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Food and Drug Administration, HHS 175.

300

175.270 Poly(vinyl fluoride) resins. c=Concentration of solution in terms of


grams per deciliter.
Poly(vinyl fluoride) resins identified
[42 FR 14534, Mar. 15, 1977, as amended at 47
in this section may be safely used as FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19,
components of food-contact coatings 1984]
for containers having a capacity of not
less than 5 gallons, subject to the pro- 175.300 Resinous and polymeric coat-
visions of this section. ings.
(a) For the purpose of this section, Resinous and polymeric coatings
poly(vinyl fluoride) resins consist of may be safely used as the food-contact
basic resins produced by the polym- surface of articles intended for use in
erization of vinyl fluoride. producing, manufacturing, packing,
(b) The poly(vinyl fluoride) basic res- processing, preparing, treating, pack-
ins have an intrinsic viscosity of not aging, transporting, or holding food, in
less than 0.75 deciliter per gram as de- accordance with the following pre-
termined by ASTM method D124379, scribed conditions:
Standard Test Method for Dilute So- (a) The coating is applied as a contin-
lution Viscosity of Vinyl Chloride uous film or enamel over a metal sub-
Polymers, which is incorporated by strate, or the coating is intended for
reference. Copies may be obtained from repeated food-contact use and is ap-
the American Society for Testing Ma- plied to any suitable substrate as a
terials, 1916 Race St., Philadelphia, PA continuous film or enamel that serves
19103, or may be examined at the Office as a functional barrier between the
of the Federal Register, 800 North Cap- food and the substrate. The coating is
itol Street, NW., suite 700, Washington, characterized by one or more of the fol-
DC 20408. lowing descriptions:
(1) Coatings cured by oxidation.
(1) Solvent. N,N-Dimethylacetamide,
(2) Coatings cured by polymerization,
technical grade.
condensation, and/or cross-linking
(2) Solution. Powdered resin and sol- without oxidation.
vent are heated at 120 C until the resin (3) Coatings prepared from prepoly-
is dissolved. merized substances.
(3) Temperature. Flow times of the (b) The coatings are formulated from
solvent and solution are determined at optional substances that may include:
110 C. (1) Substances generally recognized
(4) Viscometer. Cannon-Ubbelohde size as safe in food.
50 semimicro dilution viscometer (or (2) Substances the use of which is
equivalent). permitted by regulations in this part
(5) Calculation. The calculation meth- or which are permitted by prior sanc-
od used is that described in appendix X tion or approval and employed under
1.3 (ASTM method D124379, Standard the specific conditions, if any, of the
Test Method for Dilute Solution Vis- prior sanction or approval.
cosity of Vinyl Chloride Polymers, (3) Any substance employed in the
which is incorporated by reference; see production of resinous and polymeric
paragraph (b) of this section for avail- coatings that is the subject of a regula-
ability of the incorporation by ref- tion in subchapter B of this chapter
erence) with the reduced viscosity de- and conforms with any specification in
termined for three concentration levels such regulation. Substances named in
not greater than 0.5 gram per deciliter this paragraph (b)(3) and further identi-
and extrapolated to zero concentration fied as required:
for intrinsic viscosity. The following (i) Drying oils, including the
formula is used for determining re- triglycerides or fatty acids derived
duced viscosity: therefrom:

Reduced viscosity in terms t to


Beechnut.

of deciliters per gram = to c


Candlenut.
Castor (including dehydrated).
Chinawood (tung).
where: Coconut.
t=Solution efflux time. Corn.
to=Solvent efflux time. Cottonseed.

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175.300 21 CFR Ch. I (4100 Edition)
Fish (refined). Gum rosin.
Hempseed. Tall oil rosin.
Linseed. Wood rosin.
Oiticica.
Perilla. (b) Rosin esters formed by reacting
Poppyseed. rosin (paragraph (b)(3)(v)(a) of this sec-
Pumpkinseed. tion) with:
Safflower.
Sesame. 4,4-sec-Butylidenediphenol-epichlorohydrin
Soybean. (epoxy).
Sunflower. Diethylene glycol.
Tall oil. Ethylene glycol.
Walnut. Glycerol.
4,4-Isopropylidenediphenol-epichlorohydrin
The oils may be raw, heat-bodied, or (epoxy).
blown. They may be refined by filtra- Methyl alcohol.
tion, degumming, acid or alkali wash- Pentaerythritol.
ing, bleaching, distillation, partial de- (c) Rosin esters (paragraph (b)(3)(v)(b)
hydration, partial polymerization, or of this section) modified by reaction
solvent extraction, or modified by com- with:
bination with maleic anhydride.
Maleic anhydride.
(ii) Reconstituted oils from
o-, m-, and p-substituted phenol-formalde-
triglycerides or fatty acids derived hydes listed in paragraph (b)(3)(vi) of this
from the oils listed in paragraph section.
(b)(3)(i) of this section to form esters Phenol-formaldehyde.
with:
(d) Rosin salts:
Butylene glycol.
Ethylene glycol. Calcium resinate (limed rosin).
Pentaerythritol. Zinc resinate.
Polyethylene glycol. (vi) Phenolic resins as the basic poly-
Polypropylene glycol.
Propylene glycol.
mer formed by reaction of phenols with
Sorbitol. formaldehyde:
Trimethylol ethane. (a) Phenolic resins formed by reac-
Trimethylol propane. tion of formaldehyde with:
(iii) Synthetic drying oils, as the Alkylated (methyl, ethyl, propyl, isopropyl,
basic polymer: butyl) phenols.
p-tert-Amylphenol.
Butadiene and methylstyrene copolymer. 4,4-sec-Butylidenediphenol.
Butadiene and styrene copolymer, blown or p-tert-Butylphenol.
unblown. o-, m-, and p-Cresol.
Maleic anhydride adduct of butadiene sty- p-Cyclohexylphenol.
rene. 4,4-Isopropylidenediphenol.
Polybutadiene. p-Nonylphenol.
(iv) Natural fossil resins, as the basic p-Octylphenol.
3-Pentadecyl phenol mixture obtained from
resin:
cashew nut shell liquid.
Copal. Phenol.
Damar. Phenyl o-cresol.
Elemi. p-Phenylphenol.
Gilsonite. Xylenol.
Glycerol ester of damar, copal, elemi, and
sandarac.
(b) Adjunct for phenolic resins: Alu-
Sandarac. minum butylate.
Shellac. (vii) Polyester resins (including
Utah coal resin. alkyd-type), as the basic polymers,
formed as esters of acids listed in para-
(v) Rosins and rosin derivatives, with
graph (b)(3)(vii) (a) and (b) of this sec-
or without modification by polymeriza-
tion by reaction with alcohols in para-
tion, isomerization, incidental
graph (b)(3)(vii) (c) and (d) of this sec-
decarboxylation, and/or hydrogenation,
tion.
as follows:
(a) Polybasic acids:
(a) Rosins, refined to color grade of K
or paler: Adipic.

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Food and Drug Administration, HHS 175.300
1,4-cyclohexanedicarboxylic (CAS Reg. No. Monobutyltin tris(2-ethylhexoate) (CAS Reg.
1076977). No. 23850944), not to exceed 0.2 percent of
Dimerized fatty acids derived from oils listed the polyester resin.
in paragraph (b)(3)(i) of this section.
Fumaric. (viii) Epoxy resins, catalysts, and ad-
Isophthalic. juncts:
Maleic. (a) Epoxy resins, as the basic poly-
2,6-Naphthalenedicarboxylic. mer:
2,6-Naphthalenedicarboxylic, dimethyl ester.
(Alkoxy C10C16)-2,3-epoxypropane, in which
Orthophthalic.
the alkyl groups are even numbered and
Sebacic. consist of a maximum of 1 percent C10 car-
Terephthalic. bon atoms and a minimum of 48 percent C12
Terpene-maleic acid adduct. carbon atoms and a minimum of 18 percent
Trimellitic. C14 carbon atoms, for use only in coatings
(b) Monobasic acids: that are intended for contact with dry bulk
foods at room temperature.
Benzoic acid. 4,4-sec-Butylidenediphenol-epichlorohydrin.
4,4-Bis(4-hydroxyphenyl)-pentanoic acid. 4,4-sec-Butylidenediphenol-epichlorohydrin
tert-Butyl benzoic acid. reacted with one or more of the drying oils
Fatty acids derived from oils listed in para- or fatty acids listed in paragraph (b)(3)(i)
graph (b)(3)(i) of this section. of this section.
Rosins listed in paragraph (b)(3)(v)(a) of this 4,4-sec-Butylidenediphenol-epichlorohydrin
section, for use only as reactants in oil- chemically treated with one or more of
based or fatty acid-based alkyd resins. the following substances:
Allyl ether of mono-, di-, or trimethylol
(c) Polyhydric alcohols: phenol.
Butylene glycol. 4,4-sec-Butylidenediphenol-formaldehyde.
4,4-Isopropylidenediphenol-formaldehyde.
Diethylene glycol.
Melamine-formaldehyde.
2,2-Dimethyl-1,3-propanediol for use only in
Phenol-formaldehyde.
forming polyester resins for coatings in-
Urea-formaldehyde.
tended for use in contact with non-alco-
Epoxidized polybutadiene.
holic foods.
Glycidyl ethers formed by reacting
Ethylene glycol.
phenolnovolak resins with
Glycerol.
epichlorohydrin.
Mannitol.
4,4-Isopropylidenediphenol-epichlorohydrin.
-Methyl glucoside. 4,4-Isopropylidenediphenol-epichlorohydrin
Pentaerythritol. reacted with one or more of the drying oils
Propylene glycol. or fatty acids listed in paragraph (b)(3)(i)
Sorbitol. of this section.
Triethylene glycol, for use as a component in 4,4-Isopropylidenediphenol-epichlorohydrin
polyester resins for coatings not exceeding chemically treated with one or more of
a coating weight of 4 milligrams per square the following substances:
inch and that are intended for contact Allyl ether of mono-, di-, or trimethylol
under conditions of use D, E, F or G de- phenol.
scribed in table 2 of paragraph (d) of this 4,4-sec-Butylidenediphenol-formaldehyde.
section with alcoholic beverages con- 4,4-Isopropylidenediphenol-formaldehyde.
taining less than 8 percent alcohol. Melamine-formaldehyde.
Trimethylol ethane. 2,2-[(1-methylethylidene)bis[4,1-
Trimethylol propane. phenyleneoxy[1-(butoxymethyl)-2,1-
(d) Monohydric alcohols: ethanediyl]oxymethylene]]bisoxirane,
CAS Reg. No. 71033084, for use only in
Cetyl alcohol. coatings intended for contact with bulk
Decyl alcohol. dry foods at temperatures below 100 F.
Lauryl alcohol. Phenol-formaldehyde.
Myristyl alcohol. Urea-formaldehyde.
Octyl alcohol.
Stearyl alcohol. (b) Catalysts and cross-linking agents
for epoxy resins:
(e) Catalysts:
3-(Aminomethyl)-3,5,5-trimethylcyclohexyl-
Dibutyltin oxide (CAS Reg. No. 818086), not amine reacted with phenol and formalde-
to exceed 0.2 percent of the polyester resin. hyde in a ratio of 2.6:1.0 :2.0, for use only in
Hydroxybutyltin oxide (CAS Reg. No. 2273 coatings intended for repeated use in con-
430), not to exceed 0.2 percent of the poly- tact with foods only of the types identified
ester resin. in paragraph (d) of this section, table 1,

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175.300 21 CFR Ch. I (4100 Edition)
under Category I and Category VIII, at coatings for tanks of capacity greater than
temperatures not exceeding 88 C (190 F). 530,000 gallons.
N-Beta-(aminoethyl)-gamma-aminopropyltri- Diethylenetriamine.
methoxysilane (CAS Reg. No. 1760243), for Diphenylamine.
use only in coatings at a level not to ex- Ethylenediamine.
ceed 1.3 percent by weight of the resin Isophthalyl dihydrazide for use only in coat-
when such coatings are intended for re- ings subject to the provisions of paragraph
peated use in contact with foods only of (c) (3) or (4) of this section.
the types identified in paragraph (d) of this 4,4-Methylenedianiline, for use only in coat-
section, table 1, under Types I, II, and III, ings for containers having a capacity of
under conditions of use C, D, E, or F as de- 1,000 gallons or more when such containers
scribed in table 2 of paragraph (d) of this are intended for repeated use in contact
section; or when such coatings are in- with alcoholic beverages containing up to 8
tended for repeated use in contact with percent of alcohol by volume.
foods of the types identified in paragraph N-Oleyl-1,3-propanediamine with not more
(d) of this section, table 1, under Types V, than 10 percent by weight of
VI, VII, and VIII, under conditions of use E diethylaminoethanol.
or F as described in table 2 of paragraph (d) 3-Pentadecenyl phenol mixture (obtained
of this section. Use shall be limited to from cashew nutshell liquid) reacted with
coatings for tanks of capacity greater than formaldehyde and ethylenediamine in a
530,000 gallons. ratio of 1:2:2 (CAS Reg. No. 68413285).
Benzyl alcohol (CAS Reg. No. 100516), for Polyamine produced when 1 mole of the
use only in coatings at a level not to ex- chlorohydrin diether of polyethylene gly-
ceed 4 percent by weight of the resin when col 400 is made to react under
such coatings are intended for repeated use dehydrohalogenating conditions with 2
in contact with foods only of the types moles of N-octadecyltrimethylenediamine
identified in paragraph (d) of this section, for use only in coatings that are subject to
table 1, under Types I, II, and III, under the provisions of paragraph (c) (3) or (4) of
conditions of use C, D, E, or F as described this section and that contact food at tem-
in table 2 of paragraph (d) of this section; peratures not to exceed room temperature.
or when such coatings are intended for re- Salicylic acid, for use only in coatings for
peated use in contact with foods of the containers having a capacity of 1,000 gal-
types identified in paragraph (d) of this lons or more when such containers are in-
section, table 1, under Types V, VI, VII, tended for repeated use in contact with al-
and VIII, under conditions of use E or F as coholic beverages containing up to 8 per-
described in table 2 of paragraph (d) of this cent of alcohol by volume.
section. Use shall be limited to coatings Salicylic acid (CAS Reg. No. 69727), for use
for tanks of capacity greater than 530,000 only in coatings at a level not to exceed
gallons. 0.35 percent by weight of the resin when
Catalysts and cross-linking agents for epoxy such coatings are intended for repeated use
resins: in contact with foods only of the types
3-Aminomethyl-3,5,5- identified in paragraph (d) of this section,
trimethylcyclohexylamine (CAS Reg. No. table 1, under Types I, II, and III, under
28550913092). conditions of use C, D, E, or F as described
Cyanoguanidine. in table 2 of paragraph (d) of this section;
Dibutyl phthalate, for use only in coatings or when such coatings are intended for re-
for containers having a capacity of 1,000 peated use in contact with foods of the
gallons or more when such containers are types identified in paragraph (d) of this
intended for repeated use in contact with section, table 1, under Types V, VI, VII,
alcoholic beverages containing up to 8 per- and VIII, under conditions of use E or F as
cent of alcohol by volume. described in table 2 of paragraph (d) of this
3-Diethylaminopropylamine (CAS Reg. No. section. Use shall be limited to coatings
104789), for use in coatings at a level not for tanks of capacity greater than 530,000
to exceed 6 percent by weight of the resin gallons.
when such coatings are intended for re- Stannous 2-ethylhexanoate for use only as a
peated use in contact with foods only of catalyst at a level not to exceed 1 percent
the types identified in paragraph (d) of this by weight of the resin used in coatings that
section, table 1, under Types I, II, and III, are intended for contact with food under
under conditions of use C, D, E, or F as de- conditions of use D, E, F, and G described
scribed in table 2 of paragraph (d) of this in table 2 of paragraph (d) of this section.
section; or when such coatings are in- Styrene oxide, for use only in coatings for
tended for repeated use in contact with containers having a capacity of 1,000 gal-
foods of the types identified in paragraph lons or more when such containers are in-
(d) of this section, table 1, under Types V, tended for repeated use in contact with al-
VI, VII, and VIII, under conditions of use E coholic beverages containing up to 8 per-
or F as described in table 2 of paragraph (d) cent of alcohol by volume.
of this section. Use shall be limited to Tetraethylenepentamine.

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Food and Drug Administration, HHS 175.300
Tetraethylenepentamine reacted with (c) Adjuncts for epoxy resins:
equimolar quantities of fatty acids.
Tri(dimethylaminomethyl) phenol and its Aluminum butylate.
salts prepared from the fatty acid moieties Benzoic acid, for use as a component in
of the salts listed in paragraph epoxy resins for coatings not exceeding a
(b)(3)(xxii)(b) of this section, for use only coating weight of 4 milligrams per square
in coatings subject to the provisions of inch and that are intended for contact
paragraph (c) (3) or (4) of this section. under conditions of use D, E, F or G de-
scribed in table 2 of paragraph (d) of this
Triethylenetetramine.
section with alcoholic beverages con-
Trimellitic anhydride (CAS Reg. No. 55230 taining less than 8 percent alcohol.
7) for use only as a cross-linking agent at Polyamides from dimerized vegetable oils
a level not to exceed 15 percent by weight and the amine catalysts listed in para-
of the resin in contact with food under all graph (b)(3)(viii)(b) of this section, as the
conditions of use, except that resins in- basic polymer.
tended for use with foods containing more Silane coupled silica, prepared from the re-
than 8 percent alcohol must contact such action of microcrystalline quartz with N-
food only under conditions of use D, E, F, beta-(N-vinylbenzylamino) ethyl-gamma-
and G described in table 2 of paragraph (d) aminopropyltrimethoxy silane, mono-
of this section. hydrogen chloride, for use only in coatings
Trimellitic anhydride adducts of ethylene intended for repeated use in contact with
glycol and glycerol, prepared by the reac- foods only of the types identified in para-
tion of 1 mole of trimellitic anhydride with graph (d) of this section, table 1, under
0.40.6 mole of ethylene glycol and 0.040.12 Category I and Category VIII, at tempera-
mole of glycerol, for use only as a cross- tures not exceeding 88 C (190 F).
linking agent at a level not to exceed 10 Succinic anhydride, for use as a component
percent by weight of the cured coating, in epoxy resins for coatings not exceeding
provided that the cured coating only con- a coating weight of 4 milligrams per square
tacts food containing not more than 8 per- inch, and that are intended for contact
cent alcohol. under conditions of use D, E, F or G de-
Meta-Xylylenediamine (1,3-benzenedi- scribed in table 2 of paragraph (d) of this
methanamine, CAS Reg. No. 1477550), for section with alcoholic beverages con-
use only in coatings at a level not to ex- taining less than 8 percent alcohol.
ceed 3 percent by weight of the resin when
such coatings are intended for repeated use (ix) Coumarone-indene resin, as the
in contact with foods only of the types basic polymer.
identified in paragraph (d) of this section, (x) Petroleum hydrocarbon resin
table 1, under Types I, II, and III, under (cyclopentadiene type), as the basic
conditions of use C, D, E or F as described polymer.
in table 2 of paragraph (d) of this section; (xi) Terpene resins, as the basic poly-
or when such coatings are intended for re- mer, from one or more of the following:
peated use in contact with foods of the
types identified in paragraph (d) of this Dipentene.
section, table 1, under Types V, VI, VII, Hydrogenated dipentene resin (CAS Reg. No.
and VIII, under conditions of use E or F as 106168392). For use only with coatings in
described in table 2 of paragraph (d) of this contact with acidic and aqueous foods.
section. Use shall be limited to coatings Hydrogenated-beta-pinene-alpha-pinene-
for tanks of capacity greater than 530,000 dipentene copolymer resin (CAS Reg. No.
gallons. 106168370). For use only with coatings in
Para-Xylylenediamine (1,4 benzenedimethan- contact with acidic and aqueous foods.
amine, CAS Reg. No. 539480), for use only -Pinene.
in coatings at a level not to exceed 0.6 per- -Pinene.
cent by weight of the resin when such coat- (xii) Urea-formaldehyde, resins and
ings are intended for repeated use in con-
their curing catalyst:
tact with foods only of the types identified
in paragraph (d) of this section, table 1, (a) Urea-formaldehyde resins, as the
under Types I, II, III, under conditions of basic polymer:
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:

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175.300 21 CFR Ch. I (4100 Edition)
Dodecyl benzenesulfonic acid (C.A. Registry cent of total polymer units derived from
No. 27176870). acrylamide; the acrylamide portion may or
may not be subsequently partially
(xiii) Triazine-formaldehyde resins hydrolyzed.
and their curing catalyst: Vinyl chloride copolymerized with one or
(a) Triazine-formaldehyde resins, as more of the following substances:
the basic polymer: Acrylonitrile.
Fumaric acid and/or its methyl, ethyl,
Benzoguanamine-formaldehyde. propyl, butyl, amyl, hexyl, heptyl, or octyl
Melamine-formaldehyde. esters.
Melamine-formaldehyde chemically modified Maleic acid and/or its methyl, ethyl, propyl,
with one or more of the following amine butyl, amyl, hexyl, heptyl, or octyl esters.
catalysts: 5-Norbornene-2,3-dicarboxylic acid, mono-n-
Amine catalysts listed in paragraph butyl ester; for use such that the finished
(b)(3)(viii)(b) of this section. vinyl chloride copolymers contain not
Dimethylamine-2-methyl-1-propanol. more than 4 weight percent of total poly-
Methylpropanolamine.
mer units derived from this comonomer.
Triethanolamine.
Vinyl acetate.
Melamine-formaldehyde chemically modified Vinylidene chloride.
with methyl, ethyl, propyl, isopropyl, Vinyl chloride-vinylidene chloride-2,3-
butyl, or isobutyl alcohol. epoxypropyl methacrylate copolymers con-
(b) Curing (cross-linking) catalyst for taining not more than 10 weight percent of
triazine-formaldehyde resins: total polymer units derived from 2,3-
epoxypropyl methacrylate and not more
Dodecyl benzenesulfonic acid (C.A. Registry than 0.05 weight percent of unreacted 2,3-
No. 27176870). epoxypropyl methacrylate monomer based
on polymer solids for use only in coatings
(xiv) Modifiers (for oils and alkyds, for containers intended for contact with
including polyesters), as the basic poly- foods under conditions B, C, D, E, F, G, or
mer: H described in table 2 of paragraph (d) of
Butyl methacrylate. this section.
Cyclopentadiene. (xvi) Cellulosics, as the basic poly-
Methyl, ethyl, butyl, or octyl esters of acryl- mer:
ic acid.
Methyl methacrylate. Carboxymethylcellulose.
Styrene. Cellulose acetate.
Vinyl toluene. Cellulose acetate-butyrate.
Cellulose acetate-propionate.
(xv) Vinyl resinous substance, as the Ethylcellulose.
basic polymers: Ethyl hydroxyethylcellulose.
Hydroxyethylcellulose.
Polyvinyl acetate.
Hydroxypropyl methylcellulose.
Polyvinyl alcohol.
Methylcellulose.
Polyvinyl butyral.
Nitrocellulose.
Polyvinyl chloride.
Polyvinyl formal. (xvii) Styrene polymers, as the basic
Polyvinylidene chloride. polymer:
Polyvinyl pyrrolidone.
Polyvinyl stearate. Polystyrene.
Vinyl chloride-acetate-2,3-epoxypropyl meth- -Methyl styrene polymer.
acrylate copolymers containing not more Styrene copolymerized with one or more of
than 10 weight percent of total polymer the following:
units derived from 2,3-epoxypropyl meth- Acrylonitrile.
acrylate and not more than 0.1 weight per- -Methylstyrene.
cent of unreacted 2,3-epoxypropyl meth-
acrylate monomer for use in coatings for
(xviii) Polyethylene and its copoly-
containers. mers as the basic polymer:
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:

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Food and Drug Administration, HHS 175.300
Polypropylene. and a refractive index, nD25 (40 percent in
Maleic anhydride adduct of polypropylene 2,2,4-trimethyl pentane) of 1.41301.4190; for
The polypropylene used in the manufac- use as a modifier for nylon resins com-
ture of the adduct complies with plying with 177.1500 of this chapter and for
177.1520(c), item 1.1; and the adduct has a phenolic and epoxy resins listed in para-
maximum combined maleic anhydride con- graph (b)(3) (vi) and (viii) of this section,
tent of 0.8 percent and a minimum intrin- respectively, at a level not to exceed 1.5
sic viscosity of 0.9, determined at 135 C on percent of the coating.
a 0.1 percent solution of the modified poly- 2-Ethylhexyl acrylate-methyl methacrylate-
propylene in decahydronaphthalene as de- acrylic acid copolymers for use only as
termined by a method titled Method for modifiers for epoxy resins listed in para-
Determination of Intrinsic Viscosity of graph (b)(3)(viii) of this section.
Maleic Anhydride Adduct of Poly- Methacrylic acid and the following esters
propylene, which is incorporated by ref- thereof:
erence. Copies are available from the Cen- Butyl.
ter for Food Safety and Applied Nutrition Ethyl.
(HFS200), Food and Drug Administration, Methyl.
200 C St. SW., Washington, DC 20204, or Methacrylic acid or its ethyl and methyl
available for inspection at the Office of the esters copolymerized with one or more of
Federal Register, 800 North Capitol Street, the following:
NW., suite 700, Washington, DC 20408. Acrylic acid.
Ethyl acrylate.
(xx) Acrylics and their copolymers, Methyl acrylate.
as the basic polymer: n-Butyl acrylate-styrene-methacrylic acid-
Acrylamide with ethylacrylate and/or sty- hydroxyethyl methacrylate copolymers
rene and/or methacrylic acid, subsequently containing no more than 2 weight percent
reacted with formaldehyde and butanol. of total polymer units derived from meth-
Acrylic acid and the following esters thereof: acrylic acid and containing no more than
Ethyl. 9.5 weight percent of total polymer units
Methyl. derived from hydroxyethyl methacrylate;
Butyl acrylate-styrene-methacrylic acid-hy- for use only in coatings in contact with dry
droxyethyl methacrylate copolymers con- food (food type VIII in table 1 of paragraph
taining no more than 20 weight percent of (d) of this section). 2-(Dimethylamino) eth-
total polymer units derived from meth- anol (C.A.S. Registry No. 108010) may be
acrylic acid and containing no more than 7 employed as an optional adjuvant sub-
weight percent of total polymer units de- stance limited to no more than 2 weight
rived from hydroxyethyl methacrylate; for percent based on polymer solids in the
use only in coatings that are applied by coating emulsion.
electrodeposition to metal substrates. Styrene polymers made by the polymeriza-
Butyl acrylate-styrene-methacrylic acid- tion of any combination of styrene or
hydroxypropyl methacrylate copolymers alpha methyl styrene with acrylic acid,
containing no more than 20 weight percent methacrylic acid, 2-ethyl hexyl acrylate,
of total polymer units derived from meth- methyl methacrylate, and butyl acrylate.
acrylic acid and containing no more than 7 The styrene and alpha methyl styrene, in-
weight percent of total polymer units de- dividually, may constitute from 0 to 80
rived from hydroxypropyl methacrylate; weight percent of the polymer. The other
for use only in coatings that are applied by monomers, individually, may be from 0 to
electrodeposition to metal substrates and 40 weight percent of the polymer. The poly-
that are intended for contact, under condi- mer number average molecular weight (Mn)
tion of use D, E, F, or G described in table shall be at least 2,000 (as determined by gel
2 of paragraph (d) of this section, with food permeation chromatography). The acid
containing no more than 8 percent of alco- number of the polymer shall be less than
hol. 250. The monomer content shall be less
Ethyl acrylate-styrene-methacrylic acid co- than 0.5 percent. The polymers are for use
polymers for use only as modifiers for only in contact with food of Types IVA, V,
epoxy resins listed in paragraph VII in table 1 of paragraph (d) of this sec-
(b)(3)(viii)(a) of this section. tion, under use conditions E through G in
Ethyl acrylate-methyl methacrylate-sty- table 2 of paragraph (d), and with food of
rene-methacrylic acid copolymers for use Type VIII without use temperature restric-
only as modifiers for epoxy resins listed in tion.
paragraph (b)(3)(viii)(a) of this section. (xxi) Elastomers, as the basic poly-
2-Ethylhexyl acrylate-ethyl acrylate copoly- mer:
mers prepared by copolymerization of 2-
ethylhexyl acrylate and ethyl acrylate in a Butadiene-acrylonitrile copolymer.
7/3 weight ratio and having a number aver- Butadiene-acrylonitrile-styrene copolymer.
age molecular weight range of 5,800 to 6,500 Butadiene-styrene copolymer.

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175.300 21 CFR Ch. I (4100 Edition)
Butyl rubber. Glycerol.
Chlorinated rubber. Glyceryl monooleate.
2-Chloro-1,3-butadiene (neoprene). Glyceryl triacetate.
Natural rubber (natural latex or natural Monoisopropyl citrate.
latex solids, smoked or unsmoked). Propylene glycol.
Polyisobutylene. Sorbitol.
Rubber hydrochloride. Mono-, di-, and tristearyl citrate.
Styrene-isobutylene copolymer. Triethyl citrate.
(xxii) Driers made by reaction of a Triethylene glycol.
metal from paragraph (b)(3)(xxii)(a) of 3-(2-Xenolyl)-1,2-epoxypropane.
this section with acid, to form the salt (xxv) Release agents, as the basic
listed in paragraph (b)(3)(xxii)(b) of this polymer, when applicable:
section:
N,N-Dioleoylethylenediamine (CAS Reg. No.
(a) Metals:
110316) for use only in ionomeric resins
Aluminum. complying with 177.1330 of this chapter
Calcium. and in ethylene vinyl acetate copolymers
Cerium. complying with 177.1350 of this chapter at
Cobalt. a level not to exceed 0.0085 milligram per
Iron. square centimeter (0.055 milligram per
Lithium. square inch) in the finished food-contact
Magnesium. article.
Manganese. N,N-Distearoyl ethylenediamine.
Zinc. Linoleic acid amide.
Zirconium. Oleic acid amide.
Palmitic acid amide.
(b) Salts: Petrolatum.
Caprate. Polyethylene wax.
Caprylate. Polyoxyethylene glycol monooleate (mol.
Isodecanoate. wt. of the polyoxyethylene glycol moiety
Linoleate. greater than 300).
Naphthenate. Polytetrafluoroethylene.
Neodecanoate. Silicones (not less than 300 centistokes vis-
Octoate (2-ethylhexoate). cosity): Dimethylpolysiloxanes and/or
Oleate. methylphenylpolysiloxanes. The methyl-
Palmitate. phenylpolysiloxanes contain not more than
Resinate. 2.0 percent by weight of cyclosiloxanes
Ricinoleate. having up to and including 4 siloxy units.
Soyate. Silicones (not less than 100 centistokes vis-
Stearate. cosity): Dimethylpolysiloxanes and/or
Tallate. methylphenylpolysiloxanes limited to use
only on metal substrates. The
(xxiii) Waxes: methylphenylpolysiloxanes contain not
Paraffin, Type I. more than 2.0 percent by weight of
Paraffin, Type II. cyclosiloxanes having up to and including 4
Polyethylene. siloxy units.
Sperm oil. (xxvi) Colorants used in accordance
Spermaceti.
with 178.3297 of this chapter.
(xxiv) Plasticizers: (xxvii) Surface lubricants:
Acetyl tributyl citrate. Cottonseed oil and other edible oils.
Acetyl triethyl citrate. Dibutyl sebacate.
Butyl phthalyl butyl glycolate. Dioctyl sebacate.
Butyl stearate. Glyceryl monostearate.
p-tert-Butyl phenyl salicylate. Lanolin.
Dibutyl sebacate. Mineral oil, white.
Diethyl phthalate. Palm oil.
Diisobutyl adipate. Paraffin, Type I.
Diisooctyl phthalate. Paraffin, Type II.
Epoxidized soybean oil (iodine number max- Petrolatum.
imum 14; oxirane oxygen content 6% min- Stearic acid.
imum), as the basic polymer.
Ethyl phthalyl ethyl glycolate. (xxviii) Silicones and their curing
2-Ethylhexyl diphenyl phosphate. catalysts:
di-2-Ethylhexyl phthalate. (a) Silicones as the basic polymer:

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Food and Drug Administration, HHS 175.300
Siloxane resins originating from methyl hy- cured at temperatures of at least 193 C (380
drogen polysiloxane, dimethyl F) for 4 minutes.
polysiloxane, and methylphenyl
polysiloxane. (xxx) Antioxidants:
Siloxane resins originating from the plat- Butylated hydroxyanisole.
inum-catalyzed reaction product of vinyl- Butylated hydroxytoluene.
containing dimethylpolysiloxane (CAS Gum guaiac.
Reg. No. 68083181 and CAS Reg. No. 68083 Dilauryl thiodipropionate.
192) with methylhydrogen polysiloxane Nordihydroguaiaretic acid.
(CAS Reg. No. 63148572) and Propyl gallate.
dimethylmethylhydrogen polysiloxane Distearyl thiodipropionate.
(CAS Reg. No. 68037592), where the plat- Thiodipropionic acid.
inum content does not exceed 150 parts per 2,4,5-Trihydroxybutyrophenone.
million. The following substances may be
used as optional polymerization inhibitors: (xxxi) Can end cements (sealing com-
3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. pounds used for sealing can ends only):
107540), at a level not to exceed 0.53 In addition to the substances listed in
weight-percent; paragraph (b) of this section and those
1-Ethynylcyclohexene (CAS Reg. No. 93149 listed in 177.1210(b)(5) of this chapter,
7), at a level not to exceed 0.64 weight-per- the following may be used:
cent;
Bis(methoxymethyl)ethyl maleate (CAS Reg. Butadiene-styrene-divinylbenzene copolymer
No. 102054104), at a level not to exceed 1.0 (CAS Reg. No. 26471454) for use only at
weight-percent; levels not to exceed 23.8 percent by weight
Methylvinyl cyclosiloxane (CAS Reg. No. of the cement solids in can end cements.
68082235); and Butadiene-styrene-fumaric acid copolymer.
Tetramethyltetravinylcyclotetrasiloxane 4,4-Butylidenebis (6-tert-butyl-m-cresol).
(CAS Reg. No. 2554065). Dibenzamido phenyl disulfide.
Di--naphthyl phenylenediamine.
(b) Curing (cross-linking) catalysts Dipentamethylene thiuram tetrasulfide.
for silicones (the maximum amount of Isobutylene-isoprene-divinylbenzene copoly-
tin catalyst used shall be that required mers for use only at levels not to exceed 15
to effect optimum cure but shall not percent by weight of the dry cement com-
exceed 1 part of tin per 100 parts of si- position.
Naphthalene sulfonic acid-formaldehyde con-
loxane resins solids):
densate, sodium salt, for use only at levels
Dibutyltin dilaurate. not to exceed 0.6 percent by weight of the
Stannous oleate. cement solids in can end cements for con-
Tetrabutyl titanate. tainers having a capacity of not less than
5 gallons.
(xxix) Surface active agents: Sodium decylbenzene sulfonate.
Ethylene oxide adduct of 2,4,7,9-tetramethyl- Sodium nitrite for use only at levels not to
5-decyn-4,7-diol (CAS Reg. No. 9014851). exceed 0.3 percent by weight of the cement
solids in can end cements for containers
Poly[2-(diethylamino) ethyl methacrylate]
having a capacity of not less than 5 gal-
phosphate (minimum intrinsic viscosity in
lons.
water at 25 C is not less than 9.0 deciliters
per gram as determined by ASTM method Sodium pentachlorophenate for use as a pre-
D124379, Standard Test Method for Dilute servative at 0.1 percent by weight in can-
Solution Viscosity of Vinyl Chloride Poly- sealing compounds on containers having a
mers, which is incorporated by reference capacity of 5 gallons or more.
(copies may be obtained from the Amer- Sodium phenylphenate.
ican Society for Testing Materials, 1916 Styrene-maleic anhydride resin, partial
Race St., Philadelphia, PA 19103, or may be methyl and butyl (sec- or iso-) esters, for
examined at the Office of the Federal Reg- use only at levels not in excess of 3 percent
ister, 800 North Capitol Street, NW., suite of the cement solids in can end cement for-
700, Washington, DC 20408), for use only as mulations.
a suspending agent in the manufacture of Tetrasodium EDTA (tetrasodium ethylene-
vinyl chloride copolymers and limited to diaminetetraacetate).
use at levels not to exceed 0.1 percent by Tri (mixed mono- and dinonylphenyl)
weight 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.

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175.300 21 CFR Ch. I (4100 Edition)
p-tert-Butyl perbenzoate as a catalyst for Ammonium citrate.
epoxy resin. Ammonium potassium phosphate.
epsilon-Caprolactam-(ethylene-ethyl acry- Bentonite, modified by reaction with benzyl
late) graft polymer. dimethyl alkyl ammonium chloride, where
Dicumyl peroxide for use only as polymeriza- the alkyl groups are derived from hydro-
tion catalyst. genated tallow (CAS Reg. No. 71011240).
4(Diiodomethylsulfonyl) toluene (CAS Reg. For use only as a rheological agent in coat-
No. 20018091) for use as a preservative at ings intended to contact food under re-
a level not to exceed 0.3 percent by weight peated use conditions.
in cansealing cements. Bentonite, modified by reaction with sodium
Diisodecyl phthalate for use only as plasti- stearate and benzyl dimethyl alkyl ammo-
cizer in side seam cements for containers nium chloride, where the alkyl groups are
intended for use in contact with food only derived from hydrogenated tallow (CAS
of the types identified in paragraph (d) of Reg. No. 121888684). For use as a
this section, table 1, under Categories I, II, rheological agent only in coatings in-
and VI. tended to contact dry food under repeated-
4,4-Bis(alpha,alpha-dimethyl- use conditions.
benzyl)diphenylamine, CAS Reg. No. 10081 Calcium acetate.
671. Calcium ethyl acetoacetate.
Ethyl toluene sulfonamide. Calcium glycerophosphate.
N,N-Hexamethylenebis(3,5-di-tert-butyl-4- Calcium, sodium, and potassium oleates.
hydroxyhydrocinnamide), CAS Reg. No. Calcium, sodium, and potassium
23128747. ricinoleates.
Polyamides consisting of the following: Calcium, sodium, and potassium stearates.
Copolymer of omega-laurolactam and Castor oil, hydrogenated.
espilon-caprolactam, CAS Reg. No. 25191 Castor oil, hydrogenated polymer with ethyl-
042 (Nylon 12/6). enediamine, 12-hydroxyoctadecanoic acid
Homopolymer of omega-aminododecanoic and sebacic acid (CAS Reg. No. 68604068).
acid, CAS Reg. No. 24937164. The condensation product formed by the
Homopolymer of omega-laurolactam, CAS reaction of hydrogenated castor oil with
Reg. No. 25038748 (Nylon 12). polyamide derived from ethylenediamine,
Polyamides derived from the following acids
sebacic acid and 12-hydroxystearic acid, for
and amines:
use only in coatings at a level not to ex-
Acids:
ceed 3.2 percent by weight of the resin
Adipic.
when such coatings are intended for re-
Azelaic.
peated use in contact with foods only of
Sebacic.
the types identified in paragraph (d) of this
Vegetable oil acids (with or without
section, table 1, under Types I, II, and III,
dimerization).
under conditions of use C, D, E, or F as de-
Amines:
scribed in table 2 of paragraph (d) of this
Diethylenetriamine.
section; or when such coatings are in-
Diphenylamine.
tended for repeated use in contact with
Ethylenediamine.
foods of the types identified in paragraph
Hexamethylenediamine.
(d) of this section, table 1, under Types V,
Tetraethylenepentamine.
VI, VII, and VIII, under conditions of use E
Triethylenetetramine.
or F as described in table 2 of paragraph (d)
Polypropylene glycol CAS Reg. No. 2532269
of this section. Use shall be limited to
4.
coatings for tanks of capacity greater than
Sodium pentachlorophenate for use as a pre-
530,000 gallons.
servative at 0.1 percent by weight in can-
sealing compounds on containers having a Castor oil, sulfated, sodium salt (CAS Reg.
capacity of 5 gallons or more. No. 68187768), 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. 6683198. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS
Toluene sulfonamide formaldehyde resin Reg. No. 26172554) and 2-methyl-4-
(basic polymer). isothiazolin-3-one (CAS Reg. No. 2628204)
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. 293590
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. 10377603) 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

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Food and Drug Administration, HHS 175.300
(based on isothiazolone active ingredient) million (based on silver ion concentration)
in the coating formulations. in the dry coating.
Cyclohexanone-formaldehyde resin produced Sodium pyrophosphate.
when 1 mole of cyclohexanone is made to Stannous chloride.
react with 1.65 moles of formaldehyde such Stannous stearate.
that the finished resin has an average mo- Stannous sulfate.
lecular weight of 600610 as determined by Stearyl alcohol.
ASTM method D250382, Standard Test 2-Sulfoethyl methacrylate, sodium salt (CAS
Method for Molecular Weight (Relative Reg. No. 1804871). For use only in copoly-
Molecular Mass) of Hydrocarbons by Ther- mer coatings on metal under conditions of
moelectric Measurement of Vapor Pres- use E, F, and G described in table 2 of para-
sure, which is incorporated by reference. graph (d) of this section, and limited to use
Copies may be obtained from the American at a level not to exceed 2.0 percent by
Society for Testing Materials, 1916 Race weight of the dry copolymer coating.
St., Philadelphia, PA 19103, or may be ex- Tetrasodium pyrophosphate.
amined at the Office of the Federal Reg- Tridecyl alcohol produced from
ister, 800 North Capitol Street, NW., suite tetrapropylene by the oxo process, for use
700, Washington, DC 20408. For use only in only as a processing aid in polyvinyl chlo-
contact with nonalcoholic and nonfatty ride resins.
foods under conditions of use E, F, and G, Trimethylolpropane (CAS Reg. No. 77996).
described in table 2 of paragraph (d) this For use as a pigment dispersant at levels
section. not to exceed 0.45 percent by weight of the
Decyl alcohol. pigment.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg No. Vinyl acetate-dibutyl maleate copolymers
35691657). For use as an antimicrobial produced when vinyl acetate and dibutyl
agent at levels not to exceed 500 milli- maleate are copolymerized with or without
grams per kilogram in emulsion-based sili- one of the monomers: Acrylic acid or
cone coatings. glycidyl methacrylate. For use only in
Disodium hydrogen phosphate. coatings for metal foil used in contact with
Ethyl acetoacetate. foods that are dry solids with the surface
Hectorite, modified by reaction with a mix- containing no free fat or oil. The finished
ture of benzyl methyl dialkyl ammonium copolymers shall contain at least 50
chloride and dimethyl dialkyl ammonium weight-percent of polymer units derived
chloride, where the alkyl groups are de- from vinyl acetate and shall contain no
rived from hydrogenated tallow (CAS Reg. more than 5 weight-percent of total poly-
No. 121888673). For use as a rheological mer units derived from acrylic acid or
agent only in coatings intended to contact glycidyl methacrylate.
dry food under repeated-use conditions.
Lauryl alcohol. (xxxiv) Polyamide resins derived
Lecithin. from dimerized vegetable oil acids
Magnesium, sodium, and potassium citrate. (containing not more than 20 percent of
Magnesium glycerophosphate. monomer acids) and ethylenediamine,
Magnesium stearate. as the basic resin, for use only in coat-
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.
4,4-bis (4-hydroxyphenyl) pentanoic
Poly(ethylene oxide).
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. 116810470) 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- the polyamide resins in the finished
ester, epoxy, and acrylic coatings com-
food-contact coating does not exceed 5
plying with paragraphs (b)(3)(vii), (viii),
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

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175.300 21 CFR Ch. I (4100 Edition)

no more than 41 weight percent of total surface nor exceed 50 parts per million
polymer units derived from of the water capacity of the container
methacrylonitrile; for use only in coat- as determined by the methods provided
ings that are intended for contact, in paragraph (e) of this section.
under conditions of use D, E, F, or G (2) From a coating intended for or
described in table 2 of paragraph (d) of employed as a component of a con-
this section, with food containing no tainer having a capacity in excess of 1
more than 8 percent of alcohol. gallon and intended for one-time use,
(xxxvii) Polymeric resin as a coating not to exceed 1.8 milligrams per square
component prepared from terephthalic inch nor to exceed that amount as mil-
acid, isophthalic acid, succinic anhy- ligrams per square inch that would
dride, ethylene glycol, diethylene gly- equal 0.005 percent of the water capac-
col, and 2,2-dimethyl-1,3-propanediol ity of the container in milligrams, di-
for use in contact with aqueous foods vided by the area of the food-contact
and alcoholic foods containing not surface of the container in square
more than 20 percent (by volume) of al- inches.
cohol under conditions of use D, E, F, (3) From a coating intended for or
and G described in table 2 of 176.170 of employed as a component of a con-
this chapter. The resin shall contain no tainer for repeated use, not to exceed
more than 30 weight percent of 2,2-di- 18 milligrams per square inch nor to
methyl-1,3-propanediol. exceed that amount as milligrams per
(c) The coating in the finished form square inch that would equal 0.005 per-
in which it is to contact food, when ex- cent of the water capacity of the con-
tracted with the solvent or solvents tainer in milligrams, divided by the
characterizing the type of food, and area of the food-contact surface of the
under conditions of time and tempera- container in square inches.
ture characterizing the conditions of (4) From coating intended for re-
its intended use as determined from ta- peated use, and employed other than as
bles 1 and 2 of paragraph (d) of this sec- a component of a container, not to ex-
tion, shall yield chloroform-soluble ex- ceed 18 milligrams per square inch of
tractives, corrected for zinc extractives coated surface.
as zinc oleate, not to exceed the fol- (d) Tables:
lowing:
(1) From a coating intended for or TABLE 1TYPES OF FOOD
employed as a component of a con- I. Nonacid (pH above 5.0), aqueous products; may contain
salt or sugar or both, and including oil-in-water emulsions
tainer not to exceed 1 gallon and in- of low- or high-fat content.
tended for one-time use, not to exceed II. Acidic (pH 5.0 or below), aqueous products; may contain
0.5 milligram per square inch nor to ex- salt or sugar or both, and including oil-in-water emulsions
ceed that amount as milligrams per of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or
square inch that would equal 0.005 per- fat; may contain salt, and including water-in-oil emulsions
cent of the water capacity of the con- of low- or high-fat content.
tainer, in milligrams, divided by the IV. Dairy products and modifications:
A. Water-in-oil emulsion, high- or low-fat.
area of the food-contact surface of the B. Oil-in-water emulsion, high- or low-fat.
container in square inches. From a fab- V. Low moisture fats and oils.
ricated container conforming with the VI. Beverages:
description in this paragraph (c)(1), the A. Containing alcohol.
B. Nonalcoholic.
extractives shall not exceed 0.5 milli- VII. Bakery products.
gram per square inch of food-contact VIII. Dry solids (no end test required).

TABLE 2TEST PROCEDURES FOR DETERMINING THE AMOUNT OF EXTRACTIVES FROM RESINOUS OR
POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES
Extractant
Types of food (see
Condition of use 8 percent alcohol
table 1) Water (time and Heptane 1 2 (time (time and tempera-
temperature) and temperature) ture)

A. High temperature heat-sterilized I, IVB ................... 250 F, 2 hr ........... ................................


(e.g., over 212 F). III, IVA, VII ........... ......do .................... 150 F, 2 hr.
B. Boiling water sterilized ...................... II ............................ 212 F, 30 min ...... ................................
III, VII ..................... ......do .................... 120 F, 30 min.

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Food and Drug Administration, HHS 175.300

TABLE 2TEST PROCEDURES FOR DETERMINING THE AMOUNT OF EXTRACTIVES FROM RESINOUS OR
POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGESContin-
ued
Extractant
Types of food (see
Condition of use 8 percent alcohol
table 1) Water (time and Heptane 1 2 (time (time and tempera-
temperature) and temperature) ture)

C. Hot filled or pasteurized above 150 II, IVB .................. Fill boiling, cool to ................................
F. 100 F.
III, IVA ................. ......do .................... ................................
V ............................ 120 F, 15 min.
......do ....................
D. Hot filled or pasteurized below 150 II, IVB, VIB ........ 150 F, 2 hr ........... ................................
F. III, IVA ................. ......do .................... 100 F, 30 min. 150 F, 2 hr
V ............................ ......do ....................
VIA .......................
E. Room temperature filled and stored I, II, IVB, VIB ..... 120 F, 24 hr ......... ................................
(no thermal treatment in the con- III, IVA ................. ......do .................... 70 F, 30 min. 120 F, 24 hr
tainer). V, VII ..................... ......do ....................
VIA .......................
F. Refrigerated storage, no thermal I, II, III, IVA, IVB, 70 F, 48 hr ........... ................................
treatment in the container). VIB, VII. 70 F, 48 hr
VIA .......................
G. Frozen storage (no thermal treat- I, II, III, IVB, VII ... 70 F, 24 hr ........... ................................
ment in the container).
H. Frozen storage: Ready-prepared
foods intended to be reheated in con-
tainer at time of use:.
1. Aqueous or oil in water emulsion I, II, IVB ............... 212 F, 30 min.
of high or low fat.
2. Aqueous, high or low free oil or III, IVA, VII ........... ......do .................... 120 F, 30 min.
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 Having selected the appropriate ex-


extractability conditions. First ascertain tractant or extractants simulating var-
the type of food product (table 1, para- ious types of foods and beverages and
graph (d) of this section) that is being the time-temperature exaggerations
packed commercially in the test con- over normal use, follow the applicable
tainer and the normal conditions of extraction procedure. Adapt the proce-
thermal treatment used in packaging dure, when necessary, for containers
the type of food involved. Using table 2 having a capacity of over 1 gallon.
(paragraph (d) of this section), select (2) Selection of coated-container sam-
the food-simulating solvent or solvents ples. For consumer-sized containers up
(demineralized distilled water, to 1 gallon, quadruplicate samples of
heptane, and/or 8 percent ethyl alcohol) representative containers (using for
and the time-temperature exaggera- each replicate sample the number of
tions of the container-use conditions. containers nearest to an area of 180
Aqueous products (Types I, II, IVB, square inches) should be selected from
and VIB) require only a water- the lot to be examined.
extractability test at the temperature (3) Cleaning procedure preliminary to
and time conditions shown for the determining the amount of extractables
most severe conditions of use. Aque- from coated containers. Quadruplicate
ous products with free oil or fat, and samples of representative containers
water-oil emulsions (types III, IVA, should be selected from the lot to be
and VII) will require determinations of examined and must be carefully rinsed
both water extractability and heptane to remove extraneous material prior to
extractability. Low-moisture fats and the actual extraction procedure. Soda
oils (type V with no free water) require fountain pressure-type hot water rins-
only the heptane extractability. Alco- ing equipment, consisting in its sim-
holic beverages (type VIA) require plest form of a 18-inch14-inch internal
only the 8 percent alcohol extractant. diameter metal tube attached to a hot

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175.300 21 CFR Ch. I (4100 Edition)

water line and bent so as to direct a F. Fill the container within 14-inch of
stream of water upward, may be used. the top with a measured volume of
Be sure hot water has reached a tem- boiling, demineralized distilled water.
perature of 190 F200 F before starting Insert a thermometer in the water and
to rinse the container. Invert the con- allow the uncovered container to stand
tainer over the top of the fountain and in a room at 70 F85 F. When the tem-
direct a strong stream of hot water perature reads 100 F, composite the
against the bottom and all sides for 1 water from each replicate immediately
minute, drain, and allow to dry. in a clean Pyrex flask or beaker. Pro-
(4) Exposure conditions(i) Water (250 ceed with the determination of the
F for 2 hours), simulating high-tempera- amount of extractives by the method
ture heat sterilization. Fill the container described in paragraph (e)(5) of this
within 14-inch of the top with a meas- section.
ured volume of demineralized distilled (iv) Water (150 for 2 hours), simulating
water. Cover the container with clean hot fill or pasteurization below 150 F.
aluminum foil and place the container Preheat demineralized distilled water
on a rack in a pressure cooker. Add a to 150 F in a clean Pyrex flask. Fill
small amount of demineralized dis- the container within 14-inch of the top
tilled water to the pressure cooker, but with a measured volume of the 150 F
do not allow the water to touch the water and cover with clean aluminum
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,
and composite the water of each rep- (v) Water (120 F for 24 hours), simu-
licate immediately in a clean Pyrex lating room temperature filling and stor-
flask or beaker. Proceed with the de- age. Preheat demineralized distilled
termination of the amount of extrac- water to 120 F in a clean Pyrex flask.
tives by the method described in para- Fill the container within 14-inch of the
graph (e)(5) of this section. top with a measured volume of the 120
(ii) Water (212 F for 30 minutes), simu- F water and cover with clean alu-
lating boiling water sterilization. Fill the minum foil. Place the test container in
container within 14-inch of the top an incubator or oven maintained at 120
with a measured volume of boiling, F. After 24 hours, remove the test con-
demineralized distilled water. Cover tainer from the incubator and imme-
the container with clean aluminum foil diately composite the water of each
and place the container on a rack in a replicate in a clean Pyrex flask or
pressure cooker in which a small beaker. Proceed with the determina-
amount of demineralized distilled tion of the amount of extractives by
water is boiling. Do not close the pres- the method described in paragraph
sure vent, but operate at atmospheric (e)(5) of this section.
pressure so that there is a continuous (vi) Water (70 F for 48 hours), simu-
escape of a small amount of steam. lating refrigerated storage. Bring
Continue to heat for 30 minutes, then demineralized distilled water to 70 F
remove the test container and com- in a clean Pyrex flask. Fill the con-
posite the contents of each replicate tainer within 14-inch of the top with a
immediately in a clean Pyrex flask or measured volume of the 70 F water,
beaker. Proceed with the determina- and cover with clean aluminum foil.
tion of the amount of extractives by Place the test container in a suitable
the method described in paragraph room maintained at 70 F. After 48
(e)(5) of this section. hours, immediately composite the
(iii) Water (from boiling to 100 F), sim- water of each replicate in a clean
ulating hot fill or pasteurization above 150 Pyrex flask or beaker. Proceed with

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Food and Drug Administration, HHS 175.300

the determination of the amount of ex- After 2 hours, remove the pressure
tractives by the method described in cooker from the incubator, open the as-
paragraph (e)(5) of this section. sembly, and immediately composite
(vii) Water (70 F for 24 hours), simu- the heptane of each replicate in a clean
lating frozen storage. Bring Pyrex flask or beaker. Proceed with
demineralized distilled water to 70 F the determination of the amount of ex-
in a clean Pyrex flask. Fill the con- tractives by the method described in
tainer within 14-inch of the top with a paragraph (e)(5) of this section.
measured volume of the 70 F water (x) Heptane (120 F for 30 minutes), sim-
and cover with clean aluminum foil. ulating boiling water sterilization of fatty
Place the container in a suitable room foods only. Preheat redistilled reagent-
maintained at 70 F. After 24 hours, im- grade heptane (boiling point 208 F)
mediately composite the water of each carefully in a clean Pyrex flask on a
replicate in a clean Pyrex flask or water bath or nonsparking hot plate in
beaker. Proceed with the determina- a well-ventilated hood to 120 F. At the
tion of the amount of extractives by same time, preheat a pressure cooker
the method described in paragraph or equivalent to 120 F in an incubator.
(e)(5) of this section. This pressure cooker is to serve only as
(viii) Water (212 F for 30 minutes), sim- a vented container for the heptane-con-
ulating frozen foods reheated in the con- taining test package inside the incu-
tainer. Fill the container to within 14- bator in order to minimize the danger
inch of the top with a measured volume of explosion. Fill the test container
of boiling, demineralized distilled within 14-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 14-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 14-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

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175.300 21 CFR Ch. I (4100 Edition)

the heptane of each replicate in a clean mize the danger of explosion. Fill the
Pyrex flask or beaker. Proceed with test container within 14-inch of the top
the determination of the amount of ex- with a measured volume of the 120 F
tractives by the method described in heptane and cover with clean alu-
paragraph (e)(5) of this section. minum foil. Place the test container in
(xii) Heptane (100 F for 30 minutes), the preheated pressure cooker and then
simulating hot fill or pasteurization below put the assembly into a 120 F incu-
150 F for fatty foods only. Preheat re- bator. After 30 minutes, remove the
distilled reagent-grade heptane (boiling pressure cooker from the incubator,
point 208 F) carefully in a clean Pyrex open the assembly and immediately
flask on a water bath or nonsparking composite the heptane from each rep-
hot plate in a well-ventilated hood to licate into a clean Pyrex flask. Proceed
100 F. At the same time, preheat a with the determination of the amount
pressure cooker or equivalent to 100 F of extractives by the method described
in an incubator. This pressure cooker in paragraph (e)(5) of this section.
is to serve only as a container for the (xv) Alcohol8 percent (150 F for 2
heptane-containing test package inside hours), simulating alcoholic beverages hot
the incubator in order to minimize the filled or pasteurized below 150 F. Pre-
danger of explosion. Fill the test con- heat 8 percent (by volume) ethyl alco-
tainer within 14-inch of the top with a hol in demineralized distilled water to
measured volume of the 100 F heptane 150 F in a clean Pyrex flask. Fill the
and cover with clean aluminum foil. test container with within 14-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) Alcohol8 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 14-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 14-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) Alcohol8 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 14-
inside the incubator in order to mini- inch of the top with a measured volume

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Food and Drug Administration, HHS 175.300

of the 8 percent alcohol. Cover the con- e=Milligrams extractives per sample test-
tainer with clean aluminum foil. Place ed.
the test container in a suitable room a=Total coated area, including closure in
square inches.
maintained at 70 F. After 48 hours, im- c=Water capacity of container, in grams.
mediately composite the alcohol from s=Surface of coated area tested, in square
each replicate into a clean Pyrex flask. inches.
Proceed with the determination of the F=Five, the ratio of the amount of extrac-
amount of extractives by the method tives removed from a coated container
described in paragraph (e)(5) of this by heptane under exaggerated time-
temperature test conditions compared
section.
to the amount extracted by a fat or oil
NOTE: The tests specified in paragraph from a container tested under exagger-
(e)(4) (i) through (xvii) of this section are ap- ated conditions of thermal sterilization
plicable to flexible packages consisting of and use.
coated metal contacting food, in which case e=Chloroform-soluble extractives residue.
the closure end is double-folded and clamped ee=Zinc corrected chloroform-soluble ex-
with metal spring clips by which the package tractive residue.
can be suspended. e or ee is substituted for e in the above
equations when necessary.
(5) Determination of amount of extrac-
tives(i) Total residues. Evaporate the If when calculated by the equations in
food-simulating solvents from para- paragraph (e)(5)(i) (a) and (b) of this
graph (e)(4) (i) to (xvii), inclusive, of section, the concentration of extrac-
this section to about 100 milliliters in tives residue (Ex) exceeds 50 parts per
the Pyrex flask and transfer to a clean, million or the extractives in milli-
tared platinum dish, washing the flask grams per square inch exceed the limi-
three times with the solvent used in tations prescribed in paragraph (c) of
the extraction procedure, and evapo- this section for the particular con-
rate to a few milliliters on a non- tainer size, proceed to paragraph
sparking low-temperature hotplate. (e)(5)(ii) of this section (method for de-
The last few milliliters should be evap- termining the amount of chloroform-
orated in an oven maintained at a tem- soluble extractives residue).
perature of 212 F. Cool the platinum (ii) Chloroform-soluble extractives res-
dish in a desiccator for 30 minutes and idue. Add 50 milliliters of chloroform
weigh the residue to the nearest 0.1 (freshly distilled reagent grade or a
milligram (e). Calculate the extractives grade having an established consist-
in milligrams per square inch and in ently low blank) to the dried and
parts per million for the particular size weighed residue, (e), in the platinum
of container being tested and for the dish, obtained in paragraph (e)(5)(i) of
specific food-simulating solvent used. this section. Warm carefully, and filter
through Whatman No. 41 filter paper in
(a) Water and 8-percent alcohol.
a Pyrex funnel, collecting the filtrate
in a clean, tared platinum dish. Repeat
Milligrams extractives e
= the chloroform extraction, washing the
per square inch s filter paper with this second portion of
chloroform. Add this filtrate to the
Ex = ( e )( a )(1000) original filtrate and evaporate the
Extractives residue = total down to a few milliliters on a
( c )( s ) low-temperature hotplate. The last few
(b) Heptane. milliliters should be evaporated in an
oven maintained at 212 F. Cool the
Milligrams extractives e platinum dish in a desiccator for 30
= minutes and weigh to the nearest 0.1
per square inch ( s )( F ) milligram to get the chloroform-solu-
ble extractives residue (e). This e is
Ex = ( e )( a )(1000) substituted for e in the equations in
Extractives residue = paragraph (e)(5)(i) (a) and (b) of this
( c )( s )( F ) section. If the concentration of extrac-
where: tives (Ex) still exceeds 50 parts per mil-
Ex=Extractives residue in ppm for any con- lion or the extractives in milligrams
tainer size. per square inch exceed the limitations

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175.320 21 CFR Ch. I (4100 Edition)

prescribed in paragraph (c) of this sec- (2) Reagents.


tion for the particular container size,
Water, all water used in extraction proce-
proceed as follows to correct for zinc dure should be freshly demineralized (deion-
extractives (C enamels only): Ash ized) distilled water.
the residue in the platinum dish by Heptane, reagent grade, freshly redistilled
heating gently over a Meeker-type before use, using only material boiling at 208
burner to destroy organic matter and F.
hold at red heat for about 1 minute. Alcohol, 8 percent (by volume), prepared
Cool in the air for 3 minutes, and place from undenatured 95 percent ethyl alcohol
the platinum dish in the desiccator for diluted with demineralized or distilled
water.
30 minutes and weigh to the nearest 0.1 Chloroform, reagent grade, freshly redis-
milligram. Analyze this ash for zinc by tilled before use, or a grade having an estab-
standard Association of Official Agri- lished, consistently low blank.
cultural Chemists methods or equiva- Filter paper, Whatman No. 41 or equiva-
lent. Calculate the zinc in the ash as lent.
zinc oleate, and subtract from the
(g) In accordance with good manufac-
weight of chloroform-soluble extrac-
turing practice, finished coatings in-
tives residue (e) to obtain the zinc-cor-
tended for repeated food-contact use
rected chloroform-soluble extractives
shall be thoroughly cleansed prior to
residue (ee). This ee is substituted for
their first use in contact with food.
e in the formulas in paragraph (e)(5)(i)
(h) Acrylonitrile copolymers identi-
(a) and (b) of this section. To comply
fied in this section shall comply with
with the limitations in paragraph (c) of
the provisions of 180.22 of this chap-
this section, the chloroform-soluble ex-
ter.
tractives residue (but after correction
for the zinc extractives in case of C [42 FR 14534, Mar. 15, 1977]
enamels) must not exceed 50 parts per EDITORIAL NOTE: For FEDERAL REGISTER ci-
million and must not exceed in milli- tations affecting 175.300, see the List of CFR
grams per square inch the limitations Sections Affected in the Finding Aids sec-
for the particular article as prescribed tion of this volume.
in paragraph (c) of this section.
(f) Equipment and reagent require- 175.320 Resinous and polymeric coat-
ings for polyolefin films.
ments(1) Equipment.
Resinous and polymeric coatings
Rinsing equipment, soda fountain pressure- may be safely used as the food-contact
type hot water, consisting in simplest form
of a 18-inch14-inch inside diameter metal
surface of articles intended for use in
tube attached to a hot water line delivering producing, manufacturing, packing,
190 F200 F water and bent so as to direct processing, preparing, treating, pack-
a stream of water upward. aging, transporting, or holding food, in
Pressure cooker, 21-quart capacity with accordance with the following pre-
pressure gage, safety release, and removable scribed conditions:
rack, 12.5 inches inside diameter 11 inches (a) The coating is applied as a contin-
inside height, 20 pounds per square inch safe uous film over one or both sides of a
operating pressure.
base film produced from one or more of
Oven, mechanical convection, range to in-
clude 120 F212 F explosion-proof, inside di-
the basic olefin polymers complying
mensions (minimum), 19 19 19, con- with 177.1520 of this chapter. The base
stant temperature to 2 F (water bath may polyolefin film may contain optional
be substituted). adjuvant substances permitted for use
Incubator, inside dimensions (minimum) in polyolefin film by applicable regula-
19 19 19 for use at 100 F2 F explosion tions in parts 170 through 189 of this
proof (water bath may be substituted). chapter.
Constant-temperature room or chamber 70 (b) The coatings are formulated from
F2 F minimum inside dimensions 19 19 optional substances which are:
19.
(1) Substances generally recognized
Hot plate, nonsparking (explosion proof),
top 12 20, 2,500 watts, with temperature as safe for use in or on food.
control. (2) Substances the use of which is
Platinum dish, 100-milliliter capacity min- permitted under applicable regulations
imum. in parts 170 through 189 of this chapter,
All glass, Pyrex or equivalent. by prior sanctions, or approvals.

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