21 CFR 174 189 Food Contact Substances

Food and Drug Administration, HHS § 174.
CFR part 51. Copies are available from 174.6 Threshold of regulation for substances
the Center for Food Safety and Applied used in food-contact articles.
Nutrition (HFS–200), Food and Drug AUTHORITY: 21 U.S.C. 321, 342, 348, 371.
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or § 174.5 General provisions applicable
available for inspection at the National to indirect food additives.
Archives and Records Administration (a) Regulations prescribing condi-
(NARA). For information on the avail- tions under which food additive sub-
ability of this material at NARA, call stances may be safely used predicate
202–741–6030, or go to: http:// usage under conditions of good manu-
www.archives.gov/federallregister/ facturing practice. For the purpose of
codeloflfederallregulations/
this part and parts 175, 176, and 177 of
ibrllocations.html.
this chapter, good manufacturing prac-
(d) To assure safe use of the additive,
tice shall be defined to include the fol-
the label and labeling of the additive
lowing restrictions:
shall bear, in addition to other infor-
mation required by the Federal Food, (1) The quantity of any food additive
Drug, and Cosmetic Act, adequate di- substance that may be added to food as
rections to assure use in compliance a result of use in articles that contact
with paragraph (c) of this section. food shall not exceed, where no limits
are specified, that which results from
[56 FR 42686, Aug. 29, 1991] use of the substance in an amount not
more than reasonably required to ac-
§ 173.405 Sodium complish the intended physical or tech-
dodecylbenzenesulfonate.
nical effect in the food-contact article;
Sodium dodecylbenzenesulfonate shall not exceed any prescribed limita-
(CAS No. 25155–30–0) may be safely used tions; and shall not be intended to ac-
in accordance with the following pre- complish any physical or technical ef-
scribed conditions: fect in the food itself, except as such
(a) The additive is an antimicrobial may be permitted by regulations in
agent used in wash water for fruits and parts 170 through 189 of this chapter.
vegetables. The additive may be used (2) Any substance used as a compo-
at a level not to exceed 111 milligrams nent of articles that contact food shall
per kilogram in the wash water. Fruits be of a purity suitable for its intended
and vegetables treated by the additive use.
do not require a potable water rinse.
(b) The existence in the subchapter B
(b) The additive is limited to use in
of a regulation prescribing safe condi-
commissaries, cafeterias, restaurants,
tions for the use of a substance as an
retail food establishments, nonprofit
article or component of articles that
food establishments, and other food
contact food shall not be construed to
service operations in which food is pre-
relieve such use of the substance or ar-
pared for or served directly to the con-
ticle from compliance with any other
sumer.
provision of the Federal Food, Drug,
(c) To assure safe use of the additive,
and Cosmetic Act. For example, if a
the label or labeling of the additive
regulated food-packaging material
container shall bear, in addition to the
were found on appropriate test to im-
other information required by the Fed-
part odor or taste to a specific food
eral Food, Drug, and Cosmetic Act,
product such as to render it unfit with-
adequate directions to assure use in
in the meaning of section 402(a)(3) of
compliance with the provisions of this
the Act, the regulation would not be
section.
construed to relieve such use from
[77 FR 71697, Dec. 4, 2012] compliance with section 402(a)(3).
(c) The existence in this subchapter B
PART 174—INDIRECT FOOD of a regulation prescribing safe condi-
ADDITIVES: GENERAL tions for the use of a substance as an
article or component of articles that
Lhorne on DSK7TPTVN1PROD with CFR
Sec. contact food shall not be construed as

174.5 General provisions applicable to indi- implying that such substance may be
rect food additives. safely used as a direct additive in food.
157
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§ 174.6 21 CFR Ch. I (4–1–15 Edition)
(d) Substances that under conditions 175.250 Paraffin (synthetic).

of good manufacturing practice may be 175.260 Partial phosphoric acid esters of pol-
safely used as components of articles yester resins.
175.270 Poly(vinyl fluoride) resins.
that contact food include the fol- 175.300 Resinous and polymeric coatings.
lowing, subject to any prescribed limi- 175.320 Resinous and polymeric coatings for
tations: polyolefin films.
(1) Substances generally recognized 175.350 Vinyl acetate/crotonic acid copoly-
as safe in or on food. mer.
(2) Substances generally recognized 175.360 Vinylidene chloride copolymer coat-
as safe for their intended use in food ings for nylon film.
175.365 Vinylidene chloride copolymer coat-
packaging.
ings for polycarbonate film.
(3) Substances used in accordance 175.380 Xylene-formaldehyde resins con-
with a prior sanction or approval. densed with 4,4′-isopropylidenediphenol-
(4) Substances permitted for use by epichlorohydrin epoxy resins.
regulations in this part and parts 175, 175.390 Zinc-silicon dioxide matrix coatings.
176, 177, 178 and § 179.45 of this chapter. AUTHORITY: 21 U.S.C. 321, 342, 348, 379e.
(5) Food contact substances used in
accordance with an effective pre- SOURCE: 42 FR 14534, Mar. 15, 1977, unless
otherwise noted.
market notification for a food contact
substance (FCN) submitted under sec- EDITORIAL NOTE: Nomenclature changes to
tion 409(h) of the act. part 175 appear at 61 FR 14482, Apr. 2, 1996, 66
FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec.
[42 FR 14534, Mar. 15, 1977, as amended at 67 1, 2005.
FR 35731, May 21, 2002]
§ 174.6 Threshold of regulation for Subpart A [Reserved]

substances used in food-contact ar-
ticles. Subpart B—Substances for Use
Substances used in food-contact arti- Only as Components of Adhesives
cles (e.g., food-packaging or food-proc-
essing equipment) that migrate, or § 175.105 Adhesives.
that may be expected to migrate, into (a) Adhesives may be safely used as
food at negligible levels may be re- components of articles intended for use
viewed under § 170.39 of this chapter. in packaging, transporting, or holding
The Food and Drug Administration food in accordance with the following
will exempt substances whose uses it prescribed conditions:
determines meet the criteria in § 170.39 (1) The adhesive is prepared from one
of this chapter from regulation as food or more of the optional substances
additives and, therefore, a food addi- named in paragraph (c) of this section,
tive petition will not be required for subject to any prescribed limitations.
the exempted use. (2) The adhesive is either separated
[60 FR 36596, July 17, 1995] from the food by a functional barrier or
used subject to the following additional
limitations:
PART 175—INDIRECT FOOD ADDI- (i) In dry foods. The quantity of adhe-
TIVES: ADHESIVES AND COMPO- sive that contacts packaged dry food
NENTS OF COATINGS shall not exceed the limits of good
manufacturing practice.
Subpart A [Reserved] (ii) In fatty and aqueous foods. (a) The
quantity of adhesive that contacts
Subpart B—Substances for Use Only as packaged fatty and aqueous foods shall
Components of Adhesives not exceed the trace amount at seams
Sec. and at the edge exposure between pack-
175.105 Adhesives. aging laminates that may occur within
175.125 Pressure-sensitive adhesives. the limits of good manufacturing prac-
tice.
Subpart C—Substances for Use as (b) Under normal conditions of use
Components of Coatings
the packaging seams or laminates will

175.210 Acrylate ester copolymer coating. remain firmly bonded without visible
175.230 Hot-melt strippable food coatings. separation.
158
Food and Drug Administration, HHS § 175.105
(b) To assure safe usage of adhesives, tions of use prescribed by such sanc-
the label of the finished adhesive con- tion or approval.
tainer shall bear the statement ‘‘food- (3) Flavoring substances permitted
packaging adhesive’’. for use in food by regulations in this
(c) Subject to any limitation pre- part, provided that such flavoring sub-
scribed in this section and in any other stances are volatilized from the adhe-
regulation promulgated under section sives during the packaging fabrication
409 of the Act which prescribes safe process.
conditions of use for substances that (4) Color additives approved for use in
may be employed as constituents of ad- food.
hesives, the optional substances used (5) Substances permitted for use in
in the formulation of adhesives may in- adhesives by other regulations in this
clude the following: subchapter and substances named in
(1) Substances generally recognized this subparagraph: Provided, however,
as safe for use in food or food pack- That any substance named in this
aging. paragraph and covered by a specific
(2) Substances permitted for use in regulation in this subchapter, must
adhesives by prior sanction or approval meet any specifications in such regula-
and employed under the specific condition.
Substances Limitations
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.
159
§ 175.105 21 CFR Ch. I (4–1–15 Edition)
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.
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.
160
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.
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.
161
§ 175.105 21 CFR Ch. I (4–1–15 Edition)
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.
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.
162
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.
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.
163
§ 175.105 21 CFR Ch. I (4–1–15 Edition)
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.
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.
164
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.
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.
165
§ 175.105 21 CFR Ch. I (4–1–15 Edition)
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.
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.
166
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.
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.
167
§ 175.105 21 CFR Ch. I (4–1–15 Edition)
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.
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.
168
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).
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.
169
§ 175.105 21 CFR Ch. I (4–1–15 Edition)
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.
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.
170
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.
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).
171
§ 175.105 21 CFR Ch. I (4–1–15 Edition)
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.
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.
172
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.
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. (3) Color additives listed for use in or

on food in parts 73 and 74 of this chap-
Pressure-sensitive adhesives may be ter.
safely used as the food-contact surface (4) Substances identified in § 172.615 of
of labels and/or tapes applied to food, this chapter other than substances
in accordance with the following pre- used in accordance with paragraph
scribed conditions: (a)(2) of this section.
(a) Pressure-sensitive adhesives pre- (5) Polyethylene, oxidized; complying
pared from one or a mixture of two or with the identity prescribed in
more of the substances listed in this § 177.1620(a) of this chapter.
paragraph may be used as the food-con- (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2-
tact surface of labels and/or tapes ap- yl]amino]-2,6-di-tert-butylphenol (CAS
plied to poultry, dry food, and proc- Reg. No. 991–84–4) as an antioxidant/
essed, frozen, dried, or partially dehy- stabilizer at a level not to exceed 1.5
drated fruits or vegetables. percent by weight of the finished pres-
(1) Substances generally recognized sure-sensitive adhesive.
as safe in food. (7) 2,2′-(2,5-Thiophenediyl)-bis(5-tert-

(2) Substances used in accordance butylbenzoxazole) (CAS Reg. No. 7128–
with a prior sanction or approval. 64–5) as an optical brightener at a level
173
§ 175.210 21 CFR Ch. I (4–1–15 Edition)
not to exceed 0.05 percent by weight of Rubber hydrochloride.

the finished pressure-sensitive adhe- Rubber (natural latex solids or crepe,
sive. smoked or unsmoked).
Terpene resins (a- and b-pinene),
(8) 2-Hydroxy-1-[4-(2-hydroxyethoxy)
homopolymers, copolymers, and conden-
phenyl]-2-methyl-1-propanone (CAS sates with phenol, formaldehyde, cou-
Reg. No. 106797–53–9) as a photoinitiator marone, and/or indene.
at a level not to exceed 5 percent by Tetrasodium ethylenediaminetetraacetate.
weight of the pressure-sensitive adhe- Tri(mixed mono- and dinonylphenyl)
sive. phosphite (which may contain not more
(9) Butanedioic acid, sulfo-1,4-di-(C9- than 1 percent by weight of
C11 alkyl) ester, ammonium salt (also triisopropanolamine).
known as butanedioic acid sulfo-1, 4- (c) Acrylonitrile copolymers identi-
diisodecyl ester, ammonium salt [CAS fied in this section shall comply with
Reg. No. 144093–88–9]) as a surface ac- the provisions of § 180.22 of this chap-
tive agent at a level not to exceed 3.0 ter.
percent by weight of the finished pres-
[42 FR 14534, Mar. 15, 1977, as amended at 42
sure-sensitive adhesive. FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12,
(b) Pressure-sensitive adhesives pre- 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528,
pared from one or a mixture of two or Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999]
more of the substances listed in this
paragraph may be used as the food-con- Subpart C—Substances for Use as
tact surface of labels and/or tapes ap-
plied to raw fruit and raw vegetables.
Components of Coatings
(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
those substances prescribed by para- Acrylate ester copolymer coating
graph (a)(4) of this section that are not may safely be used as a food-contact
identified in paragraph (b)(2) of this surface of articles intended for pack-
section. aging and holding food, including heat-
(2) Substances identified in this sub- ing of prepared food, subject to the pro-
paragraph and subject to the limita- visions of this section:
tions provided: (a) The acrylate ester copolymer is a
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.
Butadiene-styrene copolymer. cured to an insoluble resin.
Butyl rubber. (b) Optional substances used in the
Butylated reaction product of p-cresol and preparation of the polymer and in the
dicyclopentadiene produced by reacting p- preparation and application of the
cresol and dicyclopentadiene in an approxi- emulsion may include substances
mate mole ratio of 1.5 to 1.0, respectively, named in this paragraph, in an amount
followed by alkylation with isobutylene so not to exceed that required to accom-
that the butyl content of the final product
is not less than 18 percent, for use at levels
plish the desired technical effect and
not to exceed 1.0 percent by weight of the subject to any limitation prescribed:
adhesive formulation. Provided, however, That any substance
Chlorinated natural rubber. named in this paragraph and covered
Isobutylene-styrene copolymer. by a specific regulation in subchapter
Petrolatum. B of this chapter must meet any speci-
Polybutene-1. fications in such regulation.
Polybutene, hydrogenated; complying with
the identity prescribed under § 178.3740(b) of List of substances Limitations
this chapter.
Polyisobutylene. Aluminum stearate.
cis-1,4-Polyisoprene. Ammonium lauryl sulfate.
Borax ............................................ Not to exceed the
Polystyrene. amount required as a
Propyl gallate. preservative in emul-
Rapeseed oil, vulcanized. sion defoamer.

Rosins and rosin derivatives as provided in Disodium hydrogen phosphate ..... Do.
§ 178.3870 of this chapter. Formaldehyde.
174
List of substances Limitations (a) The additive is synthesized by the

Fischer-Tropsch process from carbon
Glyceryl monostearate.
Methyl cellulose. monoxide and hydrogen, which are cat-
Mineral oil. alytically converted to a mixture of
Paraffin wax. paraffin hydrocarbons. Lower molec-
Potassium hydroxide.
Potassium persulfate. ular-weight fractions are removed by
Tallow. distillation. The residue is hydro-
Tetrasodium pyrophosphate. genated and may be further treated by
Titanium dioxide.
percolation through activated char-
(c) The coating in the form in which coal. This mixture can be fractionated
it contacts food meets the following into its components by a solvent sepa-
tests: ration method, using synthetic
(1) An appropriate sample when ex- isoparaffinic petroleum hydrocarbons
posed to distilled water at 212 °F for 30 complying with § 178.3530 of this chap-
minutes shall yield total chloroform- ter.
soluble extractables not to exceed 0.5 (b) Synthetic paraffin shall conform
milligram per square inch. to the following specifications:
(2) An appropriate sample when ex- (1) Congealing point. There is no speci-
posed to n-heptane at 120 °F for 30 min- fication for the congealing point of
utes shall yield total chloroform-solu- synthetic paraffin components, except
ble extractables not to exceed 0.5 milli- those components that have a con-
gram per square inch. gealing point below 50 °C when used in
contact with food Types III, IVA, V,
§ 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 propionate. tration (NARA). For information on
Mineral oil, white ........................... For use only as a com- the availability of this material at
ponent of hot-melt NARA, call 202–741–6030, or go to: http://
strippable food coat-
ings applied to frozen www.archives.gov/federallregister/
meats and complying codeloflfederallregulations/
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,
Synthetic paraffin may be safely ‘‘Tentative Method of Test for Oil Con-
used as an impregnant in, coating on, tent of Petroleum Waxes’’ (Revised
or component of coatings on articles 1956), which is incorporated by ref-
used in producing, manufacturing, erence. See paragraph (b)(1) of this sec-
packing, processing, preparing, treat- tion for availability of the incorpora-
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
175
§ 175.260 21 CFR Ch. I (4–1–15 Edition)
decahydronaphthalene at 88 °C not ex- § 175.270 Poly(vinyl fluoride) resins.

ceeding 0.01 as determined by ASTM
Poly(vinyl fluoride) resins identified
method E131–81a, ‘‘Standard Defini-
in this section may be safely used as
tions of Terms and Symbols Relating
to Molecular-Spectroscopy,’’ which is components of food-contact coatings
incorporated by reference. See para- for containers having a capacity of not
graph (b)(1) of this section for avail- less than 5 gallons, subject to the pro-
ability of the incorporation by ref- visions of this section.
erence. (a) For the purpose of this section,
(c) The provisions of this section are poly(vinyl fluoride) resins consist of
not applicable to synthetic paraffin basic resins produced by the polym-
used in food-packaging adhesives com- erization of vinyl fluoride.
plying with § 175.105. (b) The poly(vinyl fluoride) basic res-
ins have an intrinsic viscosity of not
less than 0.75 deciliter per gram as de-
FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19,
1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, termined by ASTM method D1243–79,
Aug. 3, 1995] ‘‘Standard Test Method for Dilute So-
lution Viscosity of Vinyl Chloride
§ 175.260 Partial phosphoric acid Polymers,’’ which is incorporated by
esters of polyester resins. reference. Copies may be obtained from
Partial phosphoric acid esters of pol- the American Society for Testing Ma-
yester resins identified in this section terials, 100 Barr Harbor Dr., West
and applied on aluminum may be safely Conshohocken, Philadelphia, PA 19428-
used as food-contact coatings, in ac- 2959, or may be examined at the Na-
cordance with the following prescribed tional Archives and Records Adminis-
conditions: tration (NARA). For information on
(a) For the purpose of this section, the availability of this material at
partial phosphoric acid esters of poly- NARA, call 202–741–6030, or go to: http://
ester resins are prepared by the reac- www.archives.gov/federallregister/
tion of trimellitic anhydride with 2,2- codeloflfederallregulations/
dimethyl-1,3-propanediol followed by ibrllocations.html.
reaction of the resin thus produced (1) Solvent. N,N-Dimethylacetamide,
with phosphoric acid anhydride to technical grade.
produce a resin having an acid number (2) Solution. Powdered resin and sol-
of 81 to 98 and a phosphorus content of vent are heated at 120 °C until the resin
4.05 to 4.65 percent by weight. is dissolved.
(b) The coating is chemically bonded (3) Temperature. Flow times of the
to the metal and cured at temperatures solvent and solution are determined at
exceeding 450 °F. 110 °C.
(c) The finished food-contact coating, (4) Viscometer. Cannon-Ubbelohde size
when extracted with the solvent or sol- 50 semimicro dilution viscometer (or
vents characterizing the type of food
equivalent).
and under the conditions of time and
(5) Calculation. The calculation meth-
temperature characterizing the condi-
tions of its intended use, as determined od used is that described in appendix X
from tables 1 and 2 of § 175.300(d), yields 1.3 (ASTM method D1243–79, ‘‘Standard
total extractives in each extracting Test Method for Dilute Solution Vis-
solvent not to exceed 0.3 milligrams cosity of Vinyl Chloride Polymers,’’
per square inch of food-contact surface, which is incorporated by reference; see
as determined by the methods de- paragraph (b) of this section for avail-
scribed in § 175.300(e), and the coating ability of the incorporation by ref-
yields 2,2-dimethyl-1,3-propanediol in erence) with the reduced viscosity de-
each extracting solvent not to exceed termined for three concentration levels
0.3 micrograms per square inch of food- not greater than 0.5 gram per deciliter
contact surface. In testing the finished and extrapolated to zero concentration
food-contact articles, a separate test for intrinsic viscosity. The following

sample is to be used for each required formula is used for determining re-
extracting solvent. duced viscosity:
176
Beechnut.
Reduced viscosity in terms t − to Candlenut.
of deciliters per gram = to × c Castor (including dehydrated).
Chinawood (tung).
where: Coconut.
t=Solution efflux time. Corn.
to=Solvent efflux time. Cottonseed.
c=Concentration of solution in terms of Fish (refined).
grams per deciliter. Hempseed.
[42 FR 14534, Mar. 15, 1977, as amended at 47 Linseed.
FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19, Oiticica.
1984] Perilla.
Poppyseed.
§ 175.300 Resinous and polymeric coat- Pumpkinseed.
ings. Safflower.
Sesame.
Resinous and polymeric coatings Soybean.
may be safely used as the food-contact Sunflower.
surface of articles intended for use in Tall oil.
producing, manufacturing, packing, Walnut.
processing, preparing, treating, pack-
aging, transporting, or holding food, in The oils may be raw, heat-bodied, or
accordance with the following pre- blown. They may be refined by filtra-
scribed conditions: tion, degumming, acid or alkali wash-
(a) The coating is applied as a contin- ing, bleaching, distillation, partial de-
uous film or enamel over a metal sub- hydration, partial polymerization, or
strate, or the coating is intended for solvent extraction, or modified by com-
repeated food-contact use and is ap- bination with maleic anhydride.
plied to any suitable substrate as a (ii) Reconstituted oils from
continuous film or enamel that serves triglycerides or fatty acids derived
as a functional barrier between the from the oils listed in paragraph
food and the substrate. The coating is (b)(3)(i) of this section to form esters
characterized by one or more of the fol- with:
lowing descriptions: Butylene glycol.
(1) Coatings cured by oxidation. Ethylene glycol.
(2) Coatings cured by polymerization, Pentaerythritol.
condensation, and/or cross-linking Polyethylene glycol.
without oxidation. Polypropylene glycol.
(3) Coatings prepared from prepoly- Propylene glycol.
merized substances. Sorbitol.
Trimethylol ethane.
(b) The coatings are formulated from
optional substances that may include:
(1) Substances generally recognized (iii) Synthetic drying oils, as the
as safe in food. basic polymer:
(2) Substances the use of which is Butadiene and methylstyrene copolymer.
permitted by regulations in this part Butadiene and styrene copolymer, blown or
or which are permitted by prior sanc- unblown.
tion or approval and employed under Maleic anhydride adduct of butadiene sty-
the specific conditions, if any, of the rene.
prior sanction or approval. Polybutadiene.
(3) Any substance employed in the (iv) Natural fossil resins, as the basic
production of resinous and polymeric resin:
coatings that is the subject of a regula-
tion in subchapter B of this chapter Copal.
and conforms with any specification in Damar.
Elemi.
such regulation. Substances named in
Gilsonite.
this paragraph (b)(3) and further identi- Glycerol ester of damar, copal, elemi, and
fied as required: sandarac.
(i) Drying oils, including the Sandarac.

triglycerides or fatty acids derived Shellac.
therefrom: Utah coal resin.
177
ER01JA93.387</GPH>
§ 175.300 21 CFR Ch. I (4–1–15 Edition)
(v) Rosins and rosin derivatives, with formed as esters of acids listed in para-
or without modification by polymeriza- graph (b)(3)(vii) (a) and (b) of this sec-
tion, isomerization, incidental tion by reaction with alcohols in para-
decarboxylation, and/or hydrogenation, graph (b)(3)(vii) (c) and (d) of this sec-
as follows: tion.
(a) Rosins, refined to color grade of K (a) Polybasic acids:
or paler:
Adipic.
Gum rosin. 1,4-cyclohexanedicarboxylic (CAS Reg. No.
Tall oil rosin. 1076–97–7).
Wood rosin. Dimerized fatty acids derived from oils listed
in paragraph (b)(3)(i) of this section.
(b) Rosin esters formed by reacting Fumaric.
rosin (paragraph (b)(3)(v)(a) of this sec- Isophthalic.
tion) with: Maleic.
2,6-Naphthalenedicarboxylic.
4,4′-sec-Butylidenediphenol-epichlorohydrin
2,6-Naphthalenedicarboxylic, dimethyl ester.
(epoxy).
Diethylene glycol. Orthophthalic.
Ethylene glycol. Sebacic.
Glycerol. Terephthalic.
4,4′-Isopropylidenediphenol-epichlorohydrin Terpene-maleic acid adduct.
(epoxy). Trimellitic.
Methyl alcohol. (b) Monobasic acids:
Pentaerythritol.
Benzoic acid.
(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:
(d) Rosin salts: Butylene glycol.
Diethylene glycol.
Calcium resinate (limed rosin).
2,2-Dimethyl-1,3-propanediol for use only in
Zinc resinate.
forming polyester resins for coatings in-
(vi) Phenolic resins as the basic poly- tended for use in contact with non-alco-
mer formed by reaction of phenols with holic foods.
formaldehyde: Ethylene glycol.
Glycerol.
(a) Phenolic resins formed by reac-
Mannitol.
tion of formaldehyde with: a-Methyl glucoside.
Alkylated (methyl, ethyl, propyl, isopropyl, Pentaerythritol.
butyl) phenols. Propylene glycol.
p-tert-Amylphenol. Sorbitol.
4,4′-sec-Butylidenediphenol. Triethylene glycol, for use as a component in
p-tert-Butylphenol. polyester resins for coatings not exceeding
o-, m-, and p-Cresol. a coating weight of 4 milligrams per square
p-Cyclohexylphenol. inch and that are intended for contact
4,4′-Isopropylidenediphenol. under conditions of use D, E, F or G de-
p-Nonylphenol. scribed in table 2 of paragraph (d) of this
p-Octylphenol. section with alcoholic beverages con-
3-Pentadecyl phenol mixture obtained from taining less than 8 percent alcohol.
cashew nut shell liquid. Trimethylol ethane.
Phenol. Trimethylol propane.
Phenyl o-cresol. (d) Monohydric alcohols:
p-Phenylphenol.
Xylenol. Cetyl alcohol.
Decyl alcohol.
(b) Adjunct for phenolic resins: Alu- Lauryl alcohol.
minum butylate. Myristyl alcohol.

(vii) Polyester resins (including Octyl alcohol.
alkyd-type), as the basic polymers, Stearyl alcohol.
178
(e) Catalysts: 3-(Aminomethyl)-3,5,5-trimethylcyclohexyl-

amine reacted with phenol and formalde-
Dibutyltin oxide (CAS Reg. No. 818–08–6), not hyde in a ratio of 2.6:1.0:2.0, for use only in
to exceed 0.2 percent of the polyester resin. coatings intended for repeated use in con-
Hydroxybutyltin oxide (CAS Reg. No. 2273– tact with foods only of the types identified
43–0), not to exceed 0.2 percent of the poly- in paragraph (d) of this section, table 1,
ester resin. under Category I and Category VIII, at
Monobutyltin tris(2-ethylhexoate) (CAS Reg. temperatures not exceeding 88 °C (190 °F).
No. 23850–94–4), not to exceed 0.2 percent of N-Beta-(aminoethyl)-gamma-aminopropyltri-
the polyester resin. methoxysilane (CAS Reg. No. 1760–24–3), for
(viii) Epoxy resins, catalysts, and ad- use only in coatings at a level not to ex-
ceed 1.3 percent by weight of the resin
juncts:
when such coatings are intended for re-
(a) Epoxy resins, as the basic poly- peated use in contact with foods only of
mer: the types identified in paragraph (d) of this
(Alkoxy C10-C16)-2,3-epoxypropane, in which section, table 1, under Types I, II, and III,
the alkyl groups are even numbered and under conditions of use C, D, E, or F as de-
consist of a maximum of 1 percent C10 car- scribed in table 2 of paragraph (d) of this
bon atoms and a minimum of 48 percent C12 section; or when such coatings are in-
carbon atoms and a minimum of 18 percent tended for repeated use in contact with
C14 carbon atoms, for use only in coatings foods of the types identified in paragraph
that are intended for contact with dry bulk (d) of this section, table 1, under Types V,
foods at room temperature. VI, VII, and VIII, under conditions of use E
4,4′-sec-Butylidenediphenol-epichlorohydrin. or F as described in table 2 of paragraph (d)
4,4′-sec-Butylidenediphenol-epichlorohydrin of this section. Use shall be limited to
reacted with one or more of the drying oils coatings for tanks of capacity greater than
or fatty acids listed in paragraph (b)(3)(i) 530,000 gallons.
of this section. Benzyl alcohol (CAS Reg. No. 100–51–6), for
4,4′-sec-Butylidenediphenol-epichlorohydrin use only in coatings at a level not to ex-
chemically treated with one or more of ceed 4 percent by weight of the resin when
the following substances: such coatings are intended for repeated use
Allyl ether of mono-, di-, or trimethylol in contact with foods only of the types
phenol. identified in paragraph (d) of this section,
4,4′-sec-Butylidenediphenol-formaldehyde. table 1, under Types I, II, and III, under
4,4′-Isopropylidenediphenol-formaldehyde. conditions of use C, D, E, or F as described
Melamine-formaldehyde. in table 2 of paragraph (d) of this section;
Phenol-formaldehyde. or when such coatings are intended for re-
Urea-formaldehyde. peated use in contact with foods of the
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
or fatty acids listed in paragraph (b)(3)(i) Catalysts and cross-linking agents for epoxy
of this section. resins:
4,4′-Isopropylidenediphenol-epichlorohydrin 3-Aminomethyl-3,5,5-
chemically treated with one or more of trimethylcyclohexylamine (CAS Reg. No.
the following substances: 2855–0913–092).
Allyl ether of mono-, di-, or trimethylol Cyanoguanidine.
phenol. Dibutyl phthalate, for use only in coatings
4,4′-sec-Butylidenediphenol-formaldehyde. for containers having a capacity of 1,000
4,4′-Isopropylidenediphenol-formaldehyde. gallons or more when such containers are
Melamine-formaldehyde. intended for repeated use in contact with
2,2′-[(1-methylethylidene)bis[4,1- alcoholic beverages containing up to 8 per-
phenyleneoxy[1-(butoxymethyl)-2,1- cent of alcohol by volume.
ethanediyl]oxymethylene]]bisoxirane, 3-Diethylaminopropylamine (CAS Reg. No.
CAS Reg. No. 71033–08–4, for use only in 104–78–9), for use in coatings at a level not
coatings intended for contact with bulk to exceed 6 percent by weight of the resin
dry foods at temperatures below 100 °F. when such coatings are intended for re-
Phenol-formaldehyde. peated use in contact with foods only of
Urea-formaldehyde. the types identified in paragraph (d) of this
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-
for epoxy resins: scribed in table 2 of paragraph (d) of this
179
§ 175.300 21 CFR Ch. I (4–1–15 Edition)
section; or when such coatings are in- by weight of the resin used in coatings that
tended for repeated use in contact with are intended for contact with food under
foods of the types identified in paragraph conditions of use D, E, F, and G described
(d) of this section, table 1, under Types V, in table 2 of paragraph (d) of this section.
VI, VII, and VIII, under conditions of use E Styrene oxide, for use only in coatings for
or F as described in table 2 of paragraph (d) containers having a capacity of 1,000 gal-
of this section. Use shall be limited to lons or more when such containers are in-
coatings for tanks of capacity greater than tended for repeated use in contact with al-
530,000 gallons. coholic beverages containing up to 8 per-
Diethylenetriamine. cent of alcohol by volume.
Diphenylamine. Tetraethylenepentamine.
Ethylenediamine. Tetraethylenepentamine reacted with
Isophthalyl dihydrazide for use only in coat- equimolar quantities of fatty acids.
ings subject to the provisions of paragraph Tri(dimethylaminomethyl) phenol and its
(c) (3) or (4) of this section. salts prepared from the fatty acid moieties
4,4′-Methylenedianiline, for use only in coat- of the salts listed in paragraph
ings for containers having a capacity of (b)(3)(xxii)(b) of this section, for use only
1,000 gallons or more when such containers in coatings subject to the provisions of
are intended for repeated use in contact paragraph (c) (3) or (4) of this section.
with alcoholic beverages containing up to 8 Triethylenetetramine.
percent of alcohol by volume. Trimellitic anhydride (CAS Reg. No. 552–30–
N-Oleyl-1,3-propanediamine with not more 7) for use only as a cross-linking agent at
than 10 percent by weight of a level not to exceed 15 percent by weight
diethylaminoethanol. of the resin in contact with food under all
3-Pentadecenyl phenol mixture (obtained conditions of use, except that resins in-
from cashew nutshell liquid) reacted with tended for use with foods containing more
formaldehyde and ethylenediamine in a than 8 percent alcohol must contact such
ratio of 1:2:2 (CAS Reg. No. 68413–28–5). food only under conditions of use D, E, F,
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
180
use C, D, E, or F as described in table 2 of Urea-formaldehyde.
paragraph (d) of this section; or when such Urea-formaldehyde chemically modified with
coatings are intended for repeated use in methyl, ethyl, propyl, isopropyl, butyl, or
contact with foods of the types identified isobutyl alcohol.
in paragraph (d) of this section, table 1, Urea-formaldehyde chemically modified with
under Types V, VI, VII, and VIII, under one or more of the amine catalysts listed
conditions of use E and F as described in in paragraph (b)(3)(viii)(b) of this section.
table 2 of paragraph (d) of this section. Use
shall be limited to coatings for tanks of ca- (b) Curing (cross-linking) catalyst for
pacity greater than 530,000 gallons. urea-formaldehyde resins:
(c) Adjuncts for epoxy resins: Dodecyl benzenesulfonic acid (C.A. Registry
No. 27176–87–0).
Aluminum butylate.
Benzoic acid, for use as a component in (xiii) Triazine-formaldehyde resins
epoxy resins for coatings not exceeding a and their curing catalyst:
coating weight of 4 milligrams per square (a) Triazine-formaldehyde resins, as
inch and that are intended for contact the basic polymer:
under conditions of use D, E, F or G de-
scribed in table 2 of paragraph (d) of this Benzoguanamine-formaldehyde.
section with alcoholic beverages con- Melamine-formaldehyde.
taining less than 8 percent alcohol. Melamine-formaldehyde chemically modified
Polyamides from dimerized vegetable oils with one or more of the following amine
and the amine catalysts listed in para- catalysts:
graph (b)(3)(viii)(b) of this section, as the Amine catalysts listed in paragraph
basic polymer. (b)(3)(viii)(b) of this section.
Silane coupled silica, prepared from the re- Dimethylamine-2-methyl-1-propanol.
action of microcrystalline quartz with N- Methylpropanolamine.
beta-(N-vinylbenzylamino) ethyl-gamma- Triethanolamine.
aminopropyltrimethoxy silane, mono- Melamine-formaldehyde chemically modified
hydrogen chloride, for use only in coatings with methyl, ethyl, propyl, isopropyl,
intended for repeated use in contact with butyl, or isobutyl alcohol.
foods only of the types identified in para- (b) Curing (cross-linking) catalyst for
graph (d) of this section, table 1, under
Category I and Category VIII, at tempera-
triazine-formaldehyde resins:
tures not exceeding 88 °C (190 °F). Dodecyl benzenesulfonic acid (C.A. Registry
Succinic anhydride, for use as a component No. 27176–87–0).
in epoxy resins for coatings not exceeding
a coating weight of 4 milligrams per square (xiv) Modifiers (for oils and alkyds,
inch, and that are intended for contact including polyesters), as the basic poly-
under conditions of use D, E, F or G de- mer:
scribed in table 2 of paragraph (d) of this
section with alcoholic beverages con- Butyl methacrylate.
taining less than 8 percent alcohol. Cyclopentadiene.
Methyl, ethyl, butyl, or octyl esters of acryl-
(ix) Coumarone-indene resin, as the ic acid.
basic polymer. Methyl methacrylate.
(x) Petroleum hydrocarbon resin Styrene.
(cyclopentadiene type), as the basic Vinyl toluene.
polymer. (xv) Vinyl resinous substance, as the
(xi) Terpene resins, as the basic polybasic polymers:
mer, from one or more of the following:
Polyvinyl acetate.
Dipentene. Polyvinyl alcohol.
Hydrogenated dipentene resin (CAS Reg. No. Polyvinyl butyral.
106168–39–2). For use only with coatings in Polyvinyl chloride.
contact with acidic and aqueous foods. Polyvinyl formal.
Hydrogenated-beta-pinene-alpha-pinene- Polyvinylidene chloride.
dipentene copolymer resin (CAS Reg. No. Polyvinyl pyrrolidone.
106168–37–0). For use only with coatings in Polyvinyl stearate.
contact with acidic and aqueous foods. Vinyl chloride-acetate-2,3-epoxypropyl meth-
a-Pinene. acrylate copolymers containing not more
b-Pinene. than 10 weight percent of total polymer
units derived from 2,3-epoxypropyl meth-
(xii) Urea-formaldehyde, resins and acrylate and not more than 0.1 weight per-
their curing catalyst: cent of unreacted 2,3-epoxypropyl meth-

(a) Urea-formaldehyde resins, as the acrylate monomer for use in coatings for
basic polymer: containers.
181
§ 175.300 21 CFR Ch. I (4–1–15 Edition)
Vinyl chloride-acetate, hydroxyl-modified Ethylene-ethyl acrylate copolymer.
copolymer. Ethylene-isobutyl acrylate copolymers con-
Vinyl chloride-acetate, hydroxyl-modified taining no more than 35 weight percent of
copolymer, reacted with trimellitic anhy- total polymer units derived from isobutyl
dride. acrylate.
Vinyl chloride copolymerized with acryl- Ethylene-vinyl acetate copolymer.
amide and ethylene in such a manner that Polyethylene.
the finished copolymers have a minimum
weight average molecular weight of 30,000
(xix) Polypropylene as the basic poly-
and contain not more than 3.5 weight per- mer:
cent of total polymer units derived from Polypropylene.
acrylamide; the acrylamide portion may or Maleic anhydride adduct of polypropylene
may not be subsequently partially The polypropylene used in the manufac-
hydrolyzed. ture of the adduct complies with
Vinyl chloride copolymerized with one or § 177.1520(c), item 1.1; and the adduct has a
more of the following substances: maximum combined maleic anhydride con-
Acrylonitrile. tent of 0.8 percent and a minimum intrin-
Fumaric acid and/or its methyl, ethyl, sic viscosity of 0.9, determined at 135 °C on
propyl, butyl, amyl, hexyl, heptyl, or octyl a 0.1 percent solution of the modified poly-
esters. propylene in decahydronaphthalene as de-
Maleic acid and/or its methyl, ethyl, propyl, termined by a method titled ‘‘Method for
butyl, amyl, hexyl, heptyl, or octyl esters. Determination of Intrinsic Viscosity of
5-Norbornene-2,3-dicarboxylic acid, mono-n- Maleic Anhydride Adduct of Poly-
butyl ester; for use such that the finished propylene,’’ which is incorporated by ref-
vinyl chloride copolymers contain not erence. Copies are available from the Cen-
more than 4 weight percent of total poly- ter for Food Safety and Applied Nutrition
mer units derived from this comonomer. (HFS–200), Food and Drug Administration,
Vinyl acetate. 5100 Paint Branch Pkwy., College Park,
Vinylidene chloride. MD 20740, or available for inspection at the
Vinyl chloride-vinylidene chloride-2,3- National Archives and Records Adminis-
epoxypropyl methacrylate copolymers con- tration (NARA). For information on the
taining not more than 10 weight percent of availability of this material at NARA, call
total polymer units derived from 2,3- 202–741–6030, or go to: http://
epoxypropyl methacrylate and not more www.archives.gov/federallregister/
than 0.05 weight percent of unreacted 2,3- codeloflfederallregulations/
epoxypropyl methacrylate monomer based ibrllocations.html.
on polymer solids for use only in coatings
for containers intended for contact with (xx) Acrylics and their copolymers,
foods under conditions B, C, D, E, F, G, or as the basic polymer:
H described in table 2 of paragraph (d) of
this section. Acrylamide with ethylacrylate and/or sty-
rene and/or methacrylic acid, subsequently
(xvi) Cellulosics, as the basic poly- reacted with formaldehyde and butanol.
mer: Acrylic acid and the following esters thereof:
Ethyl.
Carboxymethylcellulose. Methyl.
Cellulose acetate. Butyl acrylate-styrene-methacrylic acid-hy-
Cellulose acetate-butyrate. droxyethyl methacrylate copolymers con-
Cellulose acetate-propionate. taining no more than 20 weight percent of
Ethylcellulose. total polymer units derived from meth-
Ethyl hydroxyethylcellulose. acrylic acid and containing no more than 7
Hydroxyethylcellulose. weight percent of total polymer units de-
Hydroxypropyl methylcellulose. rived from hydroxyethyl methacrylate; for
Methylcellulose. use only in coatings that are applied by
Nitrocellulose. electrodeposition to metal substrates.
Butyl acrylate-styrene-methacrylic acid-
(xvii) Styrene polymers, as the basic
hydroxypropyl methacrylate copolymers
polymer: containing no more than 20 weight percent
Polystyrene. of total polymer units derived from meth-
a-Methyl styrene polymer. acrylic acid and containing no more than 7
Styrene copolymerized with one or more of weight percent of total polymer units de-
the following: rived from hydroxypropyl methacrylate;
Acrylonitrile. for use only in coatings that are applied by
a-Methylstyrene. electrodeposition to metal substrates and
that are intended for contact, under condi-

(xviii) Polyethylene and its copoly- tion of use D, E, F, or G described in table
mers as the basic polymer: 2 of paragraph (d) of this section, with food
182
containing no more than 8 percent of alco- 250. The monomer content shall be less
hol. than 0.5 percent. The polymers are for use
Ethyl acrylate-styrene-methacrylic acid co- only in contact with food of Types IV-A, V,
polymers for use only as modifiers for VII in table 1 of paragraph (d) of this sec-
epoxy resins listed in paragraph tion, under use conditions E through G in
(b)(3)(viii)(a) of this section. table 2 of paragraph (d), and with food of
Ethyl acrylate-methyl methacrylate-sty- Type VIII without use temperature restric-
rene-methacrylic acid copolymers for use tion.
only as modifiers for epoxy resins listed in
paragraph (b)(3)(viii)(a) of this section. (xxi) Elastomers, as the basic poly-
2-Ethylhexyl acrylate-ethyl acrylate copolymer:
mers prepared by copolymerization of 2-
ethylhexyl acrylate and ethyl acrylate in a
Butadiene-acrylonitrile-styrene copolymer.
7/3 weight ratio and having a number aver-
Butadiene-styrene copolymer.
age molecular weight range of 5,800 to 6,500
Butyl rubber.
and a refractive index, nD25° (40 percent in
Chlorinated rubber.
2,2,4-trimethyl pentane) of 1.4130–1.4190; for
2-Chloro-1,3-butadiene (neoprene).
use as a modifier for nylon resins com-
Natural rubber (natural latex or natural
plying with § 177.1500 of this chapter and for
latex solids, smoked or unsmoked).
phenolic and epoxy resins listed in para-
Polyisobutylene.
graph (b)(3) (vi) and (viii) of this section,
Rubber hydrochloride.
respectively, at a level not to exceed 1.5
Styrene-isobutylene copolymer.
percent of the coating.
2-Ethylhexyl acrylate-methyl methacrylate- (xxii) Driers made by reaction of a
acrylic acid copolymers for use only as metal from paragraph (b)(3)(xxii)(a) of
modifiers for epoxy resins listed in para- this section with acid, to form the salt
graph (b)(3)(viii) of this section.
Methacrylic acid and the following esters listed in paragraph (b)(3)(xxii)(b) of this
thereof: section:
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
Zirconium.
containing no more than 2 weight percent
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. (xxiii) Waxes:
The styrene and alpha methyl styrene, in-
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 (xxiv) Plasticizers:

permeation chromatography). The acid
number of the polymer shall be less than Acetyl tributyl citrate.
183
§ 175.300 21 CFR Ch. I (4–1–15 Edition)
Acetyl triethyl citrate. Dioctyl sebacate.
Butyl phthalyl butyl glycolate. Glyceryl monostearate.
Butyl stearate. Lanolin.
p-tert-Butyl phenyl salicylate. Mineral oil, white.
Dibutyl sebacate. Palm oil.
Diethyl phthalate. Paraffin, Type I.
Diisobutyl adipate. Paraffin, Type II.
Diisooctyl phthalate. Petrolatum.
Epoxidized soybean oil (iodine number max- Stearic acid.
imum 14; oxirane oxygen content 6% min-
imum), as the basic polymer. (xxviii) Silicones and their curing
Ethyl phthalyl ethyl glycolate. catalysts:
2-Ethylhexyl diphenyl phosphate. (a) Silicones as the basic polymer:
di-2-Ethylhexyl phthalate.
Siloxane resins originating from methyl hy-
Glycerol.
drogen polysiloxane, dimethyl
Glyceryl monooleate.
Glyceryl triacetate. polysiloxane, and methylphenyl
Monoisopropyl citrate. polysiloxane.
Propylene glycol. Siloxane resins originating from the plat-
Sorbitol. inum-catalyzed reaction product of vinyl-
Mono-, di-, and tristearyl citrate. containing dimethylpolysiloxane (CAS
Triethyl citrate. Reg. No. 68083–18–1 and CAS Reg. No. 68083–
Triethylene glycol. 19–2) with methylhydrogen polysiloxane
3-(2-Xenolyl)-1,2-epoxypropane. (CAS Reg. No. 63148–57–2) and
dimethylmethylhydrogen polysiloxane
(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,
184
Philadelphia, PA 19428-2959, or may be ex- sealing compounds on containers having a
amined at the National Archives and capacity of 5 gallons or more.
Records Administration (NARA). For in- Sodium phenylphenate.
formation on the availability of this mate- Styrene-maleic anhydride resin, partial
rial at NARA, call 202–741–6030, or go to: methyl and butyl (sec- or iso-) esters, for
http://www.archives.gov/federallregister/ use only at levels not in excess of 3 percent
codeloflfederallregulations/ of the cement solids in can end cement for-
ibrllocations.html.), for use only as a sus- mulations.
pending agent in the manufacture of vinyl Tetrasodium EDTA (tetrasodium ethylene-
chloride copolymers and limited to use at diaminetetraacetate).
levels not to exceed 0.1 percent by weight Tri (mixed mono- and dinonylphenyl)
of the copolymers. phosphite.
Sodium dioctyl sulfosuccinate. Zinc dibutyldithiocarbamate.
Sodium dodecylbenzenesulfonate
Sodium lauryl sulfate.
(xxxii) Side seam cements: In addi-
2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. tion to the substances listed in para-
Reg. No. 126-86-3), for use only in can coat- graph (b)(3) (i) to (xxx), inclusive, of
ings which are subsequently dried and this section, the following may be used.
cured at temperatures of at least 193 °C (380
p-tert-Butyl perbenzoate as a catalyst for
°F) for 4 minutes.
epoxy resin.
(xxx) Antioxidants: epsilon-Caprolactam-(ethylene-ethyl acry-
late) graft polymer.
Butylated hydroxyanisole. Dicumyl peroxide for use only as polymeriza-
Butylated hydroxytoluene. tion catalyst.
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.
185
§ 175.300 21 CFR Ch. I (4–1–15 Edition)
Sodium pentachlorophenate for use as a pre- coatings for tanks of capacity greater than
servative at 0.1 percent by weight in can- 530,000 gallons.
sealing compounds on containers having a Castor oil, sulfated, sodium salt (CAS Reg.
capacity of 5 gallons or more. No. 68187–76–8), for use only in coatings for
Tetrakis [methylene(3,5-di-tert-butyl-4- containers intended for repeated use.
hydroxyhydrocinnamate)]methane, CAS Cetyl alcohol.
Reg. No. 6683–19–8. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS
Toluene sulfonamide formaldehyde resin Reg. No. 26172–55–4) and 2-methyl-4-
(basic polymer). isothiazolin-3-one (CAS Reg. No. 2682–20–4)
Triethylene glycol methacrylate for use only mixture, at a ratio of 3 parts to 1 part, re-
as polymerization cross-linking agent in spectively, manufactured from methyl-3-
side seam cements for containers intended mercaptopropionate (CAS Reg. No. 2935–90–
for use in contact with food only of the 2) and optionally containing magnesium
types identified in paragraph (d) of this nitrate (CAS Reg. No. 10377–60–3) at a con-
section, table 1, under Categories I, II, and centration equivalent to the isothiazolone
VI. active ingredients (weight/weight). For use
Urea. only as an antimicrobial agent in emul-
sion-based silicone coatings at a level not
(xxxiii) Miscellaneous materials: to exceed 50 milligrams per kilogram
(based on isothiazolone active ingredient)
Ammonium citrate. in the coating formulations.
Ammonium potassium phosphate. Cyclohexanone-formaldehyde resin produced
Bentonite, modified by reaction with benzyl when 1 mole of cyclohexanone is made to
dimethyl alkyl ammonium chloride, where react with 1.65 moles of formaldehyde such
the alkyl groups are derived from hydro- that the finished resin has an average mo-
genated tallow (CAS Reg. No. 71011–24–0). lecular weight of 600–610 as determined by
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.
186
Mono-, di-, and tricalcium phosphate. ings that contact food at temperatures
Monodibutylamine pyrophosphate as not to exceed room temperature.
sequestrant for iron.
Mono-, di-, and trimagnesium phosphate.
(xxxv) Polyamide resins having a
Myristyl alcohol. maximum acid value of 5 and a max-
Octyl alcohol. imum amine value of 8.5 derived from
Phosphoric acid. dimerized vegetable oil acids (con-
Polybutene, hydrogenated; complying with taining not more than 10 percent of
the identity and limitations prescribed by monomer acids), ethylenediamine, and
§ 178.3740 of this chapter.
Poly(ethylene oxide).
4,4-bis (4-hydroxyphenyl) pentanoic
Siloxanes and silicones, dimethyl, 3- acid (in an amount not to exceed 10
hydroxypropyl group-terminated, diesters percent by weight of said polyamide
with poly(2-oxepanone), diacetates (CAS resins); as the basic resin, for use only
Reg. No. 116810–47–0) at a level not to ex- in coatings that contact food at tem-
ceed 0.025 weight percent of the finished peratures not to exceed room tempera-
coating having no greater than a 0.5 mil ture provided that the concentration of
thickness for use as a component of poly-
ester, epoxy, and acrylic coatings com- the polyamide resins in the finished
plying with paragraphs (b)(3)(vii), (viii), food-contact coating does not exceed 5
and (xx) of this section, respectively. milligrams per square inch of food-con-
Silver chloride-coated titanium dioxide for tact surface.
use only as a preservative in latex emul- (xxxvi) Methacrylonitrile grafted
sions at a level not to exceed 2.2 parts per
polybutadiene copolymers containing
million (based on silver ion concentration)
in the dry coating. no more than 41 weight percent of total
Sodium pyrophosphate. polymer units derived from
Stannous chloride. methacrylonitrile; for use only in coat-
Stannous stearate. ings that are intended for contact,
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
Reg. No. 1804–87–1). For use only in copoly- this section, with food containing no
mer coatings on metal under conditions of more than 8 percent of alcohol.
use E, F, and G described in table 2 of para- (xxxvii) Polymeric resin as a coating
graph (d) of this section, and limited to use component prepared from terephthalic
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.
Tridecyl alcohol produced from col, and 2,2-dimethyl-1,3-propanediol
tetrapropylene by the oxo process, for use for use in contact with aqueous foods
only as a processing aid in polyvinyl chlo- and alcoholic foods containing not
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.
Vinyl acetate-dibutyl maleate copolymers more than 30 weight percent of 2,2-di-
produced when vinyl acetate and dibutyl methyl-1,3-propanediol.
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
containing no free fat or oil. The finished
under conditions of time and tempera-
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
187
§ 175.300 21 CFR Ch. I (4–1–15 Edition)
0.5 milligram per square inch nor to ex- square inch that would equal 0.005 per-
ceed that amount as milligrams per cent of the water capacity of the con-
square inch that would equal 0.005 per- tainer in milligrams, divided by the
cent of the water capacity of the con- area of the food-contact surface of the
tainer, in milligrams, divided by the container in square inches.
area of the food-contact surface of the (4) From coating intended for re-
container in square inches. From a fab- peated use, and employed other than as
ricated container conforming with the a component of a container, not to ex-
description in this paragraph (c)(1), the ceed 18 milligrams per square inch of
extractives shall not exceed 0.5 milli- coated surface.
gram per square inch of food-contact (d) Tables:
surface nor exceed 50 parts per million
of the water capacity of the container TABLE 1—TYPES OF FOOD
as determined by the methods provided I. Nonacid (pH above 5.0), aqueous products;
in paragraph (e) of this section. may contain salt or sugar or both, and in-
(2) From a coating intended for or cluding oil-in-water emulsions of low- or
employed as a component of a con- high-fat content.
tainer having a capacity in excess of 1 II. Acidic (pH 5.0 or below), aqueous prod-
ucts; may contain salt or sugar or both,
gallon and intended for one-time use, and including oil-in-water emulsions of
not to exceed 1.8 milligrams per square low- or high-fat content.
inch nor to exceed that amount as mil- III. Aqueous, acid or nonacid products con-
ligrams per square inch that would taining free oil or fat; may contain salt,
equal 0.005 percent of the water capac- and including water-in-oil emulsions of
ity of the container in milligrams, di- low- or high-fat content.
vided by the area of the food-contact IV. Dairy products and modifications:
surface of the container in square A. Water-in-oil emulsion, high- or low-fat.
B. Oil-in-water emulsion, high- or low-fat.
inches.
V. Low moisture fats and oils.
(3) From a coating intended for or VI. Beverages:
employed as a component of a con- A. Containing alcohol.
tainer for repeated use, not to exceed B. Nonalcoholic.
18 milligrams per square inch nor to VII. Bakery products.
exceed that amount as milligrams per VIII. Dry solids (no end test required).
TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR
POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES
Extractant
Types of food
Condition of use (see Table 1) Water Heptane1 2 8% alcohol
(time and temperature) (time and temperature) (time and temperature)
A. High temperature I, IV–B ................... 250 °F, 2 hr ................... .

heat-sterilized (e.g.,
over 212 °F).
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 pasteur- II, IV–B .................. Fill boiling, cool to 100 .
ized above 150 °F. °F.
III, IV–A ................. do .................................. 120 °F, 15 min.
V ............................ ....................................... do.
D. Hot filled or pasteur- II, IV–B, VI–B ........ 150 °F, 2 hr ................... .
ized below 150 °F.
III, IV–A ................. do .................................. 100 °F, 30 min.
V ............................ ....................................... do.
VI–A ...................... ....................................... ....................................... 150 °F, 2 hr.
E. Room temperature II, IV–B, VI–B ........ 120 °F, 24 hr ................. .
filled and stored (no
thermal treatment in
the container).
III, IV–A ................. do .................................. 70 °F, 30 min.
V, VII ..................... ....................................... do.
VI–A ...................... ....................................... ....................................... 120 °F, 24 hr.
F. Refrigerated storage I, II, III, IV–A, IV–B, 70 °F, 48 hr ................... .
(no thermal treatment VI–B,VII.

in the container).
VI–A ...................... ....................................... ....................................... 70 °F, 48 hr.
188
TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR

POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES—Contin-
ued
Extractant
Types of food
Condition of use (see Table 1) Water Heptane1 2 8% alcohol
(time and temperature) (time and temperature) (time and temperature)
G. Frozen storage (no I, II, III, IV–B, VII ... 70 °F, 24 hr ................... .
the container).
H. Frozen storage:
Ready-prepared foods
intended to be re-
heated in container at
time of use:
1. Aqueous or oil in I, II, IV–B ............... 212 °F, 30 min .............. .
water emulsion of
high or low fat.
2. Aqueous, high or III, IV–A, VII ........... do .................................. 120 °F, 30 min.
low free oil or fat.
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.
(e) Analytical methods—(1) Selection of to 1 gallon, quadruplicate samples of

extractability conditions. First ascertain representative containers (using for
the type of food product (table 1, para- each replicate sample the number of
graph (d) of this section) that is being containers nearest to an area of 180
packed commercially in the test con- square inches) should be selected from
tainer and the normal conditions of the lot to be examined.
thermal treatment used in packaging (3) Cleaning procedure preliminary to
the type of food involved. Using table 2 determining the amount of extractables
(paragraph (d) of this section), select from coated containers. Quadruplicate
the food-simulating solvent or solvents samples of representative containers
(demineralized distilled water, should be selected from the lot to be
heptane, and/or 8 percent ethyl alcohol) examined and must be carefully rinsed
and the time-temperature exaggera- to remove extraneous material prior to
tions of the container-use conditions. the actual extraction procedure. Soda
Aqueous products (Types I, II, IV-B, fountain pressure-type hot water rins-
and VI-B) require only a water- ing equipment, consisting in its sim-
extractability test at the temperature plest form of a 1⁄8-inch–1⁄4-inch internal
and time conditions shown for the diameter metal tube attached to a hot
most severe ‘‘conditions of use.’’ Aque- water line and bent so as to direct a
ous products with free oil or fat, and stream of water upward, may be used.
water-oil emulsions (types III, IV-A, Be sure hot water has reached a tem-
and VII) will require determinations of perature of 190 °F–200 °F before starting
both water extractability and heptane to rinse the container. Invert the con-
extractability. Low-moisture fats and tainer over the top of the fountain and
oils (type V with no free water) require direct a strong stream of hot water
only the heptane extractability. Alco- against the bottom and all sides for 1
holic beverages (type VI-A) require minute, drain, and allow to dry.
only the 8 percent alcohol extractant. (4) Exposure conditions—(i) Water (250
Having selected the appropriate ex- °F for 2 hours), simulating high-tempera-
tractant or extractants simulating var- ture heat sterilization. Fill the container
ious types of foods and beverages and within 1⁄4-inch of the top with a meas-
the time-temperature exaggerations ured volume of demineralized distilled
over normal use, follow the applicable water. Cover the container with clean
extraction procedure. Adapt the proce- aluminum foil and place the container
dure, when necessary, for containers on a rack in a pressure cooker. Add a
having a capacity of over 1 gallon. small amount of demineralized dis-

(2) Selection of coated-container sam- tilled water to the pressure cooker, but
ples. For consumer-sized containers up do not allow the water to touch the
189
§ 175.300 21 CFR Ch. I (4–1–15 Edition)
bottom of the container. Close the foil. Place the test container in an
cooker securely and start to heat over oven maintained at 150 °F. After 2
a suitable burner. When a steady hours, remove the test container from
stream of steam emerges from the the oven and immediately composite
vent, close the vent and allow the pres- the water of each replicate in a clean
sure to rise to 15 pounds per square Pyrex flask or beaker. Proceed with
inch (250 °F) and continue to maintain the determination of the amount of ex-
this pressure for 2 hours. Slowly re- tractives by the method described in
lease the pressure, open the pressure paragraph (e)(5) of this section.
cooker when the pressure reads zero, (v) Water (120 °F for 24 hours), simu-
and composite the water of each rep- lating room temperature filling and stor-
licate immediately in a clean Pyrex age. Preheat demineralized distilled
flask or beaker. Proceed with the de- water to 120 °F in a clean Pyrex flask.
termination of the amount of extrac- Fill the container within 1⁄4-inch of the
tives by the method described in para- top with a measured volume of the 120
graph (e)(5) of this section. °F water and cover with clean alu-
(ii) Water (212 °F for 30 minutes), simu- minum foil. Place the test container in
lating boiling water sterilization. Fill the an incubator or oven maintained at 120
container within 1⁄4-inch of the top °F. After 24 hours, remove the test con-
with a measured volume of boiling, tainer from the incubator and imme-
demineralized distilled water. Cover diately composite the water of each
the container with clean aluminum foil replicate in a clean Pyrex flask or
and place the container on a rack in a beaker. Proceed with the determina-
pressure cooker in which a small tion of the amount of extractives by
amount of demineralized distilled the method described in paragraph
water is boiling. Do not close the pres- (e)(5) of this section.
sure vent, but operate at atmospheric (vi) Water (70 °F for 48 hours), simu-
pressure so that there is a continuous lating refrigerated storage. Bring
escape of a small amount of steam. demineralized distilled water to 70 °F
Continue to heat for 30 minutes, then in a clean Pyrex flask. Fill the con-
remove the test container and com- tainer within 1⁄4-inch of the top with a
posite the contents of each replicate measured volume of the 70 °F water,
immediately in a clean Pyrex flask or and cover with clean aluminum foil.
beaker. Proceed with the determina- Place the test container in a suitable
tion of the amount of extractives by room maintained at 70 °F. After 48
the method described in paragraph hours, immediately composite the
(e)(5) of this section. water of each replicate in a clean
(iii) Water (from boiling to 100 °F), sim- Pyrex flask or beaker. Proceed with
ulating hot fill or pasteurization above 150 the determination of the amount of ex-
°F. Fill the container within 1⁄4-inch of tractives by the method described in
the top with a measured volume of paragraph (e)(5) of this section.
boiling, demineralized distilled water. (vii) Water (70 °F for 24 hours), simu-
Insert a thermometer in the water and lating frozen storage. Bring
allow the uncovered container to stand demineralized distilled water to 70 °F
in a room at 70 °F–85 °F. When the tem- in a clean Pyrex flask. Fill the con-
perature reads 100 °F, composite the tainer within 1⁄4-inch of the top with a
water from each replicate immediately measured volume of the 70 °F water
in a clean Pyrex flask or beaker. Pro- and cover with clean aluminum foil.
ceed with the determination of the Place the container in a suitable room
amount of extractives by the method maintained at 70 °F. After 24 hours, im-
described in paragraph (e)(5) of this mediately composite the water of each
section. replicate in a clean Pyrex flask or
(iv) Water (150° for 2 hours), simulating beaker. Proceed with the determina-
hot fill or pasteurization below 150 °F. tion of the amount of extractives by
Preheat demineralized distilled water the method described in paragraph
to 150 °F in a clean Pyrex flask. Fill (e)(5) of this section.
(viii) Water (212 °F for 30 minutes), sim-
the container within 1⁄4-inch of the top

with a measured volume of the 150 °F ulating frozen foods reheated in the con-
water and cover with clean aluminum tainer. Fill the container to within 1⁄4-
190
inch of the top with a measured volume of explosion. Fill the test container
of boiling, demineralized distilled within 1⁄4-inch of the top with a meas-
water. Cover the container with clean ured volume of the 120 °F heptane and
aluminum foil and place the container cover with clean aluminum foil. Place
on a rack in a pressure cooker in which the test container in the preheated
a small amount of demineralized dis- pressure cooker and then put the as-
tilled water is boiling. Do not close the sembly into a 120 °F incubator. After 30
pressure vent, but operate at atmos- minutes, remove the pressure cooker
pheric pressure so that there is a con- from the incubator, open the assembly,
tinuous escape of a small amount of and immediately composite the
steam. Continue to heat for 30 minutes, heptane of each replicate in a clean
then remove the test container and Pyrex flask or beaker. Proceed with
composite the contents of each rep- the determination of the amount of ex-
licate immediately in a clean Pyrex tractives by the method described in
flask or beaker. Proceed with the de- paragraph (e)(5) of this section.
termination of the amount of extrac- (xi) Heptane (120 °F for 15 minutes),
tives by the method described in para- simulating hot fill or pasteurization above
graph (e)(5) of this section. 150 °F for fatty foods only. Preheat re-
(ix) Heptane (150 °F for 2 hours) simu- distilled reagent-grade heptane (boiling
lating high-temperature heat sterilization point 208 °F) carefully in a clean Pyrex
for fatty foods only. Preheat redistilled flask on a water bath or nonsparking
reagent-grade heptane (boiling point hot plate in a well-ventilated hood to
208 °F) carefully in a clean Pyrex flask 120 °F. At the same time, preheat a
on a water bath or nonsparking hot pressure cooker or equivalent to 120 °F
plate in a well-ventilated hood to 150 in an incubator. This pressure cooker
°F. At the same time preheat a pres- is to serve only as a container for the
sure cooker or equivalent to 150 °F in heptane-containing test package inside
an incubator. This pressure cooker is the incubator in order to minimize the
to serve only as a container for the danger of explosion. Fill the test 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 120 °F heptane
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 the
measured volume of the 150 °F heptane preheated pressure cooker and then put
and cover with clean aluminum foil. the assembly into a 120 °F incubator.
Place the test container in the After 15 minutes, remove the pressure
preheated pressure cooker and then put cooker from the incubator, open the as-
the assembly into a 150 °F incubator. sembly, and immediately composite
After 2 hours, remove the pressure the heptane of each replicate in a clean
cooker from the incubator, open the as- Pyrex flask or beaker. Proceed with
sembly, and immediately composite the determination of the amount of ex-
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
191
§ 175.300 21 CFR Ch. I (4–1–15 Edition)
and cover with clean aluminum foil. test container with within 1⁄4-inch of
Place the test container in the the top with a measured volume of the
preheated pressure cooker and then put 8 percent alcohol. Cover the container
the assembly into a 100 °F incubator. with clean aluminum foil and place in
After 30 minutes, remove the pressure an oven maintained at 150 °F. After 2
cooker from the incubator, open the as- hours, remove the container from the
sembly and immediately composite the oven and immediately composite the
heptane of each replicate in a clean alcohol from each replicate in a clean
Pyrex flask or beaker. Proceed with Pyrex flask. Proceed with the deter-
the determination of the amount of ex- mination of the amount of extractives
tractives by the method described in by the method described in paragraph
paragraph (e)(5) of this section. (e)(5) of this section.
(xiii) Heptane (70 °F for 30 minutes), (xvi) Alcohol—8 percent (120 °F for 24
simulating room temperature filling and hours), simulating alcoholic beverages
storage of fatty foods only. Fill the test room-temperature filled and stored. Pre-
container within 1⁄4-inch of the top heat 8 percent (by volume) ethyl alco-
with a measured volume of the 70 °F hol in demineralized distilled water to
heptane and cover with clean alu- 120 °F in a clean Pyrex flask. Fill the
minum foil. Place the test container in test container within 1⁄4-inch of the top
a suitable room maintained at 70 °F. with a measured volume of the 8 per-
After 30 minutes, composite the cent alcohol, cover the container with
heptane of each replicate in a clean clean aluminum foil and place in an
Pyrex flask or beaker. Proceed with oven or incubator maintained at 120 °F.
the determination of the amount of ex- After 24 hours, remove the container
tractives by the method described in from the oven or incubator and imme-
paragraph (e)(5) of this section. diately composite the alcohol from
(xiv) Heptane (120 °F for 30 minutes), each replicate into a clean Pyrex flask.
simulating frozen fatty foods reheated in Proceed with the determination of the
the container. Preheat redistilled rea- amount of extractives by the method
gent-grade heptane (boiling point 208 described in paragraph (e)(5) of this
°F) carefully in a clean Pyrex flask on section.
a water bath or hot plate in a well-ven- (xvii) Alcohol—8 percent (70 °F for 48
tilated hood to 120 °F. At the same hours), simulating alcoholic beverages in
time, preheat a pressure cooker to 120 refrigerated storage. Bring 8 percent (by
°F in an incubator. This pressure cook- volume) ethyl alcohol in demineralized
er is to serve only as a container for distilled water to 70 °F in a clean Pyrex
the heptane-containing test package flask. Fill the test container within 1⁄4-
inside the incubator in order to mini- inch of the top with a measured volume
mize the danger of explosion. Fill the of the 8 percent alcohol. Cover the con-
test container within 1⁄4-inch of the top tainer with clean aluminum foil. Place
with a measured volume of the 120 °F the test container in a suitable room
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
can be suspended.
hours), simulating alcoholic beverages hot
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
192
this section to about 100 milliliters in grams per square inch exceed the limi-
the Pyrex flask and transfer to a clean, tations prescribed in paragraph (c) of
tared platinum dish, washing the flask this section for the particular con-
three times with the solvent used in tainer size, proceed to paragraph
the extraction procedure, and evapo- (e)(5)(ii) of this section (method for de-
rate to a few milliliters on a non- termining the amount of chloroform-
sparking low-temperature hotplate. soluble extractives residue).
The last few milliliters should be evap- (ii) Chloroform-soluble extractives res-
orated in an oven maintained at a tem- idue. Add 50 milliliters of chloroform
perature of 212 °F. Cool the platinum (freshly distilled reagent grade or a
dish in a desiccator for 30 minutes and grade having an established consist-
weigh the residue to the nearest 0.1 ently low blank) to the dried and
milligram (e). Calculate the extractives weighed residue, (e), in the platinum
in milligrams per square inch and in dish, obtained in paragraph (e)(5)(i) of
parts per million for the particular size this section. Warm carefully, and filter
of container being tested and for the through Whatman No. 41 filter paper in
specific food-simulating solvent used. a Pyrex funnel, collecting the filtrate
(a) Water and 8-percent alcohol. in a clean, tared platinum dish. Repeat
the chloroform extraction, washing the
Milligrams extractives e filter paper with this second portion of
= chloroform. Add this filtrate to the
per square inch s original filtrate and evaporate the
Ex = ( e )( a )(1000) total down to a few milliliters on a
Extractives residue = low-temperature hotplate. The last few
( c )( s ) milliliters should be evaporated in an
oven maintained at 212 °F. Cool the
(b) Heptane.
platinum dish in a desiccator for 30
e minutes and weigh to the nearest 0.1
Milligrams extractives
= milligram to get the chloroform-solu-
per square inch ( s )( F ) ble extractives residue (e′). This e′ is
substituted for e in the equations in
Ex = ( e )( a )(1000) paragraph (e)(5)(i) (a) and (b) of this
Extractives residue = section. If the concentration of extrac-
( c )( s )( F ) tives (Ex) still exceeds 50 parts per mil-
where:
lion or the extractives in milligrams
per square inch exceed the limitations
Ex=Extractives residue in ppm for any con-
tainer size.
prescribed in paragraph (c) of this sec-
e=Milligrams extractives per sample tested. tion for the particular container size,
a=Total coated area, including closure in proceed as follows to correct for zinc
square inches. extractives (‘‘C’’ enamels only): Ash
c=Water capacity of container, in grams. the residue in the platinum dish by
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
ER01JA93.391</GPH>
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
ER01JA93.389</GPH> ER01JA93.390</GPH>
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
193
ER01JA93.388</GPH>
§ 175.320 21 CFR Ch. I (4–1–15 Edition)
this section, the chloroform-soluble ex- tended for repeated food-contact use
tractives residue (but after correction shall be thoroughly cleansed prior to
for the zinc extractives in case of ‘‘C’’ their first use in contact with food.
enamels) must not exceed 50 parts per (h) Acrylonitrile copolymers identi-
million and must not exceed in milli- fied in this section shall comply with
grams per square inch the limitations the provisions of § 180.22 of this chap-
for the particular article as prescribed ter.
in paragraph (c) of this section. (i) Epoxy resins derived by the reac-
(f) Equipment and reagent require- tion of 4,4′-isopropylidenediphenol and
ments—(1) Equipment. epichlorohydrin, as described in para-
Rinsing equipment, soda fountain pressure- graph (b)(3)(viii)(a) of this section, may
type hot water, consisting in simplest form be used in accordance with this section
of a 1⁄8-inch–1⁄4-inch inside diameter metal except as coatings in packaging for
tube attached to a hot water line delivering powdered and liquid infant formula.
190 °F–200 °F water and bent so as to direct
a stream of water upward. [42 FR 14534, Mar. 15, 1977]
Pressure cooker, 21-quart capacity with EDITORIAL NOTE: For FEDERAL REGISTER ci-
pressure gage, safety release, and removable tations affecting § 175.300, see the List of CFR
rack, 12.5 inches inside diameter × 11 inches Sections Affected, which appears in the
inside height, 20 pounds per square inch safe Finding Aids section of the printed volume
operating pressure. and at www.fdsys.gov.
Oven, mechanical convection, range to in-
clude 120 °F–212 °F explosion-proof, inside di-
§ 175.320 Resinous and polymeric coat-
mensions (minimum), 19″ × 19″ × 19″, constant
ings for polyolefin films.
temperature to ±2 °F (water bath may be
substituted). Resinous and polymeric coatings
Incubator, inside dimensions (minimum) may be safely used as the food-contact
19″ × 19″ × 19″ for use at 100 °F±2 °F explosion surface of articles intended for use in
proof (water bath may be substituted). producing, manufacturing, packing,
Constant-temperature room or chamber 70
°F±2 °F minimum inside dimensions 19″ × 19″
processing, preparing, treating, pack-
× 19″. aging, transporting, or holding food, in
Hot plate, nonsparking (explosion proof), accordance with the following pre-
top 12″ × 20″, 2,500 watts, with temperature scribed conditions:
control. (a) The coating is applied as a contin-
Platinum dish, 100-milliliter capacity min- uous film over one or both sides of a
imum. base film produced from one or more of
All glass, Pyrex or equivalent.
the basic olefin polymers complying
(2) Reagents. with § 177.1520 of this chapter. The base
Water, all water used in extraction proce- polyolefin film may contain optional
dure should be freshly demineralized (deion- adjuvant substances permitted for use
ized) distilled water. in polyolefin film by applicable regula-
Heptane, reagent grade, freshly redistilled tions in parts 170 through 189 of this
before use, using only material boiling at 208 chapter.
°F. (b) The coatings are formulated from
Alcohol, 8 percent (by volume), prepared optional substances which are:
from undenatured 95 percent ethyl alcohol
diluted with demineralized or distilled (1) Substances generally recognized
water. as safe for use in or on food.
Chloroform, reagent grade, freshly redis- (2) Substances the use of which is
tilled before use, or a grade having an estab- permitted under applicable regulations
lished, consistently low blank. in parts 170 through 189 of this chapter,
Filter paper, Whatman No. 41 or equiva- by prior sanctions, or approvals.
lent.
(3) Substances identified in this para-
(g) In accordance with good manufac- graph (b)(3) and subject to such limita-
turing practice, finished coatings in- tions as are provided:
(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.
194
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.
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.
195
§ 175.320 21 CFR Ch. I (4–1–15 Edition)
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.
Dipropylene glycol.
Ethylene glycol.
Glycerol.
Mannitol.
a-Methyl glucoside.
Pentaerythritol.
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Polyethylenimine .................................................................. For use only as a primer subcoat to anchor epoxy surface
coatings to the base sheet.
Polystyrene.
Polyvinyl acetate.
Polyvinyl chloride ..................................................................
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
§ 176.170(c) of this chapter.
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.
196
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.
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.
Ethyl phthalyl ethyl glycolate.
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.
197
§ 175.350 21 CFR Ch. I (4–1–15 Edition)
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.
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.
(c) The coating in the finished form (b) The quantity of any optional sub-
in which it is to contact food, when ex- stance does not exceed the amount rea-
tracted with the solvent or solvents sonably required to accomplish the in-
characterizing the type of food, and tended physical or technical effect nor
under conditions of time and tempera- any limitations further provided.
ture characterizing the conditions of (c) Any optional substance that is
its intended use as determined from ta- the subject of a regulation in parts 174,
bles 1 and 2 of § 176.170(c) of this chap- 175, 176, 177, 178, and § 179.45 of this
ter, shall yield net chloroform-soluble chapter conforms with any specifica-
extractives not to exceed 0.5 milligram tions in such regulation.
per square inch of coated surface. (d) Optional substances as provided
(d) Acrylonitrile copolymers identi- in paragraph (a) of this section include:
fied in this section shall comply with (1) Substances generally recognized
the provisions of § 180.22 of this chap- as safe in food.
ter. (2) Substances subject to prior sanc-
tion or approval for uses with a copoly-
FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29, mer of vinyl acetate and crotonic acid
1980; 47 FR 22512, May 25, 1982; 49 FR 36497, and used in accordance with such sanc-
Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR tion or approval.
49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 (3) Substances identified in this sub-
FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, paragraph and subject to such limita-
1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, tions as are provided:
June 13, 2000]
§ 175.350 Vinyl acetate/crotonic acid
Silica.
copolymer. Japan wax.
A copolymer of vinyl acetate and
crotonic acid may be safely used as a (e) Copolymer of vinyl acetate and
coating or as a component of a coating crotonic acid used as a coating or as a
which is the food-contact surface of component of a coating conforming
polyolefin films intended for packaging with the specifications of paragraph
food, subject to the provisions of this (e)(1) of this section are used as pro-
section. vided in paragraph (e)(2) of this sec-
(a) The copolymer may contain added tion.

optional substances to impart desired (1) Specifications. (i) The chloroform-
properties. soluble portion of the water extractives
198
of the coated film obtained with dis- (d) The coating in the finished form
tilled water at 120 °F for 24 hours does in which it is to contact food, when ex-
not exceed 0.5 milligram per square tracted with the solvent or solvents
inch of coated surface. characterizing the type of food, and
(ii) The chloroform-soluble portion of under conditions of time and tempera-
the n-heptane extractives of the coated ture characterizing the conditions of
film obtained with n-heptane at 70 °F its intended use as determined from ta-
for 30 minutes does not exceed 0.5 milli- bles 1 and 2 of § 176.170(c) of this chap-
gram per square inch of coated surface. ter, shall yield net chloroform-soluble
(2) Conditions of use. The copolymer extractives not to exceed 0.5 milligram
of vinyl acetate and crotonic acid is per square inch of coated surface when
used as a coating or as a component of tested by the methods described in
a coating for polyolefin films for pack- § 176.170(d) of this chapter.
aging bakery products and confec- (e) Acrylonitrile copolymers identi-
tionery. fied in this section shall comply with
the provisions of § 180.22 of this chap-
§ 175.360 Vinylidene chloride copoly- ter.
mer coatings for nylon film. [42 FR 14534, Mar. 15, 1977, as amended at 43
Vinylidene chloride copolymer coat- FR 7206, Feb. 21, 1978; 45 FR 76998, Nov. 21,
ings identified in this section and ap- 1980; 47 FR 54430, Dec. 3, 1982]
plied on nylon film may be safely used § 175.365 Vinylidene chloride copoly-
as food-contact surfaces, in accordance mer coatings for polycarbonate
with the following prescribed condi- film.
tions:
Vinylidene chloride copolymer coat-
(a) The coating is applied as a contin- ings identified in this section and ap-
uous film over one or both sides of a plied on polycarbonate film may be
base film produced from nylon resins safely used as food-contact surfaces, in
complying with § 177.1500 of this chap- accordance with the following pre-
ter. scribed conditions:
(b) The coatings are prepared from (a) The coating is applied as a contin-
vinylidene chloride copolymers pro- uous film over one or both sides of a
duced by copolymerizing vinylidene base film produced from polycarbonate
chloride with one or more of the mono- resins complying with § 177.1580 of this
mers acrylic acid, acrylonitrile, ethyl chapter.
acrylate, methacrylic acid, methyl ac- (b) The coatings are prepared from
rylate, methyl methacrylate (CAS Reg. vinylidene chloride copolymers pro-
No. 80–62–6; maximum use level 6 duced by copolymerizing vinylidene
weight percent) and 2-sulfoethyl meth- chloride with acrylonitrile, methyl ac-
acrylate (CAS Reg. No. 10595–80–9; max- rylate, and acrylic acid. The finished
imum use level 1 weight percent). The copolymers contain at least 50 weight-
finished copolymers contain at least 50 percent of polymer units derived from
weight percent of polymer units de- vinyldene chloride.
rived from vinylidene chloride. The fin- (c) Optional adjuvant substances em-
ished coating produced from vinylidene ployed in the production of the coat-
chloride copolymers produced by co- ings or added thereto to impart desired
polymerizing vinylidene chloride with properties may include sodium
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
199
§ 175.380 21 CFR Ch. I (4–1–15 Edition)
extractives in each extracting solvent 0.05 milligram per square inch of food-
not to exceed 0.5 milligram per square contact surface.
inch of coated surface as determined by (c) The resins identified in paragraph
the methods described in § 176.170(d) of (a) of this section may be used as a
this chapter. In testing the finished food-contact coating for articles in-
food-contact articles, a separate test tended for contact at temperatures not
sample is to be used for each required to exceed room temperature with food
extracting solvent. of Type VI-C described in table 1 of
(e) Acrylonitrile copolymers identi- § 176.170(c) of this chapter provided the
fied in this section shall comply with coating in the finished form in which it
the provisons of § 180.22 of this chapter. is to contact food meets the following
extractives limitations when tested by
§ 175.380 Xylene-formaldehyde resins the methods provided in § 175.300(e):
condensed with 4,4′- (1) The coating when extracted with
isopropylidenediphenol- distilled water at 180 °F for 24 hours
epichlorohydrin epoxy resins.
yields total extractives not to exceed
The resins identified in paragraph (a) 0.05 milligram per square inch of food-
of this section may be safely used as a contact surface.
food-contact coating for articles in- (2) The coating when extracted with
tended for use in contact with food, in 50 percent (by volume) ethyl alcohol in
accordance with the following pre- distilled water at 180 °F for 24 hours
scribed conditions. yields total extractives not to exceed
(a) The resins are produced by the 0.05 milligram per square inch.
condensation of xylene-formaldehyde
resin and 4,4′-isopropylidenediphenol- § 175.390 Zinc-silicon dioxide matrix
epichlorohydrin epoxy resins, to which coatings.
may have been added certain optional Zinc-silicon dioxide matrix coatings
adjuvant substances required in the may be safely used as the food-contact
production of the resins or added to im- surface of articles intended for use in
part desired physical and technical producing, manufacturing, packing,
properties. The optional adjuvant sub- processing, preparing, treating, pack-
stances may include resins produced by aging, transporting, or holding food,
the condensation of allyl ether of subject to the provisions of this sec-
mono-, di-, or trimethylol phenol and tion;
capryl alcohol and also may include (a) The coating is applied to a metal
substances identified in § 175.300(b)(3), surface, cured, and washed with water
with the exception of paragraph (b)(3) to remove soluble substances.
(xxxi) and (xxxii) of that section. (b) The coatings are formulated from
(b) The resins identified in paragraph optional substances which include:
(a) of this section may be used as a (1) Substances generally recognized
food-contact coating for articles in- as safe.
tended for contact at temperatures not (2) Substances for which safe condi-
to exceed 160 °F with food of Types I, tions of use have been prescribed in
II, VI-A and B, and VIII described in § 175.300.
table 1 of § 176.170(c) of this chapter (3) Substances identified in para-
provided that the coating in the fin- graph (c) of this section, subject to the
ished form in which it is to contact limitations prescribed.
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 List of substances Limitations
distilled water at 180 °F for 24 hours Ethylene glycol ...................... As a solvent removed by
yields total extractives not to exceed water washing.
0.05 milligram per square inch of food- Iron oxide.
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.
percent (by volume) ethyl alcohol in Silica gel.

distilled water at 160 °F for 4 hours Sodium silicate.
Zinc, as particulate metal.
yields total extractives not to exceed
200
(d) The coating in the finished form Subpart A [Reserved]

in which it is to contact food, when ex-
tracted with the solvent or solvents
characterizing the type of food, and
Subpart B—Substances for Use
under the conditions of its intended use Only as Components of Paper
as shown in table 1 and 2 of § 175.300(d) and Paperboard
(using 20 percent alcohol as the solvent
§ 176.110 Acrylamide-acrylic acid res-
when the type of food contains approxi- ins.
mately 20 percent alcohol) shall yield
total extractives not to exceed those Acrylamide-acrylic acid resins may
prescribed in § 175.300(c)(3); lithium ex- be safely used as components of arti-
tractives not to exceed 0.025 milligram cles intended for use in producing,
per square inch of surface; and chro- manufacturing, packing, processing,
mium extractives not to exceed 0.05 preparing, treating, packaging, trans-
microgram per square inch of surface. porting, or holding food, subject to the
(e) The coatings are used as food-con- provisions of this section.
tact surfaces for bulk reusable con- (a) Acrylamide-acrylic acid resins are
tainers intended for storing, handling, produced by the polymerization of ac-
and transporting food. rylamide with partial hydrolysis or by
the copolymerization of acrylamide
and acrylic acid.
PART 176—INDIRECT FOOD ADDI- (b) The acrylamide-acrylic acid res-
TIVES: PAPER AND PAPERBOARD ins contain less than 0.2 percent resid-
COMPONENTS ual monomer.
(c) The resins are used as adjuvants
Subpart A [Reserved] in the manufacture of paper and paper-
board in amounts not to exceed that
Subpart B—Substances for Use Only as necessary to accomplish the technical
Components of Paper and Paperboard effect and not to exceed 2 percent by
Sec. weight of the paper or paperboard.
176.110 Acrylamide-acrylic acid resins.
176.120 Alkyl ketene dimers.
§ 176.120 Alkyl ketene dimers.
176.130 Anti-offset substances. Alkyl ketene dimers may be safely
176.150 Chelating agents used in the manu- used as a component of articles in-
facture of paper and paperboard. tended for use in producing, manufac-
176.160 Chromium (Cr III) complex of N- turing, packing, processing, preparing,
ethyl-N-heptadecylfluoro-octane sulfonyl treating, packaging, transporting, or
glycine.
holding food, subject to the provisions
176.170 Components of paper and paperboard
in contact with aqueous and fatty foods.
of this section.
176.180 Components of paper and paperboard (a) The alkyl ketene dimers are man-
in contact with dry food. ufactured by the dehydrohalogenation
176.200 Defoaming agents used in coatings. of the acyl halides derived from the
176.210 Defoaming agents used in the manu- fatty acids of animal or vegetable fats
facture of paper and paperboard. and oils.
176.230 3,5-Dimethyl-1,3,5,2H- (b) The alkyl ketene dimers are used
tetrahydrothiadiazine-2-thione. as an adjuvant in the manufacture of
176.250 Poly-1,4,7,10,13-pentaaza-15- paper and paperboard under such condi-
hydroxyhexadecane. tions that the alkyl ketene dimers and
176.260 Pulp from reclaimed fiber. their hydrolysis products dialkyl
176.300 Slimicides.
ketones do not exceed 0.4 percent by
176.320 Sodium nitrate-urea complex.
176.350 Tamarind seed kernel powder.
weight of the paper or paperboard.
(c) The alkyl ketene dimers may be
AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. used in the form of an aqueous emul-
SOURCE: 42 FR 14554, Mar. 15, 1977, unless sion which may contain sodium
otherwise noted. lignosulfonate as a dispersant.
EDITORIAL NOTE: Nomenclature changes to § 176.130 Anti-offset substances.
part 176 appear at 61 FR 14482, Apr. 2, 1996, 66

FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. Substances named in paragraphs (b)
1, 2005. and (c) of this section may be safely
201
§ 176.150 21 CFR Ch. I (4–1–15 Edition)
used to prevent the transfer of inks to accomplish the intended technical

employed in printing and decorating effect nor greater than any specific
paper and paperboard used for food limitation, where such is provided.
packaging in accordance with the pro-
visions of this section: § 176.160 Chromium (Cr III) complex
(a) The substances are applied to the of N-ethyl-N-heptadecylfluoro-oc-
nonfood contact, printed side of the tane sulfonyl glycine.
paper or paperboard in an amount not The chromium (Cr III) complex of N-
greater than that required to accom- ethyl - N -heptadecylfluoro-octane
plish the technical effect nor greater sulfonyl glycine containing up to 20
than any specific limitations, where percent by weight of the chromium (Cr
such are provided. III) complex of heptadecylfluoro-octane
(b) Anti-offset powders are prepared sulfonic acid may be safely used as a
from substances that are generally rec- component of paper for packaging dry
ognized as safe in food, substances for food when used in accordance with the
which prior sanctions or approvals following prescribed conditions.
were granted and which are used in ac- (a) The food additive is used as a
cordance with the specific provisions of component of paper in an amount not
such sanction or approval, and sub- to exceed 0.5 percent by weight of the
stances named in paragraph (c) of this paper.
section. (b)(1) The food-contact surface of the
(c) The substances permitted are as paper is overcoated with a polymeric or
follows: resinous coating at least 1⁄3-mil in
Substances Limitations thickness, that meets the provision of
§ 176.170; or
Carbon tetrachloride.
Methyl hydrogen
(2) The treated paper forms one or
polysiloxanes. more plies of a paper in a multiwall
Industrial starch—modified .... Complying with § 178.3520 of bag and is separated from the food by
this chapter.
at least one ply of packaging films or
Stannous oleate.
Zinc-2-ethyl hexoate. grease-resistant papers which serves as
a functional barrier between the food
additive and the food. Such packaging
§ 176.150 Chelating agents used in the
manufacture of paper and paper- films or grease-resistant papers con-
board. form with appropriate food additive
regulations.
The substances named in paragraph
(c) The labeling of the food additive
(a) of this section may be safely used in
shall contain adequate directions for
the manufacture of paper and paper-
board, in accordance with the condi- its use to insure compliance with the
tions prescribed in paragraphs (b) and requirements of paragraphs (a) and (b)
(c) of this section: of this section.
(a) Chelating agents:
§ 176.170 Components of paper and pa-
List of substances Limitations perboard in contact with aqueous
and fatty foods.
Ammonium fructoheptonate.
Ammonium glucoheptonate. Substances identified in this section
Disodium ethylenediamine tetraacetate. may be safely used as components of
Pentasodium salt of diethylenetriamine the uncoated or coated food-contact
pentaacetate.
Sodium fructoheptonate. surface of paper and paperboard in-
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.
202
(a) Substances identified in paragraph (a) are present in the food-con-
graph (a) (1) through (5) of this section tact surface of such paper or paper-
may be used as components of the food- board.
contact surface of paper and paper- (1) Substances generally recognized
board. Paper and paperboard products as safe in food.
shall be exempted from compliance (2) Substances generally recognized
with the extractives limitations pre- as safe for their intended use in paper
scribed in paragraph (c) of this section: and paperboard products used in food
Provided, That the components of the packaging.
food-contact surface consist entirely of (3) Substances used in accordance
one or more of the substances identi- with a prior sanction or approval.
fied in this paragraph: And provided fur- (4) Substances that by regulation in
ther, That if the paper or paperboard parts 170 through 189 of this chapter
when extracted under the conditions may be safely used without extractives
prescribed in paragraph (c) of this sec- limitations as components of the
tion exceeds the limitations on extrac- uncoated or coated food-contact sur-
tives contained in paragraph (c) of this face of paper and paperboard in contact
section, information shall be available with aqueous or fatty food, subject to
from manufacturing records from the provisions of such regulation.
which it is possible to determine that (5) Substances identified in this para-
only substances identified in this paragraph, as follows:
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.
203
§ 176.170 21 CFR Ch. I (4–1–15 Edition)
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.
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.
204
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
202–741–6030, or go to: http://www.archives.gov/
federallregister/codeloflfederallregulations/
ibrllocations.html..
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.
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.
205
§ 176.170 21 CFR Ch. I (4–1–15 Edition)
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).
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).
206
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).
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.
207
§ 176.170 21 CFR Ch. I (4–1–15 Edition)
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.
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.
208
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).
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.
209
§ 176.170 21 CFR Ch. I (4–1–15 Edition)
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 vided that the asphalt is used at a level not to exceed 5% by
by ASTM method D5–73 (Reapproved 1978), ‘‘Standard weight of the finished dry paper and paperboard fibers.
Test 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 Ad-
ministration (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
maximum weight loss not to exceed 3% when distilled to 371
°C, nor to exceed an additional 1.1% when further distilled
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.
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.
210
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).
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).
211
§ 176.170 21 CFR Ch. I (4–1–15 Edition)
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).
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).
212
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.
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.
213
§ 176.170 21 CFR Ch. I (4–1–15 Edition)
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 25 paperboard will contain the additive at a level not in excess
°C has a Stokes viscosity range of 2.5-4.0 as determined by of 1 percent by weight of the dry paper and paperboard.
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
Archives and Records Administration (NARA). For informa-
tion on the availability of this material at NARA, call 202–
741–6030, or go to: http://www.archives.gov/
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 deci-
liter
Polypropylene glycol (minimum molecular weight 1,000).
Potassium persulfate.
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.
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.
214
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.
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.
215
§ 176.170 21 CFR Ch. I (4–1–15 Edition)
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.
(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.
216
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.
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.
217
§ 176.170 21 CFR Ch. I (4–1–15 Edition)
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.
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.
218
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
Archives and Records Administration (NARA). For informa-
tion on the availability of this material at NARA, call 202–
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.
219
§ 176.170 21 CFR Ch. I (4–1–15 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.
220
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.
221
§ 176.170 21 CFR Ch. I (4–1–15 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://
codeloflfederallregulations/ibrllocations.html..
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.
222
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.
223
§ 176.170 21 CFR Ch. I (4–1–15 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.
224
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
propriate food-simulating solvent or water.

solvents and the time-temperature ex- (iv) Chloroform. Reagent grade, fresh-
ly redistilled before use, or a grade
225
§ 176.170 21 CFR Ch. I (4–1–15 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
226
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
227
§ 176.170 21 CFR Ch. I (4–1–15 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-
228
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
EDITORIAL NOTE: For FEDERAL REGISTER ci-
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.
229
§ 176.180 21 CFR Ch. I (4–1–15 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..
230
Methyl naphthalene sulfonic acid-formaldehyde condensate,

sodium 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..
Naphthalene 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..
231
§ 176.180 21 CFR Ch. I (4–1–15 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..
232
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.
233
§ 176.200 21 CFR Ch. I (4–1–15 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.
234
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,
235
§ 176.210 21 CFR Ch. I (4–1–15 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.
236
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
weight 440–450. with any specifications and limitations

Sodium trichlorophenate. prescribed by such regulation for the
Stearyl alcohol. substance or article.
237
§ 176.250 21 CFR Ch. I (4–1–15 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
with the following prescribed condi-
§ 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.
238
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]
239
§ 176.320 21 CFR Ch. I (4–1–15 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).
240
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.
241
§ 177.1010 21 CFR Ch. I (4–1–15 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.
242
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
243
§ 177.1010 21 CFR Ch. I (4–1–15 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
to the temperature-time conditions of this 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
244
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)
245
ER01JA93.394</GPH>
§ 177.1010 21 CFR Ch. I (4–1–15 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.
246
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-
ter.
of the copolymer is in the range of 16

to 18.5 percent as determined by Micro- (f) Acrylonitrile copolymers identi-
Kjeldahl analysis. fied in this section are not authorized
247
§ 177.1030 21 CFR Ch. I (4–1–15 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
248
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
the National Archives and Records Ad-
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
249
§ 177.1050 21 CFR Ch. I (4–1–15 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-
250
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-
tion at the National Archives and
the Center for Food Safety and Applied
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-
ability of this material at NARA, call
(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
251
§ 177.1060 21 CFR Ch. I (4–1–15 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.
252
(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 propionate.
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.
253
§ 177.1200 21 CFR Ch. I (4–1–15 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.
254

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.
255
§ 177.1210 21 CFR Ch. I (4–1–15 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
256
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.
257
§ 177.1210 21 CFR Ch. I (4–1–15 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.
Naphthalene 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.
258
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 naphthalenesulfonic 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:
259
§ 177.1211 21 CFR Ch. I (4–1–15 Edition)
A. Containing alcohol. VII. Bakery products.
B. Nonalcoholic. VIII. Dry solids (no end-test required).
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
Extractant
Types of food
Conditions of use (see Table 3) Water (time and tem- Heptane1 (time and 8% alcohol
perature) temperature) (time and temperature)
A. High temperature I, IV–B ................... 250 °F, 2 hr ................... .

heat-sterilized (e.g.,
over 212 °F).
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 pasteur- II, IV–B .................. Fill boiling, cool to 100 .
ized above 150 °F. °F.
III, IV–A ................. do .................................. 120 °F, 15 min.
V ............................ ....................................... do.
D. Hot filled or pasteur- II, IV–B, VI–B ........ 150 °F, 2 hr ................... .
ized below 150 °F.
III, IV–A ................. do .................................. 100 °F, 30 min.
V ............................ ....................................... do.
VI–A ...................... ....................................... ....................................... 150 °F, 2 hr.
E. Room temperature II, IV–B, VI–B ........ 120 °F, 24 hr ................. .
filled and stored (no
the container).
III, IV–A ................. do .................................. 70 °F, 30 min.
V ............................ ....................................... do.
VI–A ...................... ....................................... ....................................... 120 °F, 24 hr.
F. Refrigerated storage I, II, III, IV–A, IV–B, 70 °F, 48 hr ................... 70 °F, 30 min.
(no thermal treatment). VI–B,VII.
VI–A ...................... ....................................... ....................................... 70 °F, 48 hr.
G. Frozen storage (no I, II, III, IV–B, VII ... 70 °F, 24 hr ................... .
the container).
1Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.
[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; 78 FR
14665, Mar. 7, 2013]
§ 177.1211 Cross-linked polyacrylate (2) 2-propenoic acid, polymer with 2-

copolymers. ethyl-2-(((1-oxo-2-pro-
penyl)oxy)methyl)-1,3-propanediyl di-2-
Cross-linked polyacrylate copoly-
propenoate and sodium 2-propenoate
mers identified in paragraph (a) of this
(CAS Reg. No. 76774–25–9).
section may be safely used as articles
(b) Adjuvants. The copolymers identi-
or components of articles intended for
fied in paragraph (a) of this section
use in contact with food in accordance may contain optional adjuvant sub-
with the following prescribed condi- stances required in the production of
tions: such copolymers. The optional adju-
(a) Identity. For the purpose of this vant substances may include sub-
section, the cross-linked polyacrylate stances permitted for such use by regu-
copolymers consist of: lations in parts 170 through 179 of this
(1) The grafted copolymer of cross- chapter, substances generally recog-
linked sodium polyacrylate identified nized as safe in food, and substances
as 2-propenoic acid, polymers with N,N- used in accordance with a prior sanc-
di-2-propenyl-2-propen-1-amine and tion or approval.
hydrolyzed polyvinyl acetate, sodium (c) Extractives limitations. The copoly-

salts, graft (CAS Reg. No. 166164–74–5); mers identified in paragraph (a) of this
or section, in the finished form in which
260
they will contact food, must yield low (b) The quantity of any optional sub-
molecular weight (less than 1,000 Dal- stance employed in the production of
tons) extractives of no more than 0.15 the copolymer does not exceed the
percent by weight of the total polymer amount reasonably required to accom-
when extracted with 0.2 percent by plish the intended physical or technical
weight of aqueous sodium chloride so- effect or any limitation further pro-
lution at 20 °C for 24 hours. The low vided.
molecular weight extractives shall be (c) Any substance employed in the
determined using size exclusion chro- production of the copolymer that is the
matography or an equivalent method. subject of a regulation in parts 174, 175,
When conducting the extraction test, 176, 177, 178 and § 179.45 of this chapter
the copolymer, with no other absorp- conforms with any specification in
tive media, shall be confined either in such regulation.
a finished absorbent pad or in any suit- (d) Substances employed in the pro-
able flexible porous article, (such as a duction of the copolymer include:
‘‘tea bag’’ or infuser), under an applied (1) Substances generally recognized
pressure of 0.15 pounds per square inch as safe in food.
(for example, a 4×6 inch square pad is (2) Substances subject to prior sanc-
subjected to a 1.6 kilograms applied tion or approval for use in the copoly-
mass). The solvent used shall be at mer and used in accordance with such
least 60 milliliters aqueous sodium sanction or approval.
chloride solution per gram of copoly- (3) Substances which by regulation in
mer. parts 174, 175, 176, 177, 178 and § 179.45 of
(d) Conditions of use. The copolymers this chapter may be safely used as
identified in paragraph (a)(1) of this components of resinous or polymeric
section are limited to use as a fluid ab- coatings and film used as food-contact
sorbent in food-contact materials used surfaces, subject to the provisions of
in the packaging of frozen or refrig- such regulation.
erated poultry. The copolymers identi- (e) The copolymer conforms with the
fied in paragraph (a)(2) of this section following specifications:
are limited to use as a fluid absorbent (1) The copolymer, when extracted
in food-contact materials used in the with distilled water at reflux tempera-
packaging of frozen or refrigerated ture for 2 hours, yields total extrac-
meat and poultry. tives not to exceed 0.05 percent.
(2) The copolymer, when extracted
[64 FR 28098, May 25, 1999, as amended at 65 with ethyl acetate at reflux tempera-
FR 16817, Mar. 30, 2000]
ture for 2 hours, yields total extrac-
§ 177.1240 1,4-Cyclohexylene tives not to exceed 0.7 percent.
dimethylene terephthalate and 1,4- (3) The copolymer, when extracted
cyclohexylene dimethylene with n-hexane at reflux temperature
isophthalate copolymer. for 2 hours, yields total extractives not
Copolymer of 1,4-cyclohexylene to exceed 0.05 percent.
dimethylene terephthalate and 1,4- [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15,
cyclohexylene dimethylene isophtha- 1984, as amended at 55 FR 34555, Aug. 23, 1990]
late may be safely used as an article or
component of articles used in pro- § 177.1310 Ethylene-acrylic acid co-
ducing, manufacturing, packing, proc- polymers.
essing, preparing, treating, packaging, The ethylene-acrylic acid copolymers
transporting, or holding food, subject identified in paragraph (a) of this sec-
to the provisions of this section: tion may be safely used as components
(a) The copolymer is a basic poly- of articles intended for use in contact
ester produced by the catalytic con- with food subject to the provisions of
densation of dimethyl terephthalate this section.
and dimethyl isophthalate with 1,4- (a) The ethylene-acrylic acid copoly-
cyclohexanedimethanol, to which may mers consist of basic copolymers pro-
have been added certain optional sub- duced by the copolymerization of
stances required in its production or ethylene and acrylic acid such that the
added to impart desired physical and finished basic copolymers contain no
technical properties. more than:
261
§ 177.1312 21 CFR Ch. I (4–1–15 Edition)
(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) [42 FR 14572, Mar. 15, 1977, as amended at 51
of this section; and FR 19060, May 27, 1986; 53 FR 44009, Nov. 1,
(2) 25 weight-percent of total polymer 1988]
units derived from acrylic acid when
used in accordance with paragraph (c) § 177.1312 Ethylene-carbon monoxide
of this section. copolymers.
(b) The finished food-contact articles The ethylene-carbon monoxide co-
made with no more than 10 percent polymers identified in paragraph (a) of
total polymer units derived from acryl- this section may be safely used as com-
ic acid, when extracted with the sol- ponents of articles intended for use in
vent or solvents characterizing the contact with food subject to the provi-
type of food and under the conditions sions of this section.
of its intended use as determined from (a) Identity. For the purposes of this
tables 1 and 2 of § 176.170(c) of this chap- section, ethylene-carbon monoxide co-
ter, yield net acidified chloroform-solu- polymers (CAS Reg. No. 25052–62–4) con-
ble extractives not to exceed 0.5 milli- sist of the basic polymers produced by
gram per square inch of food-contact the copolymerization of ethylene and
surface when tested by the methods carbon monoxide such that the copoly-
prescribed in § 177.1330(e)(1), (3)(i) mers contain not more than 30 weight-
through (iv), (4), (5), and (6), except percent of polymer units derived from
that carbon monoxide.
(1) The total residue method using 3 (b) Conditions of use. (1) The polymers
percent acetic acid, as prescribed in may be safely used as components of
§ 177.1330(e)(6)(i)(a), does not apply, and the food-contact or interior core layer
(2) The net acidified chloroform-solu- of multilaminate food-contact articles.
ble extractives from paper and paper- (2) The polymers may be safely used
board complying with § 176.170 of this as food-contact materials at tempera-
chapter may be corrected for wax, pet- tures not to exceed 121 °C (250 °F).
rolatum, and mineral oil as provided in (c) Specifications. (1) Food-contact
§ 176.170(d)(5)(iii)(b) of this chapter. layers formed from the basic copoly-
If the finished food-contact article is mer identified in paragraph (a) of this
itself the subject of a regulation in section shall be limited to a thickness
parts 174, 175, 176, 177, 178, and § 179.45 of of not more than 0.01 centimeter (0.004
this chapter, it shall also comply with inch).
any specifications and limitations pre- (2) The copolymers identified in para-
scribed for it by that regulation. graph (a) of this section shall have a
(c) The finished food-contact layer melt index not greater than 500 as de-
made with basic copolymers containing termined by ASTM method D1238–82,
more than 10 weight-percent but no condition E ‘‘Standard Test Method for
more than 25 weight-percent of total Flow Rates of Thermoplastics by Ex-
polymer units derived from acrylic trusion Plastometer,’’ which is incor-
acid and with a maximum thickness of porated by reference in accordance
0.0025 inch (2.5 mils) may be used in with 5 U.S.C. 552(a) and 1 CFR part 51.
contact with food types I, II, IVB, VIA, Copies may be obtained from the Amer-
VIB, VIIB, and VIII identified in table ican Society for Testing Materials, 100
1 of § 176.170(c) of the chapter under Barr Harbor Dr., West Conshohocken,
conditions of use B through H as de- Philadelphia, PA 19428-2959, or may be
scribed in table 2 of § 176.170(c) of this examined at the Center for Food Safety
chapter, and in contact with food types and Applied Nutrition (HFS–200), Food
III, IVA, V, VIIA, and IX identified in and Drug Administration, 5100 Paint
table 1 of § 176.170(c) of this chapter Branch Pkwy., College Park, MD 20740,
under conditions of use E through G as or at the National Archives and
described in table 2 of § 176.170(c) of this Records Administration (NARA). For
chapter. information on the availability of this
(d) The provisions of this section are material at NARA, call 202–741–6030, or
not applicable to ethylene-acrylic acid go to: http://www.archives.gov/
copolymers used in food-packaging ad- federallregister/
262
codeloflfederallregulations/ may be safely used as articles or com-

ibrllocations.html. ponents of articles intended for use in
(3) The basic copolymer identified in contact with food subject to provisions
paragraph (a) of this section, when ex- of this section and of part 174 of this
tracted with the solvent or solvents chapter.
characterizing the type of food and (a) Identity. For the purposes of this
under the conditions of time and tem- section, ethylene-1,4-cyclohexylene
perature characterizing the conditions dimethylene terephthalate copolymers
of its intended use, as determined from
(1,4-benzene dicarboxylic acid, di-
tables 1 and 2 of § 176.170(c) of this chap-
ter, yields net chloroform-soluble ex- methyl ester, polymerized with 1,4-
tractives in each extracting solvent cyclohexanedimethanol and 1,2-
not to exceed 0.5 milligram per square ethanediol) (CAS Reg. No. 25640–14–6) or
inch of food-contact surface when test- (1,4-benzenedicarboxylic acid, polym-
ed by methods described in § 176.170(d) erized with 1,4-cyclohexanedimethanol
of this chapter. and 1,2-ethanediol) (CAS Reg. No.
(4) The provisions of this section are 25038–91–9) are basic copolymers meet-
not applicable to ethylene-carbon mon- ing the specifications prescribed in
oxide copolymers complying with paragraph (b) of this section, to which
§ 175.105 of this chapter. may have been added certain optional
[57 FR 32422, July 22, 1992] substances required in their production
or added to impart desired physical or
§ 177.1315 Ethylene-1, 4-cyclohexylene technical properties.
dimethylene terephthalate copoly- (b) Specifications:
mers.
Ethylene-1, 4-cyclohexylene
dimethylene terephthalate copolymer
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.
263
§ 177.1315 21 CFR Ch. I (4–1–15 Edition)

face)
......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).
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.
264

face)
......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.
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 standards prepared in 95:5 percent (v/v)
of extractability. The total extracted heptane: tetrahydrofuran.
terephthaloyl moieties can be deter-
[45 FR 39252, June 10, 1980, as amended at 47
mined in the extracts, without evapo- FR 24288, June 4, 1982; 49 FR 25629, June 22,
ration of the solvent, by measuring the 1984; 51 FR 22929, June 24, 1986; 60 FR 57926,
ultraviolet (UV) absorbance at 240 Nov. 24, 1995]
nanometers. The spectrophotometer
(Varian 635–D, or equivalent) is zeroed § 177.1320 Ethylene-ethyl acrylate co-
with a sample of the solvent taken polymers.
from the same lot used in the extrac- Ethylene-ethyl acrylate copolymers
tion tests. The concentration of the may be safely used to produce pack-
total terephthaloyl moieties in water, 3 aging materials, containers, and equip-
percent acetic acid, and in 8 percent ment intended for use in producing,
aqueous alcohol is calculated as bis(2- manufacturing, packing, processing,
hydroxyethyl terephthalate) by ref- preparing, treating, packaging, trans-
erence to standards prepared in the ap- porting, or holding food, in accordance
propriate solvent. Concentration of the with the following prescribed condi-
tions:
terephthaloyl moieties in heptane is

calculated as cyclic trimer (a) Ethylene-ethyl acrylate copoly-
(C6H4CO2C2H4CO2)3, by reference to mers consist of basic resins produced
265
§ 177.1330 21 CFR Ch. I (4–1–15 Edition)
by the catalytic copolymerization of Plastics by the Density-Gradient Tech-

ethylene and ethyl acrylate, to which nique,’’ which is incorporated by ref-
may have been added certain optional erence. Copies may be obtained from
substances to impart desired techno- the American Society for Testing Ma-
logical properties to the resin. Subject terials, 100 Barr Harbor Dr., West
to any limitations prescribed in this Conshohocken, Philadelphia, PA 19428-
section, the optional substances may 2959, or may be examined at the Na-
include: tional Archives and Records Adminis-
(1) Substances generally recognized tration (NARA). For information on
as safe in food and food packaging. the availability of this material at
(2) Substances the use of which is NARA, call 202–741–6030, or go to: http://
permitted under applicable regulations www.archives.gov/federallregister/
in parts 170 through 189 of this chapter, codeloflfederallregulations/
prior sanction, or approvals. ibrllocations.html.
(b) The ethyl acrylate content of the (2) Limitations. Ethylene-ethyl acry-
copolymer does not exceed 8 percent by late copolymers or the blend may be
weight unless it is blended with poly- used in contact with food except as a
ethylene or with one or more olefin co- component of articles used for pack-
polymers complying with § 177.1520 or aging or holding food during cooking
with a mixture of polyethylene and one provided they meet the following
or more olefin copolymers, in such pro- extractability limits:
portions that the ethyl acrylate con- (i) Maximum soluble fraction of 11.3
tent of the blend does not exceed 8 per- percent in xylene after refluxing and
cent by weight, or unless it is used in subsequent cooling to 25 °C.
a coating complying with § 175.300 or (ii) Maximum extractable fraction of
§ 176.170 of this chapter, in such propor- 5.5 percent when extracted with n-
tions that the ethyl acrylate content hexane at 50 °C.
does not exceed 8 percent by weight of (d) The provisions of paragraphs (b)
the finished coating. and (c)(2) of this section are not appli-
(c) Ethylene-ethyl acrylate copoly- cable to ethylene-ethyl acrylate co-
mers or the blend shall conform to the polymers used in the formulation of ad-
specifications prescribed in paragraph hesives complying with § 175.105 of this
(c)(1) of this section and shall meet the chapter.
ethyl acrylate content limits pre- [42 FR 14572, Mar. 15, 1977, as amended at 49
scribed in paragraph (b) of this section, FR 10108, Mar. 19, 1984]
and the extractability limits pre-
scribed in paragraph (c)(2) of this sec- § 177.1330 Ionomeric resins.
tion, when tested by the methods pre- Ionomeric resins manufactured from
scribed for polyethylene in § 177.1520. either ethylene-methacrylic acid co-
(1) Specifications—(i) Infrared identi- polymers (and/or their ammonium, cal-
fication. Ethylene-ethyl acrylate co- cium, magnesium, potassium, sodium,
polymers can be identified by their and/or zinc partial salts), ethylene-
characteristic infrared spectra. methacrylic acid-vinyl acetate copoly-
(ii) Quantitative determination of ethyl mers (and/or their ammonium, cal-
acrylate content. The ethyl acrylate can cium, magnesium, potassium, sodium,
be determined by the infrared spectra. and/or zinc partial salts,), or meth-
Prepare a scan from 10.5 microns to 12.5 acrylic acid polymers with ethylene
microns. Obtain a baseline absorbance and isobutyl acrylate (and/or their po-
at 11.6 microns and divide by the tassium, sodium and/or zinc partial
plaque thickness to obtain absorbance salts) may be safely used as articles or
per mil. From a previously prepared components of articles intended for use
calibration curve, obtain the amount of in contact with food, in accordance
ethyl acrylate present. with the following prescribed condi-
(iii) Specific gravity. Ethylene-ethyl tions:
acrylate copolymers have a specific (a) For the purpose of this section,
gravity of not less than 0.920 nor more the ethylene-methacrylic acid copoly-
than 0.935, as determined by ASTM mers consist of basic copolymers pro-

method D1505–68 (Reapproved 1979), duced by the copolymerization of
‘‘Standard Test Method for Density of ethylene and methacrylic acid such
266
that the copolymers contain no more determined from table I of paragraph

than 20 weight percent of polymer (f) of this section, shall yield net acidi-
units derived from methacrylic acid, fied chloroform-soluble extractives as
and the ethylene-methacrylic acid- follows:
vinyl acetate copolymers consist of (1) For fatty food use. (i) For films of
basic copolymers produced by the co- 2 mil (0.002 inches) thickness or less,
polymerization of ethylene, meth- extractives shall not exceed 0.70 milli-
acrylic acid, and vinyl acetate such gram/square inch 1 (0.109 milligram/
that the copolymers contain no more square centimeter) of food-contact sur-
than 15 weight percent of polymer face (n-heptane extractions) when ex-
units derived from methacrylic acid. tracted by the abbreviated method
(b) For the purpose of this section, cited in paragraph (e)(2)(i) of this sec-
the methacrylic acid copolymers with tion.
ethylene and isobutyl acrylate consist (ii) For films of greater than 2 mils
of basic copolymers produced by the (0.002 inch) thickness, extractives shall
copolymerization of methacrylic acid, not exceed 0.40 milligram/square inch 1
ethylene, and isobutyl acrylate such (0.062 milligram/square centimeter) of
that the copolymers contain no less food-contact surface (n-heptane extrac-
than 70 weight percent of polymer tions) when extracted by the abbre-
units derived from ethylene, no more viated method cited in paragraph
than 15 weight percent of polymer (e)(2)(i) of this section, or
units derived from methacrylic acid, (iii) Alternatively, for films of great-
and no more than 20 weight percent of er than 2 mils thickness, extractives
polymer units derived from isobutyl shall not exceed 0.70 milligram/square
acrylate. From 20 percent to 70 percent inch 1 (0.109 milligram/square centi-
of the carboxylic acid groups may op- meter) of food-contact surface (n-
tionally be neutralized to form sodium heptane extractions) when extracted by
or zinc salts. the equilibrium method cited in para-
(c) The finished food-contact article graph (e)(2)(ii) of this section.
described in paragraph (a) of this sec- (2) For aqueous foods. (i) The net
tion, when extracted with the solvent acidified chloroform-soluble extrac-
or solvents characterizing the type of tives shall not exceed 0.02 milligram/
food and under the conditions of time square inch 2(0.003 milligram/square
and temperature characterizing the centimeter) of food-contact surface
conditions of its intended use as deter- (water, acetic acid, or ethanol/water
mined from tables 1 and 2 of § 176.170(c) extractions) when extracted by the ab-
of this chapter, yields net acidified breviated method cited in paragraph
chloroform-soluble extractives in each (e)(2)(i) of this section.
extracting solvent not to exceed 0.5 (ii) Alternatively, the net acidified
milligram per square inch of food-con- chloroform-soluble extractives shall
tact surface when tested by the meth- not exceed 0.05 milligram/square inch 3
ods described in paragraph (e)(1) of this (0.078 mg/square centimeter) of food-
section, and if the finished food-con- contact surface (water, acetic acid, or
tact article is itself the subject of a ethanol/water extractions) when ex-
regulation in parts 174, 175, 176, 177, 178 tracted by the equilibrium method
and § 179.45 of this chapter, it shall also cited in paragraph (e)(2)(ii) of this sec-
comply with any specifications and tion. If when exposed to n-heptane, a
limitations prescribed for it by that particular film splits along die lines,
regulation. thus permitting exposure of both sides
NOTE: In testing the finished food-contact of the film to the extracting solvent,
article, use a separate test sample for each
required extracting solvent.
1 Average of four separate values, no single
(d) The finished food-contact article
described in paragraph (b) of this sec- value of which differs from the average of
those values by more then ±10 percent.
tion, when extracted according to the 2 Average of four separate values, no single
methods listed in paragraph (e)(2) of value of which differs from the average of
this section and referenced in this those values by more than ±50 percent.
paragraph (d), using the solvent or sol- 3 See footnote 2 to paragraph (d)(2)(i) of
vents characterizing the type of food as this section.
267
§ 177.1330 21 CFR Ch. I (4–1–15 Edition)
the results for that film sample are in- lating solvent is to contact the food-
valid and the test must be repeated for contact film at a temperature of 120 °F
that sample until no splitting by the until equilibrium is demonstrated.
solvent occurs. If the finished food-con-
tact article is itself the subject of a Minimum
extraction
regulation in parts 174, 175, 176, 177, 178 Solvent times
and § 179.45 of this chapter, it shall also (hours)
comply with any specifications and n-Heptane ............................................................ 8, 10, 12
limitations prescribed for it by that Water, 3% acetic acid, or 8%/50% ethanol ........ 72, 96,
regulation. 120
NOTE: In testing the finished food-contact
article, use a separate test sample for each The results from a series of extraction
required extracting solvent. times demonstrate equilibrium when
(e) Analytical methods—(1) Selection of the net chloroform-soluble extractives
extractability conditions for ionomeric res- are unchanging within experimental
ins. First ascertain the type of food error appropriate to the method as de-
(table 1 of § 176.170(c) of this chapter) scribed in paragraphs (d) (1)(i) and (2)(i)
that is being packed or used in contact of this section. Should equilibrium not
with the finished food-contact article be demonstrated over the above time
described in paragraph (a) of this sec-
series, extraction times must be ex-
tion, and also ascertain the normal
tended until three successive unchang-
conditions of thermal treatment used
ing values for extractives are obtained.
in packaging or contacting the type of
In the case where intended uses involve
food involved. Using table 2 of § 176.170
temporary food contact above 120 °F,
(c) of this chapter, select the food-sim-
the food-simulating solvent is to be
ulating solvent or solvents and the
contacted with the food-contact article
time-temperature test conditions that
under conditions of time and tempera-
correspond to the intended use of the
ture that duplicate the actual condi-
finished food-contact article. Having
tions in the intended use. Subsequently
selected the appropriate food-simu-
lating solvent or solvents and time- the extraction is to be continued for
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),
Solvent Time Temperature
prepared from glacial acetic acid di-
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).
50% ethanol.
(4) Selection of test method. The fin-
1 Hours
ished food-contact articles shall be
tested either by the extraction cell de-
(ii) Equilibrium test. For intended use scribed in the Journal of the Association
involving food contact at or below 120 of Official Agricultural Chemists, Vol. 47,
°F (49 °C), the appropriate food-simu- No. 1, p. 177–179 (February 1964), also
268
described in ASTM method F34–76 (Re- (b) Heptane. Milligrams extractives

approved 1980), ‘‘Standard Test Method per square inch=(e)/(s)(F)
for Liquid Extraction of Flexible Bar- where:
rier Materials,’’ which are incorporated
e=Milligrams extractives per sample tested.
by reference, or by adapting the in-con- s=Surface area tested, in square inches.
tainer methods described in § 175.300(e) F=Five, the ratio of the amount of extrac-
of this chapter. Copies of the material tives removed by heptane under exagger-
incorporated by reference are available ated time-temperature test conditions
from the Center for Food Safety and compared to the amount extracted by a
Applied Nutrition (HFS–200), Food and fat or oil under exaggerated conditions of
Drug Administration, 5100 Paint thermal sterilization and use.
e′=Acidified chloroform-soluble extractives
Branch Pkwy., College Park, MD 20740, residue. e′ is substituted for e in the
and the American Society for Testing above equations when necessary (See
Materials, 100 Barr Harbor Dr., West paragraph (e)(6)(ii) of this section for
Conshohocken, Philadelphia, PA 19428- method to obtain e′).
2959, respectively, or may be examined
at the National Archives and Records If when calculated by the equations in
Administration (NARA). For informa- paragraphs (e)(6)(i) (a) and (b) of this
tion on the availability of this mate- section, the extractives in milligrams
rial at NARA, call 202–741–6030, or go per square inch exceed the limitations
to: http://www.archives.gov/ prescribed in paragraphs (c) or (d) of
federallregister/ this section, proceed to paragraph
codeloflfederallregulations/ (e)(6)(ii) of this section (method for de-
ibrllocations.html. termining the amount of acidified chlo-
roform-soluble extractives residue).
(5) Selection of samples. Quadruplicate
(ii) Acidified chloroform-soluble extrac-
samples should be tested, using for
tives residue. Add 3 milliliters of 37 per-
each replicate sample the number of
cent ACS reagent grade hydrochloric
finished articles with a food-contact
acid and 3 milliliters of distilled water
surface nearest to 100 square inches.
to the evaporating dish containing the
(6) Determination of amount of extrac- dried and weighed residue, e, obtained
tives—(i) Total residues. At the end of in paragraph (e)(6)(i) of this section.
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.
269
§ 177.1340 21 CFR Ch. I (4–1–15 Edition)
(f) The types of food and appropriate (b) The finished food-contact article,
solvents are as follows: when extracted with the solvent or sol-
vents characterizing the type of food
TABLE 1 and under the conditions of time and
temperature characterizing the condi-
Types of food Appropriate solvent
tions of its intended use as determined
1. Nonacid (pH above 5.0), aque- Water, n-heptane. from tables 1 and 2 of § 176.170(c) of this
ous products; may contain salt chapter, yields net chloroform-soluble
or sugar or both, and including
oil-in-water emulsions of low- or
extractives (corrected for zinc extrac-
high-fat content. tives as zinc oleate) in each extracting
2. Acidic (pH 5.0 or below), aque- n-heptane, water, 3% solvent not to exceed 0.5 milligram per
ous products; may contain salt acetic acid. square inch of food-contact surface
or sugar or both, and including
oil-in-water emulsions of low- or
when tested by the methods described
high-fat content. in § 176.170(d) of this chapter. If the fin-
3. Aqueous, acid or nonacid prod- Water, n-heptane, 3% ished food-contact article is itself the
ucts containing free oil or fat; acetic acid. subject of a regulation in parts 174, 175,
may contain salt, and including
water-in-oil emulsions of low- or
176, 177, 178 and § 179.45 of this chapter,
high-fat content. it shall also comply with any specifica-
4. Dairy products and modifications and limitations prescribed for it
tions: by that regulation.
Water, n-heptane.
NOTE: In testing the finished food-contact
i. Water-in-oil emulsions, high
or low fat.
article, use a separate test sample for each
ii. Oil-in-water emulsions, high required extracting solvent.
or low fat. (c) The provisions of this section are
5. Low moisture fats and oils ........ n-heptane. not applicable to ethylene-methyl ac-
6. Beverages: rylate copolymer resins used in food-
i. Containing up to 8% alcohol 8% ethanol/water.
ii. Nonalcoholic ........................ 3% acetic acid.
packaging adhesives complying with
iii. Containing more than 8% 50% ethanol/water. § 175.105 of this chapter.
alcohol.
7. Bakery products ........................ Water, n-heptane. § 177.1345 Ethylene/1,3–phenylene oxy-
8. Dry solids (without free fat or No extraction test re- ethylene isophthalate/
oil). quired. terephthalate copolymer.
9. Dry solids (with free fat or oil) .. n-heptane.
Ethylene/1,3-phenylene oxyethylene
(g) The provisions of paragraphs (c) isophthalate/terephthalate copolymer
and (d) of this section are not applica- (CAS Reg. No. 87365–98–8) identified in
ble to the ionomeric resins that are paragraph (a) of this section may be
safely used, subject to the provisions of
used in food-packaging adhesives com-
this section, as the non-food-contact
plying with § 175.105 of this chapter.
layer of laminate structures subject to
[45 FR 22916, Apr. 4, 1980, as amended at 49 the provisions of § 177.1395, and in
FR 10108, Mar. 19, 1984; 49 FR 37747, Sept. 26, blends with polyethylene terephthalate
1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, polymers complying with § 177.1630.
June 12, 1989] (a) Identity. For the purpose of this
section, ethylene/1,3-phenylene oxy-
§ 177.1340 Ethylene-methyl acrylate co-
polymer resins. ethylene isophthalate/terephthalate
copolymer consists of the basic copoly-
Ethylene-methyl acrylate copolymer mer produced by the catalytic
resins may be safely used as articles or polycondensation of isophthalic acid
components of articles intended for use and terephthalic acid with ethylene
in contact with food, in accordance glycol and 1,3-bis(2-
with the following prescribed condi- hydroxyethoxy)benzene such that the
tions: finished resin contains between 42 and
(a) For the purpose of this section, 48 mole-percent of isophthalic
the ethylene-methyl acrylate copoly- moieties, between 2 and 8 mole-percent
mer resins consist of basic copolymers of terephthalic moieties, and not more
produced by the copolymerization of than 10 mole-percent of 1,3-bis(2-
ethylene and methyl acrylate such hydroxyethoxy)benzene moieties.
that the copolymers contain no more (b) Specifications—(1) Density. Ethyl-

than 25 weight percent of polymer ene/1,3-phenylene oxyethylene
units derived from methyl acrylate. isophthalate/terephthalate copolymer
270
identified in paragraph (a) of this sec- of use C at temperatures not to exceed

tion has a density of 1.33±0.02 grams per 160 °F (71 °C).
cubic centimeter measured by ASTM
[57 FR 43399, Sept. 21, 1992, as amended at 59
Method D 1505–85 (Reapproved 1990),
FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2,
‘‘Standard Test Method for Density of 1996; 62 FR 34628, June 27, 1997]
Plastics by the Density-Gradient Tech-
nique,’’ which is incorporated by ref- § 177.1350 Ethylene-vinyl acetate co-
erence in accordance with 5 U.S.C. polymers.
552(a) and 1 CFR part 51. Copies may be
obtained from the American Society Ethylene-vinyl acetate copolymers
for Testing and Materials, 100 Barr may be safely used as articles or com-
Harbor Dr., West Conshohocken, Phila- ponents of articles intended for use in
delphia, PA 19428-2959, or may be exam- producing, manufacturing, packing,
ined at the Center for Food Safety and processing, preparing, treating, pack-
Applied Nutrition’s Library, Food and aging, transporting, or holding food in
Drug Administration, 5100 Paint accordance with the following pre-
Branch Pkwy., College Park, MD 20740, scribed conditions:
and at the National Archives and (a)(1) Ethylene-vinyl acetate copoly-
Records Administration (NARA). For mers consist of basic resins produced
information on the availability of this by the catalytic copolymerization of
material at NARA, call 202–741–6030, or ethylene and vinyl acetate to which
go to: http://www.archives.gov/ may have been added certain optional
federallregister/ substances to impart desired techno-
codeloflfederallregulations/ logical or physical properties to the
ibrllocations.html. resin. Subject to any limitations pre-
(2) Softening point. Ethylene/1,3–phen- scribed in this section, the optional
ylene oxyethylene isophthalate/ substances may include:
terephthalate copolymer identified in (i) Substances generally recognized
paragraph (a) of this section has a soft- as safe in food and food packaging.
ening point of 63±5 °C as measured by (ii) Substances the use of which is
ASTM Method D 1525–87, ‘‘Standard permitted under applicable regulations
Test Method for VICAT Softening Tem- in parts 170 through 189 of this chapter,
perature of Plastics,’’ which is incor- prior sanction, or approvals.
porated by reference in accordance (iii) Substances identified in
with 5 U.S.C. 552(a) and 1 CFR part 51. § 175.300(b)(3) (xxv), (xxvii), (xxx), and
The availability of this material is pro- (xxxiii) of this chapter, and colorants
vided in paragraph (b)(1) of this sec- used in accordance with § 178.3297 of
tion.
this chapter.
(c) Optional adjuvant substances.
(iv) Erucamide as identified in
Ethylene/1,3–phenylene oxyethylene
isophthalate/terephthalate copolymer, § 178.3860 of this chapter.
identified in paragraph (a) of this sec- (v) Xanthan gum as identified in
tion, may contain optional adjuvant § 172.695 for use as a thickening agent
substances required in their produc- at a level not to exceed 1 percent by
tion. The optional adjuvants may in- weight of coating solids in aqueous dis-
clude substances used in accordance persions of ethylene-vinyl acetate co-
with § 174.5 of this chapter. polymers, where such copolymers are
(d) Limitations. Copolymer blends de- used only as coatings or a component
scribed above shall not exceed 30 per- of coatings.
cent by weight of ethylene/1,3-phen- (vi) The copolymer of vinylidene flu-
ylene oxyethylene isophthalate/ oride and hexafluoropropene (CAS Reg.
terephthalate copolymer. The finished No. 9011–17–0), containing 65 to 71 per-
blend may be used in contact with food cent fluorine and having a Mooney Vis-
only under conditions of use C through cosity of at least 28, for use as a proc-
G, as described in table 2 of § 176.170(c) essing aid at a level not to exceed 0.2
of this chapter, except that with food percent by weight of ethylene-vinyl ac-
etate copolymers.
identified as Type III, IV-A, V, VII-A,

and IX in § 176.170(c), table 1, the co- (2) Maleic anhydride-grafted ethyl-
polymer may be used under condition ene-vinyl acetate copolymers (CAS
271
§ 177.1350 21 CFR Ch. I (4–1–15 Edition)
Reg. No. 28064–24–6) consist of basic res- Records Administration (NARA). For
ins produced by the catalytic copolym- information on the availability of this
erization of ethylene and vinyl acetate, material at NARA, call 202–741–6030, or
followed by reaction with maleic anhy- go to: http://www.archives.gov/
dride. Such polymers shall contain not federallregister/
more than 11 percent of polymer units codeloflfederallregulations/
derived from vinyl acetate by weight of ibrllocations.html. Compliance of the
total polymer prior to reaction with melt flow index specification shall be
maleic anhydride, and not more than 2 determined using conditions and proce-
percent of grafted maleic anhydride by dures corresponding to those described
weight of the finished polymer. Op- in the method as Condition E, Proce-
tional adjuvant substances that may be dure A). The copolymers shall be used
added to the copolymers include sub- in blends with other polymers at levels
stances generally recognized as safe in not to exceed 17 percent by weight of
food and food packaging, substances total polymer, subject to the limita-
the use of which is permitted under ap- tion that when contacting food of types
plicable regulations in parts 170 III, IV-A, V, VI-C, VII-A, and IX, iden-
through 189 of this chapter, and sub- tified in § 176.170(c) of this chapter,
stances identified in § 175.300(b)(3)(xxv), Table 1, the polymers shall be used
(xxvii), (xxxiii), and (xxx) of this chap- only under conditions of use C, D, E, F,
ter and colorants for polymers used in and G, described in § 176.170(c) of this
accordance with the provisions of chapter, Table 2.
§ 178.3297 of this chapter. (c) The provisions of paragraph (b) of
(b)(1) Ethylene-vinyl acetate copoly- this section are not applicable to ethyl-
mers, with or without the optional sub- ene-vinyl acetate copolymers used in
stances described in paragraph (a) of food-packaging adhesives complying
this section, when extracted with the with § 175.105 of this chapter.
solvent or solvents characterizing the
(d) Ethylene-vinyl acetate copoly-
type of food, and under conditions of
mers may be irradiated under the fol-
time and temperature characterizing
lowing conditions to produce molecular
the conditions of their intended use as
crosslinking of the polymers to impart
determined from tables 1 and 2 of
desired properties such as increased
§ 176.170(c) of this chapter, shall yield
strength and increased ability to
net chloroform-soluble extractives cor-
shrink when exposed to heat:
rected for zinc as zinc oleate not to ex-
ceed 0.5 milligram per square inch of an (1) Electron beam source of ionizing
appropriate sample. radiation at a maximum energy of 3
(2) Maleic anhydride grafted ethyl- million electron volts: Maximum ab-
ene-vinyl acetate copolymers shall sorbed dose not to exceed 150 kiloGray
have a melt flow index not to exceed 2.1 (15 megarads).
grams per 10 minutes as determined by (2) The finished food-contact film
ASTM method D 1238–82, ‘‘Standard shall meet the extractives limitations
Test Method for Flow Rates of Thermo- prescribed in paragraph (e)(2) of this
plastics by Extrusion Plastometer,’’ section.
which is incorporated by reference in (3) The ethylene-vinyl acetate co-
accordance with 5 U.S.C. 552(a). Copies polymer films may be further irradi-
may be obtained from the American ated in accordance with the provisions
Society for Testing Materials, 100 Barr of paragraph (e)(1) of this section: Pro-
Harbor Dr., West Conshohocken, Phila- vided, That the total accumulated radi-
delphia, PA 19428-2959, or at the Office ation dose from both electron beam
of Food Additive Safety (HFS–200), and gamma ray radiation does not ex-
Center for Food Safety and Applied Nu- ceed 150 kiloGray (15 megarads).
trition, Food and Drug Administration, (e) Ethylene-vinyl acetate copolymer
5100 Paint Branch Pkwy., College Park, films intended for contact with food
MD 20740, 240–402–1200, or may be exam- may be irradiated to control the
ined at the Center for Food Safety and growth of microorganisms under the
Applied Nutrition’s Library, 5100 Paint following conditions:

Branch Pkwy., College Park, MD 20740, (1) Gamma photons emitted from a
or at the National Archives and cobalt–60 sealed source in the dose
272
range of 5–50 kiloGray (0.5–5.0 F34–76 (Reapproved 1980), ‘‘Standard

megarads). Test Method for Liquid Extraction of
(2) The irradiated ethylene-vinyl ace- Flexible Barrier Materials,’’ which is
tate copolymer films, when extracted incorporated by reference. Copies may
with reagent grade n-heptane (freshly be obtained from the American Society
redistilled before use) according to for Testing Materials, 100 Barr Harbor
methods described under § 176.170(d)(3) Dr., West Conshohocken, Philadelphia,
of this chapter, at 75 °F for 30 minutes PA 19428-2959, or may be examined at
shall yield total extractives not to ex- the National Archives and Records Ad-
ceed 4.5 percent by weight of the film. ministration (NARA). For information
on the availability of this material at
FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, NARA, call 202–741–6030, or go to: http://
1989; 55 FR 18595, May 3, 1990; 56 FR 42932, www.archives.gov/federallregister/
Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999; 78 FR codeloflfederallregulations/
14665, Mar. 7, 2013] ibrllocations.html.
(1) The film when extracted with dis-
§ 177.1360 Ethylene-vinyl acetate-vinyl tilled water at 21 °C (70 °F) for 48 hours
alcohol copolymers. yields total extractives not to exceed
Ethylene-vinyl acetate-vinyl alcohol 0.0047 milligram per square centimeter
copolymers (CAS Reg. No. 26221–27–2) (0.03 milligram per square inch) of
may be safely used as articles or com- food-contact surface.
ponents of articles intended for use in (2) The film when extracted with 50
contact with food, in accordance with percent ethyl alcohol at 21 °C (70 °F) for
the following prescribed conditions: 48 hours yields total extractives not to
(a) Ethylene-vinyl acetate-vinyl alco- exceed 0.0062 milligram per square cen-
hol copolymers are produced by the timeter (0.04 milligram per square
partial or complete alcoholysis or hy- inch) of food-contact surface.
drolysis of those ethylene-vinyl acetate (c) The finished food-contact article
copolymers complying with § 177.1350. shall not exceed 0.0076 centimeter (0.003
(1) Those copolymers containing a inch) thickness and shall contact foods
minimum of 55 percent ethylene and a only of the types identified in table 1 of
maximum of 30 percent vinyl alcohol § 176.170(c) of this chapter in Categories
units by weight may be used in contact III, IV-A, VII-A, and IX under condi-
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
273
§ 177.1380 21 CFR Ch. I (4–1–15 Edition)
table 2 of § 176.170(c) of this chapter. (a) For the purpose of this section,
Film samples of 0.018 centimeter (0.007 fluorocarbon resins consist of basic res-
inch) thickness representing the fin- ins produced as follows:
ished articles shall meet the following (1) Chlorotrifluoroethylene resins
extractive limitation when tested by produced by the homopolymerization
ASTM method F34–76 (Reapproved of chlorotrifluoroethylene.
1980), ‘‘Standard Test Methods for Liq- (2) Chlorotrifluoroethylene-1,1-
uid Extraction of Flexible Barrier Ma- difluoroethylene copolymer resins pro-
terials,’’ which is incorporated by ref- duced by copolymerization of
erence. The availability of this incor- chlorotrifluoroethylene and 1,1-
poration by reference is given in para- difluoroethylene.
graph (b) of this section. The film when (3) Chlorotrifluoroethylene-1,1-
extracted with distilled water at 100 °C difluoroethylene-tetrafluoroethylene
(212 °F) for 30 minutes yields ethylene- co-polymer resins produced by co-
polymerization of
vinyl acetate-vinyl alcohol oligomers
chlorotrifluoroethylene, 1,1-
not to exceed 0.093 milligram per
difluoroethylene, and tetrafluoro-
square centimeter (0.6 milligram per
ethylene.
square inch) of food contact surface as (4) Ethylene-chlorotrifluoroethylene
determined by a method entitled ‘‘An- copolymer resins produced by copolym-
alytical Method of Determining the erization of nominally 50 mole percent
Amount of EVOH in the Extractives of ethylene and 50 mole percent of
Residue of EVOH Film,’’ dated March chlorotrifluoroethylene. The copoly-
23, 1987, as developed by the Kuraray mer shall have a melting point of 239 to
Co., Ltd., which is incorporated by ref- 243 °C and a melt index of less than or
erence in accordance with 5 U.S.C. equal to 20 as determined by ASTM
552(a) and 1 CFR part 51. Copies may be Method D 3275–89 ‘‘Standard Specifica-
obtained from the Office of Food Addi- tion for E-CTFE-Fluoroplastic Mold-
tive Safety (HFS–200)), Center for Food ing, Extrusion, and Coating Mate-
Safety and Applied Nutrition, Food and rials,’’ which is incorporated by ref-
Drug Administration, 5100 Paint erence in accordance with 5 U.S.C.
Branch Pkwy., College Park, MD 20740, 552(a) and 1 CFR part 51. Copies may be
240–402–1200, or may be examined at the obtained from the American Society
Center for Food Safety and Applied Nu- for Testing and Materials, 1916 Race
trition’s Library, 5100 Paint Branch St., Philadelphia, PA 19013, or may be
Pkwy., College Park, MD 20740, or at examined at the National Archives and
the National Archives and Records Ad- Records Administration (NARA). For
ministration (NARA). For information information on the availability of this
on the availability of this material at material at NARA, call 202–741–6030, or
NARA, call 202–741–6030, or go to: http:// go to: http://www.archives.gov/
www.archives.gov/federallregister/ federallregister/
codeloflfederallregulations/ codeloflfederallregulations/
ibrllocations.html. ibrllocations.html.
(e) The provisions of this section are (b) Fluorocarbon resins that are iden-
not applicable to ethylene-vinyl ace- tified in paragraph (a) of this section
tate-vinyl alcohol copolymers used in and that comply with extractive limi-
the food-packaging adhesives com- tations prescribed in paragraph (c) of
plying with § 175.105 of this chapter. this section may be used as articles or
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; 78 FR 14665, Mar. 7, 2013] 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
274
that are intended for one-time use in rated from the exterior layer(s) by a
contact with foods only of the types functional barrier, such as aluminum
identified in § 176.170(c) of this chapter, foil. Upon review of the physical prop-
table 1, under Types I, II, VI, VII-B, erties of a particular construction, the
and VIII. Food and Drug Administration may
(2) Fluorocarbon resins that are iden- consider other layers to serve as func-
tified in paragraph (a)(4) of this section tional barriers. This regulation is not
and that comply with the extractive intended to limit these constructions
limitations prescribed in paragraphs as to shape, degree of flexibility, thick-
(c)(1) and (c)(2) of this section may be ness, or number of layers. These layers
used only when such use is limited to may be laminated, extruded, co-
articles or components of articles that extruded, or fused.
are intended for repeated use in con- (b) When containers subject to this
tact with food. regulation undergo heat sterilization
(3) In accordance with current good to produce shelf-stable foods, certain
manufacturing practice, those food- control measures (in addition to the
contact articles intended for repeated food additive requirements in para-
use shall be thoroughly cleansed prior graphs (c) and (d) of this section) are
to their first use in contact with food. necessary to ensure proper food steri-
(c) Extractives limitations are appli- lization and package integrity. Refer
cable to the basic resins in the form of to parts 108, 110, 113, and 114 of this
pellets that have been ground or cut chapter for details.
into small particles that will pass (c) Subject to the provisions of this
through a U.S. Standard Sieve No. 6 paragraph, food-contact articles pro-
and that will be held on a U.S. Stand- duced from high-temperature lami-
ard Sieve No. 10. nates may be safely used to package all
(1) A 100-gram sample of the resin food types except those containing
pellets, when extracted with 100 milli- more than 8 percent ethyl alcohol.
liters of distilled water at reflux tem- (1) Polymeric films/layers. Films or lay-
perature for 8 hours, shall yield total ers not separated from food by a func-
extractives not to exceed 0.003 percent tional barrier must meet the following
by weight of the resins. requirements:
(2) A 100-gram sample of the resin (i) Films/layers may consist of the
pellets, when extracted with 100 milli- following:
liters of 50 percent (by volume) ethyl (a) Polyolefin resins complying with
alcohol in distilled water at reflux item 2.2 or 3.2 of the table in
temperature for 8 hours, shall yield § 177.1520(c).
total extractives not to exceed 0.003 (b) Polymeric resin blends formu-
percent by weight of the resins. lated from a base polymer complying
(3) A 100-gram sample of the resin with item 2.2 or 3.2 of the table in
pellets, when extracted with 100 milli- § 177.1520(c) blended with no more than
liters of n-heptane at reflux tempera- 10 percent by weight of a copolymer of
ture for 8 hours, shall yield total ex- ethylene and vinyl acetate complying
tractives not to exceed 0.01 percent by with § 177.1350.
weight of the resins. (c) Polymeric resin blends formulated
[42 FR 14572, Mar. 15, 1977, as amended at 57 from a base polymer complying with
FR 185, Jan. 3, 1992] item 2.2 or 3.2 of the table in
§ 177.1520(c) blended with no more than
§ 177.1390 Laminate structures for use 38 percent by weight of a homopolymer
at temperatures of 250 ≥F and of isobutylene complying with
above. § 177.1420(a)(1).
(a) The high-temperature laminates (d) Polyethylene phthalate resins
identified in this section may be safely complying with § 177.1630(e)(4) (i) and
used for food contact at temperatures (ii).
not exceeding 135 °C (275 °F) unless oth- (e) Nylon MXD–6 resins that comply
erwise specified. These articles are lay- with item 10.3 of the table in
ered constructions that are optionally § 177.1500(b) of this chapter when ex-
bonded with adhesives. The interior tracted with water and heptane under
(food-contact) layer(s) may be sepa- the conditions of time and temperature
275
§ 177.1390 21 CFR Ch. I (4–1–15 Edition)
specified for condition of use A, as set trimethylcyclohexyl isocyanate (CAS

forth in Table 2 of § 176.170(c) of this Reg. No. 4098–71–9) and optional
chapter. trimethoxysilane coupling agents con-
(f) Nylon 6⁄12 resins (CAS Reg. No. taining amino, epoxy, ether, and/or
25191–04–2) complying with item 13.3 of mercapto groups not to exceed 3 per-
the table in § 177.1500(b), for use as cent by weight of the cured adhesive.
nonfood-contact layers of laminated (b) Urethane cross-linking agent
films and in rigid multilaminate con- comprising not more than 25 percent
structions with polypropylene outer by weight of the cured adhesive and
layers. Laminate structures with au- formulated from 3-isocyanatomethyl-
thorized food-contact materials yield 3,5,5-trimethylcyclohexyl isocyanate
no more than 0.15 milligrams of epsilon- (CAS Reg. No. 4098–71–9) adduct of
caprolactam and 0.04 milligrams of trimethylol propane (Cas Reg. No. 77–
omega-laurolactam per square inch 99–6) and/or 1,3-bis(isocyanatomethyl)
when extracted with 95 percent ethanol benzene (CAS Reg. No. 25854–16–4)
at 121 °C (250 °F) for 2 hours. adduct of trimethylol propane.
(g) Polymeric resins that comply (v) Polyester-epoxy-urethane adhe-
with an applicable regulation in this sives formulated from the following:
chapter which permits food type and (a) Polyester resin formed by the re-
time/temperature conditions to which action of polybasic acids and
the container will be exposed, includ- polyhydric alcohols listed in
ing sterilization processing. § 175.300(b)(3)(vii) of this chapter. Aze-
(ii) Adjuvants used in these layers laic acid may also be used as a
must comply with an applicable regu- polybasic acid.
lation that permits food type and time/
(b) Epoxy resin listed in
temperature conditions to which the
§ 175.300(b)(3)(viii)(a) of this chapter and
container will be exposed, including
comprising no more than 30 percent by
sterilization processing.
weight of the cured adhesive.
(2) Adhesives. The use of adhesives in
(c) Urethane cross-linking agent com-
these containers is optional. Adhesives
prising no more than 14 percent weight
may be formulated from the following
of the cured adhesive and formulated
substances, subject to the prescribed
from 3-isocyanatomethyl-3,5.5-
limitations:
trimethylcyclohexyl isocyanate
(i) Any substance suitable for use in
cyanurate (CAS Reg. No. 53880–05–0).
formulating adhesives that complies
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,
276
or mercapto groups not in excess of 3 (i) Nonvolatile extractives. (a) For use
percent of the cured adhesive. at temperatures not to exceed 121 °C
(b) Urethane cross-linking agent, (250 °F): The container interior (food-
comprising not more than 20 percent contact side) shall be extracted with
by weight of the cured adhesive, and deionized distilled water at 121 °C (250
formulated from trimethylol propane °F) for 2 hours.
(CAS Reg. No. 77–99–6) adducts of 3– (1) The chloroform-soluble fraction of
isocyanatomethyl–3,5,5– the total nonvolatile extractives for
trimethylcyclohexyl isocyanate (CAS containers using adhesives listed in
Reg. No. 4098–71–9) or 1,3- paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii),
bis(isocyanatomethyl)benzene (CAS (c)(2)(iv), and (c)(2)(vii) of this section
Reg. No. 25854–16–4). shall not exceed 0.0016 milligram per
(vii) Polyester-polyurethane resin-
square centimeter (0.01 milligram per
acid dianhydride adhesives for use at
square inch) as determined by a meth-
temperatures not to exceed 121 °C (250
od entitled ‘‘Determination of Non-
°F), in contact only with food Types I,
Volatile Chloroform Soluble Residues
II, VIA, VIB, VIIB, and VIII as de-
scribed in Table I of § 176.170 of this in Retort Pouch Water Extracts,’’
chapter, and formulated from the fol- which is incorporated by reference.
lowing mixture: Copies are available from the Center
(a)(1) Polyesterpolyurethanediol res- for Food Safety and Applied Nutrition
ins prepared by the reaction of a mix- (HFS–200), Food and Drug Administra-
ture of polybasic acids and polyhydric tion, 5100 Paint Branch Pkwy., College
alcohols listed in § 175.300(b)(3)(vii) of Park, MD 20740, and may be examined
this chapter and 3-isocyanatomethyl- at the Center for Food Safety and Ap-
3,5,5-trimethylcyclohexyl isocyanate plied Nutrition’s Library, 5100 Paint
(CAS Reg. No. 4098–71–9). Additionally, Branch Pkwy., College Park, MD 20740,
dimethylol propionic acid and 1,6- or at the National Archives and
hexanediol may be used alone or in Records Administration (NARA). For
combination as reactants in lieu of a information on the availability of this
polybasic acid and a polyhydric alco- material at NARA, call 202–741–6030, or
hol. go to: http://www.archives.gov/
(2) Acid dianhydride formulated from federallregister/
3a,4,5,7a-tetrahydro-7-methyl-5- codeloflfederallregulations/
(tetrahydro-2,5-dioxo-3-furanyl)-1,3- ibrllocations.html.
isobenzofurandione (CAS Reg. No. (2) The chloroform-soluble fraction of
73003–90–4), comprising not more than the total nonvolatile extractives for
one percent of the cured adhesive. containers using adhesives listed in
(b) Urethane cross-linking agent, paragraph (c)(2)(v) of this section shall
comprising not more than twelve per- not exceed 0.016 milligram per square
cent by weight of the cured adhesive, centimeter (0.10 milligram per square
and formulated from trimethylol pro-
inch) as determined by a method titled
pane (CAS Reg. No. 77–99–6) adducts of
‘‘Determination of Non-volatile Chlo-
3-isocyanatomethyl-3,5,5-
roform Soluble Residues in Retort
trimethylcyclohexyl isocyanate (CAS
Pouch Water Extracts,’’ which is incor-
Reg. No. 4098–71–9) and/or 1,3-
bis(isocyanatomethyl)benzene (CAS porated by reference in paragraph
Reg. No. 363–48–31). (c)(3)(i)(a)(1) of this section.
(3) Test specifications. These specifica- (b) For use at temperatures not to ex-
tions apply only to materials on the ceed 135 °C (275 °F): The container inte-
food-contact side of a functional bar- rior (food-contact side) shall be ex-
rier, if present. All tests must be per- tracted with deionized distilled water
formed on containers made under pro- at 135 °C (275 °F) for 1 hour.
duction conditions. Laminated struc- (1) The chloroform-soluble fraction of
tures submitted to extraction proce- the total nonvolatile extractives for
dures must maintain complete struc- containers using no adhesive, or adhe-
tural integrity (particularly with re- sives listed in paragraphs (c)(2) (i), (ii),
gard to delamination) throughout the and (iii) of this section shall not exceed
test. 0.0020 milligram per square centimeter
277
§ 177.1395 21 CFR Ch. I (4–1–15 Edition)
(0.013 milligram per square inch) as de- crons) may be used as the food-contact
termined by a method titled ‘‘Deter- surface of the container.
mination of Non-volatile Chloroform (3) Container test specifications. On
Soluble Residues in Retort Pouch exposure to distilled water at 250 °F
Water Extracts,’’ which is incorporated (121 °C) for 2 hours, extractives from
by reference. The availability of this the food-contact side of the nylon 12
incorporation by reference is given in multilayered construction shall not ex-
paragraph (c)(3)(i)(a)(1) of this section. ceed 0.05 milligram per square inch
(2) The chloroform-soluble fraction of (0.0078 milligram per square centi-
the total nonvolatile extractives for meter) as total nonvolatile extractives.
containers using adhesives listed in
paragraph (c)(2)(v) of this section shall [45 FR 2843, Jan. 15, 1980, as amended at 47
not exceed 0.016 milligram per square FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983;
centimeter (0.10 milligram per square 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22,
1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575,
inch) as determined by a method titled
Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR
‘‘Determination of Non-volatile Chlo- 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996;
roform Soluble Residues in Retort 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1,
Pouch Water Extracts,’’ which is incor- 1999; 64 FR 46272, Aug. 25, 1999; 69 FR 15668,
porated by reference. The availability Mar. 26, 2004]
of this incorporation by reference is
given in paragraph (c)(3)(i)(a)(1) of this § 177.1395 Laminate structures for use
section. at temperatures between 120 ≥F and
(3) The chloroform-soluble fraction of 250 ≥F.
the total nonvolatile extractives for (a) The laminates identified in this
containers using adhesives listed in section may be safely used at the speci-
paragraph (c)(2)(vi) of this section shall fied temperatures. These articles are
not exceed 0.008 milligram per square layered structures that are optionally
centimeter (0.05 milligram per square bonded with adhesives. In these arti-
inch) as determined by a method enti- cles, the food-contact layer does not
tled, ‘‘Determination of Non-volatile function as a barrier to migration of
Chloroform Soluble Residues in Retort components from non-food-contact lay-
Pouch Water Extracts,’’ which is incor-
ers. The layers may be laminated, ex-
porated by reference in paragraph
truded, coextruded, or fused.
(c)(3)(i)(a)(1) of this section.
(b) Laminate structures may be man-
(ii) Volatiles. Volatile substances em-
ufactured from:
ployed in the manufacture of high-tem-
perature laminates must be removed to (1) Polymers and adjuvants com-
the greatest extent possible in keeping plying with § 177.1390 of this chapter.
with good manufacturing practice pre- (2) Any polymeric resin listed in
scribed in § 174.5(a) of this chapter. these regulations so long as the use of
(d) Nylon 12/aluminum foil high-tem- the resin in the structure complies
perature laminates: Subject to the pro- with the conditions of use (food type
visions of this paragraph, containers and time/temperature) specified in the
constructed of nylon 12 laminated to regulation for that resin.
aluminum foil may be safely used at (3) Optional adjuvant substances used
temperatures no greater than 250 °F in accordance with § 174.5 of this chap-
(121 °C) in contact with all food types ter.
except those containing more than 8 (4) The following substances in non-
percent alcohol. food-contact layers only:
(1) The container is constructed of
aluminum foil to which nylon 12 film is
fused. Prior to fusing the nylon 12, the
aluminum foil may be optionally
precoated with a coating complying
with § 175.300 of this chapter.
(2) Nylon 12 resin complying with

§ 177.1500 and having an average thick-
ness not to exceed 0.0016 inch (41 mi-
278
Substances Limitations Substances Limitations
Ethylene/1,3–phenylene oxy- For use only with poly- Nylon 6/69 resins complying For use with nonalcoholic
ethylene isophthalate/ ethylene terephthalate as with § 177.1500(b), item 14, foods under conditions of
terephthalate copolymer the food-contact layer, of this chapter (CAS Reg. use B, C, D, E, F, G, and
(CAS Reg. No. 87365–98–8) complying with No. 51995–62–1). H described in table 2 of
complying with § 177.1345. § 177.1630 under condi- § 176.170 of this chapter.
tions of use C through G Laminate structures with
described in table 2 of authorized food-contact
§ 176.170(c) of this chap- materials may contain
ter. Laminate structures, nylon 6/69 resins pro-
when extracted with 8 vided that the nitrogen
percent ethanol at 150 °F content of aqueous ex-
for 2 hours shall not yield tracts of a representative
m-pheny lenedioxy-O,O′- laminate (obtained at 100
diethyl isophthalate or cy- °C (212 °F) for 8 hours)
clic bis(ethylene does not exceed 15
isophthalate) in excess of micrograms per square
7.8 micrograms/square centimeter (100
decimeter (0.5 micrograms per square
microgram/square inch) of inch).
food-contact surface.
Nylon 6/12 resins complying For use with nonalcoholic
with § 177.1500(b), item foods at temperatures not [52 FR 33575, Sept. 4, 1987, as amended at 53
13.2, of this chapter (CAS to exceed 100 °C (212 FR 19772, May 31, 1988; 57 FR 43399, Sept. 21,
Reg. No. 25191–04–2). °F). Laminate structures 1992; 58 FR 32610, June 11, 1993; 62 FR 53957,
with authorized food-con- Oct. 17, 1997]
tact materials yield no
more than 0.15 milligram § 177.1400 Hydroxyethyl cellulose film,
of epsilon-caprolactam water-insoluble.
and 0.04 milligram of
omega-laurolactam per Water-insoluble hydroxyethyl cel-
square inch when ex- lulose film may be safely used for
tracted with water at 100
°C (212 °F) for 5 hours. packaging food in accordance with the
Nylon 6/66 resins complying For use only with: following prescribed conditions:
with § 177.1500(b), item 4.2 1. Nonalcoholic foods at (a) Water-insoluble hydroxyethyl cel-
of this chapter (CAS Reg. temperatures not to ex- lulose film consists of a base sheet
24993–04–2). ceed 82.2 °C (180 °F).
Laminate structures with manufactured by the ethoxylation of
authorized food-contact cellulose under controlled conditions,
materials yield no more to which may be added certain optional
than 0.15 milligram of ep- substances of a grade of purity suitable
silon-caprolactam per
square inch when ex- for use in food packaging as constitu-
tracted with water at 82.2 ents of the base sheet or as coatings
°C (180 °F) for 5 hours. applied to impart desired technological
2. Nonalcoholic foods at
temperatures not to ex-
properties.
ceed 100 °C (212 °F). (b) Subject to any limitations pre-
Laminate films with au- scribed in parts 170 through 189 of this
thorized food-contact ma- chapter, the optional substances used
terials yield no more than
0.15 milligram of epsilon-
in the base sheet and coating may in-
caprolactam per square clude:
inch when extracted with (1) Substances generally recognized
water at 100 °C (212 °F) as safe in food.
for 5 hours.
(2) Substances permitted to be used
in water-insoluble hydroxyethyl cel-
lulose film by prior sanction or ap-
proval and under conditions specified
in such sanctions or approval, and sub-
stances listed in part 181, subpart B of
this chapter.
(3) Substances that by any regulation
promulgated under section 409 of the
act may be safely used as components
of water-insoluble hydroxyethyl cel-
lulose film.
(4) Substances identified in and used
in compliance with § 177.1200(c).
279
§ 177.1420 21 CFR Ch. I (4–1–15 Edition)
(c) Any substance employed in the (b) The polymers identified in para-
production of the water-insoluble hy- graph (a) of this section may contain
droxyethyl cellulose film described in optional adjuvant substances required
this section that is the subject of a reg- in the production of the polymers. The
ulation in parts 174, 175, 176, 177, 178 optional adjuvant substances required
and § 179.45 of this chapter conforms in the production of the polymers may
with any specification in such regula- include substances generally recog-
tion. nized as safe in food, substances used in
§ 177.1420 Isobutylene polymers. accordance with a prior sanction or ap-
proval, and aluminum chloride.
Isobutylene polymers may be safely
(c) The provisions of this section are
used as components of articles in-
tended for use in producing, manufac- not applicable to polyisobutylene used
turing, packing, processing, preparing, in food-packaging adhesives complying
treating, packaging, transporting, or with § 175.105 of this chapter.
holding food, in accordance with the
following prescribed conditions: § 177.1430 Isobutylene-butene copoly-
mers.
(a) For the purpose of this section,
isobutylene polymers are those pro- Isobutylene-butene copolymers iden-
duced as follows: tified in paragraph (a) of this section
(1) Polyisobutylene produced by the may be safely used as components of
homopolymerization of isobutylene articles intended for use in contact
such that the finished polymers have a with food, subject to the provisions of
molecular weight of 750,000 (Flory) or this section.
higher. (a) For the purpose of this section,
(2) Isobutylene-isoprene copolymers isobutylene-butene copolymers consist
produced by the copolymerization of
of basic copolymers produced by the
isobutylene with not more than 3
copolymerization of isobutylene with
molar percent of isoprene such that the
finished polymers have a molecular mixtures of n-butenes such that the
weight of 300,000 (Flory) or higher. finished basic copolymers contain not
(3) Chlorinated isobutylene-isoprene less than 45 weight percent of polymer
copolymers produced when units derived from isobutylene and
isobutylene-isoprene copolymers (mo- meet the specifications prescribed in
lecular weight 300,000 (Flory) or higher) paragraph (b) of this section when test-
are modified by chlorination with not ed by the methods described in para-
more than 1.3 weight-percent of chlo- graph (c) of this section.
rine. (b) Specifications:
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- (1) Molecular weight. Molecular
mining whether isobutylene-butene co- weight shall be determined by Amer-
polymers conform to the specifications ican Society for Testing and Materials
in paragraph (b) are as follows: (ASTM) method D2503–82, ‘‘Standard
Test Method for Molecular Weight
280
(Relative Molecular Mass) of Hydro- tain optional adjuvant substances re-

carbons by Thermoelectric Measure- quired in the production of the resins.
ment of Vapor Pressure,’’ which is in- (b) The optional adjuvant substances
corporated by reference. Copies may be required in the production of the resins
obtained from the American Society may include substances generally rec-
for Testing Materials, 100 Barr Harbor ognized as safe in food, substances used
Dr., West Conshohocken, Philadelphia, in accordance with a prior sanction or
PA 19428-2959, or may be examined at approval, and the following:
on the availability of this material at Butyl alcohol ................... Not to exceed 300 p.p.m. as re-
NARA, call 202–741–6030, or go to: http:// sidual solvent in finished resin.
Ethyl alcohol.
www.archives.gov/federallregister/ Toluene ........................... Not to exceed 1,000 p.p.m. as re-
codeloflfederallregulations/ sidual solvent in finished resin.
ibrllocations.html.
(2) Viscosity. Viscosity shall be deter- (c) 4,4′-Isopropylidenediphenol-ep-
mined by ASTM method D445–74, ‘‘Test ichlorohydrin resins shall meet the fol-
for Kinematic Viscosity of Transparent lowing nonvolatile extractives limita-
and Opaque Liquids,’’ which is incor- tions:
porated by reference. The availability (1) Maximum extractable nonvolatile
of this incorporation by reference is fraction of 2 parts per million when ex-
given in paragraph (c)(1) of this sec- tracted with distilled water at 70 °C for
tion. 2 hours, using a volume-to-surface
(3) Maximum bromine value. Maximum ratio of 2 milliliters per square inch.
bromine value shall be determined by (2) Maximum extractable nonvolatile
ASTM method D1492–78, ‘‘Standard fraction of 3 parts per million when ex-
Test Method for Bromine Index of Aro- tracted with n-heptane at 70 °C for 2
matic Hydrocarbons by Coulometric hours, using a volume-to-surface ratio
Titration,’’ which is incorporated by of 2 milliliters per square inch.
reference. The availability of this in- (3) Maximum extractable nonvolatile
corporation by reference is given in fraction of 6 parts per million when ex-
paragraph (c)(1) of this section. tracted with 10 percent (by volume)
(d) The provisions of this section are ethyl alcohol in distilled water at 70 °C
not applicable to isobutylene-butene for 2 hours, using a volume-to-surface
copolymers used as provided under ratio of 2 milliliters per square inch.
§ 175.105 of this chapter. (d) The provisions of this section are
[52 FR 11641, Apr. 10, 1987, as amended at 63 not applicable to 4,4′-isopropylidene-
FR 36175, July 2, 1998] diphenol-epichlorohydrin resins listed
in other sections of subchapter B of
§ 177.1440 4,4′-Isopropylidenediphenol- this chapter.
epichlorohydrin resins minimum
molecular weight 10,000. § 177.1460 Melamine-formaldehyde res-
4,4′-Isopropylidenediphenol-epichlo- ins in molded articles.
rohydrin resins having a minimum mo- Melamine-formaldehyde resins may
lecular weight of 10,000 may be safely be safely used as the food-contact sur-
used as articles or components of arti- face of molded articles intended for use
cles intended for use in producing, in producing, manufacturing, packing,
manufacturing, packing, processing, processing, preparing, treating, pack-
preparing, treating, packaging, trans- aging, transporting, or holding food in
porting, or holding food in accordance accordance with the following pre-
with the following prescribed condi- scribed conditions:
tions: (a) For the purpose of this section,
(a) 4,4′-Isopropylidenediphenol-ep- melamine-formaldehyde resins are
ichlorohydrin resins consist of basic those produced when 1 mole of mel-
resins produced by the condensation of amine is made to react with not more
equimolar amounts of 4,4′- than 3 moles of formaldehyde in water
isopropylidenediphenol and solution.

epichlorohydrin terminated with phe- (b) The resins may be mixed with re-
nol, to which may have been added cer- fined woodpulp and the mixture may
281
§ 177.1480 21 CFR Ch. I (4–1–15 Edition)
contain other optional adjuvant sub- method D1243–79, ‘‘Standard Test Meth-
stances which may include the fol- od for Dilute Solution Viscosity of
lowing: Vinyl Chloride Polymers,’’ which is in-
corporated by reference. Copies may be
obtained from the American Society
Colorants used in accord- for Testing Materials, 100 Barr Harbor
ance with § 178.3297 Dr., West Conshohocken, Philadelphia,
of this chapter.
Dioctyl phthalate ............. For use as lubricant. PA 19428-2959, or may be examined at
Hexamethylenetetramine For use only as polymerization the National Archives and Records Ad-
reaction control agent. ministration (NARA). For information
Phthalic acid anhydride .. Do.
Zinc stearate ................... For use as lubricant. on the availability of this material at
NARA, call 202–741–6030, or go to: http://
(c) The molded melamine-formalde- www.archives.gov/federallregister/
hyde articles in the finished form in codeloflfederallregulations/
which they are to contact food, when ibrllocations.html.
extracted with the solvent or solvents (iii) Residual acrylonitrile monomer
characterizing the type of food and content is not more than 11 parts per
under the conditions of time and tem- million as determined by gas chroma-
perature as determined from tables 1 tography.
and 2 of § 175.300(d) of this chapter, (iv) Acetonitrile-soluble fraction
shall yield net chloroform-soluble ex- after refluxing the base polymer in ace-
tractives not to exceed 0.5 milligram tonitrile for 1 hour is not greater than
per square inch of food-contact surface. 95 percent by weight of the basic co-
[42 FR 14572, Mar. 15, 1977, as amended at 56 polymers.
FR 42933, Aug. 30, 1991] (2) Extractives limitations. The fol-
lowing extractive limitations are de-
§ 177.1480 Nitrile rubber modified ac- termined by an infrared
rylonitrile-methyl acrylate copoly-
mers. spectrophotometric method titled,
‘‘Infrared Spectrophotometric Deter-
Nitrile rubber modified acrylonitrile- mination of Polymer Extracted from
methyl acrylate copolymers identified Borex ® 210 Resin Pellets,’’ which is in-
in this section may be safely used as corporated by reference. Copies are
components of articles intended for available from the Center for Food
food-contact use under conditions of Safety and Applied Nutrition (HFS–
use D, E, F, or G described in table 2 of 200), Food and Drug Administration,
§ 176.170(c) of this chapter, subject to
5100 Paint Branch Pkwy., College Park,
the provisions of this section.
nitrile rubber modified acrylonitrile-
methyl acrylate copolymers consist of
basic copolymers produced by the graft on the availability of this material at
copolymerization of 73–77 parts by NARA, call 202–741–6030, or go to: http://
weight of acrylonitrile and 23–27 parts www.archives.gov/federallregister/
by weight of methyl acrylate in the codeloflfederallregulations/
presence of 8–10 parts by weight of bu- ibrllocations.html.Copies are applicable
tadiene-acrylonitrile copolymers con- to the basic copolymers in the form of
taining approximately 70 percent by particles of a size that will pass
weight of polymer units derived from through a U.S. standard sieve No. 6 and
butadiene. that will be held on a U.S. standard
(b) The nitrile rubber modified acry- sieve No. 10:
lonitrile-methyl acrylate basic copoly- (i) Extracted copolymer not to ex-
mers meet the following specifications ceed 2.0 parts per million in aqueous
and extractives limitations: extract obtained when a 100-gram sam-
(1) Specifications. (i) Nitrogen content ple of the basic copolymers is extracted
is in the range 16.5–19 percent as deter- with 250 milliliters of demineralized
mined by Kjeldahl analysis. (deionized) water at reflux temperature
(ii) Intrinsic viscosity in acetonitrile for 2 hours.

at 25 °C is not less than 0.29 deciliter (ii) Extracted copolymer not to ex-
per gram as determined by ASTM ceed 0.5 part per million in n-heptane
282
extract obtained when a 100-gram sam- adipic acid, and 21.6±1.2 weight percent
ple of the basic copolymers is extracted terephthalic acid.
with 250 milliliters of reagent grade n- (8) Nylon 612 resins are manufactured
heptane at reflux temperature for 2 by the condensation of
hours. hexamethylenediamine and
(c) Acrylonitrile copolymers identi- dodecanedioic acid.
fied in this section shall comply with (9) Nylon 12 resins are manufactured
the provisions of § 180.22 of this chap- by the condensation of omega-
ter. laurolactam.
(d) Acrylonitrile copolymers identi- (10)(i) Impact modified Nylon MXD–6
fied in this section are not authorized resins (CAS Reg. No. 59655–05–9) manu-
to be used to fabricate beverage con- factured by the condensation of adipic
tainers. acid, 1,3-benzenedimethanamine, and
alpha-(3-aminopropyl)-omega-(3-amino-
[42 FR 14572, Mar. 15, 1977, as amended at 42 propoxy)polyoxyethylene under such
FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19,
conditions that the alpha-(3-amino-
1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109,
Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR propyl)-omega-(3-aminopropoxy)
14481, Apr. 2, 1996] polyoxyethylene monomer content
does not exceed 7 percent by weight of
§ 177.1500 Nylon resins. the finished resin.
(ii) Nylon MXD–6 resins (CAS Reg.
The nylon resins listed in paragraph
No. 25718–70–1) manufactured by the
(a) of this section may be safely used to
condensation of adipic acid and 1,3-
produce articles intended for use in
benzenedimethanamine.
processing, handling, and packaging
(11) Nylon 12T resins are manufac-
food, subject to the provisions of this
tured by the condensation of omega-
section:
laurolactam (CAS Reg. No. 0947–04–6),
(a) The nylon resins are manufac-
isophthalic acid (CAS Reg. No. 0121–91–
tured as described in this paragraph so
5), and bis(4-amino-3-methylcycl-
as to meet the specifications prescribed
ohexyl)methane (CAS Reg. No. 6864–37–
in paragraph (b) of this section when
5) such that the composition in terms
tested by the methods described in
of ingredients is 34.4±1.5 weight percent
paragraph (d) of this section.
omega-laurolactam, 26.8±0.4 weight per-
(1) Nylon 66 resins are manufactured cent isophthalic acid, and 38.8±0.5
by the condensation of hexamethylene- weight percent bis(4-amino-3-
diamine and adipic acid. methylcyclohexyl)-methane.
(2) Nylon 610 resins are manufactured (12) Nylon 6I/6T resins (CAS Reg. No.
by the condensation of hexamethylene- 25750–23–6) are manufactured by the
diamine and sebacic acid. condensation of
(3) Nylon 66/610 resins are manufac- hexamethylenediamine, terephthalic
tured by the condensation of equal- acid, and isophthalic acid such that 65
weight mixtures of nylon 66 salts and to 80 percent of the polymer units are
nylon 610 salts. derived from hexamethylene
(4) Nylon 6/66 resins manufactured by isophthalamide.
the condensation and polymerization of (13)(i) Nylon 6/12 resins (CAS Reg. No.
Nylon 66 salts and epsilon-caprolactam. 25191–04–2) are manufactured by the co-
(5) Nylon 11 resins are manufactured polymerization of a 1 to 1 ratio by
by the condensation of 11- weight of epsilon-caprolactam and
aminoundecanoic acid. omega-laurolactam.
(6) Nylon 6 resins are manufactured (ii) Nylon 6/12 resins (CAS Reg. No.
by the polymerization of epsilon- 25191–04–2) are manufactured by the co-
caprolactam. polymerization of a ratio of at least 80
(7) Nylon 66T resins are manufac- weight percent of epsilon-caprolactam
tured by the condensation of and no more than 20 weight percent of
hexamethyl-enediamine, adipic acid, omega-laurolactam.
and terephthalic acid such that com- (14) Nylon 6/69 resins (CAS Reg. No.
position in terms of ingredients is 51995–62–1) are manufactured by the

43.1±0.2 weight percent hexamethyl- condensation of 49.5+0.5 weight percent
enediamine, 35.3±1.2 weight percent epsilon-caprolactam, 19.4+0.2 weight
283
§ 177.1500 21 CFR Ch. I (4–1–15 Edition)
percent hexamethylenediamine and by the condensation of 50 mol percent

31.2+0.3 weight percent azelaic acid. 1,4-benzenedicarboxylic acid, dimethyl
(15) Nylon 46 resins (CAS Reg. No. ester and 50 mol percent of an
50327–77–0) are manufactured by the equimolar mixture of 2,2,4-trimethyl-
condensation of 1,4-butanediamine and 1,6-hexanediamine and 2,4,4-trimethyl-
adipic acid. 1,6-hexanediamine.
(16) Nylon resins PA 6–3–T (CAS Reg- (b) Specifications:
istry No. 26246–77–5) are manufactured
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.
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.
284

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
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
§ 176.170(c) of this chap-
ter, except as provided in
§ 177.1390(d)
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 (4–1–15 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 N/A 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 (4–1–15 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 (4–1–15 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 (4–1–15 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
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
Branch Pkwy., College Park, MD 20740, or may be exam-
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 paragraph 0.880–0.913 MP: 160°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C
(a)(1)(i) of this section temperature
1.1b. Propylene homopolymer described in 0.880–0.913– MP: 150°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C
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 (4–1–15 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 (4–1–15 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 (4–1–15 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 (4–1–15 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 the film pieces to the nearest 0.1 milli-
1⁄16 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 (4–1–15 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 (4–1–15 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
Archives and Records Administration
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 (4–1–15 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 (4–1–15 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 in infant feeding bottles (baby bottles)
may include substances generally rec- and spill-proof cups, including their
ognized as safe in food, substances used closures and lids, designed to help train
in accordance with a prior sanction or babies and toddlers to drink from cups
approval, and the following: (sippy cups).
List of substances Limitations [42 FR 14572, Mar. 15, 1977, as amended at 46
FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6,
p-tert-Butylphenol .................. 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656,
Chloroform .............................
p-Cumylphenol (CAS Reg. For use only as a chain ter-
Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994; 77 FR
No. 599–64–4). minator at a level not to ex- 41902, July 17, 2012]
ceed 5 percent by weight
of the resin. § 177.1585 Polyestercarbonate resins.
Ethylene dichloride.
Heptane. Polyestercarbonate resins may be
Methylene chloride. safely used as articles or components
Monochlorobenzene .............. Not to exceed 500 p.p.m. as
residual solvent in finished
of articles intended for use in pro-
resin. ducing, manufacturing, packing, proc-
Pentaerythritol tetrastearate For use only as a mold re- essing, preparing, treating, packaging,
(CAS Reg. No. 115–83–3). lease agent, at a level not or holding food, in accordance with the
to exceed 0.5 percent by
weight of the finished resin. following prescribed conditions:
Phenol (CAS Reg. No. 108– (a) Polyestercarbonate resins (CAS
95–2). Reg. No. 71519–80–7) are produced by the
Pyridine.
Toluene: (CAS Reg. No. Not to exceed 800 parts per condensation of 4,4′-
108–88–3). million as residual solvent isopropylidenediphenol, carbonyl chlo-
in finished resin. ride, terephthaloyl chloride, and
Triethylamine.
isophthaloyl chloride such that the fin-
ished resins are composed of 45 to 85
(c) Polycarbonate resins shall con-
molepercent ester, of which up to 55
form to the specification prescribed in
mole-percent is the terephthaloyl iso-
paragraph (c)(1) of this section and
mer. The resins are manufactured
shall meet the extractives limitations
using a phthaloyl chloride/carbonyl
prescribed in paragraph (c)(2) of this
chloride mole ratio of 0.81 to 5.7/1 and
section.
isophthaloyl chloride/terephthaloyl
(1) Specification. Polycarbonate resins
chloride mole ratio of 0.81/1 or greater.
can be identified by their char-
The resins are also properly identified
acteristic infrared spectrum.
by CAS Reg. No. 114096–64–9 when pro-
(2) Extractives limitations. The
duced with the use of greater than 2
polycarbonate resins to be tested shall
but not greater than 5 weight percent
be ground or cut into small particles
p-cumylphenol (CAS Reg. No. 599–64–4),
that will pass through a U.S. standard
as an optional adjuvant substance in
sieve No. 6 and that will be held on a
accordance with paragraph (b)(2) of
U.S. standard sieve No. 10.
this section.
(i) Polycarbonate resins, when ex-
(b) Optional adjuvants. The optional
tracted with distilled water at reflux
adjuvant substances required in the
temperature for 6 hours, shall yield
production of resins identified in para-
total extractives not to exceed 0.15 per-
graph (a) of this section may include:
cent by weight of the resins.
(ii) Polycarbonate resins, when ex- (1) Substances used in accordance
tracted with 50 percent (by volume) with § 174.5 of this chapter.
ethyl alcohol in distilled water at (2) Substances identified in
reflux temperature for 6 hours, shall § 177.1580(b).
yield total extractives not to exceed (3) Substances regulated in
0.15 percent by weight of the resins. § 178.2010(b) of this chapter for use in
(iii) Polycarbonate resins, when ex- polycarbonate resins complying with
tracted with n-heptane at reflux tem- § 177.1580:
perature for 6 hours, shall yield total Provided, That the substances are used
extractives not to exceed 0.15 percent in accordance with any limitation on
by weight of the resins. concentration, conditions of use, and

(d) Polycarbonate resins may be used food types specified in § 178.2010(b) of
in accordance with this section except this chapter.
309
§ 177.1590 21 CFR Ch. I (4–1–15 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.
material at NARA, call 202–741–6030, or
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 (4–1–15 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
accordance with the following pre-
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 (4–1–15 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
(NARA). For information on the avail-
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-
Philadelphia, PA 19428-2959, or may be 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 (4–1–15 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 (4–1–15 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
chapter, substances generally recog- [48 FR 31384, July 8, 1983, as amended at 54
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-
fied in paragraph (a)(1) of this section Poly(oxy-1,2-ethanediyloxycarbonyl-
shall contain not more than 1 weight 2,6-naphthalenediylcarbonyl) resins
percent of total residual p- identified in paragraph (a) of this sec-
methystyrene monomer, as determined tion may be safely used as articles or
by a gas chromatographic method ti- components of articles intended for use
tled, ‘‘Gas Chromatographic Deter- in contact with food in accordance
mination of PMS and PET in PPMS with the following conditions:
Basic Polymers,’’ which is incorporated (a) Identity. For the purpose of this
by reference. Copies are available from section, poly(oxy-1,2-
the Center for Food Safety and Applied ethanediyloxycarbonyl-2,6-
Nutrition (HFS–200), Food and Drug naphthalenediylcarbonyl) resins (CAS
Administration, 5100 Paint Branch Reg. No. 24968–11–4) are polymers
Pkwy., College Park, MD 20740, or formed by catalytic transesterification
available for inspection at the National of 2,6-dimethylnaphthalene
Archives and Records Administration dicarboxylate with ethylene glycol fol-
(NARA). For information on the avail- lowed by catalytic polycondensation.
ability of this material at NARA, call (b) Specifications—(1) Density. The
202–741–6030, or go to: http:// density of poly(oxy-1,2-
www.archives.gov/federallregister/ ethanediyloxycarbonyl-2,6-
codeloflfederallregulations/ naphthalenediylcarbonyl) resins shall
ibrllocations.html. be between 1.33 and 1.40 grams per
(2) Rubber-modified poly(p- cubic centimeter.
methylstyrene) basic polymers identi-
(2) Inherent viscosity. The finished
fied in paragraph (a)(2) of this section
food-contact article shall have a min-
shall contain not more than 0.5 weight
imum inherent viscosity of 0.55 deci-
percent of total residual p-
methylstyrene monomer, as deter- liter per gram in a solution of 0.1 gram
mined by the method identified in of polymer in 100 milliliters of a 25/40/
paragraph (c)(1) of this section 35 (weight/weight/weight) solution of p-
(d) Other specifications and limitations. chlorophenol/tetrachloroethane/phenol.
The poly(p-methylstyrene) and rubber- The viscosity is determined by East-
modified poly(p-methylstyrene) identi- man Chemical Co.’s method ECD-A-AC-
fied in and complying with this sec- G-V-1-5, ‘‘Determination of Dilute So-
tion, when used as components of the lution Viscosity of Polyesters,’’ dated
food-contact surface of any article that May 31, 1988, which is incorporated by
is the subject of a regulation in parts reference in accordance with 5 U.S.C.
175, 176, 177, 178 and § 179.45 of this chap- 552(a) and 1 CFR part 51. Copies are
ter, shall comply with any specifica- available from the Office of Food Addi-
tions and limitations prescribed by tive Safety (HFS–200), Center for Food
such regulation for the article in the Safety and Applied Nutrition, Food and
finished form in which it is to contact Drug Administration, 5100 Paint
food. Branch Pkwy., College Park, MD 20740,
(e) Conditions of use. Poly(p- 240–402–1200, or may be examined at the
methylstyrene) basic polymers and Center for Food Safety and Applied Nu-
rubber-modified poly(p-methylstyrene) trition’s Library, Food and Drug Ad-
basic polymers identified in paragraphs ministration, 5100 Paint Branch Pkwy.,
318
College Park, MD 20740, or at the Na- styrene, either during or after polym-
tional Archives and Records Adminis- erization of the polystyrene, such that
tration (NARA). For information on the finished basic polymers contain not
the availability of this material at less than 75 weight percent of total
NARA, call 202–741–6030, or go to: http:// polymer units derived from styrene
www.archives.gov/federallregister/ monomer.
codeloflfederallregulations/ (b) Optional adjuvants. The basic
ibrllocations.html. polymers identified in paragraph (a) of
(c) Extraction limitations. A 0.5 milli- this section may contain optional adju-
meter (0.02 inch) thick sheet of resin vant substances required in the produc-
when extracted with water at 121 °C tion of such basic polymers. Such op-
(250 °F) for 2 hours shall yield total tional adjuvant substances may in-
nonvolatile extractives not exceeding clude substances permitted for such
2.0 micrograms per square inch of ex- use by regulations in parts 170 through
posed resin surface. 189 of this chapter, substances gen-
(d) Conditions of use. The finished erally recognized as safe in food, and
food contact article shall be: substances used in accordance with a
(1) Used in contact only with food of prior sanction or approval.
Types I, II, IVB, VIA, VIB, VIIB, and (c) Specifications. (1) Polystyrene
VIII identified in table 1 of § 176.170(c) basic polymers identified in paragraph
of this chapter, under conditions of use (a)(1) of this section shall contain not
A through H described in table 2 of more than 1 weight percent of total re-
§ 176.170(c) of this chapter; and with sidual styrene monomer, as determined
food of Types III, IVA, V, VIC, VIIA, by the method described in paragraph
and IX identified in table 1 of (d) of this section, except that when
§ 176.170(c) of this chapter, under condi- used in contact with fatty foods of
tions of use C through H described in Types III, IV-A, V, VII-A, and IX de-
table 2 of § 176.170(c) of this chapter; scribed in table 1 of § 176.170(c) of this
and chapter, such polystyrene basic poly-
(2) Identified in a manner that will mers shall contain not more than 0.5
differentiate the article from articles weight percent of total residual sty-
made of other polymeric resins to fa- rene monomer.
cilitate collection and sorting. (2) Rubber-modified polystyrene
[61 FR 14965, Apr. 4, 1996, as amended at 78 basic polymers identified in paragraph
FR 14666, Mar. 7, 2013] (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
319
§ 177.1650 21 CFR Ch. I (4–1–15 Edition)
polyethylene glycol (20,000 molecular (e) Other specifications and limitations.

weight) on alkaline treated 60–80 mesh The polystyrene and rubber-modified
firebrick. polystyrene identified in and com-
(iii) Recorder. Millivolt range of 0–1, plying with this section, when used as
chart speed of 30 inches per hour. components of the food-contact surface
(4) Reagents. Compressed air, purified; of any article that is the subject of a
helium gas; hydrogen gas; methylene regulation in parts 174, 175, 176, 177, 178
chloride, redistilled; and styrene mon- and § 179.45 of this chapter, shall com-
omer, redistilled. ply with any specifications and limita-
(5) Operating conditions for the gas tions prescribed by such regulation for
chromatograph. (i) The column is oper- the article in the finished form in
ated at a temperature of 100 °C with a which it is to contact food.
helium flow rate of 82 milliliters per (f) Nonapplicability. The provisions of
minute. this section are not applicable to poly-
(ii) The hydrogen burner is operated styrene and rubber-modified poly-
with 15 pounds per square inch of air styrene used in food-packaging adhe-
pressure and 7 pounds per square inch sives complying with § 175.105 of this
of hydrogen pressure. chapter.
(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. (1) Substances generally recognized
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.
Carbon black (channel process).
omer solution. Calculation: Chlorinated paraffins ......................... Cross-linking agent.
Epoxidized linseed oil.
Percent residual styrene Epoxidized soybean oil.
monomer=Milligrams monomer in stand- Epoxy resins (as listed in

ard×peak area of sample/Peak area of mon- § 175.300(b)(3)(viii)(a) of this chap-
omer standard×sample weight in grams×30 ter)..
320
List of substances Limitations isopropylidenediphenol is made to

react with 4,4′-dichlorodiphenyl sulfone
Ethylene glycol monobutyl ether ....... Solvent.
Magnesium chloride. in such a way that the finished resins
Methyl isobutyl ketone ....................... Solvent. have a minimum number average mo-
Naphthalene sulfonic acid-formalde- lecular weight of 15,000, as determined
hyde condensate, sodium salt.
Sodium dibutyl naphthalene Wetting agent. by osmotic pressure in
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
percent) and 4,4′-sulfonylbis[phenol]
(b) The resins are used as the food-
(maximum 8 percent) is made to react
contact surface for dry food.
with 4,4′-dichlorodiphenyl sulfone in
(c) An appropriate sample of the fin-
such a way that the finished resin has
ished resin in the form in which it con-
a minimum number average molecular
tacts food, when subjected to ASTM
weight of 26,000, as determined by os-
method D968–81, ‘‘Standard Test Meth-
motic pressure in dimethylformamide.
ods for Abrasion Resistance of Organic
(b) The basic polysulfone resins iden-
Coatings by the Falling Abrasive
tified in paragraph (a) of this section
Tester,’’ which is incorporated by ref-
may contain optional adjuvant sub-
erence (Copies may be obtained from
stances required in the production of
the American Society for Testing Ma-
such basic resins. The optional adju-
terials, 100 Barr Harbor Dr., West
vant substances required in the produc-
tion of the basic polysulfone resins
2959, or may be examined at the Na-
may include substances described in
tional Archives and Records Adminis-
§ 174.5(d) of this chapter and the fol-
tration (NARA). For information on
lowing:
the availability of this material at
NARA, call 202–741–6030, or go to: http:// List of substances Limitations
codeloflfederallregulations/ Dimethyl sulfoxide ..... Not to exceed 50 parts per million as
residual solvent in finished basic
ibrllocations.html.), using No. 50 Emery resin in paragraph (a)(1) of this
abrasive in lieu of Ottawa sand, shall 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
basic resin in paragraph (a)(1) of
ness. this section.
N-methyl-2- Not to exceed 0.01 percent (100
pyrrolidone. parts per million) as residual sol-
FR 10110, Mar. 19, 1984] vent in finished basic resin in para-
graph (a)(2) of this section.
§ 177.1655 Polysulfone resins.
Polysulfone resins identified in para- (c) Polysulfone resins, when ex-
graph (a) of this section may be safely tracted at reflux temperatures for 6
used as articles or components of arti- hours with the solvents—distilled
cles intended for use in contact with water, 50 percent (by volume) ethyl al-
food, in accordance with the following cohol in distilled water, 3 percent ace-
prescribed conditions: tic acid in distilled water, and n-
(a) For the purpose of this section, heptane, yield total extractives in each
polysulfone resins are: extracting solvent not to exceed 0.0078
(1) Poly(oxy-p-phenylenesulfonyl-p- milligram per square centimeter (0.05
phenyleneoxy-p- milligram per square inch) of resin sur-
phenyleneisopropylidene-p-phenylene) face. Note: In testing the finished
resins (CAS Reg. No. 25154–01–2) con- polysulfone resins, use a separate resin
sisting of basic resins produced when test sample for each required extract-
the disodium salt of 4,4′- ing solvent.
321
§ 177.1660 21 CFR Ch. I (4–1–15 Edition)
(d) Polysulfone resins intended for re- concentration of the test solution in
peated use in contact with food may be grams per 100 milliliters.
used under conditions of use A through (2) Poly(tetramethylene
H in table 2 of § 176.170(c) of this chap- terephthalate) in the finished form in
ter. The resins intended for single-serv- which it is to contact food shall yield
ice food-contact use may be used only total extractives as follows:
under condition of use H described in (i) Not to exceed 0.08 milligram per
table 2 of § 176.170(c) of this chapter. 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 square inch of food contact surface
terephthalate). 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
tion to that of the solvent and c=polymer examined at the National Archives and
322
ER01JA93.400</GPH>
Records Administration (NARA). For 1,3-Butylene glycol.

information on the availability of this 1,4–Cyclohexane dimethanol (CAS Reg. No.
material at NARA, call 202–741–6030, or 105–08–8).
go to: http://www.archives.gov/
Ethylene glycol.
federallregister/ 1,6–Hexanediol (CAS Reg. No. 629–11–8).a–
codeloflfederallregulations/ Hydro–w–hydroxypoly(oxy–1,4–butanediyl)
ibrllocations.html. (CAS Reg. No. 25190–06–1).
(c) The finished food-contact film a-Hydro-omega-hydroxypoly (oxytetra-
shall not be used as a component of methylene).
food containers intended for use in con- a,a′-(Isopropylidenedi-p-phenylene)bis[omega-
tact with water. hydroxypoly (oxypropylene)(3–4 moles)],
average molecular weight 675.
[42 FR 14572, Mar. 15, 1977, as amended at 49 Maleic anhydride.
FR 10110, Mar. 19, 1984] Methyl oxirane polymer with oxirane (CAS
Reg. No. 9003–11–6).
§ 177.1680 Polyurethane resins. Methyl oxirane polymer with oxirane, ether
The polyurethane resins identified in with 1,2,3–propanetriol (CAS Reg. No. 9082–
00–2).
paragraph (a) of this section may be a,a′a″,a″′-Neopentanetetrayltetrakis [omega-
safely used as the food-contact surface hydroxypoly (oxypropylene) (1–2 moles)],
of articles intended for use in contact average molecular weight 400.
with bulk quantities of dry food of the Pentaerythritol-linseed oil alcoholysis prod-
type identified in § 176.170(c) of this uct.
chapter, table 1, under Type VIII, in ac- Phthalic anhydride.
cordance with the following prescribed Polybutylene glycol.
conditions: Polyethyleneadipate modified with ethanol-
amine with the molar ratio of the amine to
the adipic acid less than 0.1 to 1.
polyurethane resins are those produced Poly(oxycarbonylpentamethylene).
when one or more of the isocyanates Polyoxypropylene ethers of 4.4′-isopropyl-
listed in paragraph (a)(1) of this section idenediphenol (containing an average of 2–
is made to react with one or more of 4 moles of propylene oxide).
the substances listed in paragraph Polypropylene glycol.
(a)(2) of this section: a,a′,a″-1,2,3-Propanetriyltris [omega-
(1) Isocyanates: hydroxypoly (oxypropylene) (15–18 moles)],
average molecular weight 3,000.
Bis(isocyanatomethyl) benzene (CAS Reg. Propylene glycol.
No. 25854–16–4). a,a′,a″-[Propylidynetris (methylene)] tris
Bis(isocyanatomethyl) cyclohexane (CAS [omega-hydroxypoly (oxypropylene) (min-
Reg. No. 38661–72–2). imum 1.5 moles)], minimum molecular
4,4′-Diisocyanato-3,3′-dimethylbiphenyl (bi- weight 400.
tolylene diisocyanate). a-[r(1,1,3,3-Tetramethylbutyl) - phenyl]-
Diphenylmethane diisocyanate. omega-hydroxypoly(oxyethylene) (5 moles),
Hexamethylene diisocyanate. average molecular weight 425.
3-Isocyanatomethyl - 3,5,5 - trimethylcyclo- Trimethylol propane.
hexyl isocyanate.
4,4-Methylenebis(cyclohexyl isocyanate). (b) Optional adjuvant substances em-
Toluene diisocyanate. ployed in the production of the poly-
urethane resins or added thereto to im-
(2) List of substances: part desired technical or physical prop-
Adipic acid. erties may include the following sub-
1,4-Butanediol. 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.
323
§ 177.1810 21 CFR Ch. I (4–1–15 Edition)
1,1′,1″-Nitrilotri-2-propanol ........................................................... Do.

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 (4–1–15 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.
(d) The provisions of this section are
(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]
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 (4–1–15 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 (4–1–15 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
Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be
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-
cle that is subject to a regulation in
a suspending agent and chain transfer

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 (4–1–15 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 (4–1–15 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
liliter beaker, methyl purple indicator
nitrate 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 tract of 100 grams of sample equal
nitrate 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 (4–1–15 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/
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 (4–1–15 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 (4–1–15 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
(d) The provisions of this section are
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 (4–1–15 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.
Glass fiber.
(1) Total extractives not to exceed 3.1

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 (4–1–15 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 (4–1–15 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,
chlorinated. Dr., West Conshohocken, Philadelphia,
PA 19428-2959, or may be examined at
Chlorinated polyether resins may be the Office of Food Additive Safety
safely used as articles or components (HFS–200), Center for Food Safety and
of articles intended for repeated use in Applied Nutrition, Food and Drug Ad-
producing, manufacturing, packing, ministration, 5100 Paint Branch Pkwy.,
processing, preparing, treating, pack- College Park, MD 20740, 240–402–1200 or
aging, transporting, or holding food, in at the National Archives and Records
accordance with the following pre- Administration (NARA). For informa-
scribed conditions: tion on the availability of this mate-
(a) The chlorinated polyether resins rial at NARA, call 202–741–6030, or go
are produced by the catalytic polym- to: http://www.archives.gov/
erization of 3,3-bis(chloromethyl)- federallregister/
oxetane, and shall contain not more codeloflfederallregulations/
than 2 percent residual monomer. ibrllocations.html.
(b) In accordance with good manufac- (b) The basic resins identified in
turing practice, finished articles con- paragraphs (a)(1) and (a)(2) of this sec-
taining the chlorinated polyether res- tion may contain optional adjuvant
346
substances described in § 174.5(d) of this (b) Specifications. (1) Polyamide-imide

chapter and the following: resins identified in paragraph (a)(1) of
this section shall have a nitrogen con-
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
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
graph (a)(2) of this section. 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 reference in accordance with 5 U.S.C.
for 2 hours with the following four sol- 552(a). Copies may be obtained from the
vents, yields net chloroform-soluble ex- AOAC INTERNATIONAL, 481 North
tractives in each extracting solvent Frederick Ave., suite 500, Gaithersburg,
not to exceed 0.02 milligram per square MD 20877, or may be examined at the
inch of food-contact surface: distilled National Archives and Records Admin-
water, 50 percent (by volume) ethyl al- istration (NARA). For information on
cohol in distilled water, 3 percent ace- the availability of this material at
tic acid in distilled water, and n- NARA, call 202–741–6030, or go to: http://
heptane. (Note: In testing the finished www.archives.gov/federallregister/
food-contact article, use a separate codeloflfederallregulations/
test sample for each required extract- ibrllocations.html.
ing solvent.) (2) Polyamide-imide resins identified
(d) In accordance with good manufac- in paragraph (a)(1) of this section shall
turing practice, finished food-contact have a solution viscosity of not less
articles containing the than 1.200. Polyamide-imide resins
polyethersulfone resins shall be thor- identified in paragraph (a)(2) of this
oughly cleansed before their first use section shall have a solution viscosity
in contact with food. of not less than 1.190. Solution vis-
[44 FR 34493, June 15, 1979, as amended at 47 cosity shall be determined by a method
FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, titled ‘‘Solution Viscosity’’ which is in-
1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, corporated by reference in accordance
Sept. 20, 1995; 78 FR 14666, Mar. 7, 2013] with 5 U.S.C. 552(a). Copies are avail-
able from the Center for Food Safety
§ 177.2450 Polyamide-imide resins. and Applied Nutrition (HFS–200), Food
Polyamide-imide resins identified in and Drug Administration, 5100 Paint
paragraph (a) of this section may be Branch Pkwy., College Park, MD 20740,
safely used as components of articles or available for inspection at the Na-
intended for repeated use in contact tional Archives and Records Adminis-
with food, in accordance with the fol- tration (NARA). For information on
lowing prescribed conditions: the availability of this material at
(a) Identity. (1) For the purpose of NARA, call 202–741–6030, or go to: http://
this section the polyamide-imide resins www.archives.gov/federallregister/
are derived from the condensation re- codeloflfederallregulations/
action of substantially equimolar parts ibrllocations.html.
of trimellitic anhydride and p,p′- (3) The polyamide-imide resins iden-
diphenylmethane diisocyanate. tified in paragraph (a)(1) of this section
(2) The polyamide-imide resins (CAS are heat cured at 600 °F for 15 minutes
Reg. No. 31957–38–7) derived from the when prepared for extraction tests and
condensation reaction of equimolar the residual monomers: p,p-
parts of benzoyl chloride-3,4- diphenylmethane diisocyanate should

dicarboxylic anhydride and 4,4′- not be present at greater than 100 parts
diphenylmethanediamine. per million and trimellitic anhydride
347
§ 177.2460 21 CFR Ch. I (4–1–15 Edition)
should not be present at greater than cleansed prior to their first use in con-
500 parts per million. Residual mono- tact with food.
mers are determined by gas chroma- [42 FR 14572, Mar. 15, 1977, as amended at 47
tography (the gas chromatography FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19,
method titled ‘‘Amide-Imide Polymer 1984; 54 FR 24898, June 12, 1989; 54 FR 43170,
Analysis—Analysis of Monomer Con- Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996; 70 FR
tent,’’ is incorporated by reference in 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005]
accordance with 5 U.S.C. 552(a). Copies § 177.2460 Poly(2,6-dimethyl-1,4-phen-
are available from the Center for Food ylene) oxide resins.
Safety and Applied Nutrition (HFS–
The poly(2,6-dimethyl-1,4-phenylene)
200), Food and Drug Administration,
oxide resins identified in paragraph (a)
5100 Paint Branch Pkwy., College Park, of this section may be used as an arti-
MD 20740, or available for inspection at cle or as a component of an article in-
the National Archives and Records Ad- tended for use in contact with food sub-
ministration (NARA). For information ject to the provisions of this section.
on the availability of this material at (a) Identity. For the purposes of this
NARA, call 202–741–6030, or go to: http:// section, poly(2,6-dimethyl-1,4-phen-
www.archives.gov/federallregister/ ylene) oxide resins consist of basic res-
codeloflfederallregulations/ ins produced by the oxidative coupling
ibrllocations.html.). of 2,6-xylenol such that the finished
(c) Extractive limitations are appli- basic resins meet the specifications
cable to the polyamide-imide resins and extractives limitations prescribed
identified in paragraphs (a) (1) and (2) in paragraph (c) of this section.
of this section in the form of films of 1 (b) Optional adjuvant substances. The
mil uniform thickness after coating basic poly(2,6-dimethyl-1,4-phenylene)
and heat curing at 600 °F for 15 minutes oxide resins identified in paragraph (a)
on stainless steel plates, each having of this section may contain optional
such resin-coated surface area of 100 adjuvant substances required in the
square inches. The cured-resin film production of such basic resins. The op-
tional adjuvant substances required in
coatings shall be extracted in accord-
the production of the basic poly(2,6-di-
ance with the method described in
methyl-1,4-phenylene) oxide resins may
§ 176.170(d)(3) of this chapter, using a
include substances permitted for such
plurality of spaced, coated stainless use by regulations in parts 170 through
steel plates, exposed to the respective 189 of this chapter, substances gen-
food simulating solvents. The resin erally recognized as safe in food, sub-
shall meet the following extractive stances used in accordance with a prior
limitations under the corresponding sanction or approval, and the fol-
extraction conditions: lowing:
(1) Distilled water at 250 °F for 2
Limitations (expressed as
hours: Not to exceed 0.01 milligram per List of substances percent by weight of finished
square inch. basic resin)
(2) Three percent acetic acid at 212 °F Diethylamine .......................... Not to exceed 0.16 percent
for 2 hours: Not to exceed 0.05 milli- as residual catalyst.
gram per square inch. Methyl alcohol ........................ Not to exceed 0.02 percent
as residual solvent.
(3) Fifty percent ethyl alcohol at 160 Toluene .................................. Not to exceed 0.2 percent as
°F for 2 hours: Not to exceed 0.03 milli- residual solvent.
gram per square inch.
(4) n-Heptane at 150 °F for 2 hours: (c) Specifications and extractives limita-
Not to exceed 0.05 milligram per square tions. The poly(2,6-dimethyl-1,4-phen-
inch. ylene) oxide basic resins meet the fol-
lowing:
(d) In accordance with good manufac-
(1) Specifications. Intrinsic viscosity
turing practice, those food contact ar- is not less than 0.30 deciliter per gram
ticles, having as components the poly- as determined by ASTM method D1243–
amide-imide resins identified in para-
79, ‘‘Standard Test Method for Dilute

graph (a) of this section and intended Solution Viscosity of Vinyl Chloride
for repeated use shall be thoroughly 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 (4–1–15 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-
turing practice, finished articles con-
(c) Specifications. (1) Polyoxymeth-

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)
scribed conditions: Polyoxymethylene homopolymer can
(a) Identity. For the purpose of this be identified by its characteristic in-
section, polyoxymethylene homopoly- frared spectrum.
mer is polymerized formaldehyde (2) Minimum number average molec-
[Chemical Abstracts Service Registry ular weight of the homopolymer is
No. 9002–81–7]. Certain optional adju- 25,000.
vant substances, described in para- (3) Density of the homopolymer is be-
graph (b) of this section, may be added tween 1.39 and 1.44 as determined by
to impart desired technological prop- ASTM method D1505–68 (Reapproved
erties to the homopolymer. 1979), ‘‘Standard Test Method for Den-
(b) Optional adjuvant substances. The sity of Plastics by the Density-Gra-
polyoxymethylene homopolymer iden- dient Technique,’’ which is incor-
tified in paragraph (a) of this section porated by reference. Copies may be
may contain optional adjuvant sub- obtained from the American Society
stances in its production. The quantity for Testing Materials, 100 Barr Harbor
of any optional adjuvant substance em- Dr., West Conshohocken, Philadelphia,
ployed in the production of the PA 19428-2959, or may be examined at
homopolymer does not exceed the the National Archives and Records Ad-
amount reasonably required to accom- ministration (NARA). For information
plish the intended effect. Such adju- on the availability of this material at
vants may include substances gen- NARA, call 202–741–6030, or go to: http://
erally recognized as safe in food, sub- www.archives.gov/federallregister/
stances used in accordance with prior codeloflfederallregulations/
sanction, substances permitted under ibrllocations.html.
applicable regulations in this part, and (4) Melting point is between 172 °C
the following: and 184 °C as determined by ASTM
method D2133–66, ‘‘Specifications for
(1) Stabilizers. The homopolymer may
Acetal Resin Injection Molding and Ex-
contain one or more of the following
trusion Materials’’ (Revised 1966),
stabilizers. The total amount of stabi-
which is incorporated by reference.
lizers shall not exceed 1.9 percent of
Copies are available from American So-
homopolymer by weight, and the quan-
ciety for Testing and Materials
tity of individual stabilizer used shall
(ASTM), 100 Barr Harbor Dr., West
not exceed the limitations set forth
below:
2959, or available for inspection at the
Substances Limitations National Archives and Records Admin-
istration (NARA). For information on
Hexamethylenebis(3,5-di-tert- At a maximum level of 1 per- the availability of this material at
butyl-4-hydroxy-hydro- cent by weight of
cinnamate) (CAS Reg. No. homopolymer. The finished NARA, call 202–741–6030, or go to: http://
35074–77–2). articles shall not be used www.archives.gov/federallregister/
for foods containing more codeloflfederallregulations/
than 8 percent alcohol.
2,2′-Methylenebis(4-methyl-6- At a maximum level of 0.5

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

homopolymer shall be thoroughly (1) Substances generally recognized
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 (4–1–15 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
lowing prescribed conditions:
(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 Office of Food Additive Safety (HFS–
(2) Substances used in accordance 200), Center for Food Safety and Applied
with the provisions of a prior sanction Nutrition, Food and Drug Administration,
or approval. 5100 Paint Branch Pkwy., College Park,
(3) Substances that by regulation in MD 20740, 240–402–1200, or may be examined
parts 170 through 189 of this chapter at the Center for Food Safety and Applied
may be safely used in rubber articles, Nutrition’s Library, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the
subject to the provisions of such regu-
National Archives and Records Adminis-
lation. tration (NARA). For information on the
(4) Substances identified in this para- availability of this material at NARA, call
graph (c)(4), provided that any sub- 202–741–6030, or go to: http://
stance that is the subject of a regula- www.archives.gov/federallregister/
355
§ 177.2600 21 CFR Ch. I (4–1–15 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
Dibutyl xanthogen disulfide. (dibutylammonium oleate).
2,4-Dichlorobenzoyl peroxide. Stannous chloride.
Dicumyl peroxide. Tall oil fatty acids.
N,N-Dimethylcyclohexylamine salt of Tetrachloro-p-benzoquinone.
dibutyldithiocarbamic 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
2,6-di-tert-butylphenol (CAS Reg. No. 991–
pyrocatecholborate.
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 (4–1–15 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
4-(Diiodomethylsulfonyl) toluene, Chemical 175 milligrams per square inch during

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 (4–1–15 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
EDITORIAL NOTE: For FEDERAL REGISTER ci-
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 (4–1–15 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.
178.3725 Pigment dispersants. (b) Optional adjuvant substances. Hy-
178.3730 Piperonyl butoxide and pyrethrins drogen peroxide solution identified in
as components of bags. paragraph (a) of this section may con-
178.3740 Plasticizers in polymeric sub- tain substances generally recognized as
stances. safe in or on food, substances generally
178.3750 Polyethylene glycol (mean molec- recognized for their intended use in
ular weight 200–9,500). food packaging, substances used in ac-
178.3760 Polyethylene glycol (400) cordance with a prior sanction or ap-
monolaurate. proval, and substances permitted by
178.3770 Polyhydric alcohol esters of applicable regulations in parts 174
oxidatively refined (Gersthofen process) through 179 of this chapter.
montan wax acids. (c) Specifications. Hydrogen peroxide
178.3780 Polyhydric alcohol esters of long solution shall meet the specifications
chain monobasic acids. of the Food Chemicals Codex, 7th ed.
178.3790 Polymer modifiers in semirigid and (2010), pp. 496–497, which is incorporated
rigid vinyl chloride plastics.
by reference. Hydrogen peroxide solu-
178.3800 Preservatives for wood.
tion shall also meet the specifications
178.3850 Reinforced wax.
for ‘‘Acidity,’’ ‘‘Chloride,’’ and ‘‘Other
178.3860 Release agents.
requirements’’ for Hydrogen Peroxide
178.3870 Rosins and rosin derivatives.
Concentrate in the United States Phar-
178.3900 Sodium pentachlorophenate.
macopeia 36th Revision (2013), pp. 3848–
178.3910 Surface lubricants used in the man-
ufacture of metallic articles.
3849, which is incorporated by ref-
178.3930 Terpene resins. erence. The Director of the Office of
178.3940 Tetraethylene glycol di-(2-ethyl- the Federal Register approves this in-
hexoate). corporation by reference in accordance
178.3950 Tetrahydrofuran. with 5 U.S.C. 552(a) and 1 CFR part 51.
You may obtain copies from the United
AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. States Pharmacopeial Convention,
SOURCE: 42 FR 14609, Mar. 15, 1977, unless 12601 Twinbrook Pkwy., Rockville, MD
otherwise noted. 20852 (Internet address http://
www.usp.org). Copies may be examined
EDITORIAL NOTE: Nomenclature changes to
part 178 appear at 61 FR 14482, Apr. 2, 1996, 66
at the Food and Drug Administration’s
FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, Main Library, 10903 New Hampshire
2001, 68 FR 15355, Mar. 31, 2003, and 70 FR Ave., Bldg. 2, Third Floor, Silver
72074, Dec. 1, 2005. Spring, MD 20993, 301–796–2039, or at the
National Archives and Records Admin-
Subpart A [Reserved] the availability of this material at
NARA, call 202–741–6030 or go to: http://

www.archives.gov/federal-register/cfr/ibr-
locations.html.
363
§ 178.1010 21 CFR Ch. I (4–1–15 Edition)
(d) Limitations. No use of hydrogen 108, 110, 113, and 114 of this chapter as
peroxide solution in the sterilization of applicable.
food packaging material shall be con-
[46 FR 2342, Jan. 9, 1981, as amended at 49 FR
sidered to be in compliance if more 10111, Mar. 19, 1984; 49 FR 32345, Aug. 14, 1984;
than 0.5 part per million of hydrogen 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec.
peroxide can be determined in distilled 23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186,
water packaged under production con- Nov. 22, 1988; 54 FR 5604, Feb. 6, 1989; 54 FR
ditions (assay to be performed imme- 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 55
diately after packaging). FR 47055, Nov. 9, 1990; 57 FR 32423, July 22,
(e) Conditions of use. (1) Hydrogen per- 1992; 78 FR 71467, Nov. 29, 2013]
oxide solution identified in and com-
plying with the specifications in this § 178.1010 Sanitizing solutions.
section may be used by itself or in Sanitizing solutions may be safely
combination with other processes to used on food-processing equipment and
treat food-contact surfaces to attain utensils, and on other food-contact ar-
commercial sterility at least equiva- ticles as specified in this section, with-
lent to that attainable by thermal in the following prescribed conditions:
processing for metal containers as pro- (a) Such sanitizing solutions are
vided for in part 113 of this chapter. used, followed by adequate draining,
Food-contact surfaces include the fol- before contact with food.
lowing: (b) The solutions consist of one of the
Substances Limitations following, to which may be added com-
ponents generally recognized as safe
Ethylene-acrylic acid Complying with § 177.1310 of this and components which are permitted
copolymers. chapter.
Ethylene-carbon mon- Complying with § 177.1312 of this by prior sanction or approval.
oxide copolymers. chapter. (1) An aqueous solution containing
Ethylene-methyl acry- Complying with § 177.1340 of this potassium, sodium, or calcium hypo-
late copolymer resins. chapter.
Ethylene-vinyl acetate Complying with § 177.1350 of this chlorite, with or without the bromides
copolymers. chapter. of potassium, sodium, or calcium.
Ionomeric resins ........... Complying with § 177.1330 of this (2) An aqueous solution containing
chapter.
Isobutylene polymers ... Complying with § 177.1420 (a)(1) dichloroisocyanuric acid,
and (a)(2) of this chapter. trichloroisocyanuric acid, or the so-
Olefin polymers ............ Complying with § 177.1520 of this dium or potassium salts of these acids,
chapter.
Polycarbonate resins ... Complying with § 177.1580 of this
with or without the bromides of potas-
chapter. sium, sodium, or calcium.
Polyethylene- Complying with § 177.1630 of this (3) An aqueous solution containing
terephthalate poly- chapter (excluding polymers de-
mers. scribed in § 177.1630(c)) of this
potassium iodide, sodium p-
chapter. toluenesulfonchloroamide, and sodium
Poly-l-butene resins Complying with § 177.1570 of this lauryl sulfate.
and butene/ethylene chapter.
copolymers.
(4) An aqueous solution containing
Polystryrene and rub- Complying with § 177.1640 of this iodine, butoxy monoether of mixed
ber-modified poly- chapter. (ethylene-propylene) polyalkylene gly-
styrene polymers. col having a cloudpoint of 90°–100 °C in
Vinylidene chloride/ Complying with § 177.1990 of this
methyl acrylate co- chapter.
0.5 percent aqueous solution and an av-
polymers. erage molecular weight of 3,300, and
ethylene glycol monobutyl ether. Addi-
(2) The packaging materials identi- tionally, the aqueous solution may
fied in paragraph (e)(1) of this section contain diethylene glycol monoethyl
may be used for packaging all commer- ether as an optional ingredient.
cially sterile foods except that the (5) An aqueous solution containing
olefin polymers may be used in articles elemental iodine, hydriodic acid, a-(p-
for packaging foods only of the types nonylphenyl)-omega-hydroxypoly-(oxy-
identified in § 176.170(c) of this chapter, ethylene) (complying with the identity
table 1, under Categories I, II, III, IV-B, prescribed in § 178.3400(c) and having a
V, and VI. maximum average molecular weight of
(3) Processed foods packaged in the 748) and/or polyoxyethylene-

materials identified in paragraph (e)(1) polyoxypropylene block polymers (hav-
of this section shall conform with parts ing a minimum average molecular
364
weight of 1,900). Additionally, the aque- n-alkyl (C12-C18) dimethyl ethylbenzyl

ous solution may contain isopropyl al- ammonium chloride (having an average
cohol as an optional ingredient. molecular weight of 384). In addition to
(6) An aqueous solution containing use on food-processing equipment and
elemental iodine, sodium iodide, so- utensils, this solution may be used on
dium dioctylsulfosuccinate, and food-contact surfaces in public eating
polyoxyethylene-polyoxypropylene places.
block polymers (having a minimum av- (12) An aqueous solution containing
erage molecular weight of 1,900). the sodium salt of sulfonated oleic
(7) An aqueous solution containing acid, polyoxyethylene-
dodecylbenzenesulfonic acid and either polyoxypropylene block polymers (hav-
isopropyl alcohol or polyoxyethylene- ing an average molecular weight of
polyoxypropylene block polymers (hav- 2,000 and 27 to 31 moles of
ing a minimum average molecular polyoxypropylene). In addition to use
weight of 2,800). In addition to use on on food-processing equipment and
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 (15) An aqueous solution containing
groups with 12 to 16 carbon atoms and lithium hypochlorite.
contain not more than 1 percent each (16) An aqueous solution containing
of groups with 8 and 10 carbon atoms. equal amounts of n-alkyl (C12-C18) ben-
Additionally, the aqueous solution may zyl dimethyl ammonium chloride and
contain either ethyl alcohol or iso- n-alkyl (C12-C14) dimethyl ethylbenzyl
propyl alcohol as an optional ingre- ammonium chloride (having average
dient. molecular weights of 377 to 384), with
(10) An aqueous solution containing the optional adjuvant substances
trichloromelamine and either sodium tetrasodium ethylenediaminetetra-
lauryl sulfate or dodecyl- acetate and/or alpha-(p-nonylphenol)-
benzenesulfonic acid. In addition to use omega-hydroxy poly (oxyethylene) hav-
on food-processing equipment and ing an average poly- (oxyethylene) con-
utensils and other food-contact arti- tent of 11 moles. Alpha-hydro-omega-
cles, this solution may be used on bev- hydroxypoly-(oxyethylene)
erage containers except milk con- poly(oxypropoylene) (15 to 18 mole
tainers or equipment. minimum) poly (oxyethylene) block co-
(11) An aqueous solution containing polymer, having a minimum molecular

equal amounts of n-alkyl (C12-C18) ben- weight of 1,900 (CAS Registry No. 9003–
zyl dimethyl ammonium chloride and 11–6) may be used in lieu of alpha- (p-
365
§ 178.1010 21 CFR Ch. I (4–1–15 Edition)
nonylphenol)-omega-hydroxy- The ratio of compound (1) to compound

poly(oxyethylene) having an average (2) is 60 to 40.
poly(oxyethylene) content of 11 moles. (23) An aqueous solution containing
In addition to use on food-processing n-alkyl (C12-C16) benzyl-
equipment and utensils, this solution dimethylammonium chloride and
may be used on food-contact surfaces didecyldimethylammonium chloride.
in public eating places. (24) An aqueous solution containing
(17) An aqueous solution containing elemental iodine (CAS Reg. No. 7553–56–
di-n-alkyl(C8-C10)dimethyl ammonium 2), alpha-[p-(1,1,3,3-tetramethylbutyl)-
chlorides having average molecular phenyl]-omega-hydroxypoly-(oxy-
weights of 332–361 and either ethyl al- ethylene) produced with one mole of
cohol or isopropyl alcohol. In addition the phenol and 4 to 14 moles ethylene
to use on food-processing equipment oxide, and alpha-alkyl(C12-C15)-omega-
and utensils, this solution may be used hydroxy[poly(oxyethylene)
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
(19) An aqueous solution containing equipment and on food-contact sur-
sodium dichloroisocyanurate and faces in public eating places.
tetrasodium ethylenediaminetetra- (26) [Reserved]
acetate. In addition to use on food- (27) An aqueous solution containing
processing equipment and utensils, this decanoic acid (CAS Reg. No. 334–48–5),
solution may be used on food-contact octanoic acid (CAS Reg. No. 124–07–2),
surfaces in public eating places. and sodium 1-octanesulfonate (CAS
(20) An aqueous solution containing Reg. No. 5324–84–5). Additionally, the
ortho-phenylphenol, ortho-benzyl-para- aqueous solution may contain iso-
chlorophenol, para- propyl alcohol (CAS Reg. No. 67–63–0)
tertiaryamylphenol, sodium -alpha- as an optional ingredient.
alkyl(C12-C15)-omega-hydroxypoly (oxy- (28) An aqueous solution containing
ethylene) sulfate with the sulfonated 9-octadecenoic acid (CAS
poly(oxyethylene) content averaging Reg. No. 68988–76–1) and sodium
one mole, potassium salts of coconut xylenesulfonate (CAS Reg. No. 1300–72–
oil fatty acids, and isopropyl alcohol or 7).
hexylene glycol. (29) An aqueous solution containing
(21) An aqueous solution containing dodecyldiphenyloxidedisulfonic acid
sodium dodecylbenzenesulfonate. In ad- (CAS Reg. No. 30260–73–2), sulfonated
dition to use on food-processing equip- tall oil fatty acid (CAS Reg. No. 68309–
ment and utensils, this solution may 27–3), and neo-decanoic acid (CAS Reg.
be used on glass bottles and other glass No. 26896–20–8). In addition to use on
containers intended for holding milk. food-processing equipment and uten-
(22) An aqueous solution containing sils, this solution may be used on glass
(1) di-n-alkyl(C8-C10) bottles and other glass containers in-
dimethylammonium chloride com- tended for holding milk.
pounds having average molecular (30) An aqueous solution containing
weights of 332–361, (2) n-alkyl (C12-C18) hydrogen peroxide (CAS Reg. No. 7722–
benzyldimethylammonium chloride 84–1), peracetic acid (CAS Reg. No. 79–
compounds having average molecular 21–0), acetic acid (CAS Reg. No. 64–19–
weights of 351–380 and consisting prin- 7), and 1-hydroxyethylidene-1,1-
cipally of alkyl groups with 12 to 16 diphosphonic acid (CAS Reg. No. 2809–
carbon atoms with or without not over 21–4).

1 percent each of groups with 8 and 10 (31) An aqueous solution containing
carbon atoms, and (3) ethyl alcohol. elemental iodine, alpha-alkyl(C10-C14)-
366
omega-hydroxypoly(oxyethylene)poly- of oxychloro species (predominantly

(oxypropylene) of average molecular chlorite and chlorate) followed by dilu-
weight between 768 and 837, and alpha- tion with potable water to provide the
alkyl(C12-C18)-omega- concentration of available chlorine di-
hydroxypoly(oxyethylene) oxide described in paragraph (c)(29) of
poly(oxypropylene) of average molec- this section.
ular weight between 950 and 1,120. In (35) An aqueous solution containing
addition to use on food-processing decanoic acid (CAS Reg. No. 334–48–5),
equipment and utensils, this solution octanoic acid (CAS Reg. No. 124–07–2),
may be used on food-contact surfaces lactic acid (CAS Reg. No. 050–21–5),
in public eating places. phosphoric acid (CAS Reg. No. 7664–38–
(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
367
§ 178.1010 21 CFR Ch. I (4–1–15 Edition)
(CAS Reg. No. 7758–02–3) may be added dextrin, or both starch and dextrin
as optional ingredients to this sani- (CAS Reg. No. 9004–53–9); and the op-
tizing solution. In addition to use on tional ingredient methylene blue (CAS
food-processing equipment and uten- Reg. No. 61–73–4). In addition to use on
sils, this solution may be used on food- food-processing equipment and uten-
contact surfaces in public eating sils, this solution may be used on food-
places. contact surfaces in public eating
(38) An aqueous solution containing places.
hydrogen peroxide (CAS Reg. No. 7722– (42) An aqueous solution containing
84–1); peroxyacetic acid (CAS Reg. No. decanoic acid (CAS Reg. No. 334–48–5),
79–21–0); acetic acid (CAS Reg. No. 64– nonanoic acid (CAS Reg. No. 112–05–0),
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
combining elemental iodine (CAS Reg. acid, disodium ethylenediaminetetra-
No. 7553–56–2); hydriodic acid (CAS Reg. acetate, sodium lauryl sulfate, and
No. 10034–85–2); sodium N-cyclohexyl-N- monosodium phosphate. In addition to
palmitoyl taurate (CAS Reg. No. 132– use on food-processing equipment and
43–4); chloroacetic acid, sodium salt re- utensils, this solution may be used on
action products with 4,5-dihydro-2- dairy-processing equipment.
undecyl-1H-imidazole-1-ethanol and so- (45) An aqueous solution of hydrogen
dium hydroxide (CAS Reg. No. 68608–66– peroxide, acetic acid, peroxyacetic
2); dodecylbenzene sulfonic acid (CAS acid, octanoic acid, peroxyoctanoic
Reg. No. 27176–87–0); phosphoric acid acid, sodium 1-octanesulfonate, and 1-
(CAS Reg. No. 7664–38–2); isopropyl al- hydroxyethylidene-1,1-diphosphonic
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.
368
(c) The solutions identified in para- parts per million of active quaternary
graph (b) of this section will not exceed compound.
the following concentrations: (9) The solution identified in para-
(1) Solutions identified in paragraph graph (b)(12) of this section shall pro-
(b)(1) of this section will provide not vide not more than 200 parts per mil-
more than 200 parts per million of lion of sulfonated oleic acid, sodium
available halogen determined as avail- salt.
able chlorine. (10) Solutions identified in paragraph
(2) Solutions identified in paragraph (b)(15) of this section will provide not
(b)(2) of this section will provide not more than 200 parts per million of
more than 100 parts per million of available chlorine and not more than 30
available halogen determined as avail- ppm lithium.
able chlorine. (11) Solutions identified in paragraph
(3) Solution identified in paragraph (b)(16) of this section shall provide not
(b)(3) of this section will provide not more than 200 parts per million of ac-
more than 25 parts per million of ti- tive quaternary compound.
tratable iodine. The solutions will con- (12) Solutions identified in paragraph
tain the components potassium iodide, (b)(17) of this section shall provide,
sodium p-toluenesulfonchloramide and when ready to use, a level of 150 parts
sodium lauryl sulfate at a level not in per million of the active quaternary
excess of the minimum required to compound.
produce their intended functional ef- (13) Solutions identified in paragraph
fect. (b)(18) of this section shall provide not
(4) Solutions identified in paragraph more than 200 parts per million of ac-
(b)(4), (5), (6), (8), (13), and (14) of this tive quaternary compound and not
section will contain iodine to provide more than 66 parts per million of
not more than 25 parts per million of alpha[p-(1,1,3,3-tetramethylbutyl)
titratable iodine. The adjuvants used phenyl]-omega-hydroxypoly (oxy-
with the iodine will not be in excess of ethylene).
the minimum amounts required to ac- (14) Solutions identified in paragraph
complish the intended technical effect. (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 (15) Solutions identified in paragraph
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.
369
§ 178.1010 21 CFR Ch. I (4–1–15 Edition)
(19) Solutions identified in para- (27) Solutions identified in paragraph

graphs (b)(24), (b)(25), and (b)(43) of this (b)(32) of this section shall provide,
section shall provide at least 12.5 parts when ready to use, at least 150 parts
per million and not more than 25 parts per million and no more than 400 parts
per million of titratable iodine. The ad- per million of active quarternary com-
juvants used with the iodine shall not pounds in solutions containing no more
be in excess of the minimum amounts than 600 parts per million water hard-
required to accomplish the intended ness. The adjuvants used with the
technical effect. quarternary compounds will not exceed
(20)–(21) [Reserved] the amounts required to accomplish
(22) Solutions identified in paragraph the intended technical effect.
(b)(27) of this section shall provide, (28) Solutions identified in paragraph
when ready to use, at least 109 parts (b)(33) of this section shall provide,
per million and not more than 218 parts when ready to use, at least 150 parts
per million of total active fatty acids per million and not more than 400 parts
and at least 156 parts per million and per million of active quaternary com-
not more than 312 parts per million of pounds. The adjuvants used with the
the sodium 1-octanesulfonate. quaternary compounds shall not exceed
(23) Solutions identified in paragraph the amounts required to accomplish
(b)(28) of this section shall provide, the intended technical effect.
when ready to use, at least 156 parts Tetrasodium ethylenediamine
per million and not more than 312 parts tetraacetate shall be added at a min-
per million of sulfonated 9- imum level of 60 parts per million. Use
octadecenoic acid, at least 31 parts per of these sanitizing solutions shall be
million and not more then 62 parts per limited to conditions of water hardness
million of sodium xylenesulfonate. not in excess of 300 parts per million.
(24) Solutions identified in paragraph (29) Solutions identified in paragraph
(b)(29) of this section will provide at (b)(34) of this section should provide,
least 237 parts per million and not when ready to use, at least 100 parts
more than 474 parts per million per million and not more than 200 parts
dodecyldiphenyloxidedisulfonic acid, at per million available chlorine dioxide
least 33 parts per million and not more as determined by the method titled
than 66 parts per million sulfonated ‘‘Iodometric Method for the Deter-
tall oil fatty acid, and at least 87 parts mination of Available Chlorine Dioxide
per million and not more than 174 parts (50–250 ppm available ClO2),’’ which is
per million neo-decanoic acid. incorporated by reference. Copies are
(25) Solutions identified in paragraph 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 550 200), Food and Drug Administration,
parts per million and not more than 5100 Paint Branch Pkwy., College Park,
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
370
and its alkylated derivatives, will not per million of sodium lauryl sulfate;
be in excess of the minimum amounts and at least 0.1 part per million and
required to accomplish the intended not more than 0.3 part per million of
technical effects. potassium permanganate.
(31) Solutions identified in paragraph (iii) Magnesium oxide when used in
(b)(36) of this section shall provide, paragraph (c)(32) (i) or (ii) of this sec-
when ready for use, at least 29 parts per tion shall not be used in excess of the
million and not more than 58 parts per minimum amount required to accom-
million decanoic acid; at least 88 parts plish its intended technical effect.
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
371
§ 178.1010 21 CFR Ch. I (4–1–15 Edition)
parts per million and not more than 200 contact surfaces in public eating places
parts per million of n-alkyl(C12- and dairy and beverage containers,
C16)benzyldimethylammonium chlo- shall provide when ready for use at
ride; and not more than 0.4 part per least 72 parts per million and not more
million of the colorant methylene blue. than 216 parts per million of hydrogen
Components shall be present in the peroxide; at least 46 parts per million
product used to prepare the solution in and not more than 138 parts per million
the following proportions: 1 part n- of peroxyacetic acid; at least 40 parts
alkyl(C12- per million and not more than 122 parts
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
372
acid; and at least 18 parts per million didodecylphenoxybenzenedisulfonate.

and not more than 55 parts per million Other components listed under para-
of sodium 1-octanesulfonate. graph (b)(46) of this section shall be
(40) The solution identified in para- used in the minimum amount nec-
graph (b)(46) of this section shall pro- essary to produce the intended effect.
vide, when ready for use, at least 100 (d) Sanitizing agents for use in ac-
parts per million and not more than 200 cordance with this section will bear la-
parts per million of chlorine dioxide as beling meeting the requirements of the
determined by the method developed Federal Insecticide, Fungicide, and
by Bio-cide International, Inc., enti- Rodenticide Act.
tled, ‘‘Iodometric Method for the De-
termination of Available Chlorine Di- [42 FR 14609, Mar. 16, 1977]
oxide (50–250 ppm Available ClO2),’’ EDITORIAL NOTE: For FEDERAL REGISTER ci-
dated June 11, 1987, which is incor- tations affecting § 178.1010, see the List of
porated by reference in accordance CFR Sections Affected, which appears in the
with 5 U.S.C. 552(a) and 1 CFR part 51. Finding Aids section of the printed volume
Copies of this method are available and at www.fdsys.gov.
from the Office of Food Additive Safety
(HFS–200), Center for Food Safety and Subpart C—Antioxidants and
Applied Nutrition, Food and Drug Ad- Stabilizers
ministration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, 240–402–1200, § 178.2010 Antioxidants and/or stabi-
and may be examined at the Center for lizers for polymers.
Food Safety and Applied Nutrition’s
Library, Food and Drug Administra- The substances listed in paragraph
tion, 5100 Paint Branch Pkwy., College (b) of this section may be safely used as
Park, MD 20740, or at the National Ar- antioxidants and/or stabilizers in poly-
chives and Records Administration mers used in the manufacture of arti-
(NARA). For information on the avail- cles or components of articles intended
ability of this material at NARA, call for use in producing, manufacturing,
202–741–6030, or go to: http:// packing, processing, preparing, treat-
www.archives.gov/federallregister/ ing, packaging, transporting, or hold-
codeloflfederallregulations/ ing food, subject to the provisions of
ibrllocations.html; at least 380 parts per this section:
million and not more than 760 parts per (a) The quantity used shall not ex-
million of sodium gluconate; and at ceed the amount reasonably required
least 960 parts per million and not to accomplish the intended technical
more than 1,920 parts per million of so- effect.
dium mono- and (b) List of substances:
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)..
373
§ 178.2010 21 CFR Ch. I (4–1–15 Edition)
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.
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 (4–1–15 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
377
§ 178.2010 21 CFR Ch. I (4–1–15 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 (4–1–15 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 (4–1–15 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 (4–1–15 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 (4–1–15 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
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 (4–1–15 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 (4–1–15 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 (4–1–15 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 (4–1–15 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 (4–1–15 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-
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 (4–1–15 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 (4–1–15 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
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 (4–1–15 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 (4–1–15 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 (4–1–15 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 (4–1–15 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 Food and Drug Ad-
fluorescent whiteners, which may not ministration, Center for Food Safety
and Applied Nutrition, 5100 Paint
themselves be colored, but whose use is

intended to affect the color of a food- Branch Pkwy., College Park, MD 20740,
contact material. 240–402–1200
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 (4–1–15 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
Food Additive Safety (HFS–200), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 240–402–1200, or
may be examined at the Center for Food Safety and Applied
Nutrition’s Library, 5100 Paint Branch Pkwy., College Park,
MD 20740, or at the National Archives and Records Admin-
istration (NARA). For information on the availability of this
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 (4–1–15 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 (4–1–15 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 (4–1–15 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
tations affecting § 178.3400, see the List of accordance with the following pre-
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-
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 (4–1–15 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-
lowing specifications:
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 (4–1–15 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-
tations affecting § 178.3570, see the List of
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 (4–1–15 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 α-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 (4–1–15 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 (4–1–15 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 (4–1–15 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 (4–1–15 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 re- (4) Ultraviolet absorbance limits de-
spective 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 (4–1–15 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 (4–1–15 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 (4–1–15 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 (4–1–15 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
GENERAL INSTRUCTIONS
the availability of this material at
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: www.archives.gov/federallregister/

Absorbance repeatability, ±0.01 at 0.4 ab- codeloflfederallregulations/
sorbance. ibrllocations.html.
439
§ 178.3770 21 CFR Ch. I (4–1–15 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 (4–1–15 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
prescribed in paragraph (a) of this section, alcohol in a 2:1 ratio instead of ethyl
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 (4–1–15 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 (4–1–15 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 (4–1–15 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
Barr Harbor Dr., West Conshohocken,
(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/
given in paragraph (f)(1) of this section.
449
§ 178.3900 21 CFR Ch. I (4–1–15 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 (4–1–15 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-
GENERAL INSTRUCTIONS
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 (4–1–15 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 (4–1–15 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
resins complying with § 177.1500 of this
Subpart A [Reserved]
chapter.
Subpart B—Radiation and
§ 178.3950 Tetrahydrofuran. Radiation Sources
Tetrahydrofuran may be safely used
in the fabrication of articles intended § 179.21 Sources of radiation used for
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.
(a) It is used as a solvent in the cast- Sources of radiation for the purposes
ing of film from a solution of poly- of inspection of foods, for inspection of
meric resins of vinyl chloride, vinyl ac- packaged food, and for controlling food
etate, or vinylidene chloride that have processing may be safely used under
been polymerized singly or copolym- the following conditions:
erized with one another in any com- (a) The radiation source is one of the
bination, or it may be used as a solvent following:
in the casting of film prepared from (1) X-ray tubes producing X-radiation
vinyl chloride copolymers complying from operation of the tube source at a
with § 177.1980 of this chapter. voltage of 500 kilovolt peak or lower.
(b) The residual amount of tetra- (2) Sealed units producing radiations
hydrofuran in the film does not exceed at energy levels of not more than 2.2
1.5 percent by weight of film. million electron volts from one of the
following isotopes: Americium-241, ce-
PART 179—IRRADIATION IN THE sium-137, cobalt-60, iodine-125, krypton-
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.
Subpart B—Radiation and Radiation (4) Machine sources producing X-radi-
Sources ation at energies no greater than 10
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.
179.25 General provisions for food irradia- MeV.
tion. (b) To assure safe use of these radi-
179.26 Ionizing radiation for the treatment ation sources:
of food. (1) The label of the sources shall
179.30 Radiofrequency radiation for the bear, in addition to the other informa-
heating of food, including microwave fre- tion required by the Act:
quencies. (i) Appropriate and accurate informa-
179.39 Ultraviolet radiation for the proc-
essing and treatment of food. tion identifying the source of radi-
179.41 Pulsed light for the treatment of ation.

food. (ii) The maximum energy of radi-
179.43 Carbon dioxide laser for etching 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 (4–1–15 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-
istration space flight programs. rials used need
target material and using energies not 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). products that are meat within the products; not to
meaning of 9 CFR 301.2(rr), meat exceed 7.0 kGy
2. For growth and maturation inhibition Not to exceed 1
byproducts within the meaning of 9 maximum for fro-
of fresh foods. kGy (100 krad).
CFR 301.2(tt), or meat food products zen products.
3. For disinfestation of arthropod pests Do. within the meaning of 9 CFR
in food. 301.2(uu), with or without nonfluid
4. For microbial disinfection of dry or Not to exceed 10 seasoning, that are otherwise com-
dehydrated enzyme preparations (in- kGy (1 megarad posed solely of intact or ground
cluding immobilized enzymes). (Mrad)). meat, meat byproducts, or both meat
5. For microbial disinfection of the fol- Not to exceed 30 and meat byproducts.
lowing dry or dehydrated aromatic kGy (3 Mrad). 9. For control of Salmonella in fresh Not to exceed 3.0
vegetable substances when used as shell eggs.. kGy.
ingredients in small amounts solely 10. For control of microbial pathogens Not to exceed 8.0
for flavoring or aroma: culinary herbs, on seeds for sprouting.. kGy.
seeds, spices, vegetable seasonings 11. For the control of Vibrio bacteria Not to exceed 5.5
that are used to impart flavor but that and other foodborne microorganisms kGy.
are not either represented as, or ap- in or on fresh or frozen molluscan
pear to be, a vegetable that is eaten shellfish..
for its own sake, and blends of these 12. For control of food-borne pathogens Not to exceed 4.0
aromatic vegetable substances. Tur- and extension of shelf-life in fresh kGy.
meric and paprika may also be irradi- iceberg lettuce and fresh spinach..
ated when they are to be used as 13. For control of foodborne pathogens, Not to exceed 4.5
color additives. The blends may con- and extension of shelf-life, in kGy.
tain sodium chloride and minor unrefrigerated (as well as refrig-
amounts of dry food ingredients ordi- erated) uncooked meat, meat byprod-
narily used in such blends. ucts, and certain meat food products.
6. For control of food-borne pathogens Not to exceed 4.5 14. For control of food-borne pathogens Not to exceed 6.0
in fresh (refrigerated or kGy for non-fro- in, and extension of the shelf-life of, kGy.
unrefrigerated) or frozen, uncooked zen products; not chilled or frozen raw, cooked, or par-
poultry products that are: (1) Whole to exceed 7.0 tially cooked crustaceans or dried
carcasses or disjointed portions (or kGy for frozen crustaceans (water activity less than
other parts) of such carcasses that products. 0.85), with or without spices, min-
are ‘‘ready-to-cook poultry’’ within the erals, inorganic salts, citrates, citric
meaning of 9 CFR 381.l(b) (with or acid, and/or calcium disodium EDTA.
without nonfluid seasoning; includes,
e.g., ground poultry), or (2) mechani-
cally separated poultry product (a
(c) Labeling. (1) The label and label-
finely comminuted ingredient pro- ing of retail packages of foods irradi-
duced by the mechanical deboning of ated in conformance with paragraph (b)
poultry carcasses or parts of car- of this section shall bear the following
casses).
logo along with either the statement
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
placed prominently and conspicuously [51 FR 13399, Apr. 18, 1986, as amended at 53
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; 77 FR 71316, 71321, Nov. 30,
means the written statement that dis- 2012; 79 FR 20779, Apr. 14, 2014]
closes that a food has been inten-
tionally subject to irradiation. § 179.30 Radiofrequency radiation for
(2) For irradiated foods not in pack- the heating of food, including
age form, the required logo and phrase microwave frequencies.
‘‘Treated with radiation’’ or ‘‘Treated Radiofrequency radiation, including
by irradiation’’ shall be displayed to microwave frequencies, may be safely
the purchaser with either (i) the label-
used for heating food under the fol-
ing of the bulk container plainly in
lowing conditions:
view or (ii) a counter sign, card, or
other appropriate device bearing the (a) The radiation source consists of
information that the product has been electronic equipment producing radio
treated with radiation. As an alter- waves with specific frequencies for this
native, each item of food may be indi- purpose authorized by the Federal
vidually labeled. In either case, the in- Communications Commission.
formation must be prominently and (b) The radiation is used or intended
conspicuously displayed to purchasers. for use in the production of heat in
The labeling requirement applies only food wherever heat is necessary and ef-
to a food that has been irradiated, not fective in the treatment or processing
to a food that merely contains an irra- of food.
diated ingredient but that has not
itself been irradiated. § 179.39 Ultraviolet radiation for the
(3) For a food, any portion of which is processing and treatment of food.
irradiated in conformance with para-
Ultraviolet radiation for the proc-
graph (b) of this section, the label and
essing and treatment of food may be
labeling and invoices or bills of lading
shall bear either the statement safely used under the following condi-
tions:
‘‘Treated with radiation—do not irra-

diate again’’ or the statement ‘‘Treated (a) The radiation sources consist of
by irradiation—do not irradiate again’’ low pressure mercury lamps emitting
459
ER01FE93.000</GPH>
§ 179.41 21 CFR Ch. I (4–1–15 Edition)
90 percent of the emission at a wave- (b) The ultraviolet radiation is used

length of 253.7 nanometers (2,537 or intended for use as follows:
Angstroms).
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 ing, and the etched area is imme-
of food. diately rewaxed after treatment; and
Pulsed light may be safely used for (c) The maximum total energy to
treatment of foods under the following which the etched citrus fruit is exposed
conditions: from the use of the carbon dioxide laser
(a) The radiation sources consist of shall not exceed 1.5 × 10¥3 J, and the
xenon flashlamps designed to emit maximum total etched surface area of
broadband radiation consisting of the citrus fruit shall not exceed 0.122
wavelengths covering the range of 200 cm2.
to 1,100 nanometers (nm), and operated [77 FR 34215, June 11, 2012]
so that the pulse duration is no longer
than 2 milliseconds (msec);
(b) The treatment is used for surface Subpart C—Packaging Materials
microorganism control; for Irradiated Foods
(c) Foods treated with pulsed light
shall receive the minimum treatment § 179.45 Packaging materials for use
reasonably required to accomplish the during the irradiation of pre-
packaged foods.
intended technical effect; and
(d) The total cumulative treatment The packaging materials identified
shall not exceed 12.0 Joules/square cen- in this section may be safely subjected
timeter (J/cm2.) to irradiation incidental to the radi-
ation treatment and processing of pre-
[61 FR 42383, Aug. 15, 1996]
packaged foods, subject to the provi-
§ 179.43 Carbon dioxide laser for etch- sions of this section and to the require-
ing food. ment that no induced radioactivity is
Carbon dioxide laser light may be detectable in the packaging material
safely used for etching information on itself:
the surface of food under the following (a) The radiation of the food itself
conditions: shall comply with regulations in this
(a) The radiation source consists of a part.
carbon dioxide laser designed to emit (b) The following packaging mate-
pulsed infrared radiation with a wave- rials may be subjected to a dose of ra-
length of 10.6 micrometers such that diation, not to exceed 10 kilograys, un-
the maximum energy output of the less otherwise indicated, incidental to
laser does not exceed 9.8 × 10¥3 joules the use of gamma, electron beam, or X-
per square centimeter (J/cm2); radiation in the radiation treatment of
(b) The carbon dioxide laser shall be prepackaged foods:
used only for etching information on (1) Nitrocellulose-coated or vinyli-
the skin of fresh, intact citrus fruit, dene chloride copolymer-coated cello-
providing the fruit has been adequately phane complying with § 177.1200 of this
washed and waxed prior to laser etch- chapter.
460
(2) Glassine paper complying with percent when extracted with n-hexane
§ 176.170 of this chapter. at reflux temperature for 2 hours. The
(3) Wax-coated paperboard complying finished film may contain adjuvant
with § 176.170 of this chapter. substances used in compliance with
(4) Polyolefin film prepared from one §§ 178.3740 and 181.22 through 181.30 of
or more of the basic olefin polymers this chapter.
complying with § 177.1520 of this chap- (9) Vinylidene chloride-vinyl chloride
ter. The finished film may contain: copolymer film prepared from vinyli-
(i) Adjuvant substances used in com- dene chloride-vinyl chloride basic co-
pliance with §§ 178.3740 and 181.22 polymers containing not less than 70
through 181.30 of this chapter, sodium weight percent of vinylidene chloride
citrate, sodium lauryl sulfate, poly- and having a viscosity of 0.50–1.50 cen-
vinyl chloride, and materials as listed tipoises as determined by ASTM meth-
in paragraph (d)(2)(i) of this section. od D729–81, ‘‘Standard Specification for
(ii) Coatings comprising a vinylidene Vinylidene Chloride Molding Com-
chloride copolymer containing a min- pounds,’’ which is incorporated by ref-
imum of 85 percent vinylidene chloride erence. Copies may be obtained from
with one or more of the following co- the American Society for Testing Ma-
monomers: Acrylic acid, acrylonitrile, terials, 100 Barr Harbor Dr., West
itaconic acid, methyl acrylate, and Conshohocken, Philadelphia, PA 19428-
methyl methacrylate. 2959, or may be examined at the Na-
(5) Kraft paper prepared from un- tional Archives and Records Adminis-
bleached sulfate pulp to which rosin, tration (NARA). For information on
complying with § 178.3870 of this chap- the availability of this material at
ter, and alum may be added. The kraft NARA, call 202–741–6030, or go to: http://
paper is used only as a container for www.archives.gov/federallregister/
flour and is irradiated with a dose not codeloflfederallregulations/
exceeding 500 grays. ibrllocations.html. The finished film
(6) Polyethylene terephthalate film may contain adjuvant substances used
prepared from the basic polymer as de- in compliance with §§ 178.3740 and 181.22
scribed in § 177.1630(e)(4)(i) and (ii) of through 181.30 of this chapter.
this chapter. The finished film may (10) Nylon 11 conforming to § 177.1500
contain: of this chapter.
(i) Adjuvant substances used in com- (c) Ethylene-vinyl acetate copoly-
pliance with §§ 178.3740 and 181.22 mers complying with § 177.1350 of this
through 181.30 of this chapter, sodium chapter. The ethylene-vinyl acetate
citrate, sodium lauryl sulfate, poly- packaging materials may be subjected
vinyl chloride, and materials as listed to a dose of radiation, not to exceed 30
in paragraph (d)(2)(i) of this section. kilogray (3 megarads), incidental to
(ii) Coatings comprising a vinylidene the use of gamma, electron beam, or X-
chloride copolymer containing a min- radiation in the radiation treatment of
imum of 85 percent vinylidene chloride packaged foods.
with one or more of the following co- (d) The following packaging mate-
monomers: Acrylic acid, acrylonitrile, rials may be subjected to a dose of ra-
itaconic acid, methyl acrylate, and diation, not to exceed 60 kilograys inci-
methyl methacrylate. dental to the use of gamma, electron
(iii) Coatings consisting of poly- beam, or X-radiation in the radiation
ethylene conforming to § 177.1520 of this processing of prepackaged foods:
chapter. (1) Vegetable parchments, consisting
(7) Polystyrene film prepared from of a cellulose material made from
styrene basic polymer. The finished waterleaf paper (unsized) treated with
film may contain adjuvant substances concentrated sulfuric acid, neutralized,
used in compliance with §§ 178.3740 and and thoroughly washed with distilled
181.22 through 181.30 of this chapter. water.
(8) Rubber hydrochloride film pre- (2) Films prepared from basic poly-
pared from rubber hydrochloride basic mers and with or without adjuvants, as
polymer having a chlorine content of follows:

30–32 weight percent and having a max- (i) Polyethylene film prepared from
imum extractable fraction of 2 weight the basic polymer as described in
461
Pt. 180 21 CFR Ch. I (4–1–15 Edition)
§ 177.1520(a) of this chapter. The fin-

ished film may contain one or more of
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.
(ii) Polyethylene terephthalate film PART 180—FOOD ADDITIVES PER-

prepared from the basic polymer as de- MITTED IN FOOD OR IN CON-
scribed in § 177.1630(e)(4)(ii) of this
chapter. The finished film may contain
TACT WITH FOOD ON AN IN-
one or more of the added substances TERIM BASIS PENDING ADDI-
listed in paragraph (d)(2)(i) of this sec- TIONAL STUDY
tion.
(iii) Nylon 6 films prepared from the Subpart A—General Provisions
nylon 6 basic polymer as described in
Sec.
§ 177.1500(a)(6) of this chapter and meet-
180.1 General.
ing the specifications of item 6.1 of the
table in § 177.1500(b) of this chapter. Subpart B—Specific Requirements for
The finished film may contain one or Certain Food Additives
more of the added substances listed in
paragraph (d)(2)(i) of this section. 180.22 Acrylonitrile copolymers.
(iv) Vinyl chloride-vinyl acetate co- 180.25 Mannitol.
polymer film prepared from the basic 180.30 Brominated vegetable oil.
copolymer containing 88.5 to 90.0 180.37 Saccharin, ammonium saccharin, cal-
weight percent of vinyl chloride with cium saccharin, and sodium saccharin.
10.0 to 11.5 weight percent of vinyl ace- AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371;
tate and having a maximum volatility 42 U.S.C. 241.
of not over 3.0 percent (1 hour at 105 °C)
and viscosity not less than 0.30 deter- EDITORIAL NOTE: Nomenclature changes to
part 180 appear at 61 FR 14482, Apr. 2, 1996,
mined by ASTM method D1243–79, and 66 FR 56035, Nov. 6, 2001.
‘‘Standard Test Method for Dilute So-
lution Viscosity of Vinyl Chloride
Polymers,’’ Method A, which is incor- Subpart A—General Provisions
porated by reference. The availability
§ 180.1 General.
given in paragraph (b)(9) of this sec- (a) Substances having a history of
tion. The finished film may contain use in food for human consumption or
one or more of the added substances in food contact surfaces may at any
listed in paragraph (d)(2)(i) of this sec- time have their safety or functionality
tion. brought into question by new informa-
(e) Acrylonitrile copolymers identi- tion that in itself is not conclusive. An
fied in this section shall comply with interim food additive regulation for
the provisions of § 180.22 of this chap- the use of any such substance may be
ter. promulgated in this subpart when new
information raises a substantial ques-
FR 10113, Mar. 19, 1984; 54 FR 7405, Feb. 21, tion about the safety or functionality
1989; 54 FR 24899, June 12, 1989; 59 FR 14551, of the substance but there is a reason-
Mar. 29, 1994; 61 FR 14246, Apr. 1, 1996; 66 FR able certainty that the substance is
10575, Feb. 16, 2001] not harmful and that no harm to the
462
public health will result from the con- Commissioner shall include, with re-
tinued use of the substance for a lim- spect to each study, either a statement
ited period of time while the question that the study has been or will be con-
raised is being resolved by further ducted in compliance with the good
study. laboratory practice regulations as set
(b) No interim food additive regula- forth in part 58 of this chapter, or, if
tion may be promulgated if the new in- any such study was not conducted in
formation is conclusive with respect to compliance with such regulations, a
the question raised or if there is a rea- brief statement of the reason for the
sonable likelihood that the substance noncompliance.
is harmful or that continued use of the (5) [Reserved]
substance will result in harm to the (6) If clinical investigations involving
public health. human subjects are involved, such in-
(c) The Commissioner, on his own ini- vestigations filed with the Commis-
tiative or on the petition of any inter- sioner shall include, with respect to
ested person, pursuant to part 10 of this each investigation, a statement that
chapter, may propose an interim food the investigation either was conducted
additive regulation. A final order pro- in compliance with the requirements
mulgating an interim food additive for institutional review set forth in
regulation shall provide that continued part 56 of this chapter, or was not sub-
use of the substance in food is subject ject to such requirements in accord-
to each of the following conditions: ance with §§ 56.104 or 56.105, and that it
(1) Use of the substance in food or has been or will be conducted in com-
food contact surfaces must comply pliance with the requirements for in-
with whatever limitations the Commis- formed consent set forth in part 50 of
sioner deems to be appropriate under this chapter.
the circumstances. (d) Promptly upon completion of the
(2) Within 60 days following the effec- studies undertaken on the substance,
tive date of the regulation, an inter- the Commissioner will review all avail-
ested person shall satisfy the Commis- able data, will terminate the interim
sioner in writing that studies adequate food additive regulation, and will ei-
and appropriate to resolve the ques- ther issue a food additive regulation or
tions raised about the substance have will require elimination of the sub-
been undertaken, or the Food and Drug stance from the food supply.
Administration may undertake the (e) The Commissioner may consult
studies. The Commissioner may extend with advisory committees, professional
this 60-day period if necessary to re- organizations, or other experts in the
view and act on proposed protocols. If field, in evaluating:
no such commitment is made, or ade- (1) Whether an interim food additive
quate and appropriate studies are not regulation is justified,
undertaken, an order shall imme- (2) The type of studies necessary and
diately be published in the FEDERAL appropriate to resolve questions raised
REGISTER revoking the interim food ad- about a substance,
ditive regulation effective upon publi- (3) Whether interim results indicate
cation. the reasonable likelihood that a health
(3) A progress report shall be filed on hazard exists, or
the studies every January 1 and July 1 (4) Whether the data available at the
until completion. If the progress report conclusion of those studies justify a
is inadequate or if the Commissioner food additive regulation.
concludes that the studies are not (f) Where appropriate, an emergency
being pursued promptly and diligently action level may be issued for a sub-
or if interim results indicate a reason- stance subject to paragraph (a) of this
able likelihood that a health hazard ex- section that is not an approved food ad-
ists, an order will promptly be pub- ditive, pending the issuance of a final
lished in the FEDERAL REGISTER revok- interim food additive regulation. Such
ing the interim food additive regula- an action level shall be issued pursuant
tion effective upon publication. to sections 306 and 402(a) of the act to
(4) If nonclinical laboratory studies identify, based upon available data, a
are involved, studies filed with the safe level of use for the substance.
463
§ 180.22 21 CFR Ch. I (4–1–15 Edition)
Such an action level shall be issued in food contact surface—0.3 part per mil-
a notice published in the FEDERAL REG- lion calculated on the basis of the vol-
ISTER and shall be followed as soon as ume of the container when extracted to
practicable by a proposed interim food equilibrium at 120 °F with food-simu-
additive regulation. Where the avail- lating solvents appropriate to the in-
able data do not permit establishing an tended conditions of use.
action level for the safe use of a sub- (3) In the case of repeated-use arti-
stance, use of the substance may be cles—0.003 milligram/square inch when
prohibited. The identification of a pro- extracted at a time equivalent to ini-
hibited substance may be made in part tial batch usage utilizing food-simu-
189 of this chapter when appropriate. lating solvents and temperatures ap-
propriate to the intended conditions of
FR 15674, Mar. 22, 1977; 42 FR 52821, Sept. 30, use.
1977; 46 FR 8952, Jan. 27, 1981; 46 FR 14340, The food-simulating solvents shall in-
Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR clude, where applicable, distilled
39634, Sept. 27, 1989] water, 8 percent or 50 percent ethanol,
3 percent acetic acid, and either n-
Subpart B—Specific Requirements heptane or an appropriate oil or fat.
for Certain Food Additives (b) Where necessary, current regula-
tions permitting the use of acrylo-
§ 180.22 Acrylonitrile copolymers. nitrile copolymers shall be revised to
Acrylonitrile copolymers may be specify limitations on acrylonitrile/
safely used on an interim basis as arti- mercaptan complexes utilized in the
cles or components of articles intended production of acrylonitrile copolymers.
for use in contact with food, in accord- Such copolymers, if they contain re-
ance with the following prescribed con- versible acrylonitrile/mercaptan com-
ditions: plexes and are used in other than re-
(a) Limitations for acrylonitrile peated-use conditions, shall be tested
monomer extraction for finished food- to determine the identity of the com-
contact articles, determined by a plex and the level of the complex
method of analysis titled ‘‘Gas-Solid present in the food-contact article.
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,’’
464
are incorporated by reference. Copies tween acrylonitrile monomer and cya-

are available from the Center for Food nide ion, and (6) a literature search on
Safety and Applied Nutrition (HFS– the effects of chronic ingestion of hy-
200), Food and Drug Administration, drogen cyanide. Data on levels of acryl-
5100 Paint Branch Pkwy., College Park, amide extractable from acrylonitrile
MD 20740, or available for inspection at copolymers shall also be submitted.
the National Archives and Records Ad- Protocols of testing should be sub-
ministration (NARA). For information mitted for review to the Center for
on the availability of this material at Food Safety and Applied Nutrition
NARA, call 202–741–6030, or go to: http:// (HFS–200), Food and Drug Administra-
www.archives.gov/federallregister/ tion, 5100 Paint Branch Pkwy., College
codeloflfederallregulations/ Park, MD 20740.
ibrllocations.html. (f) Acrylonitrile copolymers may be
(c) The following data shall be pro- used in contact with food only if au-
vided for finished food-contact articles thorized in parts 174 through 179 or
intended for repeated use: § 181.32 of this chapter, except that
(1) Qualitative and quantitative mi- other uses of acrylonitrile copolymers
gration values at a time equivalent to in use prior to June 14, 1976, may con-
initial batch usage, utilizing solvents tinue under the following conditions:
and temperatures appropriate to the (1) On or before August 13, 1976, each
intended conditions of use. use of acrylonitrile copolymers in a
(2) Qualitative and quantitative mi- manner not authorized by § 181.32 of
gration values at the time of equi- this chapter or parts 174 through 179 of
librium extractions, utilizing solvents this chapter shall be the subject of a
and temperatures appropriate to the notice to the Center for Food Safety
intended conditions of use. and Applied Nutrition (HFS–200), Food
(3) Data on the volume and/or weight and Drug Administration, 5100 Paint
of food handled during the initial batch Branch Pkwy., College Park, MD 20740.
time period(s), during the equilibrium Such notice shall be accompanied by a
test period, and over the estimated life statement of the basis, including any
of the food-contact surface. articles and correspondence, on which
(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
465
§ 180.25 21 CFR Ch. I (4–1–15 Edition)
monomer extraction limitation set this chapter, processing aid as defined

forth in paragraph (a) of this section in § 170.3(o)(24) of this chapter, sta-
and shall be subject to the require- bilizer and thickener as defined in
ments of paragraph (b) of this section. § 170.3(o)(28) of this chapter, surface-fin-
(g) In addition to the requirements of ishing agent as defined in § 170.3(o)(30)
this section, the use of acrylonitrile co- of this chapter, and texturizer as de-
polymers shall comply with all applica- fined in § 170.3(o)(32) of this chapter.
ble requirements in other regulations (d) The ingredient is used in food at
in this part. levels not to exceed 98 percent in
pressed mints and 5 percent in all other
FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, hard candy and cough drops as defined
1989; 61 FR 14246, Apr. 1, 1996] in § 170.3(n)(25) of this chapter, 31 per-
cent in chewing gum as defined in
§ 180.25 Mannitol. § 170.3(n)(6) of this chapter, 40 percent
(a) Mannitol is the chemical in soft candy as defined in § 170.3(n)(38)
1,2,3,4,5,6,-hexanehexol (C6H14O6) a of this chapter, 8 percent in confections
hexahydric alcohol, differing from sor- and frostings as defined in § 170.3(n)(9)
bitol principally by having a different of this chapter, 15 percent in non-
optical rotation. Mannitol is produced standardized jams and jellies, commer-
by one of the following processes: cial, as defined in § 170.3(n)(28) of this
(1) The electrolytic reduction or chapter, and at levels less than 2.5 per-
transition metal catalytic hydro- cent in all other foods.
genation of sugar solutions containing (e) The label and labeling of food
glucose or fructose. whose reasonably foreseeable consump-
(2) The fermentation of sugars or tion may result in a daily ingestion of
sugar alcohols such as glucose, sucrose, 20 grams of mannitol shall bear the
fructose, or sorbitol using the yeast statement ‘‘Excess consumption may
Zygosaccharomyces rouxii. have a laxative effect’’.
(3) A pure culture fermentation of (f) In accordance with § 180.1, ade-
sugars such as fructose, glucose, or quate and appropriate feeding studies
maltose using the nonpathogenic, have been undertaken for this sub-
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.
466
NW., Washington, DC 20418, or may be at the Food and Drug Administration’s

examined at the National Archives and Main Library, 10903 New Hampshire
Records Administration (NARA). For Ave., Bldg. 2, Third Floor, Silver
information on the availability of this Spring, MD 20993, 301–796–2039, or at the
material at NARA, call 202–741–6030, or National Archives and Records Admin-
go to: http://www.archives.gov/ istration (NARA). For information on
federallregister/ the availability of this material at
codeloflfederallregulations/ NARA, call 202–741–6030 or go to: http://
ibrllocations.html. www.archives.gov/federal-register/cfr/ibr-
(b) The additive is used on an interim locations.html.
basis as a stabilizer for flavoring oils (c) Authority for such use shall ex-
used in fruit-flavored beverages, for pire when the Commissioner receives
which any applicable standards of iden- the final reports on the ongoing studies
tity do not preclude such use, in an in Canada and publishes an order on
amount not to exceed 15 parts per mil- the safety of saccharin and its salts
lion in the finished beverage, pending based on those reports and other avail-
the outcome of additional toxicological able data.
studies on which periodic reports at 6- (d) The additives are used or intended
month intervals are to be furnished for use as a sweetening agent only in
and final results submitted to the Food special dietary foods, as follows:
and Drug Administration promptly (1) In beverages, fruit juice drinks,
after completion of the studies. 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] tions, in amounts not to exceed 12 mil-
ligrams of the additive, calculated as
§ 180.37 Saccharin, ammonium sac- saccharin, per fluid ounce.
charin, calcium saccharin, and so-
dium saccharin. (2) As a sugar substitute for cooking
or table use, in amounts not to exceed
The food additives saccharin, ammo- 20 milligrams of the additive, cal-
nium saccharin, calcium saccharin, and culated as saccharin, for each ex-
sodium saccharin may be safely used as pressed teaspoonful of sugar sweet-
sweetening agents in food in accord- ening equivalency.
ance with the following conditions, if (3) In processed foods, in amounts not
the substitution for nutritive sweet- to exceed 30 milligrams of the additive,
eners is for a valid special dietary pur- calculated as saccharin, per serving of
pose and is in accord with current spe- designated size.
cial dietary food regulations and poli- (e) The additives are used or intended
cies or if the use or intended use is for for use only for the following techno-
an authorized technological purpose logical purposes:
other than calorie reduction:
(1) To reduce bulk and enhance fla-
(a) Saccharin is the chemical, 1,2-
vors in chewable vitamin tablets,
benzisothiazolin-3-one - 1,1 - dioxide
chewable mineral tablets, or combina-
(C7H5NO3S). The named salts of sac-
tions thereof.
charin are produced by the additional
neutralization of saccharin with the (2) To retain flavor and physical
proper base to yield the desired salt. properties of chewing gum.
(b) The food additives meet the speci- (3) To enhance flavor of flavor chips
fications of the Food Chemicals Codex, used in nonstandardized bakery prod-
7th ed. (2010), pp. 52–54, 153–154, 898–899, ucts.
961–962, which is incorporated by ref- (f) To assure safe use of the additives,
erence. The Director of the Office of in addition to the other information re-
the Federal Register approves this in- quired by the Act:
corporation by reference in accordance (1) The label of the additive and any
with 5 U.S.C. 552(a) and 1 CFR part 51. intermediate mixes of the additive for
You may obtain copies from the United manufacturing purposes shall bear:
States Pharmacopeial Convention, (i) The name of the additive.
12601 Twinbrook Pkwy., Rockville, MD (ii) A statement of the concentration

20852 (Internet address http:// of the additive, expressed as saccharin,
www.usp.org). Copies may be examined in any intermediate mix.
467
(iii) Adequate directions for use to EDITORIAL NOTE: Nomenclature changes to

provide a final food product that com- part 181 appear at 61 FR 14482, Apr. 2, 1996,
plies with the limitations prescribed in and 66 FR 56035, Nov. 6, 2001.
paragraphs (d) and (e) of this section.
(2) The label of any finished food Subpart A—General Provisions
product containing the additive shall
§ 181.1 General.
bear:
(i) The name of the additive. (a) An ingredient whose use in food
(ii) The amount of the additive, cal- or food packaging is subject to a prior
culated as saccharin, as follows: sanction or approval within the mean-
(a) For beverages, in milligrams per ing of section 201(s)(4) of the Act is ex-
empt from classification as a food addi-
fluid ounce;
tive. The Commissioner will publish in
(b) For cooking or table use products,
this part all known prior sanctions.
in milligrams per dispensing unit; Any interested person may submit to
(c) For processed foods, in terms of the Commissioner a request for publi-
the weight or size of a serving which cation of a prior sanction, supported by
shall be that quantity of the food con- evidence to show that it falls within
taining 30 milligrams or less of the ad- section 201(s)(4) of the Act.
ditive. (b) Based upon scientific data or in-
(iii) When the additive is used for cal- formation that shows that use of a
orie reduction, such other labeling as is prior-sanctioned food ingredient may
required by part 105 of this chapter. be injurious to health, and thus in vio-
[42 FR 14636, Mar. 15, 1977, as amended at 49 lation of section 402 of the Act, the
FR 5610, Feb. 14, 1984; 72 FR 10357, Mar. 8, Commissioner will establish or amend
2007; 78 FR 71467, Nov. 29, 2013] an applicable prior sanction regulation
to impose whatever limitations or con-
PART 181—PRIOR-SANCTIONED ditions are necessary for the safe use of
the ingredient, or to prohibit use of the
FOOD INGREDIENTS ingredient.
(c) Where appropriate, an emergency
Subpart A—General Provisions action level may be issued for a prior-
Sec. sanctioned substance, pending the
181.1 General. issuance of a final regulation in ac-
181.5 Prior sanctions. cordance with paragraph (b) of this sec-
tion. Such an action level shall be
Subpart B—Specific Prior-Sanctioned Food issued pursuant to section 402(a) of the
Ingredients Act to identify, based upon available
data, conditions of use of the substance
181.22 Certain substances employed in the that may be injurious to health. Such
manufacture of food-packaging mate-
rials.
an action level shall be issued in a no-
181.23 Antimycotics.
tice published in the FEDERAL REG-
ISTER and shall be followed as soon as
181.24 Antioxidants.
181.25 Driers. practicable by a proposed regulation in
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 fication of a prohibited substance may
of paper and paperboard products used in be made in part 189 of this chapter
food packaging. when appropriate.
181.32 Acrylonitrile copolymers and resins.
181.33 Sodium nitrate and potassium ni- [42 FR 14638, Mar. 15, 1977, as amended at 42
trate. FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27,
181.34 Sodium nitrite and potassium nitrite. 1989]
AUTHORITY: 21 U.S.C. 321, 342, 348, 371. § 181.5 Prior sanctions.

SOURCE: 42 FR 14638, Mar. 15, 1977, unless (a) A prior sanction shall exist only
otherwise noted. for a specific use(s) of a substance in
468
food, i.e., the level(s), condition(s), porating the same provisions, in the
product(s), etc., for which there was ex- event that such a regulation is deter-
plicit approval by the Food and Drug mined to be appropriate as a result of
Administration or the United States submission of proof of such an applica-
Department of Agriculture prior to ble prior sanction in response to the
September 6, 1958. proposal.
(b) The existence of a prior sanction
exempts the sanctioned use(s) from the Subpart B—Specific Prior-
food additive provisions of the Act but Sanctioned Food Ingredients
not from the other adulteration or the
misbranding provisions of the Act. § 181.22 Certain substances employed
(c) All known prior sanctions shall be in the manufacture of food-pack-
the subject of a regulation published in aging materials.
this part. Any such regulation is sub- Prior to the enactment of the food
ject to amendment to impose whatever additives amendment to the Federal
limitation(s) or condition(s) may be Food, Drug, and Cosmetic Act, sanc-
necessary for the safe use of the ingre- tions were granted for the usage of the
dient, or revocation to prohibit use of substances listed in §§ 181.23, 181.24,
the ingredient, in order to prevent the 181.25, 181.26, 181.27, 181.28, 181.29, and
adulteration of food in violation of sec- 181.30 in the manufacture of packaging
tion 402 of the Act. materials. So used, these substances
(d) In proposing, after a general eval- are not considered ‘‘food additives’’
uation of use of an ingredient, regula- within the meaning of section 201(s) of
tions affirming the GRAS status of the Act, provided that they are of good
substances added directly to human commercial grade, are suitable for as-
food in part 184 of this chapter or sub- sociation with food, and are used in ac-
stances in food-contact surfaces in part cordance with good manufacturing
186 of this chapter, or establishing a practice. For the purpose of this sub-
food additive regulation for substances part, good manufacturing practice for
added directly to human food in parts food-packaging materials includes the
172 and 173 of this chapter or food addi- restriction that the quantity of any of
tives in food-contact surfaces in parts these substances which becomes a com-
174, 175, 176, 177, 178 and § 179.45 of this ponent of food as a result of use in
chapter, the Commissioner shall, if he food-packaging materials shall not be
is aware of any prior sanction for use intended to accomplish any physical or
of the ingredient under conditions dif- technical effect in the food itself, shall
ferent from those proposed in the regu- be reduced to the least amount reason-
lation, concurrently propose a separate ably possible, and shall not exceed any
regulation covering such use of the in- limit specified in this subpart.
gredient under this part. If the Com-
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-
plicable prior sanction in response to a [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct.
proposal will constitute a waiver of the 28, 1977]
right to assert or rely on such sanction
§ 181.24 Antioxidants.
at any later time. The notice will also

constitute a proposal to establish a Substances classified as antioxidants,
regulation under this part, incor- when migrating from food-packaging
469
§ 181.25 21 CFR Ch. I (4–1–15 Edition)
material (limit of addition to food, Diisooctyl phthalate (for foods of high water
0.005 percent) shall include: content only).
Diphenyl-2-ethylhexyl phosphate.
Butylated hydroxyanisole. Epoxidized soybean oil (iodine number max-
Butylated hydroxytoluene. imum 6; and oxirane oxygen, minimum, 6.0
Dilauryl thiodipropionate. percent).
Distearyl thiodipropionate. Ethylphthalyl ethyl glycolate.
Gum guaiac. Glycerol monooleate.
Nordihydroguairetic acid. Monoisopropyl citrate.
Propyl gallate. Mono, di-, and tristearyl citrate.
Thiodipropionic acid. Triacetin (glycerol triacetate).
2,4,5-Trihydroxy butyrophenone. Triethyl citrate.
[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 3-(2-Xenolyl)-1,2-epoxypropane.
28, 1977]
[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct.
28, 1977, as amended at 50 FR 49536, Dec. 3,
§ 181.25 Driers. 1985]
Substances classified as driers, when
migrating from food-packaging mate- § 181.28 Release agents.
rial shall include: Substances classified as release
Cobalt caprylate. agents, when migrating from food-
Cobalt linoleate. packaging material shall include:
Cobalt naphthenate.
Cobalt tallate. Dimethylpolysiloxane (substantially free
Iron caprylate. from hydrolyzable chloride and alkoxy
Iron linoleate. groups, no more than 18 percent loss in
Iron naphthenate. weight after heating 4 hours at 200 °C.; vis-
Iron tallate. cosity 300 centisokes, 600 centisokes at 25
Manganese caprylate. °C, specific gravity 0.96 to 0.97 at 25 °C, re-
Manganese linoleate. fractive index 1.400 to 1.404 at 25 °C).
Manganese naphthenate. Linoleamide (linoleic acid amide).
Manganese tallate. Oleamide (oleic acid amide).
Palmitamide (palmitic acid amide).
[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Stearamide (stearic acid amide).
28, 1977]
[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct.
§ 181.26 Drying oils as components of 28, 1977]
finished resins.
§ 181.29 Stabilizers.
Substances classified as drying oils,
when migrating from food-packaging Substances classified as stabilizers,
material (as components of finished when migrating from food-packaging
resins) shall include: material shall include:
Chinawood oil (tung oil). Aluminum mono-, di-, and tristearate.

Dehydrated castor oil. Ammonium citrate.
Linseed oil. Ammonium potassium hydrogen phosphate.
Tall oil. Calcium glycerophosphate.
Calcium phosphate.
[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. Calcium hydrogen phosphate.
28, 1977] Calcium oleate.
Calcium acetate.
§ 181.27 Plasticizers. Calcium carbonate.
Substances classified as plasticizers, Calcium ricinoleate.
when migrating from food-packaging Calcium stearate.
Disodium hydrogen phosphate.
material shall include: Magnesium glycerophosphate.
Acetyl tributyl citrate. Magnesium stearate.
Acetyl triethyl citrate. Magnesium phosphate.
p-tert-Butylphenyl salicylate. Magnesium hydrogen phosphate.
Butyl stearate. Mono-, di-, and trisodium citrate.
Butylphthalyl butyl glycolate. Mono-, di-, and tripotassium citrate.
Dibutyl sebacate. Potassium oleate.
Di-(2-ethylhexyl) phthalate (for foods of high Potassium stearate.
water content only). Sodium pyrophosphate.

Diethyl phthalate. Sodium stearate.
Diisobutyl adipate. Sodium tetrapyrophosphate.
470
Stannous stearate (not to exceed 50 parts per Vinylidine chlorides (polymerized).
million tin as a migrant in finished food).
Zinc orthophosphate (not to exceed 50 parts § 181.32 Acrylonitrile copolymers and
per million zinc as a migrant in finished resins.
food).
Zinc resinate (not to exceed 50 parts per mil- (a) Acrylonitrile copolymers and res-
lion zinc as a migrant in finished food). ins listed in this section, containing
less than 30 percent acrylonitrile and
[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct.
28, 1977]
complying with the requirements of
paragraph (b) of this section, may be
§ 181.30 Substances used in the manu- safely used as follows:
facture of paper and paperboard (1) Films. (i) Acrylonitrile/butadiene/
products used in food packaging. styrene copolymers—no restrictions.
Substances used in the manufacture (ii) Acrylonitrile/butadiene copoly-
of paper and paperboard products used mers—no restrictions.
in food packaging shall include: (iii) Acrylonitrile/butadiene copoly-
mer blended with vinyl chloride-vinyl
Aliphatic polyoxyethylene ethers.*
acetate (optional at level up to 5 per-
1-Alkyl (C6-C18)3-amino-3-aminopropane
monoacetate.* cent by weight of the vinyl chloride
Borax or boric acid for use in adhesives, resin) resin—for use only in contact
sizes, and coatings.* with oleomargarine.
Butadiene-styrene copolymer. (iv) Acrylonitrile/styrene copoly-
Chromium complex of perfluoro-octane mer—no restrictions.
sulfonyl glycine for use on paper and pa- (2) Coatings. (i) Acrylonitrile/buta-
perboard which is waxed.*
Disodium cyanodithioimidocarbamate with
diene copolymer blended with poly-
ethylene diamine and potassium N-methyl vinyl chloride resins—for use only on
dithiocarbamate and/or sodium 2- paper and paperboard in contact with
mercaptobenzothiazole (slimicides).* meats and lard.
Ethyl acrylate and methyl methacrylate co- (ii) Polyvinyl chloride resin blended
polymers of itaconic acid or methacrylic with either acrylonitrile/butadiene co-
acid for use only on paper and paperboard polymer or acrylonitrile/butadiene sty-
which is waxed.* rene copolymer mixed with neoprene,
Hexamethylene tetramine as a setting agent
for protein, including casein.* for use as components of conveyor
1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2-alkyl belts to be used with fresh fruits, vege-
(C6-C17) imidazolinium chloride.* tables, and fish.
Itaconic acid (polymerized). (iii) Acrylonitrile/butadiene/styrene
Melamine formaldehyde polymer. copolymer—no restrictions.
Methyl acrylate (polymerized). (iv) Acrylonitrile/styrene copoly-
Methyl ethers of mono-, di-, and tripropylene
mer—no restrictions.
glycol.*
Myristo chromic chloride complex. (3) Rigid and semirigid containers. (i)
Nitrocellulose. Acrylonitrile/butadiene/styrene copoly-
Polyethylene glycol 400. mer—for use only as piping for han-
Polyvinyl acetate. dling food products and for repeated-
Potassium pentachlorophenate as a slime use articles intended to contact food.
control agent.* (ii) Acrylonitrile/styrene resin—no
Potassium trichlorophenate as a slime con-
trol agent.*
restrictions.
Resins from high and low viscosity polyvinyl (iii) Acrylonitrile/butadiene copoly-
alcohol for fatty foods only. mer blended with polyvinyl chloride
Rubber hydrochloride. resin—for use only as extruded pipe.
Sodium pentachlorophenate as a slime con- (b) Limitations for acrylonitrile
trol agent.* monomer extraction for finished food-
Sodium-trichlorophenate as a slime control contact articles, determined by using
agent.*
Stearato-chromic chloride complex.
the method of analysis titled ‘‘Gas-
Titanium dioxide.* Solid Chromatographic Procedure for
Urea formaldehyde polymer. Determining Acrylonitrile Monomer in
Acrylonitrile-Containing Polymers and
*Under the conditions of normal use, these Food-Simulating Solvents,’’ which is
substances would not reasonably be expected incorporated by reference. Copies are

to migrate to food, based on available sci- available from the Center for Food
entific information and data. Safety and Applied Nutrition (HFS–
471
§ 181.33 21 CFR Ch. I (4–1–15 Edition)
200), Food and Drug Administration, nitrite, in the production of cured red
5100 Paint Branch Pkwy., College Park, meat products and cured poultry prod-
MD 20740, or available for inspection at ucts.
[48 FR 1705, Jan. 14, 1983]
on the availability of this material at § 181.34 Sodium nitrite and potassium
NARA, call 202–741–6030, or go to: http:// nitrite.
Sodium nitrite and potassium nitrite
are subject to prior sanctions issued by
ibrllocations.html.
the U.S. Department of Agriculture for
(1) In the case of single-use articles
use as color fixatives and preservative
having a volume to surface ratio of 10
agents, with or without sodium or po-
milliliters or more per square inch of
food-contact surface—0.003 milligram/ tassium nitrate, in the curing of red
square inch when extracted to equi- meat and poultry products.
librium at 120 °F with food-simulating [48 FR 1705, Jan. 14, 1983]
solvents appropriate to the intended
conditions of use. PART 182—SUBSTANCES
(2) In the case of single-use articles GENERALLY RECOGNIZED AS SAFE
having a volume to surface ratio of less
than 10 milliliters per square inch of Subpart A—General Provisions
food-contact surface—0.3 part per mil-
lion calculated on the basis of the vol- Sec.
ume of the container when extracted to 182.1 Substances that are generally recog-
equilibrium at 120 °F with food-simu- nized as safe.
lating solvents appropriate to the in- 182.10 Spices and other natural seasonings
and flavorings.
tended conditions of use. 182.20 Essential oils, oleoresins (solvent-
(3) In the case of repeated-use arti- free), and natural extractives (including
cles—0.003 milligram/square inch when distillates).
extracted at a time equivalent to ini- 182.40 Natural extractives (solvent-free)
tial batch usage utilizing food-simu- used in conjunction with spices,
lating solvents and temperatures ap- seasonings, and flavorings.
propriate to the intended conditions of 182.50 Certain other spices, seasonings, es-
use. sential oils, oleoresins, and natural ex-
tracts.
The food-simulating solvents shall in- 182.60 Synthetic flavoring substances and
clude, where applicable, distilled adjuvants.
water, 8 percent or 50 percent ethanol, 182.70 Substances migrating from cotton
3 percent acetic acid, and either n- and cotton fabrics used in dry food pack-
heptane or an appropriate oil or fat. aging.
(c) Acrylonitrile monomer may 182.90 Substances migrating to food from
paper and paperboard products.
present a hazard to health when in-
182.99 Adjuvants for pesticide chemicals.
gested. Accordingly, any food-contact
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.
182.1057 Hydrochloric acid.
in violation of section 402 of the Act.
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.
472
182.1711 Silica aerogel. 182.8159 Biotin.
182.1745 Sodium carboxymethylcellulose. 182.8217 Calcium phosphate.
182.1748 Sodium caseinate. 182.8223 Calcium pyrophosphate.
182.1778 Sodium phosphate. 182.8250 Choline bitartrate.
182.1781 Sodium aluminum phosphate. 182.8252 Choline chloride.
182.1810 Sodium tripolyphosphate. 182.8778 Sodium phosphate.
182.8890 Tocopherols.
Subpart C—Anticaking Agents 182.8892 a-Tocopherol acetate.
182.2122 Aluminum calcium silicate. 182.8985 Zinc chloride.
182.2227 Calcium silicate. 182.8988 Zinc gluconate.
182.2437 Magnesium silicate. 182.8991 Zinc oxide.
182.2727 Sodium aluminosilicate. 182.8994 Zinc stearate.
182.2729 Sodium calcium aluminosilicate, 182.8997 Zinc sulfate.
hydrated. AUTHORITY: 21 U.S.C. 321, 342, 348, 371.
182.2906 Tricalcium silicate.
SOURCE: 42 FR 14640, Mar. 15, 1977, unless
Subpart D—Chemical Preservatives otherwise noted.
182.3013 Ascorbic acid.

182.3041 Erythorbic acid. Subpart A—General Provisions
182.3089 Sorbic acid.
182.3109 Thiodipropionic acid. § 182.1 Substances that are generally
182.3149 Ascorbyl palmitate. recognized as safe.
182.3169 Butylated hydroxyanisole. (a) It is impracticable to list all sub-
182.3173 Butylated hydroxytoluene.
182.3189 Calcium ascorbate.
stances that are generally recognized
182.3225 Calcium sorbate. as safe for their intended use. However,
182.3280 Dilauryl thiodipropionate. by way of illustration, the Commis-
182.3616 Potassium bisulfite. sioner regards such common food in-
182.3637 Potassium metabisulfite. gredients as salt, pepper, vinegar, bak-
182.3640 Potassium sorbate. ing powder, and monosodium glu-
182.3731 Sodium ascorbate. tamate as safe for their intended use.
182.3739 Sodium bisulfite.
This part includes additional sub-
182.3766 Sodium metabisulfite.
182.3795 Sodium sorbate. stances that, when used for the pur-
182.3798 Sodium sulfite. poses indicated, in accordance with
182.3862 Sulfur dioxide. good manufacturing practice, are re-
182.3890 Tocopherols. garded by the Commissioner as
generaly recognized as safe for such
Subpart E—Emulsifying Agents [Reserved] uses.
(b) For the purposes of this section,
Subpart F—Dietary Supplements
good manufacturing practice shall be
[Reserved]
defined to include the following re-
Subpart G—Sequestrants strictions:
(1) The quantity of a substance added
182.6085 Sodium acid phosphate. to food does not exceed the amount
182.6197 Calcium diacetate. reasonably required to accomplish its
182.6203 Calcium hexametaphosphate.
182.6215 Monobasic calcium phosphate. intended physical, nutritional, or other
182.6285 Dipotassium phosphate. technical effect in food; and
182.6290 Disodium phosphate. (2) The quantity of a substance that
182.6757 Sodium gluconate. becomes a component of food as a re-
182.6760 Sodium hexametaphosphate. sult of its use in the manufacturing,
182.6769 Sodium metaphosphate. processing, or packaging of food, and
182.6778 Sodium phosphate. which is not intended to accomplish
182.6787 Sodium pyrophosphate.
any physical or other technical effect
182.6789 Tetra sodium pyrophosphate.
182.6810 Sodium tripolyphosphate. in the food itself, shall be reduced to
the extent reasonably possible.
Subpart H—Stabilizers (3) The substance is of appropriate
food grade and is prepared and handled
182.7255 Chondrus extract. as a food ingredient. Upon request the
Subpart I—Nutrients Commissioner will offer an opinion,

based on specifications and intended
182.8013 Ascorbic acid. use, as to whether or not a particular
473
§ 182.10 21 CFR Ch. I (4–1–15 Edition)
grade or lot of the substance is of suit- ‘‘affirmed as GRAS’’ under part 184 or
able purity for use in food and would 186 of this chapter; ‘‘food additive regu-
generally be regarded as safe for the lation’’ under parts 170 through 180 of
purpose intended, by experts qualified this chapter; ‘‘interim food additive
to evaluate its safety. regulation’’ under part 180 of this chap-
(c) The inclusion of substances in the ter; or ‘‘prohibited from use in food’’
list of nutrients does not constitute a under part 189 of this chapter.
finding on the part of the Department
that the substance is useful as a sup- [42 FR 14640, Mar. 15, 1977, as amended at 53
plement to the diet for humans. FR 44875, Nov. 7, 1988]
(d) Substances that are generally rec-
ognized as safe for their intended use § 182.10 Spices and other natural
seasonings and flavorings.
within the meaning of section 409 of
the act are listed in this part. When Spices and other natural seasonings
the status of a substance has been re- and flavorings that are generally rec-
evaluated, it will be deleted from this ognized as safe for their intended use,
part, and will be issued as a new regu- within the meaning of section 409 of
lation under the appropriate part, e.g., the Act, are as follows:
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.
474
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).
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.
475
§ 182.20 21 CFR Ch. I (4–1–15 Edition)
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.
Citronella ................................................................. Cymbopogon nardus Rendle.
Citrus peels ............................................................. Citrus spp.
Clary (clary sage) .................................................... Salvia sclarea L.
Clover ...................................................................... Trifolium spp.
Coca (decocainized) ............................................... Erythroxylum coca Lam. and other spp. of Erythroxylum.
Coffee ...................................................................... Coffea spp.
Cola nut ................................................................... Cola acuminata Schott and Endl., and other spp. of Cola.
Coriander ................................................................. Coriandrum sativum L.
Cumin (cummin) ...................................................... Cuminum cyminum L.
Curacao orange peel (orange, bitter peel) ............. Citrus aurantium L.
Cusparia bark .......................................................... Galipea officinalis Hancock.
Dandelion ................................................................ Taraxacum officinale Weber and T. laevigatum DC.
Dandelion root ......................................................... Do.
Dog grass (quackgrass, triticum) ............................ Agropyron repens (L.) Beauv.
Elder flowers ........................................................... Sambucus canadensis L. and S. nigra I.
Estragole (esdragol, esdragon, tarragon) ............... Artemisia dracunculus L.
Estragon (tarragon) ................................................. Do.
Fennel, sweet .......................................................... Foeniculum vulgare Mill.
Fenugreek ............................................................... Trigonella foenum-graecum L.
Galanga (galangal) .................................................. Alpinia officinarum Hance.
Geranium ................................................................. Pelargonium spp.
Geranium, East Indian ............................................ Cymbopogon martini Stapf.
Geranium, rose ....................................................... Pelargonium graveolens L’Her.
Ginger ...................................................................... Zingiber officinale Rosc.
Grapefruit ................................................................ Citrus paradisi Macf.
Guava ...................................................................... Psidium spp.
Hickory bark ............................................................ Carya spp.
Horehound (hoarhound) .......................................... Marrubium vulgare L.
Hops ........................................................................ Humulus lupulus L.
Horsemint ................................................................ Monarda punctata L.
Hyssop .................................................................... Hyssopus officinalis L.
Immortelle ................................................................ Helichrysum augustifolium DC.
Jasmine ................................................................... Jasminum officinale L. and other spp. of Jasminum.
Juniper (berries) ...................................................... Juniperus communis L.
Kola nut ................................................................... Cola acuminata Schott and Endl., and other spp. of Cola.
Laurel berries .......................................................... Laurus nobilis L.
Laurel leaves ........................................................... Laurus spp.
Lavender ................................................................. Lavandula officinalis Chaix.
Lavender, spike ....................................................... Lavandula latifolia Vill.
Lavandin .................................................................. Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill.
Lemon ..................................................................... Citrus limon (L.) Burm. f.
Lemon balm (see balm).
Lemon grass ........................................................... Cymbopogon citratus DC. and Cymbopogon lexuosus Stapf.
Lemon peel ............................................................. Citrus limon (L.) Burm. f.
Lime ......................................................................... Citrus aurantifolia Swingle.
Linden flowers ......................................................... Tilia spp.
Locust bean ............................................................. Ceratonia siliqua L,
Lupulin ..................................................................... Humulus lupulus L.
Mace ........................................................................ Myristica fragrans Houtt.
Mandarin ................................................................. Citrus reticulata Blanco.
Marjoram, sweet ...................................................... Majorana hortensis Moench.
Maté ........................................................................ Ilex paraguariensis St. Hil.
Melissa (see balm).

Menthol .................................................................... Mentha spp.
Menthyl acetate ....................................................... Do.
476
Molasses (extract) ................................................... Saccarum officinarum L.

Mustard ................................................................... Brassica spp.
Naringin ................................................................... Citrus paradisi Macf.
Neroli, bigarade ....................................................... Citrus aurantium L.
Nutmeg .................................................................... Myristica fragrans Houtt.
Onion ....................................................................... Allium cepa L.
Orange, bitter, flowers ............................................. Citrus aurantium L.
Orange, bitter, peel ................................................. Do.
Orange leaf ............................................................. Citrus sinensis (L.) Osbeck.
Orange, sweet ......................................................... Do.
Orange, sweet, flowers ........................................... Do.
Orange, sweet, peel ................................................ Do.
Origanum ................................................................. Origanum spp.
Palmarosa ............................................................... Cymbopogon martini Stapf.
Paprika .................................................................... Capsicum annuum L.
Parsley .................................................................... Petroselinum crispum (Mill.) Mansf.
Pepper, black .......................................................... Piper nigrum L.
Pepper, white .......................................................... Do.
Peppermint .............................................................. Mentha piperita L.
Peruvian balsam ..................................................... Myroxylon pereirae Klotzsch.
Petitgrain ................................................................. Citrus aurantium L.
Petitgrain lemon ...................................................... Citrus limon (L.) Burm. f.
Petitgrain mandarin or tangerine ............................ Citrus reticulata Blanco.
Pimenta ................................................................... Pimenta officinalis Lindl.
Pimenta leaf ............................................................ Pimenta officinalis Lindl.
Pipsissewa leaves ................................................... Chimaphila umbellata Nutt.
Pomegranate ........................................................... Punica granatum L.
Prickly ash bark ....................................................... Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava-
herculis L.
Rose absolute ......................................................... Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L.,
and vars. of these spp.
Rose (otto of roses, attar of roses) ......................... Do.
Rose buds ............................................................... Do.
Rose flowers ........................................................... Do.
Rose fruit (hips) ....................................................... Do.
Rose geranium ........................................................ Pelargonium graveolens L’Her.
Rose leaves ............................................................ Rosa spp.
Rosemary ................................................................ Rosmarinus officinalis L.
Saffron ..................................................................... Crocus sativus L.
Sage ........................................................................ Salvia officinalis L.
Sage, Greek ............................................................ Salvia triloba L.
Sage, Spanish ......................................................... Salvia lavandulaefolia Vahl.
St. John’s bread ...................................................... Ceratonia siliqua L.
Savory, summer ...................................................... Satureia hortensis L.
Savory, winter ......................................................... Satureia montana L.
Schinus molle .......................................................... Schinus molle L.
Sloe berries (blackthorn berries) ............................. Prunus spinosa L.
Spearmint ................................................................ Mentha spicata L.
Spike lavender ........................................................ Lavandula latifolia Vill.
Tamarind ................................................................. Tamarindus indica L.
Tangerine ................................................................ Citrus reticulata Blanco.
Tarragon .................................................................. Artemisia dracunculus L.
Tea .......................................................................... Thea sinensis L.
Thyme ..................................................................... Thymus vulgaris L. and Thymus zygis var. gracilis Boiss.
Thyme, white ........................................................... Do.
Thyme, wild or creeping .......................................... Thymus serpyllum L.
Triticum (see dog grass).
Tuberose ................................................................. Polianthes tuberosa L.
Turmeric .................................................................. Curcuma longa L.
Vanilla ...................................................................... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore.
Violet flowers ........................................................... Viola odorata L.
Violet leaves ............................................................ Do.
Violet leaves absolute ............................................. Do.
Wild cherry bark ...................................................... Prunus serotina Ehrh.
Ylang-ylang ............................................................. Cananga odorata Hook. f. and Thoms.
Zedoary bark ........................................................... Curcuma zedoaria Rosc.
[42 FR 14640, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 47 FR 29953, July 9, 1982;
48 FR 51613, Nov. 10, 1983; 50 FR 21043 and 21044, May 22, 1985]
477
§ 182.40 21 CFR Ch. I (4–1–15 Edition)
§ 182.40 Natural extractives (solvent- seasonings, and flavorings that are

free) used in conjunction with generally recognized as safe for their
spices, seasonings, and flavorings. intended use, within the meaning of
Natural extractives (solvent-free) section 409 of the Act, are as follows:
used in conjunction with spices,
Apricot kernel (persic oil) ........................................ Prunus armeniaca L.

Peach kernel (persic oil) ......................................... Prunus persica Sieb. et Zucc.
Peanut stearine ....................................................... Arachis hypogaea L.
Persic oil (see apricot kernel and peach kernel).
Quince seed ............................................................ Cydonia oblonga Miller.
[42 FR 14640, Mar. 15, 1977, as amended at 47 FR 47375, Oct. 26, 1982]
§ 182.50 Certain other spices, tracts that are generally recognized as

seasonings, essential oils, safe for their intended use, within the
oleoresins, and natural extracts. meaning of section 409 of the Act, are
Certain other spices, seasonings, es- as follows:
sential oils, oleoresins, and natural ex-
Common name Derivation
Ambergris ................................................................ Physeter macrocephalus L.

Castoreum ............................................................... Castor fiber L. and C. canadensis Kuhl.
Civet (zibeth, zibet, zibetum) .................................. Civet cats, Viverra civetta Schreber and Viverra zibetha Schreber.
Cognac oil, white and green ................................... Ethyl oenanthate, so-called.
Musk (Tonquin musk) ............................................. Musk deer, Moschus moschiferus L.
§ 182.60 Synthetic flavoring substances Methyl anthranilate (methyl-2-

and adjuvants. aminobenzoate).
Piperonal (3,4-methylenedioxy-benzaldehyde,
Synthetic flavoring substances and heliotropin).
adjuvants that are generally recog- Vanillin.
nized as safe for their intended use,
within the meaning of section 409 of FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19,
the Act, are as follows: 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907,
Acetaldehyde (ethanal). Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989]
Acetoin (acetyl methylcarbinol).
Anethole (parapropenyl anisole). § 182.70 Substances migrating from
Benzaldehyde (benzoic aldehyde). cotton and cotton fabrics used in
N-Butyric acid (butanoic acid). dry food packaging.
d- or l-Carvone (carvol). Substances migrating to food from
Cinnamaldehyde (cinnamic aldehyde).
Citral (2,6-dimethyloctadien-2,6-al-8, gera-
cotton and cotton fabrics used in dry
nial, neral). food packaging that are generally rec-
Decanal (N-decylaldehyde, capraldehyde, ognized as safe for their intended use,
capric aldehyde, caprinaldehyde, aldehyde within the meaning of section 409 of
C-10). the Act, are as follows:
Ethyl acetate.
Ethyl butyrate. Beef tallow.
3-Methyl-3-phenyl glycidic acid ethyl ester Carboxymethylcellulose.
(ethyl-methyl-phenyl-glycidate, so-called Coconut oil, refined.
strawberry aldehyde, C-16 aldehyde). Cornstarch.
Ethyl vanillin. Gelatin.
Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1- Lard.
ol). Lard oil.
Geranyl acetate (geraniol acetate). Oleic acid.
Limonene (d-, l-, and dl-). Peanut oil.
Linalool (linalol, 3,7-dimethyl-1,6-octadien-3- Potato starch.

ol). Sodium acetate.
Linalyl acetate (bergamol). Sodium chloride.
478
Sodium silicate. in the Finding Aids section of the printed
Sodium tripolyphosphate. volume and at www.fdsys.gov.
Soybean oil (hydrogenated).
Talc. § 182.99 Adjuvants for pesticide chemi-
Tallow (hydrogenated). cals.
Tallow flakes.
Tapioca starch. Adjuvants, identified and used in ac-
Tetrasodium pyrophosphate. cordance with 40 CFR 180.910 and 40
Wheat starch. CFR 180.920, which are added to pes-
Zinc chloride. ticide use dilutions by a grower or ap-
[42 FR 14640, Mar. 15, 1977, as amended at 43 plicator prior to application to the raw
FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, agricultural commodity, are exempt
1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, from the requirement of tolerances
27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; under section 409 of the Federal Food,
48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, Drug, and Cosmetic Act (21 U.S.C. 348).
1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18,
1983; 51 FR 16830, May 7, 1986; 51 FR 27171, [76 FR 59249, Sept. 26, 2011]
July 30, 1986; 60 FR 62208, Dec. 5, 1995]
§ 182.90 Substances migrating to food

Subpart B—Multiple Purpose GRAS
from paper and paperboard prod- Food Substances
ucts.
§ 182.1045 Glutamic acid.
Substances migrating to food from
paper and paperboard products used in (a) Product. Glutamic acid.
food packaging that are generally rec- (b) [Reserved]
ognized as safe for their intended use, (c) Limitations, restrictions, or expla-
within the meaning of section 409 of nation. This substance is generally rec-
the Act, are as follows: ognized as safe when used as a salt sub-
stitute in accordance with good manu-
Alum (double sulfate of aluminum and am- facturing practice.
monium potassium, or sodium).
Aluminum hydroxide. § 182.1047 Glutamic acid hydro-
Aluminum oleate. chloride.
Aluminum palmitate.
Casein. (a) Product. Glutamic acid hydro-
Cellulose acetate. chloride.
Cornstarch. (b) [Reserved]
Diatomaceous earth filler. (c) Limitations, restrictions, or expla-
Ethyl cellulose. nation. This substance is generally rec-
Ethyl vanillin.
Glycerin. ognized as safe when used as a salt sub-
Oleic acid. stitute in accordance with good manu-
Potassium sorbate. facturing practice.
Silicon dioxides.
Sodium aluminate. § 182.1057 Hydrochloric acid.
Sodium chloride. (a) Product. Hydrochloric acid.
Sodium hexametaphosphate.
Sodium hydrosulfite.
(b) [Reserved]
Sodium phosphoaluminate. (c) Limitations, restrictions, or expla-
Sodium silicate. nation. This substance is generally rec-
Sodium sorbate. ognized as safe when used as a buffer
Sodium tripolyphosphate. and neutralizing agent in accordance
Sorbitol. with good manufacturing practice.
Soy protein, isolated.
Starch, acid modified. § 182.1073 Phosphoric acid.
Starch, pregelatinized.
Starch, unmodified. (a) Product. Phosphoric acid.
Talc. (b) Conditions of use. This substance
Vanillin. is generally recognized as safe when
Zinc hydrosulfite. used in accordance with good manufac-
Zinc sulfate. turing practice.
[42 FR 14640, Mar. 15, 1977]
§ 182.1087 Sodium acid pyrophosphate.
EDITORIAL NOTE: For additional FEDERAL

REGISTER citations affecting § 182.90, see the (a) Product. Sodium acid
List of CFR Sections Affected, which appears pyrophosphate.
479
§ 182.1125 21 CFR Ch. I (4–1–15 Edition)
(b) Conditions of use. This substance used in accordance with good manufac-
is generally recognized as safe when turing practice.
used in accordance with good manufac-
turing practice. § 182.1320 Glycerin.
(a) Product. Glycerin.
§ 182.1125 Aluminum sulfate.
(b) Conditions of use. This substance
(a) Product. Aluminum sulfate. is generally recognized as safe when
turing practice. § 182.1480 Methylcellulose.
§ 182.1127 Aluminum ammonium sul- (a) Product. U.S.P. methylcellulose,
fate. except that the methoxy content shall
not be less than 27.5 percent and not
(a) Product. Aluminum ammonium
more than 31.5 percent on a dry-weight
sulfate.
basis.
is generally recognized as safe when
turing practice.
turing practice.
§ 182.1129 Aluminum potassium sul-
fate. § 182.1500 Monoammonium glutamate.
(a) Product. Aluminum potassium sul- (a) Product. Monoammonium glu-
fate. tamate.
(b) Conditions of use. This substance (b) Conditions of use. This substance
is generally recognized as safe when is generally recognized as safe when
used in accordance with good manufac- used in accordance with good manufac-
turing practice. turing practice.
§ 182.1131 Aluminum sodium sulfate. § 182.1516 Monopotassium glutamate.

(a) Product. Aluminum sodium sul- (a) Product. Monopotassium glu-
fate. tamate.
§ 182.1180 Caffeine. § 182.1711 Silica aerogel.

(a) Product. Caffeine. (a) Product. Silica aerogel as a finely
(b) Tolerance. 0.02 percent. powdered microcellular silica foam
(c) Limitations, restrictions, or expla- having a minimum silica content of
nation. This substance is generally rec- 89.5 percent.
ognized as safe when used in cola-type (b) [Reserved]
beverages in accordance with good (c) Limitations, restrictions, or expla-
manufacturing practice. nation. This substance is generally rec-
ognized as safe when used as a compo-
§ 182.1217 Calcium phosphate. nent of an anti-foaming agent in ac-
(a) Product. Calcium phosphate cordance with good manufacturing
(mono-, di-, and tribasic). practice.
is generally recognized as safe when § 182.1745 Sodium carboxymethylcellu-
used in accordance with good manufac- lose.
turing practice. (a) Product. Sodium carboxy-
methylcellulose is the sodium salt of
§ 182.1235 Caramel. carboxymethylcellulose not less than
(a) Product. Caramel. 99.5 percent on a dry-weight basis, with

(b) Conditions of use. This substance maximum substitution of 0.95
is generally recognized as safe when carboxymethyl groups per
480
anhydroglucose unit, and with a min- exceeding 2 percent in table salt and 5
imum viscosity of 25 centipoises for 2 percent in baking powder in accordance
percent by weight aqueous solution at with good manufacturing practice.
25 °C.
(b) Conditions of use. This substance § 182.2437 Magnesium silicate.
is generally recognized as safe when (a) Product. Magnesium silicate.
used in accordance with good manufac- (b) Tolerance. 2 percent.
turing practice. (c) Limitations, restrictions, or expla-
nation. This substance is generally rec-
§ 182.1748 Sodium caseinate.
ognized as safe when used in table salt
(a) Product. Sodium caseinate. in accordance with good manufacturing
(b) Conditions of use. This substance practice.
used in accordance with good manufac- § 182.2727 Sodium aluminosilicate.
turing practice. (a) Product. Sodium aluminosilicate
§ 182.1778 Sodium phosphate. (sodium silicoaluminate).
(b) Tolerance. This substance is gen-
(a) Product. Sodium phosphate erally recognized as safe for use at a
(mono-, di-, and tribasic). level not exceeding 2 percent in accord-
(b) Conditions of use. This substance ance with good manufacturing prac-
is generally recognized as safe when tice.
turing practice. § 182.2729 Sodium calcium
aluminosilicate, hydrated.
§ 182.1781 Sodium aluminum phos-
phate. (a) Product. Hydrated sodium calcium
aluminosilicate (sodium calcium
(a) Product. Sodium aluminum phos-
silicoaluminate).
phate.
(b) Tolerance. This substance is gen-
erally recognized as safe for use at a
level not exceeding 2 percent in accord-
ance with good manufacturing prac-
turing practice.
tice.
§ 182.1810 Sodium tripolyphosphate.
§ 182.2906 Tricalcium silicate.
(a) Product. Sodium
tripolyphosphate. (a) Product. Tricalcium silicate.
(b) Conditions of use. This substance (b) Tolerance. 2 percent.
is generally recognized as safe when (c) Limitations, restrictions, or expla-
used in accordance with good manufac- nation. This substance is generally rec-
turing practice. ognized as safe when used in table salt
in accordance with good manufacturing
practice.
Subpart C—Anticaking Agents
§ 182.2122 Aluminum calcium silicate. Subpart D—Chemical
(a) Product. Aluminum calcium sili- Preservatives
cate.
§ 182.3013 Ascorbic acid.
(b) Tolerance. 2 percent.
(c) Limitations, restrictions, or expla- (a) Product. Ascorbic acid.
nation. This substance is generally rec- (b) Conditions of use. This substance
ognized as safe when used in table salt is generally recognized as safe when
in accordance with good manufacturing used in accordance with good manufac-
practice. turing practice.
§ 182.2227 Calcium silicate. § 182.3041 Erythorbic acid.

(a) Product. Calcium silicate. (a) Product. Erythorbic acid.
(b) Tolerance. 2 percent and 5 percent. (b) Conditions of use. This substance
(c) Limitations, restrictions, or expla- is generally recognized as safe when

nation. This substance is generally rec- used in accordance with good manufac-
ognized as safe when used at levels not turing practice.
481
§ 182.3089 21 CFR Ch. I (4–1–15 Edition)
§ 182.3089 Sorbic acid. (b) Conditions of use. This substance

(a) Product. Sorbic acid. is generally recognized as safe when
used in accordance with good manufac- § 182.3280 Dilauryl thiodipropionate.
turing practice.
(a) Product. Dilauryl
§ 182.3109 Thiodipropionic acid. thiodipropionate.
(a) Product. Thiodipropionic acid. (b) Tolerance. This substance is gen-
(b) Tolerance. This substance is generally recognized as safe for use in food
erally recognized as safe for use in food when the total content of antioxidants
when the total content of antioxidants is not over 0.02 percent of fat or oil
is not over 0.02 percent of fat or oil content, including essential (volatile)
content, including essential (volatile) oil content of the food, provided the
oil content of the food, provided the substance is used in accordance with
substance is used in accordance with good manufacturing practice.
good manufacturing practice.
§ 182.3616 Potassium bisulfite.
§ 182.3149 Ascorbyl palmitate. (a) Product. Potassium bisulfite.
(a) Product. Ascorbyl palmitate. (b) [Reserved]
(b) Conditions of use. This substance (c) Limitations, restrictions, or expla-
is generally recognized as safe when nation. This substance is generally rec-
used in accordance with good manufac- ognized as safe when used in accord-
turing practice. ance with good manufacturing prac-
tice, except that it is not used in
§ 182.3169 Butylated hydroxyanisole. meats; in food recognized as a source of
(a) Product. Butylated hydroxy- vitamin B1; on fruits and vegetables in-
anisole. tended to be served raw to consumers
(b) Tolerance. This substance is gen- or sold raw to consumers, or to be pre-
erally recognized as safe for use in food sented to consumers as fresh.
when the total content of antioxidants
is not over 0.02 percent of fat or oil
FR 25025, July 9, 1986; 55 FR 9832, Mar. 15,
content, including essential (volatile) 1990; 59 FR 65939, Dec. 22, 1994]
oil content of food, provided the sub-
stance is used in accordance with good § 182.3637 Potassium metabisulfite.
(a) Product. Potassium metabisulfite.
§ 182.3173 Butylated hydroxytoluene. (b) [Reserved]
(a) Product. Butylated hydroxy- (c) Limitations, restrictions, or expla-
toluene. nation. This substance is generally rec-
(b) Tolerance. This substance is gen- ognized as safe when used in accord-
erally recognized as safe for use in food ance with good manufacturing prac-
when the total content of antioxidants tice, except that it is not used in
is not over 0.02 percent of fat or oil meats; in food recognized as a source of
content, including essential (volatile) vitamin B1; on fruits and vegetables in-
oil content of food, provided the sub- tended to be served raw to consumers
stance is used in accordance with good or sold raw to consumers, or to be pre-
manufacturing practice. sented to consumers as fresh.
§ 182.3189 Calcium ascorbate. FR 25025, July 9, 1986; 55 FR 9832, Mar. 15,
(a) Product. Calcium ascorbate. 1990; 59 FR 65939, Dec. 22, 1994]
is generally recognized as safe when § 182.3640 Potassium sorbate.
used in accordance with good manufac- (a) Product. Potassium sorbate.
turing practice. (b) Conditions of use. This substance

§ 182.3225 Calcium sorbate. used in accordance with good manufac-
(a) Product. Calcium sorbate. turing practice.
482
§ 182.3731 Sodium ascorbate. tended to be served raw to consumers

(a) Product. Sodium ascorbate. or sold raw to consumers, or to be pre-
(b) Conditions of use. This substance sented to consumers as fresh.
is generally recognized as safe when [42 FR 14640, Mar. 15, 1977, as amended at 51
used in accordance with good manufac- FR 25026, July 9, 1986; 55 FR 9833, Mar. 15,
turing practice. 1990; 59 FR 65939, Dec. 22, 1994]
§ 182.3739 Sodium bisulfite. § 182.3862 Sulfur dioxide.

(a) Product. Sodium bisulfite. (a) Product. Sulfur dioxide.
(b) [Reserved] (b) [Reserved]
(c) Limitations, restrictions, or expla- (c) Limitations, restrictions, or expla-
nation. This substance is generally rec- nation. This substance is generally rec-
ognized as safe when used in accord- ognized as safe when used in accord-
ance with good manufacturing prac- ance with good manufacturing prac-
tice, except that it is not used in tice, except that it is not used in
meats; in food recognized as a source of meats; in food recognized as a source of
vitamin B1; on fruits or vegetables in- vitamin B1; on fruits or vegetables in-
tended to be served raw to consumers tended to be served raw to consumers
or sold raw to consumers, or to be pre- or sold raw to consumers, or to be pre-
sented to the consumer as fresh. sented to consumers as fresh.
[42 FR 14640, Mar. 15, 1977, as amended at 51 [42 FR 14640, Mar. 15, 1977, as amended at 51
FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, FR 25026, July 9, 1986; 55 FR 9833, Mar. 15,
1990; 59 FR 65939, Dec. 22, 1994] 1990; 59 FR 65939, Dec. 22, 1994]
§ 182.3766 Sodium metabisulfite. § 182.3890 Tocopherols.

(a) Product. Sodium metabisulfite. (a) Product. Tocopherols.
(b) [Reserved] (b) Conditions of use. This substance
(c) Limitations, restrictions, or expla- is generally recognized as safe when
nation. This substance is generally rec- used in accordance with good manufac-
ognized as safe when used in accord- turing practice.
ance with good manufacturing prac-
tice, except that it is not used in Subpart E—Emulsifying Agents
meats; in food recognized as a source of
vitamin B1; on fruits or vegetables in-
[Reserved]
tended to be served raw to consumers
or sold raw to consumers, or to be pre- Subpart F—Dietary Supplements
sented to consumers as fresh. [Reserved]
FR 25025, July 9, 1986; 55 FR 9833, Mar. 15, Subpart G—Sequestrants 1
1990; 59 FR 65939, Dec. 22, 1994]
§ 182.6085 Sodium acid phosphate.
§ 182.3795 Sodium sorbate. (a) Product. Sodium acid phosphate.
(a) Product. Sodium sorbate. (b) Conditions of use. This substance
(b) Conditions of use. This substance is generally recognized as safe when
is generally recognized as safe when used in accordance with good manufac-
used in accordance with good manufacturing practice.
turing practice.
§ 182.6197 Calcium diacetate.
§ 182.3798 Sodium sulfite. (a) Product. Calcium diacetate.
(a) Product. Sodium sulfite. (b) Conditions of use. This substance
(b) [Reserved] is generally recognized as safe when
(c) Limitations, restrictions, or expla- used in accordance with good manufac-
nation. This substance is generally rec- turing practice.
ognized as safe when used in accord-
ance with good manufacturing prac- 1 For the purpose of this subpart, no at-
tice, except that it is not used in tempt has been made to designate those
meats; in food recognized as a source of sequestrants that may also function as
vitamin B1; on fruits or vegetables in- chemical preservatives.
483
§ 182.6203 21 CFR Ch. I (4–1–15 Edition)
§ 182.6203 Calcium (b) Conditions of use. This substance

hexametaphosphate. is generally recognized as safe when
(a) Product. Calcium used in accordance with good manufac-
hexametaphosphate. turing practice.
§ 182.6787 Sodium pyrophosphate.
used in accordance with good manufac- (a) Product. Sodium pyrophosphate.
§ 182.6215 Monobasic calcium phos- used in accordance with good manufac-
phate. turing practice.
(a) Product. Monobasic calcium phos-
phate. § 182.6789 Tetra sodium
(b) Conditions of use. This substance pyrophosphate.
is generally recognized as safe when (a) Product. Tetra sodium
used in accordance with good manufac- pyrophosphate.
§ 182.6285 Dipotassium phosphate. used in accordance with good manufac-
(a) Product. Dipotassium phosphate. turing practice.
is generally recognized as safe when § 182.6810 Sodium tripolyphosphate.
used in accordance with good manufac- (a) Product. Sodium
turing practice. tripolyphosphate.
§ 182.6290 Disodium phosphate. is generally recognized as safe when
(a) Product. Disodium phosphate. used in accordance with good manufac-
(b) Conditions of use. This substance turing practice.
used in accordance with good manufac- Subpart H—Stabilizers
turing practice.
§ 182.7255 Chondrus extract.
§ 182.6757 Sodium gluconate.
(a) Product. Chondrus extract
(a) Product. Sodium gluconate. (carrageenin).
§ 182.6760 Sodium
hexametaphosphate. Subpart I—Nutrients
(a) Product. Sodium
hexametaphosphate. SOURCE: 45 FR 58838, Sept. 5, 1980, unless
(b) Conditions of use. This substance otherwise noted.
used in accordance with good manufac- § 182.8013 Ascorbic acid.
turing practice. (a) Product. Ascorbic acid.
§ 182.6769 Sodium metaphosphate. is generally recognized as safe when
(a) Product. Sodium metaphosphate. used in accordance with good manufac-
(b) Conditions of use. This substance turing practice.
used in accordance with good manufac- § 182.8159 Biotin.
turing practice. (a) Product. Biotin.
§ 182.6778 Sodium phosphate.

(a) Product. Sodium phosphate used in accordance with good manufac-
(mono-, di-, and tribasic). turing practice.
484
Food and Drug Administration, HHS Pt. 184
§ 182.8217 Calcium phosphate. § 182.8988 Zinc gluconate.

(a) Product. Calcium phosphate (a) Product. Zinc gluconate.
(mono-, di-, and tribasic). (b) Conditions of use. This substance
turing practice.
§ 182.8991 Zinc oxide.
§ 182.8223 Calcium pyrophosphate. (a) Product. Zinc oxide.
(a) Product. Calcium pyrophosphate. (b) Conditions of use. This substance
turing practice.
§ 182.8994 Zinc stearate.
§ 182.8250 Choline bitartrate. (a) Product. Zinc stearate prepared
(a) Product. Choline bitartrate. from stearic acid free from chickedema
(b) Conditions of use. This substance factor.
is generally recognized as safe when (b) Conditions of use. This substance
used in accordance with good manufac- is generally recognized as safe when
turing practice. used in accordance with good manufac-
turing practice.
§ 182.8252 Choline chloride.
§ 182.8997 Zinc sulfate.
(a) Product. Choline chloride.
(b) Conditions of use. This substance (a) Product. Zinc sulfate.
is generally recognized as safe when (b) Conditions of use. This substance
used in accordance with good manufac- is generally recognized as safe when
turing practice. used in accordance with good manufac-
turing practice.
§ 182.8778 Sodium phosphate.
(a) Product. Sodium phosphate PART 184—DIRECT FOOD SUB-
(mono-, di-, and tribasic). STANCES AFFIRMED AS GEN-
(b) Conditions of use. This substance ERALLY RECOGNIZED AS SAFE
used in accordance with good manufac- Subpart A—General Provisions
turing practice. Sec.
184.1 Substances added directly to human
§ 182.8890 Tocopherols. food affirmed as generally recognized as
(a) Product. Tocopherols. safe (GRAS).
is generally recognized as safe when Subpart B—Listing of Specific Substances
used in accordance with good manufac- Affirmed as GRAS
turing practice. 184.1005 Acetic acid.
184.1007 Aconitic acid.
§ 182.8892 α-Tocopherol acetate. 184.1009 Adipic acid.
(a) Product. a-Tocopherol acetate. 184.1011 Alginic acid.
184.1012 a-Amylase enzyme preparation
(b) Conditions of use. This substance from Bacillus stearothermophilus.
is generally recognized as safe when 184.1021 Benzoic acid.
used in accordance with good manufac- 184.1024 Bromelain.
turing practice. 184.1025 Caprylic acid.
184.1027 Mixed carbohydrase and protease
§ 182.8985 Zinc chloride. enzyme product.
184.1033 Citric acid.
(a) Product. Zinc chloride.
184.1034 Catalase (bovine liver).
(b) Conditions of use. This substance 184.1061 Lactic acid.
is generally recognized as safe when 184.1063 Enzyme-modified lecithin.

used in accordance with good manufac- 184.1065 Linoleic acid.
turing practice. 184.1069 Malic acid.
485
184.1077 Potassium acid tartrate. 184.1307 Ferric sulfate.
184.1081 Propionic acid. 184.1307a Ferrous ascorbate.
184.1090 Stearic acid. 184.1307b Ferrous carbonate.
184.1091 Succinic acid. 184.1307c Ferrous citrate.
184.1095 Sulfuric acid. 184.1307d Ferrous fumarate.
184.1097 Tannic acid. 184.1308 Ferrous gluconate.
184.1099 Tartaric acid. 184.1311 Ferrous lactate.
184.1101 Diacetyl tartaric acid esters of 184.1315 Ferrous sulfate.
mono- and diglycerides. 184.1316 Ficin.
184.1115 Agar-agar. 184.1317 Garlic and its derivatives.
184.1120 Brown algae. 184.1318 Glucono delta-lactone.
184.1121 Red algae. 184.1321 Corn gluten.
184.1133 Ammonium alginate. 184.1322 Wheat gluten.
184.1135 Ammonium bicarbonate. 184.1323 Glyceryl monooleate.
184.1137 Ammonium carbonate. 184.1324 Glyceryl monostearate.
184.1138 Ammonium chloride. 184.1328 Glyceryl behenate.
184.1139 Ammonium hydroxide. 184.1329 Glyceryl palmitostearate.
184.1140 Ammonium citrate, dibasic. 184.1330 Acacia (gum arabic).
184.1141a Ammonium phosphate, monobasic. 184.1333 Gum ghatti.
184.1141b Ammonium phosphate, dibasic. 184.1339 Guar gum.
184.1143 Ammonium sulfate. 184.1343 Locust (carob) bean gum.
184.1148 Bacterially-derived carbohydrase 184.1349 Karaya gum (sterculia gum).
enzyme preparation. 184.1351 Gum tragacanth.
184.1150 Bacterially-derived protease en- 184.1355 Helium.
zyme preparation. 184.1366 Hydrogen peroxide.
184.1155 Bentonite. 184.1370 Inositol.
184.1157 Benzoyl peroxide. 184.1372 Insoluble glucose isomerase enzyme
184.1165 n-Butane and iso-butane. preparations.
184.1185 Calcium acetate. 184.1375 Iron, elemental.
184.1187 Calcium alginate. 184.1386 Isopropyl citrate.
184.1191 Calcium carbonate. 184.1387 Lactase enzyme preparation from
184.1193 Calcium chloride. Candida pseudotropicalis.
184.1195 Calcium citrate. 184.1388 Lactase enzyme preparation from
184.1199 Calcium gluconate. Kluyveromyces lactis.
184.1201 Calcium glycerophosphate. 184.1400 Lecithin.
184.1205 Calcium hydroxide. 184.1408 Licorice and licorice derivatives.
184.1206 Calcium iodate. 184.1409 Ground limestone.
184.1207 Calcium lactate. 184.1415 Animal lipase.
184.1210 Calcium oxide. 184.1420 Lipase enzyme preparation derived
184.1212 Calcium pantothenate. from Rhizopus niveus.
184.1221 Calcium propionate. 184.1425 Magnesium carbonate.
184.1229 Calcium stearate. 184.1426 Magnesium chloride.
184.1230 Calcium sulfate. 184.1428 Magnesium hydroxide.
184.1240 Carbon dioxide. 184.1431 Magnesium oxide.
184.1245 Beta-carotene. 184.1434 Magnesium phosphate.
184.1250 Cellulase enzyme preparation de- 184.1440 Magnesium stearate.
rived from Trichoderma longibrachi- 184.1443 Magnesium sulfate.
atum. 184.1443a Malt.
184.1257 Clove and its derivatives. 184.1444 Maltodextrin.
184.1259 Cocoa butter substitute. 184.1445 Malt syrup (malt extract).
184.1260 Copper gluconate. 184.1446 Manganese chloride.
184.1261 Copper sulfate. 184.1449 Manganese citrate.
184.1262 Corn silk and corn silk extract. 184.1452 Manganese gluconate.
184.1265 Cuprous iodide. 184.1461 Manganese sulfate.
184.1271 L-Cysteine. 184.1472 Menhaden oil.
184.1272 L-Cysteine monohydrochloride. 184.1490 Methylparaben.
184.1277 Dextrin. 184.1498 Microparticulated protein product.
184.1278 Diacetyl. 184.1505 Mono- and diglycerides.
184.1282 Dill and its derivatives. 184.1521 Monosodium phosphate derivatives
184.1287 Enzyme-modified fats. of mono- and diglycerides.
184.1293 Ethyl alcohol. 184.1530 Niacin.
184.1295 Ethyl formate. 184.1535 Niacinamide.
184.1296 Ferric ammonium citrate. 184.1537 Nickel.
184.1297 Ferric chloride. 184.1538 Nisin preparation.
184.1298 Ferric citrate. 184.1540 Nitrogen.

184.1301 Ferric phosphate. 184.1545 Nitrous oxide.
184.1304 Ferric pyrophosphate. 184.1553 Peptones.
486
184.1555 Rapeseed oil. 184.1945 Vitamin B12.
184.1560 Ox bile extract. 184.1950 Vitamin D.
184.1563 Ozone. 184.1973 Beeswax (yellow and white).
184.1583 Pancreatin. 184.1976 Candelilla wax.
184.1585 Papain. 184.1978 Carnauba wax.
184.1588 Pectins. 184.1979 Whey.
184.1595 Pepsin.
184.1979a Reduced lactose whey.
184.1610 Potassium alginate.
184.1979b Reduced minerals whey.
184.1613 Potassium bicarbonate.
184.1619 Potassium carbonate. 184.1979c Whey protein concentrate.
184.1622 Potassium chloride. 184.1983 Bakers yeast extract.
184.1625 Potassium citrate. 184.1984 Zein.
184.1631 Potassium hydroxide. 184.1985 Aminopeptidase enzyme prepara-
184.1634 Potassium iodide. tion derived from lactococcus lactis.
184.1635 Potassium iodate. AUTHORITY: 21 U.S.C. 321, 342, 348, 371.
184.1639 Potassium lactate.
184.1643 Potassium sulfate. SOURCE: 42 FR 14653, Mar 15, 1977, unless
184.1655 Propane. otherwise noted.
184.1660 Propyl gallate.
184.1666 Propylene glycol.
part 184 appear at 66 FR 56035, Nov. 6, 2001, 66
184.1670 Propylparaben.
FR 66742, Dec. 27, 2001, 68 FR 15355, Mar. 31,
184.1676 Pyridoxine hydrochloride.
184.1685 Rennet (animal-derived) and 2003, 69 FR 13717, Mar. 24, 2004, 70 FR 40880,
chymosin preparation (fermentation-de- July 15, 2005, and 70 FR 67651, Nov. 8, 2005.
rived).
184.1695 Riboflavin. Subpart A—General Provisions
184.1697 Riboflavin-5′-phosphate (sodium).
184.1698 Rue. § 184.1 Substances added directly to
184.1699 Oil of rue. human food affirmed as generally
184.1702 Sheanut oil. recognized as safe (GRAS).
184.1721 Sodium acetate.
184.1724 Sodium alginate. (a) The direct human food ingredi-
184.1733 Sodium benzoate. ents listed in this part have been re-
184.1736 Sodium bicarbonate. viewed by the Food and Drug Adminis-
184.1742 Sodium carbonate. tration and determined to be generally
184.1751 Sodium citrate. recognized as safe (GRAS) for the pur-
184.1754 Sodium diacetate.
184.1763 Sodium hydroxide.
poses and under the conditions pre-
184.1764 Sodium hypophosphite. scribed. The regulations in this part
184.1768 Sodium lactate. shall sufficiently describe each ingre-
184.1769a Sodium metasilicate. dient to identify the characteristics of
184.1784 Sodium propionate. the ingredient that has been affirmed
184.1792 Sodium sesquicarbonate. as GRAS and to differentiate it from
184.1801 Sodium tartrate. other possible versions of the ingre-
184.1804 Sodium potassium tartrate.
dient that have not been affirmed as
184.1807 Sodium thiosulfate.
184.1835 Sorbitol. GRAS. Ingredients affirmed as GRAS
184.1845 Stannous chloride (anhydrous and in this part are also GRAS as indirect
dihydrated). human food ingredients, subject to any
184.1848 Starter distillate. limitations prescribed in parts 174, 175,
184.1851 Stearyl citrate 176, 177, 178 or § 179.45 of this chapter or
184.1854 Sucrose. in part 186 of this chapter. The purity
184.1857 Corn sugar. specifications in this part do not apply
184.1859 Invert sugar.
184.1865 Corn syrup. when the ingredient is used in indirect
184.1866 High fructose corn syrup. applications. However, when used in in-
184.1875 Thiamine hydrochloride. direct applications, the ingredient
184.1878 Thiamine mononitrate. must be of a purity suitable for its in-
184.1890 a-Tocopherols. tended use in accordance with
184.1901 Triacetin. § 170.30(h)(1) of this chapter.
184.1903 Tributyrin. (b) Any ingredient affirmed as GRAS
184.1911 Triethyl citrate.
in this part shall be used in accordance
184.1914 Trypsin.
184.1923 Urea. with current good manufacturing prac-
184.1924 Urease enzyme preparation from tice. For the purpose of this part, cur-
Lactobacillus fermentum. rent good manufacturing practice in-
184.1930 Vitamin A. cludes the requirements that a direct
487
§ 184.1 21 CFR Ch. I (4–1–15 Edition)
human food ingredient be of appro- eral evaluation of use of the ingredient,

priate food grade; that it be prepared other uses may also be GRAS.
and handled as a food ingredient; and (c) The listing of a food ingredient in
that the quantity of the ingredient this part does not authorize the use of
added to food does not exceed the such substance in a manner that may
amount reasonably required to accom- lead to deception of the consumer or to
plish the intended physical, nutri- any other violation of the Federal
tional, or other technical effect in Food, Drug, and Cosmetic Act (the
food. Act).
(1) If the ingredient is affirmed as (d) The listing of more than one in-
GRAS with no limitations on its condi- gredient to produce the same techno-
tions of use other than current good logical effect does not authorize use of
manufacturing practice, it shall be re- a combination of two or more ingredi-
garded as GRAS if its conditions of use ents to accomplish the same techno-
are consistent with the requirements of logical effect in any one food at a com-
paragraph (b), (c), and (d) of this sec- bined level greater than the highest
tion. When the Food and Drug Admin- level permitted for one of the ingredi-
istration (FDA) determines that it is ents.
appropriate, the agency will describe (e) If the Commissioner of Food and
one or more current good manufac- Drugs is aware of any prior sanction
turing practice conditions of use in the
for use of an ingredient under condi-
regulation that affirms the GRAS sta-
tions different from those proposed to
tus of the ingredient. For example,
be affirmed as GRAS, he will concur-
when the safety of an ingredient has
rently propose a separate regulation
been evaluated on the basis of limited
covering such use of the ingredient
conditions of use, the agency will de-
under part 181 of this chapter. If the
scribe in the regulation that affirms
Commissioner is unaware of any such
the GRAS status of the ingredient, one
applicable prior sanction, the proposed
or more of these limited conditions of
regulation will so state and will re-
use, which may include the category of
quire any person who intends to assert
food(s), the technical effect(s) or func-
tional use(s) of the ingredient, and the or rely on such sanction to submit
level(s) of use. If the ingredient is used proof of its existence. Any regulation
under conditions that are significantly promulgated pursuant to this section
different from those described in the constitutes a determination that ex-
regulation, that use of the ingredient cluded uses would result in adultera-
may not be GRAS. In such a case, a tion of the food in violation of section
manufacturer may not rely on the reg- 402 of the Act, and the failure of any
ulation as authorizing that use but person to come forward with proof of
shall independently establish that that such an applicable prior sanction in re-
use is GRAS or shall use the ingredient sponse to the proposal will constitute a
in accordance with a food additive reg- waiver of the right to assert or rely on
ulation. Persons seeking FDA approval such sanction at any later time. The
of an independent determination that a notice will also constitute a proposal
use of an ingredient is GRAS may sub- to establish a regulation under part 181
mit a GRAS petition in accordance of this chapter, incorporating the same
with § 170.35 of this chapter. provisions, in the event that such a
(2) If the ingredient is affirmed as regulation is determined to be appro-
GRAS with specific limitation(s), it priate as a result of submission of proof
shall be used in food only within such of such an applicable prior sanction in
limitation(s), including the category of response to the proposal.
food(s), the functional use(s) of the in- (f) The label and labeling of the in-
gredient, and the level(s) of use. Any gredient and any intermediate mix of
use of such an ingredient not in full the ingredient for use in finished food
compliance with each such established shall bear, in addition to the other la-
limitation shall require a food additive beling required by the Act:
regulation. (1) The name of the ingredient, ex-

(3) If the ingredient is affirmed as cept where exempted from such label-
GRAS for a specific use, without a gen- ing in part 101 of this chapter.
488
(2) A statement of concentration of ufacturing practice in accordance with

the ingredient in any intermediate § 184.1(b)(1). Current good manufac-
mix; or other information to permit a turing practice results in a maximum
food processor independently to deter- level as served, of 0.25 percent for
mine that use of the ingredients will be baked goods as defined in § 170.3(n)(1) of
in accordance with any limitations and this chapter; 0.8 percent for cheeses as
good manufacturing practice gudelines defined in § 170.3(n)(5) of this chapter
prescribed. and dairy product analogs as defined in
(3) Adequate directions for use to § 170.3(n)(10) of this chapter; 0.5 percent
provide a final food product that com- for chewing gum as defined in
plies with any limitations prescribed § 170.3(n)(6) of this chapter; 9.0 percent
for the ingredient(s). for condiments and relishes as defined
in § 170.3(n)(8) of this chapter; 0.5 per-
FR 55205, Oct. 14, 1977; 48 FR 48457, 48459, Oct. cent for fats and oils as defined in
19, 1983; 62 FR 15110, Mar. 31, 1997] § 170.3(n)(12) of this chapter; 3.0 percent
for gravies and sauces as defined in
Subpart B—Listing of Specific § 170.3(n)(24) of this chapter; 0.6 percent
for meat products as defined in
Substances Affirmed as GRAS § 170.3(n)(29) of this chapter; and 0.15
§ 184.1005 Acetic acid. percent or less for all other food cat-
egories. The ingredient may also be
(a) Acetic acid (C2H4O2, CAS Reg. No. used in boiler water additives at levels
64–19–7) is known as ethanoic acid. It not to exceed current good manufac-
occurs naturally in plant and animal turing practice.
tissues. It is produced by fermentation (e) Prior sanctions for this ingredient
of carbohydrates or by organic syn- different from the uses established in
thesis. The principal synthetic meth- this section do not exist or have been
ods currently employed are oxidation waived.
of acetaldehyde derived from ethylene,
liquid phase oxidation of butane, and [47 FR 27814, June 25, 1982]
reaction of carbon monoxide with
methanol derived from natural gas. § 184.1007 Aconitic acid.
(b) The ingredient meets the speci- (a) Aconitic acid (1,2,3-
fications of the Food Chemicals Codex, propenetricarboxylic acid (C6H6O6),
3d Ed. (1981), p. 8, which is incorporated CAS Reg. No. 000499–12–7) occurs in the
by reference. Copies are available from leaves and tubers of Aconitum napellus
the National Academy Press, 2101 Con- L. and other Ranunculaceae.
stitution Ave. NW., Washington, DC Transaconitic acid can be isolated dur-
20418, or available for inspection at the ing sugarcane processing, by precipita-
National Archives and Records Admin- tion as the calcium salt from cane
istration (NARA). For information on sugar or molasses. It may be syn-
the availability of this material at thesized by sulfuric acid dehydration of
NARA, call 202–741–6030, or go to: http:// citric acid, but not by the
www.archives.gov/federallregister/ methanesulfonic acid method.
codeloflfederallregulations/ (b) The ingredient meets the fol-
ibrllocations.html. lowing specifications:
(c) The ingredient is used as a curing (1) Assay. Not less than 98.0 percent
and pickling agent as defined in of C3H3(COOH)3, using the ‘‘Food
§ 170.3(o)(5) of this chapter; flavor Chemicals Codex,’’ 4th ed. (1996), pp.
enhancer as defined in § 170.3(o)(11) of 102–103, test for citric acid, which is in-
this chapter; flavoring agent and adju- corporated by reference in accordance
vant as defined in § 170.3(o)(12) of this with 5 U.S.C. 552(a) and 1 CFR part 51,
chapter; pH control agent as defined in and a molecular weight of 174.11. Copies
§ 170.3(o)(23) of this chapter; as a sol- of the material incorporated by ref-
vent and vehicle as defined in erence are available from the National
§ 170.3(o)(27) of this chapter; and as a Academy Press, Box 285, 2101 Constitu-
boiler water additive complying with tion Ave. NW., Washington, DC 20055
§ 173.310 of this chapter. (Internet address http://www.nap.edu),

(d) The ingredient is used in food at or may be examined at the Center for
levels not to exceed current good man- Food Safety and Applied Nutrition’s
489
§ 184.1009 21 CFR Ch. I (4–1–15 Edition)
Library, Food and Drug Administra- this section do not exist or have been
tion, 5100 Paint Branch Pkwy., College waived.
Park, MD 20740, or at the National Ar- [43 FR 47724, Oct. 17, 1978, as amended at 49
chives and Records Administration FR 5610, Feb. 14, 1984; 64 FR 1759, Jan. 12,
(NARA). For information on the avail- 1999]
202–741–6030, or go to: http:// § 184.1009 Adipic acid.
www.archives.gov/federallregister/ (a) Adipic acid (C6H10O4, CAS Reg.
codeloflfederallregulations/ No. 00124–04–9) is also known as 1,4-
ibrllocations.html. butanedicarboxylic acid or hexane-
(2) Melting point. Not less than 195 °C dioic acid. It is prepared by nitric acid
and the determination results in de- oxidation of cyclohexanol or
composition of aconitic acid. cyclohexanone or a mixture of the two.
(b) The ingredient meets the speci-
(3) Heavy metals (as Pb). Not more
fications of the Food Chemicals Codex,
than 10 parts per million. 3d Ed. (1981), p. 11, which is incor-
(4) Arsenic (as As). Not more than 3 porated by reference (Copies are avail-
parts per million. able from the National Academy Press,
(5) Oxalate. Passes test. 2101 Constitution Ave., NW., Wash-
(6) Readily carbonizable substances. ington, DC 20418, or available for in-
Passes the test for citric acid of the spection at the National Archives and
‘‘Food Chemicals Codex,’’ 4th ed. (1996), Records Administration (NARA). For
pp. 102–103, which is incorporated by information on the availability of this
reference in accordance with 5 U.S.C. material at NARA, call 202–741–6030, or
552(a) and 1 CFR part 51. The avail- go to: http://www.archives.gov/
ability of this incorporation by ref- federallregister/
erence is given in paragraph (b)(1) of codeloflfederallregulations/
this section. ibrllocations.html.), and the following
(7) Residue on ignition. Not more than additional specifications:
(1) The adipic acid is converted to its
0.1 percent as determined by the ‘‘Food
corresponding amide. The amide is pu-
Chemicals Codex,’’ 4th ed. (1996), pp.
rified by recrystallization from water
102–103, test for citric acid, which is in-
or aqueous ethanol. The melting range
corporated by reference in accordance of the amide is 219° to 220 °C.
with 5 U.S.C. 552(a) and 1 CFR part 51. (2) The adipic acid is converted to its
The availability of this incorporation corresponding bis-p-p-bromophenacyl
by reference is given in paragraph ester. The ester is purified by recrys-
(b)(1) of this section. tallization from ethanol. The melting
(c) The ingredient is used as a fla- range of the ester is 153° to 154 °C.
voring substance and adjuvant as de- (c) The ingredient is used as a fla-
fined in § 170.3(o)(12) of this chapter. voring agent as defined in § 170.3(o)(12)
(d) The ingredient is used in food, in of this chapter; leavening agent as de-
accordance with § 184.1(b)(1), at levels fined in § 170.3(o)(17) of this chapter;
not to exceed good manufacturing and pH control agent as defined in
practice. Current good manufacturing § 170.3(o)(23) of this chapter.
practice results in a maximum level, as (d) The ingredient is used in foods at
served, of 0.003 percent for baked goods levels not to exceed current good man-
as defined in § 170.3(n)(1) of this chap- ufacturing practice in accordance with
ter, 0.002 percent for alcoholic bev- § 184.1(b)(1). Current good manufac-
erages as defined in § 170.3(n)(2) of this turing practice results in maximum
levels, as served, of 0.05 percent for
chapter, 0.0015 percent for frozen dairy
baked goods as defined in § 170.3(n)(1) of
products as defined in § 170.3(n)(20) of
this chapter; 0.005 percent for non-
this chapter, 0.0035 percent for soft alcoholic beverages as defined in
candy as defined in § 170.3(n)(38) of this § 170.3(n)(3) of this chapter; 5.0 percent
chapter, and 0.0005 percent or less for for condiments and relishes as defined
all other food categories.

(e) Prior sanctions for this ingredient cent for dairy product analogs as de-
different from the uses established in fined in § 170.3(n)(10) of this chapter; 0.3
490
percent for fats and oil as defined in this section do not exist or have been
§ 170.3(n)(12) of this chapter; 0.0004 per- waived.
cent for frozen dairy desserts as defined
[47 FR 47375, Oct. 26, 1982]
cent for gelatin and puddings as de- § 184.1012 α-Amylase enzyme prepara-
fined in § 170.3(n)(22) of this chapter; 0.1 tion from Bacillus
percent for gravies as defined in stearothermophilus.
§ 170.3(n)(24) of this chapter; 0.3 percent
for meat products as defined in (a) a-Amylase enzyme preparation is
§ 170.3(n)(29) of this chapter; 1.3 percent obtained from the culture filtrate that
for snack foods as defined in results from a pure culture fermenta-
§ 170.3(n)(37) of this chapter; and 0.02 tion of a nonpathogenic and
percent or less for all other food cat- nontoxicogenic strain of Bacillus
egories. stearothermophilus. Its characterizing
(e) Prior sanctions for adipic acid dif- enzyme activity is a-amylase (1,4 a-D
ferent from the uses established in this glucan glucanohydrolase (E.C. 3.2.1.1)).
section do not exist or have been (b) The ingredient meets the general
waived. and additional requirements for en-
[47 FR 27810, June 25, 1982] zyme preparations in the ‘‘Food Chemi-
cals Codex,’’ 3d ed. (1981), pp. 107–110,
§ 184.1011 Alginic acid. which is incorporated by reference in
(a) Alginic acid is a colloidal, hydro- accordance with 5 U.S.C. 552(a) and 1
philic polysaccharide obtained from CFR part 51. Copies are available from
certain brown algae by alkaline extrac- the National Academy Press, 2101 Con-
tion. stitution Ave. NW., Washington, DC
(b) The ingredient meets the speci- 20418, or may be examined at the Office
fications of the Food Chemicals Codex, Food Additive Safety (HFS–200), Center
3d Ed. (1981), p. 13, which is incor- for Food Safety and Applied Nutrition,
porated by reference. Copies are avail- Food and Drug Administration, 5100
able from the National Academy Press, Paint Branch Pkwy., College Park, MD
2101 Constitution Ave. NW., Wash- 20740, 240–402–1200, or at the National
ington, DC 20418, or available for in- Archives and Records Administration
spection at the National Archives and (NARA). For information on the avail-
Records Administration (NARA). For ability of this material at NARA, call
information on the availability of this 202–741–6030, or go to: http://
material at NARA, call 202–741–6030, or www.archives.gov/federallregister/
go to: http://www.archives.gov/ codeloflfederallregulations/
federallregister/
ibrllocations.html.
(c) In accordance with § 184.1(b)(1),
ibrllocations.html.
(c) In accordance with § 184.1(b)(2), the ingredient is used in food with no
the ingredient is used in food only limitation other than current good
within the following specific limita- manufacturing practices. The affirma-
tions: tion of this ingredient as GRAS as a di-
rect human food ingredient is based
Maximum level of upon the following current good manu-
Category of food use in food (as Functional use
served) facturing practice conditions of use:
(1) The ingredient is used as an en-
Soup and soup Not to exceed cur- Emulsifier, emulsi-
mixes, rent good manu- fier salt, zyme, as defined in § 170.3(o)(9) of this
§ 170.3(n) (40) facturing prac- § 170.3(o)(8) of chapter, in the hydrolysis of edible
of this chapter. tice. this chapter; for- starch to produce maltodextrins and
mulation aid,
§ 170.3(o)(14) of nutritive carbohydrate sweeteners.
this chapter; sta- (2) The ingredient is used at levels
bilizer, thickener,
§ 170.3(o)(28) of
not to exceed current good manufac-
this chapter. turing practices.
[60 FR 55789, Nov. 3, 1995, as amended at 78

(d) Prior sanctions for this ingredient FR 14666, Mar. 7, 2013]
different from the use established in
491
§ 184.1021 21 CFR Ch. I (4–1–15 Edition)
§ 184.1021 Benzoic acid. acterizing enzyme activity is that of a

peptide hydrolase (EC 3.4.22.32).
(a) Benzoic acid is the chemical
(b) The ingredient meets the general
benzenecarboxylic acid (C7H6O2), occur-
requirements and additional require-
ring in nature in free and combined
ments for enzyme preparations in the
forms. Among the foods in which ben-
Food Chemicals Codex, 3d ed. (1981), p.
zoic acid occurs naturally are cran-
110, which is incorporated by reference
berries, prunes, plums, cinnamon, ripe
in accordance with 5 U.S.C. 552(a) and 1
cloves, and most berries. Benzoic acid CFR part 51. Copies are available from
is manufactured by treating molten the National Academy Press, 2101 Con-
phthalic anhydride with steam in the stitution Ave. NW., Washington, DC, or
presence of a zinc oxide catalyst, by may be examined at Office of Food Ad-
the hydrolysis of benzotrichloride, or ditive Safety (HFS–200), Center for
by the oxidation of toluene with nitric Food Safety and Applied Nutrition,
acid or sodium bichromate or with air Food and Drug Administration, 5100
in the presence of a transition metal Paint Branch Pkwy., College Park, MD
salt catalyst. 20740, 240–402–1200, and at the National
(b) The ingredient meets the speci- Archives and Records Administration
fications of the ‘‘Food Chemicals (NARA). For information on the avail-
Codex,’’ 3d Ed. (1981), p. 35, which is in- ability of this material at NARA, call
corporated by reference. Copies may be 202–741–6030, or go to: http://
obtained from the National Academy www.archives.gov/federallregister/
Press, 2101 Constitution Ave. NW., codeloflfederallregulations/
Washington, DC 20418, or may be exam- ibrllocations.html.
ined at the National Archives and (c) In accordance with § 184.1(b)(1),
Records Administration (NARA). For the ingredient is used in food with no
information on the availability of this limitation other than current good
material at NARA, call 202–741–6030, or manufacturing practice. The affirma-
go to: http://www.archives.gov/ tion of this ingredient as GRAS as a di-
federallregister/ rect food ingredient is based upon the
codeloflfederallregulations/ following current good manufacturing
ibrllocations.html. practice conditions of use:
(c) The ingredient is used as an anti- (1) The ingredient is used as an en-
microbial agent as defined in zyme as defined in § 170.3(o)(9) of this
§ 170.3(o)(2) of this chapter, and as a fla- chapter to hydrolyze proteins or
voring agent and adjuvant as defined in polypeptides.
§ 170.3(o)(12) of this chapter. (2) The ingredient is used in food at
(d) The ingredient is used in food at levels not to exceed current good man-
levels not to exceed good manufac- ufacturing practice.
turing practice. Current usage results
in a maximum level of 0.1 percent in
FR 14666, Mar. 7, 2013]
food. (The Food and Drug Administra-
tion has not determined whether sig- § 184.1025 Caprylic acid.
nificantly different conditions of use
(a) Caprylic acid [CH3(CH2)6COOH,
would be GRAS).
CAS Reg. No. 124–07–2] is the chemical
(e) Prior sanctions for this ingredient
name for octanoic acid. It is considered
different from those uses established in
to be a short or medium chain fatty
this section, or different from that set
acid. It occurs normally in various
forth in part 181 of this chapter, do not
foods and is commercially prepared by
exist or have been waived.
oxidation of n-octanol or by fermenta-
[42 FR 14653, Mar. 15, 1977, as amended at 49 tion and fractional distillation of the
FR 5610, Feb. 14, 1984] volatile fatty acids present in coconut
oil.
§ 184.1024 Bromelain. (b) The ingredient meets the speci-
(a) Bromelain (CAS Reg. No. 9001–00– fications of the ‘‘Food Chemicals
7) is an enzyme preparation derived Codex,’’ 3d Ed. (1981), p. 207, which is in-
from the pineapples Ananas comosus corporated by reference. Copies may be

and A. bracteatus L. It is a white to obtained from the National Academy
light tan amorphous powder. Its char- Press, 2101 Constitution Ave. NW.,
492
Washington, DC 20418, or may be exam- material at NARA, call 202–741–6030, or

ined at the National Archives and go to: http://www.archives.gov/
Records Administration (NARA). For federallregister/
information on the availability of this codeloflfederallregulations/
material at NARA, call 202–741–6030, or ibrllocations.html.
go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1),
federallregister/ the ingredient is used in food with no
codeloflfederallregulations/ limitation other than current good
ibrllocations.html. manufacturing practice. The affirma-
(c) The ingredient is used as a fla- tion of this ingredient as generally rec-
voring agent and adjuvant as defined in ognized as safe as a direct human food
§ 170.3(o)(12) of this chapter. ingredient is based upon the following
(d) The ingredient is used in foods in current good manufacturing practice
accordance with § 184.1(b)(1), at levels conditions of use:
not to exceed good manufacturing (1) The ingredient is used as an en-
practice. Current good manufacturing zyme, as defined in § 170.3(o)(9) of this
practices result in maximum levels, as chapter, to hydrolyze proteins or car-
served, of: 0.013 percent for baked goods bohydrates.
as defined in § 170.3(n)(1) of this chap- (2) The ingredient is used in the fol-
ter; 0.04 percent for cheeses as defined lowing foods at levels not to exceed
in § 170.3(n)(5) of this chapter; 0.005 per- current good manufacturing practice:
cent for fats and oils as defined in alcoholic beverages, as defined in
§ 170.3(n)(12) of this chapter, for frozen § 170.3(n)(2) of this chapter, candy, nu-
dairy desserts as defined in § 170.3(n)(20) tritive sweeteners, and protein
of this chapter, for gelatins and pud- hydrolyzates.
dings as defined in § 170.3(n)(22) of this [48 FR 240, Jan. 4, 1983]
chapter, for meat products as defined
in § 170.3(n)(29) of this chapter, and for § 184.1033 Citric acid.
soft candy as defined in § 170.3(n)(38) of (a) Citric acid (C6H8O7, CAS Reg. No.
this chapter; 0.016 percent for snack 77–92–9) is the compound 2-hydroxy-
foods as defined in § 170.3(n)(37) of this 1,2,3-propanetricarboxylic acid. It is a
chapter; and 0.001 percent or less for all naturally occurring constituent of
other food categories. plant and animal tissues. It occurs as
(e) Prior sanctions for this ingredient colorless crystals or a white powder
different from the uses established in and may be anhydrous or contain one
this section do not exist or have been mole of water per mole of citric acid.
waived. Citric acid may be produced by recov-
[43 FR 19843, May 9, 1978, as amended at 49 ery from sources such as lemon or pine-
FR 5611, Feb. 14, 1984] apple juice; by mycological fermenta-
tion using Candida spp., described in
§ 184.1027 Mixed carbohydrase and §§ 173.160 and 173.165 of this chapter; and
protease enzyme product. by the solvent extraction process de-
(a) Mixed carbohydrase and protease scribed in § 173.280 of this chapter for
enzyme product is an enzyme prepara- the recovery of citric acid from Asper-
tion that includes carbohydrase and gillus niger fermentation liquor.
protease activity. It is obtained from (b) The ingredient meets the speci-
the culture filtrate resulting from a fications of the Food Chemicals Codex,
pure culture fermentation of a non- 3d ed. (1981), pp. 86–87, and its third sup-
pathogenic strain of B. licheniformis. plement (March 1992), pp. 107–108, which
(b) The ingredient meets the speci- are incorporated by reference in ac-
fications of the Food Chemicals Codex, cordance with 5 U.S.C. 552(a) and 1 CFR
3d Ed. (1981), p. 107, which is incor- part 51. Copies are available from the
porated by reference. Copies are avail- National Academy Press, 2101 Constitu-
able from the National Academy Press, tion Ave. NW., Washington, DC 20418,
2101 Constitution Ave. NW., Wash- and the Center for Food Safety and Ap-
ington, DC 20418, or available for in- plied Nutrition (HFS–200), 5100 Paint
spection at the National Archives and Branch Pkwy., College Park, MD 20740,
Records Administration (NARA). For or may be examined at the National
information on the availability of this Archives and Records Administration
493
§ 184.1034 21 CFR Ch. I (4–1–15 Edition)
(NARA). For information on the avail- (2) The ingredient is used in food at
ability of this material at NARA, call levels not to exceed current good man-
202–741–6030, or go to: http:// ufacturing practice.
FR 24512, May 4, 2004; 78 FR 14666, Mar. 7,
ibrllocations.html. 2013]
the ingredient is used in food with no § 184.1061 Lactic acid.
limitations other than current good
(a) Lactic acid (C3H6O3, CAS Reg.
Nos.: DL mixture, 598–82–3; L-isomer, 79–
(d) Prior sanctions for this ingredient
33–4; D-isomer, 10326–41–7), the chemical
different from the uses established in
2-hydroxypropanoic acid, occurs natu-
this section do not exist or have been
rally in several foods. It is produced
waived.
commercially either by fermentation
[59 FR 63895, Dec. 12, 1994] of carbohydrates such as glucose, su-
crose, or lactose, or by a procedure in-
§ 184.1034 Catalase (bovine liver). volving formation of lactonitrile from
(a) Catalase (bovine liver) (CAS Reg. acetaldehyde and hydrogen cyanide
No. 81457–95–6) is an enzyme prepara- and subsequent hydrolysis to lactic
tion obtained from extracts of bovine acid.
liver. It is a partially purified liquid or (b) The ingredient meets the speci-
powder. Its characterizing enzyme ac- fications of the Food Chemicals Codex,
tivity is catalase (EC 1.11.1.6). 3d Ed. (1981), p. 159, which is incor-
(b) The ingredient meets the general porated by reference. Copies are avail-
requirements and additional require- able from the National Academy Press,
ments for enzyme preparations in the 2101 Constitution Avenue, NW., Wash-
Food Chemicals Codex, 3d ed. (1981), p. ington, DC 20418, or available for in-
110, which is incorporated by reference spection at the National Archives and
in accordance with 5 U.S.C. 552(a) and 1 Records Administration (NARA). For
CFR part 51. Copies are available from information on the availability of this
the National Academy Press, 2101 Con- material at NARA, call 202–741–6030, or
stitution Ave., NW., Washington, DC go to: http://www.archives.gov/
20418, or may be examined at the Office federallregister/
of Food Additive Safety (HFS–200), codeloflfederallregulations/
Center for Food Safety and Applied Nu- ibrllocations.html.
trition, Food and Drug Administration,
the ingredient is used in food with no
MD 20740, 240–402–1200, and at the Na-
limitation other than current good
manufacturing practice. The affirma-
the availability of this material at tion of this ingredient as generally rec-
NARA, call 202–741–6030, or go to: http:// ognized as safe (GRAS) as a direct
www.archives.gov/federallregister/ human food ingredient is based upon
codeloflfederallregulations/ the following current good manufac-
ibrllocations.html. turing practice conditions of use:
(c) In accordance with § 184.1(b)(1), (1) The ingredient is used as an anti-
the ingredient is used in food with no microbial agent as defined in
limitation other than current good § 170.3(o)(2) of this chapter; a curing and
manufacturing practice. The affirma- pickling agent as defined in § 170.3(o)(5)
tion of this ingredient as GRAS as a di- of this chapter; a flavor enhancer as de-
rect food ingredient is based upon the fined in § 170.3(o)(11) of this chapter; a
following current good manufacturing flavoring agent and adjuvant as defined
practice conditions of use: in § 170.3(o)(12) of this chapter; a pH
(1) The ingredient is used as an en- control agent as defined in § 170.3(o)(23)
zyme as defined in § 170.3(o)(9) of this of this chapter; and a solvent and vehi-
chapter to decompose hydrogen per- cle as defined in § 170.3(o)(27) of this
oxide. chapter.
494
(2) The ingredient is used in food, ex- Copies are available from the Office of
cept in infant foods and infant for- Food Additive Safety (HFS–200), Center
mulas, at levels not to exceed current for Food Safety and Applied Nutrition,
good manufacturing practice. Food and Drug Administration, 5100
(d) Prior sanctions for this ingredient Paint Branch Pkwy., College Park, MD
different from the uses established in 20740, 240–402–1200, or may be examined
this section do not exist or have been at the Center for Food Safety and Ap-
waived. plied Nutrition’s Library, 5100 Paint
[49 FR 35367, Sept. 7, 1984] Branch Pkwy., College Park, MD 20740,
or at the National Archives and
§ 184.1063 Enzyme-modified lecithin. Records Administration (NARA). For
(a) Enzyme-modified lecithin is pre- information on the availability of this
pared by treating lecithin with either material at NARA, call 202–741–6030, or
phospholipase A2 (EC 3.1.1.4) or pan- go to: http://www.archives.gov/
creatin. federallregister/
(b) The ingredient meets the speci- codeloflfederallregulations/
fications in paragraphs (b)(1) through ibrllocations.html.
(b)(8) of this section. Unless otherwise (c) In accordance with § 184.1(b)(1),
noted, compliance with the specifica- the ingredient is used in food with no
tions listed below is determined ac- limitation other than current good
cording to the methods set forth for manufacturing practice. The affirma-
lecithin in the Food Chemicals Codex, tion of this ingredient as generally rec-
4th ed. (1996), pp. 220–221, which are in- ognized as safe as a direct human food
corporated by reference in accordance ingredient is based upon the following
with 5 U.S.C. 552(a) and 1 CFR part 51. current good manufacturing practice
Copies are available from the National conditions of use:
Academy Press, 2101 Constitution Ave.
(1) The ingredient is used as an emul-
NW., Washington DC 20418, or may be
sifier as defined in § 170.3(o)(8) of this
examined at the Center for Food Safety
and Applied Nutrition’s Library, 5100 chapter.
Paint Branch Pkwy., College Park, MD (2) The ingredient is used at levels
20740, or at the National Archives and not to exceed current good manufac-
Records Administration (NARA). For turing practice.
information on the availability of this [61 FR 45889, Aug. 30, 1996, as amended at 78
material at NARA, call 202–741–6030, or FR 14666, Mar. 7, 2013]
federallregister/ § 184.1065 Linoleic acid.
codeloflfederallregulations/ (a) Linoleic acid ((Z, Z)–9, 12-octadec-
ibrllocations.html.
adienoic acid (C17H31COOH) (CAS Reg.
(1) Acetone-insoluble matter
No. 60–33–3)), a straight chain unsatu-
(phosphatides), not less than 50.0 per-
rated fatty acid with a molecular
cent.
weight of 280.5, is a colorless oil at
(2) Acid value, not more than 40.
(3) Lead, not more than 1.0 part per room temperature. Linoleic acid may
million, as determined by atomic ab- be prepared from edible fats and oils by
sorption spectroscopy. various methods including hydrolysis
(4) Heavy metals (as Pb), not more and saponification, the Twitchell
than 20 parts per million. method, low pressure splitting with
(5) Hexane-insoluble matter, not catalyst, continuous high pressure
more than 0.3 percent. counter current splitting, and medium
(6) Peroxide value, not more than 20. pressure autoclave splitting with cata-
(7) Water, not more than 4.0 percent. lyst.
(8) Lysolecithin, 50 to 80 mole percent (b) The ingredient must be of a pu-
of total phosphatides as determined by rity suitable for its intended use. The
‘‘Determination of Lysolecithin Con- ingredient must also meet the speci-
tent of Enzyme-Modified Lecithin: fications in § 172.860(b) of this chapter.
Method I,’’ dated 1985, which is incor- (c) In accordance with § 184.1(b)(1),
porated by reference in accordance the ingredient is used in food with no
with 5 U.S.C. 552(a) and 1 CFR part 51. limitation other than current good
495
§ 184.1069 21 CFR Ch. I (4–1–15 Edition)
manufacturing practice. The affirma- (d) The ingredients are used in food,
tion of this ingredient as generally rec- except baby food, at levels not to ex-
ognized as safe (GRAS) as a direct ceed good manufacturing practice in
human food ingredient is based upon accordance with § 184.1(b)(1). Current
the following current good manufac- good manufacturing practice results in
turing practice conditions of use: a maximum level, as served, of 3.4 per-
(1) The ingredient is used as a fla- cent for nonalcoholic beverages as de-
voring agent and adjuvant as defined in fined in § 170.3(n)(3) of this chapter; 3.0
§ 170.3(o)(12) of this chapter and as a nu- percent for chewing gum as defined in
trient supplement as defined in § 170.3(n)(6) of this chapter; 0.8 percent
§ 170.3(o)(20) of this chapter. for gelatins, puddings, and fillings as
(2) The ingredient is used in foods at defined in § 170.3(n)(22) of this chapter;
levels not to exceed current good man- 6.9 percent for hard candy as defined in
ufacturing practice. The ingredient § 170.3(n)(25) of this chapter; 2.6 percent
may be used in infant formula in ac- for jams and jellies as defined in
cordance with section 412(g) of the Fed- § 170.3(n)(28) of this chapter; 3.5 percent
eral Food, Drug, and Cosmetic Act (the for processed fruits and fruit juices as
act) or with regulations promulgated defined in § 170.3(n)(35) of this chapter;
under section 412(a)(2) of the act. 3.0 percent for soft candy as defined in
(d) Prior sanctions for this ingredient § 170.3(n)(38) of this chapter; and 0.7 per-
different from the uses established in cent for all other food categories.
(e) Prior sanctions for malic acid dif-
ferent from the uses established in this
waived.
section do not exist or have been
[49 FR 48534, Dec. 13, 1984, as amended at 73 waived.
FR 8606, Feb. 14, 2008]
[44 FR 20656, Apr. 6, 1979, as amended at 49
FR 5611, Feb. 14, 1984]
§ 184.1069 Malic acid.
(a) Malic acid (C4H6O5, CAS Reg. No. § 184.1077 Potassium acid tartrate.
of L-form 97–67–6, CAS Reg. No. of DL- (a) Potassium acid tartrate (C4H5KO6,
form 617–48–1) is the common name for CAS Reg. No. 868–14–4) is the potassium
1-hydroxy-1, 2-ethanedicarboxylic acid. acid salt of L¥(+)¥tartaric acid and is
L (+) malic acid, referred to as L-malic also called potassium bitartrate or
acid, occurs naturally in various foods. cream of tartar. It occurs as colorless
Racemic DL-malic acid does not occur or slightly opaque crystals or as a
naturally. It is made commercially by white, crystalline powder. It has a
hydration of fumaric acid or maleic pleasant, acid taste. It is obtained as a
acid. byproduct of wine manufacture.
(b) The ingredient meets the speci- (b) The ingredient meets the speci-
fications of the ‘‘Food Chemicals fications of the Food Chemicals Codex,
Codex,’’ 3d Ed. (1981), pp. 183–184, which 3d Ed. (1981), P. 238, which is incor-
is incorporated by reference. Copies porated by reference. Copies are avail-
may be obtained from the National able from the National Academy Press,
Academy Press, 2101 Constitution Ave. 2101 Constitution Ave. NW., Wash-
NW., Washington, DC 20418, or may be ington, DC 20418, or available for in-
examined at the National Archives and spection at the National Archives and
Records Administration (NARA). For Records Administration (NARA). For
information on the availability of this information on the availability of this
material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/ go to: http://www.archives.gov/
federallregister/ federallregister/
(c) The ingredients are used as a fla- (c) In accordance with § 184.1(b)(1),
vor enhancer as defined in § 170.3(o)(11) the ingredient is used in food with no
of this chapter, flavoring agent and ad- limitation other than current good
juvant as defined in § 170.3(o)(12) of this manufacturing practice. The affirma-

chapter, and pH control agent as de- tion of this ingredient as generally rec-
fined in § 170.3(o)(23) of this chapter. ognized as safe (GRAS) as a direct
496
human food ingredient is based upon (c) In accordance with § 184.1(b)(1),

the following current good manufac- the ingredient is used in food with no
turing practice conditions of use: limitation other than current good
(1) The ingredient is used as an manufacturing practice. The affirma-
anticaking agent as defined in tion of this ingredient as generally rec-
§ 170.3(o)(1) of this chapter; an anti- ognized as safe (GRAS) as a direct
microbial agent as defined in human food ingredient is based upon
§ 170.3(o)(2) of this chapter; a formula- the following current good manufac-
tion aid as defined in § 170.3(o)(14) of turing practice conditions of use:
this chapter; a humectant as defined in (1) The ingredient is used as an anti-
§ 170.3(o)(16) of this chapter; a leavening microbial agent as defined in
agent as defined in § 170.3(o)(17) of this § 170.3(o)(2) of this chapter and a fla-
chapter; A pH control agent as defined voring agent as defined in § 170.3(o)(12)
in § 170.3(o)(23) of this chapter; a proc- of this chapter.
essing aid as defined in § 170.3(o)(24) of (2) The ingredient is used in foods at
this chapter; a stabilizer and thickener levels not to exceed current good man-
as defined in § 170.3(o)(28) of this chap- ufacturing practice.
ter; and a surface-active agent as de- (d) Prior sanctions for this ingredient
fined in § 170.3(o)(29) of this chapter. different from the uses established in
(2) The ingredient is used in the fol- this section do not exist or have been
lowing foods at levels not to exceed waived.
current good manufacturing practice: [49 FR 13141, Apr. 3, 1984]
baked goods as defined in § 170.3(n)(1) of
this chapter; confections and frostings § 184.1090 Stearic acid.
as defined in § 170.3(n)(9) of this chap-
(a) Stearic acid (C18H36O2, CAS Reg.
ter; gelatins and puddings as defined in
No. 57–11–4) is a white to yellowish
§ 170.3(n)(22) of this chapter; hard candy
white solid. It occurs naturally as a
glyceride in tallow and other animal or
ter; jams and jellies as defined in
vegetable fats and oils and is a prin-
§ 170.3(n)(28) of this chapter; and soft
cipal constituent of most commercially
candy as defined in § 170.3(n)(38) of this
hydrogenated fats. It is produced com-
chapter.
mercially from hydrolyzed tallow de-
rived from edible sources or from
hydrolyzed, completely hydrogenated
vegetable oil derived from edible
waived.
sources.
[48 FR 52446, Nov. 18, 1983] (b) The ingredient meets the speci-
§ 184.1081 Propionic acid. 3d Ed. (1981), p. 313, which is incor-
(a) Propionic acid (C3H6O2, CAS Reg. porated by reference, and the require-
No. 79–09–4) is an oily liquid having a ments of § 172.860(b)(2) of this chapter.
slightly pungent, rancid odor. It is Copies of the Food Chemicals Codex
manufactured by chemical synthesis or are available from the National Acad-
by bacterial fermentation. emy Press, 2101 Constitution Ave. NW.,
(b) The ingredient meets the speci- Washington, DC 20418, or available for
fications of the Food Chemicals Codex, inspection at the National Archives
3d Ed. (1981), p. 254, which is incor- and Records Administration (NARA).
porated by reference. Copies are avail- For information on the availability of
able from the National Academy Press, this material at NARA, call 202–741–
2101 Constitution Ave. NW., Wash- 6030, or go to: http://www.archives.gov/
ington, DC 20418, or available for in- federallregister/
spection at the National Archives and codeloflfederallregulations/
Records Administration (NARA). For ibrllocations.html.
information on the availability of this (c) In accordance with § 184.1(b)(1),
material at NARA, call 202–741–6030, or the ingredient is used in food with no
go to: http://www.archives.gov/ limitation other than current good
federallregister/ manufacturing practice. The affirma-

codeloflfederallregulations/ tion of this ingredient as generally rec-
ibrllocations.html. ognized as safe (GRAS) as a direct
497
§ 184.1091 21 CFR Ch. I (4–1–15 Edition)
human food ingredient is based upon this section do not exist or have been
the following current good manufac- waived.
turing practice conditions of use: [44 FR 20657, Apr. 6, 1979, as amended at 49
(1) The ingredient is used as a fla- FR 5611, Feb. 14, 1984]
voring agent and adjuvant as defined in
§ 170.3(o)(12) of this chapter. § 184.1095 Sulfuric acid.
(2) The ingredient is used in foods at (a) Sulfuric acid (H2SO4, CAS Reg.
levels not to exceed current good man- No. 7664–93–9), also known as oil of vit-
ufacturing practice. riol, is a clear, colorless, oily liquid. It
(d) Prior sanctions for this ingredient is prepared by reacting sulfur dioxide
different from the uses established in (SO2) with oxygen and mixing the re-
this section do not exist or have been sultant sulfur trioxide (SO3) with
waived. water, or by reacting nitric oxide (NO)
with sulfur dioxide and water.
FR 49536, Dec. 3, 1985; 69 FR 24512, May 4,
2004] fications of the ‘‘Food Chemicals
Codex,’’ 3d Ed. (1981), pp. 317–318, which
§ 184.1091 Succinic acid. is incorporated by reference. Copies
may be obtained from the National
(a) Succinic acid (C4H6O4, CAS Reg. Academy Press, 2101 Constitution Ave.
No. 110–15–6), also referred to as amber NW., Washington, DC 20418, or may be
acid and ethylenesuccinic acid, is the examined at the National Archives and
chemical 1,4-butanedioic acid. It is Records Administration (NARA). For
commercially prepared by hydro- information on the availability of this
genation of maleic or fumaric acid. It material at NARA, call 202–741–6030, or
can also be produced by aqueous alkali go to: http://www.archives.gov/
or acid hydrolysis of succinonitrile. federallregister/
(b) The ingredient meets the speci- codeloflfederallregulations/
fications of the ‘‘Food Chemicals ibrllocations.html.
Codex,’’ 3d Ed. (1981), pp. 314–315, which (c) The ingredient is used as a pH
is incorporated by reference. Copies control agent as defined in § 170.3(o)(23)
may be obtained from the National of this chapter and processing aid as
Academy Press, 2101 Constitution Ave. defined in § 170.3(o)(24) of this chapter.
NW., Washington, DC 20418, or may be (d) The ingredient is used in food at
examined at the National Archives and levels not to exceed good manufac-
Records Administration (NARA). For turing practice in accordance with
information on the availability of this § 184.1(b)(1). Current good manufac-
material at NARA, call 202–741–6030, or turing practice results in a maximum
go to: http://www.archives.gov/ level, as served, of 0.014 percent for al-
federallregister/ coholic beverages as defined in
codeloflfederallregulations/ § 170.3(n)(2) of this chapter and 0.0003
ibrllocations.html. percent for cheeses as defined in
(c) The ingredient is used as a flavor § 170.3(n)(5) of this chapter.
enhancer as defined in § 170.3(o)(11) of (e) Prior sanctions for this ingredient
this chapter and pH control agent as different from the uses established in
defined in § 170.3(o)(23) of this chapter. this section do not exist or have been
(d) The ingredient is used in food at waived.
levels not to exceed good manufac- [45 FR 6085, Jan. 25, 1980, as amended at 49
turing practice in accordance with FR 5611, Feb. 14, 1984]
§ 184.1(b)(1). Current good manufac-
turing practice results in a maximum § 184.1097 Tannic acid.
level, as served, of 0.084 percent in con- (a) Tannic acid (CAS Reg. No. 1401–
diments and relishes as defined in 55–4), or hydrolyzable gallotannin, is a
§ 170.3(n)(8) of this chapter and 0.0061 complex polyphenolic organic struc-
percent in meat products as defined in ture that yields gallic acid and either
§ 170.3(n)(29) of this chapter.
glucose or quinic acid as hydrolysis

(e) Prior sanctions for this ingredient products. It is a yellowish-white to
different from the uses established in light brown substance in the form of an
498
amorphous, bulky powder, glistening porated by reference. Copies are avail-

scales, or spongy masses. It is also able from the National Academy Press,
ordorless, or has a faint characteristic 2101 Constitution Ave. NW., Wash-
odor, and has an astringent taste. Tan- ington, DC 20418, or available for in-
nic acid is obtained by solvent extrac- spection at the National Archives and
tion of nutgalls or excrescences that Records Administration (NARA). For
form on the young twigs of Quercus information on the availability of this
infectoria Oliver and related species of material at NARA, call 202–741–6030, or
Quercus. Tannic acid is also obtained go to: http://www.archives.gov/
by solvent extraction of the seed pods
federallregister/
of Tara (Caesalpinia spinosa) or the
nutgalls of various sumac species, in-
cluding Rhus semialata, R. coriaria, R. ibrllocations.html.
galabra, and R. typhia. (c)(1) In accordance with § 184.1(b)(2),
(b) The ingredient meets the speci- the ingredient is used in food only
fications of the Food Chemicals Codex, within the following specific limita-
3d Ed. (1981), p. 319, which is incor- tions:
Maximum
level of use
Category of food in food (as Functional use
served) (per-
cent)
Baked goods and baking mixes, § 170.3(n)(1) of this 0.01 Flavoring agent and adjuvant, § 170.3(o)(12) of this
chapter. chapter.
Alcoholic beverages, § 170.3(n)(2) of this chapter ......... 0.015 Flavor enhancer, § 170.3(o)(11) of this chapter; fla-
voring agent and adjuvant, § 170.3(o)(12) of this
chapter; processing aid, § 170.3(o)(24) of this chap-
ter.
Nonalcoholic beverages and beverage bases, 0.005 Flavoring agent and adjuvant, § 170.3(o)(12) of this
§ 170.3(n)(3) of this chapter and for gelatins, pud- chapter; pH control agent, § 170.3(o)(23) of this
dings, and fillings, § 170.3(n)(22) of this chapter. chapter.
Frozen dairy desserts and mixes, § 170.3(n)(20) of this 0.04 Flavoring agent and adjuvant, § 170.3(o)(12) of this
chapter and for soft candy, § 170.3(n)(38) of this chapter.
chapter.
Hard candy and cough drops, § 170.3(n)(25) of this 0.013 Do.
chapter.
Meat products, § 170.3(n)(29) of this chapter ................. 0.001 Do.
(2) Tannic acid may be used in ren- 3d Ed. (1981), P. 320, which is incor-
dered animal fat in accordance with 9 porated by reference. Copies are avail-
CFR 318.7. able from the National Academy Press,
(d) Prior sanctions for this ingredient 2101 Constitution Ave. NW., Wash-
different from the uses established in ington, DC 20418, or available for in-
this section do not exist or have been spection at the National Archives and
waived. Records Administration (NARA). For
[50 FR 21043, May 22, 1985] information on the availability of this
§ 184.1099 Tartaric acid. go to: http://www.archives.gov/
federallregister/
(a) Food grade tartaric acid (C4H6O6,
CAS Reg. No. 87–69–4) has the L con-
ibrllocations.html.
figuration. The L form of tartaric acid
is dextrorotatory in solution and is (c) In accordance with § 184.1(b)(1),
also known as L¥(+)¥tartaric acid. the ingredient is used in food with no
Tartaric acid occurs as colorless or limitation other than current good
translucent crystals or as a white, manufacturing practice. The affirma-
crystalline powder. It is odorless and tion of this ingredient as generally rec-
has an acid taste. It is obtained as a ognized as safe (GRAS) as a direct
human food ingredient is based upon
byproduct of wine manufacture.

(b) The ingredient meets the speci- the following current good manufac-
fications of the Food Chemicals Codex, turing practice conditions of use:
499
§ 184.1101 21 CFR Ch. I (4–1–15 Edition)
(1) The ingredient is used as a firm- the following current good manufac-
ing agent as defined in § 170.3(o)(10) of turing practice conditions of use:
this chapter; a flavor enhancer as de- (1) The ingredient is used in food as
fined in § 170.3(o)(11) of this chapter; a an emulsifier and emulsifier salt as de-
flavoring agent as defined in fined in § 170.3(o)(8) of this chapter and
§ 170.3(o)(12) of this chapter; a humec- a flavoring agent and adjuvant as de-
tant as defined in § 170.3(o)(16) of this fined in § 170.3(o)(12) of this chapter.
chapter; and a pH control agent as de- (2) The ingredient is used in the fol-
fined in § 170.3(o)(23) of this chapter. lowing foods at levels not to exceed
(2) The ingredient is used in foods at current good manufacturing practice:
levels not to exceed current good man- baked goods and baking mixes as de-
ufacturing practice. fined in § 170.3(n)(l) of this chapter;
(d) Prior sanctions for this ingredient nonalcoholic beverages as defined in
different from the uses established in § 170.3(n)(3) of this chapter; confections
this section do not exist or have been and frostings as defined in § 170.3(n)(9)
waived. of this chapter; dairy product analogs
[48 FR 52447, Nov. 18, 1983, as amended at 50 ter; and fats and oils as defined in
FR 49536, Dec. 3, 1985] § 170.3(n)(12) of this chapter.
§ 184.1101 Diacetyl tartaric acid esters different from the uses established in
of mono- and diglycerides.
(a) Diacetyl tartaric acid esters of waived.
mono- and diglycerides, also know as (e) Labeling: The acronym ‘‘DATEM’’
DATEM, are composed of mixed esters may be used on food labeling as the al-
of glycerin in which one or more of the ternate common or usual name for the
hydroxyl groups of glycerin has been ingredient diacetyl tartaric acid esters
esterified by diacetyl tartaric acid and of mono- and diglycerides.
by fatty acids. The ingredient is pre- [54 FR 7403, Feb. 21, 1989, as amended at 54
pared by the reaction of diacetyl tar- FR 13168, Mar. 31, 1989; 54 FR 18382, Apr. 28,
taric anhydride with mono- and 1989; 60 FR 15872, Mar. 28, 1995]
diglycerides that are derived from edi-
ble sources. § 184.1115 Agar-agar.
(b) The ingredient meets the speci- (a) Agar-agar (CAS Reg. No. PM 9002–
fications of the Food Chemicals Codex, 18–0) is a dried, hydrophyllic, colloidal
3d. Ed. (1981), pp. 98–99, which is incor- polysaccharide extracted from one of a
porated by reference in accordance number of related species of red algae
with 5 U.S.C. 552(a). Copies are avail- (class Rhodophyceae).
able from the National Academy Press, (b) The ingredient meets the speci-
2101 Constitution Avenue NW., Wash- fications of the ‘‘Food Chemicals
ington, DC 20418, or available for in- Codex,’’ 3d Ed. (1981), p. 11, which is in-
spection at the National Archives and corporated by reference. Copies may be
Records Administration (NARA). For obtained from the National Academy
information on the availability of this Press, 2101 Constitution Ave. NW.,
material at NARA, call 202–741–6030, or Washington, DC 20418, or may be exam-
go to: http://www.archives.gov/ ined at the National Archives and
federallregister/ Records Administration (NARA). For
codeloflfederallregulations/ information on the availability of this
ibrllocations.html. material at NARA, call 202–741–6030, or
(c) In accordance with § 184.1(b)(1), go to: http://www.archives.gov/
the ingredient is used in food with no federallregister/
limitation other than current good codeloflfederallregulations/
manufacturing practice. The affirma- ibrllocations.html.
tion of this ingredient as generally rec- (c) The ingredient is used in food in
ognized as safe (GRAS) as a direct accordance with § 184.1(b)(2) under the
human food ingredient is based upon following conditions:
500
MAXIMUM USAGE LEVELS PERMITTED

Foods (as served) Percent Functions
Baked goods and baking mixes, § 170.3(n)(1) of this chapter 0.8 Drying agent, § 170.3(o)(7) of this chapter; flavoring
agent, § 170.3(o)(12) of this chapter; stabilizer,
thickener, § 170.3(o)(28) of this chapter.
Confections and frostings, § 170.3(n)(9) of this chapter .......... 2.0 Flavoring agent, § 170.3(o)(12) of this chapter; sta-
bilizer, thickener, § 170.3(o)(28) of this chapter; sur-
face finisher, § 170.3(o)(30) of this chapter.
Soft candy, § 170.3(n)(38) of this chapter ............................... 1.2 Stabilizer and thickener, § 170.3(o)(28) of this chapter.
All other food categories .......................................................... .25 Flavoring agent, § 170.3(o)(12) of this chapter; formu-
lation aid, § 170.3(o)(14) of this chapter; humectant,
§ 170.3(o)(16) of this chapter; stabilizer, thickener,
§ 170.3(o)(28) of this chapter.
(d) Prior sanctions for this ingredient Maximum level of

Category of food use in food (as Functional use
different from the uses established in served)
Spices, Not to exceed cur- Flavor enhancer,
waived.
seasonings, and rent good manu- § 170.3(o)(11) of
[44 FR 19391, Apr. 3, 1979, as amended at 49 flavorings, facturing prac- this chapter; fla-
§ 170.3(n) (26) tice. vor adjuvant,
FR 5611, Feb. 14, 1984] of this chapter. § 170.3(o)(12) of
this chapter.
§ 184.1120 Brown algae.
(a) Brown algae are seaweeds of the (d) Prior sanctions for this ingredient
species Analipus japonicus, Eisenia different from the use established in
bicyclis, Hizikia fusiforme, Kjellmaniella this section do not exist or have been
waived.
gyrata, Laminaria angustata, Laminaria
claustonia, Laminaria digitata, Lam- [47 FR 47376, Oct. 26, 1982]
inaria japonica, Laminaria longicruris,
Laminaria longissima, Laminaria § 184.1121 Red algae.
ochotensis, Laminaria saccharina, (a) Red algae are seaweeds of the spe-
Macrocystis pyrifera, Petalonia fascia, cies Gloiopeltis furcata, Porphyra
Scytosiphon lomentaria and Undaria crispata, Porphyra deutata, Porphyra
pinnatifida. They are harvested prin- perforata, Porphyra suborbiculata,
cipally in coastal waters of the north- Porphyra tenera and Rhodymenia
ern Atlantic and Pacific oceans. The palmata. Porphyra and Rhodymenia are
harvested principally along the coasts
material is dried and ground or
of Japan, Korea, China, Taiwan, and
chopped for use in food. the East and West coasts of the United
(b) The ingredient meets the speci- States. Gloiopeltis is harvested prin-
fications for kelp in the Food Chemi- cipally in southern Pacific coastal
cals Codex, 3d Ed. (1981), p. 157, which is waters. The material is dried and
incorporated by reference. Copies are ground or chopped for use in food.
available from the National Academy (b) The ingredient meets the speci-
Press, 2101 Constitution Ave. NW., fications for kelp in the Food Chemi-
Washington, DC 20418, or available for cals Codex, 3d Ed. (1981), p. 157, which is
inspection at the National Archives incorporated by reference, except that
and Records Administration (NARA). the loss on drying is not more than 20
For information on the availability of percent and the maximum allowable
this material at NARA, call 202–741– level for iodine is 0.05 percent. Copies
6030, or go to: http://www.archives.gov/ are available from the National Acad-
federallregister/ emy Press, 2101 Constitution Ave. NW.,
codeloflfederallregulations/ Washington, DC 20418, or available for
inspection at the National Archives
ibrllocations.html.
and Records Administration (NARA).
(c) In accordance with § 184.1(b)(2), For information on the availability of
the ingredient is used in food only

within the following specific limita- 6030, or go to: http://www.archives.gov/
tions: federallregister/
501
§ 184.1133 21 CFR Ch. I (4–1–15 Edition)
codeloflfederallregulations/ Maximum
ibrllocations.html. level of
use in
(c) In accordance with § 184.1(b)(2), Category of food Functional use
food (as
the ingredient is used in food only served)
(percent)
within the following specific limita-
tions: Gelatins, puddings, 0.5 Do.
§ 170.3(n)(22) of this
Maximum level of chapter.
Category of food use in food (as Functional use Gravies and sauces, 0.4 Do.
served) § 170.3(n)(24) of this
chapter.
Spices, Not to exceed cur- Flavor enhancer, Jams and jellies, 0.4 Do.
seasonings, and rent good manu- § 170.3(o)(11) of § 170.3(n)(28) of this
flavorings, facturing prac- this chapter; fla- chapter.
§ 170.3(n) (26) tice. vor adjuvant, Sweet sauces, 0.5 Do.
of this chapter. § 170.3(o)(12) of § 170.3(n)(43) of this
this chapter. chapter.
All other food cat- 0.1 Humectant,
(d) Prior sanctions for this ingredient egories. § 170.3(o)(16) of this
different from the use established in chapter; stabilizer,
thickener,
this section do not exist or have been § 170.3(o)(28) of this
waived. chapter.
[47 FR 47376, Oct. 26, 1982]

(d) Prior sanctions for ammonium al-
§ 184.1133 Ammonium alginate. ginate different from the uses estab-
lished in this section do not exist or
(a) Ammonium alginate (CAS Reg.
have been waived.
No. 9005–34–9) is the ammonium salt of
alginic acid, a natural polyuronide con- [47 FR 29950, July 9, 1982]
stituent of certain brown algae. Ammo-
nium alginate is prepared by the neu- § 184.1135 Ammonium bicarbonate.
tralization of purified alginic acid with (a) Ammonium bicarbonate
appropriate pH control agents. (NH4HCO3, CAS Reg. No. 1066–33–7) is
(b) The ingredient meets the speci- prepared by reacting gaseous carbon di-
fications of the Food Chemicals Codex, oxide with aqueous ammonia. Crystals
3d Ed. (1981), p. 18, which is incor- of ammonium bicarbonate are precip-
porated by reference. Copies are avail- itated from solution and subsequently
able from the National Academy Press, washed and dried.
2101 Constitution Ave. NW., Wash- (b) The ingredient meets the speci-
ington, DC 20418, or available for in- fications of the Food Chemicals Codex,
spection at the National Archives and 3d Ed. (1981), p. 19, which is incor-
Records Administration (NARA). For porated by reference. Copies are avail-
information on the availability of this able from the National Academy Press,
material at NARA, call 202–741–6030, or 2101 Constitution Ave. NW., Wash-
go to: http://www.archives.gov/ ington, DC 20418, or available for in-
federallregister/ spection at the National Archives and
codeloflfederallregulations/ Records Administration (NARA). For
ibrllocations.html. information on the availability of this
(c) In accordance with § 184.1(b)(2), material at NARA, call 202–741–6030, or
the ingredient is used in food only go to: http://www.archives.gov/
within the following specific limita- federallregister/
tions: codeloflfederallregulations/
Maximum ibrllocations.html.
level of (c) In accordance with § 184.1(b)(1),
use in
Category of food food (as Functional use the ingredient is used in food with no
served) limitation other than current good
(percent)
Confections, frostings, 0.4 Stabilizer, thickener, tion of this ingredient as generally rec-
§ 170.3(n)(9) of this § 170.3(o)(28) of this ognized as safe (GRAS) as a direct
chapter. chapter.
Fats and oils, 0.5 Do.

§ 170.3(n)(12) of this the following current good manufac-
chapter. turing practice conditions of use:
502
(1) The ingredient is used as a dough (d) Prior sanctions for this ingredient
strengthener as defined in § 170.3(o)(6) different from the uses established in
of this chapter; a leavening agent as this section do not exist or have been
defined in § 170.3(o)(17) of this chapter; waived.
a pH control agent as defined in
[48 FR 52439, Nov. 18, 1983]
§ 170.3(o)(23) of this chapter; and a
texturizer as defined in § 170.3(o)(32) of
§ 184.1138 Ammonium chloride.
this chapter.
(2) The ingredient is used in food at (a) Ammonium chloride (NH4Cl, CAS
levels not to exceed current good man- Reg. No. 12125–02–9) is produced by the
ufacturing practice. reaction of sodium chloride and an am-
(d) Prior sanctions for this ingredient monium salt in solution. The less solu-
different from the uses established in ble sodium salt separates out at ele-
this section do not exist or have been vated temperatures, and ammonium
waived. chloride is recovered from the filtrate
on cooling. Alternatively, hydrogen
[48 FR 52439, Nov. 18, 1983]
chloride formed by the burning of hy-
§ 184.1137 Ammonium carbonate. drogen in chlorine is dissolved in water
and then reacted with gaseous ammo-
(a) Ammonium carbonate ((NH4)2CO3, nia. Ammonium chloride is crystallized
CAS Reg. No. 8000–73–5) is a mixture of from the solution.
ammonium bicarbonate (NH4HCO3) and (b) The ingredient meets the speci-
ammonium carbamate (NH2COONH4). fications of the Food Chemicals Codex,
It is prepared by the sublimation of a
3d Ed. (1981), p. 20, which is incor-
mixture of ammonium sulfate and cal-
porated by reference. Copies are avail-
cium carbonate and occurs as a white
able from the National Academy Press,
powder or a hard, white or translucent
2101 Constitution Ave, NW., Wash-
mass.
ington, DC 20418, or available for in-
spection at the National Archives and
Records Administration (NARA). For
information on the availability of this
2101 Constitution Ave. NW., Wash-
federallregister/
(c) In accordance with § 184.1(b)(1), human food ingredient is based upon
the ingredient is used in food with no the following current good manufac-
limitation other than current good turing practice conditions of use:
manufacturing practice. The affirma- (1) The ingredient is used as a dough
tion of this ingredient as generally rec- strengthener as defined in § 170.3(o)(6)
ognized as safe (GRAS) as a direct of this chapter; a flavor enhancer as de-
human food ingredient is based upon fined in § 170.3(o)(11) of this chapter; a
the following current good manufac- leavening agent as defined in
turing practice conditions of use: § 170.3(o)(17) of this chapter; and a proc-
(1) The ingredient is used as a leav- essing aid as defined in § 107.3(o)(24) of
ening agent as defined in § 170.3(o)(17) of this chapter.
this chapter and a pH control agent as (2) The ingredient is used in food at
defined in § 170.3(o)(23) of this chapter. levels not to exceed current good man-
ufacturing practice.
(2) The ingredient is used in food at

levels not to exceed current good man- (d) Prior sanctions for this ingredient
ufacturing practice. different from the uses established in
503
§ 184.1139 21 CFR Ch. I (4–1–15 Edition)
this section do not exist or have been It is prepared by partially neutralizing

waived. citric acid with ammonia.
(b) The ingredient must be of a pu-
[48 FR 52439, Nov. 18, 1983]
rity suitable for its intended use.
§ 184.1139 Ammonium hydroxide.
(a) Ammonium hydroxide (NH4OH, limitation other than current good
CAS Reg. No. 1336–21–6) is produced by manufacturing practice. The affirma-
passing ammonia gas into water. tion of this ingredient as generally rec-
(b) The ingredient meets the speci- ognized as safe (GRAS) as a direct
fications of the Food Chemicals Codex, human food ingredient is based upon
3d Ed. (1981), p. 20, which is incor- the following current good manufac-
porated by reference. Copies are avail- turing practice conditions of use:
able from the National Academy Press, (1) The ingredient is used as a flavor
2101 Constitution Ave. NW., Wash- enhancer as defined in § 170.3(o)(11) of
ington, DC 20418, or available for in- this chapter and as a pH control agent
spection at the National Archives and as defined in § 170.3(o)(23) of this chap-
Records Administration (NARA). For ter.
information on the availability of this (2) The ingredient is used in non-
material at NARA, call 202–741–6030, or alcoholic beverages as defined in
go to: http://www.archives.gov/ § 170.3(n)(3) of this chapter and in
federallregister/ cheeses as defined in § 170.3(n)(5) of this
codeloflfederallregulations/ chapter at levels not to exceed current
ibrllocations.html. good manufacturing practice.
(c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient
the ingredient is used in food with no different from the uses established in
limitation other than current good this section, or different from those set
manufacturing practice. The affirma- forth in part 181 of this chapter, do not
tion of this ingredient as generally rec- exist or have been waived.
ognized as safe (GRAS) as a direct [59 FR 63896, Dec. 12, 1994, as amended at 73
human food ingredient is based upon FR 8606, Feb. 14, 2008]
the following current good manufac-
turing practice conditions of use: § 184.1141a Ammonium phosphate,
(1) The ingredient is used as a leav- monobasic.
ening agent as defined in § 170.3(o)(17) of (a) Ammonium phosphate, monobasic
this chapter; a pH control agent as de- (NH4H2PO4, CAS Reg. No. 7722–76–1) is
fined in § 170.3(o)(23) of this chapter; a manufactured by reacting ammonia
surface-finishing agent as defined in with phosphoric acid at a pH below 5.8.
§ 170.3(o)(30) of this chapter; and as a (b) The ingredient meets the speci-
boiler water additive complying with fications of the Food Chemicals Codex,
§ 173.310 of this chapter. 3d Ed. (1981), p. 21, which is incor-
(2) The ingredient is used in food at porated by reference. Copies are avail-
levels not to exceed current good man- able from the National Academy Press,
ufacturing practice. The ingredient 2101 Constitution Ave. NW., Wash-
may also be used as a boiler water ad- ington, DC 20418, or available for in-
ditive at levels not to exceed current spection at the National Archives and
good manufacturing practice. Records Administration (NARA). For
(d) Prior sanctions for this ingredient information on the availability of this
different from the uses established in material at NARA, call 202–741–6030, or
this section do not exist or have been go to: http://www.archives.gov/
waived. federallregister/
[48 FR 52440, Nov. 18, 1983, as amended at 59 ibrllocations.html.
FR 14551, Mar. 29, 1994] (c) In accordance with § 184.1(b)(1),
§ 184.1140 Ammonium citrate, dibasic. limitation other than current good
(a) Ammonium citrate, dibasic manufacturing practice. The affirma-

((NH4)2HC6H5O7, CAS Reg. No. 3012–65–5) tion of this ingredient as generally rec-
is the diammonium salt of citric acid. ognized as safe (GRAS) as a direct
504
human food ingredient is based upon (d) Prior sanctions for this ingredient
the following current good manufac- different from the uses established in
turing practice conditions of use: this section do not exist or have been
(1) The ingredient is used as a dough waived.
strengthener as defined in § 170.3(o)(6)
[48 FR 52440, Nov. 18, 1983]
of this chapter and a pH control agent
as defined in § 170.3(o)(23) of this chap- § 184.1143 Ammonium sulfate.
ter.
(2) The ingredient is used in food at (a) Ammonium sulfate ((NH4)2SO4,
levels not to exceed current good man- CAS Reg. No. 7783–20–2) occurs natu-
ufacturing practice. rally and consists of colorless or white,
(d) Prior sanctions for this ingredient odorless crystals or granules. It is pre-
different from the uses established in pared by the neutralization of sulfuric
this section do not exist or have been acid with ammonium hydroxide.
waived. (b) The ingredient meets the speci-
fications of the ‘‘Food Chemicals
[48 FR 52440, Nov. 18, 1983] Codex,’’ 3d Ed. (1981), pp. 22–23, which is
§ 184.1141b Ammonium phosphate, di- incorporated by reference. Copies may
basic. be obtained from the National Acad-
emy Press, 2101 Constitution Ave. NW.,
(a) Ammonium phosphate, dibasic Washington, DC 20418, or may be exam-
((NH4)2HPO4, CAS Reg. No. 7783–28–0) is ined at the National Archives and
manufactured by reacting ammonia
with phosphoric acid at a pH above 5.8.
federallregister/
ibrllocations.html.
(c) The ingredient is used as a dough
strengthener as defined in § 170.3(o)(6)
of this chapter, firming agent as de-
fined in § 170.3(o)(10) of this chapter,
and processing aid as defined in
federallregister/ (d) The ingredient is used in food at
codeloflfederallregulations/ levels not to exceed good manufac-
ibrllocations.html. turing practice in accordance with
(c) In accordance with § 184.1(b)(1), § 184.1(b)(1). Current good manufac-
the ingredient is used in food with no turing practice results in a maximum
limitation other than current good level, as served, of 0.15 percent for
manufacturing practice. The affirma- baked goods as defined in § 170.3(n)(1) of
tion of this ingredient as generally rec- this chapter and 0.1 percent for gela-
ognized as safe (GRAS) as a direct tins and puddings as defined in
human food ingredient is based upon § 170.1(n)(22) of this chapter.
the following current good manufac- (e) Prior sanctions for this ingredient
turing practice conditions of use: different from the uses established in
(1) The ingredient is used as a dough this section do not exist or have been
strengthener as defined in § 170.3(o)(6) waived.
of this chapter; a firming agent as de- [45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14,
fined in § 170.3(o)(10) of this chapter; a 1980, as amended at 49 FR 5611, Feb. 14, 1984]
leavening agent as defined in
§ 170.3(o)(17) of this chapter; a pH con- § 184.1148 Bacterially-derived
trol agent as defined in § 170.3(o)(23) of carbohydrase enzyme preparation.
this chapter; and a processing aid as (a) Bacterially-derived carbohydrase
defined in § 170.3(o)(24) of this chapter. enzyme preparation is obtained from
(2) The ingredient is used in food at the culture filtrate resulting from a
levels not to exceed current good man- pure culture fermentation of a non-
ufacturing practice. pathogenic and nontoxigenic strain of
505
§ 184.1150 21 CFR Ch. I (4–1–15 Edition)
Bacillus subtilis or B. amyloliquefaciens. (2) The ingredient is used in food at

The preparation is characterized by the levels not to exceed current good man-
presence of the enzymes a-amylase (EC ufacturing practice.
3.2.1.1) and b-glucanase (EC 3.2.1.6),
[64 FR 19894, Apr. 23, 1999]
which catalyze the hydrolysis of O-
glycosyl bonds in carbohydrates. § 184.1150 Bacterially-derived protease
(b) The ingredient meets the general enzyme preparation.
(a) Bacterially-derived protease en-
ments in the monograph on enzyme
zyme preparation is obtained from the
preparations in the Food Chemicals
culture filtrate resulting from a pure
Codex, 4th ed. (1996), pp. 128–135, which
culture fermentation of a nonpatho-
is incorporated by reference in accord-
genic and nontoxigenic strain of Bacil-
ance with 5 U.S.C. 552(a) and 1 CFR
lus subtilis or B. amyloliquefaciens. The
part 51. Copies are available from the
preparation is characterized by the
National Academy Press, 2101 Constitu-
presence of the enzymes subtilisin (EC
tion Ave. NW., Washington, DC 20418,
3.4.21.62) and neutral proteinase (EC
or may be examined at the Center for
3.4.24.28), which catalyze the hydrolysis
of peptide bonds in proteins.
Library, 5100 Paint Branch Pkwy., Col-
lege Park, MD 20740, or at the National
ments in the monograph on enzyme
preparations in the Food Chemicals
Codex, 4th ed. (1996), pp. 128–135, which
202–741–6030, or go to: http://
is incorporated by reference in accord-
part 51. Copies are available from the
ibrllocations.html. In addition, anti-
National Academy Press, 2101 Constitu-
biotic activity is absent in the enzyme
tion Ave. NW., Washington, DC 20418,
preparation when determined by an ap-
propriate validated method such as the
method ‘‘Determination of antibiotic
Library, 5100 Paint Branch Pkwy., Col-
activity’’ in the Compendium of Food lege Park, MD 20740, or at the National
Additive Specifications, vol. 2, Joint Archives and Records Administration
FAO/WHO Expert Committee on Food (NARA). For information on the avail-
Additives (JECFA), Food and Agri- ability of this material at NARA, call
culture Organization of the United Na- 202–741–6030, or go to: http://
tions, Rome, 1992. Copies are available www.archives.gov/federallregister/
from Bernan Associates, 4611–F Assem- codeloflfederallregulations/
bly Dr., Lanham, MD 20706, or from The ibrllocations.html. In addition, anti-
United Nations Bookshop, General As- biotic activity is absent in the enzyme
sembly Bldg., rm. 32, New York, NY preparation when determined by an ap-
10017, or by inquiries sent to http:// propriate validated method such as the
www.fao.org. Copies may be examined method ‘‘Determination of antibiotic
at the Center for Food Safety and Ap- activity’’ in the Compendium of Food
plied Nutrition’s Library, 5100 Paint Additive Specifications, vol. 2, Joint
Branch Pkwy., College Park, MD 20740. FAO/WHO Expert Committee on Food
(c) In accordance with § 184.1(b)(1), Additives (JECFA), Food and Agri-
the ingredient is used in food with no culture Organization of the United Na-
limitation other than current good tions, Rome, 1992. Copies are available
manufacturing practice. The affirma- from Bernan Associates, 4611–F Assem-
tion of this ingredient as GRAS as a di- bly Dr., Lanham, MD 20706, or from The
rect food ingredient is based upon the United Nations Bookshop, General As-
following current good manufacturing sembly Bldg., rm. 32, New York, NY
practice conditions of use: 10017, or by inquiries sent to http://
(1) The ingredient is used as an en- www.fao.org. Copies may be examined
zyme as defined in § 170.3(o)(9) of this at the Center for Food Safety and Ap-
chapter to hydrolyze polysaccharides plied Nutrition’s Library, 5100 Paint
(e.g., starch). Branch Pkwy., College Park, MD 20740.
506
(c) In accordance with § 184.1(b)(1), § 184.1157 Benzoyl peroxide.

the ingredient is used in food with no (a) Benzoyl peroxide ((C6H5CO)2O2,
limitation other than current good CAS Reg. No. 94–36–0) is a colorless,
manufacturing practice. The affirma- rhombic crystalline solid. It is pre-
tion of this ingredient as GRAS as a di- pared by reaction of benzoyl chloride,
rect food ingredient is based upon the sodium hydroxide, and hydrogen per-
following current good manufacturing oxide.
practice conditions of use: (b) The ingredient meets the speci-
(1) The ingredient is used as an en- fications of the Food Chemicals Codex,
zyme as defined in § 170.3(o)(9) of this 3d Ed. (1981), p. 35, which is incor-
chapter to hydrolyze proteins or porated by reference. Copies are avail-
polypeptides. able from the National Academy Press,
(2) The ingredient is used in food at 2101 Constitution Ave. NW., Wash-
levels not to exceed current good man- ington, DC 20418, or available for in-
ufacturing practice. spection at the National Archives and
[64 FR 19895, Apr. 23, 1999] information on the availability of this
§ 184.1155 Bentonite. go to: http://www.archives.gov/
(a) Bentonite (Al2O34SiO2nH2O, CAS federallregister/
Reg. No. 1302–78–9) is principally a col- codeloflfederallregulations/
loidal hydrated aluminum silicate. ibrllocations.html.
Bentonite contains varying quantities (c) In accordance with § 184.1(b)(1),
of iron, alkalies, and alkaline earths in the ingredient is used in food with no
the commercial products. Depending on limitation other than current good
the cations present, natural deposits of manufacturing practice. The affirma-
bentonite range in color from white to tion of this ingredient as generally rec-
gray, yellow, green, or blue. ognized as safe (GRAS) as a direct
Bentonite’s fine particles provide large human food ingredient is based upon
total surface area and, hence, pro-
turing practice conditions of use:
nounced adsorptive capability.
(1) The ingredient is used as a bleach-
(b) The ingredient must be of a pu- ing agent in food.
rity suitable for its intended use. (2) The ingredient is used in the fol-
(c) In accordance with § 184.1(b)(1), lowing foods at levels not to exceed
the ingredient is used in food with no current good manufacturing practice:
limitation other than current good flour; milk used for production of
manufacturing practice. The affirma- Asiago fresh and Asiago soft cheese
tion of this ingredient as generally rec- (§ 133.102), Asiago medium cheese
ognized as safe (GRAS) as a direct (§ 133.103), Asiago old cheese (§ 133.104),
human food ingredient is based upon Blue cheese (§ 133.106), Caciocavallo
the following current good manufac- siciliano chesse (§ 133.111), Gorgonzola
turing practice conditions of use: cheese (§ 133.141), Parmesan and
(1) The ingredient is used as a proc- reggiano cheese (§ 133.165), Provolone
essing aid as defined in § 170.3(o)(24) of cheese (§ 133.181), Romano cheese
this chapter. (§ 133.183), and Swiss and emmentaler
(2) The ingredient is used in food at cheese (§ 133.195) in part 133 of this
levels not to exceed current good man- chapter; and annatto-colored whey,
ufacturing practice. Current good man- such that the final bleached product
conforms to the descriptions and speci-
ufacturing practice results in no sig-
fications for whey, concentrated whey,
nificant residue in foods.
or dried whey in § 184.1979(a) (1), (2), or
(d) Prior sanctions for this ingredient (3), respectively.
different from the uses established in (d) Prior sanctions for this ingredient
this section do not exist or have been different from the uses established in
waived. this section do not exist or have been
[47 FR 43367, Oct. 1, 1982, as amended at 73 FR waived.

8606, Feb. 14, 2008; 76 FR 59249, Sept. 26, 2011] [51 FR 27173, July 30, 1986]
507
§ 184.1165 21 CFR Ch. I (4–1–15 Edition)
§ 184.1165 n-Butane and iso-butane. codeloflfederallregulations/

ibrllocations.html.
(a) n-Butane and iso-butane (empir-
ical formula C4H10, CAS Reg. Nos. 106– (c) The ingredient is used as a firm-
97–8 and 75–28–5, respectively) are coloring agent as defined in § 170.3(o)(10) of
less, flammable gases at normal tem- this chapter; pH control agent as de-
peratures and pressures. They are eas- fined in § 170.3(o)(23) of this chapter;
ily liquefied under pressure at room processing aid as defined in § 170.3(o)(24)
temperature and are stored and shipped of this chapter; sequestrant as defined
in the liquid state. The butanes are ob- in § 170.3(o)(26) of this chapter; sta-
tained from natural gas by fraction- bilizer and thickener as defined in
ation following absorption in oil, ad- § 170.3(o)(28) of this chapter; and
sorption to surface-active agents, or re- texturizer as defined in § 170.3(o)(32) of
frigeration. this chapter.
(b) The ingredients must be of a pu- (d) The ingredient is used in food at
rity suitable for their intended use. levels not to exceed current good man-
(c) In accordance with § 184.1(b)(1), ufacturing practices in accordance
these ingredients are used in food with with § 184.1(b)(1). Current good manu-
no limitations other than current good facturing practices result in a max-
manufacturing practice. The affirma- imum level, as served, of 0.2 percent for
tion of these ingredients as generally baked goods as defined in § 170.3(n)(1) of
recognized as safe (GRAS) as direct this chapter; 0.02 percent for cheese as
human food ingredients is based upon defined in § 170.3(n)(5) of this chapter;
the following current good manufac- 0.2 percent for gelatins, puddings, and
turing practice conditions of use: fillings as defined in § 170.3(n)(22) of
(1) The ingredients are used as pro- this chapter; 0.15 percent for sweet
pellants, aerating agents, and gases as sauces, toppings, and syrups as defined
defined in § 170.3(o)(25) of this chapter. in § 170.3(n)(43) of this chapter; and
(2) The ingredients are used in food 0.0001 percent for all other food cat-
at levels not to exceed current good egories.
manufacturing practice. (e) Prior sanctions for this ingredient
(d) Prior sanctions for these ingredi- different from the uses established in
ents different from the uses established this section or in part 181 of this chap-
in this section do not exist or have ter do not exist or have been waived.
been waived. [47 FR 27807, June 25, 1982]
[48 FR 57270, Dec. 29, 1983, as amended at 73
FR 8607, Feb. 14, 2008; 76 FR 59249, Sept. 26, § 184.1187 Calcium alginate.
2011] (a) Calcium alginate (CAS Reg. No.
9005–35–0) is the calcium salt of alginic
§ 184.1185 Calcium acetate. acid, a natural polyuronide constituent
(a) Calcium acetate (Ca (C2H3O2)2, of certain brown algae. Calcium algi-
CAS Reg. No. 62–54–4), also known as nate is prepared by the neutralization
acetate of lime or vinegar salts, is the of purified alginic acid with appro-
calcium salt of acetic acid. It may be priate pH control agents, or from so-
produced by the calcium hydroxide dium alginate by metathesis with ap-
neutralization of acetic acid. propriate calcium salts.
fications of the Food Chemicals Codex, fications of the Food Chemicals Codex,
3d Ed. (1981), p. 44, which is incor- 3d Ed. (1981), p. 45, which is incor-
porated by reference. Copies are avail- porated by reference. Copies are avail-
able from the National Academy Press, able from the National Academy Press,
2101 Constitution Ave. NW., Wash- 2101 Constitution Ave. NW., Wash-
ington, DC 20418, or available for in- ington, DC 20418, or available for in-
spection at the National Archives and spection at the National Archives and

go to: http://www.archives.gov/ go to: http://www.archives.gov/
federallregister/ federallregister/
508
codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash-

ibrllocations.html. ington, DC 20418, or available for in-
(c) In accordance with § 184.1(b)(2), spection at the National Archives and
the ingredient is used in food only Records Administration (NARA). For
within the following specific limita- information on the availability of this
tions: material at NARA, call 202–741–6030, or
Maximum
level of federallregister/
Category of food use in Functional use codeloflfederallregulations/
food (as
served) ibrllocations.html.
(percent) (c) In accordance with § 184.1(b)(1),
Baked goods, 0.002 Stabilizer, thickener,
§ 170.3(n)(1) of this § 170.3(o)(28) of this limitation other than current good
chapter. chapter. manufacturing practice.
Alcoholic beverages, 0.4 Do. (d) Prior sanctions for this ingredient
§ 170.3(n)(2) of this
chapter.
Confections and 0.4 Do. this section, or different from that set
frostings, forth in part 181 of this chapter, do not
§ 170.3(n)(9) of this exist or have been waived.
chapter.
Egg products, 0.6 Do. [48 FR 52441, Nov. 18, 1983]
§ 170.3(n)(11) of this
chapter.
Fats and oils, 0.5 Do.
§ 184.1193 Calcium chloride.
§ 170.3(n)(12) of this (a) Calcium chloride (CaCl2·2H2O,
chapter.
Gelatins, puddings, 0.25 Do.
CAS Reg. No. 10035–04–8) or anhydrous
§ 170.3(n)(22) of this calcium chloride (CaCl2, CAS Reg. No.
chapter. 10043–52–4) may be commercially ob-
Gravies and sauces, 0.4 Do. tained as a byproduct in the ammonia-
§ 170.3(n)(24) of this
chapter. soda (Solvay) process and as a joint
Jams and jellies, 0.5 Do. product from natural salt brines, or it
§ 170.3(n)(28) of this may be prepared by substitution reac-
chapter.
Sweet sauces, 0.5 Do.
tions with other calcium and chloride
§ 170.3(n)(43) of this salts.
chapter. (b) The ingredient meets the speci-
All other food cat- 0.3 Do. fications of the Food Chemicals Codex,
egories.
(d) Prior sanctions for calcium algi-
nate different from the uses established
in this section do not exist or have
been waived.
[47 FR 29951, July 9, 1982] Records Administration (NARA). For
§ 184.1191 Calcium carbonate. material at NARA, call 202–741–6030, or
(a) Calcium carbonate (CaCO3, CAS go to: http://www.archives.gov/
Reg. No. 471–34–1) is prepared by three federallregister/
common methods of manufacture: codeloflfederallregulations/
(1) As a byproduct in the ‘‘Lime soda ibrllocations.html.
process’’; (c) The ingredient is used as an
(2) By precipitation of calcium car- anticaking agent as defined in
bonate from calcium hydroxide in the § 170.3(o)(1) of this chapter; anti-
‘‘Carbonation process’’; or microbial agent as defined in
(3) By precipitation of calcium car- § 170.3(o)(2) of this chapter; curing or
bonate from calcium chloride in the pickling agent as defined in § 170.3(o)(5)
‘‘Calcium chloride process’’. of this chapter; firming agent as de-
(b) The ingredient meets the speci- fined in § 170.3(o)(10) of this chapter;
fications of the Food Chemicals Codex, flavor enhancer as defined in
3d Ed. (1981), p. 46, which is incor- § 170.3(o)(11) of this chapter; humectant

porated by reference. Copies are avail- as defined in § 170.3(o)(16) of this chap-
able from the National Academy Press, ter; nutrient supplement as defined in
509
§ 184.1195 21 CFR Ch. I (4–1–15 Edition)
§ 170.3(o)(20) of this chapter; pH control (b) The ingredient meets the speci-
agent as defined in § 170.3(o)(23) of this fications of the Food Chemicals Codex,
chapter; processing aid as defined in 3d ed. (1981), pp. 49 and 50, which is in-
§ 170.3(o)(24) of this chapter; stabilizer corporated by reference in accordance
and thickener as defined in § 170.3(o)(28) with 5 U.S.C. 552(a) and 1 CFR part 51.
of this chapter; surface-active agent as Copies are available from the National
defined in § 170.3(o)(29) of this chapter; Academy Press, 2101 Constitution Ave.
synergist as defined in § 170.3(o)(31) of NW., Washington, DC 20418, and the
this chapter; and texturizer as defined Center for Food Safety and Applied Nu-
in § 170.3(o)(32) of this chapter. trition (HFS–200), 5100 Paint Branch
(d) The ingredient is used in foods at Pkwy., College Park, MD 20740, or may
levels not to exceed current good man- be examined at the National Archives
ufacturing practices in accordance and Records Administration (NARA).
with § 184.1(b)(1). Current good manu- For information on the availability of
facturing practices result in a max- this material at NARA, call 202–741–
imum level, as served, of 0.3 percent for 6030, or go to: http://www.archives.gov/
baked goods as defined in § 170.3(n)(1) of federallregister/
this chapter and for dairy product codeloflfederallregulations/
analogs as defined in § 170.3(n)(10) of ibrllocations.html.
this chapter; 0.22 percent for non- (c) In accordance with § 184.1(b)(1),
alcoholic beverages and beverage bases the ingredient is used in food with no
as defined in § 170.3(n)(3) of this chap- limitation other than current good
ter; 0.2 percent for cheese as defined in manufacturing practice. Calcium cit-
§ 170.3(n)(5) of this chapter and for proc- rate may also be used in infant formula
essed fruit and fruit juices as defined in in accordance with section 412(g) of the
§ 170.3(n)(35) of this chapter; 0.32 per- Federal Food, Drug, and Cosmetic Act
cent for coffee and tea as defined in (the act) or with regulations promul-
§ 170.3(n)(7) of this chapter; 0.4 percent gated under section 412(a)(2) of the act.
for condiments and relishes as defined (d) Prior sanctions for this ingredient
in § 170.3(n)(8) of this chapter; 0.2 per- different from the uses established in
cent for gravies and sauces as defined this section do not exist or have been
in § 170.3(n)(24) of this chapter; 0.1 per- waived.
cent for commercial jams and jellies as [59 FR 63896, Dec. 12, 1994]
defined in § 170.3(n)(28) of this chapter;
0.25 percent for meat products as de- § 184.1199 Calcium gluconate.
fined in § 170.3(n)(29) of this chapter; 2.0
(a) Calcium gluconate
percent for plant protein products as
([CH2OH(CHOH)4COO]2Ca, CAS Reg. No.
299–28–5) is the calcium salt of gluconic
0.4 percent for processed vegetables and acid which may be produced by neu-
vegetable juices as defined in tralization of gluconic acid with lime
§ 170.3(n)(36) of this chapter; and 0.05 or calcium carbonate.
percent for all other food categories. (b) The ingredient meets the speci-
(e) Prior sanctions for this ingredient fications of the Food Chemicals Codex,
different from the uses established in 3d Ed. (1981), p. 51, which is incor-
this section do not exist or have been porated by reference. Copies are avail-
waived. able from the National Academy Press,
[47 FR 27808, June 25, 1982, as amended at 61 2101 Constitution Ave. NW., Wash-
FR 14247, Apr. 1, 1996] ington, DC 20418, or available for in-
§ 184.1195 Calcium citrate. Records Administration (NARA). For
(a) Calcium citrate information on the availability of this
(Ca3(C6H5O7)2·4H2O, CAS Reg. No. 813– material at NARA, call 202–741–6030, or
0994–095) is the calcium salt of citric go to: http://www.archives.gov/
acid. It is prepared by neutralizing cit- federallregister/
ric acid with calcium hydroxide or cal- codeloflfederallregulations/
cium carbonate. It occurs as a fine ibrllocations.html.
white, odorless powder and usually (c) The ingredient is used as a firm-
contains four moles of water per mole ing agent as defined in § 170.3(o)(10) of
of calcium citrate. this chapter; formulation aid as defined
510
in § 170.3(o)(14) of this chapter; the following current good manufac-

sequestrant as defined in § 170.3(o)(26) of turing practice conditions of use:
this chapter; stabilizer or thickener as (1) The ingredient is used as a nutri-
defined in § 170.3(o)(28) of this chapter; ent supplement as defined in
and texturizer as defined in § 170.3(o)(32) § 170.3(o)(20) of this chapter.
of this chapter. (2) The ingredient is used in gelatins,
(d) The ingredient is used in foods at puddings, and fillings as defined in
levels not to exceed current good man- § 170.3(n)(22) of this chapter.
ufacturing practices in accordance (d) Prior sanctions for this ingredient
with § 184.1(b)(1). Current good manu- different from the uses established in
facturing practices result in a max- this section or different from that as
imum level, as served, of 1.75 percent set forth in part 181 of this chapter, do
for baked goods as defined in not exist or have been waived.
§ 170.3(n)(1) of this chapter; 0.4 percent
[57 FR 10813, Mar. 31, 1992]
for dairy product analogs as defined in
§ 170.3(n)(10) of this chapter; 4.5 percent § 184.1205 Calcium hydroxide.
for gelatins and puddings as defined in
§ 170.3(n)(22) of this chapter; and 0.01 (a) Calcium hydroxide (Ca(OH)2, CAS
percent for sugar substitutes as defined Reg. No. 1305–62–0) is also known as
in § 170.3(n)(42) of this chapter. slaked lime or calcium hydrate. It is
(e) Prior sanctions for this ingredient produced by the hydration of lime.
different from the uses established in (b) The ingredient meets the speci-
this section do not exist or have been fications of the Food Chemicals Codex,
waived. 3d Ed. (1981), p. 52, which is incor-
[47 FR 27808, June 25, 1982] able from the National Academy Press,
§ 184.1201 Calcium glycerophosphate. 2101 Constitution Ave. NW., Wash-
(a) Calcium glycerophosphate spection at the National Archives and
(C3H7CaO6P, CAS Reg. No. 27214–00–2) is Records Administration (NARA). For
a fine, white, odorless, almost taste- information on the availability of this
less, slightly hygroscopic powder. It is material at NARA, call 202–741–6030, or
prepared by neutralizing glycero- go to: http://www.archives.gov/
phosphoric acid with calcium hydrox- federallregister/
ide or calcium carbonate. The commer- codeloflfederallregulations/
cial product is a mixture of calcium b- ibrllocations.html.
, and D-, and L-a-glycerophosphate. (c) In accordance with § 184.1(b)(1),
(b) The ingredient meets the speci- the ingredient is used in food with no
fications of the ‘‘Food Chemicals limitation other than current good
Codex,’’ 3d Ed. (1981), pp. 51–52, which is manufacturing practice.
incorporated by reference in accord- (d) Prior sanctions for this ingredient
ance with 5 U.S.C. 552(a) and 1 CFR different from the uses established in
part 51. Copies may be obtained from this section do not exist or have been
the National Academy Press, 2101 Con- waived.
stitution Ave. NW., Washington, DC
20418, or may be examined at the Na- [49 FR 26714, June 29, 1984]
tration (NARA). For information on § 184.1206 Calcium iodate.
the availability of this material at (a) Calcium iodate [Ca(IO3)2·H2O, CAS
NARA, call 202–741–6030, or go to: http:// Reg. No. 7789–80–2], also referred to as
www.archives.gov/federallregister/ lautarite, does not occur naturally but
codeloflfederallregulations/ can be prepared by passing chlorine
ibrllocations.html. into a hot solution of lime (CaCO3) in
(c) In accordance with § 184.1(b)(1), which iodine has been dissolved.
the ingredient is used in food with no (b) The ingredient meets the speci-
limitation other than current good fications of the ‘‘Food Chemicals
manufacturing practice. The affirma- Codex,’’ 3d Ed. (1981), p. 53, which is in-
tion of this ingredient as generally rec- corporated by reference. Copies may be

ognized as safe (GRAS) as a direct obtained from the National Academy
human food ingredient is based upon Press, 2101 Constitution Ave. NW.,
511
§ 184.1207 21 CFR Ch. I (4–1–15 Edition)
Washington, DC 20418, or may be exam- flavoring agent or adjuvant as defined

ined at the National Archives and in § 170.3(o)(12) of this chapter; a leav-
Records Administration (NARA). For ening agent as defined in § 170.3(o)(17) of
information on the availability of this this chapter; a nutrient supplement as
material at NARA, call 202–741–6030, or defined in § 170.3(o)(20) of this chapter;
go to: http://www.archives.gov/ and a stabilizer and thickener as de-
federallregister/ fined in § 170.3(o)(28) of this chapter.
codeloflfederallregulations/ (2) The ingredient is used in food, ex-
ibrllocations.html. cept in infant foods and infant for-
(c) The ingredient is used as a dough mulas, at levels not to exceed current
strengthener as defined in § 170.3(o)(6) good manufacturing practice.
of this chapter. (d) Prior sanctions for this ingredient
(d) The ingredient is used in the man- different from the uses established in
ufacture of bread in accordance with this section do not exist or have been
§ 184.1(b)(2) of this chapter in an waived.
amount not to exceed 0.0075 percent
based on the weight of the flour. [49 FR 35367, Sept. 7, 1984]
different from the uses established in § 184.1210 Calcium oxide.
this section do not exist or have been (a) Calcium oxide (CaO, CAS Reg. No.
waived. 1305–78–8) is also known as lime, quick
[43 FR 11699, Mar. 21, 1978, as amended at 49 lime, burnt lime, or calx. It is produced
FR 5611, Feb. 14, 1984] from calcium carbonate, limestone, or
oyster shells by calcination at tem-
§ 184.1207 Calcium lactate. peratures of 1,700–2,450 °F.
(a) Calcium lactate (C6H10CaO6. xH2O, (b) The ingredient meets the speci-
where x is any integer up to 5, CAS fications of the Food Chemicals Codex,
Reg. No. 814–80–2) is prepared commer- 3d Ed. (1981), p. 55, which is incor-
cially by the neutralization of lactic porated by reference. Copies are avail-
acid with calcium carbonate or cal- able from the National Academy Press,
cium hydroxide. 2101 Constitution Ave. NW., Wash-
(b) The ingredient meets the speci- ington, DC 20418, or available for in-
fications of the Food Chemicals Codex, spection at the National Archives and
3d Ed. (1981), p. 53, which is incor- Records Administration (NARA). For
porated by reference. Copies are avail- information on the availability of this
able from the National Academy Press, material at NARA, call 202–741–6030, or
2101 Constitution Avenue NW., Wash- go to: http://www.archives.gov/
federallregister/ manufacturing practice.
codeloflfederallregulations/ (d) Prior sanctions for this ingredient
ibrllocations.html. different from the uses established in
(c) In accordance with § 184.1(b)(1), this section do not exist or have been
the ingredient is used in food with no waived.
manufacturing practice. The affirma- [49 FR 26714, June 29, 1984]
tion of this ingredient as generally rec-
ognized as safe (GRAS) as a direct § 184.1212 Calcium pantothenate.
human food ingredient is based upon (a) Calcium pantothenate
the following current good manufac- ((C9H16NO5)2Ca, CAS Reg. No. of the D-
turing practice conditions of use: isomer, 137–08–6) is a salt of panto-
(1) The ingredient is used as a firm- thenic acid, one of the vitamins of the
ing agent as defined in § 170.3(o)(10) of B complex. Only the D-isomer of panto-

this chapter; a flavor enhancer as de- thenic acid has vitamin activity, al-
fined in § 170.3(o)(11) of this chapter; a though both the D-isomer and the DL-
512
racemic mixture of calcium panto- 3d Ed. (1981), p. 60, which is incor-

thenate are used in food. Commercial porated by reference. Copies are avail-
calcium pantothenate is prepared syn- able from the National Academy Press,
thetically from isobutyraldehyde and 2101 Constitution Ave. NW., Wash-
formaldehyde via 1,1-dimethyl-2-hy- ington, DC 20418, or available for in-
droxy-propionaldehyde and spection at the National Archives and
pantolactone. Records Administration (NARA). For
(b) Calcium pantothenate meets the information on the availability of this
specifications of the Food Chemicals material at NARA, call 202–741–6030, or
Codex, 3d Ed. (1981), p. 56, which is in- go to: http://www.archives.gov/
corporated by reference. Copies are federallregister/
available from the National Academy codeloflfederallregulations/
Press, 2101 Constitution Ave. NW., ibrllocations.html.
Washington, DC 20418, or available for (c) In accordance with § 184.1(b)(1),
inspection at the National Archives the ingredient is used in food with no
and Records Administration (NARA). limitation other than current good
For information on the availability of manufacturing practice. The affirma-
this material at NARA, call 202–741– tion of this ingredient as generally rec-
6030, or go to: http://www.archives.gov/ ognized as safe (GRAS) as a direct
federallregister/ human food ingredient is based upon
codeloflfederallregulations/ the following current good manufac-
ibrllocations.html. turing practice conditions of use:
(c) In accordance with § 184.1(b)(1), (1) The ingredient is used as an anti-
the ingredient is used in food with no microbial agent as defined in
limitation other than current good § 170.3(o)(2) of this chapter.
manufacturing practice. The affirma- (2) The ingredient is used in the fol-
tion of this ingredient as generally rec- lowing foods at levels not to exceed
ognized as safe (GRAS) as a direct current good manufacturing practice:
human food ingredient is based upon baked goods as defined in § 170.3(n)(1) of
the following current good manufac- this chapter; cheeses as defined in
turing practice conditions of use: § 170.3(n)(5) of this chapter; confections
(1) The ingredient is used as a nutri- and frostings as defined in § 170.3(n)(9)
ent supplement as defined in of this chapter; gelatins, puddings, and
§ 170.3(o)(20) of this chapter. fillings as defined in § 170.3(n)(22) of
(2) The ingredient is used in foods at this chapter; and jams and jellies as de-
levels not to exceed current good man- fined in § 170.3(n)(28) of this chapter.
ufacturing practice. Calcium panto- (d) Prior sanctions for this ingredient
thenate may be used in infant formula different from the uses established in
in accordance with section 412(g) of the this section do not exist or have been
Federal Food, Drug, and Cosmetic Act waived.
(the act) or with regulations promul- [49 FR 13141, Apr. 3, 1984]
gated under section 412(a)(2) of the Act.
(d) Prior sanctions for this ingredient § 184.1229 Calcium stearate.
(a) Calcium stearate (Ca(C17H35COO)2,
CAS Reg. No. 1529–23–0) is the calcium
waived.
salt of stearic acid derived from edible
[48 FR 51908, Nov. 15, 1983] sources. It is prepared as a white pre-
cipitate by mixing calcium chloride
§ 184.1221 Calcium propionate. and sodium stearate in aqueous solu-
(a) Calcium propionate (C6H10CaO4, tion.
CAS Reg. No. 4075–81–4) is the calcium (b) The ingredient meets the speci-
salt of propionic acid. It occurs as fications of the Food Chemicals Codex,
white crystals or a crystalline solid, 3d Ed. (1981), p. 64, which is incor-
possessing not more than a faint odor porated by reference, and the require-
of propionic acid. It is prepared by neu- ments of § 172.860(b)(2) of this chapter.
tralizing propionic acid with calcium Copies of the Food Chemicals Codex
hydroxide. are available from the National Acad-

(b) The ingredient meets the speci- emy Press, 2101 Constitution Ave. NW.,
fications of the Food Chemicals Codex, Washington, DC 20418, or available for
513
§ 184.1230 21 CFR Ch. I (4–1–15 Edition)
inspection at the National Archives (c) The ingredient is used as an

and Records Administration (NARA). anticaking agent as defined in
For information on the availability of § 170.3(o)(1) of this chapter, color and
this material at NARA, call 202–741– coloring adjunct as defined in
6030, or go to: http://www.archives.gov/ § 170.3(o)(4) of this chapter, dough
federallregister/ strengthener as defined in § 170.3(o)(6)
codeloflfederallregulations/ of this chapter, drying agent as defined
ibrllocations.html. in § 170.3(o)(7) of this chapter, firming
(c) In accordance with § 184.1(b)(1), agent as defined in § 170.3(o)(10) of this
the ingredient is used in food with no chapter, flour treating agent as defined
limitation other than current good in § 170.3(o)(13) of this chapter, formula-
manufacturing practice. The affirmation aid as defined in § 170.3(o)(14) of
tion of this ingredient as generally rec- this chapter, leavening agent as de-
ognized as safe (GRAS) as a direct fined in § 170.3(o)(17) of this chapter, nu-
human food ingredient is based upon trient supplement as defined in
the following current good manufac- § 170.3(o)(20) of this chapter, pH control
turing practice conditions of use: agent as defined in § 170.3(o)(23) of this
(1) The ingredient is used as a fla- chapter, processing aid as defined in
voring agent and adjuvant as defined in § 170.3(o)(24) of this chapter, stabilizer
§ 170.3(o)(12) of this chapter; a lubricant and thickener as defined in § 170.3(o)(28)
and release agent as defined in of this chapter, synergist as defined in
§ 170.3(o)(18) of this chapter; and a sta- § 170.3(o)(31) of this chapter, and
bilizer and thickener as defined in texturizer as defined in § 170.3(o)(32) of
§ 170.3(o)(28) of this chapter. this chapter.
(d) The ingredient is used in food at
(2) The ingredient is used in foods at
levels not to exceed good manufac-
levels not to exceed current good man-
turing practice in accordance with
turing practice results in a maximum
different from the uses established in level, as served, of 1.3 percent for baked
this section do not exist or have been goods as defined in § 170.3(n)(1) of this
waived. chapter, 3.0 percent for confections and
[48 FR 52445, Nov. 18, 1983] frostings as defined in § 170.3(n)(9) of
this chapter, 0.5 percent for frozen
§ 184.1230 Calcium sulfate. dairy desserts and mixes as defined in
(a) Calcium sulfate (CaSO4, CAS Reg. § 170.3(n)(20) of this chapter, 0.4 percent
No. 7778–18–9 or CaSO4·2H2O, CAS Reg. for gelatins and puddings as defined in
No. 10101–41–4), also known as plaster of § 170.3(n)(22) of this chapter, 0.5 percent
Paris, anhydrite, and gypsum, occurs for grain products and pastas as de-
naturally and exists as a fine, white to fined in § 170.3(n)(23) of this chapter,
slightly yellow-white odorless powder. 0.35 percent for processed vegetables as
The anhydrous form is prepared by defined in § 170.3(n)(36) of this chapter,
complete dehydration of gypsum, below and 0.07 percent or less for all other
300 °C, in an electric oven. food categories.
(b) The ingredient meets the speci- (e) Prior sanctions for this ingredient
fications of the ‘‘Food Chemicals different from the uses established in
Codex,’’ 3d Ed. (1981), p. 66, which is in- this section do not exist or have been
corporated by reference. Copies may be waived.
obtained from the National Academy [45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18,
Press, 2101 Constitution Ave. NW., 1980, as amended at 49 FR 5611, Feb. 14, 1984]
Washington, DC 20418, or may be exam-
ined at the National Archives and § 184.1240 Carbon dioxide.
Records Administration (NARA). For (a) Carbon dioxide (empirical formula
information on the availability of this CO2, CAS Reg. No. 124–38–9) occurs as a
material at NARA, call 202–741–6030, or colorless, odorless, noncombustible gas
go to: http://www.archives.gov/ at normal temperatures and pressures.
federallregister/ The solid form, dry ice, sublimes under

codeloflfederallregulations/ atmospheric pressure at a temperature
ibrllocations.html. of ¥78.5 °C. Carbon dioxide is prepared
514
as a byproduct of the manufacture of (c) In accordance with § 184.1(b)(1),

lime during the ‘‘burning’’ of lime- the ingredient is used in food with no
stone, from the combustion of carbo- limitation other than current good
naceous material, from fermentation manufacturing practice. The affirma-
processes, and from gases found in cer- tion of this ingredient as generally rec-
tain natural springs and wells. ognized as safe (GRAS) as a direct
(b) The ingredient must be of a pu- human food ingredient is based upon
rity suitable for its intended use. the following current good manufac-
(c) In accordance with § 184.1(b)(1), turing practice conditions of use:
the ingredient is used in food with no (1) The ingredient is used as a nutri-
limitations other than current good ent supplement as defined in
ognized as safe (GRAS) as a direct (2) The ingredient is used in the fol-
human food ingredient is based upon lowing foods at levels not to exceed
the following current good manufac- current good manufacturing practice:
turing practice conditions of use: dairy product analogs as defined in
(1) The ingredient is used as a leav- § 170.3(n)(10) of this chapter; fats and
ening agent as defined in § 170.3(o)(17) of oils as defined in § 170.3(n)(12) of this
this chapter; a processing aid as de- chapter; and processed fruits and fruit
fined in § 170.3(o)(24) of this chapter; juices as defined in § 170.3(n)(35) of this
and a propellant, aerating agent, and chapter. Beta-carotene may be used in
gas as defined in § 170.3(o)(25) of this infant formula as a source of vitamin A
chapter. in accordance with section 412(g) of the
(2) The ingredient is used in food at Federal Food, Drug, and Cosmetic Act
levels not to exceed current good man- or with regulations promulgated under
ufacturing practice. section 412(g) of the act.
(d) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient
different from the uses established in different from the uses established in
this section do not exist or have been this section do not exist or have been
waived. waived.
[48 FR 57270, Dec. 29, 1983, as amended at 73 [52 FR 25211, July 6, 1987]
FR 8607, Feb. 14, 2008]
§ 184.1250 Cellulase enzyme prepara-
§ 184.1245 Beta-carotene. tion derived from Trichoderma
(a) Beta-carotene (CAS Reg. No. 7235– longibrachiatum.
40–7) has the molecular formula C40H56.
(a) Cellulase enzyme preparation is
It is synthesized by saponification of
derived from a nonpathogenic,
vitamin A acetate. The resulting alco-
nontoxicogenic strain of Trichoderma
hol is either reacted to form vitamin A
longibrachiatum (formerly T. reesei). The
Wittig reagent or oxidized to vitamin A
enzyme, cellulase, catalyzes the
aldehyde. Vitamin A Wittig reagent
and vitamin A aldehyde are reacted to- endohydrolysis of 1,4-beta-glycosidic
gether to form beta-carotene. linkages in cellulose. It is obtained
(b) The ingredient meets the speci- from the culture filtrate resulting from
fications of the Food Chemicals Codex, a pure culture fermentation process.
3d Ed. (1981), p. 73, which is incor- (b) The ingredient meets the general
porated by reference. Copies are avail- and additional requirements for en-
able from the National Academy Press, zyme preparations in the monograph
2101 Constitution Ave. NW., specifications on enzyme preparations
Washingtion, DC 20418, or available for in the ‘‘Food Chemicals Codex,’’ 4th ed.
inspection at the National Archives (1996), pp. 129 to 134, which is incor-
and Records Administration (NARA). porated by reference in accordance
For information on the availability of with 5 U.S.C. 552(a) and 1 CFR part 51.
this material at NARA, call 202–741– Copies are available from the National
6030, or go to: http://www.archives.gov/ Academy Press, 2101 Constitution Ave.
federallregister/ NW., Box 285, Washington, DC 20055

codeloflfederallregulations/ (Internet http://www.nap.edu), or may
ibrllocations.html. be examined at the Center for Food
515
§ 184.1257 21 CFR Ch. I (4–1–15 Edition)
Safety and Applied Nutrition’s Li- NARA, call 202–741–6030, or go to: http://
brary, 5100 Paint Branch Pkwy., Col- www.archives.gov/federallregister/
lege Park, MD 20740, or at the National codeloflfederallregulations/
Archives and Records Administration ibrllocations.html. As determined by
(NARA). For information on the avail- analytical methods in the ‘‘Food
ability of this material at NARA, call Chemicals Codex,’’ clove oleoresin or
202–741–6030, or go to: http:// other natural extractives (other than
www.archives.gov/federallregister/ clove oils) meet the ‘‘Food Chemicals
codeloflfederallregulations/ Codex’’ specifications for clove (clove
ibrllocations.html. bud) oil and the following modifica-
(c) In accordance with § 184.1(b)(1), tions:
the ingredient is used in food with no (1) The assay for phenols, as eugenol,
limitation other than current good by the ‘‘Food Chemicals Codex’’ test,
manufacturing practice. The affirma- 4th ed. (pp. 104–105), or the volatile oils
tion of this ingredient as generally rec- content by the ‘‘Food Chemicals
ognized as safe (GRAS) as a direct Codex’’ test, 4th ed. (pp. 104–105) should
human food ingredient is based upon conform to the representation of the
the following current good manufac- vendor;
turing practice conditions of use: (2) Optical rotation of the volatile oil
(1) The ingredient is used in food as between ¥2° and 0°;
an enzyme as defined in § 170.3(o)(9) of (3) Refractive index of the volatile oil
this chapter for the breakdown of cel- between 1.527 and 1.538 at 20 °C;
lulose.
(4) Specific gravity of the volatile oil
between 1.036 and 1.060; and
ufacturing practice. (5) Residual solvent free, except those
solvents that are GRAS or within tol-
[64 FR 28361, May 26, 1999] erance levels as specified in part 173,
subpart C, of this chapter.
§ 184.1257 Clove and its derivatives.
(c) Clove and its derivatives are used
(a) Cloves are the dried unopened as flavoring agents and adjuvants as
flower buds and calyx tubes, harvested defined in § 170.3(0)(12) of this chapter.
before the flowers have opened, of the (d) The ingredients are used in food
clove tree Eugenia caryophyllata at levels not to exceed good manufac-
Thunberg, native to tropical Asia. turing practice in accordance with
Their derivatives include essential oils § 184.1(b)(1).
(cloves, CAS Reg. No. 8000–34–8; buds; (e) Prior sanctions for these ingredi-
leaves, CAS Reg. No. 8015–97–2; stems, ents different from the uses established
CAS Reg. No. 8015–98–3; and eugenol, in this section do not exist or have
CAS Reg. No. 97–53–0), oleoresins, and been waived.
natural extractives obtained from
clove buds, leaves, and stems. [44 FR 3964, Jan. 19, 1979, as amended at 47
(b) Clove bud oil, clove leaf oil, clove FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14,
stem oil, and eugenol meet the speci- 1984; 64 FR 1759, Jan. 12, 1999]
§ 184.1259 Cocoa butter substitute.
Codex,’’ 4th ed. (1996), pp. 104–105, which
is incorporated by reference in accord- (a) The common or usual name for
ance with 5 U.S.C. 552(a) and 1 CFR the triglyceride 1-palmitoyl-2-oleoyl-3-
part 51. Copies are available from the stearin is ‘‘cocoa butter substitute pri-
National Academy Press, Box 285, 2101 marily from palm oil.’’ The common or
Constitution Ave. NW., Washington, usual name for the triglyceride 1-3-
DC 20055 (Internet address http:// distearoyl-2-olein is ‘‘cocoa butter sub-
www.nap.edu), or may be examined at stitute primarily from high-oleic saf-
the Center for Food Safety and Applied flower or sunflower oil.’’
Nutrition’s Library, Food and Drug Ad- (1) The ingredient 1-palmitoyl-2-ole-
ministration, 5100 Paint Branch Pkwy., oyl-3-stearin is manufactured by:
College Park, MD 20740, or at the Na- (i) Directed esterification of fully
tional Archives and Records Adminis- saturated 1,3-diglycerides (derived from

tration (NARA). For information on palm oil) with the anhydride of food-
the availability of this material at grade oleic acid in the presence of the
516
catalyst trifluoromethane sulfonic acid incorporated by reference), residual

(§ 173.395 of this chapter), or fluorine; limit of detection 0.2 part per
(ii) By interesterification of partially million F; multiply fluoride result by
saturated 1,2,3-triglycerides (derived 2.63 to convert to residual catalyst.
from palm oil) with ethyl stearate in Copies of the material incorporated by
the presence of a suitable lipase en- reference may be obtained from the
zyme preparation that is either gen- AOAC INTERNATIONAL, 481 North
erally recognized as safe (GRAS) or has Frederick Ave., suite 500, Gaithersburg,
food additive approval for such use. MD 20877, or may be examined at the
(2) The ingredient 1-3-distearoyl-2- National Archives and Records Admin-
olein is manufactured by istration (NARA). For information on
interesterification of partially unsatu- the availability of this material at
rated 1,2,3-triglycerides (derived from NARA, call 202–741–6030, or go to: http://
high-oleic safflower or sunflower oil) www.archives.gov/federallregister/
with ethyl stearate or stearic acid in codeloflfederallregulations/
the presence of a suitable lipase en- ibrllocations.html. The ingredient shall
zyme preparation that is either GRAS be washed three times in batches with
or has food additive approval for such 0.5 percent sodium bicarbonate to re-
use. move catalyst residuals in accordance
(b) The ingredient meets the fol- with good manufacturing practice.
lowing specifications: (7) Residual methanol—5 parts per
(1) Over 90 percent triglycerides, not million maximum.
more than 7 percent diglycerides, not (8) Residual fatty acid ethyl esters—
more than 1 percent monoglycerides, not more than 20 parts per million as
and not more than 1 percent free fatty determined by a ‘‘Modification of
acids. Japan Institute of Oils and Fats: Anal-
(2) Total glycerides—98 percent min- ysis Method of Residual Ethyl Esters of
imum. Fatty Acids’’ issued by the Fuji Oil
(3) Heavy metals (as lead), not more Co., which is incorporated by reference.
than 10 milligrams per kilogram, as de- Copies are available from the Office of
termined by the Heavy Metals Test of Food Additive Safety (HFS–200), Center
the ‘‘Food Chemicals Codex,’’ 4th ed. for Food Safety and Applied Nutrition,
(1996), pp. 760–761, which is incorporated Food and Drug Administration, 5100
by reference in accordance with 5 Paint Branch Pkwy., College Park, MD
U.S.C. 552(a) and 1 CFR part 51. Copies 20740, 240–402–1200, or available for in-
are available from the National Acad- spection at the National Archives and
emy Press, Box 285, 2101 Constitution Records Administration (NARA). For
Ave. NW., Washington, DC 20055 (Inter- information on the availability of this
net address http://www.nap.edu), or may material at NARA, call 202–741–6030, or
be examined at the Center for Food go to: http://www.archives.gov/
Safety and Applied Nutrition’s Li- federallregister/
brary, Food and Drug Administration, codeloflfederallregulations/
5100 Paint Branch Pkwy., College Park, ibrllocations.html.
MD 20740, or at the National Archives (9) Hexane—not more than 5 parts per
and Records Administration (NARA). million as determined by the method of
For information on the availability of Dupuy et al., ‘‘Rapid Quantitative De-
this material at NARA, call 202–741– termination of Residual Hexane in Oils
6030, or go to: http://www.archives.gov/ by Direct Gas Chromatography,’’ pub-
federallregister/ lished in the ‘‘Journal of the American
codeloflfederallregulations/ Oil Chemists’ Society,’’ Vol. 52, p. 118–
ibrllocations.html. 120, 1975, which is incorporated by ref-
(4) Color—clear, bright, and free from erence. Copies are available from the
suspended matter. Division of Food and Color Additives,
(5) Odor and taste—free from foreign Center for Food Safety and Applied Nu-
and rancid odor and taste. trition (HFS–200), Food and Drug Ad-
(6) Residual catalyst (‘‘Official Meth- ministration, 5100 Paint Branch Pkwy.,
ods of Analysis of the Association of College Park, MD 20740, or available for

Official Analytical Chemists,’’ 13th Ed. inspection at the National Archives
(1980), sections 25.049–25.055, which is and Records Administration (NARA).
517
§ 184.1260 21 CFR Ch. I (4–1–15 Edition)
For information on the availability of ognized as safe (GRAS) as a direct

this material at NARA, call 202–741– human food ingredient is based upon
6030, or go to: http://www.archives.gov/ the following current good manufac-
federallregister/ turing practice conditions of use:
codeloflfederallregulations/ (1) The ingredient is used as a nutri-
ibrllocations.html. ent supplement as defined in
(c) In accordance with § 184.1(b)(1), § 170.3(o)(20) of this chapter and as a
the ingredient is used in the following synergist as defined in § 170.3(o)(31) of
food categories at levels not to exceed this chapter.
current good manufacturing practice: (2) The ingredient is used in food at
Confections and frostings as defined in levels not to exceed current good man-
§ 170.3(n)(9) of this chapter; coatings of ufacturing practice. Copper gluconate
soft candy as defined in § 170.3(n)(38) of may be used in infant formula in ac-
this chapter; and sweet sauces and top- cordance with section 412(g) of the Fed-
pings as defined in § 170.3(n)(43) of this eral Food, Drug, and Cosmetic Act (the
chapter; except that the ingredient Act) or with regulations promulgated
may not be used in a standardized food under section 412(a)(2) of the Act.
unless permitted by the standard of (d) Prior sanctions for this ingredient
identity. different from the uses established in
(d) The ingredient is used in food in this section do not exist or have been
accordance with § 184.1(b)(1) at levels waived.
not to exceed good manufacturing [49 FR 24119, June 12, 1984]
practice.
§ 184.1261 Copper sulfate.
FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, (a) Copper sulfate (cupric sulfate,
1984; 49 FR 22799, June 1, 1984; 52 FR 47920, CuSO4·5 H2O, CAS Reg. No. 7758–99–8)
Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR usually is used in the pentahydrate
36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999; form. This form occurs as large, deep
78 FR 14666, Mar. 7, 2013] blue or ultramarine, triclinic crystals;
as blue granules, or as a light blue pow-
§ 184.1260 Copper gluconate.
der. The ingredient is prepared by the
(a) Copper gluconate (cupric gluco- reaction of sulfuric acid with cupric
nate (CH2OH(CHOH)4COO)2Cu, CAS oxide or with copper metal.
Reg. No. 527–09–3) is a substance that (b) The ingredient must be of a pu-
occurs as light blue to bluish-green, rity suitable for its intended use.
odorless crystals, or as a fine, light (c) In accordance with § 184.1(b)(1),
blue powder. It is prepared by the reac- the ingredient is used in food with no
tion of gluconic acid solutions with cu- limitation other than current good
pric oxide or basic cupric carbonate. manufacturing practice. The affirma-
(b) The ingredient meets the speci- tion of this ingredient as generally rec-
fications of the Food Chemicals Codex, ognized as safe (GRAS) as a direct
3d Ed. (1981), p. 90, which is incor- human food ingredient is based upon
porated by reference. Copies are avail- the following current good manufac-
able from the National Academy Press, turing practice conditions of use:
2101 Constitution Ave. NW., Wash- (1) The ingredient is used as a nutri-
ington, DC. 20418, or available for in- ent supplement as defined in
spection at the National Archives and § 170.3(o)(20) of this chapter and as a
Records Administration (NARA). For processing aid as defined in § 170.3(o)(24)
information on the availability of this of this chapter.
material at NARA, call 202–741–6030, or (2) The ingredient is used in food at
go to: http://www.archives.gov/ levels not to exceed current good man-
federallregister/ ufacturing practice. Copper sulfate
codeloflfederallregulations/ may be used in infant formula in ac-
ibrllocations.html. cordance with section 412(g) of the Fed-
(c) In accordance with § 184.1(b)(1), eral Food, Drug, and Cosmetic Act (the
the ingredient is used in food with no Act) or with regulations promulgated
limitation other than current good under section 412(a)(2) of the Act.
manufacturing practice. The affirma- (d) Prior sanctions for this ingredient
tion of this ingredient as generally rec- different from the uses established in
518
this section do not exist or have been within the following specific limita-
waived. tions:
[49 FR 24119, June 12, 1984, as amended at 73 Cat- Maximum treatment
FR 8607, Feb. 14, 2008; 76 FR 59249, Sept. 26, egory Functional use
level in food
of food
2011]
Table 0.01 percent .................. Source of dietary iodine.
§ 184.1262 Corn silk and corn silk ex- salt.
tract.
(a) Corn silk is the fresh styles and (d) Prior sanctions for this ingredient
stigmas of Zea mays L. collected when different from the uses established in
the corn is in milk. The filaments are this section do not exist or have been
extracted with dilute ethanol to waived.
produce corn silk extract. The extract [49 FR 24119, June 12, 1984, as amended at 73
may be concentrated at a temperature FR 8607, Feb. 14, 2008]
not exceeding 60 °C.
(b) The ingredient must be of a pu- § 184.1271 L-Cysteine.
rity suitable for its intended use. (a) L-Cysteine is the chemical L-2-
(c) In accordance with § 184.1(b)(2), amino-3-mercaptopropanoic acid
the ingredients are used in food only (C3H7O2NS).
within the following specific limita- (b) The ingredient meets the appro-
tions: priate part of the specification set
forth in the ‘‘Food Chemicals Codex,’’
Maximum
level of 3d Ed. (1981), pp. 92–93, which is incor-
Category of food use in Functional use porated by reference. Copies may be
food (as
served) 1 obtained from the National Academy
Press, 2101 Constitution Ave. NW.,
Baked goods and bak- 30 Flavoring agent, Washington, DC 20418, or may be exam-
ing mixes, § 170.3(o)(12) of this
§ 170.3(n)(1) of this chapter. ined at the National Archives and
chapter. Records Administration (NARA). For
Nonalcoholic bev- 20 Do. information on the availability of this
erages, § 170.3(n)(3) material at NARA, call 202–741–6030, or
of this chapter.
Frozen dairy desserts, 10 Do. go to: http://www.archives.gov/
§ 170.3(n)(20) of this federallregister/
chapter. codeloflfederallregulations/
Soft candy, 20 Do. ibrllocations.html.
§ 170.3(n)(38) of this
chapter. (c) The ingredient is used to supply
All other food cat- 4 Do. up to 0.009 part of total L-cysteine per
egories. 100 parts of flour in dough as a dough
1 Parts per million. strengthener as defined in § 170.3(o)(6)
of this chapter in yeast-leavened baked
(d) Prior sanctions for this ingredient goods and baking mixes as defined in
different from the uses established in § 170.3(n)(1) of this chapter.
this section do not exist or have been (d) This regulation is issued prior to
waived. a general evaluation of use of this in-
[47 FR 29953, July 9, 1982, as amended at 73 gredient in order to affirm as GRAS
FR 8607, Feb. 14, 2008] the specific use named.
§ 184.1265 Cuprous iodide.
FR 5612, Feb. 14, 1984]
(a) Cuprous iodide (copper (I) iodide,
CuI, CAS Reg. No. 7681–65–4) is a pure § 184.1272 L-Cysteine
white crystalline powder. It is prepared monohydrochloride.
by the reaction of copper sulfate with (a) L-Cysteine monohydrochloride is
potassium iodide under slightly acidic the chemical L-2-amino-3-
conditions. mercaptopropanoic acid
(b) The ingredient must be of a pu- monohydrochloride monohydrate
rity suitable for its intended use. (C3H7O2NS HCl H2O).

(c) In accordance with § 184.1(b)(2), (b) The ingredient meets the speci-
the ingredient is used in food only fications of the ‘‘Food Chemicals
519
§ 184.1277 21 CFR Ch. I (4–1–15 Edition)
Codex,’’ 3d Ed. (1981), pp. 92–93, which is human food ingredient is based upon
incorporated by reference. Copies may the following current good manufac-
be obtained from the National Acad- turing practice conditions of use:
emy Press, 2101 Constitution Ave. NW., (1) The ingredient is used as a formu-
Washington, DC 20418, or may be exam- lation aid as defined in § 170.3(o)(14) of
ined at the National Archives and this chapter; as a processing aid as de-
Records Administration (NARA). For fined in § 170.3(o)(24) of this chapter; as
information on the availability of this a stabilizer and thickener as defined in
material at NARA, call 202–741–6030, or § 170.3(o)(28) of this chapter; and as a
go to: http://www.archives.gov/ surface-finishing agent as defined in
federallregister/ § 170.3(o)(30) of this chapter.
codeloflfederallregulations/ (2) The ingredient is used in food at
ibrllocations.html. levels not to exceed current good man-
(c) The ingredient is used to supply ufacturing practice.
up to 0.009 part of total L-cysteine per (d) Prior sanctions for this ingredient
100 parts of flour in dough as a dough different from the uses established in
strengthener as defined in § 170.3(o)(6) this section do not exist or have been
of this chapter in yeast-leavened baked waived.
goods and baking mixes as defined in
§ 170.3(n)(1) of this chapter. [48 FR 51909, Nov. 15, 1983]
(d) This regulation is issued prior to
a general evaluation of use of this in- § 184.1278 Diacetyl.
gredient in order to affirm as GRAS (a) Diacetyl (C4H6O2, CAS Reg. No.
the specific use named. 431–03–8) is a clear yellow to yellowish
[42 FR 14653, Mar. 15, 1977, as amended at 49 green liquid with a strong pungent
FR 5612, Feb. 14, 1984] odor. It is also known as 2,3-
butanedione and is chemically syn-
§ 184.1277 Dextrin. thesized from methyl ethyl ketone. It
(a) Dextrin ((C6H10O5)n·H2O, CAS Reg. is miscible in water, glycerin, alcohol,
No. 9004–53–9) is an incompletely and ether, and in very dilute water so-
hydrolyzed starch. It is prepared by dry lution, it has a typical buttery odor
heating corn, waxy maize, waxy milo, and flavor.
potato, arrowroot, wheat, rice, tapioca, (b) The ingredient meets the speci-
or sago starches, or by dry heating the fications of the Food Chemicals Codex,
starches after: (1) Treatment with safe 3d Ed. (1981), p. 368, which is incor-
and suitable alkalis, acids, or pH con- porated by reference. Copies are avail-
trol agents and (2) drying the acid or able from the National Academy Press,
alkali treated starch. 2101 Constitution Ave. NW., Wash-
(b) The ingredient meets the speci- ington, DC 20418, or available for in-
fication of the Food Chemicals Codex, spection at the National Archives and
2101 Constitution Ave. NW., Wash- go to: http://www.archives.gov/
manufacturing practice. The affirma- (1) The ingredient is used as a fla-

tion of this ingredient as generally rec- voring agent and adjuvant as defined in
ognized as safe (GRAS) as a direct § 170.3(o)(12) of this chapter.
520
(2) The ingredient is used in food at butterfat or milkfat; and steam-ren-

levels not to exceed current good man- dered chicken fat, respectively, with
ufacturing practice. enzymes that are generally recognized
(d) Prior sanctions for this ingredient as safe (GRAS). Enzyme-modified milk
different from the uses established in powder may be prepared with GRAS
this section do not exist or have been enzymes from reconstituted milk pow-
waived. der, whole milk, condensed or con-
centrated whole milk, evaporated
[48 FR 51907, Nov. 15, 1983]
milk, or milk powder. The lipolysis is
§ 184.1282 Dill and its derivatives. maintained at a temperature that is
optimal for the action of the enzyme
(a) Dill (American or European) is until appropriate acid development is
the herb and seeds from Anethum attained. The enzymes are then inac-
graveolens L., and dill (Indian) is the tivated. The resulting product is con-
herb and seeds from Anethum sowa, centrated or dried.
D.C. Its derivatives include essential (b) The ingredients must be of a pu-
oils, oleoresins, and natural extractives rity suitable for their intended use.
obtained from these sources of dill. (c) In accordance with § 184.1(b)(1),
(b) Dill oils meet the description and the ingredients are used in food with
specifications of the ‘‘Food Chemicals no limitation other than current good
Codex,’’ 4th ed. (1996), pp. 122–123, which manufacturing practice. The affirma-
is incorporated by reference in accord- tion of these ingredients as generally
ance with 5 U.S.C. 552(a) and 1 CFR recognized as safe (GRAS) as direct
part 51. Copies are available from the human food ingredients is based upon
National Academy Press, Box 285, 2101 the following current good manufac-
Constitution Ave. NW., Washington, turing practice conditions of use:
DC 20055 (Internet address http:// (1) The ingredients are used as fla-
www.nap.edu), or may be examined at voring agents and adjuvants as defined
the Center for Food Safety and Applied in § 170.3(o)(12) of this chapter.
Nutrition’s Library, Food and Drug Ad- (2) The ingredients are used in food
ministration, 5100 Paint Branch Pkwy., at levels not to exceed current good
College Park, MD 20740, or at the Na- manufacturing practice.
tional Archives and Records Adminis- (d) Prior sanctions for these ingredi-
tration (NARA). For information on ents different from the uses established
the availability of this material at in this section do not exist or have
NARA, call 202–741–6030, or go to: http:// been waived.
[52 FR 25976, July 10, 1987, as amended at 73
codeloflfederallregulations/ FR 8607, Feb. 14, 2008]
ibrllocations.html.
(c) Dill and its derivatives are used as § 184.1293 Ethyl alcohol.
flavoring agents and adjuvants as de- (a) Ethyl alcohol (ethanol) is the
fined in § 170.3(o)(12) of this chapter. chemical C2H5OH.
(d) The ingredients are used in food (b) The ingredient meets the speci-
at levels not to exceed good manufac- fications of the ‘‘Food Chemicals
turing practice. Codex,’’ 4th ed. (1996), p. 136, which is
(e) [Reserved] incorporated by reference in accord-
(f) Prior sanctions for these ingredi- ance with 5 U.S.C. 552(a) and 1 CFR
ents different from the uses established part 51. Copies are available from the
in this section do not exist or have National Academy Press, Box 285, 2101
been waived. Constitution Ave. NW., Washington,
[42 FR 14653, Mar. 15, 1977, as amended at 42 DC 20055 (Internet address http://
FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, www.nap.edu), or may be examined at
1984; 64 FR 1760, Jan. 12, 1999] the Center for Food Safety and Applied
Nutrition’s Library, Food and Drug Ad-
§ 184.1287 Enzyme-modified fats. ministration, 5100 Paint Branch Pkwy.,
(a) Enzyme-modified refined beef fat, College Park, MD 20740, or at the Na-
enzyme-modified butterfat, and en- tional Archives and Records Adminis-

zyme-modified steam-rendered chicken tration (NARA). For information on
fat are prepared from refined beef fat; the availability of this material at
521
§ 184.1295 21 CFR Ch. I (4–1–15 Edition)
NARA, call 202–741–6030, or go to: http:// ter; 0.02 percent in frozen dairy des-
www.archives.gov/federallregister/ serts as defined in § 170.3(n)(20) of this
codeloflfederallregulations/ chapter; 0.03 percent in gelatins, pud-
ibrllocations.html. dings, and fillings as defined in
(c) The ingredient is used as an anti- § 170.3(n)(22) of this chapter; and 0.01
microbial agent as defined in percent in all other food categories.
§ 170.3(o)(2) of this chapter on pizza (e) Prior sanctions for ethyl formate
crusts prior to final baking at levels different from the uses established in
not to exceed 2.0 percent by product this section do not exist or have been
weight. waived.
(d) This regulation is issued prior to
general evaluation of use of this ingre- [45 FR 22915, Apr. 4, 1980, as amended at 49
dient in order to affirm as GRAS the FR 5612, Feb. 14, 1984]
specific use named.
§ 184.1296 Ferric ammonium citrate.
FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, (a) Ferric ammonium citrate (iron
1999] (III) ammonium citrate) is prepared by
the reaction of ferric hydroxide with
§ 184.1295 Ethyl formate. citric acid, followed by treatment with
(a) Ethyl formate (C3H6O2, CAS Reg. ammonium hydroxide, evaporating,
No. 109–94–4) is also referred to as ethyl and drying. The resulting product oc-
methanoate. It is an ester of formic curs in two forms depending on the
acid and is prepared by esterification stoichiometry of the initial reactants.
of formic acid with ethyl alcohol or by (1) Ferric ammonium citrate (iron
distillation of ethyl acetate and formic (III) ammonium citrate, CAS Reg. No.
acid in the presence of concentrated 1332–98–5) is a complex salt of undeter-
sulfuric acid. Ethyl formate occurs mined structure composed of 16.5 to
naturally in some plant oils, fruits, and 18.5 percent iron, approximately 9 per-
juices but does not occur naturally in cent ammonia, and 65 percent citric
the animal kingdom. acid and occurs as reddish brown or
(b) The ingredient meets the speci- garnet red scales or granules or as a
fications of the ‘‘Food Chemicals brownish-yellowish powder.
Codex,’’ 3d Ed. (1981), p. 376, which is in-
(2) Ferric ammonium citrate (iron
(III) ammonium citrate, CAS Reg. No.
obtained from the National Academy
1333–00–2) is a complex salt of undeter-
mined structure composed of 14.5 to 16
ined at the National Archives and percent iron, approximately 7.5 percent
Records Administration (NARA). For ammonia, and 75 percent citric acid
information on the availability of this and occurs as thin transparent green
material at NARA, call 202–741–6030, or scales, as granules, as a powder, or as
go to: http://www.archives.gov/ transparent green crystals.
federallregister/ (b) The ingredients meet the speci-
codeloflfederallregulations/ fications of the Food Chemicals Codex,
ibrllocations.html. 3d Ed. (1981), pp. 116–117 (Ferric ammo-
(c) The ingredient is used as a fla- nium citrate, brown) and p. 117 (Ferric
voring agent and adjuvant as defined in ammonium citrate, green), which is in-
§ 170.3(o)(12) of this chapter. corporated by reference. Copies are
(d) The ingredient is used in food at available from the National Academy
levels not to exceed good manufac- Press, 2101 Constitution Ave. NW.,
turing practice in accordance with Washington, DC 20418, or available for
§ 184.1(b)(1). Current good manufac- inspection at the National Archives
turing practice results in a maximum and Records Administration (NARA).
level, as served, of 0.05 percent in baked For information on the availability of
goods as defined in § 170.3(n)(1) of this this material at NARA, call 202–741–
chapter; 0.04 percent in chewing gum as 6030, or go to: http://www.archives.gov/
defined in § 170.3(n)(6), hard candy as federallregister/

defined in § 170.3(n)(25), and soft candy codeloflfederallregulations/
as defined in § 170.3(n)(38) of this chap- ibrllocations.html.
522
(c) In accordance with § 184.1(b)(1), manufacturing practice. The ingre-

the ingredients are used in food as nu- dient may also be used in infant for-
trient supplements as defined in mula in accordance with section 412(g)
§ 170.3(o)(20) of this chapter, with no of the Federal Food, Drug, and Cos-
limitation other than current good metic Act (the act) (21 U.S.C. 350a(g))
manufacturing practice. The ingredi- or with regulations promulgated under
ents may also be used in infant formula section 412(a)(2) of the act (21 U.S.C.
in accordance with section 412(g) of the 350a(a)(2)).
Federal Food, Drug, and Cosmetic Act (d) Prior sanctions for this ingredient
(the act) (21 U.S.C. 350a(g)) or with reg- different from the uses established in
ulations promulgated under section this section do not exist or have been
412(a)(2) of the act (21 U.S.C. 350a(a)(2)). waived.
(d) Prior sanctions for these ingredi-
ents different from the uses established FR 8607, Feb. 14, 2008]
been waived. § 184.1301 Ferric phosphate.
[53 FR 16864, May 12, 1988] (a) Ferric phosphate (ferric
orthophosphate, iron (III) phosphate,
§ 184.1297 Ferric chloride. FePO4·xH2O, CAS Reg. No. 10045–86–0) is
(a) Ferric chloride (iron (III) chlo- an odorless, yellowish-white to buff-
ride, FeC13, CAS Reg. No. 7705–08–0) colored powder and contains from one
may be prepared from iron and chlorine to four molecules of water of hydra-
or from ferric oxide and hydrogen chlo- tion. It is prepared by reaction of so-
ride. The pure material occurs as dium phosphate with ferric chloride or
hydroscopic, hexagonal, dark crystals. ferric citrate.
Ferric chloride hexahydrate (iron (III) (b) The ingredient meets the speci-
chloride hexahydrate, FeC13. 6H20, CAS fications of the Food Chemicals Codex,
Reg. No. 10025–77–1) is readily formed 3d Ed. (1981), pp. 118–120, which is incor-
when ferric chloride is exposed to mois- porated by reference. Copies are avail-
ture. able from the National Academy Press,
(b) The ingredient must be of a pu- 2101 Constitution Ave. NW., Wash-
rity suitable for its intended use. ington, DC 20418, or available for in-
(c) In accordance with § 184.1(b)(1) the spection at the National Archives and
ingredient is used in food as a flavoring Records Administration (NARA). For
agent as defined in § 170.3(o)(12) of this information on the availability of this
chapter, with no limitation other than material at NARA, call 202–741–6030, or
current good manufacturing practice. go to: http://www.archives.gov/
(d) Prior sanctions for this ingredient federallregister/
different from the uses established in codeloflfederallregulations/
this section do not exist or have been ibrllocations.html.
waived. (c) In accordance with § 184.1(b)(1),
the ingredient is used in food as nutri-
FR 8607, Feb. 14, 2008] ent supplement as defined in
§ 170.3(o)(20) of this chapter, with no
§ 184.1298 Ferric citrate. limitation other than current good
manufacturing practice. The ingre-
(a) Ferric citrate (iron (III) citrate,
dient may also be used in infant for-
C6H5FeO7, CAS Reg. No. 2338–05–8) is
mula in accordance with section 412(g)
prepared from reaction of citric acid
of the Federal Food, Drug, and Cos-
with ferric hydroxide. It is a compound
metic Act (the act) (21 U.S.C. 350a(g))
of indefinite ratio of citric acid and
or with regulations promulgated under
iron.
section 412(a)(2) of the act (21 U.S.C.
350a(a)(2)).
the ingredient is used in food as a nu-
trient supplement as defined in

waived.
§ 170.3(o)(20) of this chapter, with no
limitation other than current good [53 FR 16865, May 12, 1988]
523
§ 184.1304 21 CFR Ch. I (4–1–15 Edition)
§ 184.1304 Ferric pyrophosphate. (d) Prior sanctions for this ingredient

(a) Ferric pyrophosphate (iron (III)
pyrophosphate, Fe4(P207)3·xH2O, CAS
waived.
Reg. No. 10058–44–3) is a tan or yel-
lowish white colorless powder. It is pre- [53 FR 16865, May 12, 1988, as amended at 73
pared by reacting sodium FR 8607, Feb. 14, 2008]
pyrophosphate with ferric citrate.
(b) The ingredient meets the speci- § 184.1307a Ferrous ascorbate.
fications of the Food Chemicals Codex, (a) Ferrous ascorbate (CAS Reg. No.
3d Ed. (1981), p. 120, which is incor- 24808–52–4) is a reaction product of fer-
porated by reference. Copies are avail- rous hydroxide and ascorbic acid. It is
able from the National Academy Press, a blue-violet product containing 16 per-
2101 Constitution Ave. NW., Wash- cent iron.
ington, DC 20418, or available for in- (b) The ingredient must be of a pu-
spection at the National Archives and rity suitable for its intended use.
Records Administration (NARA). For (c) In accordance with § 184.1(b)(1),
information on the availability of this the ingredient is used in food as a nu-
material at NARA, call 202–741–6030, or trient supplement as defined in
go to: http://www.archives.gov/ § 170.3(o)(20) of this chapter, with no
federallregister/ limitation other than current good
codeloflfederallregulations/ manufacturing practice. The ingre-
ibrllocations.html. dient may also be used in infant for-
(c) In accordance with § 184.1(b)(1), mula in accordance with section 412(g)
the ingredient is used in food as a nu- of the Federal Food, Drug, and Cos-
trient supplement as defined in metic Act (the act) (21 U.S.C. 350a(g))
§ 170.3(o)(20) of this chapter, with no or with regulations promulgated under
limitation other than current good section 412(a)(2) of the act (21 U.S.C.
manufacturing practice. The ingre- 350a(a)(2)).
dient may also be used in infant for- (d) Prior sanctions for this ingredient
mula in accordance with section 412(g) different from the uses established in
of the Federal Food, Drug, and Cos- this section do not exist or have been
metic Act (the act) (21 U.S.C. 350a(g)) waived.
section 412(a)(2) of the act (21 U.S.C. [53 FR 16865, May 12, 1988, as amended at 69
350a(a)(2)). FR 24512, May 4, 2004; 73 FR 8607, Feb. 14,
2008]
different from the uses established in § 184.1307b Ferrous carbonate.
waived. (a) Ferrous carbonate (iron (II) car-
bonate, FeCO3, CAS Reg. No. 563–71–3)
[53 FR 16865, May 12, 1988; 53 FR 20939, June is an odorless, white solid prepared by
7, 1988] treating solutions of iron (II) salts with
alkali carbonate salts.
§ 184.1307 Ferric sulfate.
(a) Ferric sulfate (iron (III) sulfate, rity suitable for its intended use.
Fe2(SO4)3 CAS Reg. No. 10028–22–5) is a (c) In accordance with § 184.1(b)(1),
yellow substance that may be prepared the ingredient is used in food as a nu-
by oxidizing iron (II) sulfate or by trient supplement as defined in
treating ferric oxide or ferric hydrox- § 170.3(o)(20) of this chapter, with no
ide with sulfuric acid. limitation other than current good
(b) The ingredient must be of a pu- manufacturing practice. The ingre-
rity suitable for its intended use. dient may also be used in infant for-
(c) In accordance with § 184.1(b)(1), mula in accordance with section 412(g)
the ingredient is used in food as a fla- of the Federal Foods, Drug, and Cos-
voring agent as defined in § 170.3(o)(12) metic Act (the act) (21 U.S.C. 350a(g))
of this chapter, with no limitation or with regulations promulgated under

other than current good manufacturing section 412(a)(2) of the act (21 U.S.C.
practice. 350a(a)(2)).
524
(d) Prior sanctions for this ingredient codeloflfederallregulations/

different from the uses established in ibrllocations.html.
this section do not exist or have been (c) In accordance with § 184.1(b)(1) the
waived. ingredient is used in food as a nutrient
supplement as defined in § 170.3(o)(20) of
FR 8607, Feb. 14, 2008] this chapter, with no limitation other
than current good manufacturing prac-
§ 184.1307c Ferrous citrate. tice. The ingredient may also be used
(a) Ferrous citrate (iron (II) citrate, in infant formula in accordance with
(C6H6FeO7), CAS Reg. No. 23383–11–1) is section 412(g) of the Federal Food,
a slightly colored powder or white Drug, and Cosmetic Act (the act) (21
crystals. It is prepared from the reac- U.S.C. 350a(g)), or with regulations pro-
tion of sodium citrate with ferrous sul- mulgated under section 412(a)(2) of the
fate or by direct action of citric acid on act (21 U.S.C. 350a(a)(2)).
iron filings. (d) Prior sanctions for this ingredient
(b) The ingredient must be of a pu- different from the uses established in
rity suitable for its intended use. this section do not exist or have been
(c) In accordance with § 184.1(b)(1) the waived.
ingredient is used in food as a nutrient [53 FR 16866, May 12, 1988]
supplement as defined in § 170.3(o)(20) of
this chapter, with no limitation other § 184.1308 Ferrous gluconate.
than current good manufacturing prac- (a) Ferrous gluconate (iron (II) gluco-
tice. The ingredient may also be used nate dihydrate, C12H22FeO14·2H2O, CAS
in infant formula in accordance with Reg. No. 6047-12-7) is a fine yellowish-
section 412(g) of the Federal Food, gray or pale greenish-yellow powder or
Drug, and Cosmetic Act (the act) (21 granules. It is prepared by reacting hot
U.S.C. 350a(g)) or with regulations pro- solutions of barium or calcium gluco-
mulgated under section 412(a)(2) of the nate with ferrous sulfate or by heating
act (21 U.S.C. 350a(a)(2)). freshly prepared ferrous carbonate with
(d) Prior sanctions for this ingredient gluconic acid in aqueous solution.
different from the uses established in (b) The ingredient meets the speci-
this section do not exist or have been fications of the Food Chemcials Codex,
waived. 3d Ed. (1981), pp. 122–123, which is incor-
[53 FR 16866, May 12, 1988, as amended at 73 porated by reference. Copies are avail-
FR 8607, Feb. 14, 2008] able from the National Academy Press,
2101 Constitution Avenue NW., Wash-
§ 184.1307d Ferrous fumarate. ington, DC 20418, or available for in-
(a) Ferrous fumarate (iron (II) fuma- spection at the National Archives and
rate, (C4H2FeO4), CAS Reg. No. 141–01–5) Records Administration (NARA). For
is an odorless, reddish-orange to red- information on the availability of this
dish-brown powder. It may contain soft material at NARA, call 202–741–6030, or
lumps that produce a yellow streak go to: http://www.archives.gov/
when crushed. It is prepared by federallregister/
admixing hot solutions of ferrous sul- codeloflfederallregulations/
fate and sodium fumarate. ibrllocations.html.
(b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1),
fications of the Food Chemicals Codex, the ingredient is used in food as a nu-
3d Ed. (1981), pp. 120–122, which is incor- trient supplement as defined in
porated by reference. Copies are avail- § 170.3(o)(20) of this chapter, with no
able from the National Academy Press, limitation other than current good
2101 Constitution Ave NW., Wash- manufacturing practice. The ingre-
ington, DC 20418, or available for in- dient may also be used in infant for-
spection at the National Archives and mula in accordance with section 412(g)
Records Administration (NARA). For of the Federal Food, Drug, and Cos-
information on the availability of this metic Act (the act) (21 U.S.C. 350a(g))
material at NARA, call 202–741–6030, or or with regulations promulgated under

go to: http://www.archives.gov/ section 412(a)(2) of the act (21 U.S.C.
federallregister/ 350a(a)(2)).
525
§ 184.1311 21 CFR Ch. I (4–1–15 Edition)
(d) Prior sanctions for this ingredient § 184.1315 Ferrous sulfate.

different from the uses established in (a) Ferrous sulfate heptahydrate
this section do not exist or have been (iron (II) sulfate heptahydrate,
waived. FeSO4·7H2O, CAS Reg. No. 7782–63–0) is
[53 FR 16866, May 12, 1988; 53 FR 20939, June prepared by the action of sulfuric acid
7, 1988] on iron. It occurs as pale, bluish-green
crystals or granules. Progressive heat-
§ 184.1311 Ferrous lactate. ing of ferrous sulfate heptahydrate pro-
(a) Ferrous lactate (iron (II) lactate, duces ferrous sulfate (dried). Ferrous
C6H10FeO6, CAS Reg. No. 5905–52–2) in sulfate (dried) consists primarily of fer-
the trihydrate form is a greenish-white rous sulfate monohydrate (CAS Reg.
powder or crystalline mass. It is pre- No. 17375–41–6) with varying amounts of
pared by reacting calcium lactate or ferrous sulfate tetrahydrate (CAS Reg.
sodium lactate with ferrous sulfate, di- No. 20908–72–9) and occurs as a grayish-
white to buff-colored powder.
rect reaction of lactic acid with iron
(b) The ingredients meet the speci-
filings, reaction of ferrous chloride
with sodium lactate, or reaction of fer-
3d Ed. (1981), p. 123 (Ferrous sulfate
rous sulfate with ammonium lactate.
heptahydrate) and p. 124 (ferrous sul-
(b) The ingredient meets the speci- fate, dried), which is incorporated by
fications of the Food Chemicals Codex, reference. Copies are available from
4th ed. (1996), pp. 154 to 155, which is in- the National Academy Press, 2101 Con-
corporated by reference in accordance stitution Ave., NW., Washington, DC
with 5 U.S.C. 552(a) and 1 CFR part 51. 20418, or available for inspection at the
Copies are available from the National National Archives and Records Admin-
Academy Press, 2101 Constitution Ave. istration (NARA). For information on
NW., Washington, DC 20418, or may be the availability of this material at
examined at the Center for Food Safety NARA, call 202–741–6030, or go to: http://
and Applied Nutrition’s library, 5100 www.archives.gov/federallregister/
Paint Branch Pkwy., College Park, MD codeloflfederallregulations/
20740, or at the National Archives and ibrllocations.html.
Records Administration (NARA). For (c) In accordance with § 184.1(b)(1),
information on the availability of this the ingredients are used in food as nu-
material at NARA, call 202–741–6030, or trient supplements as defined in
go to: http://www.archives.gov/ § 170.3(o)(20) of this chapter and as a
federallregister/ processing aid as defined in § 170.3(o)(24)
codeloflfederallregulations/ of this chapter, with no limitation
ibrllocations.html. other than current good manufacturing
(c) In accordance with § 184.1(b)(1), practice. The ingredients may also be
the ingredient is used in food as a nu- used in infant formula in accordance
trient supplement as defined in with section 412(g) of the Federal Food,
§ 170.3(o)(20) of this chapter and as a Drug, and Cosmetic Act (the act) (21
color fixative for ripe olives, with no U.S.C. 350a(g)) or with regulations pro-
other limitation other than current mulgated under section 412(a)(2) of the
good manufacturing practice. The in- act (21 U.S.C. 350a(a)(2)).
gredient may also be used in infant for- (d) Prior sanctions for these ingredi-
mula in accordance with section 412(g) ents different from the uses established
of the Federal Food, Drug, and Cos- in this section do not exist or have
metic Act (the act) (21 U.S.C. 350a(g)) been waived.
[53 FR 16866, May 12, 1988]
section 412(a)(2) of the act (21 U.S.C.
350a(a)(2)). § 184.1316 Ficin.
(a) Ficin (CAS Reg. No. 9001–33–6) is
an enzyme preparation obtained from
this section do not exist or have been the latex of species of the genus Ficus,
waived.
which include a variety of tropical fig

[53 FR 16866, May 12, 1988, as amended at 61 trees. It is a white to off-white powder.
FR 40319, Aug. 2, 1996] Its characterizing enzyme activity is
526
that of a peptide hydrolase (EC NARA, call 202–741–6030, or go to: http://

3.4.22.3). www.archives.gov/federallregister/
(b) The ingredient meets the general codeloflfederallregulations/
requirements and additional require- ibrllocations.html.
ments for enzyme preparations in the (c) Garlic and its derivatives are used
Food Chemicals Codex, 3d ed. (1981), p. as flavoring agents and adjuvants as
110, which is incorporated by reference defined in § 170.3(o)(12) of this chapter.
in accordance with 5 U.S.C. 552(a) and 1 (d) The ingredients are used in food
CFR part 51. Copies are available from at levels not to exceed good manufac-
the National Academy Press, 2101 Con- turing practice.
stitution Ave., NW., Washington, DC (e) [Reserved]
20418, or may be examined at the Office (f) Prior sanctions for this ingredient
of Food Additive Safety (HFS–200), different from the uses established in
Center for Food Safety and Applied Nu- this section do not exist or have been
trition, Food and Drug Administration, waived.
5100 Paint Branch Pkwy., College Park, [42 FR 14653, Mar. 15, 1977, as amended at 42
MD 20740, 240–402–1200, and at the Na- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14,
tional Archives and Records Adminis- 1984]
the availability of this material at § 184.1318 Glucono delta-lactone.
NARA, call 202–741–6030, or go to: http:// (a) Glucono delta-lactone (C6H10O6,
www.archives.gov/federallregister/ CAS Reg. No. 90–80–2), also called D-
codeloflfederallregulations/ gluconic acid delta-lactone or D-
ibrllocations.html. glucono-1,5-lactone, is the cyclic 1,5-
(c) In accordance with § 184.1(b)(1), intramolecular ester of D-gluconic
the ingredient is used in food with no acid. It is prepared by direct crys-
limitation other than current good tallization from the aqueous solution
manufacturing practice. The affirma- of gluconic acid. Gluconic acid may be
tion of this ingredient as GRAS as a di- produced by the oxidation of D-glucose
rect food ingredient is based upon the with bromine water, by the oxidation
following current good manufacturing of D-glucose by microorganisms that
practice conditions of use: are nonpathogenic and nontoxicogenic
(1) The ingredient is used as an en- to man or other animals, or by the oxi-
zyme as defined in § 170.3(o)(9) of this dation of D-glucose with enzymes de-
chapter to hydrolyze proteins or rived from these microorganisms.
polypeptides. (b) The ingredient meets the speci-
(2) The ingredient is used in food at fications of the Food Chemicals Codex,
levels not to exceed current good man- 3d Ed. (1981), p. 134, which is incor-
ufacturing practice. porated by reference. Copies are avail-
[60 FR 32910, June 26, 1995, as amended at 78 able from the National Academy Press,
FR 14666, Mar. 7, 2013] 2101 Constitution Ave. NW., Wash-
§ 184.1317 Garlic and its derivatives. spection at the National Archives and
(a) Garlic is the fresh or dehydrated Records Administration (NARA). For
bulb or cloves obtained from Allium information on the availability of this
sativum, a genus of the lily family. Its material at NARA, call 202–741–6030, or
derivatives include essential oils, oleo- go to: http://www.archives.gov/
resins, and natural extractives ob- federallregister/
tained from garlic. codeloflfederallregulations/
(b) Garlic oil meets the specifications ibrllocations.html.
of the ‘‘Food Chemicals Codex,’’ 3d Ed. (c) In accordance with § 184.1(b)(1),
(1981), p. 132, which is incorporated by the ingredient is used in food with no
reference. Copies may be obtained from limitation other than current good
the National Academy Press, 2101 Con- manufacturing practice. The affirma-
stitution Ave. NW., Washington, DC tion of this ingredient as generally rec-
20418, or may be examined at the Na- ognized as safe (GRAS) as a direct
tional Archives and Records Adminis- human food ingredient is based upon
tration (NARA). For information on the following current good manufac-
the availability of this material at turing practice conditions of use:
527
§ 184.1321 21 CFR Ch. I (4–1–15 Edition)
(1) The ingredient is used as a curing § 184.1322 Wheat gluten.

and pickling agent as defined in
(a) Wheat gluten (CAS Reg. No. 8002–
§ 170.3(o)(5) of this chapter, leavening
80–0) is the principal protein compo-
agent as defined in § 170.3(o)(17) of this nent of wheat and consists mainly of
chapter; pH control agent as defined in gliadin and glutenin. Wheat gluten is
§ 170.3(o)(23) of this chapter; and obtained by hydrating wheat flour and
sequestrant as defined in § 170.3(o)(26) of mechanically working the sticky mass
this chapter. to separate the wheat gluten from the
(2) The ingredient is used at levels starch and other flour components.
not to exceed current good manufac- Vital gluten is dried gluten that has re-
turing practice. tained its elastic properties.
(d) Prior sanctions for this ingredient (b) The ingredient must be of a pu-
different from the uses established in rity suitable for its intended use.
this section do not exist or have been (c) In accordance with § 184.1(b)(1),
waived. the ingredient is used in food with no
[51 FR 33896, Sept. 24, 1986]
§ 184.1321 Corn gluten. tion of this ingredient as generally rec-
ognized as safe (GRAS) as a direct
(a) Corn gluten (CAS Reg. No. 66071– human food ingredient is based upon
96–3), also known as corn gluten meal, the following current good manufac-
is the principal protein component of turing practice conditions of use:
corn endosperm. It consists mainly of (1) The ingredient is used as a dough
zein and glutelin. Corn gluten is a by- strengthener as defined in § 170.3(o)(6)
product of the wet milling of corn for of this chapter; a formulation aid as
starch. The gluten fraction is washed defined in § 170.3(o)(14) of this chapter;
to remove residual water soluble pro- a nutrient supplement as defined in
teins. Corn gluten is also produced as a § 170.3(o)(20) of this chapter; a proc-
byproduct during the conversion of the essing aid as defined in § 170.3(o)(24) of
starch in whole or various fractions of this chapter; a stabilizer and thickener
dry milled corn to corn syrups. as defined in § 170.3(o)(28) of this chap-
(b) The ingredient must be of a pu- ter; a surface-finishing agent as defined
rity suitable for its intended use. in § 170.3(o)(30) of this chapter; and a
(c) In accordance with § 184.1(b)(1), texturizing agent as defined in
the ingredient is used in food with no § 170.3(o)(32) of this chapter.
limitation other than current good (2) The ingredient is used in food at
manufacturing practice. The affirma- levels not to exceed current good man-
tion of this ingredient as generally rec- ufacturing practice.
ognized as safe (GRAS) as a direct (d) Prior sanctions for this ingredient
human food ingredient is based upon different from the uses established in
the following current good manufac- this section do not exist or have been
turing practice conditions of use: waived.
(1) The ingredient is used as a nutri- [50 FR 8998, Mar. 6, 1985, as amended at 73 FR
ent supplement as defined in 8607, Feb. 14, 2008]
§ 170.3(o)(20) of this chapter and a
texturizer as defined in § 170.3(o)(32) of § 184.1323 Glyceryl monooleate.
this chapter. (a) Glyceryl monooleate is prepared
(2) The ingredient is used in food at by esterification of commerical oleic
levels not to exceed current good man- acid that is derived either from edible
ufacturing practice. sources or from tall oil fatty acids
(d) Prior sanctions for this ingredient meeting the requirements of § 172.862 of
different from the uses established in this chapter. It contains glyceryl
this section do not exist or have been monooleate (C21H40O4, CAS Reg. No.
waived. 25496–72–4) and glyceryl esters of fatty
acids present in commercial oleic acid.

[50 FR 8998, Mar. 6, 1985, as amended at 73 FR (b) The ingredient must be of a pu-
8607, Feb. 14, 2008] rity suitable for its intended use.
528
(c) In accordance with § 184.1(b)(1), this section do not not exist or have
the ingredient is used in food with no been waived.
limitation other than current good [54 FR 7403 Feb. 21, 1989, as amended at 73 FR
manufacturing practice. The affirma- 8607, Feb. 14, 2008]
ognized as safe (GRAS) as a direct § 184.1328 Glyceryl behenate.
human food ingredient is based upon (a) Glyceryl behenate is a mixture of
the following current good manufac- glyceryl esters of behenic acid made
turing practice conditions of use: from glycerin and behenic acid (a satu-
(1) The ingredient is used as a fla- rated C22 fatty acid). The mixture con-
voring agent and adjuvant as defined in tains predominately glyceryl
§ 170.3(o)(12) of this chapter and as a dibehenate.
solvent and vehicle as defined in (b) The ingredient meets the fol-
§ 170.3(o)(27) of this chapter. lowing specifications:
(2) The ingredient is used in the fol- (1) 10 to 20 percent monoglyceride, 47
lowing foods at levels not to exceed to 59 percent diglyceride, 26 to 38 per-
current good manufacturing practice: cent triglyceride, and not more than
baked goods and baking mixes as de- 2.5 percent free fatty acids.
fined in § 170.3(n)(1) of this chapter; (2) Behenic acid. Between 80 and 90
nonalcoholic beverages and beverage percent of the total fatty acid content.
bases as defined in § 170.3(n)(3) of this (3) Acid value. Not more than 4.
chapter; chewing gum as defined in (4) Saponification value. Between 145
§ 170.3(n)(6) of this chapter; and meat and 165.
products as defined in § 170.3(n)(29) of (5) Iodine number. Not more than 3.
this chapter. (6) Heavy metals (as Pb). Not more
(d) Prior sanctions for this ingredient than 10 parts per million.
different from the use established in (c) In accordance with § 184.1(b)(1) of
this section do not exist or have been this chapter, the ingredient is used in
waived. food with no limitation other than cur-
rent good manufacturing practice. The
[54 FR 7403 Feb. 21, 1989, as amended at 73 FR affirmation of this ingredient is gen-
8607, Feb. 14, 2008] erally recognized as safe (GRAS) as a
direct human food ingredient is based
§ 184.1324 Glyceryl monostearate. upon the following current good manu-
(a) Glyceryl monostearate, also facturing practice conditions of use:
known as monostearin, is a mixture of (1) The ingredient is used as a formu-
variable proportions of glyceryl mono- lation aid, as defined in § 170.3(o)(14) of
stearate (C21H42O4, CAS Reg. No. 31566– this chapter.
31–1), glyceryl monopalmitate (2) The ingredient is used in excipient
(C19H38O4, CAS Reg. No. 26657–96–5) and formulations for use in tablets at levels
glyceryl esters of fatty acids present in not to exceed good manufacturing
commercial stearic acid. Glyceryl practice.
monostearate is prepared by [52 FR 42430, Nov. 5, 1987]
glycerolysis of certain fats or oils that
are derived from edible sources or by § 184.1329 Glyceryl palmitostearate.
esterification, with glycerin, of stearic (a) Glyceryl palmitostearate is a
acid that is derived from edible mixture of mono-, di-, and triglyceryl
sources. esters of palmitic and stearic acids
(b) The ingredient must be of a pu- made from glycerin, palmitic acid, and
rity suitable for its intended use. stearic acid.
(c) In accordance with § 184.1(b)(1), (b) The ingredient meets the fol-
the ingredient is used in food with no lowing specifications:
limitation other than current good (1) The substance is a mixture of
manufacturing practice. mono-, di-, and triglycerides of pal-
(d) Prior sanctions for this ingredient mitic acid and stearic acid.
different from the uses established in (2) Heavy metals (as lead): Not more
than 10 parts per million.
529
§ 184.1330 21 CFR Ch. I (4–1–15 Edition)
(c) In accordance with § 184.1(b)(1), branches of trees of various species of

the ingredient is used in food with no the genus Acacia, family Leguminosae.
limitation other than current good (b) The ingredient meets the speci-
manufacturing practice. The affirma- fications of the ‘‘Food Chemicals
tion of this ingredient as generally rec- Codex,’’ 3d Ed. (1981), p. 7, which is in-
ognized as safe (GRAS) as a direct corporated by reference. Copies may be
human food ingredient is based upon obtained from the National Academy
the following current good manufac- Press, 2101 Constitution Ave. NW.,
(1) The ingredient is used as a formu-
lation aid, as defined in § 170.3(o)(14) of ined at the National Archives and
this chapter. Records Administration (NARA). For
(2) The ingredient is used in excipient information on the availability of this
formulations for use in tablets at levels material at NARA, call 202–741–6030, or
not to exceed good manufacturing go to: http://www.archives.gov/
practice. federallregister/
[60 FR 63621, Dec. 12, 1995]
ibrllocations.html.
§ 184.1330 Acacia (gum arabic). (c) The ingredient is used in food
(a) Acacia (gum arabic) is the dried under the following conditions:
gummy exudate from stems and
Food (as served) Percent Function
Beverages and beverage bases, § 170.3(n)(3) of this chapter 2.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this
chapter; flavoring agent and adjuvant,
§ 170.3(o)(12) of this chapter; formulation aid,
§ 170.3(o)(14) of this chapter; stabilizer and thick-
ener, § 170.3(o)(28) of this chapter.
Chewing gum, § 170.3(n)(6) of this chapter ............................ 5.6 Flavoring agent and adjuvant, § 170.3(o)(12) of this
chapter; formulation aid, § 170.3(o)(14) of this chap-
ter; humectant, § 170.3(o)(16) of this chapter; sur-
face-finishing agent, § 170.3(o)(30) of this chapter.
Confections and frostings, § 170.3(n)(9) of this chapter .......... 12.4 Formulation aid, § 170.3(o)(14) of this chapter; sta-
bilizer and thickener, § 170.3(o)(28) of this chapter;
surface-finishing agent, § 170.3(o)(30) of this chap-
ter.
Dairy product analogs, § 170.3(n)(10) of this chapter ............. 1.3 Formulation aid, § 170.3(o)(14) of this chapter; sta-
bilizer and thickener, § 170.3(o)(28) of this chapter.
Fats and oils, § 170.3(n)(12) of this chapter ............................ 1.5 Formulation aid, § 170.3(o)(14) of this chapter; sta-
Gelatins, puddings, and fillings, § 170.3(n)(22) of this chapter 2.5 Emulsifier and emulsifier salt, § 170.3(o)(8) of this
ter.; stabilizer and thickener, § 170.3(o)(28) of this
chapter.
Hard candy and cough drops, § 170.3(n)(25) of this chapter .. 46.5 Flavoring agent and adjuvant, § 170.3(o)(12) of this
ter.
Nuts and nut products, § 170.3(n)(32) of this chapter ............. 8.3 Formulation aid, § 170.3(o)(14) of this chapter; sur-
face-finishing agent, § 170.3(o)(30) of this chapter.
Quiescently frozen confection products ................................... 6.0 Formulation aid, § 170.3(o)(14) of this chapter; sta-
Snack foods, § 170.3(n)(37) of this chapter ............................ 4.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this
ter.
Soft candy, § 170.3(n)(38) of this chapter ............................... 85.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this
chapter; firming agent, § 170.3(o)(10) of this chap-
ter; flavoring agent and adjuvant, § 170.3(o)(12) of
this chapter; formulation aid, § 170.3(o)(14) of this
chapter, humectant, § 170.3(o)(16) of this chapter;
stabilizer and thickener, § 170.3(o)(28) of this chap-
ter; surface-finishing agent, § 170.3(o)(30) of this
chapter.
530
MAXIMUM USAGE LEVELS PERMITTED—Continued

All other food categories .......................................................... 1.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this
chapter; flavoring agent and adjuvant,
§ 170.3(o)(12) of this chapter; formulation aid,
§ 170.3(o)(14) of this chapter; processing aid,
§ 170.3(o)(24) of this chapter; stabilizer and thick-
ener, § 170.3(o)(28) of this chapter; surface-fin-
ishing agent, § 170.3(o)(30) of this chapter;
texturizer, § 170.3(o)(32) of this chapter.
(d) [Reserved] (3) Loss on drying. Not more than 14

(e) Prior sanctions for this ingredient percent dried at 105 °C for 5 hours.
different from the uses established in (4) Identification test. Add 0.2 ml of di-
this section do not exist or have been luted lead acetate as outlined in ‘‘Offi-
waived. cial Methods of Analysis of the Asso-
[42 FR 14653, Mar. 15, 1977, as amended at 42 ciation of Official Analytical Chem-
FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, ists,’’ 13th Ed. (1980), section 31.178(b),
1983; 53 FR 5766, Feb. 26, 1988] p. 529, under ‘‘Dilute Basic Lead Ace-
tate Standard Solution,’’ which is in-
§ 184.1333 Gum ghatti.
corporated by reference (Copies are
(a) Gum ghatti (Indian gum) is an available from the AOAC INTER-
exudate from wounds in the bark of NATIONAL, 481 North Frederick Ave.,
Anogeissus latifolia, a large tree found suite 500, Gaithersburg, MD 20877, or
in the dry deciduous forests of India may be examined at the National Ar-
and Ceylon. chives and Records Administration
(b) The ingredient complies with the (NARA). For information on the avail-
following specifications: ability of this material at NARA, call
(1) Viscosity of a 1-percent solution.
202–741–6030, or go to: http://
Not less than the minimum or within
the range claimed by the vendor.
(2) Limits of impurities—(i) Arsenic (as
AL). Not more than 3 parts per million ibrllocations.html.), to 5 ml of a cold 1-
(0.0003 percent); in-100 aqueous solution of the gum. An
(ii) Ash (acid-insoluble). Not more immediate, voluminous, opaque pre-
than 1.75 percent; cipitate indicates acacia. A small pre-
(iii) Ash (total). Not more than 6.0 cipitate or clear solution which pro-
percent; duces an opaque flocculent precipitate
(iv) Heavy metals (as Pb). Not more upon the addition of 1 ml of 3 N
than 40 parts per million (0.004 per- ammonimum hydroxide indicates gum
cent); and ghatti.
(v) Lead. Not more than 10 parts per (c) The ingredient is used in food
million (0.001 percent). under the following conditions:
Beverages and beverage bases, nonalcoholic, 0.2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter.
All other food categories ............................................ .1 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter.
(d) Prior sanctions for this ingredient § 184.1339 Guar gum.

(a) Guar gum is the natural sub-
stance obtained from the maceration of
waived.
the seed of the guar plant, Cyamopsis

[42 FR 14653, Mar. 15, 1977, as amended at 49 tetragonoloba (Linne) Taub., or
FR 5612, Feb. 14, 1984] Cyamopsis psoraloides (Lam.) D.C.
531
§ 184.1343 21 CFR Ch. I (4–1–15 Edition)
(b) The ingredient meets the speci- information on the availability of this
fications of the ‘‘Food Chemicals material at NARA, call 202–741–6030, or
Codex,’’ 3d Ed. (1981), p. 141, which is in- go to: http://www.archives.gov/
corporated by reference. Copies may be federallregister/
obtained from the National Academy codeloflfederallregulations/
Press, 2101 Constitution Ave. NW., ibrllocations.html.
Washington, DC 20418, or may be exam- (c) The ingredient is used in food
ined at the National Archives and under the following conditions:
Baked goods and baking mixes, § 170.3(n)(1) of this chapter 0.35 Emulsifier and emulsifier salts, § 170.3(o)(8) of this
ter; stabilizer and thickener; § 170.3(o)(28) of this
chapter.
Breakfast cereals, § 170.3(n)(4) of this chapter ....................... 1.2 Formulation aid, § 170.3(o)(14) of this chapter; sta-
Cheese, § 170.3(n)(5) of this chapter ...................................... .8 Do.
Dairy products analogs, § 170.3(n)(10) of this chapter ........... 1.0 Firming agent, § 170.3(o)(10) of this chapter; formula-
tion aid, § 170.3(o)(14) of this chapter; stabilizer
and thickener, § 170.3(o)(28) of this chapter.
Fats and oils, § 170.3(n)(12) of this chapter ............................ 2.0 Do.
Gravies and sauces, § 170.3(n)(24) of this chapter ................ 1.2 Formulation aid, § 170.3(o)(14) of this chapter; sta-
Jams and jellies, commercial, § 170.3(n)(28) of this chapter .. 1.0 Do.
Milk products, § 170.3(n)(31) of this chapter ........................... .6 Do.
Processed vegetables and vegetable juices, § 170.3(n)(36) of 2.0 Formulation aid, § 170.3(o)(14) of this chapter; sta-
this chapter. bilizer and thickener, § 170.3(o)(28) of this chapter.
Soups and soup mixes, § 170.3(n)(40) of this chapter ........... .8 Do.
Sweet sauces, toppings and syrups, § 170.3(n)(43) of this 1.0 Do.
chapter.
All other food categories .......................................................... .5 Emulsifier and emulsifier salts, § 170.3(o)(8) of this
chapter; firming agent, § 170.3(o)(10) of this chap-
ter; formulation aid, § 170.3(o)(14) of this chapter;
stabilizer and thickener, § 170.3(o)(28) of this chap-
ter.
(d) [Reserved] (b) The ingredient meets the speci-

(e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals
different from the uses established in Codex,’’ 3d Ed. (1981), pp. 174–175, which
this section do not exist or have been is incorporated by reference. Copies
waived. may be obtained from the National
Academy Press, 2101 Constitution Ave.
[42 FR 14653, Mar. 15, 1977, as amended at 42 NW., Washington, DC 20418, or may be
FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, examined at the National Archives and
1984] Records Administration (NARA). For
§ 184.1343 Locust (carob) bean gum.
(a) Locust (carob) bean gum is pri- go to: http://www.archives.gov/
marily the macerated endosperm of the federallregister/
seed of the locust (carob) bean tree, codeloflfederallregulations/
Ceratonia siliqua (Linne), a leguminous ibrllocations.html.
evergreen tree, with lesser quantities (c) The ingredient is used at levels
of seed coat and germ. not to exceed the following maximum
levels:
Baked goods and baking mixes, § 170.3(n)(1) of this 0.15 Stabilizer and thickener, § 170.3(o)(28) of this chapter.
chapter.
532
MAXIMUM USAGE LEVELS PERMITTED—Continued

Beverages and beverage bases, nonalcoholic, .25 Do.

Cheeses, § 170.3(n)(5) of this chapter ...................... .8 Do.
Gelatins, puddings, and fillings, § 170.3(n)(22) of this .75 Do.
chapter.
Jams and jellies, commercial, § 170.3(n)(28) of this .75 Do.
chapter.
All other food categories ............................................ .5 Do.
(d) [Reserved] Codex,’’ 3d Ed. (1981), p. 157, which is in-

(e) Prior sanctions for this ingredient corporated by reference. Copies may be
different from the uses established in obtained from the National Academy
this regulation do not exist or have Press, 2101 Constitution Ave. NW.,
been waived. Washington, DC 20418, or may be exam-
[42 FR 14653, Mar. 15, 1977, as amended at 42 ined at the National Archives and
FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, Records Administration (NARA). For
1984] information on the availability of this
§ 184.1349 Karaya gum (sterculia gum).
(a) Karaya gum (sterculia gum) is the federallregister/
dried gummy exudate from the trunk codeloflfederallregulations/
of trees of various species of the genus ibrllocations.html.
Sterculia. (c) The ingredient is used in food
under the following conditions:
Frozen dairy desserts and mixes, § 170.3(n)(20) of 0.3 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and
this chapter. thickener, § 170.3(o)(28) of this chapter.
Milk products, § 170.3(n)(31) of this chapter ............. .02 Stabilizer and thickener, § 170.3(o)(28) of this chapter.
Soft candy, § 170.3(n)(38) of this chapter ................. .9 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter;
stabilizer and thickener, § 170.3(o)(28) of this chapter.
All other food categories ............................................ .002 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and
(d) [Reserved] (b) The ingredient meets the speci-

(e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals
different from the uses established in Codex,’’ 3d Ed. (1981), p. 337, which is in-
this section do not exist or have been corporated by reference. Copies may be
waived. obtained from the National Academy
[42 FR 14653, Mar. 15, 1977, as amended at 42 Washington, DC 20418, or may be exam-
FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, ined at the National Archives and
1984] Records Administration (NARA). For
§ 184.1351 Gum tragacanth.
(a) Gum tragacanth is the exudate go to: http://www.archives.gov/
from one of several species of Astrag- federallregister/
alus gummifier Labillardiere, a shrub codeloflfederallregulations/
that grows wild in mountainous re- ibrllocations.html.
gions of the Middle East. (c) The ingredient is used in food
under the following conditions:
533
§ 184.1355 21 CFR Ch. I (4–1–15 Edition)

Baked goods and baking mixes, § 170.3(n)(1) of this 0.2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter;
chapter. formulation aid, § 170.3(o)(14) of this chapter; stabilizer
Condiments and relishes, § 170.3(n)(8) of this chap- .7 Do.
ter.
Fats and oils, § 170.3(n)(12) of this chapter .............. 1.3 Do.
Gravies and sauces, § 170.3(n)(24) of this chapter .. .8 Do.
Meat products, § 170.3(n)(29) of this chapter ........... .2 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and
Processed fruits and fruit juices, § 170.3(n)(35) of .2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter;
this chapter. formulation aid, § 170.3(o)(14) of this chapter; stabilizer
All other food categories ............................................ .1 Do.
(d) [Reserved] (d) Prior sanctions for this ingredient

(e) Prior sanctions for this ingredient different from the uses established in
different from the uses established in this section do not exist or have been
this section do not exist or have been waived.
waived.
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 8607, Feb. 14, 2008]
FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14,
1984] § 184.1366 Hydrogen peroxide.
§ 184.1355 Helium. (a) Hydrogen peroxide (H2O2, CAS
(a) Helium (empirical formula He, Reg. No. 7722–84–1) is also referred to as
CAS Reg. No. 7440–59–7) is a colorless, hydrogen dioxide. It is made by the
odorless, flavorless, nonflammable, electrolytic oxidation of sulfuric acid
inert gas. It is lighter than air and is or a sulfate to persulfuric acid or a
produced by the liquefaction and puri- persulfuric acid salt with subsequent
fication of natural gas. hydrolysis and distillation of the hy-
(b) The ingredient must be of a pu- drogen peroxide formed; by decomposi-
rity suitable for its intended use. tion of barium peroxide with sulfuric
(c) In accordance with § 184.1(b)(1), or phosphoric acid; by hydrogen reduc-
the ingredient is used in food with no tion of 2-ethylanthraquinone, followed
limitations other than current good by oxidation with air, to regenerate
manufacturing practice. The affirma- the quinone and produce hydrogen per-
tion of this ingredient as generally rec- oxide; or by electrical discharge
ognized as safe (GRAS) as a direct through a mixture of hydrogen, oxy-
human food ingredient is based upon gen, and water vapor.
the following current good manufac- (b) The ingredient meets the speci-
turing practice conditions of use: fications of the Food Chemicals Codex,
(1) The ingredient is used as a proc- 3d ed. (1981), pp. 146–147, 1 which is in-
essing aid as defined in § 170.3(o)(24) of corporated by reference.
this chapter. (c) In accordance with § 184.1(b)(2),
(2) The ingredient is used in food at the ingredient is used to treat food
levels not to exceed current good man- only within the following specific limi-
ufacturing practice. tations:
1 Copies may be obtained from the National availability of this material at NARA, call
Academy of Sciences, 2101 Constitution Ave. 202–741–6030, or go to: http://www.archives.gov/
NW, Washington, DC 20037, or examined at federallregister/codeloflfederallregulations/

the National Archives and Records Adminis- ibrllocations.html.
tration (NARA). For information on the
534
Maximum treatment
Food Functional use
level in food (percent)
Milk, intended for use during the cheesemaking 0.05 ............................ Antimicrobial agent as defined in § 170.3 (o)(2) of
process as permitted in the appropriate stand- this chapter
ards of identity for cheese and related cheese
products under part 133 of this chapter.
Whey, during the preparation of modified whey by 0.04 ............................ do.
electrodialysis methods.
Dried eggs, dried egg whites, and dried egg yolks Amount sufficient for Oxidizing and reducing agent as defined in § 170.3
as in §§ 160.105, 160.145, and 160.185 of this the purpose. (o)(22) of this chapter
chapter.
Tripe ......................................................................... do ............................... Bleaching agent.
Beef feet .................................................................. Amount sufficient for Bleaching agent.
the purpose. (Hy-
drogen peroxide
may be in the form
of a compound salt,
sodium carbonate
peroxide).
Herring ..................................................................... Amount sufficient for do.
the purpose.
Wine ......................................................................... do ............................... Oxidizing and reducing agent as defined in § 170.3
(o)(22) of this chapter.
Starch ...................................................................... 0.15 ............................ Antimicrobial agent as defined in § 170.3 (o)(2) of
this chapter, to produce thermophile-free starch;
Remove sulfur dioxide from starch slurry following
steeping and grinding operations of corn refin-
ing.
Instant tea ................................................................ Amount sufficient for Bleaching agent.
the purpose.
Corn syrup ............................................................... 0.15 ............................ Reduce sulfur dioxide levels in the finished corn
syrup.
Colored (annatto) cheese whey .............................. 0.05 ............................ Bleaching agent.
Wine vinegar ............................................................ Amount sufficient for Remove sulfur dioxide from wine prior to fermenta-
the purpose. tion to produce vinegar.
Emulsifiers containing fatty acid esters ................... 1.25 ............................ Bleaching agent.
(d) Residual hydrogen peroxide is re- spection at the National Archives and
moved by appropriate physical and Records Administration (NARA). For
chemical means during the processing information on the availability of this
of food where it has been used accord- material at NARA, call 202–741–6030, or
ing to paragraph (c) of this section. go to: http://www.archives.gov/
(e) Prior sanctions for this ingredient federallregister/
different from the uses established in codeloflfederallregulations/
this section do not exist or have been ibrllocations.html.
waived. (c) In accordance with § 184.1(b)(1),
[46 FR 44439, Sept. 4, 1981, as amended at 51 limitations other than current good
FR 27172, July 30, 1986]
§ 184.1370 Inositol.
(a) Inositol, or myo-inositol (C6H12O6, human food ingredient is based upon
CAS Reg. No. 87–89–8), is cis-1,2,3,5- the following current good manufac-
trans-4,6-cyclohexanehexol. It occurs turing practice conditions of use:
naturally and is prepared from an (1) The ingredient is used as a nutri-
aqueous (0.2 percent sulfur dioxide) ex- ent supplement as defined in
tract of corn kernels by precipitation § 170.3(o)(20) of this chapter.
and hydrolysis of crude phytate. (2) The ingredient is used in special
(b) The ingredient meets the speci- dietary foods as defined in part 105 of
fications of the Food Chemicals Codex, this chapter at levels not to exceed
3d Ed. (1981), p. 150, which is incor- current good manufacturing practice.
porated by reference. Copies are avail- It may also be used in infant formula
able from the National Academy Press, in accordance with section 412(g) of the
2101 Constitution Ave. NW., Wash- Act, or with regulations promulgated
ington, DC 20418, or available for in- under section 412(a)(2) of the Act.
535
§ 184.1372 21 CFR Ch. I (4–1–15 Edition)
(d) Prior sanctions for this ingredient ceed current good manufacturing prac-
different from the uses established by tice.
this section do not exist or have been [48 FR 5720, Feb. 8, 1983, as amended at 61 FR
waived. 43450, Aug. 23, 1996]
[47 FR 38278, Aug. 31, 1982]
§ 184.1375 Iron, elemental.
§ 184.1372 Insoluble glucose isomerase (a) Iron, elemental (CAS Reg. No.
enzyme preparations. 7439–89–6) is metallic iron obtained by
any of the following processes: reduced
(a) Insoluble glucose isomerase en-
iron, electrolytic iron, and carbonyl
zyme preparations are used in the pro-
iron.
duction of high fructose corn syrup de- (1) Reduced iron is prepared by react-
scribed in § 184.1866. They are derived ing ground ferric oxide with hydrogen
from recognized species of precisely or carbon monoxide at an elevated
classified nonpathogenic and temperature. The process results in a
nontoxicogenic microorganisms, in- grayish-black powder, all of which
cluding Streptomyces rubiginosus, should pass through a 100-mesh sieve.
Actinoplanes missouriensis, Streptomyces It is lusterless or has not more than a
olivaceus, Streptomyces olivochromogenes, slight luster. When viewed under a mi-
and Bacillus coagulans, that have been croscope, it appears as an amorphous
grown in a pure culture fermentation powder free from particles having a
that produces no antibiotics. They are crystalline structure. It is stable in dry
fixed (rendered insoluble) for batch air.
production with GRAS ingredients or (2) Electrolytic iron is prepared by
may be fixed for further immobiliza- electrodeposition. It is an amorphous,
tion with either GRAS ingredients or lusterless, grayish-black powder. It is
materials approved under § 173.357 of stable in dry air.
this chapter. (3) Carbonyl iron is prepared by the
(b) The ingredient meets the general decomposition of iron pentacarbonyl.
and additional requirements for en- It occurs as a dark gray powder. When
zyme preparations in the Food Chemi- viewed under a microscope, it appears
cals Codex, 3d Ed. (1981), p. 107, which is as spheres built up with concentric
incorporated by reference. Copies are shells. It is stable in dry air.
available from the National Academy (b) Iron, elemental (carbonyl, elec-
Press, 2101 Constitution Ave. NW., trolytic, or reduced) meets the speci-
Washington, DC 20418, or available for fications of the Food Chemicals Codex,
inspection at the National Archives 3d Ed. (1981) (iron, carbonyl, p. 151;
iron, electrolytic, pp. 151–152; iron, re-
duced; pp. 152–153), which is incor-
federallregister/
codeloflfederallregulations/ spection at the National Archives and
ibrllocations.html. Records Administration (NARA). For
(c) In accordance with § 184.1(b)(1), information on the availability of this
the ingredient is used in food with no material at NARA, call 202–741–6030, or
limitation other than current good go to: http://www.archives.gov/
manufacturing practice. The affirma- federallregister/
tion of this ingredient as generally rec- codeloflfederallregulations/
ognized as safe (GRAS) as a direct ibrllocations.html.
human food ingredient is based upon (c) In accordance with § 184.1(b)(1),
the following current good manufac- the ingredient is used in food as a nu-
turing practice conditions of use: trient supplement as defined in
(1) The ingredient is used as an en- § 170.3(o)(20) of this chapter, with no
zyme, as defined in § 170.3(o)(9) of this limitation other than current good
chapter, to convert glucose to fructose.
manufacturing practice. The ingre-

(2) The ingredient is used in high dient may also be used in accordance
fructose corn syrup, at levels not to ex- with section 412(g) of the Federal Food,
536
Drug, and Cosmetic Act (the act) (21 tose. It is prepared from yeast that has
U.S.C. 350a(g)) or with regulations pro- been grown by a pure culture fermenta-
mulgated under section 412(a)(2) of the tion process.
act (21 U.S.C. 350a(2)). (b) The ingredient meets the general
(d) Prior sanctions for this ingredient requirements and additional require-
different from the uses established in ments for enzyme preparations in the
this section do not exist or have been Food Chemicals Codex, 3d ed. (1981), pp.
waived. 107–110, which are incorporated by ref-
erence in accordance with 5 U.S.C.
[53 FR 16867, May 12, 1988]
552(a) and 1 CFR part 51. Copies are
§ 184.1386 Isopropyl citrate. available from the National Academy
(a) Isopropyl citrate is a mixture of Washington, DC 20418, or may be exam-
the mono-, di-, and triisopropyl esters ined at the Center for Food Safety and
of citric acid. It is prepared by Applied Nutrition’s Library, 5100 Paint
esterifying citric acid with Branch Pkwy., College Park, MD 20740,
isopropanol. or at the National Archives and
(b) The ingredient must be of a pu- Records Administration (NARA). For
rity suitable for its intended use. information on the availability of this
(c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or
the ingredient is used in food with no go to: http://www.archives.gov/
limitation other than current good federallregister/
manufacturing practice. The affirma- codeloflfederallregulations/
tion of this ingredient as generally rec- ibrllocations.html.
ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1),
human food ingredient is based upon the ingredient is used in food with no
the following current good manufac- limitations other than current good
turing practice conditions of use: manufacturing practice. The affirma-
(1) The ingredient is used as an anti- tion of this ingredient as generally rec-
oxidant as defined in § 170.3(o)(3) of this ognized as safe as a direct human food
chapter; a sequestrant as defined in ingredient is based upon the following
§ 170.3(o)(26) of this chapter; and a sol- current good manufacturing practice
vent and vehicle as defined in conditions of use:
§ 170.3(o)(27) of this chapter. (1) The ingredient is used as an en-
(2) The ingredient is used in mar- zyme, as defined in § 170.3(o)(9) of this
garine in accordance with § 166.110 of chapter, to convert lactose to glucose
this chapter; in nonalcoholic beverages and galactose.
as defined in § 170.3(n)(3) of this chap- (2) The ingredient is used in food at
ter; and in fats and oils as defined in levels not to exceed current good man-
§ 170.3(n)(12) of this chapter at levels ufacturing practice. Current good man-
not to exceed current good manufac- ufacturing practice is limited to use of
turing practice. this ingredient to reduce the lactose
(d) Prior sanctions for this ingredient content in milk and milk-derived food
different from the uses established in products where food standards do not
this section, or different from those set preclude such use.
forth in part 181 of this chapter, do not [61 FR 7704, Feb. 29, 1996]
exist or have been waived.
[59 FR 63896, Dec. 12, 1994, as amended at 73 § 184.1388 Lactase enzyme preparation
FR 8607, Feb. 14, 2008] from Kluyveromyces lactis.
(a) This enzyme preparation is de-
§ 184.1387 Lactase enzyme preparation rived from the nonpathogenic,
from Candida pseudotropicalis. nontoxicogenic yeast Kluyveromyces
(a) This enzyme preparation is de- lactis (previously named Saccharomyces
rived from the nonpathogenic, lactis). It contains the enzyme B-
nontoxicogenic yeast C. galactoside galactohydrase (CAS Reg.
pseudotropicalis. It contains the enzyme No. CBS 683), which converts lactose to
lactase (b-D-galactoside glucose and galactose. It is prepared

galactohydrolase, EC 3.2.1.23), which from yeast that has been grown in a
converts lactose to glucose and galac- pure culture fermentation and by using
537
§ 184.1400 21 CFR Ch. I (4–1–15 Edition)
materials that are generally recognized able from the National Academy Press,
as safe or are food additives that have 2101 Constitution Ave. NW., Wash-
been approved for this use by the Food ington, DC 20418, or available for in-
and Drug Administration. spection at the National Archives and
(b) The ingredient meets the general Records Administration (NARA). For
and additional requirements for en- information on the availability of this
zyme preparations in the Food Chemi- material at NARA, call 202–741–6030, or
cals Codex, 3d Ed. (1981), p. 107–110, go to: http://www.archives.gov/
which is incorporated by reference. federallregister/
Copies are available from the National codeloflfederallregulations/
Academy Press, 2101 Constitution Ave. ibrllocations.html.
NW., Washington, DC 20418, or avail- (c) In accordance with § 184.1(b)(1),
able for inspection at the National Ar- the ingredient is used in food with no
chives and Records Administration limitation other than current good
(NARA). For information on the avail- manufacturing practice.
ability of this material at NARA, call (d) Prior sanctions for this ingredient
202–741–6030, or go to: http:// different from the uses established in
www.archives.gov/federallregister/ this section do not exist or have been
codeloflfederallregulations/ waived.
ibrllocations.html.
(c) In accordance with § 184.1(b)(1), [48 FR 51150, Nov. 7, 1983]
limitation other than current good § 184.1408 Licorice and licorice deriva-
manufacturing practice. The affirma- tives.
tion of this ingredient as generally rec- (a)(1) Licorice (glycyrrhiza) root is
ognized as safe as a direct human food the dried and ground rhizome and root
ingredient is based upon the following portions of Glycyrrhiza glabra or other
current good manufacturing practice species of Glycyrrhiza. Licorice extract
conditions of use: is that portion of the licorice root that
(1) The ingredient is used as an en- is, after maceration, extracted by boil-
zyme as defined in § 170.3(o)(9) of this ing water. The extract can be further
chapter to convert lactose to glucose purified by filtration and by treatment
and galactose. with acids and ethyl alcohol. Licorice
(2) The ingredient is used in food at extract is sold as a liquid, paste
levels not to exceed current good man- (‘‘block’’), or spray-dried powder.
ufacturing practice. Current good man- (2) Ammoniated glycyrrhizin is pre-
ufacturing practice is to use this ingre- pared from the water extract of lico-
dient in milk to produce lactase-treat- rice root by acid precipitation followed
ed milk, which contains less lactose by neutralization with dilute ammonia.
than regular milk, or lactose-reduced Monoammonium glycyrrhizinate
milk, which contains at least 70 per- (C42H61O16NH45H2O, CAS Reg. No. 1407–
cent less lactose than regular milk. 03–0) is prepared from ammoniated
[49 FR 47387, Dec. 4, 1984] glycyrrhizin by solvent extraction and
separation techniques.
§ 184.1400 Lecithin. (b) The ingredients shall meet the
(a) Commercial lecithin is a natu- following specifications when analyzed:
rally occurring mixture of the (1) Assay. The glycyrrhizin content of
phosphatides of choline, ethanolamine, each flavoring ingredient shall be de-
and inositol, with smaller amounts of termined by the method in the Official
othe lipids. It is isolated as a gum fol- Methods of Analysis of the Association
lowing hydration of solvent-extracted of Official Analytical Chemists, 13th
soy, safflower, or corn oils. Lecithin is Ed., §§ 19.136–19.140, which is incor-
bleached, if desired, by hydrogen per- porated by reference, or by methods
oxide and benzoyl peroxide and dried 19.CO1 through 19.CO4 in the Journal of
by heating. the Association of Official Analytical
(b) The ingredient meets the speci- Chemists, 65:471–472 (1982), which are
fications of the Food Chemicals Codex, also incorporated by reference. Copies

3d Ed. (1981), pp. 166–167, which is incor- of all of these methods are available
porated by reference. Copies are avail- from the AOAC INTERNATIONAL, 481
538
North Frederick Ave., suite 500, Gai- go to: http://www.archives.gov/

thersburg, MD 20877, or available for federallregister/
inspection at the National Archives codeloflfederallregulations/
and Records Administration (NARA). ibrllocations.html.
For information on the availability of (3) Acid unsoluble ash. Not more than
this material at NARA, call 202–741– 2.5 percent for licorice on an anhydrous
6030, or go to: http://www.archives.gov/ basis as determined by the method in
federallregister/ the Food Chemicals Codex, 3d Ed.
codeloflfederallregulations/ (1981), p. 466, which is incorporated by
ibrllocations.html. reference.
(2) Ash. Not more than 9.5 percent for
(4) Heavy metals (as Pb). Not more
licorice, 2.5 percent for ammoniated
than 40 parts per million as determined
glycyrrhizin, and 0.5 percent for
monoammonium glycyrrhizinate on an by method II in the Food Chemicals
anhydrous basis as determined by the Codex, 3d Ed. (1981), p. 512, which is in-
method in the Food Chemicals Codex, corporated by reference.
3d Ed. (1981), p. 466, which is incor- (5) Arsenic (As). Not more than 3 parts
porated by reference. Copies are avail- per million as determined by the meth-
able from the National Academy Press, od in the Food Chemicals Codex. 3d Ed.
2101 Constitution Ave. NW., Wash- (1981), p. 464, which is incorporated by
ington, DC 20418, or available for in- reference.
spection at the National Archives and (c) In accordance with § 184.1(b)(2),
Records Administration (NARA). For these ingredients are used in food only
information on the availability of this within the following specific limita-
material at NARA, call 202–741–6030, or tions:
Maximum level in
food (percent
Category of food glycyrrhizin con- Functional use
tent of food) (as
served)
Baked foods, § 170.3(n)(1) of this chapter ................. 0.05 Flavor enhancer, § 170.3(o)(11) of this chapter; fla-
voring agent, § 170.3(o)(12) of this chapter.
Alcoholic beverages, § 170.3(n)(2) of this chapter ..... 0.1 Flavor enhancer, § 170.3(o)(11) of this chapter; fla-
voring agent, § 170.3(o)(12) of this chapter; sur-
face-active agent, § 170.3(o)(29) of this chapter.
Nonalcoholic beverages, § 170.3(n)(3) of this chapter 0.15 Do.
Chewing gum, § 170.3(n)(6) of this chapter ............... 1.1 Flavor enhancer, § 170.3(o)(11) of this chapter; fla-
voring agent, § 170.3(n)(12) of this chapter.
Hard candy, § 170.3(n)(25) of this chapter ................ 16.0 Do.
Herbs and seasonings, § 170.3(n)(26) of this chapter 0.15 Do.
Plant protein products, § 170.3(n)(33) of this chapter 0.15 Do.
Soft candy, § 170.3(n)(38) of this chapter .................. 3.1 Do.
Vitamin or mineral dietary supplements ..................... 0.5 Do.
All other foods except sugar substitutes, 0.1 Do.
§ 170.3(n)(42) of this chapter. The ingredient is not
permitted to be used as a nonnutritive sweetener
in sugar substitutes.
(d) Prior sanctions for this ingredient classifying of naturally occurring lime-
different from the uses established in stone.
this section do not exist or have been (b) The ingredient meets the speci-
waived. fications of the Food Chemicals Codex,
FR 24899, June 12, 1989] porated by reference. Copies are avail-
§ 184.1409 Ground limestone. 2101 Constitution Ave. NW., Wash-
(a) Ground limestone consists essen-
tially (not less than 94 percent) of cal-
cium carbonate (CaCO3) and is prepared

by the crushing, grinding, and
539
§ 184.1415 21 CFR Ch. I (4–1–15 Edition)
go to: http://www.archives.gov/ (2) The ingredient is used in food at

federallregister/ levels not to exceed current good man-
codeloflfederallregulations/ ufacturing practice.
ibrllocations.html.
(c) In accordance with § 184.1(b)(1), [60 FR 32911, June 26, 1995, as amended at 78
the ingredient is used in food with no FR 14666, Mar. 7, 2013]
§ 184.1420 Lipase enzyme preparation
manufacturing practice. derived from Rhizopus niveus.
different from the uses established in (a) Lipase enzyme preparation con-
this section do not exist or have been tains lipase enzyme (CAS Reg. No.
waived. 9001–62–1), which is obtained from the
[48 FR 52442, Nov. 18, 1983] culture filtrate resulting from a pure
culture fermentation of a nonpatho-
§ 184.1415 Animal lipase. genic and nontoxigenic strain of
(a) Animal lipase (CAS Reg. No. 9001– Rhizopus niveus. The enzyme prepara-
62–1) is an enzyme preparation obtained tion also contains diatomaceous earth
from edible forestomach tissue of as a carrier. The characterizing activ-
calves, kids, or lambs, or from animal ity of the enzyme, which catalyzes the
pancreatic tissue. The enzyme prepara- interesterification of fats and oils at
tion may be produced as a tissue prepa- the 1- and 3-positions of triglycerides,
ration or as an aqueous extract. Its is triacylglycerol lipase (EC 3.1.1.3).
characterizing enzyme activity is that (b) The ingredient meets the general
of a triacylglycerol hydrolase (EC requirements and additional require-
3.1.1.3). ments for enzyme preparations in the
(b) The ingredient meets the general monograph on Enzyme Preparations in
requirements and additional require- the ‘‘Food Chemicals Codex,’’ 4th ed.
ments for enzyme preparations in the (1996), pp. 133 and 134, which is incor-
Food Chemicals Codex, 3d ed. (1981), p.
porated by reference in accordance
110, which is incorporated by reference
with 5 U.S.C. 552(a) and 1 CFR part 51.
in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from Copies are available from the National
the National Academy Press, 2101 Con- Academy Press, 2101 Constitution Ave.
stitution Ave., NW., Washington, DC NW., Washington, DC 20418, or may be
20418, or may be examined at the Office examined at the Center for Food Safety
of Food Additive Safety (HFS–200), and Applied Nutrition’s Library, 5100
Center for Food Safety and Applied Nu- Paint Branch Pkwy., College Park, MD
trition, Food and Drug Administration, 20740, or at the National Archives and
5100 Paint Branch Pkwy., College Park, Records Administration (NARA). For
MD 20740, 240–402–1200, and at the Na- information on the availability of this
tional Archives and Records Adminis- material at NARA, call 202–741–6030, or
tration (NARA). For information on go to: http://www.archives.gov/
the availability of this material at federallregister/
NARA, call 202–741–6030, or go to: http:// codeloflfederallregulations/
www.archives.gov/federallregister/ ibrllocations.html.
codeloflfederallregulations/ (c) In accordance with § 184.1(b)(1),
ibrllocations.html. the ingredient is used in food with no
manufacturing practice. The affirmation of this ingredient as generally rec-
tion of this ingredient as GRAS as a di- ognized as safe as a direct human food
rect food ingredient is based upon the ingredient is based upon the following
following current good manufacturing current good manufacturing practice
practice conditions of use: conditions of use:
(1) The ingredient is used as an en- (1) The ingredient is used as an en-
zyme as defined in § 170.3(o)(9) of this zyme as defined in § 170.3(o)(9) of this

chapter to hydrolyze fatty acid chapter for the interesterification of
glycerides. fats and oils.
540
(2) The ingredient is used in food at this section do not exist or have been
levels not to exceed current good man- waived.
[50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24,
[63 FR 24419, May 4, 1998] 1985]
§ 184.1425 Magnesium carbonate. § 184.1426 Magnesium chloride.

(a) Magnesium carbonate (molecular (a) Magnesium chloride (MgC12·6H2O,
formula approximately CAS Reg. No. 7786–30–3) is a colorless,
(MgCO3)4·Mg(OH)2·5H2O, CAS Reg. No. deliquescent, crystalline material that
39409–82–0) is also known as magnesium occurs naturally as the mineral
carbonate hydroxide. It is a white pow- bischofite. It is prepared by dissolving
der formed either by adding an alkaline magnesium oxide, hydroxide, or car-
carbonate (such as sodium carbonate) bonate in aqueous hydrochloric acid so-
to a solution of magnesium sulfate or lution and crystallizing out magnesium
by carbonation of a slurry of magne- chloride hexahydrate.
sium hydroxide followed by boiling of (b) The ingredient meets the speci-
the resulting magnesium carbonate. fications of the Food Chemicals Codex,
(b) The ingredient meets the speci- 3d Ed. (1981), p. 177, which is incor-
fications of the Food Chemicals Codex, porated by reference. Copies are avail-
3d Ed. (1981), p. 177, which is incor- able from the National Academy Press,
porated by reference. Copies are avail- 2101 Constitution Ave. NW., Wash-
able from the National Academy Press, ington, DC 20418, or available for in-
2101 Constitution Ave. NW., Wash- spection at the National Archives and
ington, DC 20418, or available for in- Records Administration (NARA). For
spection at the National Archives and information on the availability of this
Records Administration (NARA). For material at NARA, call 202–741–6030, or
information on the availability of this go to: http://www.archives.gov/
material at NARA, call 202–741–6030, or federallregister/
go to: http://www.archives.gov/ codeloflfederallregulations/
federallregister/ ibrllocations.html.
(c) In accordance with § 184.1(b)(1), limitation other than current good
the ingredient is used in food with no manufacturing practice. The affirma-
(1) The ingredient is used as a fla-
(1) The ingredient is used as an voring agent and adjuvant as defined in
anticaking and free-flow agent as de- § 170.3(o)(12) of this chapter and a nutri-
fined in § 170.3(o)(1) of this chapter; a ent supplement as defined in
flour treating agent as defined in § 170.3(o)(20) of this chapter.
§ 170.3(o)(13) of this chapter; a lubricant (2) The ingredient is used in foods at
and release agent as defined in levels not to exceed current good man-
§ 170.3(o)(18) of this chapter; a nutrient ufacturing practice. The ingredient
supplement as defined in § 170.3(o)(20) of also may be used in infant formula in
this chapter; a pH control agent as de- accordance with section 412(g) of the
fined in § 170.3(o)(23) of this chapter; a Federal Food, Drug, and Cosmetic Act
processing aid as defined in § 170.3(o)(24) (the act) or with regulations promul-
of this chapter; and a synergist as de- gated under section 412(a)(2) of the act.
fined in § 170.3(o)(31) of this chapter. (d) Prior sanctions for this ingredient
(2) The ingredient is used in foods at different from the uses established in
levels not to exceed current good man- this section do not exist or have been
waived.
(d) Prior sanctions for this ingredient [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24,
different from the uses established in 1985]
541
§ 184.1428 21 CFR Ch. I (4–1–15 Edition)
§ 184.1428 Magnesium hydroxide. erate conditions (400° to 900 °C for a few

(a) Magnesium hydroxide (Mg(OH)2, hours) produces light magnesium
CAS Reg. No. 1309–42–8) occurs natu- oxide. Heating the salts under more
rally as the colorless, crystalline min- rigorous conditions (1200 °C for 12
eral brucite. It is prepared as a white hours) produces heavy magnesium
precipitate by the addition of sodium oxide. Light magnesium oxide is con-
hydroxide to a water soluble magne- verted to heavy magnesium oxide by
sium salt or by hydration of reactive sustained heating at high tempera-
grades of magnesium oxide. tures.
3d Ed. (1981), p. 178, which is incor- 3d Ed. (1981), p. 178, which is incor-
porated by reference. Copies are avail- porated by reference. Copies are avail-
able from the National Academy Press, able from the National Academy Press,
2101 Constitution Ave. NW., Wash- 2101 Constitution Ave. NW., Wash-
ington, DC 20418, or available for in- ington, DC 20418, or available for in-
spection at the National Archives and spection at the National Archives and
federallregister/
federallregister/
ibrllocations.html.
(c) In accordance with § 184.1(b)(1), ibrllocations.html.
the ingredient is used in food with no (c) In accordance with § 184.1(b)(1),
limitation other than current good the ingredient is used in food with no
manufacturing practice. The affirma- limitation other than current good
tion of this ingredient as generally rec- manufacturing practice. The affirma-
ognized as safe (GRAS) as a direct tion of this ingredient as generally rec-
human food ingredient is based upon ognized as safe (GRAS) as a direct
the following current good manufac- human food ingredient is based upon
turing practice conditions of use: the following current good manufac-
(1) The ingredient is used as a nutri- turing practice conditions of use:
ent supplement as defined in (1) The ingredient is used as an
§ 170.3(o)(20) of this chapter; a pH con- anticaking and free-flow agent as de-
trol agent as defined in § 170.3(o)(23) of fined in § 170.3(o)(1) of this chapter; a
this chapter; and a processing aid as firming agent as defined in § 170.3(o)(10)
defined in § 170.3(o)(24) of this chapter. of this chapter; a lubricant and release
(2) The ingredient is used in foods at agent as defined in § 170.3(o)(18) of this
levels not to exceed current good man- chapter; a nutrient supplement as de-
ufacturing practice. fined in § 170.3(o)(20) of this chapter;
(d) Prior sanctions for this ingredient and a pH control agent as defined in
different from the uses established in § 170.3(o)(23) of this chapter.
(2) The ingredient is used in foods at
waived.
levels not be exceed current good man-
[50 FR 13559, Apr. 5, 1985, as amended at 64 ufacturing practice. The ingredient
FR 405, Jan. 5, 1999] also may be used in infant formula in
accordance with section 412(g) of the
§ 184.1431 Magnesium oxide.
Federal Food, Drug, and Cosmetic Act
(a) Magnesium oxide (MgO, CAS Reg. (the act) or with regulations promul-
No. 1309–48–4) occurs naturally as the gated under section 412(a)(2) of the act.
colorless, crystalline mineral periclase. (d) Prior sanctions for this ingredient
It is produced either as a bulky white different from the uses established in
powder (light) or a relatively dense this section do not exist or have been
white powder (heavy) by heating mag-

waived.
nesium hydroxide or carbonate. Heat-
ing these magnesium salts under mod- [50 FR 13559, Apr. 5, 1985]
542
§ 184.1434 Magnesium phosphate. (d) Prior sanctions for this ingredient

(a) Magnesium phosphate includes different from the uses established in
both magnesium phosphate, dibasic, this section do not exist or have been
and magnesium phosphate, tribasic. waived.
Magnesium phosphate, dibasic [50 FR 13560, Apr. 5, 1985, as amended at 69
(MgHPO4·3H2O, CAS Reg. No. 7782–0975– FR 24512, May 4, 2004]
094) occurs naturally as the white,
crystalline mineral newberyite. It is § 184.1440 Magnesium stearate.
prepared commercially as a precipitate (a) Magnesium stearate
formed by treating a solution of mag- (Mg(C17H34COO)2, CAS Reg. No. 557–04–
nesium sulfate with disodium phos-
0) is the magnesium salt of stearic
phate under controlled conditions.
acid. It is produced as a white precipi-
Magnesium phosphate, tribasic
tate by the addition of an aqueous so-
(Mg3(PO4)2·xH2O, CAS Reg. No. 7757–87–
lution of magnesium chloride to an
1) may contain 4, 5, or 8 molecules of
water of hydration. It is produced as a aqueous solution of sodium stearate de-
precipitate from a solution of mag- rived from stearic acid that is obtained
nesite with phosphoric acid. from edible sources and that conforms
(b) Magnesium phosphate, dibasic, to the requirements of § 172.860(b)(2) of
meets the specifications of the Food this chapter.
Chemicals Codex, 3d Ed. (1981), p. 179, (b) The ingredient meets the speci-
which is incorporated by reference. fications of the Food Chemicals Codex,
Magnesium phosphate, tribasic, meets 3d Ed. (1981), p. 182, which is incor-
the specifications of the Food Chemi- porated by reference. Copies are avail-
cals Codex, 3d Ed. (1981), p. 180, which is able from the National Academy Press,
incorporated by reference. Copies are 2101 Constitution Ave. NW., Wash-
available from the National Academy ington, DC 20418, or available for in-
Press, 2101 Constitution Ave. NW., spection at the National Archives and
Washington, DC 20418, or available for Records Administration (NARA). For
inspection at the National Archives information on the availability of this
and Records Administration (NARA). material at NARA, call 202–741–6030, or
For information on the availability of go to: http://www.archives.gov/
this material at NARA, call 202–741– federallregister/
6030, or go to: http://www.archives.gov/ codeloflfederallregulations/
federallregister/ ibrllocations.html.
(c) In accordance with § 184.1(b)(1), limitation other than current good
limitation other than current good tion of this ingredient as generally rec-
manufacturing practice. The affirma- ognized as safe (GRAS) as a direct
tion of this ingredient as generally rec- human food ingredient is based upon
ognized as safe (GRAS) as a direct the following current good manufac-
human food ingredient is based upon turing practice conditions of use:
the following current good manufac- (1) The ingredient is used as a lubri-
turing practice conditions of use: cant and release agent as defined in
(1) The ingredient is used as a nutri- § 170.3(o)(18) of this chapter; a nutrient
ent supplement as defined in supplement as defined in § 170.3(o)(20) of
§ 170.3(o)(20) of this chapter and a pH this chapter; and a processing aid as
control agent as defined in § 170.3(o)(23) defined in § 170.3(o)(24) of this chapter.
of this chapter. (2) The ingredient is used in foods at
(2) The ingredient is used in foods at levels not to exceed current good man-
levels not to exceed current good manufacturing practice.
ufacturing practice. The ingredient
also may be used in infant formula in

waived.
(the act) or with regulations promul-
gated under section 412(a)(2) of the Act. [50 FR 13560, Apr. 5, 1985]
543
§ 184.1443 21 CFR Ch. I (4–1–15 Edition)
§ 184.1443 Magnesium sulfate. (b) The ingredient meets the general

(a) Magnesium sulfate (MgSO4·7H2O, ments for enzyme preparations in the
CAS Reg. No. 10034–99–8) occurs natu- Food Chemicals Codex, 3d ed. (1981), p.
rally as the mineral epsomite. It is pre- 110, which is incorporated by reference
pared by neutralization of magnesium in accordance with 5 U.S.C. 552(a) and 1
oxide, hydroxide, or carbonate with CFR part 51. Copies are available from
sulfuric acid and evaporating the solu- the National Academy Press, 2101 Con-
tion to crystallization. stitution Ave., NW., Washington, DC
(b) The ingredient meets the speci- 20418, or may be examined at the Office
fications of the Food Chemicals Codex, of Premarket Approval (HFS–200), Food
3d Ed. (1981), p. 183, which is incor- and Drug Administration, 5100 Paint
porated by reference. Copies are avail- Branch Pkwy., College Park, MD 20740,
able from the National Academy Press, and at the National Archives and
2101 Constitution Ave. NW., Wash- Records Administration (NARA). For
ington, DC 20418, or available for in- information on the availability of this
spection at the National Archives and material at NARA, call 202–741–6030, or
Records Administration (NARA). For go to: http://www.archives.gov/
information on the availability of this federallregister/
material at NARA, call 202–741–6030, or codeloflfederallregulations/
go to: http://www.archives.gov/ ibrllocations.html.
federallregister/ (c) In accordance with § 184.1(b)(1),
codeloflfederallregulations/ the ingredient is used in food with no
ibrllocations.html. limitation other than current good
(c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma-
the ingredient is used in food with no tion of this ingredient as GRAS as a di-
limitation other than current good rect food ingredient is based upon the
manufacturing practice. The affirma- following current good manufacturing
tion of this ingredient as generally rec- practice conditions of use:
ognized as safe (GRAS) as a direct (1) The ingredient is used as an en-
human food ingredient is based upon zyme as defined in § 170.3(o)(9) of this
the following current good manufac- chapter to hydrolyze starch or starch-
turing practice conditions of use: derived polysaccharides.
(1) The ingredient is used as a flavor (2) The ingredient is used in food at
enhancer as defined in § 170.3(o)(11) of levels not to exceed current good man-
this chapter; a nutrient supplement as ufacturing practice.
defined in § 170.3(o)(20) of this chapter; [60 FR 32911, June 26, 1995]
and a processing aid as defined in
§ 170.3(o)(24) of this chapter. § 184.1444 Maltodextrin.
(2) The ingredient is used in foods at (a) Maltodextrin ((C6H10O5)n, CAS
levels not to exceed current good man- Reg. No. 9050–36–6) is a nonsweet nutri-
ufacturing practice. tive saccharide polymer that consists
(d) Prior sanctions for this ingredient of D-glucose units linked primarily by
different from the uses established in a-1-4 bonds and that has a dextrose
this section do not exist or have been equivalent (D.E.) of less than 20. It is
waived. prepared as a white powder or con-
centrated solution by partial hydrol-
[50 FR 13560, Apr. 5, 1985] ysis of corn starch, potato starch, or
rice starch with safe and suitable acids
§ 184.1443a Malt.
and enzymes.
(a) Malt is an enzyme preparation ob- (b)(1) Maltodextrin derived from corn
tained from barley which has been soft- starch must be of a purity suitable for
ened by a series of steeping operations its intended use.
and germinated under controlled condi- (2) Maltodextrin derived from potato
tions. It is a brown, sweet, and viscous starch meets the specifications of the
liquid or a white to tan powder. Its Food Chemicals Codex, 3d ed., 3d supp.
characterizing enzyme activities are a- (1992), p. 125, which are incorporated by

amylase (EC 3.2.1.1.) and b-amylase (EC reference in accordance with 5 U.S.C.
3.2.1.2). 552(a) and 1 CFR part 51. Copies are
544
available from the National Academy ened after cleaning by steeping oper-
Press, 2101 Constitution Ave., NW., ations and then allowed to germinate
Washington, DC 20418, or at the Divi- under controlled conditions. The ger-
sion of Petition Control (HFS–217), minated grain then undergoes proc-
Center for Food Safety and Applied Nu- essing, such as drying, grinding, ex-
trition, Food and Drug Administration, tracting, filtering, and evaporating, to
5100 Paint Branch Pkwy., College Park, produce malt syrup (malt extract) with
MD 20740, or may be examined at the 75 to 80 percent solids or dried malt
National Archives and Records Admin- syrup with higher solids content.
istration (NARA). For information on (b) The ingredient must be of a pu-
the availability of this material at rity suitable for its intended use.
NARA, call 202–741–6030, or go to: http:// (c) In accordance with § 184.1(b)(1),
www.archives.gov/federallregister/ the ingredient is used in food with no
ibrllocations.html.. manufacturing practice. The affirma-
(3) Maltodextrin derived from rice tion of this ingredient as generally rec-
starch meets the specifications of the ognized as safe (GRAS) as a direct
Food Chemicals Codex, 4th ed. (1996), human food ingredient is based upon
pp. 239 and 240, which is incorporated the following current good manufac-
by reference in accordance with 5 turing practice conditions of use:
U.S.C. 552(a) and 1 CFR part 51. Copies (1) The ingredient is used as a fla-
are available from the National Acad- voring agent and adjuvant as defined in
emy Press, 2101 Constitution Ave. NW., § 170.3(o)(12) of this chapter.
Washington, DC 20418, or may be exam- (2) The ingredient is used in food at
ined at the Center for Food Safety and levels not to exceed current good man-
Applied Nutrition’s Library, 5100 Paint ufacturing practice.
Branch Pkwy., College Park, MD 20740, (d) Prior sanctions for this ingredient
or at the National Archives and different from the uses established in
Records Administration (NARA). For this section do not exist or have been
information on the availability of this waived.
material at NARA, call 202–741–6030, or [48 FR 51613, Nov. 10, 1983, as amended at 73
go to: http://www.archives.gov/ FR 8607, Feb. 14, 2008]
federallregister/
codeloflfederallregulations/ § 184.1446 Manganese chloride.
ibrllocations.html. (a) Manganese chloride (MnCl2, CAS
(c) In accordance with § 184.1(b)(1), Reg. No. 7773–01–5) is a pink, trans-
the ingredient is used in food with no lucent, crystalline product. It is also
limitation other than current good known as manganese dichloride. It is
manufacturing practice. prepared by dissolving manganous
(d) Prior sanctions for this ingredient oxide, pyrolusite ore (MnO2), or re-
different from the uses established in duced manganese ore in hydrochloric
this section do not exist or have been acid. The resulting solution is neutral-
waived. ized to precipitate heavy metals, fil-
[48 FR 51911, Nov. 15, 1983; as amended at 60 tered, concentrated, and crystallized.
FR 48893, Sept. 21, 1995; 63 FR 14611, Mar. 26, (b) The ingredient meets the speci-
1998] fications of the Food Chemicals Codex,
§ 184.1445 Malt syrup (malt extract). porated by reference. Copies are avail-
(a) Malt is the product of barley able from the National Academy Press,
(Hordeum vulgare L.) germinated under 2101 Constitution Ave. NW., Wash-
controlled conditions. Malt syrup and ington, DC 20418, or available for in-
malt extract are interchangeable terms spection at the National Archives and
for a viscous concentrate of water ex- Records Administration (NARA). For
tract of germinated barley grain, with information on the availability of this
or without added safe preservative. material at NARA, call 202–741–6030, or
Malt syrup is usually a brown, sweet, go to: http://www.archives.gov/
and viscous liquid containing varying federallregister/

amounts of amylolytic enzymes and codeloflfederallregulations/
plant constituents. Barley is first soft- ibrllocations.html.
545
§ 184.1449 21 CFR Ch. I (4–1–15 Edition)
(c) In accordance with § 184.1(b)(1), ucts as defined in § 170.3(n)(13) of this

the ingredient is used in food with no chapter; meat products as defined in
limitation other than current good § 170.3(n)(29) of this chapter; milk prod-
manufacturing practice. The affirma- ucts as defined in § 170.3(n)(31) of this
tion of this ingredient as generally rec- chapter; and poultry products as de-
ognized as safe (GRAS) as a direct fined in § 170.3(n)(34) of this chapter.
human food ingredient is based upon The ingredient may be used in infant
the following current good manufac- formulas in accordance with section
turing practice conditions of use: 412(g) of the Federal Food, Drug, and
(1) The ingredient is used as a nutri- Cosmetic Act (the act) or with regula-
ent supplement as defined in tions promulgated under section
§ 170.3(o)(20) of this chapter. 412(a)(2) of the act.
(2) The ingredient may be used in in- (d) Prior sanctions for this ingredient
fant formulas in accordance with sec- different from the uses established in
tion 412(g) of the Federal Food, Drug, this section do not exist or have been
and Cosmetic Act (the act) or with reg- waived.
ulations promulgated under section [50 FR 19166, May 7, 1985, as amended at 73
412(a)(2) of the act. FR 8607, Feb. 14, 2008; 76 FR 59250, Sept. 26,
(d) Prior sanctions for this ingredient 2011]
this section do not exist or have been § 184.1452 Manganese gluconate.
waived. (a) Manganese gluconate
[50 FR 19165, May 7, 1985, as amended at 76 (C12H22MnO14·2H2O, CAS Reg. No. 648–
FR 59250, Sept. 26, 2011] 0953–0998) is a slightly pink colored
powder. It is obtained by reacting man-
§ 184.1449 Manganese citrate. ganese carbonate with gluconic acid in
(a) Manganese citrate (Mn3(C6H5O7)2, aqueous medium and then crystallizing
CAS Reg. No. 10024–66–5) is a pale or- the product.
ange or pinkish white powder. It is ob- (b) The ingredient meets the speci-
tained by precipitating manganese car- fications of the Food Chemicals Codex,
bonate from manganese sulfate and so- 3d Ed. (1981), p. 186, which is incor-
dium carbonate solutions. The filtered porated by reference. Copies are avail-
and washed precipitate is digested first able from the National Academy Press,
with sufficient citric acid solution to 2101 Constitution Ave. NW., Wash-
form manganous citrate and then with ington, DC 20418, or available for in-
sodium citrate to complete the reac- spection at the National Archives and
tion. Records Administration (NARA). For
(b) The ingredient must be of a pu- information on the availability of this
rity suitable for its intended use. material at NARA, call 202–741–6030, or
(c) In accordance with § 184.1(b)(1), go to: http://www.archives.gov/
the ingredient is used in food with no federallregister/
limitation other than current good codeloflfederallregulations/
manufacturing practice. The affirma- ibrllocations.html.
tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1),
ognized as safe (GRAS) as a direct the ingredient is used in food with no
human food ingredient is based upon limitation other than current good
the following current good manufac- manufacturing practice. The affirma-
turing practice conditions of use: tion of this ingredient as generally rec-
(1) The ingredient is used as a nutri- ognized as safe (GRAS) as a direct
ent supplement as defined in human food ingredient is based upon
§ 170.3(o)(20) of this chapter. the following current good manufac-
(2) The ingredient is used in the fol- turing practice conditions of use:
lowing foods at levels not to exceed (1) The ingredient is used as a nutri-
current good manufacturing practice: ent supplement as defined in
baked goods as defined in § 170.3(n)(1) of § 170.3(o)(20) of this chapter.
this chapter; nonalcoholic beverages as (2) The ingredient is used in the fol-
defined in § 170.3(n)(3) of this chapter; lowing foods at levels not to exceed

dairy product analogs as defined in current good manufacturing practice:
§ 170.3(n)(10) of this chapter; fish prod- baked goods as defined in § 170.3(n)(1) of
546
this chapter; nonalcoholic beverages as the following current good manufac-

defined in § 170.3(n)(3) of this chapter; turing practice conditions of use:
dairy product analogs as defined in (1) The ingredient is used as a nutri-
§ 170.3(n)(10) of this chapter; fish prod- ent supplement as defined in
ucts as defined in § 170.3(n)(13) of this § 170.3(o)(20) of this chapter.
chapter; meat products as defined in (2) The ingredient is used in the fol-
§ 170.3(n)(29) of this chapter; milk prod- lowing foods at levels not to exceed
ucts as defined in § 170.3(n)(31) of this current good manufacturing practice:
chapter; and poultry products as de- baked goods as defined in § 170.3(n)(1) of
fined in § 170.3(n)(34) of this chapter. this chapter; nonalcoholic beverages as
The ingredient may be used in infant
formulas in accordance with section
dairy product analogs as defined in
412(g) of the Federal Food, Drug, and
§ 170.3(n)(10) of this chapter; fish prod-
Cosmetic Act (the act) or with regula-
ucts as defined in § 170.3(n(13) of this
tions promulgated under section
412(a)(2) of the act. chapter; meat products as defined in
§ 170.3(n)(29) of this chapter; milk prod-
different from the uses established in ucts as defined in § 170.3(n)(31) of this
this section do not exist or have been chapter; and poultry products as de-
waived. fined in § 170.3(n)(34) of this chapter.
The ingredient may be used in infant
[50 FR 19166, May 7, 1985]
formulas in accordance with section
§ 184.1461 Manganese sulfate. 412(g) of the Federal Food, Drug, and
(a) Manganese sulfate (MnSO4·H2O, tions promulgated under section
CAS Reg. No. 7785–0987–097) is a pale 412(a)(2) of the act.
pink, granular, odorless powder. It is (d) Prior sanctions for this ingredient
obtained by reacting manganese com-
pounds with sulfuric acid. It is also ob-
tained as a byproduct in the manufac-
waived.
ture of hydroquinone. Other manufac-
turing processes include the action of [50 FR 19166, May 7, 1985]
sulfur dioxide on a slurry of manganese
dioxide in sulfuric acid, and the roast- § 184.1472 Menhaden oil.
ing of pyrolusite (MnO2) ore with solid (a) Menhaden oil. (1) Menhaden oil is
ferrous sulfate and coal, followed by prepared from fish of the genus
leaching and crystallization. Brevoortia, commonly known as menha-
(b) The ingredient meets the speci- den, by cooking and pressing. The re-
fications of the Food Chemicals Codex, sulting crude oil is then refined using
3d Ed. (1981), p. 188, which is incor- the following steps: Storage (winteriza-
porated by reference. Copies are avail- tion), degumming (optional), neutral-
able from the National Academy Press, ization, bleaching, and deodorization.
Winterization may separate the oil and
produce a solid fraction.
Records Administration (NARA). For (2) Menhaden oil meets the following
information on the availability of this specifications:
material at NARA, call 202–741–6030, or (i) Color and state. Yellow liquid to
go to: http://www.archives.gov/ white solid.
federallregister/ (ii) Odor. Odorless to slightly fishy.
codeloflfederallregulations/ (iii) Saponification value. Between 180
ibrllocations.html. and 200 as determined by the American
(c) In accordance with § 184.1(b)(1), Oil Chemists’ Society Official Method
the ingredient is used in food with no Cd 3–25—‘‘Saponification Value’’ (re-
limitation other than current good approved 1989), which is incorporated
manufacturing practice. The affirma- by reference in accordance with 5
tion of this ingredient as generally rec- U.S.C. 552(a) and 1 CFR part 51. Copies
ognized as safe (GRAS) as a direct of this publication are available from
human food ingredient is based upon the Office of Food Additive Safety,
547
§ 184.1472 21 CFR Ch. I (4–1–15 Edition)
Center for Food Safety and Applied Nu- by reference is given in paragraph
trition (HFS–200), Food and Drug Ad- (a)(2)(iii) of this section.
ministration, 5100 Paint Branch Pkwy., (viii) Lead. Not more than 0.1 part
College Park, MD 20740, or available for per million as determined by the Amer-
inspection at the Center for Food Safe- ican Oil Chemists’ Society Official
ty and Applied Nutrition’s Library, Method Ca 18c–91—‘‘Determination of
Food and Drug Administration, 5100 Lead by Direct Graphite Furnace
Paint Branch Pkwy., College Park, MD Atomic Absorption Spectrometry’’ (re-
20740, or at the National Archives and vised 1992), which is incorporated by
Records Administration (NARA). For reference in accordance with 5 U.S.C.
information on the availability of this 552(a) and 1 CFR part 51. The avail-
material at NARA, call 202–741–6030, or ability of this incorporation by ref-
go to: http://www.archives.gov/ erence is given in paragraph (a)(2)(iii)
federallregister/ of this section.
codeloflfederallregulations/ (ix) Mercury. Not more than 0.5 part
ibrllocations.html. per million as determined by the meth-
(iv) Iodine number. Not less than 120 od entitled ‘‘Biomedical Test Materials
as determined by the American Oil Program: Analytical Methods for the
Chemists’ Society Recommended Prac- Quality Assurance of Fish Oil,’’ pub-
tice Cd 1d–92—‘‘Iodine Value of Fats lished in the ‘‘NOAA Technical Memo-
and Oils, Cyclohexane—Acetic Acid randum NMFS-SEFC-211,’’ F. M. Van
Method,’’ which is incorporated by ref- Dolah and S. B. Galloway, editors, Na-
erence in accordance with 5 U.S.C. tional Marine Fisheries Service, U. S.
552(a) and 1 CFR part 51. The avail- Department of Commerce, pages 71–88,
ability of this incorporation by ref- November, 1988, which is incorporated
erence is given in paragraph (a)(2)(iii) by reference in accordance with 5
of this section. U.S.C. 552(a) and 1 CFR part 51. The
(v) Unsaponifiable matter. Not more availability of this incorporation by
than 1.5 percent as determined by the reference is given in paragraph
American Oil Chemists’ Society Offi- (a)(2)(iii) of this section.
cial Method Ca 6b–53—‘‘Unsaponifiable (3) In accordance with § 184.1(b)(2),
Matter’’ (reapproved 1989), which is in- the ingredient may be used in food only
corporated by reference in accordance within the following specific limita-
with 5 U.S.C. 552(a) and 1 CFR part 51. tions to ensure that total intake of
The availability of this incorporation eicosapentaenoic acid or
by reference is given in paragraph docosahexaenoic acid does not exceed
(a)(2)(iii) of this section. 3.0 grams/person/day:
(vi) Free fatty acids. Not more than 0.1
Maximum
percent as determined by the American level of use in
Category of food
Oil Chemists’ Society Official Method food (as
served)
Ca 5a–40—‘‘Free Fatty Acids’’ (re-
approved 1989), which is incorporated Baked goods, baking mixes, § 170.3(n)(1) of 5.0 percent
by reference in accordance with 5 this chapter.
Cereals, § 170.3(n)(4) of this chapter ............ 4.0 percent
U.S.C. 552(a) and 1 CFR part 51. The Cheese products, § 170.3(n)(5) of this chap- 5.0 percent
availability of this incorporation by ter.
reference is given in paragraph Chewing gum, § 170.3(n)(6) of this chapter .. 3.0 percent
Condiments, § 170.3(n)(8) of this chapter ..... 5.0 percent
(a)(2)(iii) of this section. Confections, frostings, § 170.3(n)(9) of this 5.0 percent
(vii) Peroxide value. Not more than 5 chapter.
milliequivalents per kilogram of oil as Dairy product analogs, § 170.3(n)(10) of this 5.0 percent
determined by the American Oil Chem- chapter.
Egg products, § 170.3(n)(11) of this chapter 5.0 percent
ists’ Society Official Method Cd 8–53— Fats, oils, § 170.3(n)(12) of this chapter, but 12.0 percent
‘‘Peroxide Value, Acetic Acid—Chloro- not in infant formula.
form Method’’ (updated 1992) or Rec- Fish products, § 170.3(n)(13) of this chapter 5.0 percent
Frozen dairy desserts, § 170.3(n)(20) of this 5.0 percent
ommended Practice Cd 8b–90—‘‘Per- chapter.
oxide Value, Acetic Acid—Isooctane Gelatins, puddings, § 170.3(n)(22) of this 1.0 percent
Method’’ (updated 1992), which are in- chapter.
Gravies, sauces, § 170.3(n)(24) of this chap- 5.0 percent
corporated by reference in accordance ter.

with 5 U.S.C. 552(a) and 1 CFR part 51. Hard candy, § 170.3(n)(25) of this chapter .... 10.0 percent
The availability of this incorporation Jams, jellies, § 170.3(n)(28) of this chapter .. 7.0 percent
548
Maximum (ix) Mercury. Not more than 0.5 part

level of use in
Category of food food (as per million.
served) (x) Arsenic (as As). Not more than 0.1
Meat products, § 170.3(n)(29) of this chapter 5.0 percent part per million.
Milk products, § 170.3(n)(31) of this chapter 5.0 percent (xi) Lead. Not more than 0.1 part per
Nonalcoholic beverages, § 170.3(n)(3) of this 0.5 percent million.
chapter.
Nut products, § 170.3(n)(32) of this chapter .. 5.0 percent (3) Partially hydrogenated and hy-
Pastas, § 170.3(n)(23) of this chapter ........... 2.0 percent drogenated menhaden oils are used as
Plant protein products, § 170.3(n)(33) of this 5.0 percent
chapter.
edible fats or oils, as defined in
Poultry products, § 170.3(n)(34) of this chap- 3.0 percent § 170.3(n)(12) of this chapter, in food at
ter. levels not to exceed current good man-
Processed fruit juices, § 170.3(n)(35) of this 1.0 percent
chapter. ufacturing practice.
Processed vegetable juices, § 170.3(n)(36) 1.0 percent (4) If the fat or oil is fully hydro-
of this chapter. genated, the name to be used on the
Snack foods, § 170.3(n)(37) of this chapter .. 5.0 percent
Soft candy, § 170.3(n)(38) of this chapter ..... 4.0 percent label of a product containing it shall
Soup mixes, § 170.3(n)(40) of this chapter ... 3.0 percent include the term ‘‘hydrogenated,’’ or if
Sugar substitutes, § 170.3(n)(42) of this 10.0 percent
chapter.
it is partially hydrogenated, the name
Sweet sauces, toppings, syrups, 5.0 percent shall include the term ‘‘partially hy-
§ 170.3(n)(43) of this chapter. drogenated,’’ in accordance with
White granulated sugar, § 170.3(n)(41) of 4.0 percent
this chapter. § 101.4(b)(14) of this chapter.
(4) To ensure safe use of the sub- FR 14531, Mar. 23, 2005]
stance, menhaden oil shall not be used
in combination with any other added § 184.1490 Methylparaben.
oil that is a significant source of
eicosapentaenoic acid or (a) Methylparaben is the chemical
docosahexaenoic acid. methyl p-hydroxybenzoate. It is pro-
(b) Hydrogenated and partially hydro- duced by the methanol esterification of
genated menhaden oils. (1) Partially hy- p-hydroxybenzoic acid in the presence
drogenated and hydrogenated menha- of sulfuric acid, with subsequent dis-
den oils are prepared by feeding hydro- tillation.
gen gas under pressure to a converter (b) The ingredient meets the speci-
containing crude menhaden oil and a fications of the ‘‘Food Chemicals
nickel catalyst. The reaction is begun Codex,’’ 3d Ed. (1981), p. 199, which is in-
at 150 to 160 °C and after 1 hour the corporated by reference. Copies may be
temperature is raised to 180 °C until obtained from the National Academy
the desired degree of hydrogenation is Press, 2101 Constitution Ave. NW.,
reached. Hydrogenated menhaden oil is Washington, DC 20418, or may be exam-
fully hydrogenated. ined at the National Archives and
(2) Partially hydrogenated and hy- Records Administration (NARA). For
drogenated menhaden oils meet the fol- information on the availability of this
lowing specifications: material at NARA, call 202–741–6030, or
(i) Color. Opaque white solid.
(ii) Odor. Odorless.
federallregister/
(iii) Saponification value. Between 180
and 200. codeloflfederallregulations/
(iv) Iodine number. Not more than 119 ibrllocations.html.
for partially hydrogenated menhaden (c) The ingredient is used as an anti-
oil and not more than 10 for fully hy- microbial agent as defined in
drogenated menhaden oil. § 170.3(o)(2) of this chapter.
(v) Unsaponifiable matter. Not more (d) The ingredient is used in food at
than 1.5 percent.— levels not to exceed good manufac-
(vi) Free fatty acids. Not more than 0.1 turing practices. Current good manu-
percent. facturing practice results in a max-
(vii) Peroxide value. Not more than 5 imum level of 0.1 percent in food.
milliequivalents per kilogram of oil. (e) Prior sanctions for this ingredient
(viii) Nickel. Not more than 0.5 part different from the uses established in
per million.
549
§ 184.1498 21 CFR Ch. I (4–1–15 Edition)
this regulation do not exist or have § 184.1505 Mono- and diglycerides.

been waived. (a) Mono- and diglycerides consist of
[42 FR 14653, Mar. 15, 1977, as amended at 49 a mixture of glyceryl mono- and
FR 5612, Feb. 14, 1984] diesters, and minor amounts of
triesters, that are prepared from fats
§ 184.1498 Microparticulated protein or oils or fat-forming acids that are de-
product. rived from edible sources. The most
(a) Microparticulated protein product prevalent fatty acids include lauric,
is prepared from egg whites or milk linoleic, myristic, oleic, palmitic, and
protein or a combination of egg whites stearic. Mono- and diglycerides are
and milk protein. These protein manufactured by the reaction of glyc-
sources may be used alone or in com- erin with fatty acids or the reaction of
bination with other safe and suitable glycerin with triglycerides in the pres-
ingredients to form the ence of an alkaline catalyst. The prod-
microparticulated product. The mix- ucts are further purified to obtain a
ture of ingredients is high-shear heat mixture of glycerides, free fatty acids,
processed to achieve a smooth and and free glycerin that contains at least
creamy texture similar to that of fat. 90 percent-by-weight glycerides.
Safe and suitable ingredients used in (b) The ingredient meets the speci-
the preparation of the fications of the Food Chemicals Codex,
microparticulated protein product 3d Ed. (1981), p. 201, which is incor-
must be used in compliance with the porated by reference in accordance
limitations of the appropriate regula- with 5 U.S.C. 552(a). Copies are avail-
tions in parts 172, 182, and 184 of this able from the National Academy Press,
chapter. 2101 Constitution Ave. NW., Wash-
(b) The ingredient is used in food in ington, DC 20418, or available for in-
accordance with § 184.1(b)(2) at levels spection at the National Archives and
not to exceed current good manufac- Records Administration (NARA). For
turing practice. The affirmation of the information on the availability of this
use of this ingredient as generally rec- material at NARA, call 202–741–6030, or
ognized as safe (GRAS) as a direct go to: http://www.archives.gov/
human food ingredient is based upon federallregister/
the following conditions of use: codeloflfederallregulations/
(1) The ingredient is used in food as a ibrllocations.html.
thickener as defined in § 170.3(o)(28) of
this chapter or as a texturizer as de-
fined in § 170.3(o)(32) of this chapter.
(2) The ingredient is used in frozen
dessert-type products except that the
ingredient may not be used to replace
the milk fat required in standardized
frozen desserts.
(3) The name of the ingredient used
(1) The ingredient is used in food as a
in the ingredient statement on both
dough strengthener as defined in
bulk and packaged food must include
§ 170.3(o)(6) of this chapter; an emulsi-
the source of the protein (e.g.,
fier and emulsifier salt as defined in
‘‘microparticulated egg white pro-
§ 170.3(o)(8) of this chapter; a flavoring
tein’’), followed by a parenthetical list-
agent and adjuvant as defined in
ing of each of the ingredients in the
§ 170.3(o)(12) of this chapter; a formula-
microparticulated protein product, in
tion aid as defined in § 170.3(o)(14) of
descending order of predominance.
this chapter; a lubricant and release
Microparticulated protein product
agent as defined in § 170.3(o)(18) of this
must be used in accordance with this
chapter; a solvent and vehicle as de-
requirement or its addition to food will
fined in § 170.3(o)(27) of this chapter; a
be considered by FDA to constitute the
stabilizer and thickener as defined in
use of an unapproved food additive (see
§ 170.3(o)(28) of this chapter; a surface-

§ 184.1(b)(2)).
active agent as defined in § 170.3(o)(29)
[55 FR 6391, Feb. 23, 1990] of this chapter; a surface-finishing
550
agent as defined in § 170.3(o)(30) of this pyridinecarboxylic acid (nicotinic

chapter; and a texturizer as defined in acid). It is a non-hygroscopic, stable,
§ 170.3(o)(32) of this chapter. white, crystalline solid that sublimes
(2) The ingredient is used in food at without decomposition at about 230 °C.
levels not to exceed current good man- It is soluble in water and alcohol. It is
ufacturing practice. insoluble in ether.
(d) Prior sanctions for this ingredient (b) The ingredient meets the speci-
different from the uses established in fications of the ‘‘Food Chemicals
this section do not exist or have been Codex,’’ 4th ed. (1996), p. 264, which is
waived. incorporated by reference in accord-
[54 FR 7403, Feb. 21, 1989, as amended at 57
FR 10616, Mar..27, 1992] part 51. Copies are available from the
National Academy Press, Box 285, 2101
§ 184.1521 Monosodium phosphate de- Constitution Ave. NW., Washington,
rivatives of mono- and diglycerides. DC 20055 (Internet address http://
(a) Monosodium phophate derivatives www.nap.edu), or may be examined at
of mono- and diglycerides are com- the Center for Food Safety and Applied
posed of glyceride derivatives formed Nutrition’s Library, Food and Drug Ad-
by reacting mono- and diglycerides ministration, 5100 Paint Branch Pkwy.,
that are derived from edible sources College Park, MD 20740, or at the Na-
with phosphorus pentoxide tional Archives and Records Adminis-
(tetraphosphorus decoxide) followed by tration (NARA). For information on
neutralization with sodium carbonate. the availability of this material at
(b) The ingredient must be of a pu- NARA, call 202–741–6030, or go to: http://
rity suitable for its intended use. www.archives.gov/federallregister/
(c) In accordance with § 184.1(b)(1), codeloflfederallregulations/
the ingredient is used in food with no ibrllocations.html.
limitation other than current good (c) In accordance with § 184.1(b)(1),
manufacturing practice. The affirma- the ingredient is used in food with no
tion of this ingredient as generally rec- limitation other than current good
ognized as safe (GRAS) as a direct manufacturing practice. The affirma-
human food ingredient is based upon tion of this ingredient as generally rec-
the following current good manufac- ognized as safe (GRAS) as direct
turing practice conditions of use: human food ingredient is based upon
(1) The ingredient is used in food as the following current good manufac-
an emulsifier and emulsifier salt as de- turing practice conditions of use:
fined in § 170.3(o)(8) of this chapter, a (1) The ingredient is used as a nutri-
lubricant and release agent as defined ent supplement as defined in
in § 170.3(o)(18) of this chapter, and as a § 170.3(o)(20) of this chapter.
surface-active agent as defined in (2) The ingredient is used in foods at
§ 170.3(o)(29) of this chapter. levels not to exceed current good man-
(2) The ingredient is used in the fol- ufacturing practice. The ingredient
lowing foods at levels not to exceed may also be used in infant formula in
current good manufacturing practice: accordance with section 412(g) of the
dairy product analogs as defined in Federal Food, Drug, and Cosmetic Act
§ 170.3(n)(10) of this chapter and soft (the Act) or with regulations promul-
candy as defined in § 170.3(n)(38) of this gated under section 412(a)(2) of the Act.
chapter. (d) Prior sanctions for this ingredient
(d) Prior sanctions for this ingredient different from the uses established in
different from the uses established in this section do not exist or have been
this section do not exist or have been waived.
waived. [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec.
[54 FR 7404, Feb. 21, 1989, as amended at 73 2, 1983, as amended at 64 FR 1760, Jan. 12,
FR 8607, Feb. 14, 2008] 1999]
§ 184.1530 Niacin. § 184.1535 Niacinamide.

(a) Niacin (C6H5NO2, CAS Reg. No. 59– (a) Niacinamide (C6H6N2O, CAS Reg.
67–6) is the chemical 3- No. 98–92–0) is the chemical 3-
551
§ 184.1537 21 CFR Ch. I (4–1–15 Edition)
pyridinecarboxylic acid amide (nicotin- limitation other than current good

amide). It is a white crystalline powder manufacturing practice. The affirma-
that is soluble in water, alcohol, ether, tion of this ingredient as generally rec-
and glycerol. It melts between 128° and ognized as safe (GRAS) as a direct
131 °C. human food ingredient is based upon
fications of the Food Chemicals Codex, turing practice conditions of use:
3d Ed. (1981), p. 205, which is incor- (1) The ingredient is used as a cata-
porated by reference. Copies are avail- lyst as defined in § 170.3(o)(24) of this
able from the National Academy Press, chapter.
2101 Constitution Ave. NW., Wash- (2) The ingredient is used in the hy-
ington, DC 20418, or available for in- drogenation of fats and oils as defined
spection at the National Archives and in § 170.3(n)(12) of this chapter at levels
Records Administration (NARA). For not to exceed current good manufac-
information on the availability of this turing practice. Current good manufac-
material at NARA, call 202–741–6030, or turing practice includes the removal of
go to: http://www.archives.gov/ nickel from fats and oils following hy-
federallregister/ drogenation.
codeloflfederallregulations/ (d) Prior sanctions for this ingredient
ibrllocations.html. different from the uses established in
(c) In accordance with § 184.1(b)(1), this section do not exist or have been
waived.
manufacturing practice. The affirma- [48 FR 51618, Nov. 10, 1983, as amended at 73
tion of this ingredient as generally rec- FR 8607, Feb. 14, 2008]
human food ingredient is based upon § 184.1538 Nisin preparation.
the following current good manufac- (a) Nisin preparation is derived from
turing practice conditions of use: pure culture fermentations of certain
(1) The ingredient is used as a nutri- strains of Streptococcus lactis
ent supplement as defined in Lancefield Group N. Nisin preparation
§ 170.3(o)(20) of this chapter. contains nisin (CAS Reg. No. 1414–45–5),
(2) The ingredient is used in foods at a group of related peptides with anti-
levels not to exceed current good man- biotic activity.
ufacturing practice. The ingredient (b) The ingredient is a concentrate or
may also be used in infant formula in dry material that meets the specifica-
accordance with section 412(g) of the tions that follow when it is tested as
Federal Food, Drug, and Cosmetic Act described in ‘‘Specifications for Iden-
(the act) or with regulations promul- tity and Purity of Some Antibiotics,’’
gated under section 412(a)(2) of the Act. World Health Organization, FAO Nutri-
(d) Prior sanctions for this ingredient tion Meeting Report Series, No. 45A,
different from the uses established in 1969, which is incorporated by ref-
this section do not exist or have been erence. Copies are available from the
waived. Division of Dockets Management
[48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. (HFA–305), Food and Drug Administra-
2, 1983] tion, 5630 Fishers Lane, rm. 1061, Rock-
ville, MD 20852, or available for inspec-
§ 184.1537 Nickel. tion at the National Archives and
(a) Elemental nickel (CAS Reg. No. Records Administration (NARA). For
7440–02–0) is obtained from nickel ore information on the availability of this
by transforming it to nickel sulfide material at NARA, call 202–741–6030, or
(Ni3S2). The sulfide is roasted in air to go to: http://www.archives.gov/
give nickel oxide (NiO). The oxide is federallregister/
then reduced with carbon to give ele- codeloflfederallregulations/
mental nickel. ibrllocations.html.
(b) The ingredient must be of a pu- (1) Nisin content, not less than 900
rity suitable for its intended use. international units per milligram.
(c) In accordance with § 184.1(b)(1), (2) Arsenic, not more than 1 part per
the ingredient is used in food with no million.
552
(3) Lead, not more than 2 parts per odorless, flavorless gas that is pro-
million. duced commercially by the fraction-
(4) Zinc, not more than 25 parts per ation of liquid air.
million. (b) The ingredient must be of a pu-
(5) Copper, zinc plus copper not more rity suitable for its intended use.
than 50 parts per million. (c) In accordance with § 184.1(b)(1),
(6) Total plate count, not more than the ingredient is used in food with no
10 per gram. limitations other than current good
(7) Escherichia coli, absent in 10 manufacturing practice. The affirma-
grams. tion of this ingredient as generally rec-
(8) Salmonella, absent in 10 grams. ognized as safe (GRAS) as a direct
(9) Coagulase positive staphylococci, human food ingredient is based upon
absent in 10 grams. the following current good manufac-
(c) The ingredient is used as an anti- turing practice conditions of use:
microbial agent as defined in (1) The ingredient is used as a propel-
§ 170.3(o)(2) of this chapter to inhibit lant, aerating agent, and gas as defined
the outgrowth of Clostridium botulinum in § 170.3(o)(25) of this chapter.
spores and toxin formation in pasteur- (2) The ingredient is used in food at
ized cheese spreads and pasteurized levels not to exceed current good man-
process cheese spreads listed in ufacturing practice.
§ 133.175; pasteurized cheese spread with (d) Prior sanctions for this ingredient
fruits, vegetables, or meats as defined different from the uses established in
in § 133.176; pasteurized process cheese this section do not exist or have been
spread as defined in § 133.179; pasteur- waived.
ized process cheese spread with fruits, [48 FR 57270, Dec. 29, 1983, as amended at 73
vegetables, or meats as defined in FR 8607, Feb. 14, 2008]
(d) The ingredient is used at levels § 184.1545 Nitrous oxide.
not to exceed good manufacturing (a) Nitrous oxide (empirical formula
practice in accordance with § 184.1(b)(1) N2O, CAS Reg. No. 10024–97–2) is also
of this chapter. The current good man- known as dinitrogen monoxide or
ufacturing practice level is the quan- laughing gas. It is a colorless gas,
tity of the ingredient that delivers a about 50 percent heavier than air, with
maximum of 250 parts per million of a slightly sweet smell. It does not burn
nisin in the finished product as deter- but will support combustion. Nitrous
mined by the British Standards Insti- oxide is manufactured by the thermal
tution Methods, ‘‘Methods for the Esti- decomposition of ammonium nitrate.
mation and Differentiation of Nisin in Higher oxides of nitrogen are removed
Processed Cheese,’’ BS 4020 (1974), by passing the dry gas through a series
which is incorporated by reference. of scrubbing towers.
Copies are available from the Division (b) The ingredient must be of a pu-
of Dockets Management (HFA–305), rity suitable for its intended use.
Food and Drug Administration, rm. 1– (c) In accordance with § 184.1(b)(1),
23, 12420 Parklawn Dr., Rockville, MD the ingredient is used in food with no
20857, or available for inspection at the limitations other than current good
National Archives and Records Admin- manufacturing practice. The affirma-
istration (NARA). For information on tion of this ingredient as generally rec-
the availability of this material at ognized as safe (GRAS) as a direct
NARA, call 202–741–6030, or go to: http:// human food ingredient is based upon
www.archives.gov/federallregister/ the following current good manufac-
codeloflfederallregulations/ turing practice conditions of use:
ibrllocations.html. (1) The ingredient is used as a propel-
[53 FR 11250, Apr. 6, 1988, as amended at 59 lant, aerating agent, and gas as defined
FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, in § 170.3(o)(25) of this chapter.
2003] (2) The ingredient is used in dairy
product analogs as defined in
§ 184.1540 Nitrogen.
§ 170.3(n)(10) of this chapter at levels

(a) Nitrogen (empirical formula N2, not to exceed current good manufac-
CAS Reg. No. 7727–37–9) is a colorless, turing practice.
553
§ 184.1553 21 CFR Ch. I (4–1–15 Edition)
(d) Prior sanctions for this ingredient which result from the full hydro-
different from the uses established in genation of fatty acids occurring in
this section do not exist or have been natural rapeseed oil. The rapeseed oil
waived. is obtained from the napus and
campestris varieties of Brassica of the
FR 8607, Feb. 14, 2008] family Cruciferae. It is prepared by
fully hydrogenating refined and
§ 184.1553 Peptones. bleached rapeseed oil at 310–375 °F,
using a catalyst such as nickel, until
(a) Peptones are a variable mixture
the iodine number is 4 or less.
of polypeptides, oligopeptides, and
(2) The ingredient meets the fol-
amino acids that are produced by par-
lowing specifications: Acid value not
tial hydrolysis of casein, animal tissue,
more than 6, arsenic not more than 3
soy protein isolate, gelatin, defatted
parts per million, free glycerin not
fatty tissue, egg albumin, or lactal-
more than 7 percent, heavy metals (as
bumin (whey protein). Peptones are
Pb) not more than 10 parts per million,
produced from these proteins using
iodine number not more than 4, residue
proteolytic enzymes that either are
on ignition not more than 0.5 percent.
considered to be generally recognized
(3) The ingredient is used as a sta-
as safe (GRAS) or are regulated as food
bilizer and thickener as defined in
additives. Peptones are also produced
§ 170.3(o)(28) of this chapter in peanut
by denaturing any of the proteins list-
butter. The use level of the ingredient
ed in this paragraph with safe and suit-
is limited by good manufacturing prac-
able acids or heat.
tice (GMP) to the minimum amount re-
(b) The ingredients must be of a pu-
quired to produce the intended effect.
rity suitable for their intended use.
Current good manufacturing practices
result in a maximum level of 2 percent
these ingredients are used in food with
in peanut butter.
no limitation other than current good
(b) Superglycerinated fully hydro-
genated rapeseed oil. (1)
tion of these ingredients as GRAS as
Superglycerinated fully hydrogenated
direct human food ingredients is based
rapeseed oil is a mixture of mono- and
upon the following current good manu-
diglycerides with triglycerides as a
facturing practice conditions of use:
minor component. The fatty acid com-
(1) These ingredients are used as nu- position is a mixture of saturated fatty
trient supplements as defined in acids present in the same proportions
§ 170.3(o)(20) of this chapter; as proc- as those resulting from the full hydro-
essing aids as defined in § 170.3(o)(24) of genation of fatty acids in natural
this chapter; and as surface-active rapeseed oil. It is made by adding ex-
agents as defined in § 170.3(o)(29) of this cess glycerol to the fully hydrogenated
chapter. rapeseed oil and heating, in the pres-
(2) These ingredients are used in food ence of a sodium hydroxide catalyst, to
at levels not to exceed current good 330 °F under partial vacuum and steam
manufacturing practice. sparging agitation.
(d) Prior sanctions for these ingredi- (2) The ingredient meets the speci-
ents different from the uses established fications of the ‘‘Food Chemicals
in this section do not exist or have Codex,’’ 3d Ed. (1981), p. 201, relating to
been waived. mono- and diglycerides, which is incor-
[49 FR 25430, June 21, 1984, as amended at 50 porated by reference. Copies may be
FR 49536, Dec. 3, 1985; 73 FR 8607, Feb. 14, obtained from the National Academy
2008] Press, 2101 Constitution Ave. NW.,
§ 184.1555 Rapeseed oil. ined at the National Archives and
(a) Fully hydrogenated rapeseed oil. (1) Records Administration (NARA). For
Fully hydrogenated rapeseed oil is a information on the availability of this
mixture of triglycerides in which the material at NARA, call 202–741–6030, or
fatty acid composition is a mixture of go to: http://www.archives.gov/

saturated fatty acids. The fatty acids federallregister/
are present in the same porportions codeloflfederallregulations/
554
ibrllocations.html. An additional speci- § 184.1560 Ox bile extract.

fication requires the iodine number to
(a) Ox bile extract (CAS Reg. No.
be 4 or less.
8008–63–7), also known as purified
(3) The ingredient is used as an emul- oxgall or sodium choleate, is a yel-
sifier as defined in § 170.3(o)(8) of this lowish green, soft solid, with a partly
chapter in shortenings for cake mixes. sweet, partly bitter, disagreeable taste.
The use level of the ingredient is lim- It is the purified portion of the bile of
ited by good manufacturing practice an ox obtained by evaporating the alco-
(GMP) to the minimum amount re- hol extract of concentrated bile.
quired to produce the intended effect.
(b) Food-grade ox bile extract shall
Current good manufacturing practices
meet the specifications of the U.S.
result in a maximum level, as served,
Pharmacopeia (USP), XIV, 1950, p. 410. 1
of 4 percent of the shortening or 0.5
(c) The ingredient is used as a surfac-
percent of the total weight of the cake
tant as defined in § 170.3 (o)(29) of this
mix.
chapter.
(c) Low erucic acid rapeseed oil. (1)
(d) The ingredient is used in food in
Low erucic acid rapeseed oil, also
accordance with § 184.1(b)(1) at levels
known as canola oil, is the fully re-
not to exceed good manufacturing
fined, bleached, and deodorized edible
practice. Current good manufacturing
oil obtained from certain varieties of
practice results in a maximum level, as
Brassica Napus or B. Campestris of the
served, of 0.002 percent for cheese as de-
family Cruciferae. The plant varieties
fined in § 170.3(n)(5) of this chapter.
are those producing oil-bearing seeds
with a low erucic acid content. Chemi-
cally, low erucic acid rapeseed oil is a
mixture of triglycerides, composed of
waived.
both saturated and unsaturated fatty
acids, with an erucic acid content of no [43 FR 36064, Aug. 15, 1978. Redesignated and
more than 2 percent of the component amended at 50 FR 49537, Dec. 3, 1985]
fatty acids.
(2) Low erucic acid rapeseed oil as de- § 184.1563 Ozone.
fined in paragraph (c)(1) of this section (a) Ozone (O3, CAS Reg. No. 10028–15–
may be partially hydrogenated to re- 6) is an unstable blue gas with a pun-
duce the proportion of unsaturated gent, characteristic odor, which occurs
fatty acids. When the partially hydro- freely in nature, It is produced com-
genated low erucic acid rapeseed oil is mercially by passing electrical dis-
used, it shall be referred to as partially charges or ionizing radiation through
hydrogenated low erucic acid rapeseed air or oxygen.
oil. (b) The ingredient must be of a pu-
(3) In addition to limiting the con- rity suitable for its intended use in ac-
tent of erucic acid to a level not ex- cordance with § 170.30(h)(1) of this chap-
ceeding 2 percent of the component ter.
fatty acids, low erucic acid rapeseed oil (c) In accordance with § 184.1(b)(2),
and partially hydrogenated low erucic the ingredient is used to treat food
acid rapeseed oil must be of a purity only within the following specific limi-
suitable for their intended use. tations:
(4) Low erucic acid rapeseed oil and
partially hydrogenated low erucic acid
rapeseed oil are used as edible fats and
oils in food, except in infant formula,
at levels not to exceed current good
FR 5613, Feb. 14, 1984; 50 FR 3755, Jan. 28, 1 Copies may be obtained from: U.S.
1985; 53 FR 52682, Dec. 29, 1988; 73 FR 8608, Pharmacopeial Convention, Inc., 12601
Feb. 14, 2008] Twinbrook Parkway, Rockville, MD 20852.
555
§ 184.1583 21 CFR Ch. I (4–1–15 Edition)
Category of food Maximum treat- Functional use

ment level in food
Bottled water that Not to exceed cur- Antimicrobial ufacturing practice.
prior to ozonation rent good man- agent, § 170.3
meets the micro- ufacturing prac- (o)(2) of this [60 FR 32911, June 26, 1995, as amended at 78
biological, phys- tice. Current chapter. FR 14666, Mar. 7, 2013]
ical, chemical, good manufac-
and radiological turing practice § 184.1585 Papain.
quality standards results in a
of § 165.110 maximum resid- (a) Papain (CAS Reg. No. 9001–73–4) is
(b)(2) through ual level at the
(b)(5) of this time of bottling
a proteolytic enzyme derived from
chapter. of 0.4 milligram Carica papaya L. Crude latex con-
of ozone per taining the enzyme is collected from
liter of bottled
water.
slashed unripe papaya. The food-grade
product is obtained by repeated filtra-
tion of the crude latex or an aqueous
[47 FR 50210, Nov. 5, 1982, as amended at 60 solution of latex or by precipitation
FR 57130, Nov. 13, 1995]
from an aqueous solution of latex. The
§ 184.1583 Pancreatin. resulting enzyme preparation may be
used in a liquid or dry form.
(a) Pancreatin (CAS Reg. No. 8049–47– (b) The ingredient meets the speci-
6) is an enzyme preparation obtained
from porcine or bovine pancreatic tis-
3d Ed. (1981), pp. 107–110, which is incor-
sue. It is a white to tan powder. Its
characterizing enzyme activity that of
a peptide hydrolase (EC 3.4.21.36). able from the National Academy Press,
requirements and additional require- ington, DC 20418, or available for in-
ments in the Food Chemicals Codex, 3d spection at the National Archives and
ed. (1981), p. 110, which is incorporated Records Administration (NARA). For
by reference in accordance with 5 information on the availability of this
U.S.C. 552(a) and 1 CFR part 51. Copies material at NARA, call 202–741–6030, or
are available from the National Acad- go to: http://www.archives.gov/
emy Press, 2101 Constitution Ave. NW., federallregister/
Washington, DC 20418, or may be exam- codeloflfederallregulations/
ined at the Office of Food Additive ibrllocations.html.
Safety (HFS–200), Center for Food Safe- (c) In accordance with § 184.1(b)(1),
ty and Applied Nutrition, Food and the ingredient is used in food with no
Drug Administration, 5100 Paint limitation other than currect good
Branch Pkwy., College Park, MD 20740, manufacturing practice. The affirma-
240–402–1200, and at the National Ar- tion of this ingredient as generally rec-
chives and Records Administration ognized as safe (GRAS) as a direct
(NARA). For information on the avail- human food ingredient is based upon
ability of this material at NARA, call the following current good manufac-
202–741–6030, or go to: http:// turing conditions of use:
www.archives.gov/federallregister/ (1) The ingredient is used as an en-
codeloflfederallregulations/ zyme as defined in § 170.3(o)(9) of this
ibrllocations.html. chapter; processing aid as defined in
(c) In accordance with § 184.1(b)(1), § 170.3(o)(24) of this chapter; and
the ingredient is used in food with no texturizer as defined in § 170.3(o)(32) of
limitation other than current good this chapter.
manufacturing practice. The affirma- (2) The ingredient is used in food at
tion of this ingredient as GRAS as a di- levels not to exceed current good man-
rect food ingredient is based upon the ufacturing practice.
following current good manufacturing
practice conditions of use:
zyme as defined in § 170.3(o)(9) of this

waived.
chapter to hydrolyze proteins or
polypeptides. [48 FR 48806, Oct. 21, 1983]
556
§ 184.1588 Pectins. (d) Prior sanctions for these ingredi-

(a) The pectins (CAS Reg. No. 9000– ents different from the uses established
69–5) are a group of complex, high mo- in this section do not exist or have
lecular weight polysaccharides found been waived.
in plants and composed chiefly of par- [48 FR 51149, Nov. 7, 1983]
tially methylated polygalacturonic
acid units. Portions of the carboxly § 184.1595 Pepsin.
group occur as methyl esters, and the
remaining carboxyl groups exist in the (a) Pepsin (CAS Reg. No. 9001–75–6) is
form of the free acid or as its ammo- an enzyme preparation obtained from
nium, potassium, or sodium (CAS Reg. the glandular layer of hog stomach. It
No. 9000–59–8) salts, and in some types is a white to light tan powder, amber
as the acid amide. Thus, the pectins paste, or clear amber to brown liquid.
regulated in this section are the high- Its characterizing enzyme activity is
ester pectins, low-ester pectins, that of a peptide hydrolase (EC
amidated pectins, pectinic acids, and 3.4.23.1).
pectinates. Pectin is produced commer- (b) The ingredient meets the general
cially by extracting citrus peel, apple requirements and additional require-
pomace, or beet pulp with hot dilute ments for enzyme preparations in the
acid (pH 1.0 to 3.5, 70° to 90 °C). The ex- Food Chemicals Codex, 3d ed. (1981), p.
tract is filtered, and pectin is then pre- 110, which is incorporated by reference
cipitated from the clear extract with in accordance with 5 U.S.C. 552(a) and 1
ethanol or isopropanol, or as the cop- CFR part 51. Copies are available from
per or aluminum salt. The acid extract
the National Academy Press, 2101 Con-
is sometimes spray- or roller-dried, or
it is concentrated to be sold as liquid
pectin. 20418, or may be examined at the Office
(b) The ingredients meet the speci- of Food Additive Safety (HFS–200),
fications of the Food Chemical Codex, Center for Food Safety and Applied Nu-
3d Ed. (1981), p. 215, which is incor- trition, Food and Drug Administration,
porated by reference. Copies are avail- 5100 Paint Branch Pkwy., College Park,
able from the National Academy Press, MD 20740, 240–402–1200, and at the Na-
2101 Constitution Ave. NW., Wash- tional Archives and Records Adminis-
ington, DC 20418, or available for in- tration (NARA). For information on
spection at the National Archives and the availability of this material at
Records Administration (NARA). For NARA, call 202–741–6030, or go to: http://
information on the availability of this www.archives.gov/federallregister/
material at NARA, call 202–741–6030, or codeloflfederallregulations/
go to: http://www.archives.gov/ ibrllocations.html.
federallregister/ (c) In accordance with § 184.1(b)(1),
codeloflfederallregulations/ the ingredient is used in food with no
ibrllocations.html. limitation other than current good
the ingredients are used in food with
tion of this ingredient as GRAS as a di-
no limitation other than current good
rect food ingredient is based upon the
tion of these ingredients as generally following current good manufacturing
recognized as safe (GRAS) as direct practice conditions of use:
human food ingredients is based upon (1) The ingredient is used as an en-
the following current good manufac- zyme as defined in § 170.3(o)(9) of this
turing practice conditions of use: chapter to hydrolyze proteins or
(1) The ingredients are used as emul- polypeptides.
sifiers as defined in § 170.3(o)(8) of this (2) The ingredient is used in food at
chapter and as stabilizers and thick- levels not to exceed current good man-
eners as defined in § 170.3(o)(28) of this ufacturing practice.
chapter.
(2) The ingredients are used in food

FR 14667, Mar. 7, 2013]
at levels not to exceed current good
557
§ 184.1610 21 CFR Ch. I (4–1–15 Edition)
§ 184.1610 Potassium alginate. (b) The ingredient meets the speci-

(a) Potassium alginate (CAS Reg. No.
9005–36–1) is the potassium salt of al-
ginic acid, a natural polyuronide con-
stituent of certain brown algae. Potas-
sium alginate is prepared by the neu-
tralization of purified alginic acid with
appropriate pH control agents.
federallregister/
ibrllocations.html.
federallregister/
ibrllocations.html.
the ingredient is used in food only
lation aid as defined in § 170.3(o)(14) of
within the following specific limita-
this chapter; nutrient supplemlent as
tions:
defined in § 170.3(o)(20) of this chapter;
Maximum pH control agent as defined in
level of § 170.3(o)(23) of this chapter; and proc-
use in
Category of food Functional use essing aid as defined in § 170.3(o)(24) of
food (as
served) this chapter.
(percent)
Confections and 0.1 Stabilizer, thickener, levels not to exceed current good man-
frostings, § 170.3(o)(28) of this
§ 170.3(n)(9) of this chapter
chapter. (d) Prior sanctions for this ingredient
Gelatins and puddings, 0.7 Do. different from the uses established in
§ 170.3(n)(22) of this this section do not exist or have been
chapter.
Processed fruits and 0.25 Do. waived.
fruit juices,
§ 170.3(n)(35) of this
[48 FR 52442, Nov. 18, 1983]
chapter.
All other food cat- 0.01 Do. § 184.1619 Potassium carbonate.
egories.
(a) Potassium carbonate (K2CO3, CAS
(d) Prior sanctions for potassium al- Reg. No. 584–08–7) is produced by the
ginate different from the uses estab- following methods of manufacture:
lished in this section do not exist or (1) By electrolysis of potassium chlo-
have been waived. ride followed by exposing the resultant
potassium to carbon dioxide;
[47 FR 29951, July 9, 1982] (2) By treating a solution of potas-
sium hydroxide with excess carbon di-
§ 184.1613 Potassium bicarbonate. oxide to produce potassium carbonate;
(a) Potassium bicarbonate (KHCO3, (3) By treating a solution of potas-
CAS Reg. No. 298–14–6) is made by the sium hydroxide with carbon dioxide to
following processes: produce potassium bicarbonate, which
(1) By treating a solution of potas- is then heated to yield potassium car-
sium hydroxide with carbon dioxide; bonate.

(2) By treating a solution of potas- (b) The ingredient meets the speci-
sium carbonate with carbon dioxide. fications of the Food Chemicals Codex,
558
3d Ed. (1981), p. 240, which is incor- federallregister/

porated by reference. Copies are avail- codeloflfederallregulations/
able from the National Academy Press, ibrllocations.html.
2101 Constitution Ave. NW., Wash- (c) In accordance with § 184.1(b)(1),
ington, D.C. 20418, or available for in- the ingredient is used in food with no
spection at the National Archives and limitation other than current good
Records Administration (NARA). For manufacturing practice. The affirma-
information on the availability of this tion of this ingredient as generally rec-
material at NARA, call 202–741–6030, or ognized as safe (GRAS) as a direct
go to: http://www.archives.gov/ human food ingredient is based upon
federallregister/ the following current good manufac-
codeloflfederallregulations/ turing practice conditions of use:
ibrllocations.html. (1) The ingredient is used as a flavor
(c) In accordance with § 184.1(b)(1), enhancer as defined in § 170.3(o)(11) of
the ingredient is used in food with no this chapter; as a flavoring agent as de-
limitation other than current good fined in § 170.3(o)(12) of this chapter; as
manufacturing practice. the affirma- a nutrient supplement as defined in
tion of this ingredient as generally rec- § 170.3(o)(20) of this chapter; as a pH
ognized as safe (GRAS) as a direct control agent as defined in § 170.3(o)(23)
human food ingredient is based upon of this chapter; and as a stabilizer or
the following current good manufac- thickener as defined in § 170.3(o)(28) of
turing practice conditions of use: this chapter.
(1) The ingredient is used in food as a (2) The ingredient is used in food at
flavoring agent and adjuvant as defined levels not to exceed current good man-
in § 170.3(o)(12) of this chapter; nutrient ufacturing practice. Potassium chlo-
supplement as defined in § 170.3(o)(20) of ride may be used in infant formula in
this chapter; pH control agent as de- accordance with section 412(g) of the
fined in § 170.3(o)(23) of this chapter; Federal Food, Drug, and Cosmetic Act
and processing aid as defined in (the Act) or with regulations promul-
§ 170.3(o)(24) of this chapter. gated under section 412(a)(2) of the Act.
(2) The ingredient is used in food at (d) Prior sanctions for this ingredient
levels not to exceed current good man- different from the uses established in
ufacturing practice. this section do not exist or have been
(d) Prior sanctions for this ingredient waived.
different from the uses established in [48 FR 51614, Nov. 10, 1983]
waived. § 184.1625 Potassium citrate.
[48 FR 52442, Nov. 18, 1983] (a) Potassium citrate (C6H5K3O7·H2O,
CAS Reg. No. 006100–0905–096) is the po-
§ 184.1622 Potassium chloride. tassium salt of citric acid. It is pre-
(a) Potassium chloride (KCl, CAS pared by neutralizing citric acid with
Reg. No. 7447–40–7) is a white, odorless potassium hydroxide or potassium car-
solid prepared from source minerals by bonate. It occurs as transparent crys-
fractional crystallization or flotation. tals or a white granular powder, is
It is soluble in water and glycerol and odorless and deliquescent, and contains
has a saline taste at low concentration one mole of water per mole of potas-
levels. sium citrate.
3d Ed. (1981), p. 241, which is incor- 3d ed. (1981), p. 242, which is incor-
porated by reference. Copies are avail- porated by reference in accordance
able from the National Academy Press, with 5 U.S.C. 552(a) and 1 CFR part 51.
2101 Constitution Ave. NW., Wash- Copies are available from the National
ington, DC 20418, or available for in- Academy Press, 2101 Constitution Ave.
spection at the National Archives and NW., Washington, DC 20418, and the
Records Administration (NARA). For Center for Food Safety and Applied Nu-
information on the availability of this trition (HFS–200), 5100 Paint Branch

material at NARA, call 202–741–6030, or Pkwy., College Park, MD 20740, or may
go to: http://www.archives.gov/ be examined at the National Archives
559
§ 184.1631 21 CFR Ch. I (4–1–15 Edition)
and Records Administration (NARA). of this chapter; and a stabilizer and

For information on the availability of thickener as defined in § 170.3(o)(28) of
this material at NARA, call 202–741– this chapter.
6030, or go to: http://www.archives.gov/ (2) The ingredient is used in food at
federallregister/ levels not to exceed current good man-
codeloflfederallregulations/ ufacturing practice.
ibrllocations.html. (d) Prior sanctions for this ingredient
(c) In accordance with § 184.1(b)(1), different from the uses established in
the ingredient is used in food with no this section do not exist or have been
limitation other than current good waived.
(d) Prior sanctions for this ingredient [48 FR 52444, Nov. 18, 1983]
different from the uses established in § 184.1634 Potassium iodide.
this section, or different from those set
forth in part 181 of this chapter, do not (a) Potassium iodide (KI, CAS Reg.
exist or have been waived. No. 7681–11–0) is the potassium salt of
hydriodic acid. It occurs naturally in
[59 FR 63896, Dec. 12, 1994] sea water and in salt deposits, but can
§ 184.1631 Potassium hydroxide. be prepared by reacting hydriodic acid
(HI) with potassium bicarbonate
(a) Potassium hydroxide (KOH, CAS (KHCO3).
Reg. No. 1310–58–3) is also known as (b) The ingredient meets the speci-
caustic potash, potash lye, and potassa. fications of the ‘‘Food Chemicals
The empirical formula is KOH. It is a Codex,’’ 3d Ed. (1981), pp. 246–247, which
white, highly deliquescent caustic is incorporated by reference. Copies
solid, which is marketed in several may be obtained from the National
forms, including pellets, flakes, sticks, Academy Press, 2101 Constitution Ave.
lumps, and powders. Potassium hydrox- NW., Washington, DC 20418, or may be
ide is obtained commercially from the examined at the National Archives and
electrolysis of potassium chloride solu- Records Administration (NARA). For
tion in the presence of a porous dia- information on the availability of this
phragm.
federallregister/
3d Ed. (1981), which is incorporated by
reference. Copies are available from
ibrllocations.html.
(c) The ingredient is used as a nutri-
ent supplement as defined in
20418, or available from inspection at
the National Archives and Records Ad- § 170.3(o)(20) of this chapter.
ministration (NARA). For information (d) The ingredient is used in table
on the availability of this material at salt in accordance with § 184.1(b)(2) of
NARA, call 202–741–6030, or go to: http:// this chapter as a source of dietary io-
www.archives.gov/federallregister/ dine at a maximum level of 0.01 per-
codeloflfederallregulations/ cent.
ibrllocations.html. (e) Prior sanctions for this ingredient
the ingredient is used in food with no this section do not exist or have been
limitation other than current good waived.
manufacturing practice. The affirma- [43 FR 11699, Mar. 21, 1978, as amended at 49
tion of this ingredient as generally rec- FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1,
ognized as safe (GRAS) as a direct 1996]
the following current good manufac- § 184.1635 Potassium iodate.
turing practice conditions of use: (a) Potassium iodate (KIO3, CAS Reg.
(1) The ingredient is used as a formu- No. 7758–05–6) does not occur naturally
lation aid as defined in § 170.3(o)(14) of but can be prepared by reacting iodine
this chapter; a pH control agent as de- with potassium hydroxide.

fined in § 170.3(o)(23) of the chapter; a (b) The ingredient meets the speci-
processing aid as defined in § 170.3(o)(24) fications of the ‘‘Food Chemicals
560
Codex,’’ 3d Ed. (1981), pp. 245–246, which (d) Prior sanctions for this ingredient
is incorporated by reference. Copies different from the uses established in
may be obtained from the National this section do not exist or have been
Academy Press, 2101 Constitution Ave. waived.
NW., Washington, DC 20418, or may be
[52 FR 10886, Apr. 6, 1987, as amended at 73
examined at the National Archives and FR 8608, Feb. 14, 2008]
information on the availability of this § 184.1643 Potassium sulfate.
go to: http://www.archives.gov/ (a) Potassium sulfate (K2SO4, CAS
federallregister/ Reg. No. 7778–80–5) occurs naturally and
codeloflfederallregulations/ consists of colorless or white crystals
ibrllocations.html. or crystalline powder having a bitter,
(c) The ingredient is used as a dough saline taste. It is prepared by the neu-
strengthener as defined in § 170.3(o)(6) tralization of sulfuric acid with potas-
of this chapter. sium hydroxide or potassium car-
(d) The ingredient is used in the man- bonate.
ufacture of bread in accordance with (b) The ingredient meets the speci-
§ 184.1(b)(2) of this chapter in an fications of the ‘‘Food Chemicals
amount not to exceed 0.0075 percent Codex,’’ 3d Ed. (1981), p. 252, which is in-
based on the weight of the flour. corporated by reference. Copies may be
(e) Prior sanctions for this ingredient obtained from the National Academy
different from the uses established in Press, 2101 Constitution Ave. NW.,
this section do not exist or have been Washington, DC 20418, or may be exam-
waived. ined at the National Archives and
[43 FR 11699, Mar. 21, 1978, as amended at 49 information on the availability of this
FR 5613, Feb. 14, 1984]
§ 184.1639 Potassium lactate. go to: http://www.archives.gov/
federallregister/
(a) Potassium lactate (C3H5O3K, CAS codeloflfederallregulations/
Reg. No. 996–31–6) is the potassium salt ibrllocations.html.
of lactic acid. It is a hydroscopic, (c) The ingredient is used as a fla-
white, odorless solid and is prepared voring agent and adjuvant as defined in
commercially by the neutralization of § 170.3(o)(12) of this chapter.
lactic acid with potassium hydroxide. (d) The ingredient is used in food at
levels not to exceed good manufac-
turing practice in accordance with
turing practice results in a maximum
level, as served, of 0.015 percent for
manufacturing practice. This regula-
nonalcoholic beverages as defined in
tion does not authorize its use in in-
fant foods and infant formulas. The af-
firmation of this ingredient as gen-
erally recognized as safe (GRAS) as a
direct human food ingredient is based
waived.
upon the following current good manu-
facturing practice conditions of use: [45 FR 6086, Jan. 25, 1980, as amended at 49
(1) The ingredient is used as a flavor FR 5613, Feb. 14, 1984]
enhancer as defined in § 170.3(o)(11) of
this chapter; a flavoring agent or adju- § 184.1655 Propane.
vant as defined in § 170.3(o)(12) of this (a) Propane (empirical formula C3H8,
chapter; a humectant as defined in CAS Reg. No. 74–98–6) is also known as
§ 170.3(o)(16) of this chapter; and a pH dimethylmethane or propyl hydrid. It
control agent as defined in § 170.3(o)(23) is a colorless, odorless, flammable gas
of this chapter. at normal temperatures and pressures.
(2) The ingredient is used in food at It is easily liquefied under pressure at

levels not to exceed current good man- room temperature and is stored and
ufacturing practice. shipped in the liquid state. Propane is
561
§ 184.1660 21 CFR Ch. I (4–1–15 Edition)
obtained from natural gas by fraction- tice results in a maximum total con-
ation following absorption in oil, ad- tent of antioxidants of 0.02 percent of
sorption to surface-active agents, or re- the fat or oil content, including the es-
frigeration. sential (volatile) oil content, of the
(b) The ingredient must be of a pu- food.
rity suitable for its intended use. (e) Prior sanctions for this ingredient
the ingredient is used in food with no this section, or different from that
limitations other than current good stated in part 181 of this chapter, do
manufacturing practice. The affirma- not exist or have been waived.
ognized as safe (GRAS) as a direct [42 FR 14653, Mar. 15, 1977, as amended at 44
human food ingredient is based upon FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14,
the following current good manufac- 1984]
(1) The ingredient is used as a propel- § 184.1666 Propylene glycol.
lant, aerating agent, and gas as defined (a) Propylene glycol (C3H8O2, CAS
in § 170.3(o)(25) of this chapter. Reg. No. 57–55–6) is known as 1,2-
(2) The ingredient is used in food at propanediol. It does not occur in na-
levels not to exceed current good man- ture. Propylene glycol is manufactured
ufacturing practice. by treating propylene with chlorinated
(d) Prior sanctions for this ingredient water to form the chlorohydrin which
different from the uses established in is converted to the glycol by treatment
this section do not exist or have been with sodium carbonate solution. It is
waived. also prepared by heating glyercol with
[48 FR 57271, Dec. 29, 1983, as amended at 73 sodium hydroxide.
FR 8608, Feb. 14, 2008] (b) The ingredient meets the speci-
§ 184.1660 Propyl gallate. 3d Ed. (1981), p. 255, which is incor-
(a) Propyl gallate is the n- porated by reference. Copies may be
propylester of 3,4,5-trihydroxybenzoic obtained from the National Academy
acid (C10H12O5). Natural occurrence of Press, 2101 Constitution Ave. NW.,
propyl gallate has not been reported. It Washington, DC 20418. It is also avail-
is commercially prepared by able for inspection at the National Ar-
esterification of gallic acid with propyl chives and Records Administration
alcohol followed by distillation to re- (NARA). For information on the avail-
move excess alcohol. ability of this material at NARA, call
(b) The ingredient meets the speci- 202–741–6030, or go to: http://
fications of the ‘‘Food Chemicals www.archives.gov/federallregister/
Codex,’’ 3d Ed. (1981), pp. 257–258, which codeloflfederallregulations/
is incorporated by reference. Copies ibrllocations.html.
may be obtained from the National (c) The ingredient is used as an
Academy Press, 2101 Constitution Ave. anticaking agent as defined in
NW., Washington, DC 20418, or may be § 170.3(o)(1) of this chapter; antioxidant
examined at the National Archives and as defined in § 170.3(o)(3) of this chap-
Records Administration (NARA). For ter; dough strengthener as defined in
information on the availability of this § 170.3(o)(6) of this chapter; emulsifier
material at NARA, call 202–741–6030, or as defined in § 170.3(o)(8) of this chap-
go to: http://www.archives.gov/ ter; flavor agent as defined in
federallregister/ § 170.3(o)(12) of this chapter; formula-
codeloflfederallregulations/ tion aid as defined in § 170.3(o)(14) of
ibrllocations.html. this chapter; humectant as defined in
(c) The ingredient is used as an anti- § 170.3(o)(16) of this chapter; processing
oxidant as defined in § 170.3(o)(3) of this aid as defined in § 170.3(o)(24) of this
chapter. chapter; solvent and vehicle as defined
(d) The ingredient is used in food at in § 170.3(o)(27) of this chapter; sta-
levels not to exceed good manufac- bilizer and thickener as defined in

turing practice in accordance with § 170.3(o)(28) of this chapter; surface-ac-
§ 184.1(b)(1). Good manufacturing prac- tive agent as defined in § 170.3(o)(29) of
562
this chapter; and texturizer as defined this regulation do not exist or have
in § 170.3(o)(32) of this chapter. been waived.
(d) The ingredient is used in foods at [42 FR 14653, Mar. 15, 1977, as amended at 49
levels not to exceed current good man- FR 5613, Feb. 14, 1984]
ufacturing practice in accordance with
§ 184.1(b)(1). Current good manufac- § 184.1676 Pyridoxine hydrochloride.
turing practice results in maximum (a) Pyridoxine hydrochloride
levels, as served, of 5 percent for alco- (C8H11NO3·HCl, CAS Reg. No. 58–56–0) is
holic beverages, as defined in the chemical 3-hydroxy–4,5-
§ 170.3(n)(2) of this chapter; 24 percent dihydroxymethy–2-methylpyridine hy-
for confections and frostings as defined drochloride that is prepared by chem-
in § 170.3(n)(9) of this chapter; 2.5 per- ical synthesis.
cent for frozen dairy products as de- (b) The ingredient meets the speci-
fined in § 170.3(n)(20) of this chapter; 97 fications of the Food Chemicals Codex,
percent for seasonings and flavorings 3d Ed. (1981), p. 260, which is incor-
as defined in § 170.3(n)(26) of this chap- porated by reference. Copies are avail-
ter; 5 percent for nuts and nut products able from the National Academy Press,
as defined in § 170.3(n)(32) of this chap- 2101 Constitution Ave. NW., Wash-
ter; and 2.0 percent for all other food ington, DC 20418, or available for in-
categories. spection at the National Archives and
(e) Prior sanctions for this ingredient Records Administration (NARA). For
different from the uses established in information on the availability of this
this section do not exist or have been material at NARA, call 202–741–6030, or
waived. go to: http://www.archives.gov/
federallregister/
[47 FR 27812, June 25, 1982]
§ 184.1670 Propylparaben. ibrllocations.html.
(a) Propylparaben is the chemical the ingredient is used in food with no
propyl p-hydroxybenzoate. It is pro- limitation other than current good
duced by the n-propanol esterification manufacturing practice. The affirma-
of p-hydroxybenzoic acid in the pres- tion of this ingredient as generally rec-
ence of sulfuric acid, with subsequent ognized as safe (GRAS) as a direct
distillation. human food ingredient is based upon
fications of the ‘‘Food Chemicals turing practice conditions of use:
Codex,’’ 3d Ed. (1981), p. 258, which is in- (1) The ingredient is used as a nutri-
corporated by reference. Copies may be ent supplement as defined in
obtained from the National Academy § 170.3(o)(20) of this chapter.
Press, 2101 Constitution Ave. NW., (2) The ingredient is used in the fol-
Washington, DC 20418, or may be exam- lowing foods at levels not to exceed
ined at the National Archives and current good manufacturing practice:
Records Administration (NARA). For baked goods as defined in § 170.3(n)(1) of
information on the availability of this this chapter; nonalcoholic beverages
material at NARA, call 202–741–6030, or and beverage bases as defined in
go to: http://www.archives.gov/ § 170.3(n)(3) of this chapter; breakfast
federallregister/ cereals as defined in § 170.3(n)(4) of this
codeloflfederallregulations/ chapter; dairy product analogs as de-
ibrllocations.html. fined in § 170.3(n)(10) of this chapter;
(c) The ingredient is used as an anti- meat products as defined in
microbial agent as defined in § 170.3(n)(29) of this chapter; milk prod-
§ 170.3(o)(2) of this chapter. ucts as defined in § 170.3(n)(31) of this
(d) The ingredient is used in food at chapter; plant protein products as de-
levels not to exceed good manufac- fined in § 170.3(n)(33) of this chapter;
turing practices. Current good manu- and snack foods as defined in
facturing practice results in a max- § 170.3(n)(37) of this chapter. Pyridoxine
imum level of 0.1 percent in food. hydrochloride may be used in infant

(e) Prior sanctions for this ingredient formula in accordance with section
different from the uses established in 412(g) of the Federal Food, Drug, and
563
§ 184.1685 21 CFR Ch. I (4–1–15 Edition)
Cosmetic Act (the Act) or with regula- (4) Chymosin preparation is a clear
tions promulgated under section solution containing the active enzyme
412(a)(2) of the Act. chymosin (E.C. 3.4.23.4). It is derived,
(d) Prior sanctions for this ingredient via fermentation, from a nonpatho-
different from the uses established in genic and nontoxigenic strain of Asper-
this section do not exist or have been gillus niger van Tieghem variety
waived. awamori (Nakazawa) Al-Musallam (syn-
[48 FR 51615, Nov. 10, 1983] onym A. awamori Nakazawa) con-
taining the prochymosin gene.
§ 184.1685 Rennet (animal-derived) Chymosin is recovered from the fer-
and chymosin preparation (fermentation broth after acid treatment.
mentation-derived).
All materials used in the processing
(a)(1) Rennet and bovine rennet are and formulating of chymosin prepara-
commercial extracts containing the action must be either generally recog-
tive enzyme rennin (CAS Reg. No. 9001– nized as safe (GRAS) or be food addi-
98–3), also known as chymosin (Inter- tives that have been approved by the
national Union of Biochemistry En- Food and Drug Administration for this
zyme Commission (E.C.) 3.4.23.4).
use.
Rennet is the aqueous extract prepared
from cleaned, frozen, salted, or dried (b) Rennet and chymosin preparation
fourth stomachs (abomasa) of calves, meet the general and additional re-
kids, or lambs. Bovine rennet is the quirements for enzyme preparations of
product from adults of the animals list- the ‘‘Food Chemicals Codex,’’ 3d Ed.
ed above. Both products are called (1981), pp. 107–110, which is incorporated
rennet and are clear amber to dark by reference in accordance with 5
brown liquid preparations or white to U.S.C. 552(a). Copies are available from
tan powders. the National Academy Press, 2101 Con-
(2) Chymosin preparation is a clear stitution Avenue NW., Washington, DC
solution containing the active enzyme 20418, or are available for inspection at
chymosin (E.C. 3.4.23.4). It is derived, the National Archives and Records Ad-
via fermentation, from a nonpatho- ministration (NARA). For information
genic and nontoxigenic strain of Esch- on the availability of this material at
erichia coli K–12 containing the NARA, call 202–741–6030, or go to: http://
prochymosin gene. The prochymosin is www.archives.gov/federallregister/
isolated as an insoluble aggregate that codeloflfederallregulations/
is acid-treated to destroy residual cel- ibrllocations.html.
lular material and, after solubilization, (c) In accordance with § 184.1(b)(1),
is acid-treated to form chymosin. It the ingredient is used in food with no
must be processed with materials that limitation other than current good
are generally recognized as safe, or are manufacturing practice. The affirma-
food additives that have been approved tion of this ingredient as generally rec-
by the Food and Drug Administration ognized as safe as a direct human food
for this use.
ingredient is based upon the following
(3) Chymosin preparation is a clear
current good manufacturing practice
solution containing the active enzyme
conditions of use:
chymosin (E.C. 3.4.23.4). It is derived,
via fermentation, from a nonpatho- (1) The ingredient is used as an en-
genic and nontoxigenic strain of zyme as defined in § 170.3(o)(9) of this
Kluyveromyces marxianus variety lactis, chapter; a processing aid as defined in
containing the prochymosin gene. The § 170.3(o)(24) of this chapter; and a sta-
prochymosin is secreted by cells into bilizer and thickener as defined in
fermentation broth and converted to § 170.3(o)(28) of this chapter.
chymosin by acid treatment. All mate- (2) The ingredient is used in the fol-
rials used in the processing and formu- lowing foods at levels not to exceed
lating of chymosin must be either gen- current good manufacturing practice:
erally recognized as safe (GRAS), or be In cheeses as defined in § 170.3(n)(5) of
food additives that have been approved this chapter; frozen dairy desserts and
by the Food and Drug Administration mixes as defined in § 170.3(n)(20) of this
for this use. chapter; gelatins, puddings, and fillings
564
as defined in § 170.3(n)(22) of this chap- this section do not exist or have been
ter; and milk products as defined in waived.
[48 FR 51148, Nov. 7, 1983]
different from the uses established in § 184.1697 Riboflavin–5′-phosphate (so-
this section do not exist or have been dium).
waived.
(a) Riboflavin-5′-phosphate (sodium)
[55 FR 10935, Mar. 23, 1990, as amended at 57 (C17H20N4O9PNa·2H2O, CAS Reg. No 130–
FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, 40–5) occurs as the dihydrate in yellow
1993] to orange-yellow crystals. It is pre-
pared by phosphorylation of riboflavin
§ 184.1695 Riboflavin.
with chlorophosphoric acid,
(a) Riboflavin (C17H20N4O6, CAS Reg. pyrophosphoric acid, metaphosphoric
No. 83–88–5) occurs as yellow to orange- acid, or pyrocatechol cyclic phosphate.
yellow needles that are crystallized (b) The ingredient meets the speci-
from 2N acetic acid, alcohol, water, or fications of the Food Chemicals Codex,
pyridine. It may be prepared by chem- 3d Ed. (1981), p. 263, which is incor-
ical synthesis, biosynthetically by the porated by reference. Copies are avail-
organism Eremothecium ashbyii, or iso- able from the National Academy Press,
lated from natural sources. 2101 Constitution Ave. NW., Wash-
(b) The ingredient meets the speci- ington DC 20418, or available for inspec-
fications of the Food Chemicals Codex, tion at the National Archives and
2101 Constitution Ave. NW., Wash- go to: http://www.archives.gov/
manufacturing practice. The affirma- (1) The ingredient is used as a nutri-
tion of this ingredient as generally rec- ent supplement as defined in
ognized as safe (GRAS) as a direct § 170.3(o)(20) of this chapter.
(2) The ingredient is used in milk
products, as defined in § 170.3(n)(31) of
this chapter, at levels not to exceed
(1) The ingredient is used as a nutri-
current good manufacturing practice.
ent supplement as defined in
The ingredient may also be used in in-
fant formulas in accordance with sec-
(2) The ingredient is used in foods at tion 412(g) of the Federal Food, Drug,
levels not to exceed current good man- and Cosmetic Act (the Act) or with reg-
ufacturing practice. The ingredient
ulations promulgated under section
may also be used in infant formula in
412(a)(2) of the Act.
(the Act) or with regulations promul-
gated under section 412(a)(2) of the Act.
waived.
different from the uses established in [48 FR 51148, Nov. 7, 1983]
565
§ 184.1698 21 CFR Ch. I (4–1–15 Edition)
§ 184.1698 Rue. Ruta—Ruta montana L., Ruta graveolens

L., Ruta bracteosa L., and Ruta
(a) Rue is the perennial herb of sev-
calepensis L.
eral species of Ruta (Ruta montana L.,
(b) Oil of rue meets the specifications
Ruta graveolens L., Ruta bracteosa L.,
of the ‘‘Food Chemicals Codex,’’ 4th ed.
and Ruta calepensis L.). The leaves,
(1996), pp. 342–343, which is incorporated
buds, and stems from the top of the
by reference in accordance with 5
plant are gathered, dried, and then
U.S.C. 552(a) and 1 CFR part 51. Copies
crushed in preparation for use, or left
are available from the National Acad-
whole.
emy Press, Box 285, 2101 Constitution
(b) The ingredient is used in all cat-
Ave. NW., Washington, DC 20055 (Inter-
egories of food in accordance with
net address http://www.nap.edu), or may
§ 184.1(b)(2) of this chapter at con-
be examined at the Center for Food
centrations not to exceed 2 parts per
Safety and Applied Nutrition’s Li-
million.
brary, Food and Drug Administration,
(c) Prior sanctions for this ingredient
MD 20740, or at the National Archives
waived.
[43 FR 3705, Jan. 27, 1978] this material at NARA, call 202–741–
§ 184.1699 Oil of rue. federallregister/
(a) Oil of rue is the natural substance codeloflfederallregulations/
obtained by steam distillation of the ibrllocations.html.
fresh blossoming plants of rue, the pe- (c) The ingredient is used in food
rennial herb of several species of under the following conditions:
Parts per
Food (as served) Function
million
Baked goods and baking mixes, § 170.3(n)(1), of 10 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter.
this chapter.
Frozen dairy desserts and mixes, § 170.3 (n)(20) of 10 Do.
this chapter.
Soft candy, § 170.3(n)(38) of this chapter ................. 10 Do.
All other food categories ............................................ 4 Do.
(d) Prior sanctions for this ingredient (1) Saponification value of 185 to 195,
different from the uses established in (2) Iodine value of 28 to 43,
this section do not exist or have been (3) Unsaponifiable matter not to ex-
waived. ceed 1.5 percent,
[42 FR 14653, Mar. 15, 1977, as amended at 49 (4) Free fatty acids not more than 0.1
FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, percent as oleic acid,
1999] (5) Peroxide value not more than 10
milliequivalents/equivalent (meq/eq),
§ 184.1702 Sheanut oil. (6) Lead not more than 0.1 part per
(a) Sheanut oil is produced from million (ppm),
sheanuts derived from the Shea tree (7) Copper not more than 0.1 ppm.
Butyrospermum parkii and is composed (c) In accordance with § 184.1(b)(3),
principally of triglycerides containing the ingredient is used in the following
an oleic acid moiety at the 2-position food categories at levels not to exceed
and saturated fatty acids, usually ste- current good manufacturing practice,
aric or palmitic acids, at the 1- and 3- except that the ingredient may not be
positions. used in a standardized food unless per-
(b) The ingredient meets the fol- mitted by the standard of identity:
lowing specifications when tested using Confections and frostings as defined in

any appropriate validated method- § 170.3(n)(9) of this chapter, coatings of
ology: soft candy as defined in § 170.3(n)(38) of
566
this chapter, and sweet sauces and top- tas as defined in § 170.3(n)(23) of this
pings as defined in § 170.3(n)(43) of this chapter and snack foods as defined in
chapter. § 170.3(n)(37) of this chapter; 0.15 per-
[63 FR 28895, May 27, 1998]
cent for hard candy as defined in
§ 170.3(n)(25) of this chapter; 0.12 per-
§ 184.1721 Sodium acetate. cent for jams and jellies as defined in
§ 170.3(n)(28) of this chapter and meat
(a) Sodium acetate (C2H3O2Na, CAS
products as defined in § 170.3(n)(29) of
Reg. No. 127–09–3 or C2H3O2Na·3H2O,
this chapter; 0.2 percent for soft candy
CAS Reg. No. 6131–90–4) is the sodium
salt of acetic acid and occurs naturally as defined in § 170.3(n)(38) of this chap-
in plant and animal tissues. Sodium ac- ter; 0.05 percent for soups and soup
etate may occur in either the anhy- mixes as defined in § 170.3(n)(40) of this
drous or trihydrated form. It is pro- chapter and sweet sauces as defined in
duced synthetically by the neutraliza- § 170.3(n)(43) of this chapter.
tion of acetic acid with sodium car- (e) Prior sanctions for this ingredient
bonate or by treating calcium acetate different from the uses established in
with sodium sulfate and sodium bicar- this section do not exist or have been
bonate. waived.
(b) The ingredient meets the speci- [47 FR 27815, June 25, 1982]
3d Ed. (1981), pp. 272, 273 which is incor- § 184.1724 Sodium alginate.
able from the National Academy Press, (a) Sodium alginate (CAS Reg. No.
2101 Constitution Ave. NW., Wash- 9005–38–3) is the sodium salt of alginic
ington, DC 20418, or available for in- acid, a natural polyuronide constituent
spection at the National Archives and of certain brown algae. Sodium algi-
Records Administration (NARA). For nate is prepared by the neutralization
information on the availability of this of purified alginic acid with appro-
material at NARA, call 202–741–6030, or priate pH control agents.
go to: http://www.archives.gov/ (b) The ingredient meets the speci-
federallregister/ fications of the Food Chemicals Codex,
codeloflfederallregulations/ 3d Ed. (1981), p. 274, which is incor-
ibrllocations.html. porated by reference. Copies are avail-
(c) The ingredient is used as a fla- able from the National Academy Press,
voring agent and adjuvant as defined in 2101 Constitution Ave. NW., Wash-
§ 170.3(o)(12) of this chapter; and as a pH ington, DC 20418, or available for in-
control agent as defined in § 170.3(o)(23) spection at the National Archives and
of this chapter. Records Administration (NARA). For
(d) The ingredient is used in food at information on the availability of this
levels not to exceed current good man- material at NARA, call 202–741–6030, or
ufacturing practice in accordance with go to: http://www.archives.gov/
184.1(b)(1). Current good manufacturing federallregister/
practice results in a maximum level, as codeloflfederallregulations/
served, of 0.007 percent for breakfast ibrllocations.html.
cereals as defined in § 170.3(n)(4) of this (c) In accordance with § 184.1(b)(2),
chapter; 0.5 percent for fats and oils as the ingredient is used in food only
defined in § 170.3(n)(12) of this chapter; within the following specific limita-
0.6 percent for grain products and pas- tions:
Maximum
level of
Category of food use in food Functional use
(as served)
(percent)
Condiments and relishes, § 170.3(n)(8) of this chapter, 1.0 Texturizer, § 170.3(o)(32) of this chapter, formulation aid
except pimento ribbon for stuffed olives. § 170.3(o)(14) of this chapter, stabilizer, thickener,
Pimento ribbon for stuffed olives ...................................... 6.0 Do.
Confections and frostings, § 170.3(n)(9) of this chapter .. 0.3 Stabilizer, thickener, § 170.3(o)(28) of this chapter.
567
§ 184.1733 21 CFR Ch. I (4–1–15 Edition)
Maximum
level of
Category of food use in food Functional use
(as served)
(percent)
Gelatins and puddings, § 170.3(n)(22) of this chapter ..... 4.0 Firming agent, § 170.3(o)(10) of this chapter; flavor adju-
vant, § 170.3(o)(12) of this chapter; stabilizer, thick-
ener, § 170.3(o)(28) of this chapter.
Hard candy, § 170.3(n)(25) of this chapter ...................... 10.0 Stabilizer, thickener, § 170.3(o)(28) of this chapter.
Processed fruits and fruit juices, § 170.3(n)(35) of this 2.0 Formulation aid, § 170.3(o)(14) of this chapter;
chapter. texturizer, § 170.3(o)(32) of this chapter.
All other food categories .................................................. 1.0 Emulsifier, § 170.3(o)(8) of this chapter; firming agent,
§ 170.3(o)(10) of this chapter; flavor enhancer,
§ 170.3(o)(11) of this chapter; flavor adjuvant,
§ 170.3(o)(12) of this chapter; processing aid,
§ 170.3(o)(24) of this chapter; stabilizer and thickener,
§ 170.3(o)(28) of this chapter; surface active agent,
(d) Prior sanctions for sodium algi- (e) Prior sanctions for this ingredient
nate different from the uses established different from the uses established in
in this section do not exist or have this section, or different from that set
been waived. forth in part 181 of this chapter, do not
[47 FR 29951, July 9, 1982, as amended at 48 exist or have been waived.
FR 52448, Nov. 18, 1983]
§ 184.1733 Sodium benzoate. FR 5613, Feb. 14, 1984]
(a) Sodium benzoate is the chemical § 184.1736 Sodium bicarbonate.

benzoate of soda (C7H5NaO2), produced
by the neutralization of benzoic acid (a) Sodium bicarbonate (NaHCO3,
with sodium bicarbonate, sodium car- CAS Reg. No. 144–55–8) is prepared by
bonate, or sodium hydroxide. The salt treating a sodium carbonate or a so-
is not found to occur naturally. dium carbonate and sodium bicarbon-
(b) The ingredient meets the speci- ate solution with carbon dioxide. As
fications of the ‘‘Food Chemicals carbon dioxide is absorbed, a suspen-
Codex,’’ 3d Ed. (1981), p. 278, which is in- sion of sodium bicarbonate forms. The
corporated by reference. Copies may be slurry is filtered, forming a cake which
obtained from the National Academy is washed and dried.
Press, 2101 Constitution Ave. NW., (b) The ingredient meets the speci-
Washington, DC 20418, or may be exam- fications of the Food Chemicals Codex,
ined at the National Archives and 3d Ed. (1981), p. 278, which is incor-
Records Administration (NARA). For porated by reference. Copies are avail-
information on the availability of this able from the National Academy Press,
federallregister/
ibrllocations.html. Records Administration (NARA). For
(c) The ingredient is used as an anti- information on the availability of this
microbial agent as defined in material at NARA, call 202–741–6030, or
§ 170.3(o)(2) of this chapter, and as a fla- go to: http://www.archives.gov/
voring agent and adjuvant as defined in federallregister/
§ 170.3(o)(12) of this chapter. codeloflfederallregulations/
(d) The ingredient is used in food at ibrllocations.html.
levels not to exceed good manufac- (c) In accordance with § 184.1(b)(1),
turing practice. Current usage results the ingredient is used in food with no
in a maximum level of 0.1 percent in limitation other than current good
food. (The Food and Drug Administra- manufacturing practice.
tion has not determined whether (d) Prior sanctions for this ingredient
significally different conditions of use different from the uses established in
would be GRAS.)
568
this section do not exist or have been § 184.1751 Sodium citrate.

waived.
(a) Sodium citrate (C6H5Na3O7·2H2O,
[48 FR 52442, Nov. 18, 1983] CAS Reg. No. 68–0904–092) is the sodium
salt of citric acid. It is prepared by
§ 184.1742 Sodium carbonate. neutralizing citric acid with sodium
(a) Sodium carbonate (Na2CO3, CAS hydroxide or sodium carbonate. The
Reg. No. 497–19–8) is produced (1) from product occurs as colorless crystals or
purified trona ore that has been a white crystalline powder. It may be
calcined to soda ash; (2) from trona ore prepared in an anhydrous state or may
calcined to impure soda ash and then contain two moles of water per mole of
purified; or (3) synthesized from lime- sodium citrate.
stone by the Solvay process. (b) The ingredient meets the speci-
(b) The ingredient meets the specifications of the Food Chemicals Codex,
fications of the Food Chemicals Codex, 3d ed. (1981), pp. 283–284, which is incor-
3d Ed. (1981), p. 280, which is incorporated by reference in accordance
porated by reference. Copies are avail- with 5 U.S.C. 552(a) and 1 CFR part 51.
able from the National Academy Press, Copies are available from the National
2101 Constitution Ave. NW., Wash- Academy Press, 2101 Constitution Ave.
ington, DC 20418, or available for in- NW., Washington, DC 20418, and the
spection at the National Archives and Center for Food Safety and Applied Nu-
Records Administration (NARA). For trition (HFS–200), 5100 Paint Branch
information on the availability of this Pkwy., College Park, MD 20740, or may
material at NARA, call 202–741–6030, or be examined at the National Archives
go to: http://www.archives.gov/ and Records Administration (NARA).
federallregister/ For information on the availability of
codeloflfederallregulations/ this material at NARA, call 202–741–
ibrllocations.html. 6030, or go to: http://www.archives.gov/
federallregister/
ibrllocations.html.
this section, or different from those set
(1) The ingredient is used in food as forth in part 181 of this chapter, do not
an antioxidant as defined in § 170.3(o)(3) exist or have been waived.
of this chapter; curing and pickling
agent as defined in § 170.3(o)(5) of this [59 FR 63896, Dec. 12, 1994]
chapter; flavoring agent and adjuvant
as defined in § 170.3(o)(12) of this chap- § 184.1754 Sodium diacetate.
ter; pH control agent as defined in (a) Sodium diacetate (C4H7O4Na·xH2O,
§ 170.3(o)(23) of this chapter; and proc- CAS Reg. No. 126–96–5) is a molecular
essing aid as defined in § 170.3(o)(24) of compound of acetic acid, sodium ace-
this chapter. tate, and water of hydration. The tech-
(2) The ingredient is used in food at nical grade is prepared synthetically
levels not to exceed current good man- by reacting sodium carbonate with ace-
ufacturing practice. tic acid. Special grades are produced by
(d) Prior sanctions for this ingredient reacting anhydrous sodium acetate and
different from the uses established in acetic acid.
this section do not exist or have been (b) The ingredient meets the speci-
waived. fications of the Food Chemicals Codex,

[48 FR 52442, Nov. 18, 1983, as amended at 50 porated by reference. Copies are avail-
FR 49536, Dec. 3, 1985] able from the National Academy Press,
569
§ 184.1763 21 CFR Ch. I (4–1–15 Edition)
2101 Constitution Ave. NW., Wash- istration (NARA). For information on

ington, DC 20418, or available for in- the availability of this material at
spection at the National Archives and NARA, call 202–741–6030, or go to: http://
Records Administration (NARA). For www.archives.gov/federallregister/
information on the availability of this codeloflfederallregulations/
material at NARA, call 202–741–6030, or ibrllocations.html.
go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1),
federallregister/ the ingredient is used in food with no
(c) The ingredient is used as an anti- tion of this ingredient as generally rec-
microbial agent as defined in ognized as safe (GRAS) as a direct
§ 170.3(o)(2) of this chapter; flavoring human food ingredient is based upon
agent and adjuvant as defined in the following current good manufac-
§ 170.3(o)(12) of this chapter; and pH turing practice conditions of use:
control agent as defined in § 170.3(o)(23) (1) The ingredient is used as a pH
of this chapter. control agent as defined in § 170.3(o)(23)
(d) The ingredient is used in food at of this chapter and as a processing aid
levels not to exceed current good man- as defined in § 170.3(o)(24) of this chap-
ufacturing practice in accordance with ter.
§ 184.1(b)(1). Current good manufac- (2) The ingredient is used in foods at
turing practice results in a maximum levels not to exceed current good man-
level, as served, 0.4 percent for baked ufacturing practice.
goods as defined in § 170.3(n)(1) of this
chapter; 0.1 percent for fats and oils as
defined in § 170.3(n)(12) of this chapter,
meat products as defined in
waived.
§ 170.3(n)(29) of this chapter and soft
candy as defined in § 170.3(n)(38) of this [48 FR 52444, Nov. 18, 1983]
chapter; 0.25 percent for gravies and
sauces as defined in § 170.3(n)(24) of this § 184.1764 Sodium hypophosphite.
chapter; and 0.05 percent for snack (a) Sodium hypophosphite (NaH2PO2,
foods as defined in § 170.3(n)(37) of this CAS Reg. No. 7681–53–0) is a white,
chapter and soups and soup mixes as odorless, deliquescent granular powder
defined in § 170.3(n)(40) of this chapter. with a saline taste. It is also prepared
(e) Prior sanctions for this ingredient as colorless, pearly crystalline plates.
different from the uses established in It is soluble in water, alcohol, and
this section do not exist or have been glycerol. It is prepared by neutraliza-
waived. tion of hypophosphorous acid or by di-
[47 FR 27815, June 25, 1982] rect aqueous alkaline hydrolysis of
white phosphorus.
§ 184.1763 Sodium hydroxide. (b) The ingredient must be of a pu-
(a) Sodium hydroxide (NaOH, CAS rity suitable for its intended use.
Reg. No. 1310–73–2) is also known as so- (c) In accordance with § 184.1(b)(1),
dium hydrate, soda lye, caustic soda, the ingredient is used in food with no
white caustic, and lye. The empirical limitations other than current good
formula is NaOH. Sodium hydroxide is manufacturing practice. The affirma-
prepared commercially by the elec- tion of this ingredient as generally rec-
trolysis of sodium chloride solution ognized as safe (GRAS) as a direct
and also by reacting calcium hydroxide human food ingredient is based upon
with sodium carbonate. the following current good manufac-
(b) The ingredient meets the speci- turing practice conditions of use:
fications of the Food Chemicals Codex, (1) The ingredient is used as an emul-
3d Ed. (1981), which is incorporated by sifier or stabilizer, as defined in
reference. Copies are available from §§ 170.3(o)(8) and 170.3(o)(28) of this
the National Academy Press, 2101 Con- chapter.
stitution Ave. NW., Washington, DC (2) The ingredient is used in cod-liver

20418, or available for inspection at the oil emulsions at levels not to exceed
National Archives and Records Admin- current good manufacturing practice.
570
(d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1),
different from the use established in the ingredient is used in food with no
this section do not exist or have been limitation other than current good
waived. manufacturing practice. The affirma-
[47 FR 38277, Aug. 31, 1982, as amended at 73
FR 8608, Feb. 14, 2008]
§ 184.1768 Sodium lactate. the following current good manufac-
(a) Sodium lactate (C3H5O3Na, CAS (1) The ingredient is used as a proc-
Reg. No. 72–17–3) is the sodium salt of essing aid as defined in § 170.3(o)(24) of
lactic acid. It is prepared commercially this chapter.
by the neutralization of lactic acid (2) The ingredient is used to treat the
with sodium hydroxide. following foods at levels not to exceed
(b) The ingredient must be of a pu- current good manufacturing practice:
rity suitable for its intended use. for use in washing and lye peeling of
(c) In accordance with § 184.1(b)(1), fruits, vegetables, and nuts when used
the ingredient is used in food with no in accordance with § 173.315 of this
limitation other than current good chapter; for use as a denuding agent in
manufacturing practice. This regula- tripe; for use as a hog scald agent in re-
tion does not authorize its use in in- moving hair; and for use as a corrosion
fant foods and infant formulas. The af- preventative in canned and bottled
firmation of this ingredient as gen- water when used in accordance with
erally recognized as safe (GRAS) as a § 165.110 of this chapter.
direct human food ingredient is based (d) Prior sanctions for this ingredient
upon the following current good manu- different from the uses established in
facturing practice conditions of use: this section do not exist or have been
(1) The ingredient is used as an emul- waived.
sifier as defined in § 170.3(o)(8) of this
chapter; a flavor enhancer as defined in [50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct.
17, 1985, as amended at 72 FR 10357, Mar. 8,
§ 170.3(o)(11) of this chapter; a flavoring
2007; 73 FR 8608, Feb. 14, 2008]
agent or adjuvant as defined in
§ 170.3(o)(12) of this chapter; a humec- § 184.1784 Sodium propionate.
tant as defined in § 170.3(o)(16) of this
(a) Sodium propionate (C3H5NaO2,
chapter; and a pH control agent as de-
CAS Reg. No. 137–40–6) is the sodium
salt of propionic acid. It occurs as
colorless, transparent crystals or a
granular crystalline powder. It is odor-
less, or has a faint acetic-butyric acid
odor, and is deliquescent. It is prepared
by neutralizing propionic acid with so-
dium hydroxide.
waived.
(b) The ingredients meets the speci-
[52 FR 10886, Apr. 6, 1987, as amended at 73 fications of the Food Chemicals Codex,
FR 8608, Feb. 14, 2008] 3d Ed. (1981), p. 296, which is incor-
§ 184.1769a Sodium metasilicate. able from the National Academy Press,
(a) Sodium metasilicate (CAS Reg. 2101 Constitution Ave. NW., Wash-
No. 6834–92–0) is a strongly alkaline ington DC 20418, or available for inspec-
white powder. It does not occur natu- tion at the National Archives and
rally but rather is synthesized by melt- Records Administration (NARA). For
ing sand with sodium carbonate at 1400 information on the availability of this
°C. The commercially available forms material at NARA, call 202–741–6030, or
of sodium metasilicate are the anhy- go to: http://www.archives.gov/
drous form (Na2SiO3), the pentahydrate federallregister/
(Na2SiO3·5H2O), and the nonahydrate codeloflfederallregulations/
(Na2SiO3·9H2O). ibrllocations.html.
(b) The ingredient must be of a pu- (c) In accordance with § 184.1(b)(1),
rity suitable for its intended use. the ingredient is used in food with no
571
§ 184.1792 21 CFR Ch. I (4–1–15 Edition)
limitation other than current good (c) In accordance with § 184.1(b)(1),

manufacturing practice. The affirma- the ingredient is used in food with no
tion of this ingredient as generally rec- limitation other than current good
ognized as safe (GRAS) as a direct manufacturing practice. The affirma-
human food ingredient is based upon tion of this ingredient as generally rec-
the following current good manufac- ognized as safe (GRAS) as a direct
turing practice conditions of use: human food ingredient is based upon
(1) The ingredient is used as an anti- the following current good manufac-
microbial agent as defined in turing practice conditions of use:
§ 170.3(o)(2) of this chapter and a fla- (1) The ingredient is used as a pH
voring agent as defined in § 170.3(o)(12) control agent as defined in § 170.3(o)(23)
of this chapter. of this chapter.
(2) The ingredient is used in the fol- (2) The ingredient is used in cream at
lowing foods at levels not to exceed levels not to exceed current good man-
current good manufacturing practice: ufacturing practice. Current good man-
baked goods as defined in § 170.3(n)(1) of ufacturing practice utilizes a level of
this chapter; nonalcoholic beverages as the ingredient sufficient to control lac-
defined in § 170.3(n)(3) of this chapter; tic acid prior to pasteurization and
cheeses as defined in § 170.3(n)(5) of this churning of cream into butter.
chapter; confections and frostings as (d) Prior sanctions for this ingredient
defined in § 170.3(n)(9) of this chapter; different from the uses established in
gelatins, puddings, and fillings as de- this section do not exist or have been
fined in § 170.3(n)(22) of this chapter; waived.
jams and jellies as defined in
[48 FR 52443, Nov. 18, 1983]
§ 170.3(n)(28) of this chapter; meat prod-
ucts as defined in § 170.3(n)(29) of this § 184.1801 Sodium tartrate.
chapter; and soft candy as defined in
§ 170.3(n)(38) of this chapter. (a) Sodium tartrate (C4H4Na2O6·2H2O,
(d) Prior sanctions for this ingredient CAS Reg. No. 868–18–8) is the disodium
different from the uses established in salt of L¥(+)¥tartaric acid. It occurs
this section do not exist or have been as transparent, colorless, and odorless
waived. crystals. It is obtained as a byproduct
of wine manufacture.
[49 FR 13142, Apr. 3, 1984] (b) The ingredient meets the speci-
§ 184.1792 Sodium sesquicarbonate. 3d Ed. (1981), p. 303, which is incor-
(a) Sodium sesquicarbonate porated by reference. Copies are avail-
(Na2CO3·NaHCO3·2H2O, CAS Reg. No. able from the National Academy Press,
533–96–0) is prepared by: (1) Partial 2101 Constitution Ave. NW., Wash-
carbonation of soda ash solution fol- ington, DC 20418, or available for in-
lowed by crystallization, centrifuga- spection at the National Archives and
tion, and drying; (2) double refining of Records Administration (NARA). For
trona ore, a naturally occurring im- information on the availability of this
pure sodium sesquicarbonate. material at NARA, call 202–741–6030, or
(b) The ingredient meets the speci- go to: http://www.archives.gov/
fications of the Food Chemicals Codex, federallregister/
3d Ed. (1981), p. 299, which is incor- codeloflfederallregulations/
porated by reference. Copies are avail- ibrllocations.html.
able from the National Academy Press, (c) In accordance with § 184.1(b)(1),
2101 Constitution Ave. NW., Wash- the ingredient is used in food with no
ington, DC 20418, or available for in- limitation other than current good
spection at the National Archives and manufacturing practice. The affirma-
Records Administration (NARA). For tion of this ingredient as generally rec-
information on the availability of this ognized as safe (GRAS) as a direct
material at NARA, call 202–741–6030, or human food ingredient is based upon
go to: http://www.archives.gov/ the following current good manufac-
federallregister/ turing practice conditions of use:

codeloflfederallregulations/ (1) The ingredient is used as an emul-
ibrllocations.html. sifier as defined in § 170.3(o)(8) of this
572
chapter and as a pH control agent as chapter and jams and jellies as defined
defined in § 170.3(o)(23) of this chapter. in § 170.3(n)(28) of this chapter.
(2) The ingredient is used in the fol- (d) Prior sanctions for this ingredient
lowing foods at levels not to exceed different from the uses established in
current good manufacturing practice: this section do not exist or have been
cheeses as defined in§ 170.3(n)(5) of this waived.
chapter; fats and oils as defined in
§ 170.3(n)(12) of this chapter; and jams [48 FR 52447, Nov. 18, 1983]
and jellies as defined in § 170.3(n)(28) of
this chapter. § 184.1807 Sodium thiosulfate.
(d) Prior sanctions for this ingredient (a) Sodium thiosulfate (Na2S2O3·5H2O,
different from the uses established in CAS Reg. No. 010102–0917–097) is also
this section do not exist or have been known as sodium hyposulfite. It is pre-
waived. pared synthetically by the reaction of
[48 FR 52447, Nov. 18, 1983] sulfides and sulfur dioxide (SO2), the
reaction of sulfur and sulfite, or the ox-
§ 184.1804 Sodium potassium tartrate. idation of metal sulfides and
(a) Sodium potassium tartrate hydrosulfides.
(C4H4KNaO6·4H2O, CAS Reg. No. 304–59– (b) The ingredient meets the speci-
6) is the sodium potassium salt of fications of the ‘‘Food Chemicals
L¥(+)¥tartaric acid and is also called Codex,’’ 3d Ed. (1981), p. 304, which is in-
the Rochelle salt. It occurs as colorless corporated by reference. Copies may be
crystals or as a white, crystalline pow- obtained from the National Academy
der and has a cooling saline taste. It is Press, 2101 Constitution Ave. NW.,
obtained as a byproduct of wine manu- Washington, DC 20418, or may be exam-
facture. ined at the National Archives and
(b) The ingredient meets the speci- Records Administration (NARA). For
fications of the Food Chemicals Codex, information on the availability of this
3d Ed. (1981), p. 296, which is incor- material at NARA, call 202–741–6030, or
porated by reference. Copies are avail- go to: http://www.archives.gov/
able from the National Academy Press, federallregister/
2101 Constitution Ave. NW., Wash- codeloflfederallregulations/
ington, DC 20418, or available for in- ibrllocations.html.
spection at the National Archives and (c) The ingredient is used as a formu-
Records Administration (NARA). For lation aid as defined in § 170.3(o)(14) of
information on the availability of this this chapter and reducing agent as de-
federallregister/ (d) The ingredient is used in alco-
codeloflfederallregulations/ holic beverages and table salt in ac-
ibrllocations.html. cordance with § 184.1(b)(1) at levels not
(c) In accordance with § 184.1(b)(1), to exceed good manufacturing practice.
the ingredient is used in food with no Current good manufacturing practice
limitation other than current good results in a maximum level, as served,
manufacturing practice. The affirma- of 0.00005 percent for alcoholic bev-
tion of this ingredient as generally rec- erages as defined in § 170.3(n)(2) of this
ognized as safe (GRAS) as a direct chapter and 0.1 percent for table salt as
human food ingredient is based upon defined in § 170.3(n)(26) of this chapter.
the following current good manufac- (e) Prior sanctions for this ingredient
turing practice conditions of use: different from the uses established in
(1) The ingredient is used as an emul- this section do not exist or have been
sifier as defined in § 170.3(o)(8) of this waived.
chapter and as a pH control agent as
defined in § 170.3(o)(23) of this chapter. [43 FR 22938, May 30, 1978, as amended at 49
FR 5613, Feb. 4, 1984]
(2) The ingredient is used in the fol-
lowing foods at levels not to exceed

current good manufacturing practice:
cheeses as defined in § 170.3(n)(5) of this
573
§ 184.1835 21 CFR Ch. I (4–1–15 Edition)
§ 184.1835 Sorbitol. in soft candy as defined in § 170.3(n)(38)

(a) Sorbitol is the chemical 1,2,3,4,5,6- of this chapter, 30 percent in non-
hexanehexol (C6H14O6), a hexahydric al- standardized jams and jellies, commer-
cohol, differing from mannitol prin- cial, as defined in § 170.3(n)(28) of this
cipally by having a different optical ro- chapter, 30 percent in baked goods and
tation. Sorbitol is produced by the baking mixes as defined in § 170.3(n)(1)
electrolytic reduction, or the transi- of this chapter, 17 percent in frozen
tion metal catalytic hydrogenation of dairy desserts and mixes as defined in
sugar solutions containing glucose or § 170.3(n)(20) of this chapter, and 12 per-
fructose. cent in all other foods.
(b) The ingredient meets the speci- (e) The label and labeling of food
fications of the ‘‘Food Chemicals whose reasonably foreseeable consump-
Codex,’’ 3d Ed. (1981), p. 308, which is in- tion may result in a daily ingestion of
corporated by reference. Copies may be 50 grams of sorbitol shall bear the
obtained from the National Academy statement: ‘‘Excess consumption may
Press, 2101 Constitution Ave. NW., have a laxative effect.’’
Washington, DC 20418, or may be exam- (f) Prior sanctions for this ingredient
ined at the National Archives and different from the uses established in
Records Administration (NARA). For this regulation do not exist or have
information on the availability of this been waived.
go to: http://www.archives.gov/ [42 FR 14653, Mar. 15, 1977, as amended at 49
federallregister/ FR 5613, Feb. 14, 1984]
ibrllocations.html. § 184.1845 Stannous chloride (anhy-
(c) The ingredient is used as an drous and dihydrated).
anticaking agent and free-flow agent as (a) Stannous chloride is anhydrous or
defined in § 170.3(o)(1) of this chapter, contains two molecules of water of hy-
curing and pickling agent as defined in dration. Anhydrous stannous chloride
§ 170.3(o)(5) of this chapter, drying (SnCl2, CAS Reg. No. 7772–99–8) is the
agent as defined in § 170.3(o)(7) of this chloride salt of metallic tin. It is pre-
chapter, emulsifier and emulsifier salt pared by reacting molten tin with ei-
as defined in § 170.3(o)(8) of this chap- ther chlorine or gaseous tin tetra-
ter, firming agent as defined in chloride. Dihydrated stannous chloride
§ 170.3(o)(10) of this chapter, flavoring (SnCl2·2H2O, CAS Reg. No. 10025–69–1) is
agent and adjuvant as defined in the chloride salt of metallic tin that
§ 170.3(o)(12) of this chapter, formula- contains two molecules of water. It is
tion aid as defined in § 170.3(o)(14) of prepared from granulated tin sus-
this chapter, humectant as defined in pended in water and hydrochloric acid
§ 170.3(o)(16) of this chapter, lubricant
or chlorine.
and release agent as defined in
(b) Both forms of the ingredient meet
§ 170.3(o)(18) of this chapter, nutritive
sweetener as defined in § 170.3(o)(21) of the specifications of the Food Chemi-
this chapter, sequestrant as defined in cals Codex, 3d Ed. (1981), p. 312, which is
§ 170.3(o)(26) of this chapter, stabilizer incorporated by reference. Copies are
and thickener as defined in § 170.3(o)(28) available from the National Academy
of this chapter, surface-finishing agent Press, 2101 Constitution Ave. NW.,
as defined in § 170.3(o)(30) of this chap- Washington, DC 20418, or available for
ter, and texturizer as defined in inspection at the National Archives
§ 170.3(o)(32) of this chapter. and Records Administration (NARA).
(d) The ingredient is used in food at For information on the availability of
levels not to exceed good manufac- this material at NARA, call 202–741–
turing practices. Current good manu- 6030, or go to: http://www.archives.gov/
facturing practice in the use of sorbitol federallregister/
results in a maximum level of 99 per- codeloflfederallregulations/
cent in hard candy and cough drops as ibrllocations.html.
defined in § 170.3(n)(25) of this chapter, (c) The ingredient is used as an anti-

75 percent in chewing gum as defined in oxidant as defined in § 170.3(o)(3) of this
§ 170.3(n)(6) of this chapter, 98 percent chapter.
574
(d) The ingredient is used in food at § 184.1851 Stearyl citrate.

(a) Stearyl citrate is a mixture of the
ufacturing practice in accordance with
mono-, di-, and tristearyl esters of cit-
§ 184.(b)(1). Current good manufacturing
ric acid. It is prepared by esterifying
practice results in a maximum level, as
citric acid with stearyl alcohol.
served, of 0.0015 percent or less; cal-
culated as tin, for all food categories.
different from those uses established in
waived.
[47 FR 27816, June 25, 1982, as amended at 76 tion of this ingredient as generally rec-
FR 59250, Sept. 26, 2011] ognized as safe (GRAS) as a direct
§ 184.1848 Starter distillate. the following current good manufac-
(a) Starter distillate (butter starter turing practice conditions of use:
distillate) is a steam distillate of the (1) The ingredient is used as an anti-
culture of any or all of the following oxidant as defined in § 170.3(o)(3) of this
species of bacteria grown on a medium chapter; an emulsifier and emulsifier
consisting of skim milk usually for- salt as defined in § 170.3(o)(8) of this
tified with about 0.1 percent citric acid: chapter; a sequestrant as defined in
Streptococcus lactis, S. cremoris, S. lactis § 170.3(o)(26) of this chapter; and a sur-
subsp. diacetylactis, Leuconostoc face-active agent as defined in
citrovorum, and L. dextranicum. The in- § 170.3(o)(29) of this chapter.
gredient contains more than 98 percent (2) The ingredient is used in mar-
water, and the remainder is a mixture garine in accordance with § 166.110 of
of butterlike flavor compounds. Diace- this chapter; in nonalcoholic beverages
tyl is the major flavor component, con- as defined in § 170.3(n)(3) of this chap-
stituting as much as 80 to 90 percent of ter; and in fats and oils as defined in
the mixture of organic flavor com- § 170.3(n)(12) of this chapter at levels
pounds. Besides diacetyl, starter dis- not to exceed current good manufac-
tillate contains minor amounts of acet- turing practice.
aldehyde, ethyl formate, ethyl acetate, (d) Prior sanctions for this ingredient
acetone, ethyl alcohol, 2-butanone, different from the uses established in
acetic acid, and acetoin. this section, or different from those set
(b) The ingredient must be of a pu- forth in part 181 of this chapter, do not
rity suitable for its intended use. exist or have been waived.
(c) In accordance with § 184.1(b)(1), [59 FR 63897, Dec. 12, 1994, as amended at 73
the ingredient is used in food with no FR 8608, Feb. 14, 2008]
manufacturing practice. The affirma- § 184.1854 Sucrose.
tion of this ingredient as generally rec- (a) Sucrose (C12H22O11, CAS Reg. No.
ognized as safe (GRAS) as a direct 57–50–11–1) sugar, cane sugar, or beet
human food ingredient is based upon sugar is the chemical b-D-
the following current good manufac- fructofuranosyl-a-D-glucopyranoside.
turing practice conditions of use: Sucrose is obtained by crystallization
(1) The ingredient is used as a fla- from sugar cane or sugar beet juice
voring agent and adjuvant as defined in that has been extracted by pressing or
§ 170.3(o)(12) of this chapter. diffusion, then clarified and evapo-
(2) The ingredient is used in food at rated.
levels not to exceed current good man- (b) The ingredient must be of a pu-
ufacturing practice. rity suitable for its intended use.
(d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1),
different from the uses established in the ingredient is used in food with no
this section do not exist or have been limitation other than current good
waived.
[48 FR 51907, Nov. 15, 1983, as amended at 73 (d) Prior sanctions for this ingredient
FR 8608, Feb. 14, 2008] different from the uses established in
575
§ 184.1857 21 CFR Ch. I (4–1–15 Edition)
this section do not exist or have been (c) In accordance with § 184.1(b)(1),
waived. the ingredient is used in food with no
[53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4,
1989, as amended at 73 FR 8608, Feb. 14, 2008]
§ 184.1857 Corn sugar. different from the uses established in
(a) Corn sugar (C6H12O6, CAS Reg. No. waived.
50–99–7), commonly called D-glucose or
dextrose, is the chemical a-D- [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4,
1989, as amended at 73 FR 8608, Feb. 14, 2008]
glucopyranose. It occurs as the anhy-
drous or the monohydrate form and is § 184.1865 Corn syrup.
produced by the complete hydrolysis of
corn starch with safe and suitable acids (a) Corn syrup, commonly called
or enzymes, followed by refinement and ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is
crystallization from the resulting hy- obtained by partial hydrolysis of corn
drolysate. starch with safe and suitable acids or
(b) The ingredient meets the speci- enzymes. It may also occur in the de-
fications of the Food Chemicals Codex, hydrated form (dried glucose sirup).
3d Ed. (1981), pp. 97–98 under the head- Depending on the degree of hydrolysis,
ing ‘‘Dextrose,’’ which is incorporated corn syrup may contain, in addition to
by reference in accordance with 5 glucose, maltose and higher
U.S.C. 552(a) and 1 CFR part 1. Copies saccharides.
are available from the National Acad- (b) The ingredient meets the speci-
emy Press, 2101 Constitution Ave., NW., fications as defined and determined in
Washington, DC 20418, or available for § 168.120(b) or § 168.121(a) of this chapter,
inspection at the National Archives as appropriate.
and Records Administration (NARA). (c) In accordance with § 184.1(b)(1),
For information on the availability of the ingredient is used in food with no
this material at NARA, call 202–741– limitation other than current good
6030, or go to: http://www.archives.gov/ manufacturing practice.
federallregister/ (d) Prior sanctions for this ingredient
codeloflfederallregulations/ different from the uses established in
ibrllocations.html. this section do not exist or have been
waived.
the ingredient is used in food with no [53 FR 44876, Nov. 7, 1988, as amended at 73
limitation other than current good FR 8608, Feb. 14, 2008]
(d) Prior sanctions for this ingredient § 184.1866 High fructose corn syrup.
different from the uses established in (a) High fructose corn syrup, a sweet,
this section do not exist or have been nutritive saccharide mixture con-
waived. taining either approximately 42 or 55
percent fructose, is prepared as a clear
[53 FR 44876, Nov. 7, 1988] aqueous solution from high dextrose-
equivalent corn starch hydrolysate by
§ 184.1859 Invert sugar.
partial enzymatic conversion of glu-
(a) Invert sugar (CAS Reg. No. 8013– cose (dextrose) to fructose using an in-
17–0) is an aqueous solution of inverted soluble glucose isomerase enzyme prep-
or partly inverted, refined or partly re- aration described in § 184.1372. The
fined sucrose, the solids of which con- product containing more than 50 per-
tain not more than 0.3 percent by cent fructose (dry weight) is prepared
weight of ash. The solution is colorless, through concentration of the fructose
odorless, and flavorless, except for portion of the mixture containing less
sweetness. It is produced by the hydrol- than 50 percent fructose.
ysis or partial hydrolysis of sucrose (b) The ingredient shall conform to
with safe and suitable acids or en- the identity and specifications listed in
zymes. the monograph entitled ‘‘High-Fruc-

(b) The ingredient must be of a pu- tose Corn Syrup’’ in the Food Chemi-
rity suitable for its intended use. cals Codex, 4th ed. (1996), pp. 191–192,
576
which is incorporated by reference in the following current good manufac-

accordance with 5 U.S.C. 552(a) and 1 turing practice conditions of use:
CFR part 51. Copies are available from (1) The ingredient is used as a fla-
the Office of Food Additive Safety voring agent and adjuvant as defined in
(HFS–200), Center for Food Safety and § 170.3(o)(12) of this chapter or as a nu-
Applied Nutrition, Food and Drug Ad- trient supplement as defined in
ministration, 5100 Paint Branch Pkwy., § 170.3(o)(20) of this chapter.
College Park, MD 20740, 240–402–1200, or (2) The ingredient is used in food at
may be examined at the Center for levels not to exceed current good man-
Food Safety and Applied Nutrition’s ufacturing practice. Thiamine hydro-
Library, 5100 Paint Branch Pkwy., Col- chloride may be used in infant formula
lege Park, MD 20740, or at the National in accordance with section 412(g) of the
Archives and Records Administration Federal Food, Drug, and Cosmetic Act
(NARA). For information on the avail- (the Act) or with regulations promul-
ability of this material at NARA, call gated under section 412(a)(2) of the Act.
202–741–6030, or go to: http:// (d) Prior sanctions for this ingredient
www.archives.gov/federallregister/ different from the uses established in
codeloflfederallregulations/ this section do not exist or have been
ibrllocations.html. waived.
(c) In accordance with § 184.1(b)(1), [48 FR 55124, Dec. 9, 1983]
limitation other than current good § 184.1878 Thiamine mononitrate.
manufacturing practice. (a) Thiamine mononitrate
[61 FR 43450, Aug. 23, 1996, as amended at 78
(C12H17N5O4S, CAS Reg. No. 532–43–4) is
FR 14667, Mar. 7, 2013] the mononitrate salt of thiamine. It
occurs as white crystals or a white
§ 184.1875 Thiamine hydrochloride. crystalline powder and is prepared
from thiamine hydrochloride by dis-
(a) Thiamine hydrochloride solving the hydrochloride salt in alka-
(C12H17C1N4OS·HCl, CAS Reg. No. 67–03– line solution followed by precipitation
8) is the chloride-hydrochloride salt of of the nitrate half-salt with a stoichio-
thiamine. It occurs as hygroscopic metric amount of nitric acid.
white crystals or a white crystalline (b) The ingredient meets the speci-
powder. The usual method of preparing fications of the Food Chemicals Codex,
this substance is by linking the 3d Ed. (1981), p. 325, which is incor-
preformed thiazole and pyrimidine ring porated by reference. Copies are avail-
systems. able from the National Academy Press,
(b) The ingredient meets the speci- 2101 Constitution Ave. NW., Wash-
fications of the Food Chemicals Codex, ington, DC 20418, or available for in-
3d Ed. (1981), p. 324, which is incor- spection at the National Archives and
porated by reference. Copies are avail- Records Administration (NARA). For
able from the National Academy Press, information on the availability of this
2101 Constitution Ave. NW., Wash- material at NARA, call 202–741–6030, or
ington, DC 20418, or available for in- go to: http://www.archives.gov/
spection at the National Archives and federallregister/
material at NARA, call 202–741–6030, or (c) In accordance with § 184.1(b)(1),
go to: http://www.archives.gov/ the ingredient is used in food with no
federallregister/ limitation other than current good
codeloflfederallregulations/ manufacturing practice. The affirma-
ibrllocations.html. tion of this ingredient as generally rec-
(c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct
the ingredient is used in food with no human food ingredient is based upon
limitation other than current good the following current good manufac-
manufacturing practice. The affirma- turing practice conditions of use:
tion of this ingredient as generally rec- (1) The ingredient is used as a nutri-
ognized as safe (GRAS) as a direct ent supplement as defined in
human food ingredient is based upon § 170.3(o)(20) of this chapter.
577
§ 184.1890 21 CFR Ch. I (4–1–15 Edition)
(2) The ingredient is used in food at (2) The ingredients are used in pump-
levels not to exceed current good man- cured bacon at levels not to exceed cur-
ufacturing practice. Thiamine mono- rent good manufacturing practice.
nitrate may be used in infant formula
[49 FR 13348, Apr. 4, 1984]
in accordance with section 412(g) of the
Federal Food, Drug, and Cosmetic Act § 184.1901 Triacetin.
(the Act) or with regulations promul-
gated under section 412(a)(2) of the Act. (a) Triacetin (C8 H14O6, CAS Reg. No.
(d) Prior sanctions for this ingredient 102–76–1), also known as 1,2,3,-
different from the uses established in propanetriol triacetate or glyceryl
this section do not exist or have been triacetate, is the triester of glycerin
waived. and acetic acid. Triacetin can be pre-
pared by heating glycerin with acetic
[48 FR 55124, Dec. 9, 1983] anhydride alone or in the presence of
finely divided potassium hydrogen sul-
§ 184.1890 α-Tocopherols. fate. It can also be prepared by the re-
(a) The a-tocopherols that are the action of oxygen with a liquid-phase
subject of this GRAS affirmation regu- mixture of allyl acetate and acetic acid
lation are limited to the following: using a bromide salt as a catalyst.
(1) d-a-Tocopherol (CAS Reg. No. 59– (b) The ingredient meets the speci-
02–9) is the chemical [2R,4′R,8prime;R]- fications of the Food Chemicals Codex,
2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyl- 3d Ed. (1981), pp. 337–338, as revised by
tridecyl)-6-chromanol. It occurs com- the First Supplement to the 3d Ed.,
mercially as a concentrate and is a red, which is incorporated by reference in
nearly odorless, viscous oil. It is ob- accordance with 5 U.S.C. 552(a). Copies
tained by vacuum steam distillation of are available from the National Acad-
edible vegetable oil products. emy Press, 2102 Constitution Ave., NW.,
(2) dl-a-Tocopherol (CAS Reg. No. Washington, DC 20418, or available for
10191–41–0) is a mixture of inspection at the National Archives
stereoisomers of 2,5,7,8-tetramethyl-2- and Records Administration (NARA).
(4′,8′,12′-trimethyl-tridecyl)-6- For information on the availability of
chromanol. It is chemically syn- this material at NARA, call 202–741–
thesized by condensing racemic 6030, or go to: http://www.archives.gov/
isophytol with trimethyl hydro- federallregister/
quinone. It is a pale yellow viscous oil codeloflfederallregulations/
at room temperature. ibrllocations.html.
(b) The ingredients meet the speci- (c) In accordance with § 184.1(b)(1),
fications of the Food Chemicals Codex, the ingredient is used in food with no
3d Ed. (1981), pp. 330–331, which is incor- limitation other than current good
porated by reference. Copies are avail- manufacturing practice. The affirma-
able from the National Academy Press, tion of this ingredient as generally rec-
2101 Constitution Ave. NW., Wash- ognized as safe (GRAS) as a direct
ington, DC 20418, or available for in- human food ingredient is based upon
spection at the National Archives and the following current good manufac-
Records Administration (NARA). For turing practice conditions of use:
information on the availability of this (1) The ingredient is used in food as a
material at NARA, call 202–741–6030, or flavoring agent and adjuvant as defined
go to: http://www.archives.gov/ in § 170.3(o)(12) of this chapter; a formu-
federallregister/ lation aid as defined in § 170.3(o)(14) of
codeloflfederallregulations/ this chapter; and humectant as defined
ibrllocations.html. in § 170.3(o)(16) of this chapter; and a
(c) In accordance with § 184.1(b)(3), solvent and vehicle as defined in
the affirmation of the ingredients as § 170.3(o)(27) of this chapter.
generally recognized as safe is limited (2) The ingredient is used in the fol-
to the following conditions of use while lowing foods at levels not to exceed
the agency concludes the general eval- current good manufacturing practice:
uation of all food uses of tocopherols: baked goods and baking mixes as de-
(1) The ingredients are used as inhibi- fined in § 170.3(n)(1) of this chapter, al-
tors of nitrosamine formation. coholic beverages as defined in
578
§ 170.3(n)(2) of this chapter; non- this chapter; alcoholic beverages as de-

alcoholic beverages and beverage bases fined in § 170.3(n)(2) of this chapter;
as defined in § 170.3(n)(3) of this chap- nonalcoholic beverages as defined in
ter; chewing gum as defined in § 170.3(n)(3) of this chapter; fats and oils
§ 170.3(n)(6) of this chapter; confections as defined in § 170.3(n)(12) of this chap-
and frostings as defined in § 170.3(n)(9) ter; frozen dairy desserts and mixes as
of this chapter; frozen dairy dessert defined in § 170.3(n)(20) of this chapter;
and mixes as defined in § 170.3(n)(20) of gelatins, puddings and fillngs as de-
this chapter; gelatins, puddings, and fined in § 170.3(n)(22) of this chapter;
fillngs as defined in § 170.3(n)(22) of this and soft candy as defined in
chapter; hard candy as defined in § 170.3(n)(38) of this chapter.
§ 170.3(n)(25) of this chapter; and soft (d) Prior sanctions for this ingredient
candy as defined in § 170.3(n)(38) of this different from the uses established in
chapter. this section do not exist or have been
(d) Prior sanctions for this ingredient waived.
different from the uses established in [54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13,
this section do not exist or have been 1989]
waived.
[54 FR 7404, Feb. 21, 1989] § 184.1911 Triethyl citrate.
(a) Triethyl citrate (C12H20O7, CAS
§ 184.1903 Tributyrin. Reg. No. 77–93–0) is the triethyl ester of
(a) Tributyrin (C15H26O6, CAS Reg. citric acid. It is prepared by esterifying
No. 60–01–5), also known as butyrin or citric acid with ethyl alcohol and oc-
glyceryl tributyrate, is the triester of curs as an odorless, practically color-
glycerin and butyric acid. It is pre- less, oily liquid.
pared by esterification of glycerin with (b) The ingredient meets the speci-
excess butyric acid. fications of the Food Chemicals Codex,
(b) The ingredient meets the speci- 3d ed. (1981), p. 339, which is incor-
fication of the Food Chemicals Codex, porated by reference in accordance
3d Ed. (1981), p. 416, which is incor- with 5 U.S.C. 552(a) and 1 CFR part 51.
porated by reference in accordance Copies are available from the National
with 5 U.S.C. 552(a). Copies are avail- Academy Press, 2101 Constitution Ave.
able from the National Academy Press, NW., Washington, DC 20418, and the
2101 Constitution Ave. NW., Wash- Center for Food Safety and Applied Nu-
ington, DC 20418, or available for in- trition (HFS–200), 5100 Paint Branch
spection at the National Archives and Pkwy., College Park, MD 20740, or may
Records Administration (NARA). For be examined at the National Archives
information on the availability of this and Records Administration (NARA).
material at NARA, call 202–741–6030, or For information on the availability of
go to: http://www.archives.gov/ this material at NARA, call 202–741–
federallregister/ 6030, or go to: http://www.archives.gov/
codeloflfederallregulations/ federallregister/
ibrllocations.html. codeloflfederallregulations/
(c) In accordance with § 184.1(b)(1), ibrllocations.html.
the ingredient is used in food with no (c) In accordance with § 184.1(b)(1),
limitation other than current good the ingredient is used in food with no
manufacturing practice. The affirma- limitation other than current good
tion of this ingredient as generaly rec- manufacturing practice. The affirma-
ognized as safe (GRAS) as a direct tion of this ingredient as generally rec-
human food ingredient is based upon ognized as safe (GRAS) as a direct
the following current good manufac- human food ingredient is based upon
turing practice conditions of use: the following current good manufac-
(1) The ingredient is used in food as a turing practice conditions of use:
flavoring agent and adjuvant as defined (1) The ingredient is used as a fla-
in § 170.3(o)(12) of this chapter. voring agent as defined in § 170.3(o)(12)
(2) The ingredient is used in the fol- of this chapter; a solvent and vehicle as
lowing foods at levels not to exceed defined in § 170.3(o)(27) of this chapter;

current good manufacturing practice; and a surface-active agent as defined in
baked goods as defined in § 170.3(n)(1) of § 170.3(o)(29) of this chapter.
579
§ 184.1914 21 CFR Ch. I (4–1–15 Edition)
(2) The ingredient is used in foods at § 184.1923 Urea.

(a) Urea (CO(NH2)2, CAS Reg. No. 57–
13–6) is the diamide of carbonic acid
(d) Prior sanctions for this ingredient and is also known as carbamide. It is a
different from the uses established in white, odorless solid and is commonly
this section, or different from those set produced from CO2 by ammonolysis or
forth in part 181 of this chapter, do not from cyanamide by hydrolysis.
exist or have been waived. (b) The ingredient must be of a pu-
[59 FR 63897, Dec. 12, 1994] rity suitable for its intended use.
§ 184.1914 Trypsin. the ingredient is used in food with no
(a) Trypsin (CAS Reg. No. 9002–07–7) limitation other than current good
is an enzyme preparation obtained
from purified extracts of porcine or bo-
ognized as safe as a direct human food
vine pancreas. It is a white to tan
ingredient is based upon the following
amorphous powder. Its characterizing
enzyme activity is that of a peptide hy-
conditions of use:
drolase (EC 3.4.21.4).
(b) The ingredient meets the general lation aid as defined in § 170.3(o)(14) of
requirements and additional require- this chapter and as a fermentation aid.
ments for enzyme preparations in the
(2) The ingredient is used in yeast-
Food Chemicals Codex, 3d ed. (1981), p. raised bakery products; in alcoholic
110, which is incorporated by reference beverages as defined in § 170.3(n)(2) of
in accordance with 5 U.S.C. 552(a) and 1 this chapter; and in gelatin products.
CFR part 51. Copies are available from (d) Prior sanctions for this ingredient
the National Academy Press, 2101 Con- different from the uses established in
stitution Ave. NW., Washington, DC this section do not exist or have been
20418, or may be examined at the Office waived.
of Food Additive Safety (HFS–200),
Center for Food Safety and Applied Nu- [48 FR 51616, Nov. 10, 1983, as amended at 49
trition, Food and Drug Administration, FR 19816, May 10, 1984; 73 FR 8608, Feb. 14,
5100 Paint Branch Pkwy., College Park, 2008]
MD 20740, 240–402–1200, and at the Na- § 184.1924 Urease enzyme preparation
tional Archives and Records Adminis- from Lactobacillus fermentum.
the availability of this material at (a) This enzyme preparation is de-
NARA, call 202–741–6030, or go to: http:// rived from the nonpathogenic,
www.archives.gov/federallregister/ nontoxicogenic bacterium Lactobacillus
codeloflfederallregulations/ fermentum. It contains the enzyme
ibrllocations.html. urease (CAS Reg. No. 9002–13–5), which
(c) In accordance with § 184.1(b)(1), facilitates the hydrolysis of urea to
the ingredient is used in food with no ammonia and carbon dioxide. It is pro-
limitation other than current good duced by a pure culture fermentation
manufacturing practice. The affirma- process and by using materials that are
tion of this ingredient as GRAS as a di- generally recognized as safe (GRAS) or
rect food ingredient is based upon the are food additives that have been ap-
following current good manufacturing proved for this use by the Food and
practice conditions of use: Drug Administration (FDA).
and additional requirements for en-
zyme as defined in § 170.3(o)(9) of this
zyme preparations in the ‘‘Food Chemi-
chapter to hydrolyze proteins or
cals Codex,’’ 3d ed. (1981), pp. 107–110,
polypeptides.
which is incorporated by reference in
(2) The ingredient is used in food at accordance with 5 U.S.C. 552(a) and 1
levels not to exceed current good man- CFR part 51. Copies are available from

[60 FR 32911, June 26, 1995, as amended at 78 stitution Ave. NW., Washington, DC
FR 14667, Mar. 7, 2013] 20418, or available for inspection at the
580
National Archives and Records Admin- www.archives.gov/federallregister/

istration (NARA). For information on codeloflfederallregulations/
the availability of this material at ibrllocations.html.
NARA, call 202–741–6030, or go to: http:// (c) In accordance with § 184.1(b)(1),
www.archives.gov/federallregister/ the ingredient is used in food with no
(c) In accordance with § 184.1(b)(1), tion of this ingredient as generally rec-
the ingredient is used in food with no ognized as safe (GRAS) as a direct
limitation other than current good human food ingredient is based upon
manufacturing practice. The affirma- the following current good manufac-
tion of this ingredient as GRAS as a di- turing practice conditions of use:
rect human food ingredient is based (1) The ingredient is used in food as a
upon the following current good manu- nutrient supplement as defined in
facturing practice conditions of use: § 170.3(o)(20) of this chapter.
(1) The ingredient is used in wine, as (2) The ingredient is used in foods at
defined in 27 CFR 2.5 and 4.10, as an en- levels not to exceed current good man-
zyme as defined in § 170.3(o)(9) of this ufacturing practice. Vitamin A may be
chapter to convert urea to ammonia used in infant formula in accordance
and carbon dioxide. with section 412(g) of the Federal Food,
(2) The ingredient is used in food at Drug, and Cosmetic Act (the act) or
levels not to exceed current good man- with regulations promulgated under
ufacturing practice. Current good man- section 412(a)(2) of the Act.
ufacturing practice is limited to use of (d) Prior sanctions for this ingredient
this ingredient in wine to inhibit for- different from the uses established in
mation of ethyl carbamate. this section do not exist or have been
[57 FR 60473, Dec. 21, 1992]
waived.
[48 FR 51610, Nov. 10, 1983]
§ 184.1930 Vitamin A.
(a)(1) Vitamin A (retinol; CAS Reg. § 184.1945 Vitamin B 12.
No. 68–26–8) is the alcohol 9,13-di- (a) Vitamin B12, also known as cyano-
methyl-7-(1,1,5-trimethyl-6-cyclohexen- cobalamin (C63H88CoN14O14P, CAS Reg.
5-yl)-7,9,11,13-nonatetraen-15-ol. It may No. 68–0919–099), is produced commer-
be nearly odorless or have a mild fishy cially from cultures of Streptomyces
odor. Vitamin A is extracted from fish griseus.
liver oils or produced by total syn- (b) The ingredient meets the speci-
thesis from b-ionone and a propargyl fications of the Food Chemicals Codex,
halide. 3d Ed. (1981), p. 343, which is incor-
(2) Vitamin A acetate (retinyl ace- porated by reference. Copies are avail-
tate; CAS Reg. No. 127–47–9) is the ace- able from the National Academy Press,
tate ester of retinol. It is prepared by 2101 Constitution Ave. NW., Wash-
esterifying retinol with acetic acid. ington, DC 20418, or available for in-
(3) Vitamin A palmitate (retinyl spection at the National Archives and
palmitate; CAS Reg. No. 79–81–2) is the Records Administration (NARA). For
palmitate ester of retinol. It is pre- information on the availability of this
pared by esterifying retinol with pal- material at NARA, call 202–741–6030, or
mitic acid. go to: http://www.archives.gov/
(b) The ingredient meets the speci- federallregister/
fications for vitamin A in the Food codeloflfederallregulations/
Chemicals Codex, 3d Ed. (1981), p. 342, ibrllocations.html.
which is incorporated by reference. (c) In accordance with § 184.1(b)(1),
Copies are available from the National the ingredient is used in food with no
Academy Press, 2101 Constitution Ave. limitation other than current good
NW., Washington, DC 20418, or avail- manufacturing practice. The affirma-
able for inspection at the National Ar- tion of this ingredient as generally rec-
chives and Records Administration ognized as safe (GRAS) as a direct
(NARA). For information on the avail- human food ingredient is based upon
ability of this material at NARA, call the following current good manufac-
202–741–6030, or go to: http:// turing practice conditions of use:
581
§ 184.1950 21 CFR Ch. I (4–1–15 Edition)
(1) The ingredient is used as a nutri- National Archives and Records Admin-
ent supplement as defined in istration (NARA). For information on
§ 170.3(o)(20) of this chapter. the availability of this material at
(2) The ingredient is used in food at NARA, call 202–741–6030, or go to: http://
levels not to exceed current good man- www.archives.gov/federallregister/
ufacturing practice. Vitamin B12 also codeloflfederallregulationsll
may be used in infant formula in ac- ibrllocations.html. Vitamin D2 resin
cordance with section 412(g) of the Fed- and vitamin D3 resin must be of a pu-
eral Food, Drug, and Cosmetic Act (the rity suitable for their intended use.
act) or with regulations promulgated (c)(1) In accordance with § 184.1(b)(2),
under section 412(a)(2) of the act. the ingredients are used in food as the
(d) Prior sanctions for this ingredient sole source of added vitamin D only
different from the uses established in within the following specific limita-
this section do not exist or have been tions:
waived.
Maximum levels in
Category of food Functional use
[50 FR 6341, Feb. 15, 1985] food (as served)
Breakfast cereals, 350 (IU/100 Nutrient supple-

§ 184.1950 Vitamin D. § 170.3(n)(4) of grams). ment,
(a) Vitamin D is added to food as the this chapter. § 170.3(o)(20) of
this chapter.
following food ingredients: Grain products and 90(IU/100 grams) Do.
(1) Crystalline vitamin D2 (C28H44O, pastas,
CAS Reg. No. 50–14–6), also known as § 170.3(n)(23) of
ergocalciferol, is the chemical 9,10- this chapter.
Milk, § 170.3(n)(30) 42 (IU/100 grams) Do.
seco(5Z,7E,22E)-5,7,10(19),22- of this chapter.
ergostatetraen-3-ol. The ingredient is Milk products, 89 (IU/100 grams) Do.
produced by ultraviolet irradiation of § 170.3(n)(31) of
this chapter.
ergosterol isolated from yeast and re-
lated fungi and is purified by crys-
(2) Vitamin D may be used in infant
tallization.
formula in accordance with section
(2) Crystalline vitamin D3 (C27H44O,
412(g) of the Federal Food, Drug, and
CAS Reg. No. 67–97–0), also known as
cholecalciferol, is the chemical 9,10-
tions promulgated under section
seco(5Z,7E,)-5,7,10(19)-cholestatrien-3-
412(a)(2) of the act.
ol. Vitamin D3 occurs in, and is iso-
(3) Vitamin D may be used in mar-
lated from, fish liver oils. It is also
garine in accordance with § 166.110 of
manufactured by ultraviolet irradia-
this chapter.
tion of 7-dehydrocholesterol produced
(d) Prior sanctions for these ingredi-
from cholesterol. It is purified by crys-
ents different from the uses established
tallization. Vitamin D3 is the vitamin
D form that is produced endogenously
been waived.
in humans through sunlight activation
of 7-dehydrocholesterol in the skin. [50 FR 30152, July 24, 1985, as amended at 73
(3) Vitamin D2 resin and vitamin D3 FR 8608, Feb. 14, 2008]
resin are the concentrated forms of ir-
radiated ergosterol (D2) and irradiated § 184.1973 Beeswax (yellow and white).
7-dehydrocholesterol (D3) that are sepa- (a) Beeswax (CAS Reg. No. 8012–89–3)
rated from the reacting materials in is a secretory product of honey bees
paragraphs (a) (1) and (2) of this sec- used as a structural material in honey-
tion. The resulting products are sold as combs. Beeswax is prepared from hon-
food sources of vitamin D without fur- eycombs after removal of the honey by
ther purification. draining or centrifuging. The combs
(b) Vitamin D2 and vitamin D3 as are melted in hot water or steam or
crystals meet the specifications of the with solar heat, and strained. The wax
Food Chemicals Codex, 3d Ed. (1981), is refined by melting in hot water to
pp. 344 and 345, which is incorporated which sulfuric acid or alkali may be
by reference. Copies are available from added to extract impurities. The re-
the National Academy Press, 2101 Con- sulting wax is referred to as yellow
stitution Ave. NW., Washington, DC beeswax. White beeswax is produced by
20418, or available for inspection at the bleaching the constituent pigments of
582
yellow beeswax with peroxides, or pref- porated by reference. Copies are avail-
erably it is bleached by sun light. able from the National Academy Press,
(b) The ingredient meets the speci- 2101 Constitution Ave. NW., Wash-
fications of the ‘‘Food Chemicals ington, DC 20418, or available for in-
Codex,’’ 3d Ed. (1981), pp. 34–35, which is spection at the National Archives and
incorporated by reference. Copies may Records Administration (NARA). For
be obtained from the National Acad- information on the availability of this
emy Press, 2101 Constitution Ave. NW., material at NARA, call 202–741–6030, or
Washington, DC 20418, or may be exam- go to: http://www.archives.gov/
ined at the National Archives and federallregister/
federallregister/
(c) The ingredient is used as a fla- tion of this ingredient as generally rec-
voring agent and adjuvant as defined in ognized as safe (GRAS) as a direct
§ 170.3(o)(12) of this chapter, as a lubri- human food ingredient is based upon
cant as defined in § 170.3(o)(18) of this the following current good manufac-
chapter, and as a surface-finishing turing practice conditions of use:
agent as defined in § 170.3(o)(30) of this (1) The ingredient is used as a lubri-
chapter. cant as defined in § 170.3(o)(18) of this
(d) The ingredient is used in food, in chapter and as a surface-finishing
accordance with § 184.1(b)(1) of this agent as defined in § 170.3(o)(30) of this
chapter, at levels not to exceed good chapter.
manufacturing practice. Current good (2) The ingredient is used in the fol-
manufacturing practice results in a lowing foods at levels not to exceed
maximum level, as served, of: 0.065 per- current good manufacturing practice:
cent for chewing gum as defined in in chewing gum as defined in
§ 170.3(n)(6) of this chapter; 0.005 per- § 170.3(n)(6) of this chapter and in hard
cent for confections and frostings as candy as defined in § 170.3(n)(25) of this
defined in § 170.3(n)(9) of this chapter; chapter.
0.04 percent for hard candy as defined (d) Prior sanctions for this ingredient
in § 170.3(n)(25) of this chapter; 0.1 per- different from the uses established in
cent for soft candy as defined in this section do not exist or have been
§ 170.3(n)(38) of this chapter; and 0.002 waived.
percent or less for all other food cat-
egories. [48 FR 51617, Nov. 10, 1983]
[43 FR 14644, Apr. 7, 1978, as amended at 49 § 184.1978 Carnauba wax.

FR 5613, Feb. 14, 1984; 50 FR 49536, Dec. 3,
1985] (a) Carnauba wax (CAS Reg. No. 008–
015–869) is obtained from the leaves and
§ 184.1976 Candelilla wax. buds of the Brazilian wax palm
(a) Candelilla wax (CAS Reg. No. Copernicia cerifera Martius. The wax is
8006–44–8) is obtained from the can- hard, brittle, sparingly soluble in cold
delilla plant. It is a hard, yellowish- organic solvents and insoluble in
brown, opaque-to-translucent wax. water. It is marketed in five grades
Candelilla wax is prepared by immers- designated No. 1 through No. 5. Grades
ing the plants in boiling water con- No. 4 and No. 5 represent the bulk of
taining sulfuric acid and skimming off the commercial trade volume. These
the wax that rises to the surface. It is commercial grades consist chiefly of
composed of about 50 percent hydro- C24 to C32 normal saturated
carbons with smaller amounts of esters monofunctional fatty acids and normal
and free acids. saturated monofunctional primary al-
cohols.

fications of the Food Chemicals Codex, (b) The ingredient meets the speci-
3d Ed. (1981), p. 67, which is incor- fications of the Food Chemicals Codex,
583
§ 184.1979 21 CFR Ch. I (4–1–15 Edition)
3d Ed. (1981), p. 73, which is incor- lactic acid, or from the curd formation
porated by reference. Copies are avail- by direct acidification of milk, is
able from the National Academy Press, known as acid whey. Whey obtained
2101 Constitution Ave. NW., Wash- from a procedure in which there is in-
ington, DC 20418, or available for in- significant conversion of lactose to lac-
spection at the National Archives and tic acid is known as sweet whey. Sweet
Records Administration (NARA). For whey has a maximum titratable acid-
information on the availability of this ity of not more than 0.16 percent, cal-
material at NARA, call 202–741–6030, or culated as lactic acid, and an alka-
go to: http://www.archives.gov/ linity of ash of not more than 225 milli-
federallregister/ liters of 0.1N hydrochloric acid per 100
codeloflfederallregulations/ grams. The acidity of whey, sweet or
ibrllocations.html. acid, may be adjusted by the addition
(c) In accordance with § 184.1(b)(1), of safe and suitable pH-adjusting ingre-
the ingredient is used in food with no dients.
limitation other than current good (2) Concentrated whey. Concentrated
manufacturing practice. The affirma- whey is the liquid substance obtained
tion of this ingredient as generally rec- by the partial removal of water from
ognized as safe (GRAS) as a direct whey, while leaving all other constitu-
human food ingredient is based upon ents in the same relative proportions
the following current good manufac- as in whey.
turing practice conditions of use: (3) Dry or dried whey. Dry or dried
(1) The ingredient is used as an whey is the dry substance obtained by
anticaking agent as defined § 170.3(o)(1) the removal of water from whey, while
of this chapter; as a formulation aid as leaving all other constituents in the
defined in § 170.3(o)(14) of this chapter; same relative proportions as in whey.
as a lubricant and release agent as de- (b) The ingredients meet the fol-
fined in § 170.3(o)(18) of this chapter; lowing specifications:
and as a surface-finishing agent as de- (1) The analysis of whey, con-
fined in § 170.3(o)(30) of this chapter. centrated whey, and dry (dried) whey,
(2) The ingredient is used in the fol- on a dry product basis, based on ana-
lowing foods at levels not to exceed lytical methods in the referenced sec-
current good manufacturing practice: tions of ‘‘Official Methods of Analysis
baked goods and baking mixes as de- of the Association of Official Analyt-
fined in § 170.3(n)(1) of this chapter; ical Chemists,’’ 13th ed. (1980), which is
chewing gun as defined in § 170.3(n)(6) of incorporated by reference in accord-
this chapter; confections and frostings ance with 5 U.S.C. 552(a) and 1 CFR
as defined in § 170.3(n)(9) of this chap- part 51, is given in paragraphs (b)(1)(i)
ter; fresh fruits and fruit juices as de-
through (b)(1)(vii) of this section. Cop-
fined in § 170.3(n)(16) of this chapter;
ies may be obtained from the AOAC
gravies and sauces as defined in
INTERNATIONAL, 481 North Frederick
§ 170.3(n)(24) of this chapter; processed
Ave., suite 500, Gaithersburg, MD 20877,
fruits and fruit juices as defined in
§ 170.3(n)(35) of this chapter; and soft
candy as defined in § 170.3(n)(38) of this
Library, Food and Drug Administra-
chapter.
tion, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the National Ar-
chives and Records Administration
waived.
[48 FR 51147, Nov. 7, 1983] 202–741–6030, or go to: http://
§ 184.1979 Whey. codeloflfederallregulations/
(a)(1) Whey. Whey is the liquid sub- ibrllocations.html.
stance obtained by separating the co- (i) Protein content, 10 to 15 percent—
agulum from milk, cream, or skim as determined by the methods pre-
milk in cheesemaking. Whey obtained scribed in section 16.036 (liquid sample),

from a procedure, in which a signifi- entitled ‘‘Total Nitrogen—Official
cant amount of lactose is converted to Final Action’’ under the heading
584
Food and Drug Administration, HHS § 184.1979a
‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or may

sample), entitled ‘‘Kjeldahl Method’’ be examined at the Center for Food
under the heading ‘‘Protein—Official Safety and Applied Nutrition’s Li-
Final Action.’’ brary, Food and Drug Administration,
(ii) Fat content, 0.2 to 2.0 percent—as 5100 Paint Branch Pkwy., College Park,
determined by the methods prescribed MD 20740, or at the National Archives
in section 16.059 (liquid sample), and Records Administration (NARA).
‘‘Reese-Gottlieb Method [Reference For information on the availability of
Method] (11)—Official Final Action’’ this material at NARA, call 202–741–
under the heading ‘‘Fat,’’ or in section 6030, or go to: http://www.archives.gov/
16.199 (dry sample), entitled ‘‘Fat in federallregister/
Dried Milk (45)—Official Final Action.’’ codeloflfederallregulations/
(iii) Ash content, 7 to 14 percent—as ibrllocations.html.
determined by the methods prescribed (3) The whey must be derived from
in section 16.035 (liquid sample), enti- milk that has been pasteurized, or the
tled ‘‘Ash (5)—Official Final Action’’ whey and modified whey product must
under the heading ‘‘Total Solids,’’ or in be subjected to pasteurization tech-
section 16.196 (dry sample), entitled niques or its equivalent before use in
‘‘Ash—Official Final Action’’ under the food.
heading ‘‘Dried Milk, Nonfat Dry Milk, (c) Whey, concentrated whey, and dry
and Malted Milk.’’ (dried) whey may be used in food in ac-
(iv) Lactose content, 61 to 75 per- cordance with good manufacturing
cent—as determined by the methods practice as indicated in § 184.1(b)(1).
prescribed in section 16.057 (liquid sam- (d) The label on the whey form sold
ple), entitled ‘‘Gravimetric Method— to food manufacturers shall read as fol-
Official Final Action’’ under the head- lows:
ing ‘‘Lactose,’’ or in section 31.061 (dry (1) For whey: ‘‘(Sweet or acid) whey’’
sample), entitled ‘‘Lane-Eynon General or ‘‘whey (ll% titratable acidity).
Volumetric Method’’ under the heading (2) For concentrated whey: ‘‘Con-
‘‘Lactose—Chemical Methods—Official centrated (sweet or acid) whey, ll%
Final Action.’’ solids’’ or ‘‘Concentrated whey (ll%
(v) Moisture content, 1 to 8 percent— titratable acidity), ll% solids’’.
as determined by the methods pre- (3) For dry (dried) whey: ‘‘Dry (dried)
scribed in section 16.192, entitled (sweet or acid) whey’’ or ‘‘dry (dried)
‘‘Moisture (41)—Official Final Action’’ whey, (ll% titratable acidity)’’.
under the heading ‘‘Dried Milk, Nonfat (e) Whey, concentrated whey, or dry
Dry Milk, and Malted Milk.’’ (dried) whey in a finished food product
(vi) Solids content, variable—as de- shall be listed as ‘‘whey.’’
termined by the methods prescribed in
section 16.032, entitled ‘‘Method I—Offi- [46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19,
cial Final Action’’ under the heading 1982, as amended at 54 FR 24899, June 12, 1989;
‘‘Total Solids.’’ 64 FR 1760, Jan. 12, 1999]
(vii) Titratable Acidity, variable—as
§ 184.1979a Reduced lactose whey.
determined by the methods prescribed
in section 16.023, entitled ‘‘Acidity (2)— (a) Reduced lactose whey is the sub-
Official Final Action’’ under the head- stance obtained by the removal of lac-
ing ‘‘Milk,’’ or by an equivalent poten- tose from whey. The lactose content of
tiometric method. the finished dry product shall not ex-
(2) Limits of impurities are: Heavy ceed 60 percent. Removal of the lactose
metals (as lead). Not more than 10 is accomplished by physical separation
parts per million (0.001 percent) as de- techniques such as precipitation, filtra-
termined by the method described in tion, or dialysis. As with whey, reduced
the ‘‘Food Chemicals Codex,’’ 4th ed. lactose whey can be used as a fluid,
(1996), pp. 760–761, which is incorporated concentrate, or a dry product form.
by reference in accordance with 5 The acidity of reduced lactose whey
U.S.C. 552(a) and 1 CFR part 51. Copies may be adjusted by the addition of safe
are available from the National Acad- and suitable pH-adjusting ingredients.
emy Press, Box 285, 2101 Constitution (b) The reduced lactose whey meets
Ave. NW., Washington, DC 20055 (Inter- the following specifications:
585
§ 184.1979a 21 CFR Ch. I (4–1–15 Edition)
(1) The analysis of reduced lactose heading ‘‘Lactose—Chemical Meth-

whey, on a dry product basis, based on ods—Official Final Action.’’
analytical methods in the referenced (v) Moisture content, 1 to 6 percent—
sections of ‘‘Official Methods of Anal- as determined by the method pre-
ysis of the Association of Official Ana- scribed in section 16.192, entitled
lytical Chemists,’’ 13th ed. (1980), which ‘‘Moisture (41)—Official Final Action’’
is incorporated by reference in accord- under the heading ‘‘Dried Milk, Nonfat
ance with 5 U.S.C. 552(a) and 1 CFR Dry Milk, and Malted Milk.’’
part 51, is given in paragraphs (b)(1)(i) (vi) Solids content, variable—as de-
through (b)(1)(vii) of this section. Cop- termined by the methods prescribed in
ies may be obtained from the AOAC section 16.032, entitled ‘‘Method I—Offi-
INTERNATIONAL, 481 North Frederick cial Final Action’’ under the heading
Ave., suite 500, Gaithersburg, MD 20877, ‘‘Total Solids.’’
or may be examined at the Center for (vii) Titratable Acidity, variable—as
Food Safety and Applied Nutrition’s determined by the methods prescribed
Library, Food and Drug Administra- in section 16.023, entitled ‘‘Acidity (2)—
tion, 5100 Paint Branch Pkwy., College Official Final Action’’ under the head-
Park, MD 20740, or at the National Ar- ing ‘‘Milk,’’ or by an equivalent poten-
chives and Records Administration tiometric method.
(NARA). For information on the avail- (2) Limits of impurities are: Heavy
ability of this material at NARA, call metals (as lead). Not more than 10
202–741–6030, or go to: http:// parts per million (0.001 percent), as de-
www.archives.gov/federallregister/ termined by the method described in
codeloflfederallregulations/ the ‘‘Food Chemicals Codex,’’ 4th ed.
ibrllocations.html. (1996), pp. 760–761, which is incorporated
(i) Protein content, 16 to 24 percent— by reference in accordance with 5
as determined by the methods pre- U.S.C. 552(a) and 1 CFR part 51. Copies
scribed in section 16.036 (liquid sample), are available from the National Acad-
entitled ‘‘Total Nitrogen—Official emy Press, Box 285, 2101 Constitution
Final Action’’ under the heading Ave. NW., Washington, DC 20055 (Inter-
‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or may
sample), entitled ‘‘Kjeldahl Method’’ be examined at the Center for Food
under the heading ‘‘Protein—Official Safety and Applied Nutrition’s Li-
Final Action.’’ brary, Food and Drug Administration,
(ii) Fat content, 1 to 4 percent—as de- 5100 Paint Branch Pkwy., College Park,
termined by the methods prescribed in MD 20740, or at the National Archives
section 16.059 (liquid sample), ‘‘Reese- and Records Administration (NARA).
Gottlieb Method [Reference Method] For information on the availability of
(11)—Official Final Action’’ under the this material at NARA, call 202–741–
heading ‘‘Fat,’’ or in section 16.199 (dry 6030, or go to: http://www.archives.gov/
sample), entitled ‘‘Fat in Dried Milk federallregister/
(45)—Official Final Action.’’ codeloflfederallregulations/
(iii) Ash content, 11 to 27 percent—as ibrllocations.html.
determined by the methods prescribed (3) The reduced lactose whey shall be
in section 16.035 (liquid sample), enti- derived from milk that has been pas-
tled ‘‘Ash (5)—Official Final Action’’ teurized, or the reduced lactose whey
under the heading ‘‘Total Solids,’’ or in shall be subjected to pasteurization
section 16.196 (dry sample), entitled techniques or its equivalent before use
‘‘Ash—Official Final Action’’ under the in food.
heading ‘‘Dried Milk, Nonfat Dry Milk, (c) Reduced lactose whey may be
and Malted Milk.’’ used in food in accordance with good
(iv) Lactose content, not more than manufacturing practice as indicated in
60 percent—as determined by the meth- § 184.1(b)(1).
ods prescribed in section 16.057 (liquid (d) The percent of lactose present on
sample), entitled ‘‘Gravimetric Meth- a dry product basis, i.e., ‘‘reduced lac-
od—Official Final Action’’ under the tose whey (ll% lactose),’’ shall be de-
heading ‘‘Lactose,’’ or in section 31.061 clared on the label of the package sold
(dry sample), entitled ‘‘Lane-Eynon to food manufacturers. The percent of
General Volumetric Method’’ under the lactose may be declared in 5-percent
586
Food and Drug Administration, HHS § 184.1979b
increments, expressed as a multiple of entitled ‘‘Total Nitrogen—Official

5, not greater than the actual percent- Final Action’’ under the heading
age of lactose in the product, or as an ‘‘Total Solids,’’ or in section 16.193 (dry
actual percentage provided that an sample), entitled ‘‘Kjeldahl Method’’
analysis of the product on which the under the heading ‘‘Protein—Official
actual percentage is based is supplied Final Action.’’
to the food manufacturer. (ii) Fat content, 1 to 4 percent—as de-
(e) The presence of reduced lactose termined by the methods prescribed in
whey in a finished food product shall be section 16.059 (liquid sample), ‘‘Reese-
listed as ‘‘reduced lactose whey.’’ Gottlieb Method [Reference Method]
[46 FR 44440, Sept. 4, 1981, as amended at 54 (11)—Official Final Action’’ under the
FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, heading ‘‘Fat,’’ or in section 16.199 (dry
1999] sample), entitled ‘‘Fat in Dried Milk
(45)—Official Final Action.’’
§ 184.1979b Reduced minerals whey.
(iii) Ash content, maximum 7 per-
(a) Reduced minerals whey is the sub- cent—as determined by the methods
stance obtained by the removal of a prescribed in section 16.035 (liquid sam-
portion of the minerals from whey. The ple), entitled ‘‘Ash (5)—Official Final
dry product shall not contain more Action’’ under the heading ‘‘Total Sol-
than 7 percent ash. Reduced minerals ids,’’ or in section 16.196 (dry sample),
whey is produced by physical separa- entitled ‘‘Ash—Official Final Action’’
tion techniques such as precipitation, under the heading ‘‘Dried Milk, Nonfat
filtration, or dialysis. As with whey, Dry Milk, and Malted Milk.’’
reduced minerals whey can be used as a (iv) Lactose content, maximum 85
fluid, concentrate, or a dry product percent—as determined by the methods
form. The acidity of reduced minerals prescribed in section 16.057 (liquid sam-
whey may be adjusted by the addi-
ple), entitled ‘‘Gravimetric Method—
tional of safe and suitable pH-adjusting
Official Final Action’’ under the head-
ingredients.
ing ‘‘Lactose,’’ or in section 31.061 (dry
(b) The reduced minerals whey meets
sample), entitled ‘‘Lane-Eynon General
the following specifications:
Volumetric Method’’ under the heading
(1) The analysis of reduced minerals
‘‘Lactose—Chemical Methods—Official
whey, on a dry product basis, based on
analytical methods in the referenced Final Action.’’
sections of ‘‘Official Methods of Anal- (v) Moisture content, 1 to 6 percent—
ysis of the Association of Official Ana- as determined by the methods pre-
lytical Chemists,’’ 13th ed. (1980), which scribed in section 16.192, entitled
is incorporated by reference in accord- ‘‘Moisture (41)—Official Final Action’’
ance with 5 U.S.C. 552(a) and 1 CFR under the heading ‘‘Dried Milk, Nonfat
part 51, is given in paragraphs (b)(1)(i) Dry Milk, and Malted Milk.’’
through (b)(1)(vii) of this section. Cop- (vi) Solids content, variable—as de-
ies may be obtained from the AOAC termined by the methods prescribed in
INTERNATIONAL, 481 North Frederick section 16.032, entitled ‘‘Method I—Offi-
Ave., suite 500, Gaithersburg, MD 20877, cial Final Action’’ under the heading
or may be examined at the Center for ‘‘Total Solid.’’
Food Safety and Applied Nutrition’s (vii) Titratable Acidity, variable—as
Library, Food and Drug Administra- determined by the methods prescribed
tion, 5100 Paint Branch Pkwy., College in section 16.023, entitled ‘‘Acidity (2)—
Park, MD 20740, or at the National Ar- Official Final Action’’ under the head-
chives and Records Administration ing ‘‘Milk,’’ or by an equivalent poten-
(NARA). For information on the avail- tiometric method.
ability of this material at NARA, call (2) Limits of impurities are: Heavy
202–741–6030, or go to: http:// metals (as lead). Not more than 10
www.archives.gov/federallregister/ parts per million (0.001 percent), as de-
codeloflfederallregulations/ termined by the method described in
ibrllocations.html. the ‘‘Food Chemicals Codex,’’ 4th ed.
(i) Protein content, 10 to 24 percent— (1996), pp. 760–761, which is incorporated

as determined by the methods pre- by reference in accordance with 5
scribed in section 16.036 (liquid sample), U.S.C. 552(a) and 1 CFR part 51. Copies
587
§ 184.1979c 21 CFR Ch. I (4–1–15 Edition)
are available from the National Acad- may be adjusted by the addition of safe
emy Press, Box 285, 2101 Constitution and suitable pH-adjusting ingredients.
Ave. NW., Washington, DC 20055 (Inter- (b) The whey protein concentrate
net address http://www.nap.edu), or may meets the following specifications:
be examined at the Center for Food (1) The analysis of whey protein con-
Safety and Applied Nutrition’s Li- centrate, on a dry product basis, based
brary, Food and Drug Administration, on analytical methods in the ref-
5100 Paint Branch Pkwy., College Park, erenced sections of ‘‘Official Methods
MD 20740, or at the National Archives of Analysis of the Association of Offi-
and Records Administration (NARA). cial Analytical Chemists,’’ 13th ed.
For information on the availability of (1980), which is incorporated by ref-
this material at NARA, call 202–741– erence in accordance with 5 U.S.C.
6030, or go to: http://www.archives.gov/ 552(a) and 1 CFR part 51, is given in
federallregister/ paragraphs (b)(1)(i) through (b)(1)(vii)
of this section. Copies may be obtained
ibrllocations.html.
from the AOAC INTERNATIONAL, 481
(3) The reduced minerals whey shall
North Frederick Ave., suite 500, Gai-
be derived from milk that has been pas-
thersburg, MD 20877, or may be exam-
teurized, or the reduced minerals whey
ined at the Center for Food Safety and
shall be subjected to pasteurization
techniques or its equivalent before use Applied Nutrition’s Library, Food and
in food. Drug Administration, 5100 Paint
(c) The reduced minerals whey may Branch Pkwy., College Park, MD 20740,
be used in food in accordance with good or at the National Archives and
manufacturing practice as indicated in Records Administration (NARA). For
§ 184.1(b)(1). information on the availability of this
(d) The percent of minerals present material at NARA, call 202–741–6030, or
on a dry product basis, i.e., ‘‘reduced go to: http://www.archives.gov/
minerals whey (ll% minerals),’’ shall federallregister/
be declared on the label of the package codeloflfederallregulations/
sold to food manufacturers. The per- ibrllocations.html.
cent of minerals may be declared in 2- (i) Protein content, minimum 25 per-
percent increments expressed as a mul- cent—as determined by the methods
tiple of 2, not greater than the actual prescribed in section 16.036 (liquid sam-
percentage of minerals in the product, ple), entitled ‘‘Total Nitrogen—Offi-
or as an actual percentage provided cials Final Action’’ under the heading
that an analysis of the product on ‘‘Total Solids,’’ or in section 16.193 (dry
which the actual percentage is based is sample), entitled ‘‘Kjeldahl Method’’
supplied to the food manufacturer. under the heading ‘‘Protein—Official
(e) The presence of reduced minerals Final Action.’’
whey in a finished food product shall be (ii) Fat content, 1 to 10 percent—as
listed as ‘‘reduced minerals whey’’. determined by the methods prescribed
[46 FR 44441, Sept. 4, 1981, as amended at 54 in section 16.059 (liquid sample),
FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, ‘‘Reese-Gottlieb Method [Reference
1999] Method] (11)—Official Final Action’’
under the heading ‘‘Fat,’’ or in section
§ 184.1979c Whey protein concentrate. 16.199 (dry sample), entitled ‘‘Fat in
(a) Whey protein concentrate is the Dried Milk (45)—Official Final Action.’’
substance obtained by the removal of (iii) Ash content, 2 to 15 percent—as
sufficient nonprotein constituents from determined by the methods prescribed
whey so that the finished dry product in section 16.035 (liquid sample), enti-
contains not less than 25 percent pro- tled ‘‘Ash (5)—Official Final Action’’
tein. Whey protein concentrate is pro- under the heading ‘‘Total Solids,’’ or in
duced by physical separation tech- section 16.196 (dry sample), entitled
niques such as precipitation, filtration, ‘‘Ash—Official Final Action’’ under the
or dialysis. As with whey, whey protein heading ‘‘Dried Milk, Nonfat Dry Milk,
concentrate can be used as a fluid, con- and Malted Milk.’’

centrate, or dry product form. The (iv) Lactose content, maximum 60
acidity of whey protein concentrate percent—as determined by the methods
588
prescribed in section 16.057 (liquid sam- (d) The percent of protein present on
ple), entitled ‘‘Gravimetric Method— a dry product basis, i.e., ‘‘whey protein
Official Final Action’’ under the head- concentrate (ll% protein),’’ shall be
ing ‘‘Lactose,’’ or in section 31.061 (dry declared on the label of the package
sample), entitled ‘‘Lane-Eynon General sold to food manufacturers. The per-
Volumetric Method’’ under the heading cent of protein may be declared in 5-
‘‘Lactose—Chemical Methods—Official percent increments, expressed as a
Final Action.’’ multiple of 5, not greater than the ac-
(v) Moisture content, 1 to 6 percent— tual percentage of protein in the prod-
as determined by the methods pre- uct, or as an actual percentage pro-
scribed in section 16.192, entitled vided that an analysis of the product
‘‘Moisture (41)—Official Final Action’’
on which the actual percentage is
under the heading ‘‘Dried Milk, Nonfat
based is supplied to the food manufac-
Dry Milk, and Malted Milk.’’
(vi) Solids content, variable—as de- turer.
termined by the methods prescribed in (e) The presence of whey protein con-
section 16.032, entitled ‘‘Method I—Offi- centrate in a finished food product
cial Final Action’’ under the heading shall be listed as ‘‘whey protein con-
‘‘Total Solids.’’ centrate’’.
(vii) Titratable Acidity, variable—as [46 FR 44441, Sept. 4, 1981, as amended at 54
determined by the methods prescribed FR 24899, June 12, 1989; 64 FR 1761, Jan. 12,
in section 16.023, entitled ‘‘Acidity (2)— 1999]
Official Final Action’’ under the head-
ing ‘‘Milk,’’ or by an equivalent poten- § 184.1983 Bakers yeast extract.
tiometric method.
(a) Bakers yeast extract is the food
(2) Limits of impurities are: Heavy
ingredient resulting from concentra-
metals (as lead). Not more than 10
parts per million (0.001 percent), as de- tion of the solubles of mechanically
termined by the method described in ruptured cells of a selected strain of
the ‘‘Food Chemicals Codex,’’ 4th ed. yeast, Saccharomyces cerevisiae. It may
(1996), pp. 760–761, which is incorporated be concentrated or dried.
by reference in accordance with 5 (b) The ingredient meets the fol-
U.S.C. 552(a) and 1 CFR part 51. Copies lowing specifications on a dry weight
are available from the National Acad- basis: Less than 0.4 part per million
emy Press, Box 285, 2101 Constitution (ppm) arsenic, 0.13 ppm cadmium, 0.2
Ave. NW., Washington, DC 20055 (Inter- ppm lead, 0.05 ppm mercury, 0.09 ppm
net address http://www.nap.edu), or may selenium, and 10 ppm zinc.
be examined at the Center for Food (c) The viable microbial content of
Safety and Applied Nutrition’s Li- the finished ingredient as a con-
brary, Food and Drug Administration, centrate or dry material is:
5100 Paint Branch Pkwy., College Park, (1) Less than 10,000 organisms/gram
MD 20740, or at the National Archives by aerobic plate count.
and Records Administration (NARA). (2) Less than 10 yeasts and molds/
For information on the availability of gram.
(3) Negative for Salmonella, E. coli,
coagulase positive Staphylococci, Clos-
federallregister/
tridium perfringens, Clostridium botu-
ibrllocations.html. linum, or any other recognized micro-
(3) The whey protein concentrate bial pathogen or any harmful microbial
shall be derived from milk that has toxin.
been pasteurized, or the whey protein (d) The ingredient is used as a fla-
concentrate shall be subjected to pas- voring agent and adjuvant as defined in
teurization techniques or its equiva- § 170.3(o)(12) of this chapter at a level
lent before use in food. not to exceed 5 percent in food.
(c) The whey protein concentrate (e) This regulation is issued prior to
may be used in food in accordance with general evaluation of use of this ingre-
good manufacturing practice as indi- dient in order to affirm as GRAS the
cated in § 184.1(b)(1). specific use named.
589
§ 184.1984 21 CFR Ch. I (4–1–15 Edition)
§ 184.1984 Zein. Branch Pkwy., College Park, MD 20740,

(a) Zein (CAS Reg. No. 9010–66–6) is 240–402–1200, or at the National Ar-
one of the components of corn gluten. chives and Records Administration
It is produced commercially by extrac- (NARA). For information on the avail-
tion from corn gluten with alkaline ability of this material at NARA, call
aqueous isopropyl alcohol containing 202–741–6030, or go to: http://
sodium hydroxide. The extract is then www.archives.gov/federallregister/
cooled, which causes the zein to pre- codeloflfederallregulations/
cipitate. ibrllocations.html.
(b) The ingredient must be of a pu- (c) In accordance with § 184.1(b)(1),
rity suitable for its intended use. the ingredient is used in food with no
(c) In accordance with § 184.1(b)(1), limitations other than current good
limitation other than current good tion of this ingredient as generally rec-
manufacturing practice. The affirma- ognized as safe as a direct human food
tion of this ingredient as generally rec- ingredient is based upon the following
ognized as safe (GRAS) as a direct current good manufacturing practice
human food ingredient is based upon conditions of use:
the following current good manufac- (1) The ingredient is used as an en-
turing practice conditions of use: zyme, as defined in § 170.3(o)(9) of this
(1) The ingredient is used as a sur- chapter, as an optional ingredient for
face-finishing agent as defined in flavor development in the manufacture
§ 170.3(o)(30) of this chapter. of cheddar cheese, in accordance with
(2) The ingredient is used in food at § 133.113 of this chapter, and in the
levels not to exceed current good man- preparation of protein hydrolysates.
ufacturing practice. (2) The ingredient is used at levels
(d) Prior sanctions for this ingredient not to exceed current good manufac-
different from the uses established in turing practice.
[60 FR 54193, Oct. 20, 1995, as amended at 78
waived. FR 14667, Mar. 7, 2013]
[50 FR 8999, Mar. 6, 1985, as amended at 73 FR
8608, Feb. 14, 2008] PART 186—INDIRECT FOOD SUB-
§ 184.1985 Aminopeptidase enzyme STANCES AFFIRMED AS GEN-
preparation derived from ERALLY RECOGNIZED AS SAFE
lactococcus lactis.
(a) Aminopeptidase enzyme prepara- Subpart A—General Provisions
tion is derived from the nonpathogenic Sec.
and nontoxicogenic bacterium 186.1 Substances added indirectly to human
Lactococcus lactis (previously named food affirmed as generally recognized as
Streptococcus lactis). The preparation safe (GRAS).
contains the enzyme aminopeptidase
(CAS Reg. No. 9031–94–1; EC 3.4.11.1) and Subpart B—Listing of Specific Substances
other peptidases that hydrolyze milk Affirmed as GRAS
proteins. The preparation is produced 186.1093 Sulfamic acid.
by pure culture fermentation. 186.1256 Clay (kaolin).
(b) The ingredient meets the speci- 186.1275 Dextrans.
fications for enzyme preparations in 186.1300 Ferric oxide.
the Food Chemicals Codex, 3d ed. (1981), 186.1316 Formic acid.
pp. 107–110, which are incorporated by 186.1374 Iron oxides.
reference in accordance with 5 U.S.C. 186.1551 Hydrogenated fish oil.
552(a) and 1 CFR part 51. Copies are 186.1555 Japan wax.
available from the National Academy 186.1557 Tall oil.
186.1673 Pulp.
186.1750 Sodium chlorite.
Washington, DC 20418, or may be exam- 186.1756 Sodium formate.
ined at the Office of Food Additive 186.1770 Sodium oleate.
Safety (HFS–200), Center for Food Safe- 186.1771 Sodium palmitate.

ty and Applied Nutrition, Food and 186.1797 Sodium sulfate.
Drug Administration, 5100 Paint 186.1839 Sorbose.
590
AUTHORITY: 21 U.S.C. 321, 342, 348, 371. turing practice conditions of use in the
SOURCE: 42 FR 14658, Mar. 15, 1977, unless regulation that affirms the GRAS sta-
otherwise noted. tus of the indirect ingredient. For ex-
ample, when the safety of an ingredient
Subpart A—General Provisions has been evaluated on the basis of lim-
ited conditions of use, the agency will
§ 186.1 Substances added indirectly to describe in the regulation that affirms
human food affirmed as generally the GRAS status of the indirect ingre-
recognized as safe (GRAS). dient, one or more of these limited con-
(a) The indirect human food ingredi- ditions of use, which may include the
ents listed in this part have been re- category of food-contact surface(s),
viewed by the Food and Drug Adminis- technical effect(s) or functional use(s)
tration and determined to be generally of the indirect ingredient, and the
recognized as safe (GRAS) for the pur- level(s) of use. If the ingredient is used
poses and under the conditions pre- under conditions that are significantly
scribed, providing they comply with different from those described in the
the purity specifications listed in this regulation, such use of a substance
part or, in the absence of purity speci- may not be GRAS. In such a case, a
fications, are of a purity suitable for manufacturer may not rely on the reg-
their intended use in accordance with ulation as authorizing that use but
§ 170.30(h)(1) of this chapter. Certain in- shall independently establish that the
gredients in this part may also be used use is GRAS or shall use the ingredient
in food-contact surfaces in accordance in accordance with a food additive reg-
with parts 174, 175, 176, 177, 178 or ulation. Persons seeking FDA approval
§ 179.45 of this chapter. Ingredients af- of an independent determination that a
firmed as GRAS for direct use in part use of an ingredient is GRAS may sub-
184 of this chapter are also GRAS as in- mit a GRAS petition in accordance
direct human food ingredients in ac- with § 170.35 of this chapter.
cordance with § 184.1(a) of this chapter. (2) If the ingredient is affirmed as
(b) The regulations in this part do GRAS with specific limitation(s), it
not authorize direct addition of any shall be used in food-contact surfaces
food ingredient to a food. They author- only within such limitation(s), includ-
ize only the use of these ingredients as ing the category of food-contact sur-
indirect ingredients of food, through face(s), the functional use(s) of the in-
migration from their immediate wrap- gredient, and the level(s) of use. Any
per, container, or other food-contact use of such an ingredient not in full
surface. Any ingredient affirmed as
compliance with each such established
GRAS in this part shall be used in ac-
limitation shall require a food additive
cordance with current good manufac-
regulation.
turing practice. For the purpose of this
part, current good manufacturing prac- (3) If the ingredient is affirmed as
tice includes the requirements that an GRAS for a specific use, prior to gen-
indirect human food ingredient be of a eral evaluation of use of the ingredient,
purity suitable for its intended use, other uses may also be GRAS.
and that it be used at a level no higher (c) The listing of a food ingredient in
than reasonably required to achieve its this part does not authorize the use of
intended technical effect in the food- such substance for the purpose of add-
contact article. ing the ingredient to the food through
(1) If the ingredient is affirmed as extraction from the food-contact sur-
GRAS with no limitations on its condi- face.
tions of use other than current good (d) The listing of a food ingredient in
manufacturing practice, it shall be re- this part does not authorize the use of
garded as GRAS if its conditions of use such substance in a manner that may
are consistent with the requirements of lead to deception to the consumer or to
paragraphs (b), (c), and (d) of this sec- any other violation of the Federal
tion. When the Food and Drug Admin- Food, Drug, and Cosmetic Act (the
istration (FDA) determines that it is Act).

appropriate, the agency will describe (e) If the Commissioner of Food and
one or more current good manufac- Drugs is aware of any prior sanction
591
§ 186.1093 21 CFR Ch. I (4–1–15 Edition)
for use of an ingredient under condi- § 186.1256 Clay (kaolin).

tions different from those proposed to
(a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas
be affirmed as GRAS, he will concur-
rently propose a separate regulation Reg. No. 1332–58–7) consists of hydrated
covering such use of the ingredient aluminum silicate. The commercial
under part 181 of this chapter. If the products of clay (kaolin) contain vary-
Commissioner is unaware of any such ing quantities of alkalies and alkaline
applicable prior sanction, the proposed earths. Clay (kaolin) is a white to yel-
regulation will so state and will re- lowish or grayish fine powder. There
quire any person who intends to assert are at least three different minerals,
or rely on such sanction to submit kaolinite, dickite, and nacrite, classi-
proof of its existence. Any regulation fied as kaolin. Kaolinite or china clay
promulgated pursuant to this section is whiter, less contaminated with ex-
constitutes a determination that extraneous minerals, and less plastic in
cluded uses would result in adultera- water.
tion of the food in violation of section (b) In accordance with § 186.1(b)(1),
402 of the Act, and the failure of any the ingredient is used as an indirect
person to come forward with proof of human food ingredient with no limita-
such an applicable prior sanction in re- tion other than current good manufac-
sponse to the proposal will constitute a turing practice. The affirmation of this
waiver of the right to assert or rely on ingredient as generally recognized as
such sanction at any later time. The safe (GRAS) as an indirect human food
notice will also constitute a proposal ingredient is based upon the following
to establish a regulation under part 181 current good manufacturing practice
of this chapter, incorporating the same conditions of use:
provisions, in the event that such a (1) The ingredient is used in the man-
regulation is determined to be appro- ufacture of paper and paperboard that
priate as a result of submission of proof contact food.
of such an applicable prior sanction in (2) The ingredient is used at levels
response to the proposal.
[42 FR 14658, Mar. 15, 1977, as amended at 48 turing practice.
FR 48457, 48459, Oct. 19, 1983] (c) Prior sanctions for this ingredient
Subpart B—Listing of Specific this regulation do not exist or have
Substances Affirmed as GRAS been waived.
§ 186.1093 Sulfamic acid. [47 FR 43367, Oct. 1, 1982]
(a) Sulfamic acid (H3NO3S, CAS Reg. § 186.1275 Dextrans.
No. 5329–14–6) is a white crystalline
solid manufactured from urea, sulfur (a) Dextrans (CAS Reg. No. 9004–54–0)
trioxide, and sulfuric acid. It is soluble are high molecular weight
and highly ionized in water. polysaccharides produced by bacterial
(b) In accordance with § 186.1(b)(1), fermentation of sucrose. Commercially
the ingredient is used as an indirect available dextrans are synthesized
food ingredient with no limitations from sucrose by Leuconostoc
other than current good manufacturing mesenteroides strain NRRL B–512(F).
practice. The affirmation of this ingre- Partial depolymerization and purifi-
dient as generally recognized as safe cation of the fermented mixture shall
(GRAS) as an indirect human food in- produce a product that is free of viable
gredient is based upon the current good microorganisms.
manufacturing practice of using this (b) The ingredient is used or intended
ingredient in the manufacture of paper for use as a constituent of food-contact
and paperboard that contact food. surfaces.
(c) Prior sanctions for this ingredient (c) The ingredient is used at levels
different from the uses established in not to exceed good manufacturing
this section do not exist or have been practice.
waived. (d) Prior sanctions for this ingredient

[47 FR 29954, July 9, 1982] different from the uses established in
592
this section do not exist or have been § 186.1374 Iron oxides.

waived.
(a) Iron oxides (oxides of iron, CAS
[43 FR 29288, July 7, 1978, as amended at 48 Reg. No. 1332–37–2) are undefined mix-
FR 48457, Oct. 19, 1983] tures of iron (II) oxide (CAS Reg. No.
1345–25–1, black cubic crystals) and iron
§ 186.1300 Ferric oxide. (III) oxide (CAS Reg. No. 1309–37–1, red-
(a) Ferric oxide (iron (III) oxide, brown to black trigonal crystals).
Fe2O3, CAS Reg. No. 1309–37–1) occurs (b) In accordance with § 186.1(b)(1),
naturally as the mineral hematite. It the ingredient is used as an indirect
may be prepared synthetically by heat- human food ingredient with no limita-
ing brown iron hydroxide oxide. The tion other than current good manufac-
product is red-brown to black trigonal turing practice. The affirmation of this
crystals. ingredient as generally recognized as
(b) In accordance with § 186.1(b)(1), safe (GRAS) as an indirect human food
the ingredient is used as an indirect ingredient is based upon the following
human food ingredient with no limita- current good manufacturing practice
tion other than current good manufac- conditions of use:
turing practice. The affirmation of this (1) The ingredient is used as a con-
ingredient as generally recognized as stituent of paper and paperboard used
safe (GRAS) as an indirect human food for food packaging.
ingredient is based upon the following (2) The ingredient is used at levels
current good manufacturing practice not to exceed current good manufac-
conditions of use: turing practice.
(1) The ingredient is used as a con- (c) Prior sanctions for this ingredient
stituent of paper and paperboard used different from the uses established in
for food packaging. this section do not exist or have been
(2) The ingredient is used at levels waived.
not to exceed current good manufac- [53 FR 16867, May 12, 1988; 53 FR 20939, June
turing practice. 7, 1988, as amended at 69 FR 24512, May 4,
(c) Prior sanctions for this ingredient 2004]
this section do not exist or have been § 186.1551 Hydrogenated fish oil.
waived. (a) Hydrogenated fish oil (CAS Reg.
[53 FR 16867, May 12, 1988; 53 FR 20939, June No. 91078–95–4) is a class of oils pro-
7, 1988] duced by partial hydrogenation of oils
expressed from fish, primarily menha-
§ 186.1316 Formic acid. den, and secondarily herring or tuna.
(a) Formic acid (CH2O2, CAS Reg. No. Hydrogenation of fish oils uses cata-
64–18–6) is also referred to as methanoic lysts composed of either elemental
acid or hydrogen carboxylic acid. It oc- nickel, elemental copper, or a mixture
curs naturally in some insects and is of these elements. The crude hydro-
contained in the free acid state in a genated fish oil is further processed by
number of plants. Formic acid is pre- alkali refining, bleaching, and deodori-
pared by the reaction of sodium for- zation by steam stripping.
mate with sulfuric acid and is isolated (b) Hydrogenation of fish oils results
by distillation. in a final product with a melting point
(b) Formic acid is used as a con- greater than 32 °C as determined by
stituent of paper and paperboard used Section Cc 1–25, Official and Tentative
for food packaging. Methods of the American Oil Chemists’
Society method (reapproved 1973) or
(c) The ingredient is used at levels
equivalent. The product has an approx-
imate fatty acid composition of 30 to 45
practice in accordance with § 186.1(b)(1).
percent saturated fatty acids, 40 to 55
(d) Prior sanctions for formic acid
percent monoenoic fatty acids, 7 to 15
percent dienoic fatty acids, 3 to 10 per-
cent trienoic fatty acids, and less than

waived.
2 percent tetraenoic or higher
[45 FR 22915, Apr. 4, 1980] polyenoic fatty acids. The approximate
593
§ 186.1555 21 CFR Ch. I (4–1–15 Edition)
percentages of total fatty acids by car- § 186.1557 Tall oil.

bon chain length are 15 to 30 percent
(a) Tall oil (CAS Reg. No. 8002–26–4) is
each of C16, C18, C20, C22, less than 10
essentially the sap of the pine tree. It
percent C14 or lower carbon chain
is obtained commercially from the
length, and less than 1 percent C24 or
waste liquors of pinewood pulp mills
higher carbon chain length fatty acids.
and consists mainly of tall oil resin
(c) The ingredient is used as a con-
acids and tall oil fatty acids.
stituent of cotton and cotton fabrics
used for dry food packaging. (b) In accordance with § 186.1(b)(1),
the ingredient is used as an indirect
(d) The ingredient is used at levels
human food ingredient with no limita-
tion other than current good manufac-
practice in accordance with § 186.1(b)(1).
turing practice. The affirmation of this
ingredient as generally recognized as
different from the use established in
safe (GRAS) as an indirect human food
ingredient is based on the following
waived.
[44 FR 28323, May 15, 1979, as amended at 49 conditions of use:
FR 5614, Feb. 14, 1984; 58 FR 17099, Apr. 1, (1) The ingredient is used as a con-
1993] stituent of cotton and cotton fabrics
used for dry food packaging.
§ 186.1555 Japan wax.
(2) The ingredient is used at levels
(a) Japan wax (CAS Reg. No. 8001–39– not to exceed current good manufac-
6), also known as Japan tallow or turing practice.
sumac wax, is a pale yellow vegetable (c) Prior sanctions for this ingredient
tallow, containing glycerides of the different from the uses established in
C19-C23 dibasic acids and a high content this section, or from those listed in
of tripalmitin. It is prepared from the part 181 of this chapter, do not exist or
mesocarp by hot pressing of immature have been waived.
fruits of the oriental sumac, Rhus
succedanea (Japan, Taiwan, and Indo- [51 FR 16830, May 7, 1986]
China), R. vernicifera (Japan), and R.
trichocarpa (China, Indo-China, India, § 186.1673 Pulp.
and Japan). Japan wax is soluble in hot (a) Pulp is the soft, spongy pith in-
alcohol, benzene, and naphtha, and inside the stem of a plant such as wood,
soluble in water and in cold alcohol. straw, sugarcane, or other natural
(b) In accordance with paragraph plant sources.
(b)(1) of this section, the ingredient is (b) The ingredient is used or intended
used as an indirect human food ingre- for use as a constituent of food pack-
dient with no limitation other than aging containers.
current good manufacturing practice. (c) The ingredient is used in paper
The affirmation of this ingredient as and paperboard made by conventional
generally recognized as safe (GRAS) as paper-making processes at levels not to
an indirect human food ingredient is exceed good manufacturing practice.
based on the following current good (d) Prior sanctions for this ingredient
manufacturing practice conditions of different from the uses established in
use: this section do not exist or have been
(1) The ingredient is used as a con- waived.
stituent of cotton and cotton fabrics
used for dry food packaging. § 186.1750 Sodium chlorite.
(2) The ingredient is used at levels
(a) Sodium chlorite (NaCLO2, CAS
Reg. No. 7758–19–2) exists as slightly
turing practice.
hygroscopic white crystals or flakes. It
(c) Prior sanctions for this ingredient is manufactured by passing chlorine di-
different from the uses established in oxide into a solution of sodium hydrox-
this section do not exist or have been ide and hydrogen peroxide.
waived.
(b) the ingredient is used at levels
[60 FR 62208, Dec. 5, 1995] from 125 to 250 parts per million as a
594
slimicide in the manufacture of paper aging with no limitation other than

and paperboard that contact food. current good manufacturing practice.
[45 FR 16470, Mar. 14, 1980]
(c) Prior sanctions for this ingredient
§ 186.1756 Sodium formate. this section do not exist or have been
waived.
(a) Sodium formate (CHNaO2, CAS
Reg. No. 141–53–7) is the sodium salt of [51 FR 39372, Oct. 28, 1986]
formic acid. It is produced by the reac-
tion of carbon monoxide with sodium § 186.1797 Sodium sulfate.
hydroxide. (a) Sodium sulfate (Na2SO4, CAS Reg.
(b) The ingredient is used as a con- No. 7757–82–6), also known as Glauber’s
stituent of paper and paperboard used salt, occurs naturally and exists as
for food packaging. colorless crystals or as a fine, white
(c) The ingredient is used at levels crystalline powder. It is prepared by
not to exceed good manufacturing the neutralization of sulfuric acid with
practice in accordance with § 186.1(b)(1). sodium hydroxide.
(d) Prior sanctions for sodium for- (b) The ingredient is used as a con-
mate different from the uses estab- stituent of paper and paperboard used
lished in this section do not exist or for food packaging, and cotton and cot-
have been waived. ton fabric used for dry food packaging.
[45 FR 22915, Apr. 4, 1980] (c) The ingredient is used at levels
§ 186.1770 Sodium oleate. practice in accordance with § 186.1(b)(1).
(a) Sodium oleate (C18H33O2Na, CAS (d) Prior sanctions for this ingredient
Reg. No. 143–19–1) is the sodium salt of different from the uses established in
oleic acid (cis-9-octadecenoic acid). It this section do not exist or have been
exists as a white to yellowish powder waived.
with a slight tallow-like odor. Com- [45 FR 6086, Jan. 25, 1980]
mercially, sodium oleate is made by
mixing and heating flaked sodium hy- § 186.1839 Sorbose.
droxide and oleic acid. (a) Sorbose (L-sorbose, sorbinose)
(b) In accordance with § 186.1(b)(1), (C6H12O6, CAS Reg. No. 87–79–6) is an
the ingredient is used as a constituent orthorhombic, bisphenoidal crystalline
of paper and paperboard for food pack- ketohexose. It was originally identifed
aging and as a component of lubricants in the juice of mature berries from the
with incidental food contact in accord- mountain ash (Sorbus aucuparia) where
ance with § 178.3570 of this chapter, it occurs as the result of microbial oxi-
with no limitation other than current dation of sorbitol. It also occurs natu-
good manufacturing practice. rally in other plants. Sorbose can be
(c) Prior sanctions for this ingredient synthesized by the catalytic hydro-
different from the uses established in genation of glucose to D-sorbitol. The
this section do not exist or have been resulting sorbitol can be oxidized by
waived. Acetobacter xylinum or by Acetobacter
[51 FR 39372, Oct. 28, 1986] suboxydans.
(b) The ingredient is used or intended
§ 186.1771 Sodium palmitate. for indirect food use as a constituent of
(a) Sodium palmitate (C16H31O2Na, cotton, cotton fabrics, paper, and pa-
CAS Reg. No. 408–35–5) is the sodium perboard in contact with dry food.
salt of palmitic acid (hexadecanoic (c) The ingredient migrates to food at
acid). It exists as a white to yellow levels not to exceed good manufac-
powder. Commercially, sodium turing practice.
palmitate is made by mixing and heat- (d) Prior sanctions for this ingredient
ing flaked sodium hydroxide and pal- different from the uses established in
mitic acid. this section do not exist or have been
waived.
(b) In accordance with § 186.1(b)(1),

the ingredient is used as a constituent [43 FR 11698, Mar. 21, 1978, as amended at 48
of paper and paperboard for food pack- FR 48457, Oct. 19, 1983]
595
PART 189—SUBSTANCES PROHIB- been shown by adequate scientific data

ITED FROM USE IN HUMAN to be safe for use in human food. Use of
any of these substances in violation of
FOOD this section causes the food involved to
Subpart A—General Provisions be adulterated in violation of the act.
(b) This section includes only a par-
Sec. tial list of substances prohibited from
189.1 Substances prohibited from use in use in human food, for easy reference
human food. purposes, and is not a complete list of
substances that may not lawfully be
Subpart B—Prohibited cattle materials
used in human food. No substance may
189.5 Prohibited cattle materials. be used in human food unless it meets
all applicable requirements of the act.
Subpart C—Substances Generally Prohib- (c) The Commissioner of Food and
ited From Direct Addition or Use as Drugs, either on his own initiative or
Human Food on behalf of any interested person who
189.110 Calamus and its derivatives. has submitted a petition, may publish
189.113 Cinnamyl anthranilate. a proposal to establish, amend, or re-
189.120 Cobaltous salts and its derivatives. peal a regulation under this section on
189.130 Coumarin. the basis of new scientific evaluation
189.135 Cyclamate and its derivatives. or information. Any such petition shall
189.140 Diethylpyrocarbonate (DEPC). include an adequate scientific basis to
189.145 Dulcin.
support the petition, pursuant to part
189.155 Monochloroacetic acid.
189.165 Nordihydroguaiaretic acid (NDGA). 10 of this chapter, and will be published
189.175 P–4000. for comment if it contains reasonable
189.180 Safrole. grounds.
189.190 Thiourea.
189.191 Chlorofluorocarbon propellants.
FR 24899, June 12, 1989]
Subpart D—Substances Prohibited From In-
direct Addition to Human Food Subpart B—Prohibited Cattle
Through Food-Contact Surfaces Materials
189.220 Flectol H. § 189.5 Prohibited cattle materials.
189.240 Lead solders.
189.250 Mercaptoimidazoline and 2- (a) Definitions. The definitions and in-
mercaptoimidazoline. terpretations of terms contained in
189.280 4,4′-Methylenebis (2-chloroanaline). section 201 of the Federal Food, Drug,
189.300 Hydrogenated 4,4′-isopropylidene- and Cosmetic Act (the act) apply to
diphenolphosphite ester resins.
such terms when used in this part. The
189.301 Tin-coated lead foil capsules for
wine bottles. following definitions also apply:
(1) Prohibited cattle materials means
AUTHORITY: 21 U.S.C. 321, 342, 348, 371, 381. specified risk materials, small intes-
SOURCE: 42 FR 14659, Mar. 15, 1977, unless tine of all cattle except as provided in
otherwise noted. paragraph (b)(2) of this section, mate-
EDITORIAL NOTE: Nomenclature changes to rial from nonambulatory disabled cat-
part 189 appear at 61 FR 14482, Apr. 2, 1996, 66 tle, material from cattle not inspected
FR 56035, Nov. 6, 2001, 70 FR 40880, July 15, and passed, or mechanically separated
2005, and 70 FR 67651, Nov. 8, 2005. (MS) (Beef). Prohibited cattle mate-
rials do not include the following:
Subpart A—General Provisions (i) Tallow that contains no more
than 0.15 percent insoluble impurities,
§ 189.1 Substances prohibited from use tallow derivatives, hides and hide-de-
in human food. rived products, and milk and milk
(a) The food ingredients listed in this products, and
section have been prohibited from use (ii) Cattle materials inspected and
in human food by the Food and Drug passed from a country designated
Administration because of a deter- under paragraph (e) of this section.

mination that they present a potential (2) Inspected and passed means that
risk to the public health or have not the product has been inspected and
596
passed for human consumption by the ministration (NARA). For information

appropriate regulatory authority, and on the availability of this material at
at the time it was inspected and NARA, call 202–741–6030, or go to http://
passed, it was found to be not adulter- www.archives.gov/federallregister/
ated. codeloflfederallregulations/
(3) Mechanically Separated (MS)(Beef) ibrllocations.html.
means a meat food product that is fine- (7) Tallow derivative means any chem-
ly comminuted, resulting from the me- ical obtained through initial hydrol-
chanical separation and removal of ysis, saponification, or trans-
most of the bone from attached skel- esterification of tallow; chemical con-
etal muscle of cattle carcasses and
version of material obtained by hydrol-
parts of carcasses that meets the speci-
ysis, saponification, or trans-
fications contained in 9 CFR 319.5, the
regulation that prescribes the standard esterification may be applied to obtain
of identity for MS (Species). the desired product.
(4) Nonambulatory disabled cattle (b) Requirements. (1) No human food
means cattle that cannot rise from a shall be manufactured from, processed
recumbent position or that cannot with, or otherwise contain, prohibited
walk, including, but not limited to, cattle materials.
those with broken appendages, severed (2) The small intestine is not consid-
tendons or ligaments, nerve paralysis, ered prohibited cattle material if the
fractured vertebral column, or meta- distal ileum is removed by a procedure
bolic conditions. that removes at least 80 inches of the
(5) Specified risk material means the uncoiled and trimmed small intestine,
brain, skull, eyes, trigeminal ganglia, as measured from the caeco-colic junc-
spinal cord, vertebral column (exclud- tion and progressing proximally to-
ing the vertebrae of the tail, the trans- wards the jejunum, or by a procedure
verse processes of the thoracic and that the establishment can dem-
lumbar vertebrae, and the wings of the onstrate is equally effective in ensur-
sacrum), and dorsal root ganglia of cating complete removal of the distal
tle 30 months and older and the tonsils ileum.
and distal ileum of the small intestine
(c) Records. (1) Manufacturers and
of all cattle.
(6) Tallow means the rendered fat of processors of a human food that is
cattle obtained by pressing or by ap- manufactured from, processed with, or
plying any other extraction process to otherwise contains, material from cat-
tissues derived directly from discrete tle must establish and maintain
adipose tissue masses or to other car- records sufficient to demonstrate that
cass parts and tissues. Tallow must be the food is not manufactured from,
produced from tissues that are not pro- processed with, or does not otherwise
hibited cattle materials or must con- contain, prohibited cattle materials.
tain not more than 0.15 percent insol- (2) Records must be retained for 2
uble impurities as determined by the years after the date they were created.
method entitled ‘‘Insoluble Impurities’’ (3) Records must be retained at the
(AOCS Official Method Ca 3a-46), Amer- manufacturing or processing establish-
ican Oil Chemists’ Society (AOCS), 5th ment or at a reasonably accessible lo-
Edition, 1997, incorporated by reference cation.
in accordance with 5 U.S.C. 552(a) and 1 (4) The maintenance of electronic
CFR part 51, or another method equiva- records is acceptable. Electronic
lent in accuracy, precision, and sensi- records are considered to be reasonably
tivity to AOCS Official Method Ca 3a- accessible if they are accessible from
46. You may obtain copies of the meth-
an onsite location.
od from AOCS (http://www.aocs.org) 2211
W. Bradley Ave. Champaign, IL 61821. (5) Records required by this section
Copies may be examined at the Center and existing records relevant to com-
for Food Safety and Applied Nutri- pliance with this section must be avail-
able to FDA for inspection and copy-
tion’s Library, 5100 Paint Branch

Pkwy., College Park, MD 20740, or at ing.
597
§ 189.110 21 CFR Ch. I (4–1–15 Edition)
(6) When filing entry with U.S. Cus- a written request to the Director, Of-
toms and Border Protection, the im- fice of the Center Director, Center for
porter of record of a human food manu- Food Safety and Applied Nutrition,
factured from, processed with, or oth- Food and Drug Administration, at the
erwise containing, cattle material address designated in 21 CFR 5.1100.
must affirm that the food was manu- The request shall include information
factured from, processed with, or oth- about a country’s bovine spongiform
erwise contains, cattle material and encephalopathy (BSE) case history,
must affirm that the food was manu- risk factors, measures to prevent the
factured in accordance with this sec- introduction and transmission of BSE,
tion. If a human food is manufactured and any other information relevant to
from, processed with, or otherwise con- determining whether specified risk ma-
tains, cattle material, then the im- terials, the small intestine of cattle ex-
porter of record must, if requested, pro- cept as provided in paragraph (b)(2) of
vide within 5 days records sufficient to this section, material from non-
demonstrate that the food is not manu- ambulatory disabled cattle, or MS
factured from, processed with, or does (Beef) from cattle from the country
not otherwise contain, prohibited cat- should be considered prohibited cattle
tle material. materials. FDA shall respond in writ-
(7) Records established or maintained ing to any such request and may im-
to satisfy the requirements of this sub- pose conditions in granting any such
part that meet the definition of elec- request. A country designation granted
tronic records in § 11.3(b)(6) of this by FDA under this paragraph will be
chapter are exempt from the require- subject to future review by FDA, and
ments of part 11 of this chapter. may be revoked if FDA determines
Records that satisfy the requirements that it is no longer appropriate.
of this subpart but that are also re-
quired under other applicable statutory FR 59668, Oct. 11, 2006; 73 FR 20793, Apr. 17,
provisions or regulations remain sub- 2008]
ject to part 11 of this chapter.
(d) Adulteration. (1) Failure of a man-
ufacturer or processor to operate in
Subpart C—Substances Generally
compliance with the requirements of Prohibited From Direct Addi-
paragraphs (b) or (c) of this section tion or Use as Human Food
renders human food adulterated under
section 402(a)(4) of the act. SOURCE: 42 FR 14659, Mar. 15, 1977, unless
(2) Human food manufactured from, otherwise noted. Redesignated at 69 FR 42273,
processed with, or otherwise con- July 14, 2004.
taining, prohibited cattle materials is
unfit for human food and deemed adul- § 189.110 Calamus and its derivatives.
terated under section 402(a)(3) of the (a) Calamus is the dried rhizome of
act. Acorus calamus L. It has been used as a
(3) Food additive status. Prohibited flavoring compound, especially as the
cattle materials for use in human food oil or extract.
are food additives subject to section 409 (b) Food containing any added
of the act, except when used as dietary calamus, oil of calamus, or extract of
ingredients in dietary supplements. calamus is deemed to be adulterated in
The use or intended use of any prohib- violation of the act based upon an
ited cattle material in human food order published in the FEDERAL REG-
causes the material and the food to be ISTER of May 9, 1968 (33 FR 6967).
adulterated under section 402(a)(2)(C) (c) The analytical method used for
of the act if the prohibited cattle mate- detecting oil of calamus (b-asarone) is
rial is a food additive, unless it is the in the ‘‘Journal of the Association of
subject of a food additive regulation or Official Analytical Chemists,’’ Volume
of an investigational exemption for a 56, (Number 5), pages 1281 to 1283, Sep-
food additive under § 170.17 of this chap- tember 1973, which is incorporated by
ter. reference. Copies are available from

(e) Process for designating countries. A the AOAC INTERNATIONAL, 481 North
country seeking designation must send Frederick Ave., suite 500, Gaithersburg,
598
MD 20877, also from the Office of Food to be adulterated under the act, based
Additive Safety (HFS–200), Center for upon an order published in the FED-
Food Safety and Applied Nutrition, ERAL REGISTER of March 5, 1954 (19 FR
Food and Drug Administration, 5100 1239).
Paint Branch Pkwy., College Park, MD (c) The analytical methods used for
20740, 240–402–1200, or available for in- detecting coumarin in food are in sec-
spection at the National Archives and tions 19.016–19.024 of the ‘‘Official Meth-
Records Administration (NARA). For ods of Analysis of the Association of
information on the availability of this Official Analytical Chemists,’’ 13th Ed.
material at NARA, call 202–741–6030, or (1980), which is incorporated by ref-
go to: http://www.archives.gov/ erence. Copies may be obtained from
federallregister/ the AOAC INTERNATIONAL, 481 North
codeloflfederallregulations/ Frederick Ave., suite 500, Gaithersburg,
ibrllocations.html. MD 20877, or may be examined at the
National Archives and Records Admin-
FR 11855, Mar. 19, 1982; 54 FR 24899, June 12,
1989; 78 FR 14667, Mar. 7, 2013] the availability of this material at
§ 189.113 Cinnamyl anthranilate. www.archives.gov/federallregister/
(a) The food additive cinnamyl an-
ibrllocations.html.
thranilate (C16H15NO2, CAS Reg. No. 87–
29–6) is the ester of cinnamyl alcohol [42 FR 14659, Mar. 15, 1977, as amended at 49
and anthranilic acid. Cinnamyl an- FR 10114, Mar. 19, 1984; 54 FR 24899, June 12,
thranilate is a synthetic chemical that 1989]
has not been identified in natural prod-
§ 189.135 Cyclamate and its deriva-
ucts at levels detectable by available tives.
methodology. It has been used as a fla-
voring agent in food. (a) Calcium, sodium, magnesium and
(b) Food containing any added potassium salts of cyclohexane sul-
cinnamyl anthranilate is deemed to be famic acid, (C6H12NO3S)2Ca,
adulterated in violation of the act (C6H12NO3S)Na, (C6H12NO3S)2Mg, and
based upon an order published in the (C6H12NO3S)K. Cyclamates are syn-
FEDERAL REGISTER of October 23, 1985. thetic chemicals having a sweet taste
30 to 40 times that of sucrose, are not
[50 FR 42932, Oct. 23, 1985] found in natural products at levels de-
tectable by the official methodology,
§ 189.120 Cobaltous salts and its de- and have been used as artificial sweet-
rivatives.
eners.
(a) Cobaltous salts are the chemicals, (b) Food containing any added or de-
CoC4H6O4, CoCl2, and CoSO4.They have tectable level of cyclamate is deemed
been used in fermented malt beverages to be adulterated in violation of the
as a foam stabilizer and to prevent act based upon an order published in
‘‘gushing.’’ the FEDERAL REGISTER of October 21,
(b) Food containing any added cobal- 1969 (34 FR 17063).
tous salts is deemed to be adulterated (c) The analytical methods used for
in violation of the act based upon an detecting cyclamate in food are in sec-
order published in the FEDERAL REG- tions 20.162–20.172 of the ‘‘Official Meth-
ISTER of August 12, 1966 (31 FR 8788). ods of Analysis of the Association of
Official Analytical Chemists,’’ 13th Ed.
§ 189.130 Coumarin. (1980), which is incorporated by ref-
(a) Coumarin is the chemical 1,2- erence. Copies may be obtained from
benzopyrone, C9H6O2. It is found in the AOAC INTERNATIONAL, 481 North
tonka beans and extract of tonka Frederick Ave., suite 500, Gaithersburg,
beans, among other natural sources, MD 20877, or may be examined at the
and is also synthesized. It has been National Archives and Records Admin-
used as a flavoring compound. istration (NARA). For information on
(b) Food containing any added cou- the availability of this material at
marin as such or as a constituent of NARA, call 202–741–6030, or go to: http://
tonka beans or tonka extract is deemed www.archives.gov/federallregister/
599
§ 189.140 21 CFR Ch. I (4–1–15 Edition)
codeloflfederallregulations/ § 189.155 Monochloroacetic acid.

ibrllocations.html. (a) Monochloroacetic acid is the
[42 FR 14659, Mar. 15, 1977, as amended at 49 chemical chloroacetic acid, C2H3C1O2.
FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, It is a synthetic chemical not found in
1989] natural products, and has been pro-
posed as a preservative in alcoholic and
§ 189.140 Diethylpyrocarbonate nonalcoholic beverages.
(DEPC). Monochloroacetic acid is permitted in
(a) Diethylpyrocarbonate is the food package adhesives with an accept-
chemical pyrocarbonic acid diethyl ed migration level up to 10 parts per
ester, C6H10O5. It is a synthetic chem- billion (ppb) under § 175.105 of this chap-
ical not found in natural products at ter. The official methods do not detect
levels detectable by available method- monochloroacetic acid at the 10 ppb
ology and has been used as a ferment level.
inhibitor in alcoholic and nonalcoholic (b) Food containing any added or de-
beverages. tectable level of monochloroacetic acid
(b) Food containing any added or de- is deemed to be adulterated in viola-
tectable level of DEPC is deemed to be tion of the act based upon trade cor-
adulterated in violation of the act respondence dated December 29, 1941
based upon an order published in the (TC–377).
FEDERAL REGISTER of August 2, 1972 (37 (c) The analytical methods used for
FR 15426). detecting monochloroacetic acid in
food are in sections 20.067–20.072 of the
§ 189.145 Dulcin. ‘‘Official Methods of Analysis of the
Association of Official Analytical
(a) Dulcin is the chemical 4-
Chemists,’’ 13th Ed. (1980), which is in-
ethoxyphenylurea, C9H12N2O2. It is a
synthetic chemical having a sweet
obtained from the AOAC INTER-
taste about 250 times that of sucrose, is
NATIONAL, 481 North Frederick Ave.,
not found in natural products at levels
suite 500, Gaithersburg, MD 20877, or
detectable by the official methodology, may be examined at the National Ar-
and has been proposed for use as an archives and Records Administration
tificial sweetener. (NARA). For information on the avail-
(b) Food containing any added or de- ability of this material at NARA, call
tectable level of dulcin is deemed to be 202–741–6030, or go to: http://
adulterated in violation of the act, www.archives.gov/federallregister/
based upon an order published in the codeloflfederallregulations/
FEDERAL REGISTER of January 19, 1950 ibrllocations.html.
(15 FR 321).
(c) The analytical methods used for [42 FR 14659, Mar. 15, 1977, as amended at 49
FR 10114, Mar. 19, 1984; 54 FR 24899, June 12,
detecting dulcin in food are in sections
1989]
20.173–20.176 of the ‘‘Official Methods of
Analysis of the Association of Official § 189.165 Nordihydroguaiaretic acid
Analytical Chemists,’’ 13th Ed. (1980), (NDGA).
which is incorporated by reference. (a) Nordihydroguaiaretic acid is the
Copies may be obtained from the AOAC chemical 4,4′-(2,3-dimethyltetrame-
INTERNATIONAL, 481 North Frederick thylene) dipyrocatechol, C18H22O4. It
Ave., suite 500, Gaithersburg, MD 20877, occurs naturally in the resinous
or may be examined at the National exudates of certain plants. The com-
Archives and Records Administration mercial product, which is synthesized,
(NARA). For information on the avail- has been used as an antioxidant in
ability of this material at NARA, call foods.
202–741–6030, or go to: http:// (b) Food containing any added NDGA
www.archives.gov/federallregister/ is deemed to be adulterated in viola-
codeloflfederallregulations/ tion of the act based upon an order
ibrllocations.html. published in the FEDERAL REGISTER of
[42 FR 14659, Mar. 15, 1977, as amended at 49 April 11, 1968 (33 FR 5619).
FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, (c) The analytical method used for
1989] detecting NDGA in food is in section
600
20.008(b) of the ‘‘Official Methods of plant. Oil of sassafras is about 80 per-

Analysis of the AOAC INTER- cent safrole. Isosafrole and
NATIONAL,’’ 13th Ed. (1980), which is dihydrosafrole are derivatives of saf-
incorporated by reference. Copies may role, and have been used as flavoring
be obtained from the AOAC INTER- compounds.
NATIONAL, 481 North Frederick Ave., (b) Food containing any added saf-
suite 500, Gaithersburg, MD 20877, or role, oil of sassafras, isosafrole, or
may be examined at the National Ar- dihydrosafrole, as such, or food con-
chives and Records Administration taining any safrole, oil of sassafras,
(NARA). For information on the avail- isosafrole, or dihydrosafrole, e.g., sas-
ability of this material at NARA, call safras bark, which is intended solely or
202–741–6030, or go to: http:// primarily as a vehicle for imparting
www.archives.gov/federallregister/ such substances to another food, e.g.,
codeloflfederallregulations/ sassafras tea, is deemed to be adulter-
ibrllocations.html. ated in violation of the act based upon
[42 FR 14659, Mar. 15, 1977, as amended at 49 an order published in the FEDERAL
FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, REGISTER of December 3, 1960 (25 FR
1989] 12412).
(c) The analytical method used for
§ 189.175 P–4000. detecting safrole, isosafrole and
(a) P–4000 is the chemical 5-nitro-2-n- dihydrosafrole is in the ‘‘Journal of the
propoxyaniline, C9H12N2O3. It is a syn- Association of Official Analytical
thetic chemical having a sweet taste Chemists,’’ Volume 54 (Number 4),
about 4000 times that of sucrose, is not pages 900 to 902, July 1971, which is in-
found in natural products at levels de- corporated by reference. Copies are
tectable by the official methodology, available from the Office of Food Addi-
and has been proposed for use as an ar- tive Safety (HFS–200), Center for Food
tificial sweetener. Safety and Applied Nutrition, Food and
(b) Food containing any added or de- Drug Administration, 5100 Paint
tectable level of P–4000 is deemed to be Branch Pkwy., College Park, MD 20740,
adulterated in violation of the act 240–402–1200, or available for inspection
based upon an order published in the at the National Archives and Records
FEDERAL REGISTER of January 19, 1950 Administration (NARA). For informa-
(15 FR 321). tion on the availability of this mate-
(c) The analytical methods used for rial at NARA, call 202–741–6030, or go
detecting P–4000 in food are in sections to: http://www.archives.gov/
20.177–20.181 of the ‘‘Official Methods of federallregister/
Analysis of the Association of Official codeloflfederallregulations/
Analytical Chemists,’’ 13th Ed. (1980), ibrllocations.html.
which is incorporated by reference.
Copies may be obtained from the AOAC FR 56729, Oct. 28, 1977; 47 FR 11855, Mar. 19,
INTERNATIONAL, 481 North Frederick 1982; 54 FR 24900, June 12, 1989; 78 FR 14667,
Ave., suite 500, Gaithersburg, MD 20877, Mar. 7, 2013]
or may be examined at the National
Archives and Records Administration § 189.190 Thiourea.
(NARA). For information on the avail- (a) Thiourea is the chemical
ability of this material at NARA, call thiocarbamide, CH4N2S. It is a syn-
202–741–6030, or go to: http:// thetic chemical, is not found in natural
www.archives.gov/federallregister/ products at levels detectable by the of-
codeloflfederallregulations/ ficial methodology, and has been pro-
ibrllocations.html. posed as an antimycotic for use in dip-
[42 FR 14659, Mar. 15, 1977, as amended at 49 ping citrus.
FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, (b) Food containing any added or de-
1989] tectable level of thiourea is deemed to
be adulterated under the act.
§ 189.180 Safrole. (c) The analytical methods used for
(a) Safrole is the chemical 4-allyl-1,2- detecting thiourea are in sections

methylenedioxy-benzene, C10H10O2. It is 20.115–20.126 of the ‘‘Official Methods of
a natural constituent of the sassafras Analysis of the Association of Official
601
§ 189.191 21 CFR Ch. I (4–1–15 Edition)
Analytical Chemists,’’ 13th Ed. (1980), of the Federal Food, Drug, and Cos-
which is incorporated by reference. metic Act, based upon an order pub-
Copies may be obtained from the AOAC lished in the FEDERAL REGISTER of
INTERNATIONAL, 481 North Frederick June 27, 1995.
Ave., suite 500, Gaithersburg, MD 20877, [60 FR 33109, June 27, 1995]
or may be examined at the National
Archives and Records Administration § 189.250 Mercaptoimidazoline and 2-
(NARA). For information on the avail- mercaptoimidazoline.
ability of this material at NARA, call (a) Mercaptoimidazoline and 2-
202–741–6030, or go to: http:// mercaptoimidazoline both have the
www.archives.gov/federallregister/ molecular formula C3H6N2S. They are
codeloflfederallregulations/ synthetic chemicals not found in nat-
ibrllocations.html. ural products and have been used in the
[42 FR 14659, Mar. 15, 1977, as amended at 49 production of rubber articles that may
FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, come into contact with food.
1989] (b) Food containing any added or de-
lectable levels of these substances is
§ 189.191 Chlorofluorocarbon propel- deemed to be adulterated in violation
lants. of the act based upon an order pub-
The use of chlorofluorocarbons in lished in the FEDERAL REGISTER of No-
human food as propellants in self-pres- vember 30, 1973 (38 FR 33072).
surized containers is prohibited as pro-
vided by § 2.125 of this chapter. § 189.280 4,4′-Methylenebis (2-chloro-
analine).
[43 FR 11317, Mar. 17, 1978]
(a) 4,4′-Methylenebis (2-
chloroanaline) has the molecular for-
Subpart D—Substances Prohibited mula, C13H12Cl2N2. It is a synthetic
From Indirect Addition to chemical not found in natural products
Human Food Through Food- and has been used as a polyurethane
Contact Surfaces curing agent and as a component of
food packaging adhesives and poly-
SOURCE: 42 FR 14659, Mar. 15, 1977, unless urethane resins.
otherwise noted. Redesignated at 69 FR 42273, (b) Food containing any added or de-
July 14, 2004. tectable level of this substance is
deemed to be adulterated in violation
§ 189.220 Flectol H. of the act based upon an order pub-
(a) Flectol H is the chemical 1,2- lished in the FEDERAL REGISTER of De-
dihydro-2,2,4-trimethylquinoline, po- cember 2, 1969 (34 FR 19073).
lymerized, C12H15N. It is a synthetic § 189.300 Hydrogenated 4,4′-isopropyl-
chemical not found in natural prod- idene-diphenolphosphite ester res-
ucts, and has been used as a component ins.
of food packaging adhesives.
(a) Hydrogenated 4,4′-isopropylidene-
(b) Food containing any added or de-
diphenolphosphite ester resins are the
tectable level of this substance is
condensation product of 1 mole of
deemed to be adulterated in violation
triphenyl phosphite and 1.5 moles of
of the act based upon an order pub-
hydrogenated 4,4′-isopropylidene-
lished in the FEDERAL REGISTER of
diphenol such that the finished resins
April 7, 1967 (32 FR 5675).
have a molecular weight in the range
[42 FR 14659, Mar. 15, 1977, as amended at 58 of 2,400 to 3,000. They are synthetic
FR 17099, Apr. 1, 1993] chemicals not found in natural prod-
ucts and have been used as anti-
§ 189.240 Lead solders. oxidants and as stabilizers in vinyl
(a) Lead solders are alloys of metals chloride polymer resins when such
that include lead and are used in the polymer resins are used in the manu-
construction of metal food cans. facture of rigid vinyl chloride polymer
(b) Food packaged in any container bottles.

that makes use of lead in can solder is (b) Food containing any added or de-
deemed to be adulterated in violation tectable levels of these substances is
602
deemed to be adulterated and in viola- Subpart B—New Dietary

tion of the Federal Food, Drug, and Ingredient Notification
Cosmetic Act, based upon an order pub-
lished in the FEDERAL REGISTER of Sep- § 190.6 Requirement for premarket no-
tember 9, 1987 (52 FR 33929). tification.
[54 FR 7188, Feb. 17, 1989] (a) At least 75 days before intro-
ducing or delivering for introduction
§ 189.301 Tin-coated lead foil capsules into interstate commerce a dietary
for wine bottles. supplement that contains a new die-
tary ingredient that has not been
(a) Tin-coated lead foil is composed
present in the food supply as an article
of a lead foil coated on one or both
used for food in a form in which the
sides with a thin layer of tin. Tin-coat-
food has not been chemically altered,
ed lead foil has been used as a capsule the manufacturer or distributor of that
(i.e., as a covering applied over the supplement, or of the new dietary in-
cork and neck areas) on wine bottles to gredient, shall submit to the Office of
prevent insect infestation, as a barrier Nutritional Products, Labeling and Di-
to oxygen, and for decorative purposes. etary Supplements (HFS–820), Center
Information received by the Food and for Food Safety and Applied Nutrition,
Drug Administration establishes that Food and Drug Administration, 5100
the use of such a capsule on wine bot- Paint Branch Pkwy., College Park, MD
tles may reasonably be expected to re- 20740, information including any cita-
sult in lead becoming a component of tion to published articles that is the
the wine. basis on which the manufacturer or
(b) The capping of any bottles of wine distributor has concluded that a die-
after February 8, 1996, with a tin-coat- tary supplement containing such die-
ed lead foil capsule renders the wine tary ingredient will reasonably be ex-
adulterated and in violation of section pected to be safe. An original and two
402(a)(2)(C) of the Federal Food, Drug, copies of this notification shall be sub-
and Cosmetic Act because lead from mitted.
the capsule, which is an unsafe food ad- (b) The notification required by para-
ditive within the meaning of section graph (a) of this section shall include:
409 of the act, may reasonably be ex- (1) The name and complete address of
pected to become a component of the the manufacturer or distributor of the
wine. dietary supplement that contains a
new dietary ingredient, or of the new
[61 FR 4820, Feb. 8, 1996] dietary ingredient;
(2) The name of the new dietary in-
PART 190—DIETARY SUPPLEMENTS gredient that is the subject of the pre-
market notification, including the
Subpart A [Reserved] Latin binomial name (including the au-
thor) of any herb or other botanical;
Subpart B—New Dietary Ingredient (3) A description of the dietary sup-
Notification plement or dietary supplements that
contain the new dietary ingredient in-
Sec. cluding:
190.6 Requirement for premarket notifica-
(i) The level of the new dietary ingre-
tion.
dient in the dietary supplement; and
AUTHORITY: Secs. 201(ff), 301, 402, 413, 701 of (ii) The conditions of use rec-
the Federal Food, Drug, and Cosmetic Act ommended or suggested in the labeling
(21 U.S.C. 321(ff), 331, 342, 350b, 371). of the dietary supplement, or if no con-
SOURCE: 62 FR 49891, Sept. 23, 1997, unless ditions of use are recommended or sug-
otherwise noted. gested in the labeling of the dietary
supplement, the ordinary conditions of
use of the supplement;
part 190 appear at 66 FR 56035, Nov. 6, 2001.
(4) The history of use or other evi-

dence of safety establishing that the
Subpart A [Reserved] dietary ingredient, when used under
603

21 CFR 174 189 Food Contact Substances

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21 CFR 174 189 Food Contact Substances

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Food and Drug Administration, HHS § 174.

Sec. contact food shall not be construed as

(d) Substances that under conditions 175.250 Paraffin (synthetic).

§ 174.6 Threshold of regulation for Subpart A [Reserved]

the packaging seams or laminates will

bilizer, or preservative. Total fluoride from all

p-tert-Butylpyrocatechol .............................................................................. For use only as polymerization-control agent.

Dipropylene glycol dibenzoate.

hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5-hydroxypoly-

Phenothiazine .............................................................................................. For use only as polymerization-control agent.

Allylmethacrylate (CAS Reg. No. 00096–05–09).

Poly(oxycaproyl) diols and triols (minimum molecular weight 500).

Polyoxyethylene (molecular weight 200) dibenzoate.

a, a′, a″-1,2,3-Propanetriyltris [omega-(2,3-epoxypropoxy) poly

Propyl alcohol (propanol).

Sodium dissobutylphenoxydiethoxyethyl sulfonate.

Synthetic wax polymer as described in § 176.170(a)(5) of this chapter.

[42 FR 14534, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

§ 175.125 Pressure-sensitive adhesives. (3) Color additives listed for use in or

as safe in food. (7) 2,2′-(2,5-Thiophenediyl)-bis(5-tert-

not to exceed 0.05 percent by weight of Rubber hydrochloride.

Rapeseed oil, vulcanized. sion defoamer.

List of substances Limitations (a) The additive is synthesized by the

ing, packaging, transporting, or hold-

decahydronaphthalene at 88 °C not ex- § 175.270 Poly(vinyl fluoride) resins.

food-contact articles, a separate test for intrinsic viscosity. The following

(i) Drying oils, including the Sandarac.

minum butylate. Myristyl alcohol.

(e) Catalysts: 3-(Aminomethyl)-3,5,5-trimethylcyclohexyl-

section, table 1, under Types I, II, and III,

gallons. tact with foods only of the types identified

their curing catalyst: cent of unreacted 2,3-epoxypropyl meth-

that are intended for contact, under condi-

shall be at least 2,000 (as determined by gel (xxiv) Plasticizers:

(Copies may be obtained from the Amer-

(containing not more than 20 percent of employed as a component of a con-

A. High temperature I, IV–B ................... 250 °F, 2 hr ................... .

(no thermal treatment VI–B,VII.

TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR

(e) Analytical methods—(1) Selection of to 1 gallon, quadruplicate samples of

having a capacity of over 1 gallon. small amount of demineralized dis-

the container within 1⁄4-inch of the top

e′ or ee′ is substituted for e in the above equa-

section, the concentration of extrac- e in the formulas in paragraph (e)(5)(i)

(i) Resins and polymers:

Acrylamide copolymerized with ethyl acrylate and/or sty-

List of substances Limitations

List of substances Limitations

Styrene copolymerized with one or more of the following:

List of substances Limitations

minum, ammonium, calcium, magnesium, and sodium

List of substances Limitations

Methyl ethyl ketone.

(a) The copolymer may contain added tion.

percent (by volume) ethyl alcohol in Silica gel.

(d) The coating in the finished form Subpart A [Reserved]

part 176 appear at 61 FR 14482, Apr. 2, 1996, 66

used to prevent the transfer of inks to accomplish the intended technical

Acetyl peroxide ............................................................................ For use only as polymerization catalyst.

List of Substances Limitations

List of Substances Limitations

List of Substances Limitations

List of Substances Limitations