise. tration of the absorbent or otherwise.
Hexane, spectrograde (Burdick and Jackson
Laboratories, Inc., Muskegon, Mich., or equiva- PROCEDURE
lent). Use 100 milliliters for the test. If nec- Separate portions of 200 milliliters of puri-
essary, hexane may be purified by distilla- fied water are taken through the procedure
tion or otherwise. for use as control blanks. Each citric acid
1,2-Dichloroethane, spectrograde (Matheson, sample is processed as follows: Weigh 200
Coleman and Bell, East Rutherford, N.J., or grams of anhydrous citric acid into a 500 mil-
equivalent). Use 100 milliliters for the test. If liliter flask and dissolve in 200 milliliters of
necessary, 1,2-dichloroethane may be puri- pure water. Heat the solution to 60 °C and
fied by distillation or otherwise. transfer to a 500 milliliter separatory funnel.
Rinse the flask with 50 milliliters of iso-
ELUTING MIXTURES
octane and add the isooctane to the sepa-
1. 10 percent 1,2-dichloroethane in hexane. ratory funnel. Gently shake the mixture 90
Prepare by mixing the purified solvents in times (caution: vigorous shaking will cause
the volume ratio of 1 part of 1,2- emulsions) with periodic release of the pres-
dichloroethane to 9 parts of hexane. sure caused by shaking.
2. 40 percent benzene in hexane. Prepare by Allow the phases to separate for at least 5
mixing the purified solvents in the volume minutes. Draw off the lower aqueous layer
ratio of 4 parts of benzene to 6 parts of into a second 500-milliliter separatory funnel
hexane. and repeat the extraction with a second ali-
n-Hexadecane, 99 percent olefin-free. Deter- quot of 50 milliliters of isooctane. After sep-
mine the absorbance compared to isooctane aration of the layers, draw off and discard
as reference. The absorbance per centimeter the water layer. Combine both isooctane ex-
path length shall not exceed 0.00 in the range tracts in the funnel containing the first ex-
of 280–400 nanometers. If necessary, n-hexa- tract. Rinse the funnel which contained the
decane may be purified by percolation second extract with 10 milliliters of iso-
through activated silica gel, distillation or octane and add this portion to the combined
otherwise. isooctane extract.
Silica gel, 28–200 mesh (Grade 12, Davison A chromatographic column containing 5.5
Chemical Co., Baltimore, MD, or equivalent). grams of silica gel and 3 grams of anhydrous
Activate as follows: Slurry 900 grams of sili- sodium sulfate is prepared for each citric
ca gel reagent with 2 liters of purified water acid sample as follows: Fit 18 × 300 column
in a 3-liter beaker. Cool the mixture and with a small glass wool plug. Rinse the in-
pour into a 80 × 900 chromatographic column side of the column with 10 milliliters of puri-
with coarse fritted disc. Drain the water, fied isooctane. Drain the isooctane from the
136
column. Pour 5.5 grams of activated silica § 173.170 Aminoglycoside 3′-phospho-
gel into the column. Tap the column ap- transferase II.
proximately 20 times on a semisoft, clean
surface to settle the silica gel. Carefully The food additive aminoglycoside 3′-
pour 3 grams of anhydrous sodium sulfate phosphotransferase II may be safely
onto the top of the silica gel in the column. used in the development of genetically
Carefully drain the isooctane extract of modified cotton, oilseed rape, and to-
the citric acid solution into the column in a matoes in accordance with the fol-
series of additions while the isooctane is
draining from the column at an elution rate
of approximately 3 milliliters per minute. (a) The food additive is the enzyme
Rinse the separatory funnel with 10 milli- aminoglycoside 3′-phosphotransferase
liters of isooctane after the last portion of II (CAS Reg. No. 58943–39–8) which cata-
the extract has been applied to the column lyzes the phosphorylation of certain
and add this rinse to the column. After all of aminoglycoside antibiotics, including
the extract has been applied to the column kanamycin, neomycin, and gentamicin.
and the solvent layer reaches the top of the
sulfate bed, rinse the column with 25 milli- (b) Aminoglycoside 3′-phosphotrans-
liters of isooctane followed by 10 milliliters ferase II is encoded by the kanr gene
of a 10-percent dichloroethane in hexane so- originally isolated from transposon Tn5
lution. For each rinse solution, drain the col- of the bacterium Escherichia coli.
umn until the solvent layer reaches the top (c) The level of the additive does not
of the sodium sulfate bed. Discard the rinse exceed the amount reasonably required
solvents. Place a 250-milliliter round bottom
flask containing 0.5 milliliter of purified n-
for selection of plant cells carrying the
hexadecane under the column. Elute the kanr gene along with the genetic mate-
polynuclear aromatic hydrocarbons from the rial of interest.
column with 30 milliliters of 40-percent ben-
[59 FR 26711, May 23, 1994]
zene in hexane solution. Drain the eluate
until the 40-percent benzene in the hexane
solvent reaches the top of the sodium sulfate Subpart C—Solvents, Lubricants,
bed. Release Agents and Related
Evaporate the 40-percent benzene in
hexane eluate on the rotary vacuum evapo-
Substances
rator at 45 °C until only the n-hexadecane
residue of 0.5 milliliter remains. Treat the n-
§ 173.210 Acetone.
hexadecane residue twice with the following A tolerance of 30 parts per million is
wash step: Add 6 milliliters of purified iso- established for acetone in spice
octane and remove the solvents by vacuum oleoresins when present therein as a
evaporation at 45 °C to constant volume, i.e.,
0.5 milliliter. Cool the n-hexadecane residue
residue from the extraction of spice.
and transfer the solution to an 0.5-milliliter
microcuvette. Determine the absorbance of § 173.220 1,3-Butylene glycol.
this solution compared to purified n-hexa- 1,3-Butylene glycol (1,3-butanediol)
decane as reference. Correct the absorbance may be safely used in food in accord-
values for any absorbance derived from the
ance with the following prescribed con-
control reagent blank. If the corrected ab-
sorbance does not exceed the limits pre- ditions:
scribed, the samples meet the ultraviolet ab- (a) The substance meets the fol-
sorbance specifications. lowing specifications:
The reagent blank is prepared by using 200 (1) 1,3-Butylene glycol content: Not
milliliters of purified water in place of the less than 99 percent.
citric acid solution and carrying the water (2) Specific gravity at 20/20 °C: 1.004
sample through the procedure. The typical
control reagent blank should not exceed 0.03
to 1.006.
absorbance per centimeter path length be- (3) Distillation range: 200°–215 °C.
tween 280 and 299 nanometers, 0.02 absorb- (b) It is used in the minimum amount
ance per centimeter path length between 300 required to perform its intended effect.
and 359 nanometers, and 0.01 absorbance per (c) It is used as a solvent for natural
centimeter path length between 360 and 400
and synthetic flavoring substances ex-
nanometers.
cept where standards of identity issued
[42 FR 14491, Mar. 15, 1977, as amended at 47 under section 401 of the act preclude
FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, such use.
1984; 54 FR 24897, June 12, 1989]
137
§ 173.228 21 CFR Ch. I (4–1–12 Edition)
§ 173.228 Ethyl acetate. § 173.250 Methyl alcohol residues.

Ethyl acetate (CAS Reg. No. 141–78–6) Methyl alcohol may be present in the
may be safely used in food in accord- following foods under the conditions
ance with the following conditions: specified:
(a) The additive meets the specifica- (a) In spice oleoresins as a residue
tions of the Food Chemicals Codex, 1 from the extraction of spice, at a level
(Ethyl Acetate; p. 372, 3d Ed., 1981), not to exceed 50 parts per million.
which are incorporated by reference. (b) In hops extract as a residue from
(b) The additive is used in accordance the extraction of hops, at a level not to
with current good manufacturing prac- exceed 2.2 percent by weight; Provided,
tice as a solvent in the decaffeination That:
of coffee and tea. (1) The hops extract is added to the
wort before or during cooking in the
[47 FR 146, Jan. 5, 1982, as amended at 49 FR manufacture of beer.
28548, July 13, 1984] (2) The label of the hops extract
specifies the presence of methyl alco-
§ 173.230 Ethylene dichloride. hol and provides for the use of the hops
A tolerance of 30 parts per million is extract only as prescribed by para-
established for ethylene dichloride in graph (b)(1) of this section.
spice oleoresins when present therein
as a residue from the extraction of § 173.255 Methylene chloride.
spice; Provided, however, That if resi- Methylene chloride may be present in
dues of other chlorinated solvents are food under the following conditions:
also present the total of all residues of (a) In spice oleoresins as a residue
such solvents shall not exceed 30 parts from the extraction of spice, at a level
per million. not to exceed 30 parts per million; Pro-
vided, That, if residues of other
§ 173.240 Isopropyl alcohol. chlorinated solvents are also present,
Isopropyl alcohol may be present in the total of all residues of such sol-
the following foods under the condi- vents shall not exceed 30 parts per mil-
tions specified: lion.
(a) In spice oleoresins as a residue (b) In hops extract as a residue from
from the extraction of spice, at a level the extraction of hops, at a level not to
not to exceed 50 parts per million. exceed 2.2 percent, Provided, That:
(b) In lemon oil as a residue in pro- (1) The hops extract is added to the
duction of the oil, at a level not to ex- wort before or during cooking in the
ceed 6 parts per million. manufacture of beer.
(2) The label of the hops extract iden-
(c) In hops extract as a residue from
tifies the presence of the methylene
the extraction of hops at a level not to
chloride and provides for the use of the
exceed 2.0 percent by weight: Provided,
hops extract only as prescribed by
That,
paragraph (b)(1) of this section.
(1) The hops extract is added to the
(c) In coffee as a residue from its use
wort before or during cooking in the
as a solvent in the extraction of caf-
manufacture of beer.
feine from green coffee beans, at a level
(2) The label of the hops extract not to exceed 10 parts per million (0.001
specifies the presence of the isopropyl percent) in decaffeinated roasted coffee
alcohol and provides for the use of the and in decaffeinated soluble coffee ex-
hops extract only as prescribed by tract (instant coffee).
paragraph (c)(1) of this section.
§ 173.270 Hexane.
1 Copies may be obtained from: National Hexane may be present in the fol-
Academy Press, 2101 Constitution Ave. NW., lowing foods under the conditions spec-
Washington, DC 20418 or examined at the Na- ified:
tional Archives and Records Administration
(NARA). For information on the availability
(a) In spice oleoresins as a residue
of this material at NARA, call 202–741–6030, from the extraction of spice, at a level
not to exceed 25 parts per million.
or go to: http://www.archives.gov/
federallregister/codeloflfederallregulations/ (b) In hops extract as a residue from
ibrllocations.html. the extraction of hops, at a level not to
138
exceed 2.2 percent by weight; Provided, (NARA). For information on the avail-
That: ability of this material at NARA, call
(1) The hops extract is added to the 202–741–6030, or go to: http://
wort before or during cooking in the www.archives.gov/federallregister/
manufacture of beer. codeloflfederallregulations/
(2) The label of the hops extract ibrllocations.html.), and the
specifies the presence of the hexane polynuclear aromatic hydrocarbon
and provides for the use of the hops ex- specifications of § 173.165.
tract only as prescribed by paragraph (d) Residues of n-octyl alcohol and
(b)(1) of this section. synthetic isoparaffinic petroleum hy-
drocarbons are removed in accordance
§ 173.275 Hydrogenated sperm oil. with good manufacturing practice. Cur-
The food additive hydrogenated rent good manufacturing practice re-
sperm oil may be safely used in accord- sults in residues not exceeding 16 parts
ance with the following prescribed con- per million (ppm) n-octyl alcohol and
ditions: 0.47 ppm synthetic isoparaffinic petro-
(a) The sperm oil is derived from ren- leum hydrocarbons in citric acid.
dering the fatty tissue of the sperm (e) Tridodecyl amine may be present
whale or is prepared by synthesis of as a residue in citric acid at a level not
fatty acids and fatty alcohols derived to exceed 100 parts per billion.
from the sperm whale. The sperm oil
obtained by rendering is refined. The FR 10106, Mar. 19, 1984]
oil is hydrogenated.
(b) It is used alone or as a component § 173.290 Trichloroethylene.
of a release agent or lubricant in bak-
ery pans. Tolerances are established for resi-
(c) The amount used does not exceed dues of trichloroethylene resulting
that reasonably required to accomplish from its use as a solvent in the manu-
the intended lubricating effect. facture of foods as follows:
Decaffeinated ground coffee 25 parts per million.
§ 173.280 Solvent extraction process Decaffeinated soluble (in- 10 parts per million.
for citric acid. stant) coffee extract.
Spice oleoresins .................... 30 parts per million (provided
A solvent extraction process for re- that if residues of other
covery of citric acid from conventional chlorinated solvents are
Aspergillus niger fermentation liquor also present, the total of all
residues of such solvents
may be safely used to produce food- in spice oleoresins shall
grade citric acid in accordance with not exceed 30 parts per
the following conditions: million).
(a) The solvent used in the process
consists of a mixture of n-octyl alcohol
meeting the requirements of § 172.864 of Subpart D—Specific Usage
this chapter, synthetic isoparaffinic Additives
petroleum hydrocarbons meeting the
§ 173.300 Chlorine dioxide.
requirements of § 172.882 of this chap-
ter, and tridodecyl amine. Chlorine dioxide (CAS Reg. No. 10049–
(b) The component substances are 04–4) may be safely used in food in ac-
used solely as a solvent mixture and in cordance with the following prescribed
a manner that does not result in for- conditions:
mation of products not present in con- (a)(1) The additive is generated by
ventionally produced citric acid. one of the following methods:
(c) The citric acid so produced meets (i) Treating an aqueous solution of
the specifications of the ‘‘Food Chemi- sodium chlorite with either chlorine
cals Codex,’’ 3d Ed. (1981), pp. 86–87, gas or a mixture of sodium hypo-
which is incorporated by reference chlorite and hydrochloric acid.
(Copies may be obtained from the Na- (ii) Treating an aqueous solution of
tional Academy Press, 2101 Constitu- sodium chlorate with hydrogen per-
tion Ave. NW., Washington, DC 20418, oxide in the presence of sulfuric acid.
or may be examined at the National (iii) Treating an aqueous solution of

Archives and Records Administration sodium chlorite by electrolysis.
139
§ 173.310 21 CFR Ch. I (4–1–12 Edition)
(2) The generator effluent contains at (2) The additive may be used as an
least 90 percent (by weight) of chlorine antimicrobial agent in water used to
dioxide with respect to all chlorine spe- wash fruits and vegetables that are not
cies as determined by Method 4500–ClO2 raw agricultural commodities in an
E in the ‘‘Standard Methods for the Ex- amount not to exceed 3 ppm residual
amination of Water and Wastewater,’’ chlorine dioxide as determined by
20th ed., 1998, or an equivalent method. Method 4500–ClO2 E, referenced in para-
Method 4500–ClO2 E (‘‘Amperometric graph (a)(2) of this section, or an equiv-
Method II’’) is incorporated by ref- alent method. Treatment of the fruits
erence in accordance with 5 U.S.C.
and vegetables with chlorine dioxide
552(a) and 1 CFR part 51. You may ob-
shall be followed by a potable water
tain a copy from the Center for Food
Safety and Applied Nutrition (HFS– rinse or by blanching, cooking, or can-
200), Food and Drug Administration, ning.
5100 Paint Branch Pkwy., College Park, [60 FR 11900, Mar. 3, 1995. Redesignated at 61
MD 20740, or the American Public FR 14245, Apr. 1, 1996, as amended at 61 FR
Health Association, 800 I St. NW., 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998;
Washington, DC 20001–3750. You may in- 65 FR 34587, May 31, 2000; 70 FR 7396, Feb. 14,
spect a copy at the Center for Food 2005]
Safety and Applied Nutrition’s Li-
brary, 5100 Paint Branch Pkwy., Col- § 173.310 Boiler water additives.
lege Park, MD, or at the National Ar- Boiler water additives may be safely
chives and Records Administration used in the preparation of steam that
(NARA). For information on the avail- will contact food, under the following
ability of this material at NARA, call conditions:
202–741–6030, or go to: http:// (a) The amount of additive is not in
excess of that required for its func-
tional purpose, and the amount of
ibrllocations.html.
(b)(1) The additive may be used as an steam in contact with food does not ex-
antimicrobial agent in water used in ceed that required to produce the in-
poultry processing in an amount not to tended effect in or on the food.
exceed 3 parts per million (ppm) resid- (b) The compounds are prepared from
ual chlorine dioxide as determined by substances identified in paragraphs (c)
Method 4500–ClO2 E, referenced in para- and (d) of this section, and are subject
graph (a)(2) of this section, or an equiv- to the limitations, if any, prescribed:
alent method. (c) List of substances:
Substances Limitations
Acrylamide-sodium acrylate resin ................................................. Contains not more than 0.05 percent by weight of acrylamide
monomer.
Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid copoly- Total not to exceed 20 parts per million (active) in boiler
mer having a minimum weight average molecular weight of feedwater.
9,900 and a minimum number average molecular weight of
5,700 as determined by a method entitled ‘‘Determination of
Weight Average and Number Average Molecular Weight of
60/40 AA/AMPS’’ (October 23, 1987), which is incorporated
by reference in accordance with 5 U.S.C. 552(a). Copies may
be obtained from the Center for Food Safety and Applied Nu-
trition (HFS–200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or may be examined
at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA,
call 202–741–6030, or go to: http://www.archives.gov/
federallregister/codeloflfederallregulations/
ibrllocations.html..
Ammonium alginate.
Cobalt sulfate (as catalyst).
1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No.
2809–21–4) and its sodium and potassium salts.
Lignosulfonic acid.
Monobutyl ethers of polyethylene-polypropylene glycol produced Minimum mol. wt. 1,500.

by random condensation of a 1:1 mixture by weight of ethyl-
ene oxide and propylene oxide with butanol.
140
Poly(acrylic acid-co-hypophosphite), sodium salt (CAS Reg. No. Total not to exceed 1.5 parts per million in boiler feed water.
71050–62–9), produced from a 4:1 to a 16:1 mixture by Copolymer contains not more than 0.5 percent by weight of
weight of acrylic acid and sodium hypophosphite. acrylic acid monomer (dry weight basis).
Polyethylene glycol ....................................................................... As defined in § 172.820 of this chapter.
Polymaleic acid [CAS Reg. No. 26099–09–2], and/or its sodium Total not to exceed 1 part per million in boiler feed water (cal-
salt. [CAS Reg. No. 30915–61–8 or CAS Reg. No. 70247– culated as the acid).
90–4].
Polyoxypropylene glycol ............................................................... Minimum mol. wt. 1,000.
Potassium carbonate.
Potassium tripolyphosphate.
Sodium acetate.
Sodium alginate.
Sodium aluminate.
Sodium carbonate.
Sodium carboxymethylcellulose ................................................... Contains not less than 95 percent sodium
carboxymethylcellulose on a dry-weight basis, with max-
imum substitution of 0.9 carboxymethylcellulose groups per
anhydroglucose unit, and with a minimum viscosity of 15
centipoises for 2 percent by weight aqueous solution at 25
°C; by the method prescribed in the ‘‘Food Chemicals
Codex,’’ 4th ed. (1996), pp. 744–745, which is incorporated
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the National Academy
Press, Box 285, 2101 Constitution Ave. NW., Washington,
DC 20055 (Internet address http://www.nap.edu), or may be
examined at the Center for Food Safety and Applied Nutri-
tion’s Library, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the National
Archives and Records Administration (NARA). For informa-
tion on the availability of this material at NARA, call 202–
ibrllocations.html.
Sodium glucoheptonate ................................................................ Less than 1 part per million cyanide in the sodium
glucoheptonate.
Sodium hexametaphosphate.
Sodium humate.
Sodium hydroxide.
Sodium lignosulfonate.
Sodium metabisulfite.
Sodium metasilicate.
Sodium nitrate.
Sodium phosphate (mono-, di-, tri-).
Sodium polyacrylate.
Sodium polymethacrylate.
Sodium silicate.
Sodium sulfate.
Sodium sulfite (neutral or alkaline).
Sodium tripolyphosphate.
Sorbitol anhydride esters: a mixture consisting of sorbitan The mixture is used as an anticorrosive agent in steam boiler
monostearate as defined in § 172.842 of this chapter; poly- distribution systems, with each component not to exceed 15
sorbate 60 ((polyoxyethylene (20) sorbitan monostearate)) as parts per million in the steam.
defined in § 172.836 of this chapter; and polysorbate 20
((polyoxyethylene (20) sorbitan monolaurate)), meeting the
specifications of the Food Chemicals Codex, 4th ed. (1996),
pp. 306–307, which is incorporated by reference in accord-
ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are
available from the National Academy Press, 2101 Constitu-
tion Ave. NW., Box 285, Washington, DC 20055 (Internet
http://www.nap.edu), or may be examined at the Center for
Food Safety and Applied Nutrition’s Library, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or at the National Archives and Records Administra-
tion (NARA). For information on the availability of this mate-
rial at NARA, call 202–741–6030, or go to: http://
codeloflfederallregulations/ibrllocations.html..
Tannin (including quebracho extract).
Tetrasodium EDTA.
Tetrasodium pyrophosphate.
141
§ 173.315 21 CFR Ch. I (4–1–12 Edition)
(d) Substances used alone or in com-

bination with substances in paragraph
(c) of this section:
Cyclohexylamine ............................................ Not to exceed 10 parts per million in steam, and excluding use of such steam in
contact with milk and milk products.
Diethylaminoethanol ....................................... Not to exceed 15 parts per million in steam, and excluding use of such steam in
Hydrazine ....................................................... Zero in steam.
Morpholine ...................................................... Not to exceed 10 parts per million in steam, and excluding use of such steam in
Octadecylamine .............................................. Not to exceed 3 parts per million in steam, and excluding use of such steam in
Trisodium nitrilotriacetate ............................... Not to exceed 5 parts per million in boiler feedwater; not to be used where steam
will be in contact with milk and milk products.
(e) To assure safe use of the additive, § 173.315 Chemicals used in washing
in addition to the other information re- or to assist in the peeling of fruits
quired by the Act, the label or labeling and vegetables.
shall bear: Chemicals may be safely used to
(1) The common or chemical name or wash or to assist in the peeling of
names of the additive or additives. fruits and vegetables in accordance
(2) Adequate directions for use to as- with the following conditions:
sure compliance with all the provisions
(a) The chemicals consist of one or
of this section.
more of the following:
[42 FR 14526, Mar. 15, 1977, as amended at 45 (1) Substances generally recognized
FR 73922, Nov. 7, 1980; 45 FR 85726, Dec. 30, as safe in food or covered by prior sanc-
1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. tions for use in washing fruits and
15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536,
Dec. 3, 1985; 53 FR 15199, Apr. 28, 1988; 54 FR
vegetables.
31012, July 26, 1989; 55 FR 12172, Apr. 2, 1990; (2) Substances identified in this sub-
61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, paragraph and subject to such limita-
1999; 64 FR 29227, June 1, 1999] tions as are provided:
A mixture of alkylene oxide adducts of alkyl alcohols and phosphate May be used at a level not to exceed 0.2 percent in
esters of alkylene oxide adducts of alkyl alcohols consisting of: a-alkyl lye-peeling solution to assist in the lye peeling of
(C12-C18)-omega-hydroxy-poly (oxyethylene) (7.5–8.5 moles)/poly fruit and vegetables.
(oxypropylene) block copolymer having an average molecular weight
of 810; a-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (3.3–3.7
moles) polymer having an average molecular weight of 380, and sub-
sequently esterified with 1.25 moles phosphoric anhydride; and a-alkyl
(C10-C12)-omega-hydroxypoly (oxyethylene) (11.9–12.9 moles)/poly
(oxypropylene) copolymer, having an average molecular weight of
810, and subsequently esterified with 1.25 moles phosphoric anhy-
dride.
Aliphatic acid mixture consisting of valeric, caproic, enanthic, caprylic, May be used at a level not to exceed 1 percent in lye
and pelargonic acids. peeling solution to assist in the lye peeling of fruits
and vegetables.
Polyacrylamide ............................................................................................ Not to exceed 10 parts per million in wash water.
Contains not more than 0.2 percent acrylamide
monomer. May be used in the washing of fruits
and vegetables.
Potassium bromide ..................................................................................... May be used in the washing or to assist in the lye
peeling of fruits and vegetables.
Sodium n-alkylbenzene-sulfonate (alkyl group predominantly C12 and C13 Not to exceed 0.2 percent in wash water. May be
and not less than 95 percent C10 to C16). used in washing or to assist in the lye peeling of
fruits and vegetables.
Sodium dodecylbenzene-sulfonate (alkyl group predominantly C12 and Do.
not less than 95% C10 to C16).
Sodium 2 ethyl-hexyl sulfate ....................................................................... Do.
Sodium hypochlorite .................................................................................... May be used in the washing or to assist in the lye
peeling of fruits and vegetables.
Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245–260) Not to exceed 0.2 percent in wash water. May be
used in the washing or to assist in the lye peeling
of fruits and vegetables.
142
(3) Sodium mono- and dimethyl naph- (1) The label and labeling of the addi-
thalene sulfonates (mol. wt. 245–260) tive container shall bear, in addition to
may be used in the steam/scald vacuum the other information required by the
peeling of tomatoes at a level not to act, the name of the additive or a
exceed 0.2 percent in the condensate or statement of its composition.
scald water. (2) The label or labeling of the addi-
(4) Substances identified in this para- tive container shall bear adequate use
graph (a)(4) for use in flume water for directions to assure use in compliance
washing sugar beets prior to the slicing with all provisions of this section.
operation and subject to the limita- [42 FR 14526, Mar. 15, 1977, as amended at 42
tions as are provided for the level of FR 29856, June 10, 1977; 42 FR 32229, June 24,
the substances in the flume water: 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376,
46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998;
Substance Limitations 64 FR 38564, July 19, 1999]
a-Alkyl-omega-hydroxypoly-(oxy- Not to exceed 3 ppm.
ethylene) produced by con-
§ 173.320 Chemicals for controlling
densation of 1 mole of C11- microorganisms in cane-sugar and
C486315 straight chain ran- beet-sugar mills.
domly substituted secondary al-
cohols with an average of 9
Agents for controlling microorga-
moles of ethylene oxide. nisms in cane-sugar and beet-sugar
Linear undecylbenzenesulfonic Do. mills may be safely used in accordance
acid. with the following conditions:
Dialkanolamide produced by con- Not to exceed 2 ppm.
densing 1 mole of methyl lau-
(a) They are used in the control of
rate with 1.05 moles of microorganisms in cane-sugar and/or
diethanolamine. beet-sugar mills as specified in para-
Triethanolamine ............................ Do. graph (b) of this section.
Ethylene glycol monobutyl ether .. Not to exceed 1 ppm.
Oleic acid conforming with Do.
(b) They are applied to the sugar mill
§ 172.860 of this chapter. grinding, crusher, and/or diffuser sys-
Tetrapotassium pyrophosphate .... Not to exceed 0.3 ppm. tems in one of the combinations listed
Monoethanolamine ....................... Do. in paragraph (b) (1), (2), (3), or (5) of
Ethylene dichloride ....................... Not to exceed 0.2 ppm.
Tetrasodium ethylenediamine- Not to exceed 0.1 ppm.
this section or as a single agent listed
tetraacetate. in paragraph (b) (4) or (6) of this sec-
tion. Quantities of the individual addi-
(5) Substances identified in this para- tives in parts per million are expressed
graph (a)(5) for use on fruits and vege- in terms of the weight of the raw cane
tables that are not raw agricultural or raw beets.
commodities and subject to the limita- (1) Combination for cane-sugar mills:
tions provided: Parts
per mil-
Substances Limitations lion
Hydrogen peroxide ......... Used in combination with acetic Disodium cyanodithioimidocarbonate ........................ 2.5
acid to form peroxyacetic acid. Ethylenediamine ........................................................ 1.0
Not to exceed 59 ppm in wash Potassium N-methyldithiocarbamate ......................... 3.5
water.
1-Hydroxyethylidene-1,1- May be used only with peroxy- (2) Combination for cane-sugar mills:
diphosphonic acid. acetic acid. Not to exceed 4.8
ppm in wash water. Parts
Peroxyacetic acid ............ Prepared by reacting acetic acid per mil-
with hydrogen peroxide. Not to lion
exceed 80 ppm in wash water.
Disodium ethylenebisdithiocarbamate ....................... 3.0
Sodium dimethyldithiocarbamate .............................. 3.0
(b) The chemicals are used in
amounts not in excess of the minimum (3) Combinations for cane-sugar mills
required to accomplish their intended and beet-sugar mills:
effect.
(c) The use of the chemicals listed Parts
per mil-
under paragraphs (a)(1), (a)(2), and lion
(a)(4) is followed by rinsing with pota-
ble water to remove, to the extent pos- (i) Disodium ethylenebisdithiocarbamate .................. 3.0
Ethylenediamine ........................................................ 2.0

sible, residues of the chemicals. Sodium dimethyldithiocarbamate .............................. 3.0
(d) To assure safe use of the additive: (ii) Disodium cyanodithioimidocarbonate ................... 2.9
143
§ 173.322 21 CFR Ch. I (4–1–12 Edition)
Parts (2) Substances identified in this para-

per mil- graph and subject to such limitations
lion
as are provided:
Potassium N-methyldithiocarbamate ......................... 4.1
(4) Single additive for cane-sugar alpha-Alkyl-omega- May be used at an applica-
mills and beet-sugar mills. hydroxypoly-(oxyethylene) tion rate not to exceed 0.3
produced by condensation percent by weight of cot-
Parts per million of a linear primary alcohol tonseeds to enhance
containing an average delinting of cottonseeds in-
2,2-Dibromo-3-nitrilopropionamide (CAS Not more than chain length of 10 carbons tended for the production
Reg. No. 10222–01–2). Limitations: By- 10.0 and not with poly(oxyethylene) hav- of cottonseed oil. Byprod-
product molasses, bagasse, and pulp less than 2.0. ing an average of 5 ethyl- ucts including lint, hulls,
containing residues of 2,2-dibromo-3- ene oxide units. and meal may be used in
nitrilopropionamide are not authorized animal feed.
for use in animal feed. An alkanomide produced by May be used at an applica-
condensation of coconut oil tion rate not to exceed 0.2
fatty acids and dietha- percent by weight of cot-
(5) Combination for cane-sugar mills: nolamine, CAS Reg. No. tonseeds to enhance
068603–42–9. delinting of cottonseeds in-
Parts per mil- tended for the production
lion
of cottonseed oil. Byprod-
ucts including lint, hulls,
n-Dodecyl dimethyl benzyl ammonium chlo-
and meal may be used in
ride ............................................................. 0.05±0.005
animal feed.
n-Dodecyl dimethyl ethylbenzyl ammonium
chloride ....................................................... 0.68±0.068
n-Hexadecyl dimethyl benzyl ammonium [47 FR 8346, Feb. 26, 1982]
chloride ....................................................... 0.30±0.030
n-Octadecyl dimethyl benzyl ammonium
chloride ....................................................... 0.05±0.005
§ 173.325 Acidified sodium chlorite so-
n-Tetradecyl dimethyl benzyl ammonium lutions.
chloride ....................................................... 0.60±0.060 Acidified sodium chlorite solutions
n-Tetradecyl dimethyl ethylbenzyl ammo-
nium chloride .............................................. 0.32±0.032
may be safely used in accordance with
(a) The additive is produced by mix-
Limitations. Byproduct molasses, ba-
ing an aqueous solution of sodium chlo-
gasse, and pulp containing residues of
rite (CAS Reg. No. 7758–19–2) with any
these quaternary ammonium salts are
generally recognized as safe (GRAS)
not authorized for use in animal feed.
acid.
(6) Single additive for beet-sugar (b)(1) The additive is used as an anti-
mills: microbial agent in poultry processing
Parts per million water in accordance with current in-
dustry practice under the following
Glutaraldehyde (CAS Reg. No. Not more than 250. conditions:
111–30–8).
(i) As a component of a carcass spray
or dip solution prior to immersion of
(c) To assure safe use of the addi-
the intact carcass in a prechiller or
tives, their label and labeling shall
chiller tank;
conform to that registered with the
(ii) In a prechiller or chiller solution
Environmental Protection Agency.
for application to the intact carcass;
[42 FR 14526, Mar. 15, 1977, as amended at 47 (iii) As a component of a spray or dip
FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29, solution for application to poultry car-
1985; 57 FR 8065, Mar. 6, 1992] cass parts;
(iv) In a prechiller or chiller solution
§ 173.322 Chemicals used in delinting for application to poultry carcass
cottonseed.
parts; or
Chemicals may be safely used to as- (v) As a component of a post-chill
sist in the delinting of cottonseed in carcass spray or dip solution when ap-
accordance with the following condi- plied to poultry meat, organs, or re-
tions: lated parts or trim.
(a) The chemicals consist of one or (2) When used in a spray or dip solu-
more of the following: tion, the additive is used at levels that
(1) Substances generally recognized result in sodium chlorite concentra-

as safe for direct addition to food. tions between 500 and 1,200 parts per
144
million (ppm), in combination with any commodities in the preparing, packing,

GRAS acid at a level sufficient to or holding of the food for commercial
achieve a solution pH of 2.3 to 2.9. purposes, consistent with section
(3) When used in a prechiller or chill- 201(q)(1)(B)(i) of the act, and not ap-
er solution, the additive is used at lev- plied for use under section
els that result in sodium chlorite con- 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or
centrations between 50 and 150 ppm, in (q)(1)(B)(i)(III) of the act, in accordance
combination with any GRAS acid at with current industry standards of
levels sufficient to achieve a solution good manufacturing practice. Applied
pH of 2.8 to 3.2. as a dip or a spray, the additive is used
(c) The additive is used as an anti- at levels that result in chlorite con-
microbial agent in accordance with centrations of 500 to 1200 parts per mil-
current industry practice in the proc- lion (ppm), in combination with any
essing of red meat, red meat parts, and GRAS acid at levels sufficient to
organs as a component of a spray or in achieve a pH of 2.3 to 2.9. Treatment of
the processing of red meat parts and the raw agricultural commodities with
organs as a component of a dip. Applied acidified sodium chlorite solutions
as a dip or spray, the additive is used shall be followed by a potable water
at levels that result in sodium chlorite rinse, or by blanching, cooking, or can-
concentrations between 500 and 1,200 ning.
ppm in combination with any GRAS
(f) The additive is used as an anti-
acid at levels sufficient to achieve a so-
microbial agent on processed,
lution pH of 2.5 to 2.9.
comminuted or formed meat food prod-
(d)(1) The additive is used as an anti-
ucts (unless precluded by standards of
microbial agent in water and ice that
identity in 9 CFR part 319) prior to
are used to rinse, wash, thaw, trans-
port, or store seafood in accordance packaging of the food for commercial
with current industry standards of purposes, in accordance with current
good manufacturing practice. The addi- industry standards of good manufac-
tive is produced by mixing an aqueous turing practice. Applied as a dip or
solution of sodium chlorite with any spray, the additive is used at levels
GRAS acid to achieve a pH in the range that result in sodium chlorite con-
of 2.5 to 2.9 and diluting this solution centrations of 500 to 1200 ppm, in com-
with water to achieve an actual use bination with any GRAS acid at levels
concentration of 40 to 50 parts per mil- sufficient to achieve a pH of 2.5 to 2.9.
lion (ppm) sodium chlorite. Any sea- (g) The additive is used as an anti-
food that is intended to be consumed microbial agent in the water applied to
raw shall be subjected to a potable processed fruits and processed root,
water rinse prior to consumption. tuber, bulb, legume, fruiting (i.e., egg-
(2) The additive is used as a single ap- plant, groundcherry, pepino, pepper,
plication in processing facilities as an tomatillo, and tomato), and cucurbit
antimicrobial agent to reduce patho- vegetables in accordance with current
genic bacteria due to cross-contamina- industry standards of good manufac-
tion during the harvesting, handling, turing practices, as a component of a
heading, evisceration, butchering, stor- spray or dip solution, provided that
ing, holding, packing, or packaging of such application be followed by a pota-
finfish and crustaceans; or following ble water rinse and a 24-hour holding
the filleting of finfish; in accordance period prior to consumption. However,
with current industry standards of for processed leafy vegetables (i.e.,
good manufacturing practice. Applied vegetables other than root, tuber, bulb,
as a dip or spray, the additive is used legume, fruiting, and cucurbit vegeta-
at levels that result in a sodium chlo- bles) and vegetables in the Brassica
rite concentration of 1,200 ppm, in com- [Cole] family, application must be by
bination with any GRAS acid at levels dip treatment only, and must be pre-
sufficient to achieve a pH of 2.3 to 2.9. ceded by a potable water rinse and fol-
Treated seafood shall be cooked prior lowed by a potable water rinse and a
to consumption. 24-hour holding period prior to con-
(e) The additive is used as an anti- sumption. When used in a spray or dip
microbial agent on raw agricultural solution, the additive is used at levels
145
§ 173.340 21 CFR Ch. I (4–1–12 Edition)
that result in sodium chlorite con- go to: http://www.archives.gov/

centrations between 500 and 1,200 ppm, federallregister/
in combination with any GRAS acid at codeloflfederallregulations/
a level sufficient to achieve a solution ibrllocations.html.
pH of 2.3 to 2.9.
(h) The concentration of sodium chlo- [61 FR 17829, Apr. 23, 1996, as amended at 63
FR 11119, Mar. 6, 1998; 64 FR 44123, Aug. 13,
rite is determined by a method entitled
1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776,
‘‘Determination of Sodium Chlorite: 50 Jan. 12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR
ppm to 1500 ppm Concentration,’’ Sep- 22922, May 7, 2001; 66 FR 31841, June 13, 2001;
tember 13, 1995, developed by Alcide 67 FR 15720, Apr. 3, 2002; 69 FR 78304, Dec. 30,
Corp., Redmond, WA, which is incor- 2004]
porated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. § 173.340 Defoaming agents.
Copies are available from the Division
Defoaming agents may be safely used
of Petition Control (HFS–215), Center
in processing foods, in accordance with
for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 the following conditions:
Paint Branch Pkwy., College Park, MD (a) They consist of one or more of the
20740, or may be examined at the Cen- following:
ter for Food Safety and Applied Nutri- (1) Substances generally recognized
tion’s Library, 5100 Paint Branch by qualified experts as safe in food or
Pkwy., College Park, MD 20740 20204– covered by prior sanctions for the use
0001, or at the National Archives and prescribed by this section.
Records Administration (NARA). For (2) Substances listed in this para-
information on the availability of this graph (a)(2) of this section, subject to
material at NARA, call 202–741–6030, or any limitations imposed:
Dimethylpolysiloxane (substantially free from hydrolyzable chlo- 10 parts per million in food, or at such level in a concentrated
ride and alkoxy groups; no more than 18 percent loss in food that when prepared as directed on the labels, the food
weight after heating 4 hours at 200 °C; viscosity 300 to 1,050 in its ready-for-consumption state will have not more than
centistokes at 25 °C; refractive index 1.400–1.404 at 25 °C). 10 parts per million except as follows: Zero in milk; 110
parts per million in dry gelatin dessert mixes labeled for use
whereby no more than 16 parts per million is present in the
ready-to-serve dessert; 250 parts per million in salt labeled
for cooking purposes, whereby no more than 10 parts per
million is present in the cooked food.
Formaldehyde ............................................................................... As a preservative in defoaming agents containing
dimethylpolysiloxane, in an amount not exceeding 1.0 per-
cent of the dimethylpolysiloxane content.
a-Hydro-omega-hydroxy-poly (oxyethylene)/poly(oxypropylene) For use as prescribed in § 172.808(b)(3) of this chapter.
(minimum 15 moles)/poly(oxyethylene) block copolymer (CAS
Reg. No. 9003–11–6) as defined in § 172.808(a)(3) of this
chapter.
Polyacrylic acid, sodium salt ........................................................ As a stabilizer and thickener in defoaming agents containing
dimethylpolysiloxane in an amount reasonably required to
accomplish the intended effect.
Polyethylene glycol ....................................................................... As defined in § 172.820 of this chapter.
Polyoxyethylene 40 monostearate ............................................... As defined in U.S.P. XVI.
Polysorbate 60 .............................................................................. As defined in § 172.836 of this chapter.
Polysorbate 65 .............................................................................. As defined in § 172.838 of this chapter.
Propylene glycol alginate .............................................................. As defined in § 172.858 of this chapter.
Silicon dioxide ............................................................................... As defined in § 172.480 of this chapter.
Sorbitan monostearate ................................................................. As defined in § 172.842 of this chapter.
White mineral oil: Conforming with § 172.878 of this chapter ...... As a component of defoaming agents for use in wash water
for sliced potatoes at a level not to exceed 0.008 percent of
the wash water.
(3) Substances listed in this para- use in processing beet sugar and yeast,
graph (a)(3), provided they are compo- and subject to any limitations im-
nents of defoaming agents limited to posed:
Aluminum stearate ...................................................................................... As defined in § 172.863 of this chapter.
146
Butyl stearate.
BHA ............................................................................................................. As an antioxidant, not to exceed 0.1 percent by
weight of defoamer.
BHT ............................................................................................................. Do.
Calcium stearate ......................................................................................... As defined in § 172.863 of this chapter.
Fatty acids ................................................................................................... As defined in § 172.860 of this chapter.
Formaldehyde ............................................................................................. As a preservative.
Hydroxylated lecithin ................................................................................... As defined in § 172.814 of this chapter.
Isopropyl alcohol.
Magnesium stearate .................................................................................... As defined in § 172.863 of this chapter.
Mineral oil: Conforming with § 172.878 of this chapter .............................. Not more than 150 p.p.m. in yeast, measured as hy-
drocarbons.
Odorless light petroleum hydrocarbons: Conforming with § 172.884 of
this chapter.
Petrolatum: Conforming with § 172.880 of this chapter ..............................
Petroleum wax: Conforming with § 172.886 of this chapter.
Petroleum wax, synthetic.
Polyethylene glycol (400)dioleate: Conforming with § 172.820(a)(2) of As an emulsifier not to exceed 10 percent by weight
this chapter and providing the oleic acid used in the production of this of defoamer formulation.
substance complies with § 172.860 or § 172.862 of this chapter.
Synthetic isoparaffinic petroleum hydrocarbons: Conforming with
Oleic acid derived from tall oil fatty acids ................................................... Complying with § 172.862 of this chapter.
Oxystearin ................................................................................................... As defined in § 172.818 of this chapter.
Polyoxyethylene (600) dioleate.
Polyoxyethylene (600) monoricinoleate.
Polypropylene glycol ................................................................................... Molecular weight range, 1,200–3,000.
Polysorbate 80 ............................................................................................ As defined in § 172.840 of this chapter.
Potassium stearate ..................................................................................... As defined in § 172.863 of this chapter.
Propylene glycol mono- and diesters of fats and fatty acids ..................... As defined in § 172.856 of this chapter.
Soybean oil fatty acids, hydroxylated.
Tallow, hydrogenated, oxidized or sulfated.
Tallow alcohol, hydrogenated.
147
§ 173.342 21 CFR Ch. I (4–1–12 Edition)
(4) The substances listed in this para- 1,2,2-trifluoroethane) (CAS Reg. No. 76–
graph (a)(4), provided they are compo- 13–1, also known as fluorocarbon 113,
nents of defoaming agents limited to CFC 113 and FC 113) and 1 percent
use in processing beet sugar only, and perfluorohexane (CAS Reg. No. 355–42–
subject to the limitations imposed: 0) may be safely used in accordance
tions:
n-Butoxypoly(oxyethylene)- Viscosity range, 4,850–5,350 (a) The additive chlorofluorocarbon
poly(oxypropylene)glycol. Saybolt Universal Seconds
(SUS) at 37.8 °C (100 °F).
113 has a purity of not less than 99.99
The viscosity range is de- percent.
termined by the method (b) The additive mixture is intended
‘‘Viscosity Determination of
n-butoxypoly(oxyethylene)- for use to quickly cool or crust-freeze
poly(oxypropylene) glycol’’ chickens sealed in intact bags com-
dated April 26, 1995, de- posed of substances regulated in parts
veloped by Union Carbide
Corp., P.O. Box 670, 174, 175, 177, 178, and § 179.45 of this
Bound Brook, NJ 08805, chapter and conforming to any limita-
which is incorporated by tions or specifications in such regula-
reference in accordance
with 5 U.S.C. 552(a) and 1 tions.
CFR part 51. Copies of the
material incorporated by [55 FR 8913, Mar. 9, 1990]
reference are available
from the Division of Petition § 173.345 Chloropentafluoroethane.
Control, Center for Food
Safety and Applied Nutri- The food additive
tion (HFS–215), Food and chloropentafluoroethane may be safely
Drug Administration, 5100
Paint Branch Pkwy., Col- used in food in accordance with the fol-
lege Park, MD 20740, and lowing prescribed conditions:
may be examined at the (a) The food additive has a purity of
Center for Food Safety and
Applied Nutrition’s Library, not less than 99.97 percent, and con-
5100 Paint Branch Pkwy., tains not more than 200 parts per mil-
College Park, MD 20740, lion saturated fluoro compounds and 10
or at the National Archives
and Records Administration parts per million unsaturated fluoro
(NARA). For information on compounds as impurities.
the availability of this mate-
rial at NARA, call 202–
741–6030, or go to: http:// for use alone or with one or more of the
www.archives.gov/federall following substances: Carbon dioxide,
register/codeloflfederal
lregulations/ibrlloca-
nitrous oxide, propane, and
tions.html. octafluorocyclobutane complying with
Monoester of alpha-hydro- § 173.360, as an aerating agent for
omega-hydroxy- foamed or sprayed food products, with
poly(oxyethylene)
poly(oxypropylene) any propellant effect being incidental
poly(oxyethylene) (15 mole and no more than is minimally nec-
minimum) blocked copoly-
mer derived from low eru-
essary to achieve the aerating func-
cic acid rapeseed oil. tion, except that use is not permitted
for those standardized foods that do
(b) They are added in an amount not not provide for such use.
in excess of that reasonably required to (c) To assure safe use of the additive
inhibit foaming. (1) The label of the food additive con-
[42 FR 14526, Mar. 15, 1977, as amended at 43 tainer shall bear, in addition to the
FR 2872, Jan. 20, 1978; 46 FR 30493, June 9, other information required by the act,
1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, the following:
Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR (i) The name of the additive,
29134, May 28, 1998] chloropentafluoroethane.
§ 173.342 Chlorofluorocarbon 113 and (ii) The percentage of the additive
perfluorohexane. present in the case of a mixture.
(iii) The designation ‘‘food grade’’.

A mixture of 99 percent
chlorofluorocarbon 113 (1,1,2-trichloro-
148
(2) The label or labeling of the food microns to 310 millimicrons, under the same
additive container shall bear adequate instrumental conditions. The standard ref-
directions for use. erence absorbance is the absorbance at 275
millimicrons of a standard reference solution
[42 FR 14526, Mar. 15, 1977, as amended at 43 of naphthalene (National Bureau of Stand-
FR 11317, Mar. 17, 1978; 43 FR 14644, Apr. 7, ards Material No. 577 or equivalent in purity)
1978] containing a concentration of 1.4 milligrams
per liter in purified isooctane, measured
§ 173.350 Combustion product gas. against isooctane of the same spectral purity
in 5-centimeter cells. (This absorbance will
The food additive combustion prod-
be approximately 0.30.)
uct gas may be safely used in the proc- Solvent. The solvent used is pure grade iso-
essing and packaging of the foods des- octane having an ultraviolet absorbance not
ignated in paragraph (c) of this section to exceed 0.05 measured against distilled
for the purpose of removing and dis- water as a reference. Upon passage of puri-
placing oxygen in accordance with the fied inert gas through some isooctane under
following prescribed conditions: the identical conditions of the test, a low-
(a) The food additive is manufactured ering of the absorbance value has been ob-
served. The absorbance of isooctane to be
by the controlled combustion in air of used in this procedure shall not be more than
butane, propane, or natural gas. The 0.02 lower in the range 255 millimicrons to
combustion equipment shall be pro- 310 millimicrons, inclusive, than that of the
vided with an absorption-type filter ca- untreated solvent as measured in a 5-centi-
pable of removing possible toxic impu- meter cell. If necessary to obtain the pre-
rities, through which all gas used in scribed purities, the isooctane may be passed
the treatment of food shall pass; and through activated silica gel.
with suitable controls to insure that Apparatus. To assure reproducible results,
the additive is passed into the isooctane so-
any combustion products failing to lution through a gas-absorption train con-
meet the specifications provided in this sisting of the following components and nec-
section will be prevented from reaching essary connections:
the food being treated. 1. A gas flow meter with a range up to 30
(b) The food additive meets the fol- liters per hour provided with a constant dif-
lowing specifications: ferential relay or other device to maintain a
(1) Carbon monoxide content not to constant flow rate independent of the input
pressure.
exceed 4.5 percent by volume.
2. An absorption apparatus consisting of an
(2) The ultraviolet absorbance in iso- inlet gas dispersion tube inserted to the bot-
octane solution in the range 255 milli- tom of a covered cylindrical vessel with a
microns to 310 millimicrons not to ex- suitable outlet on the vessel for effluent gas.
ceed one-third of the standard ref- The dimensions and arrangement of tube and
erence absorbance when tested as de- vessel are such that the inlet tube introduces
scribed in paragraph (e) of this section. the gas at a point not above 51⁄4 inches below
(c) It is used or intended for use to the surface of the solvent through a sintered
glass outlet. The dimensions of the vessel are
displace or remove oxygen in the proc-
such, and both inlet and vessel are so de-
essing, storage, or packaging of bev- signed, that the gas can be bubbled through
erage products and other food, except 60 milliliters of isooctane solvent at a rate
fresh meats. up to 30 liters per hour without mechanical
(d) To assure safe use of the additive loss of solvent. The level corresponding to 60
in addition to the other information re- milliliters should be marked on the vessel.
quired by the act, the label or labeling 3. A cooling bath containing crushed ice
of the combustion device shall bear and water to permit immersion of the ab-
sorption vessel at least to the solvent level
adequate directions for use to provide a
mark.
combustion product gas that complies Caution. The various parts of the absorp-
with the limitations prescribed in para- tion train must be connected by gas-tight
graph (b) of this section, including in- tubing and joints composed of materials
structions to assure proper filtration. which will neither remove components from
(e) The food additive is tested for nor add components to the gas stream. The
compliance with paragraph (b)(2) by gas source is connected in series to the flow-
the following empirical method: rate device, the flow meter, and the absorp-
tion apparatus in that order. Ventilation
Spectrophotometric measurements. All meas- should be provided for the effluent gases
urements are made in an ultraviolet spectro- which may contain carbon monoxide.
photometer in optical cells of 5 centimeters Sampling procedure. Immerse the gas-ab-
in length, and in the range of 255 milli- sorption apparatus containing 60 milliliters
149
§ 173.355 21 CFR Ch. I (4–1–12 Edition)
of isooctane in the coolant bath so that the corporated by reference. The Director
solvent is completely immersed. Cool for at of the Federal Register approves this
least 15 minutes and then pass 120 liters of
incorporation by reference in accord-
the test gas through the absorption train at
a rate of 30 liters per hour or less. Maintain ance with 5 U.S.C. 552(a) and 1 CFR
the coolant bath at 0 °C throughout. Remove part 51. You may obtain copies from
the absorption vessel from the bath, dis- the United States Pharmacopeial Con-
connect, and warm to room temperature. vention, 12601 Twinbrook Pkwy., Rock-
Add isooctane to bring the contents of the ville, MD 20852 (Internet address http://
absorption vessel to 60 milliliters, and mix. www.usp.org). Copies may be examined
Determine the absorbance of the solution in
the 5-centimeter cell in the range 255 milli-
at the Center for Food Safety and Ap-
microns to 310 millimicrons, inclusive, com- plied Nutrition’s Library, Food and
pared to isooctane. The absorbance of the so- Drug Administration, 5100 Paint
lution of combustion product gas shall not Branch Pkwy., College Park, MD 20740,
exceed that of the isooctane solvent at any 301–436–2163, or at the National Ar-
wavelength in the specified range by more chives and Records Administration
than one-third of the standard reference ab-
sorbance.
§ 173.355 Dichlorodifluoromethane. 202–741–6030, or go to: http://
The food additive dichlorodi-
fluoromethane may be safely used in
ibrllocations.html.
prescribed conditions: (b) The additive is used as an anti-
(a) The additive has a purity of not microbial agent in the production of
less than 99.97 percent. modified whey (including, but not lim-
(b) It is used or intended for use, in ited to, whey protein concentrates and
accordance with good manufacturing whey protein isolates) by
practice, as a direct-contact freezing ultrafiltration methods, at a level not
agent for foods. to exceed 0.001 percent by weight of the
(c) To assure safe use of the additive: whey, providing that residual hydrogen
(1) The label of its container shall peroxide is removed by appropriate
bear, in addition to the other informa- chemical or physical means during the
tion required by the act, the following: processing of the modified whey.
(i) The name of the additive, dichlo-
[76 FR 11330, Mar. 2, 2011]
rodifluoromethane, with or without the
parenthetical name ‘‘Food Freezant § 173.357 Materials used as fixing
12’’. agents in the immobilization of en-
(ii) The designation ‘‘food grade’’. zyme preparations.
(2) The label or labeling of the food
additive container shall bear adequate Fixing agents may be safely used in
directions for use. the immobilization of enzyme prepara-
tions in accordance with the following
§ 173.356 Hydrogen peroxide. conditions:
Hydrogen peroxide (CAS Reg. No. (a) The materials consist of one or
7722–84–1) may be safely used to treat more of the following:
food in accordance with the following (1) Substances generally recognized
conditions: as safe in food.
(a) The additive meets the specifica- (2) Substances identified in this sub-
tions of the Food Chemicals Codex, 7th paragraph and subject to such limita-
ed. (2010), pp. 496 and 497, which is in- tions as are provided:
Acrylamide-acrylic acid resin: Complying May be used as a fixing material in the immobilization of glucose isomerase en-
with § 173.5(a)(1) and (b) of this chapter. zyme preparations for use in the manufacture of high fructose corn syrup, in ac-
cordance with § 184.1372 of this chapter.
Cellulose triacetate ..................................... May be used as a fixing material in the immobilization of lactase for use in reducing
the lactose content of milk.
Diethylaminoethyl-cellulose ........................ May be used as a fixing material in the immobilization of glucose isomerase en-
zyme preparations for use in the manufacture of high fructose corn syrup, in ac-
cordance with § 184.1372 of this chapter.
150
Dimethylamine-epichlorohydrin resin: May be used as a fixing material in the immobilization of glucose isomerase en-
Complying with § 173.60(a) and (b) of zyme preparations for use in the manufacture of high fructose corn syrup, in ac-
this chapter. cordance with § 184.1372 of this chapter.
Glutaraldehyde ........................................... Do.
Periodic acid (CAS Reg. No. 10450–60–
9)..
Polyethylenimine reaction product with May be used as a fixing material in the immobilization of glucoamylase enzyme
1,2-dichloroethane (CAS Reg. No. preparations from Aspergillus niger for use in the manufacture of beer.
68130–97–2) is the reaction product of May be used as a fixing material in the immobilization of:
homopolymerization of ethylenimine in 1. Glucose isomerase enzyme preparations for use in the manufacture of high fruc-
aqueous hydrochloric acid at 100 °C tose corn syrup, in accordance with § 184.1372 of this chapter.
and of cross-linking with 1,2- 2. Glucoamylase enzyme preparations from Aspergillus niger for use in the manu-
dichloroethane. The finished polymer facture of beer. Residual ethylenimine in the finished polyethylenimine polymer
has an average molecular weight of will be less than 1 part per million as determined by gas chromatography-mass
50,000 to 70,000 as determined by gel spectrometry. The residual ethylenimine is determined by an analytical method
permeation chromatography. The analyt- entitled ‘‘Methodology for Ethylenimine Detection in Polyethylenimine,’’ which is
ical method is entitled ‘‘Methodology for incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Molecular Weight Detection of Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less
Polyethylenimine,’’ which is incorporated than 1 part per million as determined by gas chromatography. The residual 1,2-
by reference in accordance with 5 dichloroethane is determined by an analytical method entitled, ‘‘Methodology for
U.S.C. 552(a) and 1 CFR part 51. Cop- Ethylenedichloride Detection in Polyethylenimine,’’ which is incorporated by ref-
ies may be obtained from the Division of erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
Petition Control, Center for Food Safety obtained from the Division of Petition Control, Center for Food Safety and Applied
and Applied Nutrition (HFS–200), 5100 Nutrition (HFS–215), 5100 Paint Branch Pkwy., College Park, MD 20740, or may
Paint Branch Pkwy., College Park, MD be examined at the Center for Food Safety and Applied Nutrition’s Library, 5100
20740, and may be examined at the Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and
Center for Food Safety and Applied Nu- Records Administration (NARA). For information on the availability of this material
trition’s Library, 5100 Paint Branch at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/
Pkwy., College Park, MD 20740, or at codeloflfederallregulations/ibrllocations.html.
ministration (NARA). For information on
the availability of this material at NARA,
call 202–741–6030, or go to: http://
(b) The fixed enzyme preparation is standardized foods that do not provide
washed to remove residues of the fixing for such use.
materials. (c) To assure safe use of the additive:
(1) The label of the food additive con-
[48 FR 5716, Feb. 8, 1983, as amended at 52 FR
39512, Oct. 22, 1987; 55 FR 12172, Apr. 2, 1990;
tainer shall bear, in addition to the
59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, other information required by the act,
1996; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, the following:
June 25, 2002] (i) The name of the additive,
octafluorocyclobutane.
§ 173.360 Octafluorocyclobutane. (ii) The percentage of the additive
The food additive octafluorocyclo-bu- present in the case of a mixture.
tane may be safely used as a propellant (iii) The designation ‘‘food grade’’.
and aerating agent in foamed or (2) The label or labeling of the food
sprayed food products in accordance additive container shall bear adequate
with the following conditions: directions for use.
(a) The food additive meets the fol- § 173.368 Ozone.
Ozone (CAS Reg. No. 10028–15–6) may
99.99 percent octafluorocyclobutane. be safely used in the treatment, stor-
Less than 0.1 part per million fluoroolefins, age, and processing of foods, including
calculated as perfluoroisobutylene.
meat and poultry (unless such use is
(b) The additive is used or intended precluded by standards of identity in 9
for use alone or with one or more of the CFR part 319), in accordance with the
following substances: Carbon dioxide, following prescribed conditions:
nitrous oxide, and propane, as a propel- (a) The additive is an unstable, color-
lant and aerating agent for foamed or less gas with a pungent, characteristic
sprayed food products, except for those odor, which occurs freely in nature. It
151
§ 173.370 21 CFR Ch. I (4–1–12 Edition)
is produced commercially by passing (b)(1) The additive is used as an anti-

electrical discharges or ionizing radi- microbial agent on meat carcasses,
ation through air or oxygen. parts, trim, and organs in accordance
(b) The additive is used as an anti- with current industry practice where
microbial agent as defined in the maximum concentration of
§ 170.3(o)(2) of this chapter. peroxyacids is 220 parts per million
(c) The additive meets the specifica- (ppm) as peroxyacetic acid, and the
tions for ozone in the Food Chemicals maximum concentration of hydrogen
Codex, 4th ed. (1996), p. 277, which is in- peroxide is 75 ppm.
corporated by reference. The Director (2) The additive is used as an anti-
of the Office of the Federal Register microbial agent on poultry carcasses,
approves this incorporation by ref- poultry parts, and organs in accord-
erence in accordance with 5 U.S.C. ance with current industry standards
552(a) and 1 CFR part 51. Copies are of good manufacturing practice (unless
available from the National Academy precluded by the U.S. Department of
Press, 2101 Constitution Ave. NW., Agriculture’s standards of identity in 9
Washington, DC 20055, or may be exam- CFR part 381, subpart P) where the
ined at the Office of Premarket Ap- maximum concentration of
proval (HFS–200), Center for Food Safe- peroxyacids is 220 parts per million
ty and Applied Nutrition, Food and (ppm) as peroxyacetic acid, the max-
Drug Administration, 5100 Paint imum concentration of hydrogen per-
Branch Pkwy., College Park, MD 20740, oxide is 110 ppm, and the maximum
and at the National Archives and concentration of 1-hydroxyethylidene-
Records Administration (NARA). For 1,1-diphosphonic acid (HEDP) is 13 ppm.
information on the availability of this (c) The concentrations of peroxyacids
material at NARA, call 202–741–6030, or and hydrogen peroxide in the additive
go to: http://www.archives.gov/ are determined by a method entitled
federallregister/ ‘‘Hydrogen Peroxide and Peracid (as
codeloflfederallregulations/ Peracetic Acid) Content,’’ July 26, 2000,
ibrllocations.html. developed by Ecolab, Inc., St. Paul,
(d) The additive is used in contact MN, which is incorporated by ref-
with food, including meat and poultry erence. The concentration of 1-
(unless such use is precluded by stand- hydroxyethylidene-1,1-diphosphonic
ards of identity in 9 CFR part 319 or 9 acid is determined by a method enti-
CFR part 381, subpart P), in the gas- tled ‘‘Determination of 1-
eous or aqueous phase in accordance hydroxyethylidene-1,1-diphosphonic
with current industry standards of acid (HEDP) Peroxyacid/Peroxide-Con-
good manufacturing practice. taining Solutions,’’ August 21, 2001, de-
(e) When used on raw agricultural veloped by Ecolab, Inc., St. Paul, MN,
commodities, the use is consistent with which is incorporated by reference. The
section 201(q)(1)(B)(i) of the Federal Director of the Office of the Federal
Food, Drug, and Cosmetic Act (the act) Register approves these incorporations
and not applied for use under section by reference in accordance with 5
201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or U.S.C. 552(a) and 1 CFR part 51. You
(q)(1)(B)(i)(III) of the act. may obtain copies of these methods
from the Division of Petition Review,
[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, Center for Food Safety and Applied Nu-
2002] trition, Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
§ 173.370 Peroxyacids.
MD 20740, or you may examine a copy
Peroxyacids may be safely used in ac- at the Center for Food Safety and Ap-
cordance with the following prescribed plied Nutrition’s Library, 5100 Paint
conditions: Branch Pkwy., College Park, MD 20740,
(a) The additive is a mixture of per- or at the National Archives and
oxyacetic acid, octanoic acid, acetic Records Administration (NARA). For
acid, hydrogen peroxide, information on the availability of this
peroxyoctanoic acid, and 1- material at NARA, call 202–741–6030, or
hydroxyethylidene-1,1-diphosphonic go to: http://www.archives.gov/

acid. federallregister/
152
codeloflfederallregulations/ prior to or after chilling at an amount

ibrllocations.html. not to exceed 5 gallons of solution per
[65 FR 70660, Nov. 27, 2000, as amended at 66
carcass, provided that the additive is
FR 48208, Sept. 19, 2001; 67 FR 61784, Oct. 2, used in systems that recapture at least
2002] 99 percent of the solution that is ap-
plied to the poultry carcasses. The con-
§ 173.375 Cetylpyridinium chloride. centration of cetylpyridinium chloride
Cetylpyridinium chloride (CAS Reg. in the solution applied to the carcasses
No. 123–93–5) may be safely used in food shall not exceed 0.8 percent by weight.
in accordance with the following condi- When application of the additive is not
tions: followed by immersion in a chiller, the
(a) The additive meets the specifica- treatment will be followed by a potable
tions of the United States Pharma- water rinse of the carcass.
copeia (USP)/National Formulary (NF) [72 FR 67576, Nov. 29, 2007, as amended at 76
described in USP 30/NF 25, May 1, 2007, FR 59248, Sept. 26, 2011]
pp. 1700–1701, which is incorporated by
reference. The Director of the Office of § 173.385 Sodium methyl sulfate.
the Federal Register approves this in- Sodium methyl sulfate may be
corporation by reference in accordance
present in pectin in accordance with
with 5 U.S.C. 552(a) and 1 CFR part 51.
the following conditions.
You may obtain copies from the United
(a) It is present as the result of
States Pharmacopeial Convention,
methylation of pectin by sulfuric acid
Inc., 12601 Twinbrook Pkwy., Rock-
and methyl alcohol and subsequent
ville, MD 20852, or you may examine a
treatment with sodium bicarbonate.
copy at the Center for Food Safety and
(b) It does not exceed 0.1 percent by
Applied Nutrition’s Library, Food and
weight of the pectin.
Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, § 173.395 Trifluoromethane sulfonic
or at the National Archives and acid.
information on the availability of this Trifluoromethane sulfonic acid has
material at NARA, call 202–741–6030, or the empirical formula CF3SO3H (CAS
go to: http://www.archives.gov/federal- Reg. No. 1493–13–6). The catalyst
register/cfr/ibr-locations.html. (Trifluoromethane sulfonic acid) may
(b) The additive is used in food as an safely be used in the production of
antimicrobial agent as defined in cocoa butter substitute from palm oil
§ 170.3(o)(2) of this chapter to treat the (1-palmitoyl-2-oleoyl-3-stearin) (see
surface of raw poultry carcasses. The § 184.1259 of this chapter) in accordance
solution in which the additive is used with the following conditions:
to treat raw poultry carcasses shall (a) The catalyst meets the following
also contain propylene glycol (CAS specifications:
Reg. No. 57–55–6) complying with Appearance, Clear liquid.
§ 184.1666 of this chapter, at a con- Color, Colorless to amber.
centration of 1.5 times that of Neutralization equivalent, 147–151.
cetylpyridinium chloride. Water, 1 percent maximum.
(c) The additive is used as follows: Fluoride ion, 0.03 percent maximum.
(1) As a fine mist spray of an ambient Heavy metals (as Pb), 30 parts per million
temperature aqueous solution applied maximum.
Arsenic (as As), 3 parts per million max-
to raw poultry carcasses prior to im-
imum.
mersion in a chiller, at a level not to
exceed 0.3 gram cetylpyridinium chlo- (b) It is used at levels not to exceed
ride per pound of raw poultry carcass, 0.2 percent of the reaction mixture to
provided that the additive is used in catalyze the directed esterification.
systems that collect and recycle solu- (c) The esterification reaction is
tion that is not carried out of the sys- quenched with steam and water and
tem with the treated poultry carcasses; the catalyst is removed with the aque-
or ous phase. Final traces of catalyst are
(2) As a liquid aqueous solution ap- removed by washing batches of the

plied to raw poultry carcasses either product three times with an aqueous
153
§ 173.400 21 CFR Ch. I (4–1–12 Edition)
solution of 0.5 percent sodium bicar- tains not more than a total of 2 percent
bonate. by weight of free amine and amine hy-
(d) No residual catalyst may remain drochloride. The food additive de-
in the product at a detection limit of scribed in paragraph (a)(2) of this sec-
0.2 part per million fluoride as deter- tion contains not more than 3 percent
mined by the method described in ‘‘Of- by weight, each, of free amine and
ficial Methods of Analysis of the Asso- amine hydrochloride as determined by
ciation of Official Analytical Chem- A.O.C.S. method Te 3a–64, ‘‘Acid Value
ists,’’ sections 25.049–25.055, 13th Ed. and Free Amine Value of Fatty Quater-
(1980), which is incorporated by ref- nary Ammonium Chlorides,’’ 2d print-
erence. Copies may be obtained from ing including additions and revisions
the AOAC INTERNATIONAL, 481 North 1990, which is incorporated by reference
Frederick Ave., suite 500, Gaithersburg, in accordance with 5 U.S.C. 552(a) and 1
MD 20877, or may be examined at the CFR part 51. Copies are available from
National Archives and Records Admin- the Center for Food Safety and Applied
istration (NARA). For information on Nutrition (HFS–200), Food and Drug
the availability of this material at Administration, 5100 Paint Branch
NARA, call 202–741–6030, or go to: http:// Pkwy., College Park, MD 20740, and
www.archives.gov/federallregister/ from the American Oil Chemists’ Soci-
codeloflfederallregulations/ ety, P.O. Box 5037, Station A, Cham-
ibrllocations.html. paign, IL 61820, or available for inspec-
[43 FR 54237, Nov. 11, 1978, as amended at 49
FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, Records Administration (NARA). For
1989; 70 FR 40880, July 15, 2005; 70 FR 67651, information on the availability of this
Nov. 8, 2005] material at NARA, call 202–741–6030, or
§ 173.400 Dimethyldialkylammonium federallregister/
chloride. codeloflfederallregulations/
Dimethyldialkylammonium chloride ibrllocations.html.
may be safely used in food in accord- (c) The food additive is used as a de-
ance with the following prescribed con- colorizing agent in the clarification of
ditions: refinery sugar liquors under the fol-
(a) The food additive is produced by lowing limitations:
one of the following methods: (1) The food additive described in
(1) Ammonolysis of natural tallow paragraph (a)(1) of this section is added
fatty acids to form amines that are only at the defecation/clarification
subsequently reacted with methyl chlo- stage of sugar liquor refining in an
ride to form the quaternary ammonium amount not to exceed 700 parts per mil-
compounds consisting primarily of lion by weight of sugar solids.
dimethyldioctadecylammonium chlo- (2) The food additive described in
ride and dimethyldihexadecyl- paragraph (a)(2) of this section is used
ammonium chloride. The additive may under the following conditions:
contain residues of isopropyl alcohol (i) The additive is adsorbed onto a
not in excess of 18 percent by weight support column composed of suitable
when used as a processing solvent. polymers that are regulated for con-
(2) Ammonolysis of natural tallow tact with aqueous food. Excess non-
fatty acids to form amines that are adsorbed additive shall be rinsed away
then reacted with 2-ethylhexanal, re- with potable water prior to passage of
duced, methylated, and subsequently sugar liquor through the column.
reacted with methyl chloride to form (ii) The residue of the additive in the
the quaternary ammonium compound decolorized sugar liquor prior to crys-
known as dimethyl(2-ethylhexyl) hy- tallization shall not exceed 1 part per
drogenated tallow ammonium chloride million of sugar as determined by a
and consisting primarily of dimethyl(2- method entitled ‘‘Colorimetric Deter-
ethylhexyl)octadecylammonium chlo- mination of Residual Quaternary Am-
ride and dimethyl(2-ethyl- monium Compounds (Arquad HTL8) in
hexyl)hexadecylammonium chloride. Sugar and Sugar Solutions,’’ June 13,
(b) The food additive described in 1990, which is incorporated by reference

paragraph (a)(1) of this section con- in accordance with 5 U.S.C. 552(a) and 1
154
CFR part 51. Copies are available from (2) Any substance used as a compo-
the Center for Food Safety and Applied nent of articles that contact food shall
Nutrition (HFS–200), Food and Drug be of a purity suitable for its intended
Administration, 5100 Paint Branch use.
Pkwy., College Park, MD 20740, or (b) The existence in the subchapter B
available for inspection at the National of a regulation prescribing safe condi-
Archives and Records Administration tions for the use of a substance as an
(NARA). For information on the avail- article or component of articles that
ability of this material at NARA, call contact food shall not be construed to
202–741–6030, or go to: http:// relieve such use of the substance or ar-
www.archives.gov/federallregister/ ticle from compliance with any other
codeloflfederallregulations/ provision of the Federal Food, Drug,
ibrllocations.html. and Cosmetic Act. For example, if a
(d) To assure safe use of the additive, regulated food-packaging material
the label and labeling of the additive were found on appropriate test to im-
shall bear, in addition to other infor- part odor or taste to a specific food
mation required by the Federal Food, product such as to render it unfit with-
Drug, and Cosmetic Act, adequate di- in the meaning of section 402(a)(3) of
rections to assure use in compliance the Act, the regulation would not be
with paragraph (c) of this section. construed to relieve such use from
compliance with section 402(a)(3).
[56 FR 42686, Aug. 29, 1991]
(c) The existence in this subchapter B
of a regulation prescribing safe condi-
PART 174—INDIRECT FOOD tions for the use of a substance as an
ADDITIVES: GENERAL article or component of articles that
contact food shall not be construed as
Sec. implying that such substance may be
174.5 General provisions applicable to indi- safely used as a direct additive in food.
rect food additives. (d) Substances that under conditions
174.6 Threshold of regulation for substances of good manufacturing practice may be
used in food-contact articles.
safely used as components of articles
AUTHORITY: 21 U.S.C. 321, 342, 348, 371. that contact food include the fol-
lowing, subject to any prescribed limi-
§ 174.5 General provisions applicable tations:
to indirect food additives. (1) Substances generally recognized
(a) Regulations prescribing condi- as safe in or on food.
tions under which food additive sub- (2) Substances generally recognized
stances may be safely used predicate as safe for their intended use in food
usage under conditions of good manu- packaging.
facturing practice. For the purpose of (3) Substances used in accordance
this part and parts 175, 176, and 177 of with a prior sanction or approval.
this chapter, good manufacturing prac- (4) Substances permitted for use by
tice shall be defined to include the fol- regulations in this part and parts 175,
lowing restrictions: 176, 177, 178 and § 179.45 of this chapter.
(1) The quantity of any food additive (5) Food contact substances used in
substance that may be added to food as accordance with an effective pre-
a result of use in articles that contact market notification for a food contact
food shall not exceed, where no limits substance (FCN) submitted under sec-
are specified, that which results from tion 409(h) of the act.
use of the substance in an amount not [42 FR 14534, Mar. 15, 1977, as amended at 67
more than reasonably required to ac- FR 35731, May 21, 2002]
complish the intended physical or tech-
nical effect in the food-contact article; § 174.6 Threshold of regulation for
shall not exceed any prescribed limita- substances used in food-contact ar-
tions; and shall not be intended to ac- ticles.
complish any physical or technical ef- Substances used in food-contact arti-
fect in the food itself, except as such cles (e.g., food-packaging or food-proc-
may be permitted by regulations in essing equipment) that migrate, or

parts 170 through 189 of this chapter. that may be expected to migrate, into
155
food at negligible levels may be re- Subpart B—Substances for Use

viewed under § 170.39 of this chapter. Only as Components of Adhesives
The Food and Drug Administration
will exempt substances whose uses it § 175.105 Adhesives.
determines meet the criteria in § 170.39
(a) Adhesives may be safely used as
of this chapter from regulation as food
components of articles intended for use
additives and, therefore, a food addi-
in packaging, transporting, or holding
tive petition will not be required for
the exempted use.
prescribed conditions:
[60 FR 36596, July 17, 1995] (1) The adhesive is prepared from one
or more of the optional substances
PART 175—INDIRECT FOOD ADDI- named in paragraph (c) of this section,
TIVES: ADHESIVES AND COMPO- subject to any prescribed limitations.
NENTS OF COATINGS (2) The adhesive is either separated
from the food by a functional barrier or
Subpart A [Reserved] used subject to the following additional
limitations:
Subpart B—Substances for Use Only as (i) In dry foods. The quantity of adhe-
Components of Adhesives sive that contacts packaged dry food
shall not exceed the limits of good
Sec. manufacturing practice.
175.105 Adhesives.
(ii) In fatty and aqueous foods. (a) The
175.125 Pressure-sensitive adhesives.
quantity of adhesive that contacts
Subpart C—Substances for Use as packaged fatty and aqueous foods shall
Components of Coatings not exceed the trace amount at seams
and at the edge exposure between pack-
175.210 Acrylate ester copolymer coating. aging laminates that may occur within
175.230 Hot-melt strippable food coatings. the limits of good manufacturing prac-
175.250 Paraffin (synthetic). tice.
175.260 Partial phosphoric acid esters of pol- (b) Under normal conditions of use
yester resins.
the packaging seams or laminates will
175.270 Poly(vinyl fluoride) resins.
remain firmly bonded without visible
175.300 Resinous and polymeric coatings.
175.320 Resinous and polymeric coatings for
separation.
polyolefin films. (b) To assure safe usage of adhesives,
175.350 Vinyl acetate/crotonic acid copoly- the label of the finished adhesive con-
mer. tainer shall bear the statement ‘‘food-
175.360 Vinylidene chloride copolymer coat- packaging adhesive’’.
ings for nylon film. (c) Subject to any limitation pre-
175.365 Vinylidene chloride copolymer coat- scribed in this section and in any other
ings for polycarbonate film. regulation promulgated under section
175.380 Xylene-formaldehyde resins con- 409 of the Act which prescribes safe
densed with 4,4′-isopropylidenediphenol-
conditions of use for substances that
epichlorohydrin epoxy resins.
may be employed as constituents of ad-
175.390 Zinc-silicon dioxide matrix coatings.
hesives, the optional substances used
AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. in the formulation of adhesives may in-
SOURCE: 42 FR 14534, Mar. 15, 1977, unless clude the following:
otherwise noted. (1) Substances generally recognized
as safe for use in food or food pack-
EDITORIAL NOTE: Nomenclature changes to
part 175 appear at 61 FR 14482, Apr. 2, 1996, 66 aging.
FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. (2) Substances permitted for use in
1, 2005. adhesives by prior sanction or approval
and employed under the specific condi-
Subpart A [Reserved] tions of use prescribed by such sanc-
tion or approval.
(3) Flavoring substances permitted

for use in food by regulations in this
156
part, provided that such flavoring sub- subchapter and substances named in
stances are volatilized from the adhe- this subparagraph: Provided, however,
sives during the packaging fabrication That any substance named in this
process. paragraph and covered by a specific
(4) Color additives approved for use in regulation in this subchapter, must
food. meet any specifications in such regula-
(5) Substances permitted for use in tion.
adhesives by other regulations in this
Abietic acid.
Acetone.
Acetone-formaldehyde condensate (CAS Reg. No. 25619–09–4).
Acetone-urea-formaldehyde resin.
N-Acetyl ethanolamine.
Acetyl tributyl citrate.
Acetyl triethyl citrate.
2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, sodium salt
(CAS Reg. No. 35641–59–9).
Albumin, blood.
(2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived
from olefins which contain not less than 78 percent C30 and higher
groups (CAS Reg. No. 70983–55–0).
4-[2-[2-2-(Alkoxy (C12-C15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate.
1-Alkyl (C6-C18) amino-3-amino-propane monoacetate.
Alkylated (C4 and/or C8) phenols.
Alkyl (C7-C12) benzene.
Alkyl (C10-C20) dimethylbenzyl ammonium chloride.
n-Alkyl(C12, C14, C16, or C18) dimethyl (ethylbenzyl) ammonium For use as preservative only.
cyclohexylsulfamate.
Alkyl ketene dimers as described in § 176.120 of this chapter.
Alkyl (C7-C12) naphthalene.
alpha Olefin sulfonate [alkyl group is in the range of C10-C18 with not
less than 50 percent C14-C16], ammonium, calcium, magnesium, po-
tassium, and sodium salts.
2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111–41–1).
3-Aminopropanediol .................................................................................... For use only in the preparation of polyurethane res-
ins.
Aluminum.
Aluminum acetate.
Aluminum di(2-ethylhexoate).
Aluminum potassium silicate.
N-b-Aminoethyl-gamma-aminopropyl trimethoxysilane.
3-(Aminomethyl)-3,5,5-trimethylcyclohexylamine.
Aminomethylpropanol.
Ammonium benzoate .................................................................................. For use as preservative only.
Ammonium bifluoride .................................................................................. For use only as bonding agent for aluminum foil, sta-
bilizer or preservative. Total fluoride from all
sources not to exceed 1 percent by weight of the
finished adhesive.
Ammonium borate.
Ammonium citrate.
Ammonium persulfate.
Ammonium polyacrylate.
Ammonium potassium hydrogen phosphate.
Ammonium silico-fluoride ............................................................................ For use only as bonding agent for aluminum foil, sta-
bilizer, or preservative. Total fluoride from all
finished adhesive.
Ammonium sulfamate.
Ammonium thiocyanate.
Ammonium thiosulfate.
Amyl acetate.
Anhydroenneaheptitol.
Animal glue as described in § 178.3120 of this chapter.
2-Anthraquinone sulfonic acid, sodium salt ................................................ For use only as polymerization-control agent.
Antimony oxide.
Asbestos.
Asphalt, paraffinic and naphthenic.
Azelaic acid.
Azo-bis-isobutyronitrile.
Balata rubber.
Barium acetate.
157
§ 175.105 21 CFR Ch. I (4–1–12 Edition)
Barium peroxide.
Barium sulfate.
Bentonite.
Benzene (benzol).
1,4-Benzenedicarboxylic acid, bis[2-(1,1-dimethylethyl)-6-[[3-(1,1- For use as a stabilizer.
dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methyl-phenyl]ester
(CAS Reg. No. 57569–40–1).
1,2–Benzisothiazolin–3–one (CAS Registry No. 2634–33–5) .................... For use as preservative only.
Benzothiazyldisulfide.
p-Benzoxyphenol ......................................................................................... For use as preservative only.
Benzoyl peroxide.
Benzyl alcohol.
Benzyl benzoate.
Benzyl bromoacetate .................................................................................. For use as preservative only.
p-Benzyloxyphenol ...................................................................................... Do.
BHA (butylated hydroxyanisole).
BHT (butylated hydroxytoluene).
Bicyclo[2.2.1]hept-2-ene-6-methyl acrylate.
2-Biphenyl diphenyl phosphate.
Bis(benzoate-O)(2-propanolato)aluminum (CAS Reg. No. 105442–85–1) For use only as a reactant in the preparation of poly-
ester resins.
1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hy-drazine (CAS Reg. For use at a level not to exceed 2 percent by weight
No. 32687–78–8). of the adhesive.
1,3-Bis(2-benzothiazolylmercaptomethyl) urea.
4,4′-Bis(a,a-dimethylbenzyl)diphenylamine.
2,6-Bis(1,1-dimethylethyl)-4-(1-methylpropyl)phenol (CAS Reg. No. For use as an antioxidant and/or stabilizer only.
17540–75–9).
2,6-Bis (1-methylheptadecyl)-p-cresol.
4-[[4, 6-Bis(octylthio)6-Bis(octylthio)6-Bis(octylthio)-s-triazin-2-yl]amino]-
2,6-di-tert-butylphenol (CAS Reg. No. 991–84–4).
Bis(tri-n-butyltin) oxide ................................................................................ For use as preservative only.
Bis(trichloromethyl)sulfone C.A. Registry No. 3064–70–8 ......................... Do.
Borax.
Boric acid.
2-Bromo-2-nitro-1, 3-propanediol (CAS Reg. No. 52–51–7) ...................... For use only as an antibacterial preservative.
Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also For use as a surface active agent in adhesives.
known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt
[CAS Reg. No. 144093–88–9])..
1,3-Butanediol.
1,4-Butanediol.
1,4-Butanediol modified with adipic acid.
Butoxy polyethylene polyproplyene glycol (molecular weight 900–4,200).
Butyl acetate.
Butyl acetyl ricinoleate.
Butyl alcohol.
Butylated reaction product of p-cresol and dicyclopentadiene ................... As identified in § 178.2010(b) of this chapter.
Butylated, styrenated cresols identified in § 178.2010(b) of this chapter.
Butyl benzoate.
Butyl benzyl phthalate.
Butyldecyl phthalate ....................................................................................
1,3-Butylene glycoldiglycolic acid copolymer.
tert-Butyl hydroperoxide.
4,4′-Butylidenebis(6-tert-butyl-m-cresol).
Butyl lactate.
Butyloctyl phthalate.
p-tert-Butylphenyl salicylate.
Butyl phthalate butyl glycolate.
p-tert-Butylpyrocatechol .............................................................................. For use only as polymerization-control agent.
Butyl ricinoleate.
Butyl rubber polymer.
Butyl stearate.
Butyl titanate, polymerized.
Butyraldehyde.
Calcium ethyl acetoacetate.
Calcium nitrate.
Calcium metasilicate.
Camphor.
Camphor fatty acid esters.
Candelilla wax.
epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer.
Carbon black, channel process.
Carbon disulfide-1,1′-methylenedipiperidine reaction product.

Carbon tetrachloride.
Carboxymethylcellulose.
158
Castor oil, polyoxyethylated (4–84 moles ethylene oxide).

Cellulose acetate butyrate.
Cellulose acetate propionate.
Ceresin wax (ozocerite).
Cetyl alcohol.
Chloracetamide.
Chloral hydrate.
Chlorinated liquid n-paraffins with chain lengths of C10-C17, containing
40–70 percent chlorine by weight.
Chlorinated pyridine mixture with active ingredients consisting of 2,3,5,6- For use as preservative only.
tetrachloro-4-(methylsulfonyl) pyridine, 2,3,5,6-tetrachloro-4-
(methylsulfinyl) pyridine and pentachloropyridine.
Chlorinated rubber polymer (natural rubber polymer containing approxi-
mately 67 percent chlorine).
1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ....................... For use as preservative only.
Chlorobenzene.
4-Chloro-3,5-dimethylphenol (p-chloro-m-xylenol) ...................................... For use as preservative only.
4-Chloro-3-methylphenol ............................................................................. Do.
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172–55–4) and For use only as an antimicrobial agent in polymer
2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682–20–4) mixture at a latex emulsions.
ratio of 3 parts to 1 part, manufactured from methyl-3-
mercaptopropionate (CAS Reg. No. 2935–90–2). The mixture may
contain magnesium nitrate (CAS Reg. No. 10377–60–3) at a con-
centration equivalent to the isothiazolone active ingredients (weight/
weight).
Chloroform.
Chloroprene.
Chromium caseinate.
Chromium nitrate.
Chromium potassium sulfate.
Cobaltous acetate.
Coconut fatty acid amine salt of tetrachlorophenol .................................... For use as preservative only.
Copal.
Copper 8-quinolinolate ................................................................................ For use as preservative only.
Coumarone-indene resin.
Cresyl diphenyl phosphate.
Cumene hydroperoxide.
Cyanoguanidine.
Cyclized rubber as identified in § 176.170(b)(2) of this chapter.
Cyclohexane.
1,4-Cyclohexanedimethanoldibenzoate (CAS Reg. No. 35541–81–2).
Cyclohexanol.
Cyclohexanone resin.
Cyclohexanone-formaldehyde condensate.
N-Cyclohexyl p-toluene sulfonamide.
(h5-Cyclopentadienyl)-(h6-isopropylbenzene)iron(II) hexafluorophosphate For use only as a photoinitiator.
(CAS Reg. No. 32760–80–8).
Damar.
Defoaming agents as described in § 176.210 of this chapter.
Dehydroacetic acid ......................................................................................
Diacetone alcohol.
Diacetyl peroxide.
N,N′-Dialkoyl-4,4′-diaminodiphenylmethane mixtures where; the alkoyl
groups are derived from marine fatty acids (C12-C24).
2,5-Di-tert-amylhydroquinone.
Diamines derived from dimerized vegetable oil acids.
Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or
xylyl.
1,2–Dibromo–2,4–dicyanobutane (CAS Registry No. 3569–65–7) ............ For use as a preservative only.
2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No. 10222–01–2). ............. For use as a preservative only.
Di(butoxyethyl) phthalate.
2,5-Di-tert-butylhydroquinone.
Dibutyl maleate.
2,6-Di-tert-butyl-4-methylphenol .................................................................. For use as preservative only.
Di(C7, C9-alkyl)adipate.
Dibutyl phthalate.
Dibutyl sebacate.
Dibutyltin dilaurate for use only as a catalyst for polyurethane resins.
1,2-Dichloroethylene (mixed isomers).
Dicumyl peroxide.
Dicyclohexyl phthalate.
Diethanolamine.
Diethanolamine condensed with animal or vegetable fatty acids.
Diethylamine.
159
§ 175.105 21 CFR Ch. I (4–1–12 Edition)
Diethylene glycol.
Diethylene glycol adipic acid copolymer.
Diethylene glycol dibenzoate.
Diethylene glycol hydrogenated tallowate monoester.
Diethylene glycol laurate.
Diethylene glycol monobutyl ether.
Diethylene glycol monobutyl ether acetate.
Diethylene glycol monoethyl ether.
Diethylene glycol monoethyl ether acetate.
Diethylene glycol monomethyl ether.
Diethylene glycol monooleate.
Diethylene glycol monophenyl ether.
Diethylene glycol copolymer of adipic acid and phthalic anhydride.
Di(2-ethylhexyl) adipate.
Di(2-ethylhexyl)hexahydrophthalate.
Di(2-ethylhexyl)phthalate.
Diethyl oxalate.
Diethyl phthalate.
Dihexyl phthalate.
Dihydroabietylphthalate.
Di(2-hydroxy-5-tert-butylphenyl) sulfide.
2,2′-Dihydroxy-5,5′-dichlorodiphenylmethane (dichlorophene).
4,5-Dihydroxy-2-imidazolidinone.
4-(Diiodomethylsulfonyl) toluene CA Registry No.: 20018–09–01 ............. For use as an antifungal preservative only.
Diisobutyl adipate.
Diisobutyl ketone.
Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride.
Diisobutyl phthalate.
Diisodecyl adipate.
Diisodecyl phthalate.
Diisooctyl phthalate.
Diisopropylbenzene hydroperoxide.
N,N-Dimethylcyclohexylamine dibutyldithiocarbamate.
Dimethyl formamide.
Dimethyl hexynol.
2,2-Dimethyl-1,3-propanediol dibenzoate.
Dimethyl octynediol.
N-(1,1-dimethyl-3-oxobutyl) acrylamide.
Dimethyl phthalate.
3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione ................................. For use as preservative only.
Di-b-naphthyl-p-phenylenediamine.
4,6-Dinonyl-o-cresol.
Dinonylphenol.
Di-n-octyldecyl adipate.
Dioctyldiphenylamine.
Dioctylphthalate.
Dioctylsebacate.
Dioxane.
Dipentaerythritol pentastearate.
Dipentamethylene-thiuram-tetrasulfide.
Dipentene ....................................................................................................
Dipentene resins.
Dipentene-beta-pinene-styrene resins.
Dipentene-styrene resin (CAS Registry No. 64536–06–7).
Diphenyl-2-ethylhexyl phosphate.
Diphenyl, hydrogen ated.
N,N′-Diphenyl-p-phenylenediamine.
Diphenyl phthalate.
1,3-Diphenyl-2-thiourea.
Dipropylene glycol.
Dipropylene glycol dibenzoate.
Dipropylene glycol monomethyl ether.
Dipropylene glycol copolymer of adipic acid and phthalic anhydride.
Disodium cyanodithioimidocarbonate.
Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49–8).
N,N′-Distearoylethylenediamine.
Distearyl thiodipropionate.
3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hy- For use as antioxidant only.
droxyethyl)-s-triazine-2,4,6(1H, 3H, 5H)-trione.
4,4′-Dithiodimorpholine.
n-Dodecylmercaptan.
tert-Dodecylmercaptan.
Dodecylphenoxybenzene-disulfonic acid and/or its calcium, magnesium,
and sodium salts.
160
Elemi gum.
Epichlorohydrin-4,4′-isopropylidenediphenol resin.
Epichlorohydrin-4,4′-sec-butylidenediphenol resin.
Epichlorohydrin-4,4′-isopropylidene-di-o-cresol resin.
Epichlorohydrin-phenolformaldehyde resin.
Erucamide (erucylamide).
Ethanolamine.
Ethoxylated primary linear alcohols of greater than 10 percent ethylene
oxide by weight having molecular weights of 390 to 7,000 (CAS Reg.
No. 97953–22–5).
Ethoxypropanol butyl ether.
Ethyl alcohol (ethanol).
5-Ethyl-1,3-diglycidyl-5-methylhydantoin (CAS Reg. No. 15336–82–0).
Ethylene-acrylic acid-carbon monoxide copolymer (CAS Reg. No.
97756–27–9).
Ethylene-acrylic acid copolymer, partial sodium salt containing no more
than 20 percent acrylic acid by weight, and no more than 16 percent
of the acrylic acid as the sodium salt (CAS Reg. No. 25750–82–7).
Ethylenediamine.
Ethylenediaminetetra-acetic acid, calcium, ferric, potassium, or sodium
salts, single or mixed.
Ethylene dichloride.
Ethylene glycol.
Ethylene glycol monobutyl ether.
Ethylene glycol monobutyl ether acetate.
Ethylene glycol monoethyl ether.
Ethylene glycol monoethyl ether acetate.
Ethylene glycol monoethyl ether ricinoleate.
Ethylene glycol monomethyl ether.
Ethylene glycol monophenyl ether.
Ethylene-carbon monoxide copolymer (CAS Reg. No. 25052–62–4) con-
taining not more than 30 weight percent of the units derived from car-
bon monoxide.
Ethylene-maleic anhydride copolymer, ammonium or potassium salt.
Ethylene-methacrylic acid copolymer partial salts: Ammonium, calcium,
magnesium, sodium, and/or zinc.
Ethylene-methacrylic acid-vinyl acetate copolymer partial salts: Ammo-
nium, calcium, magnesium, sodium, and/or zinc.
Ethylene-octene-1 copolymers containing not less than 70 weight per-
cent ethylene (CAS Reg. No. 26221–73–8).
Ethylene-propylene-dicyclopentadiene copolymer rubber.
Ethylene, propylene, 1,4-hexadiene and 2,5-norbornadiene tetrapolymer.
Ethylene-vinyl acetate carbon monoxide terpolymer (CAS Registry No.
26337–35–9) containing not more than 15 weight percent of units de-
rived from carbon monoxide.
2,2′-Ethylidenebis (4,6-di-tert-butylphenol) (CAS Reg. No. 35958–30–6).
Ethyl-p-hydroxybenzoate ............................................................................. For use as preservative only.
Ethyl hydroxyethylcellulose.
Ethyl lactate.
2,2′-Ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite (CAS Reg. For use as an antioxidant and/or stabilizer only.
No. 118337–09–0).
Ethyl phthalyl ethyl glycolate.
Ethyl-p-toluene sulfonamide ........................................................................
Fats and oils derived from animal or vegetable sources, and the hydro-
genated, sulfated, or sulfonated forms of such fats and oils.
Fatty acids derived from animal or vegetable fats and oils; and salts of
such acids, single or mixed, as follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Zinc.
Ferric chloride.
Fluosilicic acid (hydrofluosilicic acid) .......................................................... For use only as bonding agent for aluminum foil, sta-
finished adhesive.
Formaldehyde.
Formaldehyde o- and p-toluene sulfonamide.
Formamide.
Fumaratochromium (III) nitrate.
Furfural.
161
§ 175.105 21 CFR Ch. I (4–1–12 Edition)
Furfuryl alcohol.
Fumaric acid.
gamma-Aminopropyltrimethoxysilane (CAS Reg. No. 13822–56–5).
Glutaraldehyde.
Glycerides, di- and monoesters.
Glycerol polyoxypropylene triol, minimum average molecular weight 250 For use only in the preparation of polyester and poly-
(CAS Reg. No. 25791–96–2). urethane resins in adhesives.
Glyceryl borate (glycol boriborate resin).
Glyceryl ester of damar, copal, elemi, and sandarac.
Glyceryl monobutyl ricinoleate.
Glyceryl monohydroxy stearate.
Glyceryl monohydroxy tallowate.
Glyceryl polyoxypropylene triol (average molecular weight 1,000).
Glyceryl tribenzoate.
Glycol diacetate.
Glyoxal.
Heptane.
Hexamethylenetetramine.
Hexane.
Hexanetriols.
Hexylene glycol.
Hydroabietyl alcohol.
Hydrocarbon resins (produced by polymerization of mixtures of mono-
and di-unsaturated hydrocarbons of the aliphatic, alicyclic, and
monobenzenoid type derived both from cracked petroleum and ter-
pene stocks) (CAS Reg. No. 68239–99–6).
Hydrocarbon resins (produced by the polymerization of styrene and
alpha-methyl styrene), hydrogenated (CAS Reg. No. 68441–37–2).
Hydrofluoric acid ......................................................................................... For use only as bonding agent for aluminum foil, sta-
finished adhesive.
Hydrogen peroxide.
Hydrogenated dipentene resin (CAS Reg. No. 106168–39–2).
Hydrogenated dipentene-styrene copolymer resin (CAS Reg. No.
106168–36–9).
Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin
(CAS Reg. No. 106168–37–0).
a-Hydro-omega-hydroxypoly-(oxytetramethylene) ...................................... For use only in the preparation of polyurethane res-
ins.
Hydroquinone.
Hydroquinone monobenzyl ether.
Hydroquinone monoethyl ether.
2(2′-Hydroxy-3′,5′ di-tert-amylphenyl) benzotriazole.
Hydroxyacetic acid.
7-Hydroxycoumarin.
Hydroxyethylcellulose.
2–Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone(CAS For use only as a photoinitiator at a level not to ex-
Reg. No. 106797–53–9). ceed 5 percent by weight of the adhesive.
1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2 alkyl (C6-C17) imidazolinium chlo-
ride.
Hydroxyethyldiethylenetriamine.
b-Hydroxyethyl pyridinium 2-mercaptobenzothiazol.
Hydroxyethyl starch.
Hydroxyethylurea ........................................................................................
Hydroxylamine sulfate.
5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, 5- For use only as an antibacterial preservative.
hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5-hydroxypoly-
[methyleneoxy]methyl-1-aza-3,7-dioxabicyclo[3.3.0] octane mixture.
Hydroxypropyl methylcellulose.
2-(Hydroxymethyl)-2-methyl-1,3-propanediol tribenzoate.
2-Imidazolidinone.
3–Iodo–2–propynyl-N-butyl carbamate (CAS Reg. No. 55406–53–6) ....... For use only as an antifungal preservative.
Iodoform ...................................................................................................... For use only as polymerization-control agent.
Isoascorbic acid.
Isobutyl alcohol (isobutanol).
Isobutylene-isoprene copolymer.
Isodecyl benzoate (CAS Reg. No. 131298–44–7).
Isophorone.
Isopropanolamine (mono-, di-, tri-).
Isopropyl acetate.
Isopropyl alcohol (isopropanol).

Isopropyl-m- and p-cresol (thymol derived).
4,4′-Isopropylidenediphenol.
162
4,4′-Isopropylidenediphenol, polybutylated mixture .................................... For use as preservative only.

Isopropyl peroxydicarbonate.
p-Isopropoxy diphenylamine.
4,4′-Isopropylidene-bis(p-phenyleneoxy)-di-2-propanol.
Itaconic acid.
Japan wax.
Kerosene.
Lauroyl peroxide.
Lauroyl sulfate salts:
Ammonium.
Magnesium.
Potassium.
Sodium.
Lauryl alcohol.
Lauryl pyridinium 5-chloro-2-mercaptobenzothiazole.
Lignin calcium sulfonate.
Lignin sodium sulfonate.
Linoleamide (linoleic acid amide).
Magnesium fluoride ..................................................................................... For use only as bonding agent for aluminum foil, sta-
finished adhesives.
Magnesium glycerophosphate.
Maleic acid.
Maleic anhydride-diisobutylene copolymer, ammonium or sodium salt.
Manganese acetate.
Marine oil fatty acid soaps, hydrogenated.
Melamine.
Melamine-formaldehyde copolymer.
2-Mercaptobenzothiazole.
2-Mercaptobenzothiazole and dimethyl dithiocarbamic acid mixture, so- For use as preservative only.
dium salt.
2-Mercaptobenzothiazole, sodium or zinc salt ........................................... For use as preservative only.
Methacrylate-chromic chloride complex, ethyl or methyl ester.
p-Menthane hydroperoxide.
Methyl acetate.
Methyl acetyl ricinoleate.
Methyl alcohol (methanol).
Methylcellulose.
Methylene chloride.
4,4′-Methylenebis(2,6-di-tert-butylphenol).
2,2-Methylenebis (4-ethyl-6-tert-butylphenol).
2,2-Methylenebis (4-methyl-6-nonylphenol).
2,2-Methylenebis (4-methyl-6-tert-butylphenol).
Methyl ethyl ketone.
Methyl ethyl ketone-formaldehyde condensate.
2-Methylhexane.
1-Methyl-2-hydroxy-4-isopropyl benzene.
Methyl isobutyl ketone.
Methyl oleate.
Methyl oleate-palmitate mixture.
Methyl phthalyl ethyl glycolate.
Methyl ricinoleate.
Methyl salicylate.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a
methylstyrene to 3 vinyltoluene).
Methyl tallowate.
Mineral oil.
Monochloracetic acid.
Monooctyldiphenylamine.
Montan wax.
Morpholine.
Myristic acid-chromic chloride complex.
Myristyl alcohol.
Naphtha.
Naphthalene, monosulfonated.
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt.
a-Naphthylamine.
a,a′,a″,a″′-Neopentane tetrayltetrakis [omega-hydroxypoly
(oxypropylene) (1–2 moles)], average molecular weight 400.
Nitric acid.
μ-Nitrobiphenyl.
Nitrocellulose.
2-Nitropropane.
163
§ 175.105 21 CFR Ch. I (4–1–12 Edition)
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydro-

gen phosphate and monohydrogen phosphate esters; the nonyl group
is a propylene trimer isomer and the poly (oxyethylene) content aver-
ages 6–9 moles or 50 moles.
a(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced by the
condensation of 1 mole of p-nonylphenol (nonyl group is a propylene
trimer isomer) with an average of 1–40 moles of ethylene oxide.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium
salt: the nonyl group is a propylene trimer isomer and the poly (oxy-
ethylene) content averages 9 or 30 moles.
endo-cis-5-Norbornene-2,3-dicarboxylic anhydride.
a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the octadecenyl
group is derived from oleyl alcohol and the poly (oxyethylene) content
averages 20 moles.
Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate.
Octyl alcohol.
Octyldecyl phthalate.
Octylphenol.
Octylphenoxyethanols.
Octylphenoxypolyethoxy-polypropoxyethanol (13 moles of ethylene oxide
and propylene oxide).
Odorless light petroleum hydrocarbons.
Oleamide (oleic acid amide).
Oleic acid, sulfated.
2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
(CAS Reg. No. 70331–94–1).
Oxazoline.
a-(oxiranylmethyl)-w-(oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], For use as a reactant in the preparation of epoxy-
(alternative name: epichlorohydrin-polypropylene glycol) (CAS Reg. based resins.
No. 26142–30–3).
2,2′-[oxybis[(methyl-2,1-ethanediyl)-oxymethylene]]bisoxirane, (alternative For use as a reactant in the preparation of epoxy-
name: epichlorohydrin-dipropylene glycol) (CAS Reg. No. 41638–13– based resins.
5).
n-Oxydiethylene-benzothiazole.
Palmitamide (palmitic acid amide).
Paraffin (C12-C20) sulfonate.
Paraformaldehyde.
Pentachlorophenol.
Pentaerythritol ester of maleic anhydride.
Pentaerythritol monostearate ...................................................................... For use as preservative only.
Pentaerythritol tetrabenzoate [CAS Registry No. 4196–86–5].
Pentaerythritol tetrastearate.
2,4-Pentanedione.
Pentasodium diethylenetriaminepentaacetate (CAS Reg. No. 140–01–2).
Perchloroethylene.
Petrolatum.
Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated.
Petroleum hydrocarbon resin (produced by the catalytic polymerization
and subsequent hydrogenation of styrene, vinyltoluene, and indene
types from distillates of cracked petroleum stocks).
Petroleum hydrocarbon resins (produced by the homo-and copolymeriza-
tion of dienes and olefins of the aliphatic, alicyclic, and
monobenzenoid arylalkene types from distillates of cracked petroleum
stocks).
Phenol ......................................................................................................... For use as preservative only.
Phenol-coumarone-indene resin.
Phenolic resins as described in § 175.300(b)(3)(vi).
Phenothiazine .............................................................................................. For use only as polymerization-control agent.
Phenyl-b-naphthylamine (free of b-naphthylamine).
o-Phenylphenol ........................................................................................... For use as preservative only.
o-Phthalic acid.
Pimaric acid .................................................................................................
Pine oil.
Piperazine.
Piperidinium pentamethylenedithiocarbamate.
Poly(acrylamide-[2-acrylamide-2-methylpropylsulfonate]-dimethylidiallyl
ammonium chloride) sodium salt (CAS Reg. No. 72275-68-4).
Polyamides derived from reaction of one or more of the following acids
with one or more of the following amines:
Acids:
Azelaic acid.
Dimerized vegetable oil acids.

Amines:
Bis(hexamethylene) triamine and higher homologues.
164
Diethylenetriamine.
Diphenylamine.
Ethylenediamine.
Hexamethylenediamine.
Poly(oxypropylene)diamine (weight average molecular
weight 2010) (CAS Reg. No. 9046–10–0).
Poly(oxypropylene)diamine (weight average molecular
weight 440) (CAS Reg. No. 9046–10–0).
Tetraethylenepentamine.
Triethylenetetramine.
Polybutene, hydrogenated.
Polybutylene glycol (molecular weight 1,000).
Poly [2(diethylamino) ethyl methacrylate] phosphate.
Polyester of adipic acid, phthalic acid, and propylene glycol, terminated
with butyl alcohol.
Polyester of diglycolic acid and propylene glycol containing ethylene gly-
col monobutyl ether as a chain stopper.
Polyester resins (including alkyd type), as the basic polymer, formed as
esters when one or more of the following acids are made to react with
one or more of the following alcohols:
Acids:
Azelaic acid.
Dimethyl 1,4-cyclohexanedicarboxylate (CAS Reg. No.
94–60–0).
Dimethyl-5-sulfoisophthalic acid (CAS Reg. No.
50975–82–1) and/or its sodium salt (CAS Reg. No.
3965–55–7).
Polybasic and monobasic acids identified in
§ 175.300(b)(3)(vii)(a) and (b).
5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt
(CAS Reg. No. 6362–79–4).
Tetrahydrophthalic acid.
Alcohols:
1,4-Cyclohexanedimethanol.
2,2-Dimethyl-1,3-propanediol.
1,6-Hexanediol (CAS Reg. No. 629–11–8).
Polyhydric and monohydric alcohols identified in
§ 175.300(b)(3)(vii)(c) and (d).
Polyethyleneadipate modified with ethanolamine with the molar ratio of For use only in the preparation of polyurethan resins.
the amine to the adipic acid less than 0.1 to 1.
Polyethylene glycol (molecular weight 200–6,000).
Polyethylene glycol mono-isotridecyl ether sulfate, sodium salt (CAS
Reg. No. 150413–26–6).
Polyethyleneglycol alkyl(C10-C12) ether sulfosuccinate, disodium salt
(CAS Reg. No. 68954–91–6).
Polyethylene, oxidized.
Polyethylene resins, carboxyl modified, identified in § 177.1600 of this
chapter.
Polyethylenimine.
Polyethylenimine-epichlorohydrin resins.
Poly(ethyloxazoline) (CAS Reg. No. 25805-17-8).
Polyisoprene.
Polymeric esters of polyhydric alcohols and polycarboxylic acids pre-
pared from glycerin and phthalic anhydride and modified with benzoic
acid, castor oil, coconut oil, linseed oil, rosin, soybean oil, styrene, and
vinyl toluene.
Polymers: Homopolymers and copolymers of the following monomers:.
Acrylamide.
Acrylic acid.
Acrylonitrile.
Allylmethacrylate (CAS Reg. No. 00096–05–09).
Butadiene.
Butene.
N-tert-Butylacrylamide.
Butyl acrylate.
1,3-Butylene glycol dimethacrylate.
Butyl methacrylate.
Crotonic acid.
Decyl acrylate.
Diallyl fumarate.
Diallyl maleate.
Diallyl phthalate.
Dibutyl fumarate.
Dibutyl itaconate.
165
§ 175.105 21 CFR Ch. I (4–1–12 Edition)
Dibutyl maleate.
Di(2-ethylhexyl) maleate.
Dimethyl-a-methylstyrene.
Dioctyl fumarate.
Dioctyl maleate.
Divinylbenzene.
Ethyl acrylate.
Ethylene.
Ethylene cyanohydrin.
2-Ethylhexyl acrylate.
Ethyl methacrylate.
Fatty acids, C10-13-branched, vinyl esters (CAS Reg. No. 184785–
38–4).
Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl hexyl,
heptyl and octyl esters.
Glycidyl methacrylate.
1–Hexene (CAS Reg. No. 592–41–6).
2-Hydroxyethyl acrylate.
2-Hydroxyethyl methacrylate.
2-Hydroxypropyl methacrylate.
Isobutyl acrylate.
Isobutylene.
Itaconic acid.
Maleic acid, diester with 2-hydroxyethanesulfonic acid, sodium salt.
Maleic anhydride.
Methacrylic acid.
Methyl acrylate.
N,N′-Methylenebisacrylamide.
Methyl methacrylate.
N-Methylolacrylamide.
Methyl styrene.
-Methyl styrene.
Monoethyl maleate.
Monomethyl maleate.
Mono (2-ethylhexyl) maleate.
5-Norbornene-2 3-dicarboxylic acid, mono-n-butyl ester.
1-Octene (CAS Reg. No. 111–66–0).
Propyl acrylate.
Propylene.
Styrene.
Triallyl cyanurate.
Vinyl acetate.
Vinyl alcohol (from alcoholysis or hydrolysis of vinyl acetate units).
Vinyl butyrate.
Vinyl chloride.
Vinyl crotonate.
Vinyl ethyl ether.
Vinyl hexoate.
Vinylidene chloride.
Vinyl methyl ether.
Vinyl pelargonate.
Vinyl propionate.
Vinyl pyrrolidone.
Vinyl stearate.
Polyoxyalkylated-phenolic resin (phenolic resin obtained from formalde-
hyde plus butyl- and/or amylphenols, oxyalkylated with ethylene oxide
and/or propylene oxide).
Poly(oxycaproyl) diols and triols (minimum molecular weight 500).
Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt.
Polyoxyethylene (20 mol)—anhydrous lanolin adduct.
Polyoxyethylene (molecular weight 200) dibenzoate.
Polyoxyethylene (molecular weight 200–600) esters of fatty acids derived
from animal or vegetable fats and oils (including tall oil).
Polyoxyethylene (15 moles) ester of rosin.
Polyoxyethylene (4–5 moles) ether of phenol.
Polyoxyethylene (25 moles)—glycerol adduct.
Polyoxyethylene (40 moles) stearate.
Polyoxyethylene (5–15 moles) tridecyl alcohol.
Polyoxypropylene (3 moles) tridecyl alcohol sulfate.
Polyoxypropylene (20 moles) butyl ether.
Polyoxypropylene (40 moles) butyl ether.
Polyoxypropylene (20 moles) oleate butyl ether.

Polyoxypropylene-polyoxyethylene condensate (minimum molecular
weight 1,900).
166
Polypropylene glycol (minimum molecular weight 150).

Polypropylene glycol (3–4 moles) triether with 2-ethyl-2-(hydroxymethyl)-
1,3-propane-diol, average molecular weight 730.
Polypropylene glycol dibenzoate (CAS Reg. No. 72245–46–6) ................. For use as a plasticizer at levels not to exceed 20
percent by weight of the finished adhesive.
Polypropylene, noncrystalline.
Polysiloxanes:
Diethyl polysiloxane.
Dihydrogen polysiloxane.
Dimethyl polysiloxane.
Diphenyl polysiloxane.
Ethyl hydrogen polysiloxane.
Ethyl phenyl polysiloxane.
Methyl ethyl polysiloxane.
Methyl hydrogen polysiloxane.
Methyl phenyl polysiloxane.
Phenyl hydrogen polysiloxane.
Polysorbate 60.
Polysorbate 80.
Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate).
Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate).
Poly[styrene-co-disodium maleate-co-a-(p-nonyl-phenyl)-omega-(p-vinyl-
benzyl)poly(oxyethylene)] terpolymer.
Polytetrafluoroethylene..
Polyurethane resins produced by: (1) reacting diisocyanates with one or
more of the polyols or polyesters named in this paragraph, or (2) re-
acting the chloroformate derivatives of one or more of the polyols or
polyesters named in this paragraph with one or more of the
polyamines named in this paragraph, or (3) reacting toluene
diisocyanate or 4,4′ methylenebis(cyclohexylisocyanate) (CAS Reg.
No. 5124–30–1) with: (i) one or more of the polyols or polyesters
named in this paragraph and with either N-methyldiethanolamine (CAS
Reg. No. 105–59–9) and dimethyl sulfate (CAS Reg. No. 77–78–1) or
dimethylolpropionic acid (CAS Reg. No. 4767–03–7) and triethylamine
(CAS Reg. No. 121–44–8), or (ii) a fumaric acid-modified poly-
propylene glycol or fumaric acid-modified tripropylene glycol),
triethylamine (CAS Reg. No. 107–15–3), and ethylenediamine (CAS
Reg. No. 121–44–8), or (4) reacting meta-tetramethylxylene
diisocyanate (CAS Reg. No. 2778–42–9) with one or more of the
polyols and polyesters listed in this paragraph and with
dimethylolpropionic acid (CAS Reg. No. 4767–03–7) and triethylamine
(CAS Reg. No. 121–44–8), N-methyldiethanolamine (CAS Reg. No.
105–59–9), 2–dimethylaminoethanol (CAS Reg. No. 108–01–0), 2–
dimethylamino–2–methyl–1–propanol (CAS Reg. No. 7005–47–2),
and/or 2–amino–2–methyl–1–propanol (CAS Reg. No. 124–68–5).
Polyvinyl alcohol modified so as to contain not more than 3 weight per-
cent of comonomer units derived from 1-alkenes having 12 to 20 car-
bon atoms.
Polyvinyl butyral.
Polyvinyl formal.
Potassium ferricyanide ................................................................................ For use only as polymerization-control agent.
Potassium N-methyldithiocarbamate.
Potassium pentachlorophenate ................................................................... For use as preservative only.
Potassium permanganate.
Potassium persulfate.
Potassium phosphates (mono-, di-, tribasic).
Potassium tripolyphosphate.
a, a′, a″-1,2,3-Propanetriyltris [omega-(2,3-epoxypropoxy) poly
(oxypropylene) (24 moles)].
b-Propiolactone.
Propyl alcohol (propanol).
Propylene carbonate.
Propylene glycol and p-p′-isopropylidenediphenol diether.
Propylene glycol dibenzoate (CAS Reg. No. 19224–26–1) ....................... For use as a plasticizer at levels not to exceed 20
percent by weight of the finished adhesive.
Propylene glycol esters of coconut fatty acids.
Propylene glycol monolaurate.
Propylene glycol monomethyl ether.
Propylene glycol monostearate.
a, a′, a″-[Propylidynetris (methylene)] tris [omega-hydroxypoly

(oxypropylene) (1.5 moles minimum)], minimum molecular weight 400.
Quaternary ammonium chloride (hexadecyl, octadecyl derivative) ............ For use as preservative only.
167
§ 175.105 21 CFR Ch. I (4–1–12 Edition)
Rosin (wood, gum, and tall oil rosin), rosin dimers, decarboxylated rosin
(including rosin oil, disproportionated rosin, and these substances as
modified by one or more of the following reactants:.
Alkyl (C1-C9) phenolformaldehyde.
Ammonia.
Ammonium caseinate-p-Cyclohexylphenolformaldehyde.
Diethylene glycol.
Dipentaerythritol.
Ethylene glycol.
Formaldehyde.
Fumaric acid.
Glycerin.
Hydrogen.
Isophthalic acid.
4,4′-Isopropylidenediphenol-epichlorohydrin (epoxy).
4,4′-Isopropylidenediphenol-formaldehyde.
Maleic anhydride.
Methyl alcohol.
Pentaerythritol.
Phthalic anhydride.
Polyethylene glycol.
Phenol-formaldehyde.
Phenyl μ-cresol-formaldehyde.
p-Phenylphenol-formaldehyde.
Sulfuric acid.
Triethylene glycol.
Xylenol-formaldehyde.
Rosin salts (salts of wood, gum, and tall oil rosin, and the dimers there-
of, decarboxylated rosin disproportionated rosin, hydrogenated rosin):
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Zinc.
Rosin, gasoline-insoluble fraction.
Rubber hydrochloride polymer.
Rubber latex, natural.
Salicylic acid ................................................................................................ For use as preservative only.
Sandarac.
Sebacic acid.
Shellac.
Silicon dioxide as defined in § 172.480(a) of this chapter.
Sodium alkyl (C2-C13.5 aliphatic) benezenesulfonate.
Sodium aluminum pyrophosphate.
Sodium aluminum sulfate.
Sodium bisulfate.
Sodium calcium silicate.
Sodium capryl polyphosphate.
Sodium carboxymethylcellulose.
Sodium chlorate.
Sodium chlorite.
Sodium chromate.
Sodium decylsulfate.
Sodium dehydroacetate .............................................................................. For use as preservative only.
Sodium di-(2-ethylhexoate).
Sodium di-(2-ethylhexyl) pyrophosphate.
Sodium dihexylsulfosuccinate.
Sodium dissobutylphenoxydiethoxyethyl sulfonate.
Sodium diisobutylphenoxymonoethoxyethyl sulfonate.
Sodium diisopropyl- and triisopropylnaphthalenesulfonate.
Sodium dimethyldithiocarbamate.
Sodium dioctylsulfosuccinate.
Sodium n-dodecylpolyethoxy (50 moles) sulfate.
Sodium ethylene ether of nonylphenol sulfate.
Sodium 2-ethylhexyl sulfate.
Sodium fluoride ........................................................................................... For use only as bonding agent for aluminum foil, sta-
bilizer, or preservative. Total fluoride for all sources
not to exceed 1 percent by weight of the finished
adhesive.
Sodium formaldehyde sulfoxylate.

Sodium formate.
Sodium heptadecylsulfate.
168
Sodium hypochlorite.
Sodium isododecylphenoxypolyethoxy (40 moles) sulfate.
Sodium N-lauroyl sarcosinate.
Sodium metaborate.
Sodium a-naphthalene sulfonate.
Sodium nitrate.
Sodium nitrite.
Sodium oleoyl isopropanolamide sulfosuccinate.
Sodium pentachlorophenate ....................................................................... For use as preservative only.
Sodium perborate.
Sodium persulfate.
Sodium μ-phenylphenate ............................................................................ For use as preservative only.
Sodium polyacrylate.
Sodium polymethacrylate.
Sodium polystyrene sulfonate.
Sodium salicylate ........................................................................................ For use as preservative only.
Sodium salt of 1-hydroxy 2(1H)-pyridine thione ......................................... Do.
Sodium tetradecylsulfate.
Sodium thiocyanate.
Sodium bis-tridecylsulfosuccinate.
Sodium xylene sulfonate.
Sorbitan monooleate.
Sorbitan monostearate.
Soybean oil, epoxidized.
Spermaceti wax.
Sperm oil wax.
Stannous 2-ethylhexanoate ........................................................................ For use only as a catalyst for polyurethane resins.
Stannous stearate.
Starch hydrolysates.
Starch or starch modified by one or more of the treatments described in
§§ 172.892 and 178.3520 of this chapter.
Starch, reacted with a urea-formaldehyde resin.
Starch, reacted with formaldehyde.
Stearamide (stearic acid amide).
Stearic acid.
Stearic acid-chromic chloride complex.
Stearyl-cetyl alcohol, technical grade, approximately 65 percent–80 per-
cent stearyl and 20 percent–35 percent cetyl.
Strontium salicylate.
Styrenated phenol.
Styrene block polymers with 1,3-butadiene.
Styrene-maleic anhydride copolymer, ammonium or potassium salt.
Styrene-maleic anhydride copolymer (partially methylated) sodium salt.
Styrene-methacrylic acid copolymer, potassium salt.
Sucrose acetate isobutyrate.
Sucrose benzoate.
Sucrose octaacetate.
2–sulfoethyl methacrylate (CAS Registry No. 10595–80–9) ...................... For use at levels not to exceed 2 percent by weight
of the dry adhesive.
a-Sulfo-omega-(dodecyloxy)poly (oxyethylene), ammonium salt.
Sulfonated octadecylene (sodium form).
Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether diso-
dium salt (alcohol moiety produced by condensation of 1 mole of n-
dodecyl alcohol and an average of 5–6 moles of ethylene oxide,
Chemical Abstracts Service Registry No. 039354–45–5).
Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl ether, di-
sodium salt (alcohol moiety produced by condensation of 1 mole of
nonylphenol and an average of 9–10 moles of ethylene oxide) (CAS
Reg. No. 9040–38–4).
Sulfur.
Synthetic primary linear aliphatic alcohols whose weight average molec-
ular weight is greater than 400 (CAS Reg. No. 71750–71–5).
Synthetic wax polymer as described in § 176.170(a)(5) of this chapter.
Tall oil.
Tall oil fatty acids, linoleic and oleic.
Tall oil fatty acid methyl ester.
Tall oil, methyl ester.
Tall oil pitch.
Tall oil soaps.
Tallow alcohol (hydrogenated).
Tallow amine, secondary (hexadecyl, octadecyl), of hard tallow.
Tallow, blown (oxidized).
Tallow, propylene glycol ester.

Terpene resins (a-and b-pinene) homopolymers, copolymers, and con-
densates with phenol, formaldehyde, coumarone, and/or indene.
169
§ 175.105 21 CFR Ch. I (4–1–12 Edition)
Terphenyl.
Terphenyl, hydrogenated.
Terpineol.
Tetraethylene pentamine.
Tetraethylthiuram disulfide.
Tetrahydrofuran.
Tetrahydrofurfuryl alcohol.
Tetra-isopropyl titanate.
Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxy-hydro-cinnamate)] meth-
ane.
A[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly-(oxyethylene)
produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl)
phenol with an average of 1–40 moles of ethylene oxide.
A-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxy-poly(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen phosphate esters
and their sodium, potassium, and ammonium salts having a
poly(oxyethylene) content averaging 6–9 or 40 moles.
Tetramethyl decanediol.
Tetramethyl decynediol.
Tetramethyl decynediol plus 1–30 moles of ethylene oxide.
Tetramethylthiuram monosulfide.
Tetrasodium N-(1,2-dicarboxyethyl)N-octadecylsulfosuccinamate.
4,4′-Thiobis-6-tert-butyl-m-cresol.
Thiodiethylene-bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate).
2,2′-(2,5-Thiophenediyl) bis[5-tert-butylbenzoxazole].
Thiram.
Thymol ......................................................................................................... For use as preservative only.
Titanium dioxide.
Titanium dioxide-barium sulfate.
Titanium dioxide-calcium sulfate.
Titanium dioxide-magnesium silicate.
Toluene.
Toluene 2,4-diisocyanate.
Toluene 2,6-diisocyanate.
o- and p-Toluene ethyl sulfonamide.
o- and p-Toluene sulfonamide.
p-Toluene sulfonic acid.
p-(p′-Toluene-sulfonylamide)-diphenylamide.
Triazine-formaldehyde resins as described in § 175.300(b)(3)(xiii).
Tributoxyethyl phosphate.
Tributylcitrate.
Tri-tert-butyl-p-phenyl phenol ...................................................................... For use as preservative only.
Tributyl phosphate.
Tributyltin chloride complex of ethylene oxide condensate of For use as preservative only.
dehydroabietylamine.
Tri-n-butyltin acetate ................................................................................... For use as preservative only.
Tri-n-butyltin neodecanoate ........................................................................ Do.
1,1,1-Trichloroethane.
1,1,2-Trichloroethane.
Trichloroethylene.
Tri-b-chloroethylphosphate.
Tridecyl alcohol.
Triethanolamine.
3-(Triethoxysilyl) propylamine.
Triethylene glycol.
Triethylene glycol dibenzoate.
Triethylene glycol di(2-ethylhexoate).
Triethylene glycol polyester of benzoic acid and phthalic acid.
Triethylhexyl phosphate.
Triethylphosphate.
2,4,5-Trihydroxy butyrophenone.
Triisopropanolamine.
Trimethylol propane.
2,2,4-Trimethylpentanediol-1,3-diisobutyrate.
Trimeric aromatic amine resin from diphenylamine and acetone of mo-
lecular weight approximately 500.
Tri(nonylphenyl) phosphite-formaldehyde resins ........................................ As identified in § 177.2600(c)(4)(iii) of this chapter.
For use only as a stabilizer.
Triphenylphosphate.
Tripropylene glycol monomethyl ether.
1,3,5-Tris (3,5-di-tert-butyl-4-hydroxy-benzyl)-triazine-2,4,6 (1H,3H,5H)-
trione.
Tris (p-tertiary butyl phenyl) phosphate.
Tris(2-methyl-4-hydroxy-5-tert-butyl-phenyl)butane.
170
Trisodium N-hydroxyethylethylenediaminetriacetate (CAS Reg. No. 139–

89–9).
Turpentine.
Urea-formaldehyde resins as described in § 175.300(b)(3)(xii).
Vegetable oil, sulfonated or sulfated, potassium salt.
Vinyl acetate-maleic anhydride copolymer, sodium salt.
Waxes, petroleum.
Wax, petroleum, chlorinated (40% to 70% chlorine).
Waxes, synthetic paraffin (Fischer-Tropsch process).
3-(2-Xenolyl)-1,2-epoxypropane.
Xylene.
Xylene (or toluene) alkylated with dicyclopentadiene.
Zein.
Zinc acetate.
Zinc ammonium chloride.
Zinc dibenzyl dithiocarbamate.
Zinc dibutyldithiocarbamate.
Zinc diethyldithiocarbamate.
Zinc di(2-ethylhexoate).
Zinc formaldehyde sulfoxylate.
Zinc naphthenate and dehydroabietylamine mixture.
Zinc nitrate.
Zinc orthophosphate.
Zinc resinate.
Zinc sulfide.
Zineb (zinc ethylenebis-dithiocarbamate).
Ziram (zinc dimethyldithiocarbamate).
[42 FR 14534, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 175.105, see the List of CFR
Sections Affected, which appears in the Finding Aids section of the printed volume and at
www.fdsys.gov.
§ 175.125 Pressure-sensitive adhesives. (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2-

yl]amino]-2,6-di-tert-butylphenol (CAS
Pressure-sensitive adhesives may be
Reg. No. 991–84–4) as an antioxidant/
safely used as the food-contact surface
stabilizer at a level not to exceed 1.5
of labels and/or tapes applied to food,
percent by weight of the finished pres-
in accordance with the following pre-
sure-sensitive adhesive.
scribed conditions:
(7) 2,2′-(2,5-Thiophenediyl)-bis(5-tert-
(a) Pressure-sensitive adhesives pre- butylbenzoxazole) (CAS Reg. No. 7128–
pared from one or a mixture of two or 64–5) as an optical brightener at a level
more of the substances listed in this not to exceed 0.05 percent by weight of
paragraph may be used as the food-con- the finished pressure-sensitive adhe-
tact surface of labels and/or tapes ap- sive.
plied to poultry, dry food, and proc- (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy)
essed, frozen, dried, or partially dehy- phenyl]-2-methyl-1-propanone (CAS
drated fruits or vegetables. Reg. No. 106797–53–9) as a photoinitiator
(1) Substances generally recognized at a level not to exceed 5 percent by
as safe in food. weight of the pressure-sensitive adhe-
(2) Substances used in accordance sive.
with a prior sanction or approval. (9) Butanedioic acid, sulfo-1,4-di-(C9-
(3) Color additives listed for use in or C11 alkyl) ester, ammonium salt (also
on food in parts 73 and 74 of this chap- known as butanedioic acid sulfo-1, 4-
ter. diisodecyl ester, ammonium salt [CAS
(4) Substances identified in § 172.615 of Reg. No. 144093–88–9]) as a surface ac-
this chapter other than substances tive agent at a level not to exceed 3.0
used in accordance with paragraph percent by weight of the finished pres-
(a)(2) of this section. sure-sensitive adhesive.
(5) Polyethylene, oxidized; complying (b) Pressure-sensitive adhesives pre-
with the identity prescribed in pared from one or a mixture of two or

§ 177.1620(a) of this chapter. more of the substances listed in this
171
§ 175.210 21 CFR Ch. I (4–1–12 Edition)
paragraph may be used as the food-con- Subpart C—Substances for Use as

tact surface of labels and/or tapes ap- Components of Coatings
plied to raw fruit and raw vegetables.
(1) Substances listed in paragraphs § 175.210 Acrylate ester copolymer
(a)(1), (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), coating.
(a)(8), and (a)(9) of this section, and Acrylate ester copolymer coating
those substances prescribed by para- may safely be used as a food-contact
graph (a)(4) of this section that are not surface of articles intended for pack-
identified in paragraph (b)(2) of this aging and holding food, including heat-
section. ing of prepared food, subject to the pro-
(2) Substances identified in this sub- visions of this section:
paragraph and subject to the limita- (a) The acrylate ester copolymer is a
tions provided: fully polymerized copolymer of ethyl
BHA. acrylate, methyl methacrylate, and
BHT. methacrylic acid applied in emulsion
Butadiene-acrylonitrile copolymer. form to molded virgin fiber and heat-
Butadiene-acrylonitrile-styrene copolymer. cured to an insoluble resin.
Butadiene-styrene copolymer. (b) Optional substances used in the
Butyl rubber. preparation of the polymer and in the
Butylated reaction product of p-cresol and preparation and application of the
dicyclopentadiene produced by reacting p- emulsion may include substances
cresol and dicyclopentadiene in an approxi- named in this paragraph, in an amount
mate mole ratio of 1.5 to 1.0, respectively,
not to exceed that required to accom-
followed by alkylation with isobutylene so
that the butyl content of the final product plish the desired technical effect and
is not less than 18 percent, for use at levels subject to any limitation prescribed:
not to exceed 1.0 percent by weight of the Provided, however, That any substance
adhesive formulation. named in this paragraph and covered
Chlorinated natural rubber. by a specific regulation in subchapter
Isobutylene-styrene copolymer. B of this chapter must meet any speci-
Petrolatum. fications in such regulation.
Polybutene-1.
Polybutene, hydrogenated; complying with List of substances Limitations
the identity prescribed under § 178.3740(b) of
Aluminum stearate.
this chapter. Ammonium lauryl sulfate.
Polyisobutylene. Borax ............................................ Not to exceed the
cis-1,4-Polyisoprene. amount required as a
Polystyrene. preservative in emul-
Propyl gallate. sion defoamer.
Rapeseed oil, vulcanized. Disodium hydrogen phosphate ..... Do.
Formaldehyde.
Rosins and rosin derivatives as provided in Glyceryl monostearate.
§ 178.3870 of this chapter. Methyl cellulose.
Rubber hydrochloride. Mineral oil.
Rubber (natural latex solids or crepe, Paraffin wax.
smoked or unsmoked). Potassium hydroxide.
Terpene resins (a- and b-pinene), Tallow.
homopolymers, copolymers, and conden- Tetrasodium pyrophosphate.
sates with phenol, formaldehyde, cou- Titanium dioxide.
marone, and/or indene.
Tetrasodium ethylenediaminetetraacetate. (c) The coating in the form in which
Tri(mixed mono- and dinonylphenyl) it contacts food meets the following
phosphite (which may contain not more tests:
than 1 percent by weight of
triisopropanolamine).
(1) An appropriate sample when ex-
posed to distilled water at 212 °F for 30
(c) Acrylonitrile copolymers identi- minutes shall yield total chloroform-
fied in this section shall comply with soluble extractables not to exceed 0.5
the provisions of § 180.22 of this chap- milligram per square inch.
ter. (2) An appropriate sample when ex-
[42 FR 14534, Mar. 15, 1977, as amended at 42 posed to n-heptane at 120 °F for 30 min-
utes shall yield total chloroform-solu-
FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12,

1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, ble extractables not to exceed 0.5 milli-
Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999] gram per square inch.
172
§ 175.230 Hot-melt strippable food VIIA, and IX identified in table 1 of

coatings. § 176.170(c) of this chapter and under
Hot-melt strippable food coatings conditions of use E, F, and G described
may be safely applied to food, subject in table 2 of § 176.170(c) of this chapter
to the provisions of this section. shall be limited to a concentration not
(a) The coatings are applied to and exceeding 15 percent by weight of the
used as removable coatings for food. finished coating. The congealing point
(b) The coatings may be prepared, as shall be determined by ASTM method
mixtures, from the following sub- D938–71 (Reapproved 1981), ‘‘Standard
stances: Test Method for Congealing Point of
(1) Substances generally recognized Petroleum Waxes, Including Petro-
as safe in food. latum,’’ which is incorporated by ref-
(2) Substances identified in this sub- erence. Copies may be obtained from
paragraph. the American Society for Testing Ma-
terials, 100 Barr Harbor Dr., West
List of substances Limitations Conshohocken, Philadelphia, PA 19428-
Acetylated monoglycerides ........... Complying with 172.828
2959, or may be examined at the Na-
of this chapter. tional Archives and Records Adminis-
Cellulose acetate butyrate. tration (NARA). For information on
Mineral oil, white ........................... For use only as a com-
ponent of hot-melt NARA, call 202–741–6030, or go to: http://
strippable food coat- www.archives.gov/federallregister/
ings applied to frozen codeloflfederallregulations/
meats and complying
with § 172.878 of this ibrllocations.html.
chapter. (2) Oil content. The substance has an
oil content not exceeding 2.5 percent as
§ 175.250 Paraffin (synthetic). determined by ASTM method D721–56T,
‘‘Tentative Method of Test for Oil Con-
Synthetic paraffin may be safely
tent of Petroleum Waxes’’ (Revised
used as an impregnant in, coating on,
1956), which is incorporated by ref-
or component of coatings on articles
erence. See paragraph (b)(1) of this sec-
used in producing, manufacturing,
tion for availability of the incorpora-
packing, processing, preparing, treat-
tion by reference.
ing, packaging, transporting, or hold-
ing food in accordance with the fol- (3) Absorptivity. The substance has an
lowing prescribed conditions: absorptivity at 290 millimicrons in
(a) The additive is synthesized by the decahydronaphthalene at 88 °C not ex-
Fischer-Tropsch process from carbon ceeding 0.01 as determined by ASTM
monoxide and hydrogen, which are cat- method E131–81a, ‘‘Standard Defini-
alytically converted to a mixture of tions of Terms and Symbols Relating
paraffin hydrocarbons. Lower molec- to Molecular-Spectroscopy,’’ which is
ular-weight fractions are removed by incorporated by reference. See para-
distillation. The residue is hydro- graph (b)(1) of this section for avail-
genated and may be further treated by ability of the incorporation by ref-
percolation through activated char- erence.
coal. This mixture can be fractionated (c) The provisions of this section are
into its components by a solvent sepa- not applicable to synthetic paraffin
ration method, using synthetic used in food-packaging adhesives com-
isoparaffinic petroleum hydrocarbons plying with § 175.105.
complying with § 178.3530 of this chap- [42 FR 14534, Mar. 15, 1977, as amended at 47
ter. FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19,
(b) Synthetic paraffin shall conform 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645,
to the following specifications: Aug. 3, 1995]
(1) Congealing point. There is no speci-
fication for the congealing point of § 175.260 Partial phosphoric acid
synthetic paraffin components, except esters of polyester resins.
those components that have a con- Partial phosphoric acid esters of pol-
gealing point below 50 °C when used in yester resins identified in this section
contact with food Types III, IVA, V, and applied on aluminum may be safely
173
§ 175.270 21 CFR Ch. I (4–1–12 Edition)
used as food-contact coatings, in ac- tional Archives and Records Adminis-

cordance with the following prescribed tration (NARA). For information on
conditions: the availability of this material at
(a) For the purpose of this section, NARA, call 202–741–6030, or go to: http://
partial phosphoric acid esters of poly- www.archives.gov/federallregister/
ester resins are prepared by the reac- codeloflfederallregulations/
tion of trimellitic anhydride with 2,2- ibrllocations.html.
dimethyl-1,3-propanediol followed by (1) Solvent. N,N-Dimethylacetamide,
reaction of the resin thus produced technical grade.
with phosphoric acid anhydride to (2) Solution. Powdered resin and sol-
produce a resin having an acid number vent are heated at 120 °C until the resin
of 81 to 98 and a phosphorus content of is dissolved.
4.05 to 4.65 percent by weight. (3) Temperature. Flow times of the
(b) The coating is chemically bonded solvent and solution are determined at
to the metal and cured at temperatures 110 °C.
exceeding 450 °F. (4) Viscometer. Cannon-Ubbelohde size
(c) The finished food-contact coating, 50 semimicro dilution viscometer (or
when extracted with the solvent or sol- equivalent).
vents characterizing the type of food (5) Calculation. The calculation meth-
and under the conditions of time and od used is that described in appendix X
temperature characterizing the condi- 1.3 (ASTM method D1243–79, ‘‘Standard
tions of its intended use, as determined Test Method for Dilute Solution Vis-
from tables 1 and 2 of § 175.300(d), yields cosity of Vinyl Chloride Polymers,’’
total extractives in each extracting which is incorporated by reference; see
solvent not to exceed 0.3 milligrams paragraph (b) of this section for avail-
per square inch of food-contact surface, ability of the incorporation by ref-
as determined by the methods de- erence) with the reduced viscosity de-
scribed in § 175.300(e), and the coating termined for three concentration levels
yields 2,2-dimethyl-1,3-propanediol in not greater than 0.5 gram per deciliter
each extracting solvent not to exceed and extrapolated to zero concentration
0.3 micrograms per square inch of food- for intrinsic viscosity. The following
contact surface. In testing the finished formula is used for determining re-
food-contact articles, a separate test duced viscosity:
sample is to be used for each required
extracting solvent. Reduced viscosity in terms t − to
§ 175.270 Poly(vinyl fluoride) resins. of deciliters per gram = to × c
Poly(vinyl fluoride) resins identified where:
in this section may be safely used as t=Solution efflux time.
components of food-contact coatings to=Solvent efflux time.
for containers having a capacity of not c=Concentration of solution in terms of
less than 5 gallons, subject to the programs per deciliter.
visions of this section. [42 FR 14534, Mar. 15, 1977, as amended at 47
(a) For the purpose of this section, FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19,
poly(vinyl fluoride) resins consist of 1984]
basic resins produced by the polym-
erization of vinyl fluoride. § 175.300 Resinous and polymeric coat-
(b) The poly(vinyl fluoride) basic res- ings.
ins have an intrinsic viscosity of not Resinous and polymeric coatings
less than 0.75 deciliter per gram as de- may be safely used as the food-contact
termined by ASTM method D1243–79, surface of articles intended for use in
‘‘Standard Test Method for Dilute So- producing, manufacturing, packing,
lution Viscosity of Vinyl Chloride processing, preparing, treating, pack-
Polymers,’’ which is incorporated by aging, transporting, or holding food, in
reference. Copies may be obtained from accordance with the following pre-
the American Society for Testing Ma- scribed conditions:
terials, 100 Barr Harbor Dr., West (a) The coating is applied as a contin-
Conshohocken, Philadelphia, PA 19428- uous film or enamel over a metal sub-

2959, or may be examined at the Na- strate, or the coating is intended for
174
ER01JA93.387</GPH>
repeated food-contact use and is ap- solvent extraction, or modified by com-

plied to any suitable substrate as a bination with maleic anhydride.
continuous film or enamel that serves (ii) Reconstituted oils from
as a functional barrier between the triglycerides or fatty acids derived
food and the substrate. The coating is from the oils listed in paragraph
characterized by one or more of the fol- (b)(3)(i) of this section to form esters
lowing descriptions: with:
(1) Coatings cured by oxidation.
Butylene glycol.
(2) Coatings cured by polymerization, Ethylene glycol.
condensation, and/or cross-linking Pentaerythritol.
without oxidation. Polyethylene glycol.
(3) Coatings prepared from prepoly- Polypropylene glycol.
merized substances. Propylene glycol.
(b) The coatings are formulated from Sorbitol.
optional substances that may include: Trimethylol ethane.
(1) Substances generally recognized Trimethylol propane.
as safe in food. (iii) Synthetic drying oils, as the
(2) Substances the use of which is basic polymer:
permitted by regulations in this part
or which are permitted by prior sanc- Butadiene and methylstyrene copolymer.
tion or approval and employed under Butadiene and styrene copolymer, blown or
unblown.
the specific conditions, if any, of the
Maleic anhydride adduct of butadiene sty-
prior sanction or approval. rene.
(3) Any substance employed in the Polybutadiene.
production of resinous and polymeric
coatings that is the subject of a regula- (iv) Natural fossil resins, as the basic
tion in subchapter B of this chapter resin:
and conforms with any specification in Copal.
such regulation. Substances named in Damar.
this paragraph (b)(3) and further identi- Elemi.
fied as required: Gilsonite.
(i) Drying oils, including the Glycerol ester of damar, copal, elemi, and
triglycerides or fatty acids derived sandarac.
therefrom: Sandarac.
Shellac.
Beechnut. Utah coal resin.
Candlenut.
Castor (including dehydrated). (v) Rosins and rosin derivatives, with
Chinawood (tung). or without modification by polymeriza-
Coconut. tion, isomerization, incidental
Corn. decarboxylation, and/or hydrogenation,
Cottonseed. as follows:
Fish (refined). (a) Rosins, refined to color grade of K
Hempseed. or paler:
Linseed.
Oiticica. Gum rosin.
Perilla. Tall oil rosin.
Poppyseed. Wood rosin.
Pumpkinseed.
(b) Rosin esters formed by reacting
Safflower.
Sesame.
rosin (paragraph (b)(3)(v)(a) of this sec-
Soybean. tion) with:
Sunflower. 4,4′-sec-Butylidenediphenol-epichlorohydrin
Tall oil. (epoxy).
Walnut. Diethylene glycol.
Ethylene glycol.
The oils may be raw, heat-bodied, or Glycerol.
blown. They may be refined by filtra- 4,4′-Isopropylidenediphenol-epichlorohydrin
tion, degumming, acid or alkali wash-
(epoxy).
ing, bleaching, distillation, partial de- Methyl alcohol.
hydration, partial polymerization, or Pentaerythritol.
175
§ 175.300 21 CFR Ch. I (4–1–12 Edition)
(c) Rosin esters (paragraph (b)(3)(v)(b) 4,4-Bis(4′-hydroxyphenyl)-pentanoic acid.

of this section) modified by reaction tert-Butyl benzoic acid.
with: Fatty acids derived from oils listed in para-
graph (b)(3)(i) of this section.
Maleic anhydride. Rosins listed in paragraph (b)(3)(v)(a) of this
o-, m-, and p-substituted phenol-formalde- section, for use only as reactants in oil-
hydes listed in paragraph (b)(3)(vi) of this based or fatty acid-based alkyd resins.
section.
Phenol-formaldehyde.
(c) Polyhydric alcohols:
Butylene glycol.
(d) Rosin salts: Diethylene glycol.
Calcium resinate (limed rosin). 2,2-Dimethyl-1,3-propanediol for use only in
Zinc resinate. forming polyester resins for coatings in-
tended for use in contact with non-alco-
(vi) Phenolic resins as the basic poly- holic foods.
mer formed by reaction of phenols with Ethylene glycol.
formaldehyde: Glycerol.
(a) Phenolic resins formed by reac- Mannitol.
tion of formaldehyde with: a-Methyl glucoside.
Pentaerythritol.
Alkylated (methyl, ethyl, propyl, isopropyl, Propylene glycol.
butyl) phenols. Sorbitol.
p-tert-Amylphenol. Triethylene glycol, for use as a component in
4,4′-sec-Butylidenediphenol. polyester resins for coatings not exceeding
p-tert-Butylphenol. a coating weight of 4 milligrams per square
o-, m-, and p-Cresol. inch and that are intended for contact
p-Cyclohexylphenol. under conditions of use D, E, F or G de-
4,4′-Isopropylidenediphenol. scribed in table 2 of paragraph (d) of this
p-Nonylphenol. section with alcoholic beverages con-
p-Octylphenol. taining less than 8 percent alcohol.
3-Pentadecyl phenol mixture obtained from Trimethylol ethane.
cashew nut shell liquid. Trimethylol propane.
Phenol.
Phenyl o-cresol.
(d) Monohydric alcohols:
p-Phenylphenol. Cetyl alcohol.
Xylenol. Decyl alcohol.
Lauryl alcohol.
(b) Adjunct for phenolic resins: Alu- Myristyl alcohol.
minum butylate. Octyl alcohol.
(vii) Polyester resins (including Stearyl alcohol.
alkyd-type), as the basic polymers,
(e) Catalysts:
formed as esters of acids listed in para-
graph (b)(3)(vii) (a) and (b) of this sec- Dibutyltin oxide (CAS Reg. No. 818–08–6), not
tion by reaction with alcohols in para- to exceed 0.2 percent of the polyester resin.
graph (b)(3)(vii) (c) and (d) of this sec- Hydroxybutyltin oxide (CAS Reg. No. 2273–
43–0), not to exceed 0.2 percent of the poly-
tion.
ester resin.
(a) Polybasic acids: Monobutyltin tris(2-ethylhexoate) (CAS Reg.
Adipic. No. 23850–94–4), not to exceed 0.2 percent of
1,4-cyclohexanedicarboxylic (CAS Reg. No. the polyester resin.
1076–97–7). (viii) Epoxy resins, catalysts, and ad-
Dimerized fatty acids derived from oils listed
juncts:
in paragraph (b)(3)(i) of this section.
Fumaric. (a) Epoxy resins, as the basic poly-
Isophthalic. mer:
Maleic. (Alkoxy C10-C16)-2,3-epoxypropane, in which
2,6-Naphthalenedicarboxylic. the alkyl groups are even numbered and
2,6-Naphthalenedicarboxylic, dimethyl ester. consist of a maximum of 1 percent C10 car-
Orthophthalic. bon atoms and a minimum of 48 percent C12
Sebacic. carbon atoms and a minimum of 18 percent
Terephthalic. C14 carbon atoms, for use only in coatings
Terpene-maleic acid adduct. that are intended for contact with dry bulk
Trimellitic. foods at room temperature.
(b) Monobasic acids: 4,4′-sec-Butylidenediphenol-epichlorohydrin.

4,4′-sec-Butylidenediphenol-epichlorohydrin
Benzoic acid. reacted with one or more of the drying oils
176
or fatty acids listed in paragraph (b)(3)(i) Benzyl alcohol (CAS Reg. No. 100–51–6), for
of this section. use only in coatings at a level not to ex-
4,4′-sec-Butylidenediphenol-epichlorohydrin ceed 4 percent by weight of the resin when
chemically treated with one or more of such coatings are intended for repeated use
the following substances: in contact with foods only of the types
Allyl ether of mono-, di-, or trimethylol identified in paragraph (d) of this section,
phenol. table 1, under Types I, II, and III, under
4,4′-sec-Butylidenediphenol-formaldehyde. conditions of use C, D, E, or F as described
4,4′-Isopropylidenediphenol-formaldehyde. in table 2 of paragraph (d) of this section;
Melamine-formaldehyde. or when such coatings are intended for re-
Phenol-formaldehyde. peated use in contact with foods of the
Urea-formaldehyde. types identified in paragraph (d) of this
Epoxidized polybutadiene. section, table 1, under Types V, VI, VII,
Glycidyl ethers formed by reacting and VIII, under conditions of use E or F as
phenolnovolak resins with described in table 2 of paragraph (d) of this
epichlorohydrin. section. Use shall be limited to coatings
4,4′-Isopropylidenediphenol-epichlorohydrin. for tanks of capacity greater than 530,000
4,4′-Isopropylidenediphenol-epichlorohydrin gallons.
reacted with one or more of the drying oils Catalysts and cross-linking agents for epoxy
or fatty acids listed in paragraph (b)(3)(i) resins:
of this section. 3-Aminomethyl-3,5,5-
4,4′-Isopropylidenediphenol-epichlorohydrin trimethylcyclohexylamine (CAS Reg. No.
chemically treated with one or more of 2855–0913–092).
the following substances: Cyanoguanidine.
Allyl ether of mono-, di-, or trimethylol Dibutyl phthalate, for use only in coatings
phenol. for containers having a capacity of 1,000
4,4′-sec-Butylidenediphenol-formaldehyde. gallons or more when such containers are
4,4′-Isopropylidenediphenol-formaldehyde. intended for repeated use in contact with
Melamine-formaldehyde. alcoholic beverages containing up to 8 per-
2,2′-[(1-methylethylidene)bis[4,1- cent of alcohol by volume.
phenyleneoxy[1-(butoxymethyl)-2,1- 3-Diethylaminopropylamine (CAS Reg. No.
ethanediyl]oxymethylene]]bisoxirane, 104–78–9), for use in coatings at a level not
CAS Reg. No. 71033–08–4, for use only in to exceed 6 percent by weight of the resin
coatings intended for contact with bulk when such coatings are intended for re-
dry foods at temperatures below 100 °F. peated use in contact with foods only of
Phenol-formaldehyde. the types identified in paragraph (d) of this
Urea-formaldehyde. section, table 1, under Types I, II, and III,
(b) Catalysts and cross-linking agents under conditions of use C, D, E, or F as de-
scribed in table 2 of paragraph (d) of this
for epoxy resins:
section; or when such coatings are in-
3-(Aminomethyl)-3,5,5-trimethylcyclohexyl- tended for repeated use in contact with
amine reacted with phenol and formalde- foods of the types identified in paragraph
hyde in a ratio of 2.6:1.0:2.0, for use only in (d) of this section, table 1, under Types V,
coatings intended for repeated use in con- VI, VII, and VIII, under conditions of use E
tact with foods only of the types identified or F as described in table 2 of paragraph (d)
in paragraph (d) of this section, table 1, of this section. Use shall be limited to
under Category I and Category VIII, at coatings for tanks of capacity greater than
temperatures not exceeding 88 °C (190 °F). 530,000 gallons.
N-Beta-(aminoethyl)-gamma-aminopropyltri- Diethylenetriamine.
methoxysilane (CAS Reg. No. 1760–24–3), for Diphenylamine.
use only in coatings at a level not to ex- Ethylenediamine.
ceed 1.3 percent by weight of the resin Isophthalyl dihydrazide for use only in coat-
when such coatings are intended for re- ings subject to the provisions of paragraph
peated use in contact with foods only of (c) (3) or (4) of this section.
the types identified in paragraph (d) of this 4,4′-Methylenedianiline, for use only in coat-
section, table 1, under Types I, II, and III, ings for containers having a capacity of
under conditions of use C, D, E, or F as de- 1,000 gallons or more when such containers
scribed in table 2 of paragraph (d) of this are intended for repeated use in contact
section; or when such coatings are in- with alcoholic beverages containing up to 8
tended for repeated use in contact with percent of alcohol by volume.
foods of the types identified in paragraph N-Oleyl-1,3-propanediamine with not more
(d) of this section, table 1, under Types V, than 10 percent by weight of
VI, VII, and VIII, under conditions of use E diethylaminoethanol.
or F as described in table 2 of paragraph (d) 3-Pentadecenyl phenol mixture (obtained
of this section. Use shall be limited to from cashew nutshell liquid) reacted with
coatings for tanks of capacity greater than formaldehyde and ethylenediamine in a
530,000 gallons. ratio of 1:2:2 (CAS Reg. No. 68413–28–5).
177
§ 175.300 21 CFR Ch. I (4–1–12 Edition)
Polyamine produced when 1 mole of the and G described in table 2 of paragraph (d)
chlorohydrin diether of polyethylene gly- of this section.
col 400 is made to react under Trimellitic anhydride adducts of ethylene
dehydrohalogenating conditions with 2 glycol and glycerol, prepared by the reac-
moles of N-octadecyltrimethylenediamine tion of 1 mole of trimellitic anhydride with
for use only in coatings that are subject to 0.4–0.6 mole of ethylene glycol and 0.04–0.12
the provisions of paragraph (c) (3) or (4) of mole of glycerol, for use only as a cross-
this section and that contact food at tem- linking agent at a level not to exceed 10
peratures not to exceed room temperature. percent by weight of the cured coating,
Polyethylenepolyamine (CAS Reg. No. 68131– provided that the cured coating only con-
73–7), for use only in coatings intended for tacts food containing not more than 8 per-
repeated use in contact with food, at tem- cent alcohol.
peratures not to exceed 180 °F (82 °C). Meta-Xylylenediamine (1,3-benzenedi-
Salicylic acid, for use only in coatings for methanamine, CAS Reg. No. 1477–55–0), for
containers having a capacity of 1,000 gal- use only in coatings at a level not to ex-
lons or more when such containers are in- ceed 3 percent by weight of the resin when
tended for repeated use in contact with al- such coatings are intended for repeated use
coholic beverages containing up to 8 per- in contact with foods only of the types
cent of alcohol by volume. identified in paragraph (d) of this section,
Salicylic acid (CAS Reg. No. 69–72–7), for use table 1, under Types I, II, and III, under
only in coatings at a level not to exceed conditions of use C, D, E or F as described
0.35 percent by weight of the resin when in table 2 of paragraph (d) of this section;
such coatings are intended for repeated use or when such coatings are intended for re-
in contact with foods only of the types peated use in contact with foods of the
identified in paragraph (d) of this section, types identified in paragraph (d) of this
table 1, under Types I, II, and III, under section, table 1, under Types V, VI, VII,
conditions of use C, D, E, or F as described and VIII, under conditions of use E or F as
in table 2 of paragraph (d) of this section; described in table 2 of paragraph (d) of this
or when such coatings are intended for re- section. Use shall be limited to coatings
peated use in contact with foods of the for tanks of capacity greater than 530,000
types identified in paragraph (d) of this gallons.
section, table 1, under Types V, VI, VII, Para-Xylylenediamine (1,4 benzenedimethan-
and VIII, under conditions of use E or F as amine, CAS Reg. No. 539–48–0), for use only
described in table 2 of paragraph (d) of this in coatings at a level not to exceed 0.6 per-
section. Use shall be limited to coatings cent by weight of the resin when such coat-
for tanks of capacity greater than 530,000 ings are intended for repeated use in con-
gallons. tact with foods only of the types identified
Stannous 2-ethylhexanoate for use only as a in paragraph (d) of this section, table 1,
catalyst at a level not to exceed 1 percent under Types I, II, III, under conditions of
by weight of the resin used in coatings that use C, D, E, or F as described in table 2 of
are intended for contact with food under paragraph (d) of this section; or when such
conditions of use D, E, F, and G described coatings are intended for repeated use in
in table 2 of paragraph (d) of this section. contact with foods of the types identified
Styrene oxide, for use only in coatings for in paragraph (d) of this section, table 1,
containers having a capacity of 1,000 gal- under Types V, VI, VII, and VIII, under
lons or more when such containers are in- conditions of use E and F as described in
tended for repeated use in contact with al- table 2 of paragraph (d) of this section. Use
coholic beverages containing up to 8 per- shall be limited to coatings for tanks of ca-
cent of alcohol by volume. pacity greater than 530,000 gallons.
Tetraethylenepentamine reacted with
(c) Adjuncts for epoxy resins:
equimolar quantities of fatty acids. Aluminum butylate.
Tri(dimethylaminomethyl) phenol and its Benzoic acid, for use as a component in
salts prepared from the fatty acid moieties epoxy resins for coatings not exceeding a
of the salts listed in paragraph coating weight of 4 milligrams per square
(b)(3)(xxii)(b) of this section, for use only inch and that are intended for contact
in coatings subject to the provisions of under conditions of use D, E, F or G de-
paragraph (c) (3) or (4) of this section. scribed in table 2 of paragraph (d) of this
Triethylenetetramine. section with alcoholic beverages con-
Trimellitic anhydride (CAS Reg. No. 552–30– taining less than 8 percent alcohol.
7) for use only as a cross-linking agent at Polyamides from dimerized vegetable oils
a level not to exceed 15 percent by weight and the amine catalysts listed in para-
of the resin in contact with food under all graph (b)(3)(viii)(b) of this section, as the
conditions of use, except that resins in- basic polymer.
tended for use with foods containing more Silane coupled silica, prepared from the re-
than 8 percent alcohol must contact such action of microcrystalline quartz with N-
food only under conditions of use D, E, F, beta-(N-vinylbenzylamino) ethyl-gamma-
178
aminopropyltrimethoxy silane, mono- Triethanolamine.
hydrogen chloride, for use only in coatings Melamine-formaldehyde chemically modified
intended for repeated use in contact with with methyl, ethyl, propyl, isopropyl,
foods only of the types identified in para- butyl, or isobutyl alcohol.
graph (d) of this section, table 1, under
Category I and Category VIII, at tempera-
(b) Curing (cross-linking) catalyst for
tures not exceeding 88 °C (190 °F). triazine-formaldehyde resins:
Succinic anhydride, for use as a component Dodecyl benzenesulfonic acid (C.A. Registry
in epoxy resins for coatings not exceeding No. 27176–87–0).
a coating weight of 4 milligrams per square
inch, and that are intended for contact (xiv) Modifiers (for oils and alkyds,
under conditions of use D, E, F or G de- including polyesters), as the basic poly-
scribed in table 2 of paragraph (d) of this mer:
section with alcoholic beverages con-
taining less than 8 percent alcohol. Butyl methacrylate.
Cyclopentadiene.
(ix) Coumarone-indene resin, as the Methyl, ethyl, butyl, or octyl esters of acryl-
basic polymer. ic acid.
(x) Petroleum hydrocarbon resin Methyl methacrylate.
(cyclopentadiene type), as the basic Styrene.
Vinyl toluene.
polymer.
(xi) Terpene resins, as the basic poly- (xv) Vinyl resinous substance, as the
mer, from one or more of the following: basic polymers:
Dipentene. Polyvinyl acetate.
Hydrogenated dipentene resin (CAS Reg. No. Polyvinyl alcohol.
106168–39–2). For use only with coatings in Polyvinyl butyral.
contact with acidic and aqueous foods. Polyvinyl chloride.
Hydrogenated-beta-pinene-alpha-pinene- Polyvinyl formal.
dipentene copolymer resin (CAS Reg. No. Polyvinylidene chloride.
106168–37–0). For use only with coatings in Polyvinyl pyrrolidone.
contact with acidic and aqueous foods. Polyvinyl stearate.
a-Pinene. Vinyl chloride-acetate-2,3-epoxypropyl meth-
b-Pinene. acrylate copolymers containing not more
than 10 weight percent of total polymer
(xii) Urea-formaldehyde, resins and units derived from 2,3-epoxypropyl meth-
their curing catalyst: acrylate and not more than 0.1 weight per-
(a) Urea-formaldehyde resins, as the cent of unreacted 2,3-epoxypropyl meth-
basic polymer: acrylate monomer for use in coatings for
containers.
Urea-formaldehyde. Vinyl chloride-acetate, hydroxyl-modified
Urea-formaldehyde chemically modified with copolymer.
methyl, ethyl, propyl, isopropyl, butyl, or Vinyl chloride-acetate, hydroxyl-modified
isobutyl alcohol. copolymer, reacted with trimellitic anhy-
Urea-formaldehyde chemically modified with dride.
one or more of the amine catalysts listed Vinyl chloride copolymerized with acryl-
in paragraph (b)(3)(viii)(b) of this section. amide and ethylene in such a manner that
the finished copolymers have a minimum
(b) Curing (cross-linking) catalyst for weight average molecular weight of 30,000
urea-formaldehyde resins: and contain not more than 3.5 weight per-
Dodecyl benzenesulfonic acid (C.A. Registry cent of total polymer units derived from
No. 27176–87–0). acrylamide; the acrylamide portion may or
may not be subsequently partially
(xiii) Triazine-formaldehyde resins hydrolyzed.
and their curing catalyst: Vinyl chloride copolymerized with one or
(a) Triazine-formaldehyde resins, as more of the following substances:
the basic polymer: Acrylonitrile.
Fumaric acid and/or its methyl, ethyl,
Benzoguanamine-formaldehyde. propyl, butyl, amyl, hexyl, heptyl, or octyl
Melamine-formaldehyde. esters.
Melamine-formaldehyde chemically modified Maleic acid and/or its methyl, ethyl, propyl,
with one or more of the following amine butyl, amyl, hexyl, heptyl, or octyl esters.
catalysts: 5-Norbornene-2,3-dicarboxylic acid, mono-n-
Amine catalysts listed in paragraph butyl ester; for use such that the finished
(b)(3)(viii)(b) of this section. vinyl chloride copolymers contain not

Dimethylamine-2-methyl-1-propanol. more than 4 weight percent of total poly-
Methylpropanolamine. mer units derived from this comonomer.
179
§ 175.300 21 CFR Ch. I (4–1–12 Edition)
Vinyl acetate. (HFS–200), Food and Drug Administration,
Vinylidene chloride. 5100 Paint Branch Pkwy., College Park,
Vinyl chloride-vinylidene chloride-2,3- MD 20740, or available for inspection at the
epoxypropyl methacrylate copolymers con- National Archives and Records Adminis-
taining not more than 10 weight percent of tration (NARA). For information on the
total polymer units derived from 2,3- availability of this material at NARA, call
epoxypropyl methacrylate and not more 202–741–6030, or go to: http://
than 0.05 weight percent of unreacted 2,3- www.archives.gov/federallregister/
epoxypropyl methacrylate monomer based codeloflfederallregulations/
on polymer solids for use only in coatings ibrllocations.html.
for containers intended for contact with
foods under conditions B, C, D, E, F, G, or (xx) Acrylics and their copolymers,
H described in table 2 of paragraph (d) of as the basic polymer:
this section.
Acrylamide with ethylacrylate and/or sty-
(xvi) Cellulosics, as the basic poly- rene and/or methacrylic acid, subsequently
mer: reacted with formaldehyde and butanol.
Acrylic acid and the following esters thereof:
Carboxymethylcellulose.
Ethyl.
Cellulose acetate.
Methyl.
Cellulose acetate-butyrate.
Cellulose acetate-propionate. Butyl acrylate-styrene-methacrylic acid-hy-
Ethylcellulose. droxyethyl methacrylate copolymers con-
Ethyl hydroxyethylcellulose. taining no more than 20 weight percent of
Hydroxyethylcellulose. total polymer units derived from meth-
Hydroxypropyl methylcellulose. acrylic acid and containing no more than 7
Methylcellulose. weight percent of total polymer units de-
Nitrocellulose. rived from hydroxyethyl methacrylate; for
use only in coatings that are applied by
(xvii) Styrene polymers, as the basic electrodeposition to metal substrates.
polymer: Butyl acrylate-styrene-methacrylic acid-
hydroxypropyl methacrylate copolymers
Polystyrene. containing no more than 20 weight percent
a-Methyl styrene polymer. of total polymer units derived from meth-
Styrene copolymerized with one or more of acrylic acid and containing no more than 7
the following: weight percent of total polymer units de-
Acrylonitrile. rived from hydroxypropyl methacrylate;
a-Methylstyrene. for use only in coatings that are applied by
(xviii) Polyethylene and its copoly- electrodeposition to metal substrates and
mers as the basic polymer: that are intended for contact, under condi-
tion of use D, E, F, or G described in table
Ethylene-ethyl acrylate copolymer. 2 of paragraph (d) of this section, with food
Ethylene-isobutyl acrylate copolymers con- containing no more than 8 percent of alco-
taining no more than 35 weight percent of hol.
total polymer units derived from isobutyl Ethyl acrylate-styrene-methacrylic acid co-
acrylate. polymers for use only as modifiers for
Ethylene-vinyl acetate copolymer. epoxy resins listed in paragraph
Polyethylene. (b)(3)(viii)(a) of this section.
(xix) Polypropylene as the basic poly- Ethyl acrylate-methyl methacrylate-sty-
rene-methacrylic acid copolymers for use
mer: only as modifiers for epoxy resins listed in
Polypropylene. paragraph (b)(3)(viii)(a) of this section.
Maleic anhydride adduct of polypropylene 2-Ethylhexyl acrylate-ethyl acrylate copoly-
The polypropylene used in the manufac- mers prepared by copolymerization of 2-
ture of the adduct complies with ethylhexyl acrylate and ethyl acrylate in a
§ 177.1520(c), item 1.1; and the adduct has a 7/3 weight ratio and having a number aver-
maximum combined maleic anhydride con- age molecular weight range of 5,800 to 6,500
tent of 0.8 percent and a minimum intrin- and a refractive index, nD25° (40 percent in
sic viscosity of 0.9, determined at 135 °C on 2,2,4-trimethyl pentane) of 1.4130–1.4190; for
a 0.1 percent solution of the modified poly- use as a modifier for nylon resins com-
propylene in decahydronaphthalene as de- plying with § 177.1500 of this chapter and for
termined by a method titled ‘‘Method for phenolic and epoxy resins listed in para-
Determination of Intrinsic Viscosity of graph (b)(3) (vi) and (viii) of this section,
Maleic Anhydride Adduct of Poly- respectively, at a level not to exceed 1.5
propylene,’’ which is incorporated by ref- percent of the coating.

erence. Copies are available from the Cen- 2-Ethylhexyl acrylate-methyl methacrylate-
ter for Food Safety and Applied Nutrition acrylic acid copolymers for use only as
180
modifiers for epoxy resins listed in para- this section with acid, to form the salt
graph (b)(3)(viii) of this section. listed in paragraph (b)(3)(xxii)(b) of this
Methacrylic acid and the following esters section:
thereof:
Butyl. (a) Metals:
Ethyl. Aluminum.
Methyl. Calcium.
Methacrylic acid or its ethyl and methyl Cerium.
esters copolymerized with one or more of Cobalt.
the following: Iron.
Acrylic acid. Lithium.
Ethyl acrylate.
Magnesium.
Methyl acrylate.
Manganese.
n-Butyl acrylate-styrene-methacrylic acid-
Zinc.
hydroxyethyl methacrylate copolymers
containing no more than 2 weight percent Zirconium.
of total polymer units derived from meth- (b) Salts:
acrylic acid and containing no more than
9.5 weight percent of total polymer units Caprate.
derived from hydroxyethyl methacrylate; Caprylate.
for use only in coatings in contact with dry Isodecanoate.
food (food type VIII in table 1 of paragraph Linoleate.
(d) of this section). 2-(Dimethylamino) eth- Naphthenate.
anol (C.A.S. Registry No. 108–01–0) may be Neodecanoate.
employed as an optional adjuvant sub- Octoate (2-ethylhexoate).
stance limited to no more than 2 weight Oleate.
percent based on polymer solids in the Palmitate.
coating emulsion. Resinate.
Styrene polymers made by the polymeriza- Ricinoleate.
tion of any combination of styrene or Soyate.
alpha methyl styrene with acrylic acid, Stearate.
methacrylic acid, 2-ethyl hexyl acrylate, Tallate.
methyl methacrylate, and butyl acrylate.
The styrene and alpha methyl styrene, in- (xxiii) Waxes:
dividually, may constitute from 0 to 80 Paraffin, Type I.
weight percent of the polymer. The other Paraffin, Type II.
monomers, individually, may be from 0 to
Polyethylene.
40 weight percent of the polymer. The poly-
Sperm oil.
mer number average molecular weight (Mn)
Spermaceti.
shall be at least 2,000 (as determined by gel
permeation chromatography). The acid (xxiv) Plasticizers:
number of the polymer shall be less than
250. The monomer content shall be less Acetyl tributyl citrate.
than 0.5 percent. The polymers are for use Acetyl triethyl citrate.
only in contact with food of Types IV-A, V, Butyl phthalyl butyl glycolate.
VII in table 1 of paragraph (d) of this sec- Butyl stearate.
tion, under use conditions E through G in p-tert-Butyl phenyl salicylate.
table 2 of paragraph (d), and with food of Dibutyl sebacate.
Type VIII without use temperature restric- Diethyl phthalate.
tion. Diisobutyl adipate.
Diisooctyl phthalate.
(xxi) Elastomers, as the basic poly- Epoxidized soybean oil (iodine number max-
mer: imum 14; oxirane oxygen content 6% min-
imum), as the basic polymer.
Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene copolymer.
2-Ethylhexyl diphenyl phosphate.
Butadiene-styrene copolymer.
Butyl rubber. di-2-Ethylhexyl phthalate.
Chlorinated rubber. Glycerol.
2-Chloro-1,3-butadiene (neoprene). Glyceryl monooleate.
Natural rubber (natural latex or natural Glyceryl triacetate.
latex solids, smoked or unsmoked). Monoisopropyl citrate.
Polyisobutylene. Propylene glycol.
Rubber hydrochloride. Sorbitol.
Styrene-isobutylene copolymer. Mono-, di-, and tristearyl citrate.
Triethyl citrate.
(xxii) Driers made by reaction of a Triethylene glycol.
metal from paragraph (b)(3)(xxii)(a) of 3-(2-Xenolyl)-1,2-epoxypropane.
181
§ 175.300 21 CFR Ch. I (4–1–12 Edition)
(xxv) Release agents, as the basic (CAS Reg. No. 68037–59–2), where the plat-
polymer, when applicable: inum content does not exceed 150 parts per
million. The following substances may be
N,N′-Dioleoylethylenediamine (CAS Reg. No. used as optional polymerization inhibitors:
110–31–6) for use only in ionomeric resins 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No.
complying with § 177.1330 of this chapter 107–54–0), at a level not to exceed 0.53
and in ethylene vinyl acetate copolymers weight-percent;
complying with § 177.1350 of this chapter at 1-Ethynylcyclohexene (CAS Reg. No. 931–49–
a level not to exceed 0.0085 milligram per 7), at a level not to exceed 0.64 weight-per-
square centimeter (0.055 milligram per cent;
square inch) in the finished food-contact Bis(methoxymethyl)ethyl maleate (CAS Reg.
article. No. 102054–10–4), at a level not to exceed 1.0
N,N′-Distearoyl ethylenediamine. weight-percent;
Linoleic acid amide. Methylvinyl cyclosiloxane (CAS Reg. No.
Oleic acid amide. 68082–23–5); and
Palmitic acid amide. Tetramethyltetravinylcyclotetrasiloxane
Petrolatum. (CAS Reg. No. 2554–06–5).
Polyethylene wax.
Polyoxyethylene glycol monooleate (mol. (b) Curing (cross-linking) catalysts
wt. of the polyoxyethylene glycol moiety for silicones (the maximum amount of
greater than 300). tin catalyst used shall be that required
Polytetrafluoroethylene. to effect optimum cure but shall not
Silicones (not less than 300 centistokes vis-
exceed 1 part of tin per 100 parts of si-
cosity): Dimethylpolysiloxanes and/or
methylphenylpolysiloxanes. The methyl- loxane resins solids):
phenylpolysiloxanes contain not more than Dibutyltin dilaurate.
2.0 percent by weight of cyclosiloxanes Stannous oleate.
having up to and including 4 siloxy units. Tetrabutyl titanate.
Silicones (not less than 100 centistokes vis-
cosity): Dimethylpolysiloxanes and/or (xxix) Surface active agents:
methylphenylpolysiloxanes limited to use
Ethylene oxide adduct of 2,4,7,9-tetramethyl-
only on metal substrates. The
5-decyn-4,7-diol (CAS Reg. No. 9014–85–1).
methylphenylpolysiloxanes contain not
Poly[2-(diethylamino) ethyl methacrylate]
more than 2.0 percent by weight of
phosphate (minimum intrinsic viscosity in
cyclosiloxanes having up to and including 4
water at 25 °C is not less than 9.0 deciliters
siloxy units.
per gram as determined by ASTM method
(xxvi) Colorants used in accordance D1243–79, ‘‘Standard Test Method for Dilute
with § 178.3297 of this chapter. Solution Viscosity of Vinyl Chloride Poly-
(xxvii) Surface lubricants: mers,’’ which is incorporated by reference
(Copies may be obtained from the Amer-
Cottonseed oil and other edible oils. ican Society for Testing Materials, 100
Dibutyl sebacate. Barr Harbor Dr., West Conshohocken,
Dioctyl sebacate. Philadelphia, PA 19428-2959, or may be ex-
Glyceryl monostearate. amined at the National Archives and
Lanolin. Records Administration (NARA). For in-
Mineral oil, white. formation on the availability of this mate-
Palm oil. rial at NARA, call 202–741–6030, or go to:
Paraffin, Type I. http://www.archives.gov/federallregister/
Paraffin, Type II. codeloflfederallregulations/
Petrolatum. ibrllocations.html.), for use only as a sus-
Stearic acid. pending agent in the manufacture of vinyl
(xxviii) Silicones and their curing chloride copolymers and limited to use at
levels not to exceed 0.1 percent by weight
catalysts: of the copolymers.
(a) Silicones as the basic polymer: Sodium dioctyl sulfosuccinate.
Siloxane resins originating from methyl hy- Sodium dodecylbenzenesulfonate
drogen polysiloxane, dimethyl Sodium lauryl sulfate.
polysiloxane, and methylphenyl 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S.
polysiloxane. Reg. No. 126-86-3), for use only in can coat-
Siloxane resins originating from the plat- ings which are subsequently dried and
inum-catalyzed reaction product of vinyl- cured at temperatures of at least 193 °C (380
containing dimethylpolysiloxane (CAS °F) for 4 minutes.
Reg. No. 68083–18–1 and CAS Reg. No. 68083– (xxx) Antioxidants:
19–2) with methylhydrogen polysiloxane

(CAS Reg. No. 63148–57–2) and Butylated hydroxyanisole.
dimethylmethylhydrogen polysiloxane Butylated hydroxytoluene.
182
Gum guaiac. 4–(Diiodomethylsulfonyl) toluene (CAS Reg.
Dilauryl thiodipropionate. No. 20018–09–1) for use as a preservative at
Nordihydroguaiaretic acid. a level not to exceed 0.3 percent by weight
Propyl gallate. in can-sealing cements.
Distearyl thiodipropionate. Diisodecyl phthalate for use only as plasti-
Thiodipropionic acid. cizer in side seam cements for containers
2,4,5-Trihydroxybutyrophenone. intended for use in contact with food only
of the types identified in paragraph (d) of
(xxxi) Can end cements (sealing com- this section, table 1, under Categories I, II,
pounds used for sealing can ends only): and VI.
In addition to the substances listed in 4,4′-Bis(alpha,alpha-dimethyl-
paragraph (b) of this section and those benzyl)diphenylamine, CAS Reg. No. 10081–
listed in § 177.1210(b)(5) of this chapter, 67–1.
the following may be used: Ethyl toluene sulfonamide.
N,N′-Hexamethylenebis(3,5-di-tert-butyl-4-
Butadiene-styrene-divinylbenzene copolymer hydroxyhydrocinnamide), CAS Reg. No.
(CAS Reg. No. 26471–45–4) for use only at 23128–74–7.
levels not to exceed 23.8 percent by weight Polyamides consisting of the following:
of the cement solids in can end cements. Copolymer of omega-laurolactam and
Butadiene-styrene-fumaric acid copolymer. espilon-caprolactam, CAS Reg. No. 25191–
4,4′-Butylidenebis (6-tert-butyl-m-cresol). 04–2 (Nylon 12/6).
Dibenzamido phenyl disulfide. Homopolymer of omega-aminododecanoic
Di-b-naphthyl phenylenediamine. acid, CAS Reg. No. 24937–16–4.
Dipentamethylene thiuram tetrasulfide. Homopolymer of omega-laurolactam, CAS
Isobutylene-isoprene-divinylbenzene copoly- Reg. No. 25038–74–8 (Nylon 12).
mers for use only at levels not to exceed 15 Polyamides derived from the following acids
percent by weight of the dry cement com- and amines:
position. Acids:
Naphthalene sulfonic acid-formaldehyde con- Adipic.
densate, sodium salt, for use only at levels Azelaic.
not to exceed 0.6 percent by weight of the Sebacic.
cement solids in can end cements for con- Vegetable oil acids (with or without
tainers having a capacity of not less than dimerization).
5 gallons. Amines:
Sodium decylbenzene sulfonate. Diethylenetriamine.
Sodium nitrite for use only at levels not to Diphenylamine.
exceed 0.3 percent by weight of the cement Ethylenediamine.
solids in can end cements for containers Hexamethylenediamine.
having a capacity of not less than 5 gal- Tetraethylenepentamine.
lons. Triethylenetetramine.
Sodium pentachlorophenate for use as a pre- Polypropylene glycol CAS Reg. No. 25322–69–
servative at 0.1 percent by weight in can- 4.
sealing compounds on containers having a Sodium pentachlorophenate for use as a pre-
capacity of 5 gallons or more. servative at 0.1 percent by weight in can-
Sodium phenylphenate. sealing compounds on containers having a
Styrene-maleic anhydride resin, partial capacity of 5 gallons or more.
Tetrakis [methylene(3,5-di-tert-butyl-4-
methyl and butyl (sec- or iso-) esters, for
hydroxyhydrocinnamate)]methane, CAS
use only at levels not in excess of 3 percent
Reg. No. 6683–19–8.
of the cement solids in can end cement for-
Toluene sulfonamide formaldehyde resin
mulations.
(basic polymer).
Tetrasodium EDTA (tetrasodium ethylene-
Triethylene glycol methacrylate for use only
diaminetetraacetate).
as polymerization cross-linking agent in
Tri (mixed mono- and dinonylphenyl)
side seam cements for containers intended
phosphite.
for use in contact with food only of the
Zinc dibutyldithiocarbamate.
types identified in paragraph (d) of this
(xxxii) Side seam cements: In addi- section, table 1, under Categories I, II, and
tion to the substances listed in para- VI.
graph (b)(3) (i) to (xxx), inclusive, of Urea.
this section, the following may be used. (xxxiii) Miscellaneous materials:
p-tert-Butyl perbenzoate as a catalyst for Ammonium citrate.
epoxy resin. Ammonium potassium phosphate.
epsilon-Caprolactam-(ethylene-ethyl acry- Bentonite, modified by reaction with benzyl
late) graft polymer. dimethyl alkyl ammonium chloride, where

Dicumyl peroxide for use only as polymeriza- the alkyl groups are derived from hydro-
tion catalyst. genated tallow (CAS Reg. No. 71011–24–0).
183
§ 175.300 21 CFR Ch. I (4–1–12 Edition)
For use only as a rheological agent in coat- ASTM method D2503–82, ‘‘Standard Test
ings intended to contact food under re- Method for Molecular Weight (Relative
peated use conditions. Molecular Mass) of Hydrocarbons by Ther-
Bentonite, modified by reaction with sodium moelectric Measurement of Vapor Pres-
stearate and benzyl dimethyl alkyl ammo- sure,’’ which is incorporated by reference.
nium chloride, where the alkyl groups are Copies may be obtained from the American
derived from hydrogenated tallow (CAS Society for Testing Materials, 100 Barr
Reg. No. 121888–68–4). For use as a Harbor Dr., West Conshohocken, Philadel-
rheological agent only in coatings in- phia, PA 19428-2959, or may be examined at
tended to contact dry food under repeated- the National Archives and Records Admin-
use conditions. istration (NARA). For information on the
Calcium acetate. availability of this material at NARA, call
Calcium ethyl acetoacetate. 202–741–6030, or go to: http://
Calcium glycerophosphate. www.archives.gov/federallregister/
Calcium, sodium, and potassium oleates. codeloflfederallregulations/
Calcium, sodium, and potassium ibrllocations.html. For use only in contact
ricinoleates. with nonalcoholic and nonfatty foods
Calcium, sodium, and potassium stearates. under conditions of use E, F, and G, de-
Castor oil, hydrogenated. scribed in table 2 of paragraph (d) this sec-
Castor oil, hydrogenated polymer with ethyl- tion.
enediamine, 12-hydroxyoctadecanoic acid Decyl alcohol.
and sebacic acid (CAS Reg. No. 68604–06–8). 1,2-Dibromo-2,4-dicyanobutane (CAS Reg No.
The condensation product formed by the 35691–65–7). For use as an antimicrobial
reaction of hydrogenated castor oil with agent at levels not to exceed 500 milli-
polyamide derived from ethylenediamine, grams per kilogram in emulsion-based sili-
sebacic acid and 12-hydroxystearic acid, for cone coatings.
use only in coatings at a level not to ex- Disodium hydrogen phosphate.
ceed 3.2 percent by weight of the resin Ethyl acetoacetate.
when such coatings are intended for re- Hectorite, modified by reaction with a mix-
peated use in contact with foods only of ture of benzyl methyl dialkyl ammonium
the types identified in paragraph (d) of this chloride and dimethyl dialkyl ammonium
section, table 1, under Types I, II, and III, chloride, where the alkyl groups are de-
under conditions of use C, D, E, or F as derived from hydrogenated tallow (CAS Reg.
scribed in table 2 of paragraph (d) of this No. 121888–67–3). For use as a rheological
section; or when such coatings are in- agent only in coatings intended to contact
tended for repeated use in contact with dry food under repeated-use conditions.
foods of the types identified in paragraph Lauryl alcohol.
(d) of this section, table 1, under Types V, Lecithin.
VI, VII, and VIII, under conditions of use E Magnesium, sodium, and potassium citrate.
or F as described in table 2 of paragraph (d) Magnesium glycerophosphate.
of this section. Use shall be limited to Magnesium stearate.
coatings for tanks of capacity greater than Mono-, di-, and tricalcium phosphate.
530,000 gallons. Monodibutylamine pyrophosphate as
Castor oil, sulfated, sodium salt (CAS Reg. sequestrant for iron.
No. 68187–76–8), for use only in coatings for Mono-, di-, and trimagnesium phosphate.
containers intended for repeated use. Myristyl alcohol.
Cetyl alcohol. Octyl alcohol.
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Phosphoric acid.
Reg. No. 26172–55–4) and 2-methyl-4- Polybutene, hydrogenated; complying with
isothiazolin-3-one (CAS Reg. No. 2682–20–4) the identity and limitations prescribed by
mixture, at a ratio of 3 parts to 1 part, re- § 178.3740 of this chapter.
spectively, manufactured from methyl-3- Poly(ethylene oxide).
mercaptopropionate (CAS Reg. No. 2935–90– Siloxanes and silicones, dimethyl, 3-
2) and optionally containing magnesium hydroxypropyl group-terminated, diesters
nitrate (CAS Reg. No. 10377–60–3) at a con- with poly(2-oxepanone), diacetates (CAS
centration equivalent to the isothiazolone Reg. No. 116810–47–0) at a level not to ex-
active ingredients (weight/weight). For use ceed 0.025 weight percent of the finished
only as an antimicrobial agent in emul- coating having no greater than a 0.5 mil
sion-based silicone coatings at a level not thickness for use as a component of poly-
to exceed 50 milligrams per kilogram ester, epoxy, and acrylic coatings com-
(based on isothiazolone active ingredient) plying with paragraphs (b)(3)(vii), (viii),
in the coating formulations. and (xx) of this section, respectively.
Cyclohexanone-formaldehyde resin produced Silver chloride-coated titanium dioxide for
when 1 mole of cyclohexanone is made to use only as a preservative in latex emul-
react with 1.65 moles of formaldehyde such sions at a level not to exceed 2.2 parts per
that the finished resin has an average mo- million (based on silver ion concentration)
lecular weight of 600–610 as determined by in the dry coating.
184
Sodium pyrophosphate. methacrylonitrile; for use only in coat-
Stannous chloride. ings that are intended for contact,
Stannous stearate.
Stannous sulfate.
under conditions of use D, E, F, or G
Stearyl alcohol. described in table 2 of paragraph (d) of
2-Sulfoethyl methacrylate, sodium salt (CAS this section, with food containing no
Reg. No. 1804–87–1). For use only in copoly- more than 8 percent of alcohol.
mer coatings on metal under conditions of (xxxvii) Polymeric resin as a coating
use E, F, and G described in table 2 of para-
component prepared from terephthalic
graph (d) of this section, and limited to use
at a level not to exceed 2.0 percent by acid, isophthalic acid, succinic anhy-
weight of the dry copolymer coating. dride, ethylene glycol, diethylene gly-
Tetrasodium pyrophosphate. col, and 2,2-dimethyl-1,3-propanediol
Tridecyl alcohol produced from for use in contact with aqueous foods
tetrapropylene by the oxo process, for use and alcoholic foods containing not
only as a processing aid in polyvinyl chlo-
ride resins. more than 20 percent (by volume) of al-
Trimethylolpropane (CAS Reg. No. 77–99–6). cohol under conditions of use D, E, F,
For use as a pigment dispersant at levels and G described in table 2 of § 176.170 of
not to exceed 0.45 percent by weight of the this chapter. The resin shall contain no
pigment. more than 30 weight percent of 2,2-di-
Vinyl acetate-dibutyl maleate copolymers
methyl-1,3-propanediol.
produced when vinyl acetate and dibutyl
maleate are copolymerized with or without (c) The coating in the finished form
one of the monomers: Acrylic acid or in which it is to contact food, when ex-
glycidyl methacrylate. For use only in tracted with the solvent or solvents
coatings for metal foil used in contact with characterizing the type of food, and
foods that are dry solids with the surface under conditions of time and tempera-
containing no free fat or oil. The finished
copolymers shall contain at least 50 ture characterizing the conditions of
weight-percent of polymer units derived its intended use as determined from ta-
from vinyl acetate and shall contain no bles 1 and 2 of paragraph (d) of this sec-
more than 5 weight-percent of total poly- tion, shall yield chloroform-soluble ex-
mer units derived from acrylic acid or tractives, corrected for zinc extractives
glycidyl methacrylate.
as zinc oleate, not to exceed the fol-
(xxxiv) Polyamide resins derived lowing:
from dimerized vegetable oil acids (1) From a coating intended for or
(containing not more than 20 percent of employed as a component of a con-
monomer acids) and ethylenediamine, tainer not to exceed 1 gallon and in-
as the basic resin, for use only in coat- tended for one-time use, not to exceed
ings that contact food at temperatures 0.5 milligram per square inch nor to ex-
not to exceed room temperature. ceed that amount as milligrams per
(xxxv) Polyamide resins having a square inch that would equal 0.005 per-
maximum acid value of 5 and a max- cent of the water capacity of the con-
imum amine value of 8.5 derived from
tainer, in milligrams, divided by the
dimerized vegetable oil acids (con-
area of the food-contact surface of the
taining not more than 10 percent of
container in square inches. From a fab-
monomer acids), ethylenediamine, and
ricated container conforming with the
4,4-bis (4-hydroxyphenyl) pentanoic
acid (in an amount not to exceed 10 description in this paragraph (c)(1), the
percent by weight of said polyamide extractives shall not exceed 0.5 milli-
resins); as the basic resin, for use only gram per square inch of food-contact
in coatings that contact food at tem- surface nor exceed 50 parts per million
peratures not to exceed room tempera- of the water capacity of the container
ture provided that the concentration of as determined by the methods provided
the polyamide resins in the finished in paragraph (e) of this section.
food-contact coating does not exceed 5 (2) From a coating intended for or
milligrams per square inch of food-con- employed as a component of a con-
tact surface. tainer having a capacity in excess of 1
(xxxvi) Methacrylonitrile grafted gallon and intended for one-time use,
polybutadiene copolymers containing not to exceed 1.8 milligrams per square
no more than 41 weight percent of total inch nor to exceed that amount as mil-
polymer units derived from ligrams per square inch that would
185
§ 175.300 21 CFR Ch. I (4–1–12 Edition)
equal 0.005 percent of the water capac- TABLE 1—TYPES OF FOOD

ity of the container in milligrams, di- I. Nonacid (pH above 5.0), aqueous products;
vided by the area of the food-contact may contain salt or sugar or both, and in-
surface of the container in square cluding oil-in-water emulsions of low- or
inches. high-fat content.
(3) From a coating intended for or II. Acidic (pH 5.0 or below), aqueous prod-
employed as a component of a con- ucts; may contain salt or sugar or both,
tainer for repeated use, not to exceed and including oil-in-water emulsions of
18 milligrams per square inch nor to low- or high-fat content.
exceed that amount as milligrams per III. Aqueous, acid or nonacid products con-
taining free oil or fat; may contain salt,
square inch that would equal 0.005 per- and including water-in-oil emulsions of
cent of the water capacity of the con- low- or high-fat content.
tainer in milligrams, divided by the IV. Dairy products and modifications:
area of the food-contact surface of the A. Water-in-oil emulsion, high- or low-fat.
container in square inches. B. Oil-in-water emulsion, high- or low-fat.
(4) From coating intended for re- V. Low moisture fats and oils.
peated use, and employed other than as VI. Beverages:
a component of a container, not to ex- A. Containing alcohol.
ceed 18 milligrams per square inch of B. Nonalcoholic.
coated surface. VII. Bakery products.
(d) Tables: VIII. Dry solids (no end test required).
186
VerDate Mar<15>2010
TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR POLYMERIC COATINGS, USING SOLVENTS
SIMULATING TYPES OF FOODS AND BEVERAGES
10:14 May 14, 2012

Extractant
Types of food
Condition of use (see Table 1) Water Heptane1,2 8% alcohol
(time and temperature) (time and temperature) (time and temperature)
Jkt 226069
A. High temperature heat-sterilized (e.g., over 212 °F) ....... I, IV–B ................................................... 250 °F, 2 hr ...................... .
III, IV–A, VII ........................................... do ...................................... 150 °F, 2 hr.
B. Boiling water-sterilized ...................................................... II ............................................................ 212 °F, 30 min .................. .
III, VII ..................................................... do ...................................... 120 °F, 30 min.
C. Hot filled or pasteurized above 150 °F ............................ II, IV–B .................................................. Fill boiling, cool to 100 °F .
PO 00000
III, IV–A ................................................. do ...................................... 120 °F, 15 min.
V ............................................................ ........................................... do.
D. Hot filled or pasteurized below 150 °F ............................. II, IV–B, VI–B ........................................ 150 °F, 2 hr ...................... .
III, IV–A ................................................. do ...................................... 100 °F, 30 min.
V ............................................................ ........................................... do.
Frm 00197
VI–A ...................................................... ........................................... ........................................... 150 °F, 2 hr.
E. Room temperature filled and stored (no thermal treat- II, IV–B, VI–B ........................................ 120 °F, 24 hr .................... .
Food and Drug Administration, HHS
ment in the container).

III, IV–A ................................................. do ...................................... 70 °F, 30 min.
Fmt 8010
V, VII ..................................................... ........................................... do.
VI–A ...................................................... ........................................... ...........................................
187
120 °F, 24 hr.
F. Refrigerated storage (no thermal treatment in the con- I, II, III, IV–A, IV–B, VI–B,VII ................ 70 °F, 48 hr ...................... .
tainer).
VI–A ...................................................... ........................................... ........................................... 70 °F, 48 hr.
Sfmt 8010
G. Frozen storage (no thermal treatment in the container) .. I, II, III, IV–B, VII ................................... 70 °F, 24 hr ...................... .
H. Frozen storage: Ready-prepared foods intended to be
reheated in container at time of use:
1. Aqueous or oil in water emulsion of high or low I, II, IV–B ............................................... 212 °F, 30 min .................. .
fat.
2. Aqueous, high or low free oil or fat .................... III, IV–A, VII ........................................... do ...................................... 120 °F, 30 min.
1 Heptane extractant not to be used on wax-lined containers.
2 Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.
Y:\SGML\226069.XXX
226069
§ 175.300
§ 175.300 21 CFR Ch. I (4–1–12 Edition)
(e) Analytical methods—(1) Selection of perature of 190 °F–200 °F before starting

extractability conditions. First ascertain to rinse the container. Invert the con-
the type of food product (table 1, para- tainer over the top of the fountain and
graph (d) of this section) that is being direct a strong stream of hot water
packed commercially in the test con- against the bottom and all sides for 1
tainer and the normal conditions of minute, drain, and allow to dry.
thermal treatment used in packaging (4) Exposure conditions—(i) Water (250
the type of food involved. Using table 2 °F for 2 hours), simulating high-tempera-
(paragraph (d) of this section), select ture heat sterilization. Fill the container
the food-simulating solvent or solvents within 1⁄4-inch of the top with a meas-
(demineralized distilled water, ured volume of demineralized distilled
heptane, and/or 8 percent ethyl alcohol) water. Cover the container with clean
and the time-temperature exaggera- aluminum foil and place the container
tions of the container-use conditions. on a rack in a pressure cooker. Add a
Aqueous products (Types I, II, IV-B, small amount of demineralized dis-
and VI-B) require only a water- tilled water to the pressure cooker, but
extractability test at the temperature do not allow the water to touch the
and time conditions shown for the bottom of the container. Close the
most severe ‘‘conditions of use.’’ Aque- cooker securely and start to heat over
ous products with free oil or fat, and a suitable burner. When a steady
water-oil emulsions (types III, IV-A, stream of steam emerges from the
and VII) will require determinations of vent, close the vent and allow the pres-
both water extractability and heptane sure to rise to 15 pounds per square
extractability. Low-moisture fats and inch (250 °F) and continue to maintain
oils (type V with no free water) require this pressure for 2 hours. Slowly re-
only the heptane extractability. Alco- lease the pressure, open the pressure
holic beverages (type VI-A) require cooker when the pressure reads zero,
only the 8 percent alcohol extractant. and composite the water of each rep-
Having selected the appropriate ex- licate immediately in a clean Pyrex
tractant or extractants simulating var- flask or beaker. Proceed with the de-
ious types of foods and beverages and termination of the amount of extrac-
the time-temperature exaggerations tives by the method described in para-
over normal use, follow the applicable graph (e)(5) of this section.
extraction procedure. Adapt the proce- (ii) Water (212 °F for 30 minutes), simu-
dure, when necessary, for containers lating boiling water sterilization. Fill the
having a capacity of over 1 gallon. container within 1⁄4-inch of the top
(2) Selection of coated-container sam- with a measured volume of boiling,
ples. For consumer-sized containers up demineralized distilled water. Cover
to 1 gallon, quadruplicate samples of the container with clean aluminum foil
representative containers (using for and place the container on a rack in a
each replicate sample the number of pressure cooker in which a small
containers nearest to an area of 180 amount of demineralized distilled
square inches) should be selected from water is boiling. Do not close the pres-
the lot to be examined. sure vent, but operate at atmospheric
(3) Cleaning procedure preliminary to pressure so that there is a continuous
determining the amount of extractables escape of a small amount of steam.
from coated containers. Quadruplicate Continue to heat for 30 minutes, then
samples of representative containers remove the test container and com-
should be selected from the lot to be posite the contents of each replicate
examined and must be carefully rinsed immediately in a clean Pyrex flask or
to remove extraneous material prior to beaker. Proceed with the determina-
the actual extraction procedure. Soda tion of the amount of extractives by
fountain pressure-type hot water rins- the method described in paragraph
ing equipment, consisting in its sim- (e)(5) of this section.
plest form of a 1⁄8-inch–1⁄4-inch internal (iii) Water (from boiling to 100 °F), sim-
diameter metal tube attached to a hot ulating hot fill or pasteurization above 150
water line and bent so as to direct a °F. Fill the container within 1⁄4-inch of
stream of water upward, may be used. the top with a measured volume of
Be sure hot water has reached a tem- boiling, demineralized distilled water.
188
Insert a thermometer in the water and (vii) Water (70 °F for 24 hours), simu-
allow the uncovered container to stand lating frozen storage. Bring
in a room at 70 °F–85 °F. When the tem- demineralized distilled water to 70 °F
perature reads 100 °F, composite the in a clean Pyrex flask. Fill the con-
water from each replicate immediately tainer within 1⁄4-inch of the top with a
in a clean Pyrex flask or beaker. Pro- measured volume of the 70 °F water
ceed with the determination of the and cover with clean aluminum foil.
amount of extractives by the method Place the container in a suitable room
described in paragraph (e)(5) of this maintained at 70 °F. After 24 hours, im-
section. mediately composite the water of each
(iv) Water (150° for 2 hours), simulating replicate in a clean Pyrex flask or
hot fill or pasteurization below 150 °F. beaker. Proceed with the determina-
Preheat demineralized distilled water tion of the amount of extractives by
to 150 °F in a clean Pyrex flask. Fill the method described in paragraph
the container within 1⁄4-inch of the top (e)(5) of this section.
with a measured volume of the 150 °F (viii) Water (212 °F for 30 minutes), sim-
water and cover with clean aluminum ulating frozen foods reheated in the con-
foil. Place the test container in an tainer. Fill the container to within 1⁄4-
oven maintained at 150 °F. After 2 inch of the top with a measured volume
hours, remove the test container from of boiling, demineralized distilled
the oven and immediately composite water. Cover the container with clean
the water of each replicate in a clean aluminum foil and place the container
on a rack in a pressure cooker in which
Pyrex flask or beaker. Proceed with
a small amount of demineralized dis-
the determination of the amount of ex-
tilled water is boiling. Do not close the
tractives by the method described in
pressure vent, but operate at atmos-
paragraph (e)(5) of this section.
pheric pressure so that there is a con-
(v) Water (120 °F for 24 hours), simu- tinuous escape of a small amount of
lating room temperature filling and stor- steam. Continue to heat for 30 minutes,
age. Preheat demineralized distilled then remove the test container and
water to 120 °F in a clean Pyrex flask. composite the contents of each rep-
Fill the container within 1⁄4-inch of the licate immediately in a clean Pyrex
top with a measured volume of the 120 flask or beaker. Proceed with the de-
°F water and cover with clean alu- termination of the amount of extrac-
minum foil. Place the test container in tives by the method described in para-
an incubator or oven maintained at 120 graph (e)(5) of this section.
°F. After 24 hours, remove the test con- (ix) Heptane (150 °F for 2 hours) simu-
tainer from the incubator and imme- lating high-temperature heat sterilization
diately composite the water of each for fatty foods only. Preheat redistilled
replicate in a clean Pyrex flask or reagent-grade heptane (boiling point
beaker. Proceed with the determina- 208 °F) carefully in a clean Pyrex flask
tion of the amount of extractives by on a water bath or nonsparking hot
the method described in paragraph plate in a well-ventilated hood to 150
(e)(5) of this section. °F. At the same time preheat a pres-
(vi) Water (70 °F for 48 hours), simu- sure cooker or equivalent to 150 °F in
lating refrigerated storage. Bring an incubator. This pressure cooker is
demineralized distilled water to 70 °F to serve only as a container for the
in a clean Pyrex flask. Fill the con- heptane-containing test package inside
tainer within 1⁄4-inch of the top with a the incubator in order to minimize the
measured volume of the 70 °F water, danger of explosion. Fill the test con-
and cover with clean aluminum foil. tainer within 1⁄4-inch of the top with a
Place the test container in a suitable measured volume of the 150 °F heptane
room maintained at 70 °F. After 48 and cover with clean aluminum foil.
hours, immediately composite the Place the test container in the
water of each replicate in a clean preheated pressure cooker and then put
Pyrex flask or beaker. Proceed with the assembly into a 150 °F incubator.
the determination of the amount of ex- After 2 hours, remove the pressure
tractives by the method described in cooker from the incubator, open the as-
paragraph (e)(5) of this section. sembly, and immediately composite
189
§ 175.300 21 CFR Ch. I (4–1–12 Edition)
the heptane of each replicate in a clean tractives by the method described in

Pyrex flask or beaker. Proceed with paragraph (e)(5) of this section.
the determination of the amount of ex- (xii) Heptane (100 °F for 30 minutes),
tractives by the method described in simulating hot fill or pasteurization below
paragraph (e)(5) of this section. 150 °F for fatty foods only. Preheat re-
(x) Heptane (120 °F for 30 minutes), sim- distilled reagent-grade heptane (boiling
ulating boiling water sterilization of fatty point 208 °F) carefully in a clean Pyrex
foods only. Preheat redistilled reagent- flask on a water bath or nonsparking
grade heptane (boiling point 208 °F) hot plate in a well-ventilated hood to
carefully in a clean Pyrex flask on a 100 °F. At the same time, preheat a
water bath or nonsparking hot plate in pressure cooker or equivalent to 100 °F
a well-ventilated hood to 120 °F. At the in an incubator. This pressure cooker
same time, preheat a pressure cooker is to serve only as a container for the
or equivalent to 120 °F in an incubator. heptane-containing test package inside
This pressure cooker is to serve only as the incubator in order to minimize the
a vented container for the heptane-con- danger of explosion. Fill the test con-
taining test package inside the incu- tainer within 1⁄4-inch of the top with a
bator in order to minimize the danger measured volume of the 100 °F heptane
of explosion. Fill the test container and cover with clean aluminum foil.
within 1⁄4-inch of the top with a meas- Place the test container in the
ured volume of the 120 °F heptane and preheated pressure cooker and then put
cover with clean aluminum foil. Place the assembly into a 100 °F incubator.
the test container in the preheated After 30 minutes, remove the pressure
pressure cooker and then put the as- cooker from the incubator, open the as-
sembly into a 120 °F incubator. After 30 sembly and immediately composite the
minutes, remove the pressure cooker heptane of each replicate in a clean
from the incubator, open the assembly, Pyrex flask or beaker. Proceed with
and immediately composite the the determination of the amount of ex-
heptane of each replicate in a clean tractives by the method described in
Pyrex flask or beaker. Proceed with paragraph (e)(5) of this section.
the determination of the amount of ex- (xiii) Heptane (70 °F for 30 minutes),
tractives by the method described in simulating room temperature filling and
paragraph (e)(5) of this section. storage of fatty foods only. Fill the test
(xi) Heptane (120 °F for 15 minutes), container within 1⁄4-inch of the top
simulating hot fill or pasteurization above with a measured volume of the 70 °F
150 °F for fatty foods only. Preheat re- heptane and cover with clean alu-
distilled reagent-grade heptane (boiling minum foil. Place the test container in
point 208 °F) carefully in a clean Pyrex a suitable room maintained at 70 °F.
flask on a water bath or nonsparking After 30 minutes, composite the
hot plate in a well-ventilated hood to heptane of each replicate in a clean
120 °F. At the same time, preheat a Pyrex flask or beaker. Proceed with
pressure cooker or equivalent to 120 °F the determination of the amount of ex-
in an incubator. This pressure cooker tractives by the method described in
is to serve only as a container for the paragraph (e)(5) of this section.
heptane-containing test package inside (xiv) Heptane (120 °F for 30 minutes),
the incubator in order to minimize the simulating frozen fatty foods reheated in
danger of explosion. Fill the test con- the container. Preheat redistilled rea-
tainer within 1⁄4-inch of the top with a gent-grade heptane (boiling point 208
measured volume of the 120 °F heptane °F) carefully in a clean Pyrex flask on
and cover with clean aluminum foil. a water bath or hot plate in a well-ven-
Place the test container in the tilated hood to 120 °F. At the same
preheated pressure cooker and then put time, preheat a pressure cooker to 120
the assembly into a 120 °F incubator. °F in an incubator. This pressure cook-
After 15 minutes, remove the pressure er is to serve only as a container for
cooker from the incubator, open the as- the heptane-containing test package
sembly, and immediately composite inside the incubator in order to mini-
the heptane of each replicate in a clean mize the danger of explosion. Fill the
Pyrex flask or beaker. Proceed with test container within 1⁄4-inch of the top
the determination of the amount of ex- with a measured volume of the 120 °F
190
heptane and cover with clean alu- maintained at 70 °F. After 48 hours, im-
minum foil. Place the test container in mediately composite the alcohol from
the preheated pressure cooker and then each replicate into a clean Pyrex flask.
put the assembly into a 120 °F incu- Proceed with the determination of the
bator. After 30 minutes, remove the amount of extractives by the method
pressure cooker from the incubator, described in paragraph (e)(5) of this
open the assembly and immediately section.
composite the heptane from each rep- NOTE: The tests specified in paragraph
licate into a clean Pyrex flask. Proceed (e)(4) (i) through (xvii) of this section are ap-
with the determination of the amount plicable to flexible packages consisting of
of extractives by the method described coated metal contacting food, in which case
in paragraph (e)(5) of this section. the closure end is double-folded and clamped
(xv) Alcohol—8 percent (150 °F for 2 with metal spring clips by which the package
hours), simulating alcoholic beverages hot can be suspended.
filled or pasteurized below 150 °F. Pre- (5) Determination of amount of extrac-
heat 8 percent (by volume) ethyl alco- tives—(i) Total residues. Evaporate the
hol in demineralized distilled water to food-simulating solvents from para-
150 °F in a clean Pyrex flask. Fill the graph (e)(4) (i) to (xvii), inclusive, of
test container with within 1⁄4-inch of this section to about 100 milliliters in
the top with a measured volume of the the Pyrex flask and transfer to a clean,
8 percent alcohol. Cover the container tared platinum dish, washing the flask
with clean aluminum foil and place in three times with the solvent used in
an oven maintained at 150 °F. After 2 the extraction procedure, and evapo-
hours, remove the container from the rate to a few milliliters on a non-
oven and immediately composite the sparking low-temperature hotplate.
alcohol from each replicate in a clean The last few milliliters should be evap-
Pyrex flask. Proceed with the deter- orated in an oven maintained at a tem-
mination of the amount of extractives perature of 212 °F. Cool the platinum
by the method described in paragraph dish in a desiccator for 30 minutes and
(e)(5) of this section. weigh the residue to the nearest 0.1
(xvi) Alcohol—8 percent (120 °F for 24 milligram (e). Calculate the extractives
hours), simulating alcoholic beverages in milligrams per square inch and in
room-temperature filled and stored. Pre- parts per million for the particular size
heat 8 percent (by volume) ethyl alco- of container being tested and for the
hol in demineralized distilled water to specific food-simulating solvent used.
120 °F in a clean Pyrex flask. Fill the (a) Water and 8-percent alcohol.
test container within 1⁄4-inch of the top
with a measured volume of the 8 per- Milligrams extractives e
cent alcohol, cover the container with =
per square inch s
clean aluminum foil and place in an
oven or incubator maintained at 120 °F.
Ex = ( e )( a )(1000)
After 24 hours, remove the container Extractives residue =
from the oven or incubator and imme- ( c )( s )
diately composite the alcohol from
each replicate into a clean Pyrex flask. (b) Heptane.
Proceed with the determination of the
Milligrams extractives e
amount of extractives by the method =
ER01JA93.391</GPH>
described in paragraph (e)(5) of this per square inch ( s )( F )

section.
(xvii) Alcohol—8 percent (70 °F for 48 Ex = ( e )( a )(1000)
hours), simulating alcoholic beverages in Extractives residue =
refrigerated storage. Bring 8 percent (by ( c )( s )( F )
ER01JA93.389</GPH> ER01JA93.390</GPH>
volume) ethyl alcohol in demineralized

where:
distilled water to 70 °F in a clean Pyrex
flask. Fill the test container within 1⁄4- Ex=Extractives residue in ppm for any con-
tainer size.
inch of the top with a measured volume e=Milligrams extractives per sample tested.
of the 8 percent alcohol. Cover the con-
a=Total coated area, including closure in

tainer with clean aluminum foil. Place square inches.
the test container in a suitable room c=Water capacity of container, in grams.
191
ER01JA93.388</GPH>
§ 175.300 21 CFR Ch. I (4–1–12 Edition)
s=Surface of coated area tested, in square heating gently over a Meeker-type
inches. burner to destroy organic matter and
F=Five, the ratio of the amount of extrac- hold at red heat for about 1 minute.
tives removed from a coated container by
heptane under exaggerated time-tempera-
Cool in the air for 3 minutes, and place
ture test conditions compared to the the platinum dish in the desiccator for
amount extracted by a fat or oil from a 30 minutes and weigh to the nearest 0.1
container tested under exaggerated condi- milligram. Analyze this ash for zinc by
tions of thermal sterilization and use. standard Association of Official Agri-
e′=Chloroform-soluble extractives residue. cultural Chemists methods or equiva-
ee′=Zinc corrected chloroform-soluble ex- lent. Calculate the zinc in the ash as
tractive residue.
zinc oleate, and subtract from the
e′ or ee′ is substituted for e in the above equa-
tions when necessary. weight of chloroform-soluble extrac-
tives residue (e′) to obtain the zinc-cor-
If when calculated by the equations in rected chloroform-soluble extractives
paragraph (e)(5)(i) (a) and (b) of this residue (ee′). This ee′ is substituted for
section, the concentration of extrac- e in the formulas in paragraph (e)(5)(i)
tives residue (Ex) exceeds 50 parts per (a) and (b) of this section. To comply
million or the extractives in milli- with the limitations in paragraph (c) of
grams per square inch exceed the limi- this section, the chloroform-soluble ex-
tations prescribed in paragraph (c) of tractives residue (but after correction
this section for the particular con- for the zinc extractives in case of ‘‘C’’
tainer size, proceed to paragraph enamels) must not exceed 50 parts per
(e)(5)(ii) of this section (method for de- million and must not exceed in milli-
termining the amount of chloroform- grams per square inch the limitations
soluble extractives residue). for the particular article as prescribed
(ii) Chloroform-soluble extractives resin paragraph (c) of this section.
idue. Add 50 milliliters of chloroform (f) Equipment and reagent require-
(freshly distilled reagent grade or a ments—(1) Equipment.
grade having an established consist-
ently low blank) to the dried and Rinsing equipment, soda fountain pressure-
type hot water, consisting in simplest form
weighed residue, (e), in the platinum of a 1⁄8-inch–1⁄4-inch inside diameter metal
dish, obtained in paragraph (e)(5)(i) of tube attached to a hot water line delivering
this section. Warm carefully, and filter 190 °F–200 °F water and bent so as to direct
through Whatman No. 41 filter paper in a stream of water upward.
a Pyrex funnel, collecting the filtrate Pressure cooker, 21-quart capacity with
in a clean, tared platinum dish. Repeat pressure gage, safety release, and removable
the chloroform extraction, washing the rack, 12.5 inches inside diameter × 11 inches
filter paper with this second portion of inside height, 20 pounds per square inch safe
operating pressure.
chloroform. Add this filtrate to the
Oven, mechanical convection, range to in-
original filtrate and evaporate the
clude 120 °F–212 °F explosion-proof, inside di-
total down to a few milliliters on a mensions (minimum), 19″ × 19″ × 19″, constant
low-temperature hotplate. The last few temperature to ±2 °F (water bath may be
milliliters should be evaporated in an substituted).
oven maintained at 212 °F. Cool the Incubator, inside dimensions (minimum)
platinum dish in a desiccator for 30 19″ × 19″ × 19″ for use at 100 °F±2 °F explosion
minutes and weigh to the nearest 0.1 proof (water bath may be substituted).
milligram to get the chloroform-solu- Constant-temperature room or chamber 70
ble extractives residue (e′). This e′ is °F±2 °F minimum inside dimensions 19″ × 19″
substituted for e in the equations in × 19″.
Hot plate, nonsparking (explosion proof),
paragraph (e)(5)(i) (a) and (b) of this
top 12″ × 20″, 2,500 watts, with temperature
section. If the concentration of extrac- control.
tives (Ex) still exceeds 50 parts per mil- Platinum dish, 100-milliliter capacity min-
lion or the extractives in milligrams imum.
per square inch exceed the limitations All glass, Pyrex or equivalent.
prescribed in paragraph (c) of this sec-
tion for the particular container size, (2) Reagents.
proceed as follows to correct for zinc
Water, all water used in extraction proce-

extractives (‘‘C’’ enamels only): Ash dure should be freshly demineralized (deion-
the residue in the platinum dish by ized) distilled water.
192
Heptane, reagent grade, freshly redistilled surface of articles intended for use in
before use, using only material boiling at 208 producing, manufacturing, packing,
°F.
Alcohol, 8 percent (by volume), prepared
processing, preparing, treating, pack-
from undenatured 95 percent ethyl alcohol aging, transporting, or holding food, in
diluted with demineralized or distilled accordance with the following pre-
water. scribed conditions:
Chloroform, reagent grade, freshly redis- (a) The coating is applied as a contin-
tilled before use, or a grade having an estab-
lished, consistently low blank.
uous film over one or both sides of a
Filter paper, Whatman No. 41 or equiva- base film produced from one or more of
lent. the basic olefin polymers complying
(g) In accordance with good manufac- with § 177.1520 of this chapter. The base
turing practice, finished coatings in- polyolefin film may contain optional
tended for repeated food-contact use adjuvant substances permitted for use
shall be thoroughly cleansed prior to in polyolefin film by applicable regula-
their first use in contact with food. tions in parts 170 through 189 of this
(h) Acrylonitrile copolymers identi- chapter.
fied in this section shall comply with (b) The coatings are formulated from
the provisions of § 180.22 of this chap- optional substances which are:
ter. (1) Substances generally recognized
[42 FR 14534, Mar. 15, 1977] as safe for use in or on food.
(2) Substances the use of which is
EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 175.300, see the List of CFR permitted under applicable regulations
Sections Affected, which appears in the in parts 170 through 189 of this chapter,
Finding Aids section of the printed volume by prior sanctions, or approvals.
and at www.fdsys.gov. (3) Substances identified in this para-
graph (b)(3) and subject to such limita-
§ 175.320 Resinous and polymeric coat-
ings for polyolefin films. tions as are provided:
Resinous and polymeric coatings
may be safely used as the food-contact
List of substances Limitations
(i) Resins and polymers:

Acrylic acid polymer and its ethyl or methyl esters.
Acrylamide copolymerized with ethyl acrylate and/or sty-
rene and/or methacrylic acid, and the copolymer subse-
quently reacted with formaldehyde and butanol.
Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene terpolymer.
Butyl rubber.
N,N′-Diphenyl-p-phenylenediamine ...................................... For use only as a polymerization inhibitor in 2-sulfoethyl meth-
acrylate, sodium salt.
2-Ethylhexyl acrylate copolymerized with one or more of
the following:
Acrylonitrile.
Itaconic acid.
Methacrylonitrile.
Methyl acrylate.
Methyl methacrylate.
4,4′-Isopropylidenediphenolepichlorohydrin average molec-
ular weight 900.
Melamine-formaldehyde as the basic polymer or chemi-
cally modified with methyl alcohol.
Methacrylic acid and its ethyl or methyl esters copolym-
erized with one or more of the following:
Acrylic acid.
Ethyl acrylate.
Methyl acrylate.
a-Methyl styrene polymer.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio For use only in coatings that contact food under conditions of
1 a-methylstyrene to 3 vinyltoluene). use D, E, F, or G described in table 2 of § 176.170(c) of this
chapter, provided that the concentration of a-methylstyrene-
vinyltoluene copolymer resins in the finished food-contact

coating does not exceed 1.0 milligram per square inch of
food-contact surface.
193
§ 175.320 21 CFR Ch. I (4–1–12 Edition)
Petroleum alicyclic hydrocarbon resins ................................ As defined in § 176.170 of this chapter. Blended with butyl rub-
ber for use as a component of coatings on polyolefin fabric
for bulk packaging of raw fruits and vegetables and used at
a level not to exceed 30 percent by weight of the total coat-
ing solids.
Polyamide resins (CAS Reg. No. 68139–70–8), as the For use only in coatings for polypropylene films that contact
basic resin, derived from: food at temperatures not to exceed room temperature.
Dimerized vegetable oil or tall oil acids containing not
more than 20 percent of monomer acids.
Azelaic acid (CAS Reg. No. 123–99–9) in an amount
not to exceed 3.7 percent by weight of the poly-
amide resin.
Ethylenediamine (CAS Reg. No. 107–15–3).
Piperazine (CAS Reg. No. 110–85–0) in an amount
not to exceed 6.4 percent by weight of the poly-
amide resin.
Polyamide resins, derived from dimerized vegetable oil For use only in coatings for polyolefin films that contact food at
acids (containing not more than 20% of monomer acids) temperatures not to exceed room temperature.
and ethylenediamine, as the basic resin.
Polyamide resins having a maximum acid value of 5 and a For use only in coatings that contact food at temperatures not
maximum amine value of 8.5 derived from dimerized to exceed room temperature provided that the concentration
vegetable oil acids (containing not more than 10 percent of the polyamide resins in the finished food-contact coating
of monomer acids), ethylenediamine, and 4,4-bis (4- does not exceed 5 milligrams per square inch of food-con-
hydroxyphenyl) pentanoic acids (in an amount not to ex- tact surface.
ceed 10 percent by weight of said polyamide resins); as
the basic resin.
Polyester resins formed by reaction of one or more of the
following polybasic acids and monobasic acids with one
or more of the following polyhydric alcohols:
Polybasic acids:
Adipic.
Azelaic .................................................................... For use in forming polyester resins intended for use in coatings
that contact food only of the type identified in § 176.170(c) of
this chapter, table 1, under Category VIII, and under condi-
tions of use E, F, or G, described in table 2 of § 176.170(c)
of this chapter.
Dimerized fatty acids derived from:
Animal, marine or vegetable fats and oils.
Tall oil.
Fumaric.
Isophthalic.
Maleic.
o-Phthalic.
Sebacic.
Terephthalic.
Trimellitic.
Monobasic acids:
Fatty acids derived from:
Animal, marine, or vegetable fats and oils.
Gum rosin ....................................................... As defined in § 178.3870 of this chapter. For use in forming
polyester resins intended for use in coatings that contact
food only of the type identified in § 176.170(c) of this chap-
ter, table 1, under Category VIII, and under conditions of use
E, F, or G described in table 2 of § 176.170(c) of this chap-
ter.
Polyhydric alcohols:
1,3-Butylene glycol.
Diethylene glycol.
2,2-Dimethyl-1,3-propanediol.
Dipropylene glycol.
Ethylene glycol.
Glycerol.
Mannitol.
a-Methyl glucoside.
Pentaerythritol.
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Trimethylol propane.
Polyethylenimine .................................................................. For use only as a primer subcoat to anchor epoxy surface
coatings to the base sheet.
Polystyrene.
Polyvinyl acetate.
Polyvinyl chloride ..................................................................
194
Siloxanes and silicones: platinum-catalyzed reaction product of Platinum content not to exceed 150 parts per million.
vinyl-containing dimethylpolysiloxane (CAS Reg. No. 68083–
18–1 and CAS Reg. No. 68083–19–2) with methylhydrogen
polysiloxane (CAS Reg. No. 63148–57–2) and
dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037–
59–2). The following substances may be used as optional
polymerization inhibitors:.
3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107–54–0), at
a level not to exceed 0.53 weight percent;.
1-Ethynylcyclohexene (CAS Reg. No. 931–49–7), at a
level not to exceed 0.64 weight percent;.
Bis(methoxymethyl)ethyl maleate (CAS Reg. No.
102054–10–4), at a level not to exceed 1.0 weight
percent;.
Methylvinyl cyclosiloxane (CAS Reg. No. 68082–23–5);
and.
Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No.
2554–06–5)..
Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use
vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a surface coating under the following conditions:
68083–19–2 and 68083–18–1), with methyl hydrogen 1. In coatings for olefin polymers provided the coating contacts
polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate food only of the types identified in § 176.170(c) of this chap-
(CAS Reg. No. 624–48–6) and vinyl acetate (CAS Reg. No. ter, table 1, under Types I, II, VI, and VII-B when used under
108–05–4) may be used as optional polymerization inhibitors. conditions of use E, F, and G described in table 2 in
2. In coatings for olefin polymers provided the coating contacts
food only of the types identified in § 176.170(c) of this chap-
ter, table 1, under Types III, IV, V, VII-A, VIII, and IX when
used under conditions of use A through H described in table
2 in § 176.170(c) of this chapter.
vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives.
68083–19–2 and 68083–18–1), with methyl hydrogen
polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate
(CAS Reg. No. 624–48–6), vinyl acetate (CAS Reg. No.
108–05–4), dibutyl maleate (CAS Reg. No. 105–76–0) and
diallyl maleate (CAS Reg. No. 999–21–3) may be used as
optional polymerization inhibitors. The polymer may also
contain C16-C18 olefins (CAS Reg. No. 68855–60–7) as a
control release agent.
Styrene copolymerized with one or more of the following:
Acrylonitrile.
a-Methyl styrene.
Styrene polymers made by the polymerization of any com- For use only in contact with foods of Types IV-A, V, and VII in
bination of styrene or alpha methyl styrene with acrylic table 1 of § 176.170(c) of this chapter, under use conditions
acid, methacrylic acid, 2-ethyl hexyl acrylate, methyl E through G in table 2 of § 176.170(c), and with foods of
methacrylate, and butyl acrylate. The styrene and alpha Types VIII and IX without use temperature restriction.
methyl styrene, individually, may constitute from 0 to 80
weight percent of the polymer. The other monomers, in-
dividually, may be from 0 to 40 weight percent of the
polymer. The polymer number average molecular weight
(Mn) shall be at least 2,000 (as determined by gel per-
meation chromatography). The acid number of the poly-
mer shall be less than 250. The monomer content shall
be less than 0.5 percent.
Styrene-isobutylene copolymer.
Terpene resins consisting of polymers of a-pinene, b-pi-
nene, and/or dipentene; acid value less than 5, saponi-
fication number less than 5, and color less than 4 on the
Gardner scale as measured in 50 percent mineral spirits
solution.
2-Sulfoethyl methacrylate, sodium salt Chemical Abstracts For use only in copolymer coatings under conditions of use E,
Service No. 1804–87–1]. F, and G described in table 2 of § 176.170(c) of this chapter
and limited to use at a level not to exceed 2.0 percent by
weight of the dry copolymer coating.
Vinyl chloride-acetate, hydroxyl-modified copolymer or ma-
leic acid-modified copolymer.
Vinyl chloride copolymerized with one or more of the fol-
lowing:
Acrvlonitrile.
Vinyl acetate.
195
§ 175.320 21 CFR Ch. I (4–1–12 Edition)
Vinylidene chloride copolymerized with one or more of the

following:
Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl
esters.
Acrylonitrile.
Itaconic acid.
Methacrylic acid and its methyl, ethyl, propyl, butyl, or
octyl esters.
Methacrylonitrile.
Vinyl chloride.
(ii) Plasticizers:
Butyl phthalyl butyl glycolate.
Butyl stearate.
Dibutyl sebacate.
Diethyl phthalate.
2-Ethylhexyl diphenyl phosphate.
Glycerol monooleate ............................................................
Glycerol triacetate.
Triethyl citrate.
(iii) Adjuvants (release agents, waxes, and dispersants):
Acetone.
Amides (unsubstituted) of fatty acids from vegetable or
animal oils.
n-Butyl acetate.
n-Butyl alcohol.
Candelilla wax.
Carnauba wax.
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172– For use only as an antimicrobial agent in emulsion-based sili-
55–4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. cone coatings at a level not to exceed 50 milligrams per kilo-
2682–20–4) mixture, at a ratio of 3 parts to 1 part, respec- gram (based on isothiazolone active ingredient) in the coat-
tively, manufactured from methyl-3-mercaptopropionate (CAS ing formulation.
Reg. No. 2935–90–2) and optionally containing magnesium
nitrate (CAS Reg. No. 10377–60–3) at a concentration
equivalent to the isothiazolone active ingredients (weight/
weight)..
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65– For use as an antimicrobial agent at levels not to exceed 500
7). milligrams per kilogram in emulsion-based silicone coating.
Ethyl acetate.
Fatty acids from vegetable or animal oils and their alu-
minum, ammonium, calcium, magnesium, and sodium
salts.
Hexane.
Methyl ethyl ketone.
N,N′-Dioleoylethylenediamine (CAS Reg. No. 110–31–6) ... For use only in ionomeric resins complying with § 177.1330 of
this chapter and in ethylene vinyl acetate copolymers com-
plying with § 177.1350 of this chapter at a level not to ex-
ceed 0.0085 milligram per square centimeter (0.055 milli-
gram per square inch) in the finished food-contact article.
Petroleum waxes conforming to specifications included in
a regulation in subchapter B of this chapter.
Polyvinyl alcohol, minimum viscosity of 4% aqueous solu- For use only as a dispersing agent at levels not to exceed 6%
tion at 20 °C of 4 centipoises and percent alcoholysis of of total coating weight in coatings for pol-yolefin films pro-
87–100. vided the finished polyolefin films contact food only of the
types identified in § 176.170(c) of this chapter, table 1, under
Types V, VIII, and IX.
Sodium dioctyl sulfosuccinate.
Sodium dodecylbenzenesulfonate.
Sodium lauryl sulfate.
Sorbitan and sorbitol esters of fatty acids from vegetable
or animal oils.
Spermaceti wax.
Tetrahydrofuran.
Toluene.
(iv) Preservatives:
Silver chloride-coated titanium dioxide ................................ For use only as a preservative in latex emulsions at a level not
to exceed 2.2 parts per million (based on silver ion con-
centration) in the dry coating.
196
(c) The coating in the finished form List of substances Limitations

in which it is to contact food, when ex-
Silica.
tracted with the solvent or solvents Japan wax.
characterizing the type of food, and
under conditions of time and tempera- (e) Copolymer of vinyl acetate and
ture characterizing the conditions of crotonic acid used as a coating or as a
its intended use as determined from ta- component of a coating conforming
bles 1 and 2 of § 176.17(c) of this chapter, with the specifications of paragraph
shall yield net chloroform-soluble ex- (e)(1) of this section are used as pro-
tractives not to exceed 0.5 milligram vided in paragraph (e)(2) of this sec-
per square inch of coated surface. tion.
(d) Acrylonitrile copolymers identi- (1) Specifications. (i) The chloroform-
fied in this section shall comply with soluble portion of the water extractives
the provisions of § 180.22 of this chap- of the coated film obtained with dis-
ter. tilled water at 120 °F for 24 hours does
not exceed 0.5 milligram per square
[42 FR 14534, Mar. 15, 1977, as amended at 43 inch of coated surface.
FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29,
(ii) The chloroform-soluble portion of
1980; 47 FR 22512, May 25, 1982; 49 FR 36497,
Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR the n-heptane extractives of the coated
49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 film obtained with n-heptane at 70 °F
FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, for 30 minutes does not exceed 0.5 milli-
1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, gram per square inch of coated surface.
June 13, 2000] (2) Conditions of use. The copolymer
of vinyl acetate and crotonic acid is
§ 175.350 Vinyl acetate/crotonic acid used as a coating or as a component of
copolymer. a coating for polyolefin films for pack-
A copolymer of vinyl acetate and aging bakery products and confec-
crotonic acid may be safely used as a tionery.
coating or as a component of a coating
§ 175.360 Vinylidene chloride copoly-
which is the food-contact surface of mer coatings for nylon film.
polyolefin films intended for packaging
food, subject to the provisions of this Vinylidene chloride copolymer coat-
section. ings identified in this section and ap-
(a) The copolymer may contain added plied on nylon film may be safely used
optional substances to impart desired as food-contact surfaces, in accordance
properties. with the following prescribed condi-
tions:
(b) The quantity of any optional sub-
(a) The coating is applied as a contin-
stance does not exceed the amount rea-
uous film over one or both sides of a
sonably required to accomplish the in-
base film produced from nylon resins
tended physical or technical effect nor complying with § 177.1500 of this chap-
any limitations further provided. ter.
(c) Any optional substance that is (b) The coatings are prepared from
the subject of a regulation in parts 174, vinylidene chloride copolymers pro-
175, 176, 177, 178, and § 179.45 of this duced by copolymerizing vinylidene
chapter conforms with any specifica- chloride with one or more of the mono-
tions in such regulation. mers acrylic acid, acrylonitrile, ethyl
(d) Optional substances as provided acrylate, methacrylic acid, methyl ac-
in paragraph (a) of this section include: rylate, methyl methacrylate (CAS Reg.
(1) Substances generally recognized No. 80–62–6; maximum use level 6
as safe in food. weight percent) and 2-sulfoethyl meth-
(2) Substances subject to prior sanc- acrylate (CAS Reg. No. 10595–80–9; max-
tion or approval for uses with a copoly- imum use level 1 weight percent). The
mer of vinyl acetate and crotonic acid finished copolymers contain at least 50
and used in accordance with such sanc- weight percent of polymer units de-
tion or approval. rived from vinylidene chloride. The fin-
(3) Substances identified in this sub- ished coating produced from vinylidene
paragraph and subject to such limita- chloride copolymers produced by co-

tions as are provided: polymerizing vinylidene chloride with
197
§ 175.365 21 CFR Ch. I (4–1–12 Edition)
methyl methacrylate and/or 2- dodecylbenzenesulfonate in addition to

sulfoethyl methacrylate, or with meth- substances described in § 174.5(d) of this
yl methacrylate and/or 2-sulfoethyl chapter.
methacrylate together with one or (d) The coating in the finished form
more of the other monomers from this in which it is to contact food, when ex-
section, is restricted to use at or below tracted with the solvent or solvents
room temperature. characterizing the type of food, and
(c) Optional adjuvant substances em- under the conditions of time and tem-
ployed in the production of the coat- perature characterizing the conditions
ings or added thereto to impart desired of its intended use as determined from
properties may include sodium tables 1 and 2 of § 176.170(c) of this chap-
dodecylbenzenesulfonate. ter, shall yield net chloroform-soluble
(d) The coating in the finished form extractives in each extracting solvent
in which it is to contact food, when ex- not to exceed 0.5 milligram per square
tracted with the solvent or solvents inch of coated surface as determined by
characterizing the type of food, and the methods described in § 176.170(d) of
under conditions of time and tempera- this chapter. In testing the finished
ture characterizing the conditions of food-contact articles, a separate test
its intended use as determined from ta- sample is to be used for each required
bles 1 and 2 of § 176.170(c) of this chap- extracting solvent.
ter, shall yield net chloroform-soluble (e) Acrylonitrile copolymers identi-
extractives not to exceed 0.5 milligram fied in this section shall comply with
per square inch of coated surface when the provisons of § 180.22 of this chapter.
tested by the methods described in
§ 176.170(d) of this chapter. § 175.380 Xylene-formaldehyde resins
(e) Acrylonitrile copolymers identi- condensed with 4,4′-
fied in this section shall comply with isopropylidenediphenol-
the provisions of § 180.22 of this chap- epichlorohydrin epoxy resins.
ter. The resins identified in paragraph (a)
of this section may be safely used as a
FR 7206, Feb. 21, 1978; 45 FR 76998, Nov. 21, food-contact coating for articles in-
1980; 47 FR 54430, Dec. 3, 1982] tended for use in contact with food, in
§ 175.365 Vinylidene chloride copoly- scribed conditions.
mer coatings for polycarbonate (a) The resins are produced by the
film. condensation of xylene-formaldehyde
Vinylidene chloride copolymer coat- resin and 4,4′-isopropylidenediphenol-
ings identified in this section and ap- epichlorohydrin epoxy resins, to which
plied on polycarbonate film may be may have been added certain optional
safely used as food-contact surfaces, in adjuvant substances required in the
accordance with the following pre- production of the resins or added to im-
scribed conditions: part desired physical and technical
(a) The coating is applied as a contin- properties. The optional adjuvant sub-
uous film over one or both sides of a stances may include resins produced by
base film produced from polycarbonate the condensation of allyl ether of
resins complying with § 177.1580 of this mono-, di-, or trimethylol phenol and
chapter. capryl alcohol and also may include
(b) The coatings are prepared from substances identified in § 175.300(b)(3),
vinylidene chloride copolymers pro- with the exception of paragraph (b)(3)
duced by copolymerizing vinylidene (xxxi) and (xxxii) of that section.
chloride with acrylonitrile, methyl ac- (b) The resins identified in paragraph
rylate, and acrylic acid. The finished (a) of this section may be used as a
copolymers contain at least 50 weight- food-contact coating for articles in-
percent of polymer units derived from tended for contact at temperatures not
vinyldene chloride. to exceed 160 °F with food of Types I,
(c) Optional adjuvant substances em- II, VI-A and B, and VIII described in
ployed in the production of the coat- table 1 of § 176.170(c) of this chapter
ings or added thereto to impart desired provided that the coating in the fin-
properties may include sodium ished form in which it is to contact
198
Food and Drug Administration, HHS Pt. 176
food meets the following extractives (c) The optional substances per-
limitations when tested by the meth- mitted are as follows:
ods provided in § 175.300(e):
(1) The coating when extracted with
distilled water at 180 °F for 24 hours Ethylene glycol ...................... As a solvent removed by
yields total extractives not to exceed water washing.
Iron oxide.
0.05 milligram per square inch of food- Lithium hydroxide .................. Removed by water washing.
contact surface. Methyl orange ........................ As an acid-base indicator.
(2) The coating when extracted with 8 Potassium dichromate ........... Removed by water washing.
Silica gel.
percent (by volume) ethyl alcohol in Sodium silicate.
distilled water at 160 °F for 4 hours Zinc, as particulate metal.
yields total extractives not to exceed
0.05 milligram per square inch of food- (d) The coating in the finished form
contact surface. in which it is to contact food, when ex-
(c) The resins identified in paragraph tracted with the solvent or solvents
(a) of this section may be used as a characterizing the type of food, and
food-contact coating for articles in- under the conditions of its intended use
tended for contact at temperatures not as shown in table 1 and 2 of § 175.300(d)
to exceed room temperature with food (using 20 percent alcohol as the solvent
of Type VI-C described in table 1 of when the type of food contains approxi-
§ 176.170(c) of this chapter provided the mately 20 percent alcohol) shall yield
coating in the finished form in which it total extractives not to exceed those
is to contact food meets the following prescribed in § 175.300(c)(3); lithium ex-
extractives limitations when tested by tractives not to exceed 0.025 milligram
the methods provided in § 175.300(e): per square inch of surface; and chro-
(1) The coating when extracted with mium extractives not to exceed 0.05
distilled water at 180 °F for 24 hours microgram per square inch of surface.
yields total extractives not to exceed (e) The coatings are used as food-con-
0.05 milligram per square inch of food- tact surfaces for bulk reusable con-
contact surface. tainers intended for storing, handling,
(2) The coating when extracted with and transporting food.
50 percent (by volume) ethyl alcohol in
distilled water at 180 °F for 24 hours PART 176—INDIRECT FOOD ADDI-
yields total extractives not to exceed TIVES: PAPER AND PAPERBOARD
0.05 milligram per square inch. COMPONENTS
§ 175.390 Zinc-silicon dioxide matrix Subpart A [Reserved]
coatings.
Zinc-silicon dioxide matrix coatings Subpart B—Substances for Use Only as
may be safely used as the food-contact Components of Paper and Paperboard
surface of articles intended for use in
Sec.
producing, manufacturing, packing, 176.110 Acrylamide-acrylic acid resins.
processing, preparing, treating, pack- 176.120 Alkyl ketene dimers.
aging, transporting, or holding food, 176.130 Anti-offset substances.
subject to the provisions of this sec- 176.150 Chelating agents used in the manu-
tion; facture of paper and paperboard.
(a) The coating is applied to a metal 176.160 Chromium (Cr III) complex of N-
ethyl-N-heptadecylfluoro-octane sulfonyl
surface, cured, and washed with water
glycine.
to remove soluble substances. 176.170 Components of paper and paperboard
(b) The coatings are formulated from in contact with aqueous and fatty foods.
optional substances which include: 176.180 Components of paper and paperboard
(1) Substances generally recognized in contact with dry food.
as safe. 176.200 Defoaming agents used in coatings.
(2) Substances for which safe condi- 176.210 Defoaming agents used in the manu-
facture of paper and paperboard.
tions of use have been prescribed in
176.230 3,5-Dimethyl-1,3,5,2H-
§ 175.300. tetrahydrothiadiazine-2-thione.
(3) Substances identified in para-
176.250 Poly-1,4,7,10,13-pentaaza-15-
graph (c) of this section, subject to the hydroxyhexadecane.
limitations prescribed. 176.260 Pulp from reclaimed fiber.
199
§ 176.110 21 CFR Ch. I (4–1–12 Edition)
176.300 Slimicides. their hydrolysis products dialkyl
176.320 Sodium nitrate-urea complex. ketones do not exceed 0.4 percent by
176.350 Tamarind seed kernel powder. weight of the paper or paperboard.
AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. (c) The alkyl ketene dimers may be
SOURCE: 42 FR 14554, Mar. 15, 1977, unless used in the form of an aqueous emul-
otherwise noted. sion which may contain sodium
lignosulfonate as a dispersant.
part 176 appear at 61 FR 14482, Apr. 2, 1996, 66 § 176.130 Anti-offset substances.
FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec.
1, 2005. Substances named in paragraphs (b)
and (c) of this section may be safely
Subpart A [Reserved] used to prevent the transfer of inks
employed in printing and decorating
paper and paperboard used for food
Subpart B—Substances for Use packaging in accordance with the pro-
Only as Components of Paper visions of this section:
and Paperboard (a) The substances are applied to the
nonfood contact, printed side of the
§ 176.110 Acrylamide-acrylic acid res- paper or paperboard in an amount not
ins.
greater than that required to accom-
Acrylamide-acrylic acid resins may plish the technical effect nor greater
be safely used as components of arti- than any specific limitations, where
cles intended for use in producing, such are provided.
manufacturing, packing, processing, (b) Anti-offset powders are prepared
preparing, treating, packaging, trans- from substances that are generally rec-
porting, or holding food, subject to the ognized as safe in food, substances for
provisions of this section. which prior sanctions or approvals
(a) Acrylamide-acrylic acid resins are were granted and which are used in ac-
produced by the polymerization of accordance with the specific provisions of
rylamide with partial hydrolysis or by such sanction or approval, and sub-
the copolymerization of acrylamide stances named in paragraph (c) of this
and acrylic acid. section.
(b) The acrylamide-acrylic acid res- (c) The substances permitted are as
ins contain less than 0.2 percent resid- follows:
ual monomer.
(c) The resins are used as adjuvants
in the manufacture of paper and paper- Carbon tetrachloride.
board in amounts not to exceed that Methyl hydrogen
polysiloxanes.
necessary to accomplish the technical Industrial starch—modified .... Complying with § 178.3520 of
effect and not to exceed 2 percent by this chapter.
weight of the paper or paperboard. Stannous oleate.
Zinc-2-ethyl hexoate.
§ 176.120 Alkyl ketene dimers.
Alkyl ketene dimers may be safely § 176.150 Chelating agents used in the
used as a component of articles in- manufacture of paper and paper-
tended for use in producing, manufac- board.
turing, packing, processing, preparing, The substances named in paragraph
treating, packaging, transporting, or (a) of this section may be safely used in
holding food, subject to the provisions the manufacture of paper and paper-
of this section. board, in accordance with the condi-
(a) The alkyl ketene dimers are man- tions prescribed in paragraphs (b) and
ufactured by the dehydrohalogenation (c) of this section:
of the acyl halides derived from the (a) Chelating agents:
fatty acids of animal or vegetable fats List of substances Limitations
and oils.
(b) The alkyl ketene dimers are used Ammonium fructoheptonate.
Ammonium glucoheptonate.
as an adjuvant in the manufacture of
Disodium ethylenediamine tetraacetate.

paper and paperboard under such condi- Pentasodium salt of diethylenetriamine
tions that the alkyl ketene dimers and pentaacetate.
200
List of substances Limitations the uncoated or coated food-contact

surface of paper and paperboard in-
Sodium fructoheptonate.
Sodium glucoheptonate. tended for use in producing, manufac-
Tetrasodium ethylenediamine tetra- turing, packaging, processing, pre-
acetate.
Trisodium N-hydroxyethyl ethylene-
paring, treating, packing, transporting,
diamine triacetate. or holding aqueous and fatty foods,
subject to the provisions of this sec-
(b) Any one or any combination of tion. Components of paper and paper-
the substances named is used or in- board in contact with dry food of the
tended for use as chelating agents. type identified under Type VIII of table
(c) The substances are added in an 1 in paragraph (c) of this section are
amount not greater than that required subject to the provisions of § 176.180.
to accomplish the intended technical (a) Substances identified in para-
effect nor greater than any specific
graph (a) (1) through (5) of this section
limitation, where such is provided.
may be used as components of the food-
§ 176.160 Chromium (Cr III) complex contact surface of paper and paper-
of N-ethyl-N-heptadecylfluoro-oc- board. Paper and paperboard products
tane sulfonyl glycine. shall be exempted from compliance
The chromium (Cr III) complex of N- with the extractives limitations pre-
ethyl - N -heptadecylfluoro-octane scribed in paragraph (c) of this section:
sulfonyl glycine containing up to 20 Provided, That the components of the
percent by weight of the chromium (Cr food-contact surface consist entirely of
III) complex of heptadecylfluoro-octane one or more of the substances identi-
sulfonic acid may be safely used as a fied in this paragraph: And provided fur-
component of paper for packaging dry ther, That if the paper or paperboard
food when used in accordance with the when extracted under the conditions
following prescribed conditions. prescribed in paragraph (c) of this sec-
(a) The food additive is used as a tion exceeds the limitations on extrac-
component of paper in an amount not
tives contained in paragraph (c) of this
to exceed 0.5 percent by weight of the
section, information shall be available
paper.
(b)(1) The food-contact surface of the from manufacturing records from
paper is overcoated with a polymeric or which it is possible to determine that
resinous coating at least 1⁄3-mil in only substances identified in this para-
thickness, that meets the provision of graph (a) are present in the food-con-
§ 176.170; or tact surface of such paper or paper-
(2) The treated paper forms one or board.
more plies of a paper in a multiwall (1) Substances generally recognized
bag and is separated from the food by as safe in food.
at least one ply of packaging films or (2) Substances generally recognized
grease-resistant papers which serves as as safe for their intended use in paper
a functional barrier between the food and paperboard products used in food
additive and the food. Such packaging packaging.
films or grease-resistant papers con- (3) Substances used in accordance
form with appropriate food additive
with a prior sanction or approval.
regulations.
(c) The labeling of the food additive (4) Substances that by regulation in
shall contain adequate directions for parts 170 through 189 of this chapter
its use to insure compliance with the may be safely used without extractives
requirements of paragraphs (a) and (b) limitations as components of the
of this section. uncoated or coated food-contact sur-
face of paper and paperboard in contact
§ 176.170 Components of paper and pa- with aqueous or fatty food, subject to
perboard in contact with aqueous the provisions of such regulation.
and fatty foods. (5) Substances identified in this para-
Substances identified in this section graph, as follows:
may be safely used as components of
201
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
List of Substances Limitations
Acetyl peroxide ............................................................................ For use only as polymerization catalyst.

Acrylamide-methacrylic acid-maleic anhydride copolymers con- For use only as a retention aid employed prior to the sheet-
taining not more than 0.2 percent of residual acrylamide forming operation in the manufacture of paper and paper-
monomer and having an average nitrogen content of 14.9 board in such an amount that the finished paper and paper-
percent such that a 1 percent by weight aqueous solution board will contain the additive at a level not in excess of
has a minimum viscosity of 600 centipoises at 75 °F, as de- 0.05 percent by weight of dry fibers in the finished paper and
termined by LVG-series Brookfield viscometer (or equivalent) paperboard.
using a No. 2 spindle at 30 r.p.m.
Acrylamide-b-methacrylyloxyethyltrimethylammonium methyl For use only as a retention aid and flocculant employed prior
sulfate copolymer resins containing not more than 10 molar to the sheet-forming operation in the manufacture of paper
percent of b-methacrylyloxyethyltrimethylammonium methyl and paperboard.
sulfate and containing less than 0.2% of residual acrylamide
monomer.
Acrylic acid, sodium salt copolymer with polyethyleneglycol allyl For use only in paper mill boilers.
ether (CAS Reg. No. 86830–15–1).
Acrylic acid copolymer with 2-acrylamido-2-methylpropane-sul- For use only as a scale inhibitor prior to the sheet-forming op-
fonic acid (CAS Reg. No. 40623–75–4) and/or its ammo- eration in the manufacture of paper and paperboard and
nium/alkali metal mixed salts. The copolymer is produced by used at a level not to exceed 1.0 kilogram (2.2 pounds) of
poly-merization of acrylic acid and 2-acrylamido-2- copolymer per 907 kilograms (1 ton) of dry paper and paper-
methylpropane-sulfonic acid in a weight ratio of 60/40, such board fibers.
that a 28 percent by weight aqueous solution of the polymer
has a viscosity of 75–150 centipoises at 25 °C as deter-
mined by LV-series Brookfield viscometer (or equivalent)
using a No. 2 spindle at 60 r.p.m.
Acrylonitrile polymer, reaction product with ethylenediamine For use only as a size promoter and retention aid at a level not
sulfate having a nitrogen content of 22.5–25.0 percent (Kjel- to exceed 0.5 percent by weight of the dry paper and paper-
dahl dry basis) and containing no more than 0.075 percent board.
monomer as ethylenediamine. The finished resin in a 24 per-
cent by weight aqueous solution has a viscosity of 1,000–
2,000 centipoises at 25 °C as determined by LVT-series
Brookfield viscometer using a No. 4 spindle at 50 r.p.m. (or
by other equivalent method).
Acrylonitrile polymer with styrene, reaction product with ethyl- 1. For use only as a sizing material applied after the sheet-
enediamine acetate, having a nitrogen content of 7.4–8.3 forming operation in the manufacture of paper and paper-
percent (Kjeldahl dry basis) and containing no more than board in such amount that the paper and paperboard will
0.25 percent monomer as ethylenediamine. contain the additive at a level not in excess of 0.25 percent
by weight of the dry paper and paperboard.
2. For use only as a sizing material applied prior to the sheet-
forming operation in the manufacture of paper and paper-
board in such amount that the paper and paperboard will
contain the additive at a level not in excess of 1.0 percent by
weight of the dry paper and paperboard.
1-Alkenyl olefins, containing not less than 72 percent of C30 For use only under the following conditions:
and higher olefins. 1. In coatings for paper and paperboard with food of Types I,
II, IV-B, and VII-B described in table 1 of paragraph (c) of
this section under conditions of use E, F, and G described in
table 2 of paragraph (c) of this section.
2. In coatings for paper and paperboard with food of Type VIII
described in table I of paragraph (c) of this section under
conditions of use A through H described in table 2 of para-
graph (c) of this section.
(2-Alkenyl) succinic anhydrides mixture, in which the alkenyl For use only as a sizing agent employed prior to the sheet-
groups are derived from olefins which contain not less than forming operation in the manufacture of paper and paper-
95 percent of C15-C21 groups. board and limited to use at a level not to exceed 1 percent
by weight of the finished dry paper and paperboard fibers.
Alkyl(C12-C20)methacrylatemethacrylic acid copolymers (CAS For use only as stabilizers employed prior to the sheet-forming
Reg. No. 27401–06–5). operation in the manufacture of paper and paperboard.
tert-Alkyl(C8-C16)mercaptans ....................................................... For use only as polymerization-control agent.
Aluminum acetate.
2-Amino-2-methyl-1-propanol (CAS Reg. No. 124–68–5) .......... For use as a dispersant for pigment suspension at a level not
to exceed 0.25 percent by weight of pigment. The suspen-
sion is used as a component of coatings for paper and pa-
perboard under conditions of use described in paragraph (c)
of this section, table 2, conditions of use E through G.
202
Ammonium bis(N-ethyl-2-perfluoroalkylsulfonamido ethyl) For use only as an oil and water repellant at a level not to ex-
phosphates, containing not more than 15% ammonium mono ceed 0.17 pound (0.09 pound of fluorine) per 1,000 square
(N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, feet of treated paper or paperboard of a sheet basis weight
where the alkyl group is more than 95% C8 and the salts of 100 pounds or less per 3,000 square feet of paper or pa-
have a fluorine content of 50.2% to 52.8% as determined on perboard, and at a level not to exceed 0.5 pound (0.26
a solids basis. pound of fluorine) per 1,000 square feet of treated paper or
paperboard having a sheet basis weight greater than 100 lb.
per 3,000 square feet as determined by analysis for total flu-
orine in the treated paper or paperboard without correction
for any fluorine that might be present in the untreated paper
or paperboard, when such paper or paperboard is used as
follows:
1. In contact, under conditions of use C, D, E, F, G, or H de-
scribed in table 2 of paragraph (c) of this section, with non-
alcoholic food.
2. In contact with bakery products of Type VII, VIII, and IX de-
scribed in table I of paragraph (c) of this section under good
manufacturing practices of commercial and institutional bak-
ing.
Ammonium thiosulfate.
Ammonium zirconium carbonate (CAS Reg. No. 32535–84–5) For use only as an insolubilizer for binders used in coatings for
and its tartaric acid adduct. paper and paperboard, and limited to use at a level not to
exceed 2.5 percent by weight of coating solids.
Ammonium zirconium citrate (CAS Reg. No. 149564–62–5), For use as insolubilizers with protein binders in coatings for
ammonium zirconium lactate-citrate (CAS Reg. No. 149564– paper and paperboard, at a level not to exceed 1.4 percent
64–7), ammonium zirconium lactate (CAS Reg. No. 149564– by weight of coating solids.
63–6).
Anionic polyurethane, produced by reacting the preliminary For use only as a surface sizing agent at a level not to exceed
adduct formed from the reaction of glyceryl monostearate 0.1 percent by weight of dry paper and paperboard.
and 2,4-toluenediisocyanate with not more than 10 mole per-
cent N-methyldiethanolamine and not less than 90 mole per-
cent dimethylolpropionic acid. The final product is a 15 to 20
percent by weight aqueous solution, having a Brookfield vis-
cosity of 25 to 100 centipoises at 24 °C (75 °F).
9,10–Anthraquinone (Chemical Abstracts Service Registry No. For use only as a pulping aid in the alkaline pulping of
84–65–1) which has a purity of not less than 98 percent. lignocellulosic material at levels not to exceed 0.1 percent by
weight of the raw lignocellulosic material.
Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as modifiers in wax polymer blend coatings for
Reg. No. 88526–47–0), produced by the catalytic polym- paper and paperboard at a level not to exceed 50 weight-
erization of aromatic substituted olefins from low boiling dis- percent of the coating solids under conditions of use E, F,
tillates of cracked petroleum stocks with a boiling point no and G identified in table 2 of paragraph (c) of this section.
greater than 220 °C (428 °F), and the subsequent catalytic
reduction of the resulting aromatic petroleum hydrocarbon
resin. The resin meets the following specifications: softening
point 85 °C (185 °F) minimum, as determined by ASTM
Method E 28–67 (Reapproved 1982), ‘‘Standard Test Meth-
od for Softening Point by Ring-and-Ball Apparatus,’’ and ani-
line point 70 °C (158 °F) minimum, as determined by ASTM
Method D 611–82, ‘‘Standard Test Methods for Aniline Point
and Mixed Aniline Point of Petroleum Products and Hydro-
carbon Solvents,’’ which are incorporated by reference in ac-
cordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the American Society for Testing and
Materials, 100 Barr Harbor Dr., West Conshohocken, Phila-
delphia, PA 19428-2959, or may be examined at the Na-
tional Archives and Records Administration (NARA). For in-
formation on the availability of this material at NARA, call
Azo-bisisobutyronitrile .................................................................. For use only as polymerization catalyst.
1,2-Benzisothiazolin-3-one (CAS Registry No. 2634–33–5) ....... For use only as a preservative in paper coating compositions
and limited to use at a level not to exceed 0.01 mg/in2
(0.0016 mg/cm2) of the finished paper and paperboard.
Benzoyl peroxide ......................................................................... Do.
N,N-Bis(2-hydroxyethyl)alkyl (C12-C18)amide .............................. For use only as an adjuvant to control pulp absorbency and
pitch content in the manufacture of paper and paperboard
prior to the sheet forming operation.
203
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
Bis(methoxymethyl)tetrakis-[(octadecyloxy)-methyl]melamine For use only under the following conditions:

resins having a 5.8–6.5 percent nitrogen content (CAS Reg. 1. As a water repellant employed prior to the sheet-forming op-
No. 68412–27–1). eration in the manufacture of paper and paperboard in such
amount that the finished paper and paperboard will contain
the additive at a level not in excess of 1.6 percent by weight
of the finished dry paper and paperboard fibers.
2. The finished paper and paperboard will be used in contact
with nonalcoholic foods only.
3. As a water repellant employed after the sheet-forming oper-
ation in the manufacture of paper and paperboard in such
amount that the finished paper and paperboard will contain
the additive at a level not to exceed 1.6 percent by weight of
the finished dry paper and paperboard fibers. The finished
paper and paperboard will be used only in contact with food
of Types I, II, IV-B, VI, VII-B, and VIII described in table 1 of
paragraph (c) of this section.
2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52–51–7) ........ For use only as an antimicrobial/preservative in fillers, pigment
slurries, starch sizing solutions, and latex coatings at levels
not to exceed 0.01 percent by weight of those components.
Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent in package coating inks at
salt (also known as butanedioic acid, sulfo-1,4-diisodecyl levels not to exceed 3 percent by weight of the coating ink.
ester, ammonium salt [CAS Reg. No. 144093–88–9])..
tert-Butyl hydroperoxide .............................................................. For use only as polymerization catalyst.
tert-Butyl peroxide ....................................................................... Do.
Calcium isostearate ..................................................................... For use only with n-decyl alcohol as a stabilizing material for
aqueous calcium stearate dispersions intended for use as
components of coatings for paper and paperboard.
Carrageenan and salts of carrageenan as described in
§§ 172.620 and 172.626 of this chapter.
Castor oil, hydrogenated.
Castor oil, sulfated, ammonium, potassium, or sodium salt.
Cellulose, regenerated.
Chloracetamide ............................................................................ For use only as polymerization-control agent.
Cobaltous acetate ........................................................................ For use only as polymerization catalyst.
Cumene hydroperoxide ............................................................... Do.
Cyanoguanidine ........................................................................... For use only:
1. As a modifier for amino resins.
2. As a fluidizing agent in starch and protein coatings for paper
and paperboard.
n-Decyl alcohol ............................................................................ For use only with calcium isostearate as a stabilizing material
for aqueous calcium stearate dispersions intended for use as
components of coatings for paper and paperboard.
Dialdehyde guar gum .................................................................. For use only as a wet-strength agent employed prior to the
sheet-forming operation in the manufacture of paper and pa-
perboard and used at a level not to exceed 1% by weight of
the finished dry paper and paperboard fibers.
Dialdehyde locust bean gum ....................................................... Do.
Dialkyl(C16-C18)carbamoyl chloride (CAS Reg. No. 41319–54– For use as a sizing agent at a level not to exceed 0.2 percent
4) manufactured by the reaction of secondary amines de- by weight of the dry fiber.
rived from fatty acids of animal or vegetable sources with
phosgene.
Diallyldimethyl ammonium chloride polymer with acrylamide For use only as a retention and/or drainage aid employed prior
and potassium acrylate, produced by copolymerizing either to the sheet-forming operations in the manufacture of paper
(1) diallyldimethyl ammonium chloride and acrylamide in a and paperboard and limited to use at a level not to exceed
weight ratio of 50/50, with 4.4 percent of the acrylamide sub- 0.05 percent by weight of the finished paper and paper-
sequently hydrolyzed to potassium acrylate or (2) polym- board.
erized diallyldimethyl ammonium chloride, acrylamide and
potassium acrylate (as acrylic acid) in a weight ratio of 50/
47.8/2.2, respectively, so that the finished resin in a 1 per-
cent by weight aqueous solution (active polymer) has a vis-
cosity of more than 22 centipoises at 22 °C (72 °F) as deter-
mined by LVF series, Brookfield Viscometer using No. 1
spindle at 60 RPM (or by other equivalent method) (CAS
Reg. No. 25136–75–8).
Diallyldimethylammonium chloride with acrylamide (CAS Reg. For use only as a drainage and/or retention aid employed prior
No. 26590–05–6). The copolymer is produced by copolym- to the sheet-forming operation in the manufacture of paper
erizing diallyldimethylammonium chloride with acrylamide in and paperboard and limited to use at a level not to exceed
a weight ratio of 50–50 so that the finished resin in a 1 per- 0.05 percent by weight of the finished paper and paper-
cent by weight aqueous solution (active polymer) has a vis- board.
cosity of more than 22 centipoises at 22 °C (71.6 °F), as de-

termined by LVF-series Brookfield viscometer using a No. 1
spindle at 60 r.p.m. (or by other equivalent method).
204
Diallyldiethylammonium chloride polymer with acrylamide, and

diallyldimethylammonium chloride, produced by copolym-
erizing acrylamide, diallyldiethylammonium chloride, and
diallyldimethylammonium chloride, respectively, in the fol-
lowing weight ratios and having viscosities determined at 22
°C, by LVF-series Brookfield viscometer using a No. 1 spin-
dle at 60 r.p.m. (or by other equivalent method), as follows:.
1. Weight ratio: 50–2.5–47.5. The finished resin in a 1 per- For use only as a retention aid employed prior to the sheet-
cent by weight aqueous solution has a minimum vis- forming operation in the manufacture of paper and paper-
cosity of 22 centipoises. board and limited to use at a level not to exceed 0.05 per-
cent by weight of the finished paper and paperboard.
2. Weight ratio: 25–2.5–72.5. The finished resin in a 0.20 For use only as a drainage and/or retention aid employed prior
percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper
cosity of 20 centipoises. and paperboard and limited to use at a level not to exceed
0.075 percent by weight of the finished paper and paper-
board.
3. Weight ratio: 80–2.5–17.5. The finished resin in a 0.30 For use only as a drainage and/or retention aid employed prior
percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper
cosity of 50 centipoises. and paperboard and limited to use at a level not to exceed
0.075 percent by weight of the finished paper and paper-
board.
Diallyldiethylammonium chloride polymer with acrylamide, po- For use only as a retention aid employed prior to the sheet-
tassium acrylate, and diallyldimethylammonium chloride. The forming operation in the manufacture of paper and paper-
polymer is produced by copolymerizing either: (1) acryl- board and limited to use at a level not to exceed 0.05 per-
amide, diallyldiethylammonium chloride, and cent by weight of the finished paper and paperboard.
diallyldimethylammonium chloride in a weight ratio of 50–
2.5–47.5, respectively, with 4.4 percent of the acrylamide
subsequently hydrolyzed to potassium acrylate, or (2) acryl-
amide, potassium acrylate (as acrylic acid),
diallyldiethylammonium chloride, and
diallyldimethylammonium chloride in a weight ratio of 47.8–
2.2–2.5–47.5, so that the finished resin in a 1 percent by
weight aqueous solution has a minimum viscosity of 22 cen-
tipoises at 22 °C, as determined by LVF-series Brookfield
viscometer using a No. 1 spindle at 60 r.p.m. (or by other
equivalent method).
Diallyldimethylammonium chloride polymer with acrylamide, re- For use only as a dry and wet strength agent employed prior
action product with glyoxal, produced by copolymerizing not to the sheet-forming operation in the manufacture of paper
less than 90 weight percent of acrylamide and not more than and paperboard in such an amount that the finished paper
10 weight percent of diallyldimethylammonium chloride, and paperboard will contain the additive at a level not in ex-
which is then cross-linked with not more than 30 weight per- cess of 2 percent by weight of the dry fibers in the finished
cent of glyoxal, such that a 10 percent aqueous solution has paper and paperboard.
a minimum viscosity of 25 centipoises at 25 °C as deter-
mined by Brookfield viscometer Model RVF, using a No. 1
spindle at 100 r.p.m.
2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No.10222–01–2). For use as a preservative at a level not to exceed 100 parts
per million in coating formulations and in component slurries
and emulsions, used in the production of paper and paper-
board and coatings for paper and paperboard.
2,5-Di-tert-butyl hydroquinone ..................................................... For use only as an antioxidant for fatty based coating adju-
vants provided it is used at a level not to exceed 0.005% by
weight of coating solids.
Diethanolamine ............................................................................ For use only:
1. As an adjuvant to control pulp absorbency and pitch content
in the manufacture of paper and paperboard prior to the
sheet-forming operation.
2.In paper mill boilers.
Diethanolamine salts of mono- and bis (1H,1H,2H,2H-perfluo- For use only as an oil and water repellant at a level not to ex-
roalkyl) phosphates where the alkyl group is even-numbered ceed 0.17 pound (0.09 pound of fluorine) per 1,000 square
in the range C8-C18 and the salts have a fluorine content of feet of treated paper or paperboard, as determined by anal-
52.4% to 54.4% as determined on a solids basis. ysis for total fluorine in the treated paper or paperboard with-
out correction for any fluorine which might be present in the
untreated paper or paperboard, when such paper or paper-
board is used in contact with nonalcoholic foods under the
conditions of use described in paragraph (c) of this section,
table 2, conditions of use (B) through (H).
205
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
Diethyl(2-hydroxyethyl) methylammonium methyl sulfate, acry- For use only as a retention aid and drainage aid employed
late, polymer with acrylamide, chemical abstract service reg- prior to the sheet-forming operation in the manufacture of
istry No. [26796–75–8] having 90–95 mole pct. acrylamide, a paper and paperboard at a level not to exceed 0.15 pct. by
nitrogen content of not more than 19.7 pct. (Kjeldahl, dry weight of finished dry paper and paperboard fibers.
basis), and a residual acrylamide monomer content of not
more than 0.1 pct. The finished polymer in a 1 pct. by weight
aqueous solution has a minimum viscosity of 900 centipoises
at 25 °C as determined by LVT-series Brookfield viscometer
using a No. 2 spindle at 12 r.p.m. (or by equivalent method).
Diethylenetriamine ....................................................................... For use only as a modifier for amino resins.
N,N-Diisopropanolamide of tallow fatty acids ............................. For use only as an adjuvant to control pulp absorbency and
prior to the sheet-forming operation.
Dimethylamine-epichlorohydrin copolymer in which not more For use only:
than 5 mole-percent of dimethylamine may be replaced by 1. As a retention aid employed before the sheet-forming oper-
an equimolar amount of ethylenediamine and in which the ation in the manufacture of paper and paperboard and lim-
ratio of total amine to epichlorohydrin does not exceed 1:1. ited to use at a level not to exceed 1 percent by weight of
The nitrogen content of the copolymer shall be 9.4 to 10.8 the finished paper and paperboard.
weight percent on a dry basis and a 10 percent by weight 2. At the size press at a level not to exceed 0.017 percent by
aqueous solution of the final product has a minimum vis- weight of the finished paper and paperboard.
cosity of 5.0 centipoises at 25 °C, as determined by LVT-se-
ries Brookfield viscometer using a No. 1 spindle at 60 r.p.m.
(or by other equivalent method).
N-[(Dimethylamino)methyl]-acrylamide polymer with acrylamide For use only as a dry-strength agent employed prior to the
and styrene having a nitrogen content of not more than 16.9 sheet-forming operation in the manufacture of paper and pa-
percent and a residual acrylamide monomer content of not perboard and used at a level not to exceed 1 percent by
more than 0.2 percent on a dry basis. weight of finished dry paper or paperboard fibers.
N,N′-Dioleoylethylenediamine.
Diphenylamine ............................................................................. For use only as an antioxidant for fatty based coating adju-
vants provided it is used at a level not to exceed 0.005% by
Dipropylene glycol.
Disodium salt of 1,4-dihydro-9,10-dihydroxyanthracene (CAS For use only as a catalyst in the alkaline pulping of
Reg. No. 73347–80–5). lignocellulosic materials at levels not to exceed 0.1 percent
by weight of the raw lignocellulosic materials.
n-Dodecylguanidine acetate ........................................................ For use only as an antimicrobial agent in paper and paper-
board under the following conditions:
1. For contact only with nonalcoholic food having a pH above 5

and provided it is used at a level not to exceed 0.4 percent
by weight of the paper and paperboard.
2. For use in the outer ply of multiwall paper bags for contact
with dry food of Type VIII described in table I of paragraph
(c) of this section and provided it is used at a level of 0.8
percent by weight of the paper.
n-Dodecylguanidine hydrochloride .............................................. For use only as an antimicrobial agent in paper and paper-
board under the following conditions:
1. For contact only with nonalcoholic food having a pH above 5
and provided it is used at a level not to exceed 0.4 percent
by weight of the paper and paperboard.
2. For use in the outer ply of multiwall paper bags for contact
with dry food of Type VIII described in table I of paragraph
(c) of this section and provided it is used at a level of 0.8
percent by weight of the paper.
Fatty acids derived from animal and vegetable fats and oils
and salts of such acids, single or mixed, as follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Zinc.
Ferric chloride.
Ferrous ammonium sulfate.
Fish oil, hydrogenated.
Fish oil, hydrogenated, potassium salt.
Furcelleran and salts of furcelleran as described in §§ 172.655
and 172.660 of this chapter.
Glutaraldehyde (CAS Reg. No. 111–30–8) ................................. For use only as an antimicrobial agent in pigment and filler
slurries used in the manufacture of paper and paperboard at

levels not to exceed 300 parts per million by weight of the
slurry solids.
206
Glyceryl lactostearate.
Glyceryl mono-1,2-hydroxystearate.
Glyceryl monoricinoleate.
Guar gum modified by treatment with b-diethylaminoethyl For use only as a retention aid and/or drainage aid employed
chloride hydrochloride. prior to the sheet-forming operation in the manufacture of
paper and paperboard.
Guar gum modified by treatment with not more than 25 weight For use only as a retention aid and/or internal size employed
percent of 2,3-epoxypropyltri-methylammonium chloride such prior to the sheet-forming operation in the manufacture of
that the finished product has a maximum chlorine content of paper and paperboard, and limited to use at a level: (1) Not
4.5 percent, a maximum nitrogen content of 3.0 percent, and to exceed 0.15 percent by weight of the finished dry paper
a minimum viscosity in 1-percent-by-weight aqueous solution and paperboard fibers intended for use in contact with all
of 1,000 centipoises at 77 °F, as determined by RV-series types of foods, except (2) not to exceed 0.30 pct. by weight
Brookfield viscometer (or equivalent) using a No. 3 spindle at of the finished dried paper and paperboard fibers for use
20 r.p.m. with nonalcoholic and nonfatty food of types identified under
Types I, II, IV-B, VI-B, VII-B, and VIII of table I in par. (c) of
this section.
N, N, N′, N′, N″, N″-Hexakis (methoxymethyl)-1,3,5-triazine-2,4,6- For use only as a water-repellent applied to the surface of
triamine polymer with stearyl alcohol, a-octadecenyl-omega- paper and paperboard at levels not to exceed 1 percent by
hydroxypoly(oxy-1,2-ethanediyl), and alkyl (C20+) alcohols weight of the finished dry paperboard fibers. The finished
(CAS Reg. No. 130328–24–4). paper and paperboard will be used in contact with aqueous
foods under conditions of use B through G as described in
table 2 of paragraph (c) of this section.
Hexamethylenetetramine ............................................................. For use only as polymerization cross-linking agent for protein,
including casein.
Hydroquinone and the monomethyl or monoethyl ethers of hy- For use only as an inhibitor for monomers.
droquinone.
Hydroxymethyl-5,5-dimethylhydantoin (CAS Reg. No. 27636– For use only as a preservative in clay-type fillers at a level not
82–4), mixture with 1,3-bis(hydroxymethyl)-5,5- to exceed a combined total of 1,200 milligrams/kilograms
dimethylhydantoin (CAS Reg. No. 6440–58–0). hydroxymethyl-5,5-dimethylhydantoin and 1,3-
bis(hydroxymethyl)-5,5-dimethylhydantoin in the filler.
Hydroxypropyl guar gum having a minimum viscosity of 5,000 For use only as a dry strength and formation aid agent em-
centipoises at 25 °C., as determined by RV-series Brookfield ployed prior to the sheet-forming operation in the manufac-
viscometer using a No. 4 spindle at 20 r.p.m. (or other suit- ture of paper and paperboard and used at a level not to ex-
able method) and using a test sample prepared by dissolving ceed 1.5 percent by weight of finished dry paper or paper-
5 grams of moisture-free hydroxypropyl guar gum in 495 mil- board fibers.
liliters of a 70 percent by weight aqueous propylene glycol
solution.
12-Hydroxystearic acid-polyethylene glycol block copolymers For use only as a surfactant for dispersions of polyacrylamide
(CAS Reg. No. 70142–34–6) produced by the reaction of retention and drainage aids employed prior to the sheet
polyethylene glycol (minimum molecular weight 200) with 12- forming operation in the manufacture of paper and paper-
hydroxystearic acid. board.
Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1– For use only at a level not to exceed 0.5 percent by weight of
[2–(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard.
methyl, methyl sulfates (CAS Reg. No. 72749–55–4)..
Isopropyl m- and p-cresols (thymol derived) ............................... For use only as an antioxidant for fatty based coating adju-
vants provided it is used as a level not to exceed 0.005% by
Isopropyl peroxydicarbonate ....................................................... For use only as polymerization catalyst.
Japan wax.
Lanolin.
Lauryl peroxide ............................................................................ For use only as polymerization catalyst.
Lauryl sulfate salts:
Ammonium.
Magnesium.
Potassium.
Sodium.
Lecithin, hydroxylated.
Lignin sulfonate and its calcium, potassium, and sodium salts.
Maleic anhydride, polymer with ethyl acrylate and vinyl acetate, For use only as a deposit control additive prior to the sheet
hydrolyzed (CAS Reg. No. 113221–69–5) and/or its ammo- forming operation to prevent scale buildup in the manufac-
nium, potassium, and sodium salts. ture of paper and paperboard in contact with food, at a level
not to exceed 0.075 percent (as the acid) by weight of the
dry paper and paperboard.
Methacrylic acid-acrylic acid copolymer (CAS Reg. No. 25751– For use only as a boiler water additive at a level not to exceed
21–7). 50 parts per million in the boiler water.
N-methyldiallylamine hydrochloride polymer with For use only as a retention aid, flocculating agent, and wet-
epichlorohydrin having a nitrogen content of 4.8 to 5.9 per- strength agent employed in the manufacture of paper and
cent (Kjeldahl dry basis) such that a 20 percent by weight paperboard prior to the sheet-forming operation and limited
aqueous solution has a minimum viscosity of 30 centipoises to use at a level not to exceed 1.5 percent by weight of the
and maximum viscosity of 100 centipoises at 25 °C, as de- dry paper and paperboard.
termined by LVF Model Brookfield viscometer using a No. 1
spindle at 60 r.p.m. (or equivalent method).
207
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
Methyl naphthalene sulfonic acid-formaldehyde condensate, For use only as an adjuvant to control pulp absorbency and
sodium salt. pitch content in the manufacture of paper and paperboard
N-methyl-N-(tall oil acyl) taurine, sodium salt (CAS Reg. No. For use only to control scale formation in the manufacture of
61791–41–1). paper and paperboard prior to the sheetforming operation at
a level not to exceed 0.015 percent by weight of the dry
paper and paperboard.
Mineral oil, white.
Mono-, di-, tri-(1-methyl-1-phenylethyl)-phenol, ethoxylated, For use only as an emulsifier for rosin based sizing at a level
sulfated, ammonium salt with an average of 12 to 16 moles not to exceed 0.03 percent by weight of the finished dry
of ethylene oxide (CAS Reg. No. 68130–71–2). paper and paperboard.
Monoglyceride citrate.
Monoisopropanolamine (CAS Reg. No. 78–96–6) ...................... For use as a dispersant for titanium dioxide suspensions at a
level not to exceed 0.68 percent by weight of titanium diox-
ide. The finished paper and paperboard will be used in con-
tact with all food types under conditions of use E through G
described in table 2 of paragraph (c) of this section.
Mustardseed oil, sulfated, ammonium, potassium, or sodium
salt.
Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only as an adjuvant to control pulp absorbency and
salt. pitch content in the manufacture of paper and paperboard
Nitrocellulose, 10.9–12.2% nitrogen.
Oleic acid, sulfated, ammonium, potassium, or sodium salt.
N-Oleoyl-N′-stearoylethylenediamine.
Oxystearin.
Paraformaldehyde ....................................................................... For use only as setting agent for protein.
Pentanoic acid, 4,4–bis [(gamma-omega-perfluoro-C8–20- For use only as an oil and water repellent and used at a level
alkyl)thio] derivatives, compounds with diethanolamine (CAS not to exceed 8 pounds per ton of the finished paper or pa-
Reg. No. 71608-61-2). perboard when such paper or paperboard is used in contact
with nonalcoholic foods under conditions of use E through H
described in table 2 of paragraph (c) of this section.
Perfluoroalkyl acrylate copolymer (CAS Reg. No. 92265–81–1) For use only as an oil and water repellent at a level not to ex-
containing 35 to 40 weight percent fluorine, produced by the ceed 0.5 percent by weight of the finished paper and paper-
copolymerization of ethanaminium, N,N,N-trimethyl-2-[(2- board in contact with nonalcoholic foods under conditions of
methyl-1-oxo-2-propenyl)-oxy]-, chloride; 2-propenoic acid, 2- use C, D, E, F, G, or H described in table 2 of paragraph (c)
methyl-, oxiranylmethyl ester; 2-propenoic acid, 2-ethoxyethyl of this section.
ester; and 2-propenoic acid, 2[[(heptadecafluoro-
octyl)sulfonyl] methyl amino]ethyl ester.
Perfluoroalkyl substituted phosphate ester acids, ammonium For use only as an oil and water repellant at a level not to ex-
salts formed by the reaction of 2,2-bis[ (g,w-perfluoroC4-20 ceed 0.44 percent perfluoroalkyl actives by weight of the fin-
alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ished paper and paperboard in contact with non-alcoholic
ammonium hydroxide. foods under condition of use H as described in table 2 of
paragraph (c) of this section; and in contact with food of
types III, IV-A, V, VII-A, and IX described in table 1 of para-
graph (c) of this section under conditions of use C through G
as described in table 2 of paragraph (c) of this section.
Petrolatum ................................................................................... Complying with § 178.3700 of this chapter.
Petroleum asphalt, steam and vacuum refined to meet the fol- For use only as a component of internal sizing of paper and
lowing specifications: Softening point 88° C to 93° C, as de- paperboard intended for use in contact only with raw fruits,
termined by ASTM method D36–76, ‘‘Standard Test Method raw vegetables, and dry food of the type identified under
for Softening Point of Bitumen (Ring-and-Ball Apparatus);’’ Type VIII of table 1 in paragraph (c) of this section, and pro-
penetration at 25° C not to exceed 0.3 mm, as determined by vided that the asphalt is used at a level not to exceed 5% by
ASTM method D5–73 (Reapproved 1978), ‘‘Standard Test weight of the finished dry paper and paperboard fibers.
Method for Penetration of Bituminous Materials,’’ which are
incorporated by reference (Copies may be obtained from the
American Society for Testing Materials, 100 Barr Harbor Dr.,
West Conshohocken, Philadelphia, PA 19428-2959, or may
be examined at the National Archives and Records Adminis-
tration (NARA). For information on the availability of this ma-
terial at NARA, call 202–741–6030, or go to: http://
codeloflfederallregulations/ibrllocations.html.); and
maximum weight loss not to exceed 3% when distilled to
371° C, nor to exceed an additional 1.1% when further dis-
tilled between 371° C and thermal decomposition.
Petroleum wax, synthetic ............................................................ Complying with § 178.3720 of this chapter.
Phenothiazine .............................................................................. For use only as antioxidant in dry rosin size.
Phenyl acid phosphate ................................................................ For use only as polymerization catalyst in melamine-formalde-
hyde modified alkyd coatings and limited to use at a level
not to exceed 2% by weight of the coating solids.

Phenyl-b-naphthylamine .............................................................. For use only as antioxidant in dry rosin size and limited to use
at a level not to exceed 0.4% by weight of the dry rosin size.
208
Phosphoric acid esters and polyesters (and their sodium salts) For use as an adjuvant prior to the sheet forming operation to
of triethanolamine formed by the reaction of triethanolamine control pitch and scale formation in the manufacture of paper
with polyphosphoric acid to produce a mixture of esters hav- and paperboard intended for use in contact with food only of
ing an average nitrogen content of 1.5 percent and an aver- the types identified in paragraph (c) of this section, table 1,
age phosphorus content of 32 percent (as PO4). under Types I, IV, V, VII, VIII, and IX, and used at a level
not to exceed 0.075 percent by weight of dry paper or pa-
perboard fibers.
Poly[acrylamide-acrylic acid-N-(dimethyl-aminomethyl)acryl- For use only as a drainage aid and retention aid employed
amide], produced by reacting 2.40 to 3.12 parts by weight of prior to the sheet-forming operation in the manufacture of
polyacrylamide with 1.55 parts dimethylamine and 1 part paper and paperboard for use in contact with fatty foods
formaldehyde, and containing no more than 0.2 percent under conditions of use described in paragraph (c) of this
monomer as acrylamide. section, table 2, conditions of use E, F, and G.
Poly(2-aminoethyl acrylate nitrate-co-2-hydroxypropyl acrylate) For use only as a retention and drainage aid employed prior to
produced when one mole of hydroxypropyl acrylate and the sheet-forming operation in the manufacture of paper and
three moles of acrylic acid are reacted with three moles of paperboard at a level not to exceed 0.2 percent by weight of
ethylenimine and three moles of nitric acid, such that a 35 dry paper or paperboard fiber.
percent by weight aqueous solution has a minimum viscosity
of 150 centipoises at 72 °F., as determined by RVF-series
Brookfield viscometer (or equivalent) using a No. 2 spindle at
20 r.p.m.
Polyacrolein (1 part) -sodium bisulfite (0.7 part) adduct, con- For use only as an agent in modifying starches and starch
taining excess bisulfite (ratio of excess bisulfite to adduct not gums used in the production of paper and paperboard and
to exceed 1.5 to 1). limited to use at a level not to exceed 0.09 mg/in2 of the fin-
ished paper and paperboard.
Poly[acrylamide-acrylic acid-N-(dimethylaminomethyl) acryl- For use only as a drainage aid, retention aid, or dry-strength
amide] (C.A. Registry No. 53800–41–2), produced by react- agent employed prior to the sheet-forming operation in the
ing 9.6–16.4 parts by weight of polyacrylamide with 1.6 parts manufacture of paper and paperboard at a level not to ex-
dimethylamine and 1 part formaldehyde, and containing no ceed 0.25 percent by weight of finished dry paper and pa-
more than 0.2% monomer as acrylamide, such that a 20% perboard fibers, when such paper or paperboard is used in
aqueous solution has a minimum viscosity of 4,000 cP at 25 contact with fatty foods under conditions of use described in
°C., as determined by Brookfield viscometer model RVT, paragraph (c) of this section, table 2, conditions of use E, F,
using a No. 5 spindle at 20 r/min (or equivalent method). and G.
Polyamide-epichlorohydrin modified resin produced by reacting For use only as a retention aid and flocculant employed prior
adipic acid with diethylene triamine to produce a basic poly- to the sheet-forming operation in the manufacture of paper
amide which is modified by reaction with formic acid and and paperboard and used at a level not to exceed 0.2 per-
formaldehyde and further reacted with epichlorohydrin in the cent dry resin by weight of finished dry paper or paperboard
presence of ammonium hydroxide to form a water-soluble fibers.
cationic resin having a nitrogen content of 13–16 percent
(Kjeldahl, dry basis) such that a 35 percent by weight aque-
ous solution has a minimum viscosity of 75 centipoises at 25
°C, as determined by Brookfield viscometer using a No. 1
spindle at 12 r.p.m.
Polyamide-epichlorohydrin water-soluble thermosetting resins For use only under the following conditions:
[CAS Reg. No. 68583–79–9] prepared by reacting adipic 1. As a retention aid employed prior to the sheet-forming oper-
acid with diethylenetriamine to form a basic polyamide and ation in the manufacture of paper and paperboard and lim-
further reacting the polyamide with an epichlorohydrin and ited to use at a level not to exceed 0.12 percent by weight of
dimethylamine mixture such that the finished resins have a dry paper or paperboard.
nitrogen content of 17.0 to 18.0 percent of a dry basis, and 2. The finished paper or paperboard will be used in contact
that a 30-percent-by-weight aqueous solution has a minimum with food only of the types identified in paragraph (c) of this
viscosity of 350 centipoises at 20 °C, as determined by a section, table 1, under types I and IV-B and under conditions
Brookfield viscometer using a No. 3 spindle at 30 r.p.m. (or of use described in paragraph (c) of this section, table 2,
equivalent method). conditions of use F and G.
Polyamide-epichlorohydrin water-soluble thermosetting resin For use only as a wet strength agent and/or retention aid em-
(CAS Reg. No. 96387–48–3) prepared by reacting N-methyl- ployed prior to the sheet-forming operation in the manufac-
bis(3-aminopropyl) amine with oxalic acid and urea to form a ture of paper and paperboard and used at a level not to ex-
basic polyamide and further reacting the polyamide with ceed 1.5 percent by weight of dry paper and paperboard fi-
epichlorohydrin. bers.
Polyamide-epichlorohydrin water-soluble thermosetting resins For use only in the manufacture of paper and paperboard
prepared by reacting adipic acid, isophthalic acid, itaconic under conditions such that the resins do not exceed 1.5 per-
acid or dimethyl glutarate with diethylenetriamine to form a cent by weight of the paper or paperboard.
basic polyamide and further reacting the polyamide with one
of the following:
Epichlorohydrin.
Epichlorohydrin and ammonia mixture.
Epichlorohydrin and sodium hydrosulfite mixture.
Polyamidoamine-ethyleneimine-epichlorohydrin resin prepared For use only as a retention aid employed prior to the sheet-
by reacting hexanedioic acid, N-(2-aminoethyl)-1,2- forming operation in the manufacture of paper and paper-
ethanediamine, (chloromethyl)oxirane, ethyleneimine board at a level not to exceed 0.12 percent resin by weight
(aziridine), and polyethylene glycol, partly neutralized with of the finished dry paper or paperboard.
sulfuric acid (CAS Reg. No. 167678–45–7).
209
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
Polyamidol-epichlorohydrin modified resin produced by reacting For use only as a wet strength agent employed prior to the
glutaric acid dimethyl ester with diethylene-triamine to sheet-forming operation in the manufacture of paper and pa-
produce a basic polyamide which is modified by reaction perboard, and used at a level not to exceed 2.5 percent by
with formaldehyde and further reacted with epicholorohydrin weight of dry paper and paperboard fibers when such paper
to form a water soluble cationic resin having a nitrogen con- or paperboard is used in contact with food under conditions
tent of 10.9–11.9 percent and a chlorine content of 13.8– of use E through G described in table 2 of paragraph (c) of
14.8 percent, on a dry basis, and a minimum viscosity, in this section.
12.5 percent by weight aqueous solution, of 10 centipoises
at 25 °C, as determined by a Brookfield Model LVF viscom-
eter using a No. 1 spindle at 60 r.p.m. (or equivalent meth-
od).
Polyamine-epichlorohydrin resin produced by the reaction of For use only as a flocculant, drainage aid, formation aid, reten-
epichlorohydrin with monomethylamine to form a prepolymer tion aid, or strength additive employed prior to the sheet-
and further reaction of this prepolymer with N,N,N′,N′- forming operation in the manufacture of paper and paper-
tetramethylethylenediamine such that the finished resin hav- board, and used at a level not to exceed 0.12 percent by
ing a nitrogen content of 11.6 to 14.8 percent and a chlorine weight of dry paper and paperboard fibers.
content of 20.8 to 26.4 percent and a minimum viscosity, in
25 percent by weight aqueous solution, of 500 centipoises at
25 °C, as determined by LV-series Brookfield viscometer
using a No. 2 spindle at 12 r.p.m. (or by other equivalent
method).
Polyamine-epichlorohydrin resin produced by the reaction of For use only as a clarifier in the treatment of influent water to
N,N-dimethyl-1,3-propanediamine with epichlorohydrin and be used in the manufacture of paper and paperboard, and
further reacted with sulfuric acid, Chemical Abstracts Service used at a level not to exceed 20 parts per million of the influ-
Registry Number [27029–41–0], such that the finished resin ent water.
has a maximum nitrogen content of 14.4 percent (dry basis)
and a minimum viscosity in 30 percent by weight aqueous
solution (pH 4–6) of 50 centipoises at 25 °C, as determined
by Brookfield LVT model viscometer, using a No. 1 spindle
at 12 r.p.m. (or equivalent method).
Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wetstrength agent and/or retention aid em-
produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac-
comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex-
diamines and/or their self-condensation products, and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi-
prepolymers produced by reacting 1,2-dichloroethane with bers.
the polyamines in (i). The finished resin has a nitrogen con-
tent of 5.0 to 9.0 percent, a chlorine content of 18.0 to 35.0
percent on a dry basis, and a minimum viscosity, in a 25
percent by weight aqueous solution, of 50 centipoises at 20
°C (68 °F), as determined by Brookfield HAT model viscom-
eter using a No. 1H spindle at 50 r.p.m. (or equivlent meth-
od).
Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wet-strength agent and/or retention aid em-
produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac-
comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex-
diamines and/or their seIf-condensation products and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi-
hexamethylenediamine, and/or (iii) bis(hexamethylene) tri- bers.
amine and higher homologues, and/or (iv) prepolymers pro-
duced by reacting 1,2-dichloroethane with the polyamines in
(i) and/or (ii) and/or (iii). The finished resin has a nitrogen
content of 5.0 to 9.0 percent, a chlorine content of 18.0 to
35.0 percent on a dry basis, and a minimum viscosity, in a
25 percent by weight aqueous solution, of 50 centipoises at
20 °C (68 °F), as determined by Brookfield HAT model vis-
cometer using a No. 1H spindle at 50 r.p.m. (or equivalent
method).
Polyamine-epichlorohydrin water soluble thermosetting resin For use only as a wet-strength agent and/or retention aid em-
prepared by reacting hexamethylenediamine with 1,2-di- ployed prior to the sheet-forming operation in the manufac-
chloroethane to form a prepolymer and further reacting this ture of paper and paperboard, and used at a level not to ex-
prepolymer with epichlorohydrin. This resin is then reacted ceed 1 percent by weight of dry paper and paperboard fi-
with nitrilotris (methylene-phosphonic acid), pentasodium bers.
salt, such that the finished resin has a nitrogen content of
5.0–5.3 percent; a chlorine content of 29.7–31.3 percent;
and a phosphorus content of 2.0–2.2 percent, on a dry
basis, and a minimum viscosity, in 25 percent by weight
aqueous solution, of 50 centipoises at 25 °C., as determined
on a Brookfield HAT model viscometer using a No. 1H spin-
dle at 50 r.p.m. (or equivalent method).
210
Polyamine resin produced by the reaction of 1,2-dichloroethane For use only as a retention aid and/or flocculent employed
with bis(hexamethylene)triamine and higher homologues prior to the sheet-forming operation in the manufacture of
such that the finished resin has a nitrogen content of 13.0– paper and paperboard and used at a level not to exceed 0.1
15.0 percent on a dry basis, and a minimum viscosity in 25- percent by weight of dry paper or paperboard fibers.
percent-by-weight aqueous solution of 75 centipoises at 25
°C., as determined by Brookfield HAT model viscometer
using a No. 1 spindle at 50 r.p.m. (or equivalent method).
Polyaminoamide-epichlorohydrin modified resin produced by For use only as a wet-strength agent and/or retention aid em-
reacting adipic acid with diethylenetriamine to produce a pol- ployed prior to the sheet-forming operation in the manufac-
yamide which is modified by reaction with ture of paper and paperboard, and used at a level not to ex-
diethylaminopropylamine and further reacted with dichlor- ceed 0.5 percent by weight of the finished dry paper and pa-
oethyl ether to form a polyamide intermediate. This poly- perboard.
amide intermediate is then reacted with epichlorohydrin such
that the finished resins have a nitrogen content of 10.9–12.4
percent (Kjeldahl, dry basis) and a minimum viscosity in 40
percent-by-weight aqueous solution of 250 centipoises at 22
°C, as determined by a Brookfield Model LVT viscometer
using a No. 2 spindle at 30 r.p.m. (or equivalent method).
Polybutene, hydrogenated; complying with the identity pre- For use only as provided in §§ 175.300, 178.3740 and
scribed under § 178.3740(b) of this chapter. 178.3860 of this chapter.
Poly(diallyldimethylammonium chloride) (CAS Reg. No. 26062– For use only:
79–3) produced by the polymerization of 1. As a pigment dispersant and/or retention aid prior to the
(diallyldimethylammonium chloride) so that the finished resin sheet-forming operation in the manufacture of paper and pa-
has a nitrogen content of 8.66±0.4 percent on a dry weight perboard, and used at a level not to exceed 10 pounds of
basis and a minimum viscosity in a 40 percent by weight active polymer per ton of finished paper and paperboard.
aqueous solution of 1,000 centipoises at 25 °C (77 °F), de- 2. As a pigment dispersant in coatings at a level not to exceed
termined by LVF Model Brookfield Viscometer using a No. 3 3.5 pounds of active polymer per ton of finished paper and
spindle at 30 r.p.m. (or equivalent method). The level of re- paperboard.
sidual monomer is not to exceed 1 percent by weight of the
polymer (dry basis).
Poly (diallyldimethylammonium chloride) (CAS Reg. No. For use only as a flocculant employed prior to the sheet-form-
26062–79–3) produced by the polymerization of ing operation in the manufacture of paper and paperboard,
diallyldimethylammonium chloride so that the finished resin and used at a level not to exceed 10 mg/L (10 parts per mil-
has a nitrogen content of 8.66±0.4 percent on a dry basis lion) of influent water.
and a minimum viscosity in a 15 weight-percent aqueous so-
lution of 10 centipoises at 25 °C (77 °F), as determined by
LVF Model Brookfield viscometer using a No. 1 spindle at 60
r/min (or equivalent method). The level of residual monomer
is not to exceed 1 weight-percent of the polymer (dry basis).
Poly(1,2-dimethyl-5-vinylpyridinium methyl sulfate) having a ni- For use only as an adjuvant employed in the manufacture of
trogen content of 5.7 to 7.3 percent and a sulfur content of paper and paperboard prior to the sheet-forming operation.
11.7 to 13.3 percent by weight on a dry basis and having a
minimum viscosity in 30-percent-by-weight aqueous solution
of 2,000 centipoises at 25 °C., as determined by LV-series
Brookfield viscometer (or equivalent) using a No. 4 spindle at
60 r.p.m.
Polyester resin produced by reacting dimethylolpropionic acid For use only as a surface-sizing compound applied after the
(CAS Registry No. 4767–03–7) as a comonomer, at no more sheet-forming operation in the manufacture of paper and pa-
than 30 percent by weight of total polymer solids in reaction perboard and limited to use at levels not to exceed 0.1 per-
with 2,2-dimethyl-1,3-propanediol, phthalic anhydride and cent by weight of finished dry paper or paperboard.
isophthalic acid, such that the polyester resin has a viscosity
of 200–600 centipoises at 80 °F as determined by a Brook-
field RVT viscometer using a number 3 spindle at 50 rpm (or
equivalent method).
Polyethylene, oxidized; complying with the identity prescribed For use only as component of coatings that contact food only
in § 177.1620(a) of this chapter. of the type identified under Type VII-B of table 1 in para-
graph (c) of this section, and limited to use at a level not to
exceed 50 percent by weight of the coating solids.
Polyethyleneamine mixture produced when 1 mole of ethylene For use only as a retention aid employed prior to the sheet-
dichloride, 1.05 moles of ammonia, and 2 moles of sodium forming operation in the manufacture of paper and paper-
hydroxide are made to react so that a 10 percent aqueous board.
solution has a minimum viscosity of 40 centipoises at 77 °F,
as determined by Brookfield viscometer using a No. 1 spin-
dle at 60 r.p.m.
Polyethylene glycol (200) dilaurate ............................................. For use only as an adjuvant employed in the manufacture of
paper and paperboard prior to the sheet-forming operation.
Polyethylene glycol (400) dioleate.
Polyethylene glycol (400) esters of coconut oil fatty acids.
Polyethylene glycol (600) esters of tall oil fatty acids.
Polyethylene glycol (400) monolaurate.
Polyethylene glycol (400) monooleate.

Polyethylene glycol (400) monostearate.
211
§ 176.170 21 CFR Ch. I (4–1–12 Edition)

Polyethylene glycol (3,000) monostearate.
Polyethylenimine, produced by the polymerization of For use only as an adjuvant employed prior to sheet formation
ethylenimine. in paper-making systems operated at a pH of 4.5 or higher,
and limited to use at a level not to exceed 5% by weight of
finished dry paper or paperboard fibers.
Poly(isobutene)/maleic anhydride adduct, diethanolamine reac- For use only as a surfactant for dispersions of polyacrylamide
tion product. The mole ratio of poly(isobutene)/maleic retention and drainage aids employed prior to the sheet for-
anydride adduct to diethanolamine is 1:1. mation operation in the manufacture of paper and paper-
board.
Polymethacrylic acid, sodium salt, having a viscosity in 30-per- For use only as a coating adjuvant for controlling viscosity
cent-by-weight aqueous solution of 125–325 centipoises at when used at a level not to exceed 0.3% by weight of coat-
25 °C as determined by LV-series Brookfield viscometer (or ing solids.
equivalent) using a No. 2 spindle at 60 r.p.m.
Polymethacrylic acid, sodium salt, having a viscosity in 40-per- For use only as a coating adjuvant for controlling viscosity
cent-by-weight aqueous solution of 400–700 centipoises at when used at a level not to exceed 0.1% by weight of coat-
25 °C, as determined by LV-series Brookfield viscometer (or ing solids.
equivalent) using a No. 2 spindle at 30 r.p.m.
Poly[(methylimino)(2-hydroxytrimethylene)hydrochloride] pro- For use only as a retention aid employed prior to the sheet-
duced by reaction of 1:1 molar ratio of methylamine and forming operation in such an amount that finished paper and
epichlorohydrin so that a 31-percent aqueous solution at paperboard will contain the additive at a level not in excess
25° C has a Stokes viscosity range of 2.5-4.0 as determined of 1 percent by weight of the dry paper and paperboard.
by ASTM method D1545–76 (Reapproved; 1981), ‘‘Standard
Test Method for Viscosity of Transparent Liquids by Bubble
Time Method,’’ which is incorporated by reference. Copies
may be obtained from the American Society for Testing Ma-
terials, 100 Barr Harbor Dr., West Conshohocken, Philadel-
phia, PA 19428-2959, or may be examined at the National
Poly[oxyethylene (dimethyliminio) ethylene (dimethyliminio) For use only to improve dry-strength of paper and paperboard
ethylene dichloride] produced by reacting equimolar quan- and as a retention and drainage aid employed prior to the
tities of N,N,N,N-tetramethylethylene-diamine and sheet-forming operation in the manufacture of paper and pa-
dichlorethyl ether to yield a solution of the solid polymer in perboard and limited to use at a level not to exceed 0.1 per-
distilled water at 25° C with a reduced viscosity of not less cent by weight of the finished dry paper and paperboard fi-
than 0.15 deciliter per gram as determined by ASTM method bers.
D1243–79, ‘‘Standard Test Method for -Dilute Solution Vis-
cosity of Vinyl Chloride Polymers,’’ which is incorporated by
reference. Copies may be obtained from the American Soci-
ety for Testing Materials, 100 Barr Harbor Dr., West
Conshohocken, Philadelphia, PA 19428-2959, or may be ex-
amined at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call 202–741–6030, or go to: http://www.archives.gov/
ibrllocations.html.). The following formula is used for deter-
mining reduced viscosity:.
Reduced viscosity in terms of deciliters per gram=(t¥t0)/
(t¥C),
where:
t=Solution efflux time
to=Water efflux time
C=Concentration of solution in terms of grams per deciliter
Polypropylene glycol (minimum molecular weight 1,000).
2-Propenoic acid, telomer with sodium 2-methyl-2-[(1-oxo-2- For use only as a deposit control additive employed prior to
propenyl)amino]-1-propane sulfonate and sodium phos- the sheet forming operation in the manufacture of paper and
phinate (CAS Reg. No. 110224–99–2). paperboard and at a level not to exceed 0.15 percent by
weight of the dry paper and paperboard.
Propylene glycol alginate.
Protein hydrolysate from animal hides or soybean protein con-
densed with oleic and/or stearic acid.
Rapeseed oil, sulfated ammonium, potassium, or sodium salt.
Ricebran oil, sulfated ammonium, potassium, or sodium salt.
Rosin and rosin derivatives ......................................................... As provided in § 178.3870 of this chapter.
212
Siloxanes (silicones), dimethyl, isopropyl methyl, methyl 1- For use only as a component of polyolefin coatings with
methyl-C9-49-alkyl (CAS Reg. No. 144635–08–5). § 177.1520 of this chapter at a level not to exceed 3 percent
by weight. The finished coating will be used only for paper
and paperboard that contact food of types VI-A and VI-B of
table 1 in paragraph (c) of this section, and under conditions
of use C, D, and E, as described in table 2 in paragraph (c)
of this section, with a maximum hot fill temperature of 200 °F
(94 °C).
Silver chloride-coated titanium dioxide ........................................ For use only as a preservative in polymer latex emulsions at a
level not to exceed 2.2 parts per million (based on silver ion
concentration) in the dry coating.
Sodium carboxymethyl guar gum having a minimum viscosity For use only as a dry-strength and formation-aid agent em-
of 2,700 centipoises at 25 °C after 24 hours as determined ployed prior to the sheet-forming operation in the manufac-
by RV-series Brookfield viscometer (or equivalent) using a ture of paper and paperboard and used at a level not to ex-
No. 4 spindle at 20 r.p.m. and using a test sample prepared ceed 1% by weight of finished dry paper or paperboard fi-
by dissolving 8 grams of sodium carboxymethyl guar gum in bers.
392 milliliters of 0.2-percent-by-weight aqueous sodium o-
phenylphenate solution.
Sodium formaldehyde sulfoxylate ............................................... For use only as polymerization catalyst.
Sodium N-methyl-N-oleyltaurate ................................................. For use only as an adjuvant to control pulp absorbency and
Sodium nitrite ............................................................................... For use only:
1. At levels not to exceed 0.2% by weight of lubricants or re-
lease agents applied at levels not to exceed 1 lb. per ton of
finished paper or paperboard.
2. As an anticorrosion agent at levels not to exceed 0.2% by
weight of wax emulsions used as internal sizing in the manu-
facture of paper and paperboard prior to the sheet-forming
operation.
Sodium persulfate.
Sodium polyacrylate .................................................................... For use only:
1. As a thickening agent for natural rubber latex coatings, pro-
vided it is used at a level not to exceed 2 percent by weight
of coating solids.
2. As a pigment dispersant in coatings at a level not to exceed
0.25 percent by weight of pigment.
Sodium poly(isopropenylphosphonate) (CAS Reg. No. 118632– For use only in paper mill boilers.
18–1).
Sodium zinc potassium polyphosphate (CAS Reg. No. 65997– For use only as a pigment dispersant in coatings at a level not
17–3). to exceed 1 percent by weight of pigment.
Sperm oil, sulfated, ammonium, potassium, or sodium salt.
Stannous oleate.
Stearyl-2-lactylic acid and its calcium salt.
Styrene-butadiene copolymers produced by copolymerizing sty-
rene-butadiene with one or more of the monomers: acryl-
amide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate,
itaconic acid, methacrylic acid, and N-methylolacrylamide
(CAS Reg. No. 53504–31–7). The finished copolymers shall
contain not more than 10 weight percent of total polymer
units derived from acrylic acid, fumaric acid, 2-hydroxyethyl
acrylate, itaconic acid, and methacrylic acid, and shall con-
tain not more than 3 weight percent of total polymer units
derived from N-methylolacrylamide, and shall contain not
more than 2 weight percent of polymer units derived from
acrylamide..
Styrene-maleic anhydride copolymer, amidated, ammonium so- For use only as a surface size at a level not to exceed 1 per-
dium salt; having, in a 25 percent by weight aqueous solu- cent by weight of paper or paperboard substrate.
tion at pH 8.8, a minimum viscosity of 600 centipoises at 25
°C as determined by Brookfield model LVT viscometer using
a No. 3 spindle at 60 r.p.m. (or equivalent method).
Styrene-maleic anhydride copolymer, sodium salt (minimum For use only:
molecular weight 30,000). 1. As a coating thickening agent at a level not to exceed 1%
by weight of coating solids.
2. As surface size at a level not to exceed 1% by weight of
paper or paperboard substrate.
Styrene-methacrylic acid copolymer, potassium salt (minimum For use only as a coating thickening agent at a level not to ex-
molecular weight 30,000). ceed 1% by weight of coating solids.
213
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
Synthetic wax polymer prepared by the catalytic polymerization For use only as a component of petroleum wax and/or syn-
of alpha olefins such that the polymer has a maximum iodine thetic petroleum wax complying with § 178.3710 or
number of 18 and a minimum number average molecular § 178.3720 of this chapter at levels not to exceed 5 percent
weight of 2,400. by weight of the wax:
1. Under conditions of use F and G described in table 2 of
paragraph (c) of this section for all foods.
2. Under conditions of use E described in table 2 of paragraph
(c) of this section for food Types I, II, IV-B, VI, VII-B and VIII
as described in table 1 of paragraph (c) of this section.
Tallow.
Tallow alcohol.
Tallow alcohol, hydrogenated.
Tallow fatty acid, hydrogenated.
Tallow hydrogenated.
Tallow sulfated, ammonium, potassium, or sodium salt.
Tetraethylenepentamine .............................................................. For use only as a modifier for amino resins.
1,4,4a,9a-Tetrahydro-9, 10-anthracenedione (CAS Reg. No. For use only as a catalyst in the alkaline pulping of
56136–14–2). lignocellulosic materials at levels not to exceed 0.1 percent
by weight of the raw lignocellulosic materials.
N,N,N′, N′-Tetramethylethylenediamine polymer with bis-(2- For use only as a flocculent, drainage aid or retention aid em-
chloroethyl) ether, first reacted with not more than 5 percent ployed prior to the sheet forming operation in the manufac-
by weight 1-chloro-2,3-epoxypropane and then reacted with ture of paper and paperboard and limited to use at a level
not more than 5 percent by weight poly (acrylic acid) such not to exceed 0.2 percent by weight of the finished dry paper
that a 50 percent by weight aqueous solution of the product and paperboard fibers.
has a nitrogen content of 4.7–4.9 percent and viscosity of
350–700 centipoises at 25 °C as determined by LV series
Brookfield viscometer using a No. 2 spindle at 60 r.p.m. (or
by other equivalent method).
Tetrasodium N- (1,2-dicarboxyethyl) - N - octadecylsulfo-suc- For use only as an emulsifier in aqueous dispersions of rosin
cinamate. sizes complying with § 178.3870(a)(4) of this chapter and
limited to use prior to the sheet-forming operation in the
manufacture of paper and paperboard at a level not to ex-
ceed 0.02 pct by weight of finished paper and paperboard.
Triethanolamine ........................................................................... For use only to adjust pH during the manufacture of amino res-
ins permitted for use as components of paper and paper-
board.
Triethylene glycol adipic acid monoester produced by reacting For use only as a curl-control agent at a level not to exceed
equimolar quantities of triethylene glycol and adipic acid. 2% by weight of coated or uncoated paper and paperboard.
Triethylenetetramine .................................................................... For use only as a modifier for amino resins.
1,3,5-Triethylhexahydro-1,3,5-triazine (CAS Registry No. 7779– For use only as an antimicrobial agent for coating, binder, pig-
27–3). ment, filler, sizing, and similar formulations added prior to
the heat drying step in the manufacture of paper and paper-
board and limited to use at a level between 0.05 and 0.15
percent by weight of the formulation.
Undecafluorocyclohexanemethanol ester mixture of dihydrogen For use only as an oil repellent at a level not to exceed 0.087
phosphate, compound with 2,2′ iminodiethanol (1:1); hydro- lb (0.046 lb of fluorine) per 1,000 ft2 of treated paper or pa-
gen phosphate, compound with 2,2′-iminodiethanol (1:1); and perboard, as determined by analysis for total fluorine in the
P,P′-dihydrogen pyrophosphate, compound with 2,2′- treated paper or paperboard without correction for any fluo-
iminodiethanol (1:2); where the ester mixture has a fluorine rine which might be present in the untreated paper or paper-
content of 48.3 pct to 53.1 pct as determined on a solids board, when such paper or paperboard is used in contact
basis. with food only of the types identified in paragraph (c) of this
section, table 1, under Types IVA, V, VIIA, VIII, and IX, and
under the conditions of use B through G described in table 2
of paragraph (c) of this section.
Viscose rayon fibers.
Wax, petroleum ........................................................................... Complying with § 178.3710 of this chapter.
Xanthan gum, conforming to the identity and specifications pre- For use only at a maximum level of 0.125 percent by weight of
scribed in § 172.695 of this chapter, except that the residual finished paper as a suspension aid or stabilizer for aqueous
isopropyl alcohol shall not exceed 6,000 parts per million. pigment slurries employed in the manufacture of paper and
paperboard.
Xylene sulfonic acid-formaldehyde condensate, sodium salt ..... For use only as an adjuvant to control pulp absorbency and
Zeolite Na-A (CAS Reg. No. 68989–22–0) ................................. For use as a pigment extender at levels not to exceed 5.4 per-
cent by weight of the finished paper and paperboard.
Zinc formaldehyde sulfoxylate ..................................................... For use only as polymerization catalyst.
Zinc octoate.
Zirconium oxide ........................................................................... For use only as a component of waterproof coatings where the
zirconium oxide is present at a level not to exceed 1 percent
by weight of the dry paper or paperboard fiber and where
the zirconium oxide is produced by hydrolysis of zirconium

acetate.
214
(b) Substances identified in para- (1) Substances identified in

graphs (b) (1) and (2) of this section § 175.300(b)(3) of this chapter with the
may be used as components of the food- exception of those identified in para-
contact surface of paper and paper- graphs (b)(3) (v), (xv), (xx), (xxvi),
board, provided that the food-contact (xxxi), and (xxxii) of that section and
surface of the paper or paperboard com- paragraph (a) of this section.
plies with the extractives limitations (2) Substances identified in this para-
prescribed in paragraph (c) of this sec- graph (b)(2) follow:
tion.
Acrylamide copolymerized with ethyl acrylate and/or stryene

and/or methacrylic acid, subsequently reacted with formalde-
hyde and butyl alcohol.
Acrylamide copolymerized with ethylene and vinyl chloride in For use only as coatings or components of coatings.
such a manner that the finished copolymers have a minimum
weight average molecular weight of 30,000 and contain not
more than 3.5 weight percent of total polymer units derived
from acrylamide, and in such a manner that the acrylamide
portion may or may not be subsequently partially hydrolyzed.
2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, so- For use only in coatings at a level not to exceed 0.01 mg/in2
dium salt (CAS Reg. No. 35641–59–9).
Acrylic and modified acrylic polymers ......................................... Complying with § 177.1010 of this chapter.
Acrylic copolymers produced by copolymerizing 2 or more of
the acrylate monomers butyl acrylate, ethyl acrylate, ethyl
methacrylate, methyl acrylate, methyl methacrylate, and n-
propyl methacrylate, or produced by copolymerizing one or
more of such acrylate monomers together with one or more
of the monomers acrylic acid, acrylonitrile, butadiene, 2-
ethyl-hexyl acrylate, fumaric acid, glycidyl methacrylate, n-
hexyl-methacrylate, itaconic acid, methacrylic acid, styrene,
vinyl acetate, vinyl chloride, and vinylidene chloride. The fin-
ished copolymers shall contain at least 50 weight percent of
polymer units derived from one or more of the monomers
butyl acrylate, ethyl acrylate, ethyl methacrylate, methyl acry-
late, methyl methacrylate, and n-propyl methacrylate; and
shall contain not more than 5 weight percent of total polymer
units derived from acrylic acid, fumaric acid, glycidyl meth-
acrylate, n-hexyl methacrylate, itaconic acid, and methacrylic
acid. The provision limiting the finished acrylic copolymers to
not more than 5 units derived from acrylic acid, fumaric acid,
glycidyl methacrylate, n-hexyl methacrylate, itaconic acid,
and methacrylic acid is not applicable to finished acrylic co-
polymers used as coating adjuvants at a level not exceeding
2 weight percent of total coating solids.
Alkyl mono- and disulfonic acids, sodium salts (produced from For use only:
n-alkanes in the range of C10-C18 with not less than 50 per- 1. As emulsifiers for vinylidene chloride copolymer coatings
cent C14-C16).. and limited to use at levels not to exceed 2 percent by
weight of the coating solids.
2. As emulsifiers for vinylidene chloride copolymer or
homopolymer coatings at levels not to exceed a total of
2.6 percent by weight of coating solids. The finished poly-
mer contacts food only of types identified in paragraph (c)
of this section, table 1, under Types I, II, III, IV, V, VIA,
VIB, VII, VIII, and IX and under conditions of use E, F,
and G described in table 2 of paragraph (c) of this section.
2-Bromo-4′-hydroxyacetophenone .............................................. For use only as a preservative for coating formulations, bind-
ers, pigment slurries, and sizing solutions at a level not to
exceed 0.006 percent by weight of the coating, solution, slur-
ry or emulsion.
Butylbenzyl phthalate .................................................................. Complying with § 178.3740 of this chapter.
Butyl oleate, sulfated, ammonium, potassium, or sodium salt.
Butyraldehyde.
Captan (N-trichloromethylmercapto-4-cyclohexene-1, 2- For use only as a mold- and mildew-proofing agent in coatings
dicarboximide). intended for use in contact with food only of the types identi-
fied in paragraph (c) of this section, table 1, under Type I, II,

VI-B, and VIII.
215
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
Castor Oil, polyoxyethylated (42 moles ethylene oxide) ............. For use only as an emulsifier in nitrocellulose coatings for
paper and paperboard intended for use in contact with food
only of the types identified in paragraph (c) of this section,
table 1, under Types IV A, V, VII A, VIII, and IX; and limited
to use at a level not to exceed 8 percent by weight of the
coating solids.
1-(3-Chloroallyl)-3,5,7-triaza-1- azoniaadamantane chloride For use only:
(CAS Reg. No. 4080–31–3). 1. As a preservative at a level of 0.3 weight percent in
latexes used as pigment binders in paper and paperboard
intended for use in contact with nonacidic, nonalcoholic
food and under the conditions of use described in para-
graph (c) of this section, table 2, conditions of use E, F,
and G.
2. As a preservative at a level not to exceed 0.07 weight
percent in latexes and 0.05 weight percent in pigment
slurries used as components of coatings for paper and pa-
perboard intended for use in contact with food.
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172– For use only:
55–4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 1. As an antimicrobial agent for polymer latex emulsions in
2682–20–4) mixture at a ratio of 3 parts to 1 part, manufac- paper coatings at a level not to exceed 50 parts per mil-
tured from methyl-3-mercaptopropionate (CAS Reg. No. lion (based on isothiazolone active ingredients) in the
2935–90–2). The mixture may contain magnesium nitrate coating formulation.
(CAS Reg. No. 10377–60–3) at a concentration equivalent to 2. As an antimicrobial agent for finished coating formulations
the isothiazolone active ingredients (weight/weight). and for additives used in the manufacture of paper and
paperboard including fillers, binders, pigment slurries, and
sizing solutions at a level not to exceed 25 parts per mil-
lion (based on isothiazolone active ingredients) in the
coating formulations and additives.
Copper 8-quinolinolate ................................................................ For use only as preservative for coating formulations.
Cyclized rubber produced when natural pale crepe rubber dis- For use only in coatings for paper and paperboard intended for
solved in phenol is catalytically cyclized so that the finished use in contact with food only of the types identified in para-
cyclized rubber has a melting point of 145 °C to 155 °C as graph (c) of this section, table 1, under Types VIII and IX.
determined by ASTM method E28–67 (Reapproved 1982),
‘‘Standard Test Method for Softening Point by Ring-and-Ball
Apparatus,’’ which is incorporated by reference (Copies may
be obtained from the American Society for Testing Materials,
100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA
19428-2959, or may be examined at the National Archives
and Records Administration (NARA). For information on the
availability of this material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/federallregister/
codeloflfederallregulations/ibrllocations.html.), and
contains no more than 4000 ppm of residual-free phenol as
determined by a gas liquid chromatographic procedure titled
‘‘Determination of Free Phenol in Cyclized Rubber Resin,’’
which is incorporated by reference. Copies are available
from the Center for Food Safety and Applied Nutrition (HFS–
200), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or available for inspection
at the National Archives and Records Administration
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7) .. For use only as a preservative at levels not more than 0.05
weight percent and not less than 0.01 weight percent: in
latexes used as pigment binders in coatings; in pigment
slurries used in coatings; and/or in coatings themselves. The
total level of the preservative in the finished coating shall not
exceed 0.04 weight percent of the finished coating solids.
Dibutyl phthalate.
Dibutyl sebacate.
Di(C7,C9-alkyl) adipate ................................................................. Complying with § 178.3740 of this chapter.
Dicyclohexyl phthalate.
Diethylene glycol dibenzoate (CAS Reg. No. 120–55–8) ........... For use only as a plasticizer for polyvinyl acetate coatings at a
level not to exceed 5 percent by weight of the coating solids
under conditions described in paragraph (c) of this section,
table 2, conditions of use E, F, and G.
Diethylene glycol ester of the adduct of terpene and maleic an-
hydride.
Dihydroxy dichlorodiphenyl methane .......................................... For use only as preservative for coating formulations.
Dimethylpolysiloxane, 100 centistokes viscosity.

Dimethylpolysiloxane-beta-phenylethyl methyl polysiloxane co-
polymer (2:1), 200 to 400 centistokes viscosity.
216
N,N′-Diphenyl-p-phenylenediamine ............................................. For use only as polymerization inhibitor in 2-sulfoethyl meth-

acrylate, sodium salt.
Dipropylene glycol dibenzoate (CAS Reg. No. 27138–31–4) ..... 1. For use only as a plasticizer for polyvinyl acetate coatings at
a level not to exceed 5 percent by weight of the coating sol-
ids under conditions described in paragraph (c) of this sec-
tion, table 2, condition of use E.
2. For use only as a plasticizer for polyvinyl acetate coatings at
a level not to exceed 10 percent by weight of the coating
solids under conditions described in paragraph (c) of this
section, table 2, conditions of use F and G.
Disodium N-octadecylsulfosuccinamate ...................................... For use only as an emulsifier in resin latex coatings and limited
to use at a level not to exceed 0.05% by weight of the coat-
ing solids.
EDTA (ethylenediaminetetraacetic acid) and its sodium and/or
calcium salts.
Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl- For use only as an insolubilizer for starch-based coatings and
2(1H)pyrimidinone, propoxylated (CAS Reg. No. 118299-90- limited to use at a level not to exceed 5.0 percent by weight
4). of the coating.
Ethylene-acrylic acid copolymers produced by the copolym-
erization of ethylene and acrylic acid and/or their partial am-
monium salts. The finished copolymer shall contain no more
than 25 weight percent of polymer units derived from acrylic
acid and no more than 0.35 weight percent of residual
monomeric acrylic acid, and have a melt index not to exceed
350 as determined by ASTM method D1238–82, ‘‘Standard
Test Method for Flow Rates of Thermoplastics by Extrusion
Plastometer,’’ which is incorporated by reference. Copies
may be obtained from the American Society for Testing Ma-
terials, 100 Barr Harbor Dr., West Conshohocken, Philadel-
phia, PA 19428-2959, or may be examined at the National
Formaldehyde .............................................................................. For use only as preservative for coating formulations.
Glyoxal ......................................................................................... For use only as an insolubilizing agent in starch- and protein-
based coatings that contact nonalcoholic foods, and limited
to use at a level not to exceed 6 percent by weight of the
starch or protein fraction of the coating solids.
Glyceryl monobutyl ricinoleate.
Hydroxymethyl derivatives (mixture of mono and poly) of [N-(1, For use only as a comonomer in polyvinyl acetate latex coat-
1-dimethyl-3-oxobutyl) acrylamide] produced by reacting 1 ings and limited to use at a level not to exceed 1 percent by
mole of the [N-(1,1-dimethyl-3-oxobutyl) acrylamide] with 3 weight of dry polymer solids.
moles of formaldehyde such that the finished product has a
maximum nitrogen content of 6.2 percent and a maximum
hydroxyl content of 15 percent by weight on a dry basis.
Isobutyl oleate, sulfated, ammonium, potassium, or sodium salt.
Maleic anhydride adduct of butadiene-styrene copolymer.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a-
Modified kaolin clay (CAS Reg. No. 1344–00–9) is produced For use only as a component of coatings in paper and paper-
by the reaction of sodium silicate (CAS Reg. No. 1344–09– board products at a level not to exceed 9 percent by weight
8) and kaolinite clay (CAS Reg. No. 1332–58–7) under hy- of the coating intended for use in contact with food of Types
drothermal conditions. The reaction product has a molecular I through IX described in table 1 of paragraph (c) of this sec-
weight between 246 and 365 and consists of 46 to 55 per- tion under conditions of use C through H described in table
cent silicon dioxide (Si02), 28 to 42 percent aluminum oxide 2 of paragraph (c) of this section.
(A1203), and 2 to 7 percent of sodium oxide (Na20). The re-
action product will not consist of more than 70 percent modi-
fied kaolin clay.
Naphthalene sulfonic acid-formaldehyde condensate, sodium
salt.
Oleyl alcohol.
Oxazolidinylethylmethacrylate (CAS Registry No. 46236–15–1) For use only as a binder for pigment coatings as a binder level
copolymer with ethyl acrylate and methyl methacrylate, and not to exceed 4.0 percent by weight of dry paper or paper-
containing not more than 6 percent by weight of board.
oxazolidinylethylmethacrylate. Maximum nitrogen content
shall be 0.5 percent and number average molecular weight
of that portion of the copolymer soluble in tetrahydrofuran
shall be not less than 50,000.

Pentaerythritol tetrastearate.
217
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use only as modifiers in waxpolymer blend coatings for
product thereof, meeting the following specifications: Soft- corrugated paperboard intended for use in bulk packaging or
ening point 97 °C minimum, as determined by ASTM method raw fruits, raw vegetables, iced meat, iced fish, and iced
E28–67 (Reapproved 1982), ‘‘Standard Test Method for Soft- poultry; and limited to use at a level not to exceed 30
ening Point by Ring and Ball Apparatus;’’ aniline point 120 weight-percent of the coating solids.
°C minimum, as determined by ASTM method D611–82,
‘‘Standard Test Methods for Aniline Point and Mixed Aniline
Point of Petroleum Products and Hydrocarbon Solvents,’’
which are incorporated by reference (Copies may be ob-
tained from the American Society for Testing Materials, 100
Barr Harbor Dr., West Conshohocken, Philadelphia, PA
19428-2959, or may be examined at the National Archives
codeloflfederallregulations/ibrllocations.html.). Specific
gravity 0.96–0.99 (20 °C/20 °C). Such petroleum hydro-
carbon resins are produced by the catalytic polymerization of
dienes and olefins from low-boiling distillates of cracked pe-
troleum stocks that contain no material boiling over 200 °C
and that meet the ultraviolet absorbance limits prescribed in
§ 172.880(b) of this chapter when subjected to the analytical
procedure described in § 172.886(b) of this chapter, modified
as follows: Treat the product as in the first paragraph under
‘‘Procedure’’ in § 172.250(b)(3) of this chapter. Then proceed
with § 172.886(b) of this chapter, starting with the paragraph
commencing with ‘‘Promptly complete transfer of the sample
* * *’’.
Polyester resin formed by the reaction of the methyl ester of
rosin, phthalic anhydride, maleic anhydride and ethylene gly-
col, such that the polyester resin has an acid number of 4 to
11, a drop-softening point of 70 °C–92 °C., and a color of K
or paler.
Polyester resin produced by reacting the acid groups in
montan wax with ethylene glycol.
Polyethylene, oxidized ................................................................. Complying with § 177.1620 of this chapter.
Polyethylene reacted with maleic anhydride such that the modi-
fied polyethylene has a saponification number not in excess
of 6 after Soxhlet extraction for 24 hours with anhydrous
ethyl alcohol.
Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt Not to exceed 300 p.p.m. in finished coated paper or paper-
board.
Polyoxypropylene-polyoxyethylene block polymers (minimum
molecular weight 6,800).
Polyvinyl acetate.
Polyvinyl alcohol (minimum viscosity of 4% aqueous solution at
20 °C. of 4 centipoises).
Polyvinyl butyral.
Polyvinyl formal.
Polyvinylidene chloride.
Polyvinyl pyrrolidone.
Polyvinyl stearate.
Propylene glycol mono- and diesters of fats and fatty acids.
Siloxanes and silicones; platinum-catalyzed reaction product of For use only as a surface coating. Platinum content not to ex-
vinyl-containing dimethyl polysiloxane (CAS Reg. Nos. ceed 200 parts per million.
68083–19–2 and 68083–18–1) with methyl hydrogen 1. In coatings for paper and paperboard provided the coating
polysiloxane (CAS Reg. No. 63148–57–2) or dimethyl (meth- contacts food only of the types identified in paragraph (c) of
yl hydrogen) polysiloxane (CAS Reg. No. 68037–59–2). this section, table 1, under Types I, II, VI, and VII-B when
Diallyl maleate (CAS Reg No. 999–21–3), dimethyl maleate used under conditions of use E, F, and G described in table
(CAS Reg. No. 624–48–6), 1-ethynyl-1-cyclohexanol (CAS 2 of paragraph (c) of this section.
Reg. No. 78–27–3) and vinyl acetate (CAS Reg. No. 108– 2. In coatings for paper and paperboard provided the coating
05–4) may be used as optional polymerization inhibitors. contacts food only of the types identified in paragraph (c) of
this section, table 1, under Types III, IV, V, VII-A, VIII, and
IX when used under conditions of use A through H de-
scribed in table 2 of paragraph (c) of this section.
218
vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives.
68083–19–2 and 68083–18–1), with methyl hydrogen
polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate
(CAS Reg. No. 624–48–6), vinyl acetate (CAS Reg. No.
108–05–4), dibutyl maleate (CAS Reg. No. 105–76–0) and
diallyl maleate (CAS Reg. No. 999–21–3) may be used as
optional polymerization inhibitors. The polymer may also
contain C16-C18 olefins (CAS Reg. No. 68855–60–7) as a
control release agent.
Sodium decylbenzenesulfonate.
Sodium dihexyl sulfosuccinate.
Sodium n-dodecylpolyethoxy (50 moles) sulfate-sodium For use only as an emulsifier in coatings that contact food only
isododecylphenoxypolyethoxy (40 moles) sulfate mixtures. of the types identified in paragraph (c) of this section, table
1, under Types IV-A, V, VII, VIII, and IX; and limited to use
at levels not to exceed 0.75 percent by weight of the coating
solids.
Sodium 2-ethylhexyl sulfate.
Sodium oleoyl isopropanolamide sulfosuccinate.
Sodium pentachlorophenate ........................................................ For use only as preservative for coating formulations.
Sodium o-phenylphenate ............................................................. Do.
Sodium vinyl sulfonate polymerized.
Sodium xylenesulfonate (CAS Reg. No. 1300–72–7) ................. For use only in paper and paperboard coatings at levels not to
exceed 0.01 percent by weight of the finished paper and pa-
perboard.
Styrene copolymers produced by copolymerizing styrene with For use only as a coating or component of coatings and limited
maleic anhydride and its methyl and butyl (sec- or iso-) to use at a level not to exceed 1% by weight of paper or pa-
esters. Such copolymers may contain b-nitrostyrene as a po- perboard substrate.
lymerization chain terminator.
Styrene polymers made by the polymerization of any combina- For use only in contact with foods of Types IV-A, V, and VII in
tion of styrene or alpha methyl styrene with acrylic acid, table 1 of paragraph (c) of this section, under use conditions
methacrylic acid, 2-ethyl hexyl acrylate, methyl methacrylate, E through G in table 2 of paragraph (c), and with foods of
and butyl acrylate. The styrene and alpha methyl styrene, in- Types VIII and IX without use temperature restriction.
dividually, may constitute from 0 to 80 weight percent of the
polymer. The other monomers, individually, may be from 0 to
40 weight percent of the polymer. The polymer number aver-
age molecular weight (Mn) shall be at least 2,000 (as deter-
mined by gel permeation chromatography). The acid number
of the polymer shall be less than 250. The monomer content
shall be less than 0.5 percent.
Styrene-acrylic copolymers (CAS Reg. No. 25950–40–7 pro- For use only as a component of coatings and limited to use at
duced by polymerizing 77 to 83 parts by weight of styrene a level not to exceed 20 percent by weight of the coating
with 13 to 17 parts of methyl methacrylate, 3 to 4 parts of solids.
butyl methacrylate, 0.5 to 2.5 parts of methacrylic acid, and
0.1 to 0.3 part of butyl acrylate such that the finished copoly-
mers have a minimum number average molecular weight
greater than 100,000 and a level of residual styrene mon-
omer in the polymer not to exceed 0.1 percent by weight.
Styrene-butadiene copolymers produced by copolymerizing sty-
rene-butadiene with one or more of the monomer: acryl-
amide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate,
itaconic acid, and methacrylic acid. The finished copolymers
shall contain not more than 10 weight percent of total poly-
mer units derived from acrylic acid, fumaric acid, 2-hydroxy-
ethyl acrylate, itaconic acid and methacrylic acid, and shall
contain not more than 2 weight percent of polymer units de-
rived from acrylamide.
Styrene-butadiene copolymers with 2-hydroxyethyl acrylate and
acrylic acid containing not more than 15 weight percent
acrylic acid and no more than 20 weight percent of a com-
bination of 2-hydroxyethyl acrylate and acrylic acid.
Styrene-butadiene-vinylidene chloride copolymers containing For use only as coatings or components of coatings.
not more than 40 weight percent of vinylidene chloride in the
finished copolymers. The finished copolymers may contain
not more than 10 weight percent of total polymer units de-
rived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate,
itaconic acid, and/or methacrylic acid.
219
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
Styrene-dimethylstyrene-a-methylstyrene copolymers produced For use only in coatings for paper and paperboard intended for
by polymerizing equimolar ratios of the three comonomers use in contact with nonfatty food and limited to use at a level
such that the finished copolymers have a minimum average not to exceed 50% by weight of the coating solids.
molecular weight of 835 as determined by ASTM method
D2503–82, ‘‘Standard Test Method for Molecular Weight
(Relative Molecular Mass) of Hydrocarbons by Thermo-
electric Measurement of Vapor Pressure,’’ which is incor-
porated by reference. Copies may be obtained from the
American Society for Testing Materials, 100 Barr Harbor Dr.,
West Conshohocken, Philadelphia, PA 19428-2959, or may
be examined at the National Archives and Records Adminis-
tration (NARA). For information on the availability of this ma-
terial at NARA, call 202–741–6030, or go to: http://
Styrene-isobutylene copolymers (weight average molecular For use only in coatings for paper and paperboard intended for
weight not less than 6,300). use in contact under conditions of use D G described in
table 2 of paragraph (c) of this section, with food of Types I,
II, IV-B, VI-B, VII-B, and VIII described in table 1 of para-
graph (c) of this section; and limited to use at a level not to
exceed 40 percent by weight of the coating solids.
Styrene-maleic anhydride copolymers ........................................ For use only as a coating or component of coatings and limited
for use at a level not to exceed 2 percent by weight of paper
or paperboard substrate.
Styrene-methacrylic acid copolymers containing no more than
5 weight percent of polymer units derived from methacrylic
acid.
Styrene-vinylidene chloride copolymers containing not more For use only as coatings or components of coatings.
than 40 weight percent of vinylidene chloride in the finished
copolymers. The finished copolymers may contain not more
than 5 weight percent of total polymer units derived from
acrylic acid, fumaric acid, itaconic acid, and/or methacrylic
acid.
2-Sulfoethyl methacrylate, sodium salt [Chemical Abstracts For use only in copolymer coatings under conditions of use E,
Service No. 1804–87–1]. F, and G described in paragraph (c) of this section, table 2,
and limited to use at a level not to exceed 2.0 percent by
weight of the dry copolymer coating.
a[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly (oxy- For use only as a surface-active agent at levels not to exceed
ethylene) hydrogen sulfate, sodium salt mixture with a-[p- 3 percent by weight of vinyl acetate polymer with ethylene
(1,1,3,3-tetramethylbutyl)-phenyl]-omega-hydroxypoly (oxy- and N-(hydroxymethyl) acrylamide intended for use in coat-
ethylene) with both substances having a poly(oxyethylene) ings for paper and paperboard intended for use in contact
content averaging 3 moles. with foods:
1. Of the types identified in paragraph (c) of this section, table
1, under Types I, II, III, IV, VI-B, and VII, and under the con-
ditions of use described in paragraph (c) of this section,
1, under Types V, VIII and IX and under the conditions of
use described in paragraph (c) of this section, table 2, condi-
tions of use C, D, E, F, and G.
Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecylsulfo-succina- For use only as an emulsifier in resin latex coatings, and lim-
mate. ited to use at a level not to exceed 0.05% by weight of the
coating solids.
Toluenesulfonamide-formaldehyde resins.
220
Vinyl acetate copolymers produced by copolymerizing vinyl ac-

etate with one or more of the monomers acrylamide, acrylic
acid, acrylonitrile, bicyclo-[2.2.1]hept-2-ene-6-methylacrylate,
butyl acrylate, crotonic acid, decyl acrylate, diallyl fumarate,
diallyl maleate, diallyl phthalate, dibutyl fumarate, dibutyl
itaconate, dibutylmaleate, di(2-ethylhexyl) maleate, divinyl
benzene, ethyl acrylate, 2-ethyl-hexyl acrylate, fumaric acid,
itaconic acid, maleic acid, methacrylic acid, methyl acrylate,
methyl methacrylate, mono(2-ethylhexyl) maleate, monoethyl
maleate, styrene, vinyl butyrate, vinyl crotonate, vinyl
hexoate, vinylidene chloride, vinyl pelargonate, vinyl propio-
nate, vinyl pyrrolidone, vinyl stearate, and vinyl sulfonic acid.
The finished copolymers shall contain at least 50 weight per-
cent of polymer units derived from vinyl acetate and shall
contain no more than 5 weight percent of total polymer units
derived from acrylamide, acrylic acid, crotonic acid, decyl ac-
rylate, dibutyl itaconate, di(2-ethylhexyl) maleate, fumaric
acid, itaconic acid, maleic acid, methacrylic acid, mono(2-
ethylhexyl) maleate, monoethyl maleate, vinyl butyrate, vinyl
hexoate, vinyl pelargonate, vinyl propionate, vinyl stearate,
and vinyl sulfonic acid.
Vinyl acetate polymer with ethylene and N-(hydroxymethyl) ac- For use only in coatings for paper and paperboard intended for
rylamide containing not more than 6 weight percent of total use in contact with foods:
polymer units derived from N-(hydroxymethyl) acrylamide. 1. Of the types identified in paragraph (c) of this section, table
1, under Types I, II, III, IV, VI B, and VII and under the con-
ditions of use described in paragraph (c) of this section,
1, under Types V, VIII, and IX and under the conditions of
use described in paragraph (c) of this section, table 2, condi-
tions of use C, D, E, F, and G.
Vinyl chloride copolymers produced by copolymerizing vinyl
chloride with one or more of the monomers acrylonitrile; fu-
maric acid and its methyl, ethyl, propyl, butyl, amyl, hexyl,
heptyl, or octyl esters; maleic acid and its methyl, ethyl,
propyl, butyl, amyl, hexyl, heptyl, or octyl esters; maleic an-
hydride; 5-norbornene-2, 3-dicarboxylic acid, mono-n-butyl
ester; vinyl acetate-and vinylidene chloride. The finished co-
polymers shall contain at least 50 weight percent of polymer
units derived from vinyl chloride: shall contain no more than
5 weight percent of total polymer units derived from fumaric
and/or maleic acid and/or their methyl, ethyl, propyl, butyl,
amyl, heptyl, or octyl monoesters or from maleic anhydride
or from mono-n-butyl ester of 5-norbornene-2, 3-dicarboxylic
acid (however, in any case the finished copolymers shall
derived from mono-n-butyl ester of 5-norbornene-2,3-
dicarboxylic acid).
Vinyl chloride-vinyl acetate hydroxyl-modified copolymers.
Vinyl chloride-vinyl acetate hydroxyl-modified copolymers re-
acted with trimellitic anhydride.
Vinylidene chloride copolymers produced by copolymerizing vi-
nylidene chloride with one or more of the monomers acryl-
amide acrylic acid, acrylonitrile, butyl acrylate, butyl meth-
acrylate ethyl acrylate, ethyl methacrylate, fumaric acid,
itaconic acid, methacrylic acid, methyl acrylate, methyl meth-
acrylate, octadecyl methacrylate, propyl acrylate, propyl
methacrylate, vinyl chloride and vinyl sulfonic acid. The fin-
ished copolymers shall contain at least 50 weight percent of
polymer units derived from vinylidene chloride; and shall
derived from acrylamide, acrylic acid, fumaric acid, itaconic
acid, methacrylic acid, octadecyl methacrylate, and vinyl sul-
fonic acid.
Colorants:.
Aluminum .............................................................................. For use as a colorant only.
Aluminum hydrate ................................................................ Do.
Aluminum and potassium silicate (mica) ............................. Do.
Aluminum mono-, di-, and tristearate ................................... Do.
Aluminum silicate (China clay) ............................................. Do.
Barium sulfate ...................................................................... Do.
Bentonite .............................................................................. Do.

Bentonite, modified with dimethyldioctadecylammonium ion Do.
Burnt umber .......................................................................... Do.
221
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
Calcium carbonate ............................................................... Do.

Calcium silicate .................................................................... Do.
Calcium sulfate ..................................................................... Do.
Carbon black (channel process) .......................................... Do.
Cobalt aluminate .................................................................. Do.
Diatomaceous earth ............................................................. Do.
Iron oxides ............................................................................ Do.
Magnesium oxide ................................................................. Do.
Magnesium silicate (talc) ...................................................... Do.
Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, Do.
15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147–14–
8).
Raw sienna ........................................................................... Do.
Silica ..................................................................................... Do.
Tartrazine lake (certified FD&C Yellow No. 5 only) ............. Do.
Titanium dioxide ................................................................... Do.
Titanium dioxide-barium sulfate ........................................... Do.
Titanium dioxide-magnesium ............................................... Do.
silicate.
Zinc carbonate ...................................................................... Do.
Zinc oxide ............................................................................. Do.
(c) The food-contact surface of the II. Acid, aqueous products; may contain salt
paper and paperboard in the finished or sugar or both, and including oil-in-water
emulsions of low- or high-fat content.
form in which it is to contact food,
III. Aqueous, acid or nonacid products con-
when extracted with the solvent or sol- taining free oil or fat; may contain salt,
vents characterizing the type of food, and including water-in-oil emulsions of
and under conditions of time and tem- low- or high-fat content.
perature characterizing the conditions IV. Dairy products and modifications:
of its intended use as determined from A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
tables 1 and 2 of this paragraph, shall V. Low-moisture fats and oil.
yield net chloroform-soluble extrac- VI. Beverages:
tives (corrected for wax, petrolatum, A. Containing up to 8 percent of alcohol.
mineral oil and zinc extractives as zinc B. Nonalcoholic.
oleate) not to exceed 0.5 milligram per C. Containing more than 8 percent alcohol.
square inch of food-contact surface as VII. Bakery products other than those in-
cluded under Types VIII or IX of this table:
determined by the methods described A. Moist bakery products with surface con-
in paragraph (d) of this section. taining free fat or oil.
B. Moist bakery products with surface con-
TABLE 1—TYPES OF RAW AND PROCESSED taining no free fat or oil.
FOODS VIII. Dry solids with the surface containing
I. Nonacid, aqueous products; may contain no free fat or oil (no end test required).
salt or sugar or both (pH above 5.0). IX. Dry solids with the surface containing
free fat or oil.
TABLE 2—TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF
EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER-
BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES
Food-simulating solvents
8 percent al- 50 percent al-

Types of food Water Heptane 1
Condition of use cohol cohol
(see table 1)
Time and Time and Time and Time and tem-
temperature temperature temperature perature
A. High temperature heat-sterilized (e.g., I, IV-B, VII-B ...... 250 °F, 2 hr ..................... ..................... ........................
over 212 °F).
III, IV-A, VII-A .... ......do .......... 150 °F, 2 hr ..................... ........................
B. Boiling water sterilized .............................. II, VII-B ............... 212 °F, 30
min.
III, VII-A .............. ......do .......... 120 °F, 30 ..................... ........................

min.
222
TABLE 2—TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF
EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER-
BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES—Continued
Food-simulating solvents
8 percent al- 50 percent al-

Types of food Water Heptane 1
Condition of use cohol cohol
(see table 1)
Time and Time and Time and Time and tem-
temperature temperature temperature perature
C. Hot filled or pasteurized above 150 °F .... II, IV-B, VII-B ..... Fill boiling, ..................... ..................... ........................
cool to
100 °F.
III, IV-A, VII-A .... ......do .......... 120 °F, 15 ..................... ........................
min.
V, IX ................... ..................... ......do .......... ..................... ........................
D. Hot filled or pasteurized below 150 °F ..... II, IV-B, VI-B, ..... ..................... ..................... ..................... ........................
VII-B ................... 150 °F, 2 hr ..................... ..................... ........................
III, IV-A, VII-A .... ......do .......... 100 °F, 30 ..................... ........................
min.
V, IX ................... ..................... ......do .......... ..................... ........................
VI-A .................... ..................... ..................... 150 °F, 2 hr ........................
VI-C .................... ..................... ..................... ..................... 150 °F, 2 hr.
E. Room temperature filled and stored (no I, II, IV-B, VI-B, 120 °F, 24 hr ..................... ..................... ........................
thermal treatment in the container). VII-B.
III, IV-A, VII-A .... ......do .......... 70 °F, 30 ..................... ........................
min.
V, IX ................... ..................... ......do .......... ..................... ........................
VI-A .................... ..................... ..................... 120 °F, 24 hr ........................
VI-C .................... ..................... ..................... ..................... 120 °F, 24 hr.
F. Refrigerated storage (no thermal treat- III, IV-A, VII-A .... 70 °F, 48 hr 70 °F, 30 ..................... ........................
ment in the container). min.
I, II, IV-B, VI-B, ......do .......... ..................... ..................... ........................
VII-B.
VI-A .................... ..................... ..................... 70 °F, 48 hr ........................
VI-C .................... ..................... ..................... ..................... 70 °F, 48 hr.
G. Frozen storage (no thermal treatment in I, II, IV-B, VII-B .. 70 °F, 24 hr ..................... ..................... ........................
the container).
III, VII-A .............. ......do .......... 70 °F, 30 ..................... ........................
min.
H. Frozen or refrigerated storage: Ready-
prepared foods intended to be reheated in
container at time of use:
1. Aqueous or oil-in-water emulsion of I, II, IV-B, VII-B .. 212 °F, 30 ..................... ..................... ........................
high- or low-fat. min.
2. Aqueous, high- or low-free oil or fat .. III, IV-A, VII-A, IX ......do .......... 120 °F, 30 ..................... ........................
min.
1 Heptane extractability results must be divided by a factor of five in arriving at the extractability for a food product having
water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required in the case of wax-polymer blend coatings
for corrugated paperboard containers intended for use in bulk packaging of iced meat, iced fish, and iced poultry.
(d) Analytical methods—(1) Selection of aggeration over normal use, follow the
extractability conditions. First ascertain applicable extraction procedure.
the type of food product (table 1, para- (2) Reagents—(i) Water. All water used
graph (c) of this section) that is being in extraction procedures should be
packed commercially in the paper or freshly demineralized (deionized) dis-
paperboard and the normal conditions tilled water.
of thermal treatment used in pack- (ii) n-Heptane. Reagent grade, freshly
aging the type of food involved. Using redistilled before use, using only mate-
table 2, paragraph (c) of this section, rial boiling at 208 °F.
select the food-simulating solvent or (iii) Alcohol. 8 or 50 percent (by vol-
solvents and the time-temperature ex- ume), prepared from undenatured 95
aggerations of the paper or paperboard percent ethyl alcohol diluted with
use conditions. Having selected the ap- demineralized (deionized) distilled
water.
propriate food-simulating solvent or

solvents and the time-temperature ex- (iv) Chloroform. Reagent grade, fresh-
ly redistilled before use, or a grade
223
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
having an established consistently low holding at least one 800-milliliter beak-

blank. er partially submersed in bath.
(3) Selection of test method. Paper or (b) Analytical balance sensitive to 0.1
paperboard ready for use in packaging milligram with an approximate capac-
shall be tested by use of the extraction ity of 100 grams.
cell described in ‘‘Official Methods of (c) Tongs.
Analysis of the Association of Official (d) Hood and hot-plate facilities.
Analytical Chemists,’’ 13th Ed. (1980), (e) Forced draft oven.
sections 21.010–21.015, under ‘‘Exposing For each extraction, the following ad-
Flexible Barrier Materials for Extrac- ditional apparatus is necessary:
tion,’’ which is incorporated by ref- (f) One No. 2 paper clip.
erence (Copies may be obtained from (g) One 800-milliliter beaker with
the AOAC INTERNATIONAL, 481 North watch-glass cover.
Frederick Ave., suite 500, Gaithersburg, (h) One 250-milliliter beaker.
MD 20877, or may be examined at the (i) Five 21⁄2-inch-square aluminum
National Archives and Records Admin- screens (standard aluminum window
istration (NARA). For information on screening is acceptable).
the availability of this material at (j) One wire capable of supporting
NARA, call 202–741–6030, or go to: http:// sample stack.
www.archives.gov/federallregister/ (ii) Procedure. (a) For each extrac-
codeloflfederallregulations/ tion, accurately cut eight 21⁄2-inch-
ibrllocations.html.); also described in square samples from the formed paper
ASTM method F34–76 (Reapproved or paperboard product to be tested.
1980), ‘‘Standard Test Method for Liq- (b) Carefully stack the eight 21⁄2-inch-
uid Extraction of Flexible Barrier Ma- square samples and the five 21⁄2-inch-
terials,’’ which is incorporated by ref- square aluminum screens in sandwich
erence (copies may be obtained from form such that the food-contact side of
the American Society for Testing Ma- each sample is always next to an alu-
terials, 100 Barr Harbor Dr., West minum screen, as follows: Screen, sam-
Conshohocken, Philadelphia, PA 19428- ple, sample, screen, sample, sample,
2959, or may be examined at the Na- screen, etc. Clip the sandwich together
tional Archives and Records Adminis- carefully with a No. 2 paper clip, leav-
tration (NARA). For information on ing just enough space at the top to slip
the availability of this material at a wire through.
NARA, call 202–741–6030, or go to: http:// (c) Place an 800-milliliter beaker con-
www.archives.gov/federallregister/ taining 100-milliliters of the appro-
codeloflfederallregulations/ priate food-simulating solvent into the
ibrllocations.html.), except that formed constant temperature bath, cover with
paper and paperboard products may be a watch glass and condition at the de-
tested in the container by adapting the sired temperature.
in-container methods described in (d) After conditioning, carefully
§ 175.300(e) of this chapter. Formed lower the sample sandwich with tongs
paper and paperboard products such as into the beaker.
containers and lids, that cannot be (e) At the end of the extraction pe-
tested satisfactorily by any of the riod, using the tongs, carefully lift out
above methods may be tested in spe- the sample sandwich and hang it over
cially designed extraction equipment, the beaker with the wire.
usually consisting of clamping devices (f) After draining, pour the food-sim-
that fit the closure or container so ulating solvent solution into a tared
that the food-contact surface can be 250-milliliter beaker. Rinse the 800-mil-
tested, or, if flat samples can be cut liliter beaker three times, using a total
from the formed paper or paperboard of not more than 50 milliliters of the
products without destroying the integ- required solvent.
rity of the food-contact surface, they (g) Determine total nonvolatile ex-
may be tested by adapting the fol- tractives in accordance with paragraph
lowing ‘‘sandwich’’ method: (d)(5) of this section.
(i) Apparatus. (a) Thermostated (±1.0 (4) Selection of samples. Quadruplicate
°F) water bath, variable between 70 °F samples should be tested, using for
and 120 °F water bath cover capable of each replicate sample the number of
224
cups, containers, or preformed or con- (freshly distilled reagent grade or a

verted products nearest to an area of grade having an established consist-
100 square inches. ently low blank) to the dried and
(5) Determination of amount of extrac- weighed residue, (e), in the evaporating
tives—(i) Total residues. At the end of dish obtained in paragraph (d)(5)(i) of
the exposure period, remove the test this section. Warm carefully, and filter
container or test cell from the oven through Whatman No. 41 filter paper
and combine the solvent for each rep- (or equivalent) in a Pyrex (or equiva-
licate in a clean Pyrex (or equivalent) lent) funnel, collecting the filtrate in a
flask or beaker being sure to rinse the clean, tared evaporating dish (platinum
test container or cell with a small or Pyrex). Repeat the chloroform ex-
quantity of clean solvent. Evaporate traction, washing the filter paper with
the food-simulating solvents to about this second portion of chloroform. Add
100 milliliters in the flask or beaker, this filtrate to the original filtrate and
and transfer to a clean, tared
evaporate the total down to a few mil-
evaporating dish (platinum or Pyrex),
liliters on a low-temperature hotplate.
washing the flask three times with
The last few milliliters should be evap-
small portions of solvent used in the
extraction procedure, and evaporate to orated in an oven maintained at ap-
a few milliliters on a nonsparking, low- proximately 221 °F. Cool the
temperature hotplate. The last few evaporating dish in a desiccator for 30
milliliters should be evaporated in an minutes and weigh to the nearest 0.1
oven maintained at a temperature of milligram to get the chloroform-solu-
approximately 221 °F. Cool the ble extractives residue (′). This ′ is sub-
evaporating dish in a desiccator for 30 stituted for e in the equations in para-
minutes and weigh the residue to the graph (d)(5)(i) (a) and (b) of this sec-
nearest 0.1 milligram, (e). Calculate the tion. If the chloroform-soluble extrac-
extractives in milligrams per square tives in milligrams per square inch
inch of the container or sheeted paper still exceeds the limitation prescribed
or paperboard surface. in paragraph (c) of this section, proceed
(a) Water and 8- and 50-percent alcohol. to paragraph (d)(5)(iii) of this section
Milligrams extractives per square (method for determining corrected
inch=(e)/(s). chloroform-soluble extractives res-
(b) Heptane. Milligrams extractives idue).
per square inch=(e)/(s)(F) (iii) Corrected chloroform-soluble ex-
where: tractives residue—(a) Correction for zinc
e=Milligrams extractives per sample tested. extractives. Ash the residue in the
s=Surface area tested, in square inches. evaporating dish by heating gently
F=Five, the ratio of the amount of extrac- over a Meker-type burner to destroy
tives removed by heptane under exagger- organic matter and hold at red heat for
ated time-temperature test conditions about 1 minute. Cool in the air for 3
compared to the amount extracted by a fat
or oil under exaggerated conditions of
minutes, and place the evaporating
thermal sterilization and use. dish in the desiccator for 30 minutes
e′=Chloroform-soluble extractives residue. and weigh to the nearest 0.1 milligram.
ee′=Corrected chloroform-soluble extractives Analyze this ash for zinc by standard
residue. Association of Official Agricultural
e′ or ee′ is substituted for e in the above equa- Chemists methods or equivalent. Cal-
tions when necessary.
culate the zinc in the ash as zinc ole-
If when calculated by the equations in ate, and subtract from the weight of
paragraph (d)(5)(i) (a) and (b) of this chloroform-soluble extractives residue
section, the extractives in milligrams (′) to obtain the zinc-corrected chloro-
per square inch exceeds the limitations form-soluble extractives residue (e′).
prescribed in paragraph (c) of this sec- This e′ is substituted for e in the equa-
tion, proceed to paragraph (d)(5)(ii) of tions in paragraph (d)(5)(i) (a) and (b) of
this section (method for determining this section.
the amount of chloroform-soluble ex- (b) Correction for wax, petrolatum, and
tractives residues). mineral oil—(1) Apparatus. Standard 10
(ii) Chloroform-soluble extractives res- millimeter inside diameter × 60 centi-

idue. Add 50 milliliters of chloroform meter chromatographic column (or
225
§ 176.170 21 CFR Ch. I (4–1–12 Edition)
standard 50-milliliter buret with an in- through the column into a clean, tared
side diameter of 10–11 millimeters) evaporating dish (platinum or Pyrex)
with a stopcock of glass, at a dropwise rate of about 2 milliliters
perfluorocarbon resin, or equivalent per minute until the liquid surface
material. The column (or buret) may reaches the top glass wool plug; then
be optionally equipped with an integral close the stopcock temporarily. Rinse
coarse, fritted glass disc and the top of the Pyrex flask which contained the
the column (or buret) may be option- filtrate with an additional 10–15 milli-
ally fitted with a 100-millimeter sol- liters of heptane and add to the col-
vent reservoir. umn. Wash (elute) the column with
(2) Preparation of column. Place a more heptane collecting about 100 mil-
snug pledget of fine glass wool in the liliters of total eluate including that
bottom of the column (or buret) if the already collected in the evaporating
column (or buret) is not equipped with dish. Evaporate the combined eluate in
integral coarse, fritted glass disc. Over- the evaporating dish to dryness on a
lay the glass wool pledget (or fritted steam bath. Dry the residue for 15 min-
glass disc) with a 15–20 millimeter deep utes in an oven maintained at a tem-
layer of fine sand. Measure in a grad- perature of approximately 221 °F. Cool
uated cylinder 15 milliliters of the evaporating dish in a desiccator for
chromatographic grade aluminum 30 minutes and weigh the residue to the
oxide (80–200 mesh) that has been tight- nearest 0.1 milligram. Subtract the
ly settled by tapping the cylinder. weight of the residue from the weight
Transfer the aluminum oxide to the of chloroform-soluble extractives res-
chromatographic tube, tapping the idue (′) to obtain the wax-, petrolatum-
tube during and after the transfer so as , and mineral oil-corrected chloroform-
to tightly settle the aluminum oxide. soluble extractives residue (e′). This e′
Overlay the layer of aluminum oxide is substituted for e in the equations in
with a 1.0–1.5 centimeter deep layer of paragraph (d)(5)(i) (a) and (b) of this
anhydrous sodium sulfate and on top of section.
this place an 8–10 millimeter thick plug (ii) For chloroform residues weighing
of fine glass wool. Next carefully add more than 0.5 gram. Redissolve the
about 25 milliliters of heptane to the dried and weighed chloroform-soluble
column with stopcock open, and allow extract residue as described in para-
the heptane to pass through the col- graph (d)(5)(iii)(b)(3)(i) of this section
umn until the top level of the liquid using proportionately larger quantities
just passes into the top glass wool plug of heptane. Transfer the heptane solu-
in the column, and close stopcock. tion to an appropriate-sized volumetric
(3) Chromatographing of sample ex- flask (i.e., a 250-milliliter flask for
tract—(i) For chloroform residues weigh- about 2.5 grams of residue) and adjust
ing 0.5 gram or less. To the dried and to volume with additional heptane. Pi-
weighed chloroform-soluble extract pette out an aliquot (about 50 milli-
residue in the evaporating dish, ob- liters) calculated to contain 0.1–0.5
tained in paragraph (d)(5)(ii) of this gram of the chloroform-soluble extract
section, add 20 milliliters of heptane residue and analyze
and stir. If necessary, heat carefully to chromatographically as described in
dissolve the residue. Additional paragraph (d)(5)(iii)(b)(3)(i) of this sec-
heptane not to exceed a total volume of tion. In this case the weight of the
50 milliliters may be used if necessary dried residue from the heptane eluate
to complete dissolving. Cool to room must be multiplied by the dilution fac-
temperature. (If solution becomes tor to obtain the weight of wax, petro-
cloudy, use the procedure in paragraph latum, and mineral oil residue to be
(d)(5)(iii)(b)(3)(ii) of this section to ob- subtracted from the weight of chloro-
tain an aliquot of heptane solution cal- form-soluble extractives residue (′) to
culated to contain 0.1–0.5 gram of chlo- obtain the wax-, petrolatum-, and min-
roform-soluble extract residue.) Trans- eral oil-corrected chloroform-soluble
fer the clear liquid solution to the col- extractives residue (e′). This e′ is sub-
umn (or buret). Rinse the dish with 10 stituted for e in the equations in para-
millimeters of additional heptane and graph (d)(5)(i) (a) and (b) of this sec-
add to column. Allow the liquid to pass tion. (Note: In the case of chloroform-
226
soluble extracts which contain high surface of paper and paperboard in-
melting waxes (melting point greater tended for use in producing, manufac-
than 170 °F), it may be necessary to di- turing, packing, processing, preparing,
lute the heptane solution further so treating, packaging, transporting, or
that a 50-milliliter aliquot will contain holding dry food of the type identified
only 0.1–0.2 gram of the chloroform- in § 176.170(c), table 1, under Type VIII,
soluble extract residue.) subject to the provisions of this sec-
(e) Acrylonitrile copolymers identi- tion.
fied in this section shall comply with (a) The substances are used in
the provisions of § 180.22 of this chap- amounts not to exceed that required to
ter, except where the copolymers are accomplish their intended physical or
restricted to use in contact with food technical effect, and are so used as to
only of the type identified in paragraph accomplish no effect in food other than
(c), table 1 under Category VIII. that ordinarily accomplished by pack-
[42 FR 14554, Mar. 15, 1977] aging.
(b) The substances permitted to be
used include the following:
tations affecting § 176.170, see the List of CFR
Sections Affected, which appears in the (1) Substances that by § 176.170 and
Finding Aids section of the printed volume other applicable regulations in parts
and at www.fdsys.gov. 170 through 189 of this chapter may be
safely used as components of the
§ 176.180 Components of paper and pa- uncoated or coated food-contact sur-
perboard in contact with dry food. face of paper and paperboard, subject
The substances listed in this section to the provisions of such regulation.
may be safely used as components of (2) Substances identified in the fol-
the uncoated or coated food-contact lowing list:
Acrylamide polymer with sodium 2-acrylamido-2- For use at a level not to exceed 0.015 weight percent of dry
methylpropane-sulfonate (CAS Reg. No. 38193–60–1). fiber.
(2-Alkenyl) succinic anhydrides in which the alkenyl groups are
derived from olefins which contain not less than 78 percent
C30 and higher groups (CAS Reg. No. 70983–55–0)..
4-[2-[2-(2-Alkoxy(C12-C15) ethoxy) ethoxy]ethyl]disodium sulfo- For use as a polymerization emulsifier and latex emulsion sta-
succinate. bilizer at levels not to exceed 5 percent by weight of total
emulsion solids.
Alkyl mono- and disulfonic acids, sodium salts (produced from
n-alkanes in the range of C10-C18 with not less than 50 per-
cent C14-C16)..
Aluminum and calcium salts of FD & C dyes on a substrate of Colorant.
alumina.
Ammonium nitrate..
Amylose..
Barium metaborate ...................................................................... For use as preservative in coatings and sizings.
1,2-Benzisothiazolin-3-one (CAS Registry No. 2634–33–5) ....... For use only as a preservative in paper coating compositions
and limited to use at a level not to exceed 0.02 mg/in2
(0.0031 mg/cm2) of finished paper and paperboard.
N,N′-Bis(hydroxyethyl)lauramide.
Bis(trichloromethyl) sulfone C.A. Registry No. 3064–70–8 ......... For use only as a preservative in coatings.
Borax ........................................................................................... For use as preservative in coatings.
Boric acid ..................................................................................... Do.
sec-Butyl alcohol..
Butyl benzyl phthalate..
Candelilla wax..
Carbon tetrachloride..
Castor oil, polyoxyethylated (42 moles ethylene oxide)..
Cationic soy protein hydrolyzed (hydrolyzed soy protein isolate For use only as a coating adhesive, pigment structuring agent,
modified by treatment with 3-chloro-2-hydroxypropyl- and fiber retention aid.
trimethylammonium chloride).
Cationic soy protein (soy protein isolate modified by treatment For use only as a coating adhesive, pigment structuring agent,
with 3-chloro-2-hydroxypropyltrimethyl-ammonium chloride). and fiber retention aid.
Chloral hydrate ............................................................................ Polymerization reaction-control agent.

N-Cyclohexyl-p-toluene sulfonamide..
2,5-Di-tert-butyl hydroquinone.
227
§ 176.180 21 CFR Ch. I (4–1–12 Edition)
Diethanolamine..
Diethylene glycol dibenzoate (CAS Reg. No. 120–55–8) ........... For use only as a plasticizer in polymeric substances.
Diethylene glycol monobutyl ether..
Diethylene glycol monoethyl ether..
Diethylenetriamine..
N,N-Diisopropanolamide of tallow fatty acids..
N-[(dimethylamino)methyl]acrylamide polymer with acrylamide
and styrene..
N,N-Dioleoylethylenediamine, N,N-dilinoeoyl-ethylenediamine,
and N-oleoyl-N-linoleoyl-ethylenediamine mixture produced
when tall oil fatty acids are made to react with ethylene-
diamine such that the finished mixture has a melting point of
212°–228 °F, as determined by ASTM method D127–60, and
an acid value of 10 maximum. ASTM Method D127–60
‘‘Standard Method of Test for Melting Point of Petrolatum
and Microcrystalline Wax’’ (Revised 1960) is incorporated by
reference. Copies are available from University Microfilms
International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of
this material at NARA, call 202–741–6030, or go to: http://
Diphenylamine..
Dipropylene glycol dibenzoate (CAS Reg. No. 27138–31–4) ..... For use only as plasticizer in polymeric substances.
Disodium N-octadecylsulfosuccinamate..
tert-Dodecyl thioether of polyethylene glycol..
Erucamide (erucylamide)..
Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl-
2(1H)pyrimidinone, propoxylated..
Ethylene oxide ............................................................................. Fumigant in sizing.
Ethylene oxide adduct of mono-(2-ethylhexyl) o-phosphate..
Fatty acid (C12-C18) diethanolamide..
Fish oil fatty acids, hydrogenated, potassium salt..
Formaldehyde..
Glyceryl monocaprate..
Glyceryl tribenzoate (CAS Reg. No. 614–33–5) ......................... For use only as a plasticizer in polymeric coatings.
Glyoxal..
Glyoxal-urea-formaldehyde condensate (CAS Reg. No. 27013– For use as an insolubilizer for starch in coatings.
01–0) formed by reaction in the molar ratio of approximately
47:33:15, respectively. The reaction product has a number
average molecular weight of 278±14 as determined by a
suitable method.
Glyoxal-urea polymer (CAS Reg. No. 53037–34–6) ................... For use as an insolubilizer for starch.
Hexamethylenetetramine ............................................................. Polymerization crosslinking agent for protein, including casein.
As neutralizing agent with myristochromic chloride complex
and stearato-chromic chloride complex.
Hexylene glycol (2-methyl-2,4-pentanediol)..
Hydroabietyl alcohol..
5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0] octane, For use only as an antibacterial preservative.
5-hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5-
hydroxypoly-[methyleneoxy]methyl-1-aza-3,7-
dioxabicyclo[3.3.0] octane mixture.
Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1– For use only at levels not to exceed 0.5 percent by weight of
[2–(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard.
methyl, methyl sulfates (CAS Reg. No. 72749–55–4)..
Isopropanolamine hydrochloride..
Isopropyl m- and p-cresol (thymol derived)..
Itaconic acid..
Maleic anhydride-diisobutylene copolymer, ammonium or so-
dium salt..
Melamine-formaldehyde modified with: Basic polymer.
Alcohols (ethyl, butyl, isobutyl, propyl, or isopropyl).
Diethylenetriamine.
Imino-bis-butylamine.
Imino-bis-ethyleneimine.
Imino-bis-propylamine.
Polyamines made by reacting ethylenediamine or
trimethylenediamine with dichloroethane or dichloropropane.
Sulfanilic acid.
Methyl alcohol..
Methyl ethers of mono-, di-, and tripropylene glycol..
228
Methyl napthalene sulfonic acid-formaldehyde condensate, so-

dium salt..
Methylated poly(N-1,2-dihydroxyethylene-1,3-imidazolidin-2- For use only only as an in solubilizer for starch.
one).
Modified polyacrylamide resulting from an epichlorohydrin addi- For use only as a dry strength and pigment retention aid agent
tion to a condensate of formaldehyde-dicyandiamide- employed prior to the sheetforming operation in the manu-
diethylene triamine and which product is then reacted with facture of paper and paperboard and used at a level not to
polyacrylamide and urea to produce a resin having a nitro- exceed 1 percent by weight of dry fibers.
gen content of 5.6 to 6.3 percent and having a minimum vis-
cosity in 56 percent-by-weight aqueous solution of 200 centi-
poises at 25 °C, as determined by LVT-series Brookfield vis-
cometer using a No. 4 spindle at 60 r.p.m. (or equivalent
method).
Mono- and di(2-alkenyl)succinyl esters of polyethylene glycol For use only as an emulsifier.
containing not less than 90 percent of the diester product
and in which the alkenyl groups are derived from olefins that
contain not less than 95 percent of C15-C21 groups.
Monoglyceride citrate..
Myristo chromic chloride complex..
Napthalene sulfonic acid-formaldehyde condensate, sodium
salt..
Nickel..
b-Nitrostyrene .............................................................................. Basic polymer.
Octadecanoic acid, reaction products with 2-[(2- For use prior to sheet forming at levels not to exceed 12
aminoethyl)amino]ethanol and urea (CAS Reg. No. 68412– pounds per ton of paper.
14–6), and the acetate salts thereof (CAS Reg. No. 68784–
21–4), which may be emulsified with ethoxylated tallow alkyl
amines (CAS Reg. No. 61791–26–2).
a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the
octadecenyl group is derived from oleyl alcohol and the
poly(oxyethylene) content averages not less than 20 moles..
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate,
ammonium salt; the nonyl group is a propylene trimer isomer
and the poly (oxyethylene) content averages 9 or 30 moles..
Oleic acid reacted with N-alkyl-(C16-C18) trimethylenediamine..
Oxidized soy isolate having 50 to 70 percent of its cystine resi- For use as a binder adhesive component of coatings.
dues oxidized to cysteic acid.
Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use as modifiers at levels up to 30 weight-percent of the
product thereof, complying with the identity prescribed in solids content of wax-polymer blend coatings.
§ 176.170(b)(2).
Petroleum hydrocarbon resins (produced by the catalytic po-
lymerization and subsequent hydrogenation of styrene,
vinyltoluene, and indene types from distillates of cracked pe-
troleum stocks)..
Petroleum hydrocarbons, light and odorless..
o-Phthalic acid modified hydrolyzed soy protein isolate..
Pine oil..
Poly(2-aminoethyl acrylate nitrate-co-2-hydroxypropyl acrylate)
complying with the identity described in § 176.170(a)..
Polyamide-epichloro hydrin modified resins resulting from the
reaction of the initial caprolactam-itaconic acid product with
diethylenetriamine and then condensing this prepolymer with
epichlorohydrin to form a cationic resin having a nitrogen
content of 11–15 percent and chlorine level of 20–23 percent
on a dry basis..
Polyamide-ethyleneimine-epichlorohydrin resin is prepared by
reacting equimolar amounts of adipic acid and three amines
(21 mole percent of 1,2-ethanediamine, 51 mole percent of
N-(2-aminoethyl)-1,3-propanediamine, and 28 mole percent
of N, N′-1,2-ethanediylbis(1,3-propanediamine)) to form a
basic polyamidoamine which is modified by reaction with
ethyleneimine (5.5:1.0 ethyleneimine:polyamidoamine). The
modified polyamidoamine is reacted with a crosslinking
agent made by condensing approximately 34 ethylene glycol
units with (chloromethyl)oxirane, followed by pH adjustment
with formic acid or sulfuric acid to provide a finished product
as a formate (CAS Reg. No. 114133–44–7) or a sulfate
(CAS Reg. No. 167678–43–5), having a weight-average mo-
lecular weight of 1,300,000 and a number-average molecular

weight of 16,000..
229
§ 176.180 21 CFR Ch. I (4–1–12 Edition)
Polyamide-ethyleneimine-epichlorohydrin resin (CAS Reg. No.

115340–77–7), prepared by reacting equimolar amounts of
adipic acid and N-(2-aminoethyl)-1,2-ethanediamine to form
a basic polyamidoamine which is modified by reaction with
ethyleneimine, and further reacted with formic acid and
(chloromethyl)oxirane-a-hydro-omega-hydroxypoly(oxy-1,2-
ethanediyl)..
Polybutene, hydrogenated; complying with the identity pre-
scribed under § 178.3740(b) of this chapter..
Poly [2-(diethylamino) ethyl methacrylate] phosphate..
Polyethylene glycol (200) dilaurate..
Polyethylene glycol monoisotridecyl ether sulfate, sodium salt For use only as a surfactant at levels not to exceed 3 percent
(CAS Reg. No. 150413–26–6). in latex formulations used in pigment binders for paper and
paperboard.
Polymers: Homopolymers and copolymers of the following Basic polymer.
monomers:
Acrylamide.
Acrylic acid and its methyl, ethyl, butyl, propyl, or octyl
esters.
Acrylonitrile.
Butadiene.
Crotonic acid.
Cyclol acrylate.
Decyl acrylate.
Diallyl fumarate.
Diallyl maleate.
Diallyl phthalate.
Dibutyl fumarate.
Dibutyl itaconate.
Dibutyl maleate.
Di(2-ethylhexyl) maleate.
Dioctyl fumarate.
Dioctyl maleate.
Divinylbenzene.
Ethylene.
2-Ethylhexyl acrylate.
Fumaric acid.
Glycidyl methacrylate.
2-Hydroxyethyl acrylate.
N-(Hydroxymethyl) acrylamide.
Isobutyl acrylate.
Isobutylene.
Isoprene.
Itaconic acid.
Maleic anhydride and its methyl or butyl esters.
Methacrylic acid and its methyl, ethyl, butyl, or propyl esters.
Methylstyrene.
Mono(2-ethylhexyl) maleate.
Monoethyl maleate.
5-Norbornene-2,3-dicarboxylic acid, mono-n-butyl ester.
Styrene.
Vinyl acetate.
Vinyl butyrate.
Vinyl chloride.
Vinyl crotonate.
Vinyl hexoate.
Vinyl pelargonate.
Vinyl propionate.
Vinyl pyrrolidone.
Vinyl stearate.
Vinyl sulfonic acid.
Polymer prepared from urea, ethanedial, formaldehyde, and For use only as a starch and protein reactant in paper and pa-
propionaldehyde (CAS Reg. No. 106569–82–8). perboard coatings.
Polyoxyethylene (minimum 12 moles) ester of tall oil (30%–
40% rosin acids)..
Polyoxypropylene-polyoxyethylene glycol (minimum molecular
weight 1,900)..
Polyvinyl alcohol..
Potassium titanate fibers produced by calcining titanium diox-
ide, potassium chloride, and potassium carbonate, such that
the finished crystalline fibers have a nominal diameter of
0.20–0.25 micron, a length-to-diameter ratio of approximately

25:1 or greater, and consist principally of K2Ti4O9 and K2Ti
6O13..
230
Sodium diisobutylphenoxy diethoxyethyl sulfonate..

Sodium diisobutylphenoxy monoethoxy ethylsulfonate..
Sodium n-dodecylpolyethoxy (50 moles) sulfate..
Sodium isododecylphenoxypolyethoxy (40 moles) sulfate..
Sodium N-methyl-N-oleyl taurate..
Sodium methyl siliconate..
Sodium nitrite..
Sodium polyacrylate..
Sodium bis-tridecylsulfosuccinate..
Sodium xylene sulfonate..
Stearato chromic chloride complex..
Styrene-allyl alcohol copolymers..
Styrene-methacrylic acid copolymer, potassium salt..
Tetraethylenepentamine .............................................................. Polymerization cross-linking agent.
a-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-omega
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate
and monohydrogen phosphate esters and their sodium, po-
tassium, and ammonium salts having a poly(oxyethylene)
content averaging 6–9 or 40 moles..
a-[p-(1,1,3,3-Tetramethylbutyl)phenyl or p-nonylphenyl]-omega-
hydroxypoly (oxyethylene) where nonyl group is a propylene
trimer isomer..
Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl
sulfosuccinamate..
Toluene..
Triethanolamine..
Triethylenetetramine .................................................................... Polymerization cross-linking agent.
Triethylenetetramine monoacetate, partially stearoylated..
Urea-formaldehyde chemically modified with:
Alcohol (methyl, ethyl, butyl, isobutyl, propyl, or isopropyl).
Aminomethylsulfonic acid.
Diaminobutane.
Diaminopropane.
Diethylenetriamine.
N,N′-Dioleoylethylenediamine.
Diphenylamine.
Ethylenediamine.
Guanidine.
Imino-bis-butylamine.
Imino-bis-ethylamine.
Imino-bis-propylamine.
N-Oleoyl-N′-stearoylethylenediamine.
Polyamines made by reacting ethylenediamine or
triethylenediamine with dichloroethane or dichloropropane.
Xylene..
Xylene sulfonic acid-formaldehyde condensate, sodium salt..
Zinc stearate..
[42 FR 14554, Mar. 15, 1977]

EDITORIAL NOTE: For additional FEDERAL REGISTER citations affecting § 176.180, see the List
of CFR Sections Affected, which appears in the Finding Aids section of the printed volume
and at www.fdsys.gov.
§ 176.200 Defoaming agents used in (a) The defoaming agents are pre-
coatings. pared as mixtures of substances de-
The defoaming agents described in scribed in paragraph (d) of this section.
this section may be safely used as com- (b) The quantity of any substance
ponents of articles intended for use in employed in the formulation of de-
producing, manufacturing, packing, foaming agents does not exceed the
processing, preparing, treating, pack- amount reasonably required to accom-
aging, transporting, or holding food, plish the intended physical or technical
subject to the provisions of this sec- effect in the defoaming agents or any
tion. limitation further provided.
231
§ 176.200 21 CFR Ch. I (4–1–12 Edition)
(c) Any substance employed in the (1) Substances generally recognized

production of defoaming agents and as safe in food.
which is the subject of a regulation in (2) Substances subject to prior sanc-
parts 174, 175, 176, 177, 178 and § 179.45 of tion or approval for use in defoaming
this chapter conforms with any speci- agents and used in accordance with
fication in such regulation. such sanction or approval.
(d) Substances employed in the for- (3) Substances identified in this para-
mulation of defoaming agents include: graph (d)(3) and subject to such limita-
tions as are provided:
n-Butyl alcohol.
tert-Butyl alcohol.
Butyl stearate.
Castor oil, sulfated, ammonium, potassium, or sodium salt.
Cetyl alcohol.
Cyclohexane.
Cyclohexanol.
Diethylene glycol monolaurate.
Diethylene glycol monostearate.
Dimers and trimers of unsaturated C18 fatty acids derived from: For use only at levels not to exceed 0.1% by weight of total
coating solids.
Animal and vegetable fats and oils.
Tall oil.
Dimethylpolysiloxane.
a-(Dinonylphenyl)-w-hydroxy-poly(oxy-1,2-ethanediyl), con- For use only in defoaming agents for the production of styrene-
taining 7 to 24 moles of ethylene oxide per mole of butadiene coatings at a level not to exceed 0.05 percent by
dinonylphenol (CAS Reg. No. 9014–93–1). weight of the finished coating.
Dipropylene glycol.
Ethyl alcohol.
Fats and oils derived from animal, marine, or vegetable
sources:
Fatty acids derived from animal, marine, or vegetable
fats and oils, and salts of such acids, single or
mixed, as follows:
Aluminum..
Ammonium..
Calcium..
Magnesium..
Potassium..
Sodium..
Zinc..
Formaldehyde .............................................................................. For use as preservative of defoamer only.
Glyceryl mono-12-hydroxystearate.
Glyceryl monostearate.
Hexane.
Hexylene glycol (2-methyl-2,4-pentanediol).
Isobutyl alcohol.
Isopropyl alcohol.
Kerosene.
Lecithin hydroxylated.
Methyl alcohol.
Methylcellulose.
Methyl esters of fatty acids derived from animal, marine, or
vegetable fats and oils.
Methyl oleate.
Methyl palmitate.
Mineral oil.
Mustardseed oil, sulfated, ammonium, potassium, or sodium
salt.
Myristyl alcohol.
Naphtha.
b-Naphthol ................................................................................... For use as preservative of defoamer only.
Nonylphenol.
Odorless light petroleum hydrocarbons ...................................... As defined in § 178.3650 of this chapter.
Oleic acid, sulfated, ammonium, potassium, or sodium salt.
Parachlorometacresol .................................................................. For use as preservative of defoamer only.
Peanut oil, sulfated, ammonium, potassium, or sodium salt.
Petrolatum.
Pine oil.
Polyacrylic acid, sodium salt ....................................................... As a stabilizer and thickener in defoaming agents containing
dimethylpolysiloxane.
Polyethylene.
232
Polyethylene, oxidized.
Polyethylene glycol (200) dilaurate.
Polyethylene glycol (400) esters of coconut oil fatty acids.
Polyethylene glycol (600) monoricinoleate.
Polyoxybutylene-polyoxypropylene-polyoxyethylene glycol (min.
mol. wt. 3,700).
Polyoxyethylated (min. 3 mols) cetyl alcohol.
Polyoxyethylated (min. 5 mols) oleyl alcohol.
Polyoxyethylated (min. 1.5 mols) tridecyl alcohol.
Polyoxyethylene (min. 15 mols) ester of rosin.
Polyoxyethylene (min. 8 mols) monooleate.
Polyoxyethylene (40) stearate.
Polyoxypropylated (min. 20 mols) butyl alcohol.
Polyoxypropylene glycol (min. mol. wt. 200).
Polyoxypropylene (min. 20 mols) oleate butyl ether.
Polyoxypropylene-polyoxyethylene glycol (min. mol. wt. 1,900).
Polyoxypropylene (min. 40 mols) stearate butyl ether.
Potassium pentachlorophenate ................................................... For use as preservative of defoamer only.
Potassium trichlorophenate ......................................................... Do.
Propylene glycol monoester of soybean oil fatty acids.
Propylene glycol monoester of tallow fatty acids.
Ricebran oil, sulfated, ammonium, potassium, or sodium salt.
Rosins and rosin derivatives ....................................................... As provided in § 178.3870 of this chapter.
Silica.
Sodium 2-mercaptobenzothiazole ............................................... For use as preservative of defoamer only.
Sodium pentachlorophenate ........................................................ Do.
Sodium trichlorophenate .............................................................. Do.
Sperm oil, sulfated, ammonium, potassium, or sodium salt.
Stearyl alcohol.
Tall oil fatty acids.
Tallow fatty acids, hydrogenated or sulfated.
Tallow, sulfated, ammonium, potassium, or sodium salt.
Triethanolamine.
Triisopropanolamine.
Waxes, petroleum.
(e) The defoaming agents are used as (a) The defoaming agents are pre-
follows: pared from one or more of the sub-
(1) The quantity of defoaming agent stances named in paragraph (d) of this
or agents used shall not exceed the section, subject to any prescribed limi-
amount reasonably required to accom- tations.
plish the intended effect, which is to (b) The defoaming agents are used to
prevent or control the formation of prevent or control the formation of
foam. foam during the manufacture of paper
(2) The defoaming agents are used in and paperboard prior to and during the
the preparation and application of sheet-forming process.
coatings for paper and paperboard. (c) The quantity of defoaming agent
or agents added during the manufac-
[42 FR 14554, Mar. 15, 1977, as amended at 62 turing process shall not exceed the
FR 39772, July 24, 1997] amount necessary to accomplish the
intended technical effect.
§ 176.210 Defoaming agents used in the (d) Substances permitted to be used
manufacture of paper and paper- in the formulation of defoaming agents
board. include substances subject to prior
Defoaming agents may be safely used sanctions or approval for such use and
in the manufacture of paper and paper- employed subject to the conditions of
board intended for use in packaging, such sanctions or approvals, substances
transporting, or holding food in accord- generally recognized as safe for use in
ance with the following prescribed con- food, substances generally recognized
ditions: as safe for use in paper and paperboard,
233
§ 176.210 21 CFR Ch. I (4–1–12 Edition)
and substances listed in this para- Triethanolamine (amides and soaps).

graph, subject to the limitations, if Triisopropanolamine (amides and soaps).
any, prescribed. Trimethylolethane (esters).
Zinc hydroxide (soaps).
(1) Fatty triglycerides, and the fatty
acids, alcohols, and dimers derived (3) Miscellaneous:
therefrom: Alcohols and ketone alcohols mixture (still-
Beef tallow. bottom product from C12-C18 alcohol manu-
Castor oil. facturing process).
Coconut oil. Amyl alcohol.
Corn oil. Butoxy polyethylene polypropylene glycol
Cottonseed oil. molecular weight 900–4,200.
Fish oil. Butoxy-polyoxypropylene molecular weight
Lard oil. 1,000–2,500.
Linseed oil. Butylated hydroxyanisole.
Mustardseed oil. Butylated hydroxytoluene.
Palm oil. Calcium lignin sulfonate.
Peanut oil. Capryl alcohol.
p-Chlorometacresol.
Rapeseed oil.
Cyclohexanol.
Ricebran oil.
Diacetyltartaric acid ester of tallow mono-
Soybean oil.
glyceride.
Sperm oil.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No.
Tall oil.
35691–65–7), for use as a preservative at a
(2) Fatty triglycerides, and marine level not to exceed 0.05 weight-percent of
oils, and the fatty acids and alcohols the defoaming agent.
derived therefrom (paragraph (d)(1) of Diethanolamine.
Diethylene triamine.
this section) reacted with one or more Di-(2-ethylhexyl) phthalate.
of the following, with or without dehy- 2,6-Dimethyl heptanol-4 (nonyl alcohol).
dration, to form chemicals of the cat- Dimethylpolysiloxane.
egory indicated in parentheses: Di-tert-butyl hydroquinone.
Dodecylbenzene sulfonic acids.
Aluminum hydroxide (soaps). Ethanol.
Ammonia (amides). 2-Ethylhexanol.
Butanol (esters). Ethylenediamine tetraacetic acid tetra-
Butoxy-polyoxypropylene, molecular weight sodium salt.
1,000–2,500 (esters). Formaldehyde.
Butylene glycol (esters). Heavy oxo-fraction (a still-bottom product of
Calcium hydroxide (soaps). iso-octyl alcohol manufacture, of approxi-
Diethanolamine (amides). mate composition: Octyl alcohol 5 percent
Diethylene glycol (esters). nonyl alcohol 10 percent, decyl and higher
Ethylene glycol (esters). alcohols 35 percent, esters 45 percent, and
Ethylene oxide (esters and ethers). soaps 5 percent).
Glycerin (mono- and diglycerides). 2-Heptadecenyl-4-methyl-4-hydroxymethyl-2-
Hydrogen (hydrogenated compounds). oxazoline.
Hydrogen (amines). Hexylene glycol (2-methyl-2-4-pentanediol).
Isobutanol (esters). 12-Hydroxystearic acid.
Isopropanol (esters). Isobutanol.
Magnesium hydroxide (soaps). Isopropanol.
Methanol (esters). Isopropylamine salt of dodecylbenzene sul-
Morpholine (soaps). fonic acid.
Oxygen (air-blown oils). Kerosine.
Pentaerythritol (esters). Lanolin.
Polyoxyethylene, molecular weights 200, 300, Methanol.
400, 600, 700, 1,000, 1,540, 1,580, 1,760, 4,600 Methyl 12-hydroxystearate.
(esters). Methyl taurine-oleic acid condensate, molec-
Polyoxypropylene, molecular weight 200– ular weight 486.
2,000 (esters). a,a′-[Methylenebis[4-(1,1,3,3-tetramethylbu-
Potassium hydroxide (soaps). tyl)-o-phenylene]]bis[omega-hydroxypoly
Propanol (esters). (oxyethylene)] having 6–7.5 moles of ethyl-
Propylene glycol (esters). ene oxide per hydroxyl group.
Propylene oxide (esters). Mineral oil.
Sodium hydroxide (soaps). Mono-, di-, and triisopropanolamine.
Sorbitol (esters). Mono- and diisopropanolamine stearate.

Sulfuric acid (sulfated and sulfonated com- Monobutyl ether of ethylene glycol.
pounds). Monoethanolamine.
234
Morpholine. a-[p-(1,1,3,3-Tetramethylbutyl) phenyl-, p-
Myristyl alcohol. nonylphenyl-, or p-dodecylphenyl]-omega-
Naphtha. hydroxypoly(oxyethylene) produced by the
b-Naphthol. condensation of 1 mole of p-alkylphenol
Nonylphenol. (alkyl group is 1,1,3,3-tetramethylbutyl, a
Odorless light petroleum hydrocarbons. propylene trimer isomer, or a propylene
Oleyl alcohol. tetramer isomer) with an average of 1.5–15
Petrolatum. moles of ethylene oxide.
o-Phenylphenol. Tetrahydrofurfuryl alcohol.
Pine oil. Tributoxyethyl phosphate.
Polybutene, hydrogenated; complying with Tributyl phosphate.
the identity prescribed under § 178.3740(b) of Tridecyl alcohol.
this chapter. Triethanolamine.
Polyethylene. Triethylene glycol di(2-ethyl hexanoate).
Polyethylene, oxidized (air-blown). Tri-(2-ethylhexyl) phosphate.
Polymer derived from N-vinyl pyrrolidone Tristearyl phosphate.
and copolymers derived from the mixed Wax, petroleum, Type I and Type II.
alkyl (C12-C15, C16, C18, C20, and C22) meth- Wax, petroleum (oxidized).
acrylate esters, butyl methacrylate (CAS Wax (montan).
Reg. No. 97–88–1), isobutyl methacrylate
(CAS Reg. No. 97–86–9) and methyl meth-
FR 17986, Apr. 27, 1982; 47 FR 46495, Oct. 19,
acrylate (CAS Reg. No. 80–62–6); the com-
1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897,
bined polymer contains no more than 5
June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR
weight percent of polymer units derived
14246, Apr. 1, 1996]
from N-vinyl pyrrolidone and is present at
a level not to exceed 7 parts per million by
weight of the finished dry paper and paper-
§ 176.230 3,5-Dimethyl-1,3,5,2H-
board fibers.
tetrahydrothiadiazine-2-thione.
Polyoxyethylene (4 mols) decyl phosphate. 3,5-Dimethyl-1,3,5,2H-tetrahydrothi-
Polyoxyethylene (4 mols) di(2-ethyl hexano- adiazine-2-thione may safely be used as
ate). a preservative in the manufacture and
Polyoxyethylene (15 mols) ester of rosin. coating of paper and paperboard in-
Polyoxyethylene (3–15 mols) tridecyl alcohol.
tended for use in contact with food in
Polyoxypropylene, molecular weight 200–
2,000. accordance with the following pre-
Polyoxypropylene-polyoxethylene conden- scribed conditions:
sate, minimum molecular weight 950. (a) It is used as follows:
Polyoxypropylene-ethylene oxide condensate (1) In the manufacture of paper and
of ethylene diamine, molecular weight paperboard as a preservative for sub-
1,700–3,800. stances added to the pulp suspension
Polyvinyl pyrrolidone, molecular weight prior to the sheet-forming operation
40,000.
provided that the preservative is vola-
Potassium distearyl phosphate.
Potassium pentachlorophenate.
tilized by heat in the drying and fin-
Potassium trichlorophenate. ishing of the paper and paperboard.
Rosins and rosin derivatives identified in (2) As a preservative for coatings for
§ 175.105(c)(5) of this chapter. paper and paperboard, Provided, That
Silica. the preservative is volatilized by heat
Siloxanes and silicones, dimethyl, methylhy- in the drying and finishing of the coat-
drogen, reaction products with poly- ed paper or paperboard.
ethylene-polypropylene glycol monoallyl (b) The quantity used shall not ex-
ether (CAS Reg. No. 71965–38–3).
Sodium alkyl (C9-C15) benzene-sulfonate.
ceed the least amount reasonably re-
Sodium dioctyl sulfosuccinate. quired to accomplish the intended
Sodium distearyl phosphate. technical effect and shall not be in-
Sodium lauryl sulfate. tended to nor, in fact, accomplish any
Sodium lignin sulfonate. physical or technical effect in the food
Sodium 2-mercaptobenzothiazole. itself.
Sodium naphthalenesulfonic acid (3 mols) (c) The use of a preservative in any
condensed with formaldehyde (2 mols). substance or article subject to any reg-
Sodium orthophenylphenate.
ulation in parts 174, 175, 176, 177, 178
Sodium pentachlorophenate.
Sodium petroleum sulfonate, molecular and § 179.45 of this chapter must comply
with any specifications and limitations
weight 440–450.
Sodium trichlorophenate. prescribed by such regulation for the
Stearyl alcohol. substance or article.
235
§ 176.250 21 CFR Ch. I (4–1–12 Edition)
§ 176.250 Poly-1,4,7,10,13-pentaaza-15- or contains any poisonous or delete-

hydroxyhexadecane. rious substance which is retained in
Poly-1,4,7,10,13-pentaaza-15-hydrox- the recovered pulp and that migrates
yhexadecane may be safely used as a to the food, except as provided in regu-
retention aid employed prior to the lations promulgated under sections 406
sheet-forming operation in the manu- and 409 of the act or (ii) has been used
facture of paper and paperboard infor shipping or handling any such sub-
tended for use in contact with food in stance.
an amount not to exceed that nec-
essary to accomplish the intended § 176.300 Slimicides.
physical or technical effect and not to (a) Slimicides may be safely used in
exceed 6 pounds per ton of finished the manufacture of paper and paper-
paper or paperboard. board that contact food, in accordance
§ 176.260 Pulp from reclaimed fiber.
tions:
(a) Pulp from reclaimed fiber may be (1) Slimicides are used as anti-
safely used as a component of articles microbial agents to control slime in
used in producing, manufacturing, the manufacture of paper and paper-
packing, processing, preparing, treat- board.
ing, packaging, transporting, or hold- (2) Subject to any prescribed limita-
ing food, subject to the provisions of tions, slimicides are prepared from one
paragraph (b) of this section.
or more of the slime-control substances
(b) Pulp from reclaimed fiber is pre-
named in paragraph (c) of this section
pared from the paper and paperboard
to which may be added optional adju-
products described in paragraphs (b) (1)
vant substances as provided for under
and (2) of this section, by repulping
with water to recover the fiber with paragraph (d) of this section.
the least possible amount of nonfibrous (3) Slimicides are added to the proc-
substances. ess water used in the production of
(1) Industrial waste from the manu- paper or paperboard, and the quantity
facture of paper and paperboard prod- added shall not exceed the amount nec-
ucts excluding that which bears or con- essary to accomplish the intended
tains any poisonous or deleterious sub- technical effect.
stance which is retained in the recov- (b) To insure safe usage, the label or
ered pulp and that migrates to the labeling of slimicides shall bear ade-
food, except as provided in regulations quate directions for use.
promulgated under sections 406 and 409 (c) Slime-control substances per-
of the Federal Food, Drug, and Cos- mitted for use in the preparation of
metic Act. slimicides include substances subject
(2) Salvage from used paper and pa- to prior sanction or approval for such
perboard excluding that which (i) bears use and the following:
Acrolein.
Alkenyl (C16-C18) dimethylethyl-ammonium bromide.
n-Alkyl (C12-C18) dimethyl benzyl ammonium chloride.
1,2-Benzisothiazolin-3-one .......................................................... At a level of 0.06 pound per ton of dry weight fiber.
Bis(1,4-bromoacetoxy)-2-butene.
5,5-Bis(bromoacetoxymethyl) m-dioxane.
2,6-Bis(dimethylaminomethyl) cyclohexanone.
1,2-Bis(monobromoacetoxy) ethane [CA Reg. No. 3785–34–0] At a maximum level of 0.10 pound per ton of dry weight fiber.
Bis(trichloromethyl)sulfone.
4-Bromoacetoxymethyl-m-dioxolane.
2-Bromo-4′-hydroxyacetophenone.
2-Bromo-2-nitropropane-1,3-diol (CAS Reg. No. 52–51–7) ........ At a maximum level of 0.6 pound per ton of dry weight fiber.
b-Bromo-b-nitrostyrene ................................................................ At a maximum level of 1 pound per ton of dry weight fiber.
Chloroethylenebisthiocyanate.
5-Chloro-2 - methyl - 4 - isothiazolin-3-one calcium chloride At a level of 2.5 pounds per ton of dry weight fiber.
and 2-methyl-4-isothiazolin-3-one calcium chloride mixture at
a ratio of 3 parts to 1 part.
Chlorinated levulinic acids.

Chloromethyl butanethiolsulfonate.
Cupric nitrate.
236
n-Dialkyl (C12-C18) benzylmethylammonium chloride.

1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7) .. At a maximum level of 0.005% of dry weight fiber.
2,2-Dibromo-3-nitrilopropionamide .............................................. At a maximum level of 0.1 lb/ton of dry weight fiber.
2,3-Dibromopropionaldehyde.
4,5-dichloro-1, 2-dithiol-3-one (CAS Reg. No. 1192–52–5) ........ For use only at levels not to exceed 10 milligrams per kilogram
in the pulp slurry.
1,3-Dihalo-5,5-dimethylhydantoin (where the dihalo (halogen) At a maximum level of 1.0 kilogram (kg) per 1,000 kg of dry
may be bromine and/or chlorine) that may contain no more weight fiber.
than 20 weight percent 1,3-dihalo-5-ethyl-5-methylhydantoin
(where the dihalo (halogen) may be bromine and/or chlo-
rine)..
4-(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018–09–1). At a maximum level of 0.2 pound per ton (100 grams/1,000
kilograms) of dry weight fiber.
3,5-Dimethyl 1,3,5,2H-tetrahydrothiadiazine-2-thione.
Dipotassium and disodium ethylenebis(dithiocarba-mate).
Disodium cyanodithioimidocarbonate.
n-Dodecylguanidine hydrochloride .............................................. At a maximum level of 0.20 pound per ton of dry weight fiber.
Glutaraldehyde (CAS Reg. No. 111-30-8).
2-(p-hydroxyphenyl) glyoxylohydroximoyl chloride (CAS Reg- At a level of 0.02 pound per ton of dry weight fiber.
istry No. 34911–46–1).
2-Hydroxypropyl methanethiol sulfonate.
2-Mercaptobenzothiazole.
Methylenebisbutanethiolsulfonate.
Methylenebisthiocyanate.
2-Nitrobutyl bromoacetate [CA Reg. No. 32815–96–6] .............. At a maximum level of 0.15 pound per ton of dry weight fiber.
N-[a-(Nitroethyl)benzyl] ethylenediamine.
Potassium 2-mercaptobenzothiazole.
Potassium N-hydroxymethyl-N-methyldithiocarba-mate.
Potassium N-methyldithiocarbamate.
Potassium pentachlorophenate.
Potassium trichlorophenate.
Silver fluoride ............................................................................... Limit of addition to process water not to exceed 0.024 pound,
calculated as silver fluoride, per ton of paper produced.
Silver nitrate.
Sodium dimethyldithiocarbamate.
Sodium 2-mercaptobenzothiazole.
Sodium pentachlorophenate.
Sodium trichlorophenate.
1,3,6,8-Tetraazatricyclo[6.2.1.13,6] dodecane.
3,3,4,4-Tetrachlorotetrahydrothiophene-1,1-dioxide.
Tetrakis(hydroxymethyl)phosphonium sulfate (CAS Reg. No. Maximum use level of 84 mg/kg in the pulp slurry. The additive
55566–30–8). may also be added to water, which when introduced into the
pulp slurry, results in a concentration in the pulp slurry not to
exceed 84 mg/kg.
2-(Thiocyanomethylthio) benzothiazole.
Vinylene bisthiocyanate.
(d) Adjuvant substances permitted to a,a′-[Methylenebis[4-(1,1,3,3-tetramethyl-

be used in the preparation of slimicides butyl)-o-phenylene]] bis[omega-hydroxypoly
include substances generally recog- (oxyethylene)] having 6–7.5 moles of ethyl-
nized as safe for use in food, substances ene oxide per hydroxyl group.
generally recognized as safe for use in Monomethyl ethers of mono-, di-, and tri-
propylene glycol.
paper and paperboard, substances per-
Nonylphenol reaction product with 9 to 12
mitted to be used in paper and paper-
molecules of ethylene oxide.
board by other regulations in this
Octylphenol reaction product with 25 mol-
chapter, and the following: ecules of propylene oxide and 40 molecules
Acetone. of ethylene oxide.
Butlylene oxide.
Dibutyl phthalate.
Didecyl phthalate. FR 41854, Aug. 19, 1977; 44 FR 75627, Dec. 21,
N,N-Dimethylformamide. 1979; 46 FR 36129, July 14, 1981; 49 FR 5748,
Dodecyl phthalate. Feb. 15, 1984; 51 FR 19059, May 27, 1986; 51 FR
Ethanolamine. 43734, Dec. 4, 1986; 54 FR 18103, Apr. 27, 1989;
Ethylene glycol. 55 FR 31825, Aug. 6, 1990; 64 FR 46130, Aug. 24,
Ethylenediamine. 1999; 64 FR 69900, Dec. 15, 1999; 65 FR 40497,

N-methyl-2-pyrrolidone (CAS Reg. No. 872– June 30, 2000; 65 FR 70790, Nov. 28, 2000; 69 FR
50–4). 24512, May 4, 2004]
237
§ 176.320 21 CFR Ch. I (4–1–12 Edition)
§ 176.320 Sodium nitrate-urea complex. 177.1040 Acrylonitrile/styrene copolymer.

177.1050 Acrylonitrile/styrene copolymer
Sodium nitrate-urea complex may be modified with butadiene/styrene elas-
safely used as a component of articles tomer.
intended for use in producing, manu- 177.1060 n-Alkylglutarimide/acrylic copoly-
facturing, packing, processing, pre- mers.
paring, treating, packaging, trans- 177.1200 Cellophane.
porting, or holding food, subject to the 177.1210 Closures with sealing gaskets for
food containers.
provisions of this section. 177.1211 Cross-linked polyacrylate copoly-
(a) Sodium nitrate-urea complex is a mers.
clathrate of approximately two parts 177.1240 1,4-Cyclohexylene dimethylene
urea and one part sodium nitrate. terephthalate and 1,4-cyclohexylene
(b) Sodium nitrate-urea complex con- dimethylene isophthalate copolymer.
forming to the limitations prescribed 177.1310 Ethylene-acrylic acid copolymers.
in paragraph (b)(1) of this section is 177.1312 Ethylene-carbon monoxide copoly-
used as provided in paragraph (b)(2) of mers.
177.1315 Ethylene-1,4-cyclohexylene
this section. dimethylene terephthalate copolymers.
(1) Limitations. (i) It is used as a plas- 177.1320 Ethylene-ethyl acrylate copoly-
ticizer in glassine and greaseproof mers.
paper. 177.1330 Ionomeric resins.
(ii) The amount used does not exceed 177.1340 Ethylene-methyl acrylate copoly-
that required to accomplish its in- mer resins.
tended technical effect or exceed 15 177.1345 Ethylene/1,3-phenylene oxyethylene
percent by weight of the finished paper. isophthalate/terephthalate copolymer.
177.1350 Ethylene-vinyl acetate copolymers.
(2) Conditions of use. The glassine and 177.1360 Ethylene-vinyl acetate-vinyl alco-
greaseproof papers are used for pack- hol copolymers.
aging dry food or as the food-contact 177.1380 Fluorocarbon resins.
surface for dry food. 177.1390 Laminate structures for use at tem-
peratures of 250 °F and above.
§ 176.350 Tamarind seed kernel pow- 177.1395 Laminate structures for use at tem-
der. peratures between 120 °F and 250 °F.
Tamarind seed kernel powder may be 177.1400 Hydroxyethyl cellulose film, water-
insoluble.
safely used as a component of articles 177.1420 Isobutylene polymers.
intended for use in producing, manu- 177.1430 Isobutylene-butene copolymers.
facturing, packing, processing, pre- 177.1440 4,4′-Isopropylidenediphenol-
paring, treating, packaging, trans- epichlorohydrin resins minimum molec-
porting, or holding food, subject to the ular weight 10,000.
provisions of this section. 177.1460 Melamine-formaldehyde resins in
(a) Tamarind seed kernel powder is molded articles.
177.1480 Nitrile rubber modified acrylo-
the ground kernel of tamarind seed
nitrile-methyl acrylate copolymers.
(Tamarindus indica L.) after removal of 177.1500 Nylon resins.
the seed coat. 177.1520 Olefin polymers.
(b) It is used in the manufacture of 177.1550 Perfluorocarbon resins.
paper and paperboard. 177.1555 Polyarylate resins.
177.1556 Polyaryletherketone resins.
177.1560 Polyarylsulfone resins.
PART 177—INDIRECT FOOD 177.1570 Poly-1-butene resins and butene/
ADDITIVES: POLYMERS ethylene copolymers.
177.1580 Polycarbonate resins.
Subpart A [Reserved] 177.1585 Polyestercarbonate resins.
177.1590 Polyester elastomers.
Subpart B—Substances for Use as Basic 177.1595 Polyetherimide resin.
Components of Single and Repeated 177.1600 Polyethylene resins, carboxyl modi-
Use Food Contact Surfaces fied.
177.1610 Polyethylene, chlorinated.
Sec. 177.1615 Polyethylene, fluorinated.
177.1010 Acrylic and modified acrylic plas- 177.1620 Polyethylene, oxidized.
tics, semirigid and rigid. 177.1630 Polyethylene phthalate polymers.
177.1020 Acrylonitrile/butadiene/styrene co- 177.1632 Poly(phenyleneterephthalamide)
polymer. resins.
177.1030 Acrylonitrile/butadiene/styrene/ 177.1635 Poly(p-methylstyrene) and rubber-
methyl methacrylate copolymer. modified poly(p-methylstyrene).
238
177.1637 Poly(oxy-1,2- 177.2800 Textiles and textile fibers.
ethanediyloxycarbonyl-2,6- 177.2910 Ultra-filtration membranes.
naphthalenediylcarbonyl) resins.
AUTHORITY: 21 U.S.C. 321, 342, 348, 379e.
177.1640 Polystyrene and rubber-modified
polystyrene. SOURCE: 42 FR 14572, Mar. 15, 1977, unless
177.1650 Polysulfide polymer-polyepoxy res- otherwise noted.
ins.
177.1655 Polysulfone resins. EDITORIAL NOTE: Nomenclature changes to
177.1660 Poly(tetramethylene part 177 appear at 61 FR 14482, Apr. 2, 1996, 66
terephthalate). FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27,
177.1670 Polyvinyl alcohol film. 2001, 68 FR 15355, Mar. 31, 2003, and 70 FR
177.1680 Polyurethane resins. 72074, Dec. 1, 2005.
177.1810 Styrene block polymers.
177.1820 Styrene-maleic anhydride copoly- Subpart A [Reserved]
mers.
177.1830 Styrene-methyl methacrylate co-
polymers. Subpart B—Substances for Use as
177.1850 Textryls. Basic Components of Single
177.1900 Urea-formaldehyde resins in molded and Repeated Use Food Con-
articles.
177.1950 Vinyl chloride-ethylene copoly-
tact Surfaces
mers.
177.1960 Vinyl chloride-hexene-1 copoly-
§ 177.1010 Acrylic and modified acrylic
mers.
plastics, semirigid and rigid.
177.1970 Vinyl chloride-lauryl vinyl ether Semirigid and rigid acrylic and modi-
copolymers. fied acrylic plastics may be safely used
177.1980 Vinyl chloride-propylene copoly- as articles intended for use in contact
mers. with food, in accordance with the fol-
177.1990 Vinylidene chloride/methyl acry-
late copolymers. lowing prescribed conditions. The
177.2000 Vinylidene chloride/methyl acry- acrylic and modified acrylic polymers
late/methyl methacrylate polymers. or plastics described in this section
also may be safely used as components
Subpart C—Substances for Use Only as of articles intended for use in contact
Components of Articles Intended for with food.
Repeated Use (a) The optional substances that may
be used in the formulation of the
177.2210 Ethylene polymer,
chlorosulfonated. semirigid and rigid acrylic and modi-
177.2250 Filters, microporous polymeric. fied acrylic plastics, or in the formula-
177.2260 Filters, resin-bonded. tion of acrylic and modified acrylic
177.2280 4,4′-Isopropylidenediphenol- components of articles, include sub-
epichlorohydrin thermosetting epoxy stances generally recognized as safe in
resins. food, substances used in accordance
177.2355 Mineral reinforced nylon resins. with a prior sanction or approval, sub-
177.2400 Perfluorocarbon cured elastomers.
177.2410 Phenolic resins in molded articles.
stances permitted for use in such plas-
177.2415 Poly(aryletherketone) resins. tics by regulations in parts 170 through
177.2420 Polyester resins, cross-linked. 189 of this chapter, and substances
177.2430 Polyether resins, chlorinated. identified in this paragraph. At least 50
177.2440 Polyethersulfone resins. weight-percent of the polymer content
177.2450 Polyamide-imide resins. of the acrylic and modified acrylic ma-
177.2460 Poly(2,6-dimethyl-1,4-phenylene) terials used as finished articles or as
oxide resins.
177.2465 Polymethylmethacrylate/poly(tri
components of articles shall consist of
methoxysilylpropyl) methacrylate copolymer units derived from one or
polymers. more of the acrylic or methacrylic
177.2470 Polyoxymethylene copolymer. monomers listed in paragraph (a)(1) of
177.2480 Polyoxymethylene homopolymer. this section.
177.2490 Polyphenylene sulfide resins. (1) Homopolymers and copolymers of
177.2500 Polyphenylene sulfone resins. the following monomers:
177.2510 Polyvinylidene fluoride resins.
177.2550 Reverse osmosis membranes. n-Butyl acrylate.
177.2600 Rubber articles intended for re- n-Butyl methacrylate.
peated use. Ethyl acrylate.

177.2710 Styrene-divinylbenzene resins, 2-Ethylhexyl acrylate.
cross-linked. Ethyl methacrylate.
239
§ 177.1010 21 CFR Ch. I (4–1–12 Edition)
Methyl acrylate. Methacryloxyacetamidoethylethylene urea.
Methyl methacrylate. Methacryloxyacetic acid.
n-Propyl methacrylate.
(2) Copolymers produced by copolym- 3,5,5-Trimethylcyclohexyl methacrylate.
erizing one or more of the monomers
listed in paragraph (a)(1) of this section (4) Polymers identified in paragraphs
with one or more of the following (a)(1), (2), and (3) of this section are
monomers: mixed together and/or with the fol-
lowing polymers, provided that no
Acrylonitrile. chemical reactions, other than addi-
Methacrylonitrile.
a-Methylstyrene.
tion reactions, occur when they are
Styrene. mixed:
Vinyl chloride. Butadiene-acrylonitrile copolymers.
Vinylidene chloride. Butadiene-acrylonitrile-styrene copolymers.
(3) Polymers identified in paragraphs Butadiene-acrylonitrile-styrene-methyl
methacrylic copolymers.
(a)(1) and (2) of this section containing
Butadiene-styrene copolymers.
no more than 5 weight-percent of total Butyl rubber.
polymer units derived by copolym- Natural rubber.
erization with one or more of the Polybutadiene.
monomers listed in paragraph (a)(3)(i) Poly (3-chloro-1,3-butadiene).
and (ii) of this section. Monomers list- Polyester identified in § 175.300(b)(3)(vii) of
ed in paragraph (a)(3)(ii) of this section this chapter.
are limited to use only in plastic arti- Polyvinyl chloride.
Vinyl chloride copolymers complying with
cles intended for repeated use in con- § 177.1980.
tact with food. Vinyl chloride-vinyl acetate copolymers.
(i) List of minor monomers:
(5) Antioxidants and stabilizers iden-
Acrylamide. tified in § 175.300(b)(3)(xxx) of this chap-
Acrylic acid
1,3-Butylene glycol dimethacrylate.
ter and the following:
1,4-Butylene glycol dimethacrylate. Di-tert-butyl-p-cresol.
Diethylene glycol dimethacrylate. 2-Hydroxy-4-methoxybenzophenone.
Diproplylene glycol dimethacrylate. 2-Hydroxy-4-methoxy-2-
Divinylbenzene. carboxybenzophenone.
Ethylene glycol dimethacrylate. 3-Hydroxyphenyl benzoate.
Itaconic acid. p-Methoxyphenol.
Methacrylic acid. Methyl salicylate.
N-Methylolacrylamide. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro-
N-Methylolmethacrylamide. cinnamate (CAS Reg. No. 2082–79–3): For
4-Methyl-1,4-pentanediol dimethacrylate. use only: (1) At levels not exceeding 0.2
Propylene glycol dimethacrylate. percent by weight in semirigid and rigid
Trivinylbenzene. acrylic and modified acrylic plastics,
(ii) List of minor monomers limited where the finished articles contact foods
to use only in plastic articles intended containing not more than 15 percent alco-
hol; and (2) at levels not exceeding 0.01 per-
for repeated use in contact with food: cent by weight in semirigid and rigid
Allyl methacrylate [Chemical Abstracts acrylic and modified acrylic plastics in-
Service Registry No. 96–05–9] tended for repeated food-contact use where
tert-Butyl acrylate. the finished article may be used for foods
tert-Butylaminoethyl methacrylate. containing more than 15 percent alcohol.
sec-Butyl methacrylate. Phenyl salicylate.
tert-Butyl methacrylate.
Cyclohexyl methacrylate.
(6) Release agents: Fatty acids de-
Dimethylaminoethyl methacrylate. rived from animal and vegetable fats
2-Ethylhexyl methacrylate. and oils, and fatty alcohols derived
Hydroxyethyl methacrylate. from such acids.
Hydroxyethyl vinyl sulfide. (7) Surface active agent: Sodium
Hydroxypropyl methacrylate. dodecylbenzenesulfonate.
Isobornyl methacrylate. (8) Miscellaneous materials:
Isobutyl methacrylate.
Isopropyl acrylate. Di(2-ethylhexyl) phthalate, for use only as a
Isopropyl methacrylate. flow promoter at a level not to exceed 3

Methacrylamide. weight-percent based on the monomers.
Methacrylamidoethylene urea. Dimethyl phthalate.
240
Oxalic acid, for use only as a polymerization prepared in a still using a block tin
catalyst aid. condenser. The 8 and 50 percent (by vol-
Tetraethylenepentamine, for use only as a ume) alcohol solvents shall be prepared
catalyst activator at a level not to exceed
0.5 weight-percent based on the monomers.
from ethyl alcohol meeting the speci-
Toluene. fications of the United States Pharma-
Xylene. copeia XX and diluted with double-dis-
tilled water that has been prepared in a
(b) The semirigid and rigid acrylic
still using a tin block condenser. The
and modified acrylic plastics, in the
n-heptane shall be spectrophotometric
finished form in which they are to con-
grade. Adequate precautions must be
tact food, when extracted with the sol-
taken to keep all solvents dust-free.
vent or solvents characterizing the
(4) Blank values on solvents. (i) Dupli-
type of food and under the conditions
cate determinations of residual solids
of time and temperature as determined
shall be run on samples of each solvent
from tables 1 and 2 of § 176.170(c) of this
that have been exposed to the tempera-
chapter, shall yield extractives not to
ture-time conditions of the extraction
exceed the following, when tested by
the methods prescribed in paragraph test without the plastic sample. Sixty
(c) of this section. The acrylic and milliliters of exposed solvent is
modified acrylic polymers or plastics pipetted into a clean, weighed plat-
intended to be used as components of inum dish, evaporated to 2–5 milliliters
articles also shall yield extractives not on a nonsparking, low-temperature hot
to exceed the following limitations plate and dried in 212 °F oven for 30
when prepared as strips as described in minutes. The residue for each solvent
paragraph (c)(2) of this section: shall be determined by weight and the
(1) Total nonvolatile extractives not average residue weight used as the
to exceed 0.3 milligram per square inch blank value in the total solids deter-
of surface tested. mination set out in paragraph (c)(6) of
(2) Potassium permanganate oxidiz- this section. The residue for an accept-
able distilled water and 8 and 50 per- able solvent sample shall not exceed 0.5
cent alcohol extractives not to exceed milligram per 60 milliliters.
an absorbance of 0.15. (ii) For acceptability in the ultra-
(3) Ultraviolet-absorbing distilled violet absorbers test, a sample of each
water and 8 and 50 percent alcohol ex- solvent shall be scanned in an ultra-
tractives not to exceed an absorbance violet spectrophotometer in 5-centi-
of 0.30. meter silica spectrophotometric ab-
(4) Ultraviolet-absorbing n-heptane sorption cells. The absorbance of the
extractives not to exceed an absorb- distilled water when measured versus
ance of 0.10. air in the reference cell shall not ex-
(c) Analytical methods—(1) Selection of ceed 0.03 at any point in the wave-
extractability conditions. These are to be length region of 245 to 310 mμ. The ab-
chosen as provided in § 176.170(c) of this sorbance of the 8 percent alcohol when
chapter. measured versus distilled water in the
(2) Preparation of samples. Sufficient reference cell shall not exceed 0.01 at
samples to allow duplicates of all ap- any point in the wavelength region of
plicable tests shall be cut from the ar- 245 to 310 mμ. The absorbance of the 50
ticles or formed from the plastic com- percent alcohol when measured versus
position under tests, as strips about 2.5 distilled water in the reference cell
inches by about 0.85-inch wide by about shall not exceed 0.05 at any point in the
0.125-inch thick. The total exposed sur- wavelength region of 245 to 310 mμ. The
face should be 5 square inches ±0.5- absorbance of the heptane when meas-
square inch. The samples, after prepa- ured versus distilled water in the ref-
ration, shall be washed with a clean erence cell shall not exceed 0.15 at 245,
brush under hot tapwater, rinsed under 0.09 at 260, 0.04 at 270, and 0.02 at any
running hot tapwater (140 °F min- point in the wavelength region of 280 to
imum), rinsed with distilled water, and 310 mμ.
air-dried in a dust-free area or in a des- (iii) Duplicate ultraviolet blank de-
iccator. terminations shall be run on samples of
(3) Preparation of solvents. The water each solvent that has been exposed to
used shall be double-distilled water, the temperature-time conditions of the
241
§ 177.1010 21 CFR Ch. I (4–1–12 Edition)
extraction test without the plastic tents to room temperature if nec-

sample. An aliquot of the exposed sol- essary.
vent shall be measured versus the un- (6) Determination of total nonvolatile
exposed solvent in the reference cell. extractives. Remove the plastic strip
The average difference in the from the solvent with a pair of clean
absorbances at any wavelength in the forceps and wash the strip with 5 milli-
region of 245 to 310 mμ shall be used as liters of the appropriate solvent, add-
a blank correction for the ultraviolet ing the washings to the contents of the
absorbers measured at the same wave- test tube. Pour the contents of the test
length according to paragraph (c)(8)(ii) tube into a clean, weighed platinum
of this section. dish. Wash the tube with 5 milliliters
(iv) The acceptability of the solvents of the appropriate solvent and add the
for use in the permanganate test shall solvent to the platinum dish. Evapo-
be determined by preparing duplicate rate the solvent to 2–5 milliliters on a
permanganate test blanks according to nonsparking, low-temperature
paragraph (c)(7)(iv) of this section. For hotplate. Complete the evaporation in
this test, the directions referring to a 212 °F oven for 30 minutes. Cool the
the sample extract shall be dis- dish in a desiccator for 30 minutes and
regarded. The blanks shall be scanned weigh to the nearest 0.1 milligram. Cal-
in 5-centimeter silica culate the total nonvolatile extractives
spectrophotometric cells in the spec- as follows:
trophotometer versus the appropriate
Milligrams extractives e − b
solvent as reference. The absorbance in
=
distilled water in the wavelength re- per square inch s
gion of 544 to 552 mμ should be 1.16 but
must not be less than 1.05 nor more
Extractives in parts eb
than 1.25. The absorbance in the 8 and = × 100
50 percent alcohol must not be less per million s
than 0.85 nor more than 1.15. where:
(v) Duplicate permanganate test de- e=Total increase in weight of the dish, in
terminations shall be run on samples of milligrams.
distilled water and 8 and 50 percent al- b=Blank value of the solvent in milligrams,
cohol solvents that have been exposed as determined in paragraph (c)(4)(i) of this
to the temperature-time conditions of section.
the extraction test without the plastic s=Total surface of the plastic sample in
square inches.
sample. The procedure shall be as de-
scribed in paragraph (c)(7)(iv) of this (7) Determination of potassium per-
section, except that the appropriate ex- manganate oxidizable extractives. (i) Pi-
posed solvent shall be substituted pette 25 milliliters of distilled water
where the directions call for sample ex- into a clean 125-milliliter Erlenmeyer
tract. The average difference in the flask that has been rinsed several
absorbances in the region of 544 to 552 times with aliquots of distilled water.
mμ shall be used as a blank correction This is the blank. Prepare a distilled
for the determination of permanganate water solution containing 1.0 part per
oxidizable extractives according to million of p-methoxyphenol (melting
paragraph (c)(7)(iv) of this section. point 54–56 °C, Eastman grade or equiv-
(5) Extraction procedure. For each ex- alent). Pipette 25 milliliters of this p-
traction, place a plastic sample in a methoxyphenol solution into a rinsed
clean 25 millimeters × 200 millimeters Erlenmeyer flask. Pipette exactly 3.0
hard-glass test tube and add solvent milliliters of 154 parts per million
equal to 10 milliliters of solvent per aqueous potassium permanganate solu-
square inch of plastic surface. This tion into the p-methoxyphenol and ex-
amount will be between 45 milliliters actly 3.0 milliliters into the blank, in
and 55 milliliters. The solvent must be that order. Swirl both flasks to mix the
preequilibrated to the temperature of contents and then transfer aliquots
the extraction test. Close the test tube from each flask into matched 5-centi-
with a ground-glass stopper and expose meter spectrophotometric absorption
ER01JA93.393</GPH>
to the specified temperature for the cells. The cells are placed in the spec-
specified time. Cool the tube and con- trophotometer cell compartment with
242
ER01JA93.392</GPH>
the p-methoxyphenol solution in the pose of ascertaining compliance with

reference beam. Spectrophotometric the limitations in paragraph (b)(2) of
measurement is conducted as in para- this section, the absorbance measure-
graph (c)(7)(iv) of this section. The ab- ments obtained on the distilled water
sorbance reading in the region 544–552 extracts according to paragraph
mμ should be 0.24 but must be not less (c)(7)(iv) of this section shall be multi-
than 0.12 nor more than 0.36. This test plied by a correction factor, calculated
shall be run in duplicate. For the pur- as follows:
0.24
= Correction factor for water extracts.
Average of duplicate ρ-methoxyphenol
absorbance determinations according to
this paragraph (c)(7)(i) of this section
(ii) The procedure in paragraph ascertaining compliance with the limi-

(c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of
cept that, in this instance, the solvent this section, the absorbance measure-
shall be 8 percent alcohol. The absorb- ments obtained on the 8 percent alco-
ance in the region 544–552 mμ should be hol extracts according to paragraph
0.26 but must be not less than 0.13 nor (c)(7)(iv) of this section shall be multi-
more than 0.39. This test shall be run in plied by a correction factor, calculated
duplicate. For the purpose of as follows:
0.26 Correction factor for aqueous

=
Average of duplicate ρ-methoxyphenol 8 percent alcohol extracts.
absorbance determination according to
this paragraph (c)(7)(ii) of this section
(iii) The procedure in paragraph ascertaining compliance with the limi-

(c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of
cept that, in this instance, the solvent this section, the absorbance measure-
shall be 50 percent alcohol. The absorb- ments obtained on the 50 percent alco-
ance in the region 544–552 mμ should be hol extracts according to paragraph
0.25 but must be not less than 0.12 nor (c)(7)(iv) of this section shall be multi-
more than 0.38. This test shall be run in plied by a correction factor, calculated
duplicate. For the purpose of as follows:
0.25 Correction factor for 50 percent

=
Average of duplicate ρ-methoxyphenol aqueous alcohol extracts.
paragraph (c)(7)(ii) of this section
ER01JA93.395</GPH> ER01JA93.396</GPH>
(iv) Water and 8 and 50 percent alcohol the same solvent. This is the blank.
extracts. Pipette 25 milliliters of the ap- Into another similarly rinsed flask, pi-
propriate solvent into a clean, 125-mil- pette 25 milliliters of the sample ex-
liliter Erlenmeyer flask that has been tract that has been exposed under the
rinsed several times with aliquots of conditions specified in paragraph (c)(5)
243
ER01JA93.394</GPH>
§ 177.1010 21 CFR Ch. I (4–1–12 Edition)
of this section. Pipette exactly 3.0 mil- propriate correction factor determined
liliters of 154 parts per million aqueous according to paragraph (c)(7) (i), (ii),
potassium permanganate solution into and (iii) of this section. This test shall
the sample and exactly 3.0 milliliters be run in duplicate and the two results
into the blank, in that order. Before averaged.
use, the potassium permanganate solu- (8) Determination of ultraviolet-absorb-
tion shall be checked as in paragraph ing extractives. (i) A distilled water so-
(c)(7)(i) of this section. Both flasks are lution containing 1.0 part per million
swirled to mix the contents, and then of p-methoxyphenol (melting point 54
aliquots from each flask are trans-
°C–56 °C. Eastman grade or equivalent)
ferred to matched 5-centimeter
shall be scanned in the region 360 to 220
spectrophotometric absorption cells.
Both cells are placed in the spectro- mμ in 5-centimeter silica spectrophoto-
photometer cell compartment with the metric absorption cells versus a dis-
sample solution in the reference beam. tilled water reference. The absorbance
The spectrophotometer is adjusted for at the wavelength of maximum absorb-
0 and 100 percent transmittance at 700 ance (should be about 285 mμ) is about
mμ. The spectrum is scanned on the ab- 0.11 but must be not less than 0.08 nor
sorbance scale from 700 mμ to 500 mμ in more than 0.14. This test shall be run in
such a way that the region 544 mμ to duplicate. For the purpose of
552 mμ is scanned within 5 minutes to ascertaining compliance with the limi-
10 minutes of the time that permanga- tations prescribed in paragraph (b) (3)
nate was added to the solutions. The and (4) of this section, the absorbance
height of the absorbance peak shall be obtained on the extracts according to
measured, corrected for the blank as paragraph (c)(8)(ii) of this section shall
determined in paragraph (c)(4)(v) of be multiplied by a correction factor,
this section, and multiplied by the ap- calculated as follows:
0.11
= Correction factor for ultraviolet
Average of duplicate ρ-methoxyphenol absorbers test.
this paragraph (c)(8)(i) of this section
(ii) An aliquot of the extract that has (e) Acrylonitrile copolymers identi-
been exposed under the conditions fied in this section shall comply with
specified in paragraph (c)(5) of this sec- the provisions of § 180.22 of this chap-
tion is scanned in the wavelength re- ter.
gion 360 to 220 mμ versus the appro- (f) The acrylic and modified acrylic
priate solvent reference in matched 5- polymers identified in and complying
centimeter silica spectrophotometric with this section, when used as compo-
absorption cells. The height of any ab- nents of the food-contact surface of an
sorption peak shall be measured, cor- article that is the subject of a regula-
rected for the blank as determined in tion in this part and in parts 174, 175,
paragraph (c)(4)(iii) of this section, and 176, and 178 of this chapter, shall com-
multiplied by the correction factor de- ply with any specifications and limita-
termined according to paragraph tions prescribed by such regulation for
(c)(8)(i) of this section. the article in the finished form in
(d) In accordance with current good which it is to contact food.
manufacturing practice, finished
semirigid and rigid acrylic and modi- [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct.
fied acrylic plastics, and articles con- 28, 1977, as amended at 43 FR 54927, Nov. 24,
1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796,
taining these polymers, intended for
Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR
repeated use in contact with food shall
13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985]

be thoroughly cleansed prior to their
first use in contact with food.
244
ER01JA93.397</GPH>
§ 177.1020 Acrylonitrile/butadiene/sty- (2) Residual acrylonitrile monomer

rene co-polymer. content of the finished copolymer arti-
Acrylonitrile/butadiene/styrene co- cles is not more than 11 parts per mil-
polymer identified in this section may lion as determined by a gas
be safely used as an article or compo- chromatographic method titled ‘‘De-
nent of articles intended for use with termination of Residual Acrylonitrile
all foods, except those containing alco- and Styrene Monomers-Gas
hol, under conditions of use E, F, and G Chromatographic Internal Standard
described in table 2 of § 176.170(c) of this Method,’’ which is incorporated by ref-
chapter. erence. Copies are available from the
(a) Identity. For the purpose of this Center for Food Safety and Applied Nu-
section, the acrylonitrile/butadiene/ trition (HFS–200), Food and Drug Ad-
styrene copolymer consists of: ministration, 5100 Paint Branch Pkwy.,
(1) Eighty-four to eighty-nine parts College Park, MD 20740, or available for
by weight of a matrix polymer con- inspection at the National Archives
taining 73 to 78 parts by weight of acry- and Records Administration (NARA).
lonitrile and 22 to 27 parts by weight of For information on the availability of
styrene; and this material at NARA, call 202–741–
(2) Eleven to sixteen parts by weight 6030, or go to: http://www.archives.gov/
of a grafted rubber consisting of (i) 8 to federallregister/
13 parts of butadiene/styrene elastomer codeloflfederallregulations/
containing 72 to 77 parts by weight of ibrllocations.html.
butadiene and 23 to 28 parts by weight
(d) Extractive limitations. (1) Total
of styrene and (ii) 3 to 8 parts by
weight of a graft polymer having the nonvolatile extractives not to exceed
same composition range as the matrix 0.0005 milligram per square inch sur-
polymer. face area when the finished food con-
(b) Adjuvants. The copolymer identi- tact article is exposed to distilled
fied in paragraph (a) of this section water, 3 percent acetic acid, or n-
may contain adjuvant substances re- heptane for 8 days at 120 °F.
quired in its production. Such adju- (2) The finished food-contact article
vants may include substances gen- shall yield not more than 0.0015 milli-
erally recognized as safe in food, sub- gram per square inch of acrylonitrile
stances used in accordance with prior monomer when exposed to distilled
sanction, substances permitted in this water and 3 percent acetic acid at 150
part, and the following: °F for 15 days when analyzed by a po-
larographic method titled ‘‘Extracted
Substance Limitations
Acrylonitrile by Differential Pulse Po-
2-Mercapto- ethanol The finished copolymer shall contain larography,’’ which is incorporated by
not more than 100 ppm 2- reference. Copies are available from
mercaptoethanol acrylonitrile adduct
as determined by a method titled the Center for Food Safety and Applied
‘‘Analysis of Cycopac Resin for Re- Nutrition (HFS–200), Food and Drug
sidual b-(2-Hydroxyethylmercapto) Administration, 5100 Paint Branch
propionitrile,’’ which is incorporated
by reference. Copies are available Pkwy., College Park, MD 20740, or
from the Bureau of Foods (HFS– available for inspection at the National
200), Food and Drug Administra- Archives and Records Administration
tion, 5100 Paint Branch Pkwy., Col-
lege Park, MD 20740, or available (NARA). For information on the avail-
for inspection at the National Ar- ability of this material at NARA, call
chives and Records Administration 202–741–6030, or go to: http://
(NARA). For information on the
availability of this material at NARA, www.archives.gov/federallregister/
call 202–741–6030, or go to: http:// codeloflfederallregulations/
www.archives.gov/federallregister/ ibrllocations.html.
ibrllocations.html. (e) Acrylonitrile copolymers identi-
fied in this section shall comply with
(c) Specifications. (1) Nitrogen content the provisions of § 180.22 of this chap-
of the copolymer is in the range of 16 ter.
to 18.5 percent as determined by Micro- (f) Acrylonitrile copolymers identi-

Kjeldahl analysis. fied in this section are not authorized
245
§ 177.1030 21 CFR Ch. I (4–1–12 Edition)
to be used to fabricate beverage con- Substances Limitations

tainers.
2–Mercaptoethanol .. The finished copolymer shall contain
[42 FR 14572, Mar. 15, 1977, as amended at 42 not more than 800 ppm 2–
mercaptoethanol acrylonitrile adduct
FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19,
as determined by a method titled
1982; 54 FR 24897, June 12, 1989] ‘‘Analysis of Cycopac Resin for Re-
sidual b–(2–Hydroxyethylmercapto)
§ 177.1030 Acrylonitrile/butadiene/sty- propionitrile,’’ which is incorporated
rene/methyl methacrylate copoly- by reference. Copies are available
from the Bureau of Foods (HFS–
mer. 200), Food and Drug Administra-
Acrylonitrile/butadiene/styrene/ tion, 5100 Paint Branch Pkwy., Col-
lege Park, MD 20740, or available
methyl methacrylate copolymer iden- for inspection at the National Ar-
tified in this section may be safely chives and Records Administration
used as an article or component of arti- (NARA). For information on the
availability of this material at NARA,
cles intended for use with food identi- call 202–741–6030, or go to: http://
fied in table 1 of § 176.170(c) of this www.archives.gov/federallregister/
chapter as Type I, II, III, IVA, IVB, V, codeloflfederallregulations/
ibrllocations.html.
VIB, (except bottles intended to hold
carbonated beverages), VIIA, VIIB, VIII (c) Specifications. (1) Nitrogen content
and IX, under conditions of use C, D, E, of the copolymer is in the range of 13.0
F, and G described in table 2 of to 16.0 percent as determined by Micro-
§ 176.170(c) of this chapter with a high Kjeldahl analysis.
temperature limitation of 190 °F.
(2) Residual acrylonitrile monomer
(a) Identity. For the purpose of this content of the finished copolymer arti-
section, acrylonitrile/butadiene/sty- cles is not more than 11 parts per mil-
rene/methyl methacrylate copolymer lion as determined by a gas
consists of: (1) 73 to 79 parts by weight chromatographic method titled ‘‘De-
of a matrix polymer containing 64 to 69 termination of Residual Acrylonitrile
parts by weight of acrylonitrile, 25 to and Styrene Monomers-Gas
30 parts by weight of styrene and 4 to Chromatographic Internal Standard
6 parts by weight of methyl methacry- Method,’’ which is incorporated by ref-
late; and (2) 21 to 27 parts by weight of erence. Copies are available from the
a grafted rubber consisting of (i) 16 to Center for Food Safety and Applied Nu-
20 parts of butadiene/styrene/elastomer trition (HFS–200), Food and Drug Ad-
containing 72 to 77 parts by weight of ministration, 5100 Paint Branch Pkwy.,
butadiene and 23 to 28 parts by weight College Park, MD 20740, or available for
of styrene and (ii) 5 to 10 parts by inspection at the National Archives
weight of a graft polymer having the and Records Administration (NARA).
same composition range as the matrix For information on the availability of
polymer. this material at NARA, call 202–741–
(b) Adjuvants. The copolymer identi- 6030, or go to: http://www.archives.gov/
fied in paragraph (a) of this section federallregister/
may contain adjuvant substances re- codeloflfederallregulations/
quired in its production. Such adju- ibrllocations.html.
vants may include substances gen- (d) Extractive limitations. (1) Total
erally recognized as safe in food, sub- nonvolatile extractives not to exceed
stances used in accordance with prior 0.0005 milligram per square inch sur-
sanction, substances permitted under face area of the food-contact article
applicable regulations in this part, and when exposed to distilled water, 3 per-
the following: cent acetic acid, 50 percent ethanol,
and n-heptane for 10 days at 120 °F.
(2) The finished food-contact article
shall yield not more than 0.0025 milli-
gram per square inch of acrylonitrile
monomer when exposed to distilled
water, 3 percent acetic acid and n-

heptane at 190 °F for 2 hours, cooled to
246
120 °F (80 to 90 minutes) and main- used as a component of packaging ma-

tained at 120 °F for 10 days when ana- terials subject to the provisions of this
lyzed by a polarographic method titled section.
‘‘Extracted Acrylonitrile by Differen- (a) Identity. For the purposes of this
tial Pulse Polarography,’’ which is in- section acrylonitrile/styrene copoly-
corporated by reference. Copies are mers are basic copolymers meeting the
available from the Center for Food specifications prescribed in paragraph
Safety and Applied Nutrition (HFS– (c) of this section.
200), Food and Drug Administration, (b) Adjuvants. (1) The copolymers
5100 Paint Branch Pkwy., College Park, identified in paragraph (c) of this sec-
MD 20740, or available for inspection at
tion may contain adjuvant substances
required in their production, with the
ministration (NARA). For information
exception that they shall not contain
on the availability of this material at
NARA, call 202–741–6030, or go to: http:// mercaptans or other substances which
www.archives.gov/federallregister/ form reversible complexes with acryl-
codeloflfederallregulations/ onitrile monomer. Permissible adju-
ibrllocations.html. vants may include substances gen-
(e) Acrylonitrile copolymers identi- erally recognized as safe in food, sub-
fied in this section shall comply with stances used in accordance with prior
the provisions of § 180.22 of this chap- sanction, substances permitted under
ter. applicable regulations in this part, and
(f) Acrylonitrile copolymers identi- those authorized in paragraph (b)(2) of
fied in this section are not authorized this section.
to be used to fabricate beverage con- (2) The optional adjuvants for the ac-
tainers. rylonitrile/styrene copolymer identi-
[42 FR 14572, Mar. 15, 1977, as amended at 42 fied in paragraphs (c) (1) and (3) of this
FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, section are as follows:
1982; 54 FR 24898, June 12, 1989]
Substances Limitation
§ 177.1040 Acrylonitrile/styrene copoly- Condensation polymer of toluene 0.15 pct maximum.
mer. sulfonamide and formaldehyde.
Acrylonitrile/styrene copolymers
identified in this section may be safely (c) Specifications.
Maximum re-
sidual acrylo- Nitrogen con-
nitrile mon- Maximum extractable fractions at Conformance with
Acrylonitrile/styrene copolymers tent of co-
omer content specified temperatures and times certain specifications
polymer
of finished
article
1. Acrylonitrile/styrene copolymer 80 ppm1 ...... 17.4 to 19 Total nonvolatile extractives not to Minimum number av-
consisting of the copolymer pro- pct. exceed 0.01 mg/in 2 surface erage molecular
duced by polymerization of 66– area of the food contact article weight is 30,000. 1
72 parts by weight of acrylo- when exposed to distilled water
nitrile and 28–34 parts by weight and 3 pct acetic acid for 10 d at
of styrene; for use with food of 66 °C (150 °F).
Type VI-B identified in table 1 of The extracted copolymer shall not
§ 176.170(c) of this chapter exceed 0.001 mg/in 2 surface
under conditions of use C, D, E, area of the food contact article
F, G described in table 2 of when exposed to distilled water
§ 176.170(c) of this chapter. and 3 pct acetic acid for 10 d at
66 °C (150 °F) 1.
2. Acrylonitrile/styrene copolymer 50 ppm1 ...... 12.2 to 17.2 Extracted copolymer not to exceed Minimum 10 pct solu-
consisting of the copolymer pro- pct. 2.0 ppm in aqueous extract or n- tion viscosity at 25
duced by polymerization of 45– heptane extract obtained when °C (77 °F) is
65 parts by weight of acrylo- 100 g sample of the basic co- 10cP. 1
nitrile and 35–55 parts by weigth polymer in the form of particles
of styrene; for use with food of of a size that will pass through a
Types, I, II, III, IV, V, VI (except U.S. Standard Sieve No. 6 and
bottles), VII, VIII, and IX identi- that will be held on a U.S.
fied in table 1 of § 176.170(c) of Standard Sieve No. 10 is ex-
this chapter under conditions B tracted with 250 mil of deionized
(not to exceed 93 °C (200 °F)), water or reagent grade n-

C, D, E, F, G described in table heptane at reflux temperature
2 of § 176.170(c) of this chapter. for 2 h.1
247
§ 177.1050 21 CFR Ch. I (4–1–12 Edition)
Maximum re-
sidual acrylo- Nitrogen con-
nitrile mon- Maximum extractable fractions at Conformance with
Acrylonitrile/styrene copolymers tent of co-
omer content specified temperatures and times certain specifications
polymer
of finished
article
3. Acrylonitrile/styrene copolymer 0.10 ppm 17.4 to 19 Total nonvolatile extractives not to Maximum carbon di-
consisting of the copolymer pro- (calculated pct. exceed 0.01 mg/in 2 surface oxide permeability
duced by polymerization of 66– on the area of the food contact article at 23 °C (73 °F) for
72 parts by weight of acrylo- basis of when exposed to distilled water the finished article
nitrile and 28–34 parts by weight the weight and 3 pct acetic acid for 10 d at is 0.04 barrer. 3
of styrene; for use with food of of the ac- 66 °C (150 °F).
Types VI-A and VI-B identified in rylonitrile The extracted copolymer shall not
table 1 of § 176.170(c) of this copolymer exceed 0.001 mg/in 2 surface
chapter under conditions of use resin in the area of the food contact article
C, D, E, F, G described in table finished ar- when exposed to distilled water
2 of § 176.170(c) of this chapter. ticles). 2 and 3 pct acetic acid for 10 d at
66 °C (150 °F). 1.
1 Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction, number average mo-
lecular weight, and solution viscosity, titled: ‘‘Determination of Residual Acrylonitrile and Styrene Monomers-Gas
Chromatographic Internal Standard Method’’; ‘‘Infrared Spectrophotometric Determination of Polymer Extracted from Barex 210
Resin Pellets’’; ‘‘Procedure for the Determination of Molecular Weights of Acrylonitrile/Styrene Copolymers,’’ and ‘‘Analytical
Method for 10% Solution Viscosity of Tyril,’’ which are incorproated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS–200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Na-
tional Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–
6030, or go to: http://www.archives.gov/federallregister/codeloflfederallregulations/ibrllocations.html.
2 As determined by the method titled ‘‘Headspace Sampling and Gas-Solid Chromatographic Determination of Residual Acrylo-
nitrile in Acrylonitrile Copolyemr Solutions,’’ which is incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS–200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Na-
tional Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–
6030, or go to: http://www.archives.gov/federallregister/codeloflfederallregulations/ibrllocations.html.
3 As determined on appropriately shaped test samples of the article or acrylonitrile copolymer layer in a multilayer construction
by ASTM method D–1434–82, ‘‘Standard Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting,’’
which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5100
Paint Branch Pkwy., College Park, MD 20740, and the American Society for Testing Materials, 100 Barr Harbor Dr., West
Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/
federallregister/codeloflfederallregulations/ibrllocations.html.
(d) Interim listing. Acrylonitrile co- mer modified with butadiene/styrene

polymers identified in this section elastomer consists of a blend of:
shall comply with the provisions of (1) 82–88 parts by weight of a matrix
§ 180.22 of this chapter. copolymer produced by polymerization
(e) Acrylonitrile copolymer identified of 77–82 parts by weight of acrylonitrile
in this section may be used to fabricate and 18–23 parts of styrene; and
beverage containers only if they com- (2) 12–18 parts by weight of a grafted
ply with the specifications of item 3 in rubber consisting of (i) 8–12 parts of bu-
paragraph (c) of this section. tadiene/styrene elastomer containing
[42 FR 14572, Mar. 15, 1977, as amended at 42 77–82 parts by weight of butadiene and
FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, 18–23 parts by weight of styrene and (ii)
1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, 4–6 parts by weight of a graft copoly-
Sept. 8, 1987] mer consisting of 70–77 parts by weight
of acrylonitrile and 23–30 parts by
§ 177.1050 Acrylonitrile/styrene copoly- weight of styrene.
mer modified with butadiene/sty-
rene elastomer. (b) Adjuvants. The modified copoly-
mer identified in paragraph (a) of this
Acrylonitrile/styrene copolymer section may contain adjuvant sub-
modified with butadiene/styrene elas- stances required in its production.
tomer identified in this section may be Such adjuvants may include substances
safely used as a component of bottles generally recognized as safe in food,
intended for use with foods identified substances used in accordance with
in table I of § 176.170(c) of this chapter prior sanction, substances permitted
as Type VI-B under conditions for use
under applicable regulations in this
E, F, or G described in table 2 of
part, and the following:
(a) Identity. For the purpose of this

section, acrylonitrile/styrene copoly-
248
Substances Limitations 202–741–6030, or go to: http://

n-Dodecylmercaptan The finished copolymer shall contain
not more than 500 parts per million codeloflfederallregulations/
(ppm) dodecylmercaptan as ibrllocations.html.
dodecylmercapto-propionitrile as de- (d) Extractives limitations. The fol-
termined by the method titled, ‘‘De-
termination of b-Dodecyl-
lowing extractives limitations are de-
mercaptopropionitrile in NR–16 termined by an infrared spectrophoto-
Polymer,’’ which is incorporated by metric method titled ‘‘Infrared
reference. Copies are available Spectrophotometric Determination of
from the Center for Food Safety
and Applied Nutrition (HFS–200), Polymer Extracted from Borex ® 210
Food and Drug Administration, 5100 Resin Pellets,’’ which is incorporated
Paint Branch Pkwy., College Park, by reference. Copies are available from
MD 20740, or available for inspec-
Records Administration (NARA). For Nutrition (HFS–200), Food and Drug
information on the availability of this Administration, 5100 Paint Branch
material at NARA, call 202–741– Pkwy., College Park, MD 20740, or
6030, or go to: http://
www.archives.gov/federallregister/ available for inspection at the National
codeloflfederallregulations/ Archives and Records Administration
ibrllocations.html. (NARA). For information on the avail-
(c) Specifications. (1) Nitrogen content 202–741–6030, or go to: http://
of the modified copolymer is in the www.archives.gov/federallregister/
range of 17.7–19.8 percent. codeloflfederallregulations/
(2) Intrinsic viscosity of the matrix ibrllocations.html. Copies are applica-
copolymer in butyrolactone is not less ble to the modified copolymers in the
than 0.5 deciliter/gram at 35 °C, as de- form of particles of a size that will pass
termined by the method titled ‘‘Molec- through a U.S. Standard Sieve No. 6
ular Weight of Matrix Copolymer by and that will be held on a U.S. Stand-
Solution Viscosity,’’ which is incor- ard Sieve No. 10:
porated by reference. Copies are avail- (1) The extracted copolymer shall not
able from the Center for Food Safety exceed 2.0 ppm in aqueous extract ob-
and Applied Nutrition (HFS–200), Food tained when a 100-gram sample of co-
and Drug Administration, 5100 Paint polymer is extracted with 250 milli-
Branch Pkwy., College Park, MD 20740, liters of freshly distilled water at
or available for inspection at the Na- reflux temperature for 2 hours.
tional Archives and Records Adminis- (2) The extracted copolymer shall not
tration (NARA). For information on exceed 0.5 ppm in n-heptane when a 100-
the availability of this material at gram sample of the basic copol-ymer is
NARA, call 202–741–6030, or go to: http:// extracted with 250 milliliters spectral
www.archives.gov/federallregister/ grade n-heptane at reflux temperature
codeloflfederallregulations/ for 2 hours.
ibrllocations.html. (e) Accelerated extraction end test. The
(3) Residual acrylonitrile monomer modified copolymer shall yield acrylo-
content of the modified copolymer ar- nitrile monomer not in excess of 0.4
ticles is not more than 11 ppm as deter- ppm when tested as follows:
mined by a gas chromatographic meth- (1) The modified copolymer shall be
od titled ‘‘Determination of Residual in the form of eight strips 1⁄2 inch by 4
Acrylonitrile and Styrene Monomers- inches by .03 inch.
Gas Chromatographic Internal Stand- (2) The modified copolymer strips
ard Method,’’ which is incorporated by shall be immersed in 225 milliliters of 3
reference. Copies are available from percent acetic acid in a Pyrex glass
the Center for Food Safety and Applied pressure bottle.
Nutrition (HFS–200), Food and Drug (3) The pyrex glass pressure bottle is
Administration, 5100 Paint Branch then sealed and heated to 150 °F in ei-
Pkwy., College Park, MD 20740, or ther a circulating air oven or a thermo-
available for inspection at the National stat controlled bath for a period of 8
Archives and Records Administration days.
(NARA). For information on the avail- (4) The Pyrex glass pressure bottle is
ability of this material at NARA, call then removed from the oven or bath
249
§ 177.1060 21 CFR Ch. I (4–1–12 Edition)
and cooled to room temperature. A such use by applicable regulations, as

sample of the extracting solvent is set forth in part 174 of this chapter.
then withdrawn and analyzed for acry- (c) Specifications. Maximum nitrogen
lonitrile monomer by a gas content of the copolymer determined
chromatographic method titled ‘‘Gas- by micro-Kjeldahl analysis, shall not
Solid Chromatographic Procedure for exceed 8 percent.
Determining Acrylonitrile Monomer in (d) Limitations. (1) The n-alkylglutar-
Acrylonitrile-Containing Polymers and imide/acrylic copolymers in the fin-
Food Simulating Solvents,’’ which is ished form in which they shall contact
incorporated by reference. Copies, are food, when extracted with the solvent
available from the Center for Food or solvents characterizing the type of
Safety and Applied Nutrition (HFS– food and under the conditions of time
200), Food and Drug Administration, and temperature described in tables 1
5100 Paint Branch Pkwy., College Park, and 2 of § 176.170(c) of this chapter,
MD 20740, or available for inspection at shall yield extractives not to exceed
the National Archives and Records Ad- the limitations of § 177.1010(b) of this
ministration (NARA). For information chapter, when prepared as strips, as de-
on the availability of this material at scribed in § 177.1010(c)(2) of this chapter.
NARA, call 202–741–6030, or go to: http:// (2) The n-alkylglutarimide/acrylic co-
polymers shall not be used as polymer
modifiers in vinyl chloride homo- or
copolymers.
ibrllocations.html.
(e) Conditions of use. The n-
(f) Acrylonitrile copolymers identi- alkylglutarimide/acrylic copolymers
fied in this section shall comply with are used as articles or components of
the provisions of § 180.22 of this chap- articles (other than articles composed
ter. of vinyl chloride homo- or copolymers)
(g) Acrylonitrile copolymers identi- intended for use in contact with all
fied in this section are not authorized foods except beverages containing
to be used to fabricate beverage con- more than 8 percent alcohol under con-
tainers. ditions of use D, E, F, and G as de-
[42 FR 14572, Mar. 15, 1977, as amended at 42 scribed in table 2 of § 176.170(c) of this
FR 48544, Sept. 23, 1977; 47 FR 11841, Mar. 19, chapter.
1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898, [54 FR 20382, May 11, 1989, as amended at 58
June 12, 1989] FR 17098, Apr. 1, 1993]
§ 177.1060 n-Alkylglutarimide/acrylic § 177.1200 Cellophane.
copolymers.
Cellophane may be safely used for
n-Alkylglutarimide/acrylic copoly- packaging food in accordance with the
mers identified in this section may be following prescribed conditions:
safely used as articles or components (a) Cellophane consists of a base
of articles intended for use in contact sheet made from regenerated cellulose
with food subject to provisions of this to which have been added certain op-
section and part 174 of this chapter. tional substances of a grade of purity
(a) Identity. For the purpose of this suitable for use in food packaging as
section, n-alkylglutarimide/acrylic co- constituents of the base sheet or as
polymers are copolymers obtained by coatings applied to impart desired
reaction of substances permitted by technological properties.
§ 177.1010(a) (1), (2), and (3) with the fol- (b) Subject to any limitations pre-
lowing substance: Monomethylamine scribed in this part, the optional sub-
(CAS Reg. No. 74–89–5), to form n- stances used in the base sheet and
methylglutarimide/acrylic copolymers. coating may include:
(b) Adjuvants. The copolymers identi- (1) Substances generally recognized
fied in paragraph (a) of this section as safe in food.
may contain adjuvant substances re- (2) Substances for which prior ap-
quired in their production. The op- proval or sanctions permit their use in
tional adjuvant substances required in cellophane, under conditions specified
the production of the basic polymer in such sanctions and substances listed
may include substances permitted for in § 181.22 of this chapter.
250
(3) Substances that by any regulation (4) Substances named in this section
promulgated under section 409 of the and further identified as required.
act may be safely used as components (c) List of substances:
of cellophane.
Limitations (residue and limits of addition expressed as percent
List of substances by weight of finished packaging cellophane)
Acrylonitrile-butadiene copolymer resins ..................................... As the basic polymer.

Acrylonitrile-butadiene-styrene copolymer resins ........................ Do.
Acrylonitrile-styrene copolymer resins ......................................... Do.
Acrylonitrile-vinyl chloride copolymer resins ............................... Do.
N-Acyl sarcosines where the acyl group is lauroyl or stearoyl ... For use only as release agents in coatings at levels not to ex-
ceed a total of 0.3 percent by weight of the finished pack-
aging cellophane.
Alkyl ketene dimers identified in § 176.120 of this chapter.
Aluminum hydroxide.
Aluminum silicate.
Ammonium sulfate.
Behenamide.
Butadiene-styrene copolymer ...................................................... As the basic polymer.
1,3-Butanediol.
n-Butyl acetate ............................................................................. 0.1 percent.
n-Butyl alcohol ............................................................................. Do.
Calcium ethyl acetoacetate.
Calcium stearoyl-2-lactylate identified in § 172.844 of this chap- Not to exceed 0.5 percent weight of cellophane.
ter.
Carboxymethyl hydroxyethylcellulose polymer.
Castor oil phthalate with adipic acid and fumaric acid-diethyl- As the basic polymer.
ene glycol polyester.
Castor oil phthalate, hydrogenated ............................................. Alone or in combination with other phthalates where total
phthalates do not exceed 5 percent.
Castor oil, sulfonated, sodium salt.
Cellulose acetate butyrate.
Cetyl alcohol.
Clay, natural.
Coconut oil fatty acid (C12-C18) diethanolamide, coconut oil For use only as an adjuvant employed during the processing of
fatty acid (C12-C18) diethanolamine soap, and diethanolamine cellulose pulp used in the manufacture of cellophane base
mixture having total alkali (calculated as potassium hydrox- sheet.
ide) of 16–18% and having an acid number of 25–35.
Copal resin, heat processed ....................................................... As basic resin.
Damar resin.
Defoaming agents identified in § 176.200 of this chapter.
Dialkyl ketones where the alkyl groups are lauryl or stearyl ...... Not to exceed a total of 0.35 percent.
Dibutylphthalate ........................................................................... Alone or in combination with other phthalates where total
Dicyclohexyl phthalate ................................................................. Do.
Diethylene glycol ester of the adduct of terpene and maleic an-
hydride.
Di(2-ethylhexyl) adipate.
Di(2-ethylhexyl) phthalate ............................................................ Alone or in combination with other phthalates where total
Diisobutyl phthalate ..................................................................... Do.
Dimethylcyclohexyl phthalate ...................................................... Do.
Dimethyldialkyl (C8-C18) ammonium chloride .............................. 0.005 percent for use only as a flocculant for slip agents.
Di-n-ocyltin bis (2-ethylhexyl maleate) ........................................ For use only as a stabilizer at a level not to exceed 0.55 per-
cent by weight of the coating solids in vinylidene chloride co-
polymer waterproof coatings prepared from vinylidene chlo-
ride copolymers identified in this paragraph, provided that
such vinylidene chloride copolymers contain not less than 90
percent by weight of polymer units derived from vinylidene
chloride.
251
§ 177.1200 21 CFR Ch. I (4–1–12 Edition)

N,N′-Dioleoyethylenediamine, N,N′-dilinoleoylethylene-diamine 0.5 percent.

and N-oleoyl-N′linoleoylethylene-diamine mixture produced
when tall oil fatty acids are made to react with ethylene-
diamine such that the finished mixture has a melting point of
212°–228 °F., as determined by ASTM method D127–60
(‘‘Standard Method of Test for Melting Point of Petrolatum
and Microcrystalline Wax’’ (Revised 1960), which is incor-
porated by reference; copies are available from University
Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI
48106, or available for inspection at the National Archives
codeloflfederallregulations/ibrllocations.html.), and an
acid value of 10 maximum.
N,N′-Dioleoylethylenediamine (N,N′-ethylenebisoleamide).
Disodium EDTA.
Distearic acid ester of di(hydroxyethyl) diethylenetriamine 0.06 percent.
monoacetate.
N,N′-Distearoylethylenediamine (N,N′-ethylenebis stearamide).
Epoxidized polybutadiene ............................................................ For use only as a primer subcoat to anchor surface coatings to
the base sheet.
Erucamide.
Ethyl acetate.
Ethylene-vinyl acetate copolymers complying with § 177.1350.
2-Ethylhexyl alcohol ..................................................................... 0.1 percent for use only as lubricant.
Fatty acids derived from animal and vegetable fats and oils,
and the following salts of such acids, single or mixed: Alu-
minum, ammonium, calcium, magnesium, potassium, sodium.
Ferrous ammonium sulfate.
Fumaric acid.
Glycerin-maleic anhydride ........................................................... As the basic polymer.
Glycerol diacetate.
Glycerol monoacetate.
Hydroxyethyl cellulose, water-insoluble.
Hydroxypropyl cellulose identified in § 172.870 of this chapter.
Isopropyl acetate ......................................................................... Residue limit 0.1 percent
Isopropyl alcohol .......................................................................... Do.
Itaconic acid.
Lanolin.
Lauryl alcohol.
Lauryl sulfate salts: ammonium, magnesium, potassium, so-
dium.
Maleic acid ................................................................................... 1 percent.
Maleic acid adduct of butadienestyrene copolymer.
Melamine formaldehyde .............................................................. As the basic polymer.
Melamine-formaldehyde modified with one or more of the fol- As the basic polymer, and used as a resin to anchor coatings
lowing: Butyl alcohol, diaminopropane, diethylenetriamine, to substrate.
ethyl alcohol, guanidine, imino-bis-butylamine, imino-bis-eth-
ylamine, imino-bis-propylamine, methyl alcohol, polyamines
made by reacting ethylenediamine or trimethylenediamine
with dichloroethane or dichloropropane, sulfanilic acid,
tetraethylenepentamine, triethanolamine, triethylenetetra-
mine.
Methyl ethyl ketone ..................................................................... Residue limit 0.1 percent
Methyl hydrogen siloxane ............................................................ 0.1 percent as the basic polymer.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a-
Mineral oil, white.
Mono- and bis-(octadecyldiethylene oxide) phosphates (CAS For use only as a release agent at a level not to exceed 0.6
Reg. No. 62362–49–6). percent by weight of coatings for cellophane.
Naphthalenesulfonic acid-formaldehyde condensate, sodium 0.1 percent, for use only as an emulsifier.
salt.
Nitrocellulose, 10.9 percent–12.2 percent nitrogen.
Nylon resins complying with § 177.1500.
n-Octyl alcohol ............................................................................. For use only as a defoaming agent in the manufacture of cello-
phane base sheet.
Olefin copolymers complying with § 177.1520.
Oleic acid reacted with N-alkyl trimethylenediamine (alkyl C16
to C18).
Oleic acid, sulfonated, sodium salt.
Oleyl palmitamide.
252

N,N′-Oleoyl-stearylethylenediamine (N-(2-stearoyl-
aminoethyl)oleamide).
Paraffin, synthetic, complying with § 175.250 of this chapter.
Pentaerythritol tetrastearate ........................................................ 0.1 percent.
Polyamide resins derived from dimerized vegetable oil acids For use only in cellophane coatings that contact food at tem-
(containing not more than 20 percent of monomer acids) and peratures not to exceed room temperature.
ethylenediamine as the basic resin.
Polyamide resins having a maximum acid value of 5 and a As the basic resin, for use only in coatings that contact food at
maximum amine value of 8.5 derived from dimerized vege- temperatures not to exceed room temperature provided that
table oil acids (containing not more than 10 percent mon- the concentration of the polyamido resins in the finished
omer acids), ethylenediamine, and 4,4-bis(4- food-contact coating does not exceed 5 milligrams per
hydroxyphenyl)pentanoic acid (in an amount not to exceed square inch of food-contact surface.
10 percent by weight of said polyamide resins).
Polybutadiene resin (molecular weight range 2,000–10,200; For use only as an adjuvant in vinylidene chloride copolymer
bromine number range 210–320). coatings.
Polycarbonate resins complying with § 177.1580.
Polyester resin formed by the reaction of the methyl ester of
rosin, phthalic anhydride, maleic anhydride, and ethylene
glycol, such that the polyester resin has an acid number of 4
to 11, a drop-softening point of 70 °C–92 °C, and a color of
K or paler.
Polyethylene.
Polyethyleneaminostearamide ethyl sulfate produced when ste- 0.1 percent.
aric acid is made to react with equal parts of
diethylenetriamine and triethylenetetramine and the reaction
product is quaternized with diethyl sulfate.
Polyethylene, oxidized: complying with the identity prescribed
in § 177.1620(a).
Polyethylenimine .......................................................................... As the basic polymer, for use as a resin to anchor coatings to
the substrate and for use as an impregnant in the food-con-
tact surface of regenerated cellulose sheet in an amount not
to exceed that required to improve heat-sealable bonding
between coated and uncoated sides of cellophane.
Polyisobutylene complying with § 177.1420.
Polyoxypropylene-polyoxyethylene block polymers (molecular For use as an adjuvant employed during the processing of cel-
weight 1,900–9,000). lulose pulp used in the manufacture of cellophane base
sheet.
Polypropylene complying with § 177.1520.
Polystyrene .................................................................................. As the basic polymer.
Polyvinyl acetate .......................................................................... Do.
Polyvinyl alcohol (minimum viscosity of 4 percent aqueous so-
lution at 20 °C of 4 centipoises).
Polyvinyl chloride ......................................................................... As the basic polymer.
Polyvinyl stearate ........................................................................ Do.
n-Propyl acetate .......................................................................... Residue limit 0.1 percent.
n-Propyl alcohol ........................................................................... Do.
Rapeseed oil, blown.
Rosins and rosin derivatives as provided in § 178.3870 of this
chapter.
Rubber, natural (natural latex solids).
Silica.
Silicic acid.
Sodium m-bisulfite.
Sodium lauroyl sarcosinate ......................................................... 0.35 percent; for use only in vinylidene chloride copolymer
coatings.
Sodium oleyl sulfate-sodium cetyl sulfate mixture ...................... For use only as an emulsifier for coatings; limit 0.005 percent
where coating is applied to one side only and 0.01 percent
where coating is applied to both sides.
Sodium silicate.
Sodium stearoyl-2-lactylate identified in § 172.846 of this chap- Not to exceed 0.5 percent weight of cellophane.
ter.
Sodium sulfate.
Sodium sulfite.
Spermaceti wax.
Stannous oleate.
253
§ 177.1210 21 CFR Ch. I (4–1–12 Edition)

2-Stearamido-ethyl stearate.
Stearyl alcohol.
Styrene-maleic anhydride resins ................................................. As the basic polymer.
Terpene resins identified in § 172.615 of this chapter.
Tetrahydrofuran ........................................................................... Residue limit of 0.1 percent.
Titanium dioxide.
Toluene ........................................................................................ Residue limit of 0.1 percent.
Toluene sulfonamide formaldehyde ............................................ 0.6 percent as the basic polymer.
Triethylene glycol.
Triethylene glycol diacetate, prepared from triethylene glycol
containing not more than 0.1 percent of diethylene glycol.
2,2,4-Trimethyl-1,3 pentanediol diisobutyrate ............................. For use only in cellophane coatings and limited to use at a
level not to exceed 10 percent by weight of the coating sol-
ids except when used as provided in § 178.3740 of this
chapter
Urea (carbamide).
Urea formaldehyde ...................................................................... As the basic polymer.
Urea formaldehyde modified with methanol, ethanol, butanol As the basic polymer, and used as a resin to anchor coatings
diethylenetriamine, triethylenetetramine, tetraethylenepenta- to the substrate.
mine, guanidine, sodium sulfite, sulfanilic acid, imino-bis-eth-
ylamine, imino-bis-propylamine, imino-bis-butylamine,
diaminopropane, diaminobutane, aminomethylsulfonic acid,
polyamines made by reacting ethylenediamine or
trimethylenediamine with dichlorethane or dichloropropane.
Vinyl acetate-vinyl chloride copolymer resins ............................. As the basic polymer.
Vinyl acetate-vinyl chloride-maleic acid copolymer resins .......... Do.
Vinylidene chloride copolymerized with one or more of the fol- Do.
lowing: Acrylic acid, acrylonitrile, butyl acrylate, butyl meth-
acrylate, ethyl acrylate, 2-ethylhexyl acrylate, 2-ethylhexyl
methacrylate, ethyl methacrylate, itaconic acid, methacrylic
acid, methyl acrylate, methyl methacrylate, propyl acrylate,
propyl methacrylate, vinyl chloride.
Vinylidene chloride-methacrylate decyloctyl copolymer .............. Do.
Wax, petroleum, complying with § 178.3710 of this chapter.
(d) Any optional component listed in in parts 174, 175, 176, 177, 178 and § 179.45
this section covered by a specific food of this chapter; and closure-sealing
additive regulation must meet any gaskets, as further prescribed in this
specifications in that regulation. section.
(e) Acrylonitrile copolymers identi- (b) Closure-sealing gaskets and over-
fied in this section shall comply with all discs are formulated from sub-
the provisions of § 180.22 of this chap- stances identified in § 175.300(b) of this
ter. chapter, with the exception of para-
graph (b)(3) (v), (xxxi), and (xxxii) of
FR 11842, Mar. 19, 1982; 64 FR 57978, Oct. 28, that section, and from other optional
1999] substances, including the following:
(1) Substances generally recognized
§ 177.1210 Closures with sealing gas- as safe in food.
kets for food containers. (2) Substances used in accordance
Closures with sealing gaskets may be with the provisions of a prior sanction
safely used on containers intended for or approval within the meaning of sec-
use in producing, manufacturing, pack- tion 201(s) of the act.
ing, processing, preparing, treating, (3) Substances that are the subject of
packaging, transporting, or holding regulations in parts 174, 175, 176, 177, 178
food in accordance with the following and § 179.45 of this chapter and used in
prescribed conditions: accordance with the conditions pre-
(a) Closures for food containers are scribed.
manufactured from substances gen- (4) Substances identified in para-
erally recognized as safe for contact graph (b)(5) of this section, used in
with food; substances that are subject amounts not to exceed those required
to the provisions of prior sanctions; to accomplish the intended physical or

substances authorized by regulations technical effect and in conformance
254
with any limitation provided; and fur- conforms with the identity or speci-
ther provided that any substance em- fications prescribed.
ployed in the production of closure- (5) Substances that may be employed
sealing gasket compositions that is the in the manufacture of closure-sealing
subject of a regulation in parts 174, 175, gaskets include:
176, 177, 178 and § 179.45 of this chapter
TABLE 1
Limitations (expressed as percent by weight of closure-sealing
List of substances gasket composition)
Arachidy-l-behenyl amide (C20-C22fatty acid amides) ................. 5 percent.

Azodicarbonamide ....................................................................... 1. 2 percent.
2. 5 percent; for use only in the manufacture of polyethylene
complying with item 2.1 in § 177.1520(c) of this chapter.
Balata rubber.
Benzyl alcohol ............................................................................. 1 percent.
Brominated isobutylene-isoprene copolymers, produced when
isobutylene-isoprene copolymers complying with
§ 177.1420(a)(2) are modified by bromination with not more
than 2.3 weight-percent of bromine and having a Mooney
Viscosity (ML 1+8 (125 °C)) of 27 or higher. The viscosity is
determined by the American Society for Testing and Mate-
rials (ASTM) method D 1646–81, ‘‘Standard Test Method for
Rubber—Viscosity and Vulcanization Characteristics (Moon-
ey Viscometer),’’ which is incorporated by reference in ac-
cordance with 5 U.S.C. 522(a) and 1 CFR part 51. Copies
are available from the AOAC INTERNATIONAL, 481 North
Frederick Ave., Suite 500, Gaithersburg, MD 20877-2504
and the Center for Food Safety and Applied Nutrition (HFS–
1,3-Butanediol.
Calcium tin stearate ..................................................................... 2 percent.
Calcium zinc stearate .................................................................. Do.
Carbon, activated ........................................................................ 1 percent.
Castor oil, hydrogenated ............................................................. 2 percent.
Chlorinated isobutylene-isoprene copolymers complying with
§ 177.1420.
Coco amide (coconut oil fatty acids amides) .............................. 2 percent.
Cork (cleaned, granulated).
Diebenzamide phenyl disulfide .................................................... 1 percent; for use only in vulcanized natural or synthetic rubber
gasket compositions.
Di(C7, C9-alkyl) adipate ............................................................... Complying with § 178.3740 of this chapter; except that, there is
no limitation on polymer thickness.
Di-2-ethylhexyl adipate.
Di-2-ethylhexyl sebacate ............................................................. 2 percent.
Di-2-ethylhexyl terephthalate (CAS Reg. No. 006422–86–2). .... For use as a plasticizer at levels not exceeding 75 parts per
hundred by weight of permitted vinyl chloride homo- and/or
copolymer resins used in contact with food of Types I, II, IV-
B, VI-A, VI-B, VI-C (up to 15 percent alcohol by volume), VII-
B, and VIII described in § 176.170(c) of this chapter, table 1,
and under conditions of use A through H described in § 176.
170 (c) of this chapter, table 2.
Dihexyl ester of sodium sulfosuccinate ....................................... 1 percent.
Diisodecyl phthalate .................................................................... No limitation on amount used but for use only in closure-seal-
ing gasket compositions used in contact with non-fatty foods
containing no more than 8 percent of alcohol.
Di-b-naphthyl-p-phenylenediamine .............................................. 1 percent.
Dipentamethylenethiurametetrasulfide ........................................ 0.4 percent; for use only in vulcanized natural or synthetic rub-
ber gasket compositions.
Eicosane (technical grade) (water-white mixture of predomi-
nantly straight-chain paraffin hydrocarbons averaging 20 car-
bon atoms per molecule).
Epoxidized linseed oil.
Epoxidized linseed oil modified with trimellitic anhydride.
Epoxidized safflower oil.

Epoxidized safflower oil modified with trimellitic anhydride.
Epoxidized soybean oil modified with trimellitic anhydride.
255
§ 177.1210 21 CFR Ch. I (4–1–12 Edition)
TABLE 1—Continued
Erucylamide ................................................................................. 5 percent.

Ethylene-propylene copolymer.
Ethylene-propylene modified copolymer elastomers produced
when ethylene and propylene are copolymerized with 5-
methylene-2-norbornene and/or 5-ethylidine-2-norbornene.
The finished copolymer elastomers so produced shall con-
tain not more than 5 weight-percent of total polymer units
derived from 5-methylene-2-norbornene and/or 5-ethylidine-
2-norbornene, and shall have a minimum viscosity average
molecular weight of 120,000 as determined by the method
described in § 177.1520(d)(5), and a minimum Mooney vis-
cosity of 35 as determined by the method described in
§ 177.1520(d)(6).
Ethylene-vinyl acetate copolymer.
Glyceryl mono-12-hydroxystearate (hydrogenated glyceryl 2 percent.
ricinoleate).
Gutta-percha.
Hexamethylenetetramine ............................................................. 1 percent.
Hexylene glycol ........................................................................... 0.5 percent.
Isobutylene-isoprene copolymers complying with § 177.1420.
Maleic anhydride-polyethylene copolymer .................................. 5 percent.
Maleic anhydride-styrene copolymer ........................................... Do.
2,2′-Methylenebis[6-(1-methylcylcohexyl)-p-cresol] ..................... 1 percent.
Mixed octylated diphenylamine (CAS Reg. No. 68411–46–1) ... 0.1 percent in isobutylene-isoprene and chlorinated
isobutylene-isoprene copolymers complying with § 177.1420,
and brominated isobutylene-isoprene copolymers complying
with this section.
Napthalene sulfonic acid-formaldehyde condensate, sodium 0.2 percent.
salt.
Natural rubber (crepe, latex, mechanical dispersions).
a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the 0.5 percent.
octadecenyl group is derived from oleyl alcohol and the poly
(oxyethylene) content averages 20 moles.
Oleyl alcohol ................................................................................ 1 percent.
4,4′-Oxybis (benzene sulfonyl hydrazide) ................................... 0.5 percent.
Paraformaldehyde ....................................................................... 1 percent.
Polybutadiene.
Poly-p-dinitroso benzene (activator for butyl rubber) .................. 1 percent; for use only in vulcanized natural or synthetic rubber
gasket compositions.
Polyethylene glycol 400 esters of fatty acids derived from ani- 1 percent.
mal and vegetable fats and oils.
Polyisobutylene complying with § 177.1420.
Polyoxypropylene-polyoxyethylene condensate, average mol. 0.05 percent.
wt. 2750–3000.
Polyurethane resins manufactured from diphenylmethane For use only:
diisocyanate, 1,4-butanediol, and adipic acid (CAS Reg. No. No limitation on amount used, but for use only in closure
26375–23–5).. gasket compositions used in contact with food types VI-A
and VI-C (up to 15 percent alcohol) under conditions of use
D, E, F, and G, as described in § 176.170(c) of this chapter,
tables 1 and 2, respectively.
Potassium benzoate .................................................................... 1 percent.
Potassium perchlorate ................................................................. Do.
Potassium propionate .................................................................. 2 percent.
Potassium and sodium persulfate ............................................... 1 percent.
Resorcinol .................................................................................... 0.24 percent; for use only as a reactive adjuvant substance
employed in the production of gelatin-bonded cord composi-
tions for use in lining crown closures. The gelatin so used
shall be technical grade or better.
Rosins and rosin derivatives as defined in § 175.300(b)(3)(v) of
this chapter for use only in resinous and polymeric coatings
on metal substrates; for all other uses as defined in
Sodium cetyl sulfate .................................................................... 1 percent.
Sodium decylbenzenesulfonate ................................................... Do.
Sodium decyl sulfate ................................................................... Do.
Sodium formaldehyde sulfoxylate ............................................... 0.05 percent.
Sodium lauryl sulfate ................................................................... 1 percent.

Sodium lignin sulfonate ............................................................... 0.2 percent.
Sodium myristyl sulfate (sodium tetradecyl sulfate) .................... 0.6 percent.
256
TABLE 1—Continued
Sodium nitrite ............................................................................... 0.2 percent; for use only in annular ring gaskets applied in
aqueous dispersions to closures for containers having a ca-
pacity of not less than 5 gallons.
Sodium o-phenylphenate ............................................................. 0.05 percent.
Sodium polyacrylate .................................................................... 5 percent.
Sodium and potassium pentachlorophenate ............................... 0.05 percent.
Sodium salt of trisopropyl napthalenesulfonic acid ..................... 0.2 percent.
Sodium tridecylsulfate ................................................................. 0.6 percent.
Stearic acid amide ....................................................................... 5 percent.
Sulfur ........................................................................................... For use only as a vulcanizing agent in vulcanized natural or
synthetic rubber gasket compositions at a level not to ex-
ceed 4 percent by weight of the elastomer content of the
rubber gasket composition.
Tallow, sulfated ............................................................................ 1 percent.
Tin-zinc stearate .......................................................................... 2 percent.
Tri(mixed mono- and dinonylphenyl) phosphite .......................... 1 percent.
Vinyl chloride-vinyl stearate copolymer.
Zinc dibutyldithiocarbamate ......................................................... 0.8 percent; for use only in vulcanized natural or synthetic rub-
ber gasket compositions.
TABLE 2—MAXIMUM EXTRACTIVES TOLERANCES cork, or glass that forms a part of the
[In parts per million] food-contact surface of the assembly,
when extracted on a suitable glass con-
Chloro-
Chloro- form Chloro- tainer with a solvent or solvents char-
form form
Type of closure-sealing gas- fraction fraction fraction acterizing the type of foods, and under
of
ket composition of water heptane of alco- conditions of time and temperature
extrac- hol ex-
tives extrac- tractives characterizing the conditions of its use
tives
as determined from tables 3 and 4 shall
1. Plasticized polymers, in- yield net chloroform-soluble extrac-
cluding unvulcanized or tives (corrected for zinc as zinc oleate)
vulcanized or otherwise not to exceed the tolerances specified
cured natural and syn-
thetic rubber formed in in table 2, calculated on the basis of
place as overall discs or the water capacity of the container on
annular rings from a hot which the closure is to be used. Employ
melt, solution, plastisol,
organisol, mechanical dis-
the analytical method described in
persion, or latex ............... 50 500 50 § 175.300 of this chapter, adapting the
2. Preformed overall discs procedural details to make the method
or annular rings of plasti- applicable to closures; such as, for ex-
cized polymers, including
unvulcanized natural or ample, placing the closed glass con-
synthetic rubber ............... 50 250 50 tainer on its side to assure contact of
3. Preformed overall discs the closure’s food-contacting surface
or annular rings of vulcan- with the solvent.
ized plasticized polymers,
including natural or syn-
TABLE 3—TYPES OF FOOD
thetic rubber ..................... 50 50 50
4. Preformed overall discs I. Nonacid (pH above 5.0), aqueous products;
or annular rings of poly- may contain salt or sugar or both, and in-
meric or resinous-coated cluding oil-in-water emulsions of low- or
paper, paperboard, plas-
tic, or metal foil substrates 50 250 50
high-fat content.
5. Closures with sealing II. Acidic (pH 5.0 or below), aqueous prod-
gaskets or sealing com- ucts; may contain salt or sugar or both,
positions as described in and including oil-in-water emulsions of
1, 2, 3, and 4, and includ- low- or high-fat content.
ing paper, paperboard, III. Aqueous, acid or nonacid products con-
and glassine used for dry taining free oil or fat; may contain salt,
foods only ........................ (1) (1) (1)
and including water-in-oil emulsions of
1 Extractability tests not applicable. low- or high-fat content.
IV. Dairy products and modifications:
(c) The closure assembly to include A. Water-in-oil emulsions, high- or low-fat.
the sealing gasket or sealing com-
B. Oil-in-water emulsions, high- or low-fat.

pound, together with any polymeric or V. Low-moisture fats and oils.
resinous coating, film, foil, natural VI. Beverages:
257
§ 177.1210 21 CFR Ch. I (4–1–12 Edition)
A. Containing alcohol. VII. Bakery products.
B. Nonalcoholic. VIII. Dry solids (no end-test required).
258
VerDate Mar<15>2010
TABLE 4—TEST PROCEDURES WITH TIME-TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM CLOSURE-SEALING
GASKETS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES
10:14 May 14, 2012

Extractant
Types of food
Conditions of use (see Table 3) Water (time and tempera- Heptane1 (time and tem- 8% alcohol
ture) perature) (time and temperature)
Jkt 226069
A. High temperature heat-sterilized (e.g., over 212 °F) ....... I, IV–B ................................................... 250 °F, 2 hr ...................... .
III, IV–A, VII ........................................... do ...................................... 150 °F, 2 hr.
B. Boiling water-sterilized ...................................................... II ............................................................ 212 °F, 30 min .................. .
III, VII ..................................................... do ...................................... 120 °F, 30 min.
C. Hot filled or pasteurized above 150 °F ............................ II, IV–B .................................................. Fill boiling, cool to 100 °F .
PO 00000
III, IV–A ................................................. do ...................................... 120 °F, 15 min.
V ............................................................ ........................................... do.
D. Hot filled or pasteurized below 150 °F ............................. II, IV–B, VI–B ........................................ 150 °F, 2 hr ...................... .
III, IV–A ................................................. do ...................................... 100 °F, 30 min.
V ............................................................ ........................................... do.
Frm 00269
VI–A ...................................................... ........................................... ........................................... 150 °F, 2 hr.
E. Room temperature filled and stored (no thermal treat- II, IV–B, VI–B ........................................ 120 °F, 24 hr .................... .
Food and Drug Administration, HHS
ment in the container).

III, IV–A ................................................. do ...................................... 70 °F, 30 min.
Fmt 8010
V ............................................................ ........................................... do.
VI–A ...................................................... ........................................... ...........................................
259
120 °F, 24 hr.
F. Refrigerated storage (no thermal treatment) .................... I, II, III, IV–A, IV–B, VI–B,VII ................ 70 °F, 48 hr ...................... 70 °F, 30 min.
VI–A ...................................................... ........................................... ........................................... 70 °F, 48 hr.
G. Frozen storage (no thermal treatment in the container) .. I, II, III, IV–B, VII ................................... 70 °F, 24 hr ...................... .
Sfmt 8010
1Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.
Y:\SGML\226069.XXX
226069
§ 177.1210
§ 177.1211 21 CFR Ch. I (4–1–12 Edition)
[42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 47 FR 22090, May 21, 1982;
49 FR 5748, Feb. 15, 1984; 55 FR 34555, Aug. 23, 1990; 61 FR 14480, Apr. 2, 1996; 65 FR 26745, May
9, 2000; 65 FR 52908, Aug. 31, 2000; 70 FR 67651, Nov. 8, 2005; 76 FR 59249, Sept. 26, 2011]
§ 177.1211 Cross-linked polyacrylate ‘‘tea bag’’ or infuser), under an applied

copolymers. pressure of 0.15 pounds per square inch
Cross-linked polyacrylate copoly- (for example, a 4×6 inch square pad is
mers identified in paragraph (a) of this subjected to a 1.6 kilograms applied
section may be safely used as articles mass). The solvent used shall be at
or components of articles intended for least 60 milliliters aqueous sodium
use in contact with food in accordance chloride solution per gram of copoly-
with the following prescribed condi- mer.
(d) Conditions of use. The copolymers
tions:
identified in paragraph (a)(1) of this
(a) Identity. For the purpose of this
section are limited to use as a fluid ab-
section, the cross-linked polyacrylate
sorbent in food-contact materials used
copolymers consist of:
in the packaging of frozen or refrig-
(1) The grafted copolymer of cross- erated poultry. The copolymers identi-
linked sodium polyacrylate identified fied in paragraph (a)(2) of this section
as 2-propenoic acid, polymers with N,N- are limited to use as a fluid absorbent
di-2-propenyl-2-propen-1-amine and in food-contact materials used in the
hydrolyzed polyvinyl acetate, sodium packaging of frozen or refrigerated
salts, graft (CAS Reg. No. 166164–74–5); meat and poultry.
or
(2) 2-propenoic acid, polymer with 2- [64 FR 28098, May 25, 1999, as amended at 65
ethyl-2-(((1-oxo-2-pro- FR 16817, Mar. 30, 2000]
penyl)oxy)methyl)-1,3-propanediyl di-2- § 177.1240 1,4-Cyclohexylene
propenoate and sodium 2-propenoate dimethylene terephthalate and 1,4-
(CAS Reg. No. 76774–25–9). cyclohexylene dimethylene
(b) Adjuvants. The copolymers identi- isophthalate copolymer.
fied in paragraph (a) of this section Copolymer of 1,4-cyclohexylene
may contain optional adjuvant sub- dimethylene terephthalate and 1,4-
stances required in the production of cyclohexylene dimethylene isophtha-
such copolymers. The optional adju- late may be safely used as an article or
vant substances may include sub- component of articles used in pro-
stances permitted for such use by regu- ducing, manufacturing, packing, proc-
lations in parts 170 through 179 of this essing, preparing, treating, packaging,
chapter, substances generally recog- transporting, or holding food, subject
nized as safe in food, and substances to the provisions of this section:
used in accordance with a prior sanc- (a) The copolymer is a basic poly-
tion or approval. ester produced by the catalytic con-
(c) Extractives limitations. The copoly- densation of dimethyl terephthalate
mers identified in paragraph (a) of this and dimethyl isophthalate with 1,4-
section, in the finished form in which cyclohexanedimethanol, to which may
they will contact food, must yield low have been added certain optional sub-
molecular weight (less than 1,000 Dal- stances required in its production or
tons) extractives of no more than 0.15 added to impart desired physical and
percent by weight of the total polymer technical properties.
when extracted with 0.2 percent by (b) The quantity of any optional sub-
weight of aqueous sodium chloride so- stance employed in the production of
lution at 20 °C for 24 hours. The low the copolymer does not exceed the
molecular weight extractives shall be amount reasonably required to accom-
determined using size exclusion chro- plish the intended physical or technical
matography or an equivalent method. effect or any limitation further pro-
When conducting the extraction test, vided.
the copolymer, with no other absorp- (c) Any substance employed in the
tive media, shall be confined either in production of the copolymer that is the
a finished absorbent pad or in any suit- subject of a regulation in parts 174, 175,
able flexible porous article, (such as a 176, 177, 178 and § 179.45 of this chapter
260
conforms with any specification in ic acid, when extracted with the sol-
such regulation. vent or solvents characterizing the
(d) Substances employed in the pro- type of food and under the conditions
duction of the copolymer include: of its intended use as determined from
(1) Substances generally recognized tables 1 and 2 of § 176.170(c) of this chap-
as safe in food. ter, yield net acidified chloroform-solu-
(2) Substances subject to prior sanc- ble extractives not to exceed 0.5 milli-
tion or approval for use in the copoly- gram per square inch of food-contact
mer and used in accordance with such surface when tested by the methods
sanction or approval. prescribed in § 177.1330(e)(1), (3)(i)
(3) Substances which by regulation in through (iv), (4), (5), and (6), except
parts 174, 175, 176, 177, 178 and § 179.45 of that
this chapter may be safely used as (1) The total residue method using 3
components of resinous or polymeric percent acetic acid, as prescribed in
coatings and film used as food-contact § 177.1330(e)(6)(i)(a), does not apply, and
surfaces, subject to the provisions of (2) The net acidified chloroform-solu-
such regulation. ble extractives from paper and paper-
(e) The copolymer conforms with the board complying with § 176.170 of this
following specifications: chapter may be corrected for wax, pet-
(1) The copolymer, when extracted rolatum, and mineral oil as provided in
with distilled water at reflux tempera- § 176.170(d)(5)(iii)(b) of this chapter.
ture for 2 hours, yields total extrac-
tives not to exceed 0.05 percent. If the finished food-contact article is
(2) The copolymer, when extracted itself the subject of a regulation in
with ethyl acetate at reflux tempera- parts 174, 175, 176, 177, 178, and § 179.45 of
ture for 2 hours, yields total extrac- this chapter, it shall also comply with
tives not to exceed 0.7 percent. any specifications and limitations pre-
(3) The copolymer, when extracted scribed for it by that regulation.
with n-hexane at reflux temperature (c) The finished food-contact layer
for 2 hours, yields total extractives not made with basic copolymers containing
to exceed 0.05 percent. more than 10 weight-percent but no
more than 25 weight-percent of total
[42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, polymer units derived from acrylic
1984, as amended at 55 FR 34555, Aug. 23, 1990] acid and with a maximum thickness of
§ 177.1310 Ethylene-acrylic acid co- 0.0025 inch (2.5 mils) may be used in
polymers. contact with food types I, II, IVB, VIA,
VIB, VIIB, and VIII identified in table
The ethylene-acrylic acid copolymers 1 of § 176.170(c) of the chapter under
identified in paragraph (a) of this sec- conditions of use B through H as de-
tion may be safely used as components scribed in table 2 of § 176.170(c) of this
of articles intended for use in contact chapter, and in contact with food types
with food subject to the provisions of III, IVA, V, VIIA, and IX identified in
this section. table 1 of § 176.170(c) of this chapter
(a) The ethylene-acrylic acid copoly- under conditions of use E through G as
mers consist of basic copolymers pro- described in table 2 of § 176.170(c) of this
duced by the copolymerization of chapter.
ethylene and acrylic acid such that the
(d) The provisions of this section are
finished basic copolymers contain no
not applicable to ethylene-acrylic acid
more than:
copolymers used in food-packaging ad-
(1) 10 weight-percent of total polymer
hesives complying with § 175.105 of this
units derived from acrylic acid when
chapter.
used in accordance with paragraph (b)
of this section; and [42 FR 14572, Mar. 15, 1977, as amended at 51
(2) 25 weight-percent of total polymer FR 19060, May 27, 1986; 53 FR 44009, Nov. 1,
units derived from acrylic acid when 1988]
used in accordance with paragraph (c)
of this section. § 177.1312 Ethylene-carbon monoxide
(b) The finished food-contact articles copolymers.
made with no more than 10 percent The ethylene-carbon monoxide co-

total polymer units derived from acryl- polymers identified in paragraph (a) of
261
§ 177.1315 21 CFR Ch. I (4–1–12 Edition)
this section may be safely used as com- (3) The basic copolymer identified in
ponents of articles intended for use in paragraph (a) of this section, when ex-
contact with food subject to the provi- tracted with the solvent or solvents
sions of this section. characterizing the type of food and
(a) Identity. For the purposes of this under the conditions of time and tem-
section, ethylene-carbon monoxide co- perature characterizing the conditions
polymers (CAS Reg. No. 25052–62–4) con- of its intended use, as determined from
sist of the basic polymers produced by tables 1 and 2 of § 176.170(c) of this chap-
the copolymerization of ethylene and
ter, yields net chloroform-soluble ex-
carbon monoxide such that the copoly-
tractives in each extracting solvent
mers contain not more than 30 weight-
percent of polymer units derived from not to exceed 0.5 milligram per square
carbon monoxide. inch of food-contact surface when test-
(b) Conditions of use. (1) The polymers ed by methods described in § 176.170(d)
may be safely used as components of of this chapter.
the food-contact or interior core layer (4) The provisions of this section are
of multilaminate food-contact articles. not applicable to ethylene-carbon mon-
(2) The polymers may be safely used oxide copolymers complying with
as food-contact materials at tempera- § 175.105 of this chapter.
tures not to exceed 121 °C (250 °F).
[57 FR 32422, July 22, 1992]
(c) Specifications. (1) Food-contact
layers formed from the basic copoly-
§ 177.1315 Ethylene-1, 4-cyclohexylene
mer identified in paragraph (a) of this dimethylene terephthalate copoly-
section shall be limited to a thickness mers.
of not more than 0.01 centimeter (0.004
inch). Ethylene-1, 4-cyclohexylene
(2) The copolymers identified in para- dimethylene terephthalate copolymer
graph (a) of this section shall have a may be safely used as articles or com-
melt index not greater than 500 as de- ponents of articles intended for use in
termined by ASTM method D1238–82, contact with food subject to provisions
condition E ‘‘Standard Test Method for of this section and of part 174 of this
Flow Rates of Thermoplastics by Ex- chapter.
trusion Plastometer,’’ which is incor- (a) Identity. For the purposes of this
porated by reference in accordance section, ethylene-1,4-cyclohexylene
with 5 U.S.C. 552(a) and 1 CFR part 51. dimethylene terephthalate copolymers
Copies may be obtained from the Amer- (1,4-benzene dicarboxylic acid, di-
ican Society for Testing Materials, 100 methyl ester, polymerized with 1,4-
cyclohexanedimethanol and 1,2-
Philadelphia, PA 19428-2959, or may be
ethanediol) (CAS Reg. No. 25640–14–6) or
examined at the Center for Food Safety
and Applied Nutrition (HFS–200), Food (1,4-benzenedicarboxylic acid, polym-
and Drug Administration, 5100 Paint erized with 1,4-cyclohexanedimethanol
Branch Pkwy., College Park, MD 20740, and 1,2-ethanediol) (CAS Reg. No.
or at the National Archives and 25038–91–9) are basic copolymers meet-
Records Administration (NARA). For ing the specifications prescribed in
information on the availability of this paragraph (b) of this section, to which
material at NARA, call 202–741–6030, or may have been added certain optional
go to: http://www.archives.gov/ substances required in their production
federallregister/ or added to impart desired physical or
codeloflfederallregulations/ technical properties.
ibrllocations.html. (b) Specifications:
262
Maximum extractable fractions

of the copolymer in the fin-
Ethylene-1,4- ished form at specified tem-
cyclohexylene peratures and times (ex- Test for
Inherent viscosity Conditions of use
dimethylene pressed in micrograms of the orientability
terephthalate copolymers terephthaloyl moletles/square
centimeter of food-contact sur-
face)
1. Non-oriented ethyl- Inherent viscosity (1) 0.23 microgram per square No test required ... In contact with foods, in-
ene-1,4-cyclohexylene of a 0.50 per- centimeter (1.5 micrograms cluding foods con-
dimethylene cent solution of per square inch) of food-containing not more than
terephthalate copoly- the copolymer in tact surface when extracted 25 percent (by vol-
mer is the reaction phenol- with water added at 82.2 °C ume) aqueous alcohol,
product of dimethyl tetrachloroetha- (180 °F) and allowed to cool excluding carbonated
terephthalate or ter- ne (60:40 ratio to 48.9 °C (120 °F) in con- beverages and beer.
ephthalic acid with a wt/wt) solvent is tact with the food-contact ar- Conditions of hot fill
mixture containing 99 not less than ticle. not to exceed 82.2 °C
to 66 mole percent of 0.669 as deter- (180 °F), storage at
ethylene glycol and 1 mined by using temperatures not in
to 34 mole percent of a Wagner vis- excess of 48.9 °C
1,4-cyclo- cometer (or (120 °F). No thermal
hexanedimethanol (70 equivalent) and treatment in the con-
percent trans isomer, calculated from tainer.
30 percent cls isomer). the following
equation: Inher-
ent viscosity =
(Natural loga-
rithm of (Nr)/(c)
where: Nr=Ratio
of flow time of
the polymer so-
lution to that of
the solvent, and
c=concentration
of the test solu-
tion expressed
in grams per
100 milliliters.
......do ................... (2) 0.23 microgram per square ......do ................... Do.
centimeter (1.5 micrograms
per square inch) of food-con-
tact surface when extracted
with 3 percent (by volume)
aqueous acetic acid added
at 82.2 °C (180 °F) and al-
lowed to cool to 48.9 °C
(120 °F) in contact with the
food-contact article.
centimeter (0.5 microgram
for 2 hours with n-heptane at
48.9 °C (120 °F). The
heptane extractable results
are to be divided by a factor
of 5.
for 24 hours with 25 percent
(by volume) aqueous ethanol
at 48.9 °C (120 °F).
263
§ 177.1315 21 CFR Ch. I (4–1–12 Edition)

face)
2. Oriented ethylene-1,4- ......do ................... (1) 0.23 microgram per square When extracted In contact with non-
cyclohexylene centimeter (1.5 micrograms with heptane at alcoholic foods includ-
dimethylene per square inch) of food-con- 65.6 °C (150 °F) ing carbonated bev-
terephthalate copoly- tact surface of the oriented for 2 hours: erages. Conditions of
mer is the reaction copolymer when extracted terephthaloyl hot fill not exceeding
product of dimethyl with water added at 87.8 °C moieties do not 87.8 °C (190 °F), stor-
terephthalate or ter- (190 °F) and allowed to cool exceed 0.09 age at temperatures
ephthalic acid with a to 48.9 °C (120 °F) in con- microgram per not in excess of 48.9
mixture containing 99 tact with the food-contact ar- square centi- °C (120 °F). No ther-
to 85 mole percent ticle. meter (0.60 mal treatment in the
ethylene glycol and 1 microgram per container.
to 15 mole percent of square inch) of
1,4-cyclohexane-di- food-contact
methanol (70 percent surface.
trans isomer, 30 per-
cent cls isomer).
centimeter (1.5 micrograms
tact surface of oriented co-
polymer when extracted with
3 percent (by volume) aque-
ous acetic acid added at
87.8 °C (190 °F) and al-
lowed to cool to 48.9 °C
(120 °F) in contact with the
tact surface of oriented co-
polymer when extracted for
2 hours with n-heptane at
48.9 °C (120 °F). The
heptane extractable results
are to be divided by a factor
of 5.
......do ................... (4) 0.23 microgram per square ......do ................... In contact with foods and
centimeter (1.5 micrograms beverages containing
per square inch) of food-con- up to 20 percent (by
tact surface of oriented co- volume) alcohol. Con-
polymer when extracted with ditions of thermal
20 percent (by volume) treatment in the con-
aqueous ethanol heated to tainer not exceeding
65.6 °C (150 °F) for 20 min- 65.6 °C (150 °F) for
utes and allowed to cool to 20 minutes. Storage at
48.9 °C (120 °F) in contact temperatures not in
with the food-contact article. excess of 48.9 °C
(120 °F).
......do ................... (5) 0.23 microgram per square ......do ................... In contact with foods and
centimeter (1.5 micrograms beverages containing
per square inch) of food-con- up to 50 percent (by
tact surface of oriented co- volume) alcohol. Con-
polymer when extracted with ditions of fill and stor-
50 percent (by volume) age not exceeding
aqueous ethanol at 48.9 °C 48.9 °C (120 °F). No
(120 °F) for 24 hours. thermal treatment in
the container.
264

face)
3. Ethylene-1,4- No test required ... For each corresponding condi- No test required ... For each corresponding
cyclohexylene tion of use, must meet speci- specification, may be
dimethylene fications described in used as a base sheet
terephthalate copoly- § 177.1630(f), (g), (h), or (j). and base polymer in
mer is the reaction accordance with con-
product of dimethyl ditions of use de-
terephthalate or ter- scribed in
ephthalic acid with a § 177.1630(f), (g), (h),
mixture containing 99 or (j).
to 95 mole percent of
ethylene glycol and 1
to 5 mole percent of
1,4-
cyclohexanedimethan-
ol (70 percent trans
isomer, 30 percent cis
isomer).
(c) Analytical method for determination with the following prescribed condi-
of extractability. The total extracted tions:
terephthaloyl moieties can be deter- (a) Ethylene-ethyl acrylate copoly-
mined in the extracts, without evapo- mers consist of basic resins produced
ration of the solvent, by measuring the by the catalytic copolymerization of
ultraviolet (UV) absorbance at 240 ethylene and ethyl acrylate, to which
nanometers. The spectrophotometer may have been added certain optional
(Varian 635–D, or equivalent) is zeroed substances to impart desired techno-
with a sample of the solvent taken logical properties to the resin. Subject
from the same lot used in the extrac- to any limitations prescribed in this
tion tests. The concentration of the section, the optional substances may
total terephthaloyl moieties in water, 3 include:
percent acetic acid, and in 8 percent (1) Substances generally recognized
aqueous alcohol is calculated as bis(2- as safe in food and food packaging.
hydroxyethyl terephthalate) by ref- (2) Substances the use of which is
erence to standards prepared in the ap- permitted under applicable regulations
propriate solvent. Concentration of the in parts 170 through 189 of this chapter,
terephthaloyl moieties in heptane is prior sanction, or approvals.
calculated as cyclic trimer (b) The ethyl acrylate content of the
(C6H4CO2C2H4CO2)3, by reference to copolymer does not exceed 8 percent by
weight unless it is blended with poly-
standards prepared in 95:5 percent (v/v)
ethylene or with one or more olefin co-
heptane: tetrahydrofuran.
polymers complying with § 177.1520 or
[45 FR 39252, June 10, 1980, as amended at 47 with a mixture of polyethylene and one
FR 24288, June 4, 1982; 49 FR 25629, June 22, or more olefin copolymers, in such pro-
1984; 51 FR 22929, June 24, 1986; 60 FR 57926, portions that the ethyl acrylate con-
Nov. 24, 1995] tent of the blend does not exceed 8 per-
cent by weight, or unless it is used in
§ 177.1320 Ethylene-ethyl acrylate co- a coating complying with § 175.300 or
polymers.
§ 176.170 of this chapter, in such propor-
Ethylene-ethyl acrylate copolymers tions that the ethyl acrylate content
may be safely used to produce pack- does not exceed 8 percent by weight of
aging materials, containers, and equip- the finished coating.
ment intended for use in producing, (c) Ethylene-ethyl acrylate copoly-
manufacturing, packing, processing, mers or the blend shall conform to the
preparing, treating, packaging, trans- specifications prescribed in paragraph

porting, or holding food, in accordance (c)(1) of this section and shall meet the
265
§ 177.1330 21 CFR Ch. I (4–1–12 Edition)
ethyl acrylate content limits pre- hesives complying with § 175.105 of this
scribed in paragraph (b) of this section, chapter.
and the extractability limits pre- [42 FR 14572, Mar. 15, 1977, as amended at 49
scribed in paragraph (c)(2) of this sec- FR 10108, Mar. 19, 1984]
tion, when tested by the methods pre-
scribed for polyethylene in § 177.1520. § 177.1330 Ionomeric resins.
(1) Specifications—(i) Infrared identi- Ionomeric resins manufactured from
fication. Ethylene-ethyl acrylate co- either ethylene-methacrylic acid co-
polymers can be identified by their polymers (and/or their ammonium, cal-
characteristic infrared spectra. cium, magnesium, potassium, sodium,
(ii) Quantitative determination of ethyl and/or zinc partial salts), ethylene-
acrylate content. The ethyl acrylate can methacrylic acid-vinyl acetate copoly-
be determined by the infrared spectra. mers (and/or their ammonium, cal-
Prepare a scan from 10.5 microns to 12.5 cium, magnesium, potassium, sodium,
microns. Obtain a baseline absorbance and/or zinc partial salts,), or meth-
at 11.6 microns and divide by the acrylic acid polymers with ethylene
plaque thickness to obtain absorbance and isobutyl acrylate (and/or their po-
tassium, sodium and/or zinc partial
per mil. From a previously prepared
salts) may be safely used as articles or
calibration curve, obtain the amount of
components of articles intended for use
ethyl acrylate present.
in contact with food, in accordance
(iii) Specific gravity. Ethylene-ethyl with the following prescribed condi-
acrylate copolymers have a specific tions:
gravity of not less than 0.920 nor more (a) For the purpose of this section,
than 0.935, as determined by ASTM the ethylene-methacrylic acid copoly-
method D1505–68 (Reapproved 1979), mers consist of basic copolymers pro-
‘‘Standard Test Method for Density of duced by the copolymerization of
Plastics by the Density-Gradient Tech- ethylene and methacrylic acid such
nique,’’ which is incorporated by ref- that the copolymers contain no more
erence. Copies may be obtained from than 20 weight percent of polymer
the American Society for Testing Ma- units derived from methacrylic acid,
terials, 100 Barr Harbor Dr., West and the ethylene-methacrylic acid-
Conshohocken, Philadelphia, PA 19428- vinyl acetate copolymers consist of
2959, or may be examined at the Na- basic copolymers produced by the co-
tional Archives and Records Adminis- polymerization of ethylene, meth-
tration (NARA). For information on acrylic acid, and vinyl acetate such
the availability of this material at that the copolymers contain no more
NARA, call 202–741–6030, or go to: http:// than 15 weight percent of polymer
www.archives.gov/federallregister/ units derived from methacrylic acid.
codeloflfederallregulations/ (b) For the purpose of this section,
ibrllocations.html. the methacrylic acid copolymers with
(2) Limitations. Ethylene-ethyl acry- ethylene and isobutyl acrylate consist
of basic copolymers produced by the
late copolymers or the blend may be
copolymerization of methacrylic acid,
used in contact with food except as a
ethylene, and isobutyl acrylate such
component of articles used for pack-
that the copolymers contain no less
aging or holding food during cooking
than 70 weight percent of polymer
provided they meet the following
units derived from ethylene, no more
extractability limits: than 15 weight percent of polymer
(i) Maximum soluble fraction of 11.3 units derived from methacrylic acid,
percent in xylene after refluxing and and no more than 20 weight percent of
subsequent cooling to 25 °C. polymer units derived from isobutyl
(ii) Maximum extractable fraction of acrylate. From 20 percent to 70 percent
5.5 percent when extracted with n- of the carboxylic acid groups may op-
hexane at 50 °C. tionally be neutralized to form sodium
(d) The provisions of paragraphs (b) or zinc salts.
and (c)(2) of this section are not appli- (c) The finished food-contact article
cable to ethylene-ethyl acrylate co- described in paragraph (a) of this sec-

polymers used in the formulation of ad- tion, when extracted with the solvent
266
or solvents characterizing the type of the equilibrium method cited in para-

food and under the conditions of time graph (e)(2)(ii) of this section.
and temperature characterizing the (2) For aqueous foods. (i) The net
conditions of its intended use as deter- acidified chloroform-soluble extrac-
mined from tables 1 and 2 of § 176.170(c) tives shall not exceed 0.02 milligram/
of this chapter, yields net acidified square inch 2(0.003 milligram/square
chloroform-soluble extractives in each centimeter) of food-contact surface
extracting solvent not to exceed 0.5 (water, acetic acid, or ethanol/water
milligram per square inch of food-con- extractions) when extracted by the ab-
tact surface when tested by the meth- breviated method cited in paragraph
ods described in paragraph (e)(1) of this (e)(2)(i) of this section.
section, and if the finished food-con- (ii) Alternatively, the net acidified
tact article is itself the subject of a chloroform-soluble extractives shall
regulation in parts 174, 175, 176, 177, 178 not exceed 0.05 milligram/square inch 3
and § 179.45 of this chapter, it shall also (0.078 mg/square centimeter) of food-
comply with any specifications and contact surface (water, acetic acid, or
limitations prescribed for it by that ethanol/water extractions) when ex-
regulation. tracted by the equilibrium method
NOTE: In testing the finished food-contact cited in paragraph (e)(2)(ii) of this sec-
article, use a separate test sample for each tion. If when exposed to n-heptane, a
required extracting solvent. particular film splits along die lines,
(d) The finished food-contact article thus permitting exposure of both sides
described in paragraph (b) of this sec- of the film to the extracting solvent,
tion, when extracted according to the the results for that film sample are in-
methods listed in paragraph (e)(2) of valid and the test must be repeated for
this section and referenced in this that sample until no splitting by the
paragraph (d), using the solvent or sol- solvent occurs. If the finished food-con-
vents characterizing the type of food as tact article is itself the subject of a
determined from table I of paragraph regulation in parts 174, 175, 176, 177, 178
(f) of this section, shall yield net acidi- and § 179.45 of this chapter, it shall also
fied chloroform-soluble extractives as comply with any specifications and
follows: limitations prescribed for it by that
(1) For fatty food use. (i) For films of regulation.
2 mil (0.002 inches) thickness or less, NOTE: In testing the finished food-contact
extractives shall not exceed 0.70 milli- article, use a separate test sample for each
required extracting solvent.
gram/square inch 1 (0.109 milligram/
(e) Analytical methods—(1) Selection of
square centimeter) of food-contact sur-
extractability conditions for ionomeric res-
face (n-heptane extractions) when ex-
ins. First ascertain the type of food
tracted by the abbreviated method
(table 1 of § 176.170(c) of this chapter)
cited in paragraph (e)(2)(i) of this sec- that is being packed or used in contact
tion. with the finished food-contact article
(ii) For films of greater than 2 mils described in paragraph (a) of this sec-
(0.002 inch) thickness, extractives shall tion, and also ascertain the normal
not exceed 0.40 milligram/square inch 1 conditions of thermal treatment used
(0.062 milligram/square centimeter) of in packaging or contacting the type of
food-contact surface (n-heptane extrac- food involved. Using table 2 of § 176.170
tions) when extracted by the abbre- (c) of this chapter, select the food-sim-
viated method cited in paragraph ulating solvent or solvents and the
(e)(2)(i) of this section, or time-temperature test conditions that
(iii) Alternatively, for films of great- correspond to the intended use of the
er than 2 mils thickness, extractives finished food-contact article. Having
shall not exceed 0.70 milligram/square selected the appropriate food-simu-
inch 1 (0.109 milligram/square centi- lating solvent or solvents and time-
meter) of food-contact surface (n-
heptane extractions) when extracted by 2 Average of four separate values, no single
value of which differs from the average of

those values by more than ±50 percent.
1 Average of four separate values, no single
value of which differs from the average of 3 See footnote 2 to paragraph (d)(2)(i) of
those values by more then ±10 percent. this section.
267
§ 177.1330 21 CFR Ch. I (4–1–12 Edition)
temperature exaggeration over normal the time period and under the condi-
use, follow the applicable extraction tions specified in the above table.
procedure. (3) Reagents—(i) Water. All water used
(2) Selection of extractability conditions in extraction procedures should be
for ionomeric resins. Using table I of freshly demineralized (deionized) dis-
paragraph (f) of this section ascertain tilled water.
the type of food that is being packed or (ii) n-Heptane. Reagent grade, freshly
used in contact with the finished food- redistilled before use, using only mate-
contact article described in paragraph rial boiling at 208 °F (97.8 °C).
(b) of this section, and also ascertain (iii) Alcohol. 8 or 50 percent (by vol-
the food-simulating solvent or solvents ume), prepared from undenatured 95
that correspond to the intended use of percent ethyl alcohol diluted with
the finished food-contact article. demineralized (deionized), distilled
(i) Abbreviated test. For intended use water.
involving food contact at or below 120 (iv) Chloroform. Reagent grade, fresh-
°F (49 °C), the appropriate food-simu- ly redistilled before use, or a grade
lating solvent is to contact the food- having an established, consistently low
contact film for the time and tempera- blank.
tures as follows: (v) Acetic acid. 3 percent (by weight),
prepared from glacial acetic acid di-
Solvent Time Temperature luted with demineralized (deionized),
n-Heptane ................................. 12 120 °F (49 °C).
distilled water.
Water, 3% acetic acid, or 8%/ 1 48 120 °F (49 °C). (4) Selection of test method. The fin-
50% ethanol. ished food-contact articles shall be
1 Hours tested either by the extraction cell de-
scribed in the Journal of the Association
(ii) Equilibrium test. For intended use of Official Agricultural Chemists, Vol. 47,
involving food contact at or below 120 No. 1, p. 177–179 (February 1964), also
°F (49 °C), the appropriate food-simu- described in ASTM method F34–76 (Re-
lating solvent is to contact the food- approved 1980), ‘‘Standard Test Method
contact film at a temperature of 120 °F for Liquid Extraction of Flexible Bar-
until equilibrium is demonstrated. rier Materials,’’ which are incorporated
by reference, or by adapting the in-con-
Minimum
extraction tainer methods described in § 175.300(e)
Solvent times of this chapter. Copies of the material
(hours)
incorporated by reference are available
n-Heptane ............................................................ 8, 10, 12 from the Center for Food Safety and
Water, 3% acetic acid, or 8%/50% ethanol ........ 72, 96, Applied Nutrition (HFS–200), Food and
120 Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
The results from a series of extraction and the American Society for Testing
times demonstrate equilibrium when Materials, 100 Barr Harbor Dr., West
the net chloroform-soluble extractives Conshohocken, Philadelphia, PA 19428-
are unchanging within experimental 2959, respectively, or may be examined
error appropriate to the method as de- at the National Archives and Records
scribed in paragraphs (d) (1)(i) and (2)(i) Administration (NARA). For informa-
of this section. Should equilibrium not tion on the availability of this mate-
be demonstrated over the above time rial at NARA, call 202–741–6030, or go
series, extraction times must be ex- to: http://www.archives.gov/
tended until three successive unchang- federallregister/
ing values for extractives are obtained. codeloflfederallregulations/
In the case where intended uses involve ibrllocations.html.
temporary food contact above 120 °F, (5) Selection of samples. Quadruplicate
the food-simulating solvent is to be samples should be tested, using for
contacted with the food-contact article each replicate sample the number of
under conditions of time and tempera- finished articles with a food-contact
ture that duplicate the actual condi- surface nearest to 100 square inches.
tions in the intended use. Subsequently (6) Determination of amount of extrac-

the extraction is to be continued for tives—(i) Total residues. At the end of
268
the exposure period, remove the test Mix well so every portion of the residue
container or test cell from the oven, if is wetted with the hydrochloric acid
any, and combine the solvent for each solution. Then add 50 milliliters of
replicate in a clean Pyrex (or equiva- chloroform. Warm carefully, and filter
lent) flask or beaker, being sure to through Whatman No. 41 filter paper
rinse the test container or cell with a (or equivalent) in a Pyrex (or equiva-
small quantity of clean solvent. Evapo- lent) funnel, collecting the filtrate in a
rate the food-simulating solvents to clean separatory funnel. Shake for 1
about 100 milliliters in the flask, and minute, then draw off the chloroform
transfer to a clean, tared evaporating layer into a clean tared evaporating
dish (platinum or Pyrex), washing the dish (platinum or Pyrex). Repeat the
flask three times with small portions chloroform extraction, washing the
of solvent used in the extraction proce- dish, the filter paper, and the sepa-
dure, and evaporate to a few milliliters ratory funnel with this second portion
on a nonsparking, low-temperature of chloroform. Add this filtrate to the
hotplate. The last few milliliters original filtrate and evaporate the
should be evaporated in an oven main- total down to a few milliliters on a
tained at a temperature of 221 °F (105 low-temperature hotplate. The last few
°C). Cool the evaporating dish in a des- milliliters should be evaporated in an
iccator for 30 minutes and weigh the oven maintained at 221 °F. Cool the
residues to the nearest 0.1 milligram, e. evaporating dish in a desiccator for 30
Calculate the extractives in milligrams minutes and weigh to the nearest 0.1
per square inch of the container or ma- milligram to get the acidified chloro-
terial surface. form-soluble extractives residue, e′.
(a) Water, 3 percent acetic acid, and 8 This e′ is substituted for e in the equa-
percent and 50 percent alcohol. Milli- tions in paragraphs (e)(6)(i) (a) and (b)
grams extractives per square inch=e/s. of this section.
(b) Heptane. Milligrams extractives (f) The types of food and appropriate
per square inch=(e)/(s)(F) solvents are as follows:
where: TABLE 1
e=Milligrams extractives per sample tested.
s=Surface area tested, in square inches. Types of food Appropriate solvent
F=Five, the ratio of the amount of extrac-
1. Nonacid (pH above 5.0), aque- Water, n-heptane.
tives removed by heptane under exagger-
ous products; may contain salt
ated time-temperature test conditions or sugar or both, and including
compared to the amount extracted by a fat oil-in-water emulsions of low- or
or oil under exaggerated conditions of high-fat content.
thermal sterilization and use. 2. Acidic (pH 5.0 or below), aque- n-heptane, water, 3%
e′=Acidified chloroform-soluble extractives ous products; may contain salt acetic acid.
residue. e′ is substituted for e in the above or sugar or both, and including
equations when necessary (See paragraph oil-in-water emulsions of low- or
high-fat content.
(e)(6)(ii) of this section for method to ob- 3. Aqueous, acid or nonacid prod- Water, n-heptane, 3%
tain e′). ucts containing free oil or fat; acetic acid.
may contain salt, and including
If when calculated by the equations in water-in-oil emulsions of low- or
paragraphs (e)(6)(i) (a) and (b) of this high-fat content.
section, the extractives in milligrams 4. Dairy products and modifica-
tions:
per square inch exceed the limitations Water, n-heptane.
prescribed in paragraphs (c) or (d) of i. Water-in-oil emulsions, high
this section, proceed to paragraph or low fat.
(e)(6)(ii) of this section (method for de- ii. Oil-in-water emulsions, high
or low fat.
termining the amount of acidified chlo- 5. Low moisture fats and oils ........ n-heptane.
roform-soluble extractives residue). 6. Beverages:
(ii) Acidified chloroform-soluble extrac- i. Containing up to 8% alcohol 8% ethanol/water.
tives residue. Add 3 milliliters of 37 per- ii. Nonalcoholic ........................ 3% acetic acid.
iii. Containing more than 8% 50% ethanol/water.
cent ACS reagent grade hydrochloric alcohol.
acid and 3 milliliters of distilled water 7. Bakery products ........................ Water, n-heptane.
to the evaporating dish containing the 8. Dry solids (without free fat or No extraction test re-
dried and weighed residue, e, obtained oil). quired.

9. Dry solids (with free fat or oil) .. n-heptane.
in paragraph (e)(6)(i) of this section.
269
§ 177.1340 21 CFR Ch. I (4–1–12 Edition)
(g) The provisions of paragraphs (c) § 177.1345 Ethylene/1,3–phenylene oxy-

and (d) of this section are not applica- ethylene isophthalate/ terephtha-
ble to the ionomeric resins that are late copolymer.
used in food-packaging adhesives com- Ethylene/1, 3-phenylene oxyethylene
plying with § 175.105 of this chapter. isophthalate/terephthalate copolymer
(CAS Reg. No. 87365–98–8) identified in
[45 FR 22916, Apr. 4, 1980, as amended at 49
paragraph (a) of this section may be
FR 10108, Mar. 19, 1984; 49 FR 37747, Sept. 26,
safely used, subject to the provisions of
1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898,
June 12, 1989]
this section, as the non-food-contact
layer of laminate structures subject to
§ 177.1340 Ethylene-methyl acrylate co- the provisions of § 177.1395, and in
polymer resins. blends with polyethylene terephthalate
polymers complying with § 177.1630.
Ethylene-methyl acrylate copolymer (a) Identity. For the purpose of this
resins may be safely used as articles or section, ethylene/1,3-phenylene oxy-
components of articles intended for use ethylene isophthalate/terephthalate
in contact with food, in accordance copolymer consists of the basic copoly-
with the following prescribed condi- mer produced by the catalytic
tions: polycondensation of isophthalic acid
(a) For the purpose of this section, and terephthalic acid with ethylene
the ethylene-methyl acrylate copoly- glycol and 1,3-bis(2-
mer resins consist of basic copolymers hydroxyethoxy)benzene such that the
produced by the copolymerization of finished resin contains between 42 and
ethylene and methyl acrylate such 48 mole-percent of isophthalic
that the copolymers contain no more moieties, between 2 and 8 mole-percent
than 25 weight percent of polymer of terephthalic moieties, and not more
units derived from methyl acrylate. than 10 mole-percent of 1,3-bis(2-
(b) The finished food-contact article, hydroxyethoxy)benzene moieties.
(b) Specifications—(1) Density. Ethyl-
when extracted with the solvent or sol-
ene/1,3-phenylene oxyethylene
vents characterizing the type of food
isophthalate/terephthalate copolymer
and under the conditions of time and identified in paragraph (a) of this sec-
temperature characterizing the condition has a density of 1.33±0.02 grams per
tions of its intended use as determined cubic centimeter measured by ASTM
from tables 1 and 2 of § 176.170(c) of this Method D 1505–85 (Reapproved 1990),
chapter, yields net chloroform-soluble ‘‘Standard Test Method for Density of
extractives (corrected for zinc extrac- Plastics by the Density-Gradient Tech-
tives as zinc oleate) in each extracting nique,’’ which is incorporated by ref-
solvent not to exceed 0.5 milligram per erence in accordance with 5 U.S.C.
square inch of food-contact surface 552(a) and 1 CFR part 51. Copies may be
when tested by the methods described obtained from the American Society
in § 176.170(d) of this chapter. If the fin- for Testing and Materials, 100 Barr
ished food-contact article is itself the Harbor Dr., West Conshohocken, Phila-
subject of a regulation in parts 174, 175, delphia, PA 19428-2959, or may be exam-
176, 177, 178 and § 179.45 of this chapter, ined at the Center for Food Safety and
it shall also comply with any specifica- Applied Nutrition’s Library, Food and
tions and limitations prescribed for it Drug Administration, 5100 Paint
by that regulation. Branch Pkwy., College Park, MD 20740,
NOTE: In testing the finished food-contact and at the National Archives and
article, use a separate test sample for each Records Administration (NARA). For
required extracting solvent. information on the availability of this
(c) The provisions of this section are material at NARA, call 202–741–6030, or
not applicable to ethylene-methyl ac- go to: http://www.archives.gov/
rylate copolymer resins used in food- federallregister/
packaging adhesives complying with
ibrllocations.html.
(2) Softening point. Ethylene/1,3–phen-
ylene oxyethylene isophthalate/

terephthalate copolymer identified in
270
paragraph (a) of this section has a soft- (ii) Substances the use of which is
ening point of 63±5 °C as measured by permitted under applicable regulations
ASTM Method D 1525–87, ‘‘Standard in parts 170 through 189 of this chapter,
Test Method for VICAT Softening Tem- prior sanction, or approvals.
perature of Plastics,’’ which is incor- (iii) Substances identified in
porated by reference in accordance § 175.300(b)(3) (xxv), (xxvii), (xxx), and
with 5 U.S.C. 552(a) and 1 CFR part 51. (xxxiii) of this chapter, and colorants
The availability of this material is pro- used in accordance with § 178.3297 of
vided in paragraph (b)(1) of this sec- this chapter.
tion. (iv) Erucamide as identified in
(c) Optional adjuvant substances. § 178.3860 of this chapter.
Ethylene/1,3–phenylene oxyethylene (v) Xanthan gum as identified in
isophthalate/terephthalate copolymer, § 172.695 for use as a thickening agent
identified in paragraph (a) of this sec- at a level not to exceed 1 percent by
tion, may contain optional adjuvant weight of coating solids in aqueous dis-
substances required in their produc- persions of ethylene-vinyl acetate co-
tion. The optional adjuvants may in- polymers, where such copolymers are
clude substances used in accordance used only as coatings or a component
with § 174.5 of this chapter. of coatings.
(d) Limitations. Copolymer blends de- (vi) The copolymer of vinylidene flu-
scribed above shall not exceed 30 per- oride and hexafluoropropene (CAS Reg.
cent by weight of ethylene/1, 3-phen- No. 9011–17–0), containing 65 to 71 per-
ylene oxyethylene isophthalate/ cent fluorine and having a Mooney Vis-
terephthalate copolymer. The finished cosity of at least 28, for use as a proc-
blend may be used in contact with food essing aid at a level not to exceed 0.2
only under conditions of use C through percent by weight of ethylene-vinyl ac-
G, as described in table 2 of § 176.170(c) etate copolymers.
of this chapter, except that with food (2) Maleic anhydride-grafted ethyl-
identified as Type III, IV-A, V, VII-A, ene-vinyl acetate copolymers (CAS
and IX in § 176.170(c), table 1, the co- Reg. No. 28064–24–6) consist of basic res-
polymer may be used under condition ins produced by the catalytic copolym-
of use C at temperatures not to exceed erization of ethylene and vinyl acetate,
160 °F (71 °C). followed by reaction with maleic anhy-
[57 FR 43399, Sept. 21, 1992, as amended at 59 dride. Such polymers shall contain not
FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2, more than 11 percent of polymer units
1996; 62 FR 34628, June 27, 1997] derived from vinyl acetate by weight of
total polymer prior to reaction with
§ 177.1350 Ethylene-vinyl acetate co- maleic anhydride, and not more than 2
polymers. percent of grafted maleic anhydride by
Ethylene-vinyl acetate copolymers weight of the finished polymer. Op-
may be safely used as articles or com- tional adjuvant substances that may be
ponents of articles intended for use in added to the copolymers include sub-
producing, manufacturing, packing, stances generally recognized as safe in
processing, preparing, treating, pack- food and food packaging, substances
aging, transporting, or holding food in the use of which is permitted under ap-
accordance with the following pre- plicable regulations in parts 170
scribed conditions: through 189 of this chapter, and sub-
(a)(1) Ethylene-vinyl acetate copoly- stances identified in § 175.300(b)(3)(xxv),
mers consist of basic resins produced (xxvii), (xxxiii), and (xxx) of this chap-
by the catalytic copolymerization of ter and colorants for polymers used in
ethylene and vinyl acetate to which accordance with the provisions of
may have been added certain optional § 178.3297 of this chapter.
substances to impart desired techno- (b)(1) Ethylene-vinyl acetate copoly-
logical or physical properties to the mers, with or without the optional sub-
resin. Subject to any limitations pre- stances described in paragraph (a) of
scribed in this section, the optional this section, when extracted with the
substances may include: solvent or solvents characterizing the
(i) Substances generally recognized type of food, and under conditions of

as safe in food and food packaging. time and temperature characterizing
271
§ 177.1360 21 CFR Ch. I (4–1–12 Edition)
the conditions of their intended use as desired properties such as increased

determined from tables 1 and 2 of strength and increased ability to
§ 176.170(c) of this chapter, shall yield shrink when exposed to heat:
net chloroform-soluble extractives cor- (1) Electron beam source of ionizing
rected for zinc as zinc oleate not to ex- radiation at a maximum energy of 3
ceed 0.5 milligram per square inch of an million electron volts: Maximum ab-
appropriate sample. sorbed dose not to exceed 150 kiloGray
(2) Maleic anhydride grafted ethyl- (15 megarads).
ene-vinyl acetate copolymers shall (2) The finished food-contact film
have a melt flow index not to exceed 2.1 shall meet the extractives limitations
grams per 10 minutes as determined by prescribed in paragraph (e)(2) of this
ASTM method D 1238–82, ‘‘Standard section.
Test Method for Flow Rates of Thermo- (3) The ethylene-vinyl acetate co-
plastics by Extrusion Plastometer,’’ polymer films may be further irradi-
which is incorporated by reference in ated in accordance with the provisions
accordance with 5 U.S.C. 552(a). Copies of paragraph (e)(1) of this section: Pro-
may be obtained from the American vided, That the total accumulated radi-
Society for Testing Materials, 100 Barr ation dose from both electron beam
Harbor Dr., West Conshohocken, Phila- and gamma ray radiation does not ex-
delphia, PA 19428-2959, or at the Divi- ceed 150 kiloGray (15 megarads).
sion of Petition Control (HFS–215), (e) Ethylene-vinyl acetate copolymer
Center for Food Safety and Applied Nu- films intended for contact with food
trition, Food and Drug Administration, may be irradiated to control the
5100 Paint Branch Pkwy., College Park, growth of microorganisms under the
MD 20740, or may be examined at the following conditions:
Center for Food Safety and Applied Nu- (1) Gamma photons emitted from a
trition’s Library, 5100 Paint Branch cobalt–60 sealed source in the dose
Pkwy., College Park, MD 20740, or at range of 5–50 kiloGray (0.5–5.0
the National Archives and Records Ad- megarads).
ministration (NARA). For information (2) The irradiated ethylene-vinyl ace-
on the availability of this material at tate copolymer films, when extracted
NARA, call 202–741–6030, or go to: http:// with reagent grade n-heptane (freshly
www.archives.gov/federallregister/ redistilled before use) according to
codeloflfederallregulations/ methods described under § 176.170(d)(3)
ibrllocations.html. Compliance of the of this chapter, at 75 °F for 30 minutes
melt flow index specification shall be shall yield total extractives not to ex-
determined using conditions and proce- ceed 4.5 percent by weight of the film.
dures corresponding to those described [42 FR 14572, Mar. 15, 1977, as amended at 43
in the method as Condition E, Proce- FR 29287, July 7, 1978; 54 FR 35874, Aug. 30,
dure A). The copolymers shall be used 1989; 55 FR 18595, May 3, 1990; 56 FR 42932,
in blends with other polymers at levels Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999]
not to exceed 17 percent by weight of
total polymer, subject to the limita- § 177.1360 Ethylene-vinyl acetate-vinyl
tion that when contacting food of types alcohol copolymers.
III, IV-A, V, VI-C, VII-A, and IX, iden- Ethylene-vinyl acetate-vinyl alcohol
tified in § 176.170(c) of this chapter, copolymers (CAS Reg. No. 26221–27–2)
Table 1, the polymers shall be used may be safely used as articles or com-
only under conditions of use C, D, E, F, ponents of articles intended for use in
and G, described in § 176.170(c) of this contact with food, in accordance with
chapter, Table 2. the following prescribed conditions:
(c) The provisions of paragraph (b) of (a) Ethylene-vinyl acetate-vinyl alco-
this section are not applicable to ethyl- hol copolymers are produced by the
ene-vinyl acetate copolymers used in partial or complete alcoholysis or hy-
food-packaging adhesives complying drolysis of those ethylene-vinyl acetate
with § 175.105 of this chapter. copolymers complying with § 177.1350.
(d) Ethylene-vinyl acetate copoly- (1) Those copolymers containing a
mers may be irradiated under the fol- minimum of 55 percent ethylene and a
lowing conditions to produce molecular maximum of 30 percent vinyl alcohol

crosslinking of the polymers to impart units by weight may be used in contact
272
with foods as described in paragraph (b) tions of use F and G described in table
of this section. 2 of § 176.170(c) of this chapter. Film
(2) Those copolymers containing a samples of 0.0076 centimeter (0.003 inch)
minimum of 55 percent ethylene and a thickness representing the finished ar-
maximum of 15 percent vinyl alcohol ticles shall meet the following extrac-
units by weight may be used in contact tive limitation when tested by ASTM
with foods as described in paragraph (c) method F34–76 (Reapproved 1980),
of this section. ‘‘Standard Test Method for Liquid Ex-
(3) Those copolymers containing 17 to traction of Flexible Barrier Materials,’’
40 percent ethylene and 60 to 83 percent which is incorporated by reference. The
vinyl alcohol units by weight may be availability of this incorporation by
used in contact with foods as described reference is given in paragraph (b) of
in paragraph (d) of this section. this section. The film when extracted
(b) The finished food-contact article with n-heptane at 38 °C (100 °F) for 30
shall not exceed 0.013 centimeter (0.005 minutes yields total extractives not to
inch) thickness and shall contact foods exceed 0.0078 milligram per square cen-
only of the types identified in table 1 of timeter (0.05 milligram per square
§ 176.170(c) of this chapter in Categories inch) of food-contact surface, after cor-
I, II, IV-B, VI, VII-B, and VIII under recting the total extractives by divid-
conditions of use D through G de- ing by a factor of five.
scribed in table 2 of § 176.170(c) of this (d) The finished food-contact article
chapter. Film samples of 0.013 centi- shall not exceed 0.018 centimeter (0.007
meter (0.005) inch thickness rep- inch) thickness and may contact all
resenting the finished article shall foods, except those containing more
meet the following extractive limita- than 8 percent alcohol, under condi-
tion when tested by ASTM method tions of use B through H described in
F34–76 (Reapproved 1980), ‘‘Standard table 2 of § 176.170(c) of this chapter.
Test Method for Liquid Extraction of Film samples of 0.018 centimeter (0.007
Flexible Barrier Materials,’’ which is inch) thickness representing the fin-
incorporated by reference. Copies may ished articles shall meet the following
be obtained from the American Society extractive limitation when tested by
for Testing Materials, 100 Barr Harbor ASTM method F34–76 (Reapproved
Dr., West Conshohocken, Philadelphia, 1980), ‘‘Standard Test Methods for Liq-
PA 19428-2959, or may be examined at uid Extraction of Flexible Barrier Ma-
the National Archives and Records Ad- terials,’’ which is incorporated by ref-
ministration (NARA). For information erence. The availability of this incor-
on the availability of this material at poration by reference is given in para-
NARA, call 202–741–6030, or go to: http:// graph (b) of this section. The film when
www.archives.gov/federallregister/ extracted with distilled water at 100 °C
codeloflfederallregulations/ (212 °F) for 30 minutes yields ethylene-
ibrllocations.html. vinyl acetate-vinyl alcohol oligomers
(1) The film when extracted with dis- not to exceed 0.093 milligram per
tilled water at 21 °C (70 °F) for 48 hours square centimeter (0.6 milligram per
yields total extractives not to exceed square inch) of food contact surface as
0.0047 milligram per square centimeter determined by a method entitled ‘‘An-
(0.03 milligram per square inch) of alytical Method of Determining the
food-contact surface. Amount of EVOH in the Extractives
(2) The film when extracted with 50 Residue of EVOH Film,’’ dated March
percent ethyl alcohol at 21 °C (70 °F) for 23, 1987, as developed by the Kuraray
48 hours yields total extractives not to Co., Ltd., which is incorporated by ref-
exceed 0.0062 milligram per square cen- erence in accordance with 5 U.S.C.
timeter (0.04 milligram per square 552(a) and 1 CFR part 51. Copies may be
inch) of food-contact surface. obtained from the Office of Premarket
(c) The finished food-contact article Approval (HFS–200), Center for Food
shall not exceed 0.0076 centimeter (0.003 Safety and Applied Nutrition, Food and
inch) thickness and shall contact foods Drug Administration, 5100 Paint
only of the types identified in table 1 of Branch Pkwy., College Park, MD 20740,
§ 176.170(c) of this chapter in Categories or may be examined at the Center for

III, IV-A, VII-A, and IX under condi- Food Safety and Applied Nutrition’s
273
§ 177.1380 21 CFR Ch. I (4–1–12 Edition)
Library, 5100 Paint Branch Pkwy., Col- examined at the National Archives and
lege Park, MD 20740, or at the National Records Administration (NARA). For
Archives and Records Administration information on the availability of this
(NARA). For information on the avail- material at NARA, call 202–741–6030, or
ability of this material at NARA, call go to: http://www.archives.gov/
202–741–6030, or go to: http:// federallregister/
www.archives.gov/federallregister/ codeloflfederallregulations/
codeloflfederallregulations/ ibrllocations.html.
ibrllocations.html. (b) Fluorocarbon resins that are iden-
(e) The provisions of this section are tified in paragraph (a) of this section
not applicable to ethylene-vinyl ace- and that comply with extractive limi-
tate-vinyl alcohol copolymers used in tations prescribed in paragraph (c) of
the food-packaging adhesives com- this section may be used as articles or
plying with § 175.105 of this chapter. components of articles intended for use
[47 FR 41531, Sept. 21, 1982, as amended at 49 in contact with food as follows:
FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, (1) Fluorocarbon resins that are iden-
2000] tified in paragraphs (a)(1), (a)(2), and
(a)(3) of this section and that comply
§ 177.1380 Fluorocarbon resins. only with the extractive limitations
Fluorocarbon resins may be safely prescribed in paragraphs (c)(1) and
used as articles or components of arti- (c)(2) of this section may be used when
cles intended for use in contact with such use is limited to articles or com-
food, in accordance with the following ponents of articles that are intended
prescribed conditions: for repeated use in contact with food or
(a) For the purpose of this section, that are intended for one-time use in
fluorocarbon resins consist of basic res- contact with foods only of the types
ins produced as follows: identified in § 176.170(c) of this chapter,
(1) Chlorotrifluoroethylene resins table 1, under Types I, II, VI, VII-B,
produced by the homopolymerization and VIII.
of chlorotrifluoroethylene. (2) Fluorocarbon resins that are iden-
(2) Chlorotrifluoroethylene-1,1- tified in paragraph (a)(4) of this section
difluoroethylene copolymer resins pro- and that comply with the extractive
duced by copolymerization of limitations prescribed in paragraphs
chlorotrifluoroethylene and 1,1- (c)(1) and (c)(2) of this section may be
difluoroethylene. used only when such use is limited to
(3) Chlorotrifluoroethylene-1,1- articles or components of articles that
difluoroethylene-tetrafluoroethylene are intended for repeated use in con-
co-polymer resins produced by co- tact with food.
polymerization of (3) In accordance with current good
chlorotrifluoroethylene, 1,1- manufacturing practice, those food-
difluoroethylene, and tetrafluoro- contact articles intended for repeated
ethylene. use shall be thoroughly cleansed prior
(4) Ethylene-chlorotrifluoroethylene to their first use in contact with food.
copolymer resins produced by copolym- (c) Extractives limitations are appli-
erization of nominally 50 mole percent cable to the basic resins in the form of
of ethylene and 50 mole percent of pellets that have been ground or cut
chlorotrifluoroethylene. The copoly- into small particles that will pass
mer shall have a melting point of 239 to through a U.S. Standard Sieve No. 6
243 °C and a melt index of less than or and that will be held on a U.S. Stand-
equal to 20 as determined by ASTM ard Sieve No. 10.
Method D 3275–89 ‘‘Standard Specifica- (1) A 100-gram sample of the resin
tion for E-CTFE-Fluoroplastic Mold- pellets, when extracted with 100 milli-
ing, Extrusion, and Coating Mate- liters of distilled water at reflux tem-
rials,’’ which is incorporated by ref- perature for 8 hours, shall yield total
erence in accordance with 5 U.S.C. extractives not to exceed 0.003 percent
552(a) and 1 CFR part 51. Copies may be by weight of the resins.
obtained from the American Society (2) A 100-gram sample of the resin
for Testing and Materials, 1916 Race pellets, when extracted with 100 milli-
St., Philadelphia, PA 19013, or may be liters of 50 percent (by volume) ethyl
274
alcohol in distilled water at reflux (a) Polyolefin resins complying with

temperature for 8 hours, shall yield item 2.2 or 3.2 of the table in
total extractives not to exceed 0.003 § 177.1520(c).
percent by weight of the resins. (b) Polymeric resin blends formu-
(3) A 100-gram sample of the resin lated from a base polymer complying
pellets, when extracted with 100 milli- with item 2.2 or 3.2 of the table in
liters of n-heptane at reflux tempera- § 177.1520(c) blended with no more than
ture for 8 hours, shall yield total ex- 10 percent by weight of a copolymer of
tractives not to exceed 0.01 percent by ethylene and vinyl acetate complying
weight of the resins. with § 177.1350.
(c) Polymeric resin blends formulated
FR 185, Jan. 3, 1992] from a base polymer complying with
item 2.2 or 3.2 of the table in
§ 177.1390 Laminate structures for use § 177.1520(c) blended with no more than
at temperatures of 250 ≥F and 38 percent by weight of a homopolymer
above. of isobutylene complying with
(a) The high-temperature laminates § 177.1420(a)(1).
identified in this section may be safely (d) Polyethylene phthalate resins
used for food contact at temperatures complying with § 177.1630(e)(4) (i) and
not exceeding 135 °C (275 °F) unless oth- (ii).
erwise specified. These articles are lay- (e) Nylon MXD–6 resins that comply
ered constructions that are optionally with item 10.3 of the table in
bonded with adhesives. The interior § 177.1500(b) of this chapter when ex-
(food-contact) layer(s) may be sepa- tracted with water and heptane under
rated from the exterior layer(s) by a the conditions of time and temperature
functional barrier, such as aluminum specified for condition of use A, as set
foil. Upon review of the physical prop- forth in Table 2 of § 176.170(c) of this
erties of a particular construction, the chapter.
Food and Drug Administration may (f) Nylon 6⁄12 resins (CAS Reg. No.
consider other layers to serve as func- 25191–04–2) complying with item 13.3 of
tional barriers. This regulation is not the table in § 177.1500(b), for use as
intended to limit these constructions nonfood-contact layers of laminated
as to shape, degree of flexibility, thick- films and in rigid multilaminate con-
ness, or number of layers. These layers structions with polypropylene outer
may be laminated, extruded, co- layers. Laminate structures with au-
extruded, or fused. thorized food-contact materials yield
(b) When containers subject to this no more than 0.15 milligrams of epsilon-
regulation undergo heat sterilization caprolactam and 0.04 milligrams of
to produce shelf-stable foods, certain omega-laurolactam per square inch
control measures (in addition to the when extracted with 95 percent ethanol
food additive requirements in para- at 121 °C (250 °F) for 2 hours.
graphs (c) and (d) of this section) are (g) Polymeric resins that comply
necessary to ensure proper food steri- with an applicable regulation in this
lization and package integrity. Refer chapter which permits food type and
to parts 108, 110, 113, and 114 of this time/temperature conditions to which
chapter for details. the container will be exposed, includ-
(c) Subject to the provisions of this ing sterilization processing.
paragraph, food-contact articles pro- (ii) Adjuvants used in these layers
duced from high-temperature lami- must comply with an applicable regu-
nates may be safely used to package all lation that permits food type and time/
food types except those containing temperature conditions to which the
more than 8 percent ethyl alcohol. container will be exposed, including
(1) Polymeric films/layers. Films or lay- sterilization processing.
ers not separated from food by a func- (2) Adhesives. The use of adhesives in
tional barrier must meet the following these containers is optional. Adhesives
requirements: may be formulated from the following
(i) Films/layers may consist of the substances, subject to the prescribed

following: limitations:
275
§ 177.1390 21 CFR Ch. I (4–1–12 Edition)
(i) Any substance suitable for use in trimethylcyclohexyl isocyanate

formulating adhesives that complies cyanurate (CAS Reg. No. 53880–05–0).
with an applicable regulation of this (vi) Polyurethane-polyester resin-
chapter which permits food type and epoxy adhesives formulated from the
time/temperature conditions to which following mixture:
the container will be exposed, includ- (a)(1) Polyester-polyurethanediol res-
ing sterilization processing. ins prepared by the reaction of a mix-
(ii) Substances complying with ture of polybasic acids and polyhydric
§ 175.105 of this chapter may be used in alcohols listed in § 175.300(b)(3)(vii) of
these constructions, provided they are this chapter and 3-isocyanatomethyl-
separated from the interior (food-con- 3,5,5-trimethylcyclohexyl isocyanate
tact) layer(s) by a functional barrier as (CAS Reg. No. 4098–71–9).
discussed under paragraph (a) of this (2) Polyester resin formed by the re-
section. action of polybasic acids and
(iii) Maleic anhydride adduct of poly- polyhydric alcohols listed in
propylene complying with § 175.300 of § 175.300(b)(3)(vii) of this chapter. Addi-
this chapter. tionally, azelaic acid and 1,6-
(iv) Polyester-urethane adhesive for hexanediol may also be used as
use at temperatures not exceeding 121 reactants in lieu of a polyhydric alco-
°C (250 °F) and formulated from the fol- hol.
lowing: (3) Epoxy resin listed in
(a) Polyester-urethanediol resin pre- § 175.300(b)(3)(viii)(a) of this chapter and
pared by the reaction of a mixture of comprising not more than 5 percent by
polybasic acids and polyhydric alcohols weight of the cured adhesive.
listed in § 175.300(b)(3)(vii) of this chap- (4) Optional trimethoxy silane curing
ter, 3-isocyanatomethyl-3,5,5- agents, containing amino, epoxy, ether,
trimethylcyclohexyl isocyanate (CAS or mercapto groups not in excess of 3
Reg. No. 4098–71–9) and optional percent of the cured adhesive.
trimethoxysilane coupling agents con- (b) Urethane cross-linking agent,
taining amino, epoxy, ether, and/or comprising not more than 20 percent
mercapto groups not to exceed 3 per- by weight of the cured adhesive, and
cent by weight of the cured adhesive. formulated from trimethylol propane
(b) Urethane cross-linking agent (CAS Reg. No. 77–99–6) adducts of 3–
comprising not more than 25 percent isocyanatomethyl–3,5,5–
by weight of the cured adhesive and trimethylcyclohexyl isocyanate (CAS
formulated from 3-isocyanatomethyl- Reg. No. 4098–71–9) or 1,3-
3,5,5-trimethylcyclohexyl isocyanate bis(isocyanatomethyl)benzene (CAS
(CAS Reg. No. 4098–71–9) adduct of Reg. No. 25854–16–4).
trimethylol propane (Cas Reg. No. 77– (vii) Polyester-polyurethane resin-
99–6) and/or 1,3-bis(isocyanatomethyl) acid dianhydride adhesives for use at
benzene (CAS Reg. No. 25854–16–4) temperatures not to exceed 121 °C (250
adduct of trimethylol propane. °F), in contact only with food Types I,
(v) Polyester-epoxy-urethane adhe- II, VIA, VIB, VIIB, and VIII as de-
sives formulated from the following: scribed in Table I of § 176.170 of this
(a) Polyester resin formed by the re- chapter, and formulated from the fol-
action of polybasic acids and lowing mixture:
polyhydric alcohols listed in (a)(1) Polyesterpolyurethanediol res-
§ 175.300(b)(3)(vii) of this chapter. Aze- ins prepared by the reaction of a mix-
laic acid may also be used as a ture of polybasic acids and polyhydric
polybasic acid. alcohols listed in § 175.300(b)(3)(vii) of
(b) Epoxy resin listed in this chapter and 3-isocyanatomethyl-
§ 175.300(b)(3)(viii)(a) of this chapter and 3,5,5-trimethylcyclohexyl isocyanate
comprising no more than 30 percent by (CAS Reg. No. 4098–71–9). Additionally,
weight of the cured adhesive. dimethylol propionic acid and 1,6-
(c) Urethane cross-linking agent com- hexanediol may be used alone or in
prising no more than 14 percent weight combination as reactants in lieu of a
of the cured adhesive and formulated polybasic acid and a polyhydric alco-
from 3-isocyanatomethyl-3,5.5- hol.
276
(2) Acid dianhydride formulated from codeloflfederallregulations/

3a,4,5,7a-tetrahydro-7-methyl-5- ibrllocations.html.
(tetrahydro-2,5-dioxo-3-furanyl)-1,3- (2) The chloroform-soluble fraction of
isobenzofurandione (CAS Reg. No. the total nonvolatile extractives for
73003–90–4), comprising not more than containers using adhesives listed in
one percent of the cured adhesive. paragraph (c)(2)(v) of this section shall
(b) Urethane cross-linking agent, not exceed 0.016 milligram per square
comprising not more than twelve per- centimeter (0.10 milligram per square
cent by weight of the cured adhesive, inch) as determined by a method titled
and formulated from trimethylol pro- ‘‘Determination of Non-volatile Chlo-
pane (CAS Reg. No. 77–99–6) adducts of roform Soluble Residues in Retort
3-isocyanatomethyl-3,5,5- Pouch Water Extracts,’’ which is incor-
trimethylcyclohexyl isocyanate (CAS porated by reference in paragraph
Reg. No. 4098–71–9) and/or 1,3- (c)(3)(i)(a)(1) of this section.
bis(isocyanatomethyl)benzene (CAS (b) For use at temperatures not to ex-
Reg. No. 363–48–31). ceed 135 °C (275 °F): The container inte-
(3) Test specifications. These specifica- rior (food-contact side) shall be ex-
tions apply only to materials on the tracted with deionized distilled water
food-contact side of a functional bar- at 135 °C (275 °F) for 1 hour.
rier, if present. All tests must be per- (1) The chloroform-soluble fraction of
formed on containers made under pro- the total nonvolatile extractives for
duction conditions. Laminated struc- containers using no adhesive, or adhe-
tures submitted to extraction proce- sives listed in paragraphs (c)(2) (i), (ii),
dures must maintain complete struc- and (iii) of this section shall not exceed
tural integrity (particularly with re- 0.0020 milligram per square centimeter
gard to delamination) throughout the (0.013 milligram per square inch) as de-
test. termined by a method titled ‘‘Deter-
(i) Nonvolatile extractives. (a) For use mination of Non-volatile Chloroform
at temperatures not to exceed 121 °C Soluble Residues in Retort Pouch
(250 °F): The container interior (food- Water Extracts,’’ which is incorporated
contact side) shall be extracted with by reference. The availability of this
deionized distilled water at 121 °C (250 incorporation by reference is given in
°F) for 2 hours. paragraph (c)(3)(i)(a)(1) of this section.
(1) The chloroform-soluble fraction of (2) The chloroform-soluble fraction of
the total nonvolatile extractives for the total nonvolatile extractives for
containers using adhesives listed in containers using adhesives listed in
paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii), paragraph (c)(2)(v) of this section shall
(c)(2)(iv), and (c)(2)(vii) of this section not exceed 0.016 milligram per square
shall not exceed 0.0016 milligram per centimeter (0.10 milligram per square
square centimeter (0.01 milligram per inch) as determined by a method titled
square inch) as determined by a meth- ‘‘Determination of Non-volatile Chlo-
od entitled ‘‘Determination of Non- roform Soluble Residues in Retort
Volatile Chloroform Soluble Residues Pouch Water Extracts,’’ which is incor-
in Retort Pouch Water Extracts,’’ porated by reference. The availability
which is incorporated by reference. of this incorporation by reference is
Copies are available from the Center given in paragraph (c)(3)(i)(a)(1) of this
for Food Safety and Applied Nutrition section.
(HFS–200), Food and Drug Administra- (3) The chloroform-soluble fraction of
tion, 5100 Paint Branch Pkwy., College the total nonvolatile extractives for
Park, MD 20740, and may be examined containers using adhesives listed in
at the Center for Food Safety and Ap- paragraph (c)(2)(vi) of this section shall
plied Nutrition’s Library, 5100 Paint not exceed 0.008 milligram per square
Branch Pkwy., College Park, MD 20740, centimeter (0.05 milligram per square
or at the National Archives and inch) as determined by a method enti-
Records Administration (NARA). For tled, ‘‘Determination of Non-volatile
information on the availability of this Chloroform Soluble Residues in Retort
material at NARA, call 202–741–6030, or Pouch Water Extracts,’’ which is incor-
go to: http://www.archives.gov/ porated by reference in paragraph

federallregister/ (c)(3)(i)(a)(1) of this section.
277
§ 177.1395 21 CFR Ch. I (4–1–12 Edition)
(ii) Volatiles. Volatile substances em- (1) Polymers and adjuvants com-
ployed in the manufacture of high-tem- plying with § 177.1390 of this chapter.
perature laminates must be removed to (2) Any polymeric resin listed in
the greatest extent possible in keeping these regulations so long as the use of
with good manufacturing practice pre- the resin in the structure complies
scribed in § 174.5(a) of this chapter. with the conditions of use (food type
(d) Nylon 12/aluminum foil high-tem- and time/temperature) specified in the
perature laminates: Subject to the pro- regulation for that resin.
visions of this paragraph, containers (3) Optional adjuvant substances used
constructed of nylon 12 laminated to in accordance with § 174.5 of this chap-
aluminum foil may be safely used at ter.
temperatures no greater than 250 °F (4) The following substances in non-
(121 °C) in contact with all food types food-contact layers only:
except those containing more than 8
percent alcohol.
(1) The container is constructed of Ethylene/1,3–phenylene oxy- For use only with poly-
aluminum foil to which nylon 12 film is ethylene isophthalate/ ethylene terephthalate as
terephthalate copolymer the food-contact layer,
fused. Prior to fusing the nylon 12, the (CAS Reg. No. 87365–98–8) complying with
aluminum foil may be optionally complying with § 177.1345. § 177.1630 under condi-
precoated with a coating complying tions of use C through G
with § 175.300 of this chapter. described in table 2 of
§ 176.170(c) of this chap-
(2) Nylon 12 resin complying with ter. Laminate structures,
§ 177.1500 and having an average thick- when extracted with 8
ness not to exceed 0.0016 inch (41 mi- percent ethanol at 150 °F
for 2 hours shall not yield
crons) may be used as the food-contact m-pheny lenedioxy-O,O′-
surface of the container. diethyl isophthalate or cy-
(3) Container test specifications. On clic bis(ethylene
isophthalate) in excess of
exposure to distilled water at 250 °F 7.8 micrograms/square
(121 °C) for 2 hours, extractives from decimeter (0.5
the food-contact side of the nylon 12 microgram/square inch) of
food-contact surface.
multilayered construction shall not ex- Nylon 6/12 resins complying For use with nonalcoholic
ceed 0.05 milligram per square inch with § 177.1500(b), item foods at temperatures not
(0.0078 milligram per square centi- 13.2, of this chapter (CAS to exceed 100 °C (212
meter) as total nonvolatile extractives. Reg. No. 25191–04–2). °F). Laminate structures
with authorized food-con-
[45 FR 2843, Jan. 15, 1980, as amended at 47 tact materials yield no
FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983; more than 0.15 milligram
of epsilon-caprolactam
48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22, and 0.04 milligram of
1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, omega-laurolactam per
Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR square inch when ex-
24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; tracted with water at 100
63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, °C (212 °F) for 5 hours.
1999; 64 FR 46272, Aug. 25, 1999; 69 FR 15668, Nylon 6/66 resins complying For use only with:
Mar. 26, 2004] with § 177.1500(b), item 4.2 1. Nonalcoholic foods at
of this chapter (CAS Reg. temperatures not to ex-
24993–04–2). ceed 82.2 °C (180 °F).
§ 177.1395 Laminate structures for use Laminate structures with
at temperatures between 120 ≥F and authorized food-contact
250 ≥F. materials yield no more
than 0.15 milligram of ep-
(a) The laminates identified in this silon-caprolactam per
section may be safely used at the speci- square inch when ex-
fied temperatures. These articles are tracted with water at 82.2
°C (180 °F) for 5 hours.
layered structures that are optionally 2. Nonalcoholic foods at
bonded with adhesives. In these arti- temperatures not to ex-
cles, the food-contact layer does not ceed 100 °C (212 °F).
Laminate films with au-
function as a barrier to migration of thorized food-contact ma-
components from non-food-contact lay- terials yield no more than
ers. The layers may be laminated, ex- 0.15 milligram of epsilon-
truded, coextruded, or fused. caprolactam per square
inch when extracted with

(b) Laminate structures may be man- water at 100 °C (212 °F)
ufactured from: for 5 hours.
278
Substances Limitations (c) Any substance employed in the

production of the water-insoluble hy-
Nylon 6/69 resins complying For use with nonalcoholic
with § 177.1500(b), item 14, foods under conditions of droxyethyl cellulose film described in
of this chapter (CAS Reg. use B, C, D, E, F, G, and this section that is the subject of a reg-
No. 51995–62–1). H described in table 2 of ulation in parts 174, 175, 176, 177, 178
Laminate structures with
and § 179.45 of this chapter conforms
authorized food-contact with any specification in such regula-
materials may contain tion.
nylon 6/69 resins pro-
vided that the nitrogen § 177.1420 Isobutylene polymers.
content of aqueous ex-
tracts of a representative Isobutylene polymers may be safely
laminate (obtained at 100 used as components of articles in-
°C (212 °F) for 8 hours)
does not exceed 15 tended for use in producing, manufac-
micrograms per square turing, packing, processing, preparing,
centimeter (100 treating, packaging, transporting, or
micrograms per square
inch).
holding food, in accordance with the
following prescribed conditions:
(a) For the purpose of this section,
[52 FR 33575, Sept. 4, 1987, as amended at 53 isobutylene polymers are those pro-
FR 19772, May 31, 1988; 57 FR 43399, Sept. 21,
1992; 58 FR 32610, June 11, 1993; 62 FR 53957,
duced as follows:
Oct. 17, 1997] (1) Polyisobutylene produced by the
homopolymerization of isobutylene
§ 177.1400 Hydroxyethyl cellulose film, such that the finished polymers have a
water-insoluble. molecular weight of 750,000 (Flory) or
Water-insoluble hydroxyethyl cel- higher.
lulose film may be safely used for (2) Isobutylene-isoprene copolymers
packaging food in accordance with the produced by the copolymerization of
following prescribed conditions: isobutylene with not more than 3
(a) Water-insoluble hydroxyethyl cel- molar percent of isoprene such that the
lulose film consists of a base sheet finished polymers have a molecular
manufactured by the ethoxylation of weight of 300,000 (Flory) or higher.
cellulose under controlled conditions, (3) Chlorinated isobutylene-isoprene
to which may be added certain optional copolymers produced when
substances of a grade of purity suitable isobutylene-isoprene copolymers (mo-
for use in food packaging as constitu- lecular weight 300,000 (Flory) or higher)
ents of the base sheet or as coatings are modified by chlorination with not
applied to impart desired technological more than 1.3 weight-percent of chlo-
properties. rine.
(b) Subject to any limitations pre- (b) The polymers identified in para-
scribed in parts 170 through 189 of this graph (a) of this section may contain
chapter, the optional substances used optional adjuvant substances required
in the base sheet and coating may in- in the production of the polymers. The
clude: optional adjuvant substances required
(1) Substances generally recognized in the production of the polymers may
as safe in food. include substances generally recog-
(2) Substances permitted to be used nized as safe in food, substances used in
in water-insoluble hydroxyethyl cel- accordance with a prior sanction or ap-
lulose film by prior sanction or approval, and aluminum chloride.
proval and under conditions specified (c) The provisions of this section are
in such sanctions or approval, and sub- not applicable to polyisobutylene used
stances listed in part 181, subpart B of in food-packaging adhesives complying
this chapter. with § 175.105 of this chapter.
(3) Substances that by any regulation
promulgated under section 409 of the § 177.1430 Isobutylene-butene copoly-
act may be safely used as components mers.
of water-insoluble hydroxyethyl cel- Isobutylene-butene copolymers iden-
lulose film. tified in paragraph (a) of this section
(4) Substances identified in and used may be safely used as components of

in compliance with § 177.1200(c). articles intended for use in contact
279
§ 177.1440 21 CFR Ch. I (4–1–12 Edition)
with food, subject to the provisions of less than 45 weight percent of polymer
this section. units derived from isobutylene and
(a) For the purpose of this section, meet the specifications prescribed in
isobutylene-butene copolymers consist paragraph (b) of this section when test-
of basic copolymers produced by the ed by the methods described in para-
copolymerization of isobutylene with graph (c) of this section.
mixtures of n-butenes such that the (b) Specifications:
finished basic copolymers contain not
Maximum
Molecular
Isobutylene-butene copolymers Viscosity (range) bromine
weight (range) value
1. Used as release agents in petroleum wax complying with 300 to 5,000 ... 40 to 20,000 seconds 40
§ 178.3710 of this chapter. Saybolt at 200 °F.
2. Used as plasticizers in polyethylene or polypropylene complying 300 to 5,000 ... 40 to 20,000 seconds 40
with § 177.1520, and in polystyrene complying with § 177.1640. Saybolt at 200 °F.
3. Used as components of nonfood articles complying with 300 to 5,000 ... 40 to 20,000 seconds 40
§§ 175.300, 176.170, 176.210, 177.2260(d)(2), 177.2800, and Saybolt at 200 °F.
178.3570 (provided that addition to food does not exceed 10 parts
per million), or § 176.180 of this chapter.
4. Used as production aids in the manufacture of expanded 150 to 5,000 ... Less than 20,000 seconds 90.
(foamed) polystyrene articles complying with § 177.1640 of this Saybolt at 200 °F.
chapter.
5. Used in release coatings on backings or linings for pressure-sen- 150 to 5,000 ... Less than 20,000 seconds 90
sitive adhesive labels complying with § 175.125 of this chapter. Saybolt at 200 °F.
(c) The analytical methods for deter- Test Method for Bromine Index of Aro-
mining whether isobutylene-butene co- matic Hydrocarbons by Coulometric
polymers conform to the specifications Titration,’’ which is incorporated by
in paragraph (b) are as follows: reference. The availability of this in-
(1) Molecular weight. Molecular corporation by reference is given in
weight shall be determined by Amer- paragraph (c)(1) of this section.
ican Society for Testing and Materials (d) The provisions of this section are
(ASTM) method D2503–82, ‘‘Standard not applicable to isobutylene-butene
Test Method for Molecular Weight copolymers used as provided under
(Relative Molecular Mass) of Hydro- § 175.105 of this chapter.
carbons by Thermoelectric Measure- [52 FR 11641, Apr. 10, 1987, as amended at 63
ment of Vapor Pressure,’’ which is in- FR 36175, July 2, 1998]
corporated by reference. Copies may be
obtained from the American Society § 177.1440 4,4′-Isopropylidenediphenol-
for Testing Materials, 100 Barr Harbor epichlorohydrin resins minimum
Dr., West Conshohocken, Philadelphia, molecular weight 10,000.
PA 19428-2959, or may be examined at 4,4′-Isopropylidenediphenol-epichlo-
the National Archives and Records Ad- rohydrin resins having a minimum mo-
ministration (NARA). For information lecular weight of 10,000 may be safely
on the availability of this material at used as articles or components of arti-
NARA, call 202–741–6030, or go to: http:// cles intended for use in producing,
www.archives.gov/federallregister/ manufacturing, packing, processing,
codeloflfederallregulations/ preparing, treating, packaging, trans-
ibrllocations.html. porting, or holding food in accordance
(2) Viscosity. Viscosity shall be deter- with the following prescribed condi-
mined by ASTM method D445–74, ‘‘Test tions:
for Kinematic Viscosity of Transparent (a) 4,4′-Isopropylidenediphenol-ep-
and Opaque Liquids,’’ which is incor- ichlorohydrin resins consist of basic
porated by reference. The availability resins produced by the condensation of
of this incorporation by reference is equimolar amounts of 4,4′-
given in paragraph (c)(1) of this sec- isopropylidenediphenol and
tion. epichlorohydrin terminated with phe-
(3) Maximum bromine value. Maximum nol, to which may have been added cer-
bromine value shall be determined by tain optional adjuvant substances re-

ASTM method D1492–78, ‘‘Standard quired in the production of the resins.
280
(b) The optional adjuvant substances stances which may include the fol-
required in the production of the resins lowing:
may include substances generally rec-
ognized as safe in food, substances used
in accordance with a prior sanction or Colorants used in accord-
approval, and the following: ance with § 178.3297
of this chapter.
List of substances Limitations Dioctyl phthalate ............. For use as lubricant.
Hexamethylenetetramine For use only as polymerization
Butyl alcohol ................... Not to exceed 300 p.p.m. as re- reaction control agent.
sidual solvent in finished resin. Phthalic acid anhydride .. Do.
Ethyl alcohol. Zinc stearate ................... For use as lubricant.
Toluene ........................... Not to exceed 1,000 p.p.m. as re-
sidual solvent in finished resin. (c) The molded melamine-formalde-
hyde articles in the finished form in
(c) 4,4′-Isopropylidenediphenol-ep- which they are to contact food, when
ichlorohydrin resins shall meet the fol- extracted with the solvent or solvents
lowing nonvolatile extractives limita- characterizing the type of food and
tions: under the conditions of time and tem-
(1) Maximum extractable nonvolatile perature as determined from tables 1
fraction of 2 parts per million when ex- and 2 of § 175.300(d) of this chapter,
tracted with distilled water at 70 °C for shall yield net chloroform-soluble ex-
2 hours, using a volume-to-surface tractives not to exceed 0.5 milligram
ratio of 2 milliliters per square inch. per square inch of food-contact surface.
(2) Maximum extractable nonvolatile
fraction of 3 parts per million when ex- FR 42933, Aug. 30, 1991]
tracted with n-heptane at 70 °C for 2
hours, using a volume-to-surface ratio § 177.1480 Nitrile rubber modified ac-
of 2 milliliters per square inch. rylonitrile-methyl acrylate copoly-
(3) Maximum extractable nonvolatile mers.
fraction of 6 parts per million when ex- Nitrile rubber modified acrylonitrile-
tracted with 10 percent (by volume) methyl acrylate copolymers identified
ethyl alcohol in distilled water at 70 °C in this section may be safely used as
for 2 hours, using a volume-to-surface components of articles intended for
ratio of 2 milliliters per square inch. food-contact use under conditions of
(d) The provisions of this section are use D, E, F, or G described in table 2 of
not applicable to 4,4′-isopropylidene- § 176.170(c) of this chapter, subject to
diphenol-epichlorohydrin resins listed the provisions of this section.
in other sections of subchapter B of (a) For the purpose of this section,
this chapter. nitrile rubber modified acrylonitrile-
methyl acrylate copolymers consist of
§ 177.1460 Melamine-formaldehyde res- basic copolymers produced by the graft
ins in molded articles.
copolymerization of 73–77 parts by
Melamine-formaldehyde resins may weight of acrylonitrile and 23–27 parts
be safely used as the food-contact sur- by weight of methyl acrylate in the
face of molded articles intended for use presence of 8–10 parts by weight of bu-
in producing, manufacturing, packing, tadiene-acrylonitrile copolymers con-
processing, preparing, treating, pack- taining approximately 70 percent by
aging, transporting, or holding food in weight of polymer units derived from
accordance with the following pre- butadiene.
scribed conditions: (b) The nitrile rubber modified acry-
(a) For the purpose of this section, lonitrile-methyl acrylate basic copoly-
melamine-formaldehyde resins are mers meet the following specifications
those produced when 1 mole of mel- and extractives limitations:
amine is made to react with not more (1) Specifications. (i) Nitrogen content
than 3 moles of formaldehyde in water is in the range 16.5–19 percent as deter-
solution. mined by Kjeldahl analysis.
(b) The resins may be mixed with re- (ii) Intrinsic viscosity in acetonitrile
fined woodpulp and the mixture may at 25 °C is not less than 0.29 deciliter
contain other optional adjuvant sub- per gram as determined by ASTM
281
§ 177.1500 21 CFR Ch. I (4–1–12 Edition)
method D1243–79, ‘‘Standard Test Meth- ple of the basic copolymers is extracted
od for Dilute Solution Viscosity of with 250 milliliters of reagent grade n-
Vinyl Chloride Polymers,’’ which is in- heptane at reflux temperature for 2
corporated by reference. Copies may be hours.
obtained from the American Society (c) Acrylonitrile copolymers identi-
for Testing Materials, 100 Barr Harbor fied in this section shall comply with
Dr., West Conshohocken, Philadelphia, the provisions of § 180.22 of this chap-
PA 19428-2959, or may be examined at ter.
the National Archives and Records Ad- (d) Acrylonitrile copolymers identi-
ministration (NARA). For information fied in this section are not authorized
on the availability of this material at to be used to fabricate beverage con-
NARA, call 202–741–6030, or go to: http:// tainers.
www.archives.gov/federallregister/ [42 FR 14572, Mar. 15, 1977, as amended at 42
codeloflfederallregulations/ FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19,
ibrllocations.html. 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109,
(iii) Residual acrylonitrile monomer Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR
content is not more than 11 parts per 14481, Apr. 2, 1996]
million as determined by gas chroma-
tography. § 177.1500 Nylon resins.
(iv) Acetonitrile-soluble fraction The nylon resins listed in paragraph
after refluxing the base polymer in ace- (a) of this section may be safely used to
tonitrile for 1 hour is not greater than produce articles intended for use in
95 percent by weight of the basic co- processing, handling, and packaging
polymers. food, subject to the provisions of this
(2) Extractives limitations. The fol- section:
lowing extractive limitations are de- (a) The nylon resins are manufac-
termined by an infrared tured as described in this paragraph so
spectrophotometric method titled, as to meet the specifications prescribed
‘‘Infrared Spectrophotometric Deter- in paragraph (b) of this section when
mination of Polymer Extracted from tested by the methods described in
Borex ® 210 Resin Pellets,’’ which is in- paragraph (d) of this section.
corporated by reference. Copies are (1) Nylon 66 resins are manufactured
available from the Center for Food by the condensation of hexamethylene-
Safety and Applied Nutrition (HFS– diamine and adipic acid.
200), Food and Drug Administration, (2) Nylon 610 resins are manufactured
5100 Paint Branch Pkwy., College Park, by the condensation of hexamethylene-
MD 20740, or available for inspection at diamine and sebacic acid.
the National Archives and Records Ad- (3) Nylon 66/610 resins are manufac-
ministration (NARA). For information tured by the condensation of equal-
on the availability of this material at weight mixtures of nylon 66 salts and
NARA, call 202–741–6030, or go to: http:// nylon 610 salts.
www.archives.gov/federallregister/ (4) Nylon 6/66 resins manufactured by
codeloflfederallregulations/ the condensation and polymerization of
ibrllocations.html.Copies are applicable Nylon 66 salts and epsilon-caprolactam.
to the basic copolymers in the form of (5) Nylon 11 resins are manufactured
particles of a size that will pass by the condensation of 11-
through a U.S. standard sieve No. 6 and aminoundecanoic acid.
that will be held on a U.S. standard (6) Nylon 6 resins are manufactured
sieve No. 10: by the polymerization of epsilon-
(i) Extracted copolymer not to ex- caprolactam.
ceed 2.0 parts per million in aqueous (7) Nylon 66T resins are manufac-
extract obtained when a 100-gram sam- tured by the condensation of
ple of the basic copolymers is extracted hexamethyl-enediamine, adipic acid,
with 250 milliliters of demineralized and terephthalic acid such that com-
(deionized) water at reflux temperature position in terms of ingredients is
for 2 hours. 43.1±0.2 weight percent hexamethyl-
(ii) Extracted copolymer not to ex- enediamine, 35.3±1.2 weight percent
ceed 0.5 part per million in n-heptane adipic acid, and 21.6±1.2 weight percent
extract obtained when a 100-gram sam- terephthalic acid.
282
(8) Nylon 612 resins are manufactured condensation of

by the condensation of hexamethylenediamine, terephthalic
hexamethylenediamine and acid, and isophthalic acid such that 65
dodecanedioic acid. to 80 percent of the polymer units are
(9) Nylon 12 resins are manufactured derived from hexamethylene
by the condensation of omega- isophthalamide.
laurolactam. (13)(i) Nylon 6/12 resins (CAS Reg. No.
(10)(i) Impact modified Nylon MXD–6 25191–04–2) are manufactured by the co-
resins (CAS Reg. No. 59655–05–9) manu- polymerization of a 1 to 1 ratio by
factured by the condensation of adipic weight of epsilon-caprolactam and
acid, 1,3-benzenedimethanamine, and omega-laurolactam.
alpha-(3-aminopropyl)-omega-(3-amino- (ii) Nylon 6/12 resins (CAS Reg. No.
propoxy)polyoxyethylene under such 25191–04–2) are manufactured by the co-
conditions that the alpha-(3-amino- polymerization of a ratio of at least 80
propyl)-omega-(3-aminopropoxy) weight percent of epsilon-caprolactam
polyoxyethylene monomer content and no more than 20 weight percent of
does not exceed 7 percent by weight of omega-laurolactam.
the finished resin. (14) Nylon 6/69 resins (CAS Reg. No.
(ii) Nylon MXD–6 resins (CAS Reg. 51995–62–1) are manufactured by the
No. 25718–70–1) manufactured by the condensation of 49.5+0.5 weight percent
condensation of adipic acid and 1,3- epsilon-caprolactam, 19.4+0.2 weight
benzenedimethanamine. percent hexamethylenediamine and
(11) Nylon 12T resins are manufac- 31.2+0.3 weight percent azelaic acid.
tured by the condensation of omega- (15) Nylon 46 resins (CAS Reg. No.
laurolactam (CAS Reg. No. 0947–04–6), 50327–77–0) are manufactured by the
isophthalic acid (CAS Reg. No. 0121–91– condensation of 1,4-butanediamine and
5), and bis(4-amino-3-methylcycl- adipic acid.
ohexyl)methane (CAS Reg. No. 6864–37– (16) Nylon resins PA 6–3–T (CAS Reg-
5) such that the composition in terms istry No. 26246–77–5) are manufactured
of ingredients is 34.4±1.5 weight percent by the condensation of 50 mol percent
omega-laurolactam, 26.8±0.4 weight per- 1,4-benzenedicarboxylic acid, dimethyl
cent isophthalic acid, and 38.8±0.5 ester and 50 mol percent of an
weight percent bis(4-amino-3- equimolar mixture of 2,2,4-trimethyl-
methylcyclohexyl)-methane. 1,6-hexanediamine and 2,4,4-trimethyl-
(12) Nylon 6I/6T resins (CAS Reg. No. 1,6-hexanediamine.
25750–23–6) are manufactured by the (b) Specifications:
Maximum extractable fraction
in selected solvents
Melting (expressed in percent
point Solubility by weight of resin)
Specific Viscosity No.
Nylon resins (degrees in boiling
gravity (mL/g)
Fahr- 4.2N HC1 95 Ethyl
enheit) percent Ben-
Water ace-
ethyl zene
tate
alcohol
1. Nylon 66 resins .............. 1.14±.015 475–495 Dissolves in .................................. 1.5 1.5 0.2 0.2
1 h.
2. Nylon 610 resins ............ 1.09±.015 405–425 Insoluble .................................. 1.0 2.0 1.0 1.0
after 1 h.
3.1 Nylon 66/610 resins ..... 1.10±.015 375–395 Dissolves in .................................. 1.5 2.0 1.0 1.0
1 h.
4.1 Nylon 6/66 resins, ep- 1.13±.015 440–460 ......do ......... .................................. 2.0 2.0 1.5 1.5
silon-caprolactam mon-
omer content not to ex-
ceed 0.7 percent by
weight.
283
§ 177.1500 21 CFR Ch. I (4–1–12 Edition)

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
4.2 Nylon 6/66 resins with 1.14±.015 380–425 ......do ......... .................................. 0.8 1.0 0.5 0.5
combined caprolactam
content greater than 60
percent and residual ep-
silon-caprolactam mon-
omer content not to ex-
ceed 0.4 percent by
weight. For use only as
specified in § 177.1395 of
this chapter (CAS Reg.
No. 24993–04–2).
5.1 Nylon 11 resins for use 1.04±.015 355–375 Insoluble .................................. .30 .35 .25 .3
in articles intended for 1- after 1 h.
time use or repeated use
in contact with food.
5.2 Nylon 11 resins for use 1.04±.015 355–375 ......do ......... .................................. .35 1.60 .35 .40
only:
a. In articles intended for
repeated use in contact
with food.
b. In side-seam cements
for articles intended for
1-time use in contact
with food and which
are in compliance with
§ 175.300 of this chap-
ter.
6.1 Nylon 6 resins .............. 1.15±.015 392–446 Dissolves in .................................. 1.0 2.0 1.0 1.0
1 h.
6.2 Nylon 6 resins for use 1.15±.015 392–446 ......do ......... .................................. 1.5 2.0 1.0 1.0
only in food-contact films
having an average thick-
ness not to exceed 0.001
in.
7. Nylon 66T resins for use 1.16±.015 482–518 Insoluble .................................. 1.0 1.0 .25 .25
only in food-contact films after 1 h.
having an average thick-
ness not to exceed 0.001
in.
8. Nylon 612 resins for use 1.06±.015 406–420 ......do ......... .................................. .50 1.50 .50 .50
only in articles intended
for repeated use in con-
tact with food at tempera-
tures not to exceed 212
°F.
9. Nylon 12 resins for use 1.01±.015 335–355 ......do ......... .................................. 1.0 2.0 1.50 1.50
only:.
a. In food-contact films hav-
ing an average thickness
not to exceed 0.0016
inch intended for use in
contact with nonalcoholic
food under the conditions
of use A (sterilization not
to exceed 30 minutes at
a temperature not to ex-
ceed 250 °F), and B
through H of table 2 of
ter, except as provided in
§ 177.1390(d)
284

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
b. In coatings intended for

repeated use in contact
with all food types de-
scribed in table 1 of
ter, except those con-
taining more than 8 per-
cent alcohol, under con-
ditions of use B through
H described in table 2 of
ter.
10.1 Nylon MXD–6 and im- 1.21±0.02 437–491 Dissolves in .................................. 2.0 2.5 1.0 1.0
pact modified Nylon 1h.
MXD–6 film having an
average thickness not to
exceed 40 microns
(0.0016 inch) for use in
processing, handling, and
packaging of food of
types V and IX listed in
table 1 of § 176.170(c) of
this chapter under condi-
tions of use C, D, E, F,
G, and H in table 2 of
§ 176.170(C) of this
chapter.
10.2 Impact modified Nylon 1.21±0.02 437–491 do ............... .................................. 2.0 2.5 1.0 1.0
MXD–6 resins for use as
polymer use as polymer
modifiers in Nylon 6 resin
films complying with
paragraph (a)(6) of this
section, at levels not to
exceed 13 percent by
weight of films whose av-
erage thickness will not
exceed 15 microns (0.6
mils). The finished film is
used for packaging,
transporting, or holding
food, excluding bev-
erages containing more
than 8 percent alcohol
(by volume) at tempera-
tures not to exceed 49
°C (120 °F) (conditions of
use E, F, and G in table
2 of § 176.170(c) of this
chapter).
285
§ 177.1500 21 CFR Ch. I (4–1–12 Edition)

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
10.3 Nylon MXD–6 resins 1.22±0.02 455–470 Dissolves in 1.0 1.5 0.2 0.2
for use only as nonfood- 1 h.
contact layers of: (1) Mul-
tilayer films and (2) rigid
plastic containers com-
posed of polypropylene
food-contact and exterior
layers, as defined in
§ 177.1520(c), item 1.1(a)
and 1.1(b), of this chap-
ter. The finished food-
contact laminate, in the
form in which it contacts
food, when extracted with
the food simulating sol-
vent or solvents charac-
terizing the conditions of
the intended use as de-
termined from Table 2 of
ter, shall yield not more
than 0.5 micrograms of
m-xylylenediamine-adipic
acid cyclic monomer per
square inch of food-con-
tact surface, when the
food simulating solvent is
analyzed by any appro-
priate, properly validated
method.
11. Nylon 12T resins for 1.06±0.015 290–310 Insoluble .................................. 0.1 ............ 0.5 0.5
use in contact with all after 1
types of food except hour.
those containing more
than 8 percent alcohol.
12. Nylon 6I/6T resins for 1.207±0.1 N/A Insoluble .................................. 0.2 1.0 0.1 0.1
use in contact with all after 1
types of food except al- hour.
coholic beverages con-
cent alcohol.
13.1 Nylon 6/12 resins for 1.06±0.015 260–285 Dissolves in Greater than 140 ..... 2.0 ............ 1.5 1.5
use only in food-contact 1 hour.
films having an average
thickness not to exceed
51 microns (0.002 inch).
The finished film is in-
tended to contact all
foods except those con-
cent ethanol under condi-
tions of use B, C, D, E,
F, G, and H listed in
table 2 of § 176.170(c) of
this chapter.
13.2 Nylon 6/12 resins with 1.10±0.15 380–400 Dissolves in Greater than 160 ..... 0.8 1.0 0.5 0.5
residual epsilon- 1 h.
caprolactam not to ex-
ceed 0.5 percent by
weight and residual
omega-laurolactam not to
exceed 0.1 percent by
this chapter.
286

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
13.3 Nylon 6/12 resins with 1.13 ±0.15 400–420 Dissolves in ............................. 1.0 1.5 0.5 0.5
residual epsilon- 1 h.
caprolactam not to ex-
ceed 0.8 percent by
weight and residual
omega-laurolactam not to
exceed 0.1 percent by
this chapter.
14. Nylon 6/69 resins for 1.09±0.02 270–277 .................... >140 using the meth- 3.0
use only as specified in od described in
21 CFR 177.1395 of this § 177.1500(c)(5)(ii)
chapter. of this chapter.
15. Nylon 46 resins for use 1.18±0.015 551–592 Dissolves in .................................. 0.3 0.2 0.2 0.3
only in food-contact 1 h.
membrane filters in-
tended for repeated use.
The finished membrane
filter is intended to con-
tact beverages containing
no more than 13 percent
alcohol, under conditions
of use E, F, and G listed
in table 2 of § 176.170(c)
of this chapter.
16. Nylon resins PA 6–3–T 1.12±0.03 NA Insoluble > 110 ....................... 0.007 0.64 0.003 0
for repeated-use (exclud- after 1 h.
ing bottles) in contact
with food of type VIA and
VIB described in table 1
of § 176.170(c) of this
chapter under conditions
of use D through H de-
scribed in table 2 of
ter with a hot-fill tempera-
ture limitation of 40 °C.
(c) Nylon modifier—(1) Identity. Co- (2) Specifications. The finished copoly-
polyester-graft-acrylate copolymer is ester-graft-acrylate copolymer shall
the substance 1,4-benzenedicarboxylic meet the following specifications:
acid, polymer with 1,4-butanediol, (E)- (i) Weight average molecular weight
2-butenedioic acid, 1,2-ethanediol, 15,000–35,000,
ethyl 2-propenoate, hexanedioic acid (ii) pH 7.2 to 8.2, and
and 2-propenoic acid, graft (CAS Reg. (iii) Glass transition temperature
No. 175419–23–5), and is derived from ¥15 to ¥25 °C.
grafting of 25 weight percent of acrylic (3) Conditions of use. (i) Copolyester-
polymer with 75 weight percent of co- graft acrylate copolymer described in
paragraph (c)(1) of this section is in-
polyester. The copolyester is polym-
tended to improve the adhesive quali-
erized terephthalic acid (55 mol%),
ties of film. It is limited for use as a
adipic acid (40 mol%), and fumaric acid
modifier of Nylon 6 and Nylon 6 modi-
(5 mol%) with ethylene glycol (40 fied with Nylon MXD–6 at a level not
mol%) and 1,4-butanediol (60 mol%). to exceed 0.17 weight percent of the ad-
The acrylic polymer is made from ditive in the finished film.
acrylic acid (70 mol%) and ethyl acry- (ii) The finished film is used for pack-
late (30 mol%). aging, transporting, or holding all

types of foods under conditions of use B
287
§ 177.1500 21 CFR Ch. I (4–1–12 Edition)
through H, described in table 2 of hours in a nitrogen atmosphere then

§ 176.170(c) of this chapter, except that repeat the test.
in the case of Nylon 6 films modified (3) Solubility in boiling 4.2N HCl. The
with Nylon MXD–6 (complying with test shall be run on a sample approxi-
§ 177.1500, item 10.2), the use complies mately the size of a 1⁄8-inch cube in at
with the conditions of use specified in least 25 milliliters of 4.2 normal hydro-
table 2. chloric acid.
(iii) Extractives. Food contact films (4) Maximum extractable fraction in se-
described in paragraphs (c)(1) of this lected solvents. The procedure for deter-
section, when extracted with solvent or mining the maximum extractable frac-
solvents prescribed for the type of food tion of the nylon resins in selected sol-
and under conditions of time and tem- vents is as follows:
perature specified for the intended use, (i) Film should be cut with ordinary
shall yield total extractives not to ex- scissors into pieces of a convenient size
ceed 0.5 milligram per inch squared of such as 1⁄4-inch squares, for the extrac-
food-contact surface when tested by tion tests described in this section. The
the methods described in § 176.170(d) of granules of nylon molding powders are
this chapter. in the proper form for the extraction
(iv) Optional adjuvant substances. The tests. Samples of fabricated articles
substances employed in the production such as pipe, fittings, and other similar
of Nylon modifiers listed in paragraph articles must be cut to approximately
(c)(1) of this section may include: the size of the molding powder. This
can be done conveniently by using a
(A) Substances generally recognized
small-scale commercial plastics
as safe for use in food and food pack-
granulator and cutting the sample
aging;
through a screen having 1⁄4-inch mesh.
(B) Substances subject to prior sanc- Fine particles should be separated from
tion or approval for use in Nylon resins the cut resin by screening through a 20-
and used in accordance with such sanc- mesh screen. The material retained on
tions or approval; and the screen is suitable for the extraction
(C) Optional substances required in tests.
the production of the additive identi- (ii) The organic solvents must be of
fied in this paragraph and other op- American Chemical Society analytical
tional substances that may be required reagent grade; distilled water is used.
to accomplish the intended physical or Approximately 30 grams of the pre-
technical effect. pared sample is weighed to the nearest
(d) Analytical methods—(1) Specific milligram. The weighed resin is trans-
gravity. Specific gravity shall be deter- ferred to a 500-milliliter round-bottom
mined by weighing a 1-gram to 5-gram flask equipped with a reflux condenser.
sample first in air and then in freshly Approximately 300-milliliters of sol-
boiled distilled water at 23 °C±2 °C. vent is added to the flask and the con-
(2) Melting point. The melting point tents refluxed gently for 8 hours with a
shall be determined as follows: Use a heating mantle. The solvent is then fil-
hot-stage apparatus. The use of crossed tered off immediately while still hot,
nicol prisms with a microscope hot using a Buchner funnel approximately
stage and reading of the thermometer 5 inches in diameter, a suction flask,
when the birefringence disappears in- and a hardened filter paper (Whatman
creases the accuracy. If the crossed No. 50 or equivalent). The paper is wet
nicol apparatus is not available, use with the solvent and a slight suction
the lowest temperature at which the applied just before starting the filtra-
sample becomes transparent or the tion. The resin is washed twice with
sharp edges or corners of the sample approximately 100-milliliter portions of
become rounded as the melting point. solvent and the combined filtrate and
In case of doubt as to the onset of washings are reduced to approximately
melting, the sample is prodded with a 25 milliliters by evaporation at reduced
sharp instrument. If it sticks to the pressure (50 millimeters to 100 millime-
heating block, it is considered to have ters of mercury, absolute), heating as
melted. If the melting point is low, dry necessary. The contents of the flask
the sample in an oven at 85 °C for 24 are transferred to an evaporation dish
288
(which has been held in a vacuum des- (a) For the purpose of this section,
iccator over anhydrous calcium sulfate olefin polymers are basic polymers
until constant weight has been at- manufactured as described in this para-
tained) and carefully evaporated to graph, so as to meet the specifications
dryness. The weight of the solid residue prescribed in paragraph (c) of this sec-
is determined by difference after hold- tion, when tested by the methods de-
ing in a vacuum desiccator over anhy- scribed in paragraph (d) of this section.
drous calcium sulfate until constant (1)(i) Polypropylene consists of basic
weight has been attained. The percent polymers manufactured by the cata-
of solids extracted is calculated by di- lytic polymerization of propylene.
viding the weight of the solid residue (ii) Propylene homopolymer consists
by the weight of the sample and multi- of basic polymers manufactured by the
plying by 100. catalytic polymerization of propylene
(5) Viscosity number (VN). (i) The vis- with a metallocene catalyst.
cosity number (VN) for Nylon 6/12 resin (2)(i) Polyethylene consists of basic
in a 96 percent sulfuric acid solution (5 polymers manufactured by the cata-
milligrams resin per milliliter) shall be lytic polymerization of ethylene.
determined at 25 °C (77 °F) by method (ii) Fumaric acid-grafted poly-
ISO 307–1984(E), ‘‘Plastics-Polyamides- ethylene (CAS Reg. No. 26877–81–6) con-
Determination of Viscosity Number,’’ sists of basic polymers manufactured
which is incorporated by reference. by the catalytic polymerization of
Copies are available from the Center ethylene followed by reaction with fu-
for Food Safety and Applied Nutrition maric acid in the absence of free rad-
(HFS–200), Food and Drug Administra- ical initiators. Such polymers shall
tion, 5100 Paint Branch Pkwy., College contain grafted fumaric acid at levels
Park, MD 20740, or available for inspec- not to exceed 2 percent by weight of
tion at the National Archives and the finished polymer.
Records Administration (NARA). For (3) Olefin basic copolymers consist of
information on the availability of this basic copolymers manufactured by the
material at NARA, call 202–741–6030, or catalytic copolymerization of:
go to: http://www.archives.gov/ (i) Two or more of the 1-alkenes hav-
federallregister/ ing 2 to 8 carbon atoms. Such olefin
codeloflfederallregulations/ basic copolymers contain not less than
ibrllocations.html. 96 weight-percent of polymer units de-
(ii) The viscosity number (VN) for rived from ethylene and/or propylene,
Nylon 6/69 and Nylon PA–6–3–T resins except that:
in a 99 percent cresol solution (5 milli- (a)(1) Olefin basic copolymers manu-
grams resin per milliliter) shall be de- factured by the catalytic copolym-
termined at 25 °C (77 °F) by method ISO erization of ethylene and hexene-1 or
307–1984(E), ‘‘Plastics-Polyamides-De- ethylene and octene-1 shall contain not
termination of Viscosity Number,’’ less than 90 weight-percent of polymer
which is incorporated by reference. The units derived from ethylene;
availability of this incorporation by (2) Olefin basic copolymers manufac-
reference is given in paragraph (d)(5)(i) tured by the catalytic copolymeriza-
of this section. tion of ethylene and hexene-1 shall con-
[42 FR 14572, Mar. 15, 1977] tain not less than 80 but not more than
EDITORIAL NOTE: For FEDERAL REGISTER ci- 90 weight percent of polymer units de-
tations affecting § 177.1500, see the List of rived from ethylene.
CFR Sections Affected, which appears in the (3) Olefin basic copolymers manufac-
Finding Aids section of the printed volume tured by the catalytic copolymeriza-
and at www.fdsys.gov. tion of ethylene and pentene-1 shall
contain not less than 90 weight-percent
§ 177.1520 Olefin polymers. of polymer units derived from ethyl-
The olefin polymers listed in para- ene.
graph (a) of this section may be safely (4) Olefin basic copolymers manufac-
used as articles or components of arti- tured by the catalytic polymerization
cles intended for use in contact with of ethylene and octene-1 shall contain
food, subject to the provisions of this not less than 50 weight-percent of poly-
section. mer units derived from ethylene.
289
§ 177.1520 21 CFR Ch. I (4–1–12 Edition)
(b) Olefin basic copolymers manufac- derived by copolymerization with 1,4-

tured by the catalytic copolymeriza- hexadiene.
tion of ethylene and 4-methylpentene-1 (v) Ethylene and butene-1 copolymers
shall contain not less than 89 weight- (CAS Reg. No. 25087–34–7) that shall
percent of polymer units derived from contain not less than 80 weight percent
ethylene; of polymer units derived from ethyl-
(c)(1) Olefin basic copolymers manu- ene.
factured by the catalytic copolym- (vi) Olefin basic copolymers (CAS
erization of two or more of the mono- Reg. No. 61615–63–2) manufactured by
mers ethylene, propylene, butene-1, 2- the catalytic copolymerization of
methylpropene-1, and 2,4,4- ethylene and propylene with 1,4-
trimethylpentene-1 shall contain not hexadiene, followed by reaction with
less than 85 weight-percent of polymer fumaric acid in the absence of free rad-
units derived from ethylene and/or pro- ical initiators. Such polymers shall
pylene; contain not more than 4.5 percent of
(2) Olefin basic copolymers manufac- polymer units deriving from 1,4-
tured by the catalytic copolymeriza- hexadiene by weight of total polymer
tion of propylene and butene-1 shall prior to reaction with fumaric acid and
contain greater than 15 but not greater not more than 2.2 percent of grafted fu-
than 35 weight percent of polymer maric acid by weight of the finished
units derived from butene-1 with the polymer.
remainder being propylene. (vii) Ethylene and 2-norbornene (CAS
(d) Olefin basic terpolymers manufac- Reg. No. 26007–43–2) copolymers that
tured by the catalytic copolymeriza- shall contain not less than 30 and not
tion of ethylene, hexene-1, and either more than 70 mole percent of polymer
propylene or butene-1, shall contain units derived from 2-norbornene.
not less than 85 weight percent poly- (4) Poly(methylpentene) consists of
mer units derived from ethylene. basic polymers manufactured by the
(e) Olefin basic copolymers manufac- catalytic polymerization of 4-
tured by the catalytic polymerization methylpentene-1.
of ethylene and octene-1, or ethylene, (5) Polyethylene graft copolymers
octene-1, and either hexene-1, butene-1, consist of polyethylene complying with
propylene, or 4-methylpentene-1 shall item 2.2 of paragraph (c) of this section
contain not less than 80 weight percent which subsequently has 3a,4,7,7a-
of polymer units derived from ethyl- tetrahydromethyl-4,7-
ene. methanoisobenzofuran-1,3-dione graft-
(ii) 4-Methylpentene-1 and 1-alkenes ed onto it at a level not to exceed 1.7
having from 6 to 18 carbon atoms. Such percent by weight of the finished co-
olefin basic copolymers shall contain polymer.
not less than 95 molar percent of poly- (6) Ethylene-maleic anhydride co-
mer units derived from 4- polymers (CAS Reg. No. 9006–26–2) con-
methylpentene-1, except that copoly- taining no more than 2 percent by
mers manufactured with 1-alkenes hav- weight of copolymer units derived from
ing from 12 to 18 carbon atoms shall maleic anhydride.
contain not less than 97 molar percent (b) The basic olefin polymers identi-
of polymer units derived from 4- fied in paragraph (a) of this section
methylpentene-1; or may contain optional adjuvant sub-
(iii) Ethylene and propylene that stances required in the production of
may contain as modifiers not more such basic olefin polymers. The op-
than 5 weight-percent of total polymer tional adjuvant substances required in
units derived by copolymerization with the production of the basic olefin poly-
one or more of the following monomers or finished food-contact articles
mers: may include substances permitted for
such use by applicable regulations in
5-Ethylidine-2-norbornene. parts 170 through 189 of this chapter,
5-Methylene-2-norbornene.
substances generally recognized as safe
(iv) Ethylene and propylene that may in food and food packaging, substances
contain as a modifier not more than 4.5 used in accordance with a prior sanc-
weight percent of total polymer units tion or approval, and the following:
290
Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as an adjuvant at levels not to exceed 25 percent
Reg. No. 88526–47–0), produced by the catalytic polym- by weight in blends with polypropylene complying with para-
erization of aromatic-substituted olefins from distillates of graph (c), item 1.1 of this section. The finished polymer may
cracked petroleum stocks with a boiling point no greater than be used in contact with food Types I, II, IV-B, VI-A through
220 °C (428 °F), and the subsequent catalytic hydrogenation VI-C, VII-B, and VIII identified in table 1 of § 176.170(c) of
of the resulting aromatic petroleum hydrocarbon resin, hav- this chapter and under conditions of use B through H de-
ing a minimum softening point of 110 °C (230 °F), as deter- scribed in table 2 of § 176.170(c) of this chapter; and with
mined by ASTM Method E 28–67 (Reapproved 1982), food Types III, IV-A, V, VII-A, and IX identified in table 1 of
‘‘Standard Test Method for Softening Point by Ring-and-Ball § 176.170(c) of this chapter and under conditions of use D
Apparatus,’’ and a minimum aniline point of 107 °C (225 °F), through G described in table 2 of § 176.170(c) of this chap-
as determined by ASTM Method D 611–82, ‘‘Standard Test ter.
Methods for Aniline Point and Mixed Aniline Point of Petro-
leum Products and Hydrocarbon Solvents,’’ both of which
are incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the
American Society for Testing and Materials, 100 Barr Harbor
Dr., West Conshohocken, Philadelphia, PA 19428-2959, or
Pkwy., College Park, MD 20740, or may be examined at the
National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call
Colorants used in accordance with § 178.3297 of this chapter.
2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– For use as an initiator in the production of propylene
63–7). homopolymer complying with § 177.1520(c), item 1.1 and
olefin copolymers complying with § 177.1520(c), items 3.1
and 3.2 and containing not less than 75 weight percent of
polymer units derived from propylene, provided that the max-
imum concentration of tert-butyl alcohol in the polymer does
not exceed 100 parts per million, as determined by a method
titled ‘‘Determination of tert-Butyl Alcohol in Polypropylene,’’
which is incorporated by reference. Copies are available
codeloflfederallregulations/ibrllocations.html.
Methyl methacrylate/butyl acrylate-grafted polypropylene co- For use only at levels not to exceed 6 percent by weight of
polymer containing methyl methacrylate/butyl acrylate-grafted olefin polymers complying with paragraph (c) of this section,
polypropylene (CAS Reg. No. 121510–09–6), methyl meth- items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com-
acrylate/butyl acrylate copolymer (CAS Reg. No. 25852–37– plying with items 3.1a, 3.2a, and 3.2b contain not less than
3), methyl methacrylate homopolymer (CAS Reg. No. 9011– 85 weight-percent of polymer units derived from propylene.
14–7), and polypropylene (CAS Reg. No. 9003–07–0), re-
sulting from the reaction of a mixture of methyl methacrylate
and butyl acrylate with polypropylene. The finished product
contains no more than 55 percent by weight of polymer units
derived from methyl methacrylate and butyl acrylate as de-
termined by a method entitled, ‘‘Determination of the Total
Acrylic in PP-MMA/BA Polymers,’’ which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the Office of Premarket
Approval, Center for Food Safety and Applied Nutrition
(HFS–200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or may be exam-
ined at the Center for Food Safety and Applied Nutrition’s Li-
brary, 5100 Paint Branch Pkwy., College Park, MD 20740, or
291
§ 177.1520 21 CFR Ch. I (4–1–12 Edition)
Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent
genated (CAS Reg. No. 68132–00–3) produced by the ther- by weight in blends with: (1) Polypropylene complying with
mal polymerization of dicyclopentadiene and cyclodiene paragraph (c), item 1.1 of this section, or (2) a copolymer of
codimers (consisting of a mixture of cyclopentadiene, methyl propylene and ethylene containing not less than 94 weight
cyclopentadiene, and C4-C5 acyclic dienes), followed by hy- percent propylene and complying with paragraph (c), item
drogenation and having a ring-and-ball softening point of 119 3.2 of this section. The average thickness of the food-con-
°C minimum as determined by ASTM Method E 28–67 (Re- tact film is not to exceed 0.1 millimeter (0.004 inch). The fin-
approved 1982), ‘‘Standard Test Method for Softening Point ished polymer may be used in contact with (1) Food types I,
by Ring-and-Ball Apparatus,’’ and a minimum viscosity of II, IV-B, VI-A, VI-B, VII-B, and VIII identified in table 1 of
3,000 centipoise, measured at 160 °C, as determined by § 176.170(c) of this chapter and under conditions of use C
ASTM Method D 3236–88, ‘‘Standard Test Method for Ap- through G described in table 2 of § 176.170(c) of this chap-
parent Viscosity of Hot Melt Adhesives and Coating Mate- ter; and (2) food types III, IV-A, V, VI-C, VII-A, and IX identi-
rials,’’ both of which are incorporated by reference in accord- fied in table 1 of § 176.170(c) of this chapter and under con-
ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are ditions of use D through G described in table 2 of
available from the American Society for Testing and Mate- § 176.170(c) of this chapter.
rials, 100 Barr Harbor Dr., West Conshohocken, Philadel-
phia, PA 19428-2959, or from the Center For Food Safety
and Applied Nutrition (HFS–200), Food and Drug Administra-
tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or
may be examined at the National Archives and Records Ad-
ministration (NARA). For information on the availability of this
material at NARA, call 202–741–6030, or go to: http://
Polymethylsilsesquioxane (CAS Reg. No. 68554–70–1) ............ For use only as a surface lubricant or anti-blocking agent in
films.
Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– For use only as a processing aid in the production of olefin
79–9), having a melt viscosity of 6 to 37 kilopoise at a shear polymers complying with paragraph (c) of this section at lev-
rate of 100¥1 seconds at 232 °C as determined by ASTM els not to exceed 1.0 percent by weight of the polymer. The
Method D 3835–79 (Reapproved 1983), ‘‘Standard Test finished polymers may be used only under the conditions de-
Method for Rheological Properties of Thermoplastics with a scribed in § 176.170(c) of this chapter, table 2, under condi-
Capillary Rheometer’’ using a capillary of 15:1 L/D, which is tions of use B though H.
incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the
Center for Food Safety and Applied Nutrition (HFS–200),
Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or may be examined at the Na-
Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. For use as an extrusion aid in the production of extruded olefin
68937–54–2). polymers that comply with § 177.1520(c) at levels not to ex-
ceed 0.3 percent by weight of the polymer. The finished
polymer is used in contact with foods under conditions of
use B through H described in table 2 of § 176.170 of this
chapter.
Triisopropanolamine (CAS Reg. No. 122–20–3) ........................ For use as a Zeigler-Natta-type catalyst deactivator and anti-
oxidant in the production of olefin polymers complying with
§ 177.1520(c), items 2.1, 2.2, and 2.3, and having a min-
imum density of 0.94 grams per cubic centimeter, and co-
polymers complying with § 177.1520(c), items 3.1 and 3.2,
for use in contact with all foods under the following condi-
tions of use: (a) films with a maximum thickness of 0.102
millimeter (0.004 inch) may be used under conditions A
through H defined in table 2 of § 176.170(c) of this chapter;
and (b) articles with thickness greater than 0.102 millimeter
(0.004 inch) may be used under conditions C through G de-
fined in table 2 of § 176.170(c) of this chapter.
Trimethylpyridine and dimethylpyridine mixture having percent For use only as an adjuvant substance in the production of
by weight composition as follows: 2,4,6-trimethylpyridine propylene homopolymers complying with items 1.1, 1.2, and
(CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1,
trimethylpyridine (CAS Reg. No. 1462–84–6), not more than and 3.2 of paragraph (c) of this section provided that the ad-
27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), juvant is used at a level not to exceed 20 parts per million
not more than 12 percent; and other dimethylpyridines, not by weight of the olefin polymers.
more than 6 percent.
292
Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as an extrusion aid in the production of extruded
No. 9011–17–0) having a fluorine content of 65 to 71 per- olefin polymers at levels not to exceed 0.2 percent by weight
cent and a Mooney viscosity of at least 28, as determined by of the polymer. The finished polymers may be used only
a method entitled ‘‘Mooney Viscosity,’’ which is incorporated under the conditions described in § 176.170(c) of this chap-
by reference in accordance with 5 U.S.C. 552(a). Copies are ter, table 2, under conditions of use B through H.
available from the Center for Food Safety and Applied Nutri-
tion (HFS–200), Food and Drug Administration, 5100 Paint
ined at the National Archives and Records Administration
Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a processing aid in the production of olefin
No. 9011–17–0), having a vinylidene fluoride content of not polymers complying with paragraph (c) of this section at lev-
less than 87 percent but less than 100 percent by weight els not to exceed 1.0 percent by weight of the polymer. The
and a melt viscosity of 12 to 27 kilopoise at a shear rate of finished polymers may be used only under the conditions de-
100¥1 seconds at 232 °C as determined by ASTM Method D scribed in § 176.170(c) of this chapter, table 2, under condi-
3835–79 (Reapproved 1983), ‘‘Standard Test Method for tions of use B though H.
Rheological Properties of Thermoplastics with a Capillary
Rheometer’’ using a capillary of 15:1 L/D, which is incor-
porated by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies are available from the Center for
Food Safety and Applied Nutrition (HFS–200), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park,
MD 20740, or may be examined at the National Archives
(c) Specifications:
Maximum extract- Maximum soluble
Melting Point able fraction (ex- fraction (ex-
(MP) or softening pressed as per- pressed as per-
Olefin polymers Density point (SP) (De- cent by weight of cent by weight of
grees Centi- the polymer) in N- polymer) in xy-
grade)— hexane at speci- lene at specified
fied temperatures temperatures
1.1a. Polypropylene described in para- 0.880–0.913 MP: 160°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C
graph (a)(1)(i) of this section temperature
1.1b. Propylene homopolymer described 0.880–0.913– MP: 150°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C
in paragraph (a)(1)(ii) of this section temperature
1.2. Polypropylene, noncrystalline; for use 0.80–0.88
only to plasticize polyethylene described
under items 2.1 and 2.2 of this table, pro-
vided that such plasticized polymers meet
the maximum extractable fraction and max-
imum soluble fraction specifications pre-
scribed for such basic polyethylene
1.3. Polypropylene, noncrystalline, for use 0.80–0.88 SP:115°–138 °C.
only: To plasticize polypropylene described
by item 1.1 of this table, provided that such
plasticized polymers meet the maximum ex-
tractable fraction and maximum soluble
fraction specifications prescribed for such
basic polypropylene, and further provided
that such plasticized polypropylene contacts
food only of the types identified in
§ 176.170(c) of this chapter, table 1, under
Types I, II, IV-B, VI-B, VII-B, and VIII; and
for use at levels not to exceed 50 pct by
weight of any mixture employed as a food-
contact coating provided such coatings con-
tact food only of the types identified in
Types I, II, IV-B, VI-B, VII-B, and VIII
2.1. Polyethylene for use in articles that con- 0.85–1.00 ............................. 5.5 pct at 50 °C 11.3 pct at 25 °C
tact food except for articles used for pack-
ing or holding food during cooking
293
§ 177.1520 21 CFR Ch. I (4–1–12 Edition)

2.2. Polyethylene for use in articles used for 0.85–1.00 ............................. 2.6 pct at 50 °C Do.
packing or holding food during cooking
2.3. Polyethylene for use only as component 0.85–1.00 ............................. 53 pct at 50 °C 75 pct at 25 °C
of food-contact coatings at levels up to and
including 50 percent by weight of any mix-
ture employed as a food-contact coating
2.4. Olefin polymers described in paragraph
(a)(2)(ii) of this section, having a melt flow
index not to exceed 17 grams/per 10 min-
utes as determined by the method de-
scribed in paragraph (d)(7) of this section,
for use in blends with other polymers at lev-
els not to exceed 20 percent by weight of
total polymer, subject to the limitation that
when contacting food of types III, IV-A, V,
VI-C, VII-A, and IX identified in § 176.170(c)
of this chapter, Table 1, the polymers shall
be used only under conditions of use C, D,
E, F, and G, described in § 176.170(c) of
this chapter, Table 2.
3.1a. Olefin copolymers described in para- 0.85–1.00 ............................. 5.5 pct at 50 °C 30 pct at 25 °C
graph (a)(3)(i) of this section for use in arti-
cles that contact food except for articles
used for packing or holding food during
cooking; except olefin copolymers described
in paragraph (a)(3)(i)(a)(3) of this section
and listed in item 3.1c of this table and
olefin copolymers described in paragraph
(a)(3)(i)(e) of this section and listed in item
3.1b of this table
3.1b. Olefin copolymers described in para- 0.9–1.00 ............................. Do Do.
graph (a)(3)(i)(e) of this section for use in
contact with food only under conditions of
use D, E, F, G, and H described in
§ 176.170(c) of this chapter, table 2
3.1c. Olefin copolymers described in para- Not less than 0.92
graph (a)(3)(i)(a)(3) of this section for use in
contact with food only under conditions of
use B, C, D, E, F, G, and H described in
§ 176.170(c) of this chapter, table 2; except
that such copolymers when used in contact
with food of the types identified in
§ 176.170(c), table 1, under types III, IVA,
V, VIIA, and IX, shall be used only under
conditions of use D, E, F, and G described
in § 176.170(c) of this chapter, table 2
294

3.2a. Olefin copolymers described in para- 0.85–1.00 ............................. 2.6 pct at 50 °C Do.
graph (a)(3)(i) of this section for use in arti-
cles used for packing or holding food during
cooking; except olefin copolymers described
in paragraph (a)(3)(i)(c)(2) of this section
and listed in item 3.2b of this table; except
that olefin copolymers containing 89 to 95
percent ethylene with the remainder being
4-methyl-pentene-1 contacting food Types
III, IVA, V, VIIA, and IX identified in
§ 176.170(c) of this chapter, table 1, shall
not exceed 0.051 millimeter (mm) (0.002
inch (in)) in thickness when used under
conditions of use A and shall not exceed
0.102 mm (0.004 in) in thickness when
used under conditions of use B, C, D, E,
and H described in § 176.170(c) of this
chapter, table 2. Additionally, olefin copoly-
mers described in (a)(3)(i)(a)(2) of this sec-
tion may be used only under conditions of
use B, C, D, E, F, G, and H described in
§ 176.170(c) of this chapter, table 2, in con-
tact with all food types identified in
§ 176.170(c) of this chapter, table 1
3.2b. Olefin copolymers described in para- Do.
graph (a)(3)(i)(c)(2) of this section have a
melt flow index no greater than 10 grams
per 10 minutes as determined by the meth-
od described in paragraph (d)(7) of this sec-
tion, and the thickness of the finished poly-
mer contacting food shall not exceed 0.025
mm (0.001 in). Additionally, optional adju-
vants permitted for use in olefin copolymers
complying with item 3.2a of this table may
be used in the production of this copolymer
3.2c. Olefin copolymers described in para- 0.85–0.92
graph (a)(3)(i)(a)(4) of this section have a
melt flow index no greater than 50 grams
per 10 minutes as determined by the meth-
od described in paragraph (d)(7) of this sec-
tion. Articles manufactured using these
polymers may be used with all types of food
under conditions of use C through H as de-
scribed in table 2 of § 176.170(c) of this
chapter
3.3a. Olefin copolymers described in para-
graph (a)(3)(ii) of this section and manufac-
tured with 1-alkenes having from 6 to 10
carbon atoms
3.3b. Olefin copolymers described in para-
graph (a)(3)(ii) of this section, provided that
such olefin polymers have a melt tempera-
ture of 220 °C to 250 °C (428 °F to 482 °F)
as determined by the method described in
paragraph (d)(8) of this section and min-
imum intrinsic viscosity of 1.0 as determined
in paragraph (d)(9) of this section.
295
§ 177.1520 21 CFR Ch. I (4–1–12 Edition)

3.4. Olefin copolymers, primarily non-crys- 0.85–0.90

talline, described in par. (a)(3) (iii) of this
section provided that such olefin polymers
have a minimum viscosity average molec-
ular weight of 120,000 as determined by the
method described in par. (d)(5) of this sec-
tion and a minimum Mooney viscosity of 35
as determined by the method described in
par. (d)(6) of this section, and further pro-
vided that such olefin copolymers contact
food only of the types identified in
Types I, II, III, IV-B, VI, VII, VIII, and IX
3.5. Olefin copolymers, primarily non-crys- 0.85–0.90
talline, described in paragraph (a)(3)(iv) of
this section, provided that such olefin poly-
mers have a minimum viscosity average
molecular weight of 95,600 as determined
by the method described in paragraph
(d)(5) of this section, and further provided
that such olefin polymers are used only in
blends with olefin polymers described under
items 1.1, 2.1, and 2.2 of this table at a
maximum level of 25 pct by weight, and
provided that such olefin copolymers con-
tact food only of the types identified in
§ 176.170 (c) of this chapter, table 1, under
Types I, II, IV-B, VI, VII-B, and VIII at tem-
peratures not exceeding 190 °F
3.6. Olefin copolymers described in para- Not less than 0.88
graph (a)(3)(v) of this section for use in
blends with olefin polymer resins have a
melt flow index no greater than 5 grams/10
minutes as determined by the method de-
scribed in paragraph (d)(7) of this section
and the thickness of the finished blends
shall not exceed 0.1 millimeter (0.004 inch).
The ethylene/butene-1 copolymer may be
used subject to the following conditions: (1)
For use at a level not to exceed 20 weight
percent in polypropylene as described
under item 1.1 of this table. (2) For use at a
level not to exceed 40 weight percent in
polyethylene as described under items 2.1
and 2.2 of this table. (3) For use at a level
not to exceed 40 weight percent in olefin
copolymers as described under items 3.1
and 3.2 of this table
296

3.7. Ethylene/propylene copolymers, meeting Not less than 0.86

the identity described in paragraph (a)(3)(i)
of this section, containing not less than 80
mole-percent of polymer units derived from
ethylene and having a minimum viscosity
average molecular weight of 95,000 as de-
termined by the method described in para-
graph (d)(5) of this section, and a minimum
Mooney viscosity of 13 as determined by
the method described in paragraph (d)(6) of
this section. Ethylene/propylene copolymers
described in this item 3.7 are to be used
only in blends with other olefin polymers
complying with this section, at levels not to
exceed 30 percent by weight of the total
polymer blend, and in contact with food only
of types identified in § 176.170(c) of this
chapter, Table 1, under Types I, II, III, IV-B,
VI, VII, VIII, and IX. Additionally, optional
adjuvants permitted for use in olefin copoly-
mers complying with item 3.4 of this table
may be used in the production of this
copolymer
3.8. Olefin polymers described in paragraph
(a)(3)(vi) of this section, having a melt flow
index not to exceed 9.2 grams per 10 min-
utes as determined by the method de-
scribed in paragraph (d)(7) of this section,
for use in blends with other polymers at lev-
els not to exceed 8 percent by weight of
total polymer, subject to the limitation that
when contacting food of types III, IV-A, V,
VI-C, VII-A, and IX, identified in
§ 176.170(c) of this chapter, Table 1, the
polymers shall be used only under condi-
tions of use C, D, E, F, and G, described in
§ 176.170(c) of this chapter, Table 2.
3.9. Olefin copolymers described in paragraph Not less than 1.0
(a)(3)(vii) of this section may only be used
in contact with dry foods, Type VIII, as iden-
tified in § 176.170(c) of this chapter, Table 1
4. Poly(methylpentene) 0.82–0.85 MP: 235°–250 °C 6.6 pct at reflux 7.5 pct at 25 °C
temperature
5. Polyethylene copolymer described in para- Not less than 0.94 ............................. 0.45 pct at 15 °C 1.8 pct at 25 °C
graph (a)(5) of this section and having a
melt index not to exceed 2, for use, either
alone or in blends with other olefin poly-
mers, subject to the limitation that when
contacting foods of types III, IV-A, V, VI-C,
VII-A, VIII, and IX identified in § 176.170(c)
of this chapter, table 1, the thickness of the
film (in mils) containing the polyethylene
graft copolymer times the concentration of
the polyethylene graft copolymer shall not
exceed a value of 2
6. Ethylene-maleic anhydride copolymers de- 0.92 or greater ........................ 1.36 pct at 50 °C 2.28 pct at 25 °C
scribed in paragraph (a)(6) of this section
for use as the adhesive component in multi-
laminate structures, or as the sealant layer
in flexible packaging, in contact with food at
temperatures not exceeding 49 °C (120 °F)
(d) The analytical methods for deter- this section are as follows, and are ap-
mining whether olefin polymers con- plicable to the basic polymer in film
form to the specifications prescribed in form not exceeding 4 mils in thickness.
297
§ 177.1520 21 CFR Ch. I (4–1–12 Edition)
The film to be tested shall be cut into polypropylene, and poly(methylpentene).

approximately 1-inch squares by any A sample is refluxed in the solvent for
convenient method that avoids con- 2 hours and filtered at the boiling
tamination by dust, dirt, or grease point. The filtrate is evaporated and
(NOTE: Do not touch samples with bare the total residue weighed as a measure
fingers—use forceps to hold or transfer of the solvent extractable fraction.
samples). (a) Apparatus. (1) Erlenmeyer flasks,
(1) Density. Density shall be deter- 250-milliliter, with ground joint.
mined by ASTM method D1505–68 (Re- (2) Condensers, Allihn, 400-millimeter
approved 1979), ‘‘Standard Test Method jacket, with ground joint.
for Density of Plastics by the Density- (3) Funnels, ribbed 75-millimeter di-
Gradient Technique,’’ which is incor- ameter, stem cut to 40 millimeters.
porated by reference. Copies may be (4) Funnels, Buchner type, with
obtained from the American Society
coarse-porosity fritted disc, 60-milli-
for Testing Materials, 100 Barr Harbor
meter diameter.
Dr., West Conshohocken, Philadelphia,
(5) Bell jar for vacuum filtration into
PA 19428-2959, or may be examined at
the National Archives and Records Ad- beaker.
ministration (NARA). For information (b) Reagent. n-Hexane, commercial
on the availability of this material at grade, specific gravity 0.663–0.667 (20 °C/
NARA, call 202–741–6030, or go to: http:// 20 °C), boiling range 66 °C-69 °C, or
www.archives.gov/federallregister/ equivalent.
codeloflfederallregulations/ (c) Procedure. Weigh 1 gram of sample
ibrllocations.html. accurately and place in a 250-milliliter
(2) Melting point or softening point—(i) Erlenmeyer flask containing two or
Melting point. The melting point shall three boiling stones. Add 100 milliliters
be determined by ASTM method D2117– of solvent, attach the flask to the con-
82, ‘‘Standard Test Method for Melting denser (use no grease), and reflux the
Point of Semicrystalline Polymers by mixture for 2 hours. Remove the flask
the Hot Stage Microscopy Method,’’ from the heat, disconnect the con-
which is incorporated by reference. The denser, and filter rapidly, while still
availability of this incorporation by hot, through a small wad of glass wool
reference is given in paragraph (d)(1) of packed in a short-stem funnel into a
this section. tared 150-millimeter beaker. Rinse the
(ii) Softening point. The softening flask and filter with two 10-milliliter
point shall be determined by ASTM portions of the hot solvent, and add the
method E28–67 (Reapproved 1982), rinsings to the filtrate. Evaporate the
‘‘Standard Test Method for Softening filtrate on a stream bath with the aid
Point by Ring-and-Ball Apparatus,’’ of a stream of nitrogen. Dry the res-
which is incorporated by reference. The idue in a vacuum oven at 110 °C for 2
availability of this incorporation by hours, cool in a desiccator, and weigh
reference is given in paragraph (d)(1) of to the nearest 0.0001 gram. Determine
this section. the blank on 120 milliliters of solvent
(3) Maximum extractable fraction in n- evaporated in a tared 150-milliliter
hexane—(i) Olefin copolymers described beaker. Correct the sample residue for
in paragraph (a)(3)(ii) of this section, this blank if significant. Calculation:
Grams of residue
= Percent extractable with n-hexane.
Grams of sample × 100
(ii) Olefin copolymers described in para- residue weighed as a measure of the

graph (a)(3)(i) of this section and poly- solvent extractable fraction. Alter-
ethylene. A preweighed sample is ex- natively, the sample is reweighed after
tracted at 50 °C for 2 hours and filtered.
the extraction period to give a measure

The filtrate is evaporated and the total of the solvent extractable fraction. The
298
ER01JA93.398</GPH>
maximum n-hexane-extractable frac- vent temperature has reached 50 °C,

tion may be determined by the meth- disconnect the heater, remove the resin
ods set forth in paragraphs (d)(3)(ii)(a) kettle from the heating jacket, and de-
through (d)(3)(ii)(i) of this section. cant the solvent, while still warm,
(a) Extraction apparatus. Two-liter, through a coarse filter paper placed on
straight-walled, Pyrex (or equivalent) top of a fritted-glass funnel, collecting
resin kettles, fitted with three-hole the filtrate in a tared, glass-stoppered
ground-glass covers are most conven- Erlenmeyer flask of 1-liter capacity.
ient for this purpose. The cover is Determine the weight of the filtrate re-
fitted with a thermometer, a gas-tight covered to the nearest gram. Recovery
stirrer driven by an air motor or explo- should be at least 90 percent of the
sion-proof electric motor, and a reflux original solvent. Losses due to evapo-
condenser. The kettle is fitted with an ration during heating and filtering
electric heating mantle of appropriate have been found not to exceed 10 per-
size and shape, which is controlled by a cent. Transfer about half of the solvent
variable-voltage transformer. filtrate to a 1-liter beaker placed on an
(b) Evaporating apparatus. Rapid opening in the steam bath and imme-
evaporation of large volumes of solvent diately cover with the special ‘‘gas’’
requires special precautions to prevent cover, the inlet tube of which has been
contamination by dust. This is facili- attached with flexible tetrafluoro-
tated by a special ‘‘gas’’ cover con- ethylene tubing to a source of high-pu-
sisting of an inverted flat Pyrex crys-
rity nitrogen in series with a stainless
tallizing dish of an appropriate size (190
steel heating coil immersed directly in
millimeters × 100 millimeters) to fit a
the body of the steam bath. Maintain a
1-liter beaker. Through the center of
positive flow of warm nitrogen gas
the dish are sealed an inlet tube for
throughout the evaporation of the sol-
preheated, oxygen-free nitrogen, and
an outlet tube located 1 inch off center. vent, adding the remainder of the fil-
Nitrogen is fed from the supply source trate from the Erlenmeyer flask as the
through a coil of 1⁄4-inch stainless steel evaporation proceeds. When the volume
tubing immersed in the same steam of the solvent has been reduced to
bath used to supply heat for solvent about 50 milliliters, transfer the con-
evaporation. All connections are made centrated liquid to a previously tared
with flexible tetrafluoroethylene tub- weighing dish of suitable size. Wash the
ing. beaker twice with 20–30 milliliter por-
(c) Reagents—(1) n-Hexane. Spectro- tions of warm solvent, adding the
grade n-hexane. washings to the weighing dish while
(2) Nitrogen. High-purity dry nitrogen continuing to evaporate the remainder
containing less than 10 parts per mil- of the solvent under the gas cover with
lion of oxygen. its flow of warm nitrogen directed to-
(d) Procedure. Transfer 2.5 grams (ac- ward the center of the dish. In the
curately weighed to nearest 0.001 gram) event that an insoluble residue that
of the polymer to the resin kettle. Add cannot be removed with warm solvent
1 liter of solvent and clamp top in posi- remains in the beaker, it may be nec-
tion. Start water flowing through jack- essary to heat with a small amount of
et of the reflux condenser and apply air a higher boiling solvent such as ben-
pressure to the stirring motor to zene or toluene, transferring these
produce vigorous agitation. Turn on washings to the weighing dish before
heating jacket with transformer set at final evaporation to dryness. Transfer
a predetermined voltage to bring the the weighing dish with its residue to a
temperature of the contents to 50 °C vacuum desiccator, and allow it to re-
within 20–25 minutes. As the thermom- main overnight (at least 12 hours),
eter reading approaches 45 °C–47 °C, re- after which the net weight of the dry
duce the voltage to the predetermined residue is determined to the nearest
setting that will just maintain the 0.0001 gram. Correct the result for any
temperature at 50 °C. Do not overshoot solvent blank equivalent to the non-
the prescribed temperature. Should volatile matter determined to be con-
this occur discard the test and start tained in the amount of solvents used
afresh. Exactly 2 hours after the sol- in the test.
299
§ 177.1520 21 CFR Ch. I (4–1–12 Edition)
(e) Extraction apparatus for alternate should be prepared by the same process
method. Two-liter extraction vessel, as will be used with the production
such as a resin kettle or round bottom resin. Using gloves and metal tweezers
flask, fitted with an Allihn condenser to avoid sample contamination, cut
(size C), a 45/50 male joint with a Teflon about 2.7 grams of the prepared film (4
sleeve, and a Teflon coated stir bar. mils or less in thickness) into about 1-
Water bath maintained at 49.5 °C ±0.5 inch squares using clean sharp scissors.
°C containing a submersible magnetic Proceed with Option 1 or 2.
stirrer motor with power supply. Other Option 1. Using tweezers and noting
suitable means of maintaining tem- the number of film pieces, transfer 2.5
perature control, such as electric heat- grams (accurately weighed to 0.1 milli-
ing mantles, may be used provided that gram) of polymer to the extraction ves-
the temperature range can be strictly
sel. Extract the film sample for 2
maintained.
hours. Allow the vessel to cool and fil-
(f) Sample basket (Optional). A per-
ter the contents through a fritted por-
forated stainless steel cylindrical bas-
ket that is approximately 1.5 inches in celain funnel. Wash the film pieces
diameter, 1.6 inches high, and has per- with fresh n-hexane, aspirate to dry-
forations of 0.125 inches in diameter for ness, and transfer, using tweezers, to a
33 holes/in2, or 40 percent open area. beaker. Recount the film pieces to
The basket should pass freely through verify that none were lost during the
the 45/50 female joint of the extraction transfer. Place the beaker in the vacu-
flask. A No. 6–32 stainless steel eye- um oven for 2 hours at 80 °C ±5 °C. After
bolt is attached to the lid for posi- 2 hours, remove and place in a desic-
tioning the basket in the extraction cator to cool to room temperature
vessel. The positioning rod, approxi- (about 1 hour). After cooling, reweigh
mately 18 inches long and made from 1/ the film pieces to the nearest 0.1 milli-
16 inch outside diameter 316 stainless gram. Calculate the percent hexane-
steel welding rod or equivalent and extractables content from the weight
hooked at both ends, is used to position loss of the original sample. Multiply
the basket in the extraction apparatus. the result by 0.935 and compare with
(g) Vacuum oven. Capable of main- extraction limits in paragraph (c) of
taining 80 °C ±5 °C and a minimum of this section. Repeat the above proce-
635 millimeters of mercury pressure. dure for successive samples.
(h) Reagents. n-Hexane, reagent or Option 2. Transfer 2.5±0.05 grams of
spectrograde, aromatic free (less than 1 the prepared 1-inch film sections into a
milligram per liter), minimum 85 per- tared sample basket and accurately
cent n-hexane. This reagent may be reweigh to the nearest 0.1 milligram.
used until it contains a maximum of 1.5 Carefully raise the condenser until the
grams polyolefin extractables or has hook on the positioning rod is above
been used for 12 determinations. the neck of the 2-liter extraction ves-
(i) Procedure. Assemble the extraction
sel. The basket should be totally below
vessel, condenser, and magnetic stir
the level of n-hexane solvent. Extract
bar. Add n-hexane (1 liter) to the ex-
the sample resin film for 2 hours and
traction vessel and clamp the assembly
into a water bath set at 49.5 °C ±0.5 °C. then raise the basket above the solvent
Start the water flowing through the level to drain momentarily. Remove
jacket of the reflux condenser. Adjust the basket and rinse the contents by
the air flow through the stirring motor immersing several times in fresh n-
to give a smooth and uniform stir rate. hexane. Allow the basket to dry be-
Allow the n-hexane to preheat for 1 tween rinsings. Remove the excess sol-
hour to bring the temperature to 49.5 vent by briefly blowing the basket with
°C±0.5 °C. Temperature is a critical fac- a stream of nitrogen or dry air. Place
tor in this analysis and it must not the basket in the vacuum oven for 2
vary more than 1 °C. If the temperature hours at 80 °C ±5 °C. After 2 hours, re-
exceeds these limits, the test must be move and place in a desiccator to cool
discontinued and restarted. Blown, to room temperature (about 1 hour).
compression molded, or extrusion cast After cooling, reweigh the basket to

films can be tested. Ideally, the film the nearest 0.1 milligram. Calculate
300
the percent hexane extractables con- thylamine in 1 liter of industrial grade

tent from the weight loss of the origi- xylene having specific gravity 0.856–
nal sample. Multiply the result by 0.935 0.867 (20 °C/20 °C) and boiling range 123
and compare with extraction limits in °C–160 °C.
paragraph (c) of this section. Repeat (c) Procedure. Weigh 1 to 2 grams of
the above procedure for successive sample to the nearest 0.001 gram and
samples. The same solvent charge place in a 125-milliliter Pyrex reagent
should remain clear and can be used for bottle containing a 1-inch long tetra-
at least 12 determinations. Applica- fluoroethylene-resin-coated stirring
tions of solvent reuse should be con- bar. Add 100 milliliters of solvent, set
firmed for each resin type before use. the stopper in lightly, and place the
(4) Maximum soluble fraction in xy- bottle in the heating mantle or alu-
lene—(i) Olefin copolymers described in minum block maintained at a tempera-
paragraph (a)(3)(ii) of this section, poly- ture of 120 °C, and stir with a magnetic
propylene, and poly(methylpen-tene). A stirrer until the sample is completely
sample is dissolved completely in xy- dissolved. Remove the bottle from the
lene by heating and stirring in a bottle heat and allow it to cool 1 hour in the
with little free space. The solution is air, without stirring. Then place the
allowed to cool without stirring, bottle in a water bath maintained at 25
whereupon the insoluble portion pre- °C ±0.5 °C, and allow to stand 1 hour
cipitates and is filtered off; the total without stirring. Next, remove the bot-
solids content of the filtrate is then de- tle from the water bath, shake, and
termined as a measure of the soluble pour part of the contents into the
fraction. coarse-porosity fritted-glass funnel.
(a) Apparatus. (1) Pyrex (or equiva- Apply suction, and draw 30–40 milli-
lent) reagent bottle, 125-milliliter, liters of filtrate through, adding more
glass-stoppered. slurry to the funnel, and catching the
(2) Heating mantle of size for 150-mil- filtrate in a large test tube. (If the
liliter beaker (or suitable aluminum slurry is hard to filter, add 10 grams of
block to fit the 125-milliter bottle de- diatomaceous earth filter aid to the
scribed in paragraph (d)(4)(i)(a)(1) of bottle and shake vigorously just prior
this section. to the filtration.) Pipet a suitable ali-
(3) Magnetic stirrer for use under the quot (preferably 20 milliliters) of the
heating mantle (combination magnetic filtrate into a tared aluminum dispos-
stirrer and hotplate may be used if alu- able dish. Place the dish on a steam
minum block is used in place of heat- bath covered with a fresh sheet of alu-
ing mantle). minum foil and invert a short-stemmed
(4) Variable-voltage transformer, 7.5 4-inch funnel over the dish. Pass nitro-
amperes. gen (heated if desired) down through
(5) Tetrafluoroethylene-resin-coated the funnel at a rate sufficient to just
stirring bar, 1-inch long. ripple the surface of the solvent. When
(6) Constant temperature water bath the liquid has evaporated, place the
maintained at 25 °C±0.5 °C. dish in a vacuum oven at 140 °C and
(7) Aluminum dishes, 18 millimeters × less than 50 millimeters mercury pres-
60 millimeters, disposable. sure for 2 hours. Cool in a desiccator
(8) Funnel, Buchner type, with and weigh. (Note: If the residue value
coarse-porosity fritted disc, 30–60 milli- seems high, redry in the vacuum oven
meter diameter. for one-half hour to ensure complete
(b) Reagent. Xylene with antioxidant. removal of all xylene solvent.) Calcula-
Dissolve 0.020 gram of phenyl-b- naph- tion:
Grams of residue 100 milliters

× × 100 = Percent soluble in xylene
Grams of sample volume of aliquot in milliliters
301
ER01JA93.399</GPH>
§ 177.1520 21 CFR Ch. I (4–1–12 Edition)
(ii) Olefin copolymers described in para- reflux condenser and apply full voltage
graph (a)(3)(i) of this section and poly- (115 volts) to the heating mantle. When
ethylene. A sample is extracted in xy- the xylene starts to boil, reduce the
lene at reflux temperature for 2 hours voltage to a level just sufficient to
and filtered. The filtrate is evaporated maintain reflux. After refluxing for at
and the total residue weighed as a least 2 hours, disconnect the power
measure of soluble fraction. source to the mantle, remove the ket-
(a) Apparatus—(1) Extraction appa- tle, and allow to cool in air until the
ratus. Two-liter, straight-walled Pyrex temperature of the contents drops to 50
(or equivalent) resin kettles, fitted °C, after which the kettle may be rap-
with ground-glass covers, are most con- idly cooled to 25 °C–30 °C by immersing
venient for this purpose. The cover is in a cold water bath. Transfer the ket-
equipped with a thermometer and an tle to a constant temperature bath set
efficient reflux condenser. The kettle is to maintain 25 °C ±0.1 °C, and allow to
fitted with an electric heating mantle equilibrate for a least 1 hour (may be
of appropriate size and shape which is left overnight if convenient). Break up
controlled by a variable-voltage trans- any precipitated polymers that may
former. have formed, and decant the xylene so-
(2) Constant temperature water bath. It lution successively through a fast filter
must be large enough to permit immer- paper and then through a fritted-glass
sion of the extraction kettle and set to filter into a tared 1-liter Erlenmeyer
maintain 25 °C ±0.1 °C. flask, collecting only the first 450 mil-
(3) Evaporating apparatus. Gas cover liliters—500 milliliters of filtrate (any
consisting of a flat Pyrex crystallizing attempt to collect more of the xylene
dish (190 millimeters × 100 millimeters) solution usually results in clogging the
inverted to fit over a 1-liter beaker filter and risking losses). Reweigh the
with 8-millimeter gas inlet tube sealed Erlenmeyer flask and calculate the
through center and an outlet tube 1 weight of the filtrate obtained to the
inch off center. The beaker with gas nearest 0.1 gram. Transfer the filtrate,
cover is inserted in an electric heating quantitatively, from the Erlenmeyer
mantle equipped with a variable-volt- flask to the 1-liter beaker, insert the
age transformer. The outlet tube is at- beaker in its heating mantle, add a
tached to an efficient condenser glass-coated magnetic stirring bar, and
mounted on a receiving flask for sol- mount the gas cover in place, con-
vent recovery and having an outlet for necting the inlet tube to the nitrogen
connection to an aspirator pump. The source and the outlet to the condenser
heating mantle (with the beaker) is of the receiving flask. Start a flow of
mounted on a magnetic stirring device. nitrogen (2 to 3 liters per minute) into
An infrared heat lamp is mounted the gas cover and connect an aspirator
vertically 3–4 inches above the gas to the receiver using a free-flow rate
cover to prevent condensation of the equivalent to 6–7 liters of air per
solvent inside the cover. Make all con- minute. With the infrared lamp on, ad-
nections with flexible tetrafluoro- just the voltage to the heating mantle
ethylene tubing. to give a distillation rate of 12–13 milli-
(b) Reagents—(1) Xylene. American liters per minute when the magnetic
Chemical Society reagent grade that stirrer is revolving just fast enough to
has been redistilled through a promote good boiling. When the vol-
fractionating column to reduce the ume of solvent in the beaker has been
nonvolatile residue. reduced to 30–50 milliliters, transfer
(2) Nitrogen. High-purity dry nitrogen the concentrated extractive to a suit-
containing less than 104 parts per mil- able weighing dish that has been pre-
lion oxygen. viously tared (dry). Rinse the beaker
(c) Procedure. Transfer 5 grams ±0.001 twice with 10–20 milliliter portions of
gram of sample to the resin kettle, add fresh xylene, adding the rinsings to the
1,000 milliliters (840 grams) of xylene, weighing dish. Evaporate the remain-
and clamp top in position after insert- der of the xylene on an electric
ing a piece of glass rod to prevent hotplate set at low heat under the gas
bumping during reflux. Start water cover with a stream of nitrogen di-
flowing through the jacket of the rected toward the center of the dish.
302
Avoid any charring of the residue. termined at 100 °C. The apparatus con-
Transfer the weighing dish to a vacu- taining the sample is warmed for 1
um desiccator at room temperature minute, run for 8 minutes, and vis-
and allow to remain under reduced cosity measurements are then made.
pressure for at least 12 hours (over- (7) Melt flow index. The melt flow
night), after which determine the net index of olefin polymers described
weight of the residue to the nearest below shall be determined by ASTM
0.0001 gram. Correct the result for non- method D–1238–82, ‘‘Standard Test
volatile solvent blank obtained by Method for Flow Rates of Thermo-
evaporating the equivalent amount of plastics by Extrusion Plastometer,’’
xylene under identical conditions. Cal- which is incorporated by reference in
culate the weight of residue originally accordance with 5 U.S.C. 552(a). The
present in the total weight of solvent availability of this incorporation by
(840 grams), using the appropriate fac- reference is given in paragraph (d)(1) of
tor based on the weight of filtrate this section. The olefin polymers and
evaporated. test conditions and procedures are as
(5) Viscosity average molecular weight follows:
olefin copolymers described in paragraphs List of polymers Conditions/procedures
(a)(3) (iii) and (iv) of this section. The
viscosity average molecular weight Olefin copolymers described in para- Condition L, proce-
graph (a)(3)(i)(c)(2) of this section. dure A.
shall be determined from the kine- Olefin copolymers described in para- Condition E, proce-
matic viscosity (using ASTM method graph (a)(3)(v) of this section. dure A.
D445–74, ‘‘Test for Kinematic Viscosity Olefin polymers described in para- Condition E, proce-
graph (a)(2)(ii) of this section. dure A.
of Transparent and Opaque Liquids’’ Olefin polymers described in para- Condition E, proce-
(Revised 1974), which is incorporated by graph (a)(3)(vi) of this section. dure A.
reference; copies are available from
American Society for Testing and Ma- (8) Melting peak temperature. The melt
terials (ASTM), 100 Barr Harbor Dr., temperature of the olefin polymers de-
West Conshohocken, Philadelphia, PA scribed in paragraph (a)(3)(ii) of this
19428-2959, or available for inspection at section shall be determined by ASTM
the National Archives and Records Ad- method D 3418–82, ‘‘Standard Test
ministration (NARA). For information Method for Transition Temperatures of
on the availability of this material at Polymers by Thermal Analysis,’’ which
NARA, call 202–741–6030, or go to: http:// is incorporated by reference in accord-
www.archives.gov/federallregister/ ance with 5 U.S.C. 552(a). The avail-
codeloflfederallregulations/ ability of this incorporation by ref-
ibrllocations.html.) of solutions of the erence is given in paragraph (d)(1) of
copolymers in solvents and at tempera- this section.
tures as follows: (9) Intrinsic viscosity. The intrinsic
(i) Olefin polymers described in para- viscosity of the olefin polymers de-
graph (a)(3)(iii) of this section in scribed in paragraph (a)(3)(ii) of this
decahydronaphthalene at 135 °C. section shall be determined by ASTM
(ii) Olefin polymers described in method D 1601–78, ‘‘Standard Test
paragraph (a)(3)(iv) of this section in Method for Dilute Solution Viscosity
tetrachloroethylene at 30 °C. of Ethylene Polymers,’’ which is incor-
(6) Mooney viscosity—olefin copolymers porated by reference in accordance
described in paragraph (a)(3)(iii) of this with 5 U.S.C. 552(a). The availability of
section. Mooney viscosity is determined this incorporation by reference is given
by ASTM method D1646–81, ‘‘Standard in paragraph (d)(1) of this section.
Test Method for Rubber—Viscosity and (e) Olefin copolymers described in
Vulcanization Characteristics (Mooney paragraph (a)(3) (i) of this section and
Viscometer),’’ which is incorporated by polyethylene, alone or in combination,
reference (the availability of this in- may be subjected to irradiation bom-
corporation by reference is given in bardment from a source not to exceed
paragraph (d)(1) of this section), using 2.3 million volts intensity to cause mo-
the large rotor at a temperature of 100 lecular crosslinking of the polymers to
°C, except that a temperature of 127 °C impart desired properties, such as in-
shall be used for those copolymers creased strength and increased ability
whose Mooney viscosity cannot be de- to shrink when exposed to heat.
303
§ 177.1550 21 CFR Ch. I (4–1–12 Edition)
(f) The olefin polymers identified in (3) Substances authorized under ap-
and complying with this section, when plicable regulations in this part and in
used as components of the food-contact parts 175 and 178 of this chapter and
surface of any article that is the sub- subject to any limitations prescribed
ject of a regulation in parts 174, 175, therein.
176, 177, 178, and § 179.45 of this chapter, (4) The following substances, subject
shall comply with any specifications to any limitations prescribed:
and limitations prescribed by such reg-
ulation for the article in the finished List of substances Limitations
form in which it is to contact food.
Lithium polysilicate containing For use only as a compo-
(g) The provisions of this section are not more than 20 weight per- nent of repeated-use
not applicable to olefin polymers iden- cent silica, not more than 2.1 coatings not exceeding
tified in § 175.105(c) (5) of this chapter percent lithium oxide and 0.030 millimeter (0.0012
having a maximum mole inch) in thickness where
and used in food-packaging adhesives ratio of Si02/Li20 of 8.5 to 1. the coatings are thermally
complying with § 175.105 of this chapter. cured at minimum sinter-
ing temperatures of 371
[42 FR 14572, Mar. 15, 1977] °C (700 °F). Lithium ex-
EDITORIAL NOTE: For FEDERAL REGISTER ci- tractives shall not exceed
tations affecting § 177.1520, see the List of 1.55 milligrams per
square decimeter (0.1
CFR Sections Affected, which appears in the milligram per square inch)
Finding Aids section of the printed volume of coating surface when
and at www.fdsys.gov. tested in accordance with
paragraph (e)(2) of this
§ 177.1550 Perfluorocarbon resins. section.
Naphthalene sulfonic acid For use only:
Perfluorocarbon resins identified in formaldehyde condensate, 1. As a component of re-
this section may be safely used as arti- sodium salt. peated-use coatings,
cles or components of articles intended based on the
to contact food, subject to the provi- perfluorocarbon resin
identified in paragraph
sions of this section: (a)(1) of this section, not
(a) Identity. For the purpose of this to exceed 0.030 milli-
section, perfluorocarbon resins are meter (0.0012 inch) in
thickness, and at a level
those produced by: (1) The not to exceed 0.4 weight
homopolymerization and/or copolym- percent of the coating.
erization of hexafluoropropylene and 2. As a component of re-
tetrafluoroethylene, and (2) the co- peated-use coatings,
based on the
polymerization of perfluorocarbon resin
perfluoropropylvinylether and tetra- identified in paragraph
fluoroethylene (CAS Reg. No. 26655–00– (a)(2) of this section, not
to exceed 0.10 millimeter
5). The resins shall meet the extrac- (0.004 inch) in thickness,
tives limitations in paragraph (d) of and at a level not to ex-
this section. ceed 0.4 weight percent
(b) Optional components. The of the coating.
perfluorocarbon resins identified in
paragraph (a) of this section as well as (c) Optional processing. Poly- tetra-
articles or coating made from these fluoroethylene resins may be irradi-
resins may include the following op- ated by either a cobalt-60 sealed
tional components except that the source, at a maximum dose of gamma
resin identified in paragraph (a)(2) of radiation not to exceed 7.5 megarads,
this section may not be used with the or an electron beam at energy levels
optional component, lithium not to exceed 2.5 million electron volts
polysilicate, mentioned in paragraph with a maximum dosage of 7.5
(b)(4) of this section. megarads, to produce lubricant pow-
(1) Substances generally recognized ders having a particle diameter of not
as safe (GRAS) in food or food pack- more than 20 microns for use only as
aging subject to any limitations cited components of articles intended for re-
on their use. peated use in contact with food.
(2) Substances used in accordance (d) Specifications—(1) Infrared identi-
with a prior sanction or approval, sub- fication. Perfluorocarbon resins can be
ject to any limitations cited in the identified by their characteristic infra-

prior sanction or approval. red spectra.
304
(2) Melt-viscosity. (i) The perfluoro- this material at NARA, call 202–741–
carbon resins identified in paragraph 6030, or go to: http://www.archives.gov/
(a)(1) of this section shall have a melt federallregister/
viscosity of not less than 104 poises at codeloflfederallregulations/
380 °C (716 °F) as determined by ASTM ibrllocations.html. The requirements of
method D1238–82, ‘‘Standard Test Meth- this paragraph do not apply to poly-
od for Flow Rates of Thermoplastics by tetrafluoroethylene resin lubricant
Extrusion Plastometer,’’ which is in- powders described in paragraph (c) of
corporated by reference. Copies may be this section.
obtained from the American Society (e) Limitations. 1 (1) Perfluorocarbon-
for Testing Materials, 100 Barr Harbor molded articles having a surface area
Dr., West Conshohocken, Philadelphia, of 6.45 square decimeters (100 square
PA 19428-2959, or may be examined at inches) or more and at least 1.27 milli-
the National Archives and Records Ad- meters (0.05 inch) thick shall be ex-
ministration (NARA). For information tracted at reflux temperatures for 2
on the availability of this material at hours separately with distilled water,
NARA, call 202–741–6030, or go to: http:// 50 percent ethanol, n-heptane, and
www.archives.gov/federallregister/ ethyl acetate.
codeloflfederallregulations/ (2) Perfluorocarbon resins identified
ibrllocations.html. The melt viscosity in paragraphs (a)(1) and (2) of this sec-
of the perfluorocarbon resins identified tion and intended for use as coatings or
in paragraph (a)(1) of this section shall components of coatings shall meet
not vary more than 50 percent within extractability limits prescribed in
one-half hour at 380 °C (716 °F). paragraph (e)(3) of this section when
(ii) Perfluorocarbon resins identified the resins in the form of coatings de-
in paragraph (a)(2) of this section shall scribed in paragraphs (e)(2) (i) and (ii)
have a melt viscosity of not less than of this section are extracted at reflux
104 poises at 372 °C (702 °F) as deter- temperatures for 2 hours separately
mined by a more detailed method ti- with distilled water, 8 percent ethanol,
tled ‘‘Determination of Melt Viscosity, and n-heptane:
Molecular Weight Distribution Index (i) Perfluorocarbon resin coatings
and Viscosity Stability,’’ which is in- based on resins identified in paragraph
corporated by reference. Copies are (a)(1) of this section shall be applied to
available from the Center for Food both sides of a 0.025-millimeter (0.001
Safety and Applied Nutrition (HFS– inch) thick aluminum foil to a thick-
200), Food and Drug Administration, ness of 0.025 millimeter (0.001 inch)
5100 Paint Branch Pkwy., College Park, after thermal curing at 399 °C (750 °F)
MD 20740, or available for inspection at for 10 minutes. If a primer is used, the
the National Archives and Records Ad- total thickness of the primer plus top-
ministration (NARA). For information coat shall equal 0.025 millimeter (0.001
on the availability of this material at inch) after heat curing.
NARA, call 202–741–6030, or go to: http:// (ii) Perfluorocarbon resin coatings
www.archives.gov/federallregister/ based on resins identified in paragraph
codeloflfederallregulations/ (a)(2) of this section shall be applied to
ibrllocations.html. both sides of a 0.025-millimeter (0.001
(3) Thermal instability index. The ther-
mal instability index of the tetra- 1 A more detailed procedure of extraction
fluoroethylene homopolymer shall not conditions is entitled, ‘‘Preparation of Ex-
exceed 50 as determined by ASTM tracts,’’ which is incorporated by reference.
method D1457–56T, ‘‘Test for Thermal Copies are available from the Center for
Instablility index of Tetrafluoro- Food Safety and Applied Nutrition (HFS–
ethylene Homopolymer’’ (Revised 1956), 200), Food and Drug Administration, 5100
which is incorporated by reference. Paint Branch Pkwy., College Park, MD 20740,
Copies are available from University or available for inspection at the National
Microfilms International, 300 N. Zeeb (NARA). For information on the availability
Rd., Ann Arbor, MI 48106, or available of this material at NARA, call 202–741–6030,
for inspection at the National Archives
or go to: http://www.archives.gov/
and Records Administration (NARA). federallregister/codeloflfederallregulations/
For information on the availability of ibrllocations.html.
305
§ 177.1555 21 CFR Ch. I (4–1–12 Edition)
inch) thick aluminum foil to a thick- (250 °F) for 2 hours, shall yield total
ness of 0.10 millimeter (0.004 inch) after nonvolatile extractives not to exceed
thermal curing at 427 °C (800 °F) for 10 2.33 micrograms per square centimeter
minutes. If a primer is used, the total (15 micrograms per square inch) of the
thickness of the primer plus topcoat exposed resin surface.
shall equal 0.10 millimeter (0.004 inch) (d) Limitations. Polyarylate resin ar-
after heat curing. ticles may be used in contact with all
(3) The extracted surfaces shall meet foods except beverages containing
the following extractability limits: more than 8 volume percent ethanol
(i) Total extractives not to exceed 3.1 under conditions of use A through H,
milligrams per square decimeter (0.2 described in table 2 of § 176.170(c) of this
milligram per square inch). chapter.
(ii) Fluoride extractives calculated as [52 FR 35540, Sept. 22, 1987]
fluorine not to exceed 0.46 milligram
per square decimeter (0.03 milligram § 177.1556 Polyaryletherketone resins.
per square inch). The poly(oxy-1,4-phenylenecarbonyl-
(f) Conditions of use. Perfluorocarbon 1,4-phenyleneoxy-1,4-
resins identified in paragraph (a)(2) of phenylenecarbonyl-1,4-
this section are limited to use as coat- phenylenecarbonyl-1,4-phenylene) res-
ings or components of coatings for arti- ins (CAS Reg. No. 55088–54–5 and CAS
cles intended for repeated food-contact Reg. No. 60015–05–6 and commonly re-
use. ferred to as polyaryletherketone res-
[43 FR 44834, Sept. 29, 1978, as amended at 47 ins) identified in paragraph (a) of this
FR 11843, Mar. 19, 1982; 47 FR 14699, Apr. 6, section may be safely used as articles
1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, or components of articles intended for
Jan. 11, 1985; 54 FR 24898, June 12, 1989; 61 FR repeated use in contact with food, sub-
14481, Apr. 2, 1996] ject to the provisions of this section.
(a) Identity. Polyaryletherketone res-
§ 177.1555 Polyarylate resins.
ins consist of basic resins produced by
Polyarylate resins (CAS Reg. No. reacting 4,4′-diphenoxy benzophenone
51706–10–6) may be safely used as arti- and terephthaloyl dichloride in such a
cles or components of articles intended way that the finished resins have a
for use in contact with food in accord- minimum weight average molecular
ance with the following prescribed con- weight of 20,000 grams per mole, as de-
ditions: termined by light scattering measure-
(a) Identity. Polyarylate resins (1, 3- ments in sulfuric acid at room tem-
benzenedicarboxylic acid, diphenyl perature.
ester, polymer with diphenyl 1,4- (b) Optional adjuvant substances. The
benzenedicarboxylate and 4-4′-(1- basic polyaryletherketone resins iden-
methylethylidine) bis(phenol)) are tified in paragraph (a) of this section
formed by melt polycondensation of may contain optional adjuvant sub-
bisphenol-A with diphenylisophthalate stances required in the production of
and diphenylterephthalate. such basic resins. These adjuvants may
(b) Specifications. (1) The finished co- include substances used in accordance
polymers shall contain from 70 to 80 with § 174.5 of this chapter and the fol-
weight percent of polymer units de- lowing:
rived from diphenylisophthalate and 20 (1) Benzoyl chloride, poly(tetrafluoro
to 30 weight percent of polymer units ethylene).
derived from diphenylterephthalate. (2) [Reserved]
(2) Polyarylate resins shall have a (c) Extractive limitations. The finished
minimum weight average molecular food-contact article yields net total ex-
weight of 20,000. tractives in each extracting solvent
(3) Polyarylate resins may be identi- not to exceed 0.052 milligram per
fied by their characteristic infrared square inch (corresponding to 0.008 mil-
spectra. ligram per square centimeter) of food-
(c) Extractive limitations. The finished contact surface, when extracted at
polyarylate resins in sheet form at reflux temperature for 2 hours with the
least 0.5 millimeter (0.020 inch) thick, following solvents: Distilled water, 50
when extracted with water at 121 °C percent (by volume) ethyl alcohol in
306
distilled water, 3 percent acetic acid paragraph and further identified as re-
(by weight) in distilled water, and n- quired:
heptane.
(d) In testing the finished food-con- Substances Limitations
tact article made of Sulfolane ..... Not to exceed 0.15 percent as residual sol-
polyaryletherketone resin, use a sepa- vent in the finished basic resin.
rate test sample for each required ex-
tracting solvent. (c) Extractive limitations. The finished
[61 FR 42381, Aug. 15, 1996] polyarylsulfone resin when extracted
for 2 hours with the following solvents
§ 177.1560 Polyarylsulfone resins. at the specified temperatures yields
total extractives in each extracting
Polyarylsulfone resins (CAS Reg. No.
79293–56–4) may be safely used as arti- solvent not to exceed 0.008 milligram
cles or components of articles intended per square centimeter of food-contact
for use in contact with food, at tem- surface: distilled water at 121 °C (250
peratures up to and including normal °F), 50 percent (by volume) ethyl alco-
baking temperatures, in accordance hol in distilled water at 71.1 °C (160 °F),
with the following prescribed condi- 3 percent acetic acid in distilled water
tions: at 100 °C (212 °F), and n-heptane at 65.6
(a) Identity. Polyarylsulfone resins °C (150 °F).
are copolymers containing not more NOTE: In testing the finished polyaryl-
than 25 percent of oxy-p-phenylene- sulfone resin use a separate test sample for
oxy-p-phenylenesulfonyl-p-phenylene each required extracting solvent.
polymer units and not less than 75 per- [50 FR 31046, July 24, 1985]
cent of oxy-p-phenylenesulfonyl-p-
phenylene-oxy-p-phenylenesulfonyl-p- § 177.1570 Poly-1-butene resins and
phenylene polymer units. The copoly- butene/ethylene copolymers.
mers have a minimum reduced vis-
The poly-1-butene resins and butene/
cosity of 0.40 deciliter per gram in 1-
ethylene copolymers identified in this
methyl-2-pyrrolidinone in accordance
with ASTM method D2857–70 (Re- section may be safely used as articles
approved 1977), ‘‘Standard Test Method or components of articles intended for
for Dilute Solution Viscosity of Poly- use in contact with food subject to the
mers,’’ which is incorporated by ref- provisions of this section.
erence. Copies may be obtained from (a) Identity. Poly-1-butene resins are
the American Society for Testing and produced by the catalytic polymeriza-
Materials, 100 Barr Harbor Dr., West tion of 1-butene liquid monomer.
Conshohocken, Philadelphia, PA 19428- Butene/ethylene copolymers are pro-
2959, or may be examined at the Na- duced by the catalytic polymerization
tional Archives and Records Adminis- of 1-butene liquid monomer in the pres-
tration (NARA). For information on ence of small amounts of ethylene
the availability of this material at monomer so as to yield no higher than
NARA, call 202–741–6030, or go to: http:// a 6-weight percent concentration of
www.archives.gov/federallregister/ polymer units derived from ethylene in
codeloflfederallregulations/ the copolymer.
ibrllocations.html. (b) Specifications and limitations. Poly-
(b) Optional adjuvant substances. The 1-butene resins and butene/ethylene co-
basic polyarylsulfone resins identified polymers shall conform to the speci-
in paragraph (a) of this section may fications prescribed in paragraph (b)(1)
contain optional adjuvant substances of this section, and shall meet the
required in the production of such extractability limits prescribed in
basic copolymers. These optional adju- paragraph (b)(2) of this section.
vant substances may include sub- (1) Specifications—(i) Infrared identi-
stances permitted for such use by regu- fication. Poly-1-butene resins and
lations in parts 170 through 179 of this butene/ethylene copolymers can be
chapter, substances generally recog- identified by their characteristic infra-
nized as safe in food, substances used in red spectra.
accordance with a prior sanction of ap- (ii) Viscosity. Poly-1-butene resins and
proval, and substances named in this the butene/ethylene copolymers have
307
§ 177.1580 21 CFR Ch. I (4–1–12 Edition)
an intrinsic viscosity 1.0 to 3.2 as deter- contact with food under conditions of
mined by ASTM method D1601–78, use B, C, D, E, F, G, or H described in
‘‘Standard Test Method for Dilute So- table 2 of § 176.170(c) of this chapter,
lution Viscosity of Ethylene Poly- subject to the provisions of this section
mers,’’ which is incorporated by ref- and provided that the maximum
erence. Copies may be obtained from extractables from test films 0.1 to 0.2
the American Society for Testing Ma- millimeter (0.004 to 0.008 inch) in thick-
terials, 100 Barr Harbor Dr., West ness do not exceed 0.80 percent by
Conshohocken, Philadelphia, PA 19428- weight of the polymer when extracted
2959, or may be examined at the Na- in a soxhlet extractor for 6 hours with
tional Archives and Records Adminis- refluxing 95 percent ethanol.
tration (NARA). For information on (iii) Poly-1-butene resins may be used
the availability of this material at as articles or components of articles
NARA, call 202–741–6030, or go to: http:// intended for packaging or holding food
www.archives.gov/federallregister/ during cooking, provided that the
codeloflfederallregulations/ thickness of such polymers in the form
ibrllocations.html. in which they contact food shall not
(iii) Density. Poly-1-butene resins exceed 0.1 millimeter (0.004 inch) and
have a density of 0.904 to 0.920 gms/cm3, yield maximum extractables of not
and butene/ethylene copolymers have a more than 2.5 percent by weight of the
density of 0.890 to 0.916 gms/cm3 as de- polymer when films are extracted for 2
termined by ASTM method D1505–68 hours at 50 °C (122 °F) in n-heptane.
(Reapproved 1979), ‘‘Standard Test [42 FR 14572, Mar. 15, 1977, as amended at 49
Method for Density of Plastics by the FR 10109, Mar. 19, 1984; 50 FR 31349, Aug. 2,
Density-Gradient Technique,’’ which is 1985]
incorporated by reference. The avail-
ability of this incorporation by ref- § 177.1580 Polycarbonate resins.
erence is given in paragraph (b)(1)(ii) of Polycarbonate resins may be safely
this section. used as articles or components of arti-
(iv) Melt index. Poly-1-butene resins cles intended for use in producing,
have a melt index of 0.1 to 24 and the manufacturing, packing, processing,
butene/ethylene copolymers have a preparing, treating, packaging, trans-
melt index of 0.1 to 20 as determined by porting, or holding food, in accordance
ASTM method D1238–82, condition E, with the following prescribed condi-
‘‘Standard Test Method for Flow Rates tions:
of Thermoplastics by Extrusion Plas- (a) Polycarbonate resins are poly-
tometer,’’ which is incorporated by ref- esters produced by:
erence. The availability of this incor- (1) The condensation of 4,4′-iso-
poration by reference is given in para- propylidenediphenol and carbonyl chlo-
graph (b)(1)(ii) of this section. ride to which may have been added cer-
(2) Limitations. Poly-1-butene resins tain optional adjuvant substances re-
and butene/ethylene copolymers for use quired in the production of the resins;
in articles that contact food, and for or by
articles used for packing or holding (2) The reaction of molten 4,4′-iso-
food during cooking shall yield no propylidenediphenol with molten di-
more than the following extractables: phenyl carbonate in the presence of the
(i) Poly-1-butene resins may be used disodium salt of 4,4′-isopro-
as articles or components of articles pylidenediphenol.
intended for use in contact with food, (3) The condensation of 4,4′-isopro-
provided that the maximum pylidenediphenol, carbonyl chloride,
extractables do not exceed 2.5 percent and 0.5 percent weight maximum of
by weight of the polymer when film or a2,a6-bis (6-hydroxy-m-tolyl) mesitol to
molded samples are tested for 2 hours which may have been added certain op-
at 50 °C (122 °F) in n-heptane. tional adjuvant substances required in
(ii) Butene/ethylene copolymers con- the production of branched
taining no more than 6 percent by polycarbonate resins.
weight of polymer units derived from (b) The optional adjuvant substances
ethylene may be used as articles or required in the production of resins

components of articles intended for produced by the methods described in
308
paragraph (a)(1) and (3) of this section extractives not to exceed 0.15 percent
may include substances generally rec- by weight of the resins.
ognized as safe in food, substances used
in accordance with a prior sanction or FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6,
approval, and the following: 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656,
Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994]
p-tert-Butylphenol .................. § 177.1585 Polyestercarbonate resins.

Chloroform .............................
Polyestercarbonate resins may be
p-Cumylphenol (CAS Reg. For use only as a chain ter-
No. 599–64–4). minator at a level not to ex- safely used as articles or components
ceed 5 percent by weight of articles intended for use in pro-
of the resin. ducing, manufacturing, packing, proc-
Ethylene dichloride.
Heptane.
essing, preparing, treating, packaging,
Methylene chloride. or holding food, in accordance with the
Monochlorobenzene .............. Not to exceed 500 p.p.m. as following prescribed conditions:
residual solvent in finished (a) Polyestercarbonate resins (CAS
resin.
Pentaerythritol tetrastearate For use only as a mold re- Reg. No. 71519–80–7) are produced by the
(CAS Reg. No. 115–83–3). lease agent, at a level not condensation of 4,4′-
to exceed 0.5 percent by isopropylidenediphenol, carbonyl chlo-
weight of the finished resin.
Phenol (CAS Reg. No. 108–
ride, terephthaloyl chloride, and
95–2). isophthaloyl chloride such that the fin-
Pyridine. ished resins are composed of 45 to 85
Toluene: (CAS Reg. No. Not to exceed 800 parts per molepercent ester, of which up to 55
108–88–3). million as residual solvent
in finished resin. mole-percent is the terephthaloyl iso-
Triethylamine. mer. The resins are manufactured
using a phthaloyl chloride/carbonyl
(c) Polycarbonate resins shall con- chloride mole ratio of 0.81 to 5.7/1 and
form to the specification prescribed in isophthaloyl chloride/terephthaloyl
paragraph (c)(1) of this section and chloride mole ratio of 0.81/1 or greater.
shall meet the extractives limitations The resins are also properly identified
prescribed in paragraph (c)(2) of this by CAS Reg. No. 114096–64–9 when pro-
section. duced with the use of greater than 2
(1) Specification. Polycarbonate resins but not greater than 5 weight percent
can be identified by their char- p-cumylphenol (CAS Reg. No. 599–64–4),
acteristic infrared spectrum. as an optional adjuvant substance in
(2) Extractives limitations. The accordance with paragraph (b)(2) of
polycarbonate resins to be tested shall this section.
be ground or cut into small particles (b) Optional adjuvants. The optional
that will pass through a U.S. standard adjuvant substances required in the
sieve No. 6 and that will be held on a production of resins identified in para-
U.S. standard sieve No. 10. graph (a) of this section may include:
(i) Polycarbonate resins, when ex- (1) Substances used in accordance
tracted with distilled water at reflux with § 174.5 of this chapter.
temperature for 6 hours, shall yield (2) Substances identified in
total extractives not to exceed 0.15 per- § 177.1580(b).
cent by weight of the resins. (3) Substances regulated in
(ii) Polycarbonate resins, when ex- § 178.2010(b) of this chapter for use in
tracted with 50 percent (by volume) polycarbonate resins complying with
ethyl alcohol in distilled water at § 177.1580:
reflux temperature for 6 hours, shall Provided, That the substances are used
yield total extractives not to exceed in accordance with any limitation on
0.15 percent by weight of the resins. concentration, conditions of use, and
(iii) Polycarbonate resins, when ex- food types specified in § 178.2010(b) of
tracted with n-heptane at reflux tem-
this chapter.
perature for 6 hours, shall yield total
309
§ 177.1590 21 CFR Ch. I (4–1–12 Edition)
(c) Polyestercarbonate resins shall ethyl alcohol in distilled water at

conform to the specifications pre- reflux temperature for 6 hours, shall
scribed in paragraph (c)(1) of this sec- yield total nonvolatile extractives not
tion and shall meet the extractive lim- to exceed 0.005 percent by weight of the
itations prescribed in paragraph (c)(2) resins.
of this section. (iii) Polyestercarbonate resins, when
(1) Specifications. Polyestercarbonate extracted with n-heptane at reflux
resins identified in paragraph (a) of temperature for 6 hours, shall yield
this section can be identified by their total nonvolatile extractives not to ex-
characteristic infrared spectrum. The ceed 0.002 percent by weight of the res-
resins shall comply with either or both ins.
of the following specifications: (3) Residual methylene chloride levels in
(i) The solution intrinsic viscosity of polyestercarbonate resins. Polyester-
the polyestercarbonate resins shall be carbonate resin articles in the finished
a minimum of 0.44 deciliter per gram, form shall not contain residual meth-
as determined by a method entitled ylene chloride in excess of 5 parts per
‘‘Intrinsic Viscosity (IV) of Lexan ® million as determined by a method ti-
Polyestercarbonate Resin by a Single tled ‘‘Analytical Method for Deter-
Point Method Using Dichloromethane mination of Residual Methylene Chlo-
as the Solvent,’’ developed by the Gen- ride in Polyestercarbonate Resin,’’ de-
eral Electric Co., September 20, 1985, veloped by the General Electric Co.,
which is incorporated by reference in July 23, 1991, which is incorporated by
accordance with 5 U.S.C. 552(a) and 1 reference in accordance with 5 U.S.C.
CFR part 51. Copies are available from 552(a) and 1 CFR part 51. Copies are
the Office of Premarket Approval, Cen- available from the Center for Food
ter for Food Safety and Applied Nutri- Safety and Applied Nutrition (HFS–
tion (HFS–215), Food and Drug Admin- 200), Food and Drug Administration,
istration, 5100 Paint Branch Pkwy., 5100 Paint Branch Pkwy., College Park,
College Park, MD 20740, or may be ex- MD 20740, or may be examined at the
amined at the Center for Food Safety National Archives and Records Admin-
and Applied Nutrition’s Library, Food istration (NARA). For information on
and Drug Administration, 5100 Paint the availability of this material at
Branch Pkwy., College Park, MD 20740, NARA, call 202–741–6030, or go to: http://
or at the National Archives and www.archives.gov/federallregister/
Records Administration (NARA). For codeloflfederallregulations/
information on the availability of this ibrllocations.html.
go to: http://www.archives.gov/ [57 FR 3940, Feb. 3, 1992, as amended at 64 FR
federallregister/ 27178, May 19, 1999]
§ 177.1590 Polyester elastomers.
ibrllocations.html.
(ii) A minimum weight-average mo- The polyester elastomers identified
lecular weight of 27,000, as determined in paragraph (a) of this section may be
by gel permeation chromatography safely used as the food-contact surface
using polystyrene standards. of articles intended for use in contact
(2) Extractives limitations. The with bulk quantities of dry food of the
polyestercarbonate resins to be tested type identified in § 176.170(c) of this
shall be ground or cut into small par- chapter, table 1, under Type VIII, in ac-
ticles that will pass through a U.S. cordance with the following prescribed
standard sieve No. 6 and that will be conditions:
held on U.S. standard sieve No. 10. (a) For the purpose of this section,
(i) Polyestercarbonate resins, when polyester elastomers are those pro-
extracted with distilled water at reflux duced by the ester exchange reaction
temperature for 6 hours, shall yield when one or more of the following
total nonvolatile extractives not to ex- phthalates—dimethyl terephthalate,
ceed 0.005 percent by weight of the res- dimethyl orthophthalate, and dimethyl
ins. isophthalate—is made to react with
(ii) Polyestercarbonate resins, when alpha-hydroomega-hydroxypoly

extracted with 50 percent (by volume) (oxytetramethylene) and/or 1,4-
310
butanediol such that the finished elas- this section may contain optional adju-
tomer has a number average molecular vant substances required in the produc-
weight between 20,000 and 30,000. tion of basic resins or finished food-
(b) Optional adjuvant substances em- contact articles. The optional adjuvant
ployed in the production of the poly- substances required in the production
ester elastomers or added thereto to of the basic polymer may include sub-
impart desired technical or physical stances permitted for such use by ap-
properties may include the following plicable regulations as set forth in part
substances: 174 of this chapter.
(c) Specifications and extractives limita-
List of substances Limitations tions—(1) Specifications. Polyetherimide
4,4′ - Bis (alpha, alpha-di- For use only as an anti- resin identified in paragraph (a) of this
methyl-benzyl) oxidant. section shall have an intrinsic vis-
diphenylamine. cosity in chloroform at 25 °C (77 °F) of
Tetrabutyl titanate .................. For use only as a catalyst.
not less than 0.35 deciliter per gram as
determined by a method titled ‘‘In-
(c) An appropriate sample of the fin- trinsic Viscosity of ULTEM
ished polyester elastomer in the form Polyetherimide Using Chloroform as
in which it contacts food when sub- the Solvent,’’ which is incorporated by
jected to ASTM method D968–81, reference. Copies are available from
‘‘Standard Test Methods for Abrasion the Center for Food Safety and Applied
Resistance of Organic Coatings by the Nutrition (HFS–200), Food and Drug
Falling Abrasive Tester,’’ which is in- Administration, 5100 Paint Branch
corporated by reference (Copies may be Pkwy., College Park, MD 20740, or
obtained from the American Society available for inspection at the National
for Testing Materials, 100 Barr Harbor Archives and Records Administration
Dr., West Conshohocken, Philadelphia, (NARA). For information on the avail-
PA 19428-2959, or may be examined at ability of this material at NARA, call
the National Archives and Records Ad- 202–741–6030, or go to: http://
ministration (NARA). For information www.archives.gov/federallregister/
on the availability of this material at codeloflfederallregulations/
NARA, call 202–741–6030, or go to: http:// ibrllocations.html.
www.archives.gov/federallregister/ (2) Extractive limitations. Extractive
codeloflfederallregulations/ limitations are applicable to the basic
ibrllocations.html.), using No. 50 emery polyetherimide resin in the form of
abrasive in lieu of Ottawa sand, shall molded discs of thickness 0.16 centi-
exhibit an abrasion coefficient of not meter (0.063 inch). The resin discs when
less than 100 liters per mil of thickness. extracted with distilled water at 121 °C
[42 FR 14572, Mar. 15, 1977, as amended at 49 (250 °F) for 2 hours yield total nonvola-
FR 10109, Mar. 19, 1984] tile extractives of not more than 12.3
micrograms per square centimeter.
§ 177.1595 Polyetherimide resin.
[50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept.
The polyetherimide resin identified 3, 1985]
in this section may be safely used as an
article or component of an article in- § 177.1600 Polyethylene resins,
tended for use in contact with food, carboxyl modified.
subject to the provisions of this sec- Carboxyl-modified polyethylene res-
tion. ins may be safely used as the food-con-
(a) Identity. For the purpose of this tact surface of articles intended for use
section, the polyetherimide resin is 1,3- in contact with food in accordance
isobenzofurandione, 5,5′[(1-methyl- with the following prescribed condi-
ethylidene)bis(4,1-phenyleneoxy)] bis- tions:
polymer with 1,3-benzenediamine (CAS (a) For the purpose of this section,
Reg. No. 61128–46–9), and is derived from carboxyl-modified polyethylene resins
the condensation reaction of m- consist of basic polymers produced
phenylenediamine and bisphenol A- when ethylene-methyl acrylate basic
dianhydride. copolymers, containing no more than
(b) Optional adjuvants. The basic 25 weight percent of polymer units de-
polymer identified in paragraph (a) of rived from methyl acrylate, are made
311
§ 177.1610 21 CFR Ch. I (4–1–12 Edition)
to react in an aqueous medium with (Copies may be obtained from the

one or more of the following sub- American Society for Testing Mate-
stances: rials, 100 Barr Harbor Dr., West
Ammonium hydroxide. Conshohocken, Philadelphia, PA 19428-
Calcium carbonate. 2959, or may be examined at the Na-
Potassium hydroxide. tional Archives and Records Adminis-
Sodium hydroxide. tration (NARA). For information on
(b) The finished food-contact article, the availability of this material at
when extracted with the solvent or sol- NARA, call 202–741–6030, or go to: http://
vents characterizing the type of food www.archives.gov/federallregister/
and under the conditions of time and codeloflfederallregulations/
temperature characterizing the condi- ibrllocations.html.), and has a 7.0 per-
tions of its intended use as determined cent maximum extractable fraction in
from tables 1 and 2 of § 176.170(c) of this n-hexane at 50 °C, as determined by the
chapter, yields total extractives in method described in § 177.1520(d)(3)(ii).
each extracting solvent not to exceed (b) Chlorinated polyethylene may be
0.5 milligram per square inch of food- used in contact with all types of food,
contact surface as determined by the except that when used in contact with
methods described in § 176.170(d) of this fatty food of Types III, IV-A, V, VII-A,
chapter; and if the finished food-con- and IX described in table 1 of § 176.170(c)
tact article is itself the subject of a of this chapter, chlorinated poly-
regulation in parts 174, 175, 176, 177, 178, ethylene is limited to use only as a
and § 179.45 of this chapter, it shall also modifier admixed at levels not exceed-
comply with any specifications and ing 15 weight percent in plastic articles
limitations prescribed for it by that prepared from polyvinyl chloride and/
regulation. In testing the finished food- or from vinyl chloride copolymers com-
contact articles, a separate test sample plying with § 177.1980.
is to be used for each required extract-
ing solvent. FR 10109, Mar. 19, 1984; 59 FR 14550, Mar. 29,
(c) The provisions of paragraph (b) of 1994]
this section are not applicable to
carboxyl-modified polyethylene resins § 177.1615 Polyethylene, fluorinated.
used in food-packaging adhesives com-
plying with § 175.105 of this chapter. Fluorinated polyethylene, identified
in paragraph (a) of this section, may be
§ 177.1610 Polyethylene, chlorinated. safely used as food-contact articles in
Chlorinated polyethylene identified
scribed conditions:
in this section may be safely used as
articles or components of articles that (a) Fluorinated polyethylene food-
contact food, except for articles used contact articles are produced by modi-
for packing or holding food during fying the surface of polyethylene arti-
cooking, subject to the provisions of cles through action of fluorine gas in
this section. combination with gaseous nitrogen as
(a) For the purpose of this section, an inert diluent. Such modification af-
chlorinated polyethylene consists of fects only the surface of the polymer,
basic polymers produced by the direct leaving the interior unchanged.
chlorination of polyethylene con- Fluorinated polyethylene articles are
forming to the density, maximum n- manufactured from basic resins con-
hexane extractable fraction, and max- taining not less than 85 weight-percent
imum xylene soluble fraction specifica- of polymer units derived from ethylene
tions prescribed under item 2.1 of the and identified in § 177.1520 (a)(2) and
table in § 177.1520(c). Such chlorinated (3)(i).
polyethylene contains a maximum of 60 (b) Fluorinated polyethylene articles
percent by weight of total chlorine, as conform to the specifications and use
determined by ASTM 1method D1303–55 limitations of § 177.1520(c), items 2.1 and
(Reapproved 1979), ‘‘Standard Test 3.1.
Method for Total Chlorine in Vinyl (c) The finished food-contact article,
Chloride Polymers and Copolymers,’’ when extracted with the solvent or sol-
which is incorporated by reference vents characterizing the type of food
312
and under conditions of time and tem- used as provided in §§ 175.105 and 176.210
perature characterizing the conditions of this chapter, and § 177.2800. The pro-
of its intended use as determined from visions of paragraph (b) of this section
tables 1 and 2 of § 176.170(c) of this chap- are not applicable to oxidized poly-
ter, yields fluoride ion not to exceed 5 ethylene used as provided in §§ 175.125
parts per million calculated on the and 176.170(a)(5) of this chapter and
basis of the volume of food held by the § 177.1200.
§ 177.1630 Polyethylene phthalate
[48 FR 39057, Aug. 29, 1983] polymers.
§ 177.1620 Polyethylene, oxidized. Polyethylene phthalate polymers
Oxidized polyethylene identified in identified in this section may be safely
paragraph (a) of this section may be used as, or components of plastics
safely used as a component of food-con- (films, articles, or fabric) intended for
tact articles, in accordance with the use in contact with food in accordance
following prescribed conditions: with the following prescribed condi-
(a) Oxidized polyethylene is the basic tions:
resin produced by the mild air oxida- (a) Polyethylene phthalate films con-
tion of polyethylene conforming to the sist of a base sheet of ethylene
density, maximum n-hexane extract- terephthalate polymer, ethylene
able fraction, and maximum xylene terephthalate-isophthalate copolymer,
soluble fraction specifications pre- or ethylene-1,4-cyclohexylene
scribed under item 2.3 of the table in dimethylene terephthalate copoly-
§ 177.1520(c). Such oxidized polyethylene esters described in § 177.1315(b)(3), to
has a minimum number average molec- which have been added optional sub-
ular weight of 1,200, as determined by stances, either as constituents of the
high temperature vapor pressure os- base sheet or as constituents of coat-
mometry, contains a maximum of 5 ings applied to the base sheet.
percent by weight of total oxygen, and (b) Polyethylene phthalate articles
has an acid value of 9 to 19. consist of a base polymer of ethylene
(b) The finished food-contact article, terephthalate polymer, or ethylene-1,4-
when extracted with the solvent or sol- cyclohexylene dimethylene
vents characterizing the type of food terephthalate copolyesters described in
and under the conditions of time and § 177.1315(b)(3), to which have been
temperature characterizing the condi- added optional substances, either as
tions of its intended use as determined constituents of the base polymer or as
from tables 1 and 2 of § 176.170(c) of this constituents of coatings applied to the
chapter, yields net acidified chloro- base polymer.
form-soluble extractives not to exceed (c)(1) Polyethylene phthalate
0.5 milligram per square inch of food- spunbonded nonwoven fabric consist of
contact surface when tested by the continuous filaments of ethylene
methods described in § 177.1330(c), ex- terephthalate polymer and ethylene
cept that net acidified chloroform-solu- terephthalate-isophthalate copolymer
ble extractives from paper and paper- to which may have been added optional
board complying with § 176.170 of this adjuvant substances required in their
chapter may be corrected for wax, pet- preparation and finishing.
rolatum, and mineral oil as provided in (2) The ethylene terephthalate-
§ 176.170(d) (5)(iii)(b) of this chapter. If isophthalate copolymer component of
the finished food-contact article is the fabric shall not exceed 25 percent
itself the subject of a regulation in by weight. The filaments may be blend-
parts 174, 175, 176, 177, 178 and § 179.45 of ed with other fibers regulated for the
this chapter, it shall also comply with specific use and the spunbonded fabric
any specifications and limitations pre- may be further bonded by application
scribed for it by such regulations. of heat and/or pressure.
(NOTE: In testing the finished food-con- (3) The fabric shall be used only in
tact article, use a separate test sample accordance with paragraph (i) of this
for each extracting solvent.) section.
(c) The provisions of this section are (d) The quantity of any optional sub-
not applicable to oxidized polyethylene stance employed in the production of
313
§ 177.1630 21 CFR Ch. I (4–1–12 Edition)
polyethylene phthalate plastics does Ethylene-1,4-cyclohexylene dimethylene

not exceed the amount reasonably re- terephthalate copolyesters described in
quired to accomplish the intended § 177.1315(b)(3).
Ethylene terephthalate polymer: Prepared
physical or technical effect or any lim- by the condensation of dimethyl
itations further provided. Any sub- terephthalate and ethylene glycol.
stance employed in the production of Ethylene terephthalate polymer: Prepared
polyethylene phthalate plastics that is by the condensation of terephthalic acid
the subject of a regulation in parts 174, and ethylene glycol.
175, 176, 177, 178 and 179 of this chapter (iii) Coatings:
conforms with any specification in Acrylic copolymers (CAS Reg. No. 30394–86–
such regulation. 6): Prepared by reaction of ethyl acrylate
(e) Substances employed in the pro- (CAS Reg. No. 140–88–5), methyl methacry-
duction of polyethylene phthalate plas- late (CAS Reg. No. 80–62–6), and
tics include: methacrylamide (CAS Reg. No. 79–39–0)
(1) Substances generally recognized blended with melamine-formaldehyde resin
as safe in food. (CAS Reg. No. 68002–20–0). For use in coat-
(2) Substances subject to prior sanc- ings for polyethylene phthalate films com-
tion or approval for use in poly- plying with paragraph (a) of this section.—
Ethylene azelate-terephthalate copolymer:
ethylene phthalate plastics and used in The copolymer, dissolved in 1,1,2-trichloro-
accordance with such sanction or ap- ethane and/or methylene chloride, may be
proval. used as a heat-activated sealant on poly-
(3) Substances which by regulation in ethylene terephthalate film intended for
parts 174, 175, 176, 177, 178 and § 179.45 of sealing polyethylene terephthalate pouch-
this chapter may be safely used as es that are used as containers of either
components of resinous or polymeric nonalcoholic beverages or alcoholic bev-
food-contact surfaces subject to the erages containing not more than 15 percent
provisions of such regulation. ethyl alcohol. The copolymer has a
terephthalate/azelate molecular ratio of
(4) Substances identified in this para-
1.25/1.00 and a relative viscosity of not less
graph (e)(4) subject to the limitations than 1.5 as determined by a method title
prescribed: ‘‘General Procedure of Determining the
Relative Viscosity of Resin Polymers,’’
LIST OF SUBSTANCES AND LIMITATIONS which is incorporated by reference. Copies
(i) Base sheet: are available from the Center for Food
Safety and Applied Nutrition (HFS–200),
Ethylene terephthalate copolymers: Pre-
Food and Drug Administration, 5100 Paint
pared by the condensation of dimethyl
Branch Pkwy., College Park, MD 20740, or
terephthalate or terephthalic acid with
available for inspection, at the National
ethylene glycol, modified with one or more
of the following: Azelaic acid, dimethyl
azelate, dimethyl sebacate, sebacic acid.
Ethylene terephthalate copolymers: Pre- ability of this material at NARA, call 202–
pared by the condensation of dimethyl 741–6030, or go to: http://www.archives.gov/
terephthalate or terephthalic acid with federallregister/
ethylene glycol, modified with one or more codeloflfederallregulations/
of the following: Azelaic acid, dimethyl ibrllocations.html. Total residual copoly-
azelate, dimethyl sebacate, sebacic acid, mer solvent (1,1,2-trichloroethane and/or
pyromellitic dianhydride. The level of methylene chloride) shall not exceed 0.13
pyromellitic dianhydride shall not exceed milligram per square inch of film, and food
0.5 percent by weight of the finished co- contact of the film shall be limited to not
polymer which may be used under condi- more than 1 square inch per 250 grams of
tions of use E through H as described in beverage.
table 2 of § 176.170(c) of this chapter. 2-Ethylhexyl acrylate copolymerized with
Ethylene terephthalate-isophthalate copoly- one or more of the following:
mers: Prepared by the condensation of Acrylonitrile.
dimethyl terephthalate or terephthalic Methacrylonitrile.
acid and dimethyl isophthalate or iso- Methyl acrylate.
phthalic acid with ethylene glycol. The Methyl methacrylate.
finished copolymers contain either: Itaconic acid.
(a) 77 to 83 weight percent or Vinylidene chloride copolymerized with one
(b) At least 97 weight percent of polymer or more of the following:
units derived from ethylene Methacrylic acid and its methyl, ethyl,
terephthalate. propyl, butyl, or octyl esters.

Acrylic acid and its methyl, ethyl, propyl,
(ii) Base sheet and base polymer: butyl, or octyl esters.
314
Acrylonitrile. formation on the availability of this ma-
Methacrylonitrile. terial at NARA, call 202–741–6030, or go
Vinyl chloride. to: http://www.archives.gov/
Itaconic acid. federallregister/
Styrene-maleic anhydride resin, partial 2- codeloflfederallregulations/
butoxyethyl ester, ammonium salt (CAS ibrllocations.html.
Reg. No. 68890–80–2). For use only as a coat- The modifier is used at a level not to ex-
ing for polyethylene phthalate films com- ceed 5 percent by weight of polyethylene
plying with paragraph (a) of this section, terephthalate film. The average thick-
at levels not to exceed 0.025 gram per ness of the finished film shall not exceed
square meter (0.016 milligram per square 0.016 millimeter (0.0006 inch).
inch) of the film, in contact with food of Hexanedioic acid polymer with 1,3-
types VIII and IX in table 1 of § 176.170(c) of benzenedimethanamine (CAS Reg. No.
this chapter, under use conditions E, F, 25718–70–1) meeting the specifications in
and G in table 2 of § 176.170(c) of this chap- § 177.1500(b), item 10, when tested by the
ter. methods given in § 177.1500(c). The modi-
fier is used in polyethylene terephthalate
(iv) Emulsifiers: at a level not to exceed 30 percent by
Sodium dodecylbenzenesulfonate: As an ad- weight of the polyethylene
juvant in the application of coatings to the terephthalate.
base sheet or base polymer. Chloroform-soluble extractives shall not
Sodium lauryl sulfate: As an adjuvant in the exceed 0.08 milligram/centimeter2 (0.5
application of coatings to the base sheet or milligram/inch2) of food-contact surface
base polymer. of the modified polyethylene
2-Sulfoethyl methacrylate, sodium salt (CAS terephthalate article when exposed to
Reg. No. 1804–87–1). For use only in copoly- the following solvents at temperatures
mer coatings on polyethylene phthalate and times indicated:
film under conditions of use E, F, and G de- (a) Distilled water at 49 °C (120 °F) for 24
scribed in table 2 of § 175.300(d) of this chap- hours;
ter, and limited to use at a level not to ex- (b) n-Heptane at 49 °C (120 °F) for 24 hours;
ceed 2.0 percent by weight of the dry co- (c) 8 percent ethyl alcohol at 49 °C (120 °F)
polymer coating. for 24 hours.
For use in contact with all types of foods
(v) Modifier: except (a) those containing more than 8
1,4-Benzenedicarboxylic acid, dimethyl ester, percent alcohol, or (b) those at tempera-
polymer with 1,4-butanediol and a-hydro- tures over 49 °C (120 °F).
omega-hydroxypoly(oxy-1,4-butanediyl)
CAS Reg. No. 9078–71–1) meeting the fol- (f) Polyethylene phthalate plastics
lowing specifications: conforming with the specifications pre-
Melting point: 200° to 215 °C as determined scribed in paragraph (f)(1) of this sec-
by ASTM method D2117–82, ‘‘Standard tion are used as provided in paragraph
Test Method for Melting Point of (f)(2) of this section:
Semicrystalline Polymers by the Hot
(1) Specifications. (i) The food contact
Stage Microscopy Method,’’ which is in-
corporated by reference. Copies may be surface, when exposed to distilled
obtained from the American Society for water at 250 °F for 2 hours, yields chlo-
Testing Materials, 100 Barr Harbor Dr., roform-soluble extractives not to ex-
West Conshohocken, Philadelphia, PA ceed 0.5 mg/in2 of food contact surface
19428-2959, or may be examined at the Na- exposed to the solvent; and
tional Archives and Records Administra- (ii) The food contact surface, when
tion (NARA). For information on the exposed to n-heptane at 150 °F for 2
availability of this material at NARA, hours, yields chloroform-soluble ex-
call 202–741–6030, or go to: http://
tractives not to exceed 0.5 mg/in2 of
codeloflfederallregulations/ food contact surface exposed to the sol-
ibrllocations.html. vent.
Density: 1.15 to 1.20 as determined by ASTM (2) Conditions of use. The plastics are
method D1505–68 (Reapproved 1979), used for packaging, transporting, or
‘‘Standard Test Method for Density of holding food, excluding alcoholic bev-
Plastics by the Density-Gradient Tech- erages, at temperatures not to exceed
nique,’’ which is incorporated by ref- 250 °F.
erence. Copies may be obtained from the
(g) Polyethylene phthalate plastics
American Society for Testing Materials,
100 Barr Harbor Dr., West Conshohocken, conforming with the specifications pre-
scribed in paragraph (g)(1) of this sec-

examined at the National Archives and tion are used as provided in paragraph
Records Administration (NARA). For in- (g)(2) of this section.
315
§ 177.1632 21 CFR Ch. I (4–1–12 Edition)
(1) Specifications. (i) The food contact including filtration, at temperatures

surface meets the specifications in not exceeding 212 °F.
paragraph (f)(1) of this section; and (iii) Filtration of bulk alcoholic bev-
(ii) The food contact surface when ex- erages, not exceeding 50 percent alco-
posed to 50 percent ethyl alcohol at 120 hol by volume, at temperatures not ex-
°F for 24 hours, yields chloroform-solu- ceeding 120 °F.
ble extractives not to exceed 0.5 mg/in2 (j) Polyethylene phthalate plastics,
of food contact surface exposed to the composed of ethylene terephthalate-
solvent. isophthalate containing a minimum of
(2) Conditions of use. The plastics are 98 weight percent of polymer units de-
used for packaging, transporting, or rived from ethylene terephthalate, or
holding alcoholic beverages that do not ethylene-1,4-cyclohexylene
exceed 50 percent alcohol by volume. dimethylene terephthalate copoly-
(h) Uncoated polyethylene phthalate esters described in § 177.1315(b)(3), con-
plastics consisting of a base sheet or forming with the specifications pre-
base polymer prepared as prescribed scribed in paragraph (j)(1) of this sec-
from substances identified in para- tion, are used as provided in paragraph
graphs (e)(4)(i) and (ii) of this section (j)(2) of this section.
and conforming with the specifications (1) Specifications. (i) The food contact
prescribed in paragraph (h)(1) of this surface meets the specifications in
section are used as provided in para- paragraph (f)(1) of this section and
graph (h)(2) of this section: (ii)(a) Containers with greater than 500
(1) Specifications. (i) The food contact mL capacity. The food-contact surface
surface, when exposed to distilled when exposed to 95 percent ethanol at
water at 250 °F for 2 hours yields chlo- 120 °F for 24 hours should not yield
roform-soluble extractives not to ex- chloroform-soluble extractives in ex-
ceed 0.02 milligram/inch 2 of food con- cess of 0.005 mg/in 2.
tact surface exposed to the solvent; and (b) Containers with less than or equal to
(ii) The food contact surface, when 500 mL capacity. The food contact sur-
exposed to n-heptane at 150 °F for 2 face when exposed to 95 percent eth-
hours, yields chloroform-soluble ex- anol at 120 °F for 24 hours should not
tractives not to exceed 0.02 milligram/ yield chloroform-soluble extractives in
inch 2 of food contact surface exposed excess of 0.05 mg/in 2.
to the solvent. (2) Conditions of use. The plastics are
(2) Conditions of use. The plastics are used for packaging, transporting, or
used to contain foods during oven bak- holding alcoholic foods that do not ex-
ing or oven cooking at temperatures ceed 95 percent alcohol by volume.
above 250 °F.
(i) Polyethylene phthalate fabric, [42 FR 14572, Mar. 15, 1977, as amended at 42
identified in paragraph (c) of this sec- FR 18611, Apr. 8, 1977; 44 FR 40886, July 13,
tion and conforming with the specifica- 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844,
Mar. 19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR
tions prescribed in paragraph (i)(1) of
30361, July 1, 1983; 49 FR 10110, Mar. 19, 1984;
this section, is used only as provided in 50 FR 31047, July 24, 1985; 51 FR 3772, Jan. 30,
paragraph (i)(2) of this section. 1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750,
(1) Specifications. Chloroform-soluble Apr. 19, 1989; 54 FR 24898, June 12, 1989; 60 FR
extractives shall not exceed 0.2 milli- 57927, Nov. 24, 1995; 60 FR 61654, Dec. 1, 1995;
gram/inch 2 of food-contact surface 61 FR 46718, Sept. 5, 1996]
when exposed to the following solvents
at temperatures and times indicated: § 177.1632
(i) Distilled water at 212 °F for 2 Poly(phenyleneterephthalamide)
resins.
hours.
(ii) n-Heptane at 150 °F for 2 hours. Poly(phenyleneterephthalamide) res-
(iii) 50 percent ethyl alcohol at 120 °F ins identified in paragraph (a) of this
for 24 hours. section may be safely used as articles
(2) Conditions of use. The plastics are or components of articles intended for
intended for: repeated contact with food.
(i) Dry food contact. (a) Identity. For the purpose of this
(ii) Bulk food (excluding alcoholic section, the poly(phenylene-

beverages) repeated use applications, terephthalamide) resins (CAS Reg. No.
316
26125–61–1) are produced by the polym- refluxed in a 50 percent ethanol/water

erization of terephthalolyl chloride mixture for 24 hours, yields total
with p-phenylenediamine. The extractables not exceeding 0.65 percent
poly(phenyleneterephthalamide) resin by weight of the sample.
fibers and yarns may contain optional (d) Conditions of use. (1)
adjuvant substances required in their Poly(phenyleneterephthalamide) resins
preparation and finishing. in the form of continuous filament
(b) Optional adjuvant substances. The yarns and fibers may be used as compo-
poly(phenyleneterephthalamide) resins nents of articles intended for repeated
identified in paragraph (a) of this sec- use in contact with food at tempera-
tion may contain the following op- tures not to exceed 260 °C (500 °F). All
tional adjuvant substances, subject to items are scoured prior to use by agita-
any limitation on their use: tion in a water bath containing 0.5
(1) Optional adjuvant substances au- gram/liter of tetrasodium
thorized for this use in accordance with pyrophosphate and 0.5 percent deter-
§ 174.5 of this chapter. gent. The items are agitated at 80 °C
(2) Optional finish components, total (180 °F) for 20 minutes, and then sub-
weight not to exceed 1 percent by jected to a cold water rinse.
weight of the base polymer, as follows: (2) Poly(phenyleneterephthalamide)
resins in the form of pulp may be used
as gaskets and packing for food proc-
Diundecylphthalate (CAS essing equipment at temperatures not
Reg. No. 3648–20–2). to exceed 260 °C (500 °F).
Mono- and dipotassium salts
of lauryl phosphate (CAS [57 FR 3125, Jan. 28, 1992, as amended at 69
Reg. No. 39322–78–6). FR 24512, May 4, 2004]
o-Phenylphenol (CAS Reg. For use as a fungicide for fin-
No. 90–43–7). ish coating materials. Not
to exceed 0.01 percent by
§ 177.1635 Poly(p-methylstyrene) and
weight of the base poly- rubber-modified poly(p-methyl-
mer. styrene).
Poly(oxyethylene/
oxypropylen-
Poly(p-methylstyrene) and rubber-
e)monobutylether (CAS modified poly(p-methylstyrene) identi-
Reg. No. 9038–95–3). fied in this section may be safely used
Poly(oxyethylene) as components of articles intended for
mono(nonylphenyl)ether
(CAS Reg. No. 9016–45– use in contact with food, subject to the
9). provisions of this section:
Polyvinyl methylether (CAS (a) Identity. For the purposes of this
Reg. No. 9003–09–2).
Poly(oxyethylene) sorbitol
section, poly(p-methylstyrene) and
monolaurate tetraoleate rubber-modified poly(p-methylstyrene)
(CAS Reg. No. 71243–28– are basic polymers, manufactured as
2). described in this paragraph, meeting
Poly(oxyethylene) sorbitol
hexaoleate (CAS Reg. No. the specifications prescribed in para-
57171–56–9). graph (c) of this section.
4,4′-Butylidenebis (6-tert- For use only as an oxidation (1) Poly(p-methylstyrene) (CAS Reg.
butyl-m-cresol) (CAS Reg. inhibitor for finish coating No. 24936–41–2) polymer produced by the
No. 85–60–9). materials. Not to exceed
0.01 percent by weight of polymerization of p-methylstyrene.
the base polymer. (2) Rubber-modified poly(p-
methylstyrene) (CAS Reg. No. 33520–88–
(c) Specifications. (1) 6) polymer produced by combining sty-
Poly(phenyleneterephthalamide) resins rene-butadiene copolymer and/or
in the form of continuous filament polybutadiene with poly(p-
yarns or fibers that have been scoured methylstyrene), either during or after
in accordance with paragraph (d)(1) of polymerization of the poly(p-
this section, when refluxed in a 50 per- methylstyrene), such that the finished
cent ethanol/water mixture for 24 polymers contain not less than 75
hours, yields total extractables not ex- weight percent of total polymer units
ceeding 0.5 percent by weight of the derived from p-methylstyrene) mon-
sample. omer.
(2) Poly(phenyleneterephthalamide) (b) Optional adjuvants. The basic

resins in the form of pulp, when polymers identified in paragraph (a) of
317
§ 177.1637 21 CFR Ch. I (4–1–12 Edition)
this section may contain optional adju- (a)(1) and (a)(2), respectively, of this
vant substances required in the produc- section shall be used in contact with
tion of such basic polymers. Such op- food only under conditions of use B
tional adjuvant substances may in- through H set forth in table 2 of
clude substances permitted for such § 176.170(c) of this chapter.
use by applicable regulations in this [48 FR 31384, July 8, 1983, as amended at 54
chapter, substances generally recog- FR 24898, June 12, 1989; 55 FR 52989, Dec. 26,
nized as safe in food, substances gen- 1990]
erally recognized as safe in indirect ad-
ditives, and substances used in accord- § 177.1637 Poly(oxy-1,2-
ance with prior sanction or approval. ethanediyloxycarbonyl-2,6-
(c) Specifications. (1) Poly(p- naphthalenediylcarbonyl) resins.
methylstyrene) basic polymers identi- Poly(oxy-1,2-ethanediyloxycarbonyl-
fied in paragraph (a)(1) of this section 2,6-naphthalenediylcarbonyl) resins
shall contain not more than 1 weight identified in paragraph (a) of this sec-
percent of total residual p- tion may be safely used as articles or
methystyrene monomer, as determined components of articles intended for use
by a gas chromatographic method ti- in contact with food in accordance
tled, ‘‘Gas Chromatographic Deter- with the following conditions:
mination of PMS and PET in PPMS (a) Identity. For the purpose of this
Basic Polymers,’’ which is incorporated section, poly(oxy-1,2-
by reference. Copies are available from ethanediyloxycarbonyl-2,6-
the Center for Food Safety and Applied naphthalenediylcarbonyl) resins (CAS
Nutrition (HFS–200), Food and Drug Reg. No. 24968–11–4) are polymers
Administration, 5100 Paint Branch formed by catalytic transesterification
Pkwy., College Park, MD 20740, or of 2,6-dimethylnaphthalene
available for inspection at the National dicarboxylate with ethylene glycol fol-
Archives and Records Administration lowed by catalytic polycondensation.
(NARA). For information on the avail- (b) Specifications—(1) Density. The
ability of this material at NARA, call density of poly(oxy-1,2-
202–741–6030, or go to: http:// ethanediyloxycarbonyl-2,6-
www.archives.gov/federallregister/ naphthalenediylcarbonyl) resins shall
codeloflfederallregulations/ be between 1.33 and 1.40 grams per
ibrllocations.html. cubic centimeter.
(2) Rubber-modified poly(p- (2) Inherent viscosity. The finished
methylstyrene) basic polymers identi- food-contact article shall have a min-
fied in paragraph (a)(2) of this section imum inherent viscosity of 0.55 deci-
shall contain not more than 0.5 weight liter per gram in a solution of 0.1 gram
percent of total residual p- of polymer in 100 milliliters of a 25/40/
methylstyrene monomer, as deter- 35 (weight/weight/weight) solution of p-
mined by the method identified in chlorophenol/tetrachloroethane/phenol.
paragraph (c)(1) of this section The viscosity is determined by East-
(d) Other specifications and limitations. man Chemical Co.’s method ECD-A-AC-
The poly(p-methylstyrene) and rubber- G-V-1-5, ‘‘Determination of Dilute So-
modified poly(p-methylstyrene) identi- lution Viscosity of Polyesters,’’ dated
fied in and complying with this sec- May 31, 1988, which is incorporated by
tion, when used as components of the reference in accordance with 5 U.S.C.
food-contact surface of any article that 552(a) and 1 CFR part 51. Copies are
is the subject of a regulation in parts available from the Office of Premarket
175, 176, 177, 178 and § 179.45 of this chap- Approval, Center for Food Safety and
ter, shall comply with any specifica- Applied Nutrition (HFS–215), Food and
tions and limitations prescribed by Drug Administration, 5100 Paint
such regulation for the article in the Branch Pkwy., College Park, MD 20740,
finished form in which it is to contact or may be examined at the Center for
food. Food Safety and Applied Nutrition’s
(e) Conditions of use. Poly(p- Library, Food and Drug Administra-
methylstyrene) basic polymers and tion, 5100 Paint Branch Pkwy., College
rubber-modified poly(p-methylstyrene) Park, MD 20740, or at the National Ar-

basic polymers identified in paragraphs chives and Records Administration
318
(NARA). For information on the avail- less than 75 weight percent of total
ability of this material at NARA, call polymer units derived from styrene
202–741–6030, or go to: http:// monomer.
www.archives.gov/federallregister/ (b) Optional adjuvants. The basic
codeloflfederallregulations/ polymers identified in paragraph (a) of
ibrllocations.html. this section may contain optional adju-
(c) Extraction limitations. A 0.5 milli- vant substances required in the produc-
meter (0.02 inch) thick sheet of resin tion of such basic polymers. Such op-
when extracted with water at 121 °C tional adjuvant substances may in-
(250 °F) for 2 hours shall yield total clude substances permitted for such
nonvolatile extractives not exceeding use by regulations in parts 170 through
2.0 micrograms per square inch of ex- 189 of this chapter, substances gen-
posed resin surface. erally recognized as safe in food, and
(d) Conditions of use. The finished substances used in accordance with a
food contact article shall be: prior sanction or approval.
(1) Used in contact only with food of (c) Specifications. (1) Polystyrene
Types I, II, IVB, VIA, VIB, VIIB, and basic polymers identified in paragraph
VIII identified in table 1 of § 176.170(c) (a)(1) of this section shall contain not
of this chapter, under conditions of use more than 1 weight percent of total re-
A through H described in table 2 of sidual styrene monomer, as determined
§ 176.170(c) of this chapter; and with by the method described in paragraph
food of Types III, IVA, V, VIC, VIIA, (d) of this section, except that when
and IX identified in table 1 of used in contact with fatty foods of
§ 176.170(c) of this chapter, under condi- Types III, IV-A, V, VII-A, and IX de-
tions of use C through H described in scribed in table 1 of § 176.170(c) of this
table 2 of § 176.170(c) of this chapter; chapter, such polystyrene basic poly-
and mers shall contain not more than 0.5
(2) Identified in a manner that will weight percent of total residual sty-
differentiate the article from articles rene monomer.
made of other polymeric resins to fa- (2) Rubber-modified polystyrene
cilitate collection and sorting. basic polymers identified in paragraph
[61 FR 14965, Apr. 4, 1996] (a)(2) of this section shall contain not
more than 0.5 weight percent of total
§ 177.1640 Polystyrene and rubber- residual styrene monomer, as deter-
modified polystyrene. mined by the method described in para-
Polystyrene and rubber-modified pol- graph (d) of this section.
ystyrene identified in this section may (d) Analytical method for determination
be safely used as components of arti- of total residual styrene monomer con-
cles intended for use in contact with tent—(1) Scope. This method is suitable
food, subject to the provisions of this for the determination of residual sty-
section. rene monomer in all types of styrene
(a) Identity. For the purposes of this polymers.
section, polystyrene and rubber-modi- (2) Principle. The sample is dissolved
fied polystyrene are basic polymers in methylene chloride. An aliquot of
manufactured as described in this para- the solution is injected into a gas chro-
graph so as to meet the specifications matograph. The amount of styrene
prescribed in paragraph (c) of this sec- monomer present is determined from
tion when tested by the method de- the area of the resulting peak.
scribed in paragraph (d) of this section. (3) Apparatus—(i) Gas chromatograph.
(1) Polystyrene consists of basic poly- Beckman GC-2A gas chromatograph
mers produced by the polymerization with hydrogen flame detector or appa-
of styrene. ratus of equivalent sensitivity.
(2) Rubber-modified polystyrene con- (ii) Chromatograph column. One-quar-
sists of basic polymers produced by ter inch outside diameter stainless
combining styrene-butadiene copoly- steel tubing (0.028 inch wall thickness),
mers and/or polybutadiene with poly- 4 feet in length, packed with 20 percent
styrene, either during or after polym- polyethylene glycol (20,000 molecular
erization of the polystyrene, such that weight) on alkaline treated 60–80 mesh
the finished basic polymers contain not firebrick.
319
§ 177.1650 21 CFR Ch. I (4–1–12 Edition)
(iii) Recorder. Millivolt range of 0–1, components of the food-contact surface

chart speed of 30 inches per hour. of any article that is the subject of a
(4) Reagents. Compressed air, purified; regulation in parts 174, 175, 176, 177, 178
helium gas; hydrogen gas; methylene and § 179.45 of this chapter, shall com-
chloride, redistilled; and styrene mon- ply with any specifications and limita-
omer, redistilled. tions prescribed by such regulation for
(5) Operating conditions for the gas the article in the finished form in
chromatograph. (i) The column is oper- which it is to contact food.
ated at a temperature of 100 °C with a (f) Nonapplicability. The provisions of
helium flow rate of 82 milliliters per this section are not applicable to poly-
minute. styrene and rubber-modified poly-
(ii) The hydrogen burner is operated styrene used in food-packaging adhe-
with 15 pounds per square inch of air sives complying with § 175.105 of this
pressure and 7 pounds per square inch chapter.
of hydrogen pressure.
(iii) The attenuation of the hydrogen § 177.1650 Polysulfide polymer-
flame detector is set at 2×102. polyepoxy resins.
(6) Standardization. (i) Prepare a Polysulfide polymer-polyepoxy res-
standard solution by weighing accu- ins may be safely used as the food-con-
rately 15 to 20 milligrams of styrene tact surface of articles intended for
monomer into a 2-ounce bottle con- packaging, transporting, holding, or
taining 25.0 milliliters of methylene otherwise contacting dry food, in ac-
chloride. Cap the bottle tightly and cordance with the following prescribed
shake to thoroughly mix the solution. conditions:
(ii) By means of a microliter syringe, (a) Polysulfide polymer-polyepoxy
inject 1 microliter of the standard solu- resins are the reaction products of liq-
tion into the gas chromatograph. Meas- uid polysulfide polymers and
ure the area of the styrene monomer polyfunctional epoxide resins, cured
peak which emerges after approxi- with the aid of
mately 12 minutes. tri(dimethylaminomethyl) phenol, to
(7) Procedure. (i) Transfer 1 gram of
which have been added certain optional
sample (accurately weighed to the
substances to impart desired techno-
nearest 0.001 gram to a 2-ounce bottle
logical properties to the resins. Subject
and add several glass beads. Pipette
to any limitations prescribed in this
25.0 milliliters of methylene chloride
section, the optional substances may
into the bottle. Cap the bottle tightly
include:
and place on a mechanical shaker.
Shake until the polymer is completely
as safe in food and food packaging.
dissolved. If any insoluble residue re-
(2) Substances the use of which is
mains, allow the bottle to stand (or
permitted under applicable regulations
centrifuge at a low speed) until a clear
in this part, prior sanctions, or approv-
supernatant layer appears.
als.
(ii) By means of a microliter syringe,
(3) Substances named in this subpara-
inject 3 microliters of the clear super-
graph and further identified as re-
natant liquid into the gas chro-
quired:
matograph.
(iii) Measure the area of the resulting List of substances Limitations
styrene monomer peak. Compare the
Bis(2-chloroethyl) formal.
sample peak area with the area pro- Bis(dichloropropyl) formal .................. Cross-linking agent.
duced by the standard styrene mon- Butyl alcohol ...................................... Solvent.
omer solution. Calculation: Carbon black (channel process).
Chlorinated paraffins ......................... Cross-linking agent.
Percent residual styrene Epoxidized linseed oil.
monomer=Milligrams monomer in stand- Epoxidized soybean oil.
ard×peak area of sample/Peak area of mon- Epoxy resins (as listed in
omer standard×sample weight in grams×30 § 175.300(b)(3)(viii)(a) of this chap-
ter)..
(e) Other specifications and limitations. Ethylene glycol monobutyl ether ....... Solvent.
Magnesium chloride.
The polystyrene and rubber-modified
Methyl isobutyl ketone ....................... Solvent.

polystyrene identified in and com- Naphthalene sulfonic acid-formalde-
plying with this section, when used as hyde condensate, sodium salt.
320
List of substances Limitations lecular weight of 15,000, as determined

by osmotic pressure in
Sodium dibutyl naphthalene Wetting agent.
sulfonate. monochlorobenzene; or
Sodium hydrosulfide. (2) 1,1′-Sulfonylbis[4-chlorobenzene]
Sodium polysulfide.
b,b′,g,g′-Tetrachloro normal propyl Cross-linking agent.
polymer with 4,4′-(1-
ether. methylethylidene)bis[phenol] (min-
Titanium dioxide. imum 92 percent) and 4,4′-
Toluene .............................................. Solvent.
Trichloroethane .................................. Cross-linking agent.
sulfonylbis[phenol] (maximum 8 per-
1,2,3-Trichloropropane ...................... Do. cent) (CAS Reg. No. 88285–91–0) pro-
Urea-formaldehyde resins. duced when a mixture of 4,4′-
Xylene ................................................ Solvent.
isopropylidenediphenol (minimum 92
(b) The resins are used as the food- percent) and 4,4′-sulfonylbis[phenol]
contact surface for dry food. (maximum 8 percent) is made to react
(c) An appropriate sample of the fin- with 4,4′-dichlorodiphenyl sulfone in
ished resin in the form in which it con- such a way that the finished resin has
tacts food, when subjected to ASTM a minimum number average molecular
method D968–81, ‘‘Standard Test Meth- weight of 26,000, as determined by os-
ods for Abrasion Resistance of Organic motic pressure in dimethylformamide.
Coatings by the Falling Abrasive (b) The basic polysulfone resins iden-
Tester,’’ which is incorporated by ref- tified in paragraph (a) of this section
erence (Copies may be obtained from may contain optional adjuvant sub-
the American Society for Testing Ma- stances required in the production of
terials, 100 Barr Harbor Dr., West such basic resins. The optional adju-
Conshohocken, Philadelphia, PA 19428- vant substances required in the produc-
2959, or may be examined at the Na- tion of the basic polysulfone resins
tional Archives and Records Adminis- may include substances described in
tration (NARA). For information on § 174.5(d) of this chapter and the fol-
the availability of this material at lowing:
www.archives.gov/federallregister/ List of substances Limitations
codeloflfederallregulations/ Dimethyl sulfoxide ..... Not to exceed 50 parts per million as
ibrllocations.html.), using No. 50 Emery residual solvent in finished basic
abrasive in lieu of Ottawa sand, shall resin in paragraph (a)(1) of this
section.
exhibit and abrasion coefficient of not
Monochlorobenzene .. Not to exceed 500 parts per million
less than 20 liters per mil of film thick- as residual solvent in finished
ness. basic resin in paragraph (a)(1) of
this section.
[42 FR 14572, Mar. 15, 1977, as amended at 49 N-methyl-2- Not to exceed 0.01 percent (100
FR 10110, Mar. 19, 1984] pyrrolidone. parts per million) as residual sol-
vent in finished basic resin in para-
§ 177.1655 Polysulfone resins. graph (a)(2) of this section.
Polysulfone resins identified in para-
graph (a) of this section may be safely (c) Polysulfone resins, when ex-
used as articles or components of arti- tracted at reflux temperatures for 6
cles intended for use in contact with hours with the solvents—distilled
food, in accordance with the following water, 50 percent (by volume) ethyl al-
prescribed conditions: cohol in distilled water, 3 percent ace-
(a) For the purpose of this section, tic acid in distilled water, and n-
polysulfone resins are: heptane, yield total extractives in each
(1) Poly(oxy-p-phenylenesulfonyl-p- extracting solvent not to exceed 0.0078
phenyleneoxy-p- milligram per square centimeter (0.05
phenyleneisopropylidene-p-phenylene) milligram per square inch) of resin sur-
resins (CAS Reg. No. 25154–01–2) con- face. Note: In testing the finished
sisting of basic resins produced when polysulfone resins, use a separate resin
the disodium salt of 4,4′- test sample for each required extract-
isopropylidenediphenol is made to ing solvent.
react with 4,4′-dichlorodiphenyl sulfone (d) Polysulfone resins intended for re-
in such a way that the finished resins peated use in contact with food may be
have a minimum number average mo- used under conditions of use A through
321
§ 177.1660 21 CFR Ch. I (4–1–12 Edition)
H in table 2 of § 176.170(c) of this chap- (2) Poly(tetramethylene terephtha-

ter. The resins intended for single-serv- late) in the finished form in which it is
ice food-contact use may be used only to contact food shall yield total extrac-
under condition of use H described in tives as follows:
table 2 of § 176.170(c) of this chapter. (i) Not to exceed 0.08 milligram per
square inch of food contact surface
[51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, when extracted for 2 hours at 250 °F
1986; 61 FR 29475, June 11, 1996]
with distilled water.
(ii) Not to exceed 0.02 milligram per
§ 177.1660 Poly (tetramethylene tere-
phthalate). square inch of food contact surface
when extracted for 2 hours at 150 °F
Poly(tetramethylene terephthalate) with n-heptane.
(poly (oxytetramethyleneoxyter- (iii) Not to exceed 0.04 milligram per
ephthaloyl)) [Chemical Abstracts Serv- square inch of food contact surface
ice Registry No. 24968–12–5] identified when extracted for 2 hours at 212 °F
in this section may be safely used as with 3 percent aqueous acetic acid.
articles or components of articles in- (iv) Not to exceed 0.02 milligram per
tended to contact food, in accordance square inch of food contact surface
with the following prescribed condi- when extracted for 2 hours at 65.6 °C
tions: (150 °F) with 50 percent ethanol.
(a) Identity. For the purpose of this [42 FR 14572, Mar. 15, 1977, as amended at 50
section, poly (tetramethylene FR 20748, May 20, 1985; 52 FR 20069, May 29,
terephthalate) is the reaction product 1987]
of dimethyl terephthalate with 1,4-
butanediol to which may have been § 177.1670 Polyvinyl alcohol film.
added certain optional substances to Polyvinyl alcohol film may be safely
impart desired technological properties used in contact with food of the types
to the polymer. identified in § 176.170(c) of this chapter,
(b) Optional adjuvant substances. table 1, under Types V, VIII, and IX, in
Poly(tetramethylene terephthalate) accordance with the following pre-
identified in paragraph (a) of this sec- scribed conditions:
tion may contain optional adjuvant (a) The polyvinyl alcohol film is pro-
substances. The quantity of any op- duced from polyvinyl alcohol having a
tional adjuvant substance employed in minimum viscosity of 4 centipoises
the production of the polymer does not when a 4-percent aqueous solution is
exceed the amount reasonably required tested at 20 °C.
to accomplish the intended technical (b) The finished food-contact film for
or physical effect. Such adjuvants may use in contact with Food Types V or
include substances generally recog- IX, when extracted with the solvent
nized as safe in food, substances used in characterizing the type of food and
accordance with prior sanction, and under the conditions of time and tem-
substances permitted under applicable perature characterizing its intended
regulations in this part. use as determined from tables 1 and 2
(c) Specifications. (1) Inherent vis- of § 176.170(c) of this chapter, yields
cosity of a 0.50 percent solution of the total extractives not to exceed 0.078
polymer in phenol/tetrachloroethane milligram per square centimeter (0.5
(60/40 weight ratio) solvent is not less milligram per square inch) of food-con-
than 0.6 as determined using a Wagner tact surface when tested by ASTM
viscometer (or equivalent) and cal- method F34–76 (Reapproved 1980),
culated from the following equation: ‘‘Standard Test Method for Liquid Ex-
traction of Flexible Barrier Materials,’’
Inherent ( natural logarithm of N r ) which is incorporated by reference.
viscosity = Copies may be obtained from the Amer-
(c) ican Society for Testing Materials, 100
where: Barr Harbor Dr., West Conshohocken,
Nr=Ratio of flow time of the polymer solu- Philadelphia, PA 19428-2959, or may be
examined at the National Archives and
tion to that of the solvent and c=polymer

concentration of the test solution in grams Records Administration (NARA). For
per 100 milliliters. information on the availability of this
322
ER01JA93.400</GPH>
material at NARA, call 202–741–6030, or 1,4–Cyclohexane dimethanol (CAS Reg. No.

go to: http://www.archives.gov/ 105–08–8).
federallregister/ 2,2-Dimethyl-1,3-propanediol.
Ethylene glycol.
1,6–Hexanediol (CAS Reg. No. 629–11–8).a–
ibrllocations.html. Hydro–w–hydroxypoly(oxy–1,4–butanediyl)
(c) The finished food-contact film (CAS Reg. No. 25190–06–1).
shall not be used as a component of a-Hydro-omega-hydroxypoly (oxytetra-
food containers intended for use in con- methylene).
tact with water. a,a′-(Isopropylidenedi-p-phenylene)bis[omega-
hydroxypoly (oxypropylene)(3–4 moles)],
[42 FR 14572, Mar. 15, 1977, as amended at 49 average molecular weight 675.
FR 10110, Mar. 19, 1984] Maleic anhydride.
Methyl oxirane polymer with oxirane (CAS
§ 177.1680 Polyurethane resins. Reg. No. 9003–11–6).
The polyurethane resins identified in Methyl oxirane polymer with oxirane, ether
paragraph (a) of this section may be with 1,2,3–propanetriol (CAS Reg. No. 9082–
00–2).
safely used as the food-contact surface a,a′a″,a″′-Neopentanetetrayltetrakis [omega-
of articles intended for use in contact hydroxypoly (oxypropylene) (1–2 moles)],
with bulk quantities of dry food of the average molecular weight 400.
type identified in § 176.170(c) of this Pentaerythritol-linseed oil alcoholysis prod-
chapter, table 1, under Type VIII, in ac- uct.
cordance with the following prescribed Phthalic anhydride.
conditions: Polybutylene glycol.
(a) For the purpose of this section, Polyethyleneadipate modified with ethanol-
amine with the molar ratio of the amine to
polyurethane resins are those produced the adipic acid less than 0.1 to 1.
when one or more of the isocyanates Poly(oxycarbonylpentamethylene).
listed in paragraph (a)(1) of this section Polyoxypropylene ethers of 4.4′-isopropyl-
is made to react with one or more of idenediphenol (containing an average of 2–
the substances listed in paragraph 4 moles of propylene oxide).
(a)(2) of this section: Polypropylene glycol.
(1) Isocyanates: a,a′,a″-1,2,3-Propanetriyltris [omega-
hydroxypoly (oxypropylene) (15–18 moles)],
Bis(isocyanatomethyl) benzene (CAS Reg. average molecular weight 3,000.
No. 25854–16–4). Propylene glycol.
Bis(isocyanatomethyl) cyclohexane (CAS a,a′,a″-[Propylidynetris (methylene)] tris
Reg. No. 38661–72–2). [omega-hydroxypoly (oxypropylene) (min-
4,4′-Diisocyanato-3,3′-dimethylbiphenyl (bi- imum 1.5 moles)], minimum molecular
tolylene diisocyanate). weight 400.
Diphenylmethane diisocyanate. a-[r(1,1,3,3-Tetramethylbutyl) - phenyl]-
Hexamethylene diisocyanate. omega-hydroxypoly(oxyethylene) (5 moles),
3-Isocyanatomethyl - 3,5,5 - trimethylcyclo- average molecular weight 425.
hexyl isocyanate. Trimethylol propane.
4,4-Methylenebis(cyclohexyl isocyanate).
Toluene diisocyanate. (b) Optional adjuvant substances em-
ployed in the production of the poly-
(2) List of substances: urethane resins or added thereto to im-
Adipic acid. part desired technical or physical prop-
1,4-Butanediol. erties may include the following sub-
1,3-Butylene glycol. stances:
1-[(2-Aminoethyl)amino]2-propanol ............................................. As a curing agent.

1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ....... As a preservative.
Colorants used in accordance with § 178.3297 of this chapter..
Dibutyltin diacetate ...................................................................... As a catalyst.
Dibutyltin dichloride ..................................................................... Do.
Dibutyltin dilaurate ....................................................................... Do.
N,N-Dimethyldodecylamine ......................................................... Do.
N-Dodecylmorpholine .................................................................. Do.
a,a′-[Isopropylidenebis[p-phenyleneoxy(2-hydroxytrimethylene) As a stabilizer.
]]bis[omega-hydroxypoly-(oxyethylene) (136–170 moles)], av-
erage molecular weight 15,000.

4,4′-Methylenedianiline ................................................................ As a curing agent.
1,1′,1″-Nitrilotri-2-propanol ........................................................... Do.
323
§ 177.1810 21 CFR Ch. I (4–1–12 Edition)
2,2′-(p-Phenylenedioxy) diethanol ............................................... Do.

Polyvinyl isobutyl ether.
Polyvinyl methyl ether.
Soyaalkyd resin ........................................................................... Conforming in composition with § 175.300 of this chapter and
containing litharge not to exceed that residual from its use
as the reaction catalyst and creosol not to exceed that re-
quired as an antioxidant.
Tetrakis [methylene–(2,5–di-tert-butyl-4-hydroxyhydrocinna- Stabilizer.
mate)]methane (CAS Reg. No. 6683–19–8).
N,N,N′N′-Tetrakis (2-hydroxypropyl)ethylenediamine ................. As a curing agent.
Triethanolamine ........................................................................... Do.
Trimethyleneglycol di (p-aminobenzoate) (CAS Reg. No. As a curing agent.
57609–64–0).
(c) An appropriate sample of the fin- § 177.1810 Styrene block polymers.

ished resin in the form in which it con- The styrene block polymers identi-
tacts food, when subjected to ASTM fied in paragraph (a) of this section
method D968–81, ‘‘Standard Test Meth- may be safely used as articles or as
ods for Abrasion Resistance of Organic components of articles intended for use
Coatings by the Falling Abrasive in contact with food, subject to provi-
Tester,’’ which is incorporated by ref- sions of this section.
erence (Copies may be obtained from (a) For the purpose of this section,
the American Society for Testing Ma- styrene block polymers are basic poly-
terials, 100 Barr Harbor Dr., West mers manufactured as described in this
Conshohocken, Philadelphia, PA 19428- paragraph, so that the finished poly-
2959, or may be examined at the Na- mers meet the specifications prescribed
tional Archives and Records Adminis- in paragraph (b) of this section, when
tration (NARA). For information on tested by the methods described in
the availability of this material at paragraph (c) of this section.
NARA, call 202–741–6030, or go to: http:// (1) Styrene block polymers with 1,3-
www.archives.gov/federallregister/ butadiene are those produced by the
codeloflfederallregulations/ catalytic solution polymerization of
ibrllocations.html.), using No. 50 Emery styrene and 1,3-butadiene.
abrasive in lieu of Ottawa sand, shall (2) Styrene block polymers with 2-
methyl-1,3-butadiene are those pro-
exhibit an abrasion coefficient of not
duced by the catalytic solution polym-
less than 20 liters per mil of film thick-
erization of styrene and 2-methyl-1,3-
ness.
butadiene.
[42 FR 14572, Mar. 15, 1977, as amended at 46 (3) Styrene block polymers with 1,3-
FR 57033, Nov. 20, 1981; 49 FR 10110, Mar. 19, butadiene, hydrogenated are those pro-
1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, duced by the catalytic solution polym-
Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991] erization of styrene and 1,3-butadiene,
and subsequently hydrogenated.
(b) Specifications:
Maximum extract- Maximum extract-
able fraction in dis- able fraction in 50
Molecular Glass transi- tilled water at spec- percent ethanol at
Styrene block polymers weight Solubility tion points ified temperatures, specified tempera-
(minimum) times, and tures, times, and
thicknesses thicknesses
1. (i) Styrene block polymers with 1,3- 29,000 Completely ¥98 °C 0.0039 mg/cm2 0.002 mg/cm2 (0.01
butadiene; for use as articles or as soluble in (¥144 °F) (0.025 mg/in2) of mg/in2) of sur-
components of articles that contact toluene. to ¥71 °C surface at reflux face at 66 °C
food of Types I, II, IV-B, VI, VII-B, (¥96 °F) temperature for (150 °F) for 2 hr
and VIII identified in table 1 in and 86 °C 30 min on a 0.19 on a 0.19 cm
§ 176.170(c) of this chapter under (187 °F) to cm (0.075 in) (0.075 in) thick
conditions of use D, E, F, and G de- 122 °C thick sample. sample.
scribed in table 2 in § 176.170(c) of (252 °F).
this chapter.
324

able fraction in dis- able fraction in 50
Molecular Glass transi- tilled water at spec- percent ethanol at
Styrene block polymers weight Solubility tion points ified temperatures, specified tempera-
(minimum) times, and tures, times, and
thicknesses thicknesses
(ii) Styrene block polymers with 1,3-bu- 29,000 ......do .......... ......do .......... ......do .................... Do.
tadiene; for use as components of
pressure-sensitive adhesives that
contact food of Types I, II, IV-B, VI,
VII-B, and VIII identified in table 1 in
§ 176.170(c) of this chapter under
conditions of use C, D, E, F and G
described in table 2 in § 176.170(c) of
this chapter, provided the pressure-
sensitive adhesives be applied only
to closure tapes for sealing con-
tainers having a capacity of not less
than 160 cc (5.5 fluid ounces) and
that the area of the adhesive ex-
posed to food shall not exceed 4.03
cm2 (0.625 in2). The pressure-sen-
sitive adhesive may contain terpene
resins as identified in § 175.125(b)(2)
of this chapter.
2. Styrene block polymers with 2-meth- 29,000 ......do .......... ¥65 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01
yl-1,3-butadiene; for use as articles (¥85 °F) mg/in2) of sur- mg/in2) of sur-
or as components of articles that to ¥47 °C face at reflux face at 66 °C
contact food of Types I, II, IV-B, VI, (¥53 °F) temperature for 2 (150 °F) for 2 hr
VII-B, and VIII identified in table 1 in and 86 °C hr on a 0.071 cm on a 0.071 cm
§ 176.170(c) of this chapter. (187 °F) to (0.028 in) thick (0.028 in) thick
122 °C sample. (Option- sample. (Option-
(252 °F). ally, maximum ally, maximum
net residue solu- net residue solu-
ble in chloroform ble in chloroform
shall not exceed shall not exceed
0.00020 mg/cm2 0.00040 mg/cm2
(0.0013 mg/in2) (0.0025 mg/in2)
of surface.). of surface.)
3. (i) Styrene block polymers with 1,3- 16,000 ......do .......... ¥50 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01
butadiene, hydrogenated (CAS Reg. (¥58 °F) mg/in2) of sur- mg/in2) of sur-
No. 66070–58–4): for use as articles to ¥30 °C face at reflux face at 66 °C
or as components of articles that (¥22 °F) temperature for 2 (150 °F) for 2 hr
contact food of Types I, II, IV-B, VI, and 92 °C hr on a 0.071 cm on a 0.071 cm
VII-B, and VIII identified in table 1 in (198 °F) to (0.028 in) thick (0.028 in) thick
§ 176.170(c) of this chapter. 98 °C (208 sample. sample.
°F).
(ii) Styrene block polymers with 1,3-bu- 16,000 ......do .......... ......do .......... ......do .................... Do.
tadiene, hydrogenated (CAS Reg.
No. 66070–58–4): for use at levels
not to exceed 42.4 percent by weight
as a component of closures with
sealing gaskets that would contact
food of Types III, IV-A, V, VII-A, VIII,
and IX identified in table 1 in
§ 176.170(c) of this chapter, and in
condition of use D as described
under table 2 in § 176.170(c) of this
chapter.
(c) The analytical methods for deter- (2) Glass transition points. The glass
mining whether styrene block poly- transition points shall be determined
mers conform to the specifications pre- by either of the following methods:
scribed in this section are as follows (i) ASTM method D2236–70 (‘‘Stand-
and are applicable to the finished poly- ard Method of Test for Dynamic Me-
mer. chanical Properties of Plastics by
(1) Molecular weight. Molecular Means of Torsional Pendulum,’’ which
weight shall be determined by intrinsic is incorporated by reference; copies are
viscosity (or other suitable method). available from American Society for
Testing and Materials (ASTM), 100
325
§ 177.1820 21 CFR Ch. I (4–1–12 Edition)
Barr Harbor Dr., West Conshohocken, (3) Maximum extractable fractions in

Philadelphia, PA 19428-2959, or avail- distilled water and 50 percent ethanol and
able for inspection at the National Ar- the maximum net residue solubles in chlo-
chives and Records Administration roform. The maximum extractable frac-
(NARA). For information on the avail- tions in distilled water and 50 percent
ability of this material at NARA, call ethanol, and the maximum net residue
202–741–6030, or go to: http:// solubles in chloroform, shall be deter-
www.archives.gov/federallregister/ mined in accordance with § 176.170(d)(3)
codeloflfederallregulations/ of this chapter using a sandwich form
ibrllocations.html.) modified by using a of the finished copolymer of the speci-
forced resonant vibration instead of a fied thickness and for the time and
fixed vibration and by using fre- temperature specified in paragraph (b)
quencies of 25 to 40 cycles per second of this section.
instead of 0.1 to 10 cycles per second.
(ii) Direct reading viscoelastometric
not applicable to butadiene-styrene co-
method titled ‘‘Direct Reading
Viscoelastrometric Method for Deter- polymers listed in other sections of
mining Glass Transition Points of Sty- this subpart.
rene Block Polymers’’ (which is incor- (e) The provisions of this section are
porated by reference; copies are avail- not applicable to styrene block poly-
able from the Center for Food Safety mers with 1,3-butadiene listed in
and Applied Nutrition (HFS–200), Food § 175.105 of this chapter.
and Drug Administration, 5100 Paint [42 FR 14572, Mar. 15, 1977, as amended at 42
Branch Pkwy., College Park, MD 20740, FR 43621, Aug. 30, 1977; 47 FR 11844, Mar. 19,
or available for inspection at the Na- 1982; 51 FR 16828, May 7, 1986; 54 FR 24898,
tional Archives and Records Adminis- June 12, 1989; 58 FR 65546, Dec. 15, 1993]
tration (NARA). For information on
the availability of this material at § 177.1820 Styrene-maleic anhydride
NARA, call 202–741–6030, or go to: http:// copolymers.
www.archives.gov/federallregister/ Styrene-maleic anhydride copoly-
codeloflfederallregulations/ mers identified in paragraph (a) of this
ibrllocations.html.), by which the glass section may be safely used as articles
transition points are determined in the
or components of articles intended for
tensile mode of deformation at a fre-
use in contact with food, subject to
quency of 35 hertz using a Rheovibron
provisions of this section.
Model DDV-II (or equivalent) Direct
Reading Viscoelastometer. Take maxi- (a) For the purpose of this section,
ma in the out-of-phase component of styrene-maleic anhydride copolymers
the complex modulus as the glass tran- are those produced by the polymeriza-
sition points. For block polymers of tion of styrene and maleic anhydride so
low styrene content or for simple block that the finished polymers meet the
polymers, the polymer may be treated specifications prescribed in paragraph
with 0.3 part per hundred dicumyl per- (b) of this section, when tested by the
oxide and cured for 30 minutes at 153 °C methods described in paragraph (c) of
to accentuate the upper transition this section.
point. (b) Specifications:
326

Molecular Residual able fraction in dis- able fraction in n-
weight Residual sty- maleic anhy- tilled water at spec- heptane at speci-
Styrene-maleic copolymers (minimum rene mon- dride mon- ified temperatures, fied temperatures,
number omer omer times, and particle times, and particle
average) size size
1. Styrene-maleic anhydride copoly- 70,000 0.3 weight 0.1 weight 0.006 weight per- 0.02 weight percent
mers containing not more than 15 pct percent. percent. cent at reflux at 73 °F for 2 hr
maleic anhydride units by weight; for temperature for 1 utilizing particles
use as articles or as components of hr utilizing par- of a size that will
articles that contact food of Types I, ticles of a size pass through a
II, III, IV-A, IV-B, V, VI-B (except car- that will pass U.S. standard
bonated beverages), VII-A, VII-B, through a U.S. sieve No. 10 and
VIII, and IX identified in table 1 in standard sieve will be held on a
§ 176.170(c) of this chapter under No. 10 and will U.S. standard
conditions of use B, C, D, E, F, G, be held on a sieve No. 20.
and H described in table 2 in U.S. standard
§ 176.170(c) of this chapter. sieve No. 20.
2. Styrene-maleic anhydride copolymer .................. 0.3 ............... 0.1 ............... 0.015 weight per- 1.0 weight percent
modified with butadiene, (CAS Reg. cent at reflux at 23 °C (73 °F)
No. 27288–99–9) containing not temperature for 1 for 2 hours uti-
more than 15 percent maleic anhy- hour utilizing par- lizing particles of
dride units by weight and not more ticles of a size a size that will
than 20 percent styrene-butadiene that will pass pass through a
and/or butadiene rubber units by through a U.S. U.S. standard
weight; for use (except carbonated standard sieve sieve No. 10 and
beverage bottles) as articles or as No. 10 and will will be held on a
components of articles that contact be held on a U.S. standard
food of Types I, II, III, IV-A, IV-B, V, U.S. standard sieve No. 20.
VI, VII-A, VII-B, VIII, and IX identified sieve No. 20.
in table I in § 176.170(c) of this chap-
ter under conditions of use B, C, D,
E, F, G, and H described in table 2 in
(c) The analytical methods for deter- codeloflfederallregulations/

mining conformance with specifica- ibrllocations.html.
tions for styrene-maleic anhydride co- (d) The provisions of this section are
polymers prescribed in this section are not applicable to styrene-maleic anhy-
as follows: dride copolymers listed in other sec-
(1) Molecular weight. Molecular tions of this subpart.
weight shall be determined by mem-
brane osmometry. [42 FR 14572, Mar. 15, 1977, as amended at 47
(2) Residual styrene monomer content. FR 11844, Mar. 19, 1982; 47 FR 14698, Apr. 6,
1982; 54 FR 24898, June 12, 1989]
Residual styrene monomer content
shall be determined by the method de- § 177.1830 Styrene-methyl methacry-
scribed in § 177.1640(d). late copolymers.
(3) Residual maleic anhydride monomer
content. Residual maleic anhydride Styrene-methyl methacrylate co-
monomer content shall be determined polymers identified in this section may
by a gas chromatographic method ti- be safely used as components of plastic
tled ‘‘Determination of Residual Ma- articles intended for use in contact
leic Anhydride in Polymers by Gas with food, subject to the provisions of
Chromatography,’’ which is incor- this section.
porated by reference. Copies are avail- (a) For the purpose of this section,
able from the Center for Food Safety styrene-methyl methacrylate copoly-
and Applied Nutrition (HFS–200), Food mers consist of basic copolymers pro-
and Drug Administration, 5100 Paint duced by the copolymerization of sty-
Branch Pkwy., College Park, MD 20740, rene and methyl methacrylate such
or available for inspection at the Na- that the finished basic copolymers con-
tional Archives and Records Adminis- tain more than 50 weight percent of
tration (NARA). For information on polymer units derived from styrene.
the availability of this material at (b) The finished plastic food-contact
NARA, call 202–741–6030, or go to: http:// article, when extracted with the sol-
www.archives.gov/federallregister/ vent or solvents characterizing the
327
§ 177.1850 21 CFR Ch. I (4–1–12 Edition)
type of food and under the conditions Substances Limitations

of time and temperature characterizing
(3) Adjuvant substance, As a solvent in the prepara-
the conditions of intended use as deter- dimethylformamide. tion of fibryl.
mined from tables 1 and 2 of § 176.170(c)
of this chapter, yields extractives not (d) Textryls meeting the conditions
to exceed the following when tested by of test prescribed in paragraph (d)(1) of
the methods prescribed in § 177.1010(c); this section are used as prescribed in
(1) Total nonvolatile extractives not paragraph (d)(2) of this section.
to exceed 0.3 milligram per square inch (1) Conditions of test. Textryls, when
of surface tested.
extracted with distilled water at reflux
(2) Potassium permanganate oxidiz-
temperature for 1 hour, yield total ex-
able distilled water and 8 and 50 per-
tractives not to exceed 1 percent.
cent alcohol extractives not to exceed
an absorbance of 0.15. (2) Uses. Textryls are used for pack-
(3) Ultraviolet-absorbing distilled aging or holding food at ordinary tem-
water and 8 and 50 percent alcohol ex- peratures and in the brewing of hot
tractives not to exceed an absorbance beverages.
of 0.30.
(4) Ultraviolet-absorbing n-heptane § 177.1900 Urea-formaldehyde resins in
molded articles.
extractives not to exceed an absorb-
ance of 0.40. Urea-formaldehyde resins may be
safely used as the food-contact surface
§ 177.1850 Textryls. of molded articles intended for use in
Textryls identified in this section contact with food, in accordance with
may be safely used as articles or com- the following prescribed conditions:
ponents of articles, intended for use in (a) For the purpose of this section,
producing, manufacturing, packing, urea-formaldehyde resins are those
processing, preparing, treating, pack- produced when 1 mole of urea is made
aging, transporting or holding food, to react with not more than 2 moles of
subject to the provisions of this sec- formaldehyde in water solution.
tion. (b) The resins may be mixed with re-
(a) Textryls are nonwoven sheets pre- fined wood pulp and the mixture may
pared from natural or synthetic fibers, contain other optional adjuvant sub-
bonded with fibryl (Fibryl consists of a stances which may include the fol-
polymeric resin in fibrous form com- lowing:
mingled with fiber to facilitate sheet
formation and subsequently heat cured List of substances Limitations
to fuse the fibryl and effect bonding).
Hexamethylenetetramine ....... For use only as polymeriza-
(b) Textryls are prepared from the fi- tion-control agent.
bers, fibryls, and adjuvants identified Tetrachlorophthalic acid an- Do.
in paragraph (c) of this section, and hydride.
subject to limitations prescribed in Zinc stearate .......................... For use as lubricant.
that paragraph, provided that any sub-
stance that is the subject of a regula- (c) The finished food-contact article,
tion in parts 174, 175, 176, 177, 178 and when extracted with the solvent or sol-
§ 179.45 of this chapter conforms with vents characterizing the type of food
any specifications in such regulation and under the conditions of time and
for that substance as a component of temperature characterizing the condi-
polymeric resins used as food contact tions of its intended use as determined
surfaces. from tables 1 and 2 of § 175.300(d) of this
(c) The fibers, fibryls, and adjuvants chapter, yields total extractives in
permitted are as follows: each extracting solvent not to exceed
0.5 milligram per square inch of food-
contact surface as determined by the
(1) Fibers prepared from pol- Conforming with § 177.1630. methods described in § 175.300(e) of this
yethylene terephthalate chapter.
resins.
(2) Fibryls prepared from As the basic polymer. NOTE: In testing the finished food-contact
vinyl chloride-vinyl acetate article, use a separate test sample for each
copolymer. required extracting solvent.
328
§ 177.1950 Vinyl chloride-ethylene co- codeloflfederallregulations/

polymers. ibrllocations.html.
The vinyl chloride-ethylene copoly- (2) Extractives limitations. The fol-
mers identified in paragraph (a) of this lowing extractives limitations are de-
section may be safely used as compo- termined by the methods described in
nents of articles intended for contact paragraph (d) of this section:
with food, under conditions of use D, E, (i) Total extractives do not exceed
F, or G described in table 2 of § 176.170 0.10 weight-percent when extracted
(c) of this chapter, subject to the provi- with n-heptane at 150 °F for 2 hours.
sions of this section. (ii) Total extractives do not exceed
(a) For the purpose of this section, 0.03 weight-percent when extracted
vinyl chloride-ethylene copolymers with water at 150 °F for 2 hours.
consist of basic copolymers produced (iii) Total extractives obtained by ex-
by the copolymerization of vinyl chlo- tracting with water at 150 °F for 2
ride and ethylene such that the fin- hours contain no more than 0.5 milli-
ished basic copolymers meet the speci- gram of vinyl chloride-ethylene copol-
fications and extractives limitations ymer per 100 grams of sample tested as
prescribed in paragraph (c) of this sec- determined from the organic chlorine
tion, when tested by the methods de- content. The organic chlorine content
scribed in paragraph (d) of this section. is determined as described in paragraph
(b) The basic vinyl chloride-ethylene (d)(3) of this section.
copolymers identified in paragraph (a) (d) Analytical methods: The analyt-
of this section may contain optional ical methods for determining whether
adjuvant substances required in the vinyl chloride-ethylene basic copoly-
production of such basic copolymers. mers conform to the extractives limi-
The optional adjuvant substances re- tations prescribed in paragraph (c) of
quired in the production of the basic this section are as follows and are ap-
vinyl chloride-ethylene copolymers plicable to the basic copolymers in
may include substances permitted for powder form having a particle size such
such use by regulations in parts 170 that 100 percent will pass through a
through 189 of this chapter, substances U.S. Standard Sieve No. 40 and 80 per-
generally recognized as safe in food, cent will pass through a U.S. Standard
and substances used in accordance with Sieve No. 80:
a prior sanction or approval. (1) Reagents—(i) Water. All water used
(c) The vinyl chloride-ethylene basic in these procedures shall be
copolymers meet the following speci- demineralized (deionized), freshly dis-
fications and extractives limitations: tilled water.
(1) Specifications. (i) Total chlorine (ii) n-Heptane. Reagent grade, freshly
content is in the range of 53 to 56 per- distilled n-heptane shall be used.
cent as determined by any suitable an- (2) Determination of total amount of ex-
alytical procedure of generally accept- tractives. All determinations shall be
ed applicability. done in duplicate using duplicate
(ii) Intrinsic viscosity in blanks. Approximately 400 grams of
cyclohexanone at 30 °C is not less than sample (accurately weighed) shall be
0.50 deciliter per gram as determined placed in a 2-liter Erlenmeyer flask.
by ASTM method D1243–79, ‘‘Standard Add 1,200 milliliters of solvent and
Test Method for Dilute Solution Vis- cover the flask with aluminum foil.
cosity of Vinyl Chloride Polymers,’’ The covered flask and contents are sus-
which is incorporated by reference. pended in a thermostated bath and are
Copies may be obtained from the Amer- kept, with continual shaking at 150 °F
ican Society for Testing Materials, 100 for 2 hours. The solution is then fil-
Barr Harbor Dr., West Conshohocken, tered through a No. 42 Whatman filter
Philadelphia, PA 19428-2959, or may be paper, and the filtrate is collected in a
examined at the National Archives and graduated cylinder. The total amount
Records Administration (NARA). For of filtrate (without washing) is meas-
information on the availability of this ured and called A milliliters. The fil-
material at NARA, call 202–741–6030, or trate is transferred to a Pyrex (or
go to: http://www.archives.gov/ equivalent) beaker and evaporated on a

federallregister/ steam bath under a stream of nitrogen
329
§ 177.1950 21 CFR Ch. I (4–1–12 Edition)
to a small volume (approximately 50–60 aqueous extract or to a vacuum oven at

milliliters). The concentrated filtrate 150 °F in the case of the heptane ex-
is then quantitatively transferred to a tract. In the case of the aqueous ex-
tared 100-milliliter Pyrex beaker using tract, the evaporation to constant
small, fresh portions of solvent and a weight is completed in 15 minutes at
rubber policeman to effect the transfer. 230 °F; and in the case of heptane ex-
The concentrated filtrate is evaporated tract, it is overnight under vacuum at
almost to dryness on a hotplate under 150 °F. The residue is weighed and cor-
nitrogen, and is then transferred to a rected for the solvent blank. Calcula-
drying oven at 230 °F in the case of the tion:
Grams of corrected residue 1,200 milliliters Total extractives expressed as

× × 100 =
Grams of sample Volume of filtrate percent by weight of sample.
A in milliliters
(3) Vinyl chloride-ethylene copolymer extract and washings are collected in a

content of aqueous extract—(i) Principle. 1,500-milliliter beaker. The solution is
The vinyl chloride-ethylene copolymer evaporated carefully on a steam plate
content of the aqueous extract can be to a volume of approximately 50 milli-
determined by determining the organic liters and then transferred quan-
chlorine content and calculating the titatively, a little at a time, to a clean
amount of copolymer equivalent to the 22-milliliter Parr cup, also on the
organic chlorine content. steam plate. The solution is evaporated
(ii) Total organic chlorine content. A to dryness. Next 0.25 gram of sucrose
weighed sample of approximately 400 and 0.5 gram of benzoic acid are added
grams is extracted with 1,200 milliliters to the cup. One scoop (approximately
of water at 150 °F for 2 hours, filtered, 15 grams) of sodium peroxide is then
and the volume of filtrate is measured added to the cup. The bomb is assem-
(A milliliters) as described in para- bled and ignition is conducted in the
graph (d)(2) of this section. usual fashion.
(a) A slurry of Amberlite IRA–400, or (d) After the bomb has cooled, it is
equivalent, is made with distilled
rinsed thoroughly with distilled water
water in a 150-milliliter beaker. The
and disassembled. The top of the bomb
slurry is added to a chromatographic
is rinsed into a 250-milliliter beaker
column until it is filled to about half
with distilled water. The beaker is
its length. This should give a volume of
placed on the steam plate. The bomb
resin of 15–25 milliliters. The liquid
must not be allowed to drain below the cup is placed in the beaker and care-
top of the packed column. fully tipped over to allow the water to
(b) The column is regenerated to the leach out the combustion mixture.
basic (OH) form by slowly passing After the bubbling has stopped, the cup
through it (10–15 milliliters per minute) is removed from the beaker and rinsed
10 grams of sodium hydroxide dissolved thoroughly. The solution is cooled to
in 200 milliliters of water. The column room temperature and cautiously neu-
is washed with distilled water until the tralized with concentrated nitric acid
effluent is neutral to phenolphthalein. by slowly pouring the acid down a stir-
One drop of methyl red indicator is ring rod until the bubbling ceases. The
added to the A milliliters of filtered solution is cooled and an equal volume
aqueous extract and, if on the basic of acetone is added.
side (yellow), nitric acid is added drop (e) The solution is titrated with 0.005
by drop until the solution turns pink. N silver nitrate using standard poten-
(c) The extract is deionized by pass- tiometric titration techniques with a
ing it through the exchange column at silver electrode as indicator and a po-
a rate of 10–15 milliliters per minute. tassium nitrate modified calomel elec-
The column is washed with 200 milli- trode as a reference electrode. An ex-
liters of distilled water. The deionized panded scale recording titrimeter.
330
ER01JA93.401</GPH>
Metrohm Potentiograph 2336 or equiva- (iii) Calculations.

lent, should be used; a complete blank
must be run in duplicate.
Milligrams of aqueous extracted T × F × 64.3

= × 100
copolymer per 100-gram sample Weight of sample in grams
where: (b) Specifications and limitations. The

T=Milliliters of silver nitrate (sample minus vinyl chloride-hexene-1 basic copoly-
blank)×normality of silver nitrate. mers meet the following specifications
F=1,200/A (as defined above)
and extractives limitations:
(e) The vinyl chloride-ethylene co- (1) Specifications. (i) Total chlorine
polymers identified in and complying content is 53 to 56 percent as deter-
with this section, when used as compo- mined by any suitable analytical pro-
nents of the food-contact surface of cedure of generally accepted applica-
any article that is the subject of a reg- bility.
ulation in parts 174, 175, 176, 177, 178 (ii) Inherent viscosity in
and § 179.45 of this chapter, shall com- cyclohexanone at 30 °C is not less than
ply with any specifications and limita-
0.59 deciliters per gram as determined
tions prescribed by such regulation for
by ASTM method D1243–79, ‘‘Standard
the article in the finished form in
which it is to contact food. Test Method for Dilute Solution Vis-
(f) The provisions of this section are cosity of Vinyl Chloride Polymers,’’
not applicable to vinyl chloride-ethyl- which is incorporated by reference.
ene copolymers used as provided in Copies may be obtained from the Amer-
§§ 175.105 and 176.180 of this chapter. ican Society for Testing Materials, 100
FR 10110, Mar. 19, 1984]
examined at the National Archives and
§ 177.1960 Vinyl chloride-hexene-1 co- Records Administration (NARA). For
polymers. information on the availability of this
The vinyl chloride-hexene-1 copoly- material at NARA, call 202–741–6030, or
mers identified in paragraph (a) of this go to: http://www.archives.gov/
section or as components of articles in- federallregister/
tended for use in contact with food, codeloflfederallregulations/
under conditions of use D, E, F, or G ibrllocations.html.
described in table 2 of § 176.170(c) of this (2) Extractives limitations. The fol-
chapter, subject to the provisions of lowing extractives limitations are de-
this section. termined by the methods prescribed in
(a) Identity. For the purposes of this § 177.1970(d).
section vinyl chloride-hexene-1 copoly- (i) Total extractives do not exceed
mers consist of basic copolymers pro- 0.01 weight percent when extracted
duced by the copolymerization of vinyl with water at 150 °F for 2 hours.
chloride and hexene-1 such that the fin- (ii) Total extractives do not exceed
ished copolymers contain not more
0.30 weight percent when extracted
than 3 mole-percent of polymer units
with n-heptane at 150 °F for 2 hours.
derived from hexene-1 and meet the
specifications and extractives limita- (c) Other specifications and limitations.
tions prescribed in paragraph (b) of this The vinyl chloride-hexene-1 copoly-
section. The copolymers may option- mers identified in and complying with
ally contain hydroxypropyl methyl- this section, when used as components
cellulose and trichloroethylene used as of the food-contact surface of any arti-
a suspending agent and chain transfer cle that is subject to a regulation in
agent, respectively, in their produc- parts 174, 175, 176, 177, 178 and § 179.45 of
tion. this chapter, shall comply with any
331
ER01JA93.402</GPH>
§ 177.1970 21 CFR Ch. I (4–1–12 Edition)
specifications and limitations pre- Conshohocken, Philadelphia, PA 19428-

scribed by such regulation for the arti- 2959, or may be examined at the Na-
cle in the finished form in which it is tional Archives and Records Adminis-
to contact food. tration (NARA). For information on
[42 FR 14572, Mar. 15, 1977, as amended at 49 the availability of this material at
FR 10110, Mar. 19, 1984] NARA, call 202–741–6030, or go to: http://
§ 177.1970 Vinyl chloride-lauryl vinyl codeloflfederallregulations/
ether copolymers. ibrllocations.html.
The vinyl chloride-lauryl vinyl ether (2) Extractives limitations. The fol-
copolymers identified in paragraph (a) lowing extractives limitations are de-
of this section may be used as an arti- termined by the method described in
cle or as a component of an article in- paragraph (d) of this section:
tended for use in contact with food sub- (i) Total extractives do not exceed
ject to the provisions of this section. 0.03 weight-percent when extracted
(a) Identity. For the purposes of this with water at 150 °F for 2 hours.
section vinyl chloride-lauryl vinyl (ii) Total extractives do not exceed
ether copolymers consist of basic co- 0.60 weight-percent when extracted
polymers produced by the copolym- with n-heptane at 150 °F for 2 hours.
erization of vinyl chloride and lauryl (d) Analytical methods. The analytical
vinyl ether such that the finished co- methods for determining total extrac-
polymers contain not more than 3 tives are applicable to the basic co-
weight-percent of polymer units de- polymers in powder form having a par-
rived from lauryl vinyl ether and meet ticle size such that 100 percent will
the specifications and extractives limi- pass through a U.S. Standard Sieve No.
tations prescribed in paragraph (c) of 40 and such that not more than 10 per-
this section. cent will pass through a U.S. Standard
(b) Optional adjuvant substances. The Sieve No. 200.
basic vinyl chloride-lauryl vinyl ether (1) Reagents—(i) Water. All water used
copolymers identified in paragraph (a) in these procedures shall be
of this section may contain optional demineralized (deionized), freshly dis-
adjuvant substances required in the tilled water.
production of such basic copolymers. (ii) n-Heptane. Reagent grade, freshly
These optional adjuvant substances distilled n-heptane shall be used.
may include substances permitted for (2) Determination of total amount of ex-
such use by regulations in parts 170 tractives. Place an accurately weighed
through 189 of this chapter, substances sample of suitable size in a clean
generally recognized as safe in food, borosilicate flask, and for each gram of
and substances used in accordance with sample add 3 milliliters of solvent pre-
a prior sanction or approval. viously heated to 150 °F. Maintain the
(c) Specifications and limitations. The temperature of the contents of the
vinyl chloride-lauryl vinyl ether basic flask at 150 °F for 2 hours using a hot
copolymers meet the following speci- plate while also maintaining gentle
fications and extractives limitations: mechanical agitation. Filter the con-
(1) Specifications. (i) Total chlorine tents of the flask rapidly through No.
content is 53 to 56 percent as deter- 42 Whatman filter paper with the aid of
mined by any suitable analytical pro- suction. Transfer the filtrate to flat
cedure of generally accepted applica- glass dishes that are warmed on a hot
bility. plate and evaporate the solvent with
(ii) Inherent viscosity in the aid of a stream of filtered air. When
cylcoHhexanone at 30 °C is not less the volume of the filtrate has been re-
than 0.60 deciliter per gram as deter- duced to 10 to 15 milliliters, transfer
mined by ASTM method D1243–79, the filtrate to tared 50-milliliter
‘‘Standard Test Method for Dilute So- borosilicate glass beakers and com-
lution Viscosity of Vinyl Chloride plete evaporation to a constant weight
Polymers,’’ which is incorporated by in a 140 °F vacuum oven. Carry out a
reference. Copies may be obtained from corresponding blank determination
the American Society for Testing Ma- with each solvent. Determine the
terials, 100 Barr Harbor Dr., West weight of the residue corrected for the
332
solvent blank and calculate the result (ii) Intrinsic viscosity in cyclo-
as percent of the initial weight of the hexanone at 30 °C is not less than 0.50
resin sample taken for analysis. deciliter per gram as determined by
(e) Other specifications and limitations. ASTM method D1243–79, ‘‘Standard
The vinyl chloride-lauryl vinyl ether Test Method for Dilute Solution Vis-
copolymers identified in and complying cosity of Vinyl Chloride Polymers,’’
with this section, when used as compo- which is incorporated by reference.
nents of the food-contact surface of Copies may be obtained from the Amer-
any article that is subject to a regula- ican Society for Testing Materials, 100
tion in parts 174, 175, 176, 177, 178 and Barr Harbor Dr., West Conshohocken,
§ 179.45 of this chapter, shall comply Philadelphia, PA 19428-2959, or may be
with any specifications and limitations examined at the National Archives and
prescribed by such regulation for the Records Administration (NARA). For
article in the finished form in which it information on the availability of this
is to contact food. material at NARA, call 202–741–6030, or
[42 FR 14572, Mar. 15, 1977, as amended at 49 go to: http://www.archives.gov/
FR 10110, Mar. 19, 1984] federallregister/
§ 177.1980 Vinyl chloride-propylene co- ibrllocations.html.
polymers. (2) Extractives limitations. The fol-
The vinyl chloride-propylene copoly- lowing extractives limitations are de-
mers identified in paragraph (a) of this termined by the methods described in
section may be safely used as compo- paragraph (d) of this section:
nents of articles intended for contact (i) Total extractives do not exceed
with food, subject to the provisions of 0.10 weight-percent when extracted
this section. with n-heptane at 150 °F for 2 hours.
(a) For the purpose of this section, (ii) Total extractives do not exceed
vinyl chloride-propylene copolymers 0.03 weight-percent when extracted
consist of basic copolymers produced with water at 150 °F for 2 hours.
by the copolymezation of vinyl chlo- (iii) Total extractives obtained by ex-
ride and propylene such that the fin- tracting with water at 150 °F for 2
ished basic copolymers meet the speci- hours contain no more than 0.17 milli-
fications and extractives limitations gram of vinyl chloride-propylene co-
prescribed in paragraph (c) of this sec- polymer per 100 grams of sample tested
tion, when tested by the methods de- as determined from the organic chlo-
scribed in paragraph (d) of this section. rine content. For the purpose of this
(b) The basic vinyl chloride-pro- section, the organic chlorine content is
pylene copolymers identified in para- the difference between the total chlo-
graph (a) of this section may contain rine and ionic chlorine contents deter-
optional adjuvant substances required mined as described in paragraph (d) of
in the production of such basic copoly- this section.
mers. The optional adjuvant sub- (d) Analytical methods: The analyt-
stances required in the production of ical methods for determining whether
the basic vinyl chloride-propylene co- vinyl chloride-propylene basic copoly-
polymers may include substances per- mers conform to the extractives limi-
mitted for such use by regulations in tations prescribed in paragraph (c) of
parts 170 through 189 of this chapter, this section are as follows and are ap-
substances generally recognized as safe plicable to the basic copolymers in
in food, and substances used in accord- powder form having a particle size such
ance with a prior sanction or approval. that 100 percent will pass through a
(c) The vinyl chloride-propylene U.S. Standard Sieve No. 40 and 80 per-
basic copolymers meet the following cent will pass through a U.S. Standard
specifications and extractives limita- Sieve No. 80:
tions: (1) Reagents—(i) Water. All water used
(1) Specifications. (i) Total chlorine in these procedures shall be
content is in the range of 53 to 56 per- demineralized (deionized), freshly dis-
cent as determined by any suitable an- tilled water.
alytical procedure of generally accept- (ii) n-Heptane. Reagent grade, freshly

ed applicability. distilled n-heptane shall be used.
333
§ 177.1980 21 CFR Ch. I (4–1–12 Edition)
(2) Determination of total amount of ex- to a small volume (approximately 50–60

tractives. All determinations shall be milliliters). The concentrated filtrate
done in duplicate using duplicate is then quantitatively transferred to a
blanks. Approximately 400 grams of tared 100-milliliter Pyrex beaker using
sample (accurately weighed) shall be small, fresh portions of solvent and a
placed in a 2-liter Erlenmeyer flask. rubber policeman to effect the transfer.
Add 1,200 milliliters of solvent and The concentrated filtrate is evaporated
cover the flask with aluminum foil. almost to dryness on a hotplate under
The covered flask and contents are sus- nitrogen, and is then transferred to a
pended in a thermostated bath and are drying oven at 230 °F in the case of the
kept, with continual shaking, at 150 °F aqueous extract or to a vacuum oven at
for 2 hours. The solution is then fil- 150 °F in the case of the heptane ex-
tered through a No. 42 Whatman filter tract. In the case of the aqueous ex-
paper, and the filtrate is collected in a tract the evaporation to constant
graduated cylinder. The total amount weight is completed in 15 minutes at
of filtrate (without washing) is meas- 230 °F; and in the case of heptane ex-
ured and called A milliliters. The fil- tract, it is overnight under vacuum at
trate is transferred to a Pyrex (or 150 °F. The residue is weighed and cor-
equivalent) beaker and evaporated on a rected for the solvent blank. Calcula-
steam bath under a stream of nitrogen tion:
Grams of corrected residue 1,200 milliliters Total extractives expressed as

× × 100 =
Grams of sample Volume of filtrate percent by weight of sample.
A in milliliters
(3) Vinyl chloride-propylene copolymer sembled, water is added to the recess at

content of aqueous extract—(i) Principle. the top of the bomb and ignition is con-
The vinyl chloride-propylene copoly- ducted in the usual fashion using a
mer content of the aqueous extract can Meeker burner. The heating is contin-
be determined by determining the or- ued for 1 minute after the water at the
ganic chlorine content and calculating top has evaporated. The bomb is
the amount of copolymer equivalent to quenched in water, rinsed with distilled
the organic chlorine content. The or- water, and placed in a 400-milliliter
ganic chlorine content is the difference beaker. The bomb cover is rinsed with
between the total chlorine content and water, catching the washings in the
the ionic chlorine content. same 400-milliliter beaker. The bomb is
(ii) Total chlorine content. A weighed covered with distilled water and a
sample is extracted with water at 150 watch glass and heated until the melt
°F for 2 hours, filtered, and the volume has dissolved. The bomb is removed,
of filtrate is measured (A milliliters) as rinsed, catching the rinsings in the
described in paragraph (d)(2) of this beaker, and the solution is acidified
section. Two drops of 50 percent by with concentrated nitric acid using
weight sodium hydroxide solution are methyl purple as an indicator. The
added to prevent loss of chloride from beaker is covered with a watch glass,
ammonium chloride, if present, and the and the contents are boiled gently for
solution is evaporated to approxi- 10–15 minutes. After cooling to room
mately 15 milliliters. The concentrated temperature the solution is made
filtrate is quantitatively transferred to slightly alkaline with 50 percent by
a 22-milliliter Parr bomb fusion cup weight sodium hydroxide solution,
and gently evaporated to dryness. To then acidified with dilute (1:5) nitric
the contents of the cup are added 3.5 acid. Then 1.5 milliliters of 2 N nitric
grams of granular sodium peroxide, 0.1 acid per 100 milliliters of solution is
gram of powdered starch, and 0.02 gram added and the solution is titrated with
potassium nitrate; and the contents 0.005 N silver nitrate to the equivalence
are mixed thoroughly. The bomb is as- potential end point using an expanded
334
ER01JA93.403</GPH>
scale pH meter (Beckman Model 76, or

equivalent). A complete blank must be
run in duplicate. Calculation:
Grams of sample 1,200 milliliters Milliequivalents of total chlorine in

× × 100 =
(B − C) Volume of filtrate aqueous extract of 100 grams of sample
A in milliliters
where: solution is evaporated to approxi-

A=volume of filtrate obtained in extraction. mately 150 milliliters. The solution is
B=milliliters of silver nitrate solution used quantitatively transferred to a 250-mil-
in sample titration×normality of silver ni-
liliter beaker, methyl purple indicator
trate solution.
C=milliliters of silver nitrate solution used is added, and the solution is neutral-
in blank titration×normality of silver ni- ized with 0.1 N nitric acid. For each 100
trate solution. milliliters of solution is added 1.5 mil-
(iii) Ionic chlorine content. A weighed liliters of 2 N nitric acid. The solution
sample is extracted with water at 150 is titrated with 0.005 N silver nitrate to
°F for 2 hours, filtered, and the volume the equivalence potential end point,
of filtrate is measured (A milliliters) as using the expanded scale pH meter de-
in paragraph (d)(2) of this section. Two scribed in paragraph (d)(3)(ii) of this
drops of 50 percent by weight sodium section. A complete blank must be run
hydroxide solution are added and the in duplicate. Calculation:
D−E 1,200 milliliters Milliequivalents of ionic chlorine in

× × 100 =
Grams of sample Volume of filtrate aqueous extract of 100 grams of sample.
A in milliliters
where: (b) Vinyl chloride-propylene copolymer

A=volume of filtrate obtained in extraction. content. Milligrams of vinyl chloride-
D=milliliters of silver nitrate solution used propylene copolymer in aqueous ex-
in sample titration×normality of silver ni- tract of 100 grams of sample equal
trate solution. milliequivalents of organic chlorine in
E=milliliters of silver nitrate solution used aqueous extract of 100 grams of sample
in blank titration×normality of silver ni-
trate solution.
(as calculated in paragraph (d)(3)(iv) (a)
of this section) multiplied by 84.5.
(iv) Organic chlorine content and vinyl NOTE: The conversion factor, 84.5, is de-
chloride-propylene copolymer content of rived from the equivalent weight of chlorine
aqueous extract. The organic chlorine divided by the chlorine content of the
content and the vinyl chloride pro- heptane extractable fraction.)
pylene copolymer content of the aque- (e) The vinyl chloride-propylene co-
ous extract is calculated as follows: polymers identified in and complying
(a) Organic chlorine content. Milli- with this section, when used as compo-
equivalents of organic chlorine in nents of the food-contact surface of
aqueous extract of 100 grams of sample any article that is the subject of a reg-
equal milliequivalents of total chlorine ulation in parts 174, 175, 176, 177, 178
in aqueous extract of 100 grams of sam- and § 179.45 of this chapter, shall com-
ple (as calculated in paragraph (d)(3)(ii) ply with any specifications and limita-
of this section) minus milliequivalents tions prescribed by such regulation for
of ionic chlorine in aqueous extract of
the article in the finished form in

ER01JA93.405</GPH>
100 grams of sample (as calculated in which it is to contact food.

paragraph (d)(3)(iii) of this section).
335
ER01JA93.404</GPH>
§ 177.1990 21 CFR Ch. I (4–1–12 Edition)
(f) The provisions of this section are (2) The weight average molecular
not applicable to vinyl chloride-pro- weight of the copolymer is not less
pylene copolymers used in food-pack- than 50,000 when determined by gel per-
aging adhesives complying with meation chromatography using tetra-
§ 175.105 of this chapter. hydrofuran as the solvent. The gel per-
meation chromatograph is calibrated
FR 10111, Mar. 19, 1984] with polystyrene standards. The basic
gel permeation chromatographic meth-
§ 177.1990 Vinylidene chloride/methyl od is described in ANSI/ASTM D3536–76,
acrylate copolymers. ‘‘Standard Test Method for Molecular
The vinylidene chloride/methyl acry- Weight Averages and Molecular Weight
late copolymers (CAS Reg. No. 25038– Distribution of Polystyrene by Liquid
72–6) identified in paragraph (a) of this Exclusion Chromatography (Gel Per-
section may be safely used as an article meation Chromatography-GPC),’’
or as a component of an article in- which is incorporated by reference.
tended for use in contact with food sub- Copies are available from University
ject to the provisions of this section. Microfilms International, 300 North
(a) Identity. For the purposes of this Zeeb Rd., Ann Arbor, MI 48106, or avail-
section vinylidene chloride/methyl ac- able for inspection at the National Ar-
rylate copolymers consist of basic co- chives and Records Administration
polymers produced by the copolym- (NARA). For information on the avail-
erization of vinylidene chloride and ability of this material at NARA, call
methyl acrylate such that the copoly- 202–741–6030, or go to: http://
mers contain not more than 15 weight- www.archives.gov/federallregister/
percent of polymer units derived from codeloflfederallregulations/
methyl acrylate. ibrllocations.html.
(b) Optional adjuvant substances. The (3) Residual vinylidene chloride and
basic vinylidene chloride/methyl acry- residual methyl acrylate in the copoly-
late copolymers identified in paragraph mer in the form in which it will con-
(a) of this section may contain optional tact food (unsupported film, barrier
adjuvant substances required in the layer, or as a copolymer for blending)
production of such basic copolymers. will not exceed 10 parts per million and
These optional adjuvant substances 5 parts per million, respectively, as de-
may include substances permitted for termined by either a gas
such use by regulations in parts 170 chromatographic method titled ‘‘De-
through 179 of this chapter, substances termination of Residual Vinylidene
generally recognized as safe in food, Chloride and Methyl Acrylate in Vinyl-
and substances used in accordance with idene Chloride/Methyl Acrylate Co-
a prior sanction or approval. polymer Resins and Films,’’ or, alter-
(c) Specifications. (1) The methyl acry- natively, ‘‘Residual Methyl Acrylate
late content is determined by an infra- and Vinylidene Chloride Monomers in
red spectrophotometric method titled Saran MA/VDC Resins and Pellets by
‘‘Determination of Copolymer Ratio in Headspace Gas Chromatography,’’
Vinylidene Chloride/Methyl Acrylate dated March 3, 1986, which are incor-
Copolymers,’’ which is incorporated by porated by reference in accordance
reference. Copies are available from with 5 U.S.C. 552(a). Copies are avail-
the Center for Food Safety and Applied able from the Center for Food Safety
Nutrition (HFS–200), Food and Drug and Applied Nutrition (HFS–200), Food
Administration, 5100 Paint Branch and Drug Administration, 5100 Paint
Pkwy., College Park, MD 20740, or Branch Pkwy., College Park, MD 20740,
available for inspection at the National or available for inspection at the Na-
Archives and Records Administration tional Archives and Records Adminis-
(NARA). For information on the avail- tration (NARA). For information on
ability of this material at NARA, call the availability of this material at
202–741–6030, or go to: http:// NARA, call 202–741–6030, or go to: http://
www.archives.gov/federallregister/ www.archives.gov/federallregister/
codeloflfederallregulations/ codeloflfederallregulations/
ibrllocations.html. ibrllocations.html.
336
(d) Extractives limitations. The basic the copolymerization of vinylidene

copolymer resin in the form of granules chloride/methyl acrylate/methyl meth-
that will pass through a U.S. Standard acrylate such that the basic polymers
Sieve No. 45 (350 microns) shall meet or the finished food-contact articles
the following extractives limitations: meet the specifications prescribed in
(1) 10-gram samples of the resin, paragraph (d) of this section.
when extracted separately with 100 (b) Optional adjuvant substances. The
milliliters of distilled water at 121 °C basic vinylidene chloride/methyl acry-
(250 °F) for 2 hours, and 100 milliliters late/methyl methacrylate polymers
of n-heptane at 66 °C (150 °F) for 2 identified in paragraph (a) of this sec-
hours, shall yield total nonvolatile ex- tion may contain optional adjuvant
tractives not to exceed 0.5 percent by substances required in the production
weight of the resin. of such basic polymers. These optional
(2) The basic copolymer in the form adjuvant substances may include sub-
of film when extracted separately with stances permitted for such use by regu-
distilled water at 121 °C (250 °F) for 2 lations in parts 170 through 179 of this
hours shall yield total nonvolatile ex- chapter, substances generally recog-
tractives not to exceed 0.047 milligram nized as safe in food, and substances
per square centimeter (0.3 milligram used in accordance with a prior sanc-
per square inch). tion of approval.
(e) Conditions of use. The copolymers (c) Conditions of use. The polymers
may be safely used as articles or com- may be safely used as articles or as
ponents of articles intended for use in components of articles intended for use
producing, manufacturing, processing, in producing, manufacturing, proc-
preparing, treating, packaging, trans- essing, preparing, treating, packaging,
porting, or holding food, including transporting, or holding food, including
processing of packaged food at tem- processing of packaged food at tem-
peratures not to exceed 135 °C (275 °F). peratures up to 121 °C (250 °F).
(f) Other specifications and limitations. (d) Specifications and limitations. The
The vinylidene chloride-methyl acry- vinylidene chloride/methyl acrylate/
late copolymers identified in and com- methyl methacrylate basic polymers
plying with this section, when used as and/or finished food-contact articles
components of the food contact surface meet the following specifications and
of any article that is subject to a regu- limitations:
lation in parts 174 through 178 and (1)(i) The basic vinylidene chloride/
§ 179.45 of this chapter, shall comply methyl acrylate/methyl methacrylate
with any specifications and limitations polymers contain not more than 2
prescribed by such regulation for the weight percent of polymer units de-
article in the finished form in which it rived from methyl acrylate monomer
is to contact food. and not more than 6 weight percent of
[48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. polymer units derived from methyl
31, 1983, as amended at 53 FR 47185, Nov. 22, methacrylate monomer.
1988; 54 FR 24898, June 12, 1989] (ii) The basic polymers are limited to
a thickness of not more than 0.005 cen-
§ 177.2000 Vinylidene chloride/methyl timeter (0.002 inches).
acrylate/methyl methacrylate poly- (2) The weight average molecular
mers. weight of the basic polymer is not less
The vinylidene chloride/methyl acry- than 100,000 when determined by gel
late/methyl methacrylate polymers permeation chromatography using tet-
(CAS Reg. No. 34364–83–5) identified in rahydrofuran as the solvent. The gel
paragraph (a) of this section may be permeation chromatography is cali-
safely used as articles or as a compo- brated with polystyrene standards. The
nent of articles intended for use in con- basic gel permeation chromatographic
tact with food subject to the provisions method is described in ANSI/ASTM
of this section. D3536–76, which is incorporated by ref-
(a) Identity. For the purpose of this erence. Copies are available from the
section, vinylidene chloride/methyl ac- American Society for Testing Mate-
rylate/methyl methacrylate polymers rials, 100 Barr Harbor Dr., West

consist of basic polymers produced by Conshohocken, Philadelphia, PA 19428-
337
§ 177.2210 21 CFR Ch. I (4–1–12 Edition)
2959, or available for inspection at the Methods for the specifications in this
National Archives and Records Admin- paragraph (b), titled ‘‘Chlorine and
istration (NARA). For information on Bromine—Coulometric Titration Meth-
the availability of this material at od by Aminco Chloridometer,’’
NARA, call 202–741–6030, or go to: http:// ‘‘Hypolon ® Synthetic Rubber—Deter-
www.archives.gov/federallregister/ mination of Sulfur by Parr Bomb,’’ and
codeloflfederallregulations/ ASTM method D2857–70 (Reapproved
ibrllocations.html. 1977), ‘‘Standard Test Method for Di-
(3) The basic polymer or food-contact lute Solution Viscosity of Polymers,’’
article described in paragraph (a) of are incorporated by reference. Copies
this section, when extracted with the of the ASTM method may be obtained
solvent or solvents characterizing the from the American Society for Testing
type of food and under the conditions Materials, 100 Barr Harbor Dr., West
of time and temperature characterizing Conshohocken, Philadelphia, PA 19428-
the conditions of its intended use as de- 2959. Copies of the other two methods
termined from tables 1 and 2 of are available from the Center for Food
§ 176.170(c) of this chapter, yields net Safety and Applied Nutrition (HFS–
chloroform-soluble extractives in each 200), Food and Drug Administration,
extracting solvent not to exceed .08 5100 Paint Branch Pkwy., College Park,
milligram per square centimeter (0.5 MD 20740. Copies of all three methods
milligram per square inch) of food-con- may be examined at the National Ar-
tact surface when tested by the meth- chives and Records Administration
ods described in § 176.170(d). If the fin- (NARA). For information on the avail-
ished food-contact article is itself the ability of this material at NARA, call
subject of a regulation in parts 174 202–741–6030, or go to: http://
through 178 and § 179.45 of this chapter, www.archives.gov/federallregister/
it shall also comply with any specifica- codeloflfederallregulations/
tions and limitations prescribed for it ibrllocations.html.
by the regulation. (c) The additive is used as the article,
or a component of articles, intended for
[49 FR 29578, July 23, 1984]
use as liners and covers for reservoirs
intended for the storage of water for
Subpart C—Substances for Use drinking purposes.
Only as Components of Arti- (d) Substances permitted by § 177.2600
cles Intended for Repeated may be employed in the preparation of
Use ethylene polymers, chlorosulfonated,
subject to any limitations prescribed
§ 177.2210 Ethylene polymer, chloro- therein.
sulfonated. (e) The finished ethylene copolymers,
Ethylene polymer, chlorosulfonated chlorosulfonated shall conform to
as identified in this section may be § 177.2600(e) and (g).
safely used as an article or component [42 FR 14572, Mar. 15, 1977, as amended at 49
of articles intended for use in contact FR 10111, Mar. 19, 1984; 54 FR 24898, June 12,
with food, subject to the provisions of 1989]
this section.
(a) Ethylene polymer, chloro- § 177.2250 Filters, microporous poly-
sulfonated is produced by chloro- meric.
sulfonation of a carbon tetrachloride Microporous polymeric filters identi-
solution of polyethylene with chlorine fied in paragraph (a) of this section
and sulfuryl chloride. may be safely used, subject to the pro-
(b) Ethylene polymer, chloro- visions of this section, to remove par-
sulfonated shall meet the following ticles of insoluble matter in producing,
specifications: manufacturing, processing, and pre-
(1) Chlorine not to exceed 25 percent paring bulk quantities of liquid food.
by weight. (a) Microporous polymeric filters
(2) Sulfur not to exceed 1.15 percent consist of a suitably permeable, contin-
by weight. uous, polymeric matrix of polyvinyl
(3) Molecular weight is in the range chloride, vinyl chloride-propylene, or

of 95,000 to 125,000. vinyl chloride-vinyl acetate, in which
338
finely divided silicon dioxide is embed- (c) Any substance employed in the
ded. Cyclohexanone may be used as a production of resin-bonded filters that
solvent in the production of the filters. is the subject of a regulation in parts
(b) Any substance employed in the 174, 175, 176, 177, 178 and § 179.45 of this
production of microporous polymeric chapter conforms with any specifica-
filters that is the subject of a regulation in such regulation.
tion in parts 170 through 189 of this (d) Substances employed in the pro-
chapter must conform with any speci- duction of resin-bonded filters include
fication in such regulation. the following, subject to any limita-
(c) Cyclohexanone when used as a sol- tions provided:
vent in the production of the filters
shall not exceed 0.35 percent by weight LIST OF SUBSTANCES AND LIMITATIONS
of the microporous polymeric filters. (1) Fibers:
(d) The microporous polymeric filters
may be colored with colorants used in Cellulose pulp.
accordance with § 178.3297 of this chap- Cotton.
ter. Nylon. (From nylon resins complying with
the provisions of applicable regulations in
(e) The temperature of food being subchapter B of this chapter.
processed through the microporous pol- Polyethylene terephthalate complying in
ymeric filters shall not exceed 180 °F. composition with the provisions of
(f) The microporous polymeric filters § 177.1630; for use in inline filtration only as
shall be maintained in a sanitary man- provided for in paragraphs (e) and (f) of
ner in accordance with good manufac- this section.
turing practice so as to prevent poten- Rayon (viscose).
tial microbial adulteration of the food. (2) Substances employed in fiber fin-
(g) To assure safe use of the micro- ishing:
porous polymeric filters, the label or
labeling shall include adequate direc- BHT.
Butyl (or isobutyl) palmitate or stearate.
tions for a pre-use treatment, con- 2,5-Di-tert-butyl hydroquinone for use only in
sisting of washing with a minimum of lubricant formulations for rayon fiber fin-
2 gallons of potable water at a tem- ishing and at a usage level not to exceed
perature of 180 °F for each square foot 0.1 percent by weight of the lubricant for-
of filter, prior to the filter’s first use in mulations.
contact with food. Dimethylpolysiloxane.
4-Ethyl-4-hexadecyl morpholinium ethyl sul-
[42 FR 14572, Mar. 15, 1977, as amended at 56 fate for use only as a lubricant in the man-
FR 42933, Aug. 30, 1991] ufacture of polyethylene terephthalate fi-
bers specified in paragraph (d)(1) of this
§ 177.2260 Filters, resin-bonded. section at a level not to exceed 0.03 percent
Resin-bonded filters may be safely by weight of the finished fibers.
used in producing, manufacturing, Fatty acid (C10-C18) diethanolamide conden-
sates.
processing, and preparing food, subject Fatty acids derived from animal or vegetable
to the provisions of this section. fats and oils, and salts of such acids, sin-
(a) Resin-bonded filters are prepared gle or mixed, as follows:
from natural or synthetic fibers to Aluminum.
which have been added substances re- Ammonium.
quired in their preparation and fin- Calcium.
ishing, and which are bonded with res- Magnesium.
Potassium.
ins prepared by condensation or polym- Sodium.
erization of resin-forming materials, Triethanolamine.
together with adjuvant substances re- Fatty acid (C10-C18) mono- and diesters of
quired in their preparation, applica- polyoxyethylene glycol (molecular weight
tion, and curing. 400–3,000).
(b) The quantity of any substance Methyl esters of fatty acids (C10-C18).
employed in the production of the Mineral oil.
Polybutene, hydrogenated; complying with
resin-bonded filter does not exceed the
the identity prescribed under § 178.3740 (b)
amount reasonably required to accom- of this chapter.
plish the intended physical or technical
Polyoxyethylene (4 mols) ethylenediamine

effect or any limitation further pro- monolauramide for use only in lubricant
vided. formulations for rayon fiber finishing and
339
§ 177.2260 21 CFR Ch. I (4–1–12 Edition)
at a usage level not to exceed 10 percent by (f) Resin-bonded filters conforming
weight of the lubricant formulations. with the specifications of paragraph (f)
Ricebran oil. (1) of this section are used as provided
Titanium dioxide.
in paragraph (e)(2) of this section:
(3) Resins: (1) Total extractives. The finished fil-
Acrylic polymers produced by polymerizing ter, when exposed to distilled water at
ethyl acrylate alone or with one or more of 145 °F for 2 hours, yields total extrac-
the monomers: Acrylic acid, acrylonitrile, tives not to exceed 4 percent by weight
N-methylolacrylamide, and styrene. The of the filter.
finished copolymers shall contain at least (2) Conditions of use. It is used to fil-
70 weight percent of polymer units derived ter milk or potable water at operating
from ethyl acrylate, no more than 2 weight temperatures not to exceed 145 °F.
percent of total polymer units derived
(g) Resin-bonded filters conforming
from acrylic acid, no more than 10 weight
percent of total polymer units derived with the specifications of paragraph (g)
from acrylonitrile, no more than 2 weight (1) of this section are used as provided
percent of total polymer units derived in paragraph (g)(2) of this section:
from N-methylolacrylamide, and no more (1) Total extractives. The finished fil-
than 25 weight percent of total polymer ter, when exposed to n-hexane at reflux
units derived from styrene. For use only as temperature for 2 hours, yields total
provided in paragraph (m) of this section. extractives not to exceed 0.5 percent by
Melamine-formaldehyde.
Melamine-formaldehyde chemically modified
weight of the filter.
with one or more of the amine catalysts (2) Conditions of use. It is used to fil-
identified in § 175.300(b)(3)(xiii) of this chapter edible oils.
ter. (h) Resin-bonded filters conforming
Melamine-formaldehyde chemically modified with the specifications of paragraph (h)
with methyl alcohol. (1) of this section are used as provided
Melamine-formaldehyde chemically modified in paragraph (h)(2) of this section:
with urea; for use only as provided for in
(1) Total extractives. The finished fil-
paragraphs (e), (f), (g), (h), and (i) of this
section. ter, when exposed to distilled water at
Phenol-formaldehyde resins. 212 °F for 2 hours, yields total extrac-
Polyvinyl alcohol. tives not to exceed 4 percent by weight
Polyvinyl alcohol with the copolymer of of the filter.
acrylic acid-allyl sucrose. (2) Conditions of use. It is used to fil-
Polyvinyl alcohol with melamine formalde- ter milk, coffee, tea, and potable water
hyde. at temperatures not to exceed 212 °F.
Polyvinyl acetate with melamine formalde-
hyde.
(i) Resin-bonded filters conforming
p--Toluenesulfonamide-formaldehyde chemi- with the specifications of paragraph (i)
cally modified with one or more of the (1) of this section are used as provided
amine catalysts identified in § 175.300 in paragraph (i)(2) of this section:
(b)(3)(xiii) of this chapter. (1) Total extractives. The finished fil-
(4) Adjuvant substances: ter, when exposed to distilled water for
2 hours at a temperature equivalent to,
Dimethyl polysiloxane with methylcellulose or higher than, the filtration tempera-
and sorbic acid (as an antifoaming agent). ture of the aqueous food, yields total
Phosphoric acid.
extractives not to exceed 4 percent, by
(5) Colorants: Colorants used in ac- weight, of the filter.
cordance with § 178.3297 of this chapter. (2) Conditions of use. It is used in com-
(e) Resin-bonded filters conforming mercial filtration of bulk quantities of
with the specifications of paragraph (e) nonalcoholic, aqueous foods having a
(1) of this section are used as provided pH above 5.0.
in paragraph (e)(2) of this section: (j) Resin-bonded filters conforming
(1) Total extractives. The finished fil- with the specifications of paragraph (j)
ter, when exposed to distilled water at (1) of this section are used as provided
100 °F for 2 hours, yields total extrac- in paragraph (j)(2) of this section:
tives not to exceed 2.8 percent by (1) Total extractives. The finished fil-
weight of the filter. ter, when exposed to 5 percent (by
(2) Conditions of use. It is used to fil- weight) acetic acid for 2 hours at a
ter milk or potable water at operating temperature equivalent to, or higher

temperatures not to exceed 100 °F. than, the filtration temperature of the
340
aqueous food, yields total extractives not to exceed 1.2 percent by weight of
not to exceed 4 percent, by weight, of the filter.
the filter. (n) Acrylonitrile copolymers identi-
(2) Conditions of use. It is used in com- fied in this section shall comply with
mercial filtration of bulk quantities of the provisions of § 180.22 of this chap-
nonalcoholic, aqueous foods having a ter.
pH of 5.0 or below.
(k) Resin-bonded filters conforming [42 FR 14572, Mar. 15, 1977, as amended at 56
FR 42933, Aug. 30, 1991]
with the specifications of paragraph (k)
(1) of this section are used as provided § 177.2280 4,4′-Isopropylidenediphenol-
in paragraph (k)(2) of this section: epichlorohydrin thermosetting
(1) Total extractives. The finished fil- epoxy resins.
ter, when exposed to 8 percent (by vol-
ume) ethyl alcohol in distilled water 4,4′-Isopropylidenediphenol-epichlo-
for 2 hours at a temperature equivalent rohydrin thermosetting epoxy resins
to, or higher than, the filtration tem- may be safely used as articles or com-
perature of the alcoholic beverage, ponents of articles intended for re-
yields total extractives not to exceed 4 peated use in producing, manufac-
percent, by weight, of the filter. turing, packing, processing, preparing,
(2) Conditions of use. It is used in com- treating, packaging, transporting, or
mercial filtration of bulk quantities of holding food, in accordance with the
alcoholic beverages containing not following prescribed conditions:
more than 8 percent alcohol. (a) The basic thermosetting epoxy
(l) Resin-bonded filters conforming resin is made by reacting 4,4′-
with the specifications of paragraph (l) isopropylidenediphenol with epichloro-
(1) of this section are used as provided hydrin.
in paragraph (l)(2) of this section: (b) The resin may contain one or
(1) Total extractives. The finished fil- more of the following optional sub-
ter, when exposed to 50 percent (by vol- stances provided the quantity used
ume) ethyl alcohol in distilled water does not exceed that reasonably re-
for 2 hours at a temperature equivalent quired to accomplish the intended ef-
to, or higher than, the filtration tem- fect:
perature of the alcoholic beverage, Allyl glycidyl ether .................. As curing system additive.
yields total extractives not to exceed 4 Di- and tri-glycidyl ester mix- As modifier at levels not to
percent, by weight, of the filter. ture resulting from the re- exceed equal parts by
(2) Conditions of use. It is used in com- action of epichlorohydrin weight of the 4,4′-
with mixed dimers and isopropylidenediphenol-
mercial filtration of bulk quantities of trimers of unsaturated C18 epichlorohydrin basic resin
alcoholic beverages containing more monobasic fatty acids de- and limited to use in con-
than 8 percent alcohol. rived from animal and veg- tact with alcoholic bev-
etable fats and oils. erages containing not more
(m) Resin-bonded filters fabricated than 8 percent of alcohol.
from acrylic polymers as provided in 1,2-Epoxy-3-phenoxypropane As curing system additive.
paragraph (d)(3) of this section to- Glyoxal ................................... Do.
gether with other substances as pro- 4,4′-Isopropylidenediphenol ... Do.
vided in paragraph (d), (1), (2), and (4) 4,4′-Methylenedianiline .......... Do.
m-Phenylenediamine ............. Do.
of this section may be used as follows:
Tetrahydrophthalic anhydride Do.
(1) The finished filter may be used to
filter milk or potable water at oper-
(c) In accordance with good manufac-
ating temperatures not to exceed 100
turing practice, finished articles con-
°F, provided that the finished filter
taining the resins shall be thoroughly
when exposed to distilled water at 100
cleansed prior to their first use in con-
°F for 2 hours yields total extractives
tact with food.
not to exceed 1 percent by weight of
the filter.
not applicable to 4,4′-isopropylidenedi-
(2) The finished filter may be used to
phenol-epichlorohydrin resins listed in
filter milk or potable water at oper-
other sections of parts 174, 175, 176, 177,
ating temperatures not to exceed 145
178 and 179 of this chapter.
°F, provided that the finished filter
when exposed to distilled water at 145 [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15,
°F for 2 hours yields total extractives 1984]
341
§ 177.2355 21 CFR Ch. I (4–1–12 Edition)
§ 177.2355 Mineral reinforced nylon § 177.2400 Perfluorocarbon cured

resins. elastomers.
Mineral reinforced nylon resins iden- Perfluorocarbon cured elastomers
tified in paragraph (a) of this section identified in paragraph (a) of this sec-
may be safely used as articles or com- tion may be safely used as articles or
ponents of articles intended for re- components of articles intended for re-
peated use in contact with nonacidic peated use in contact with nonacid
food (pH above 5.0) and at use tempera- food (pH above 5.0), subject to the pro-
tures not exceeding 212 °F. in accord- visions of this section.
ance with the following prescribed con- (a) Identity. (1) For the purpose of
ditions: this section, perfluorocarbon cured
(a) For the purpose of this section elastomers are produced by
the mineral reinforced nylon resins terpolymerizing tetrafluorethylene
consist of nylon 66, as identified in and (CAS Reg. No. 116–14–3),
complying with the specifications of perfluoromethyl vinyl ether (CAS Reg.
§ 177.1500, reinforced with up to 40 No. 1187–93–5), and perfluoro-2-
phenoxypropyl vinyl ether (CAS Reg.
weight percent of calcium silicate and
No. 24520–19–2) and subsequent curing of
up to 0.5 weight percent 3-
the terpolymer (CAS Reg. No. 26658–70–
(triethoxysilyl) propylamine (Chemical
8) using the crosslinking agent, phenol,
Abstracts Service Registry No. 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)
000919302) based on the weight of the ethylidene] bis-,dipotassium salt (CAS
calcium silicate. Reg. No. 25088–69–1) and accelerator,
(b) The mineral reinforced nylon res- 1,4,7,10,13,16-hexaoxacyclooctadecane
ins may contain up to 0.2 percent by (CAS Reg. No. 17455–13–9).
weight of titanium dioxide as an op- (2) The perfluorocarbon base polymer
tional adjuvant substance. shall contain no less than 40 weight-
(c) The mineral reinforced nylon res- percent of polymer units derived from
ins with or without the optional sub- tetrafluoroethylene, no less than 40
stance described in paragraph (b) of weight-percent of polymer units de-
this section, and in the form of 1⁄8-inch rived from perfluoromethyl vinyl ether
molded test bars, when extracted with and no more than 5 weight-percent
the solvents, i.e., distilled water and 50 polymer units derived from perfluoro-2-
percent (by volume) ethyl alcohol in phenoxy-propyl vinyl ether.
distilled water, at reflux temperature (3) The composition limitations of
for 24 hours using a volume-to-surface the cured elastomer, calculated as
ratio of 2 milliliters of solvent per parts per 100 parts of terpolymer, are
square inch of surface tested, shall as follows:
meet the following extractives limita- Phenol, 4,4′-[2,2,2-trifluoro-1-
tions: (trifluoromethyl)-ethylidene] bis-
(1) Total extractives not to exceed 5.0 ,dipotassium salt—not to exceed 5 parts.
milligrams per square inch of food-con- 1,4,7,10,13,16-Hexaoxacyclo-octadecane—not
tact surface tested for each solvent. to exceed 5 parts.
(2) The ash after ignition of the ex- (b) Optional adjuvant substances. The
tractives described in paragraph (c)(1) perfluorocarbon cured elastomer iden-
of this section, not to exceed 0.5 milli- tified in paragraph (a) of this section
gram per square inch of food-contact may contain the following optional ad-
surface tested. juvant substances, subject to any limi-
(d) In accordance with good manufac- tations cited on their use:
turing practice, finished articles con- (1) Substances generally recognized
taining the mineral reinforced nylon as safe (GRAS) in food or food pack-
resins shall be thoroughly cleansed aging.
prior to their first use in contact with (2) Substances used in accordance
food. with a prior sanction.
(3) Substances authorized under ap-
[42 FR 54533, Oct. 7, 1977, as amended at 42 FR

61594, Dec. 6, 1977]
plicable regulations in this part and in
parts 175 and 178 of this chapter and
342
subject to any limitations prescribed (2) Fluoride extractives calculated as

therein. fluorine not to exceed 0.47 milligram
(4) Substances identified in this para- per square decimeter (0.03 milligram
graph (b)(4) subject to such limitations per square inch).
as are provided: (e) Conditions of use. In accordance
with current good manufacturing prac-
tice, finished food contact articles con-
Carbon black (channel proc- Not to exceed 15 parts per taining the perfluorocarbon cured
ess of furnace combustion 100 parts of the elastomers shall be thoroughly cleaned
process) (CAS Reg. No. terpolymer.
1333–86–4). prior to their first use in contact with
Magnesium oxide (CAS Reg. Not to exceed 5 parts per food.
No. 1309–48–4). 100 parts of the
terpolymer. [49 FR 43050, Oct. 26, 1984]
(c) Specifications—(1) Infrared identi- § 177.2410 Phenolic resins in molded

fication. Perfluorocarbon cured articles.
elastomers may be identified by the Phenolic resins identified in this sec-
characteristic infrared spectra of the tion may be safely used as the food-
pyrolysate breakdown product that is contact surface of molded articles in-
obtained by heating and decomposing tended for repeated use in contact with
the elastomer using the method enti- nonacid food (pH above 5.0), in accord-
tled ‘‘Qualitative Identification of ance with the following prescribed con-
Kalrez ® by Infrared Examination of ditions:
Pyrolysate.’’ This method is incor- (a) For the purpose of this section,
porated by reference. Copies of the the phenolic resins are those produced
method are available from the Center when one or more of the phenols listed
for Food Safety and Applied Nutrition in paragraph (a)(1) of this section are
(HFS–200), Food and Drug Administra- made to react with one or more of the
tion, 5100 Paint Branch Pkwy., College aldehydes listed in paragraph (a)(2) of
Park, MD 20740, or available for inspec- this section, with or without aniline
tion at the National Archives and and/or anhydro-formaldehyde aniline
Records Administration (NARA). For (hexahydro-1, 3,5-triphenyl-s-triazine):
information on the availability of this (1) Phenols:
p-tert-Amylphenol.
go to: http://www.archives.gov/ p-tert-Butylphenol.
federallregister/ o-, m-, and p-Cresol.
codeloflfederallregulations/ p-Octylphenol.
ibrllocations.html. Phenol.
(2) Thermogravimetry. Perfluorocarbon o- and p-Phenylethylphenol mixture pro-
cured elastomers have a major decom- duced when phenol is made to react with
position peak occurring at 490 ° ±15 °C styrene in the presence of sulfuric acid cat-
alyst.
(914 °F). Less than 1.5 percent of the
elastomers will volatilize below 400 °C (2) Aldehydes:
(752 °F) when run under nitrogen at a 10 Acetaldehyde.
°C or 18 °F per minute heating rate Formaldehyde.
using a Du Pont Thermal Analyzer Paraldehyde.
Model 1099 with Model 951 TGA unit or
the equivalent. (b) Optional adjuvant substances em-
(d) Extractive limitations. Articles fab- ployed in the production of the phe-
ricated from perfluorocarbon cured nolic resins or added thereto to impart
elastomers having a thickness of at desired technical or physical properties
least 1.0 millimeter (0.039 inch) when include the following:
extracted at reflux temperatures for 2 Asbestos fiber.
hours separately with distilled water, Barium hydroxide ................... For use as catalyst.
Calcium stearate .................... For use as lubricant.
50 percent ethanol, and n-heptane, Carbon black (channel proc-
shall meet the following extractability ess).
limits: Diatomaceous earth.
(1) Total extractives not to exceed 3.1 Glass fiber.
Hexamethylenetetramine ....... For use as curing agent.

milligrams per square decimeter (0.2 Mica.
milligrams per square inch). Oxalic acid ............................. For use as catalyst.
343
§ 177.2415 21 CFR Ch. I (4–1–12 Edition)
Zinc stearate .......................... For use as lubricant. Substance Limitations
Diphenyl sulfone .................... Not to exceed 0.2 percent by

(c) The finished food-contact article, weight as a residual sol-
when extracted with distilled water at vent in the finished basic
reflux temperature for 2 hours, using a resin.
volume-to-surface ratio of 2 milliliters
of distilled water per square inch of (c) Extractive limitations. The finished
surface tested, shall meet the following food contact article, when extracted at
extractives limitations: reflux temperatures for 2 hours with
the following four solvents, yields in
(1) Total extractives not to exceed
each extracting solvent net chloroform
0.15 milligram per square inch of food- soluble extractives not to exceed 0.05
contact surface. milligrams per square inch of food con-
(2) Extracted phenol not to exceed tact surface: Distilled water, 50 percent
0.005 milligram per square inch of food- (by volume) ethanol in distilled water,
contact surface. 3 percent acetic acid in distilled water,
(3) No extracted aniline when tested and n-heptane. In testing the final food
by a spectrophotometric method sen- contact article, a separate test sample
sitive to 0.006 milligram of aniline per- shall be used for each extracting sol-
square inch of food-contact surface. vent.
(d) In accordance with good manufac- [63 FR 20315, Apr. 24, 1998]
turing practice, finished molded arti-
cles containing the phenolic resins § 177.2420 Polyester resins, cross-
shall be thoroughly cleansed prior to linked.
their first use in contact with food. Cross-linked polyester resins may be
safely used as articles or components
§ 177.2415 Poly(aryletherketone) res- of articles intended for repeated use in
ins. contact with food, in accordance with
Poly(aryletherketone) resins identi- the following prescribed conditions:
fied in paragraph (a) of this section (a) The cross-linked polyester resins
may be safely used as articles or com- are produced by the condensation of
ponents of articles intended for re- one or more of the acids listed in para-
peated use in contact with food subject graph (a)(1) of this section with one or
to the provisions of this section. more of the alcohols or epoxides listed
in paragraph (a)(2) of this section, fol-
(a) Identity. For the purposes of this
lowed by copolymerization with one or
section, poly(aryletherketone) resins
more of the cross-linking agents listed
are poly(p-oxyphenylene p-
in paragraph (a)(3) of this section:
oxyphenylene p-carboxyphenylene) res- (1) Acids:
ins (CAS Reg. No. 29658–26–2) produced
by the polymerization of hydroquinone Adipic.
Fatty acids, and dimers thereof, from nat-
and 4,4′-difluorobenzophenone, and ural sources.
have a minimum weight-average mo- Fumaric.
lecular weight of 12,000, as determined Isophthalic.
by gel permeation chromatography in Maleic.
comparison with polystyrene stand- Methacrylic.
Orthophthalic.
ards, and a minimum mid-point glass Sebacic.
transition temperature of 142 °C, as de- Terephthalic.
termined by differential scanning Trimellitic.
calorimetry. (2) Polyols and polyepoxides:
(b) Optional adjuvant substances. The
basic resins identified in paragraph (a) Butylene glycol.
Diethylene glycol.
may contain optional adjuvant sub- 2,2-Dimethyl-1,3-propanediol.
stances used in their production. These Dipropylene glycol.
adjuvants may include substances de- Ethylene glycol.
scribed in § 174.5(d) of this chapter and Glycerol.
the following: 4,4′-Isopropylidenediphenol-epichlorohydrin.

Mannitol.
a-Methyl glucoside.
344
Pentaerythritol. Triglycidyl isocyanurate (CAS Reg. No. 2451–
Polyoxypropylene ethers of 4,4′-isopropylide- 62–9), for use only in coatings contacting
nediphenol (containing an average of 2–7.5 bulk quantities of dry food of the type
moles of propylene oxide). identified in § 176.170(c) of this chapter,
Propylene glycol. table 1, under type VIII.
Sorbitol. Vinyl toluene.
Trimethylol ethane.
Trimethylol propane. (b) Optional adjuvant substances em-
2,2,4-Trimethyl-1,3-pentanediol. ployed to facilitate the production of
(3) Cross-linking agents: the resins or added thereto to impart
desired technical or physical properties
Butyl acrylate. include the following, provided that
Butyl methacrylate. the quantity used does not exceed that
Ethyl acrylate.
Ethylhexyl acrylate. reasonably required to accomplish the
Methyl acrylate. intended physical or technical effect
Methyl methacrylate. and does not exceed any limitations
Styrene. prescribed in this section:
Limitations (limits of addition expressed as percent by weight
List of substances of finished resin)
1. Inhibitors: Total not to exceed 0.08 percent.

Benzoquinone ....................................................................... 0.01 percent.
tert-Butyl catechol.
TBHQ.
Di-tert-butyl hydroquinone.
Hydroquinone.
2. Accelerators: Total not to exceed 1.5 percent.
Benzyl trimethyl ammonium chloride ................................... 0.05 percent.
Calcium naphthenate.
Cobalt naphthenate.
Copper naphthenate.
N, N-Diethylaniline ................................................................ 0.4 percent.
N, N-Dimethylaniline ............................................................. Do.
Ethylene guanidine hydrochloride ........................................ 0.05 percent.
3. Catalysts: Total not to exceed 1.5 percent, except that methyl ethyl ke-
tone peroxide may be used as the sole catalyst at levels not
to exceed 2 percent.
Azo-bis-isobutyronitrile.
Benzoyl peroxide.
tert-Butyl perbenzoate.
Chlorbenzoyl peroxide.
Cumene hydroperoxide.
Dibutyltin oxide (CAS Reg. No. 818–08–6) ......................... For use in the polycondensation reaction at levels not to ex-
ceed 0.2 percent of the polyester resin.
Dicumyl peroxide.
Hydroxybutyltin oxide (CAS Reg. No. 2273–43–0) ............. For use in the polycondensation reaction at levels not to ex-
ceed 0.2 percent of the polyester resin.
Lauroyl peroxide.
p-Menthane hydroperoxide.
Methyl ethyl ketone peroxide.
Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850– For use in the polycondensation reaction at levels not to ex-
94–4). ceed 0.2 percent of the polyester resin.
4. Solvents for inhibitors, accelerators, and catalysts:
Butyl benzyl phthalate (containing not more than 1.0 per-
cent by weight of dibenzyl phthalate).
Dibutyl phthalate.
Diethylene glycol .................................................................. As a solvent for benzyl trimethyl ammonium chloride or ethyl-
ene guanidine hydrochloride only.
Dimethyl phthalate.
Methyl alcohol.
Styrene.
Triphenyl phosphate.
5. Reinforcements:
Asbestos.
Glass fiber.
Polyester fiber produced by the condensation of one or
more of the acids listed in paragraph (a)(1) of this sec-
tion with one or more of the alcohols listed in paragraph
(a)(2) of this section.
6. Miscellaneous materials:
a-Methylstyrene.
345
§ 177.2430 21 CFR Ch. I (4–1–12 Edition)
Limitations (limits of addition expressed as percent by weight

List of substances of finished resin)
Polyethylene glycol 6000.

Silicon dioxide.
Wax, petroleum .................................................................... Complying with § 178.3710 of this chapter.
(c) The cross-linked polyester resins, ins shall be thoroughly cleansed prior
with or without the optional sub- to their first use in contact with food.
stances described in paragraph (b) of
this section, and in the finished form in § 177.2440 Polyethersulfone resins.
which they are to contact food, when Polyethersulfone resins identified in
extracted with the solvent or solvents paragraph (a) of this section may be
characterizing the type of food and safely used as articles or components
under the conditions of time and tem- of articles intended for repeated use in
perature characterizing the conditions contact with food in accordance with
of their intended use, as determined the following prescribed conditions:
from tables 1 and 2 of § 176.170(c) of this (a) For the purpose of this section,
chapter, shall meet the following ex- polyethersulfone resins are:
tractives limitations: (1) Poly(oxy-p-phenylenesulfonyl-p-
(1) Net chloroform-soluble extrac- phenylene) resins (CAS Reg. No. 25667–
tives not to exceed 0.1 milligram per 42–9), which have a minimum number
square inch of food-contact surface average molecular weight of 16,000.
tested when the prescribed food-simu- (2) 1,1′-sulfonylbis[4-chlorobenzene]
lating solvent is water or 8 or 50 per- polymer with 4,4′-(1-methylethyl-
cent alcohol. idene)bis[phenol] (maximum 8 percent)
(2) Total nonvolatile extractives not and 4,4′-sulfonylbis[phenol] (minimum
to exceed 0.1 milligram per square inch 92 percent) (CAS Reg. No. 88285–91–0),
of food-contact surface tested when the which have a minimum number aver-
prescribed food-simulating solvent is age molecular weight of 26,000.
heptane. (3) In paragraphs (a)(1) and (a)(2) of
(d) In accordance with good manufac- this section, the minimum number av-
turing practice, finished articles con- erage molecular weight is determined
taining the cross-linked polyester res- by reduced viscosity in dimethyl form-
ins shall be thoroughly cleansed prior amide in accordance with ASTM meth-
to their first use in contact with food. od D2857–70 (Reapproved 1977), ‘‘Stand-
ard Test Method for Dilute Solution
[42 FR 14572, Mar. 15, 1977, as amended at 48 Viscosity of Polymers,’’ which is incor-
FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, porated by reference. Copies may be
1989] obtained from the American Society
for Testing Materials, 100 Barr Harbor
§ 177.2430 Polyether resins, chlori-
nated. Dr., West Conshohocken, Philadelphia,
PA 19428-2959, or may be examined at
Chlorinated polyether resins may be the Division of Petition Control (HFS–
safely used as articles or components 215), Center for Food Safety and Ap-
of articles intended for repeated use in plied Nutrition, 1110 Vermont Ave.
producing, manufacturing, packing, NW., suite 1200, Washington, DC, or at
processing, preparing, treating, pack- the National Archives and Records Ad-
aging, transporting, or holding food, in ministration (NARA). For information
accordance with the following pre- on the availability of this material at
scribed conditions: NARA, call 202–741–6030, or go to: http://
(a) The chlorinated polyether resins www.archives.gov/federallregister/
are produced by the catalytic polym- codeloflfederallregulations/
erization of 3,3-bis(chloromethyl)- ibrllocations.html.
oxetane, and shall contain not more (b) The basic resins identified in
than 2 percent residual monomer. paragraphs (a)(1) and (a)(2) of this sec-
(b) In accordance with good manufac- tion may contain optional adjuvant
turing practice, finished articles con- substances described in § 174.5(d) of this

taining the chlorinated polyether res- chapter and the following:
346
List of substances Limitations tent of not less than 7.8 weight percent
Diphenylsulfone ................ Not to exceed 0.2 percent as re-
and not more than 8.2 weight percent.
sidual solvent in the finished Polyamide-imide resins identified in
basic resin described in para- paragraph (a)(2) of this section shall
graph (a)(1) of this section.
Dimethyl sulfoxide ............ Not to exceed 0.01 percent as
have a nitrogen content of not less
residual solvent in the finished than 7.5 weight percent and not more
basic resin described in para- than 7.8 weight percent. Nitrogen con-
N-methyl-2-pyrrolidone ..... Not to exceed 0.01 percent as
tent is determined by the Dumas Nitro-
residual solvent in the finished gen Determination as set forth in the
basic resin described in para- ‘‘Official Methods of Analysis of the
Association of Official Analytical
Chemists,’’ 13th Ed. (1980), sections
(c) The finished food-contact article,
7.016–7.020, which is incorporated by
when extracted at reflux temperatures
for 2 hours with the following four sol- reference in accordance with 5 U.S.C.
vents, yields net chloroform-soluble ex- 552(a). Copies may be obtained from the
tractives in each extracting solvent AOAC INTERNATIONAL, 481 North
not to exceed 0.02 milligram per square Frederick Ave., suite 500, Gaithersburg,
inch of food-contact surface: distilled MD 20877, or may be examined at the
water, 50 percent (by volume) ethyl al- National Archives and Records Admin-
cohol in distilled water, 3 percent ace- istration (NARA). For information on
tic acid in distilled water, and n- the availability of this material at
heptane. (Note: In testing the finished NARA, call 202–741–6030, or go to: http://
food-contact article, use a separate www.archives.gov/federallregister/
test sample for each required extract- codeloflfederallregulations/
ing solvent.) ibrllocations.html.
(d) In accordance with good manufac- (2) Polyamide-imide resins identified
turing practice, finished food-contact in paragraph (a)(1) of this section shall
articles containing the have a solution viscosity of not less
polyethersulfone resins shall be thor- than 1.200. Polyamide-imide resins
oughly cleansed before their first use identified in paragraph (a)(2) of this
in contact with food. section shall have a solution viscosity
[44 FR 34493, June 15, 1979, as amended at 47 of not less than 1.190. Solution vis-
FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, cosity shall be determined by a method
1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, titled ‘‘Solution Viscosity’’ which is in-
Sept. 20, 1995] corporated by reference in accordance
with 5 U.S.C. 552(a). Copies are avail-
§ 177.2450 Polyamide-imide resins.
able from the Center for Food Safety
Polyamide-imide resins identified in and Applied Nutrition (HFS–200), Food
paragraph (a) of this section may be and Drug Administration, 5100 Paint
safely used as components of articles Branch Pkwy., College Park, MD 20740,
intended for repeated use in contact or available for inspection at the Na-
with food, in accordance with the fol- tional Archives and Records Adminis-
(a) Identity. (1) For the purpose of
this section the polyamide-imide resins
are derived from the condensation re- NARA, call 202–741–6030, or go to: http://
action of substantially equimolar parts www.archives.gov/federallregister/
of trimellitic anhydride and p,p′- codeloflfederallregulations/
diphenylmethane diisocyanate. ibrllocations.html.
(2) The polyamide-imide resins (CAS (3) The polyamide-imide resins iden-
Reg. No. 31957–38–7) derived from the tified in paragraph (a)(1) of this section
condensation reaction of equimolar are heat cured at 600 °F for 15 minutes
parts of benzoyl chloride-3,4- when prepared for extraction tests and
dicarboxylic anhydride and 4,4′- the residual monomers: p,p-
diphenylmethanediamine. diphenylmethane diisocyanate should
(b) Specifications. (1) Polyamide-imide not be present at greater than 100 parts
resins identified in paragraph (a)(1) of per million and trimellitic anhydride

this section shall have a nitrogen con- should not be present at greater than
347
§ 177.2460 21 CFR Ch. I (4–1–12 Edition)
500 parts per million. Residual mono- cleansed prior to their first use in con-
mers are determined by gas chroma- tact with food.
tography (the gas chromatography [42 FR 14572, Mar. 15, 1977, as amended at 47
method titled ‘‘Amide-Imide Polymer FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19,
Analysis—Analysis of Monomer Con- 1984; 54 FR 24898, June 12, 1989; 54 FR 43170,
tent,’’ is incorporated by reference in Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996; 70 FR
accordance with 5 U.S.C. 552(a). Copies 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005]
are available from the Center for Food § 177.2460 Poly(2,6-dimethyl-1,4-phen-
Safety and Applied Nutrition (HFS– ylene) oxide resins.
200), Food and Drug Administration,
The poly(2,6-dimethyl-1,4-phenylene)
oxide resins identified in paragraph (a)
MD 20740, or available for inspection at of this section may be used as an arti-
the National Archives and Records Ad- cle or as a component of an article in-
ministration (NARA). For information tended for use in contact with food sub-
on the availability of this material at ject to the provisions of this section.
NARA, call 202–741–6030, or go to: http:// (a) Identity. For the purposes of this
www.archives.gov/federallregister/ section, poly(2,6-dimethyl-1,4-phen-
codeloflfederallregulations/ ylene) oxide resins consist of basic res-
ibrllocations.html.). ins produced by the oxidative coupling
(c) Extractive limitations are appli- of 2,6-xylenol such that the finished
cable to the polyamide-imide resins basic resins meet the specifications
identified in paragraphs (a) (1) and (2) and extractives limitations prescribed
of this section in the form of films of 1 in paragraph (c) of this section.
mil uniform thickness after coating (b) Optional adjuvant substances. The
and heat curing at 600 °F for 15 minutes basic poly(2,6-dimethyl-1,4-phenylene)
on stainless steel plates, each having oxide resins identified in paragraph (a)
such resin-coated surface area of 100 of this section may contain optional
square inches. The cured-resin film adjuvant substances required in the
coatings shall be extracted in accord- production of such basic resins. The op-
tional adjuvant substances required in
ance with the method described in
the production of the basic poly(2,6-di-
§ 176.170(d)(3) of this chapter, using a
methyl-1,4-phenylene) oxide resins may
plurality of spaced, coated stainless
include substances permitted for such
steel plates, exposed to the respective use by regulations in parts 170 through
food simulating solvents. The resin 189 of this chapter, substances gen-
shall meet the following extractive erally recognized as safe in food, sub-
limitations under the corresponding stances used in accordance with a prior
extraction conditions: sanction or approval, and the fol-
(1) Distilled water at 250 °F for 2 lowing:
hours: Not to exceed 0.01 milligram per
Limitations (expressed as
square inch. List of substances percent by weight of finished
(2) Three percent acetic acid at 212 °F basic resin)
for 2 hours: Not to exceed 0.05 milli- Diethylamine .......................... Not to exceed 0.16 percent
gram per square inch. as residual catalyst.
Methyl alcohol ........................ Not to exceed 0.02 percent
(3) Fifty percent ethyl alcohol at 160
as residual solvent.
°F for 2 hours: Not to exceed 0.03 milli- Toluene .................................. Not to exceed 0.2 percent as
gram per square inch. residual solvent.
(4) n-Heptane at 150 °F for 2 hours:
Not to exceed 0.05 milligram per square (c) Specifications and extractives limita-
inch. tions. The poly(2,6-dimethyl-1,4-phen-
ylene) oxide basic resins meet the fol-
(d) In accordance with good manufac-
lowing:
turing practice, those food contact ar-
(1) Specifications. Intrinsic viscosity
ticles, having as components the poly- is not less than 0.30 deciliter per gram
amide-imide resins identified in para- as determined by ASTM method D1243–
graph (a) of this section and intended 79, ‘‘Standard Test Method for Dilute
for repeated use shall be thoroughly Solution Viscosity of Vinyl Chloride

Polymers,’’ which is incorporated by
348
reference, modified as follows. Copies section, when used as components of

of the incorporation by reference may the food-contact surface of any article
be obtained from the American Society that is the subject of a regulation in
for Testing Materials, 100 Barr Harbor parts 174, 175, 176, 177, 178 and § 179.45 of
Dr., West Conshohocken, Philadelphia, this chapter, shall comply with any
PA 19428-2959, or may be examined at specifications and limitations pre-
the National Archives and Records Ad- scribed by such regulation for the arti-
ministration (NARA). For information cle in the finished form in which it is
on the availability of this material at to contact food.
(e) Uses. The poly(2,6-dimethyl-1,4-
codeloflfederallregulations/ phenylene) oxide resins identified in
ibrllocations.html. and complying with the limitations in
(i) Solvent: Chloroform, reagent grade this section may be used as articles or
containing 0.01 percent tert- components of articles intended for re-
butylcatechol. peated food-contact use or as articles
(ii) Resin sample: Powdered resin ob- or components of articles intended for
tained from production prior to mold- single-service food-contact use only
ing or extrusion. under the conditions described in
(iii) Viscometer: Cannno-Ubbelohde se- § 176.170(c) of this chapter, table 2, con-
ries 25 dilution viscometer (or equiva- ditions of use H.
lent).
(iv) Calculation: The calculation [42 FR 14572, Mar. 15, 1977, as amended at 49
FR 10111, Mar. 19, 1984; 63 FR 8852, Feb. 23,
method used is that described in appen-
1998]
dix X.1.3 (ASTM method D1243–79, cited
and incorporated by reference in para- § 177.2465 Polymethylmethacrylate/
graph (c)(1) of this section) with the re- poly(trimethoxysilylpropyl)meth-
duced viscosity determined for three acrylate copolymers.
concentration levels (0.4, 0.2, and 0.1
gram per deciliter) and extrapolated to Polymethylmethacrylate/
zero concentration for intrinisic vis- poly(trimethoxysilylpropyl) methacry-
cosity. The following formula is used late copolymers (CAS Reg. No. 26936–
for determining reduced viscosity: 30–1) may be safely used as components
of surface primers used in conjunction
Reduced viscosity in terms t − t o with silicone polymers intended for re-
of deciliters per gram = t × c peated use and complying with § 175.300
of this chapter and § 177.2600, in accord-
o
where: ance with the following prescribed con-
t=Solution efflux time. ditions.
to=Solvent efflux time. (a) Identity. For the purpose of this
c=Concentration of solution in terms of section, polymethylmethacrylate/
grams per deciliter. poly(trimethoxysilylpropyl)methacry-
(2) Extractives limitations. Total resin late copolymers are produced by the
extracted not to exceed 0.02 weight-per- polymerization of methylmethacrylate
cent when extracted with n-heptane at and
160 °F for 2 hours as determined using trimethoxysilylpropylmethacrylate.
200 milliliters of reagent grade n- (b) Conditions of use. (1) The
heptane which has been freshly dis- polymethylmethacrylate/
tilled before use and 25 grams of poly poly(trimethoxysilylpropyl)methacry-
(2,-6-dimethyl-1,4-phenylene) oxide late copolymers are used at levels not
resin. The resin as tested is in pellet to exceed 6.0 percent by weight of the
form having a particle size such that primer formulation.
100 percent of the pellets will pass (2) The copolymers may be used in
through a U.S. Standard Sieve No. 6 food contact applications with all food
and 100 percent of the pellets will be types under conditions of use B
held on a U.S. Standard Sieve No. 10. through H as described in table 2 of
(d) Other limitations. The poly(2,6-di-

methyl-1,4-phenylene) oxide resins
identified in and complying with this [59 FR 5948, Feb. 9, 1994]
349
ER01JA93.406</GPH>
§ 177.2470 21 CFR Ch. I (4–1–12 Edition)
§ 177.2470 Polyoxymethylene copoly- (2) Minimum number average molec-

mer. ular weight of the copolymer is 15,000
Polyoxymethylene copolymer identi- as determined by a method titled
fied in this section may be safely used ‘‘Number Average Molecular Weight,’’
as an article or component of articles which is incorporated by reference.
intended for food-contact use in ac- Copies are available from the Center
cordance with the following prescribed for Food Safety and Applied Nutrition
conditions: (HFS–200), Food and Drug Administra-
(a) Identity. For the purpose of this tion, 5100 Paint Branch Pkwy., College
section, polyoxymethylene copolymers Park, MD 20740, or available for inspec-
are identified as the following: The re- tion at the National Archives and
action product of trioxane (cyclic Records Administration (NARA). For
trimer of formaldehyde) and ethylene information on the availability of this
oxide (CAS Reg. No. 24969–25–3) or the material at NARA, call 202–741–6030, or
reaction product of trioxane (cyclic go to: http://www.archives.gov/
trimer of formaldehyde) and a max- federallregister/
imum of 5 percent by weight of codeloflfederallregulations/
butanediol formal (CAS Reg. No. 25214
ibrllocations.html.
85–1). Both copolymers may have cer-
(d) Extractive limitations. (1) Polyoxy-
tain optional substances added to im-
part desired technological properties to methylene copolymer in the finished
the copolymer. form in which it is to contact food,
(b) Optional adjuvant substances. The when extracted with the solvent or sol-
polyoxymethylene copolymer identi- vents characterizing the type of food
fied in paragraph (a) of this section and under conditions of time and tem-
may contain optional adjuvant sub- perature as determined from tables 1
stances required in its production. The and 2 of § 175.300(d) of this chapter,
quantity of any optional adjuvant sub- shall yield net chloroform-soluble ex-
stance employed in the production of tractives not to exceed 0.5 milligram
the copolymer does not exceed the per square inch of food-contact surface.
amount reasonably required to accom- (2) Polyoxymethylene copolymer
plish the intended technical or physical with or without the optional sub-
effect. Such adjuvants may include stances described in paragraph (b) of
substances generally recognized as safe this section, when ground or cut into
in food, substances used in accordance particles that pass through a U.S.A.
with prior sanction, substances per- Standard Sieve No. 6 and that are re-
mitted under applicable regulations in tained on a U.S.A. Standard Sieve No.
parts 170 through 189 of this chapter, 10, shall yield total extractives as fol-
and the following: lows:
(1) Stabilizers (total amount of stabi-
(i) Not to exceed 0.20 percent by
lizers not to exceed 2.0 percent and
amount of any one stabilizer not to ex- weight of the copolymer when ex-
ceed 1.0 percent of polymer by weight) tracted for 6 hours with distilled water
at reflux temperature.
Calcium ricinoleate. (ii) Not to exceed 0.15 percent by
Cyanoguanidine.
Hexamethylene bis(3,5-di-tert-butyl-4-
weight of the copolymer when ex-
hydroxyhydrocinnamate) (CAS Reg. No. tracted for 6 hours with n-heptane at
35074–77–2). reflux temperature.
Melamine-formaldehyde resin. (e) Conditions of use. (1) The
2,2′-Methylenebis(4-methyl-6-tert-butyl- polyoxymethylene copolymer is for use
phenol).
Nylon 6/66, weight ratio 2/3.
as articles or components of articles
Tetrakis [methylene (3,5-di-tert-butyl-4- intended for repeated use.
hydroxyhydrocinnamate)] methane. (2) Use temperature shall not exceed
250 °F.
(2) Lubricant: N,N′Distearoylethyl-
enediamine. (3) In accordance with good manufac-
(c) Specifications. (1) Polyoxymeth- turing practice, finished articles con-
ylene copolymer can be identified by taining polyoxymethylene copolymer

its characteristic infrared spectrum.
350
shall be thoroughly cleansed before Substances Limitations

their first use in contact with food.
Nylon 66/610/6 terpolymer, At a maximum level of 1.5
[42 FR 14572, Mar. 15, 1977, as amended at 48 respective proportions of percent by weight of
nylon polymers by weight homopolymer.
FR 56204, Dec. 20, 1983; 49 FR 5748, Feb. 15,
are: 3/2/4.
1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, Nylon 612/6 copolymer (CAS Do.
May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR Reg. No. 51733-10-9),
24898, June 12, 1989] weight ratio 6/1.
Tetrakis[methylene(3,5-di-tert- At a maximum level of 0.5
§ 177.2480 Polyoxymethylene butyl-4-hydroxy-hydro- percent by weight of
cinnamate)] methane. homopolymer.
homopolymer.
Polyoxymethylene homopolymer (2) Lubricant. N,N′-Distearoylethyl-
identified in this section may be safely enediamine.
used as articles or components of arti- (3) Molding assistant. Polyethylene
cles intended for food-contact use in glycol 6,000.
accordance with the following pre- (c) Specifications. (1) Polyoxymethy-
scribed conditions: lene homopolymer can be identified by
(a) Identity. For the purpose of this its characteristic infrared spectrum.
section, polyoxymethylene homopoly- (2) Minimum number average molec-
mer is polymerized formaldehyde ular weight of the homopolymer is
[Chemical Abstracts Service Registry 25,000.
No. 9002–81–7]. Certain optional adju- (3) Density of the homopolymer is be-
vant substances, described in para- tween 1.39 and 1.44 as determined by
graph (b) of this section, may be added ASTM method D1505–68 (Reapproved
to impart desired technological prop- 1979), ‘‘Standard Test Method for Den-
erties to the homopolymer. sity of Plastics by the Density-Gra-
(b) Optional adjuvant substances. The dient Technique,’’ which is incor-
polyoxymethylene homopolymer iden- porated by reference. Copies may be
tified in paragraph (a) of this section obtained from the American Society
may contain optional adjuvant sub- for Testing Materials, 100 Barr Harbor
stances in its production. The quantity Dr., West Conshohocken, Philadelphia,
of any optional adjuvant substance em- PA 19428-2959, or may be examined at
ployed in the production of the the National Archives and Records Ad-
homopolymer does not exceed the ministration (NARA). For information
amount reasonably required to accom- on the availability of this material at
plish the intended effect. Such adju- NARA, call 202–741–6030, or go to: http://
vants may include substances gen- www.archives.gov/federallregister/
erally recognized as safe in food, sub- codeloflfederallregulations/
stances used in accordance with prior ibrllocations.html.
sanction, substances permitted under (4) Melting point is between 172 °C
applicable regulations in this part, and and 184 °C as determined by ASTM
the following: method D2133–66, ‘‘Specifications for
Acetal Resin Injection Molding and Ex-
(1) Stabilizers. The homopolymer may
trusion Materials’’ (Revised 1966),
contain one or more of the following
which is incorporated by reference.
stabilizers. The total amount of stabi-
Copies are available from American So-
lizers shall not exceed 1.9 percent of
ciety for Testing and Materials
homopolymer by weight, and the quan-
(ASTM), 100 Barr Harbor Dr., West
tity of individual stabilizer used shall
Conshohocken, Philadelphia, PA 19428-
not exceed the limitations set forth
2959, or available for inspection at the
below:
National Archives and Records Admin-
Substances Limitations istration (NARA). For information on
Hexamethylenebis(3,5-di-tert- At a maximum level of 1 per- NARA, call 202–741–6030, or go to: http://
butyl-4-hydroxy-hydro- cent by weight of
cinnamate) (CAS Reg. No. homopolymer. The finished www.archives.gov/federallregister/
35074–77–2). articles shall not be used codeloflfederallregulations/
for foods containing more ibrllocations.html.
than 8 percent alcohol.
(d) Extractive limitations. (1)
2,2′-Methylenebis(4-methyl-6- At a maximum level of 0.5

tert-butylphenol). percent by weight of Polyoxymethylene homopolymer, in
homopolymer. the finished form which is to contact
351
§ 177.2490 21 CFR Ch. I (4–1–12 Edition)
food, when extracted with the solvent cleansed prior to first use in contact
or solvents characterizing the type of with food.
food and under conditions of time and [42 FR 14572, Mar. 15, 1977, as amended at 43
temperature characterizing the condi- FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19,
tions of intended use under paragraphs 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111,
(c)(3) and (d) of § 175.300 of this chapter Mar. 19, 1984; 54 FR 24898, June 12, 1989]
and as limited by paragraph (e) of this
§ 177.2490 Polyphenylene sulfide res-
section, shall yield net chloroform- ins.
soluble extractives not to exceed 0.5
milligram per square inch of food-con- Polyphenylene sulfide resins
tact surface. (poly(1,4-phenylene sulfide) resins) may
be safely used as coatings or compo-
(2) Polyoxymethylene homopolymer,
nents of coatings of articles intended
with or without the optional adjuvant
for repeated use in contact with food,
substances described in paragraph (b) in accordance with the following pre-
of this section, when ground or cut into scribed conditions.
particles that pass through a U.S.A. (a) Polyphenylene sulfide resins con-
Standard Sieve No. 6 and that are re- sist of basic resins produced by the re-
tained on a U.S.A. Standard Sieve No. action of equimolar parts of p-
10, shall yield extractives as follows: dichlorobenzene and sodium sulfide,
(i) Formaldehyde not to exceed 0.0050 such that the finished resins meet the
percent by weight of homopolymer as following specifications as determined
determined by a method titled ‘‘Form- by methods titled ‘‘Oxygen Flask Com-
aldehyde Release and Formaldehyde bustion-Gravimetric Method for Deter-
Analysis,’’ which is incorporated by mination of Sulfur in Organic Com-
reference. Copies are available from pounds,’’ ‘‘Determination of the Inher-
Center for Food Safety and Applied Nu- ent Viscosity of Polyphenylene Sul-
trition (HFS–200) Food and Drug Ad- fide,’’ and ‘‘Analysis for
ministration, 5100 Paint Branch Pkwy., Dichlorobenzene in Ryton
College Park, MD 20740, or available for Polyphenylene Sulfide,’’ which are in-
inspection at the National Archives corporated by reference. Copies are
and Records Administration (NARA). available from the Center for Food
For information on the availability of Safety and Applied Nutrition (HFS–
this material at NARA, call 202–741–
6030, or go to: http://www.archives.gov/
MD 20740, or available for inspection at
federallregister/
codeloflfederallregulations/ ministration (NARA). For information
ibrllocations.html. on the availability of this material at
(ii) Total extractives not to exceed NARA, call 202–741–6030, or go to: http://
0.20 percent by weight of homopolymer www.archives.gov/federallregister/
when extracted for 6 hours with dis- codeloflfederallregulations/
tilled water at reflux temperature and ibrllocations.html.
0.15 percent by weight of homopolymer (1) Sulfur content: 28.2–29.1 percent
when extracted for 6 hours with n- by weight of finished resin.
heptane at reflux temperature. (2) Minimum inherent viscosity: 0.13
(e) Conditions of use. (1) Polyoxy- deciliters per gram.
methylene homopolymer is for use as (3) Maximum residual p-
articles or components of articles in- dichlorobenzene: 0.8 ppm.
tended for repeated use. (b) Subject to any limitations pre-
(2) Use temperature shall not exceed scribed in parts 170 through 189 of this
250 °F. chapter, the following optional sub-
stances may be added to the
(3) In accordance with good manufac-
polyphenylene sulfide basic resins in an
turing practice, finished articles con-
amount not to exceed that reasonably
taining polyoxymethylene required to accomplish the intended
homopolymer shall be thoroughly physical or technical effect.

as safe in food.
352
(2) Substances used in accordance acetic acid such that the finished res-
with prior sanction or approval. ins meet the specifications set forth in
(3) Substances the use of which is paragraph (c) of this section. The
permitted in coatings under regula- polyphenylene sulfide used to manufac-
tions in parts 170 through 189 of this ture polyphenylene sulfone is prepared
chapter. by the reaction of sodium sulfide and p-
(c) The finished coatings are ther- dichlorobenzene, and has a minimum
mally cured at temperatures of 700 °F weight average molecular weight of
and above. 5,000 Daltons.
(d) Polyphenylene sulfide resin coat- (b) Optional adjuvant substances. The
ings may be used in contact with food basic polyphenylene sulfone resins
at temperatures not to exceed the boil- identified in paragraph (a) of this sec-
ing point of water; provided that the tion may contain optional adjuvant
finished cured coating, when extracted substances required in the production
at reflux temperatures for 8 hours sepa- of such basic resins. These optional ad-
rately with distilled water, 50 percent juvant substances may include sub-
ethanol in water, and 3 percent acetic stances permitted for such use by regu-
acid, yields total extractives in each lations in parts 170 through 189 of this
extracting solvent not to exceed 0.02 chapter, substances generally recog-
milligram per square inch of surface nized as safe in food, or substances
and when extracted at reflux tempera- used in accordance with a prior sanc-
ture for 8 hours with heptane yields tion or approval.
total extractives not to exceed 0.1 mil- (c) Specifications. The glass transition
ligram per square inch of surface. temperature of the polymer is 360±5 °C
(e) Polyphenylene sulfide resin coat- as determined by the use of differential
ings containing perfluorocarbon resins scanning calorimetry.
complying with § 177.1550 may be used
in contact with food at temperatures [65 FR 15058, Mar. 21, 2000]
up to and including normal baking and
frying temperatures; provided that the § 177.2510 Polyvinylidene fluoride res-
finished cured coating, when extracted ins.
at reflux temperatures for 2 hours sepa- Polyvinylidene fluoride resins may
rately with distilled water, 50 percent be safely used as articles or compo-
ethanol in water, 3 percent acetic acid nents of articles intended for repeated
and heptane, yields total extractives in use in contact with food, in accordance
each extracting solvent not to exceed with the following prescribed condi-
0.2 milligram per square inch of surface tions:
and when extracted at reflux tempera- (a) For the purpose of this section,
ture for 1 hour with diphenyl ether the polyvinylidene fluoride resins con-
yields total extractives not to exceed sist of basic resins produced by the po-
4.5 milligrams per square inch of sur- lymerization of vinylidene fluoride.
face. (b) The finished food-contact article,
[42 FR 14572, Mar. 15, 1977, as amended at 47 when extracted at reflux temperatures
FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, for 2 hours with the solvents distilled
1989] water, 50 percent (by volume) ethyl al-
cohol in distilled water, and n-heptane,
§ 177.2500 Polyphenylene sulfone res- yields total extractives in each ex-
ins. tracting solvent not to exceed 0.01 mil-
The polyphenylene sulfone resins ligram per square inch of food-contact
(CAS Reg. No. 31833–61–1) identified in surface tested; and if the finished food-
paragraph (a) of this section may be contact article is itself the subject of a
safely used as articles or components regulation in parts 174, 175, 176, 177, 178
of articles intended for repeated use in and § 179.45 of this chapter, it shall also
contact with food, subject to the provi- comply with any specifications and
sions of this section. limitations prescribed for it by that
(a) Identity. For the purpose of this regulation. (NOTE: In testing the fin-
section, polyphenylene sulfone resins ished food-contact article, use a sepa-
consist of basic resin produced by re- rate test sample for each required ex-
acting polyphenylene sulfide with per- tracting solvent.)
353
§ 177.2550 21 CFR Ch. I (4–1–12 Edition)
(c) In accordance with good manufac- dichloride (CAS Reg. No. 39443–76–0).
turing practice, finished food-contact The membrane is the food contact sur-
articles containing the polyvinylidene face and may be applied as a film on a
fluoride resins shall be thoroughly suitable support. Its maximum weight
cleansed prior to their first use in con- is 512 milligrams per square decimeter
tact with food. (33 milligrams per square inch).
(4) A cross-linked high molecular
§ 177.2550 Reverse osmosis mem-
branes. weight polyamide reaction product of
poly(N-vinyl-N-methylamine) (CAS
Substances identified in paragraph Reg. No. 31245–56–4), N,N′-bis(3-
(a) of this section may be safely used as aminopropyl)ethylenediamine (CAS
reverse osmosis membranes intended Reg. No. 10563–26–5), 1,3-
for use in processing bulk quantities of
benzenedicarbonyl dichloride (CAS
liquid food to separate permeate from
Reg. No. 99–63–8) and 1,3,5-
food concentrate or in purifying water
benzenetricarbonyl trichloride (CAS
for food manufacturing under the fol-
Reg. No. 4422–95–1). The membrane is
(a) Identity. For the purpose of this the food-contact surface. Its maximum
section, reverse osmosis membranes weight is 20 milligrams per square deci-
may consist of either of the following meter (1.3 milligrams per square inch)
formulations: as a thin film composite on a suitable
(1) A cross-linked high molecular support.
weight polyamide reaction product of (5) A polyamide reaction product of
1,3,5-benzenetricarbonyl trichloride 1,3,5-benzenetricarbonyl trichloride
with 1,3-benzenediamine (CAS Reg. No. polymer (CAS Reg. No. 4422–95–1) with
83044–99–9) or piperazine (CAS Reg. No. piperazine (CAS Reg. No. 110–85–0) and
110–85–0). The membrane is on the food- 1,2-diaminoethane (CAS Reg. No. 107–
contact surface, and its maximum 15–3). The membrane is the food-con-
weight is 62 milligrams per square deci- tact layer and may be applied as a film
meter (4 milligrams per square inch) as on a suitable support. Its maximum
a thin film composite on a suitable weight is 15 milligrams per square deci-
support. meter (1 milligram per square inch).
(2) A cross-linked polyetheramine (b) Optional adjuvant substances. The
(CAS Reg. No. 101747–84–6), identified as basic polymer identified in paragraph
the copolymer of epichlorohydrin, 1,2- (a) of this section may contain optional
ethanediamine and 1,2-dichloroethane, adjuvant substances required in the
whose surface is the reaction product production of such basic polymer.
of this copolymer with 2,4- These optional adjuvant substances
toluenediisocyanate (CAS Reg. No. of may include substances permitted for
the final polymer is 99811–80–0) for use such use by regulations in parts 170
as the food-contact surface of reverse
through 186 of this chapter, substances
osmosis membranes used in processing
generally recognized as safe in food,
liquid food. The composite membrane
and substances used in accordance with
is on the food-contact surface and its
maximum weight is 4.7 milligrams per a prior sanction or approval.
square decimeter (0.3 milligrams per (c) Supports. Suitable supports for re-
square inch) as a thin film composite verse osmosis membranes are mate-
on a suitable support. The maximum rials permitted for such use by regula-
weight of the 2,4-toluenediisocyanate tions in parts 170 through 186 of this
component of the thin film composite chapter, substances generally recog-
is 0.47 milligrams per square decimeter nized as safe in food, and substances
(0.03 milligrams per square inch). used in accordance with a prior sanc-
(3) For the purpose of this section, tion or approval.
the reverse osmosis membrane consists (d) Conditions of use. (1) Reverse os-
of a polyaramide identified as 2,4- mosis membranes described in para-
diaminobenzenesulfonic acid, calcium graphs (a)(1), (a)(2), (a)(3), and (a)(5) of
salt (2:1) polymer with 1,3- this section may be used in contact
benzenediamine, 1,3-benzenedicarbonyl with all types of liquid food at tem-

dichloride, and 1,4-benzenedicarbonyl peratures up to 80 °C (176 °F).
354
(2) Reverse osmosis membranes de- tion in parts 174, 175, 176, 177, 178 and
scribed in paragraph (a)(4) of this sec- § 179.45 of this chapter conforms with
tion may be used in contact with all any specification in such regulation.
types of liquid food, except food con- (i) Elastomers.
taining more than 8 percent alcohol, at Acrylonitrile-butadiene copolymer.
temperatures up to 80 °C (176 °F). Brominated isobutylene-isoprene copolymers
(3) Reverse osmosis membranes shall complying with § 177.1210.
be maintained in a sanitary manner in Butadiene-acrylonitrile-ethylene glycol
accordance with current good manufac- dimethacrylate copolymers containing not
turing practice so as to prevent micro- more than 5 weight percent of polymer
bial adulteration of food. units derived from ethylene glycol
dimethacrylate.
(4) To assure their safe use, reverse Butadiene-acrylonitrile-methacrylic acid co-
osmosis membranes and their supports polymer.
shall be thoroughly cleaned prior to Butadiene-styrene-methacrylic acid copoly-
their first use in accordance with cur- mer.
rent good manufacturing practice. Chloroprene polymers.
Chlorotrifluoroethylene-vinylidene fluoride
[49 FR 49448, Dec. 20, 1984, as amended at 52 copolymer.
FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, Ethylene-propylene copolymer elastomers
1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, which may contain not more than 5
Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] weight-percent of total polymer units de-
rived from 5-methylene-2-norbornene and/
§ 177.2600 Rubber articles intended for or 5-ethylidine-2-norbornene.
repeated use. Ethylene-propylene-dicyclopentadiene co-
Rubber articles intended for repeated polymer.
Ethylene-propylene-1,4-hexadiene copoly-
use may be safely used in producing, mers containing no more than 8 weight
manufacturing, packing, processing, percent of total polymer units derived
preparing, treating, packaging, trans- from 1,4-hexadiene.
porting, or holding food, subject to the Hydrogenated butadiene/acrylonitrile co-
provisions of this section. polymers (CAS Reg. No. 88254–10–8) pro-
(a) The rubber articles are prepared duced when acrylonitrile/butadiene copoly-
from natural and/or synthetic polymers mers are modified by hydrogenation of the
olefinic unsaturation to leave either: (1)
and adjuvant substances as described Not more than 10 percent trans olefinic
in paragraph (c) of this section. unsaturation and no a, b-olefinic
(b) The quantity of any substance unsaturation as determined by a method
employed in the production of rubber entitled ‘‘Determination of Residual a, b-
articles intended for repeated use shall Olefinic and Trans Olefinic Unsaturation
not exceed the amount reasonably re- Levels in HNBR,’’ developed October 1,
quired to accomplish the intended ef- 1991, by Polysar Rubber Corp., 1256 South
Vidal St., Sarnia, Ontario, Canada N7T
fect in the rubber article and shall not
7MI; or (2) 0.4 percent to 20 percent olefinic
be intended to accomplish any effect in unsaturation and Mooney viscosities great-
food. er than 45 (ML 1 + 4 @ 100 °C), as deter-
(c) Substances employed in the prep- mined by ASTM Standard Method D1646–
aration of rubber articles include the 92, ‘‘Standard Test Method for Rubber—
following, subject to any limitations Viscosity and Vulcanization Characteris-
prescribed: tics (Mooney Viscometer),’’ which are both
(1) Substances generally recognized incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Cop-
as safe for use in food or food pack- ies of these methods may be obtained from
aging. the Division of Petition Control (HFS–215),
(2) Substances used in accordance Center for Food Safety and Applied Nutri-
with the provisions of a prior sanction tion, Food and Drug Administration, 5100
or approval. Paint Branch Pkwy., College Park, MD
(3) Substances that by regulation in 20740, or may be examined at the Center for
parts 170 through 189 of this chapter Food Safety and Applied Nutrition’s Li-
may be safely used in rubber articles, brary, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the National Ar-
subject to the provisions of such regu-
chives and Records Administration
lation. (NARA). For information on the avail-
(4) Substances identified in this para-
ability of this material at NARA, call 202–

graph (c)(4), provided that any sub- 741–6030, or go to: http://www.archives.gov/
stance that is the subject of a regula- federallregister/
355
§ 177.2600 21 CFR Ch. I (4–1–12 Edition)
codeloflfederallregulations/ Silicone (Fsi) elastomers containing meth-
ibrllocations.html. A copy of ASTM Stand- yl and fluorine groups.
ard Method D1646–92 may also be obtained Silicone (PVsi) elastomers containing
from the American Society for Testing and phenyl, methyl, and vinyl groups.
Materials, 100 Barr Harbor Dr., West Styrene-butadiene copolymer.
Conshohocken, PA 19428–2959. Vinylidene fluoride-hexafluoropropylene co-
Isobutylene-isoprene copolymer. polymers (minimum number average mo-
Polyamide/polyether block copolymers (CAS lecular weight 70,000 as determined by os-
Reg. No. 77402–38–1 prepared by reacting a motic pressure in methyl ethyl ketone).
copolymer of omega-laurolactam and adipic Vinylidene fluoride-hexafluoropropylene-
acid with poly(tetramethylene ether gly- tetrafluoroethylene copolymers (minimum
col). The polyamide and polyether compo- number average molecular weight 100,000
nents are reacted in ratios such that the as determined by osmotic pressure in
polyamide component constitutes a min- methyl ethyl ketone).
imum of 30 weight-percent of total polymer
units. The copolymers may be used in con- (ii) Vulcanization materials—(a) Vul-
tact with foods of Types I, II, III, IV, V, VI, canizing agents.
VII, VIII, and IX identified in table 1 of
§ 176.170(c) of this chapter at temperatures 4,4′-Bis(aminocyclohexyl)methane carbamate
not to exceed 150 °F except that those co- for use only as cross-linking agent in the
polymers prepared with less than 50 vulcanization of vinylidene
weight-percent of polyamide are limited to fluoridehexafluoropropylene copolymer
use in contact with such foods at tempera- and vinylidene fluoride-
tures not to exceed 100 °F. hexafluoropropylene-tetrafluoroethylene
Polybutadiene. copolymer elastomers identified under
Polyester elastomers derived from the reac- paragraph (c)(4)(i) of this section and lim-
tion of dimethyl terephthalate, 1,4- ited to use at levels not to exceed 2.4 per-
butanediol, and a-hydro-omega- cent by weight of such copolymers.
hydroxypoly (oxytetramethylene). Addi- Diisopropyl xanthogen polysulfide (a 1:2:1
tionally, trimethyl trimellitate may be mixture of O,O-di(1-methylethyl)trithio-
used as a reactant. The polyester bis-thioformate, O,O-di(1-
elastomers may be used only in contact methylethyl)tetrathio-bis-thioformate,
with foods containing not more than 8 per- and O,O-di(1-methylethyl)pentathio-bis-
cent alcohol and limited to use in contact thioformate) for use as a cross linking
with food at temperatures not exceeding agent in the vulcanization of natural rub-
150 °F. ber, styrene-butadiene copolymer, acrylo-
Polyisoprene. nitrile-butadiene copolymer, and ethylene-
Polyurethane resins (CAS Reg. Nos. 37383–28– propylene terpolymers identified under
1 or 9018–04–6) derived from the reaction of paragraph (c)(4)(i) of this section and lim-
diphenylmethane diisocyanate with 1,4- ited to use at levels not to exceed 2.4 per-
butanediol and polytetramethylene ether cent by weight of such copolymers.
glycol. Hexamethylenediamine carbamate for use
Polyurethane resins derived from reactions only as cross-linking agent in the vul-
of diphenylmethane diisocyanate with canization of vinylidene fluoride-
adipic acid and 1,4-butanediol. hexafluoropropylene copolymer and vinyli-
Rubber, natural. dene fluoride-hexafluoropropylene-tetra-
Silicone basic polymer as described in ASTM fluoroethylene copolymer elastomers iden-
method D1418–81, ‘‘Standard Practice for tified under paragraph (c)(4)(i) of this sec-
Rubber and Rubber Latices—Nomen- tion and limited to use at levels not to ex-
clature,’’ which is incorporated by ref- ceed 1.5 percent by weight of such copoly-
erence. Copies may be obtained from the mers.
American Society for Testing Materials, Sulfur, ground.
100 Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be ex- (b) Accelerators (total not to exceed 1.5
amined at the National Archives and percent by weight of rubber product).
Records Administration (NARA). For in- 2-Benzothiazyl-N,N-diethylthiocarbamyl-sul-
formation on the availability of this mate- fide.
rial at NARA, call 202–741–6030, or go to: Benzoyl peroxide.
http://www.archives.gov/federallregister/ 1,3-Bis(2-benzothiazolylmercaptomethyl)
codeloflfederallregulations/ urea.
ibrllocations.html. N-tert-Butyl-2-benzothiazole sulfenamide.
Silicone (Si) elastomers containing methyl Butyraldehyde-aniline resin (iodine number
groups. 670–705).
Silicone (Psi) elastomers containing meth- Carbon disulfide-1,1′-methylenedipiperidine
yl and phenyl groups. reaction product.

Silicone (Vsi) elastomers containing meth- Copper dimethyldithiocarbamate.
yl and vinyl groups. N-Cyclohexyl-2-benzothiazole sulfenamide.
356
Dibenzoyl-p-quinone dioxime. (c) Retarders (total not to exceed 10 per-
Dibenzylamine. cent of weight of rubber product).
Diisopropyl xanthogen polysulfide (a 1:2:1
mixture of O,O-di(1-methylethyl)trithio- Cyanoguanidine.
bis-thioformate, O,O-di(1- Phthalic anhydride.
methylethyl)tetrathio-bis-thioformate, Salicylic acid.
and O,O-di(1-methylethyl)pentathio-bis-
thioformate). (d) Activators (total not to exceed 5 per-
Di(4-methylbenzoyl) peroxide (CAS Reg. No. cent by weight of rubber product except
895–85–2) for use only as a crosslinking magnesium oxide may be used at higher
agent in silicone polymers and elastomers levels).
identified under paragraph (c)(4)(i) of this
section at levels not to exceed 1 percent by Diethylamine.
weight of such polymers and elastomers Fatty acid amines, mixed.
where the total of all accelerators does not Fatty acids.
exceed 1.5 percent by weight of rubber Magnesium carbonate.
product. Magnesium oxide, light and heavy.
Di-tert-butyl peroxide. Oleic acid, dibutylamine salt (dibutylammo-
Dibutyl xanthogen disulfide. nium oleate).
2,4-Dichlorobenzoyl peroxide. Stannous chloride.
Dicumyl peroxide. Tall oil fatty acids.
N,N-Dimethylcyclohexylamine salt of dibu- Tetrachloro-p-benzoquinone.
tyldithiocarbamic acid. Triethanolamine.
2,6-Dimethylmorpholine thiobenzothiazol. Zinc salts of fatty acids.
Dipentamethylenethiuram hexasulfide (CAS
Reg. No. 971–15–3).
(iii) Antioxidants and antiozonants
Diphenylguanidine. (total not to exceed 5 percent by weight of
Diphenylguanidine phthalate. rubber product).
1,3-Diphenyl-2-thiourea.
Aldol-a-naphthylamine.
2,2′-Dithiobis[benzothiazole].
Alkylated (C4 and/or C8) phenols.
4,4′-Dithiodimorpholine.
BHT (butylated hydroxytoluene).
N,N′-Di-o-tolylguanidine.
4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]-
Di-o-tolylguanidine salt of pyrocatecholbo-
2,6-di-tert-butylphenol (CAS Reg. No. 991–
rate.
84–4) for use only as a stabilizer at levels
Ethylenediamine carbamate.
not to exceed 0.5 percent by weight of the
Heptaldehyde-aniline resin (iodine number
finished rubber product.
430–445).
Hexamethylenetetramine. Butylated reaction product of p-cresol and
2-Mercaptobenzothiazole. dicyclopentadiene as identified in
2-Mercaptothiazoline. § 178.2010(b) of this chapter.
N-Oxydiethylene-benzothiazole-2- Butylated, styrenated cresols identified in
sulfenamide. § 178.2010(b) of this chapter.
Piperidinium pentamethylenedithiocarba- 4,4′-Butylidinebis(6-tert-butyl-m-cresol).
mate. N-Cyclohexyl-N′-phenylphenylenediamine.
Potassium pentamethylenedithiocarbamate. p,p′-Diaminodiphenylmethane.
p-Quinone dioxime. 2,5-Di-tert-amylhydroquinone.
Sodium dibutyldithiocarbamate. Diaryl-p-phenylenediamine, where the aryl
Sodium dimethyldithiocarbamate. group may be phenyl, tolyl, or xylyl.
Stannous oleate for use only as an accel- 2,6-Di-tert-butyl-p-phenylphenol.
erator for silicone elastomers. 1,2-Dihydro-2,2,4-trimethyl-6-
Tetrabutylthiuram monosulfide. dodecylquinoline.
Tetraethylthiuram disulfide. 1,2-Dihydro-2,2,4-trimethyl-6-
(1,1,4,4-Tetramethyltetramethylene)bis [tert- ethoxyquinoline.
butyl peroxide]. 1,2-Dihydro-2,2,4-trimethyl-6-
Tetramethylthiuram monosulfide. phenylquinoline.
Thiram (tetramethylthiuram disulfide). 4,4′-Dimethoxydiphenylamine.
Triallyl cyanurate. 4,6-Dinonyl-o-cresol.
Triethylenetetramine. N,N′-Dioctyl-p-phenylenediamine.
1,3,5-Triethyl-hexahydro-s-triazine Diphenylamine-acetone resin.
(triethyltrimethylenetriamine). Diphenylamine-acetone-formaldehyde resin.
Triphenylguanidine. N,N′-Diphenylethylenediamine.
Zinc butyl xanathate. N,N′-Disalicylalpropylenediamine.
Zinc dibenzyl dithiocarbamate. N,N′-Di-o-tolylethylenediamine.
Zinc dibutyldithiocarbamate. Hydroquinone monobenzyl ether.
Zinc diethyldithiocarbamate. Isopropoxydiphenylamine.

Zinc 2-mercaptobenzothiazole. N-Isopropyl-N′-phenyl-p-phenylenediamine.
Ziram (zinc dimethyldithiocarbamate). 2,2′-Methylenebis(6-tert-butyl-4-ethylphenol).
357
§ 177.2600 21 CFR Ch. I (4–1–12 Edition)
2,2′-Methylenebis(4-methyl-6-tert-butyl- Diisooctyl sebacate.
phenol). Dioctyl adipate.
2,2′-Methylenebis(4-methyl-6-nonylphenol). Dioctyl phthalate.
2,2′-Methylenebis(4-methyl-6-tert- Dioctyl sebacate.
octylphenol). Dipentene resin.
Monooctyl- and dioctyldiphenylamine. Diphenyl ketone.
N,N′-Di-b-naphthyl-p-phenylenediamine. Fatty acids.
Phenyl-a-naphthylamine. Fatty acids, hydrogenated.
Phenyl-b-naphthylamine. Isooctyl ester of tall oil fatty acids.
Phenyl-b-naphthylamine-acetone aromatic Lanolin.
amine resin (average molecular weight 600; a-Methylstyrene-vinyltoluene copolymer
nitrogen content 5.3 percent). resins (molar ratio 1 a-methylstyrene to 3
o- and p-Phenylphenol. vinyltoluene).
Polybutylated (mixture) 4,4′- Mineral oil; (1) In rubber articles complying
isopropylidenediphenol. with this section, not to exceed 30 percent
Sodium pentachlorophenate. by weight; (2) Alone or in combination
Styrenated cresols produced when 2 moles of with waxes, petroleum, total not to exceed
styrene are made to react with 1 mole of a 45 percent by weight of rubber articles that
mixture of phenol and o-, m-, and p-cresols contain at least 20 percent by weight of
so that the final product has a Brookfield ethylene-propylene copolymer elastomer
viscosity at 25 °C of 1400 to 1700 centipoises. complying with paragraph (c)(4)(i) of this
Styrenated phenol. section, in contact with foods of Types I,
4,4′-Thiobis (6-tert-butyl-m-cresol). II, III, IV, VI, VII, VIII, and IX idenified in
Toluene-2,4-diamine. table 1 of § 176.170(c) of this chapter.
N-o-Tolyl-N′-phenyl-p-phenylenediamine. Montan wax.
p(p-Tolylsufanilamide) diphenylamine. n-Octyl n-decyl adipate.
Tri(mixed mono- and dinonylphenyl) n-Octyl n-decyl phthalate.
phosphite. Petrolatum.
Tri(nonylphenyl) phosphite-formaldehyde Petroleum hydrocarbon resin
resins produced when 1 mole of (cyclopentadiene type), hydrogenated.
tri(nonylphenyl) phosphite is made to Petroleum hydrocarbon resin (produced by
react with 1.4 moles of formaldehyde or the homo- and copolymerization of dienes
produced when 1 mole of nonylphenol is and olefins of the aliphatic, alicyclic, and
made to react with 0.36 mole of formalde- monobenzenoid arylalkene types from dis-
hyde and the reaction product is then fur- tillates of cracked petroleum stocks).
ther reacted with 0.33 mole of phosphorus Petroleum hydrocarbon resin (produced by
trichloride. The finished resins have a min- the catalytic polymerization and subse-
imum viscosity of 20,000 centipoises at 25 quent hydrogenation of styrene,
°C, as determined by LV-series Brookfield vinyltoluene, and indene types from dis-
viscometer (or equivalent) using a No. 4 tillates of cracked petroleum stocks).
spindle at 12 r.p.m., and have an organic Petroleum oil, sulfonated.
phosphorus content of 4.05 to 4.15 percent Phenol-formaldehyde resin.
by weight. Pine tar.
Polybutene.
(iv) Plasticizers (total not to exceed 30 Polystyrene.
percent by weight of rubber product un- Propylene glycol.
less otherwise specified). n-Propyl ester of tall oil fatty acids.
Rapeseed oil vulcanized with rubber maker’s
n-Amyl n-decyl phthalate. sulfur.
Butylacetyl ricinoleate. Rosins and rosin derivatives identified in
n-Butyl ester of tall oil fatty acids. § 175.105(c)(5) of this chapter.
Butyl laurate. Soybean oil vulcanized with rubber maker’s
Butyl oleate. sulfur.
Butyl stearate. Styrene-acrylonitrile copolymer.
Calcium stearate. Terpene resins.
Castor oil. Triethylene glycol dicaprate.
Coumarone-indene resins. Triethylene glycol dicaprylate.
2,2′-Dibenzamidodiphenyl disulfide. Waxes, petroleum.
Dibenzyl adipate. Xylene (or toluene) alkylated with
Dibutoxyethoxyethyl adipate. dicyclopentadiene.
Dibutyl phthalate. Zinc 2-benzamidothiophenate.
Dibutyl sebacate. (v) Fillers.
Didecyl adipate.
Didecyl phthalate. Aluminum hydroxide.
Diisodecyl adipate. Aluminum silicate.

Diisodecyl phthalate. Asbestos fiber, chrysotile or crocidolite.
Diisooctyl adipate. Barium sulfate.
358
Carbon black (channel process or furnace levels not to exceed 0.3 percent by weight
combustion process; total carbon black not of the sealants and caulking materials.
to exceed 50 percent by weight of rubber Dodecyl mercaptan isomers, single or mixed.
product; furnace combustion black content 2-Ethoxyethanol.
not to exceed 10 percent by weight of rub- Iodoform.
ber products intended for use in contact p-Menthane hydroperoxide.
with milk or edible oils). a-(p-Nonylphenyl)-omega-hydroxypoly (oxy-
Cork. ethylene) mixture of dihydrogen phosphate
Cotton (floc, fibers, fabric). and monohydrogen phosphate esters, bar-
Mica. ium salt; the nonyl group is a propylene
Nylon (floc, fibers, fabric). trimer isomer and the poly (oxyethylene)
Silica. content averages 9 moles; for use only as
Titanium dioxide. residual polymerization emulsifier at lev-
Zinc carbonate. els not to exceed 0.7 percent by weight of
Zinc sulfide. ethylene-propylene-1,4-hexadiene copoly-
(vi) Colorants. Colorants used in ac- mers identified under paragraph (c)(4)(i) of
cordance with § 178.3297 of this chapter. this section.
4,4′-Oxybis (benzenesulfonhydrazide) as
(vii) Lubricants (total not to exceed 2
chemical blowing agent.
percent by weight of rubber product). Phenothiazine.
Polyethylene. Potassium persulfate.
Sodium stearate. Sodium formaldehyde sulfoxylate.
Sodium polysulfide.
(viii) Emulsifiers. Sodium nitrite.
Fatty acid salts, sodium or potassium. Sodium salt of ethylenediamine tetraacetic
Naphthalene sulfonic acid-formaldehyde con- acid and glycine.
densate, sodium salt. Sodium sulfide.
Rosins and rosin-derivatives identified in Styrene monomer.
§ 175.105(c)(5) of this chapter. Tall oil.
Sodium decylbenzenesulfonate Thioxylenois as peptizing agents.
Sodium dodecylbenzenesulfonate Tridecyl mercaptan.
Sodium lauryl sulfate. Zinc 4-tert-butylthiophenate as peptizing
Tall oil mixed soap (calcium, potassium, and agent.
sodium).
(d) Rubber articles intended for use
(ix) Miscellaneous (total not to exceed 5 with dry food are so formulated and
percent by weight of rubber product). cured under conditions of good manu-
Animal glue as described in § 178.3120 of this facturing practice as to be suitable for
chapter. repeated use.
Azodicarbonamide as chemical blowing (e) Rubber articles intended for re-
agent. peated use in contact with aqueous
2-Anthraquinone sulfonic acid sodium salt food shall meet the following specifica-
for use only as polymerization inhibitor in tions: The food-contact surface of the
chloroprene polymers and not to exceed rubber article in the finished form in
0.03 percent by weight of the chloroprene
polymers.
which it is to contact food, when ex-
1,2-Benzisothiazolin-3-one (CAS Reg. No. tracted with distilled water at reflux
2634–33–5) for use as a biocide in uncured temperature, shall yield total extrac-
liquid rubber latex not to exceed 0.02 per- tives not to exceed 20 milligrams per
cent by weight of the latex solids, where square inch during the first 7 hours of
the total of all items listed in paragraph extraction, nor to exceed 1 milligram
(c)(4)(ix) of this section does not exceed 5 per square inch during the succeeding 2
percent of the rubber product. hours of extraction.
n-Butyllithium for use only as polymeriza-
tion catalyst for polybutadiene. (f) Rubber articles intended for re-
4-tert-Butyl-o-thiocresol as peptizing agent. peated use in contact with fatty foods
tert-Butyl peracetate. shall meet the following specifications:
p-tert-Butylpyrocatechol. The food-contact surface of the rubber
Dialkyl (C8–C18) dimethylammonium chlo- article in the finished form in which it
ride for use only as a flocculating agent in is to contact food, when extracted with
the manufacture of silica. n-hexane at reflux temperature, shall
Di- and triethanolamine.
Diethyl xanthogen disulfide. yield total extractives not to exceed
175 milligrams per square inch during
4-(Diiodomethylsulfonyl) toluene, Chemical

Abstracts Service Registry No. 20018–09–01, the first 7 hours of extraction, nor to
for use as an antifungal preservative at exceed 4 milligrams per square inch
359
§ 177.2710 21 CFR Ch. I (4–1–12 Edition)
during the succeeding 2 hours of ex- taining the resins shall be thoroughly
traction. cleansed prior to their first use in con-
(g) In accordance with good manufac- tact with food.
turing practice finished rubber articles
intended for repeated use in contact § 177.2800 Textiles and textile fibers.
with food shall be thoroughly cleansed Textiles and textile fibers may safely
prior to their first use in contact with be used as articles or components of ar-
food. ticles intended for use in producing,
(h) The provisions of this section are manufacturing, packing, processing,
not applicable to rubber nursing-bottle preparing, treating, packaging, trans-
nipples. porting, or holding food, subject to the
(i) Acrylonitrile copolymers identi- provisions of this section.
fied in this section shall comply with (a) The textiles and textile fibers are
the provisions of § 180.22 of this chap- prepared from one or more of the fibers
ter. identified in paragraph (d) of this sec-
[42 FR 14572, Mar. 15, 1977] tion and from certain other adjuvant
substances required in the production
of the textiles or textile fibers or added
tations affecting § 177.2600, see the List of
CFR Sections Affected, which appears in the to impart desired properties.
Finding Aids section of the printed volume (b) The quantity of any adjuvant sub-
and at www.fdsys.gov. stance employed in the production of
textiles or textile fibers does not ex-
§ 177.2710 Styrene-divinylbenzene res- ceed the amount reasonably required
ins, cross-linked. to accomplish the intended physical or
Styrene-divinylbenzene cross-linked technical effect or any limitation fur-
copolymer resins may be safely used as ther provided.
articles or components of articles in- (c) Any substance employed in the
tended for repeated use in producing, production of textiles or textile fibers
manufacturing, packing, processing, that is the subject of a regulation in
preparing, treating, packaging, trans- parts 174, 175, 176, 177, 178 and § 179.45 of
porting, or holding food, in accordance this chapter conforms with any speci-
with the following prescribed condi- fication in such regulation.
tions: (d) Substances employed in the pro-
(a) The resins are produced by the co- duction of or added to textiles and tex-
polymerization of styrene with tile fibers may include:
divinylbenzene. (1) Substances generally recognized
(b) The resins meet the extractives as safe in food.
limitations prescribed in this para- (2) Substances subject to prior sanc-
graph: tion or approval for use in textiles and
(1) The resins to be tested are ground textile fibers and used in accordance
or cut into small particles that will with such sanction or approval.
pass through a U.S. standard sieve No. (3) Substances generally recognized
3 and that will be held on a U.S. stand- as safe for use in cotton and cotton fab-
ard sieve No. 20. rics used in dry-food packaging.
(2) A 100-gram sample of the resins, (4) Substances that by regulation in
when extracted with 100 milliliters of this part may safely be used in the pro-
ethyl acetate at reflux temperature for duction of or as a component of tex-
1 hour, yields total extractives not to tiles or textile fibers and subject to
exceed 1 percent by weight of the res- provisions of such regulation.
ins. (5) Substances identified in this para-
(c) In accordance with good manufac- graph (d)(5), subject to such limitations
turing practice, finished articles con- as are provided:
(i) Fibers:
Cotton.
Polyethylene terephthalate complying in composition with For use only in the manufacture of items for repeated use.
the provisions of § 177.1630(e)(4)(ii).
Rayon.
360
(ii) Adjuvant substances:

Aluminum stearate.
Borax .................................................................................... For use as preservative only.
Butyl-acetyl ricinoleate.
Colorants used in accordance with § 178.3297 of this chapter..
Di-tert-butyl hydroquinone.
Dimethylpolysiloxane.
Ethylenediaminetetraacetic acid, sodium salt.
4-Ethyl-4-hexadecyl morpholinium ethyl sulfate .......................... For use only as a lubricant in the manufacture of polyethylene
terephthalate fibers specified in paragraph (d)(5)(i) of this
section at a level not to exceed 0.03 percent by weight of
the finished fibers.
Eugenol.
Fats, oils, fatty acids, and fatty alcohols derived from castor,
coconut, cottonseed, fish, mustardseed, palm, peanut,
rapeseed, ricebran, soybean, sperm, and tall oils and tallow.
Fats, oils, fatty acids, and fatty alcohols described in the pre-
ceding item reacted with one or more of the following sub-
stances:
n-Butyl and isobutyl alcohol.
Diethylene glycol.
Diethanolamine.
Glycerol.
Hexylene glycol (2-methyl-2,4-pentanediol).
Hydrogen.
Isopropyl alcohol.
Methyl alcohol.
Oxygen.
Polyethylene glycol (molecular weight 400–3,000).
Potassium hydroxide.
Propylene glycol.
Sodium hydroxide.
Sulfuric acid.
Formaldehyde .............................................................................. For use as preservative only.
Glyceryl mono-12-hydroxystearate.
2-(9-Heptadecenyl)-1-[2-(10-octadecenamido)ethyl-2-
imidazolinium ethyl sulfate.
Hexylene glycol (2-methyl,-2,4-pentanediol).
Isobutyl alcohol.
Isopropyl alcohol.
Kerosene.
Methyl ester of sulfated ricebran oil.
Mineral oil .................................................................................... For use only at a level not to exceed 0.15 percent by weight of
finished fibers.
Mono- and diisopropylated m- and p-cresols (isothymol deriva-
tive).
N-Oleyl, N′-acetyl, N′-b-hydroxy-ethylenediamine.
Petrolatum.
Petroleum sulfonate.
Pine oil.
Polybutene, hydrogenated; complying with the identity pre-
scribed under 21 CFR 178.3740(b) of this chapter.
Polyethylene, oxidized (air blown).
Polyvinyl acetate.
Polyvinyl alcohol.
Potassium soap of a saponified sulfated castor oil.
Sodium bis(2,6-dimethylheptyl-4) sulfosuccinate.
Sodium dodecyl benzenesulfonate.
Sodium fluoride ............................................................................ For use as preservative only.
Sodium hydrosulfite.
Sodium 2-mercaptobenzothiazole ............................................... Do.
Sodium pentachlorophenate ........................................................ Do.
Styrene-butadiene copolymer.
Sulfated butyl, isobutyl and propyl oleate.
Tallow.
Tallow, sulfonated.
Titanium dioxide.
Triethanolamine.
Ultramarine blue.
Waxes, petroleum.
Zinc hydrosulfite.
361
§ 177.2910 21 CFR Ch. I (4–1–12 Edition)
(e) Textile and textile fibers are used practice so as to prevent potential mi-
as articles or components of articles crobial adulteration of the food.
that contact dry food only. (e) Ultrafiltration membranes identi-
(f) The provisions of this section are fied in paragraph (a)(4) may be used to
not applicable to jute fibers used as filter aqueous or acidic foods con-
prescribed by § 178.3620(d)(2) of this taining up to 13 percent of alcohol at
chapter. temperatures not to exceed 21 °C (70
°F).
[42 FR 14572, Mar. 15, 1977, as amended at 46 (f) To assure safe use of the ultra-fil-
FR 37042, July 17, 1981; 49 FR 4372, Feb. 6,
1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933,
tration membranes, the label or label-
Aug. 30, 1991] ing shall include adequate directions
for a pre-use treatment, consisting of
§ 177.2910 Ultra-filtration membranes. conditioning and washing with a min-
imum of 8 gallons of potable water
Ultra-filtration membranes identi- prior to their first use in contact with
fied in paragraphs (a)(1), (a)(2), (a)(3), food.
and (a)(4) of this section may be safely (g) Acrylonitrile copolymers identi-
used in the processing of food, under fied in this section shall comply with
the following prescribed conditions; the provisions of § 180.22 of this chap-
(a)(1) Ultra-filtration membranes ter.
that consist of paper impregnated with
cured phenol-formaldehyde resin, [42 FR 14572, Mar. 15, 1977, as amended at 53
which is used as a support and is coat- FR 17925, May 19, 1988; 58 FR 48599, Sept. 17,
1993; 60 FR 54426, Oct. 24, 1995]
ed with a vinyl chloride-acrylonitrile
copolymer.
(2) Ultra-filtration membranes that PART 178—INDIRECT FOOD ADDI-
consist of a sintered carbon support TIVES: ADJUVANTS, PRODUCTION
that is coated with zirconium oxide AIDS, AND SANITIZERS
(CAS Reg. No. 1314–23–4) containing up
to 12 percent yttrium oxide (CAS Reg. Subpart A [Reserved]
No. 1314–36–9).
Subpart B—Substances Utilized To Control
(3) Ultra-filtration membranes that
the Growth of Microorganisms
consist of an aluminum oxide support
that is coated with zirconium oxide Sec.
(CAS Reg. No. 1314–23–4) containing up 178.1005 Hydrogen peroxide solution.
to 5 percent yttrium oxide (CAS Reg. 178.1010 Sanitizing solutions.
No. 1314–36–9).
Subpart C—Antioxidants and Stabilizers
(4) Ultrafiltration membranes that
consist of a microporous 178.2010 Antioxidants and/or stabilizers for
poly(vinylidene fluoride) membrane polymers.
with a hydrophilic surface modifier 178.2550 4-Hydroxymethyl-2,6-di-tert-butyl-
consisting of hydroxypropyl acrylate/ phenol.
178.2650 Organotin stabilizers in vinyl chlo-
tetraethylene glycol diacrylate copoly-
ride plastics.
mer.
(b) Any substance employed in the Subpart D—Certain Adjuvants and
production of ultra-filtration mem- Production Aids
branes that is the subject of a regula-
tion in parts 174, 175, 176, 177, 178 and 178.3010 Adjuvant substances used in the
manufacture of foamed plastics.
§ 179.45 of this chapter conforms with
178.3120 Animal glue.
the specifications of such regulation. 178.3125 Anticorrosive agents.
(c) Ultra-filtration membranes are 178.3130 Antistatic and/or antifogging
used in the physical separation of dis- agents in food-packaging materials.
solved or colloidally suspended varying 178.3280 Castor oil, hydrogenated.
molecular size components of liquids 178.3290 Chromic chloride complexes.
during the commercial processing of 178.3295 Clarifying agents for polymers.
178.3297 Colorants for polymers.
bulk quantities of food. 178.3300 Corrosion inhibitors used for steel
(d) Ultra-filtration membranes shall
or tinplate.
be maintained in a sanitary manner in 178.3400 Emulsifiers and/or surface-active
accordance with good manufacturing agents.
362
178.3450 Esters of stearic and palmitic acids. Subpart B—Substances Utilized To
178.3480 Fatty alcohols, synthetic.
178.3500 Glycerin, synthetic.
Control the Growth of Micro-
178.3505 Glyceryl tri-(12-acetoxystearate).
organisms
178.3520 Industrial starch-modified. § 178.1005 Hydrogen peroxide solution.
178.3530 Isoparaffinic petroleum hydro-
carbons, synthetic. Hydrogen peroxide solution identi-
178.3570 Lubricants with incidental food fied in this section may be safely used
contact. to sterilize polymeric food-contact sur-
178.3600 Methyl glucoside-coconut oil ester. faces identified in paragraph (e)(1) of
178.3610 a-Methylstyrene-vinyltoluene res- this section.
ins, hydrogenated. (a) Identity. For the purpose of this
178.3620 Mineral oil. section, hydrogen peroxide solution is
178.3650 Odorless light petroleum hydro- an aqueous solution containing not
carbons. more than 35 percent hydrogen per-
178.3690 Pentaerythritol adipate-stearate. oxide (CAS Reg. No. 7722–84–1) by
178.3700 Petrolatum. weight, meeting the specifications pre-
178.3710 Petroleum wax. scribed in paragraph (c) of this section.
178.3720 Petroleum wax, synthetic. (b) Optional adjuvant substances. Hy-
178.3725 Pigment dispersants. drogen peroxide solution identified in
178.3730 Piperonyl butoxide and pyrethrins paragraph (a) of this section may con-
as components of bags. tain substances generally recognized as
178.3740 Plasticizers in polymeric sub- safe in or on food, substances generally
stances. recognized for their intended use in
178.3750 Polyethylene glycol (mean molec- food packaging, substances used in ac-
ular weight 200–9,500). cordance with a prior sanction or ap-
178.3760 Polyethylene glycol (400) proval, and substances permitted by
monolaurate. applicable regulations in parts 174
178.3770 Polyhydric alcohol esters of through 179 of this chapter.
oxidatively refined (Gersthofen process) (c) Specifications. Hydrogen peroxide
montan wax acids.
solution shall meet the specifications
178.3780 Polyhydric alcohol esters of long
of the ‘‘Food Chemicals Codex,’’ 3d Ed.
chain monobasic acids.
(1981), pp. 146–147, which is incorporated
178.3790 Polymer modifiers in semirigid and
rigid vinyl chloride plastics.
by reference (Copies may be obtained
178.3800 Preservatives for wood.
from the National Academy Press, 2101
178.3850 Reinforced wax.
Constitution Ave. NW., Washington,
178.3860 Release agents.
DC 20418, or may be examined at the
178.3870 Rosins and rosin derivatives.
National Archives and Records Admin-
178.3900 Sodium pentachlorophenate. istration (NARA). For information on
178.3910 Surface lubricants used in the man- the availability of this material at
ufacture of metallic articles. NARA, call 202–741–6030, or go to: http://
178.3930 Terpene resins. www.archives.gov/federallregister/
178.3940 Tetraethylene glycol di-(2-ethyl- codeloflfederallregulations/
hexoate). ibrllocations.html.), and the United
178.3950 Tetrahydrofuran. States Pharmacopeia XX (1980), except
that hydrogen peroxide may exceed the
AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. concentration specified therein.
SOURCE: 42 FR 14609, Mar. 15, 1977, unless (d) Limitations. No use of hydrogen
otherwise noted. peroxide solution in the sterilization of
food packaging material shall be con-
part 178 appear at 61 FR 14482, Apr. 2, 1996, 66 sidered to be in compliance if more
FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, than 0.5 part per million of hydrogen
2001, 68 FR 15355, Mar. 31, 2003, and 70 FR peroxide can be determined in distilled
72074, Dec. 1, 2005. water packaged under production con-
ditions (assay to be performed imme-
diately after packaging).
Subpart A [Reserved] (e) Conditions of use. (1) Hydrogen per-
oxide solution identified in and com-
plying with the specifications in this

section may be used by itself or in
363
§ 178.1010 21 CFR Ch. I (4–1–12 Edition)
combination with other processes to utensils, and on other food-contact ar-

treat food-contact surfaces to attain ticles as specified in this section, with-
commercial sterility at least equiva- in the following prescribed conditions:
lent to that attainable by thermal (a) Such sanitizing solutions are
processing for metal containers as pro- used, followed by adequate draining,
vided for in part 113 of this chapter. before contact with food.
Food-contact surfaces include the fol- (b) The solutions consist of one of the
lowing: following, to which may be added com-
ponents generally recognized as safe
and components which are permitted
Ethylene-acrylic acid Complying with § 177.1310 of this by prior sanction or approval.
copolymers. chapter. (1) An aqueous solution containing
Ethylene-carbon mon- Complying with § 177.1312 of this
oxide copolymers. chapter. potassium, sodium, or calcium hypo-
Ethylene-methyl acry- Complying with § 177.1340 of this chlorite, with or without the bromides
late copolymer resins. chapter. of potassium, sodium, or calcium.
Ethylene-vinyl acetate Complying with § 177.1350 of this
copolymers. chapter. (2) An aqueous solution containing
Ionomeric resins ........... Complying with § 177.1330 of this dichloroisocyanuric acid,
chapter. trichloroisocyanuric acid, or the so-
Isobutylene polymers ... Complying with § 177.1420 (a)(1)
and (a)(2) of this chapter.
dium or potassium salts of these acids,
Olefin polymers ............ Complying with § 177.1520 of this with or without the bromides of potas-
chapter. sium, sodium, or calcium.
Polycarbonate resins ... Complying with § 177.1580 of this
chapter.
(3) An aqueous solution containing
Polyethylene- Complying with § 177.1630 of this potassium iodide, sodium p-
terephthalate poly- chapter (excluding polymers de- toluenesulfonchloroamide, and sodium
mers. scribed in § 177.1630(c)) of this lauryl sulfate.
chapter.
Poly-l-butene resins Complying with § 177.1570 of this (4) An aqueous solution containing
and butene/ethylene chapter. iodine, butoxy monoether of mixed
copolymers. (ethylene-propylene) polyalkylene gly-
Polystryrene and rub-
ber-modified poly-
Complying with § 177.1640 of this
chapter.
col having a cloudpoint of 90°–100 °C in
styrene polymers. 0.5 percent aqueous solution and an av-
Vinylidene chloride/ Complying with § 177.1990 of this erage molecular weight of 3,300, and
methyl acrylate co- chapter. ethylene glycol monobutyl ether. Addi-
polymers.
tionally, the aqueous solution may
(2) The packaging materials identi- contain diethylene glycol monoethyl
fied in paragraph (e)(1) of this section ether as an optional ingredient.
may be used for packaging all commer- (5) An aqueous solution containing
cially sterile foods except that the elemental iodine, hydriodic acid, a-(p-
olefin polymers may be used in articles nonylphenyl)-omega-hydroxypoly-(oxy-
for packaging foods only of the types ethylene) (complying with the identity
identified in § 176.170(c) of this chapter, prescribed in § 178.3400(c) and having a
table 1, under Categories I, II, III, IV-B, maximum average molecular weight of
V, and VI. 748) and/or polyoxyethylene-
(3) Processed foods packaged in the polyoxypropylene block polymers (hav-
materials identified in paragraph (e)(1) ing a minimum average molecular
of this section shall conform with parts weight of 1,900). Additionally, the aque-
108, 110, 113, and 114 of this chapter as ous solution may contain isopropyl al-
applicable. cohol as an optional ingredient.
[46 FR 2342, Jan. 9, 1981, as amended at 49 FR elemental iodine, sodium iodide, so-
10111, Mar. 19, 1984; 49 FR 32345, Aug. 14, 1984;
dium dioctylsulfosuccinate, and
49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec.
23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, polyoxyethylene-polyoxypropylene
Nov. 22, 1988; 54 FR 5604, Feb. 6, 1989; 54 FR block polymers (having a minimum av-
13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 55 erage molecular weight of 1,900).
FR 47055, Nov. 9, 1990; 57 FR 32423, July 22, (7) An aqueous solution containing
1992] dodecylbenzenesulfonic acid and either
isopropyl alcohol or polyoxyethylene-
§ 178.1010 Sanitizing solutions. polyoxypropylene block polymers (hav-
Sanitizing solutions may be safely ing a minimum average molecular

used on food-processing equipment and weight of 2,800). In addition to use on
364
food-processing equipment and uten- utensils, this solution may be used on

sils, this solution may be used on glass glass bottles and other glass containers
bottles and other glass containers in- intended for holding milk. All equip-
tended for holding milk. ment, utensils, glass bottles, and other
(8) An aqueous solution containing glass containers treated with this sani-
elemental iodine, butoxy monoether of tizing solution shall have a drainage
mixed (ethylene-propylene) period of 15 minutes prior to use in
polyalkylene glycol having a minimum contact with food.
average molecular weight of 2,400 and (13) An aqueous solution containing
a-lauroyl-omega-hydroxypoly (oxy- elemental iodine and alkyl (C12-C15)
ethylene) with an average 8–9 moles of monoether of mixed (ethylene-pro-
ethylene oxide and an average molec- pylene) polyalkylene glycol, having a
ular weight of 400. In addition to use on cloud-point of 70°–77 °C in 1 percent
food-processing equipment and uten- aqueous solution and an average mo-
sils, this solution may be used on bev- lecular weight of 807.
erage containers, including milk con- (14) An aqueous solution containing
tainers or equipment. Rinse water iodine, butoxy monoether of mixed
treated with this solution can be recir- (ethylene-propylene) polyalkylene gly-
culated as a preliminary rinse. It is not col, having a cloud-point of 90°–100 °C
to be used as final rinse. in 0.5 percent aqueous solution and an
(9) An aqueous solution containing n- average molecular weight of 3,300, and
alkyl (C12-C18) benzyldimethylam- polyoxyethylene-polyoxypropylene
monium chloride compounds having block polymers (having a minimum av-
average molecular weights of 351 to 380. erage molecular weight of 2,000).
The alkyl groups consist principally of
groups with 12 to 16 carbon atoms and
lithium hypochlorite.
contain not more than 1 percent each
of groups with 8 and 10 carbon atoms. (16) An aqueous solution containing
Additionally, the aqueous solution may equal amounts of n-alkyl (C12-C18) ben-
contain either ethyl alcohol or iso- zyl dimethyl ammonium chloride and
propyl alcohol as an optional ingre- n-alkyl (C12-C14) dimethyl ethylbenzyl
dient. ammonium chloride (having average
(10) An aqueous solution containing molecular weights of 377 to 384), with
trichloromelamine and either sodium the optional adjuvant substances
lauryl sulfate or dodecyl- tetrasodium ethylenediaminetetra-
benzenesulfonic acid. In addition to use acetate and/or alpha-(p-nonylphenol)-
on food-processing equipment and omega-hydroxy poly (oxyethylene) hav-
utensils and other food-contact arti- ing an average poly- (oxyethylene) con-
cles, this solution may be used on bev- tent of 11 moles. Alpha-hydro-omega-
erage containers except milk con- hydroxypoly-(oxyethylene)
tainers or equipment. poly(oxypropoylene) (15 to 18 mole
(11) An aqueous solution containing minimum) poly (oxyethylene) block co-
equal amounts of n-alkyl (C12-C18) ben- polymer, having a minimum molecular
zyl dimethyl ammonium chloride and weight of 1,900 (CAS Registry No. 9003–
n-alkyl (C12-C18) dimethyl ethylbenzyl 11–6) may be used in lieu of alpha- (p-
ammonium chloride (having an average nonylphenol)-omega-hydroxy-
molecular weight of 384). In addition to poly(oxyethylene) having an average
use on food-processing equipment and poly(oxyethylene) content of 11 moles.
utensils, this solution may be used on In addition to use on food-processing
food-contact surfaces in public eating equipment and utensils, this solution
places. may be used on food-contact surfaces
(12) An aqueous solution containing in public eating places.
the sodium salt of sulfonated oleic (17) An aqueous solution containing
acid, polyoxyethylene- di-n-alkyl(C8-C10)dimethyl ammonium
polyoxypropylene block polymers (hav- chlorides having average molecular
ing an average molecular weight of weights of 332–361 and either ethyl al-
2,000 and 27 to 31 moles of cohol or isopropyl alcohol. In addition
polyoxypropylene). In addition to use to use on food-processing equipment

on food-processing equipment and and utensils, this solution may be used
365
§ 178.1010 21 CFR Ch. I (4–1–12 Edition)
on food-contact surfaces in public eat- poly(oxypropylene)] (having an average

ing places. molecular weight of 965).
(18) An aqueous solution containing (25) An aqueous solution containing
n-alkyl(C12-C18) benzyldimethylammo- elemental iodine (CAS Reg. No. 7553–56–
nium chloride, sodium metaborate, 2), potassium iodide (CAS Reg. No.
alpha-terpineol and alpha[p-(1,1,3,3- 7681–11–0), and isopropanol (CAS Reg.
tetramethylbutyl)phenyl] -omega-hy- No. 67–63–0). In addition to use on food
droxy-poly (oxyethylene) produced processing equipment and utensils, this
with one mole of the phenol and 4 to 14 solution may be used on beverage con-
moles ethylene oxide. tainers, including milk containers and
equipment and on food-contact sur-
sodium dichloroisocyanurate and
faces in public eating places.
tetrasodium ethylenediaminetetra-
acetate. In addition to use on food- (26) [Reserved]
processing equipment and utensils, this (27) An aqueous solution containing
solution may be used on food-contact decanoic acid (CAS Reg. No. 334–48–5),
surfaces in public eating places. octanoic acid (CAS Reg. No. 124–07–2),
(20) An aqueous solution containing and sodium 1-octanesulfonate (CAS
ortho-phenylphenol, ortho-benzyl-para- Reg. No. 5324–84–5). Additionally, the
chlorophenol, para- aqueous solution may contain iso-
tertiaryamylphenol, sodium -alpha- propyl alcohol (CAS Reg. No. 67–63–0)
alkyl(C12-C15)-omega-hydroxypoly (oxy- as an optional ingredient.
ethylene) sulfate with the (28) An aqueous solution containing
poly(oxyethylene) content averaging sulfonated 9-octadecenoic acid (CAS
one mole, potassium salts of coconut Reg. No. 68988–76–1) and sodium
oil fatty acids, and isopropyl alcohol or xylenesulfonate (CAS Reg. No. 1300–72–
hexylene glycol. 7).
(21) An aqueous solution containing (29) An aqueous solution containing
sodium dodecylbenzenesulfonate. In ad- dodecyldiphenyloxidedisulfonic acid
dition to use on food-processing equip-
(CAS Reg. No. 30260–73–2), sulfonated
ment and utensils, this solution may
tall oil fatty acid (CAS Reg. No. 68309–
be used on glass bottles and other glass
27–3), and neo-decanoic acid (CAS Reg.
containers intended for holding milk.
(22) An aqueous solution containing No. 26896–20–8). In addition to use on
(1) di-n-alkyl(C8-C10) food-processing equipment and uten-
dimethylammonium chloride com- sils, this solution may be used on glass
pounds having average molecular bottles and other glass containers in-
weights of 332–361, (2) n-alkyl (C12-C18) tended for holding milk.
benzyldimethylammonium chloride (30) An aqueous solution containing
compounds having average molecular hydrogen peroxide (CAS Reg. No. 7722–
weights of 351–380 and consisting prin- 84–1), peracetic acid (CAS Reg. No. 79–
cipally of alkyl groups with 12 to 16 21–0), acetic acid (CAS Reg. No. 64–19–
carbon atoms with or without not over 7), and 1-hydroxyethylidene-1,1-
1 percent each of groups with 8 and 10 diphosphonic acid (CAS Reg. No. 2809–
carbon atoms, and (3) ethyl alcohol. 21–4).
The ratio of compound (1) to compound (31) An aqueous solution containing
(2) is 60 to 40. elemental iodine, alpha-alkyl(C10-C14)-
(23) An aqueous solution containing omega-hydroxypoly(oxyethylene)poly-
n-alkyl (C12-C16) benzyl- (oxypropylene) of average molecular
dimethylammonium chloride and weight between 768 and 837, and alpha-
didecyldimethylammonium chloride. alkyl(C12-C18)-omega-
hydroxypoly(oxyethylene)
elemental iodine (CAS Reg. No. 7553–56–
poly(oxypropylene) of average molec-
2), alpha-[p-(1,1,3,3-tetramethylbutyl)-
phenyl]-omega-hydroxypoly-(oxy- ular weight between 950 and 1,120. In
ethylene) produced with one mole of addition to use on food-processing
the phenol and 4 to 14 moles ethylene equipment and utensils, this solution
oxide, and alpha-alkyl(C12-C15)-omega- may be used on food-contact surfaces

hydroxy[poly(oxyethylene) in public eating places.
366
(32) An aqueous solution containing 2) and a mixture of the sodium salt of

(i) di-n-alkyl(C8-C10)dimethyl- ammo- naphthalenesulfonic acid (CAS Reg.
nium chloride compounds having aver- No. 1321–69–3); the methyl, dimethyl,
age molecular weights of 332 to 361, (ii) and trimethyl dervatives of the sodium
n-alkyl(C12-C18)benzyldimethylammo- salt of naphthalenesulfonic acid; and a
nium chloride compounds having aver- mixture of the sodium salt of
age molecular weights of 351 to 380 and naphthalenesulfonic acid, and the
consisting principally of alkyl groups methyl, dimethyl, and trimethyl de-
with 12 to 16 carbon atoms with no rivatives of the sodium salt of
more than 1 percent of groups with 8 naphthalenesulfonic acid alkylated at 3
and 10, (iii) ethyl alcohol, and (iv) percent by weight with C6-C9 linear
alpha-(p-nonylphenyl)-omega- olefins, as components of a sanitizing
hydroxypoly(oxyethylene) produced by solution to be used on food-processing
the condensation of 1 mole of p- equipment and utensils. The methyl
nonylphenol with 9 to 12 moles of and dimethyl substituted derivatives
ethylene oxide. The ratio of compound (described within this paragraph
(i) to compound (ii) is 3 to 2. (b)(35)) constitute no less than 70 per-
(33) An aqueous solution containing cent by weight of the mixture of
(i) di-n-alkyl-(C8-C10)- naphthalenesulfonates.
dimethylammonium chloride com- (36) The sanitizing solution contains
pounds having average molecular decanoic acid (CAS Reg. No. 334–48–5);
weights of 332 to 361; (ii) n-alkyl(C12- octanoic acid (CAS Reg. No. 124–07–2);
C18) -benzyldimethylammonium chlo- lactic acid (CAS Reg. No. 050–21–5);
ride compounds having molecular phosphoric acid (CAS Reg. No. 7664–38–
weights of 351 to 380 and consisting 2); a mixture of 1-octanesulfonic acid
principally of alkyl groups with 12 to 16 (CAS Reg. No. 3944–72–7), and 1-
carbon atoms with no more than 1 per- octanesulfonic-2-sulfinic acid (CAS
cent of the groups with 8 to 10; and (iii) Reg. No. 113652–56–5) or 1,2-
tetrasodium ethylenediamine octanedisulfonic acid (CAS Reg. No.
tetraacetate. Additionally, the aqueous 113669–58–2); the condensate of four
solution contains either alpha-(p- moles of
nonylphenyl)-omega-hydroxypoly-(oxy- poly(oxyethylene)poly(oxypropylene)
ethylene) or alpha-alkyl(C11-C15)-omega- block copolymers with one mole of
hydroxypoly-(oxyethylene), each pro- ethylenediamine (CAS Reg. No. 11111–
duced with 9 to 13 moles of ethylene 34–5); and the optional ingredient
oxide. The ratio of compound (i) to FD&C Yellow No. 5 (CAS Reg. No.
compound (ii) is 3 to 2. 001934210). In addition to use on food-
(34) An aqueous solution of an equi- processing equipment and utensils, this
librium mixture of oxychloro species solution may be used on dairy-proc-
(predominantly chlorite, chlorate, and essing equipment.
chlorine dioxide) generated either (i) (37) The sanitizing solution contains
by directly metering a concentrated sodium hypochlorite (CAS Reg. No.
chlorine dioxide solution, prepared just 7681–52–9), trisodium phosphate (CAS
prior to use, into potable water to pro- Reg. No. 7601–54–9), sodium lauryl sul-
vide the concentration of available fate (CAS Reg. No. 151–21–3), and potas-
chlorine dioxide stated in paragraph sium permanganate (CAS Reg. No.
(c)(29) of this section, or (ii) by acidifi- 7722–64–7). Magnesium oxide (CAS Reg.
cation of an aqueous alkaline solution No. 1309–48–4) and potassium bromide
of oxychloro species (predominantly (CAS Reg. No. 7758–02–3) may be added
chlorite and chlorate) followed by dilu- as optional ingredients to this sani-
tion with potable water to provide the tizing solution. In addition to use on
concentration of available chlorine di- food-processing equipment and uten-
oxide described in paragraph (c)(29) of sils, this solution may be used on food-
this section. contact surfaces in public eating
(35) An aqueous solution containing places.
decanoic acid (CAS Reg. No. 334–48–5), (38) An aqueous solution containing
octanoic acid (CAS Reg. No. 124–07–2), hydrogen peroxide (CAS Reg. No. 7722–
lactic acid (CAS Reg. No. 050–21–5), 84–1); peroxyacetic acid (CAS Reg. No.
phosphoric acid (CAS Reg. No. 7664–38– 79–21–0); acetic acid (CAS Reg. No. 64–
367
§ 178.1010 21 CFR Ch. I (4–1–12 Edition)
19–7); sulfuric acid (CAS Reg. No. 7664– phosphoric acid (CAS Reg. No. 7664–38–
93–9); and 2,6-pyridinedicarboxylic acid 2), propionic acid (CAS Reg No. 79–09–
(CAS Reg. No. 499–83–2). In addition to 04), and sodium 1-octanesulfonate (CAS
use on food-processing equipment and Reg. No. 5324–84–5). Sulfuric acid (CAS
utensils, this solution may be used on Reg. No. 7664–93–9) may be added as an
dairy-processing equipment. optional ingredient. In addition to use
(39) An aqueous solution containing on food-processing equipment and
phosphoric acid (CAS Reg. No. 7664–38– utensils, this solution may be used on
2); octenyl succinic acid (CAS Reg. No. dairy-processing equipment.
28805–58–5); N,N-dimethyloctanamine (43) An aqueous solution of iodine
(CAS Reg. No. 7378–99–6); and a mixture and hypochlorous acid generated by
of n-carboxylic acids (C6-C12, consisting the dilution of an aqueous acidic (21.5
of not less than 56 percent octanoic percent nitric acid) solution of iodine
acid and not less than 40 percent deca- monochloride. In addition to use on
noic acid). This solution may be used food-processing equipment and uten-
on food-processing equipment and sils, this solution may be used on
utensils, including dairy-processing dairy-processing equipment.
equipment. (44) An aqueous solution of citric
(40) An aqueous solution prepared by acid, disodium ethylenediaminetetra-
combining elemental iodine (CAS Reg. acetate, sodium lauryl sulfate, and
No. 7553–56–2); hydriodic acid (CAS Reg. monosodium phosphate. In addition to
No. 10034–85–2); sodium N-cyclohexyl-N- use on food-processing equipment and
palmitoyl taurate (CAS Reg. No. 132– utensils, this solution may be used on
43–4); chloroacetic acid, sodium salt re- dairy-processing equipment.
action products with 4,5-dihydro-2-
(45) An aqueous solution of hydrogen
undecyl-1H-imidazole-1-ethanol and so-
peroxide, acetic acid, peroxyacetic
dium hydroxide (CAS Reg. No. 68608–66–
acid, octanoic acid, peroxyoctanoic
2); dodecylbenzene sulfonic acid (CAS
acid, sodium 1-octanesulfonate, and 1-
Reg. No. 27176–87–0); phosphoric acid
hydroxyethylidene-1,1-diphosphonic
(CAS Reg. No. 7664–38–2); isopropyl al-
cohol (CAS Reg. No. 67–63–0); and cal- acid. In addition to use on food-proc-
cium chloride (CAS Reg. No. 10043–52– essing equipment and utensils, this so-
4). In addition to use on food-proc- lution may be used on food-contact
essing equipment and utensils, this so- surfaces in public eating places, sub-
lution may be used on dairy-processing ject to the limitations in paragraph
equipment. (c)(39) of this section.
(41) An aqueous solution containing (46) An aqueous solution of chlorine
n-alkyl(C12- dioxide and related oxychloro species
C16)benzyldimethylammonium chlo- generated by acidification of an aque-
ride, having average molecular weights ous solution of sodium chlorite with a
ranging from 351 to 380 wherein the solution of sodium gluconate, citric
alkyl groups contain principally 12 to acid, phosphoric acid, and sodium
16 carbons and not more than 1 percent mono- and
each of the groups with 8 and 10 carbon didodecylphenoxybenzenedisulfonate.
atoms; ammonium chloride (CAS Reg. In addition to use on food-processing
No. 12125–02–9); calcium stearate (CAS equipment and utensils, this solution
Reg. No. 1592–23–0); sodium bicarbonate may be used on dairy-processing equip-
(CAS Reg. No. 144–55–8); starch or ment.
dextrin, or both starch and dextrin (c) The solutions identified in para-
(CAS Reg. No. 9004–53–9); and the op- graph (b) of this section will not exceed
tional ingredient methylene blue (CAS the following concentrations:
Reg. No. 61–73–4). In addition to use on (1) Solutions identified in paragraph
food-processing equipment and uten- (b)(1) of this section will provide not
sils, this solution may be used on food- more than 200 parts per million of
contact surfaces in public eating available halogen determined as avail-
places. able chlorine.
(42) An aqueous solution containing (2) Solutions identified in paragraph
decanoic acid (CAS Reg. No. 334–48–5), (b)(2) of this section will provide not
nonanoic acid (CAS Reg. No. 112–05–0), more than 100 parts per million of
368
available halogen determined as avail- available chlorine and not more than 30
able chlorine. ppm lithium.
(3) Solution identified in paragraph (11) Solutions identified in paragraph
(b)(3) of this section will provide not (b)(16) of this section shall provide not
more than 25 parts per million of ti- more than 200 parts per million of ac-
tratable iodine. The solutions will con- tive quaternary compound.
tain the components potassium iodide, (12) Solutions identified in paragraph
sodium p-toluenesulfonchloramide and (b)(17) of this section shall provide,
sodium lauryl sulfate at a level not in when ready to use, a level of 150 parts
excess of the minimum required to per million of the active quaternary
produce their intended functional ef- compound.
fect. (13) Solutions identified in paragraph
(4) Solutions identified in paragraph (b)(18) of this section shall provide not
(b)(4), (5), (6), (8), (13), and (14) of this more than 200 parts per million of ac-
section will contain iodine to provide tive quaternary compound and not
not more than 25 parts per million of more than 66 parts per million of
titratable iodine. The adjuvants used alpha[p-(1,1,3,3-tetramethylbutyl)
with the iodine will not be in excess of phenyl]-omega-hydroxypoly (oxy-
the minimum amounts required to ac- ethylene).
complish the intended technical effect. (14) Solutions identified in paragraph
(b)(19) of this section shall provide,
(5) Solutions identified in paragraph
when ready to use, a level of 100 parts
(b)(7) of this section will provide not
per million of available chlorine.
more than 400 parts per million
dodecylbenzenesulfonic acid and not
(b)(20) of this section are for single use
more than 80 parts per million of
applications only and shall provide,
polyoxyethylene-polyoxypropylene
when ready to use, a level of 800 parts
block polymers (having a minimum av-
per million of total active phenols con-
erage molecular weight of 2,800) or not
sisting of 400 parts per million ortho-
more than 40 parts per million of iso-
phenylphenol, 320 parts per million
propyl alcohol.
ortho-benzyl-para-chlorophenol and 80
(6) Solutions identified in paragraph parts per million para-
(b)(9) of this section shall provide when tertiaryamylphenol.
ready to use no more than 200 parts per (16) Solution identified in paragraph
million of the active quaternary com- (b)(21) of this section shall provide not
pound. more than 430 parts per million and not
(7) Solutions identified in paragraph less than 25 parts per million of sodium
(b)(10) of this section shall provide not dodecylbenzenesulfonate.
more than sufficient (17) Solutions identified in paragraph
trichloromelamine to produce 200 parts (b)(22) of this section shall provide,
per million of available chlorine and ei- when ready to use, at least 150 parts
ther sodium lauryl sulfate at a level per million and not more than 400 parts
not in excess of the minimum required per million of active quaternary com-
to produce its intended functional ef- pound.
fect or not more than 400 parts per mil- (18) Solutions identified in paragraph
lion of dodecylbenzenesulfonic acid. (b)(23) of this section shall provide at
(8) Solutions identified in paragraph least 150 parts per million and not
(b)(11) of this section shall provide, more than 200 parts per million of the
when ready to use, not more than 200 active quaternary compound.
parts per million of active quaternary (19) Solutions identified in para-
compound. graphs (b)(24), (b)(25), and (b)(43) of this
(9) The solution identified in para- section shall provide at least 12.5 parts
graph (b)(12) of this section shall proper million and not more than 25 parts
vide not more than 200 parts per mil- per million of titratable iodine. The ad-
lion of sulfonated oleic acid, sodium juvants used with the iodine shall not
salt. be in excess of the minimum amounts
(10) Solutions identified in paragraph required to accomplish the intended
(b)(15) of this section will provide not technical effect.

more than 200 parts per million of (20)–(21) [Reserved]
369
§ 178.1010 21 CFR Ch. I (4–1–12 Edition)
(22) Solutions identified in paragraph the amounts required to accomplish

(b)(27) of this section shall provide, the intended technical effect.
when ready to use, at least 109 parts (28) Solutions identified in paragraph
per million and not more than 218 parts (b)(33) of this section shall provide,
per million of total active fatty acids when ready to use, at least 150 parts
and at least 156 parts per million and per million and not more than 400 parts
not more than 312 parts per million of per million of active quaternary com-
the sodium 1-octanesulfonate. pounds. The adjuvants used with the
(23) Solutions identified in paragraph quaternary compounds shall not exceed
(b)(28) of this section shall provide, the amounts required to accomplish
when ready to use, at least 156 parts the intended technical effect.
per million and not more than 312 parts Tetrasodium ethylenediamine
per million of sulfonated 9- tetraacetate shall be added at a min-
octadecenoic acid, at least 31 parts per imum level of 60 parts per million. Use
million and not more then 62 parts per of these sanitizing solutions shall be
million of sodium xylenesulfonate. limited to conditions of water hardness
(24) Solutions identified in paragraph not in excess of 300 parts per million.
(b)(29) of this section will provide at (29) Solutions identified in paragraph
least 237 parts per million and not (b)(34) of this section should provide,
more than 474 parts per million when ready to use, at least 100 parts
dodecyldiphenyloxidedisulfonic acid, at per million and not more than 200 parts
least 33 parts per million and not more per million available chlorine dioxide
than 66 parts per million sulfonated as determined by the method titled
tall oil fatty acid, and at least 87 parts ‘‘Iodometric Method for the Deter-
per million and not more than 174 parts mination of Available Chlorine Dioxide
per million neo-decanoic acid. (50–250 ppm available ClO2),’’ which is
incorporated by reference. Copies are
available from the Center for Food
(b)(30) of this section shall provide,
Safety and Applied Nutrition (HFS–
when ready to use, not less than 550
parts per million and not more than
1,100 parts per million hydrogen per- MD 20740, or available for inspection at
oxide, not less than 100 parts per mil- the National Archives and Records Ad-
lion and not more than 200 parts per ministration (NARA). For information
million peracetic acid, not less than 150 on the availability of this material at
parts per million and not more than 300 NARA, call 202–741–6030, or go to: http://
parts per million acetic acid, and not www.archives.gov/federallregister/
less than 15 parts per million and not codeloflfederallregulations/
more than 30 parts per million 1- ibrllocations.html.
hydroxyethylidene-1,1-diphosphonic (30) Solutions identified in paragraph
acid. (b)(35) of this section shall provide,
(26) The solution identified in para- when ready for use, at least 117 parts
graph (b)(31) of this section shall proper million and not more than 234 parts
vide, when ready to use, at least 12.5 per million of total fatty acids and at
parts per million and not more than 25 least 166 parts per million and not
parts per million of titratable iodine. more than 332 parts per million of a
The adjuvants used with the iodine will mixture of naphthalenesulfonates. The
not be in excess of the minimum adjuvants phosphoric acid and lactic
amounts required to accomplish the in- acid, used with decanoic acid, octanoic
tended technical effect. acid, and sodium naphthalenesulfonate
(27) Solutions identified in paragraph and its alkylated derivatives, will not
(b)(32) of this section shall provide, be in excess of the minimum amounts
when ready to use, at least 150 parts required to accomplish the intended
per million and no more than 400 parts technical effects.
per million of active quarternary com- (31) Solutions identified in paragraph
pounds in solutions containing no more (b)(36) of this section shall provide,
than 600 parts per million water hard- when ready for use, at least 29 parts per
ness. The adjuvants used with the million and not more than 58 parts per
quarternary compounds will not exceed million decanoic acid; at least 88 parts
370
per million and not more than 176 parts (33) Solutions identified in paragraph
per million of octanoic acid; at least 69 (b)(38) of this section shall provide
parts per million and not more than 138 when ready for use not less than 300
parts per million of lactic acid; at least parts per million and not more than 465
256 parts per million and not more than parts per million of hydrogen peroxide;
512 parts per million of phosphoric not less than 200 parts per million and
acid; at least 86 parts per million and not more than 315 parts per million of
not more than 172 parts per million of peroxyacetic acid; not less than 200
1-octanesulfonic acid; at least 51 parts parts per million and not more than 340
per million and not more than 102 parts parts per million of acetic acid; not
per million of 1-octanesulfonic-2- less than 10 parts per million and not
sulfinic acid or 1,2-octanedisulfonic more than 20 parts per million of sul-
acid; and at least 10 parts per million furic acid; and not less than 0.75 parts
and not more than 20 parts per million per million and not more than 1.2 parts
of the condensate of four moles of per million of 2,6-pyridinedicarboxylic
poly(oxyethylene)poly(oxypropylene) acid.
block copolymers with one mole of (34) Solutions identified in paragraph
ethylenediamine. The colorant adju- (b)(39) of this section shall provide
vant FD&C Yellow No. 5 shall not be when ready for use not less than 460
used in excess of the minimum amount parts per million and not more than 625
required to accomplish the intended parts per million of phosphoric acid,
technical effect. and all components shall be present in
(32)(i) The solution identified in para- the following proportions: 1 part phos-
graph (b)(37) of this section without po- phoric acid to 0.25 octenyl succinic acid
tassium bromide shall provide, when to 0.18 part N,N-dimethyloctanamine to
ready to use, at least 100 parts per mil- 0.062 part of a mixture of n-carboxylic
lion and not more than 200 parts per acids (C6-C12, consisting of not less
million of available halogen deter- than 56 percent octanoic acid and not
mined as available chlorine; at least less than 40 percent decanoic acid).
2,958 parts per million and not more (35) Solutions identified in paragraph
than 5,916 parts per million of tri- (b)(40) of this section shall provide
sodium phosphate; at least 1 part per when ready for use not less than 12.5
million and not more than 3 parts per parts per million and not more than
million of sodium lauryl sulfate; and at 25.0 parts per million of titratable io-
least 0.3 part per million and not more dine; and not less than 2.7 parts per
than 0.7 part per million on potassium million and not more than 5.5 parts per
permanganate. million of dodecylbenzene sulfonic
(ii) The solution identified in para- acid. All components shall be present
graph (b)(37) of this section with potas- in the following proportions: 1.0 part
sium bromide shall provide, when dodecylbenzene sulfonic acid to 43
ready to use, at least 25 parts per mil- parts sodium N-cyclohexyl-N-palmitoyl
lion and not more than 200 parts per taurate to 7.7 parts chloroacetic acid,
million of available halogen deter- sodium salt, reaction products with 4,5-
mined as available chlorine; at least 15 dihydro-2-undecyl-1H-imidazole-1-eth-
parts per million and not more than 46 anol and sodium hydroxide to 114 parts
parts per million of potassium bro- phosphoric acid to 57 parts isopropyl
mide; at least 690 parts per million and alcohol to 3.0 parts calcium chloride.
not more than 2,072 parts per million of (36) Solutions identified in paragraph
trisodium phosphate; at least 0.3 part (b)(41) of this section shall provide,
per million and not more than 1 part when ready for use, not less than 150
per million of sodium lauryl sulfate; parts per million and not more than 200
and at least 0.1 part per million and parts per million of n-alkyl(C12-
not more than 0.3 part per million of C16)benzyldimethylammonium chlo-
potassium permanganate. ride; and not more than 0.4 part per
(iii) Magnesium oxide when used in million of the colorant methylene blue.
paragraph (c)(32) (i) or (ii) of this sec- Components shall be present in the
tion shall not be used in excess of the product used to prepare the solution in
minimum amount required to accom- the following proportions: 1 part n-

plish its intended technical effect. alkyl(C12-
371
§ 178.1010 21 CFR Ch. I (4–1–12 Edition)
C16)benzyldimethylammonium chloride per million of octanoic acid (including

to 0.24 part ammonium chloride to 0.08 peroxyoctanoic acid); at least 281 parts
part calcium stearate to 0.60 part so- per million and not more than 686 parts
dium bicarbonate to 0.08 part starch or per million of acetic acid; at least 7
dextrin, or a combination of starch and parts per million and not more than 34
dextrin. parts per million of 1-
(37)(i) The solution identified in para- hydroxyethylidene-1,1-diphosphonic
graph (b)(42) of this section not con- acid; and at least 36 parts per million
taining sulfuric acid shall provide when and not more than 109 parts per million
ready for use not less than 45 parts per of sodium 1-octanesulfonate.
million and not more than 90 parts per (ii) The solution identified in para-
million of decanoic acid; and all com- graph (b)(45) of this section, when used
ponents shall be present in the fol- on food-contact equipment and utensils
lowing proportions (weight/weight (w/ in warewashing machines, including
w)): 1 part decanoic acid to 1 part nona- warewashing machines in public eating
noic acid to 9.5 parts phosphoric acid to places, at temperatures no less than 120
3.3 parts propionic acid to 3.3 parts so- °F (49 °C) shall provide when ready for
dium 1-octanesulfonate. use at least 30 parts per million and
(ii) The solution identified in para- not more than 91 parts per million of
graph (b)(42) of this section containing hydrogen peroxide; at least 19 parts per
sulfuric acid shall provide when ready million and not more than 58 parts per
for use not less than 45 parts per mil- million of peroxyacetic acid; at least 17
lion and not more than 90 parts per parts per million and not more than 52
million of decanoic acid; and all com- parts per million of octanoic acid (in-
ponents shall be present in the fol- cluding peroxyoctanoic acid); at least
lowing proportions (w/w): 1 part deca- 119 parts per million and not more than
noic acid to 1 part nonanoic acid to 2.8 290 parts per million of acetic acid; at
parts phosphoric acid to 3.3 parts propi- least 3 parts per million and not more
onic acid to 3.3 parts sodium 1- than 14 parts per million of 1-
octanesulfonate to 3.2 parts sulfuric hydroxyethylidene-1,1-diphosphonic
acid. acid; and at least 15 parts per million
(38) The solution identified in para- and not more than 46 parts per million
graph (b)(44) of this section shall proof sodium 1-octanesulfonate.
vide, when ready for use, at least 16,450 (iii) The solution identified in para-
parts per million and not more than graph (b)(45) of this section, when used
32,900 parts per million of citric acid; at on dairy or beverage containers, shall
least 700 parts per million and not provide when ready for use at least 36
more than 1,400 parts per million of di- parts per million and not more than 108
sodium ethylenediaminetetraacetate; parts per million of hydrogen peroxide;
at least 175 parts per million and not at least 23 parts per million and not
more than 350 parts per million of so- more than 69 parts per million of per-
dium lauryl sulfate; and at least 175 oxyacetic acid; at least 20 parts per
parts per million and not more than 350 million and not more than 61 parts per
parts per million of monosodium phos- million of octanoic acid (including
phate. peroxyoctanoic acid); at least 140 parts
(39)(i) The solution identified in para- per million and not more than 343 parts
graph (b)(45) of this section, when used per million of acetic acid; at least 3
on food processing equipment and uten- parts per million and not more than 17
sils, including dairy and beverage-proc- parts per million of 1-
essing equipment but excluding food- hydroxyethylidene-1,1-diphosphonic
contact surfaces in public eating places acid; and at least 18 parts per million
and dairy and beverage containers, and not more than 55 parts per million
shall provide when ready for use at of sodium 1-octanesulfonate.
least 72 parts per million and not more (40) The solution identified in para-
than 216 parts per million of hydrogen graph (b)(46) of this section shall pro-
peroxide; at least 46 parts per million vide, when ready for use, at least 100
and not more than 138 parts per million parts per million and not more than 200
of peroxyacetic acid; at least 40 parts parts per million of chlorine dioxide as

per million and not more than 122 parts determined by the method developed
372
by Bio-cide International, Inc., enti- (d) Sanitizing agents for use in ac-
tled, ‘‘Iodometric Method for the De- cordance with this section will bear la-
termination of Available Chlorine Di- beling meeting the requirements of the
oxide (50–250 ppm Available ClO2),’’ Federal Insecticide, Fungicide, and
dated June 11, 1987, which is incor- Rodenticide Act.
porated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. [42 FR 14609, Mar. 16, 1977]
Copies of this method are available EDITORIAL NOTE: For FEDERAL REGISTER ci-
from the Division of Petition Control, tations affecting § 178.1010, see the List of
Center for Food Safety and Applied Nu- CFR Sections Affected, which appears in the
trition (HFS–215), Food and Drug Ad- Finding Aids section of the printed volume
ministration, 5100 Paint Branch Pkwy., and at www.fdsys.gov.
College Park, MD 20740, and may be ex-
amined at the Center for Food Safety Subpart C—Antioxidants and
and Applied Nutrition’s Library, Food
and Drug Administration, 5100 Paint
Stabilizers
Branch Pkwy., College Park, MD 20740, § 178.2010 Antioxidants and/or stabi-
or at the National Archives and lizers for polymers.
information on the availability of this The substances listed in paragraph
material at NARA, call 202–741–6030, or (b) of this section may be safely used as
go to: http://www.archives.gov/ antioxidants and/or stabilizers in poly-
federallregister/ mers used in the manufacture of arti-
codeloflfederallregulations/ cles or components of articles intended
ibrllocations.html; at least 380 parts per for use in producing, manufacturing,
million and not more than 760 parts per packing, processing, preparing, treat-
million of sodium gluconate; and at ing, packaging, transporting, or hold-
least 960 parts per million and not ing food, subject to the provisions of
more than 1,920 parts per million of so- this section:
dium mono- and (a) The quantity used shall not ex-
didodecylphenoxybenzenedisulfonate. ceed the amount reasonably required
Other components listed under para- to accomplish the intended technical
graph (b)(46) of this section shall be
effect.
used in the minimum amount nec-
(b) List of substances:
essary to produce the intended effect.
N-n-Alkyl-N′-(carboxymethyl)-N,N′- For use only:

trimethylenediglycine; the alkyl group is even 1. As component of nonfood articles complying with §§ 175.105 and
numbered in the range C14–C18 and the nitrogen 177.2600 of this chapter.
content is in the range 5.4–5.6 weight percent. 2. At levels not to exceed 1.35 percent by weight of natural rubber, buta-
diene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene
polymers that are used in contact with nonalcoholic food at temperatures
not to exceed room temperature and that are employed in closure-sealing
gaskets complying with § 177.1210 of this chapter or in coatings com-
plying with § 175.300, § 176.170, or § 175.320 of this chapter. The aver-
age thickness of such coatings and closure-sealing gaskets shall not ex-
ceed 0.004 inch.
Alkylthiophenolics: ................................................... For use only:
1. Acid-catalyzed condensation reaction products 1. At levels not to exceed 2 percent by weight of adhesives complying with
of 4-nonylphenol, formaldehyde, and 1- § 175.105 of this chapter, of pressure-sensitive adhesives complying with
dodecanethiol (CAS Reg. No. 164907–73–7).. § 175.125 of this chapter, and of rubber articles complying with
2. Acid-catalyzed condensation reaction products 2. Do.
of branched 4-nonylphenol, formaldehyde, and
1-dodecanethiol (CAS Reg. No. 203742–97–6)..
p-tert-Amylphenolformaldehyde resins produced For use only at levels not to exceed 2.1 percent by weight of polyamide
when one mole of p-tert-amylphenol is made to resins that are:
react under acid conditions with one mole of 1. Derived from dimerized vegetable oil acids (containing not more than 20
formaldehyde. percent of monomer acids) and ethylenediamine.
2. Used in compliance with regulations in parts 174, 175, 176, 177, 178
and § 179.45 of this chapter.
373
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
1,4-Benzenedicarboxylic acid, bis[2-(1,1- For use only at levels not to exceed 0.075 percent by weight of olefin poly-
dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hy- mers complying with § 177.1520 of this chapter.
droxy-5-methylphenyl]methyl]-4-methyl-
phenyl]ester (CAS Reg. No. 57569–40–1).
2-(2H-Benzotriazol-2-yl)-4,6-bis(1-methyl-1- For use only:
phenylethyl)phenol (CAS Reg. No. 70321–86–7). 1. At levels not to exceed 0.5 percent by weight of polyethylene phthalate
polymers complying with § 177.1630 of this chapter.
2. At levels not to exceed 3.0 percent by weight of polycarbonate resins
complying with § 177.1580 of this chapter.
2-(2H-Benzotriazol-2-yl)-4-(1, 1, 3, 3- For use only at levels not to exceed 0.5 percent by weight of polycarbonate
tetramethylbutyl) phenol (CAS Reg. No. 3147– resins complying with § 177.1580 of this chapter: Provided, That the fin-
75–9). ished resins contact food only under conditions of use E, F, and G de-
scribed in table 2 of § 176.170(c) of this chapter.
2-[4,6-Bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5- For use only:
(octyloxy)phenol (CAS Reg. No. 2725–22–6).. 1. At levels not to exceed 0.3 percent by weight of olefin polymers com-
plying with § 177.1520(c) of this chapter in contact with food types I, II,
IV-B, VI, VII-B, and VIII described in § 176.170(c) of this chapter, table 1,
under conditions of use D through G as described in § 176.170(c), table
2, of this chapter.
2. At levels not to exceed 0.1 percent by weight of polypropylene complying
with § 177.1520(c) of this chapter, items 1.1a, 1.2, and 1.3 in contact with
food under conditions of use A through H as described in § 176.170(c),
table 2, of this chapter.
3. At levels not to exceed 0.04 percent by weight of polyethylene and olefin
copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2,
2.3, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b having a minimum density of 0.94
gram per cubic centimeter, in contact with food under conditions of use A
through H as described in § 176.170, table 2, of this chapter provided
that the finished articles used in contact with fatty food types III, IV-A, V,
VII-A, and IX as described in table 1 of § 176.170(c) of this chapter hold
a minimum of 2 gallons (7.6 liters) of food.
4. At levels not to exceed 0.4 percent by weight of ethylene copolymers
complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.1c, 3.2a,
and 3.2b, having a density of less than 0.94 gram per cubic centimeter,
in contact with food under conditions of use B through H, as described in
§ 176.170(c), table 2, of this chapter provided that the finished articles
used in contact with fatty food types III, IV-A, V, VII-A, and IX hold a min-
imum of 5 gallons (18.9 liters) of food.
5. At levels not to exceed 0.04 percent by weight of polyethylene having a
density of less than 0.94 gram per cubic centimeter, and olefin polymers
complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.3a,
3.3b, 3.4, 3.5, 3.6, 4, 5, and 6, in contact with food under conditions of
use D through G as described in § 176.170(c) of this chapter, table 2,
provided that the finished articles used in contact with fatty food types III,
IV-A, V, VII-A, and IX hold a minimum of 5 gallons (18.9 liters) of food.
b, 3(or 4)-Bis(octadecylthio)cyclohexylethane (CAS For use only:
Reg. No. 37625–75–5); CAS synonym: 1-[(beta- 1. At levels not to exceed 0.3 percent by weight of all polymers for use in
(octadecylthio)ethyl]-3(or 4)- contact with foods of Types I, II, IV-B, VI, VII-B, and VIII under conditions
(octadecylthio)cyclohexane. of use B through H as described in tables 1 and 2 of § 176.170(c) of this
chapter.
2. At levels not to exceed 0.3 percent by weight of polyolefins complying
with § 177.1520 of this chapter, for use in contact with food of types III,
IV-A, V, VII-A, and IX under conditions of use C through G as described
in tables 1 and 2 of § 176.170(c) of this chapter.
Bis(2,2,6,6-tetramethyl-4-piperidinyl) sebacate For use only:
(CAS Reg. No. 52829–07–9). 1. In adhesives complying with § 175.105 of this chapter.
2. At levels not to exceed 0.1 percent by weight of pressure-sensitive adhe-
sives complying with § 175.125 of this chapter.
374
Bis(2,4-di-tert-butyl-6-methylphenyl) ethyl For use only:

phosphite (CAS Reg. No. 145650–60–8). 1. At levels not to exceed 0.3 percent by weight of olefin polymers com-
plying with § 177.1520(c) of this chapter. The finished polymers may only
be used with food of the types identified in § 176.170(c) of this chapter,
table 1, under Categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under
conditions of use B through H described in table 2 of § 176.170(c) of this
chapter.
2. At levels not to exceed 0.1 percent by weight of propylene polymers
complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 3.2b,
3.4, or 3.5, or 3.1a (where the density of this polymer is at least 0.85
gram per cubic centimeter and less than 0.91 gram per cubic centimeter).
The finished polymers may only be used in contact with food of the types
identified in § 176.170(c) of this chapter, table 1, under Categories III, IV-
A, V, VI-C, VII-A, and IX, and under conditions of use B through H de-
3. At levels not to exceed 0.1 percent by weight of high-density ethylene
polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2,
2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers
is at least 0.94 gram per cubic centimeter), or 5. The finished polymers
may only be used in contact with food of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions of use C (maximum temperature 70
°C) through G described in table 2 of § 176.170(c) of this chapter. Pro-
vided, that the finished food contact articles have a volume of at least
18.9 liters (5 gallons).
4. At levels not to exceed 0.01 percent by weight of low-density ethylene
2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these
polymers is less than 0.94 gram per cubic centimeter). The finished poly-
mers may only be used in contact with food of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions of use B through H described in table
2 of § 176.170(c) of this chapter. Provided, that the average thickness of
such polymers in the form in which they contact food shall not exceed
0.001 inch.
1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)- For use only:
hydrazine (CAS Reg. No. 32687–78–8). 1. As provided in § 175.105 of this chapter.
2. At levels not exceeding 0.1 percent by weight of acrylonitrile-butadiene-
styrene copolymers used in accordance with parts 175, 176, 177, and
181 of this chapter.
3. At levels not exceeding 0.1 percent by weight of polyoxymethylene co-
polymers complying with § 177.2470 of this chapter and of
polyoxymethylene homopolymers complying with § 177.2480 of this chap-
ter.
2,6-Bis(1-methylheptadecyl)-p-cresol ...................... For use only at levels not exceeding 0.3 percent by weight of olefin poly-
mers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3,
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4. The average thickness of such polymers
in the form in which they contact fatty food or food containing more than
8 percent of alcohol shall not exceed 0.004 inch.
3,9-Bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]- For use only:
2,4,8,10-tetraoxa-3,9- 1. At levels not to exceed 0.15 percent by weight of all polymers, except as
diphosphaspiro[5.5]undecane (CAS Reg. No. specified below.
154862–43–8), which may contain not more 2. At levels not to exceed 0.2 percent by weight of polycarbonate resins
than 2 percent by weight of triisopropanolamine complying with § 177.1580 of this chapter.
(CAS Reg. No. 122–20–3). 3. At levels not to exceed 0.3 percent by weight of polyetherimide resins
375
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
5,7-Bis(1,1-dimethylethyl)-3-hydroxy-2(3H)- For use only:

benzofuranone, reaction products with o-xylene 1. At levels not to exceed 0.1 percent by weight of olefin polymers com-
(CAS Reg. No. 181314–48–7). plying with § 177.1520(c) of this chapter. The finished polymers may only
be used in contact with food of the types identified in § 176.170(c) of this
chapter, Table 1, under Categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII,
and under conditions of use B through H described in Table 2 of
2. At levels not to exceed 0.02 percent by weight of:
(a) Propylene polymers and copolymers complying with § 177.1520(c) of
this chapter, items 1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished
polymer may only be used in contact with food of types identified in
§ 176.170(c) of this chapter, Table 1, under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions of use B through H described in
Table 2 of § 176.170(c) of this chapter; or
(b) Ethylene polymers and copolymers complying with § 177.1520(c) of this
chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of
each of these polymers is at least 0.94 gram per cubic centimeter), or 5.
The finished polymers may only be used in contact with food of the types
identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV-
A, V, VI-C, VII-A, and IX, and under conditions of use B through H de-
scribed in Table 2 of § 176.170(c) of this chapter; provided that the fin-
ished food-contact articles have a volume of at least 18.9 liters (5 gal-
lons).
3. At levels not to exceed 0.02 percent by weight of ethylene polymers and
polymers is less than 0.94 gram per cubic centimeter). The finished poly-
mers may only be used in contact with food of the types identified in
§ 176.170(c) of this chapter, Table 1, under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions of use B through H described in
Table 2 of § 176.170(c) of this chapter; provided that the average thick-
ness of such polymers in the form in which they contact food shall not
exceed 50 micrometers (0.002 inch).
3,9-Bis[2-{3-(3-tert-butyl-4-hydroxy-5- For use only:
methylphenyl)propionyloxy}-1,1-dimethylethyl]- 1. At levels not to exceed 0.2 percent by weight of polypropylene complying
2,4,8,10-tetraoxaspiro[5.5]undecane (CAS Reg. with § 177.1520(c), item 1.1 of this chapter. The finished polymer is to be
No. 90498–90–1). used in contact with food only under conditions of use D through H de-
2. At levels not to exceed 0.3 percent by weight of polyethylene complying
with § 177.1520(c) of this chapter, item 2.1, provided that the polymer
has a minimum density of 0.94 grams per cubic centimeter and is used in
contact with food only under conditions of use D through G described in
table 2 of § 176.170(c) of this chapter.
3. At levels not to exceed 0.3 percent by weight of olefin polymers com-
plying with § 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where
the copolymers complying with items 3.1 and 3.2 contain not less than 85
weight percent of polymer units derived from propylene. The finished
polymer is to be used in contact with food of types I, II, IV-B, VI-A, VI-B,
VI-C, VII-B, and VIII under conditions of use A through H described in ta-
bles 1 and 2 of § 176.170(c) of this chapter.
376
4-[[4,6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di- For use only:

tert-butylphenol (CAS Reg. No. 991–84–4). 1. At levels not to exceed 0.5 percent by weight: in styrene block copoly-
mers complying with § 177.1810 of this chapter; in rosins and rosin de-
rivatives complying with § 175.300(b)(3)(v) of this chapter; in can end ce-
ment formulations complying with § 175.300(b)(3)(xxxi) of this chapter; in
side seam cement formulations complying with § 175.300(b)(3)(xxxii) of
this chapter; in petroleum alicyclic hydrocarbon resins and terpene resins
complying with § 175.320(b)(3) of this chapter; in rosin and rosin deriva-
tives complying with § 176.170(a)(5) of this chapter; in petroleum alicyclic
hydrocarbon resins or their hydrogenated products complying with
§ 176.170(b)(2) of this chapter; in terpene resins complying with
§ 175.300(b)(2)(xi) of this chapter, when such terpene resins are used in
accordance with § 176.170(b)(1) of this chapter; in resins and polymers
complying with § 176.180(b) of this chapter; in closures with sealing gas-
kets complying with § 177.1210 of this chapter; in petroleum hydrocarbon
resin and rosins and rosin derivatives complying with § 178.3800(b) of
this chapter; and in reinforced wax complying with § 178.3850 of this
chapter.
2. At levels not to exceed 0.2 percent by weight of the finished cellophane
3. At levels not to exceed 0.1 percent by weight in polystyrene and rubber-
modified polystyrene complying with § 177.1640 of this chapter: Provided,
That the finished polystyrene and rubber-modified polystyrene polymer
contact food only under conditions of use B through G described in table
2 of § 176.170(c) of this chapter.
4. In adhesives complying with § 175.105 of this chapter; in pressure-sen-
sitive adhesives complying with § 175.125 of this chapter; and as pro-
vided in § 177.2600 of this chapter.
4,4′-Bis(a,a-dimethylbenzyl)diphenylamine (CAS For use at levels not to exceed 0.3 percent by weight of polypropylene
Reg. No. 10081–67–1). complying with § 177.1520(c) of this chapter. The polypropylene articles
are limited to use in contact with non-fatty foods only.
Boric acid (CAS Reg. No. 10043–35–3) ................. For use only at levels not to exceed 0.16 percent by weight of ethylene-
vinyl acetate-vinyl alcohol copolymers complying with § 177.1360(a)(3)
and (d) of this chapter.
1,3–Butanediol.
Butylated reaction product of p-cresol and For use only:
dicyclopentadiene produced by reacting p-cresol 1. As components of nonfood articles complying with §§ 175.105 and
and dicyclopentadiene in an approximate mole 177.2600(c)(4)(iii) of this chapter.
ratio of 1.5 to 1, respectively, followed by 2. At levels not to exceed 1.0 percent by weight of acrylonitrile/butadiene/
alkylation with isobutylene so that the butyl con- styrene copolymers. The finished copolymers may be used in contact
tent of the final product is not less than 18 per- with food of Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII under conditions
cent. of use B through H, as described in tables 1 and 2 of § 176.170(c) of this
chapter, and with food of Types III, IV-A, V, VI-C, VII-A, and IX under
conditions of use C through G as described in tables 1 and 2 of § 176.
170(c) of this chapter.
377
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
Butylated, styrenated cresols produced when For use only:

equal moles of isobutylene, styrene, and a 1. As provided in §§ 175.105 and 177.2600 of this chapter.
metacresol-paracresol mixture having a no more 2. At levels not to exceed 0.5 percent by weight of polystyrene, rubber-
than 3 °C distillation range including 202 °C are modified polystyrene, or olefin polymers complying with § 177.1520 (c) of
made to react so that the final product meets this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4, or com-
the following specifications: Not less than 95 plying with other sections in parts 174, 175, 176, 177, 178 and § 179.45
percent by weight of total alkylated phenols con- of this chapter, used in articles that contact food only unded the condi-
sisting of 13–25 percent by weight of butylated tions described in § 176.170(c) of this chapter, table 2, under conditions
m- and p-cresols, 26–38 percent by weight of of use C through G.
styrenated m- and p-cresols, 37–49 percent by
weight of butylated styrenated m- and p-cresols,
and not more than 10 percent by weight total of
alkylated xylenols, alkylated o-cresol, alkylated
phenol, and alkylated ethylphenol; acidity not
more than 0.003 percent; and refractive index at
25 °C of 1.5550–1.5650, as determined by
ASTM method D1218–82, ‘‘Standard Test Meth-
od for Refractive Index and Refractive Disper-
sion of Hydrocarbon Liquids,’’ which is incor-
porated by reference. Copies may be obtained
from the American Society for Testing Materials,
Philadelphia, PA 19428-2959, or may be exam-
ined at the National Archives and Records Ad-
ministration (NARA). For information on the
availability of this material at NARA, call 202–
federallregister/
2-tert-Butyl-a(3-tert-butyl-4-hydroxyphenyl)-p-cu- For use only:
menyl bis(p-nonylphenyl) phosphite; the nonyl 1. As components of nonfood articles complying with §§ 175.105 and
group is a propylene trimer isomer and the 177.2600 of this chapter.
phosphorus content is in the range 3.8–4.0 2. At levels not to exceed 1.35 percent by weight of natural rubber, buta-
weight percent. diene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene
polymers that are used in contact with nonalcoholic food at temperatures
not to exceed room temperature and that are employed in closure-sealing
gaskets complying with § 177.1210 of this chapter or in coatings com-
plying with § 175.300, § 175.320, or § 176.170 of this chapter. The aver-
age thickness of such coatings and closure-sealing gaskets shall not ex-
ceed 0.004 inch.
2-(3′-tert-Butyl-2′-hydroxy-5′-methyl-phenyl)-5- For use only at levels not to exceed 0.5 percent by weight of olefin poly-
chlorobenzotriazole with a melting point of 137– mers complying with § 177.1520(c) of this chapter, provided that the fin-
141 °C. ished polymer contacts foods only of the types identified in Categories I,
II, IV-B, VI-A and B, VII-B, and VIII in table 1, § 176.170 of this chapter.
4,4′-Butylidenebis(6-tert-butyl-m-cresol) ................. For use only.
1. As provided in §§ 175.105 and 177.2600 of this chapter.
2. At levels not to exceed 0.5 percent by weight of polypropylene complying
with § 177.1520 of this chapter and for use at levels not to exceed 0.3
percent by weight of polyethylene complying with § 177.1520 of this
chapter, provided that the finished polypropylene and polyethylene con-
tact food only of the types identified in § 176.170(c) of this chapter, table
1, under Categories I, II, VI-B, and VIII.
Butyric acid, 3,3-bis(3-tert-butyl-4- For use only:
hydroxyphenyl)ethylene ester (CAS Reg. No. 1. At levels not to exceed 0.5 percent by weight of olefin copolymers com-
32509–66–3). plying with § 177.1520(c) of this chapter, items 3.1 and 3.2 except that
when used in contact with foods described as types III, IV-A, V, VII-A,
and IX in table 1 of § 176.170(c) of this chapter, the olefin copolymers
may only be used under conditions of use E, F, and G set forth in table 2
of § 176.170(c) of this chapter.
plying with § 177.1520(c) of this chapter, item 1.1, 3.1, or 3.2 (where the
copolymers complying with items 3.1 and 3.2 contain not less than 85
weight-percent of polymer units derived from propylene).
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2.
Calcium benzoate..
378
Calcium bis[monoethyl(3,5-di-tert-butyl-4-hydroxy- For use only:

benzyl)phosphonate] (CAS Reg. No. 65140–91– 1. At levels not to exceed 0.25 percent by weight of polypropylene that
2). complies with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3.
2. At levels not to exceed 0.2 percent by weight of polyethylene and olefin
copolymers that comply with § 177.1520(c) of this chapter, items 2.1, 2.2,
2.3, 3.1, 3.2, 3.3, 3.4, 3.5, and 3.6. Finished polymers having a density
less than 0.94 gram per cubic centimeter shall be used in contact with
food only under conditions of use B through H described in table 2 of
3. In adhesives complying with § 175.105 of this chapter.
4. At levels not to exceed 0.5 percent by weight of pressure-sensitive adhe-
5. At levels not to exceed 0.5 percent by weight of rosins and rosin deriva-
tives complying with § 175.300(b)(3)(v) of this chapter.
6. At levels not to exceed 0.5 percent by weight of can end cement formu-
lations complying with § 175.300(b)(3)(xxxi) of this chapter.
7. At levels not to exceed 0.5 percent by weight of side seam cement for-
mulations complying with § 175.300(b)(3)(xxxii) of this chapter.
8. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hy-
drocarbon resins complying with § 175.320(b)(3) of this chapter.
9. At levels not to exceed 0.5 percent by weight of rosin and rosin deriva-
tives complying with § 176.170(a)(5) of this chapter; and petroleum alicy-
clic hydrocarbon resins, or the hydrogenated product thereof, complying
with § 176.170(b)(2) of this chapter.
10. At levels not to exceed 0.5 percent by weight of resins and polymers
used as components of paper and paperboard in contact with dry food in
compliance with § 176.180 of this chapter.
11. At levels not to exceed 0.5 percent by weight of closures with sealing
gaskets complying with § 177.1210 of this chapter.
12. At levels not to exceed 0.5 percent by weight of the finished rubber arti-
cle complying with § 177.2600 of this chapter.
13. At levels not to exceed 0.5 percent by weight of petroleum hydrocarbon
resin and rosins and rosin derivatives complying with § 178.3800(b).
14. At levels not to exceed 0.5 percent by weight of reinforced wax com-
plying with § 178.3850.
15. At levels not to exceed 0.3 percent by weight of polyethylene phthalate
polymers, complying with § 177.1630 of this chapter. Provided, that the
finished polymers contact food only under conditions of use B through H
described in Table 2 of § 176.170(c) of this chapter.
Calcium myristate..
Calcium ricinoleate .................................................. For use only at levels not to exceed 1 percent by weight of
polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this
chapter.
Calcium stearate..
Carbethoxymethyl diethyl phosphonate (CAS Reg. At levels not to exceed 0.07 percent by weight of polyethylene phthalate
No. 867–13–0). polymers complying with § 177.1630 of this chapter.
Cerium stereate (CAS Reg. No. 10119–53–6) ....... For use only at levels not to exceed 0.5 percent by weight in rigid and
semirigid vinyl chloride homo– and copolymer articles modified in accord-
ance with § 178.3790(b)(1) of this chapter that contact food under condi-
tions of use B through H described in table 2 of § 176.170(c) of this chap-
ter.
Cupric acetate and lithium iodide ........................... For use at levels not exceeding 0.025 percent cupric acetate and 0.065
percent lithium iodide by weight of nylon 66 resins complying with
§ 177.1500 of this chapter; the finished resins are used or are intended to
be used to contain foods during oven baking or oven cooking at tempera-
tures above 250 °F. The average thickness of such resins in the form in
which they contact food shall not exceed 0.0012 inch.
Cuprous iodide ........................................................ For use at levels not exceeding 0.01 percent cuprous iodide by weight of
nylon 66T resins complying with § 177.1500 of this chapter; the finished
resins are used or are intended to be used to contain foods during oven
baking or oven cooking at temperatures above 250 °F. The average
thickness of such resins in the form in which they contact food shall not
exceed 0.001 inch.
Cuprous iodide and cuprous bromide ..................... For use at levels not exceeding 0.0025 percent cuprous iodide and 0.0175
percent cuprous bromide by weight of nylon 66 resins complying with
§ 177.1500 of this chapter; the finished resins are used or are intended to
be used to contain foods during oven baking or oven cooking at tempera-
tures above 250 °F. The average thickness of such resins in the form in
Cyanoguanidine ...................................................... For use only at levels not to exceed 1 percent by weight of
polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this
chapter.
379
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
Cyclic neopentanetetrayl bis(octadecyl phosphite) For use only at levels not to exceed 0.1 percent by weight of ethylene-vinyl
(CAS Reg. No. 3806–34–6); the phosphorus acetate copolymers complying with § 177.1350 of this chapter that con-
content is in the range of 7.8 to 8.2 weight per- tact food under conditions of use E, F, and G described in table 2 of
cent. § 176.170(c) of this chapter.
Cyclic neopentanetetrayl bis(octadecyl phosphite) For use only:
(CAS Reg. No. 3806–34–6) (which may contain 1. At levels not to exceed 0.25 percent by weight of olefin polymers com-
not more than 1 percent by weight of plying with § 177.1520(c) of this chapter, items 1.1, 2.1, and 3.1.
triisopropanolamine (CAS Reg. No. 122–20–3)); 2. At levels not to exceed 0.25 percent by weight of olefin polymers com-
the phosphorus content is in the range of 7.8 to plying with § 177.1520(c) of this chapter, item 2.2, that contact food
8.2 weight percent. Types I, II, VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of
this chapter under conditions of use B (for boil-in-bag applications), C, D,
E, F, G, and H described in table 2 of § 176.170(c) of this chapter.
plying with § 177.1520, items 1.1 and 3.2, that contact food Types I, II,
VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of this chapter
under conditions of use B (for boil-in-bag applications), C, D, E, F, G,
and H described in table 2 of § 176.170(c) of this chapter.
4. At levels not to exceed 0.20 percent by weight of polystyrene and/or rub-
ber modified polystyrene complying with § 177.1640 of this chapter that
contact food under conditions of use E, F, and G described in table 2 of
4,4′-Cyclohexylidenebis(2-cyclohexylphenol) .......... For use only at levels not to exceed 0.1 percent by weight of olefin poly-
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4: Provided, That the finished polymers
contact food only of the types identified in § 176.170(c) of this chapter,
table 1, under Categories I, II, IV-B, VI, VII-B, and VIII.
Dicetyl thiodipropionate having a melting point of The concentration of this additive and any other permitted antioxidants in
59°–62 °C as determined by ASTM method the finished food-contact article shall not exceed a total of 0.5 milligram
E324–79, ‘‘Standard Test Method for Relative per square inch of food-contact surface.
Initial and Final Melting Points and the Melting
Range of Organic Chemicals,’’ and a saponifica-
tion value in the range 176–183 as determined
by ASTM method D1962–67 (Reapproved
1979), ‘‘Standard Test Method for Saponification
Value of Drying Oils, Fatty Acids, and Polym-
erized Fatty Acids,’’ which are incorporated by
reference. Copies may be obtained from the
American Society for Testing Materials, 100
Barr Harbor Dr., West Conshohocken, Philadel-
phia, PA 19428-2959, or may be examined at
the National Archives and Records Administra-
tion (NARA). For information on the availability
of this material at NARA, call 202–741–6030, or
Didodecyl– 1,4–dihydro–2,6–dimethyl–3,5– For use only at levels not to exceed 0.3 percenmt by weight in rigid poly-
pyridinedicarboxylate (CAS Reg. No. 36265–41– mer articles modified in accordance with § 178.3790 that contact food,
5). under conditions of use E, F, and G described in table 2 of § 176.170 of
this chapter.
2,6-Di(a-methyl benzyl)-4-methyl phenol [Chemical For use only at levels not to exceed 0.2 percent by weight of olefin poly-
Abstracts Service Registry No. 1817–68–1]. mers complying with item 3.4 in § 177.1520(c) of this chapter, provided
that such olefin polymers are limited to use at a level not to exceed 25
percent by weight in other olefin polymers complying with § 177.1520 of
this chapter; and the total amount in such finished olefin polymers not to
exceed 0.05 percent by weight, including the level that may be contrib-
uted by its presence at 6 percent in the item ‘‘butylated, styrenated
cresols * * * ’’ listed in this paragraph; and further provided that the fin-
ished olefin polymers are intended for contact with foods, except those
containing more than 8 percent alcohol.
2,4-Dimethyl-6-(1-methylpentadecyl)phenol (CAS For use only:
Reg. No. 134701–20–5). 1. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene-
styrene copolymers used in accordance with applicable regulations in
parts 175, 176, 177, and 181 of this chapter, under conditions of use C
through H as described in table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 0.033 percent by weight of rigid polyvinyl chlo-
ride, under conditions of use A through H as described in table 2 of
380
Dimethyl succinate polymer with 4-hydroxy- For use only:

2,2,6,6-tetramethyl-1-piperidineethanol (CAS 1. At levels not to exceed 0.3 percent by weight of olefin polymers com-
Reg. No. 65447–77–0). plying with § 177.1520 of this chapter and under conditions of use B
through H described in table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 0.3 percent by weight of ethylene-vinyl acetate
copolymers complying with § 177.1350 of this chapter and under condi-
ter.
Dimethyltin/monomethyltin For use only at levels not to exceed 2 percent by weight:
isooctylmercaptoacetates consisting of 5 to 90 1. In rigid polyvinyl chloride used in the manufacture of pipes intended for
percent by weight of monomethyltin tris contact with water in food-processing plants, and
(isooctylmercaptoacetate) (CAS Reg. No. 2. In rigid polyvinyl chloride and in rigid vinyl chloride copolymers complying
54849–38–6) or monomethyltin tris(2- with § 177.1950 of this chapter or § 177.1980 of this chapter for use in
ethylhexylmercaptoacetate) (CAS Reg. No. contact with food of Types I, II, III, IV (except liquid milk), V, VI, VII, VIII,
57583–34–3) and 10 to 95 percent by weight of and IX described in table 1 of § 176.170(c) of this chapter under condi-
dimethyltin bis (isooctylmercaptoacetate) (CAS tions of use C through G described in table 2 of § 176.170(c) of this
Reg. No. 26636–01–1) or dimethyltin bis(2– chapter at temperatures not to exceed 88 °C (190 °F).
ethylhexylmercaptoacetate) (CAS Reg. No.
57583–35–4), and no more than 0.4 percent by
weight of trimethyltin compounds, and having
the following specifications: Tin content (as Sn)
in the range of 15 to 21 percent and
mercaptosulfur content in the range of 11 to
13.5 percent. Other alkyltin compounds are not
to exceed 20 ppm.
Dimyristyl thiodipropionate having a melting point Finished food-contact articles containing this additive shall meet the extrac-
of 48°–52 °C as determined by ASTM method tives limitations prescribed in § 176.170(c) of this chapter.
E324–79, ‘‘Standard Test Method for Relative
Initial and Final Melting Points and the Melting
Range of Organic Chemicals,’’ and a saponifica-
tion equivalent in the range 280–290 as deter-
mined by ASTM method D1962–67 (Re-
approved 1979), ‘‘Standard Test Method for Sa-
ponification Value of Drying Oils, Fatty Acids,
and Polymerized Fatty Acids,’’ which are incor-
porated by reference. Copies may be obtained
from the American Society for Testing Materials,
1916 Race St., Philadelphia PA 19103, or may
be examined at the National Archives and
Records Administration (NARA). For information
on the availability of this material at NARA, call
202–741–6030, or go to: http://
Di(n-octyl)tin bis(2-ethylhexyl maleate) [CAS Reg. For use only at levels not to exceed 0.5 percent by weight of acrylonitrile
No. 10039–33–5] having 12.5 to 15.0 percent by copolymers complying with §§ 177.1020 and 177.1030 of this chapter and
weight of tin (Sn) and having a saponification used in contact with all food types under conditions of use C through G
number of 260 to 280. The additive is made described in table 2 of § 176.170(c) of this chapter.
from di(n-octyl)tin oxide meeting the specifica-
tions of § 178.2650(a)(1).
N,N′-Diphenylthiourea ............................................. For use only:
1. At levels not to exceed 0.5 percent by weight of polyvinyl chloride and/or
vinyl chloride copolymers complying with § 177.1980 of this chapter.
2. At levels not to exceed 0.5 percent by weight of vinyl chloride-vinyl ace-
tate copolymers containing not more than 20 molar percent of vinyl ace-
tate.
2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5- For use only
hexyloxy)phenol (CAS Reg. No. 147315–50–2). 1. At levels not to exceed 0.5 percent by weight of polycarbonate resins
2. At levels not to exceed 0.5 percent by weight of polyester elastomers
3. At levels not to exceed 0.5 percent by weight of polyethylene phthalate
polymers complying with § 177.1630 of this chapter, in contact with food
under conditions of use A through H described in Table 2 of § 176.170(c)
of this chapter.
381
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
2,6-Di-tert-butyl-4-ethylphenol ................................. For use only in contact with nonalcoholic foods:

1. At levels not exceeding 0.04 mg/in 2 of food contact surface and not ex-
ceeding 0.1 percent by weight in ethylene polymers and copolymers
complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2,
and 3.3; § 177.1340; and § 177.1350 of this chapter. The average thick-
ness of such polymers and copolymers in the form in which they contact
food shall not exceed 0.0025 in.
2. At levels not exceeding 0.04 mg/in 2 of food contact surface in ethylene
polymers and copolymers complying with § 177.1520(c) of this chapter,
items 2.1, 2.2, 2.3, 3.1, 3.2, and 3.3; § 177.1340; and § 177.1350 of this
chapter. The average thickness of such polymers and copolymers in the
form in which they contact food shall be greater than 0.0025 in but shall
not exceed 0.025 in.
3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid For use only:
triester with 1,3,5-tris(2-hydroxyethyl)-s-triazine- 1. At levels not to exceed 0.5 percent by weight of polypropylene complying
2,4,6-(1H,3H,5H)-trione (CAS Reg. No. 34137- with § 177.1520 of this chapter in articles that contact food not in excess
09-2). of high temperature heat-sterilized condition of use A described in
§ 176.170(c) of this chapter, table 2.
with § 177.1520 of this chapter in articles that contact food not in excess
of high temperature heat-sterilized condition of use A described in
176.170(c) of this chapter, table 2.
4. At levels not to exceed 0.25 percent by weight of olefin copolymers com-
plying with § 177.1520(c) of this chapter, items 3.1, 3.2, 3.3, 3.4, 3.5, and
4.0.
5. At levels not to exceed 2 percent by weight of polyester elastomers,
complying with § 177.1590 of this chapter, in contact with dry food only,
and finished rubber articles for repeated use, complying with § 177.2600
of this chapter, in contact with all foods, at temperatures not to exceed
150 °F.
Di-tert-butyl-m-cresyl phosphonite condensation For use only:
product with biphenyl (CAS Reg. No. 178358– 1. At levels not to exceed 0.1 percent by weight of olefin polymers com-
58–2) produced by the condensation of 4,6-di- plying with § 177.1520(c) of this chapter, items 1.1, 2.1, 2.2, 3.1(a),
tert-butyl-m-cresol with the Friedel-Crafts addi- 3.1(b), 3.2(a), or 3.2(b).
tion product (phosphorus trichloride and
biphenyl) so that the food additive has a min-
imum phosphorus content of 5.0 percent.
Di-tert-butylphenyl phosphonite condensation For use only:
product with biphenyl (CAS Reg. No. 119345– 1. At levels not to exceed 0.1 percent by weight of olefin polymers com-
01–6) produced by the condensation of 2,4-di- plying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 3.2b, 3.3a,
tert-butylphenol with the Friedel-Crafts addition 3.3b, 3.4, 3.5, and 3.1a (where the density is not less than 0.85 gram per
product (phosphorus trichloride and biphenyl) so cubic centimeter and not more than 0.91 gram per cubic centimeter); and
that the food additive has a minimum phos- 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, and 3.6 (where the density is not less than
phorus content of 5.4 percent, an acid value not 0.94 gram per cubic centimeter) and 5.
exceeding 10 mg KOH/gm, and a melting range 2. At levels not to exceed 0.1 percent by weight of polycarbonate resins
of 85 °C to 110 °C (185 °F to 230 °F). complying with § 177.1580 of this chapter.
3. At levels not to exceed 0.2 percent by weight of polystyrene and 0.3 per-
cent by weight of rubber-modified polystyrene complying with § 177.1640
of this chapter.
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b,
3.2a, 3.4, 3.5, and 3.6 (where the polyethylene component has a density
less than 0.94 gram per cubic centimeter).
5. At levels not to exceed 0.1 percent by weight of repeated use rubber ar-
ticles complying with § 177.2600 of this chapter.
382
2,4-Di-tert-butylphenyl-3,5-di-tert-butyl-4-hydroxy- For use only:

benzoate (CAS Reg. No. 4221–80–1). 1. At levels not to exceed 0.6 percent by weight of olefin polymers com-
plying with § 177.1520(c) of this chapter, item 1.1: (1) when used in sin-
gle-use articles that contact food of types I, II, IV-B, VI-A, VI-B, VII-B, and
VIII, identified in table 1 of § 176.170(c) of this chapter; and (2) when
used in repeated-use articles that contact food of types I, II, III, IV, V, VI,
VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter. The
additive is used under conditions of use B through H described in table 2
2. At levels not to exceed 0.25 percent by weight of olefin polymers having
a density of not less than 0.94 gram per cubic centimeter and complying
with § 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2: (1) when
used in single-use articles that contact food of types I, II, IV-B, VI-A, VI-
B, VII-B, and VIII, identified in table 1 of § 176.170(c) of this chapter; and
(2) when used in repeated-use articles that contact food of types I, II, III,
IV, V, VI, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chap-
ter. The additive is used under conditions of use B through H described
in table 2 of § 176.170(c) of this chapter.
2,4-Di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2- For use only:
hydroxyphenyl)ethyl]phenyl acrylate (CAS Reg. 1. At levels not to exceed 0.2 percent by weight of polypropylene complying
No. 123968–25–2). with § 177.1520 of this chapter in contact with food under conditions of
use D through G as described in Table 2 of § 176.170(c) of this chapter,
except that polypropylene containing the additive at levels not to exceed
0.075 percent by weight may contact food under conditions of use A
through H described in Table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 1.0 percent by weight of of styrene block poly-
mers complying with § 177.1810 of this chapter. The additive is used
under conditions of use D through G as described in Table 2 of
3. At levels not to exceed 1.0 percent by weight of polystyrene and rubber
modified polystyrene complying with § 177.1640 of this chapter in contact
with food under conditions of use D through G as described in Table 2 of
N,N″–1,2–Ethanediylbis[N–[3–[[4,6- For use only:
bis[butyl(1,2,2,6,6-pentamethyl-4- 1. At levels not to exceed 0.06 percent by weight of olefin polymers com-
piperidinyl)amino]-1,3,5-triazin-2- plying with § 177.1520(c) of this chapter, items 1.1a, 1.1b, 1.2, or 1.3.
yl]amino]propyl]-N′,N″-dibutyl-N′,N″-bis(1,2,2,6,6- The finished polymers may only be used in contact with food of the
pentamethyl-4-piperidinyl)-1,3,5-triazine-2,4,6-tri- Types III, IV-A, V, VI-C, VII-A, and IX as described in table 1 of
amine] (CAS Reg. No. 106990–43–6). § 176.170(c) of this chapter, and under conditions of use A through H as
described in table 2 of § 176.170(c) of this chapter.
plying with § 177.1520(c) of this chapter. The finished polymers may only
be used in contact with food of the Types I, II, IV-B, VI-A, VI-B, VII-B,
and VIII as described in table 1 of § 176.170(c) of this chapter, and under
conditions of use A through H as described in table 2 of § 176.170(c) of
this chapter.
Ethylenebis(oxyethylene)-bis-(3-tert-butyl-4-hy- 1. At levels not to exceed 0.3 percent by weight of polystyrene and/or rub-
droxy-5-methylhydrocinnamate) (CAS Reg. No. ber modified polystyrene polymers complying with § 177.1640 of this
36443–68–2). chapter.
2. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene-
styrene copolymers used in accordance with applicable regulations in
parts 175, 176, 177, and 181 of this chapter.
3. At levels not to exceed 0.75 percent by weight of polyoxymethylene co-
polymers used in accordance with § 177.2470 of this chapter. The fin-
ished articles shall not be used for foods containing more than 15 per-
cent alcohol.
4. At levels not to exceed 0.25 percent by weight of polyoxymethylene
homopolymers used in accordance with § 177.2480 of this chapter. The
finished articles shall not be used for foods containing more than 15 per-
cent alcohol.
5. At levels not to exceed 0.2 percent by weight of rigid vinyl chloride plas-
tics prepared from vinyl chloride homopolymers and/or vinly chloride co-
polymers used in accordance with a prior sanction or applicable regula-
tions in parts 175, 176, and 177 of this chapter. The vinyl chloride co-
polymers shall contain not less than 50 weight percent of total polymer
units derived from vinyl chloride.
6. At levels not to exceed 0.1 percent by weight of vinylidene chloride
homopolymers and/or vinylidene chloride copolymers used in accordance
with a prior sanction or applicable regulations in parts 175, 176, and 177
of this chapter. The vinylidene chloride copolymers shall contain not less
than 50 weight percent of total polymer units derived from vinylidene

chloride.
7. In adhesives used in accordance with § 175.105 of this chapter.
383
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
2,2′-Ethylidenebis(4,6-di-tert-butylphenol) (CAS For use only:

Reg. No. 35958–30–6). 1. At levels not to exceed 0.1 percent by weight of olefin polymers com-
plying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 3.1, or 3.2
(where the polymers complying with items 3.1 and 3.2 contain primarily
polymer units derived from propylene).
plying with § 177.1520(c) of this chapter, item 2.1, 2.2, or 2.3. The fin-
ished polymers are to be used only under conditions of use B through H
plying with § 177.1520(c) of this chapter, item 2.1, 2.2, or 2.3 (where the
density of each of these polymers is not less than 0.94 g/cc) and item 3.1
or 3.2 (where each of these polymers contains primarily polymer units
derived from ethylene).
plying with § 177.1520(c) of this chapter, item 3.3, 3.4, 3.5, or 4.
5. At levels not to exceed 0.1 percent by weight of ethylene vinyl acetate
copolymers complying with § 177.1350 of this chapter and under condi-
tions of use C through G described in table 2 of § 176.170(c) of this
chapter.
6. At levels not to exceed 0.1 percent by weight of rigid or semirigid poly-
vinyl chloride and under conditions of use B through H described in table
styrene copolymers containing less than 30 percent by weight of acrylo-
nitrile and under conditions of use D through G described in table 2 of
8. At levels not to exceed 0.1 percent by weight of polystyrene complying
with § 177.1640 of this chapter and under conditions of use D through G
9. At levels not to exceed 0.2 percent by weight of rubber-modified poly-
styrene complying with § 177.1640 of this chapter.
384
2,2′-Ethylidenebis(4,6-di-tert- For use only:

butylphenyl)fluorophosphonite (CAS Reg. No. 1. As provided in § 175.105 of this chapter.
118337–09–0). 2. In all polymers used in contact with food of types I, II, IV-B, VI-A, VI-B,
VII-B, and VIII, under conditions of use B through H described in Tables
1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.25 per-
cent by weight of polymers.
3. In polypropylene complying with § 177.1520(c) of this chapter, item 1.1,
in contact with food of types III, IV-A, V, VII-A, and IX, under:
(a) Conditions of use B through H described in Tables 1 and 2 of
§ 176.170(c) of this chapter at levels not to exceed 0.25 percent by
weight of the polymer; or
(b) Condition of use A, limited to levels not to exceed 0.1 percent by weight
of the polymer; provided that the food-contact surface has an average
thickness not exceeding 375 micrometers (0.015 inch).
4. In olefin copolymers complying with § 177.1520(c) of this chapter, items
3.1a or 3.2a, and containing not less than 85 percent by weight of poly-
mer units derived from propylene, in contact with food of types III, IV-A,
V, VII-A, and IX, and under:
(a) Conditions of use C through G, described in Tables 1 and 2 of
§ 176.170(c) of this chapter, limited to levels no greater than 0.2 percent
by weight of the copolymers; or
(b) Conditions of use A, B, and H, limited to levels no greater than 0.1 per-
cent by weight of the olefin copolymers; provided that the food-contact
surface has an average thickness not exceeding 375 micrometers (0.015
inch).
5. In olefin polymers complying with § 177.1520(c) of this chapter, items 1.2
or 1.3 in contact with food of types III, IV-A, V, VII-A, and IX, under con-
ditions of use A through H, described in Tables 1 and 2 of § 176.170(c)
of this chapter at levels not to exceed 0.1 percent by weight of the poly-
mers; provided that the food-contact surface has an average thickness
not exceeding 375 micrometers (0.015 inch).
6. In polyethylene complying with § 177.1520(c) of this chapter, items 2.1 or
2.2, having a density of not less than 0.94, in contact with food of types
III, IV-A, V, VII-A, and IX, and under:
(a) Conditions of use B through H, described in Tables 1 and 2 of
§ 176.170(c) of this chapter limited to levels not to exceed 0.2 percent by
weight of the polymers; or
(b) Condition of use A, described in Tables 1 and 2 of § 176.170(c) of this
chapter, limited to levels not to exceed 0.1 percent by weight of the poly-
mer; provided that the food-contact surface has an average thickness not
exceeding 125 micrometers (0.005 inch).
7. In olefin copolymers complying with § 177.1520(c) of this chapter, items
3.1a, 3.1b, 3.2a, or 3.2b, containing not less than 85 percent by weight of
polymer units derived from ethylene and having a density of not less than
0.94, in contact with food of types III, IV-A, V, VII-A, and IX, and under:
(a) Conditions of use C through G, described in Tables 1 and 2 of
§ 176.170(c) of this chapter limited to levels not to exceed 0.2 percent by
weight of the copolymers; or
(b) Conditions of use A, B, and H, limited to levels not to exceed 0.1 per-
cent by weight of the copolymers; provided that the food-contact surface
has an average thickness not exceeding 125 micrometers (0.005 inch).
8. In olefin polymers complying with § 177.1520(c) of this chapter, items
3.1a, 3.1b, 3.2a, or 3.2b containing not less than 85 percent by weight of
polymer units derived from ethylene, in contact with food of types III, IV-
A, V, VII-A, and IX, under conditions of use A through H, as described in
Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.1
percent by weight of the copolymer; provided that the food-contact sur-
face has an average thickness not exceeding 75 micrometers (0.003
inch).
9. In polyethylene phthalate polymers complying with § 177.1630 of this
chapter in contact with food of types III, IV-A, V, VI-C, VII-A, and IX, and
under:
(a) Conditions of use B through H, described in tables 1 and 2 of
§ 176.170(c) of this chapter, limited to levels not to exceed 0.3 percent by
weight of the polymers; or
(b) Condition of use A with food of types III, IV-A, V, VII-A, and IX, and lim-
ited to levels not to exceed 0.1 percent by weight of the polymers; pro-
vided that the film thickness does not exceed 875 micrometers (0.035
inch).
Hexadecyl 3,5-di-tert-butyl-4-hydroxybenzoate For use only at levels not to exceed 0.5 percent by weight of olefin poly-
(CAS Reg. No. 67845–93–6). mers complying with § 177.1520 of this chapter.
385
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
Hexamethylenebis (3,5-di-tert-butyl-4- For use only:

hydroxyhydrocinnamate) (CAS Reg. No. 35074- 1. As provided in § 177.2470(b)(1) and § 177.2480(b)(1) of this chapter.
77-2). 2. In adhesives complying with § 175.105 of this chapter.
3. At levels not to exceed 1 percent by weight in pressure-sensitive adhe-
4. At levels not to exceed 1 percent by weight in can end cement formula-
tions complying with § 175.300(b)(3)(xxxi) of this chapter.
5. At levels not to exceed 1 percent by weight in side seam cement formu-
lations complying with § 175.300(b)(3)(xxxii) of this chapter.
6. At levels not to exceed 1 percent by weight in petroleum alicyclic hydro-
carbon resins, polyamide resins, and terpene resins complying with
7. At levels not to exceed 1 percent by weight in rosin and rosin derivatives
when used in accordance with § 176.170(a)(5) of this chapter.
8. At levels not to exceed 1 percent by weight in petroleum alicyclic hydro-
carbon resins or their hydrogenated products complying with
§ 176.170(b)(2) of this chapter.
9. At levels not to exceed 1 percent by weight in terpene resins complying
with § 175.300(b)(3)(xi) of this chapter, when such terpene resins are
used in accordance with § 176.170(b)(1) of this chapter.
10. At levels not to exceed 1 percent by weight in resins and polymers au-
thorized for use in accordance with § 176.180 of this chapter.
11. At levels not to exceed 1 percent by weight in closures with sealing
12. At levels not to exceed 1 percent by weight in rubber articles intended
for repeated use complying with § 177.2600 of this chapter.
13. At levels not to exceed 1 percent by weight in petroleum hydrocarbon
resin and rosins and rosin derivatives used in accordance with
14. At levels not to exceed 1 percent by weight in reinforced wax complying
with § 178.3850 of this chapter.
N,N′-Hexamethylenebis (3,5-di-tert-butyl-4- For use only:
hydroxyhydrocinnamamide) (CAS Reg. No. 1. At levels not to exceed 1 percent by weight of nylon resins complying
23128–74–7). with § 177.1500(b) of this chapter, items 1 through 8, that contact food
only of the types identified in categories in § 176.170(c) of this chapter,
table 1 except VI-A and VI-C.
2. At levels not to exceed 0.75 percent by weight of nylon 12 resins com-
plying with § 177.1500(b) of this chapter, item 9, that contact food only of
the types identified in categories in § 176.170(c) of this chapter, table 1,
except VI-A and VI-C.
3. At levels not to exceed 0.6 percent by weight of polyester resins com-
plying with § 175.300(b)(3)(vii) of this chapter.
5. At levels not to exceed 0.6 percent by weight of repeated use rubber ar-
ticles complying with § 177.2600 of this chapter.
6. At levels not to exceed 0.5 percent by weight of polyoxymethylene co-
polymer complying with § 177.2470 of this chapter.
homopolymer complying with § 177.2480 of this chapter.
1,6–Hexanediamine, N, N′-bis(2,2,6,6-tetramethyl- For use only as a stabilizer at levels not to exceed 0.3 percent by weight of
4-piperidinyl)-, polymers with morpholine-2,4,6- olefin polymers complying with § 177.1520(c) of this chapter. The finished
trichloro-1,3,5-triazine reaction products, polymers are to contact food only under conditions of use C, D, E, F, and
methylated (CAS Reg. No. 193098–40–7). G, as described in Table 2 of § 176.170(c) of this chapter. Provided that
the finished food-contact articles have a volume of at least 18.9 liters (5
gallons).
386
1,6-Hexanediamine, N,N’-bis(2,2,6,6-tetramethyl-4- For use only:

piperidinyl)-, polymer with 2,4,6-trichloro-1,3,5- 1. At levels not to exceed 0.5 percent by weight of propylene polymers and
triazine, reaction products with N-butyl-1- copolymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2,
butanamine and N-butyl-2,2,6,6-tetramethyl-4- 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymers may contact food only
piperidinamine (CAS Reg. No. 192268–64–7). of the types identified in § 176.170(c) of this chapter, table 1, under cat-
egories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under conditions of use
B through H described in table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 0.3 percent by weight of propylene polymers and
3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymers may contact food only
of the types identified in § 176.170(c) of this chapter, table 1, under cat-
egories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B
through H described in table 2 of § 176.170(c) of this chapter.
may contact food only of the types identified in § 176.170(c) of this chap-
ter, table 1, under categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and
under conditions of use B through H described in table 2 of § 176.170(c)
of this chapter.
may contact food only of the types identified in § 176.170(c) of this chap-
ter, table 1, under categories III, IV-A, V, VI-C, VII-A, and IX, and under
conditions of use B through H described in table 2 of § 176.170(c) of this
chapter.
polymers is less than 0.94 gram per cubic centimeter), or 5. The finished
polymers may contact food only of the types identified in § 176.170(c) of
this chapter, table 1, under categories I, II, IV-B, VI-A, VI-B, VII-B, and
VIII, and under conditions of use C through G described in table 2 of
polymers is less than 0.94 gram per cubic centimeter), or 5. The finished
polymers may contact food only of the types identified in § 176.170(c) of
this chapter, table 1, under categories III, IV-A, V, VI-C, VII-A, and IX,
and under conditions of use C through G described in table 2 of
2-Hydroxy-4-isooctoxy-benzophenone. Chemical For use only at levels not to exceed 0.5 percent by weight of olefin copoly-
Abstracts (CA) name: Methanone, [2-hydroxy-4- mers complying with § 177.1520(c) of this chapter: Items 1.1, 1.2, 1.3,
(isooctyloxy) phenyl]phenyl; CA Registry No. 2.1, 2.2, 2.3, 3.1, 3.2, 3.3 or 4: Provided, That the finished polymer con-
33059–05–1. tacts food only of the types identified in § 176.170(c) of this chapter, table
1, under Categories I, VII-B and VIII under conditions of use E, F, and G
387
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
2(2′-Hydroxy-5′-methylphenyl)benzotriazole meet- For use only:

ing the following specification: melting point 1. As component of nonfood articles complying with § 177.1010 of this
126° –132 °C (258.8° –269.6 °F) (CAS Reg. No. chapter.
2440–22–4). 2. At levels not to exceed 0.25 percent by weight of rigid polyvinyl chloride
and/or rigid vinyl chloride copolymers complying with § 177.1980 of this
chapter.
3. In polystyrene that complies with § 177.1640 of this chapter and that is
limited to use in contact with dry food of Type VIII described in table 1 of
4. At levels not to exceed 0.25 percent by weight of polystyrene and/or rub-
ber-modified polystyrene polymers complying with § 177.1640 of this
chapter intended to contact nonalcoholic food: Provided, That the finished
basic rubber-modified polystyrene polymers in contact with fatty foods
shall contain not less than 90 weight percent of total polymer units de-
rived from styrene monomer.
complying with § 177.1580 of this chapter. Provided, That the finished
polycarbonate resins contact food only of Types I, II, III, IV, V, VI-A, VI-B,
VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter and
under conditions of use E, F, and G described in table 2 of § 176.170(c)
of this chapter.
6. At levels not to exceed 0.5 percent by weight of ethylene-1,4-
cyclohexylene dimethylene terephthalate copolymers complying with
§ 177.1315 of this chapter and of ethylene phthalate polymers complying
with § 177.1630 of this chapter and that contact food only under condi-
tions of use D through G described in table 2, § 176.170(c) of this chap-
ter.
2-Hydroxy-4-n-octoxy-benzophenone ..................... For use only at levels not to exceed 0.5 percent by weight of olefin poly-
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4: Provided, That the finished polymer con-
tacts food only of the types identified in § 176.170(c) of this chapter, table
1, under Categories I, IV-B, VII-B, and VIII , and under the conditions of
use B through H described in table 2 of § 176.170(c) of this chapter.
4,4′-Isopropylidenediphenol alkyl(C12-C15) For use only at levels not exceeding 1.0 percent by weight in rigid polyvinyl
phosphites; the phosphorus content is in the chloride and/or rigid vinyl chloride copolymers complying with
range of 5.2–5.6 weight percent. §§ 177.1950, 177.1970 or 177.1980 of this chapter, and used in contact
with food, except milk, only under the conditions described in
§ 176.170(c) of this chapter, table 2, under conditions of use D through
G.
Magnesium salicylate .............................................. For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copoly-
mers complying with § 177.1980 of this chapter: Provided, That total
salicylates (calculated as the acid) do not exceed 0.3 percent by weight
of such polymers.
2-Methyl-4,6-bis-[(octylthio)methyl] phenol (CAS For use only:
Reg. No. 110553–27–0). 1. In adhesives complying with § 175.105 of this chapter.
2. At levels not to exceed 0.5 percent by weight of can-end cements and
side-seam cements complying with § 175.300(b)(xxxi) and (xxxii) of this
chapter.
3. At levels not to exceed 1 percent by weight of pressure sensitive adhe-
sives complying with § 175.125 of this chapter petrolium alicyclic hydro-
carbon resins complying with § 176.170 of this chapter, resins and poly-
mers complying with § 176.180 of this chapter, and closures with sealing
4. At levels not to exceed 1.7 percent by weight of the finished rubber prod-
ucts complying with § 177.2600 of this chapter.
drocarbon resins complying with § 175.320 of this chapter; rubber-modi-
fied polystyrene complying with § 177.1640 of this chapter; and petroleum
hydrocarbon resins and rosins and rosins and rosin derivatives complying
6. At levels not to exceed 0.2 percent by weight of styrene block polymenrs
complying with § 177.1810 of this chapter that contact food of Types I, II,
IV-B, VI, VII-B, and VIII described in table 1, § 176.170(c) of this chapter,
only under conditions of use C through H described in table 2,
388
2,2′-Methylenebis(4,6-di-tert-butylphenyl)2- For use only at levels not to exceed 0.25 percent by weight of poly-
ethylhexyl phosphite (CAS Reg. No. 126050– propylene complying with § 177.1520 of this chapter. The finished poly-
54–2). mers may only be used in contact with food of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI-B,
VII-B, and VIII under conditions of use B through H described in table 2,
§ 176.170(c) of this chapter, and with food of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-A,
VI-C, VII-A, and IX under conditions of use C through G described in
table 2, § 176.170(c) of this chapter.
2,2′-Methylenebis (6-tert-butyl-4-ethylphenol) ........ For use only:
1. In acrylonitrile-butadiene-styrene copolymers at levels not to exceed 0.6
percent by weight of the copolymer.
2. In semirigid and rigid acrylic and modified acrylic plastics complying with
§ 177.1010 of this chapter at levels not to exceed 0.1 percent by weight
of the plastic.
4,4′-Methylenebis (2,6-di-tert-butyl-phenol) ............ For use only:
1. As provided in § 175.105 of this chapter.
resins used in compliance with regulations in parts 174, 175, 176, 177,
178 and § 179.45 of this chapter.
3. At levels not to exceed 0.25 percent by weight of terpene resins used in
compliance with regulations in parts 174, 175, 176, 177, 178 and
with § 177.1520 of this chapter: Provided, That the polyethylene end
product contacts foods only of the types identified in Categories I, II, IV-
B, VI, VII-B, and VIII in table 1, § 176.170(c) of this chapter.
5. At levels not to exceed 0.5 percent by weight of polybutadiene used in
rubber articles complying with § 177.2600 of this chapter: Provided, That
the rubber end product contacts foods only of the types identified in Cat-
egories I, II, IV-B, VI, VII-B, and VIII in table 1, § 176.170(c) of this chap-
ter.
2,2′-Methylenebis(4-methyl-6-tert-butylphenol) ....... For use only:
plying with sec. 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2,
2.3, 3.1, 3.2, 3.3, or 4 used in articles that contact food of the types iden-
tified in sec. 176.170(c) of this chapter, table 1, under Categories I, II, IV-
B, VI, VII-B, and VIII.
2. At levels not to exceed 1 percent by weight of polyoxymethylene copoly-
mer as provided in sec. 177.2470(b)(1) of this chapter.
homopolymer as provided in § 177.2480(b)(1) of this chapter.
2,2′-Methylenebis(4-methyl-6-tert-butylphenol) For use only:
monoacrylate (CAS Reg. No. 61167–58–6). 1. At levels not to exceed 0.5 percent by weight of polystyrene and rubber-
modified polystyrene complying with § 177.1640 of this chapter.
2. At levels not to exceed 0.5 percent by weight of styrene block ploymers
3. At levels not to exceed 1 percent by weight of adhesives complying with
§ 175.105 of this chapter and pressure sensitive adhesives complying
styrene copolymers that comply with § 177.1020 of this chapter when
used in articles that contact food only under conditions of use E, F, and
G as described in table 2, § 176.170 (c) of this chapter.
2,2′-Methylenebis[6-(1-methylcyclo-hexyl)-p-cresol] For use only:
with § 177.1520 of this chapter: Provided, That the finished polyethylene
contacts foods only of the type identified in § 176.170(c) of this chapter,
table 1, under Categories I, II, VI-B, and VIII.
3. In polyethylene complying with § 177.1520 of this chapter: Provided, That
the finished polyethylene contacts foods only of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories III, IV, V, VI-A, VII,
and IX, and only at temperatures not to exceed room temperature: And
further provided, That percentage concentration of the antioxidant in the
polyethylene, when multiplied by the thickness in inches of the finished
polyethylene, shall not be greater than 0.0005.
2,2′-Methylenebis(4-methyl-6-nonylphenol) and For use only in acrylonitrile-butadiene-styrene copolymers used in contact
2,6-bis(2-hydroxy-3-nonyl-5-methyl-benzyl)-p- with nonalcoholic foods.
cresol mixtures (varying proportions).
389
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
Methyltin-2-mercaptoethyloleate sulfide, which is For use only in rigid poly(vinyl chloride) and rigid vinyl chloride copolymers
defined as one or more of the following: complying with §§ 177.1950 and 177.1980 of this chapter, respectively,
used in the manufacture of pipes and pipe fittings intended for contact
with water in food processing plants, at levels not to exceed:
1. 1.0 percent by weight in pipes, and
2. 2.0 percent by weight in pipe fittings.
1. 9-Octadecenoic acid (Z)-, 2-mercaptoethyl
ester, reaction products with dichlorodime
thylstannane, sodium sulfide, and
trichloromethylstannane (CAS Reg. No.
68442–12–6);
2. Fatty acids, tall oil, 2-mercaptoethyl esters,
reaction products with
dichlorodimethylstannane, 2-mercaptoethyl
decanoate, 2-mercaptoethyl octanoate, so-
dium sulfide, and trichloromethylstannane
(CAS Reg. No. 151436–98–5); or
3. Fatty acids, tall oil, 2-mercaptoethyl esters,
reaction products with
dichlorodimethylstannane, sodium sulfide,
and trichloromethylstannane (CAS Reg. No.
201687–57–2);and which has the following
specifications: Tin content (as Sn) 5 to 21
percent by weight; mercaptosulfur content 5
to 13 percent by weight; acid value no
greater than 4.
Methyltin-2-Mercaptoethyloleate sulfide may
also be used with one or more of the fol-
lowing optional substances:
1.1a 2-Mercaptoethyl oleate (CAS Reg. No.
59118–78–4),
1.1b 2-Mercaptoethyl tallate (CAS Reg. No.
68440–24–4),
1.1c 2-Mercaptoethyl octanoate (CAS Reg.
No. 57813–59–9),
1.1d 2-Mercaptoethyl decanoate (CAS Reg.
No. 68928–33–6), alone or in combination;
not to exceed 40 percent by weight of the
stabilizer formulation;
2.1 2-Mercaptoethanol (CAS Reg. No. 60–24–
2): Not to exceed 2 percent by weight of
the stabilizer formulation.
3.1 Mineral oil (CAS Reg. No. 8012–95–1):
Not to exceed 40 percent by weight of the
stabilizer formulation.
4.1 Butylated hydroxytoluene (CAS Reg. No.
128–37–0): Not to exceed 5 percent by
weight of the stabilizer formulation.
The total of the optional substances (1.1a
through 4.1) shall not exceed 60 percent by
weight of the stabilizer formulation.
Nylon 66/610/6 terpolymer (see § 177.1500 of this For use only at levels not to exceed 1.5 percent by weight of
chapter for identification) polyoxymethylene homopolymer as provided in § 177.2480 (b)(1) of this
chapter.
Nylon 612/6 copolymer. (CAS Reg. No. 51733– For use only at levels not to exceed 1.5 percent by weight of
10–9), weight ratio 6/1. polyoxymethylene homopolymer as provided in § 177.2480(b)(1).
390
Octadecyl 3,5-di-tert-butyl-4- For use only:

hydroxyhydrocinnamate (CAS Reg. No. 2082– 1. At levels not exceeding 0.25 percent by weight of olefin polymers com-
79–3). plying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 2.1, 2.2, 2.3,
3.1, 3.2, 3.3, or 4.
2. As provided in §§ 175.105 and 177.1010(a)(5) of this chapter.
3. At levels not exceeding 0.25 percent by weight of polystyrene and/or rub-
chapter, except that the finished basic rubber-modified polystyrene poly-
mers in contact with fatty foods shall contain not less than 85 weight per-
cent of total polymer units derived from styrene monomer.
styrene copolymers used in accordance with prior sanction or regulations
in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter.
5. At levels not exceeding 0.25 percent by weight of olefin copolymers com-
plying with § 177.1520(c) of this chapter, items 3.4 and 3.5 as follows: (a)
item 3.4, Provided, That the finished copolymer contacts foods only of
types identified in § 176.170(c) of this chapter, table 1, under Categories
I, II, III, IV-B, VI, VII, VIII, and IX; (b) item 3.5, Provided, That the finished
copolymer contacts non-fatty foods only of types identified in § 176.170(c)
of this chapter, table 1, under Categories I, II, IV-B, VI, VII-B, and VIII.
6. At levels not exceeding 0.05 percent by weight of modified semi-rigid
and rigid vinyl chloride plastics modified with methacrylate-butadiene-sty-
rene copolymers in accordance with § 178.3790.
7. At levels not exceeding 0.2 percent by weight of rigid polyvinyl chloride.
that comply with § 177.1580 and that contact food only under conditions
of use E, F, and G described in table 2, § 176.170(c) of this chapter.
9. At levels not exceeding 0.1 percent by weight of ethylene-vinyl acetate
copolymers complying with § 177.1350 of this chapter.
10. At levels not to exceed 0.2 percent by weight of nitrile rubber-modified
acrylonitrile-methyl acrylate copolymers that comply with § 177.1480 of
this chapter when used in articles that contact food only under conditions
of use D, E, F, and G described in table 2, § 176.170(c) of this chapter.
11. At levels not exceeding 0.3 percent by weight of styrene block polymers
complying with § 177.1810 of this chapter when used in articles that con-
tact food only of the types identified in § 176.170(c) of this chapter, table
1, under Categories I, II, IV-B, VI, VII-B, and VIII, and under conditions of
use D, E, F, and G described in table 2 of § 176.170(c) of this chapter.
12. At levels not exceeding 0.2 percent by weight of vinylidene chloride
homopolymers and/or vinylidene chloride copolymers complying with ap-
plicable regulations in parts 175, 176, 177, 179, and 181 of this chapter.
The vinylidene chloride copolymers shall contain not less than 50 weight
percent of total polymer units derived from vinylidene chloride.
13. At levels not exceeding 0.025 percent by weight of chlorinated
isobutylene-isoprene copolymers complying with § 177.1420(a)(3) of this
chapter.
14. At levels not exceeding 0.5 percent by weight of the finished rubber ar-
ticle complying with § 177.2600 of this chapter.
391
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
7-Oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21- For use only:

one,2,2,4,4-tetramethyl-,hydrochloride, reaction 1. At levels not to exceed 0.5 percent by weight of olefin polymers com-
products with epichlorohydrin, hydrolyzed, po- plying with § 177.1520 of this chapter, items 1.1, 3.1, and 3.2, where the
lymerized (CAS Reg. No. 202483–55–4). copolymers complying with items 3.1 and 3.2 contain not less than 85
weight percent of polymer units derived from propylene; in contact with
all types of food described in Table 1 of § 176.170 of this chapter, pro-
vided that the finished food-contact article will have a capacity of at least
18.9 liters (5 gallons) when in contact with food of types III, IV-A, V, VII-
A, and IX, described in Table 1 of § 176.170 of this chapter.
plying with § 177.1520 of this chapter, items 2.1, 2.2, 3.1, and 3.2, having
a density of not less than 0.94 gram/milliliter, where the copolymers com-
plying with items 3.1 and 3.2 contain not less than 85 weight percent of
polymer units derived from ethylene; in contact with food only under con-
ditions of use C, D, E, F, and G, described in Table 2 of § 176.170 of this
chapter, provided that the finished food-contact article will have a capac-
ity of at least 18.9 liters (5 gallons) when in contact with food of types III,
IV-A, V, VII-A, and IX, described in Table 1 of § 176.170 of this chapter.
plying with § 177.1520 of this chapter, items 2.1, 2.2, 3.1, 3.2, 3.3, 3.4,
3.5, 3.6, and 4.0, having a density of less than 0.94 gram/milliliter, in con-
tact with food only under conditions of use D, E, F, and G, described in
Table 2 of § 176.170 of this chapter, provided that the finished food-con-
tact article will have a capacity of at least 18.9 liters (5 gallons) except
that, films and molded articles containing not more than 0.2 percent by
weight of the stabilizer may contact aqueous food of types I, II, IV-B, VI,
and VIII, described in Table 1 of § 176.170 of this chapter with no restric-
tions on the amount of food contacted.
Oxidized bis (hydrogenated tallow alkyl) amines ..... For use only:
1. At levels not to exceed 0.1 percent by weight of polypropylene polymers
complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 3.1a
(density not less than 0.85 gram per cubic centimeter and less than 0.91
gram per cubic centimeter), 3.2b, 3.4, and 3.5. The finished polymers
may be used in contact with food types I, II, IV-B, VII-B and VIII de-
scribed in table 1 of § 176.170(c) of this chapter, under conditions of use
B through H described in table 2 of § 176.170(c) of this chapter and with
food types III, IV-A, V, VI, VII-A, and IX described in table 1 of
§ 176.170(c) of this chapter, under conditions of use D through H de-
2. At levels not to exceed 0.075 percent by weight of high-density poly-
ethylene polymers complying with § 177.1520(c) of this chapter, item 2.1,
2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.6 (density not less than 0.94 gram per cubic
centimeter), and 5. The finished polymers may be used in contact with
food types I, II, IV-B, VII-B and VIII described in table 1 of § 176.170(c) of
this chapter, under conditions of use B through H described in table 2 of
§ 176.170(c) of this chapter, and with food types III, IV-A, V, VI, VII-A and
IX described in table 1 of § 176.170(c) of this chapter, under conditions of
use D through H described in table 2 of § 176.170(c) of this chapter.
2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4- For use only:
hydroxyphenyl)propionate] (CAS Reg. No. 1. At levels not to exceed 0.5 percent by weight of polystyrene and rubber-
70331–94–1). modified polystyrene complying with § 177.1640 of this chapter.
plying with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3.
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3,
3.4, 3.5, and 4.0 that contact food Types I, II, IV-B, VI, VII-B and VIII de-
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3,
and 4.0 that contact food Types III, IV-A, V, VII-A, and IX described in
table 1 of § 176.170(c) of this chapter; except that olefin copolymers com-
plying with items 3.1 and 3.2 where the majority of polymer units are de-
rived from propylene may contain the additive at levels not to exceed 0.5
percent by weight.
plying with item 3.4 of § 177.1520(c) of this chapter, that contact food
Types III, VII-A, and IX described in table 1 of § 176.170(c) of this chap-
ter; except that olefin copolymers complying with item 3.4 where the ma-
jority of the polymer units are derived from propylene may contain the ad-
ditive at levels not to exceed 0.5 percent by weight.
392
Pentaerythritol and its stearate ester ...................... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copoly-
mers complying with § 177.1980 of this chapter: Provided, That the total
amount of pentaerythritol and/or pentaerythritol stearate (calculated as
free pentaerythritol) does not exceed 0.4 percent by weight of such poly-
mers.
N-Phenylbenzenamine reaction products with For use at levels not to exceed 0.5 percent by weight of pressure-sensitive
2,4,4-trimethylpentenes (CAS Reg. No. 68411– adhesives complying with § 175.125 of this chapter.
46–1).
Phosphoric acid triesters with triethylene glycol At levels not to exceed 0.1 percent by weight of polyethylene phthalate
(CAS Reg. No. 64502–13–2). polymers complying with § 177.1630 of this chapter, such that the poly-
mers contact foods only of Type VI-B described in table 1 of § 176.170(c)
of this chapter.
Phosphorous acid, cyclic butylethyl propanediol, For use only:
2,4,6-tri-tert-butylphenyl ester (CAS Reg. No. 1. At levels not to exceed 0.2 percent by weight of olefin polymers com-
161717–32–4), which may contain not more plying with § 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, and items
than 1 percent by weight of triisopropanolamine 2.1, 2.2, or 2.3 (where the density of these polymers is not less than 0.94
(CAS Reg. No. 122–20–3). gram per cubic centimeter), and items 3.1 or 3.2, provided that the fin-
ished polymer contacts foods of types I, II, and VI-B as described in table
1 of § 176.170(c) of this chapter only under conditions of use B, C, D, E,
F, G, and H as described in table 2 of § 176.170(c) of this chapter.
plying with § 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, that con-
tact food of types III, IV, V, VI-A, VI-C, VII, VIII, and IX as described in
table 1 of § 176.170(c) of this chapter, only under conditions of use C, D,
E, F, and G as described in table 2 of § 176.170(c) of this chapter.
plying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.2a, or 3.2b,
having a density less than 0.94 grams per cubic centimeter, in contact
with food only of types III, IV, V, VI-A, VI-C, VII, VIII, and IX and under
conditions of use B, C, D, E, F, G, and H as described in tables 1 and 2
of § 176.170(c) of this chapter; provided that the food-contact surface
does not exceed 0.003 inch (0.076 mm) in thickness.
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1(a),
3.1(b), 3.1(c), 3.2 (a), or 3.2(b), having a density not less than 0.94
grams per cubic centimeter, in contact with foods only of types III, IV, V,
VI-A, VI-C, VII, VIII, and IX identified in Table 1 of § 176.170(c) of this
chapter, and under conditions of use B through H as described in Table
2 of § 176.170(c) of this chapter; provided that the food-contact surface
does not exceed 0.003 inch (0.076 mm) in thickness.
Phosphorous acid, cyclic neopentanetetrayl For use only at levels not to exceed 0.10 percent by weight of olefin poly-
bis(2,4-di-tert-butylphenyl) ester (CAS Reg. No. mers complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 2.1,
26741–53–7) which may contain not more than 2.2, 2.3, 3.1, or 3.2, and limited to use in contact with food only under
1 percent by weight of triisopropanolamine (CAS conditions of use B, C, D, E, F, G, and H described in table 2 of
Reg. No. 122–20–3). § 176.170(c) of this chapter. Olefin polymers that contain more than 50
weight-percent of polymer units derived from ethylene shall have a den-
sity equal to or greater than 0.94 gram per cubic centimeter.
Phosphorous acid, cyclic neopentanetetrayl bis For use only:
(2,6-di-tert-butyl-4-methylphenyl)ester (CAS 1. At levels not to exceed 0.25 percent by weight of polypropylene
Reg. No. 80693–00–1). homopolymer and copolymers complying with § 177.1520 of this chapter,
for use with all food types described in table 1 of § 176.170(c) of this
chapter only under conditions of use B through H described in table 2 of
2. At levels not to exceed 0.05 percent by weight of polymers complying
with § 177.1520(c) of this chapter, item 3.1 or 3.2, and with a maximum
thickness of 100 micrometers (0.004 inch) for use with all food types
under conditions of use B, C, D, E, F, G, and H described in table 2 of
393
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
Phosphorous acid, cyclic neopentanetetrayl For use only:

bis(2,4-di-tert-butylphenyl)ester (CAS Reg. No. 1. At levels not to exceed 0.86 percent by weight in polyvinyl chloride and/
26741–53–7). or vinyl chloride copolymers that comply with §§ 177.1950, 177.1960,
177.1970, or 177.1980 of this chapter for use with all food types de-
scribed in table 1 of § 176.170(c) of this chapter, except those containing
more than 15 percent alcohol, under conditions of use B, C, D, E, F, G,
that comply with § 177.1580 of this chapter for use with all food types de-
scribed in table 1 of § 176.170(c) of this chapter, except those containing
more than 15 percent alcohol, under conditions of use B, C, D, E, F, G,
3. At levels not to exceed 0.05 percent by weight in olefin polymers com-
plying with § 177.1520(c) of this chapter, item 3.1, that contain more than
50 weight percent of polymer units derived from ethylene and whose
density is less than 0.94 gram per cubic centimeter. The average thick-
ness of such polymers intended for use in contact with food types V and
VII-A described in table 1 of § 176.170(c) of this chapter shall not exceed
80 micrometers (0.003 inch).
Poly(1,4-cyclohexylenedimethylene-3,3′- For use only:
thiodipropionate) partially terminated with stearyl 1. In polypropylene complying with § 177.1520(c) of this chapter, item 1.1,
alcohol and produced when approximately equal and used in contact with nonfatty, nonalcoholic food.
moles of 1,4-cyclohexanedimethanol and 3,3′- 2. At levels not to exceed 0.5 percent by weight of polypropylene complying
thiodipropionic acid are made to react in the with § 177.1520(c) of this chapter, item 1.1, and used in contact with
presence of stearyl alcohol so that the final fatty, nonalcoholic food. The average thickness of such polymers in the
product has an average molecular weight in the form in which they contact fatty nonalcoholic food shall not exceed 0.005
range of 1,800–2,200, as determined by vapor inch.
pressure osmometry, and has a maximum acid
value of 2.5.
Poly[(1,3-dibutyldistannthianediylidene)-1,3-dithio] For use only at levels not to exceed 0.2 by percent weight in polyvinyl chlo-
having the formula [C8H18Sn2S3]n (where n aver- ride resin where such resin constitutes not less than 98.7 percent of a
ages 1.5–2) and produced so as to meet the fol- finished semirigid or rigid polyvinyl chloride food-contact surface, pro-
lowing specifications: Softening point, 130–145 vided that the finished food-contact article is employed only to package
°C; volatile components at 150 °C, less than 1.0 meat, cheese, and food Types I, VIII, and IX as described in table 1 of
percent; sulphur (sulfide) content in the range § 176.170(c) of this chapter. The finished food-contact article containing
20.5–22.0 percent; tin content in the range this stabilizer, when extracted with refined cottonseed oil at 120 °F for 48
52.0–53.2 percent. hours, using a volume-to-surface ratio of 2 milliliters per square inch of
surface tested, shall yield tin (Sn) not to exceed 0.0005 milligram per
square inch of food-contact surface.
Poly[(6-morpholino-s-triazine-2,4-diyl)[(2,2,6,6- For use only:
tetramethyl-4-piperidyl)imino]hexamethylene 1. At levels not to exceed 0.3 percent by weight of polypropylene complying
[(2,2,6,6-tetramethyl-4-piperidyl)imino]] (CAS with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3, and of ethyl-
Reg. No. 82451–48–7). ene polymers complying with § 177.1520(c) of this chapter, items 2.1,
2.3, and 3.1, whose specific gravity is not less than 0.94. The finished
polymers are to contact food only under conditions of use D, E, F, and G
plying with § 177.1520(c) of this chapter, items 2.1, 2.3, and 3.1, whose
specific gravity is less than 0.94, and of olefin polymers complying with
items 3.3., 3.4, 3.5, and 4.0. The finished polymers are to contact food in
articles having a volume of at least 18.9 liters (5 gallons) only under con-
ditions of use D, E, F, and G described in table 2 of § 176.170(c) of this
chapter.
Poly[[6-[(1,1,3,3-tetramethybutyl) amino]-s-triazine- For use only:
2,4-diyl][2,2,6,6-tetramethyl-4- 1. At levels not to exceed 0.3 percent by weight of polypropylene complying
piperidyl)imino]hexamethylene[(2,2,6,6- with § 177.1520 of this chapter.
tetramethyl-4-piperidyl)imino]] (CAS Reg. No. 2. At levels not to exceed 0.2 percent by weight of polyethylene complying
70624–18–9). with § 177.1520 of this chapter, that has a density equal to or greater
than 0.94 gram per cubic centimeter.
3. At levels not to exceed 0.3 percent by weight of polyethylene that has a
density less than 0.94 gram per cubic centimeter complying with
§ 177.1520 of this chapter, items 2.1, 2.2, and 2.3, and of olefin polymers
and copolymers complying with items 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4.
The finished polymers are to contact food only under conditions of use B
through H described in table 2 of § 176.170(c) of this chapter, and when
contacting fatty foods of Types III, IV-A, V, VII-A, and IX described in
table 1 of § 176.170(c) of this chapter, the finished articles are to have a
volume of at least 18.9 liters (5 gallons).
394
Potassium bromide and either cupric acetate or For use at levels not exceeding 0.18 percent potassium bromide and 0.005
cupric carbonate. percent copper as cupric acetate or cupric carbonate by weight of nylon
66 resins complying with § 177.1500 of this chapter; the finished resins
are used or are intended to be used to contain foods during oven baking
or oven cooking at temperatures above 250 °F. The average thickness of
such resins in the form in which they contact food shall not exceed
0.0015 inch.
1,3-propanediamine, N,N-1,2-ethanediylbis-, poly- For use only:
mer with 2,4,6-trichloro-1,3,5-triazine, reaction 1. At levels not to exceed 0.3 percent by weight of polypropylene complying
products with N-butyl-2,2,6,6-tetramethyl-4- with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3.
piperidinamine (CAS Reg. No. 136504–96–6). 2. At levels not to exceed 0.2 percent by weight of olefin polymers having a
density greater than or equal to 0.94 grams per cubic centimeter and
complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, and
3.2.
3. At levels not to exceed 0.3 percent by weight of olefin polymers having a
density less than 0.94 grams per cubic centimeter and complying with
§ 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5,
3.6, and 4.0. The finished polymers are to contact food only under condi-
tions of use B through H described in Table 2 of § 176.170(c) of this
chapter, and when used in contact with fatty foods of Types III, IV-A, V,
VII-A, and IX as described in Table 1 of § 176.170(c) of this chapter, the
finished articles are to have a volume of at least 18.9 liters (5 gallons).
N,N′-1,3-Propanediylbis (3,5-di-tert-butyl-4- For use only at levels not to exceed 0.6 percent by weight of rubber articles
hydroxyhydrocinnamamide) (CAS Reg. No. for repeated use complying with § 177.2600 of this chapter.
69851–61–2).
Siloxanes and silicones, methyl hydrogen, reaction For use as an ultraviolet (UV) stabilizer only at levels not to exceed 0.33
products with 2,2,6,6-tetramethyl-4-(2- percent by weight of polypropylene complying with § 177.1520(c) of this
propenyloxy)piperidine (CAS Reg. No. 182635– chapter, items 1.1a, 1.1b, 1.2, and 1.3, under conditions of use D, E, F,
99–0). and G, as described in Table 2 of § 176.170 of this chapter.
Stearoylbenzoylmethane (CAS Reg. No. 58446– For use only at levels not to exceed 0.5 percent by weight of vinyl chloride
52–9) consisting of a mixture of b–diketones homopolymers modified in accordance with § 178.3790(b)(1). The fin-
produced by the condensation of acetophenone ished polymers may be used in contact with food containing up to 50 per-
and technical methyl stearate.. cent alcohol under conditions of use B through H described in table 2 of
Styrenated diphenylamine (CAS Reg. No. 68442– For use only in adhesives complying with § 175.105 of this chapter and in
68–2). rubber articles intended for repeated use complying with § 177.2600 of
this chapter.
Tetradecanoic acid, lithium salt (CAS Reg. No. For use only at levels not to exceed 0.15 percent by weight of poly-
20336–96–3). propylene and polypropylene copolymers complying with § 177.1520(c) of
this chapter, items 1.1a, 1.1b, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b. The fin-
ished polymers may only be used in contact with food of Types I, II, IV-B,
VI-B, VII-B, and VIII as described in table 1 of § 176.170(c) of this chap-
ter under conditions of use B through H as described in table 2 of
§ 176.170(c) of this chapter, and with food of Types III, IV-A, V, VI-A, VI-
C, VII-A, and IX described in table 1 of § 176.170(c) of this chapter under
conditions of use C through G as described in table 2 of § 176.170(c) of
this chapter.
2-[[2,4,8,10-Tetrakis(1,1- For use only at levels not to exceed 0.075 percent by weight of olefin co-
dimethylethyl)dibenzo[d,f][1,3,2]- polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2,
dioxaphosphepin-6-yl]oxy]-N,N-bis[2-[[2,4,8,10- 1.3, 2.1, 2.2, or 2.3: Provided, That the density of the olefin polymers
tetrakis(1,1- complying with items 2.1, 2.2, or 2.3 is not less than 0.94 gram per cubic
dimethylethy- centimeter: And further provided, That the finished polymers contact food
l)dibenzo[d,f][1,3,2]dioxaphosphepin-6- only of Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII described in table 1, of
yl]oxy]ethyl]ethanamine (CAS Reg. No. 80410– § 176.170(c) of this chapter, under conditions of use B through H de-
33–9). scribed in table 2 of § 176.170(c) of this chapter and food only of Types
III, IV-A, V, VI-C, VII-A, and IX described in table 1 of § 176.170(c) of this
chapter, under conditions of use C through G described in table 2 of
395
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
Tetrakis [methylene(3,5- di-tert-butyl-4- For use only:

hydroxyhydrocinnamate)] methane (CAS Reg. 1. At levels not to exceed 0.5 percent by weight of all polymers used as in-
No. 6683–19–8). direct additives in food packaging, except as specified below.
2. At levels not to exceed 0.1 percent by weight of petroleum wax or syn-
thetic petroleum wax complying with § 176.170(a)(5) of this chapter.
3. At levels not to exceed 1.0 percent by weight of:
(a) Pressure sensitive adhesives complying with § 175.125 of this chap-
ter.
(b) Can end cement formulations complying with § 175.300(b)(3)(xxxi) of
this chapter.
(c) Petroleum alicyclic hydrocarbon resins complying with § 175.320(b)(3)
of this chapter, § 176.170(b)(2) of this chapter, or their hydrogenated
products complying with § 176.170(b)(2) of this chapter.
(d) Rosin and rosin derivatives used in accordance with parts 175
through 178 of this chapter.
(e) Terpene resins complying with § 175.300(b)(2)(xi) of this chapter
when such terpene resins are used in accordance with § 176.170(b) of
this chapter.
(f) Resins and polymers complying with § 176.180 of this chapter.
(g) Closures with sealing gaskets complying with § 177.1210 of this chap-
ter.
(h) Polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this
chapter.
(i) Petroleum hydrocarbon resin complying with § 178.3800.
(j) Reinforced wax complying with § 178.3850.
4,4-Thiobis(6-tert-butyl-m-cresol) ............................ For use only:
with § 177.1520 of this chapter: Provided, That the specific gravity of the
polyethylene is not less than 0.926: And further provided, That the fin-
ished polyethylene contacts food only of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories I, II, VI-B, and VIII.
Thiodiethylene bis(3,5-di-tert-butyl-4- For use only:
hydroxyhydrocinnamate) (CAS Reg. No. 41484- 1. In adhesives complying with § 175.105 of this chapter.
35-9). 2. At levels not to exceed 0.5 percent by weight of pressure-sensitive adhe-
sives complying with § 175.125 of this chapter, petroleum alicyclic hydro-
carbon resins complying with § 176.170 of this chapter, resins and poly-
mers complying with § 176.180 of this chapter, closures with sealing gas-
kets complying with § 177.1210 of this chapter, and finished rubber prod-
ucts complying with § 177.2600 of this chapter.
Thiodipropionic acid.
1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4- For use only:
hydroxybenzyl) benzene (CAS Reg. No. 1709– 1. At levels not to exceed 0.5 percent by weight of polymers except nylon
70–2). resins identified in § 177.1500 of this chapter.
2. At levels not to exceed 1 percent by weight of nylon resins identified in
Tri(mixed mono-and dinonylphenyl) phosphite
(which may contain not more than 1 percent by
weight of triisopropanolamine)..
1, 11-(3, 6, 9-Trioxaundecyl) bis-3-(dodecylthio) For use only as provided in § 175.300(b)(3)(xxxi) of this chapter at 4.0 parts
propionate (CAS Reg. No. 64253–30–1). per 100 parts rubber.
1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-s-tri- For use only:
azine-2,4,6(1H,3H,5H)trione (CAS Reg. No. 1. At levels not to exceed 0.25 percent by weight of polypropylene com-
27676–62–6). plying with § 177.1520 of this chapter.
2. In polyethylene complying with § 177.1520 of this chapter:
(a) At levels not to exceed 0.1 weight percent.
(b) At levels not to exceed 0.5 weight percent in contact with nonfatty
food.
3. At levels not to exceed 0.5 percent by weight of ethylene-propylene-5-
ethylidine-2-norbornene terpolymers complying with § 177.1520 of this
chapter. The maximum thickness of such polymers in the form in which
they contact food shall not exceed 0.005 inch.
plying with § 177.1520(c) of this chapter, items 3.1, 3.2, 3.3, 3.4, or 3.5.
plying with § 177.1520(c) of this chapter, items 3.1 and 3.2, and also con-
taining not less than 85 weight percent of polymer units derived from pro-
pylene.
plying with § 177.1520(c)(4) of this chapter. The finished polymers may
be used in contact with food under conditions of use A through H de-

396
1,3,5-Tris(3,5-di-tert-butyl-4-hydro- For use only in contact with nonfatty foods:

xyhydrocinnamoyl) hexahydro-s-triazine. 1. At levels not to exceed 0.25 percent by weight of polypropylene com-
plying with § 177.1520 of this chapter.
3. At levels not to exceed 0.5 percent by weight of ethylene-propylene-5-
ethylidine-2-norbornene terpolymers complying with § 177.1520 of this
chapter. The maximum thickness of such polymers in the form in which
1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethyl- For use only:
benzyl)-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione. 1. At levels not to exceed 0.1 percent by weight of olefin polymers com-
[CAS Reg. No. 40601–76–1]. plying with § 177.1520 of this chapter, under conditions of use A through
H described in table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 0.1 percent by weight of polystyrene and rubber-
modified polystyrene that comply with § 177.1640 of this chapter, pro-
vided that the finished polystyrene and rubber-modified polystyrene con-
tact food only under the conditions described in § 176.170(c) of this chap-
ter, table 2, under conditions of use E through G.
397
§ 178.2010 21 CFR Ch. I (4–1–12 Edition)
Tris(2,4-di-tert-butylphenyl)phosphite. (CAS Reg. For use only:

No. 31570–04–4). 1. At levels not to exceed 0.5 percent by weight of elastomers used in rub-
ber articles complying with § 177.2600 of this chapter.
2. At levels not to exceed 1 percent by weight of nylon resins complying
with § 177.1500 of this chapter: Provided, That the finished polymer con-
tacts food only under conditions of use E, F, and G described in table 2
4. At levels not to exceeds 0.2 percent by weight of polystyrene and rub-
chapter: Provided, that the finished polymer contacts food only under
conditions of use B, C, D, E, F, G, and H described in table 2 of
plying with § 177.1520(c) of this chapter, item 1.1, 1.2, or 1.3.
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1(a),
3.1(b), 3.1(c), 3.2(a), or 3.2(b). The finished polymers complying with
items 2.1, 2.2, or 2.3 having a density less than 0.94 gram per cubic cen-
timeter and a thickness greater than 0.051 millimeter (0.002 inch), either
shall have a level of tris(2,4-di-tert-butylphenyl)phosphite that shall not
exceed 0.062 milligram per square inch of food-contact surface or shall
contact all food types identified in Table 1 of § 176.170(c) of this chapter
only under conditions of use E, F, and G described in Table 2 of
7. At levels not to exceed 0.2 percent by weight of ethylene-vinyl-acetate
copolymers complying with § 177.1350 of this chapter, and that are lim-
ited to use in contact with food only under conditions of use E, F, and G
described in table 2 of § 176.170(c) of this chapter. The average thick-
ness of such polymers in the form in which they contact fatty food shall
not exceed 0.1 millimeter (0.004 inch).
plying with § 177.1520(c) of this chapter, item 4. The finished polymers
having a thickness greater than 0.051 millimeter (0.002 inch), shall con-
tact food only under conditions of use E, F, and G described in table 2 of
9. At levels not to exceed 0.5 percent by weight of acrylic and modified
acrylic plastics, semirigid and rigid, complying with § 177.1010 of this
chapter.
10. At levels not to exceed 0.1 percent by weight of isobutylene polymers
12. At levels not to exceed 0.5 percent by weight of pressure sensitive ad-
hesives complying with § 175.125 of this chapter.
13. At levels not to exceed 0.5 percent by weight of can end cement formu-
lations complying with § 175.300(b)(3) (xxxi) of this chapter.
14. At levels not to exceed 0.5 percent by weight of side seam cement for-
mulations complying with § 175.300(b)(3) (xxxii) of this chapter.
drocarbon resins complying with § 175.320(b)(3) of this chapter.
drocarbon resins or their hydrogenated products complying with
§ 176.170(b) (2) of this chapter.
17. At levels not to exceed 0.5 percent by weight of resins and polymers
complying with § 176.180(b) of this chapter.
18. At levels not to exceed 0.5 percent by weight of rosins and rosin deriva-
tives complying with § 176.210(d)(3) of this chapter.
resin, and rosins and rosin derivatives complying with § 178.3800(b).
21. At levels not to exceed 0.5 percent by weight of reinforced wax com-
plying with § 178.3850.
plying with § 177.1520(c) of this chapter, item 3.3. The finished polymers
may be used in contact with food under conditions of use A through H
23. At levels not to exceed 0.15 percent by weight of poly-1-butene resins
and butene/ethylene copolymers complying with § 177.1570 of this chap-
ter: Provided, that the finished polymer contacts food only under condi-

ter.
398
Tris(2-methyl-4-hydroxy-5-tert-butylphenyl)butane For use only:

(CAS Reg. No. 1843–03–4). 1. At levels not to exceed 0.25 percent by weight of polymers used as pro-
vided in § 176.180 of this chapter.
2. At levels not to exceed 0.25 percent by weight of the following polymers
when used in articles that contact food of Types I, II, IV-B, VI-B, VII-B,
and VIII described in table 1 of § 176.170(c) of this chapter: Olefin poly-
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 or complying with other sections in parts
174, 175, 176, 177, 178 and § 179.45 of this chapter; vinyl chloride poly-
mers; and/or vinyl chloride copolymers complying with § 177.1980 of this
chapter.
3. At levels not to exceed 0.1 percent by weight of the following polymers
when used in articles that contact food of Types III, IV-A, V, VI-A, VI-C,
VII-A, and IX described in table 1 of § 176.170(c) of this chapter: Olefin
1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 or complying with other sections in
parts 174, 175, 176, 177, 178 and § 179.45 of this chapter; vinyl chloride
polymers; and/or vinyl chloride copolymers complying with § 177.1980 of
this chapter.
5. At levels not to exceed 0.2 percent by weight of polystyrene and/or modi-
fied polystyrene polymers identified in § 177.1640 of this chapter.
styrene copolymers used in contact with nonalcoholic foods.
7. At levels not to exceed 1 percent by weight of closure-sealing gasket
compositions complying with § 177.1210(b) of this chapter.
Zinc dibutyldithiocarbamate (CAS Reg. No. 136– For use only:
23–2). 1. At levels not to exceed 0.2 percent by weight of isobutyleneisoprene co-
polymers complying with § 177.1420 of this chapter: Provided, That the
finished copolymers contact food only of the types identified in
§ 176.170(c) of this chapter, table 1, under Types V, VII, VIII, and IX.
2. At levels not to exceed 0.02 percent by weight of polypropylene poly-
mers complying with § 177.1520(c), item 1.1 of this chapter.
Zinc palmitate.
Zinc salicylate .......................................................... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copoly-
mers complying with § 177.1980 of this chapter: Provided, That total
salicylates (calculated as the acid) do not exceed 0.3 percent by weight
of such polymers.
Zinc stearate.
1 Copies are available from the American Society for Testing and Materials, 1916 Race Street, Philadelphia, Pa. 19103.
[42 FR 14609, Mar. 15, 1977]

www.fdsys.gov.
§ 178.2550 4-Hydroxymethyl-2,6-di-tert- § 178.2650 Organotin stabilizers in

butylphenol. vinyl chloride plastics.
4-Hydroxymethyl-2,6-di-tert-butyl- The organotin chemicals identified in
phenol may be safely used as an anti- paragraph (a) of this section may be
oxidant in articles intended for use in safety used alone or in combination, at
contact with food, in accordance with levels not to exceed a total of 3 parts
the following prescribed conditions: per hundred of resin, as stabilizers in
(a) The additive has a solidification vinyl chloride homopolymers and co-
point of 140°–141 °C. polymers complying with the provi-
(b) The concentration of the additive sions of § 177.1950 or § 177.1980 of this
and any other permitted antioxidants chapter and that are identified for use
in the finished food-contact article in contact with food of types I, II, III,
does not exceed a total of 0.5 milligram IV (except liquid milk), V, VI (except
per square inch of food-contact surface. malt beverages and carbonated non-
alcoholic beverages), VII, VIII, and IX
described in table 1 of § 176.170(c) of this
chapter, except for the organotin

chemical identified in paragraph (a)(3)
399
§ 178.2650 21 CFR Ch. I (4–1–12 Edition)
of this section, which may be used in (3) C10-16-Alkyl mercaptoacetates re-

contact with food of types I through IX action products with
at temperatures not exceeding 75 °C dichlorodioctylstannane and
(167 °F), and further that the organotin trichlorooctylstannane (CAS Reg. No.
chemicals identified in paragraphs (a) 83447–69–2) is an organotin chemical
(5) and (6) of this section may be used mixture having 10.8 to 11.8 percent by
in contact with food of types I through weight of tin (Sn) and having 8.0 to 8.6
IX at temperatures not exceeding 66 °C percent by weight of mercapto sulfur.
(150 °F), conditions of use D through G It is made from a mixture of di(n-
described in table 2 of § 176.170(c) of this octyl)tin dichloride and (n-octyl)tin
chapter, and further that dodecyltin trichloride which has an organotin
chemicals identified in paragraph (a)(7) composition that is not less than 95
of this section which may be used in percent by weight di(n-octyl)tin dichlo-
contact with food of types I, II, III, IV ride/(n-octyl)tin trichloride, and not
(except liquid milk), V, VI (except malt more than 1.5 percent by weight of
beverages and carbonated nonalcoholic tri(n-octyl)tin chloride. The alkyl rad-
beverages), VII, VIII, and IX described ical in the mercaptoacetate is derived
in table 1 of § 176.170(c) of this chapter from a mixture of saturated n-alcohols
at temperatures not exceeding 71 °C which has a composition that is not
(160 °F), in accordance with the fol- less than 50 percent by weight
lowing prescribed conditions: tetradecyl alcohol, and that is not
more than 50 percent by weight total of
(a) For the purpose of this section,
decyl alcohol and/or dodecyl alcohol,
the organotin chemicals are those list-
and/or hexadecyl alcohol.
ed in paragraphs (a) (1), (2), (3), (4), (5),
(4) (n-Octyl)tin S,S′S″ tris(isooctyl-
(6), and (7) of this section.
mercaptoacetate) is an octyltin chem-
(1) Di(n-octyl)tin S,S′- ical having the formula n-
bis(isooctylmercaptoacetate) is an C8H17Sn(SCH2CO2C8H17)3 (CAS Reg. No.
octyltin chemical having 15.1 to 16.4 26401–86–5) having 13.4 to 14.8 percent by
percent by weight of tin (Sn) and hav- weight of tin (Sn) and having 10.9 to
ing 8.1 to 8.9 percent by weight of mer- 11.9 percent by weight of mercapto sul-
capto sulfur. It is made from di(n- fur. It is made from (n-octyl)tin tri-
octyl)tin dichloride or di(n-octyl)tin chloride. The isooctyl radical in the
oxide. The isooctyl radical in the mercaptoacetate is derived from oxo
mercaptoacetate is derived from oxo process isooctyl alcohol. The (n-
process isooctyl alcohol. Di(n-octyl)tin octyl)tin trichloride has an organotin
dichloride has an organotin composi- composition that is not less than 95
tion that is not less than 95 percent by percent by weight of (n-octyl)tin tri-
weight of di(n-octyl)tin dichloride and chloride and not more than 5 percent
not more than 5 percent by weight of by weight of tri(n-octyl)tin chloride.
tri(n-octyl)tin chloride. Di(n-octyl)tin (5) Bis(beta-carbobutoxyethyl)tin
oxide has an organotin composition bis(isooctylmercaptoacetate) (CAS
that is not less than 95 percent by Reg. No. 63397–60–4) is an estertin
weight of di(n-octyl)tin oxide and not chemical having 14.0 to 15.0 percent by
more than 5 percent by weight of weight of tin (Sn) and having 7.5 to 8.5
bis[tri(n-octyl)tin] oxide, and/or mono percent by weight of mercapto sulfur.
n-octyltin oxide. It is made from bis(beta-
(2) Di(n-octyl) tin maleate polymer is carbobutoxyethyl)tin dichloride. The
an octyltin chemical having the for- isooctyl radical in the mercaptoacetate
mula [(C8H17)2SnC4H2O4]n (where n is be- is derived from oxo process primary
tween 2 and 4 inclusive), having 25.2 to octyl alcohols. The bis(beta-
26.6 percent by weight of tin (Sn) and carbobutoxyethyl)tin dichloride has an
having a saponification number of 225 organotin composition that is not less
to 255. It is made from di(n-octyl)tin di- than 95 percent by weight of bis(beta-
chloride or di(n-octyl)tin oxide meet- carbobutoxyethyl)tin dichloride and
ing the specifications prescribed for not more than 5 percent by weight of
di(n-octyl) tin dichloride or di(n-octyl) bis(beta-carbobutoxyethyltin tri-
tin oxide in paragraph (a)(1) of this sec- chloride. The triestertin chloride con-
tion. tent of bis(beta-carbobutoxyethyltin)
400
dichloride shall not exceed 0.02 percent. cover at least three equilibrium peri-
p odic determinations, as follows:
(6) Beta-carbobutoxyethyltin (i) The exposure time for the first de-
tris(isooctylmercaptoacetate) (CAS termination shall be at least 72 hours
Reg. No. 63438–80–2) is an estertin for aqueous solvents, and at least 6
chemical having 13.0 to 14.0 percent by hours for heptane.
weight of tin (Sn) and having 10.5 to (ii) Subsequent determinations shall
11.5 percent by weight of mercapto sul- be at a minimum of 24-hour intervals
fur. It is made from beta- for aqueous solvents, and 2-hour inter-
carbobutoxyethyltin trichloride. The vals for heptane. These tests shall yield
isooctyl radical in the mercaptoacetate total octylin stabilizers not to exceed
is derived from oxo process primary 0.5 parts per million as determined by
octyl alcohol. The beta- analytical method entitled ‘‘Atomic
carbobutoxyethyltin trichloride has an Absorption Spectrometric Determina-
organotin composition that is not less tion of Sub-part-per-Million Quantities
than 95 percent by weight of beta-
of Tin in Extracts and Biological Mate-
carbobutoxyethyltin trichloride and
rials with Graphite Furnace,’’ Analyt-
not more than 5 percent total of
ical Chemistry, Vol. 49, p. 1090–1093
triestertin chloride and diestertin chlo-
(1977), which is incorporated by ref-
ride.
erence. Copies are available from the
(7) The dodecyltin stabilizer is a mix-
Center for Food Safety and Applied Nu-
ture of 50 to 60 percent by weight of n-
trition (HFS–200), Food and Drug Ad-
dodecyltin S,S′,S″-
ministration, 5100 Paint Branch Pkwy.,
tris(isooctylmercaptoacetate) (CAS
College Park, MD 20740, or available for
Reg. No. 67649–65–4) and 40 to 50 percent
inspection at the National Archives
by weight of di(n-dodecyl)tin S,S′-
di(isooctylmercaptoacetate) (CAS Reg. and Records Administration (NARA).
No. 84030–61–5) having 13 to 14 percent For information on the availability of
by weight of tin (Sn) and having 8 to 9 this material at NARA, call 202–741–
percent by weight of mercapto sulfur. 6030, or go to: http://www.archives.gov/
It is made from a mixture of dodecyltin federallregister/
trichloride and di(dodecyl)tin dichlo- codeloflfederallregulations/
ride which has not more than 0.2 per- ibrllocations.html.
cent by weight of dodecyltin tri- (iii) Subsequent determinations for
chloride, not more than 2 percent by the dodecyltin mixture described in
weight of dodecylbutyltin dichloride paragraph (a)(7) of this section shall be
and not more than 3 percent by weight at a minimum of 24-hour intervals for
of tri(dodecyl)tin chloride. The aqueous solvents and 2-hour intervals
isooctyl radical in the mercaptoacetate for heptane. These tests shall yield
is derived from oxo process primary di(n-octyl)tin S,S′-
octyl alcohols. bis(isooctylmercaptoacetate), or di(n-
(b) The vinyl chloride plastic con- octyl)tin maleate polymer, or (C10-C16)-
tainers, film or panels in the finished alkylmercaptoacetate reaction prod-
form in which they are to contact food, ucts with dichlorodioctylstannane and
shall meet the following limitations: trichlorooctylstannane, or n-octyltin
(1) The finished plastics intended for S,S′,S″-tris(isooctylmercaptoacetate),
contact with foods of the types listed tris(isooctylmercaptoacetate) and di(n-
in this section shall be extracted with dodecyl)tin
the solvent or solvents characterizing bis(isooctylmercaptoacetate) or any
those types of foods as determined combination thereof, not to exceed 0.5
from table 2 of § 176.170(c) of this chap- parts per million as determined by an
ter at the temperature reflecting the analytical method entitled ‘‘Atomic
conditions of intended use as deter- Absorption Spectrophotometric Deter-
mined therein. Additionally, extrac- mination of Sub-part-per-Million Quan-
tion tests for acidic foods shall be in- tities of Tin in Extracts and Biological
cluded and simulated by 3-percent ace- Materials with Graphite Furnace,’’ An-
tic acid at temperatures specified for alytical Chemistry, Vol. 49, pp. 1090–1093
water in table 2 of § 176.170(c) of this (1977), which is incorporated by ref-

chapter. The extraction tests shall erence in accordance with 5 U.S.C.
401
§ 178.3010 21 CFR Ch. I (4–1–12 Edition)
552(a). The availability of this incorpo- List of substances Limitations

ration by reference is given in para- 1,1,2,2-Tetra- For use only as a blowing agent ad-
graph (b)(1)(ii) of this section. chloroethylene. juvant in polystyrene at a level not
(2) In lieu of the tests prescribed in to exceed 0.3 percent by weight of
finished foamed polystyrene in-
paragraph (b) (1) of this section, the tended for use in contact with food
finished plastics intended for contact only of the types identified in
with foods only of Types II, V, VI-A § 176.170(c) of this chapter, table
1, under Categories I, II, VI, and
(except malt beverages), and VI-C may VIII.
be end-tested with food-simulating sol- Toluene ...................... For use only as a blowing agent ad-
vents, under conditions of time and juvant in polystyrene at a level not
to exceed 0.35 percent by weight
temperature, as specified below, where- of finished foamed polystyrene.
by such tests shall yield the octyltin
residues cited in paragraph (b)(1) of
[47 FR 22090, May 21, 1982, as amended at 58
this section not in excess of 0.5 ppm: FR 64895, Dec. 10, 1993]
Tem-
perature § 178.3120 Animal glue.
Time
Food-simulating solvent (degrees
(hours) Fahr- Animal glue may be safely used as a
enheit) component of articles intended for use
Type II ......... Acetic acid, 3 pct ......... 48 135
in producing, manufacturing, packing,
Type V ......... Heptane ....................... 2 100 processing, preparing, treating, pack-
Type VI-A .... Ethyl alcohol, 8 pct ...... 24 120 aging, transporting, or holding food,
Type VI-C .... Ethyl alcohol, 50 per- 24 120 subject to the provisions of this sec-
cent. tion.
(a) Animal glue consists of the pro-
[42 FR 14609, Mar. 15, 1977, as amended at 47 teinaceous extractives obtained from
FR 11847, Mar. 19, 1982; 48 FR 7170, Feb. 18, hides, bones, and other collagen-rich
1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612, substances of animal origin (excluding
Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR diseased or rotted animals), to which
62, Jan. 2, 1985; 50 FR 3510, Jan. 25, 1985; 50 FR may be added other optional adjuvant
37998, Sept. 19, 1985; 50 FR 47212, Nov. 15, 1985; substances required in its production
54 FR 24898, June 12, 1989] or added to impart desired properties.
(b) The quantity of any substance
Subpart D—Certain Adjuvants and employed in the production of animal
Production Aids glue does not exceed the amount rea-
sonably required to accomplish the in-
§ 178.3010 Adjuvant substances used in tended physical or technical effect nor
the manufacture of foamed plastics. any limitation further provided.
(c) Any substance employed in the
The following substances may be
production of animal glue and which is
safely used as adjuvants in the manu-
the subject of a regulation in parts 174,
facture of foamed plastics intended for
175, 176, 177, 178 and § 179.45 of this chap-
use in contact with food, subject to any ter conforms with any specification in
prescribed limitations: such regulation.
List of substances Limitations (d) Optional adjuvant substances em-
ployed in the production of animal glue
Azodicarbonamide ..... For use as a blowing agent in pol- include:
yethylene complying with item 2.1
in § 177.1520(c) of this chapter at
a level not to exceed 5 percent by as safe in food.
weight of finished foamed poly- (2) Substances subject to prior sanc-
ethylene. tion or approval for use in animal glue
1,1-Difluoroethane For use as a blowing agent in poly-
(CAS Reg. No. 75– styrene.
and used in accordance with such sanc-
37–6). tion or approval.
Isopentane ................. For use as a blowing agent in poly- (3) Substances identified in this para-
styrene. graph (d)(3) and subject to such limita-
n-Pentane .................. Do. tions as are provided:
402
Alum (double sulfate of aluminum and ammonium, potassium, or sodium).

4-Chloro-3-methylphenol(p-chlorome-tacresol) ............................................ For use as preservative only.
Chromium potassium sulfate (chrome alum) ............................................... For use only in glue used as a colloidal flocculant
added to the pulp suspension prior to the sheet-
forming operation in the manufacture of paper and
paper board.
3,5-Dimethyl-1,3,5,H-tetrahydrothiadia-zine-2-thione .................................. For use as preservative only.
Disodium cyanodithioimidocarbonate .......................................................... Do.
Defoaming agents ........................................................................................ As provided in § 176.210 of this chapter.
Ethanolamine.
Ethylenediamine.
Formaldehyde .............................................................................................. For use as a preservative only.
Potassium N-methyldithiocarbamate ........................................................... Do.
Potassium pentachlorophenate .................................................................... Do.
Rosins and rosin derivatives ........................................................................ As provided in § 178.3870.
Sodium chlorate.
Sodium 2-mercaptobenzothiazole ................................................................ For use as preservative only.
Sodium pentachlorophenate ........................................................................ Do.
Sodium o-phenylphenate ............................................................................. Do.
Zinc dimethyldithiocarbamate ...................................................................... Do.
Zinc 2-mercaptobenzothiazole ..................................................................... Do.
(e) The conditions of use are as fol- food-contact materials subject to the
lows: provisions of this section:
(1) The use of animal glue in any sub-
stance or article that is the subject of
a regulation in this subpart conforms Zinc hydroxy For use only as a component of resinous
with any specifications or limitations phosphite and polymeric food-contact coatings in-
(CAS Reg. tended for repeated use in contact with
prescribed by such regulation for the No. 55799– dry foods.
finished form of the substance or arti- 16–1).
cle.
(2) It is used as an adhesive or compo- [50 FR 21835, May 29, 1985]
nent of an adhesive in accordance with
the provisions of § 175.105 of this chap- § 178.3130 Antistatic and/or anti-
ter. fogging agents in food-packaging
(3) It is used as a colloidal flocculant materials.
added to the pulp suspension prior to The substances listed in paragraph
the sheet-forming operation in the (b) of this section may be safely used as
manufacture of paper and paperboard. antistatic and/or antifogging agents in
(4) It is used as a protective colloid in food-packaging materials, subject to
resinous and polymeric emulsion coat- the provisions of this section:
ings. (a) The quantity used shall not ex-
ceed the amount reasonably required
§ 178.3125 Anticorrosive agents. to accomplish the intended technical
The substances listed in this section effect.
may be used as anticorrosive agents in (b) List of substances:
N-Acyl sarcosines where the acyl group is lauroyl, oleoyl, or For use only:
derived from the combined fatty acids of coconut oil. 1. As antistatic and/or antifogging agent at levels not to exceed
a total of 0.15 pct by weight of polyolefin film used for pack-
aging meat, fresh fruits, and fresh vegetables. The average
thickness of such polyolefin film shall not exceed 0.003 inch.
2. As antistatic and/or antifogging agent at levels not to exceed
a total of 0.15 pct by weight of ethylene-vinyl acetate copoly-
mer film complying with § 177.1350 of this chapter and used
for packaging meat, fresh fruits, fresh vegetables, and dry
food of Type VIII described in table 1 of § 176.170(c) of this
chapter. The average thickness of such ethylene-vinyl ace-
tate copolymer film shall not exceed 0.003 inch when used
for packaging meat, fresh fruits, and fresh vegetables.
403
§ 178.3130 21 CFR Ch. I (4–1–12 Edition)
Alpha-(Carboxymethyl)-omega-(tetradecyloxy)polyoxyethylene) For use only as an antistatic and/or antifogging agent at levels

not to exceed 0.2 pct by weight in polyolefin film not exceed-
ing 0.001 inch thickness.
n-alkanes in the range of C10-C18 with not less than 50 per- 1. As antistatic agents at levels not to exceed 0.1 percent by
cent C14-C16). weight of polyolefin films that comply with § 177.1520 of this
chapter: Provided, that the finished olefin polymers contact
foods of Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX de-
scribed in table 1 of § 176.170(c) of this chapter, and under
conditions of use E, F, and G described in table 2 of
2. As antistatic agents at levels not to exceed 3.0 percent by
weight of polystyrene or rubber-modified polystyrene com-
plying with § 177.1640(c) of this chapter under conditions of
use B through H described in table 2 of § 176.170(c) of this
chapter.
Aluminum Borate ((9Al2O3)·2(B2O3), CAS Reg. No. 11121–16– For use only:
7) produced by reaction between aluminum oxide and/or alu- 1. At levels not to exceed 1 percent by weight of poly-
minum hydroxide with boric acid and/or metaboric acid at propylene films complying with § 177.1520(c) of this chapter,
temperatures in excess of 1000 °C. item 1.1, of polyethylene films complying with § 177.1520(c)
of this chapter, items 2.1 and 2.2 and having a density
greater than 0.94 gram per cubic centimeter, and of
polyolefin copolymer films complying with § 177.1520(c) of
this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The fin-
ished polymers may be used in contact with all food types
identified in Table 1 of § 176.170(c) of this chapter, under
conditions of use A through H as described in Table 2 of
§ 176.170(c) of this chapter. The thickness of the films shall
not exceed 0.005 inch.
2. At levels not to exceed 2 percent by weight of poly-
propylene films complying with § 177.1520(c) of this chapter,
item 1.1, of polyethylene films complying with § 177.1520(c)
of this chapter, items 2.1 and 2.2 and having a density
greater than 0.94 gram per cubic centimeter, and of
polyolefin copolymer films complying with § 177.1520(c) of
this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The fin-
ished polymers may be used in contact with all food types
identified in Table 1 of § 176.170(c) of this chapter under
conditions of use B through H as described in Table 2 of
§ 176.170(c) of this chapter. The thickness of the films shall
N,N-Bis(2-hydroxyethyl)alkyl(C12-C18)amine ............................... For use only as an antistatic agent at levels not to exceed 0.1
pct by weight of polyolefin food-contact films.
N,N-bis(2-hydroxyethyl)alkyl (C13-C15) amine (CAS Reg. No. For use only:
70955–14–5). 1. As an antistatic agent at levels not to exceed 0.2 percent by
weight in molded or extruded high-density polyethylene (hav-
ing a density ≥0.95 g/cm3 and polypropylene containers that
contact food only of the types identified in § 176.170(c) of
this chapter, Table 1, under types I, VI-B, VII-B, and VIII,
under the conditions of use E through G described in Table
2 of § 176.170(c) of this chapter, provided such foods have a
pH above 5.0.
2. As an antistatic agent at levels not to exceed 0.1 percent by
weight in molded or extruded polypropylene homopolymers
and copolymers that contact food only of the types identified
in § 176.170(c) of this chapter, Table 1, under Types II, III,
IV, V, VII-A, and IX, under the conditions of use C through G
404
N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups For use only:

(C14–C18) are derived from tallow.. 1. As an antistatic agent at levels not to exceed 0.15 pct by
weight in molded or extruded polyethylene containers that
contact food only of the types identified in § 176.170(c) of
this chapter, table 1, under Types I, IV-B, VI-B, VII-B, and
VIII, under the conditions of use E through G described in
table 2 of § 176.170(c) of this chapter provided such foods
have a pH above 5.0.
2. As an antistatic agent at levels not to exceed 0.10 mg. per
square inch of food-contact surface in vinylidene chloride co-
polymer coatings complying with § 175.320, § 177.1200, or
§ 177.1630 of this chapter, provided that such coatings con-
tact food only of the types identified in § 176.170(c) of this
chapter, table 1, under Types I, IV, VII, VIII, and IX under
the conditions of use E through G described in table 2 of
§ 176.170(c) of this chapter. The finished copolymers shall
contain at least 70 weight pct of polymer units derived from
vinylidene chloride; and shall contain not more than 5 weight
pct of total polymer units derived from acrylamide, acrylic
acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl
methacrylate, and vinyl sulfonic acid.
N,N-Bis(2-hydroxyethyl)dodecanamide produced when For use only:
diethanolamine is made to react with methyl laurate such 1. As an antistatic agent at levels not to exceed 0.5 percent by
that the finished product: Has a minimum melting point of 36 weight of molded or extruded polyethylene containers in-
°C; has a minimum amide assay of 90 percent; contains no tended for contact with honey, chocolate syrup, liquid sweet-
more than 2 percent by weight of free diethanolamine; and eners, condiments, flavor extracts and liquid flavor con-
contains no more than 0.5 percent by weight of N,N, bis(2- centrates, grated cheese, light and heavy cream, yogurt, and
hydroxyethyl)piperazine, as determined by paper chroma- foods of Type VIII as described in table 1 of § 176.170(c) of
tography method. this chapter.
2. As an antistatic agent at levels not to exceed 0.2 percent by
weight in polypropylene films complying with § 177.1520 of
this chapter, and used in contact with food of Types I, II, III,
IV, V, VI-B, VII, VIII, and IX described in table 1 of
§ 176.170(c) of this chapter, and under conditions of use B
through H described in table 2 of § 176.170(c) of this chap-
ter. The average thickness of such polypropylene film shall
not exceed 0.001 inches (30 micrometers).
N,N-Bis(2-hydroxyethyl) dodecanamide produced when For use only as an antistatic agent at levels not to exceed 0.5
diethanolamine is made to react with methyl laurate such percent by weight of molded or extruded polyethylene con-
that the finished product: Has a minimum melting point of 36 tainers intended for contact with honey, chocolate syrup, liq-
°C; has a minimum amide assay of 90 percent; contains no uid sweeteners, condiments, flavor extracts and liquid flavor
more than 2 percent by weight of free diethanolamine; and concentrates, grated cheese, light and heavy cream, yogurt,
contains no more than 0.5 percent by weight of N,N′-bis(2- and foods of Type VIII as described in table 1 of
hydroxyethyl) piperazine, as determined by paper chroma- § 176.170(c) of this chapter.
tography method.
N,N-Bis(2-hydroxyethyl) octadecylamine, Chemical Abstracts For use only as an antistatic agent at levels not to exceed 0.45
Service Registry No. 10213–78–2, N-(2-hydroxyethyl)-N- percent by weight in polypropylene films complying with
octadecylglycine (monosodium salt), Chemical Abstracts § 177.1520 of this chapter, and used for packaging food of
Service Registry No. 66810–88–6, and N,N-Bis(2-hydroxy- Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table
ethyl)-N-(carboxymethyl) octadecanaminum hydroxide (inner 1 of § 176.170(c) of this chapter, and under conditions of use
salt), Chemical Abstracts Service Registry No. 24170–14–7, B through H described in table 2 of § 176.170(c). The aver-
as the major components of a mixture prepared by reacting age thickness of such polypropylene film shall not exceed
ethylene oxide with octadecylamine and further reacting this 0.002 inch.
product with sodium monochloroacetate and sodium hydrox-
ide, such that the final product has: A nitrogen content of
3.3–3.8 percent; a melting point of 42°–50 °C; and a pH of
10.0–11.5 in a 1 percent by weight aqueous solution.
a-n-Dodecanol-omega-hydroxypoly (oxyethylene) produced by For use only as an antistatic agent at levels not to exceed 0.2
the condensation of 1 mole of n-dodecanol with an average pct by weight in low-density polyethylene film having an av-
of 9.5 moles of ethylene oxide to form a condensate having erage thickness not exceeding 0.005 inch.
a hydroxyl content of 2.7 to 2.9 pct and having a cloud point
of 80 °C to 92 °C in 1 pct by weight aqueous solution.
Glycerol ester mixtures of ricinoleic acid, containing not more As an antifogging agent at levels not exceeding 1.5 pct by
than 50 percent monoricinoleate, 45 pct diricinoleate, 10 pct weight of permitted plasticized vinyl chloride homo-and/or
triricinoleate, and 3.3 pct free glycerine. copolymers.
N-Methacryloyloxyethyl-N, N-dimethylammonium-a-N-methyl For use only as an antistatic agent at levels not to exceed 0.2
carboxylate chloride sodium salt, octadecyl methacrylate, percent by weight of polyolefin films that contact foods under
ethyl methacrylate, cyclohexyl methacrylate, N-vinyl-2- the conditions of use B through H described in table 2 of
pyrrolidone copolymer (CAS Reg. No. 66822–60–4). § 176.170(c) of this chapter. The average thickness of such
polyolefin film shall not exceed 0.02 centimeter (0.008 inch).
405
§ 178.3280 21 CFR Ch. I (4–1–12 Edition)
Octadecanoic acid 2-[2-hydroxyethyl) octadecylamino]ethyl For use only as an antistatic agent at levels such that the
ester (CAS Reg. No. 52497–24–2), (octadecylimino) diethyl- product of film thickness in microns times the weight percent
ene distearate (CAS Reg. No. 94945–28–5), and octadecyl additive does not exceed 16, in polypropylene films com-
bis(hydroxyethyl)amine (CAS Reg. No. 10213–78–2), as the plying with § 177.1520(c)1.1 of this chapter, and used for
major components of a mixture prepared by reacting ethyl- packaging food (except for food containing more than 8 per-
ene oxide with octadecylamine and further reacting this prod- cent alcohol) under conditions of use B through H described
uct with octadecanoic acid, such that the final product has: a in table 2 of § 176.170(c) of this chapter.
maximum acid value of 5 mg KOH/g and total amine value
of 86±6 mg KOH/g as determined by a method entitled
‘‘Total Amine Value,’’ which is incorporated by reference.
Copies of the method are available from the Center for Food
Safety and Applied Nutrition (HFS–200), Food and Drug Ad-
ministration, 5100 Paint Branch Pkwy., College Park, MD
20740, or available for inspection at the National Archives
[42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26, 1980; 45 FR 85727, Dec. 30, 1980;
46 FR 13688, Feb. 24, 1981; 47 FR 26824, June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457,
Aug. 21, 1991; 58 FR 57556, Oct. 26, 1993; 60 FR 54430, Oct. 24, 1995; 60 FR 18351, Apr. 11, 1995;
62 FR 31511, June 10, 1997; 63 FR 38748, July 20, 1998; 64 FR 62585, Nov. 17, 1999; 76 FR 59249,
Sept. 26, 2011]
§ 178.3280 Castor oil, hydrogenated. (a) The quantity used shall not ex-
Hydrogenated castor oil may be safe- ceed the amount reasonably required
ly used in the manufacture of articles to accomplish the intended technical
or components of articles intended for effect.
use in contact with food subject to the (b) The additive is used as follows:
provisions of this section.
Use Limitations
1. As a lubricant for vinyl chloride polymers used in the manu- For use only at levels not to exceed 4 pct by weight of vinyl
facture of articles or components of articles authorized for chloride polymers.
food-contact use.
2. As a component of cellophane ............................................... Complying with § 177.1200 of this chapter.
3. As a component of resinous and polymeric coatings ............. Complying with § 175.300 of this chapter.
4. As a component of paper and paperboard in contact with Complying with § 176.170 of this chapter.
aqueous and fatty food.
5. As a component of closures with sealing gaskets for food Complying with § 177.1210 of this chapter.
containers.
6. As a component of cross-linked polyester resins ................... Complying with § 177.2420 of this chapter.
7. As a component of olefin polymers complying with For use only at levels not to exceed 2 percent by weight of the
§ 177.1520 of this chapter. polymer.
[42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990]
§ 178.3290 Chromic chloride com- complish the intended technical effect

plexes. nor exceed 7 micrograms of chromium
Myristo chromic chloride complex per square inch of closure area.
and stearato chromic chloride complex (b) The packaging container which
may be safely used as release agents in has its closure area treated with the
the closure area of packaging con- release agent shall have a capacity of
tainers intended for use in producing, not less than 120 grams of food per
manufacturing, packing, processing, square inch of such treated closure
preparing, treating, packaging, trans- area.
porting, or holding food, subject to the
provisions of this section:
(a) The quantity used shall not ex-

ceed that reasonably required to ac-
406
§ 178.3295 Clarifying agents for poly- nents of articles intended for use in
mers. contact with food, subject to the provi-
Clarifying agents may be safely used sions of this section:
in polymers that are articles or compo-
Aluminum, hydroxybis[2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hy- For use only as a clarifying agent at levels not to exceed 0.25
droxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxidato]- percent by weight of polypropylene and polypropylene co-
(CAS Reg. No. 151841–65–5). polymers complying with § 177.1520(c) of this chapter, items
1.1, 3.1, or 3.2. The finished polymers contact food only of
types I, II, IV-B, VI-B, VII-B, and VIII as identified in Table 1
of § 176.170(c) of this chapter, under conditions of use B
through H described in Table 2 of § 176.170(c) of this chap-
ter or foods only of types III, IV-A, V, VI-A, VI-C, VII-A, and
IX as identified in Table 1 of § 176.170(c) of this chapter,
under conditions of use C through G described in Table 2 of
Bis(p-ethylbenzylidene) sorbitol (CAS Reg. No. 79072–96–1) ... For use only as a clarifying agent at a level not to exceed 0.35
percent by weight of olefin polymers complying with
§ 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.2a, or
3.2b, where the copolymers complying with items 3.1a, 3.2a,
or 3.2b contain not less than 85 weight percent of polymer
units derived from propylene.
Di(p-tolylidene) sorbitol (CAS Reg. No. 54686–97–4) ................ For use only as a clarifying agent at a level not to exceed 0.32
percent by weight in propylene homopolymer complying with
§ 177.1520(c) of this chapter, item 1.1, and in olefin copoly-
mers complying with § 177.1520(c) of this chapter, item 3.1
(containing at least 85 weight percent of polymer units de-
rived from propylene), in contact with all food types under
conditions of use C through G described in table 2 of
Dibenzylidene sorbitol (CAS Reg. No. 32647–67–9) formed by For use only as a clarifying agent for olefin polymers com-
the condensation of two moles of benzaldehyde with one plying with § 177.1520(c) 1.1, 3.1, and 3.2 of this chapter
mole of sorbitol, such that the final product has a minimum under conditions of use C, D, E, F, and G, described in table
content of 95 percent dibenzylidene sorbitol. 2 of § 176.170(c) of this chapter at a level not exceeding
0.25 percent by weight of the polymer.
Dimethyldibenzylidene sorbitol (CAS Reg. No. 135861–56–2) For use only as a clarifying agent at a level not to exceed 0.4
percent by weight of olefin polymers complying with
§ 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where
the copolymers complying with items 3.1 and 3.2 contain not
less than 85 weight percent of polymer units derived from
polypropylene. The finished polymers shall be used in con-
tact with food under conditions of use A through H described
in table 2 of § 176.170(c) of this chapter.
Polyvinylcyclohexane (CAS Reg. No. 25498–06–0) ................... For use only as a clarfiying agent for polypropylene complying
with § 177.1520(c) of this chapter, item 1.1., and in pro-
pylene containing copolymers complying with § 177.1520(c)
of this chapter, items 3.1 and 3.2, at a level not exceeding
0.1 percent by weight of the polyolefin.
Sodium di(p-tert-butylphenyl)phosphate (CAS Reg. No. 10491– For use only as a clarifying agent at a level not exceeding 0.35
31–3). parts per hundred of the resin in olefin polymers complying
with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2
(where the copolymers complying with items 3.1 and 3.2
contain not less than 85 weight percent of polymer units de-
rived from propylene).
407
§ 178.3297 21 CFR Ch. I (4–1–12 Edition)
Sodium 2,2′-methylenebis(4,6-di-tert-butylphenyl)phosphate For use only:

(CAS Reg. No. 85209–91–2). 1. As a clarifying agent at a level not exceeding 0.30 percent
by weight of olefin polymers complying with § 177.1520(c) of
this chapter, items 1.1, 3.1, or 3.2 (where the copolymers
complying with items 3.1 and 3.2 contain not less than 85
weight percent of polymer units derived from polypropylene).
The finished polymers contact foods only of types I, II, IV-B,
VI-B, VII-B, and VIII as identified in table 1 of § 176.170(c) of
this chapter and limited to conditions of use B through H, de-
scribed in table 2 of § 176.170(c), or foods of all types, lim-
ited to conditions of use C through H described in table 2 of
§ 176.170(c).
2. As a clarifying agent at levels not exceeding 0.10 percent by
weight of polypropylene complying with § 177.1520(c) of this
chapter, items 1.1(a) or 1.1(b) and of olefin polymers com-
plying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b),
3.1(c), 3.2(a), or 3.2(b) (where the copolymers contain not
less than 85 weight percent of the polymer units derived
from polypropylene.) The finished polymers shall be used in
contact with foods only under conditions of use A through H
3. As a clarifying agent at a level not exceeding 0.30 percent
by weight of olefin polymers complying with § 177.1520(c) of
this chapter, item 2.2, where the finished polymer contacts
food only of types I, II, IV-B, VI-A, VI-B, and VII-B as identi-
fied in Table 1 of § 176.170(c) of this chapter, and limited to
conditions of use B through H described in Table 2 of
§ 176.170(c) of this chapter, or foods of types III, IV-A, V, VI-
C, and VII-A as identified in Table 1 of § 176.170(c) of this
chapter and limited to conditions of use C through G de-
scribed in Table 2 of § 176.170(c) of this chapter.
[46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987; 53 FR 30049, Aug. 10, 1988;
54 FR 12432, Mar. 27, 1989; 54 FR 14734, Apr. 12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan.
11, 1991; 59 FR 13650, Mar. 23, 1994; 59 FR 25323, May 16, 1994; 61 FR 33847, July 1, 1996; 61 FR
51588, Oct. 3, 1996; 61 FR 65943, Dec. 16, 1996; 63 FR 56789, Oct. 23, 1998; 63 FR 68392, Dec. 11,
1998; 64 FR 26843, May 18, 1999; 65 FR 16316, Mar. 28, 2000]
§ 178.3297 Colorants for polymers. (b) The colorant must be used in ac-
cordance with current good manufac-
The substances listed in paragraph
turing practice, including use levels
(e) of this section may be safely used as
which are not in excess of those reason-
colorants in the manufacture of arti-
ably required to accomplish the in-
cles or components of articles intended
tended coloring effect.
for use in producing, manufacturing,
packing, processing, preparing, treat- (c) Colorants in this section must
ing, packaging, transporting, or hold- conform to the description and speci-
ing food, subject to the provisions and fications indicated. If a polymer de-
definitions set forth in this section: scribed in this section is itself the sub-
ject of a regulation promulgated under
(a) The term colorant means a dye,
section 409 of the Federal Food, Drug,
pigment, or other substance that is
and Cosmetic Act, it shall also comply
used to impart color to or to alter the
with any specifications and limitations
color of a food-contact material, but
prescribed by that regulation. Extrac-
that does not migrate to food in
tion testing guidelines to conduct stud-
amounts that will contribute to that
ies for additional uses of colorants
food any color apparent to the naked
eye. For the purpose of this section, under this section are available from
the term ‘‘colorant’’ includes sub- the Food and Drug Administration free
stances such as optical brighteners and of charge from the Center for Food
fluorescent whiteners, which may not Safety and Applied Nutrition, (HFS–
themselves be colored, but whose use is 200) Food and Drug Administration,
intended to affect the color of a food- 5100 Paint Branch Pkwy., College Park,
contact material. MD 20740.
408
(d) Color additives and their lakes chapter, may also be used as colorants
listed for direct use in foods, under the for food-contact polymers.
provisions of the color additive regula- (e) List of substances:
tions in parts 73, 74, 81, and 82 of this
Aluminum.
Aluminum hydrate.
Aluminum and potassium silicate (mica).
Aluminum mono-, di-, and tristearate.
Aluminum silicate (China clay).
4-[[5-[[[4-(Aminocarbonyl) phenyl] amino]carbonyl]- 2- For use at levels not to exceed 1 percent by weight of poly-
methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hy- mers. The finished articles are to contact foods only under
droxy-2-naphthalene-carboxamide (C.I. Pigment Red 187, conditions of use B through H described in table 2 of
CAS Reg. No. 59487–23–9). § 176.170(c) of this chapter.
N-[4-(Aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H- For use at levels not to exceed 1 percent by weight of poly-
benzimidazol-5-yl)amino]carbonyl]-2- mers. The finished articles are to contact food only under
oxopropyl]azo]benzamide (C. I. Pigment Yellow 181, CAS conditions of use B through H described in table 2 of
Reg. No. 74441–05–7). § 176.170(c) of this chapter.
Anthra(2,1,9-def:(6,5,10-d′e′f)diisoquinoline-1,3,8,10(2H,9H)- For use at levels not to exceed 1% by weight of polymers. The
tetrone (C.I. Pigment Violet 29; CAS Reg. No. 81–33–4). finished articles are to contact food only under conditions of
use B through H as described in Table 2 of § 176.170(c) of
this chapter.
Barium sulfate.
Bentonite.
Bentonite, modified with 3-dimethyldioctadecylammonium ion.
1,4-Bis[(2,4,6-trimethylphenyl)amino]-9,10-anthracenedione For use at levels not to exceed 0.0004 percent by weight of
(CAS Reg. No. 116–75–6). polyethylene phthalate polymers complying with § 177.1630
of this chapter.
3,6-Bis(4-chlorophenyl)-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4- For use only at levels not to exceed 1 percent by weight of
dione (C.I. Pigment Red 254, CAS Reg. No. 84632–65–5). polymers. The finished articles are to contact food only
under conditions of use B through H, described in table 2 of
4,4′-Bis(4-anilino-6-diethanolamine-a-triazin-2-ylamino)-2,2′-stil- For use only in the textile fibers specified in § 177.2800 of this
bene disulfonic acid, disodium salt. chapter.
4,4′-Bis(4-anilino-6-methylethanolamine-a-triazin-2-ylamino)- Do.
2,2′-stilbene disulfonic acid, disodium salt.
Burnt umber.
Calcium carbonate.
Calcium silicate.
Calcium sulfate.
Carbon black (channel process, prepared by the impingement
process from stripped natural gas).
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 1.0 percent by weight of the
yl]azo]-5-methylbenzenesulfonic acid, calcium salt (1:1); (C.I. finished polymers. The finished articles are to contact food
Pigment Yellow 191, CAS Reg. No. 129423–54–7). only under conditions of use B through H as described in
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 0.5 percent by weight of poly-
yl]azo]-5-methylbenzenesulfonic acid, diammonium salt (1:2): mers. The finished articles are to contact food under condi-
(C.I. Pigment Yellow 191:1, CAS Reg. No. 154946–66–4). tions of use A through H described in Table 2 of
Chrome antimony titanium buff rutile (C.I. Pigment Brown 24, For use at levels not to exceed 1 percent by weight of poly-
CAS Reg. No. 68186–90–3). mers. The finished articles are to contact food only under
Chromium oxide green, Cr2O3 (C.I. Pigment Green 17, C.I. No. For use only:
77288). 1. In polymers used in contact with food at a level not to ex-
ceed 5 percent by weight of the polymer, except as specified
below.
2. In olefin polymers complying with § 177.1520 of this chapter.
3. In repeat-use rubber articles complying with § 177.2600 of
this chapter; total use is not to exceed 10 percent by weight
of rubber articles.
409
§ 178.3297 21 CFR Ch. I (4–1–12 Edition)
Cobalt aluminate .......................................................................... For use only:

1. In resinous and polymeric coatings complying with § 175.300
of this chapter.
2. Melamine-formaldehyde resins in molded articles complying
3. Xylene-formaldehyde resins condensed with 4-
4′isopropylidenediphenol-epichlorohydrin epoxy resins com-
4. Ethylene-vinyl acetate copolymers complying with
5. Urea-formaldehyde resins in molded articles complying with
6. At levels not to exceed 5 percent by weight of all polymers
except those listed under limitations 1 through 5 of this item.
The finished articles are to contact food under conditions of
use A through H described in table 2 of § 176.170(c) of this
chapter.
Copper chromite black spinel (C.I. Pigment Black 28, CAS For use at levels not to exceed 5 percent by weight of poly-
Reg. No. 68186–91–4). mers. The finished articles are to contact food only under
conditions of use A through H as described in table 2 of
D&C Red No. 7 and its lakes.
Diatomaceous earth.
4,4′-Diamino-[1,1′-bianthracene]-9,9′,10,10′-tetrone (CAS Reg. For use at levels not to exceed 1 percent by weight of poly-
No. 4051–63–2). mers. The finished articles are to contact food only under
conditions of use B through H described in table 2 of
2,9-Dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. For use at levels not to exceed 1.0 percent by weight of poly-
Pigment Red 202, CAS Reg. No. 3089–17–6). mers.
4,5-Dichloro-2-((5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H- For use only:
pyrazol-4- yl)azo)benzenesulfonic acid, calcium salt(1:1), 1. At levels not to exceed 1 percent by weight of polypropylene
(C.I. Pigment Yellow 183, CAS Reg. No. 65212–77–3). polymers and copolymers complying with § 177.1520(c) of
this chapter, items 1.1a, 1.1b, 1.2, 1.3, 3.1a, 3.1b, 3.1c,
3.2a, 3.2b, 3.4, or 3.5. The finished articles are to contact
food only under conditions of use E through G, as described
in Table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 1 percent by weight of high density
polyethylene polymers and copolymers complying with
§ 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b,
3.1c, 3.2a, 3.2b, 3.6 (density not less than 0.94 grams per
cubic centimeter), or 5. The finished articles are to contact
food only under conditions of use E through G, as described
in Table 2 of § 176.170(c) of this chapter.
5-[(2,3-Dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]- For use at levels not to exceed 1 percent by weight of poly-
2,4,6(1H, 3H, 5H)-pyrimidinetrione (CAS Reg. No. 72102– mers. The finished articles are to contact food only under
84–2). conditions of use B through H described in table 2 of
2,9-Dimethylanthra(2,1,9-def:6,5,10-d′e′f′)diisoquinoline- For use at levels not to exceed 1 percent by weight of poly-
1,3,8,10(2H,9H)-tetrone (C.I. Pigment Red 179, CAS Reg. mers. The finished articles are to contact food only under
No. 5521–31–3). conditions of use B through H as described in Table 2 of
3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino(1-acetyl-2-oxo-2,1- For use at levels not to exceed 1 percent by weight of poly-
ethanediyl)azo]]bis[4-chloro-N-(5-chloro-2-methylphenyl)- mers. The finished articles are to contact food only under
benzamide] (CAS Reg. No. 5280–80–8). conditions of use B through H described in table 2 of
3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino-carbonyl(2-hydroxy- For use at levels not to exceed 1 percent by weight of poly-
3,1-naphthalenediyl) azo]] bis(4-methylbenzoic acid), bis(2- mers. The finished articles are to contact food only under
chloroethyl) ester (CAS Reg. No. 68259–05–2). conditions of use B through H described in table 2 of
2,2′-[1,2-Ethanediylbis(oxy-2,1-phenyleneazo)]bis[N-(2,3- For use at levels not to exceed 1.0 percent by weight of poly-
dihydro-2-oxo-1H-benzimidazol-5-yl)]-3-oxo-butanamide (C.I. mers. The finished articles are to contact food only under
Pigment Yellow 180, CAS Reg. No. 77804–81–0). conditions of use B through G described in table 2 of
2,2′-(1,2-Ethenediyldi-4,1-phenylene) bis(benzoxazole) (CAS For use as an optical brightener for all polymers at a level not
Reg. No. 1533–45–5). to exceed 0.025 percent by weight of polymer. The finished
polymer shall contact foods only of the types identified in
table 1 of § 176.170(c) of this chapter, under categories I, II,
IV-B, VI-A, VI-B, VII-B, and VIII at temperatures not to ex-
ceed 275 °F.
410
High-purity furnace black (CAS Reg. No. 1333–86–4) con- For use at levels not to exceed 2.5 percent by weight of the
taining total polynuclear aromatic hydrocarbons not to ex- polymer.
ceed 0.5 parts per million, and benzo[a]pyrene not to exceed
5.0 parts per billion, as determined by a method entitled
‘‘Determination of PAH Content of Carbon Black,’’ dated July
8, 1994, as developed by the Cabot Corp., which is incor-
porated by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies may be obtained from the Office of
Premarket Approval (HFS–200), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint
ined at the Center for Food Safety and Applied Nutrition’s Li-
brary, 5100 Paint Branch Pkwy., College Park, MD 20740, or
Iron oxides.
Kaolin-modified, produced by treating kaolin with a reaction For use only in olefin polymers complying with § 177.1520 of
product of isopropyl titanate and oleic acid in which 1 mole this chapter at levels not to exceed 40 percent by weight of
of isopropyl titanate is reacted with 1 to 2 moles of oleic olefin polymer.
acid. The reaction product will not exceed 8 percent of the
modified kaolin. The oleic acid used shall meet the require-
ments specified in § 172.860 of this chapter.
Magnesium oxide.
Magnesium silicate (talc).
Manganese Violet (manganese ammonium pyrophosphate; For use at levels not to exceed 2 percent by weight of poly-
CAS Reg. No. 10101–66–3).. mers. The finished articles are to contact food only under
conditions of use A through H as described in table 2 of
Mixed methylated 4,4′-bis(2-benzoxazolyl)stilbenes with the For use as an optical brightener only at levels not to exceed
major portion consisting of 4-(2-benzoxazolyl)-4′-(5-methyl-2- 0.05 percent by weight of rigid and semirigid polyvinyl chlo-
benzoxazolyl)stilbene (CAS Registry No. 5242–49–9) and ride and not to exceed 0.03 percent by weight in all other
lesser portions consisting of 4,4′-bis(5-methyl-2- polymers. The finished food-contact articles shall be used
benzoxazolyl)stilbene (CAS Registry No. 2397–00–4) and only under conditions of use D, E, F, and G described in
4,4′-bis(2-benzoxazolyl)stilbene (CAS Registry No. 1533–45– table 2 of § 176.170(c) of this chapter.
5).
7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-phenylcoumarin (CAS Reg. For use as an optical brightener only in:
No. 3333–62–8) having a melting point of 250 °C to 251 °C 1. Olefin polymers complying with § 177.1520 of this chapter
and a nitrogen content of 10.7 to 11.2 percent. only at levels such that the product of concentration of the
optical brightener (expressed in parts per million by weight of
the olefin polymer) multiplied by the thickness of the olefin
polymer (expressed in thousandths of an inch and limited to
no more than 0.400 inch) shall not exceed 500; provided
that the level of the brightener shall not exceed 20 parts per
million by weight of the olefin polymer, and further that the
olefin polymers shall comply with specifications for items 1.1,
2.1, 3.1, 3.3, and 4 of § 177.1520(c) of this chapter. The
polymer may be used under the conditions described in
§ 176.170(c) of this chapter, table 2, under conditions of use
E, F, and G.
2. Polyethylene terephthalate specified in § 177.2800(d)(5)(i) of
this chapter at a level not to exceed 0.035 percent by weight
of the finished fibers.
Nickel antimony titanium yellow rutile (C.I. Pigment Yellow 53, For use at levels not to exceed 1 percent by weight of poly-
CAS Reg. No. 8007–18–9). mers. The finished articles are to contact food only under
1,1′-[(6-Phenyl-1,3,5-triazine-2,4-diyl)diimino]bis-9,10- For use at levels not to exceed 0.25 percent by weight of poly-
anthracenedione (CAS Reg. No. 4118–16–5). ethylene phthalate polymers that comply with § 177.1630 of
this chapter. The finished articles are to contact food only
under conditions of use E, F, and G described in table 2,
§ 176.170(c) of this chapter, except, when such articles are
used with food types III, IV-A, and V, described in table 1,
§ 176.170(c) of this chapter, the finished articles are to con-
tact food only under conditions of use D, E, F, and G.
Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, 15:3,
and 15:4; C.I. No. 74160; CAS Reg. No. 147–14–8).
Phthalocyanine green (C.I. pigment green 7, C.I. No. 74260).
C.I. Pigment red 38 (C.I. No. 21120) .......................................... For use only in rubber articles for repeated use complying with
§ 177.2600 of this chapter; total use is not to exceed 10 per-
cent by weight of rubber article.
411
§ 178.3297 21 CFR Ch. I (4–1–12 Edition)
Quinacridone red (C.I. Pigment violet 19, C.I. No. 73900).

Sienna (raw and burnt).
Silica.
2,3,4,5-Tetrachloro-6-cyanobenzoic acid, methyl ester reaction For use only at levels not to exceed 1 percent by weight of
products with p-phenyllenediamine and sodium methoxide polymers. The finished articles are to contact food only
(CAS reg. No. 106276–80–6). under conditins of use B through H, described in table 2, of
4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3- For use only at levels not to exceed 1 percent by weight of
dioxo-1H-inden-2-yl)-8-quinolinyl]-1H-isoindole-1,3(2H)-dione polymers. The finished articles are to contact food only
(C. I. Pigment Yellow 138, CAS Reg. No.30125–47–4). under conditions of use C through H, as described in table 2
of § 176.170(c) of this chapter; provided further that the fin-
ished articles shall not be filled at temperatures exceeding
158 °F (70 °C).
2,2′-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg. For use as an optical brightener:
No. 7128–64–5). 1. In all polymers at levels not to exceed 0.015 percent by
weight of the polymer. The finished articles are to contact
food only under conditions of use A through H described in
2. In all polymers at levels not to exceed 0.05 percent by
weight of the polymer. The finished articles shall contact
foods only of the types identified in table 1 of § 176.170(c) of
this chapter, under Categories I, II, IV-B, VI-A, VI-B, VI-C,
VII-B, and VIII under conditions of use A through H de-
3. In adhesives complying with § 175.105 of this chapter and in
pressure-sensitive adhesives complying with § 175.125 of
this chapter.
Titanium dioxide.
Titanium dioxide-barium sulfate.
Titanium dioxide-magnesium silicate.
Ultramarines ................................................................................ As identified in § 73.2725 of this chapter.
Zinc carbonate ............................................................................. For use only:
of this chapter.
2. Melamineformaldehyde resins in molded articles complying
3. Xylene-formaldehyde resins condensed with 4-4′-
isopropylidene diphenol-epichlorohydrin epoxy resins com-
Zinc chromate .............................................................................. For use only in rubber articles for repeated use complying with
§ 177.2600 of this chapter; total use is not to exceed 10 per-
cent by weight of rubber article.
Zinc oxide .................................................................................... For use only:
of this chapter.
2. Melamine-formaldehyde resins in molded articles complying
3. Xylene-formaldehyde resins condensed with 4-4′-
isopropylidene-diphenol-epichlorohydrin epoxy resins com-
Zinc sulfide .................................................................................. For use at levels not to exceed 10 percent by weight.
[48 FR 46775, Oct. 14, 1983]

www.fdsys.gov.
412
§ 178.3300 Corrosion inhibitors used List of substances Limitations

for steel or tinplate.
Propylene glycol.
Corrosion inhibitors may be safely
used for steel or tinplate intended for § 178.3400 Emulsifiers and/or surface-
use in, or to be fabricated as, food con- active agents.
tainers or food-processing or handling
The substances listed in paragraph
equipment, subject to the provisions of
(c) of this section may be safely used as
this section.
emulsifiers and/or surface-active
(a) The corrosion inhibitors are pre- agents in the manufacture of articles
pared from substances identified in this or components of articles intended for
section and used subject to the limita- use in producing, manufacturing, pack-
tions prescribed. ing, processing, preparing, treating,
(b) The following corrosion inhibitors packaging, transporting, or holding
or adjuvants are used in amounts not food, subject to the provisions of this
to exceed those reasonably required to section.
accomplish the intended physical or (a) The quantity used shall not ex-
technical effect: ceed the amount reasonably required
(1) Corrosion inhibitors (active ingre- to accomplish the intended technical
dients) used in packaging materials for effect; and the quantity that may be-
the packaging of steel or tinplate or ar- come a component of food as a result of
ticles fabricated therefrom: such use shall not be intended to, nor
in fact, accomplish any physical or
technical effect in the food itself.
Dicyclohexylamine and its salts of (b) The use as an emulsifier and/or
fatty acids derived from animal surface-active agent in any substance
or vegetable oil. or article that is the subject of a regu-
Dicyclohexylamine nitrite.
Morpholine and its salts of fatty
lation in parts 174, 175, 176, 177, 178 and
acids derived from animal or § 179.45 of this chapter conforms with
vegetable oils. any specifications and limitations pre-
scribed by such regulation for the fin-
(2) Adjuvants employed in the appli- ished form of the substance or article.
cation and use of corrosion inhibitors: (c) List of substances:
a-Alkyl-, a-alkenyl-, and a-alkylaryl-omega- For use only at levels not to exceed 0.5 pct by weight of coat-
hydroxypoly(oxyethylene) mixture consisting of 30 weight pct ings complying with § 175.320 of this chapter and limited to
of a-(2,4,6-triisobutylphenyl)-omega- use as an emulsifier for polyhydric alcohol diesters used as
hydroxypoly(oxyethylene) having an average provided in § 178.3770(b). The weight of the finished coating
poly(oxyethylene) content of 7 moles and 70 weight pct of a shall not exceed 2 milligrams per square inch of food-contact
1:1 weight ratio mixture of a-(Z)-9-octadecenyl-omega- surface.
hydroxypoly(oxyethylene) having an average
poly(oxyethylene) content of 18 moles and a-alkyl(C16-C18)-
omega-hydroxypoly(oxyethylene) having an average
poly(oxyethylene) content of 18 moles.
n-Alkylbenzenesulfonic acid (alkyl group consisting of not less For use only as emulsifiers and/or surface active agents as
than 95 percent C10 to C16) and its ammonium, calcium, components of nonfood articles complying with §§ 175.300,
magnesium, potassium, and sodium salts. 175.320, 175.365, 175.380, 176.170, 176.180, 177.1010,
177.1200, 177.1210, 177.1630, 177.2600, and 177.2800 of
this chapter and § 178.3120.
413
§ 178.3400 21 CFR Ch. I (4–1–12 Edition)
n-alkanes in the range of C10-C18 with not less than 50 per- 1. As provided in § 176.170 of this chapter.
cent C14-C16). 2. At levels not to exceed 2 percent by weight of polyvinyl
chloride and/or vinyl chloride copolymers complying with
3. As emulsifiers in vinylidene chloride copolymer or
homopolymer coatings at levels not to exceed a total of 2.6
percent by weight of coating solids. The finished polymer
contacts food only of the Types I, II, III, IV, V, VIA, VIB, VII,
VIII, and IX as identified in table 1 of § 176.170(c) of this
chapter, and limited to conditions of use E, F, and G de-
scribed in table 2 of § 176.170 of this chapter.
4. As emulsifiers and/or surface-active agents at levels not to
exceed 3.0 percent by weight of polystyrene or rubber-modi-
fied polystyrene complying with § 177.1640(c) of this chapter
under conditions of use B through H described in table 2 of
a-Alkyl-omega-hydroxypoly(oxyethylene) produced by con-
densation of 1 mole of C11-C15 straight-chain randomly
substitued secondary alcohols with an average of 7–20
moles of ethylene oxide.
alpha Olefin sulfonate [alkyl group is in the range of C10-C18 For use only:
with not less than 50 percent C14-C16], ammonium, calcium, 1. In acrylonitrile-butadiene copolymers identified in
magnesium, potassium, and sodium salts. § 177.2600(c)(4)(i) of this chapter.
2. At levels not to exceed 1 percent by weight of acrylic coat-
ings complying with § 175.300(b)(3)(xx) of this chapter and
having a maximum thickness of 0.051 millimeter (0.002
inch). The finished polymers contact food only of the Types
V, VIII, and IX as identified in table 1 of § 176.170(c) of this
chapter.
3. At levels not to exceed 2 percent by weight of vinyl chloride
copolymer coatings having a maximum thickness of 0.051
millimeter (0.002 inch) and complying with
§ 175.300(b)(3)(xv) of this chapter. The finished polymers
contact food only of the Types V, VIII, and IX as identified in
Alpha-sulfo-omega-(dodecyloxy)poly(oxyethylene) ammonium For use only as an emulsifier at levels not to exceed 0.3 per-
salt (CAS Reg. No. 32612–48–9). cent by weight of styrene-butadiene copolymer coatings for
paper and paperboard complying with § 176.170 of this
chapter.
Ammonium salt of epoxidized oleic acid, produced from For use only:
epoxidized oleic acid (predominantly dihydroxystearic and 1. As a polymerization emulsifier at levels not to exceed 1.5
acetoxyhydroxystearic acids) meeting the following specifica- pct by weight of vinyl chloride polymers used as components
tions: Acid number 160–180, saponification number 210– of nonfood articles complying with §§ 175.105, 175.300,
235, iodine number 2–15, and epoxy groups 0–0.4 percent. 176.170, 176.180, and 177.1210 of this chapter. Such vinyl
chloride polymers are limited to polyvinyl chloride and/or
vinyl chloride copolymers complying with § 177.1980 of this
chapter.
2. As a polymerization emulsifier at levels not to exceed 1.5
pct by weight of vinyl chloride-vinyl acetate copolymers used
as components of nonfood articles complying with
§§ 175.105, 175.300, 176.170, 176.180, and 177.1210 of this
chapter.
Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent as provided in §§ 175.105,
salt (also known as butanedioic acid, sulfo-1,4-diisodecyl 175.125, 176.170, and 176.180 of this chapter.
a-Di-sec-butylphenyl-omega-hydroxypoly(oxyethylene) pro-
duced by the condensation of 1 mole of di-sec-butylphenol
with an average of 4–14 or 30–50 moles of ethylene oxide; if
a blend of products is used, the average number of moles of
ethylene oxide reacted to produce any product that is a com-
ponent of the blend shall be in the range 4–14 or 30–50;
sec-butyl groups are predominantly (90 percent or more) o-,
p-substituents.
Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49– For use only as an emulsifier at levels not to exceed 5 percent
8). by weight of polymers intended for use in coatings.
a-Dodecyl-omega-hydroxpoly (oxyethylene) mixture of dihydro-
gen phosphate and monohydrogen phosphate esters that
have an acid number (to pH 5.2) of 103–111 and that are
produced by the esterification of the condensation product of

1 mole of n-dodecyl alcohol with 4–4.5 moles of ethylene
oxide.
414
a-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) pro-

duced by the condensation of 1 mole of dodecylphenol
(dodecyl group is a propylene tetramer isomer) with an aver-
age of 4–14 or 30–50 moles of ethylene oxide; if a blend of
products is used, the average number of moles of ethylene
oxide reacted to produce any product that is a component of
the blend shall be in the range 4–14 or 30–50.
Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only:
salt (CAS Reg. No. 9084–06–4). 1. At levels not to exceed 10 micrograms/in2 (0.16 mg/dm2) in
vinylidene chloride copolymer or homopolymer coatings ap-
plied to films of propylene polymers complying with
2. At levels not to exceed 14 micrograms/in2 (0.21 mg/dm2) in
vinylidene chloride copolymer or homopolymer coatings ap-
plied to films of polyethylene phthalate polymers complying
a-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of
dihydrogen phosphate and monohydrogen phosphate esters
that have an acid number (to pH 5.2) of 49–59 and that are
produced by the esterification of a-(p-nonylphenyl)-omega-
hydroxypoly (oxyethylene) complying with the identity pre-
scribed in § 178.3400(c) and having an average
poly(oxyethylene) content of 5.5–6.5 moles.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of
produced by the esterification of ′-(p-nonylphenyl)omega-
poly(oxyethylene) content of 9–10 moles.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of
produced by the esterification of a-(p-nonylphenyl)-omega-
poly(oxyethylene) content of 45–55 moles.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced
by the condensation of 1 mole of nonylphenol (nonyl group
is a propylene trimer isomer) with an average of 4–14 or 30–
50 moles of ethylene oxide: if a blend of products is used,
the average number of moles of ethylene oxide reacted to
produce any product that is a component of the blend shall
be in the range 4–14 or 30–50.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate,
ammonium or sodium salt: the nonyl group is a propylene
trimer isomer and the poly (oxyethylene) content average 4
moles.
Polyethyleneglycol alkyl(C10-C12) ether sulfosuccinate, disodium For use only at levels not to exceed 5 percent by weight of
salt (CAS Reg. No. 68954–91–6). total monomers used in the emulsion polymerization of poly-
vinyl acetate, acrylic, and vinyl/acrylic polymers intended for
use as coatings for paper and paperboard.
Poly[(methylene-p-nonylphenoxy) poly(oxypropylene)(4–12 For use in coatings at levels not to exceed 1 mg per square
moles) propanol] of minimum molecular weight 3500. foot of food-contact surface.
Poly(oxypropylene) (45–48 moles) block polymer with For use only as a surface-active agent at levels not to exceed
poly(oxyethylene). The finished block polymers meet the fol- 0.5 percent by weight of polyolefin film or polyolefin coatings.
lowing specifications: Average molecular weight 11,000– Such polyolefin film and polyolefin coatings shall have an av-
18,000; hydroxyl number 6.2–10.2; ·cloud point above 100 erage thickness not to exceed 0.005 inch and shall be lim-
°C. for 10 pct solution. ited to use in contact with foods that have a pH above 5.0
and that contain no more than 8 pct of alcohol.
Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate)
meeting the following specifications: Saponification number
40–50, acid number 0–2, hydroxyl number 60–108, oxy-
ethylene content 70–74 pct.
Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate)
meeting the following specifications: Saponification number
41–52, oxyethylene content 66–70.5 pct.
Polysorbate 60 conforming to the identity prescribed in

415
§ 178.3450 21 CFR Ch. I (4–1–12 Edition)
Polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) meet-

ing the following specifications: Saponification number 80–
95, oxyethylene content 46–50 percent.
Sodium 1,4-dicylcohexyl sulfosuccinate.
Sodium 1,4-dihexyl sulfosuccinate.
Sodium 1,4 diisobutyl sulfosuccinate.
Sodium 1,4-dipentyl sulfosuccinate.
Sodium 1,4-ditridecyl sulfosuccinate.
Sodium monoalkylphenoxybenzenedisulfonate and sodium
dialkylphenoxybenzenedisulfonate mixtures containing not
less than 70 pct of the monoalkylated product where the
alkyl group is C8C16.
Sorbitan monolaurate meeting the following specifications. Sa-
ponification number 153–170; and hydroxyl number 330–360.
Sorbitan monooleate meeting the following specifications: Sa-
ponification number 145–160, hydroxyl number 193–210.
Sorbitan monopalmitate meeting the following specifications:
Saponification No. 140–150; and hydroxyl No. 275–305.
Sorbitan monostearate conforming to the identity prescribed in
Sorbitan trioleate meeting the following specifications: Saponi-
fication No. 170–190; and hydroxyl No. 55–70.
Sorbitan tristearate meeting the following specifications: Sa-
ponification No. 176–188; and hydroxyl No. 66–80.
Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl For use only at levels not to exceed 5 percent by weight of
ether, disodium salt (CAS Reg. No. 39354–45–5). total monomers used in the emulsion polymerization of poly-
vinyl acetate, acrylic, and vinyl/acrylic polymers intended for
use as coatings for paper and paperboard.
Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl For use only at levels not to exceed 5 percent by weight of the
ether, disodium salt (alcohol moiety produced by condensa- total coating monomers used in the emulsion polymerization
tion of 1 mole nonylphenol and an average of 9–10 moles of of polyvinyl acetate and vinyl-acrylate copolymers intended
ethylene oxide) (CAS Reg. No. 9040–38–4). for use as coatings for paper and paperboard.
a-[p-(1,1,3,3-Tetramethylbutyl)phenyl] omega-
hydroxypoly(oxyethylene) produced by the condensation of 1
mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average
of 4–14 or 30–40 moles of ethylene oxide; if a blend of prod-
ucts is used, the average number of moles of ethylene oxide
reacted to produce any product that is a component of the
blend shall be in the range 4–14 or 30–50.
Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinate For use only as a polymerization emulsifier for resins applied
to tea-bag material.
a-Tridecyl-omega-hydroxypoly (oxyethylene) mixture of di-
hydrogen phosphate and monohydrogen phosphate esters
one mole of ‘‘oxo’’ process tridecyl alcohol with 5.5–6.5
moles of ethylene oxide.
a-Tridecyl-omega-hydroxypoly (oxyethyl-ene) mixture of di-
hydrogen phosphate and monohydrogen phosphate esters
one mole of ‘‘oxo’’ process tridecyl alcohol with 9–10 moles
of ethylene oxide.
(d) The provisions of this section are Finding Aids section of the printed volume
not applicable to emulsifiers and/or and at www.fdsys.gov.
surface-active agents listed in
§ 178.3450 Esters of stearic and pal-
§ 175.105(c)(5) of this chapter and used in
mitic acids.
food-packaging adhesives complying
with § 175.105 of this chapter. The ester stearyl palmitate or
palmityl stearate or mixtures thereof
[42 FR 14609, Mar. 15, 1977] may be safely used as adjuvants in
EDITORIAL NOTE: For FEDERAL REGISTER ci- food-packaging materials when used in

CFR Sections Affected, which appears in the scribed conditions:
416
(a) They are used or intended for use www.archives.gov/federallregister/

as plasticizers or lubricants in poly- codeloflfederallregulations/
styrene intended for use in contact ibrllocations.html.
with food. (1) Synthetic fatty alcohols. (i) Hexyl,
(b) They are added to the formulated octyl, decyl, lauryl, myristyl, cetyl,
polymer prior to extrusion. and stearyl alcohols meeting the speci-
(c) The quantity used shall not ex- fications and definition prescribed in
ceed that required to accomplish the § 172.864 of this chapter, except that
intended technical effect. they may contain not more than 0.8
weight percent total diols.
§ 178.3480 Fatty alcohols, synthetic. (ii) Lauryl, myristyl, cetyl, and ste-
Synthetic fatty alcohols may be safe- aryl alcohols manufactured by the
ly used as components of articles in- process described in § 172.864(a)(2) of
tended for use in contact with food, this chapter such that lauryl and
and in synthesizing food additives and myristyl alcohols meet the specifica-
other substances permitted for use as tions in § 172.864(a)(1)(i) of this chapter,
components of articles intended for use and cetyl and stearyl alcohols meet the
in contact with food in accordance specifications in § 172.864(a)(1)(ii) of this
with the following prescribed condi- chapter.
tions: (2) Conditions of use. (i) Synthetic
(a) The food additive consists of fatty fatty alcohols as substitutes for the
alcohols meeting the specifications and corresponding naturally derived fatty
definition prescribed in § 172.864 of this alcohols permitted for use in compli-
chapter, except as provided in para- ance with § 178.3910.
graph (c) of this section. (ii) Synthetic lauryl alcohol as a sub-
(b) It is used or intended for use as stitute for the naturally derived lauryl
follows: alcohol permitted as an intermediate
(1) As substitutes for the cor- in the synthesis of sodium lauryl sul-
responding naturally derived fatty al- fate used in compliance with § 178.3400.
cohols permitted for use as components
of articles intended for use in contact [42 FR 14609, Mar. 15, 1977, as amended at 47
with food by existing regulations in FR 11847, Mar. 19, 1982; 54 FR 24898, June 12,
1989]
parts 174, 175, 176, 177, 178 and § 179.45 of
this chapter: Provided, That the use is § 178.3500 Glycerin, synthetic.
in compliance with any prescribed lim-
itations. Synthetic glycerin may be safely
(2) As substitutes for the cor- used as a component of articles in-
responding naturally derived fatty al- tended for use in packaging materials
cohols used as intermediates in the for food, subject to the provisions of
synthesis of food additives and other this section:
substances permitted for use as compo- (a) It is produced by the hydro-
nents of food-contact articles. genolysis of carbohydrates, and shall
(c) Synthetic fatty alcohols identi- contain not in excess of 0.2 percent by
fied in paragraph (c)(1) of this section weight of a mixture of butanetriols.
may contain not more than 0.8 weight (b) It is used in a quantity not to ex-
percent of total diols as determined by ceed that amount reasonably required
a method titled ‘‘Diols in Monohydroxy to produce its intended physical or
Alcohol by Miniature Thin Layer Chro- technical effect, and in accordance
matography (MTLC),’’ which is incor- with any limitations prescribed by ap-
porated by reference. Copies are avail- plicable regulations in parts 174, 175,
able from the Center for Food Safety 176, 177, 178 and 179 of this chapter. It
and Applied Nutrition (HFS–200), Food shall not be intended to, nor in fact ac-
and Drug Administration, 5100 Paint complish, any direct physical or tech-
Branch Pkwy., College Park, MD 20740, nical effect in the food itself.
or available for inspection at the Na-
tional Archives and Records Adminis- § 178.3505 Glyceryl tri-(12-acetoxy-
tration (NARA). For information on stearate).
the availability of this material at Glyceryl tri-(12-acetoxystearate)

NARA, call 202–741–6030, or go to: http:// (CAS Reg. No. 139–43–5) may be safely
417
§ 178.3520 21 CFR Ch. I (4–1–12 Edition)
used as a component of articles in- § 178.3520 Industrial starch-modified.

tended for use in producing, manufac- Industrial starch-modified may be
turing, packing, processing, preparing, safely used as a component of articles
treating, packaging, transporting, or intended for use in producing, manu-
holding food, subject to the provisions facturing, packing, processing, pre-
of this section. paring, treating, packaging, trans-
(a) The additive is applied to the sur- porting, or holding food, subject to the
face of calcium carbonate at a level not provisions of this section.
to exceed 1 weight-percent of the total (a) Industrial starch-modified is iden-
mixture. tified as follows:
(b) The calcium carbonate/glyceryl (1) A food starch-modified or starch
tri-(12-acetoxystearate) mixture is used or any combination thereof that has
as an adjuvant in polymers in contact been modified by treatment with one of
with nonfatty foods at a level not to the reactants hereinafter specified, in
exceed 20 weight-percent of the poly- an amount reasonably required to
mer. achieve the desired functional effect
but in no event in excess of any limita-
[50 FR 1503, Jan. 11, 1985] tion prescribed, with or without subse-
quent treatment as authorized in
List of reactants Limitations
Ammonium persulfate, not to exceed 0.3 pct. or in alkaline

starch not to exceed 0.6 pct..
(4-Chlorobutene-2) trimethylammonium chloride, not to exceed Industrial starch modified by this treatment shall be used only
5 pct. as internal sizing for paper and paperboard intended for food
packaging.
b-Diethylaminoethyl chloride hydrochloride, not to exceed 4 pct.
Dimethylaminoethyl methacrylate, not to exceed 3 pct.
Dimethylol ethylene urea, not to exceed 0.375 pct .................... Industrial starch modified by this treatment shall be used only
as internal sizing for paper and paperboard intended for food
packaging.
2,3-Epoxypropyltrimethylammonium chloride, not to exceed 5
pct.
Ethylene oxide, not to exceed 3 pct of reacted ethylene oxide
in finished product.
Phosphoric acid, not to exceed 6 pct and urea, not to exceed Industrial starch modified by this treatment shall be used only
20 pct. as internal sizing for paper and paperboard intended for food
packaging and as surface sizing and coating for paper and
paperboard that contact food only of Types IV-A, V, VII, VIII,
and IX described in table 1 of § 176.170(c) of this chapter.
(2) A starch irradiated under one of (ii) An electron beam source at a

the following conditions to produce maximum energy of 7 million electron
free radicals for subsequent graft po- volts of ionizing radiation, maximum
lymerization with the reactants listed absorbed dose not to exceed 5.0
in this paragraph (a)(2): megarads.
(i) Radiation from a sealed cobalt 60
source, maximum absorbed dose not to
exceed 5.0 megarads.
Acrylamide and [2-(methacryloyloxy) ethyl]trimethylammonium For use only as a retention aid and dry strength agent em-
methyl sulfate, such that the finished industrial starch-modi- ployed before the sheet-forming operation in the manufac-
fied shall contain: ture of paper and paperboard intended to contact food, and
used at a level not to exceed 0.25 pct by weight of the fin-
ished dry paper and paperboard fibers.
1. Not more than 60 weight percent vinyl copolymer (of
which not more than 32 weight percent is [2-
(methacryloyloxy)ethyl] trimethylammonium methyl sul-
fate).
418
2. Not more than 0.20 pct residual acrylamide.

3. A minimum nitrogen content of 9.0 pct.
(b) The following adjuvants may be Nonvolatile residue 0.002 gram per 100 milli-
used as surface-active agents in the liters maximum.
processing of industrial starch-modi- Synthetic isoparaffinic petroleum hydro-
fied: carbons containing antioxidants shall meet
the specified ultraviolet absorbance limits
Polyethylene glycol (400) dilaurate.
after correction for any absorbance due to
the antioxidants. The ultraviolet absorb-
Polyoxyethylene (4) lauryl ether.
ance shall be determined by the procedure
(c) To insure safe use of the indus- described for application to mineral oil
trial starch-modified, the label of the under ‘‘Specifications’’ on page 66 of the
food additive container shall bear the ‘‘Journal of the Association of Official Ag-
name of the additive ‘‘industrial ricultural Chemists,’’ Vol. 45 (February
starch-modified,’’ and in the instance 1962), which is incorporated by reference,
of an industrial starch-modified which disregarding the last sentence of that pro-
cedure. For hydrocarbons boiling below 121
is limited with respect to conditions of
°C, the nonvolatile residue shall be deter-
use, the label of the food additive con-
mined by ASTM method D1353–78, ‘‘Stand-
tainer shall contain a statement of ard Test Method for Nonvolatile Matter in
such limited use. Volatile Solvents for Use in Paint, Var-
[42 FR 14609, Mar. 15, 1977, as amended at 42 nish, Lacquer, and Related Products;’’ for
FR 49453, Sept. 27, 1977] those boiling above 121 °C, ASTM proce-
dure D381–80, ‘‘Standard Test Method for
§ 178.3530 Isoparaffinic petroleum hy- Existent Gum in Fuels by Jet Evapo-
drocarbons, synthetic. ration,’’ which are incorporated by ref-
Isoparaffinic petroleum hydro- erence. Copies may be obtained from the
American Society for Testing Materials,
carbons, synthetic, may be safely used
in the production of nonfood articles Philadelphia, PA 19428-2959, or may be ex-
intended for use in producing, manu- amined at the National Archives and
facturing, packing, processing, pre- Records Administration (NARA). For in-
paring, treating, packaging, trans- formation on the availability of this mate-
porting, or holding food, subject to the rial at NARA, call 202–741–6030, or go to:
provisions of this section. http://www.archives.gov/federallregister/
(a) The isoparaffinic petroleum hy- codeloflfederallregulations/
drocarbons, produced by synthesis from ibrllocations.html.
petroleum gases consist of a mixture of
(b) Isoparaffinic petroleum hydro-
liquid hydrocarbons meeting the fol-
carbons may contain antioxidants au-
thorized for use in food in an amount
Boiling point 63° –260 °C, as determined by not to exceed that reasonably required
ASTM method D86–82, ‘‘Standard Method to accomplish the intended technical
for Distillation of Petroleum Products,’’
which is incorporated by reference. Copies effect.
may be obtained from the American Soci- (c) Isoparaffinic petroleum hydro-
ety for Testing Materials, 100 Barr Harbor carbons are used in the production of
Dr., West Conshohocken, Philadelphia, PA nonfood articles. The quantity used
19428-2959, or may be examined at the Na- shall not exceed the amount reason-
tional Archives and Records Administra-
tion (NARA). For information on the avail-
ably required to accomplish the in-
ability of this material at NARA, call 202– tended technical effect, and the resid-
741–6030, or go to: http://www.archives.gov/ ual remaining in the finished article
federallregister/ shall be the minimum amount reason-
codeloflfederallregulations/ ably attainable.
ibrllocations.html.
Ultraviolet absorbance: [42 FR 14609, Mar. 15, 1977, as amended at 47
260–319 millimicrons—1.5 maximum. FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19,
320–329 millimicrons—0.08 maximum. 1984]
330–350 millimicrons—0.05 maximum.
419
§ 178.3570 21 CFR Ch. I (4–1–12 Edition)
§ 178.3570 Lubricants with incidental (a) The lubricants are prepared from
food contact. one or more of the following sub-
stances:
Lubricants with incidental food con-
tact may be safely used on machinery
as safe for use in food.
used for producing, manufacturing, (2) Substances used in accordance
packing, processing, preparing, treat- with the provisions of a prior sanction
ing, packaging, transporting, or hold- or approval.
ing food, subject to the provisions of (3) Substances identified in this para-
this section: graph (a)(3).
Aluminum stearoyl benzoyl hydroxide ......................................... For use only as a thickening agent in mineral oil lubricants at a
level not to exceed 10 pct by weight of the mineral oil.
N,N-Bis(2-ethylhexyl)-ar-methyl-1H-benzotriazole-1- For use as a copper deactivator at a level not to exceed 0.1
methanamine (CAS Reg. No. 94270–86–7). percent by weight of the lubricant.
BHA.
BHT.
a-Butyl-omega-hydroxypoly(oxyethylene) poly(oxypropylene) Addition to food not to exceed 10 parts per million.
produced by random condensation of a 1:1 mixture by
weight of ethylene oxide and propylene oxide with butanol;
minimum molecular weight 1,500; Chemical Abstracts Serv-
ice Registry No. 9038–95–3.
a-Butyl-omega-hydroxypoly(oxypropylene); minimum molecular Do.
weight 1,500; Chemical Abstracts Service Registry No.
9003–13–8.
Castor oil ..................................................................................... Do.
Castor oil, dehydrated ................................................................. Do.
Castor oil, partially dehydrated .................................................... Do.
Dialkyldimethylammonium aluminum silicate (CAS Reg. No. For use only as a gelling agent in mineral oil lubricants at a
68953–58–2), which may contain up to 7 percent by weight level not to exceed 15 percent by weight of the mineral oil.
1,6-hexanediol (CAS Reg. No. 629–11–8), where the alkyl
groups are derived from hydrogenated tallow fatty acids
(C14-C18) and where the aluminum silicate is derived from
bentonite.
Dimethylpolysiloxane (viscosity greater than 300 centistokes) ... Addition to food not to exceed 1 part per million.
Di (n-octyl) phosphite (CAS Reg. No. 1809–14–9) ..................... For use only as an extreme pressure-antiwear adjuvant at a
level not to exceed 0.5 percent by weight of the lubricant.
Disodium decanedioate (CAS Reg. No. 17265–14–4) ............... For use only:
1. As a corrosion inhibitor or rust preventative in mineral oil-
bentonite lubricants at a level not to exceed 2 percent by
weight of the grease.
2. As a corrosion inhibitor or rust preventative only in greases
at a level not to exceed 2 percent by weight of the grease.
Disodium EDTA (CAS Reg. No. 139–33–3) ............................... For use only as a chelating agent and sequestrant at a level
not to exceed 0.06 percent by weight of lubricant at final use
dilution.
Ethoxylated resin phosphate ester mixture consisting of the fol- For use only as a surfactant to improve lubricity in lubricating
lowing compounds: fluids complying with this section at a level not to exceed 5
percent by weight of the lubricating fluid.
1. Poly(methylene-p-tert-butyl- phenoxy)poly-(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen
phosphate esters (0 to 40 percent of the mixture). The
resin is formed by condensation of 1 mole of p-tert-
butylphenol with 2 to 4 moles of formaldehyde and sub-
sequent ethoxylation with 4 to 12 moles of ethylene
oxide;.
2. Poly(methylene-p-nonylphenoxy) poly(oxyethylene) mix-
ture of dihydrogen phosphate and monohydrogen phos-
phate esters (0 to 40 percent of the mixture). The resin
is formed by condensation of 1 mole of p-nonylphenol
with 2 to 4 moles of formaldehyde and subsequent
ethoxylation with 4 to 12 moles of ethylene oxide; and.
3. n-Tridecyl alcohol mixture of dihydrogen phosphate and
monohydrogen phosphate esters (40 to 80 percent of
the mixture; CAS Reg. No. 56831–62–0).
Fatty acids derived from animal or vegetable sources, and the
hydrogenated forms of such fatty acids.
2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol (CAS For use at levels not to exceed 0.5 percent by weight of the lu-
Reg. No. 95–38–5). bricant.

Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent
(CAS Reg. No. 35074–77–2). by weight of the lubricant.
420
a-Hydro-omega-hydroxypoly (oxyethylene) poly(oxypropylene) Addition to food not to exceed 10 parts per million.
produced by random condensation of mixtures of ethylene
oxide and propylene oxide containing 25 to 75 percent by
weight of ethylene oxide; minimum molecular weight 1,500;
Chemical Abstracts Service Registry No. 9003–11–6.
12-Hydroxystearic acid.
Isopropyl oleate ........................................................................... For use only as an adjuvant (to improve lubricity) in mineral oil
lubricants.
Magnesium ricinoleate ................................................................. For use only as an adjuvant in mineral oil lubricants at a level
not to exceed 10 percent by weight of the mineral oil.
Mineral oil .................................................................................... Addition to food not to exceed 10 parts per million.
N-Methyl-N-(1-oxo-9- octadecenyl)glycine (CAS Reg. No. 110– For use as a corrosion inhibitor at levels not to exceed 0.5 per-
25–8). cent by weight of the lubricant.
N-phenylbenzenamine, reaction products with 2,4,4- For use only as an antioxidant at levels not to exceed 0.5 per-
trimethylpentene (CAS Reg. No. 68411–46–1). cent by weight of the lubricant.
Petrolatum ................................................................................... Complying with § 178.3700. Addition to food not to exceed 10
parts per million.
Phenyl-a-and/or phenyl-b-naphthylamine ................................... For use only, singly or in combination, as antioxidant in mineral
oil lubricants at a level not to exceed a total of 1 percent by
weight of the mineral oil.
Phosphoric acid, mono- and dihexyl esters, compounds with For use only as an adjuvant at levels not to exceed 0.5 per-
tetramethylnonylamines and C11-14 alkylamines. cent by weight of the lubricant.
Phosphoric acid, mono- and diisooctyl esters, reacted with tert- For use only as a corrosion inhibitor or rust preventative
alkyl and (C12-C14) primary amines (CAS Reg. No. 68187– inlubricants at a level not to exceed 0.5 percent by weight of
67–7). the lubricant.
Phosphorothioic acid, O, O, O-triphenyl ester, tert-butyl deriva- For use only as an extreme pressure-antiwear adjuvant at a
tives (CAS Reg. No. 192268–65–8). level not to exceed 0.5 percent by weight of the lubricant.
Polyurea, having a nitrogen content of 9–14 percent based on For use only as an adjuvant in mineral oil lubricants at a level
the dry polyurea weight, produced by reacting tolylene not to exceed 10 percent by weight of the mineral oil.
diisocyanate with tall oil fatty acid (C16 and C18) amine and
ethylene diamine in a 2:2:1 molar ratio.
Polybutene (minimum average molecular weight 80,000) .......... Addition to food not to exceed 10 parts per million.
Polybutene, hydrogenated; complying with the identity pre- Do.
scribed under § 178.3740.
Polyethylene ................................................................................ Do.
Polyisobutylene (average molecular weight 35,000–140,000 For use only as a thickening agent in mineral oil lubricants.
(Flory)).
Sodium nitrite ............................................................................... For use only as a rust preventive in mineral oil lubricants at a
level not to exceed 3 percent by weight of the mineral oil.
Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydro- For use only as an antioxidant in lubricants at a level not to ex-
cinnamate)]methane (CAS Reg. No. 6683–19–8). ceed 0.5 percent by weight of the lubricant.
Thiodiethylenebis (3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent
(CAS Reg. No. 41484-35-9). by weight of the lubricant.
Tri[2(or 4)-C9-10-branched alkylphenyl]phosphorothioate (CAS For use only as an extreme pressure-antiwear adjuvant at lev-
Reg. No. 126019–82–7). els not to exceed 0.5 percent by weight of the lubricant.
Triphenyl phosphorothionate (CAS Reg. No. 597–82–0) ........... For use as an adjuvant in lubricants herein listed at a level not
to exceed 0.5 percent by weight of the lubricant.
Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. NO. 31570– For use only as a stabilizer at levels not to exceed 0.5 percent
04–4). by weight of the lubricant.
Thiodiethylenebis(3,5-di-tert-butyl-4-hydroxy-hydro- cinnamate) For use as an antioxidant at levels not to exceed 0.5 percent
(CAS Reg. No. 41484–35–9). by weight of the lubricant.
Zinc sulfide .................................................................................. For use at levels not to exceed 10 percent by weight of the lu-
bricant.
(b) The lubricants are used on food- (c) Any substance employed in the
processing equipment as a protective production of the lubricants described
antirust film, as a release agent on gas- in this section that is the subject of a
kets or seals of tank closures, and as a regulation in parts 174, 175, 176, 177, 178
lubricant for machine parts and equip- and § 179.45 of this chapter conforms
ment in locations in which there is ex- with any specification in such regula-
posure of the lubricated part to food. tion.
The amount used is the minimum re- [42 FR 14609, Mar. 15, 1977]
quired to accomplish the desired tech-
nical effect on the equipment, and the EDITORIAL NOTE: For FEDERAL REGISTER ci-
addition to food of any constituent
CFR Sections Affected, which appears in the

identified in this section does not ex- Finding Aids section of the printed volume
ceed the limitations prescribed. and at www.fdsys.gov.
421
§ 178.3600 21 CFR Ch. I (4–1–12 Edition)
§ 178.3600 Methyl glucoside-coconut oil this chapter may be used as a compo-

ester. nent of nonfood articles provided such
Methyl glucoside-coconut oil ester use complies with any applicable limi-
identified in § 172.816(a) of this chapter tations in parts 170 through 189 of this
may be safely used as a processing aid chapter. The use of white mineral oil in
(filter aid) in the manufacture of or on food itself, including the use of
starch, including industrial starch- white mineral oil as a protective coat-
modified complying with § 178.3520, in- ing or release agent for food, is subject
tended for use as a component of arti- to the provisions of § 172.878 of this
cles that contact food. chapter.
(b) Technical white mineral oil iden-
§ 178.3610 ù-Methylstyrene- tified in paragraph (b)(1) of this section
vinyltoluene resins, hydrogenated. may be used as provided in paragraph
Hydrogenated a-methylstyrene- (b)(2) of this section.
vinyltoluene copolymer resins having a (1) Technical white mineral oil con-
molar ratio of 1 a-methylstyrene to 3 sists of specially refined distillates of
vinyltoluene may be safely used as virgin petroleum or of specially refined
components of polyolefin film intended distillates that are produced syn-
for use in contact with food, subject to thetically from petroleum gases. Tech-
the following provisions: nical white mineral oil meets the fol-
(a) Hydrogenated a-methylstyrene- lowing specifications:
vinyltoluene copolymer resins have a (i) Saybolt color 20 minimum as de-
drop-softening point of 125° to 165 °C termined by ASTM method D156–82,
and a maximum absorptivity of 0.17 ‘‘Standard Test Method for Saybolt
liter per gram centimeter at 266 nano- Color of Petroleum Products (Saybolt
meters, as determined by methods ti- Chromometer Method),’’ which is in-
tled ‘‘Determination of Softening Point corporated by reference. Copies may be
(Drop Method)’’ and ‘‘Determination of obtained from the American Society
Unsaturation of Resin 1977,’’ which are for Testing Materials, 100 Barr Harbor
incorporated by reference. Copies are Dr., West Conshohocken, Philadelphia,
available from the Center for Food PA 19428-2959, or may be examined at
Safety and Applied Nutrition (HFS– the National Archives and Records Ad-
200), Food and Drug Administration, ministration (NARA). For information
5100 Paint Branch Pkwy., College Park, on the availability of this material at
MD 20740, or available for inspection at NARA, call 202–741–6030, or go to: http://
the National Archives and Records Ad- www.archives.gov/federallregister/
ministration (NARA). For information codeloflfederallregulations/
on the availability of this material at ibrllocations.html.
NARA, call 202–741–6030, or go to: http:// (ii) Ultraviolet absorbance limits as
www.archives.gov/federallregister/ follows:
ibrllocations.html. Maximum
absorb-
(b) The polyolefin film is produced ance per
Wavelength (mμ)
from olefin polymers complying with centimeter
optical
§ 177.1520 of this chapter, and the aver- pathlength
age thickness of the film in the form in
280 to 289 ........................................................... 4.0
which it contacts food does not exceed
290 to 299 ........................................................... 3.3
0.002 inch. 300 to 329 ........................................................... 2.3
330 to 350 ........................................................... 0.8
FR 11847, Mar. 19, 1982; 54 FR 24898, June 12,
1989] Technical white mineral oil containing
antioxidants shall meet the specified
§ 178.3620 Mineral oil. ultraviolet absorbance limits after cor-
Mineral oil may be safely used as a rection for any absorbance due to the
component of nonfood articles intended antioxidants. The ultraviolet absorb-
for use in contact with food, subject to ance shall be determined by the proce-
the provisions of this section: dure described for application to min-
(a) White mineral oil meeting the eral oil under ‘‘Specification’’ on page
specifications prescribed in § 172.878 of 66 of the ‘‘Journal of the Association of
422
Official Agricultural Chemists,’’ Vol- reference is given in paragraph (b)(1)(i)

ume 45 (February 1962) (which is incor- of this section.
porated by reference; copies are avail- (iii) Ultraviolet absorbance limits as
able from the Center for Food Safety follows as determined by the analytical
and Applied Nutrition (HFS–200), Food method described in paragraph (c)(3) of
and Drug Administration, 5100 Paint this section:
Branch Pkwy., College Park, MD 20740,
or available for inspection at the Na- Maximum
absorb-
tional Archives and Records Adminis- Wavelength (mμ) ance per
tration (NARA). For information on centimeter
optical
the availability of this material at pathlength
280 to 289 ........................................................... 0.7
www.archives.gov/federallregister/ 290 to 299 ........................................................... 0.6
codeloflfederallregulations/ 300 to 359 ........................................................... 0.4
ibrllocations.html.), disregarding the 360 to 400 ........................................................... .09
last two sentences of that procedure
and substituting therefor the fol- (2) The mineral oil may be used wher-
lowing: Determine the absorbance of ever mineral oil is permitted for use as
the mineral oil extract in a 10-milli- a component of nonfood articles com-
meter cell in the range from 260–350 plying with §§ 175.105 and 176.210 of this
mμ, inclusive, compared to the solvent chapter and § 178.3910 (for use only in
control. If the absorbance so measured rolling of metallic foil and sheet
exceeds 2.0 at any point in range 280–350 stock), §§ 176.200, 177.2260, 177.2600, and
mμ, inclusive, dilute the extract and 177.2800 of this chapter.
the solvent control, respectively, to (3) The analytical method for deter-
twice their volume with dimethyl sulf- mining ultraviolet absorbance limit is
oxide and remeasure the absorbance. as follows:
Multiply the remeasured absorbance
values by 2 to determine the absorb- GENERAL INSTRUCTIONS
ance of the mineral oil extract per cen- Because of the sensitivity of the test, the
timeter optical pathlength. possibility of errors arising from contamina-
(2) Technical white mineral oil may tion is great. It is of the greatest importance
be used wherever mineral oil is per- that all glassware be scrupulously cleaned to
mitted for use as a component of remove all organic matter such as oil,
grease, detergent residues, etc. Examine all
nonfood articles complying with
glassware, including stoppers and stopcocks,
§§ 175.105, 176.200, 176.210, 177.2260, under ultraviolet light to detect any residual
177.2600, and 177.2800 of this chapter and fluorescent contamination. As a pre-
§§ 178.3570 and 178.3910. cautionary measure it is recommended prac-
(3) Technical white mineral oil may tice to rinse all glassware with purified iso-
contain any antioxidant permitted in octane immediately before use. No grease is
food by regulations issued in accord- to be used on stopcocks or joints. Great care
ance with section 409 of the Act, in an to avoid contamination of oil samples in
handling and to assure absence of any extra-
amount not greater than that required
neous material arising from inadequate
to produce its intended effect. packaging is essential. Because some of the
(c) Mineral oil identified in para- polynuclear hydrocarbons sought in this test
graph (c)(1) of this section may be used are very susceptible to photo-oxidation, the
as provided in paragraph (c)(2) of this entire procedure is to be carried out under
section. subdued light.
(1) The mineral oil consists of virgin
APPARATUS
petroleum distillates refined to meet
the following specifications: Separatory funnels. 250-milliliter, 500-milli-
(i) Initial boiling point of 450 °F min- liter, 1,000-milliliter, and preferably 2,000-
imum. milliliter capacity, equipped with tetra-
fluoroethylene polymer stopcocks.
(ii) Color 5.5 maximum as determined
Reservoir. 500-milliliter capacity, equipped
by ASTM method D1500–82, ‘‘Standard with a 24/40 standard taper male fitting at
Test Method for ASTM Color of Petro- the bottom and a suitable ball-joint at the
leum Products (ASTM Color Scale),’’
top for connecting to the nitrogen supply.

which is incorporated by reference. The The male fitting should be equipped with
availability of this incorporation by glass hooks.
423
§ 178.3620 21 CFR Ch. I (4–1–12 Edition)
Chromatographic tube. 180 millimeters in REAGENTS AND MATERIALS
length, inside diameter to be 15.7 millimeters
±0.1 millimeter, equipped with a coarse, frit- Organic solvents. All solvents used through-
ted-glass disc, a tetrafluoroethylene polymer out the procedure shall meet the specifica-
stopcock, and a female 24/40 standard tapered tions and tests described in this specifica-
fitting at the opposite end. (Overall length of tion. The isooctane, benzene, acetone, and
the column with the female joint is 235 milli- methyl alcohol designated in the list fol-
meters.) The female fitting should be lowing this paragraph shall pass the fol-
equipped with glass hooks. lowing test:
Disc. Tetrafluoroethylene polymer 2-inch To the specified quantity of solvent in a
diameter disk approximately 3⁄16-inch thick 250-milliliter Erlenmeyer flask, add 1 milli-
with a hole bored in the center to closely fit liter of purified n-hexadecane and evaporate
the stem of the chromatographic tube. on the steam bath under a stream of nitro-
Suction flask. 250-milliliter or 500-milliliter gen (a loose aluminum foil jacket around the
filter flask. flask will speed evaporation). Discontinue
Condenser. 24/40 joints, fitted with a drying evaporation when not over 1 milliliter of res-
tube, length optional. idue remains. (To the residue from benzene
Evaporation flask (optional). 250-milliliter or add a 10-milliliter portion of purified iso-
500-milliliter capacity all-glass flask octane, reevaporate, and repeat once to in-
equipped with standard taper stopper having sure complete removal of benzene.)
inlet and outlet tubes to permit passage of Alternatively, the evaporation time can be
nitrogen across the surface of contained liq- reduced by using the optional evaporation
uid to be evaporated. flask. In this case the solvent and n-hexa-
Spectrophotometric cells. Fused quartz cells, decane are placed in the flask on the steam
optical path length in the range of 5,000 cen- bath, the tube assembly is inserted, and a
timeter ±0.005 centimeter; also for checking stream of nitrogen is fed through the inlet
spectrophotometer performance only, optical tube while the outlet tube is connected to a
path length in the range 1,000 centimeter solvent trap and vacuum line in such a way
±0.005 centimeter. With distilled water in the as to prevent any flow-back of condensate
cells, determine any absorbance differences. into the flask.
Spectrophotometer. Spectral range 250 milli- Dissolve the 1 milliliter of hexadecane res-
microns—400 millimicrons with spectral slit idue in isooctane and make to 25 milliliters
width of 2 millimicrons or less; under instru- volume. Determine the absorbance in the 5-
ment operating conditions for these absorb- centimeter path length cells compared to
ance measurements, the spectrophotometer isooctane as reference. The absorbance of the
shall also meet the following performance solution of the solvent residue (except for
requirements: methyl alcohol) shall not exceed 0.01 per cen-
Absorbance repeatability, ±0.01 at 0.4 ab- timeter path length between 280 and 400 mμ.
sorbance. For methyl alcohol this absorbance value
Absorbance accuracy 1 ±0.05 at 0.4 absorb- shall be 0.00.
ance. Isooctane (2,2,4-trimethylpentane). Use 180
Wavelength accuracy, ±1.0 millimicron. milliliters for the test described in the pre-
Nitrogen cylinder. Water-pumped or equiva- ceding paragraph. Purify, if necessary, by
lent purity nitrogen in cylinder equipped passage through a column of activated silica
with regulator and valve to control flow at 5 gel (Grade 12, Davison Chemical Company,
p.s.i.g. Baltimore, Maryland, or equivalent) about 90
centimeters in length and 5 centimeters to 8
1 As determined by procedure using potas- centimeters in diameter.
sium chromate for reference standard and Benzene, A.C.S. reagent grade. Use 150 milli-
described in National Bureau of Standards liters for the test. Purify, if necessary, by
Circular 484, Spectrophotometry, U.S. De- distillation or otherwise.
partment of Commerce (1949). The accuracy Acetone, A.C.S. reagent grade. Use 200 milli-
is to be determined by comparison with the liters for the test. Purify, if necessary, by
standard values at 290, 345, and 400 milli- distillation.
microns. Circular 484 is incorporated by ref- Eluting mixtures:
erence. Copies are available from the Center 1. 10 percent benzene in isooctane. Pipet 50
for Food Safety and Applied Nutrition (HFS– milliliters of benzene into a 250-milliliter
200), Food and Drug Administration, 5100 glass-stoppered volumetric flask and adjust
Paint Branch Pkwy., College Park, MD 20740, to volume with isooctane, with mixing.
or available for inspection at the National 2. 20 percent benzene in isooctane. Pipet 50
Archives and Records Administration milliliters of benzene into a 250-milliliter
(NARA). For information on the availability glass-stoppered volumetric flask and adjust
of this material at NARA, call 202–741–6030, to volume with isooctane, with mixing.
or go to: http://www.archives.gov/ 3. Acetone-benzene-water mixture. Add 20

federallregister/codeloflfederallregulations/ milliliters of water to 380 milliliters of ace-
ibrllocations.html. tone and 200 milliliters of benzene, and mix.
424
n-Hexadecane, 99-percent olefin-free. Dilute meter to 2 centimeters thick. Reheat the
1.0 milliliter of n-hexadecane to 25 milliliters mixture at 160 °C ±1 °C for 2 hours, and store
with isooctane and determine the absorbance in a tightly closed flask.
in a 5-centimeter cell compared to isooctane Sodium sulfate, anhydrous, A.C.S. reagent
as reference point between 280 mμ–400 mμ. grade, preferably in granular form. For each
The absorbance per centimeter path length bottle of sodium sulfate reagent used, estab-
shall not exceed 0.00 in this range. Purify, if lish as follows the necessary sodium sulfate
necessary, by percolation through activated prewash to provide such filters required in
silica gel or by distillation. the method: Place approximately 35 grams of
Methyl alcohol, A.C.S. reagent grade. Use anhydrous sodium sulfate in a 30-milliliter
10.0 milliliters of methyl alcohol. Purify, if course, fritted-glass funnel or in a 65-milli-
necessary, by distillation. meter filter funnel with glass wool plug;
Dimethyl sulfoxide. Spectrophotometric wash with successive 15-milliliter portions of
grade (Crown Zellerbach Corporation, the indicated solvent until a 15-milliliter
Camas, Washington, or equivalent). Absorb- portion of the wash shows 0.00 absorbance
ance (1-centimeter cell, distilled water ref- per centimeter path length between 280 mμ
erence, sample completely saturated with ni- and 400 mμ when tested as prescribed under
trogen). ‘‘Organic solvents.’’ Usually three portions
of wash solvent are sufficient.
Absorb- Before proceeding with analysis of a sam-
Wavelength ance (max- ple, determine the absorbance in a 5-centi-
imum)
meter path cell between 250 millimicrons and
261.5 .................................................................... 1.00 400 millimicrons for the reagent blank by
270 ....................................................................... .20 carrying out the procedure, without an oil
275 ....................................................................... .09 sample, recording the spectra after the ex-
280 ....................................................................... .06 traction stage and after the complete proce-
300 ....................................................................... .015 dure as prescribed. The absorbance per centi-
meter pathlength following the extraction
There shall be no irregularities in the ab- stage should not exceed 0.02 in the wave-
sorbance curve within these wavelengths. length range from 280 mμ to 400 mμ; the ab-
Phosphoric acid. 85 percent A.C.S. reagent sorbance per centimeter pathlength fol-
grade. lowing the complete procedure should not
Sodium borohydride. 98 percent. exceed 0.02 in the wavelength range from 280
Magnesium oxide (Sea Sorb 43, Food Machin- mμ to 400 mμ. If in either spectrum the char-
ery Company, Westvaco Division, distributed by acteristic benzene peaks in the 250 mμ–260
chemical supply firms, or equivalent). Place 100 mμ region are present, remove the benzene
grams of the magnesium oxide in a large by the procedure under ‘‘Organic solvents’’
beaker, add 700 milliliters of distilled water and record absorbance again.
to make a thin slurry, and heat on a steam Place 300 milliliters of dimethyl sulfoxide
bath for 30 minutes with intermittent stir- in a 1-liter separatory funnel and add 75 mil-
ring. Stir well initially to insure that all the liliters of phosphoric acid. Mix the contents
adsorbent is completely wetted. Using a of the funnel and allow to stand for 10 min-
Buchner funnel and a filter paper (Schleicher utes. (The reaction between the sulfoxide
& Schuell No. 597, or equivalent) of suitable and the acid is exothermic. Release pressure
diameter, filter with suction. Continue suc- after mixing, then keep funnel stoppered.)
tion until water no longer drips from the Add 150 milliliters of isooctane and shake to
funnel. Transfer the adsorbent to a glass pre-equilibrate the solvents. Draw off the in-
trough lined with aluminum foil (free from dividual layers and store in glass-stoppered
rolling oil). Break up the magnesia with a flasks.
clean spatula and spread out the adsorbent Weigh a 20-gram sample of the oil and
on the aluminum foil in a layer about 1 cen- transfer to a 500-milliliter separatory funnel
timeter to 2 centimeters thick. Dry for 24 containing 100 milliliters of pre-equilibrated
hours at 160 °C ±1 °C. Pulverize the magnesia sulfoxide-phosphoric acid mixture. Complete
with mortar and pestle. Sieve the pulverized the transfer of the sample with small por-
adsorbent between 60–180 mesh. Use the mag- tions of preequilibrated isooctane to give a
nesia retained on the 180-mesh sieve. total volume of the oil and solvent of 75 mil-
Celite 545. Johns Mansville Company, diato- liliters. Shake the funnel vigorously for 2
maceous earth, or equivalent. minutes. Set up three 250-milliliter sepa-
Magnesium oxide-Celite 545 mixture (2+1) by ratory funnels with each containing 30 milli-
weight. Place the magnesium oxide (60–180 liters of pre-equilibrated isooctane. After
mesh) and the Celite 545 in 2 to 1 propor- separation of liquid phases, carefully draw
tions, respectively, by weight in a glass- off lower layer into the first 250-milliliter
stoppered flask large enough for adequate separatory funnel and wash in tandem with
mixing. Shake vigorously for 10 minutes. the 30-milliliter portions of isooctane con-
Transfer the mixture to a glass trough lined tained in the 250-milliliter separatory fun-
with aluminum foil (free from rolling oil) nels. Shaking time for each wash is 1
and spread it out on a layer about 1 centi- minute. Repeat the extraction operation
425
§ 178.3620 21 CFR Ch. I (4–1–12 Edition)
with two additional portions of the sulf- denser equipped with a 24/40 joint and with a
oxide-acid mixture and wash each extractive drying tube into the flask, mix until the
in tandem through the same three portions borohydride is dissolved, and allow to stand
of isooctane. for 30 minutes at room temperature, with
Collect the successive extractives (300 mil- intermittent swirling. At the end of this pe-
liliters total) in a separatory funnel (pref- riod, disconnect the flask and evaporate the
erably 2-liter) containing 480 milliliters of methyl alcohol on the steam bath under ni-
distilled water; mix, and allow to cool for a trogen until the sodium borohydride begins
few minutes after the last extractive has to come out of the solution. Then add 10 mil-
been added. Add 80 milliliters of isooctane to
liliters of isooctane and evaporate to a vol-
the solution and extract by shaking the fun-
ume of about 2–3 milliliters. Again, add 10
nel vigorously for 2 minutes. Draw off the
lower aqueous layer into a second separatory milliliters of isooctane and concentrate to a
funnel (preferably 2-liter) and repeat the ex- volume of approximately 5 milliliters. Swirl
traction with 80 milliliters of isooctane. the flask repeatedly to assure adequate
Draw off and discard the aqueous layer. washing of the sodium borohydride residues.
Wash each of the 80-milliliter extractives Fit the tetrafluoroethylene polymer disc
three times with 100-milliliter portions of on the upper part of the stem of the
distilled water. Shaking time for each wash chromatographic tube, then place the tube
is 1 minute. Discard the aqueous layers. Fil- with the disc on the suction flask and apply
ter the first extractive through anhydrous the vacuum (approximately 135 millimeters
sodium sulfate prewashed with isooctane (see Hg pressure). Weigh out 14 grams of the 2:1
Sodium sulfate under ‘‘Reagents and Mate- magnesium oxide-Celite 545 mixture and
rials’’ for preparation of filter) into a 250- pour the adsorbent mixture into the
milliliter Erlenmeyer flask (or optionally chromatographic tube in approximately 3-
into the evaporation flask). Wash the first centimeter layers. After the addition of each
separatory funnel with the second 80-milli- layer, level off the top of the adsorbent with
liter isooctane extractive and pass through a flat glass rod or metal plunger by pressing
the sodium sulfate. Then wash the second
down firmly until the adsorbent is well
and first separatory funnels successively
packed. Loosen the topmost few millimeters
with a 20-milliliter portion of isooctane and
of each adsorbent layer with the end of a
pass the solvent through the sodium sulfate
into the flask. Add 1 milliliter of n-hexa- metal rod before the addition of the next
decane and evaporate the isooctane on the layer. Continue packing in this manner until
steam bath under nitrogen. Discontinue all the 14 grams of the adsorbent is added to
evaporation when not over 1 milliliter of res- the tube. Level off the top of the adsorbent
idue remains. To the residue, add a 10-milli- by pressing down firmly with a flat glass rod
liter portion of isooctane, reevaporate to 1 or metal plunger to make the depth of the
milliliter of hexadecane, and repeat this op- adsorbent bed approximately 12.5 centi-
eration once. meters in depth. Turn off the vacuum and re-
Quantitatively transfer the residue with move the suction flask. Fit the 500–milliliter
isooctane to a 200-milliliter volumetric reservoir onto the top of the
flask, make to volume, and mix. Determine chromatographic column and prewet the col-
the absorbance of the solution in the 1-centi- umn by passing 100 milliliters of isooctane
meter pathlength cells compared to iso- through the column. Adjust the nitrogen
octane as reference between 280 mμ–400 mμ pressure so that the rate of descent of the
(take care to lose none of the solution in fill- isooctane coming off the column is between
ing the sample cell). Correct the absorbance 2–3 milliliters per minute. Discontinue pres-
values for any absorbance derived from re- sure just before the last of the isooctane
agents as determined by carrying out the
reaches the level of the adsorbent. (Caution:
procedure without an oil sample. If the cor-
Do not allow the liquid level to recede below
rected absorbance does not exceed the limits
the adsorbent level at any time.) Remove the
prescribed in this paragraph, the oil meets
reservoir and decant the 5–milliliter iso-
the ultraviolet absorbance specifications. If
the corrected absorbance per centimeter octane concentrate solution onto the column
pathlength exceeds the limits prescribed in and with slight pressure again allow the liq-
this paragraph, proceed as follows: Quan- uid level to recede to barely above the ad-
titatively transfer the isooctane solution to sorbent level. Rapidly complete the transfer
a 125-milliliter flask equipped with 24/40 similarly with two 5–milliliter portions of
joint, and evaporate the isooctane on the isooctane, swirling the flask repeatedly each
steam bath under a stream of nitrogen to a time to assure adequate washing of the res-
volume of 1 milliliter of hexadecane. Add 10 idue. Just before the final 5–milliliter wash
milliliters of methyl alcohol and approxi- reaches the top of the adsorbent, add 100 mil-
mately 0.3 gram of sodium borohydride. liliters of isooctane to the reservoir and con-
(Minimize exposure of the borohydride to the tinue the percolation at the 2–3 milliliters
atmosphere. A measuring dipper may be per minute rate. Just before the last of the
used.) Immediately fit a water-cooled con- isooctane reaches the adsorbent level, add
426
100 milliliters of 10 percent benzene in iso- 2 percent, as determined by ASTM
octane to the reservoir and continue the per- method D86–82, ‘‘Standard Method for
colation at the aforementioned rate. Just be-
fore the solvent mixture reaches adsorbent
Distillation of Petroleum Products,’’
level, add 25 milliliters of 20 percent benzene which is incorporated by reference. The
in isooctane to the reservoir and continue availability of this incorporation by
the percolation at 2–3 milliliters per minute reference is given in paragraph (b)(1)(i)
until all this solvent mixture has been re- of this section.
moved from the column. Discard all the
elution solvents collected up to this point.
(ii) Ultraviolet absorbance limits as
Add 300 milliliters of the acetone-benzene- follows as determined by the method
water mixture to the reservoir and percolate described in paragraph (d)(3) of this
through the column to eluate the section.
polynuclear compounds. Collect the eluate in
a clean 1-liter separatory funnel. Allow the Maximum
column to drain until most of the solvent absorb-
ance per
mixture is removed. Wash the eluate three Wavelength (mμ) centimeter
times with 300-milliliter portions of distilled optical
water, shaking well for each wash. (The addi- pathlength
tion of small amounts of sodium chloride fa-
280 to 299 ........................................................... 2.3
cilitates separation.) Discard the aqueous
300 to 319 ........................................................... 1.2
layer after each wash. After the final separa-
320 to 359 ........................................................... .8
tion, filter the residual benzene through an-
360 to 400 ........................................................... .3
hydrous sodium sulfate pre-washed with ben-
zene (see Sodium sulfate under ‘‘Reagents
and Materials’’ for preparation of filter) into (iii) Pyrene content not to exceed a
a 250-milliliter Erlenmeyer flask (or option- maximum of 25 parts per million as de-
ally into the evaporation flask). Wash the termined by the method described in
separatory funnel with two additional 20- paragraph (d)(3) of this section.
milliliter portions of benzene which are also
filtered through the sodium sulfate. Add 1
(2) The mineral oil may be used only
milliliter of n-hexadecane and completely re- in the processing of jute fiber employed
move the benzene by evaporation under ni- in the production of textile bags in-
trogen, using the special procedure to elimi- tended for use in contact with the fol-
nate benzene as previously described under lowing types of food: Dry grains and
‘‘Organic solvents.’’ Quantitatively transfer dry seeds (for example, beans, peas,
the residue with isooctane to a 200-milliliter
volumetric flask and adjust to volume. De- rice, and lentils); whole root crop vege-
termine the absorbance of the solution in the tables of the types identified in 40 CFR
1-centimeter pathlength cells compared to 180.34(f); unshelled and shelled nuts (in-
isooctane as reference between 250 mμ–400 cluding peanuts); and dry animal feed.
mμ. Correct for any absorbance derived from The finished processed jute fiber shall
the reagents as determined by carrying out contain no more than 6 percent by
the procedure without an oil sample. If ei-
ther spectrum shows the characteristic ben- weight of residual mineral oil.
zene peaks in the 250 mμ–260 mμ region, evap- (3) The analytical method for deter-
orate the solution to remove benzene by the mining ultraviolet absorbance limits
procedure under ‘‘Organic solvents.’’ Dis- and pyrene content is as follows:
solve the residue, transfer quantitatively,
and adjust to volume in isooctane in a 200- I. Apparatus. A. Assorted beakers, sepa-
milliliter volumetric flask. Record the ab- ratory funnels fitted with tetrafluoro-
sorbance again. If the corrected absorbance ethylene polymer stopcocks, and graduated
does not exceed the limits proposed in this cylinders.
paragraph, the oil meets the proposed ultra- B. Volumetric flasks, 200-milliliter.
violet absorbance specifications. C. A chromatographic column made from
(d) Mineral oil identified in para- nominal 1.3 centimeters outside diameter ×
75 centimeters glass tubing tapered at one
graph (d)(1) of this section may be used
end and joined to a 2-millimeter-bore tetra-
as provided in paragraph (d)(2) of this fluoroethylene polymer stopcock. The oppo-
section. site end is flanged and joined to a female 24/
(1) The mineral oil consists of virgin 40 standard taper fitting. This provides for
petroleum distillates refined to meet accommodating the 500-milliliter reservoir
the following specifications: described in item I.E below.
(i) Distillation endpoint at 760 milli-
D. A chromatographic column made from

meters pressure not to exceed 371 °C, nominal 1.7 centimeters outside diameter ×
with a maximum residue not to exceed 115 centimeters glass tubing tapered at one
427
§ 178.3620 21 CFR Ch. I (4–1–12 Edition)
end and joined to a 2-millimeter-bore tetra- n-hexadecane residue in isooctane and make
fluoroethylene polymer stopcock. The oppo- to 10-milliliter volume. Determine the ab-
site end is flanged and joined to a 2.5 centi- sorbance in 1.0-centimeter pathlength cells
meters outside diameter × 9.0 centimeters compared to water as reference. The absorb-
glass tube having a female 24/40 standard ance of the solution of solvent residue shall
taper fitting. This provides for accommo- not exceed 0.05 between 280 and 400 mμ.
dating the 500-milliliter reservoir described 1. Isooctane (2,2,4-trimethylpentane). Use 240
in item I. E below. milliliters for the above test. Purify, if nec-
E. A 500-milliliter reservoir having a 24/40 essary, by passage through a column of acti-
standard taper male fitting at bottom and a vated silica gel.
suitable ball joint at the top for connecting 2. Benzene. Use 200 milliliters for the above
to the nitrogen supply. The female fitting of test. Purify, if necessary, by distillation or
the chromatographic columns described in otherwise.
items I. C and D above and the male fitting 3. Cyclohexane. Use 70 milliliters for the
of the reservoir described in this item E above test. Purify, if necessary, by distilla-
should both be equipped with glass hooks. tion, silica gel percolation, or otherwise.
(NOTE: Rubber stoppers are not to be used. 4. Nitromethane. Use 125 milliliters for the
Stopcock grease is not to be used on ground- above test. Purify, if necessary, by distilla-
glass joints in this method.) tion or otherwise.
5. n-Hexadecane. Determine the absorbance
F. A spectrophotometer equipped to auto-
on this solvent directly. Purify, if necessary,
matically record absorbance of liquid sam-
by silica gel percolation or otherwise.
ples in 1-centimeter pathlength cells in the
B. Other materials—1. Pyrene standard ref-
spectral region of 280–400 mμ with a spectral
erence. Pyrene, reagent grade, melting point
slit width of 2 mμ or less. At an absorbance
level of about 0.4, absorbance measurements range 150–152 °C. (Organic Chemical 3627,
shall be repeatable within ±0.01 and accurate Eastman Kodak Co., Rochester, N.Y., or
within ±0.05. Wavelength measurements shall equivalent). The standard reference absorb-
be repeatable with ±0.2 mμ and accurate ance is the absorbance at 334 millimicrons of
within ±1.0 mμ. Instrument operating condi- a standard reference solution of pyrene con-
tions are selected to realize this performance taining a concentration of 1.0 milligram per
under dynamic (automatic) recording oper- liter in purified isooctane measured against
ations. Accuracy of absorbance measure- isooctane of the same spectral purity in 1.0-
ments are determined at 290, 345, and 400 mμ, centimeter cells. (This absorbance will be ap-
using potassium chromate as the reference proximately 0.28.)
standard. (National Bureau of Standards Cir- 2. Chrysene solution. Prepare a solution at a
cular 484, Spectrophotometry, U.S. Depart- concentration of 5.0 milligrams per liter by
ment of Commerce, 1949.) dissolving 5.0 milligrams of chrysene in puri-
G. Two fused quartz cells having fied isooctane in a 1-liter volumetric flask.
pathlengths of 1.00±0.005 centimeter or bet- Adjust to volume with isooctane.
ter. 3. Nitrogen gas. Water pumped or equivalent
II. Purity of reagents and materials. Reagent- purity, cylinder with regulator, and valve
grade chemicals shall be used in all tests. It control flow at 5 p.s.i.
is further specified that each chemical shall 4. Silica gel. 100–200 mesh (Davison Chem-
be tested for purity in accordance with the ical, Baltimore, Md., Grade 923, or equiva-
instruction given under ‘‘Reagents and Mate- lent), purified and activated by the following
rials’’ in III below. In addition, a blank run procedure: Place about 1 kilogram of silica
by the procedure shall be made on each puri- gel in a large column and wash with con-
fied lot of reagents and materials. Unless taminant-free benzene until a 200-milliliter
otherwise indicated, references to water sample of the benzene coming off the column
shall be understood to mean distilled water. will pass the ultraviolet absorption test for
III. Reagents and materials— A. Organic sol- benzene. This test is performed as stipulated
vents. All solvents used throughout the pro- under ‘‘Organic solvents’’ in A under III
cedure shall meet the specifications and above. When the silica gel has been suffi-
tests described in this section III. The iso- ciently cleaned, activate the gel before use
octane, benzene, cyclohexane, nitromethane, by placing the 1-kilogram batch in a shallow
and n-hexadecane designated shall pass the container in a layer no greater than 1 inch in
following test: To the specified quantity of depth and heating in an oven (Caution! Ex-
solvent in a 150-milliliter beaker, add 1 milli- plosion Hazard) at 130 °C. for 16 hours, and
liter of purified n-hexadecane and evaporate store in a vacuum desiccator. Reheating
on the steam bath under a stream of nitro- about once a week is necessary if the silica
gen. Discontinue evaporation when not over gel is repeatedly removed from the desic-
1 milliliter of residue remains (to the residue cator.
from benzene and nitromethane add a 10-mil- 5. Aluminum oxide (Aluminum Co. of America,
liliter portion of purified isooctane, re-evap- Grade F-20, or equivalent grade). 80–200 mesh,
orate, and repeat once to insure complete re- purified and activated by the following pro-
moval of solvent). Dissolve the 1 milliliter of cedure: Place about 1 kilogram of aluminum
428
oxide in a large column and wash with con- tion until a 100-milliliter eluate has been ob-
taminant-free benzene until a 200-milliliter tained.
sample of the benzene coming off the column h. Measure the amount of chrysene in this
will pass the ultraviolet absorption test for 100-milliliter fraction by ultraviolet anal-
benzene. This test is performed as stipulated ysis. If the aluminum oxide is satisfactory,
under ‘‘Organic solvents’’ in A under III more than 80 percent of the original amount
above. (Caution! Remove Benzene From Ad- of chrysene should be found in this fraction.
sorbent Under Vacuum To Minimize Explo- (NOTE: If the amount of chrysene recovered
sion Hazard in Subsequent Heating!) When is less than 80 percent, the original batch of
the aluminum oxide has been sufficiently aluminum oxide should be sieved between
cleaned and freed of solvent, activate it be- 100–160 mesh. Activation and testing of this
fore use by placing the 1-kilogram batch in a sieved batch should indicate a satisfactory
shallow container in a layer no greater than aluminum oxide for use.)
1 inch in depth. Heat in an oven at 130 °C for IV. Sampling. Precautions must be taken to
16 hours. Upon removal from heat, store at insure that an uncontaminated sample of the
atmospheric pressure over 80 percent (by mineral oil is obtained since ultraviolet ab-
weight) sulfuric acid in a desiccator for at sorption is very sensitive to small amounts
least 36 hours before use. This gives alu- of extraneous material contaminating the
minum oxide with between 6 to 9.5 percent sample through careless handling.
volatiles. This is determined by heating a V. Procedure. A. Blank. Before proceeding
weighed sample of the prepared aluminum with the analysis of a sample, determine the
oxide at 2,000 °F for 2 hours and then quickly absorbance of the solvent residues by car-
reweighing. To insure the proper adsorptive rying out the procedure without a sample.
properties of the aluminum oxide, perform B. Sample. 1. Weigh out 20.0 grams ±0.1
the following test: gram of the mineral oil into a beaker and
a. Weigh 50 grams ±1 gram of the activated transfer to a 250-milliliter separatory funnel
aluminum oxide and pack into the fitted with a tetrafluoroethylene polymer
chromatographic column (1.3 centimeters × stopcock, using enough cyclohexane (25 mil-
75 centimeters) described under ‘‘Apparatus’’ liliters) to give a final total volume of 50
in C under I above. Use glass wool at the col- milliliters (mineral oil plus cyclohexane).
umn exit to prevent the aluminum oxide 2. Add 25 milliliters of nitromethane satu-
from passing through the column. rated with cyclohexane and shake by hand
b. Place a 250-milliliter graduated cylinder vigorously for 3 minutes. Recover the lower
under the column to measure the amount of nitromethane layer in a 150-milliliter beaker
eluate coming from the column. containing 1 milliliter of n-hexadecane and
c. Prewet the aluminum oxide by passing evaporate on the steam bath under nitrogen.
40 milliliters of isooctane through the col- Repeat the extraction four more times, re-
umn. Adjust the nitrogen pressure so that covering each extract in the 150-milliliter
the rate of descent of the isooctane coming beaker. Exercise care not to fill the beaker
off the column is between 1.5 to 2.5 milli- to such a capacity that solvent losses may
liters per minute. occur. Evaporate the combined
d. Just prior to the last of the isooctane nitromethane extracts to 1 milliliter of n-
reaching the top of the aluminum oxide bed, hexadecane residue containing the
add 10 milliliters of the isooctane solution nitromethane-soluble mineral oil extrac-
containing 5.0 milligrams of chrysene per tives. (NOTE: Complete removal of the
liter. nitromethane is essential. This can be as-
e. Continue percolation until the isooctane sured by two successive additions of 5 milli-
is just above the aluminum oxide. Then add liters of isooctane and reevaporation.)
200 milliliters of a mixture of benzene and 3. Remove the beaker from the steam bath
isooctane (331⁄3 percent benzene and 662⁄3 per- and allow to cool.
cent isooctane by volume) to the reservoir 4. Weigh 50 grams ±1 gram of activated alu-
and continue percolation. minum oxide and pack into the
f. Continue percolation, collecting the chromatographic column (1.3 centimeters ×
eluates (40 milliliters of the prewet solution, 75 centimeters) described under ‘‘Apparatus’’
10 milliliters of the sample solution, and 200 in C under I above. (NOTE: A small plug of
milliliters of the gradient solution) in the glass wool is placed at the column exit to
250-milliliter graduated cylinder until the prevent the aluminum oxide from passing
level of the gradient solution is just above through the column. After adding aluminum
the aluminum oxide. Add 200 milliliters of oxide, tap the column lightly to remove air
the eluting solution of benzene and isooctane voids. All percolations using aluminum oxide
(90 percent benzene and 10 percent isooctane are performed under nitrogen pressure. The
by volume) to the column and continue col- 500-milliliter reservoir described under ‘‘Ap-
lecting until a total of 250 milliliters of solu- paratus’’ in E under I above is to be used to
tion has been obtained. This may be dis- hold the elution solvents.)
carded. Now begin to collect the final eluate. 5. Prewet the column by adding 40 milli-
g. Place a 100-milliliter graduated cylinder liters of isooctane to the column. Adjust ni-
under the column and continue the percola- trogen pressure so that rate of descent of the
429
§ 178.3620 21 CFR Ch. I (4–1–12 Edition)
isooctane coming off the column is 2.0 to 3.0 glass-stoppered Erlenmeyer flask. Add to the
milliliters per minute. Be careful to main- silica gel 46.2 grams (41 milliliters) of
tain the level of solvent in the reservoir to nitromethane. Stopper and shake the flask
prevent air from entering the aluminum vigorously until no lumps of silica gel are
oxide bed. New or additional solvent is added observed and then shake occasionally during
just before the last portion of the previous a period of 1 hour. The resultant
solvent enters the bed. To minimize possible nitromethane-treated silica gel is 29 weight-
photo-oxidation effects, the following proce- percent nitro-methane and 71 weight-percent
dures (steps 6 through 18) shall be carried out silica gel.
in subdued light. 15. Place a small plug of glass wool in the
6. Before the last of the isooctane reaches tapered end of the 1.7 centimeters outside di-
the top of the aluminum oxide bed, release ameter × 115 centimeters column, described
the nitrogen pressure and turn off the stop- under ‘‘Apparatus’’ in D of I above, adjacent
cock on the column. Transfer the n-hexa- to the stopcock to prevent silica gel from
decane residue from the 150-milliliter beaker passing through the stopcock. Pack the
from procedure step 3 above onto the col- nitromethane-treated silica gel into the col-
umn, using several washes of isooctane (total umn, tapping lightly. The resultant silica gel
volume of washes should be no greater than bed should be about 95 centimeters in depth.
10–15 milliliters). Place into a flask 170 milliliters of isooctane
7. Open the stopcock and continue percola- saturated with nitromethane.
tion until the isooctane is about 1 centi- 16. Place a 100-milliliter graduated cyl-
meter above the top of the aluminum oxide inder under the column and transfer the res-
bed. Add 200 milliliters of isooctane to the idue from the beaker in procedure step 13
reservoir, and continue the percolation at above with several washes of the 170 milli-
the specified rate. liters of isooctane, saturated with
8. Just before the isooctane surface reaches nitromethane, onto the top of the column.
the top of the aluminum oxide bed, add 200 (Total volume of washes should be no greater
milliliters of a mixture of benzene and iso- than 10 to 15 milliliters.) Permit isooctane
octane (331⁄3 percent benzene and 662⁄3 percent solution to enter the silica gel bed until the
isooctane by volume) to the reservoir, and liquid level is at the top bed level. Place the
continue the percolation. remaining amount of the 170 milliliters of
9. Just before the surface of this mixture isooctane, saturated with nitromethane, in
reaches the top of the aluminum oxide bed, the reservoir above the bed for percolation
release the nitrogen pressure, turn off the through the silica gel. Apply nitrogen pres-
stopcock, and discard all the elution solvents sure to the top of the column, adjusting the
collected up to this point. pressure so that the isooctane is collected at
10. Add to the reservoir 300 milliliters of a the rate of 2.5 to 3.5 milliliters per minute,
mixture of benzene and isooctane (90 percent and percolate isooctane through the bed
benzene and 10 percent isooctane by volume), until a quantity of 75.0 milliliters of eluate is
place a 25-milliliter graduated cylinder collected. Discard the 75 milliliters of eluate.
under the column, continue the percolation Turn off the stopcock and add 250 milliliters
until 20 milliliters of eluate has been col- of benzene to the reservoir above the bed.
lected, and then discard the eluate. Use a 400-milliliter beaker to collect the re-
11. At this point, place a clean 250-milli- maining eluate.
liter Erlenmeyer flask under the column. 17. Open the stopcock, renew the pressure,
Continue the percolation and collect all the and percolate the remaining isooctane and
remaining eluate. benzene through the column eluting the re-
(NOTE: Allow the column to drain com- maining aromatics. Transfer the eluate in
pletely. An increase in the nitrogen pressure small portions from the 400 milliliter beaker
may be necessary as the last of the solvent to a 150-milliliter beaker containing 1 milli-
comes off the column.) liter of n-hexadecane and evaporate on the
12. Place 1 milliliter of n-hexadecane into a steam bath under nitrogen. Rinse the 400-
150-milliliter beaker. Place this onto a steam milliliter beaker well with small portions of
bath under a nitrogen stream and transfer in isooctane to obtain a complete transfer.
small portions the eluate from step 11 above. (NOTE: Complete removal of the
Wash out the Erlenmeyer flask with small nitromethane and benzene is essential. This
amounts of benzene and transfer to the evap- can be assured by successive additions of 5
oration beaker. Evaporate until only 1 milli- milliliters of isooctane and reevaporation.)
liter of hexadecane residue remains. (NOTE: 18. Transfer the residue with several wash-
Complete removal of the benzene is essen- es of isooctane into a 200-milliliter volu-
tial. This can be assured by two successive metric flask. Add isooctane to mark.
additions of 5 milliliters of isooctane and re- 19. Record the spectrum of the sample solu-
evaporation.) tion in a 1-centimeter cell compared to iso-
13. Remove the beaker from the steam bath octane from 270 to 400 mμ. After making nec-
and cool. essary corrections in the spectrum for cell

14. Place a sample of 113.5 grams activated differences and for the blank absorbance,
100- 200-mesh silica gel in a 500-milliliter record the maximum absorbance in each of
430
the wavelength intervals (mμ), 280–299, 300– fied wavelength intervals shall not exceed
319, 320–359, 360–400. the limits prescribed in paragraph (d)(1)(ii)
a. If the spectrum then shows no discern- of this section.
ible peak corresponding to the absorbance d. If the spectrum as a whole of the sample
maximum of the pyrene reference standard solution is in any respect clearly incompat-
solution at 334 mμ, the maximum ible with the presence of pyrene as the
absorbances in the respective wavelength in- source of the peak at 334 mμ, then the max-
tervals recorded shall not exceed those pre- imum absorbances in the respective wave-
scribed in paragraph (d)(1)(ii) of this section. length intervals without correction for any
b. If such a peak is evident in the spectrum assumed pyrene content shall not exceed the
of the sample solution, and the spectrum as limits prescribed in paragraph (d)(1)(ii) of
a whole is not incompatible with that of a this section.
pyrene contaminant yielding such a peak of
the observed absorbance, calculate the con- [42 FR 14609, Mar. 15, 1977, as amended at 47
centration of pyrene that would yield this FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19,
peak (334 m) by the base-line technique de- 1984; 54 FR 24898, June 12, 1989]
scribed in ASTM method E169–63 (Re-
approved 1981), ‘‘Standard Recommended § 178.3650 Odorless light petroleum hy-
Practices for General Techniques of Ultra- drocarbons.
violet Quantitative Analysis,’’ which is in- Odorless light petroleum hydro-
corporated by reference. The availability of
carbons may be safely used, as a com-
this incorporation by reference is given in
paragraph (b)(1)(i) of this section. Correct ponent of nonfood articles intended for
each of the maximum absorbances in the reuse in contact with food, in accordance
spective specified wavelength intervals by with the following prescribed condi-
subtracting the absorbance due to pyrene, tions:
determined as follows: (a) The additive is a mixture of liquid
hydrocarbons derived from petroleum
Cp × Sa or synthesized from petroleum gases.
Absorbance due to pyrene =
The additive is chiefly paraffinic,
Sp isoparaffinic, or naphthenic in nature.
where: (b) The additive meets the following
Cp=Calculated concentration of pyrene in specifications:
sample solution; (1) Odor is faint and not kerosenic.
Sp=Concentration of pyrene reference stand-
ard solution in same units of concentra-
(2) Initial boiling point is 300 °F min-
tion; imum.
Sa=Absorbance of pyrene reference standard (3) Final boiling point is 650 °F max-
solution at wavelength of maximum ab- imum.
sorbance of sample solution in the respec- (4) Ultraviolet absorbance limits de-
tive specified wavelength intervals. termined by method specified in
Also calculate the pyrene content of the § 178.3620(b)(1)(ii), as follows:
oil sample in parts per million as follows:
Maximum
Pyrene content ( 200/1000 ) × C absorb-
= = 10 C Wavelength (Mμ) ance per
(p. p. m.) 20/1000
centimeter
optical
pathlength
where:
C=Calculated concentration of pyrene in mil- 280 to 289 ........................................................... 4.0
ligrams per liter of sample solution. 290 to 299 ........................................................... 3.3
c. The pyrene content so determined shall 300 to 329 ........................................................... 2.3
not exceed 25 p.p.m. The maximum 330 to 360 ........................................................... .8
absorbances corrected for pyrene content as
described in this step 19 for each of the speci- (c) The additive is used as follows:
Use Limitations
As a plasticizer and absorber oil in the manufacture of In an amount not to exceed that required to produce intended
polyolefin articles authorized for food contact use. effect, consistent with good manufacturing practice.
As a lubricant of fibers of textiles authorized for food contact At a use level not to exceed 0.15 percent by weight of finished
use. fibers.
As a component of adhesives ..................................................... Complying with § 175.105 of this chapter.
As a defoamer in the manufacture of paper and paperboard .... Complying with § 176.210 of this chapter.
As a defoamer in coatings .......................................................... Complying with § 176.200 of this chapter.
ER01JA93.408</GPH>
431
ER01JA93.407</GPH>
§ 178.3690 21 CFR Ch. I (4–1–12 Edition)
§ 178.3690 Pentaerythritol adipate-ste- NARA, call 202–741–6030, or go to: http://

arate. www.archives.gov/federallregister/
Pentaerythritol adipate-stearate codeloflfederallregulations/
identified in paragraph (a) of this sec- ibrllocations.html.
tion may be safely used as a lubricant (3) Saponification number of 270–280
in the fabrication of rigid and semi- as determined by ASTM method D1387–
rigid polyvinyl chloride and/or vinyl 78, ‘‘Standard Test Method for Acid
chloride-propylene copolymers com- Number (Empirical) of Synthetic and
plying with § 177.1980 of this chapter Natural Waxes’’ (Revised 1978), which is
used as articles or components of arti- incorporated by reference. Copies are
cles that contact food, excluding food available from American Society for
with alcohol content greater than 8 Testing and Materials (ASTM), 100
percent under conditions of use of E, F, Barr Harbor Dr., West Conshohocken,
and G described in table 2 in § 175.300(d) Philadelphia, PA 19428-2959, or avail-
of this chapter, subject to the provi- able for inspection at the National Ar-
sions of this section. chives and Records Administration
(a) Identity. For the purpose of this (NARA). For information on the avail-
section, pentaerythritol adipate-stea- ability of this material at NARA, call
rate is an ester of pentaerythritol with 202–741–6030, or go to: http://
adipic acid and stearic acid and its as- www.archives.gov/federallregister/
sociated fatty acids (chiefly palmitic), codeloflfederallregulations/
with adipic acid comprising 14 percent ibrllocations.html.
and stearic acid and its associated (4) Iodine number not to exceed 2 as
acids (chiefly palmitic) comprising 71 determined by Iodine Absorption Num-
percent of the organic moieties. ber, Hanus Method, of the ‘‘Official
(b) Specifications. Pentaerythritol adi- Methods of Analysis of the Association
pate-stearate has the following speci- of Official Analytical Chemists,’’ sec-
fications: tions 28.018–28.019, 13th Ed. (1980), which
(1) Melting point (dropping) of 55–58 is incorporated by reference. Copies
°C as determined by ASTM method may be obtained from the AOAC
D566–76 (Reapproved 1982), ‘‘Standard INTERNATIONAL, 481 North Frederick
Test Method for Dropping Point of Lu- Ave., suite 500, Gaithersburg, MD 20877,
bricating Grease,’’ which is incor- or may be examined at the National
porated by reference. Copies may be Archives and Records Administration
obtained from the American Society (NARA). For information on the avail-
for Testing Materials, 100 Barr Harbor ability of this material at NARA, call
Dr., West Conshohocken, Philadelphia, 202–741–6030, or go to: http://
PA 19428-2959, or may be examined at www.archives.gov/federallregister/
the National Archives and Records Ad- codeloflfederallregulations/
ministration (NARA). For information ibrllocations.html.
on the availability of this material at (c) The total amount of ester (cal-
NARA, call 202–741–6030, or go to: http:// culated as free pentaerythritol) shall
www.archives.gov/federallregister/ not exceed 0.4 percent by weight of the
codeloflfederallregulations/ polyvinyl chloride and/or the vinyl
ibrllocations.html. chloride-propylene copolymers com-
(2) Acid value not to exceed 15 as de- plying with § 177.1980.
termined by ASTM method D1386–78, [45 FR 1018, Jan. 4, 1980, as amended at 47 FR
‘‘Standard Test Method for Saponifica- 11848, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984;
tion Number (Empirical) of Synthetic 54 FR 24898, June 12, 1989; 57 FR 18082, Apr.
and Natural Waxes’’ (Revised 1978), 29, 1992; 70 FR 40880, July 15, 2005; 70 FR 67651,
which is incorporated by reference. Nov. 8, 2005]
Copies are available from American So-
ciety for Testing and Materials § 178.3700 Petrolatum.
(ASTM), 100 Barr Harbor Dr., West Petrolatum may be safety used as a
Conshohocken, Philadelphia, PA 19428- component of nonfood articles in con-
2959, or available for inspection at the tact with food, in accordance with the
National Archives and Records Admin- following conditions:
istration (NARA). For information on (a) Petrolatum complies with the

the availability of this material at specifications set forth in the United
432
States Pharmacopeia XX (1980) for Ultraviolet absorbance per centi-

white petrolatum or in the National meter pathlength:
Formulary XV (1980) for yellow petro-
latum. Millimicrons Maximum
(b) Petrolatum meets the following 280 to 289 ........................................................... 0.15
ultraviolet absorbance limits when 290 to 299 ........................................................... .12
subjected to the analytical procedure 300 to 359 ........................................................... .08
described in § 172.886(b) of this chapter: 360 to 400 ........................................................... .02
Ultraviolet absorbance per centi-
meter pathlength: (c) Petroleum wax may contain any
antioxidant permitted in food by regu-
Millimicrons Maximum
lations issued in accordance with sec-
280 to 289 ........................................................... 0.25 tion 409 of the act, in an amount not
290 to 299 ........................................................... .20 greater than that required to produce
300 to 359 ........................................................... .14
360 to 400 ........................................................... .04
its intended effect.
(d) Petroleum wax may contain a
(c) It is used or intended for use as a total of not more than 1 weight percent
protective coating of the surfaces of of residues of the following polymers
metal or wood tanks used in fermenta- when such residues result from use of
tion process, in an amount not in ex- the polymers as processing aids (filter
cess of that required to produce its in- aids) in the production of the petro-
tended effect. leum wax: Homopolymers and/or co-
(d) Petrolatum as defined by this sec- polymers derived from one or more of
tion may be used for the functions de- the mixed n-alkyl (C12, C14, C16, and C18)
scribed and within the limitations pre- methacrylate esters where the C12 and
scribed by specific regulations in parts C14 alkyl groups are derived from coco-
175, 176, 177, and 178 of this chapter nut oil and the C16 and C18 groups are
which prescribe uses of petrolatum. derived from tallow.
For the purpose of cross-reference, (e) Petroleum wax may contain 2-hy-
such specific regulations include: droxy-4-n-octoxybenzophenone as a sta-
§§ 175.105, 175.125, 175.300, 176.170, 176.200, bilizer at a level not to exceed 0.01
176.210, 177.2600, 177.2800, and 178.3570 of weight percent of the petroleum wax.
this chapter. (f) Petroleum wax may contain
(e) Petrolatum may contain any anti- poly(alkylacrylate) (CAS Reg. No.
oxidant permitted in food by regula- 27029–57–8), as described in § 172.886(c)(2)
tions issued pursuant to section 409 of of this chapter, as a processing aid in
the act, in an amount not greater than the manufacture of petroleum wax.
that required to produce its intended
effect. [42 FR 14609, Mar. 15, 1977, as amended at 51
FR 19545, May 30, 1986]
FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, § 178.3720 Petroleum wax, synthetic.
1990]
Synthetic petroleum wax may be
§ 178.3710 Petroleum wax. safely used in applications and under
Petroleum wax may be safely used as the same conditions where naturally
a component of nonfood articles in con- derived petroleum wax is permitted in
tact with food, in accordance with the subchapter B of this chapter as a com-
following conditions: ponent of articles intended to contact
(a) Petroleum wax is a mixture of food, provided that the synthetic petro-
solid hydrocarbons, paraffinic in na- leum wax meets the definition and
ture, derived from petroleum, and re- specifications prescribed in § 172.888 of
fined to meet the specifications pre- this chapter.
scribed in this section.
(b) The petroleum wax meets the fol- § 178.3725 Pigment dispersants.
lowing ultraviolet absorbance limits Subject to the provisions of this reg-
when subjected to the analytical proce- ulation, the substances listed in this
dure described in § 172.886(b) of this section may be safely used as pigment
chapter. dispersants in food-contact materials.
433
§ 178.3730 21 CFR Ch. I (4–1–12 Edition)
Dimethylolpropionic acid (CAS Reg. No. 4767–03–7) ................ For use only at levels not to exceed 0.45 percent by weight of
the pigment. The pigmented articles may contact all foods
under conditions of use A through H as described in Table 2
Phosphorylated tall oil fatty acids (CAS Reg. No. 68604–99–9), For use only at levels not to exceed 1.0 percent by weight of
prepared by the reaction of dimethyl hydrogen phosphite the pigment. The pigmented polymeric films may contact all
with tall oil fatty acids. food under conditions of use D, E, F, and G described in
Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, compd. For use only at levels not to exceed 0.45 percent by weight of
with 1,1′,1″-nitrilotris [2-propanol] (1:1) (CAS Reg. No. the pigment. The pigmented articles may contact all food
221281–21–6). under conditions of use A through H as described in Table 2
Siloxanes and silicones; cetylmethyl, dimethyl, methyl 11- For use only at levels not to exceed 0.5 percent by weight of
methoxy-11-oxoundecyl (CAS Reg. No. 155419–59–3). the pigment. The pigmented polymers may contact all foods
under conditions of use C, D, E, F, and G described in Table
Trimethylolethane (CAS Reg. No. 77–85–0) .............................. For use only at levels not to exceed 0.45 percent by weight of
inorganic pigment. The pigmented articles may contact all
food under conditions of use A through H described in Table
[61 FR 43157, Aug. 21, 1996, as amended at 63 FR 35799, July 1, 1998; 64 FR 48292, Sept. 3, 1999;
64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 31, 2000]
§ 178.3730 Piperonyl butoxide and graph (b) of this section may be safely
pyrethrins as components of bags. used as plasticizers in polymeric sub-
Piperonyl butoxide in combination stances used in the manufacture of ar-
with pyrethrins may be safely used for ticles or components of articles in-
insect control on bags that are intended for use in producing, manufac-
tended for use in contact with dried turing, packing, processing, preparing,
feed in compliance with §§ 561.310 and treating, packaging, transporting, or
561.340 of this chapter, or that are in- holding food.
tended for use in contact with dried (a) The quantity used shall not ex-
food in compliance with §§ 193.60 and ceed the amount reasonably required
193.390 of this chapter. to accomplish the intended technical
§ 178.3740 Plasticizers in polymeric effect.
substances. (b) List of substances:
Subject to the provisions of this reg-
ulation, the substances listed in para-
Butylbenzyl phthalate .............................................. For use only:

2. In polymeric substances used in food-contact articles complying with
§ 175.300, § 175.320, or § 176.170 of this chapter: Provided, That the
butyl benzyl phthalate contains not more than 1 percent by weight of
dibenzyl phthalate.
3. In polymeric substances used in other permitted food-contact articles:
Provided, That the butyl benzyl phthalate contains not more than 1 per-
cent by weight of dibenzyl phthalate; and Provided further, That the fin-
ished food-contact article, when extracted with the solvent or solvents
characterizing the type of food and under the conditions of time and tem-
perature characterizing the conditions of its intended use as determined
from tables 1 and 2 of § 175.300(d) of this chapter, shall yield net chloro-
form-soluble extractives not to exceed 0.5 mg. per square inch, as deter-
mined by the methods prescribed in § 175.300(e) of this chapter.
1,3-Butylene glycoladipic acid polyester (1,700– For use at levels not exceeding 33 percent by weight of polyvinyl chloride
2,200 molecular weight) terminated with a 16 homopolymers used in contact with food (except foods that contain more
percent by weight mixture of myristic, palmitic, than 8 percent of alcohol) at temperatures not to exceed room tempera-
and stearic acids. ture. The average thickness of such homopolymers in the form in which
434
Di(C7, C9-alkyl) adipate, in which the C7, C9-alkyl For use only under the conditions listed below, and excluding use as a
groups are derived from linear alpha olefins by component of resinous and polymeric coatings described in § 175.300 of
the oxo process. this chapter.
1. At levels not to exceed 24 percent by weight of permitted vinyl chloride
homo- and/or copolymers used in contact with nonfatty foods. The aver-
age thickness of such polymers in the form in which they contact food
shall not exceed 0.005 inch.
2. At levels not to exceed 24 pct by weight of permitted vinyl chloride
homo- and/or copolymers used in contact, under conditions of use F and
G described in table 2 of § 176.170(c) of this chapter, with fatty foods
having a fat and oil content not exceeding a total of 40 pct by weight.
The average thickness of such polymers in the form in which they con-
tact food shall not exceed 0.005 inch.
3. At levels not exceeding 35 pct by weight of permitted vinyl chloride
age thickness of such polymer in the form in which they contact food
G described in table 2 of § 176.170(c) of this chapter with fatty foods hav-
ing a fat and oil content not exceeding a total of 40 pct by weight. The
average thickness of such polymers in the form in which they contact
food shall not exceed 0.002 inch.
Di-n-alkyl adipate made from C6 C8-C10 (predomi- For use only:
nately C8 and C10) or C8-C10 synthetic fatty alco- 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride
hols complying with § 172.864 of this chapter. homo- and/or copolymers used in contact with nonfatty foods. The aver-
The average thickness of such polymers in the form in which they con-
tact food shall not exceed 0.005 inch.
The average thickness of such polymers in which they contact food shall
Dicyclohexyl phthalate ............................................ For use only:
1. As provided in §§ 175.105, 176.170, 176.180, and 177.1200 of this chap-
ter.
2. Alone or in combination with other phthalates, in plastic film or sheet pre-
pared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride co-
polymers complying with § 177.1980 of this chapter. Such plastic film or
sheet shall be used in contact with food at temperatures not to exceed
room temperature and shall contain no more than 10 pct by weight of
total phthalates, calculated as phthalic acid.
Di(2-ethylhexyl) adipate ..........................................
435
§ 178.3740 21 CFR Ch. I (4–1–12 Edition)
Diisononyl adipate ................................................... For use only:

homo- and/or copolymers used in contact with nonfatty, nonalcoholic
foods. The average thickness of such polymers in the form in which they
contact food shall not exceed 0.005 inch.
homo- and/or copolymers used in contact under conditions of use F and
G described in table 2 of § 176.170(c) of this chapter with fatty, non-
alcoholic foods having a fat and oil content not exceeding a total of 30
pct by weight. The average thickness of such polymers in the form in
foods. The average thickness of such polymers in the form in which they
G described in table 2 of § 176.170(c) of this chapter with fatty, non-
alcoholic foods having a fat and oil content not exceeding a total of 40
pct by weight. The average thickness of such polymers in the form in
Diisononyl phthalate ................................................ For use only at levels not exceeding 43 pct by weight of permitted vinyl
chloride homo- and/or copolymers used in contact with food only of the
types identified in § 176.170(c) of this chapter, table 1, under Categories
I, II, IV-B, and VIII, at temperatures not exceeding room temperature. The
average thickness of such polymers in the form in which they contact
food shall not exceed 0.005 inch.
Di(2-ethylhexyl) azelate ........................................... For use only:
food. The average thickness of such polymers in the form in which they
G described in table 2 of § 176.170(c) of this chapter, with fatty, non-
alcoholic food having a fat and oil content not exceeding a total of 30
percent by weight. The average thickness of such polymers in the form in
Di-n-hexylazelate ..................................................... For use only:
1. In polymeric substances used in contact with nonfatty food.
2. In polymeric substances used in contact with fatty food and limited to
use at levels not exceeding 15 pct by weight of such polymeric sub-
stance except as provided under limitation 3.
3. At levels greater than 15 but not exceeding 24 pct by weight of permitted
vinyl chloride homo- and/or copolymers used in contact, under conditions
of use F or G described in table 2 of § 176.170(c) of this chapter, with
fatty food having a fat and oil content not exceeding a total of 30 pct by
weight. The average thickness of such polymers in the form in which they
Dihexyl phthalate ..................................................... For use only:
2. In articles that contact food only of the types identified in § 176.170(c) of
this chapter, table 1, under Categories I, II, IV-B, VI-B, and VIII.
Diphenyl phthalate .................................................. For use only:
2. Alone or in combination with other phthalates, in plastic film or sheet pre-
pared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride co-
polymers complying with § 177.1980 of this chapter. Such plastic film or
sheet shall be used in contact with food at temperatures not to exceed
room temperature and shall contain no more than 10 pct by weight of
total phthalates, calculated as phthalic acid.
Epoxidized butyl esters of linseed oil fatty acids .... Iodine number, maximum 5; oxirane oxygen, minimum 7.8 pct.
Epoxidized linseed oil ............................................. Iodine number, maximum 5; oxirane oxygen, minimum 9-pct.
Mineral oil, white.
436
Polybutene, hydrogenated (minimum viscosity at For use only:

99 °F, 39 Saybolt Universal seconds, as deter- 1. In polymeric substances used in contact with non-fatty food.
mined by ASTM methods D445–82 (‘‘Standard 2. In polyethylene complying with § 177.1520 of this chapter and used in
Test Method for Kinematic Viscosity of Trans- contact with fatty food, provided that the hydrogenated polybutene is
parent and Opaque Liquids (and the Calculation added in an amount not to exceed 0.5 pct by weight of the polyethylene,
of Dynamic Viscosity)’’) and D2161–82 (‘‘Stand- and further provided that such plasticized polyethylene shall not be used
ard Method for Conversion of Kinematic Vis- as a component of articles intended for packing or holding food during
cosity to Saybolt Universal Viscosity or to cooking.
Saybolt Furol Viscosity’’), and bromine number 3. In polystyrene complying with § 177.1640 of this chapter and used in
of 3 or less, as determined by ASTM method contact with fatty food, provided that the hydrogenated polybutene is
D1492–78 (‘‘Standard Test Method for Bromine added in an amount not to exceed 5 pct by weight of the polystyrene,
Index of Aromatic Hydrocarbons by Coulometric and further provided that such plasticized polystyrene shall not be used
Titration’’), which are incorporated by reference. as a component of articles intended for packing or holding food during
Copies may be obtained from the American So- cooking.
ciety for Testing Materials, 100 Barr Harbor Dr.,
West Conshohocken, Philadelphia, PA 19428-
2959, or may be examined at the National Ar-
chives and Records Administration (NARA). For
information on the availability of this material at
Polyisobutylene (mol weight 300–5,000) ................ For use in polyethylene complying with § 177.1520 of this chapter, provided
that the polyisobutylene is added in an amount not exceeding 0.5 pct by
weight of the polyethylene, and further provided that such plasticized pol-
yethylene shall not be used as a component of articles intended for pack-
ing or holding food during cooking.
Polyisobutylene complying with § 177.1420 of this
chapter.
Polypropylene glycol (CAS registry No. 25322–69– For use only in polystyrene plastics, identified in § 177.1640(a)(1), in an
4) (minimum mean molecular weight 1,200). amount not to exceed 6 pct by weight of the finished food-contact article.
Propylene glycol azelate (average mol. weight For use only at levels not exceeding 41 pct by weight of permitted polyvinyl
3,000). chloride coatings. Such coatings shall be used only as bulk food contact
surfaces of articles intended for repeated use, complying with § 177.2600
of this chapter.
Triethylene glycol .................................................... Diethylene glycol content not to exceed 0.1 pct.
2,2,4-Trimethyl-1,3-pentanediol diisobutyrate ......... For use only in cellulosic plastics in an amount not to exceed 15 pct by
weight of the finished food-contact article, provided that the finished plas-
tic article contacts food only of the types identified in § 176.170(c) of this
chapter, table 1, under Categories I, II, VI-B, VII-B, and VIII.
(c) The use of the plasticizers in any (b) It contains no more than 0.2 per-
polymeric substance or article subject cent total by weight of ethylene and
to any regulation in parts 174, 175, 176, diethylene glycols if its mean molec-
177, 178 and 179 of this chapter must ular weight is 350 or higher and no
comply with any specifications and more than 0.5 percent total by weight
limitations prescribed by such regula- of ethylene and diethylene glycols if its
tion for the finished form of the sub- mean molecular weight is below 350,
stance or article. when tested by the analytical methods
prescribed in § 172.820(b) of this chapter.
FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, (c) The provisions of paragraph (b) of
1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, this section are not applicable to poly-
Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986] ethylene glycols used in food-pack-
aging adhesives complying with
§ 178.3750 Polyethylene glycol (mean § 175.105 of this chapter.
molecular weight 200–9,500).
Polyethylene glycol identified in this § 178.3760 Polyethylene glycol (400)
section may be safely used as a compo- monolaurate.
nent of articles intended for use in con- Polyethylene glycol (400)
tact with food, in accordance with the monolaurate containing not more than
following prescribed conditions: 0.1 percent by weight of ethylene and/
(a) The additive is an addition poly- or diethylene glycol may be used at a
mer of ethylene oxide and water with a level not to exceed 0.3 percent by
mean molecular weight of 200 to 9,500. weight of twine as a finish on twine to
437
§ 178.3770 21 CFR Ch. I (4–1–12 Edition)
be used for tying meat provided the on the availability of this material at
twine fibers are produced from nylon NARA, call 202–741–6030, or go to: http://
resins complying with § 177.1500 of this www.archives.gov/federallregister/
chapter. codeloflfederallregulations/
ibrllocations.html.) using as solvent xy-
§ 178.3770 Polyhydric alcohol esters of lene-ethyl alcohol in a 2:1 ratio instead
oxidatively refined (Gersthofen of toluene-ethyl alcohol in a 2:1 ratio.
process) montan wax acids. (3) Saponification value 100–160, as
Polyhydric alcohol esters of determined by ASTM method D1387–78
oxidatively refined (Gersthofen proc- (‘‘Standard Test Method for Saponi-
ess) montan wax acids identified in this fication Number (Empirical) of Syn-
section may be safely used as compo- thetic and Natural Waxes’’ (Revised
nents of articles intended for use in 1978), which is incorporated by ref-
contact with food in accordance with erence; copies are available from Amer-
the following prescribed conditions: ican Society for Testing and Materials
(a) The polyhydric alcohol esters (ASTM), 100 Barr Harbor Dr., West
identified in this paragraph may be Conshohocken, Philadelphia, PA 19428-
used as lubricants in the fabrication of 2959, or available for inspection at the
vinyl chloride plastic food-contact ar- National Archives and Records Admin-
ticles prepared from polyvinyl chloride istration (NARA). For information on
and/or from vinyl chloride copolymers the availability of this material at
complying with § 177.1980 of this chap- NARA, call 202–741–6030, or go to: http://
ter. Such esters meet the following www.archives.gov/federallregister/
specifications and are produced by par- codeloflfederallregulations/
tial esterification of oxidatively re- ibrllocations.html.) using xylene-ethyl
fined (Gersthofen process) montan wax alcohol in a 2:1 ratio instead of ethyl
acids by either ethylene glycol or 1,3- alcohol in preparation of potassium hy-
butanediol with or without neutraliza- droxide solution.
tion of unreacted carboxylic groups (4) Ultraviolet absorbance limits as
with calcium hydroxide: follows, as determined by the analyt-
(1) Dropping point 76°–105 °C, as de- ical method described in this subpara-
termined by ASTM method D566–76 graph:
(Reapproved 1982), ‘‘Standard Test Ultraviolet absorbance per centi-
Method for Dropping Point of Lubri- meter pathlength.
cating Grease,’’ which is incorporated Millimicrons Maximum
by reference. Copies may be obtained
from the American Society for Testing 280 to 289 ........................................................... 0.07
290 to 299 ........................................................... .06
Materials, 100 Barr Harbor Dr., West 300 to 359 ........................................................... .04
Conshohocken, Philadelphia, PA 19428- 360 to 400 ........................................................... .01
2959, or may be examined at the Na-
tional Archives and Records Adminis- ANALYTICAL METHOD
NARA, call 202–741–6030, or go to: http:// Because of the sensitivity of the test, the
www.archives.gov/federallregister/ possibility of errors arising from contamina-
codeloflfederallregulations/ tion is great. It is of the greatest importance
that all glassware be scrupulously cleaned to
ibrllocations.html. remove all organic matter such as oil,
(2) Acid value 10–20, as determined by grease, detergent residues, etc. Examine all
ASTM method D1386–78 (‘‘Standard glassware, including stoppers and stopcocks,
Test Method for Acid Number (Empir- under ultraviolet light to detect any residual
ical) of Synthetic and Natural Waxes’’ fluorescent contamination. As a pre-
(Revised 1978), which is incorporated by cautionary measure it is recommended prac-
reference; copies are available from tice to rinse all glassware with purified iso-
American Society for Testing and Ma- octane immediately before use. No grease is
to be used on stopcocks or joints. Great care
terials (ASTM), 100 Barr Harbor Dr., to avoid contamination of wax samples in
West Conshohocken, Philadelphia, PA handling and to assure absence of any extra-
19428-2959, or available for inspection at
neous material arising from inadequate

the National Archives and Records Ad- packaging is essential. Because some of the
ministration (NARA). For information polynuclear hydrocarbons sought in this test
438
are very susceptible to photo-oxidation, the Absorbance accuracy, 1 ±0.05 at 0.4 absorb-
entire procedure is to be carried out under ance.
subdued light. Wavelength repeatability, ±0.2 milli-
micron.
APPARATUS
Wavelength accuracy, ±1.0 millimicron.
Separatory funnels. 250-milliliter, 500-milli- Recording time, 50 seconds.
liter, 1,000-milliliter, and preferably 2,000- Time constant, 0.6 second.
milliliter capacity, equipped with tetra- Sensitivity, 30.
fluoroethylene polymer stopcocks. Ordinate scale, 90–100 percent transmission
Reservoir. 1,000-milliliter capacity, through scale.
equipped with a 24/40 standard taper male fit- Abscissa scale, 8X.
ting at the bottom and a suitable balljoint at Nitrogen cylinder. Water-pumped or equiva-
the top. lent purity nitrogen in cylinder equipped
Chromatographic tube. 1,200 millimeters in with regulator and valve to control flow at 5
length, inside diameter to be 16.5 millimeters p.s.i.g.
±0.5 millimeter, equipped with a coarse, frit-
ted-glass disc, a tetrafluoroethylene polymer REAGENTS AND MATERIALS
stopcock, and a female 24/40 standard tapered
fitting at the opposite end. (Overall length of Organic solvents. All solvents used through-
the column with the female joint is 1,255 mil- out the procedure shall meet the specifica-
limeters.) The female fitting should be tions and tests described in this specifica-
equipped with glass hooks. tion. The isooctane and benzene designated
Disc. Tetrafluoroethylene polymer 2-inch in the list following this paragraph shall
diameter disc approximately 3⁄16-inch thick pass the following test:
with a hole bored in the center to closely fit To be specified quantity of solvent in a 250-
the stem of the chromatographic tube. milliliter Erlenmeyer flask, add 1 milliliter
Heating jackets. Conical, for 500-milliliter of purified n-hexadecane and evaporate on
and 1,000-milliliter separatory funnels. (Used the steam bath under a stream of nitrogen (a
with variable transformer heat control.) loose aluminum foil jacket around the flask
Suction flask. 250-milliliter or 500-milliliter will speed evaporation). Discontinue evapo-
filter flask. ration when not over 1 milliliter of residue
Condenser. 24⁄40 joints, fitted with a drying remains. (To the residue from benzene add a
tube, length optional. 10-milliliter portion of purified isooctane, re-
Evaporation flasks (optional). A 250-milli- evaporate, and repeat once to insure com-
liter or 500-milliliter capacity and a 1-liter plete removal of benzene.)
capacity all-glass flask equipped with stand- Alternatively, the evaporation time can be
ard taper stopper having inlet and outlet reduced by using the optional evaporation
tubes to permit passage of nitrogen across flask. In this case the solvent and n-hexa-
the surface of contained liquid to be evapo- decane are placed in the flask on the steam
rated. bath, the tube assembly is inserted, and a
Vacuum distillation assembly. All glass (for stream of nitrogen is fed through the inlet
purification of dimethyl sulfoxide) 2-liter tube while the outlet tube is connected to a
distillation flask with heating mantle; solvent trap and vacuum line in such a way
Vigreaux vacuum-jacketed condenser (or as to prevent any flow-back of condensate
equivalent) about 45 centimeters in length into the flask.
and distilling head with separable cold finger
condenser. Use of tetrafluoroethylene poly- 1 As determined by procedure using potas-
mer sleeves on the glass joints will prevent
sium chromate for reference standard and
freezing. Do not use grease on stopcocks or
described in National Bureau of Standards
joints.
Circular 484, Spectrometry, U.S. Department
Oil bath. Capable of heating to 90 °C. of Commerce (1949). The accuracy is to be de-
Spectrophotometric cells. Fused quartz cells, termined by comparison with the standard
optical pathlength in the range 1.000 centi- values at 290, 345, and 400 millimicrons. Cir-
meter ±0.005 centimeter. With distilled water cular 484 is incorporated by reference. Copies
in the cells, determine any absorbance dif- are available from the Center for Food Safe-
ferences. ty and Applied Nutrition (HFS–200), Food
Spectrophotometer. Spectral range 250 milli- and Drug Administration, 5100 Paint Branch
microns-400 millimicrons with spectral slit Pkwy., College Park, MD 20740, or available
width of 0.2 millimicron or less; under infor inspection at the National Archives and
strument operating conditions for these ab- Records Administration (NARA). For infor-
sorbance measurements. The spectrophotom- mation on the availability of this material
eter shall also meet the following perform- at NARA, call 202–741–6030, or go to: http://
ance requirements:
Absorbance repeatability, ±0.01 at 0.4 ab- codeloflfederallregulations/
sorbance. ibrllocations.html.
439
§ 178.3770 21 CFR Ch. I (4–1–12 Edition)
Dissolve the 1 milliliter of hexadecane res- nitrogen. Discontinue evaporation when not
idue in isooctane and make up to 25 milli- over 1 milliliter of residue remains. To the
liters volume. Determine the absorbance in residue, add a 10-milliliter portion of iso-
the 1-centimeter pathlength cells compared octane and reevaporate to 1 milliliter of
to isooctane as reference. The absorbance of hexadecane. Again, add 10 milliliters of iso-
the solution of the solvent residue (except octane to the residue and evaporate to 1 mil-
for methyl alcohol) shall not exceed 0.01 per liliter of hexadecane to insure complete re-
centimeter pathlength between 280 mμ and moval of all volatile materials. Dissolve the
400 mμ. 1 milliliter of hexadecane in isooctane and
Isooctane (2,2,4-trimethylpentane). Use 180 make to 25-milliliter volume. Determine the
milliliters for the test described in the pre- absorbance in 1-centimeter pathlength cells
ceding paragraph. Purify, if necessary, by compared to isooctane as reference. The ab-
passage through a column of activated silica sorbance of the solution should not exceed
gel (Grade 12, Davison Chemical Co., Balti- 0.02 per centimeter pathlength in the 280 mμ-
more, Md., or equivalent) about 90 centi- 400 mμ range. (NOTE: Difficulty in meeting
meters in length and 5 centimeters to 8 cen- this absorbance specification may be due to
timeters in diameter. organic impurities in the distilled water.
Benzene, A.C.S. reagent grade. Use 150 milli- Repetition of the test omitting the dimethyl
liters for the test. Purify, if necessary, by sulfoxide will disclose their presence. If nec-
distillation or otherwise. essary to meet the specification, purify the
n-Hexadecane, 99 percent olefin-free. Dilute water by redistillation, passage through an
1.0 milliliter of n-hexadecane to 25 milliliters ion-exchange resin, or otherwise.)
with isooctane and determine the absorbance Purify, if necessary, by the following pro-
in a 1-centimeter cell compared to isooctane cedure: To 1,500 milliliters of dimethyl sulf-
as reference point between 280 mμ-400 mμ. oxide in a 2-liter glass-stoppered flask, add
The absorbance per centimeter pathlength 6.0 milliliters of phosphoric acid and 50
shall not exceed 0.00 in this range. If nec- grams of Norit A (decolorizing carbon, alka-
essary, purify by filtering through a column line) or equivalent. Stopper the flask, and
containing 100 grams of aluminum oxide (use with the use of a magnetic stirrer (tetra-
same grade as described below) in the lower fluoroethylene polymer coated bar) stir the
half and 100 grams of activated silica gel in solvent for 15 minutes. Filter the dimethyl
the upper half keeping the column at 150 °C., sulfoxide through four thicknesses of fluted
for a period of 15 hours or overnight. The paper (18.5 centimeters, Schleicher &
first 100 milliliters of eluate are used. Purifi- Schuell, No. 597, or equivalent). If the initial
cation can also be accomplished by distilla- filtrate contains carbon fines, refilter
tion. through the same filter until a clear filtrate
Dimethyl sulfoxide. Pure grade, clear, is obtained. Protect the sulfoxide from air
water-white, m.p. 18° minimum. Dilute 120 and moisture during this operation by cov-
milliliters of dimethyl sulfoxide with 240 ering the solvent in the funnel and collection
milliliters of distilled water in a 500-milli- flask with a layer of isooctane. Transfer the
liter separatory funnel, mix and allow to filtrate to a 2-liter separatory funnel and
cool for 5–10 minutes. Add 40 milliliters of draw off the dimethyl sulfoxide into the 2-
isooctane to the solution and extract by liter distillation flask of the vacuum dis-
shaking the funnel vigorously for 2 minutes. tillation assembly and distill at approxi-
Draw off the lower aqueous layer into a sec- mately 3-millimeter Hg pressure or less. Dis-
ond 500-milliliter separatory funnel and re- card the first 200-milliliter fraction of the
peat the extraction with 40 milliliters of iso- distillate and replace the distillate collec-
octane. Draw off and discard the aqueous tion flask with a clean one. Continue the dis-
layer. Wash each of the 40-milliliter extrac- tillation until approximately 1 liter of the
tives three times with 50-milliliter portions sulfoxide has been collected.
of distilled water. Shaking time for each At completion of the distillation, the rea-
wash is 1 minute. Discard the aqueous lay- gent should be stored in glass-stoppered bot-
ers. Filter the first extractive through anhy- tles since it is very hygroscopic and will
drous sodium sulfate prewashed with iso- react with some metal containers in the
octane (see Sodium sulfate under ‘‘Reagents presence of air.
and materials’’ for preparation of filter), into Phosphoric acid. 85 percent A.C.S. reagent
a 250-milliliter Erlenmeyer flask, or option- grade.
ally into the evaporating flask. Wash the Aluminum oxide (80–200 mesh Woelm neutral
first separatory funnel with the second 40- activity grade 1 [Brockmann], Alupharm Chemi-
milliliter isooctane extractive, and pass cals, New Orleans, La., or equivalent). Pipette
through the sodium sulfate into the flask. 1 milliliter of distilled water into a dry 250-
Then wash the second and first separatory milliliter Erlenmeyer flask equipped with a
funnels successively with a 10-milliliter por- ground-glass stopper. Stopper the flask and
tion of isooctane, and pass the solvent rotate it in such a manner as to completely
through the sodium sulfate into the flask. wet out the inside surfaces. When this has
Add 1 milliliter of n-hexadecane and evapo- been done add 180 grams of the aluminum
rate the isooctane on the steam bath under oxide and shake until no lumps or wet spots
440
remain. Allow to stand at room temperature the wax redissolves. (Remove stopper from
for a period of 2 hours. At the end of this the funnel at intervals to release pressure.)
time the water should be evenly distributed When the wax is in solution, remove the fun-
throughout the aluminum oxide powder, and nel from the jacket and shake it vigorously
it should have the same free flowing prop- for 2 minutes. Set up three 250-milliliter
erties as the original material (flow velocity separatory funnels with each containing 30
with water 0.2 milliliter per minute). At this milliliters of preequilibrated isooctane.
point the aluminum oxide has an activity of After separation of the liquid phases, allow
1 as expressed in Brockmann degrees, and to cool until the main portion of the wax-iso-
the amount of added water is 0.5 percent by octane solution begins to show a precipitate.
volume. This product is used in toto and as Gently swirl the funnel when precipitation
is, without further screening. first occurs on the inside surface of the fun-
Sodium sulfate, anhydrous, A.C.S. reagent nel to accelerate this process. Carefully draw
grade, preferably in granular form. For each off the lower layer, filter it slowly through a
bottle of sodium sulfate reagent used, estab- thin layer of glass wool fitted loosely in a fil-
lish as follows the necessary sodium sulfate ter funnel into the first 250-milliliter sepa-
prewash to provide such filters required in ratory funnel, and wash in tandem with the
the method: Place approximately 35 grams of 30-milliliter portions of isooctane contained
anhydrous sodium sulfate in a 30-milliliter in the 250-milliliter separatory funnels.
coarse, fritted-glass funnel or in a 65-milli- Shaking time for each wash is 1 minute. Re-
meter filter funnel with glass wool plug; peat the extraction operation with two addi-
wash with successive 15-milliliter portions of tional portions of the sulfoxide-acid mixture,
the indicated solvent until a 15-milliliter replacing the funnel in the jacket after each
portion of the wash shows 0.00 absorbance extraction to keep the wax in solution and
per centimeter pathlength between 280 mμ washing each extractive in tandem through
and 400 mμ when tested as prescribed under the same three portions of isooctane.
‘‘Organic solvents.’’ Usually three portions Collect the successive extractives (300 mil-
of wash solvent are sufficient. liliters total) in a separatory funnel (pref-
erably 2-liter), containing 480 milliliters of
PROCEDURE distilled water, mix, and allow to cool for a
few minutes after the last extractive has
Before proceeding with analysis of a sam- been added. Add 80 milliliters of isooctane to
ple, determine the absorbance in a 1-centi- the solution and extract by shaking the fun-
meter path cell between 250 mμ and 400 mμ nel vigorously for 2 minutes. Draw off the
for the reagent blank by carrying out the lower aqueous layer into a second separatory
procedure, without a wax sample, at room funnel (preferably 2-liter) and repeat the ex-
temperature, recording the spectrum after traction with 80 milliliters of isooctane.
the complete procedure as prescribed. The Draw off and discard the aqueous layer.
absorbance per centimeter pathlength fol- Wash each of the 80-milliliter extractives
lowing the complete procedure should not three times with 100-milliliter portions of
exceed 0.04 in the wavelength range from 280 distilled water. Shaking time for each wash
mμ to 299 mμ, inclusive, nor 0.02 in the wave- is 1 minute. Discard the aqueous layers. Fil-
length range from 300 mμ to 400 mμ. If in ei- ter the first extractive through anhydrous
ther spectrum the characteristic benzene sodium sulfate prewashed with isooctane (see
peaks in the 250 mμ-260 mμ region are Sodium sulfate under ‘‘Reagents and Mate-
present, remove the benzene by the proce- rials’’ for preparation of filter) into a 250-
dure under ‘‘Organic solvents’’ and record milliliter Erlenmeyer flask (or optionally
absorbance again. Place 300 milliliters of di- into the evaporation flask). Wash the first
methyl sulfoxide in a 1-liter separatory fun- separatory funnel with the second 80-milli-
nel and add 75 milliliters of phosphoric acid. liter isooctane extractive and pass through
Mix the contents of the funnel and allow to the sodium sulfate. Then wash the second
stand for 10 minutes. (The reaction between and first separatory funnels successively
the sulfoxide and the acid is exothermic. Re- with a 20-milliliter portion of isooctane and
lease pressure after mixing, then keep funnel pass the solvent through the sodium sulfate
stoppered.) Add 150 milliliters of isooctane into the flask. Add 1 milliliter of n-hexa-
and shake to preequilibrate the solvents. decane and evaporate the isooctane using an
Draw off the individual layers and store in aspirator vacuum under nitrogen and in an
glass-stoppered flasks. oil bath temperature of approximately 90 °C.
In a 1-liter separatory funnel place a rep- Discontinue evaporation when not over 1
resentative 25-gram sample of wax, add 50 milliliter of residue remains. To the residue,
milliliters of isooctane, heat gently, stir add a 10-milliliter portion of isooctane, re-
until the wax is in solution; add 100 milli- evaporate to 1 milliliter of hexadecane, and
liters of preequilibrated sulfoxide-phosphoric repeat this operation once.
acid mixture and shake, making sure it re- Reserve the residue for column chroma-
mains in solution. If the wax comes out of tography on the aluminum oxide. Fit the
solution during these operations, let the tetrafluoroethylene polymer disc on the
stoppered funnel remain in the jacket until upper part of the stem of the
441
§ 178.3770 21 CFR Ch. I (4–1–12 Edition)
chromatographic tube, then place the tube (b) The polyhydric alcohol esters
with the disc on the suction flask and apply identified in this paragraph may be
the vacuum (approximately 135 millimeters used as release agents in resinous and
Hg pressure). Weigh out 180 grams of the alu- polymeric coatings for polyolefin films
minum oxide and pour the adsorbent mixture
into the chromatographic tube in approxi-
mately 30-centimeter layers. After the addi- Such esters meet the following speci-
tion of each layer, level off the top of the ad- fications and are produced by partial
sorbent with a flat glass rod or metal plung- esterification of oxidatively refined
er by pressing down firmly until the adsorb- (Gersthofen process) montan wax acids
ent is well packed. Loosen the topmost few with equimolar proportions of ethylene
millimeters of each adsorbent layer with the glycol and 1,3-butanediol:
end of a metal rod before the addition of the (1) Dropping point 77°–82 °C, as deter-
next layer. Continue packing in this manner mined by ASTM method D566–76 (Re-
until all the 180 grams of the adsorbent is approved 1982), ‘‘Standard Test Method
added to the tube. Level off the top of the ad-
for Dropping Point of Lubricating
sorbent by pressing down firmly with a flat
glass rod or metal plunger to make the depth Grease,’’ which is incorporated by ref-
of the adsorbent bed approximately 80 centi- erence. The availability of this incor-
meters in depth. Turn off the vacuum and re- poration by reference is given in para-
move the suction flask. Dissolve the hexa- graph (a)(1) of this section.
decane residue in 10 milliliters of warm ben- (2) Acid value 25–35, as determined by
zene and decant the solution onto the col- ASTM method D1386–78 (‘‘Standard
umn and allow the liquid level to recede to Test Method for Acid Number (Empir-
barely above the adsorbent level. Rapidly ical) of Synthetic and Natural Waxes’’
complete the transfer similarly with two 10- (Revised 1978), which is incorporated by
milliliter portions of benzene swirling the
reference; copies are available from
flask repeatedly each time to assure ade-
quate washing of the residue. Fix the 1,000-
American Society for Testing and Ma-
milliliter reservoir onto the top of the terials (ASTM), 100 Barr Harbor Dr.,
chromatographic column. Just before the West Conshohocken, Philadelphia, PA
final 10-milliliter wash reaches the top of the 19428-2959, or available for inspection at
adsorbent, add 670 milliliters of benzene to the National Archives and Records Ad-
the reservoir and continue the percolation at ministration (NARA). For information
the 2–3 milliliter per minute rate until a on the availability of this material at
total of 670 milliliters of benzene has been NARA, call 202–741–6030, or go to: http://
utilized. Collect the eluate in a clean 1-liter www.archives.gov/federallregister/
Erlenmeyer flask (or optionally into a 1-liter
evaporation flask). Allow the column to
drain until most of the solvent mixture is re-
ibrllocations.html.) using as solvent xy-
moved. Add 1 milliliter of n-hexadecane and lene-ethyl alcohol in a 2:1 ratio instead
completely remove the benzene by evapo- of toluene-ethyl alcohol in a 1:2 ratio.
ration under nitrogen, using the special pro- (3) Saponification value 135–150, as
cedure to eliminate benzene as previously determined by ASTM method D1387–78
described under ‘‘Organic Solvents.’’ Quan- (‘‘Standard Test Method for Saponi-
titatively transfer the residue with isooctane fication Number (Empirical) of Syn-
to a 25-milliliter volumetric flask and adjust thetic and Natural Waxes’’ (Revised
to volume. Determine the absorbance of the 1978), which is incorporated by ref-
solution in the 1-centimeter pathlength cells
erence; copies are available from Amer-
compared to isooctane as reference between
250 mμ-400 mμ. Correct for any absorbance
ican Society for Testing and Materials
derived from the reagents as determined by (ASTM), 100 Barr Harbor Dr., West
carrying out the procedure without a wax Conshohocken, Philadelphia, PA 19428-
sample. If either spectrum shows the char- 2959, or available for inspection at the
acteristic benzene peaks in the 250 mμ-260 mμ National Archives and Records Admin-
region, evaporate the solution to remove istration (NARA). For information on
benzene by the procedure under ‘‘Organic the availability of this material at
Solvents.’’ Dissolve the residue, transfer NARA, call 202–741–6030, or go to: http://
quantitatively, and adjust to volume in iso-
octane in a 25-milliliter volumetric flask.
Record the absorbance again. If the cor-
rected absorbance does not exceed the limits ibrllocations.html.) using xylene-ethyl
alcohol in a 2:1 ratio instead of ethyl
prescribed in paragraph (a) of this section,

the wax meets the ultraviolet absorbance alcohol in preparation of potassium hy-
specifications. droxide solution.
442
(4) Ultraviolet absorbance limits reference in accordance with 5 U.S.C.

specified in paragraph (a)(4) of this sec- 552(a); the availability of this incorpo-
tion, as determined by the analytical ration by reference is given in para-
method described therein. graph (a)(2) of this section), using as a
(c) The polyhydric alcohol esters of solvent xylene-ethyl alcohol in a 2:1
oxidatively refined (Gersthofen proc- ratio instead of toluene-ethyl alcohol
ess) montan wax acids, identified in in a 2:1 ratio.
paragraph (a) or (b) of this section, (3) Saponification value 130–160, as
may also be used as a component of an determined by ASTM Method D–1387–78
aqueous dispersion of vinylidene chlo- ‘‘Standard Test Method for Saponifica-
ride copolymers, subject to the condition Number (Empirical) of Synthetic
tions described in paragraphs (c) (1) and Natural Waxes’’ (Revised 1978),
and (2) of this section. (which is incorporated by reference in
(1) The aqueous dispersion of the ad- accordance with 5 U.S.C. 552(a); the
ditive contains not more that 18 per- availability of this incorporation by
cent polyhydric alcohol esters of reference is given in paragraph (a)(3) of
oxidatively refined (Gersthofen proc- this section), using xylene-ethyl alco-
ess) montan wax acids, not more than 2 hol in a 2:1 ratio instead of ethyl alco-
percent poly(oxyethylene) (minimum hol in the preparation of potassium hy-
20 moles of ethylene oxide) oleyl ether droxide solution.
(CAS Reg. No. 9004–98–2), and not more (4) Ultraviolet absorbance limits
than 1 percent poly(oxyethylene) (min- specified in paragraph (a)(4) of this sec-
imum 3 moles ethylene oxide) cetyl al- tion, as determined by the analytical
cohols (CAS Reg. No. 9004–95–9). method described therein.
(2) The aqueous dispersion described [42 FR 14609, Mar. 15, 1977, as amended at 47
in paragraph (c)(1) of this section is FR 11848, Mar. 19, 1982; 49 FR 10113, Mar. 19,
used as an additive to aqueous disper- 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898,
sions of vinylidene chloride copoly- June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR
mers, regulated in §§ 175.300, 175.320, 17512, Apr. 5, 1993; 69 FR 24512, May 4, 2004]
175.360, 176.170, 176,180, and 177.1630 of
this chapter, at levels not to exceed 1.5 § 178.3780 Polyhydric alcohol esters of
percent (solids basis) in the finished long chain monobasic acids.
coating. Polyhydric alcohol esters of long
(d) The polyhydric alcohol esters chain monobasic acids identified in
identified in this paragraph may be this section may be safely used as lu-
used as lubricants in the fabrication of bricants in the fabrication of polyvinyl
vinyl chloride plastic food contact arti- chloride and/or polyvinyl chloride co-
cles prepared from vinyl chloride poly- polymer articles complying with
mers. Such esters meet the following § 177.1980 of this chapter that contact
specifications and are produced by par- food of Types I, II, IV-B, VI-B, VII-B,
tial esterification of oxidatively re- and VIII identified in table 1 in
fined (Gersthofen process) montan wax § 176.170(c) of this chapter under condi-
acids with glycerol followed by neu- tions of use E, F, and G described in
tralization: table 2 in § 176.170(c) of this chapter,
(1) Dropping point 79 to 85 °C, as de- subject to the provisions of this sec-
termined by the American Society for tion.
Testing and Materials (ASTM), Method (a) Identity. For the purpose of this
D–566–76 (Reapproved 1982), ‘‘Standard section, polyhydric alcohol esters of
Test Method for Dropping Point of Lu- long chain monobasic acids consist of
bricating Grease,’’ which is incor- polyhydric alcohol esters having num-
porated by reference in accordance ber average molecular weights in the
with 5 U.S.C. 552(a). The availability of range of 1,050 to 1,700. The esters are
this incorporation by reference is given produced by the reaction of either
in paragraph (a)(1) of this section. ethylene glycol or glycerol with long
(2) Acid value 20–30, as determined by chain monobasic acids containing from
ASTM Method D–1386–78 ‘‘Standard 9 to 49 carbon atoms obtained by the
Test Method for Acid Number (Empir- ozonization of long chain alpha-olefins,
ical) of Synthetic and Natural Waxes’’ the unreacted carboxylic acids in the
(Revised 1978) (which is incorporated by formation of the glycerol esters being
443
§ 178.3790 21 CFR Ch. I (4–1–12 Edition)
neutralized with calcium hydroxide to reference. Copies are available from

produce a composition having up to 2 American Association of Oil Chemists,
percent by weight calcium. The alpha- 36 East Wacker Drive, Chicago, IL
olefins, obtained from the polymeriza- 60601, or available for inspection at the
tion of ethylene, have 20 to 50 carbon National Archives and Records Admin-
atoms and contain a minimum of 75 istration (NARA). For information on
percent by weight straight chain alpha- the availability of this material at
olefins and not more than 25 percent NARA, call 202–741–6030, or go to: http://
vinylidene compounds. www.archives.gov/federallregister/
(b) Specifications. The polyhydric al- codeloflfederallregulations/
cohol esters have the following speci- ibrllocations.html.
fications: (4) Ultraviolet absorbance as speci-
(1) Melting point of 60–80 °C for the fied in § 178.3770(a)(4) of this chapter
ethylene glycol ester and 90–105 °C for when tested by the analytical method
the glycerol ester as determined by the described therein.
Fisher Johns method as described in [42 FR 14609, Mar. 15, 1977, as amended at 47
‘‘Semimicro Qualitative Organic Anal- FR 11849, Mar. 19, 1982; 54 FR 24899, June 12,
ysis—The Systematic Identification of 1989; 61 FR 14481, Apr. 2, 1996]
Organic Compounds,’’ by Cheronis and
Entrikin, 2d Ed., Interscience Pub- § 178.3790 Polymer modifiers in
lishers, NY, which is incorporated by semirigid and rigid vinyl chloride
plastics.
reference. Copies are available from
the Center for Food Safety and Applied The polymers identified in paragraph
Nutrition (HFS–200), Food and Drug (a) of this section may be safely
Administration, 5100 Paint Branch admixed, alone or in mixture with
Pkwy., College Park, MD 20740, or other permitted polymers, as modifiers
available for inspection at the National in semirigid and rigid vinyl chloride
Archives and Records Administration plastic food-contact articles prepared
(NARA). For information on the avail- from vinyl chloride homopolymers and/
ability of this material at NARA, call or from vinyl chloride copolymers com-
202–741–6030, or go to: http:// plying with § 177.1950, § 177.1970, and/or
www.archives.gov/federallregister/ § 177.1980 of this chapter, in accordance
codeloflfederallregulations/ with the following prescribed condi-
ibrllocations.html. tions:
(2) Acid value 15–25 for each ester as (a) For the purpose of this section,
determined by the A.O.C.S. method the polymer modifiers are identified as
Trla-64T ‘‘Titer Test,’’ which is incor- follows:
porated by reference. Copies are avail- (1) Acrylic polymers identified in this
able from American Association of Oil subparagraph provided that such poly-
Chemists, 36 East Wacker Drive, Chi- mers contain at least 50 weight-percent
cago, IL 60601, or available for inspec- of polymer units derived from one or
tion at the National Archives and more of the monomers listed in para-
Records Administration (NARA). For graph (a)(1)(i) of this section.
information on the availability of this (i) Homopolymers and copolymers of
material at NARA, call 202–741–6030, or the following monomers:
go to: http://www.archives.gov/ n-Butyl acrylate.
federallregister/ n-Butyl methacrylate.
codeloflfederallregulations/ Ethyl acrylate.
ibrllocations.html. The method is modi- Methyl methacrylate.
fied to use as the acid solvent a 1:1 vol- (ii) Copolymers produced by co-
ume mixture of anhydrous isopropyl al- polymerizing one or more of the mono-
cohol and toluene. The solution is mers listed in paragraph (a)(1)(i) of this
titrated with 0.1N methanolic sodium section with one or more of the fol-
hydroxide. lowing monomers:
(3) Saponification value 120–160 for
Acrylonitrile.
the ethylene glycol ester and 90–130 for Butadiene.
the glycerol ester as determined the
a-Methylstyrene.
A.O.C.S. method Trla-64T ‘‘Saponifica- Styrene.
tion Value,’’ which is incorporated by Vinylidene chloride.
444
(iii) Polymers identified in para- than 30 weight-percent of polymer

graphs (a)(1) (i) and (ii) of this section units derived from copolymers of meth-
containing no more than 5 weight-per- yl methacrylate, a-methylstyrene and
cent of total polymer units derived by acrylonitrile and may optionally con-
copolymerization with one or more of tain up to 15 weight-percent of polymer
the following monomers: units derived from butadiene-styrene
Acrylic acid.
copolymers.
1,3-Butylene glycol dimethacrylate. (c) No chemical reactions, other than
Divinylbenzene. addition reactions, occur among the
Methacrylic acid. vinyl chloride polymers and the modi-
(iv) Mixtures of polymers identified fying polymers present in the polymer
in paragraph (a)(1) (i), (ii), and (iii) of mixture used in the manufacture of the
this section; provided that no chemical finished plastic food-contact article.
reactions, other than addition reac- (d) The finished plastic food-contact
tions, occur when they are mixed. article, when extracted with the sol-
(2) Polymers identified in paragraph vent or solvents characterizing the
(a)(1) of this section combined during type of food and under the conditions
their polymerization with butadiene- of time and temperature characterizing
styrene copolymers; provided that no the conditions of its intended use as de-
chemical reactions, other than addi- termined from tables 1 and 2 of
tion reactions, occur when they are § 176.170(c) of this chapter, yields ex-
combined. Such combined polymers tractives not to exceed the limits pre-
may contain 50 weight-percent or more scribed in § 177.1010 (b) (1), (2), (3), and
of total polymer units derived from the (4) of this chapter when tested by the
butadiene-styrene copolymers. methods prescribed in § 177.1010 (c) of
(b) The polymer content of the fin- this chapter.
ished plastic food-contact article con- (e) Acrylonitrile copolymers identi-
sists of: fied in this section shall comply with
(1) Not less than 80 weight-percent of the provisions of § 180.22 of this chap-
polymer units derived from the vinyl ter.
chloride polymers identified in the in-
§ 178.3800 Preservatives for wood.
troduction to this section and not more
than 5 weight-percent of polymer units Preservatives may be safely used on
derived from polymers identified in wooden articles that are used or in-
paragraph (a)(1) of this section and tended for use in packaging, trans-
may optionally contain up to 15 porting, or holding raw agricultural
weight-percent of polymer units de- products subject to the provisions of
rived from butadiene-styrene copoly- this section:
mers; or (a) The preservatives are prepared
(2) Not less than 50 weight-percent of from substances identified in para-
polymer units derived from the vinyl graph (b) of this section and applied in
chloride polymers identified in the in- amounts not to exceed those necessary
troduction to this section, not more to accomplish the technical effect of
than 50 weight-percent of polymer protecting the wood from decay, mil-
units derived from homopolymers and/ dew, and water absorption.
or copolymers of ethyl acrylate and (b) The substances permitted are as
methyl methacrylate, and not more follows:
Copper-8-quinolinolate.
Mineral spirits.
Paraffin wax ................................................................................. Used singly or in combination so as to constitute not less than
50% of the solids.
Petroleum hydrocarbon resin, produced by the homo- and co- Do.
polymerization of dienes and olefins of the aliphatic, alicyclic,
and monobenzenoid arylalkene type from distillates of
cracked petroleum stocks.
Pentachlorophenol and its sodium salt ....................................... Not to exceed 50 p.p.m. in the treated wood, calculated as
pentachlorophenol.
445
§ 178.3850 21 CFR Ch. I (4–1–12 Edition)
Rosins and rosin derivatives ....................................................... As provided in § 178.3870.

Zinc salt of sulfonated petroleum.
§ 178.3850 Reinforced wax. List of substances Limitations
Reinforced wax may be safely used as Copolymer of isobutylene modi-

an article or component of articles in- fied with isoprene.
Petroleum wax, Type I and Type
tended for use in producing, manufac- II.
turing, packing, processing, trans- Polyethylene.
porting, or holding food subject to the Rosins and rosin derivatives as
provided in § 178.3870.
provisions of this section. Synthetic wax polymer as de- Not to exceed 5 percent
(a) Reinforced wax consists of petro- scribed in § 176.170(a)(5) of by weight of the petro-
leum wax to which have been added this chapter. leum wax.
certain optional substances required in
its production, or added to impart de- (e) Reinforced wax conforming with
sired physical or technical properties. the specifications in this paragraph is
(b) The quantity of any optional ad- used as provided in paragraph (e)(2) of
juvant substance employed in the pro- this section.
duction of or added to reinforced wax (1) The chloroform-soluble portion of
does not exceed the amount reasonably the water extract obtained by exposing
required to accomplish the intended reinforced wax to demineralized water
physical or technical effect or any lim- at 70 °F for 48 hours shall not exceed 0.5
itation provided in this section. milligram per square inch of food-con-
(c) Any substance employed in the tact surface.
production of reinforced wax, including (2) It is used as a packaging material
any optional substance, that is the sub- or component of packaging materials
ject of a regulation in parts 174, 175, for cheese and cheese products.
176, 177, 178 and § 179.45 of this chapter, [42 FR 14609, Mar. 15, 1977, as amended at 47
conforms with any specification in FR 1288, Jan. 12, 1982]
such regulation.
(d) The substances and optional adju- § 178.3860 Release agents.
vant substances employed in the pro- Substances listed in paragraph (b) of
duction of or added to reinforced wax this section may be safely used as re-
include: lease agents in petroleum wax com-
(1) Substances generally recognized plying with § 178.3710 and in polymeric
as safe in food. resins that contact food, subject to the
(2) Substances subject to prior sanc- provisions of this section.
tion for use in reinforced wax and used (a) The quantity used shall not ex-
in accordance with such sanction or ap- ceed the amount reasonably required
proval. to accomplish the intended technical
(3) Substances identified in this sub- effect or any limitations prescribed in
paragraph and subject to any limita- this section.
tions provided therein: (b) Release agents:
Erucamide (erucylamide).
Formaldehyde, polymer with 1-naphthalenol (CAS For use only as an antiscaling or release agent, applied on the internal
Reg. No. 25359–91–5). parts of reactors employed in the production of polyvinyl chloride and
acrylic copolymers, provided that the residual levels of the additive in the
ploymer do not exceed 4 parts per million.
N,N′-Dioleoylethylenediamine ................................. For use only in polyvinyl chloride films in amounts such that the concentra-
tion of the substance in these films in the form in which the films contact
food shall not exceed 0.055 milligram of the substance per square inch of
film.
Oleyl palmitamide.
Polybutene, hydrogenated; complying with the For use only subject to the limitations prescribed for hydrogenated
identity prescribed under § 178.3740(b). polybutene under § 178.3740(b).
446
Poly(vinyl acetate/vinyl N-octadecylcarbamate) For use only in application to the backing of pressuresensitive adhesive
(CAS Reg. No. 70892–21–6) produced by the tapes at levels not to exceed 0.2 milligram per square centimeter (1.29
reaction between stoichiometrically equivalent milligrams per square inch) of backing.
amounts of octadecyl isocyanate and vinyl alco-
hol/vinyl acetate copolymer; minimum average
molecular weight is 500,000.
Rice bran wax ......................................................... For use only in plastics intended for contact with dry foods identified as
Type VIII in table 1 of § 176.170(c) of this chapter, at levels not in excess
of 1.0 percent by weight of the polymer.
Saturated fatty acid amides manufactured from
fatty acids derived from animal, marine, or vege-
table fats and oils.
Stearyl erucamide.
[42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979; 46 FR 51902, Oct. 23, 1981;
61 FR 25396, May 21, 1996; 61 FR 42381, Aug. 15, 1996]
§ 178.3870 Rosins and rosin deriva- cent, a minimum drop-softening point

tives. of 79 °C, and a color of X or paler.
The rosins and rosin derivatives iden- (iii) Partially dimerized rosin,
tified in paragraph (a) of this section dimerized by sulfuric acid catalyst to a
may safely be used in the manufacture drop-softening point of 95°–105 °C and a
of articles or components of articles in- color of WG or paler.
tended for use in producing, manufac- (iv) Fully dimerized rosin, dimerized
turing, packing, processing, preparing, by sulfuric acid catalyst, and from
treating, packaging, transporting, or which sufficient nondimerized rosin
holding food, subject to the provisions has been removed by distillation to
of this section. achieve a minimum drop-softening
(a) The rosins and rosin derivatives point of 143 °C, and a color of H or
are identified as follows: paler.
(1) Rosins: (v) Disproportionated rosin, catalyt-
(i) Gum rosin, refined to color grade ically disproportionated to a minimum
of K or paler. dehydroabietic acid content of 35 per-
(ii) Wood rosin, refined to color grade cent, a maximum abietic acid content
of K or paler. of 1 percent, a maximum content of
(iii) Tall oil rosin, refined to color substituted phenanthrenes (as retene)
grade of K or paler. of 0.25 percent, and a color of WG or
(iv) Dark tall oil rosin, a fraction re- paler.
sulting from the refining of tall oil (3) Rosin esters manufactured from
rosin produced by multicolumnar dis- rosins and modified rosins identified in
tillation of crude tall oil to effect re- paragraphs (a)(1) and (2) of this section:
moval of fatty acids and pitch compo-
(i) Glycerol ester of wood rosin puri-
nents and having a saponification num-
fied by steam stripping to have an acid
ber of from 110–135 and 32 percent–44
number of 3 to 9, a drop-softening point
percent rosin acids.
(v) Dark wood rosin, all or part of the of 88°–96 °C, and a color of N or paler.
residue after the volatile terpene oils (ii) Glycerol ester of partially hydro-
are distilled from the oleoresin ex- genated wood rosin, having an acid
tracted from pine wood. number of 3 to 10, a drop-softening
(2) Modified rosins manufactured point of 79°–88 °C, and a color of N or
from rosins identified in paragraph paler.
(a)(1) of this section: (iii) Glycerol ester of partially
(i) Partially hydrogenated rosin, cat- dimerized rosin, having an acid number
alytically hydrogenated to a maximum of 3 to 8, a drop-softening point of 109°–
refractive index of 1.5012 at 100 °C, and 119 °C, and a color of M or paler.
a color of WG or paler. (iv) Glycerol ester of fully dimerized
(ii) Fully hydrogenated rosin, cata- rosin, having an acid number of 5 to 16,
lytically hydrogenated to a maximum a drop-softening point of 165°–175 °C,

dehydroabietic acid content of 2 per- and a color of H or paler.
447
§ 178.3870 21 CFR Ch. I (4–1–12 Edition)
(v) Glycerol ester of maleic anhy- (xiv) Mixed methyl and pentaeryth-
dride-modified wood rosin, having an ritol ester of maleic anhydride-modi-
acid number of 30 to 40, a drop-soft- fied wood rosin, having an acid number
ening point of 138°–146 °C, a color of M of 73 to 83, a drop-softening point of
or paler, and a saponification number 113°–123 °C, a color of M or paler, and a
less than 280. saponification number less than 280.
(vi) Methyl ester of rosin, partially (xv) Triethylene glycol ester of par-
hydrogenated, purified by steam strip- tially hydrogenated wood rosin, having
ping to have an acid number of 4 to 8, an acid number of 2 to 10, a color of K
a refractive index of 1.5170 to 1.5205 at or paler, and a viscosity of 350 to 425
20 °C, and a viscosity of 23 to 66 poises seconds Saybolt at 100 °C.
at 25 °C. (xvi) Glycerol ester of maleic anhy-
(vii) Pentaerythritol ester of wood dride-modified wood rosin, having an
rosin, having an acid number of 6 to 16, acid number of 17 to 23, a drop-soft-
a drop-softening point of 109°–116 °C, ening point of 136°–140 °C, a color of M
and a color of M or paler. or paler, and a saponification number
(viii) Pentaerythritol ester of par- less than 280. For use only in cello-
tially hydrogenated wood rosin, having phane complying with § 177.1200 of this
an acid number of 7 to 18, a drop-soft- chapter.
ening point of 102°–110 °C, and a color of (xvii) Citric acid-modified glycerol
K or paler. ester of rosin, having an acid number
(ix) Pentaerythritol ester of maleic less than 20, a drop-softening point of
anhydride-modified wood rosin, having 105°–115 °C, and a color of K or paler.
an acid number of 8 to 16, a drop-soft- For use only as a blending agent in
ening point of 154°–162 °C, a color of M coatings for cellophane complying with
or paler, and having a saponification § 177.1200 of this chapter.
number less than 280. (xviii) Glycerol ester of tall oil rosin,
(x) Pentaerythritol ester of maleic purified by steam stripping to have an
anhydride-modified wood rosin, having acid number of 5–12, a softening point
an acid number of 9 to 16, a drop-soft- of 80°–88 °C, and a color of N or paler.
ening point of 130°–140 °C, a color of N (xix) Glycerol ester of maleic anhy-
or paler, and having a saponification dride-modified tall oil rosin, having an
number less than 280. acid number of 30 to 40, a drop-soft-
(xi) Pentaerythritol ester of maleic ening point of 141°–146 °C, a color of N
anhydride-modified wood rosin, having or paler, and a saponification number
an acid number of 134 to 145, a drop- less than 280.
softening point of 127°–137 °C, a color of (xx) Glycerol ester of
M or paler, and having a saponification disproportionated tall oil rosin, having
number less than 280. an acid number of 5 to 10, a drop-soft-
(xii) Pentaerythritol ester of maleic ening point of 84°–93 °C, a color of WG
anhydride-modified wood rosin, having or paler, and a saponification number
an acid number of 30 to 40, a drop-soft- less than 180.
ening point of 131°–137 °C, a color of N (4) Rosin salts and sizes—Ammo-
or paler, and having a saponification nium, calcium, potassium, sodium, or
number less than 280. zinc salts of rosin manufactured by the
(xiii) Pentaerythritol ester of maleic partial or complete saponification of
anhydride-modified wood rosin, further any one of the rosins or modified rosins
modified by reaction with 4,4′-iso- identified in paragraph (a)(1) and (2) of
propyl-idenediphenol-formaldehyde this section, or blends thereof, and
condensate, having an acid number of with or without modification by reac-
10 to 22, a drop-softening point of 162°– tion with one or more of the following:
172 °C, a color of K or paler, a saponi- (i) Formaldehyde.
fication number less than 280, and a (ii) Fumaric acid.
maximum ultraviolet absorbance of (iii) Maleic anhydride.
0.14 at 296 mμ (using a 1-centimeter cell (iv) Saligenin.
and 200 milligrams of the rosin ester (b) The quantity used shall not ex-
per liter of solvent consisting of ethyl ceed the amount reasonably required
alcohol made alkaline by addition of to accomplish the intended technical

0.1 percent of potassium hydroxide). effect.
448
(c) The use in any substance or arti- (4) Viscosity: Viscosity in poises
cle that is the subject of a regulation shall be as determined by ASTM meth-
in parts 174, 175, 176, 177, 178 and § 179.45 od D1824–66 (Reapproved 1980), ‘‘Stand-
of this chapter shall conform with any ard Test Method for Apparent Vis-
specifications and limitations pre- cosity of Plastisols and Organosols at
scribed by such regulation for the fin- Low Shear Rates by Brookfield Vis-
ished form of the substance or article. cometer,’’ and in Saybolt seconds by
(d) The provisions of this section are ASTM method D88–81, ‘‘Standard Test
not applicable to rosins and rosin de- Method for Saybolt Viscosity,’’ which
rivatives identified in § 175.300(b)(3)(v) are incorporated by reference. The
of this chapter and used in resinous availability of this incorporation by
and polymeric coatings complying with reference is given in paragraph (f)(1) of
§ 175.300 of this chapter. this section.
(e) The provisions of this section are (5) Softening point: Softening point
not applicable to rosins and rosin de- shall be as determined by ASTM meth-
rivatives identified in § 175.105(c)(5) of od E28–67, ‘‘Standard Test Method for
this chapter and used in defoaming Softening Point by Ring and Ball Ap-
agents complying with § 176.210 of this
paratus’’ (Reapproved 1977), which is
chapter, food-packaging adhesives
incorporated by reference. Copies are
complying with § 175.105 of this chapter,
available from American Society for
and rubber articles complying with
Testing and Materials (ASTM), 100
(f) The analytical methods for deter-
Philadelphia, PA 19428-2959, or avail-
mining whether rosins and rosin de-
rivatives conform to the specifications able for inspection at the National Ar-
prescribed in paragraph (a) of this sec- chives and Records Administration
tion are as follows: (NARA). For information on the avail-
(1) Color: Color shall be as deter- ability of this material at NARA, call
mined by ASTM method D509–70 (Re- 202–741–6030, or go to: http://
approved 1981), ‘‘Standard Methods of www.archives.gov/federallregister/
Sampling and Grading Rosin,’’ which is codeloflfederallregulations/
incorporated by reference. Copies may ibrllocations.html.
be obtained from the American Society (6) Analytical methods for deter-
for Testing Materials, 100 Barr Harbor mining drop-softening point, saponi-
Dr., West Conshohocken, Philadelphia, fication number, and any other speci-
PA 19428-2959, or may be examined at fications not listed under paragraphs
the National Archives and Records Ad- (f)(1) through (5) of this section, titled:
ministration (NARA). For information (i) ‘‘Determination of Abeitic Acid and
on the availability of this material at Dehydroabietic Acid in Rosins’’; (ii)
NARA, call 202–741–6030, or go to: http:// ‘‘Determination of Softening Point of
www.archives.gov/federallregister/ Solid Resins’’; (iii) ‘‘Determination of
codeloflfederallregulations/ Saponification Number of Rosin
ibrllocations.html. Esters,’’ and (iv) ‘‘Determination of
(2) Refractive index: Refractive index Phenolic Modification of Rosin Deriva-
shall be as determined by ASTM meth- tives,’’ which are incorporated by ref-
od D1747–62 (Reapproved 1978), ‘‘Stand- erence. Copies are available from the
ard Test Method for Refractive Index of Center for Food Safety and Applied Nu-
Viscous Materials,’’ which is incor- trition (HFS–200), Food and Drug Ad-
porated by reference. The availability ministration, 5100 Paint Branch Pkwy.,
of this incorporation by reference is College Park, MD 20740, or available for
given in paragraph (f)(1) of this section. inspection at the National Archives
(3) Acid number: Acid number shall and Records Administration (NARA).
be as determined by ASTM method For information on the availability of
D465–82, ‘‘Standard Test Methods for this material at NARA, call 202–741–
Acid Number of Rosin,’’ which is incor- 6030, or go to: http://www.archives.gov/
porated by reference. The availability
federallregister/
of this incorporation by reference is
given in paragraph (f)(1) of this section.
449
§ 178.3900 21 CFR Ch. I (4–1–12 Edition)
codeloflfederallregulations/ § 178.3910 Surface lubricants used in

ibrllocations.html. the manufacture of metallic arti-
cles.
FR 11849, Mar. 19, 1982; 49 FR 10113, Mar. 19, The substances listed in this section
1984; 54 FR 24899, June 12, 1989] may be safely used in surface lubri-
cants employed in the manufacture of
§ 178.3900 Sodium metallic articles that contact food,
pentachlorophenate. subject to the provisions of this sec-
tion.
Sodium pentachlorophenate may be
(a) The following substances may be
safely used as a preservative for ammo-
used in surface lubricants used in the
nium alginate employed as a proc-
rolling of metallic foil or sheet stock
essing aid in the manufacture of poly- provided that total residual lubricant
vinyl chloride emulsion polymers in- remaining on the metallic article in
tended for use as articles or compo- the form in which it contacts food does
nents of articles that contact food at not exceed 0.015 milligram per square
temperatures not to exceed room tem- inch of metallic food-contact surface:
perature. The quantity of sodium (1) Substances identified in para-
pentachlorophenate used shall not ex- graphs (b)(1) and (2) of this section.
ceed 0.5 percent by weight of ammo- (2) Substances identified in this para-
nium alginate solids. graph.
a-Butyl-W-–hydroxypoly (oxyethylene)-poly (oxypropylene)

(CAS Reg. No. 9038–95–3) produced by random condensa-
tion of a 1:1 mixture by weight of ethylene oxide and pro-
pylene oxide with butanol and having a minimum molecular
weight of 1,000.
a–Butyl–W–hydroxypoly(oxypropylene) (CAS Reg. No. 9003-
13–8) having a minimum molecular weight of 1000.
a–Lauroyl–W–hydroxpoly(oxyethylene) (CAS Reg. No. 9004–
81–3) having a minimum molecular weight of 200.
Acetate esters derived from synthetic straight chain alcohols
(complying with § 172.864 of this chapter) that have even
numbers of carbon atoms in the range C8-C18.
alpha-Alkyl–omega-hydroxypoly(oxyethylene) produced by the
condensation of 1 mole of C12-C15 straight chain primary al-
cohols with an average of 3 moles of ethylene oxide (CAS
Reg. No. 68002–97–1).
Benzotriazole (CAS Reg. No. 95–14–7).
Bis(hydrogenated tallow alkyl)amine (CAS Reg. No. 61789– Not to be used in combination with sodium nitrite.
79–5).
Bis(hydrogenated tallow alkyl)aminoethanol (CAS Reg. No.
116438–56–3).
N,N-Bis(2-hydroxyethyl)butylamine (CAS Reg. No. 102–79–4).
Tert-Butyl alcohol.
Di(2-ethylhexyl)phthalate.
Diethyl phthalate.
Diethylene glycol monobutylether (CAS Reg. No. 112–34–5).
Dimers, trimers, and/or their partial methyl esters; such dimers For use only at a level not to exceed 10 percent by weight of
and trimers are of unsaturated C18 fatty acids derived from finished lubricant formulation.
animal and vegetable fats and oils and/or tall oil, and such
partial methyl esters meet the following specifications: Sa-
ponification value 180–200, acid value 70–130, and max-
imum iodine value 120.
Di-n-octyl sebacate.
Ethylenediaminetetraacetic acid, sodium salts.
Isopropyl alcohol.
Isopropyl laurate (CAS Reg. No. 10233–13–3) .......................... For use at a level not to exceed 10 percent by weight of the
finished lubricant formulation.
Isopropyl oleate.
Isotridecyl alcohol, ethoxylated (CAS Reg. No. 9043–30–5).
Methyl esters of coconut oil fatty acids.
Methyl esters of fatty acids (C16-C18) derived from animal and
vegetable fats and oils.
Polybutene, hydrogenated: complying with the identity pre-
scribed under § 178.3740(b).

Polyisobutylene (minimum molecular weight 300).
450
Polyoxyethylated (5 moles) tallow amine (CAS Reg. No.

61791–26–2).
Polyvinyl alcohol.
Sodium nitrite ............................................................................... For use only as a rust inhibitor in lubricant formulations pro-
vided the total residual sodium nitrite on the metallic article
in the form in which it contacts food does not exceed 0.007
milligram per square inch of metallic food-contact surface.
Sodium petroleum sulfonate, MW 440–450 (CAS Reg. No.
68608–26–4) derived from naphthenic oil having a Saybolt
viscosity range of 500–600 Saybolt Universal Seconds (SUS
at 37–8 °C (100 °F) as determined by ASTM method D88–
81, ‘‘Standard Test Method for Saybolt Viscosity,’’ which is
incorporated by reference. Copies are available from the
American Society for Testing Materials, 1961 Race St.,
Philadelphia, PA 19103, or available for inspection at the Na-
Synthetic alcohol mixture of straight-and branched-chain alco-
hols that have even numbers of carbon atoms in the range
C4C18 and that are prepared from ethylene, aluminum, and
hydrogen such that the finished synthetic alcohol mixture
contains not less than 75 pct of straight-chain primary alco-
hols and contains not less than 85 pct total C10 and C12 al-
cohols.
Synthetic primary alcohol mixture of straight- and branched- For use at a level not to exceed 8 pct by weight of the finished
chain alcohols that contain at least 99 pct primary alcohols lubricant formulation.
consisting of the following: not less than 70 pct normal alco-
hols; not less than 96.5 pct C12-C15 alcohols; and not more
than 2.5 pct alpha, omega C13-C16 diols. The alcohols are
prepared from linear olefins from a purified kerosene frac-
tion, carbon monoxide and hydrogen using a modified oxo
process, such that the finished primary alcohol mixture
meets the following specifications: Molecular weight, 207±4;
hydroxyl number, 266–276.
Synthetic primary alcohol mixture of straight- and branched- For use only at a level not to exceed 8 pct by weight of the fin-
chain alcohols that contain at least 99 pct primary alcohols ished lubricant formulation.
consisting of the following: not less than 70 percent normal
alcohols; not less than 93 pct C12-C13 alcohols; not more
than 5 pct C14-C15 alcohols; and not more than 2.5 pct
alpha, omega, C13-C16 diols. The alcohols are prepared from
linear olefins from a purified kerosene fraction, carbon mon-
oxide and hydrogen using a modified oxo process, such that
the finished primary alcohol mixture meets the following
specifications:
Molecular weight 194±5; hydroxyl number, 283–296.
Tallow, sulfonated.
Triethanolamine.
(3) Mineral oil conforming to the affinic, isoparaffinic, napthenic, or aro-

identity prescribed in § 178.3620(c). matic in nature, and meet the fol-
(4) Light petroleum hydrocarbons lowing specifications:
identified in paragraph (a)(4) (i) of this (a) Initial boiling point is 24 °C min-
section: Provided, That the total resid- imum and final boiling point is 288 °C
ual lubricant on the metallic article in maximum, as determined by ASTM
the form in which it contacts food method D86–82, ‘‘Standard Method for
meets the ultraviolet absorbance lim- Distillation of Petroleum Products,’’
its prescribed in paragraph (a) (4) (ii) of which is incorporated by reference.
this section as determined by the ana- Copies may be obtained from the Amer-
lytical method described in paragraph ican Society for Testing Materials, 100
(a) (4) (iii) of this section. Barr Harbor Dr., West Conshohocken,
(i) Light petroleum hydrocarbons are Philadelphia, PA 19428-2959, or may be
derived by distillation from virgin pe- examined at the National Archives and
troleum stocks or are synthesized from Records Administration (NARA). For

petroleum gases. They are chiefly par- information on the availability of this
451
§ 178.3910 21 CFR Ch. I (4–1–12 Edition)
material at NARA, call 202–741–6030, or under ultraviolet light to detect any residual
go to: http://www.archives.gov/ fluorescent contamination. As a pre-
federallregister/ cautionary measure it is recommended prac-
tice to rinse all glassware with purified iso-
codeloflfederallregulations/ octane immediately before use. No grease is
ibrllocations.html. to be used on stopcocks or joints. Great care
(b) Nonvolatile residue is 0.005 gram to avoid contamination of oil samples in
per 100 milliliters, maximum, as deter- handling and to assure absence of any extra-
mined by ASTM method D381–80, neous material arising from inadequate
‘‘Standard Test Method for Existent packaging is essential. Because some of the
Gum in Fuels by Jet Evaporation,’’ polynuclear hydrocarbons sought in this test
when the final boiling point is 121 °C or are very susceptible to photo-oxidation, the
above and by ASTM method D1353–78, entire procedure is to be carried out under
subdued light.
‘‘Standard Test Method for Nonvolatile
Matter in Volatile Solvents for Use in APPARATUS
Paint, Varnish, Lacquer, and Related Separatory funnels. 250-milliliter, 500-milli-
Products,’’ when the final boiling point liter, 1,000-milliliter, and preferably 2,000-
is below 121 °C. These ASTM methods milliliter capacity, equipped with tetra-
are incorporated by reference. The fluoroethylene polymer stopcocks.
availability of these incorporations by Evaporation flask (optional). 250-milliliter or
reference is given in paragraph 500-milliliter capacity all-glass flask
(a)(4)(i)(a) of this section. equipped with standard-taper stopper having
(c) Saybolt color 20 minimum as de- inlet and outlet tubes to permit passage of
nitrogen across the surface of contained liq-
termined by ASTM method D156–82,
uid to be evaporated.
‘‘Standard Test Method for Saybolt Spectrophotometric cells. Fused quartz cells,
Color of Petroleum Products (Saybolt optical path length in the range of 5,000 cen-
Chromometer Method),’’ which is in- timeters ±0.005 centimeter; also for checking
corporated by reference. The avail- spectrophotometer performance only, optical
ability of this incorporation by ref- path length in the range 1.000 centimeter
erence is given in paragraph (a)(4)(i)(a) ±0.005 centimeter. With distilled water in the
of this section. cells, determine any absorbance differences.
Spectrophotometer. Special range 250
(d) Aromatic component content
millicrons-400 millimicrons with spectral slit
shall not exceed 32 percent. width of 2 millimicrons or less; under instru-
(e) Conforms with ultraviolet absorb- ment operating conditions for these absorb-
ance limits prescribed in § 178.3620(c) as ance measurements, the spectrophotometer
determined by the analytical method shall also meet the following performance
described therein. requirements:
(ii) Ultraviolet absorbance limits on Absorbance repeatability, ±0.01 at 0.4 ab-
residual lubricants are as follows: sorbance.
Absorbance accuracy, 1 ±0.05 at 0.4 absorb-
Maximum ance.
absorb- Wavelength repeatability, ±0.2 milli-
ance per 5
Wavelength (mμ) centi- micron.
meters op- Wavelength accuracy, ±1.0 millimicron.
tical
pathlength
1 As determined by procedure using potas-
280–289 ............................................................... 0.7 sium chromate for reference standard and
290–299 ............................................................... .6 described in National Bureau of Standards
300–359 ............................................................... .4
360–400 ............................................................... .09
Circular 484, Spectrometry, U.S. Department
of Commerce (1949), which is incorporated by
reference. Copies are available from the Cen-
(iii) The analytical method for deter- ter for Food Safety and Applied Nutrition
mining ultraviolet absorbance limits (HFS–200), Food and Drug Administration,
on residual lubricants is as follows: 5100 Paint Branch Pkwy., College Park, MD
20740, or available for inspection at the Na-
tional Archives and Records Administration
Because of the sensitivity of the test, the (NARA). For information on the availability
possibility of errors arising from contamina- of this material at NARA, call 202–741–6030,
tion is great. It is of the greatest importance or go to: http://www.archives.gov/
that all glassware be scrupulously cleaned to federallregister/codeloflfederallregulations/
remove all organic matter such as oil, ibrllocations.html. The accuracy is to be de-
grease, detergent, residues, etc. Examine all termined by comparison with the standard
glassware including stoppers and stopcocks, values at 210, 345, and 400 millimicrons.
452
Soxhlet apparatus. 60-millimeter diameter Absorb-
body tubes fitted with condenser and 500-mil- Wavelength ance (max-
liliter round-bottom boiling flask. A supply imum)
of paper thimbles to fit is required. 280 ....................................................................... .06
Nitrogen cylinder. Water-pumped or equiva- 300 ....................................................................... .015
lent purity nitrogen in cylinder equipped
with regulator and valve to control flow at 5 There shall be no irregularities in the ab-
p.s.i.g. sorbance curve within these wavelengths.
Phosphoric acid. 85 percent A.C.S. reagent
REAGENTS AND MATERIALS
grade.
Organic solvents. All solvents used through- Sodium sulfate, anhydrous, A.C.S. reagent
out the procedure shall meet the specifica- grade, preferably in granular form. For each
tions and tests described in this specifica- bottle of sodium sulfate reagent used, estab-
tion. The isooctane (2,2,4-trimethylpentane) lish as follows the necessary sodium sulfate
shall pass the following test: prewash to provide such filters required in
Place 180 milliliters of solvent in a 250-mil- the method: Place approximately 35 grams of
liliter Erlenmeyer flask, add 1 milliliter of anhydrous sodium sulfate in a 30-milliliter
purified n-hexadecane and evaporate on the coarse, fritted-glass funnel or in a 65-milli-
steam bath under a stream of nitrogen (a liter filter funnel with glass wool plug; wash
loose aluminum foil jacket around the flask with successive 15-milliliter portions of the
will speed evaporation). Discontinue evapo- indicated solvent until a 15-milliliter portion
ration when not over 1 milliliter of residue of the wash shows 0.00 absorbance per centi-
remains. meter path length between 280 mμ and 400 mμ
Alternatively, the evaporation time can be when tested as prescribed under ‘‘Organic
reduced by using the optional evaporation solvents.’’ Usually three portions of wash
flask. In this case the solvent and n-hexa- solvent are sufficient.
decane are placed in the flask on the steam Before proceeding with analysis of a sam-
bath, the tube assembly is inserted, and a ple, determine the absorbance in a 5-centi-
stream of nitrogen is fed through the inlet meter path cell between 250 millimicrons and
tube while the outlet tube is connected to a 400 millimicrons for the reagent blank by
solvent trap and vacuum line in such a way carrying out the procedure, without a metal
as to prevent any flow-back of condensate sample. The absorbance per centimeter path
into the flask. length should not exceed 0.02 in the wave-
Dissolve the 1 milliliter of hexadecane res- length range from 280 mμ to 400 mμ.
idue in isooctane and make to 25 milliliters Place 300 milliliters of dimethyl sulfoxide
volume. Determine the absorbance in the 5- in a 1-liter separatory funnel and add 75 mil-
centimeter path length cells compared to liliters of phosphoric acid. Mix the contents
isooctane as reference. The absorbance of the of the funnel and allow to stand for 10 min-
solution of the solvent residue shall not ex- utes. (The reaction between the sulfoxide
ceed 0.01 per centimeter path length between and the acid is exothermic. Release pressure
280 and 400 mμ. Purify, if necessary, by pas- after mixing, then keep funnel stoppered.)
sage through a column of activated silica gel Add 150 milliliters of isooctane and shake to
(Grade 12, Davison Chemical Co., Baltimore, pre-equilibrate the solvents. Draw off the in-
Maryland, or equivalent) about 90 centi- dividual layers and store in glass-stoppered
meters in length and 5 centimeters to 8 cen- flasks.
timeters in diameter.
n-Hexadecane, 99-percent olefin-free. Dilute PROCEDURE
1.0 milliliter of n-hexadecane to 25 milliliters
Sample. Select metal foil or sheet stock for
with isooctane and determine the absorbance
the test which has not been previously con-
in a 5-centimeter cell compared to isooctane
taminated by careless handling or exposure
as reference point between 280 mμ-400 mμ.
to atmospheric dust and fumes. A commer-
The absorbance per centimeter path length
cial coil in the form supplied for spindle
shall not exceed 0.00 in this range. Purify, if
mounting in a packaging line or wrapping
necessary, by percolation through activated
machine is most suitable. Strip off the out-
silica gel or by distillation.
Dimethyl sulfoxide. Spectrophotometric side turn of metal and discard. Carefully
grade (Crown Zellerbach Corp., Camas, avoid contamination or damage from han-
Washington, or equivalent). Absorbance (1- dling the metal (wear gloves). Remove a 16–
centimeter cell, distilled water reference, 18-foot length from the coil and place it on a
sample completely saturated with nitrogen). flat surface protected by a length of new
kraft paper. Cut four 15-foot strips from the
Absorb- sample, each 3 inches wide (avoid tearing the
Wavelength ance (max- edges of the strips). Using a piece of suitable
imum) glass rod, roll the strips of metal into loose
261.5 .................................................................... 1.00 coils and insert each into a Soxhlet thimble.
270 ....................................................................... .20 Each turn of coil should be visibly separated
275 ....................................................................... .09 from the adjacent turn.
453
§ 178.3910 21 CFR Ch. I (4–1–12 Edition)
Extraction. Fill each of the four Soxhlet tractive through anhydrous sodium sulfate
tubes with purified isooctane (see under pre-washed with isooctane (see sodium sul-
heading ‘‘Reagents and Materials,’’ above) fate under ‘‘Reagents and Materials’’ for
until siphon action occurs and then refill the preparation of filter) into a 250-milliliter Er-
tube body. Supply heat to the boiling flask lenmeyer flask (or optionally into the evapo-
and allow extraction to continue for at least ration flask). Wash the first separatory fun-
8 hours or until repeated weighings of the nel with the second 80-milliliter isooctane
dried and cooled coil show no further weight extractive and pass through the sodium sul-
loss. fate. Then wash the second and first sepa-
Combine the isooctane extracts from the ratory funnels successively with a 20-milli-
four Soxhlet units in a suitable beaker, rins- liter portion of isooctane and pass the sol-
ing each tube and flask into the beaker with vent through the sodium sulfate into the
fresh purified solvent. Evaporate the solvent
flask. Add 1 milliliter of n-hexadecane and
under an atmosphere of inert gas (nitrogen)
evaporate the isooctane on the steam bath
to residual volume of 50–60 milliliters and
under nitrogen. Discontinue evaporation
transfer this solution to a 500-milliliter sepa-
when not over 1 milliliter of residue remains.
ratory funnel containing 100 milliliters of
To the residue, add a 10-milliliter portion of
pre-equilibrated sulfoxide-phosphoric acid
mixture. Complete the transfer of the sample isooctane, reevaporate to 1 milliliter of
with small portions of pre-equilibrated iso- hexadecane, and repeat this operation once.
octane to give a total volume of the residue Quantitatively transfer the residue with
and solvent of 75 milliliters. Shake the fun- isooctane to a 25-milliliter volumetric flask,
nel vigorously for 2 minutes. Set up three make to volume, and mix. Determine the ab-
250-milliliter separatory funnels with each sorbance of the solution in 5-centimeter
containing 30 milliliters of pre-equilibrated pathlength cells compared to isooctane as
isooctane. After separation of liquid phases, reference between 280mμ–400mμ (take care to
carefully draw off lower layer into the first lose none of the solution in filling the sam-
250-milliliter separatory funnel and wash in ple cell). Correct the absorbance values for
tandem with the 30-milliliter portion of iso- any absorbance derived from reagents as de-
octane contained in the 250-milliliter sepa- termined by carrying out the procedure
ratory funnels. Shaking time for each wash without a metal sample. If the corrected ab-
is 1 minute. Repeat the extraction operation sorbance does not exceed the limits pre-
with two additional portions of the sulf- scribed in this paragraph, the residue meets
oxide-acid mixture and wash each extractive the ultraviolet absorbance specifications.
in tandem through the same three portions
of isooctane. (b) The following substances may be
Collect the successive extractives (300 mil- used in surface lubricants used to fa-
liliters total) in a separatory funnel (pref- cilitate the drawing, stamping, or
erably 2-liter) containing 480 milliliters of forming of metallic articles from rolled
distilled water; mix, and allow to cool for a foil or sheet stock by further proc-
few minutes after the last extractive has
been added. Add 80 milliliters of isooctane to
essing provided that the total residual
the solution and extract by shaking the fun- lubricant remaining on the metallic ar-
nel vigorously for 2 minutes. Draw off the ticle in the form in which it contacts
lower aqueous layer into a second separatory food does not exceed 0.2 milligram per
funnel (preferably 2-liter) and repeat the ex- square inch of food-contact surface:
traction with 80 milliliter of isooctane. Draw (1) Antioxidants used in compliance
off and discard the aqueous layer. Wash each
with regulations in parts 170 through
of the 80 milliliter extractives three times
with 100-milliliter portions distilled water. 189 of this chapter.
Shaking time for each wash is 1 minute. Dis- (2) Substances identified in this sub-
card the aqueous layers. Filter the first ex- paragraph.

Butyl stearate.
Castor oil.
Dibutyl sebacate.
Di(2-ethylhexyl) azelate.
Di(2-ethylhexyl) sebacate.
Diisodecyl phthalate.
Dimethylpolysiloxane ................................................................... Conforming to the identity prescribed in § 181.28 of this chap-
ter.
Dipropylene glycol.
Epoxidized soybean oil ................................................................ Conforming to the identity prescribed in § 181.27 of this chap-
ter.
454
Fatty acids derived from animal and vegetable fats and oils,
and salts of such acids, single or mixed, as follows:
Aluminum
Magnesium
Potassium
Sodium
Zinc
Fatty alcohols, straight-chain with even number carbon atoms
(C10 or greater).
Isobutyl stearate.
Lanolin.
Linoleic acid amide.
Mineral oil .................................................................................... Conforming to the identity prescribed in § 178.3620 (a) or (b).
Mono-, di-, and tristearyl citrate.
Oleic acid amide.
Palmitic acid amide.
Petrolatum ................................................................................... Conforming to the identity prescribed in § 178.3700.
Phosphoric acid, mono- and dihexyl esters, compounds with For use only at levels not to exceed 0.5 percent by weight of
tetramethylnonylamines and C11–14-alkylamines (CAS Reg. the finished surface lubricant formulation.
No. 80939–62–4).
Polyethylene glycol (molecular weight 300 or greater) ............... Mono- and diethylene glycol content not to exceed a total of
0.2 pct.
Stannous stearate.
Stearic acid amide.
Stearyl stearate.
Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate)] For use at a level not to exceed 0.5 percent by weight of the
methane (CAS Registry No. 6683–19–8). finished surface lubricant formulation.
Triethylene glycol ......................................................................... Diethylene glycol content not to exceed 0.1 pct.
Wax, petroleum ........................................................................... Complying with § 178.3710.
(c) The substances identified in para- with any applicable specifications pre-
graph (a)(2) of this section may be used scribed by such regulation.
in surface lubricants used to facilitate
the drawing, stamping, and forming of FR 238, Jan. 4, 1983; 49 FR 10113, Mar. 19, 1984;
metallic articles from rolled foil and 49 FR 29579, July 23, 1984; 50 FR 36874, Sept.
sheet stock provided that total resid- 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124,
ual lubricant remaining on the metal- Feb. 8, 1989; 54 FR 24899, June 12, 1989; 56 FR
lic article in the form in which it con- 55456, Oct. 28, 1991; 57 FR 23953, June 5, 1992;
58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30,
tacts food does not exceed 0.015 milli-
1999; 69 FR 24512, May 4, 2004]
gram per square inch of food-contact
surface. § 178.3930 Terpene resins.
(d) Subject to any prescribed limita-
The terpene resins identified in para-
tions, the quantity of surface lubricant
graph (a) of this section may be safely
used in the manufacture of metallic ar-
used as components of polypropylene
ticles shall not exceed the least
film intended for use in contact with
amount reasonably required to accom- food, and the terpene resins identified
plish the intended technical effect and in paragraph (b) of this section may be
shall not be intended to nor, in fact, safely used as components of polyolefin
accomplish any technical effect in the film intended for use in contact with
food itself. food;
(e) The use of the surface lubricants (a) Terpene resins consisting of the
in the manufacture of any article that hydrogenated polymers of terpene hy-
is the subject of a regulation in parts drocarbons obtainable from sulfate tur-
174, 175, 176, 177, 178 and § 179.45 of this pentine and meeting the following
chapter must comply with any speci- specifications: Drop-softening point of
fications prescribed by such regulation 118°–138 °C; iodine value less than 20.
for the finished form of the article. (b) Terpene resins consisting of poly-
(f) Any substance that is listed in mers of beta-pinene and meeting the
this section and the subject of a regula- following specifications: Acid value
tion in parts 174, 175, 176, 177, 178 and less than 1; saponification number less
§ 179.45 of this chapter shall comply than 1; color less than 4 on the Gardner
455
§ 178.3940 21 CFR Ch. I (4–1–12 Edition)
scale as measured in 50 percent mineral Subpart C—Packaging Materials for

spirits solution. Irradiated Foods
§ 178.3940 Tetraethylene glycol di-(2- 179.45 Packaging materials for use during
ethylhexoate). the irradiation of prepackaged foods.
Tetraethylene glycol di-(2- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 373,
ethylhexoate) containing not more 374.
than 22 parts per million ethylene and/ SOURCE: 42 FR 14635, Mar. 15, 1977, unless
or diethylene glycols may be used at a otherwise noted.
level not to exceed 0.7 percent by EDITORIAL NOTE: Nomenclature changes to
weight of twine as a finish on twine to part 179 appear at 70 FR 72074, Dec. 1, 2005.
be used for tying meat provided the
twine fibers are produced from nylon Subpart A [Reserved]
resins complying with § 177.1500 of this
chapter.
Subpart B—Radiation and
§ 178.3950 Tetrahydrofuran. Radiation Sources
Tetrahydrofuran may be safely used § 179.21 Sources of radiation used for
in the fabrication of articles intended inspection of food, for inspection of
for packaging, transporting, or storing packaged food, and for controlling
foods, subject to the provisions of this food processing.
section. Sources of radiation for the purposes
(a) It is used as a solvent in the cast- of inspection of foods, for inspection of
ing of film from a solution of poly- packaged food, and for controlling food
meric resins of vinyl chloride, vinyl ac- processing may be safely used under
etate, or vinylidene chloride that have the following conditions:
been polymerized singly or copolym- (a) The radiation source is one of the
erized with one another in any com- following:
bination, or it may be used as a solvent (1) X-ray tubes producing X-radiation
in the casting of film prepared from from operation of the tube source at a
vinyl chloride copolymers complying voltage of 500 kilovolt peak or lower.
(2) Sealed units producing radiations
(b) The residual amount of tetra- at energy levels of not more than 2.2
hydrofuran in the film does not exceed million electron volts from one of the
1.5 percent by weight of film. following isotopes: Americium-241, ce-
sium-137, cobalt-60, iodine-125, krypton-
PART 179—IRRADIATION IN THE 85, radium-226, and strontium-90.
PRODUCTION, PROCESSING AND (3) Sealed units producing neutron
HANDLING OF FOOD radiation from the isotope Califor-
nium-252 (CAS Reg. No. 13981–17–4) to
Subpart A [Reserved] measure moisture in food.
(4) Machine sources producing X-radi-
Subpart B—Radiation and Radiation ation at energies no greater than 10
Sources million electron volts (MeV).
Sec.
(5) Monoenergetic neutron sources
179.21 Sources of radiation used for inspec- producing neutrons at energies not less
tion of food, for inspection of packaged than 1 MeV but no greater than 14
food, and for controlling food processing. MeV.
179.25 General provisions for food irradia- (b) To assure safe use of these radi-
tion. ation sources:
179.26 Ionizing radiation for the treatment (1) The label of the sources shall
of food. bear, in addition to the other informa-
179.30 Radiofrequency radiation for the tion required by the Act:
heating of food, including microwave fre-
quencies.
(i) Appropriate and accurate informa-
179.39 Ultraviolet radiation for the proc- tion identifying the source of radi-
ation.
essing and treatment of food.

179.41 Pulsed light for the treatment of (ii) The maximum energy of radi-
food. ation emitted by X-ray tube sources.
456
(iii) The maximum energy of X-radi- a food contact substance for such use
ation emitted by machine source. submitted under § 170.100 of this chap-
(iv) The minimum and maximum enter.
ergy of radiation emitted by neutron (d) Radiation treatment of food shall
source. conform to a scheduled process. A
(2) The label or accompanying label- scheduled process for food irradiation
ing shall bear: is a written procedure that ensures
(i) Adequate directions for installa- that the radiation dose range selected
tion and use. by the food irradiation processor is
(ii) A statement that no food shall be adequate under commercial processing
exposed to radiation sources listed in conditions (including atmosphere and
paragraph (a) (1) and (2) of this section temperature) for the radiation to
so as to receive an absorbed dose in ex- achieve its intended effect on a specific
cess of 10 grays. product and in a specific facility. A
(iii) A statement that no food shall food irradiation processor shall operate
be exposed to a radiation source listed with a scheduled process established by
in paragraph (a)(3) of this section so as qualified persons having expert knowl-
to receive an absorbed dose in excess of edge in radiation processing require-
2 milligrays. ments of food and specific for that food
(iv) A statement that no food shall be and for that irradiation processor’s
exposed to a radiation source listed in treatment facility.
paragraph (a)(4) of this section so as to (e) A food irradiation processor shall
receive a dose in excess of 0.5 gray maintain records as specified in this
(Gy). section for a period of time that ex-
(v) A statement that no food shall be ceeds the shelf life of the irradiated
exposed to a radiation source listed in food product by 1 year, up to a max-
paragraph (a)(5) of this section so as to imum of 3 years, whichever period is
receive a dose in excess of 0.01 gray shorter, and shall make these records
(Gy). available for inspection and copy by
[42 FR 14635, Mar. 15, 1977, as amended at 48 authorized employees of the Food and
FR 46022, Oct. 11, 1983; 61 FR 14246, Apr. 1, Drug Administration. Such records
1996; 64 FR 69191, Dec. 10, 1999; 66 FR 18539, shall include the food treated, lot iden-
Apr. 10, 2001; 69 FR 76404, Dec. 21, 2004] tification, scheduled process, evidence
of compliance with the scheduled proc-
§ 179.25 General provisions for food ir- ess, ionizing energy source, source cali-
radiation.
bration, dosimetry, dose distribution in
For the purposes of § 179.26, current the product, and the date of irradia-
good manufacturing practice is defined tion.
to include the following restrictions:
(a) Any firm that treats foods with [51 FR 13399, Apr. 18, 1986, as amended at 67
FR 9585, Mar. 4, 2002; 67 FR 35731, May 21,
ionizing radiation shall comply with
2002]
the requirements of part 110 of this
chapter and other applicable regula- § 179.26 Ionizing radiation for the
tions. treatment of food.
(b) Food treated with ionizing radi-
ation shall receive the minimum radi- Ionizing radiation for treatment of
ation dose reasonably required to ac- foods may be safely used under the fol-
complish its intended technical effect lowing conditions:
and not more than the maximum dose (a) Energy sources. Ionizing radiation
specified by the applicable regulation is limited to:
for that use. (1) Gamma rays from sealed units of
(c) Packaging materials subjected to the radionuclides cobalt-60 or cesium-
irradiation incidental to the radiation 137.
treatment and processing of pre- (2) Electrons generated from machine
packaged food shall be in compliance sources at energies not to exceed 10
with § 179.45, shall be the subject of an million electron volts.
exemption for such use under § 170.39 of (3) X rays generated from machine
this chapter, or shall be the subject of sources at energies not to exceed 5 mil-
an effective premarket notification for lion electron volts (MeV), except as
457
§ 179.26 21 CFR Ch. I (4–1–12 Edition)
permitted by paragraph (a)(4) of this Use Limitations

section.
7. For the sterilization of frozen, pack- Minimum dose 44
(4) X rays generated from machine aged meats used solely in the Na- kGy (4.4 Mrad).
sources using tantalum or gold as the tional Aeronautics and Space Admin- Packaging mate-
target material and using energies not istration space flight programs. rials used need
not comply with
to exceed 7.5 (MeV). § 179.25(c) pro-
(b) Limitations. vided that their
use is otherwise
Use Limitations permitted by ap-
plicable regula-
1. For control of Trichinella spiralis in Minimum dose 0.3
tions in parts 174
pork carcasses or fresh, non-heat- kiloGray (kGy)
through 186 of
processed cuts of pork carcasses. (30 kilorad
this chapter.
(krad)); maximum
8. For control of foodborne pathogens Not to exceed 4.5
dose not to ex-
in, and extension of the shelf-life of, kGy maximum
ceed 1 kGy (100
refrigerated or frozen, uncooked for refrigerated
krad).
2. For growth and maturation inhibition Not to exceed 1 products that are meat within the products; not to
of fresh foods. kGy (100 krad). meaning of 9 CFR 301.2(rr), meat exceed 7.0 kGy
3. For disinfestation of arthropod pests Do. byproducts within the meaning of 9 maximum for fro-
in food. CFR 301.2(tt), or meat food products zen products.
4. For microbial disinfection of dry or Not to exceed 10 within the meaning of 9 CFR
dehydrated enzyme preparations (in- kGy (1 megarad 301.2(uu), with or without nonfluid
cluding immobilized enzymes). (Mrad)). seasoning, that are otherwise com-
5. For microbial disinfection of the fol- Not to exceed 30 posed solely of intact or ground
lowing dry or dehydrated aromatic kGy (3 Mrad). meat, meat byproducts, or both meat
vegetable substances when used as and meat byproducts.
ingredients in small amounts solely 9. For control of Salmonella in fresh Not to exceed 3.0
for flavoring or aroma: culinary herbs, shell eggs.. kGy.
seeds, spices, vegetable seasonings 10. For control of microbial pathogens Not to exceed 8.0
that are used to impart flavor but that on seeds for sprouting.. kGy.
are not either represented as, or ap- 11. For the control of Vibrio bacteria Not to exceed 5.5
pear to be, a vegetable that is eaten and other foodborne microorganisms kGy.
for its own sake, and blends of these in or on fresh or frozen molluscan
aromatic vegetable substances. Tur- shellfish..
meric and paprika may also be irradi- 12. For control of food-borne pathogens Not to exceed 4.0
ated when they are to be used as and extension of shelf-life in fresh kGy.
color additives. The blends may con- iceberg lettuce and fresh spinach..
tain sodium chloride and minor
amounts of dry food ingredients ordi-
narily used in such blends. (c) Labeling. (1) The label and label-
6. For control of food-borne pathogens Not to exceed 3 ing of retail packages of foods irradi-
in fresh or frozen, uncooked poultry kGy (300 krad); ated in conformance with paragraph (b)
products that are: (1) Whole car- any packaging
casses or disjointed portions of such used shall not of this section shall bear the following
carcasses that are ‘‘ready-to-cook exclude oxygen. logo along with either the statement
poultry’’ within the meaning of 9 CFR
381.1(b)(44), or (2) mechanically sep-
arated poultry product (a finely
comminuted ingredient produced by
the mechanical deboning of poultry
carcasses or parts of carcasses).
458
‘‘Treated with radiation’’ or the when shipped to a food manufacturer

statement ‘‘Treated by irradiation’’ in or processor for further processing, la-
addition to information required by beling, or packing.
other regulations. The logo shall be
[51 FR 13399, Apr. 18, 1986, as amended at 53
placed prominently and conspicuously FR 12757, Apr. 18, 1988; 53 FR 53209, Dec. 30,
in conjunction with the required state- 1988; 54 FR 32335, Aug. 7, 1989; 55 FR 14415,
ment. The radiation disclosure state- Apr. 18, 1990; 55 FR 18544, May 2, 1990; 60 FR
ment is not required to be more promi- 12670, Mar. 8, 1995; 62 FR 64121, Dec. 3, 1997; 63
nent than the declaration of ingredi- FR 43876, Aug. 17, 1998; 65 FR 45282, July 21,
ents required under § 101.4 of this chap- 2000; 65 FR 64607, Oct. 30, 2000; 69 FR 76846,
ter. As used in this provision, the term Dec. 23, 2004; 70 FR 48072, Aug. 16, 2005; 73 FR
‘‘radiation disclosure statement’’ 49603, Aug. 22, 2008]
means the written statement that dis-
§ 179.30 Radiofrequency radiation for
closes that a food has been inten- the heating of food, including
tionally subject to irradiation. microwave frequencies.
(2) For irradiated foods not in pack-
age form, the required logo and phrase Radiofrequency radiation, including
‘‘Treated with radiation’’ or ‘‘Treated microwave frequencies, may be safely
by irradiation’’ shall be displayed to used for heating food under the fol-
the purchaser with either (i) the label- lowing conditions:
ing of the bulk container plainly in (a) The radiation source consists of
view or (ii) a counter sign, card, or electronic equipment producing radio
other appropriate device bearing the waves with specific frequencies for this
information that the product has been purpose authorized by the Federal
treated with radiation. As an alter- Communications Commission.
native, each item of food may be indi- (b) The radiation is used or intended
vidually labeled. In either case, the infor use in the production of heat in
formation must be prominently and food wherever heat is necessary and ef-
conspicuously displayed to purchasers. fective in the treatment or processing
The labeling requirement applies only of food.
to a food that has been irradiated, not
to a food that merely contains an irra- § 179.39 Ultraviolet radiation for the
diated ingredient but that has not processing and treatment of food.
itself been irradiated. Ultraviolet radiation for the proc-
(3) For a food, any portion of which is essing and treatment of food may be
irradiated in conformance with para- safely used under the following condi-
graph (b) of this section, the label and tions:
labeling and invoices or bills of lading (a) The radiation sources consist of
shall bear either the statement low pressure mercury lamps emitting
‘‘Treated with radiation—do not irra- 90 percent of the emission at a wave-
diate again’’ or the statement ‘‘Treated length of 253.7 nanometers (2,537

by irradiation—do not irradiate again’’ Angstroms).
459
ER01FE93.000</GPH>
§ 179.41 21 CFR Ch. I (4–1–12 Edition)
(b) The ultraviolet radiation is used

or intended for use as follows:
Irradiated food Limitations Use
Food and food products ................. Without ozone production: high fat-content food irradiated Surface microorganism con-
in vacuum or in an inert atmosphere; intensity of radi- trol.
ation, 1 W (of 2,537 A. radiation) per 5 to 10 ft.2.
Potable water .................................. Without ozone production; coefficient of absorption, 0.19 Sterilization of water used in
per cm or less; flow rate, 100 gal/h per watt of 2,537 A. food production.
radiation; water depth, 1 cm or less; lamp-operating
temperature, 36 to 46 °C..
Juice products ................................. Turbulent flow through tubes with a minimum Reynolds Reduction of human patho-
number of 2,200.. gens and other microorga-
nisms.
[42 FR 14635, Mar. 15, 1977, as amended at 65 FR 71057, Nov. 29, 2000]
§ 179.41 Pulsed light for the treatment (b) The following packaging mate-
of food. rials may be subjected to a dose of ra-
Pulsed light may be safely used for diation, not to exceed 10 kilograys, un-
treatment of foods under the following less otherwise indicated, incidental to
conditions: the use of gamma, electron beam, or X-
(a) The radiation sources consist of radiation in the radiation treatment of
xenon flashlamps designed to emit prepackaged foods:
broadband radiation consisting of (1) Nitrocellulose-coated or vinyli-
wavelengths covering the range of 200 dene chloride copolymer-coated cello-
to 1,100 nanometers (nm), and operated phane complying with § 177.1200 of this
so that the pulse duration is no longer chapter.
than 2 milliseconds (msec); (2) Glassine paper complying with
(b) The treatment is used for surface § 176.170 of this chapter.
microorganism control; (3) Wax-coated paperboard complying
(c) Foods treated with pulsed light with § 176.170 of this chapter.
shall receive the minimum treatment (4) Polyolefin film prepared from one
reasonably required to accomplish the or more of the basic olefin polymers
intended technical effect; and complying with § 177.1520 of this chap-
(d) The total cumulative treatment ter. The finished film may contain:
shall not exceed 12.0 Joules/square cen- (i) Adjuvant substances used in com-
timeter (J/cm2.) pliance with §§ 178.3740 and 181.22
through 181.30 of this chapter, sodium
[61 FR 42383, Aug. 15, 1996] citrate, sodium lauryl sulfate, poly-
vinyl chloride, and materials as listed
Subpart C—Packaging Materials in paragraph (d)(2)(i) of this section.
for Irradiated Foods (ii) Coatings comprising a vinylidene
chloride copolymer containing a min-
§ 179.45 Packaging materials for use imum of 85 percent vinylidene chloride
during the irradiation of pre- with one or more of the following co-
packaged foods. monomers: Acrylic acid, acrylonitrile,
The packaging materials identified itaconic acid, methyl acrylate, and
in this section may be safely subjected methyl methacrylate.
to irradiation incidental to the radi- (5) Kraft paper prepared from un-
ation treatment and processing of pre- bleached sulfate pulp to which rosin,
packaged foods, subject to the provi- complying with § 178.3870 of this chap-
sions of this section and to the require- ter, and alum may be added. The kraft
ment that no induced radioactivity is paper is used only as a container for
detectable in the packaging material flour and is irradiated with a dose not
itself: exceeding 500 grays.
(a) The radiation of the food itself (6) Polyethylene terephthalate film
shall comply with regulations in this prepared from the basic polymer as de-
part. scribed in § 177.1630(e)(4)(i) and (ii) of
460
this chapter. The finished film may the American Society for Testing Ma-
contain: terials, 100 Barr Harbor Dr., West
(i) Adjuvant substances used in com- Conshohocken, Philadelphia, PA 19428-
pliance with §§ 178.3740 and 181.22 2959, or may be examined at the Na-
through 181.30 of this chapter, sodium tional Archives and Records Adminis-
citrate, sodium lauryl sulfate, poly- tration (NARA). For information on
vinyl chloride, and materials as listed the availability of this material at
in paragraph (d)(2)(i) of this section. NARA, call 202–741–6030, or go to: http://
(ii) Coatings comprising a vinylidene www.archives.gov/federallregister/
chloride copolymer containing a min- codeloflfederallregulations/
imum of 85 percent vinylidene chloride ibrllocations.html. The finished film
with one or more of the following co- may contain adjuvant substances used
monomers: Acrylic acid, acrylonitrile, in compliance with §§ 178.3740 and 181.22
itaconic acid, methyl acrylate, and through 181.30 of this chapter.
methyl methacrylate. (10) Nylon 11 conforming to § 177.1500
(iii) Coatings consisting of poly- of this chapter.
ethylene conforming to § 177.1520 of this (c) Ethylene-vinyl acetate copoly-
chapter. mers complying with § 177.1350 of this
(7) Polystyrene film prepared from chapter. The ethylene-vinyl acetate
styrene basic polymer. The finished packaging materials may be subjected
film may contain adjuvant substances to a dose of radiation, not to exceed 30
used in compliance with §§ 178.3740 and kilogray (3 megarads), incidental to
181.22 through 181.30 of this chapter. the use of gamma, electron beam, or X-
(8) Rubber hydrochloride film pre- radiation in the radiation treatment of
pared from rubber hydrochloride basic packaged foods.
polymer having a chlorine content of (d) The following packaging mate-
30–32 weight percent and having a max- rials may be subjected to a dose of ra-
imum extractable fraction of 2 weight diation, not to exceed 60 kilograys inci-
percent when extracted with n-hexane dental to the use of gamma, electron
at reflux temperature for 2 hours. The beam, or X-radiation in the radiation
finished film may contain adjuvant processing of prepackaged foods:
substances used in compliance with (1) Vegetable parchments, consisting
§§ 178.3740 and 181.22 through 181.30 of of a cellulose material made from
this chapter. waterleaf paper (unsized) treated with
(9) Vinylidene chloride-vinyl chloride concentrated sulfuric acid, neutralized,
copolymer film prepared from vinyli- and thoroughly washed with distilled
dene chloride-vinyl chloride basic co- water.
polymers containing not less than 70 (2) Films prepared from basic poly-
weight percent of vinylidene chloride mers and with or without adjuvants, as
and having a viscosity of 0.50–1.50 cen- follows:
tipoises as determined by ASTM meth- (i) Polyethylene film prepared from
od D729–81, ‘‘Standard Specification for the basic polymer as described in
Vinylidene Chloride Molding Com- § 177.1520(a) of this chapter. The fin-
pounds,’’ which is incorporated by ref- ished film may contain one or more of
erence. Copies may be obtained from the following added substances:
Amides of erucic, linoleic, oleic, palmitic, and stearic acid ......... Not to exceed 1 pct by weight of the polymer.
BHA as described in § 172.110 of this chapter ........................... Do.
BHT as described in § 172.115 of this chapter ........................... Do.
Calcium and sodium propionates ................................................ Do.
Petroleum wax as described in § 178.3710 of this chapter ........ Do.
Polypropylene, noncrystalline, as described in § 177.1520(c) of Not to exceed 2 pct by weight of the polymer.
this chapter.
Stearates of aluminum, calcium, magnesium, potassium, and Not to exceed 1 pct by weight of the polymer.
sodium as described in § 172.863(a) of this chapter.
Triethylene glycol as described in § 178.3740(b) of this chapter Do.
Mineral oil as described in § 178.3620 (a) or (b) of this chapter Do.
461
(ii) Polyethylene terephthalate film 180.30 Brominated vegetable oil.

prepared from the basic polymer as de- 180.37 Saccharin, ammonium saccharin, cal-
scribed in § 177.1630(e)(4)(ii) of this cium saccharin, and sodium saccharin.
chapter. The finished film may contain AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371;
one or more of the added substances 42 U.S.C. 241.
listed in paragraph (d)(2)(i) of this sec- EDITORIAL NOTE: Nomenclature changes to
tion. part 180 appear at 61 FR 14482, Apr. 2, 1996,
(iii) Nylon 6 films prepared from the and 66 FR 56035, Nov. 6, 2001.
nylon 6 basic polymer as described in
§ 177.1500(a)(6) of this chapter and meet- Subpart A—General Provisions
ing the specifications of item 6.1 of the
table in § 177.1500(b) of this chapter. § 180.1 General.
The finished film may contain one or (a) Substances having a history of
more of the added substances listed in use in food for human consumption or
paragraph (d)(2)(i) of this section. in food contact surfaces may at any
(iv) Vinyl chloride-vinyl acetate co- time have their safety or functionality
polymer film prepared from the basic brought into question by new informa-
copolymer containing 88.5 to 90.0 tion that in itself is not conclusive. An
weight percent of vinyl chloride with interim food additive regulation for
10.0 to 11.5 weight percent of vinyl ace- the use of any such substance may be
tate and having a maximum volatility promulgated in this subpart when new
of not over 3.0 percent (1 hour at 105 °C) information raises a substantial ques-
and viscosity not less than 0.30 deter- tion about the safety or functionality
mined by ASTM method D1243–79, of the substance but there is a reason-
‘‘Standard Test Method for Dilute So- able certainty that the substance is
lution Viscosity of Vinyl Chloride not harmful and that no harm to the
Polymers,’’ Method A, which is incor- public health will result from the con-
porated by reference. The availability tinued use of the substance for a lim-
of this incorporation by reference is ited period of time while the question
given in paragraph (b)(9) of this sec- raised is being resolved by further
tion. The finished film may contain study.
one or more of the added substances (b) No interim food additive regula-
listed in paragraph (d)(2)(i) of this section may be promulgated if the new in-
tion. formation is conclusive with respect to
(e) Acrylonitrile copolymers identi- the question raised or if there is a rea-
fied in this section shall comply with sonable likelihood that the substance
the provisions of § 180.22 of this chap- is harmful or that continued use of the
ter. substance will result in harm to the
[42 FR 14635, Mar. 15, 1977, as amended at 49 public health.
FR 10113, Mar. 19, 1984; 54 FR 7405, Feb. 21, (c) The Commissioner, on his own ini-
1989; 54 FR 24899, June 12, 1989; 59 FR 14551, tiative or on the petition of any inter-
Mar. 29, 1994; 61 FR 14246, Apr. 1, 1996; 66 FR ested person, pursuant to part 10 of this
10575, Feb. 16, 2001] chapter, may propose an interim food
additive regulation. A final order pro-
PART 180—FOOD ADDITIVES PER- mulgating an interim food additive
MITTED IN FOOD OR IN CON- regulation shall provide that continued
TACT WITH FOOD ON AN IN- use of the substance in food is subject
TERIM BASIS PENDING ADDI- to each of the following conditions:
TIONAL STUDY (1) Use of the substance in food or
food contact surfaces must comply
Subpart A—General Provisions with whatever limitations the Commis-
sioner deems to be appropriate under
Sec. the circumstances.
180.1 General. (2) Within 60 days following the effec-
tive date of the regulation, an inter-
Subpart B—Specific Requirements for ested person shall satisfy the Commis-
Certain Food Additives sioner in writing that studies adequate
180.22 Acrylonitrile copolymers. and appropriate to resolve the ques-

180.25 Mannitol. tions raised about the substance have
462
been undertaken, or the Food and Drug will require elimination of the sub-
Administration may undertake the stance from the food supply.
studies. The Commissioner may extend (e) The Commissioner may consult
this 60-day period if necessary to re- with advisory committees, professional
view and act on proposed protocols. If organizations, or other experts in the
no such commitment is made, or ade- field, in evaluating:
quate and appropriate studies are not (1) Whether an interim food additive
undertaken, an order shall imme- regulation is justified,
diately be published in the FEDERAL (2) The type of studies necessary and
REGISTER revoking the interim food ad- appropriate to resolve questions raised
ditive regulation effective upon publi- about a substance,
cation. (3) Whether interim results indicate
(3) A progress report shall be filed on the reasonable likelihood that a health
the studies every January 1 and July 1 hazard exists, or
until completion. If the progress report (4) Whether the data available at the
is inadequate or if the Commissioner conclusion of those studies justify a
concludes that the studies are not food additive regulation.
being pursued promptly and diligently (f) Where appropriate, an emergency
or if interim results indicate a reason- action level may be issued for a sub-
able likelihood that a health hazard ex- stance subject to paragraph (a) of this
ists, an order will promptly be pub- section that is not an approved food ad-
lished in the FEDERAL REGISTER revok- ditive, pending the issuance of a final
ing the interim food additive regula- interim food additive regulation. Such
tion effective upon publication. an action level shall be issued pursuant
(4) If nonclinical laboratory studies to sections 306 and 402(a) of the act to
are involved, studies filed with the identify, based upon available data, a
Commissioner shall include, with re- safe level of use for the substance.
spect to each study, either a statement Such an action level shall be issued in
that the study has been or will be con- a notice published in the FEDERAL REG-
ducted in compliance with the good ISTER and shall be followed as soon as
laboratory practice regulations as set practicable by a proposed interim food
forth in part 58 of this chapter, or, if additive regulation. Where the avail-
any such study was not conducted in able data do not permit establishing an
compliance with such regulations, a action level for the safe use of a sub-
brief statement of the reason for the stance, use of the substance may be
noncompliance. prohibited. The identification of a pro-
(5) [Reserved] hibited substance may be made in part
(6) If clinical investigations involving 189 of this chapter when appropriate.
human subjects are involved, such in- [42 FR 14636, Mar. 15, 1977, as amended at 42
vestigations filed with the Commis- FR 15674, Mar. 22, 1977; 42 FR 52821, Sept. 30,
sioner shall include, with respect to 1977; 46 FR 8952, Jan. 27, 1981; 46 FR 14340,
each investigation, a statement that Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR
39634, Sept. 27, 1989]
the investigation either was conducted
in compliance with the requirements
for institutional review set forth in Subpart B—Specific Requirements
part 56 of this chapter, or was not sub- for Certain Food Additives
ject to such requirements in accord-
ance with §§ 56.104 or 56.105, and that it § 180.22 Acrylonitrile copolymers.
has been or will be conducted in com- Acrylonitrile copolymers may be
pliance with the requirements for in- safely used on an interim basis as arti-
formed consent set forth in part 50 of cles or components of articles intended
this chapter. for use in contact with food, in accord-
(d) Promptly upon completion of the ance with the following prescribed con-
studies undertaken on the substance, ditions:
the Commissioner will review all avail- (a) Limitations for acrylonitrile
able data, will terminate the interim monomer extraction for finished food-
food additive regulation, and will ei- contact articles, determined by a

ther issue a food additive regulation or method of analysis titled ‘‘Gas-Solid
463
§ 180.22 21 CFR Ch. I (4–1–12 Edition)
Chromatographic Procedure for Deter- Such testing shall include determina-

mining Acrylonitrile Monomer in Ac- tion of the rate of decomposition of the
rylonitrile-Containing Polymers and complex at temperatures of 100 °F, 160
Food Simulating Solvents,’’ which is °F, and 212 °F using 3 percent acetic
incorporated by reference. Copies are acid as the hydrolic agent. Acrylo-
available from the Center for Food nitrile monomer levels, acrylonitrile/
Safety and Applied Nutrition (HFS– mercaptan complex levels, acrylo-
200), Food and Drug Administration, nitrile oligomer levels, descriptions of
5100 Paint Branch Pkwy., College Park, the analytical methods used to deter-
MD 20740, or available for inspection at mine the complex and the acrylonitrile
the National Archives and Records Ad- migration, and validation studies of
ministration (NARA). For information these analytical methods shall be sub-
on the availability of this material at mitted by June 9, 1977, to the Center
NARA, call 202–741–6030, or go to: http:// for Food Safety and Applied Nutrition
www.archives.gov/federallregister/ (HFS–200), Food and Drug Administra-
codeloflfederallregulations/ tion, 5100 Paint Branch Pkwy., College
ibrllocations.html. Park, MD 20740, unless an extension is
(1) In the case of single-use articles granted by the Food and Drug Admin-
having a volume to surface ratio of 10 istration for good cause shown. Analyt-
milliliters or more per square inch of ical methods for the determination of
food contact surface—0.003 milligram/ acrylonitrile complexes with n-
square inch when extracted to equi- dodecyl-mercaptan, n-octyl mercaptan,
librium at 120 °F with food-simulating and 2-mercaptoethanol, titled ‘‘Deter-
solvents appropriate to the intended mination of b-Dodecyl-
conditions of use. mercaptopropionitrile in NR–16R Aque-
(2) In the case of single-use articles ous Extracts’’ and ‘‘Measurement of b-
having a volume to surface ratio of less (2-Hdroxyethylmercapto) Propionitrile
than 10 milliliters per square inch of in Heptane Food-Simulating Solvent,’’
food contact surface—0.3 part per mil- are incorporated by reference. Copies
lion calculated on the basis of the vol- are available from the Center for Food
ume of the container when extracted to Safety and Applied Nutrition (HFS–
equilibrium at 120 °F with food-simu- 200), Food and Drug Administration,
lating solvents appropriate to the in- 5100 Paint Branch Pkwy., College Park,
tended conditions of use. MD 20740, or available for inspection at
(3) In the case of repeated-use arti- the National Archives and Records Ad-
cles—0.003 milligram/square inch when ministration (NARA). For information
extracted at a time equivalent to ini- on the availability of this material at
tial batch usage utilizing food-simu- NARA, call 202–741–6030, or go to: http://
lating solvents and temperatures ap- www.archives.gov/federallregister/
propriate to the intended conditions of codeloflfederallregulations/
use. ibrllocations.html.
The food-simulating solvents shall in- (c) The following data shall be pro-
clude, where applicable, distilled vided for finished food-contact articles
water, 8 percent or 50 percent ethanol, intended for repeated use:
3 percent acetic acid, and either n- (1) Qualitative and quantitative mi-
heptane or an appropriate oil or fat. gration values at a time equivalent to
(b) Where necessary, current regula- initial batch usage, utilizing solvents
tions permitting the use of acrylo- and temperatures appropriate to the
nitrile copolymers shall be revised to intended conditions of use.
specify limitations on acrylonitrile/ (2) Qualitative and quantitative mi-
mercaptan complexes utilized in the gration values at the time of equi-
production of acrylonitrile copolymers. librium extractions, utilizing solvents
Such copolymers, if they contain re- and temperatures appropriate to the
versible acrylonitrile/mercaptan com- intended conditions of use.
plexes and are used in other than re- (3) Data on the volume and/or weight
peated-use conditions, shall be tested of food handled during the initial batch
to determine the identity of the com- time period(s), during the equilibrium
plex and the level of the complex test period, and over the estimated life
present in the food-contact article. of the food-contact surface.
464
(d) Where acrylonitrile copolymers the user in good faith believed the use
represent only a minor component of a to be prior-sanctioned. The Commis-
polymer system, calculations based on sioner of Food and Drugs shall, by no-
100 percent migration of the acrylo- tice in the FEDERAL REGISTER, identify
nitrile component may be submitted in any use of acrylonitrile copolymers not
lieu of the requirements of paragraphs in accordance with this paragraph.
(a), (b), and (c) of this section in sup- Those uses are thereafter unapproved
port of the continued safe use of acry- food additives and consequently unlaw-
lonitrile copolymers. ful.
(e) On or before September 13, 1976, (2) Any use of acrylonitrile copoly-
any interested person shall satisfy the mers subject to paragraph (f)(1) of this
Commissioner of Food and Drugs that section shall be the subject of a peti-
toxicological feeding studies adequate tion submitted on or before December
and appropriate to establish safe condi- 13, 1976, in accordance with § 171.1 of
tions for the use of acrylonitrile co- this chapter, unless an extension of
polymers have been, or soon will be, time is granted by the Food and Drug
undertaken. Toxicity studies of acrylo- Administration for good cause shown.
nitrile monomer shall include: (1) Life- Any application for extension shall be
time feeding studies with a mamma- by petition submitted in accordance
lian species, preferably with animals with the requirements of part 10 of this
exposed in utero to the chemical, (2) chapter. If a petition is denied, in
studies of multigeneration reproduc- whole or in part, those uses subject to
tion with oral administration of the the denial are thereafter unapproved
test material, (3) assessment of food additives and consequently unlaw-
teratogenic and mutagenic potentials, ful.
(4) subchronic oral administration in a (3) Any use of acrylonitrile copoly-
nonrodent mammal, (5) tests to deter- mers subject to paragraph (f)(1) of this
mine any synergistic toxic effects be- section shall meet the acrylonitrile
tween acrylonitrile monomer and cya- monomer extraction limitation set
nide ion, and (6) a literature search on forth in paragraph (a) of this section
the effects of chronic ingestion of hy- and shall be subject to the require-
drogen cyanide. Data on levels of acryl- ments of paragraph (b) of this section.
amide extractable from acrylonitrile (g) In addition to the requirements of
copolymers shall also be submitted. this section, the use of acrylonitrile co-
Protocols of testing should be sub- polymers shall comply with all applica-
mitted for review to the Center for ble requirements in other regulations
Food Safety and Applied Nutrition in this part.
(HFS–200), Food and Drug Administra- [42 FR 14636, Mar. 15, 1977, as amended at 47
tion, 5100 Paint Branch Pkwy., College FR 11850, Mar. 19, 1982; 54 FR 24899, June 12,
Park, MD 20740. 1989; 61 FR 14246, Apr. 1, 1996]
(f) Acrylonitrile copolymers may be
used in contact with food only if au- § 180.25 Mannitol.
thorized in parts 174 through 179 or (a) Mannitol is the chemical
§ 181.32 of this chapter, except that 1,2,3,4,5,6,-hexanehexol (C6H14O6) a
other uses of acrylonitrile copolymers hexahydric alcohol, differing from sor-
in use prior to June 14, 1976, may con- bitol principally by having a different
tinue under the following conditions: optical rotation. Mannitol is produced
(1) On or before August 13, 1976, each by one of the following processes:
use of acrylonitrile copolymers in a (1) The electrolytic reduction or
manner not authorized by § 181.32 of transition metal catalytic hydro-
this chapter or parts 174 through 179 of genation of sugar solutions containing
this chapter shall be the subject of a glucose or fructose.
notice to the Center for Food Safety (2) The fermentation of sugars or
and Applied Nutrition (HFS–200), Food sugar alcohols such as glucose, sucrose,
and Drug Administration, 5100 Paint fructose, or sorbitol using the yeast
Branch Pkwy., College Park, MD 20740. Zygosaccharomyces rouxii.
Such notice shall be accompanied by a (3) A pure culture fermentation of
statement of the basis, including any sugars such as fructose, glucose, or

articles and correspondence, on which maltose using the nonpathogenic,
465
§ 180.30 21 CFR Ch. I (4–1–12 Edition)
nontoxicogenic bacterium Lactobacillus stance. Continued uses of this ingre-

intermedius (fermentum). dient are contingent upon timely and
(b) The ingredient meets the speci- adequate progress reports of such tests,
fications of the ‘‘Food Chemicals and no indication of increased risk to
Codex,’’ 3d Ed. (1981), pp. 188–190, which public health during the test period.
is incorporated by reference. Copies (g) Prior sanctions for this ingredient
may be obtained from the National different from the uses established in
Academy Press, 2101 Constitution Ave. this regulation do not exist or have
NW., Washington, DC 20418, or may be been waived.
examined at the National Archives and [42 FR 14636, Mar. 15, 1977, as amended at 49
Records Administration (NARA). For FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996;
information on the availability of this 69 FR 65542, Nov. 15, 2004]
go to: http://www.archives.gov/ § 180.30 Brominated vegetable oil.
federallregister/ The food additive brominated vege-
codeloflfederallregulations/ table oil may be safely used in accord-
ibrllocations.html. ance with the following prescribed con-
(c) The ingredient is used as an ditions:
anticaking agent and free-flow agent as (a) The additive complies with speci-
defined in § 170.3(o)(1) of this chapter, fications prescribed in the ‘‘Food
formulation aid as defined in § 170.3(o) Chemicals Codex,’’ 3d Ed. (1981), pp. 40–
(14) of this chapter, firming agent as 41, which is incorporated by reference,
defined in § 170.3(o)(10) of this chapter, except that free fatty acids (as oleic)
flavoring agent and adjuvant as defined shall not exceed 2.5 percent and iodine
in § 170.3(o)(12) of this chapter, lubri- value shall not exceed 16. Copies of the
cant and release agent as defined in material incorporated by reference
§ 170.3(o)(18) of this chapter, nutritive may be obtained from the National
sweetener as defined in § 170.3(o)(21) of Academy Press, 2101 Constitution Ave.
this chapter, processing aid as defined NW., Washington, DC 20418, or may be
in § 170.3(o)(24) of this chapter, sta- examined at the National Archives and
bilizer and thickener as defined in Records Administration (NARA). For
§ 170.3(o)(28) of this chapter, surface-fin- information on the availability of this
ishing agent as defined in § 170.3(o)(30) material at NARA, call 202–741–6030, or
of this chapter, and texturizer as de- go to: http://www.archives.gov/
fined in § 170.3(o)(32) of this chapter. federallregister/
(d) The ingredient is used in food at codeloflfederallregulations/
levels not to exceed 98 percent in ibrllocations.html.
pressed mints and 5 percent in all other (b) The additive is used on an interim
hard candy and cough drops as defined basis as a stabilizer for flavoring oils
in § 170.3(n)(25) of this chapter, 31 per- used in fruit-flavored beverages, for
cent in chewing gum as defined in which any applicable standards of iden-
§ 170.3(n)(6) of this chapter, 40 percent tity do not preclude such use, in an
in soft candy as defined in § 170.3(n)(38) amount not to exceed 15 parts per mil-
of this chapter, 8 percent in confections lion in the finished beverage, pending
and frostings as defined in § 170.3(n)(9) the outcome of additional toxicological
of this chapter, 15 percent in non- studies on which periodic reports at 6-
standardized jams and jellies, commer- month intervals are to be furnished
cial, as defined in § 170.3(n)(28) of this and final results submitted to the Food
chapter, and at levels less than 2.5 per- and Drug Administration promptly
cent in all other foods. after completion of the studies.
(e) The label and labeling of food [42 FR 14636, Mar. 15, 1977, as amended at 49
whose reasonably foreseeable consump- FR 5610, Feb. 14, 1984]
tion may result in a daily ingestion of
20 grams of mannitol shall bear the § 180.37 Saccharin, ammonium sac-
statement ‘‘Excess consumption may charin, calcium saccharin, and so-
have a laxative effect’’. dium saccharin.
(f) In accordance with § 180.1, ade- The food additives saccharin, ammo-
quate and appropriate feeding studies nium saccharin, calcium saccharin, and
have been undertaken for this sub- sodium saccharin may be safely used as
466
Food and Drug Administration, HHS Pt. 181
sweetening agents in food in accord- (1) To reduce bulk and enhance fla-
ance with the following conditions, if vors in chewable vitamin tablets,
the substitution for nutritive sweet- chewable mineral tablets, or combina-
eners is for a valid special dietary pur- tions thereof.
pose and is in accord with current spe- (2) To retain flavor and physical
cial dietary food regulations and poli- properties of chewing gum.
cies or if the use or intended use is for (3) To enhance flavor of flavor chips
an authorized technological purpose used in nonstandardized bakery prod-
other than calorie reduction: ucts.
(a) Saccharin is the chemical, 1,2- (f) To assure safe use of the additives,
benzisothiazolin-3-one - 1,1 - dioxide in addition to the other information re-
(C7H5NO3S). The named salts of sac- quired by the Act:
charin are produced by the additional (1) The label of the additive and any
neutralization of saccharin with the intermediate mixes of the additive for
proper base to yield the desired salt. manufacturing purposes shall bear:
(b) The food additives meet the speci- (i) The name of the additive.
fications of the ‘‘Food Chemicals (ii) A statement of the concentration
Codex,’’ 3d Ed. (1981), pp. 22, 62, 266–267, of the additive, expressed as saccharin,
297–299, which is incorporated by ref- in any intermediate mix.
erence. Copies may be obtained from (iii) Adequate directions for use to
the National Academy Press, 2101 Con- provide a final food product that com-
stitution Ave. NW., Washington, DC plies with the limitations prescribed in
20418, or may be examined at the Na- paragraphs (d) and (e) of this section.
tional Archives and Records Adminis- (2) The label of any finished food
tration (NARA). For information on product containing the additive shall
the availability of this material at bear:
NARA, call 202–741–6030, or go to: http:// (i) The name of the additive.
www.archives.gov/federallregister/ (ii) The amount of the additive, cal-
codeloflfederallregulations/ culated as saccharin, as follows:
ibrllocations.html. (a) For beverages, in milligrams per
(c) Authority for such use shall ex- fluid ounce;
pire when the Commissioner receives (b) For cooking or table use products,
the final reports on the ongoing studies in milligrams per dispensing unit;
in Canada and publishes an order on (c) For processed foods, in terms of
the safety of saccharin and its salts the weight or size of a serving which
based on those reports and other avail- shall be that quantity of the food con-
able data. taining 30 milligrams or less of the ad-
(d) The additives are used or intended ditive.
for use as a sweetening agent only in (iii) When the additive is used for cal-
special dietary foods, as follows: orie reduction, such other labeling as is
(1) In beverages, fruit juice drinks, required by part 105 of this chapter.
and bases or mixes when prepared for [42 FR 14636, Mar. 15, 1977, as amended at 49
consumption in accordance with direc- FR 5610, Feb. 14, 1984; 72 FR 10357, Mar. 8,
tions, in amounts not to exceed 12 mil- 2007]
ligrams of the additive, calculated as
saccharin, per fluid ounce. PART 181—PRIOR-SANCTIONED
(2) As a sugar substitute for cooking
or table use, in amounts not to exceed FOOD INGREDIENTS
20 milligrams of the additive, cal-
Subpart A—General Provisions
culated as saccharin, for each ex-
pressed teaspoonful of sugar sweet- Sec.
ening equivalency. 181.1 General.
(3) In processed foods, in amounts not 181.5 Prior sanctions.
to exceed 30 milligrams of the additive,
calculated as saccharin, per serving of Subpart B—Specific Prior-Sanctioned Food
designated size. Ingredients
(e) The additives are used or intended
181.22 Certain substances employed in the

for use only for the following techno- manufacture of food-packaging mate-
logical purposes: rials.
467
§ 181.1 21 CFR Ch. I (4–1–12 Edition)
181.23 Antimycotics. ISTER and shall be followed as soon as
181.24 Antioxidants. practicable by a proposed regulation in
181.25 Driers.
181.26 Drying oils as components of finished
accordance with paragraph (b) of this
resins. section. Where the available data dem-
181.27 Plasticizers. onstrate that the substance may be in-
181.28 Release agents. jurious at any level, use of the sub-
181.29 Stabilizers. stance may be prohibited. The identi-
181.30 Substances used in the manufacture
of paper and paperboard products used in
fication of a prohibited substance may
food packaging. be made in part 189 of this chapter
181.32 Acrylonitrile copolymers and resins. when appropriate.
181.33 Sodium nitrate and potassium ni-
trate. [42 FR 14638, Mar. 15, 1977, as amended at 42
181.34 Sodium nitrite and potassium nitrite. FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27,
1989]
AUTHORITY: 21 U.S.C. 321, 342, 348, 371.
SOURCE: 42 FR 14638, Mar. 15, 1977, unless § 181.5 Prior sanctions.
otherwise noted.
(a) A prior sanction shall exist only
EDITORIAL NOTE: Nomenclature changes to for a specific use(s) of a substance in
part 181 appear at 61 FR 14482, Apr. 2, 1996, food, i.e., the level(s), condition(s),
and 66 FR 56035, Nov. 6, 2001.
product(s), etc., for which there was ex-
plicit approval by the Food and Drug
Subpart A—General Provisions Administration or the United States
§ 181.1 General. Department of Agriculture prior to
September 6, 1958.
(a) An ingredient whose use in food
(b) The existence of a prior sanction
or food packaging is subject to a prior
exempts the sanctioned use(s) from the
sanction or approval within the mean-
ing of section 201(s)(4) of the Act is ex- food additive provisions of the Act but
empt from classification as a food addi- not from the other adulteration or the
tive. The Commissioner will publish in misbranding provisions of the Act.
this part all known prior sanctions. (c) All known prior sanctions shall be
Any interested person may submit to the subject of a regulation published in
the Commissioner a request for publi- this part. Any such regulation is sub-
cation of a prior sanction, supported by ject to amendment to impose whatever
evidence to show that it falls within limitation(s) or condition(s) may be
section 201(s)(4) of the Act. necessary for the safe use of the ingre-
(b) Based upon scientific data or in- dient, or revocation to prohibit use of
formation that shows that use of a the ingredient, in order to prevent the
prior-sanctioned food ingredient may adulteration of food in violation of sec-
be injurious to health, and thus in vio- tion 402 of the Act.
lation of section 402 of the Act, the (d) In proposing, after a general eval-
Commissioner will establish or amend uation of use of an ingredient, regula-
an applicable prior sanction regulation tions affirming the GRAS status of
to impose whatever limitations or con- substances added directly to human
ditions are necessary for the safe use of food in part 184 of this chapter or sub-
the ingredient, or to prohibit use of the
stances in food-contact surfaces in part
ingredient.
186 of this chapter, or establishing a
(c) Where appropriate, an emergency
action level may be issued for a prior- food additive regulation for substances
sanctioned substance, pending the added directly to human food in parts
issuance of a final regulation in ac- 172 and 173 of this chapter or food addi-
cordance with paragraph (b) of this sec- tives in food-contact surfaces in parts
tion. Such an action level shall be 174, 175, 176, 177, 178 and § 179.45 of this
issued pursuant to section 402(a) of the chapter, the Commissioner shall, if he
Act to identify, based upon available is aware of any prior sanction for use
data, conditions of use of the substance of the ingredient under conditions dif-
that may be injurious to health. Such ferent from those proposed in the regu-
an action level shall be issued in a no- lation, concurrently propose a separate

tice published in the FEDERAL REG-
468
regulation covering such use of the in- ably possible, and shall not exceed any
gredient under this part. If the Com- limit specified in this subpart.
missioner is unaware of any such appli- [42 FR 56728, Oct. 28, 1977]
cable prior sanction, the proposed regu-
lation will so state and will require any § 181.23 Antimycotics.
person who intends to assert or rely on
Substances classified as
such sanction to submit proof of its ex-
antimycotics, when migrating from
istence. Any food additive or GRAS food-packaging material shall include:
regulation promulgated after a general
evaluation of use of an ingredient con- Calcium propionate.
stitutes a determination that excluded Methylparaben (methyl p-hydroxybenzoate).
Propylparaben (propyl p-hydroxybenzoate).
uses would result in adulteration of the
Sodium benzoate.
food in violation of section 402 of the Sodium propionate.
Act, and the failure of any person to Sorbic acid.
come forward with proof of such an ap-
[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct.
plicable prior sanction in response to a 28, 1977]
proposal will constitute a waiver of the
right to assert or rely on such sanction § 181.24 Antioxidants.
at any later time. The notice will also
Substances classified as antioxidants,
constitute a proposal to establish a
when migrating from food-packaging
regulation under this part, incor-
material (limit of addition to food,
porating the same provisions, in the 0.005 percent) shall include:
event that such a regulation is deter-
mined to be appropriate as a result of Butylated hydroxyanisole.
submission of proof of such an applica- Butylated hydroxytoluene.
ble prior sanction in response to the Dilauryl thiodipropionate.
Distearyl thiodipropionate.
proposal. Gum guaiac.
Nordihydroguairetic acid.
Subpart B—Specific Prior- Propyl gallate.
Sanctioned Food Ingredients Thiodipropionic acid.
2,4,5-Trihydroxy butyrophenone.
§ 181.22 Certain substances employed [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct.
in the manufacture of food-pack- 28, 1977]
aging materials.
§ 181.25 Driers.
Prior to the enactment of the food
additives amendment to the Federal Substances classified as driers, when
Food, Drug, and Cosmetic Act, sanc- migrating from food-packaging mate-
tions were granted for the usage of the rial shall include:
substances listed in §§ 181.23, 181.24, Cobalt caprylate.
181.25, 181.26, 181.27, 181.28, 181.29, and Cobalt linoleate.
181.30 in the manufacture of packaging Cobalt naphthenate.
materials. So used, these substances Cobalt tallate.
are not considered ‘‘food additives’’ Iron caprylate.
Iron linoleate.
within the meaning of section 201(s) of Iron naphthenate.
the Act, provided that they are of good Iron tallate.
commercial grade, are suitable for as- Manganese caprylate.
sociation with food, and are used in ac- Manganese linoleate.
cordance with good manufacturing Manganese naphthenate.
practice. For the purpose of this sub- Manganese tallate.
part, good manufacturing practice for [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct.
food-packaging materials includes the 28, 1977]
restriction that the quantity of any of
these substances which becomes a com- § 181.26 Drying oils as components of
ponent of food as a result of use in finished resins.
food-packaging materials shall not be Substances classified as drying oils,
intended to accomplish any physical or when migrating from food-packaging
technical effect in the food itself, shall material (as components of finished
be reduced to the least amount reason- resins) shall include:
469
§ 181.27 21 CFR Ch. I (4–1–12 Edition)
Chinawood oil (tung oil). Ammonium citrate.
Dehydrated castor oil. Ammonium potassium hydrogen phosphate.
Linseed oil. Calcium glycerophosphate.
Tall oil. Calcium phosphate.
Calcium hydrogen phosphate.
[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Calcium oleate.
28, 1977] Calcium acetate.
Calcium carbonate.
§ 181.27 Plasticizers. Calcium ricinoleate.
Substances classified as plasticizers, Calcium stearate.
when migrating from food-packaging Disodium hydrogen phosphate.
Magnesium glycerophosphate.
material shall include:
Magnesium stearate.
Acetyl tributyl citrate. Magnesium phosphate.
Acetyl triethyl citrate. Magnesium hydrogen phosphate.
p-tert-Butylphenyl salicylate. Mono-, di-, and trisodium citrate.
Butyl stearate. Mono-, di-, and tripotassium citrate.
Butylphthalyl butyl glycolate. Potassium oleate.
Dibutyl sebacate. Potassium stearate.
Di-(2-ethylhexyl) phthalate (for foods of high Sodium pyrophosphate.
water content only). Sodium stearate.
Diethyl phthalate. Sodium tetrapyrophosphate.
Diisobutyl adipate. Stannous stearate (not to exceed 50 parts per
Diisooctyl phthalate (for foods of high water million tin as a migrant in finished food).
content only). Zinc orthophosphate (not to exceed 50 parts
Diphenyl-2-ethylhexyl phosphate. per million zinc as a migrant in finished
Epoxidized soybean oil (iodine number max- food).
imum 6; and oxirane oxygen, minimum, 6.0 Zinc resinate (not to exceed 50 parts per mil-
percent). lion zinc as a migrant in finished food).
Ethylphthalyl ethyl glycolate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct.
Glycerol monooleate. 28, 1977]
Monoisopropyl citrate.
Mono, di-, and tristearyl citrate. § 181.30 Substances used in the manu-
Triacetin (glycerol triacetate). facture of paper and paperboard
Triethyl citrate. products used in food packaging.
3-(2-Xenolyl)-1,2-epoxypropane.
Substances used in the manufacture
[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. of paper and paperboard products used
28, 1977, as amended at 50 FR 49536, Dec. 3, in food packaging shall include:
1985]
Aliphatic polyoxyethylene ethers.*
§ 181.28 Release agents. 1-Alkyl (C6-C18)3-amino-3-aminopropane
monoacetate.*
Substances classified as release Borax or boric acid for use in adhesives,
agents, when migrating from food- sizes, and coatings.*
packaging material shall include: Butadiene-styrene copolymer.
Dimethylpolysiloxane (substantially free Chromium complex of perfluoro-octane
from hydrolyzable chloride and alkoxy sulfonyl glycine for use on paper and pa-
groups, no more than 18 percent loss in perboard which is waxed.*
Disodium cyanodithioimidocarbamate with
weight after heating 4 hours at 200 °C.; vis-
ethylene diamine and potassium N-methyl
cosity 300 centisokes, 600 centisokes at 25
dithiocarbamate and/or sodium 2-
°C, specific gravity 0.96 to 0.97 at 25 °C, re-
mercaptobenzothiazole (slimicides).*
fractive index 1.400 to 1.404 at 25 °C).
Ethyl acrylate and methyl methacrylate co-
Linoleamide (linoleic acid amide).
polymers of itaconic acid or methacrylic
Oleamide (oleic acid amide).
acid for use only on paper and paperboard
Palmitamide (palmitic acid amide).
which is waxed.*
Stearamide (stearic acid amide).
Hexamethylene tetramine as a setting agent
[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. for protein, including casein.*
28, 1977] 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2-alkyl
(C6-C17) imidazolinium chloride.*
§ 181.29 Stabilizers. Itaconic acid (polymerized).
Substances classified as stabilizers,
when migrating from food-packaging *Under the conditions of normal use, these
material shall include: substances would not reasonably be expected

to migrate to food, based on available sci-
Aluminum mono-, di-, and tristearate. entific information and data.
470
Melamine formaldehyde polymer. mer—for use only as piping for han-
Methyl acrylate (polymerized). dling food products and for repeated-
Methyl ethers of mono-, di-, and tripropylene
use articles intended to contact food.
glycol.*
Myristo chromic chloride complex. (ii) Acrylonitrile/styrene resin—no
Nitrocellulose. restrictions.
Polyethylene glycol 400. (iii) Acrylonitrile/butadiene copoly-
Polyvinyl acetate. mer blended with polyvinyl chloride
Potassium pentachlorophenate as a slime resin—for use only as extruded pipe.
control agent.*
Potassium trichlorophenate as a slime con- (b) Limitations for acrylonitrile
trol agent.* monomer extraction for finished food-
Resins from high and low viscosity polyvinyl contact articles, determined by using
alcohol for fatty foods only. the method of analysis titled ‘‘Gas-
Rubber hydrochloride. Solid Chromatographic Procedure for
Sodium pentachlorophenate as a slime con-
Determining Acrylonitrile Monomer in
trol agent.*
Sodium-trichlorophenate as a slime control Acrylonitrile-Containing Polymers and
agent.* Food-Simulating Solvents,’’ which is
Stearato-chromic chloride complex. incorporated by reference. Copies are
Titanium dioxide.* available from the Center for Food
Urea formaldehyde polymer. Safety and Applied Nutrition (HFS–
Vinylidine chlorides (polymerized). 200), Food and Drug Administration,
§ 181.32 Acrylonitrile copolymers and
resins. MD 20740, or available for inspection at
(a) Acrylonitrile copolymers and res- ministration (NARA). For information
ins listed in this section, containing on the availability of this material at
less than 30 percent acrylonitrile and NARA, call 202–741–6030, or go to: http://
complying with the requirements of www.archives.gov/federallregister/
paragraph (b) of this section, may be codeloflfederallregulations/
safely used as follows: ibrllocations.html.
(1) Films. (i) Acrylonitrile/butadiene/ (1) In the case of single-use articles
styrene copolymers—no restrictions. having a volume to surface ratio of 10
(ii) Acrylonitrile/butadiene copoly- milliliters or more per square inch of
mers—no restrictions. food-contact surface—0.003 milligram/
(iii) Acrylonitrile/butadiene copoly- square inch when extracted to equi-
mer blended with vinyl chloride-vinyl librium at 120 °F with food-simulating
acetate (optional at level up to 5 per- solvents appropriate to the intended
cent by weight of the vinyl chloride conditions of use.
resin) resin—for use only in contact
(2) In the case of single-use articles
with oleomargarine.
having a volume to surface ratio of less
(iv) Acrylonitrile/styrene copoly-
than 10 milliliters per square inch of
mer—no restrictions.
food-contact surface—0.3 part per mil-
(2) Coatings. (i) Acrylonitrile/buta-
lion calculated on the basis of the vol-
diene copolymer blended with poly-
ume of the container when extracted to
vinyl chloride resins—for use only on
equilibrium at 120 °F with food-simu-
paper and paperboard in contact with
lating solvents appropriate to the in-
meats and lard.
(ii) Polyvinyl chloride resin blended tended conditions of use.
with either acrylonitrile/butadiene co- (3) In the case of repeated-use arti-
polymer or acrylonitrile/butadiene sty- cles—0.003 milligram/square inch when
rene copolymer mixed with neoprene, extracted at a time equivalent to ini-
for use as components of conveyor tial batch usage utilizing food-simu-
belts to be used with fresh fruits, vege- lating solvents and temperatures ap-
tables, and fish. propriate to the intended conditions of
(iii) Acrylonitrile/butadiene/styrene use.
copolymer—no restrictions. The food-simulating solvents shall in-
(iv) Acrylonitrile/styrene copoly- clude, where applicable, distilled
mer—no restrictions. water, 8 percent or 50 percent ethanol,
(3) Rigid and semirigid containers. (i) 3 percent acetic acid, and either n-
Acrylonitrile/butadiene/styrene copoly- heptane or an appropriate oil or fat.
471
§ 181.33 21 CFR Ch. I (4–1–12 Edition)
(c) Acrylonitrile monomer may 182.90 Substances migrating to food from

present a hazard to health when in- paper and paperboard products.
gested. Accordingly, any food-contact 182.99 Adjuvants for pesticide chemicals.
article containing acrylonitrile copoly- Subpart B—Multiple Purpose GRAS Food
mers or resins that yield acrylonitrile Substances
monomer in excess of that amount pro-
vided for in paragraph (b) of this sec- 182.1045 Glutamic acid.
tion shall be deemed to be adulterated 182.1047 Glutamic acid hydrochloride.
in violation of section 402 of the Act. 182.1057 Hydrochloric acid.
182.1073 Phosphoric acid.
[42 FR 14638, Mar. 15, 1977, as amended at 47 182.1087 Sodium acid pyrophosphate.
FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 182.1125 Aluminum sulfate.
1989] 182.1127 Aluminum ammonium sulfate.
182.1129 Aluminum potassium sulfate.
§ 181.33 Sodium nitrate and potassium 182.1131 Aluminum sodium sulfate.
nitrate. 182.1180 Caffeine.
182.1217 Calcium phosphate.
Sodium nitrate and potassium ni-
182.1235 Caramel.
trate are subject to prior sanctions 182.1320 Glycerin.
issued by the U.S. Department of Agri- 182.1480 Methylcellulose.
culture for use as sources of nitrite, 182.1500 Monoammonium glutamate.
with or without sodium or potassium 182.1516 Monopotassium glutamate.
nitrite, in the production of cured red 182.1711 Silica aerogel.
meat products and cured poultry prod- 182.1745 Sodium carboxymethylcellulose.
ucts. 182.1748 Sodium caseinate.
182.1778 Sodium phosphate.
[48 FR 1705, Jan. 14, 1983] 182.1781 Sodium aluminum phosphate.
182.1810 Sodium tripolyphosphate.
§ 181.34 Sodium nitrite and potassium
nitrite. Subpart C—Anticaking Agents
Sodium nitrite and potassium nitrite 182.2122 Aluminum calcium silicate.
are subject to prior sanctions issued by 182.2227 Calcium silicate.
the U.S. Department of Agriculture for 182.2437 Magnesium silicate.
use as color fixatives and preservative 182.2727 Sodium aluminosilicate.
agents, with or without sodium or po- 182.2729 Sodium calcium aluminosilicate,
tassium nitrate, in the curing of red hydrated.
182.2906 Tricalcium silicate.
meat and poultry products.
[48 FR 1705, Jan. 14, 1983] Subpart D—Chemical Preservatives
182.3013 Ascorbic acid.
PART 182—SUBSTANCES 182.3041 Erythorbic acid.
GENERALLY RECOGNIZED AS SAFE 182.3089 Sorbic acid.
182.3109 Thiodipropionic acid.
Subpart A—General Provisions 182.3149 Ascorbyl palmitate.
182.3169 Butylated hydroxyanisole.
Sec. 182.3173 Butylated hydroxytoluene.
182.1 Substances that are generally recog- 182.3189 Calcium ascorbate.
nized as safe. 182.3225 Calcium sorbate.
182.10 Spices and other natural seasonings 182.3280 Dilauryl thiodipropionate.
and flavorings. 182.3616 Potassium bisulfite.
182.20 Essential oils, oleoresins (solvent- 182.3637 Potassium metabisulfite.
free), and natural extractives (including 182.3640 Potassium sorbate.
distillates). 182.3731 Sodium ascorbate.
182.40 Natural extractives (solvent-free) 182.3739 Sodium bisulfite.
used in conjunction with spices, 182.3766 Sodium metabisulfite.
seasonings, and flavorings. 182.3795 Sodium sorbate.
182.50 Certain other spices, seasonings, es- 182.3798 Sodium sulfite.
sential oils, oleoresins, and natural ex- 182.3862 Sulfur dioxide.
tracts. 182.3890 Tocopherols.
182.60 Synthetic flavoring substances and
adjuvants. Subpart E—Emulsifying Agents [Reserved]
182.70 Substances migrating from cotton

and cotton fabrics used in dry food pack- Subpart F—Dietary Supplements
aging. [Reserved]
472
Subpart G—Sequestrants defined to include the following re-

strictions:
182.6085 Sodium acid phosphate.
182.6197 Calcium diacetate. (1) The quantity of a substance added
182.6203 Calcium hexametaphosphate. to food does not exceed the amount
182.6215 Monobasic calcium phosphate. reasonably required to accomplish its
182.6285 Dipotassium phosphate. intended physical, nutritional, or other
182.6290 Disodium phosphate. technical effect in food; and
182.6757 Sodium gluconate. (2) The quantity of a substance that
182.6760 Sodium hexametaphosphate.
182.6769 Sodium metaphosphate.
becomes a component of food as a re-
182.6778 Sodium phosphate. sult of its use in the manufacturing,
182.6787 Sodium pyrophosphate. processing, or packaging of food, and
182.6789 Tetra sodium pyrophosphate. which is not intended to accomplish
182.6810 Sodium tripolyphosphate. any physical or other technical effect
in the food itself, shall be reduced to
Subpart H—Stabilizers the extent reasonably possible.
182.7255 Chondrus extract. (3) The substance is of appropriate
food grade and is prepared and handled
Subpart I—Nutrients as a food ingredient. Upon request the
Commissioner will offer an opinion,
182.8013 Ascorbic acid.
182.8159 Biotin. based on specifications and intended
182.8217 Calcium phosphate. use, as to whether or not a particular
182.8223 Calcium pyrophosphate. grade or lot of the substance is of suit-
182.8250 Choline bitartrate. able purity for use in food and would
182.8252 Choline chloride. generally be regarded as safe for the
182.8778 Sodium phosphate. purpose intended, by experts qualified
182.8890 Tocopherols. to evaluate its safety.
182.8892 a-Tocopherol acetate.
182.8985 Zinc chloride. (c) The inclusion of substances in the
182.8988 Zinc gluconate. list of nutrients does not constitute a
182.8991 Zinc oxide. finding on the part of the Department
182.8994 Zinc stearate. that the substance is useful as a sup-
182.8997 Zinc sulfate. plement to the diet for humans.
AUTHORITY: 21 U.S.C. 321, 342, 348, 371. (d) Substances that are generally rec-
SOURCE: 42 FR 14640, Mar. 15, 1977, unless
ognized as safe for their intended use
otherwise noted. within the meaning of section 409 of
the act are listed in this part. When
the status of a substance has been re-
Subpart A—General Provisions evaluated, it will be deleted from this
§ 182.1 Substances that are generally part, and will be issued as a new regu-
recognized as safe. lation under the appropriate part, e.g.,
‘‘affirmed as GRAS’’ under part 184 or
(a) It is impracticable to list all sub-
186 of this chapter; ‘‘food additive regu-
stances that are generally recognized
lation’’ under parts 170 through 180 of
as safe for their intended use. However,
this chapter; ‘‘interim food additive
by way of illustration, the Commis-
regulation’’ under part 180 of this chap-
sioner regards such common food in-
ter; or ‘‘prohibited from use in food’’
gredients as salt, pepper, vinegar, bak-
under part 189 of this chapter.
ing powder, and monosodium glu-
tamate as safe for their intended use. [42 FR 14640, Mar. 15, 1977, as amended at 53
This part includes additional sub- FR 44875, Nov. 7, 1988]
stances that, when used for the pur-
poses indicated, in accordance with § 182.10 Spices and other natural
good manufacturing practice, are re- seasonings and flavorings.
garded by the Commissioner as Spices and other natural seasonings
generaly recognized as safe for such and flavorings that are generally rec-
uses. ognized as safe for their intended use,
(b) For the purposes of this section, within the meaning of section 409 of
good manufacturing practice shall be the Act, are as follows:
473
§ 182.10 21 CFR Ch. I (4–1–12 Edition)
Common name Botanical name of plant source
Alfalfa herb and seed .............................................. Medicago sativa L.

Allspice .................................................................... Pimenta officinalis Lindl.
Ambrette seed ......................................................... Hibiscus abelmoschus L.
Angelica ................................................................... Angelica archangelica L. or other spp. of Angelica.
Angelica root ........................................................... Do.
Angelica seed .......................................................... Do.
Angostura (cusparia bark) ....................................... Galipea officinalis Hancock.
Anise ....................................................................... Pimpinella anisum L.
Anise, star ............................................................... Illicium verum Hook. f.
Balm (lemon balm) .................................................. Melissa officinalis L.
Basil, bush ............................................................... Ocimum minimum L.
Basil, sweet ............................................................. Ocimum basilicum L.
Bay .......................................................................... Laurus nobilis L.
Calendula ................................................................ Calendula officinalis L.
Camomile (chamomile), English or Roman ............ Anthemis nobilis L.
Camomile (chamomile), German or Hungarian ...... Matricaria chamomilla L.
Capers ..................................................................... Capparis spinosa L.
Capsicum ................................................................ Capsicum frutescens L. or Capsicum annuum L.
Caraway .................................................................. Carum carvi L.
Caraway, black (black cumin) ................................. Nigella sativa L.
Cardamom (cardamon) ........................................... Elettaria cardamomum Maton.
Cassia, Chinese ...................................................... Cinnamomum cassia Blume.
Cassia, Padang or Batavia ..................................... Cinnamomum burmanni Blume.
Cassia, Saigon ........................................................ Cinnamomum loureirii Nees.
Cayenne pepper ...................................................... Capsicum frutescens L. or Capsicum annuum L.
Celery seed ............................................................. Apium graveolens L.
Chervil ..................................................................... Anthriscus cerefolium (L.) Hoffm.
Chives ..................................................................... Allium schoenoprasum L.
Cinnamon, Ceylon ................................................... Cinnamomum zeylanicum Nees.
Cinnamon, Chinese ................................................. Cinnamomum cassia Blume.
Cinnamon, Saigon ................................................... Cinnamomum loureirii Nees.
Clary (clary sage) .................................................... Salvia sclarea L.
Clover ...................................................................... Trifolium spp.
Coriander ................................................................. Coriandrum sativum L.
Cumin (cummin) ...................................................... Cuminum cyminum L.
Cumin, black (black caraway) ................................. Nigella sativa L.
Elder flowers ........................................................... Sambucus canadensis L.
Fennel, common ..................................................... Foeniculum vulgare Mill.
Fennel, sweet (finocchio, Florence fennel) ............. Foeniculum vulgare Mill. var. duice (DC.) Alex.
Fenugreek ............................................................... Trigonella foenum-graecum L.
Galanga (galangal) .................................................. Alpinia officinarum Hance.
Geranium ................................................................. Pelargonium spp.
Ginger ...................................................................... Zingiber officinale Rosc.
Grains of paradise ................................................... Amomum melegueta Rosc.
Horehound (hoarhound) .......................................... Marrubium vulgare L.
Horseradish ............................................................. Armoracia lapathifolia Gilib.
Hyssop .................................................................... Hyssopus officinalis L.
Lavender ................................................................. Lavandula officinalis Chaix.
Linden flowers ......................................................... Tilia spp.
Mace ........................................................................ Myristica fragrans Houtt.
Marigold, pot ........................................................... Calendula officinalis L.
Marjoram, pot .......................................................... Majorana onites (L.) Benth.
Marjoram, sweet ...................................................... Majorana hortensis Moench.
Mustard, black or brown ......................................... Brassica nigra (L.) Koch.
Mustard, brown ....................................................... Brassica juncea (L.) Coss.
Mustard, white or yellow ......................................... Brassica hirta Moench.
Nutmeg .................................................................... Myristica fragrans Houtt.
Oregano (oreganum, Mexican oregano, Mexican Lippia spp.
sage, origan).
Paprika .................................................................... Capsicum annuum L.
Parsley .................................................................... Petroselinum crispum (Mill.) Mansf.
Pepper, black .......................................................... Piper nigrum L.
Pepper, cayenne ..................................................... Capsicum frutescens L. or Capsicum annuum L.
Pepper, red ............................................................. Do.
Pepper, white .......................................................... Piper nigrum L.
Peppermint .............................................................. Mentha piperita L.
Poppy seed ............................................................. Papayer somniferum L.
Pot marigold ............................................................ Calendula officinalis L.
Pot marjoram ........................................................... Majorana onites (L.) Benth.
Rosemary ................................................................ Rosmarinus officinalis L.
Saffron ..................................................................... Crocus sativus L.
Sage ........................................................................ Salvia officinalis L.

Sage, Greek ............................................................ Salvia triloba L.
Savory, summer ...................................................... Satureia hortensis L. (Satureja).
474
Savory, winter ......................................................... Satureia montana L. (Satureja).

Sesame ................................................................... Sesamum indicum L.
Spearmint ................................................................ Mentha spicata L.
Star anise ................................................................ Illicium verum Hook. f.
Tarragon .................................................................. Artemisia dracunculus L.
Thyme ..................................................................... Thymus vulgaris L.
Thyme, wild or creeping .......................................... Thymus serpyllum L.
Turmeric .................................................................. Curcuma longa L.
Vanilla ...................................................................... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore.
Zedoary ................................................................... Curcuma zedoaria Rosc.
[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 FR 3963, Jan. 19, 1979;
50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 1996]
§ 182.20 Essential oils, oleoresins (sol- ing distillates) that are generally rec-
vent-free), and natural extractives ognized as safe for their intended use,
(including distillates). within the meaning of section 409 of
Essential oils, oleoresins (solvent- the Act, are as follows:
free), and natural extractives (includ-
Alfalfa ...................................................................... Medicago sativa L.

Allspice .................................................................... Pimenta officinalis Lindl.
Almond, bitter (free from prussic acid) ................... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.)
Batsch.
Ambrette (seed) ...................................................... Hibiscus moschatus Moench.
Angelica root ........................................................... Angelica archangelica L.
Angelica seed .......................................................... Do.
Angelica stem .......................................................... Do.
Angostura (cusparia bark) ....................................... Galipea officinalis Hancock.
Anise ....................................................................... Pimpinella anisum L.
Asafetida ................................................................. Ferula assa-foetida L. and related spp. of Ferula.
Balm (lemon balm) .................................................. Melissa officinalis L.
Balsam of Peru ....................................................... Myroxylon pereirae Klotzsch.
Basil ......................................................................... Ocimum basilicum L.
Bay leaves ............................................................... Laurus nobilis L.
Bay (myrcia oil) ....................................................... Pimenta racemosa (Mill.) J. W. Moore.
Bergamot (bergamot orange) .................................. Citrus aurantium L. subsp. bergamia Wright et Arn.
Bitter almond (free from prussic acid) .................... Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.)
Batsch.
Bois de rose ............................................................ Aniba rosaeodora Ducke.
Cacao ...................................................................... Theobroma cacao L.
Camomile (chamomile) flowers, Hungarian ............ Matricaria chamomilla L.
Camomile (chamomile) flowers, Roman or English Anthemis nobilis L.
Cananga .................................................................. Cananga odorata Hook. f. and Thoms.
Capsicum ................................................................ Capsicum frutescens L. and Capsicum annuum L.
Caraway .................................................................. Carum carvi L.
Cardamom seed (cardamon) .................................. Elettaria cardamomum Maton.
Carob bean ............................................................. Ceratonia siliqua L.
Carrot ...................................................................... Daucus carota L.
Cascarilla bark ........................................................ Croton eluteria Benn.
Cassia bark, Chinese .............................................. Cinnamomum cassia Blume.
Cassia bark, Padang or Batavia ............................. Cinnamomum burmanni Blume.
Cassia bark, Saigon ................................................ Cinnamomum loureirii Nees.
Celery seed ............................................................. Apium graveolens L.
Cherry, wild, bark .................................................... Prunus serotina Ehrh.
Chervil ..................................................................... Anthriscus cerefolium (L.) Hoffm.
Chicory .................................................................... Cichorium intybus L.
Cinnamon bark, Ceylon .......................................... Cinnamomum zeylanicum Nees.
Cinnamon bark, Chinese ........................................ Cinnamomum cassia Blume.
Cinnamon bark, Saigon .......................................... Cinnamomum loureirii Nees.
Cinnamon leaf, Ceylon ............................................ Cinnamomum zeylanicum Nees.
Cinnamon leaf, Chinese .......................................... Cinnamomum cassia Blume.
Cinnamon leaf, Saigon ............................................ Cinnamomum loureirii Nees.
Citro

CFR Title 21 - 2012

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

CFR Title 21 - 2012

Uploaded by

Copyright:

Available Formats

Title 21

Food and Drugs

Revised as of April 1, 2012

Containing a codification of documents

Published by the Office of the Federal Register

Legal Status and Use of Seals and Logos

Use of ISBN Prefix

U.S. GOVERNMENT PRINTING OFFICE

U.S. Superintendent of Documents • Washington, DC 20402–0001

Phone: toll-free (866) 512-1800; DC area (202) 512-1800

Chapter I—Food and Drug Administration, Department of Health

Table of CFR Titles and Chapters ....................................................... 607

Alphabetical List of Agencies Appearing in the CFR ......................... 627

List of CFR Sections Affected ............................................................. 637

To cite the regulations in

lishing in the CFR are also included in this volume.

CHAPTER I—Food and Drug Administration, Department of

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED)

189 Substances prohibited from use in human food ...... 595

PART 170—FOOD ADDITIVES 170.106 Notification for a food contact sub-

(FDA’s) determination that a premarket

Recognized as Safe’’ (September 1972), to precipitate residual pectin, thus

and preventing its collapse during (23) pH control agents: Substances

FR 11835, Mar. 19, 1982; 53 FR 16546, May 10,

of the kind described in paragraph (c) standard of identity contains a pro-

investigational use only in laboratory re-

§ 170.22 Safety factors to be consid- generally available data and informa-

of the substance prior to January 1, ists, will ordinarily be regarded as

identical to a GRAS counterpart of significantly different from those re-

tion in the Division of Dockets Man- regulation is determined to be appro-

of such an applicable prior sanction in the Food and Drug Administration’s

longer safe, FDA may determine that PART 171—FOOD ADDITIVE

additive petition should be accom- be followed by a complete quantitative

may authorize specific reference to the chapter or they relate to a product or

nut oil, palm kernel oil, or both oils.

compliance with any other provision of www.archives.gov/federallregister/

chives and Records Administration Dry breakfast cereals .......................................... 50

Dry mixes for beverages and desserts ............... 1 90

Limitations § 172.120 Calcium disodium EDTA.

Salad dressing .............. 75 Preservative.

Limita- Sodium salt of dehydroacetic acid: Assay,

stirring. For determining the blank con-

canned, other than black- tention.

Limita- § 172.140 Ethoxyquin.

§ 172.155 Natamycin (pimaricin). § 172.165 Quaternary ammonium chlo-

(1) The label of the additive or of a (ii) A statement of the concentration

bear: A temperature of 38 °F or below shall

Fatty acids ............................................................ Complying with § 172.860.

ibrllocations.html.) using as a solvent xylene-ethyl alcohol in a 2:1 ratio

Wood rosin ........................................................... Color of K or paler.

§ 172.215 Coumarone-indene resin. Barr Harbor Dr., West Conshohocken,

(2) The label or accompanying label- Arabinogalactan—Complying with § 172.610;

§ 172.225 Methyl and ethyl esters of COMPONENT AND LIMITATIONS

cent by combined weight of the microcap-

(a) It is used as the salt(s) of one or APPARATUS

280–289 ............................................................... 0.15 Isooctane (2,2,4-trimethylpentane). Use 180

741–6030, or go to: http://www.archives.gov/

be safely used as a component of food, federallregister/

Park, MD 20740, or available for inspec- marily-intact naturally occurring pro-

as a statistically significant difference make such records available upon re-

quired to assure effectiveness and com- million (ppm) as zinc.

202–741–6030, or go to: http://www.archives.gov/

tary use, when the use is consistent