[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.300]
[Page 160-177]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS--Table of Contents
Subpart C--Substances for Use as Components of Coatings
Sec. 175.300 Resinous and polymeric coatings.
Resinous and polymeric coatings may be safely used as the food-
contact surface of articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, in accordance with the following
prescribed conditions:
(a) The coating is applied as a continuous film or enamel over a
metal substrate, or the coating is intended for repeated food-contact
use and is applied to any suitable substrate as a continuous film or
enamel that serves as a functional barrier between the food and the
substrate. The coating is characterized by one or more of the following
descriptions:
(1) Coatings cured by oxidation.
(2) Coatings cured by polymerization, condensation, and/or cross-
linking without oxidation.
(3) Coatings prepared from prepolymerized substances.
(b) The coatings are formulated from optional substances that may
include:
(1) Substances generally recognized as safe in food.
(2) Substances the use of which is permitted by regulations in this
part or which are permitted by prior sanction or approval and employed
under the specific conditions, if any, of the prior sanction or
approval.
(3) Any substance employed in the production of resinous and
polymeric coatings that is the subject of a regulation in subchapter B
of this chapter and conforms with any specification in such regulation.
Substances named in this paragraph (b)(3) and further identified as
required:
(i) Drying oils, including the triglycerides or fatty acids derived
therefrom:
Beechnut.
Candlenut.
Castor (including dehydrated).
Chinawood (tung).
Coconut.
Corn.
Cottonseed.
Fish (refined).
Hempseed.
Linseed.
Oiticica.
Perilla.
Poppyseed.
Pumpkinseed.
Safflower.
Sesame.
Soybean.
Sunflower.
Tall oil.
Walnut.
The oils may be raw, heat-bodied, or blown. They may be refined by
filtration, degumming, acid or alkali washing, bleaching, distillation,
partial dehydration, partial polymerization, or solvent extraction, or
modified by combination with maleic anhydride.
(ii) Reconstituted oils from triglycerides or fatty acids derived
from the oils listed in paragraph (b)(3)(i) of this section to form
esters with:
Butylene glycol.
Ethylene glycol.
Pentaerythritol.
Polyethylene glycol.
Polypropylene glycol.
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Trimethylol propane.
(iii) Synthetic drying oils, as the basic polymer:
Butadiene and methylstyrene copolymer.
Butadiene and styrene copolymer, blown or unblown.
Maleic anhydride adduct of butadiene styrene.
Polybutadiene.
(iv) Natural fossil resins, as the basic resin:
Copal.
Damar.
Elemi.
Gilsonite.
Glycerol ester of damar, copal, elemi, and sandarac.
Sandarac.
Shellac.
Utah coal resin.
(v) Rosins and rosin derivatives, with or without modification by
polymerization, isomerization, incidental decarboxylation, and/or
hydrogenation, as follows:
(a) Rosins, refined to color grade of K or paler:
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Gum rosin.
Tall oil rosin.
Wood rosin.
(b) Rosin esters formed by reacting rosin (paragraph (b)(3)(v)(a) of
this section) with:
4,4'-sec-Butylidenediphenol-epichlorohydrin (epoxy).
Diethylene glycol.
Ethylene glycol.
Glycerol.
4,4'-Isopropylidenediphenol-epichlorohydrin (epoxy).
Methyl alcohol.
Pentaerythritol.
(c) Rosin esters (paragraph (b)(3)(v)(b) of this section) modified
by reaction with:
Maleic anhydride.
o-, m-, and p-substituted phenol-formaldehydes listed in paragraph
(b)(3)(vi) of this section.
Phenol-formaldehyde.
(d) Rosin salts:
Calcium resinate (limed rosin).
Zinc resinate.
(vi) Phenolic resins as the basic polymer formed by reaction of
phenols with formaldehyde:
(a) Phenolic resins formed by reaction of formaldehyde with:
Alkylated (methyl, ethyl, propyl, isopropyl, butyl) phenols.
p-tert-Amylphenol.
4,4'-sec-Butylidenediphenol.
p-tert-Butylphenol.
o-, m-, and p-Cresol.
p-Cyclohexylphenol.
4,4'-Isopropylidenediphenol.
p-Nonylphenol.
p-Octylphenol.
3-Pentadecyl phenol mixture obtained from cashew nut shell liquid.
Phenol.
Phenyl o-cresol.
p-Phenylphenol.
Xylenol.
(b) Adjunct for phenolic resins: Aluminum butylate.
(vii) Polyester resins (including alkyd-type), as the basic
polymers, formed as esters of acids listed in paragraph (b)(3)(vii) (a)
and (b) of this section by reaction with alcohols in paragraph
(b)(3)(vii) (c) and (d) of this section.
(a) Polybasic acids:
Adipic.
1,4-cyclohexanedicarboxylic (CAS Reg. No. 1076-97-7).
Dimerized fatty acids derived from oils listed in paragraph (b)(3)(i) of
this section.
Fumaric.
Isophthalic.
Maleic.
2,6-Naphthalenedicarboxylic.
2,6-Naphthalenedicarboxylic, dimethyl ester.
Orthophthalic.
Sebacic.
Terephthalic.
Terpene-maleic acid adduct.
Trimellitic.
(b) Monobasic acids:
Benzoic acid.
4,4-Bis(4'-hydroxyphenyl)-pentanoic acid.
tert-Butyl benzoic acid.
Fatty acids derived from oils listed in paragraph (b)(3)(i) of this
section.
Rosins listed in paragraph (b)(3)(v)(a) of this section, for use only as
reactants in oil-based or fatty acid-based alkyd resins.
(c) Polyhydric alcohols:
Butylene glycol.
Diethylene glycol.
2,2-Dimethyl-1,3-propanediol for use only in forming polyester resins
for coatings intended for use in contact with non-alcoholic foods.
Ethylene glycol.
Glycerol.
Mannitol.
-Methyl glucoside.
Pentaerythritol.
Propylene glycol.
Sorbitol.
Triethylene glycol, for use as a component in polyester resins for
coatings not exceeding a coating weight of 4 milligrams per square inch
and that are intended for contact under conditions of use D, E, F or G
described in table 2 of paragraph (d) of this section with alcoholic
beverages containing less than 8 percent alcohol.
Trimethylol ethane.
Trimethylol propane.
(d) Monohydric alcohols:
Cetyl alcohol.
Decyl alcohol.
Lauryl alcohol.
Myristyl alcohol.
Octyl alcohol.
Stearyl alcohol.
(e) Catalysts:
Dibutyltin oxide (CAS Reg. No. 818-08-6), not to exceed 0.2 percent of
the polyester resin.
Hydroxybutyltin oxide (CAS Reg. No. 2273-43-0), not to exceed 0.2
percent of the polyester resin.
[[Page 162]]
Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850-94-4), not to
exceed 0.2 percent of the polyester resin.
(viii) Epoxy resins, catalysts, and adjuncts:
(a) Epoxy resins, as the basic polymer:
(Alkoxy C10-C16)-2,3-epoxypropane, in which the
alkyl groups are even numbered and consist of a maximum of 1 percent
C10 carbon atoms and a minimum of 48 percent C12
carbon atoms and a minimum of 18 percent C14 carbon atoms,
for use only in coatings that are intended for contact with dry bulk
foods at room temperature.
4,4'-sec-Butylidenediphenol-epichlorohydrin.
4,4'-sec-Butylidenediphenol-epichlorohydrin reacted with one or more of
the drying oils or fatty acids listed in paragraph (b)(3)(i) of this
section.
4,4'-sec-Butylidenediphenol-epichlorohydrin chemically treated with one
or more of the following substances:
Allyl ether of mono-, di-, or trimethylol phenol.
4,4'-sec-Butylidenediphenol-formaldehyde.
4,4'-Isopropylidenediphenol-formaldehyde.
Melamine-formaldehyde.
Phenol-formaldehyde.
Urea-formaldehyde.
Epoxidized polybutadiene.
Glycidyl ethers formed by reacting phenolnovolak resins with
epichlorohydrin.
4,4'-Isopropylidenediphenol-epichlorohydrin.
4,4'-Isopropylidenediphenol-epichlorohydrin reacted with one or more of
the drying oils or fatty acids listed in paragraph (b)(3)(i) of this
section.
4,4'-Isopropylidenediphenol-epichlorohydrin chemically treated with one
or more of the following substances:
Allyl ether of mono-, di-, or trimethylol phenol.
4,4'-sec-Butylidenediphenol-formaldehyde.
4,4'-Isopropylidenediphenol-formaldehyde.
Melamine-formaldehyde.
2,2'-[(1-methylethylidene)bis[4,1-phenyleneoxy[1-(butoxymethyl)-2,1-
ethanediyl]oxymethylene]]bisoxirane, CAS Reg. No. 71033-08-4, for use
only in coatings intended for contact with bulk dry foods at
temperatures below 100 deg.F.
Phenol-formaldehyde.
Urea-formaldehyde.
(b) Catalysts and cross-linking agents for epoxy resins:
3-(Aminomethyl)-3,5,5-trimethylcyclohexylamine reacted with phenol and
formaldehyde in a ratio of 2.6:1.0:2.0, for use only in coatings
intended for repeated use in contact with foods only of the types
identified in paragraph (d) of this section, table 1, under Category I
and Category VIII, at temperatures not exceeding 88 deg.C (190 deg.F).
N-Beta-(aminoethyl)-gamma-aminopropyltrimethoxysilane (CAS Reg. No.
1760-24-3), for use only in coatings at a level not to exceed 1.3
percent by weight of the resin when such coatings are intended for
repeated use in contact with foods only of the types identified in
paragraph (d) of this section, table 1, under Types I, II, and III,
under conditions of use C, D, E, or F as described in table 2 of
paragraph (d) of this section; or when such coatings are intended for
repeated use in contact with foods of the types identified in paragraph
(d) of this section, table 1, under Types V, VI, VII, and VIII, under
conditions of use E or F as described in table 2 of paragraph (d) of
this section. Use shall be limited to coatings for tanks of capacity
greater than 530,000 gallons.
Benzyl alcohol (CAS Reg. No. 100-51-6), for use only in coatings at a
level not to exceed 4 percent by weight of the resin when such coatings
are intended for repeated use in contact with foods only of the types
identified in paragraph (d) of this section, table 1, under Types I, II,
and III, under conditions of use C, D, E, or F as described in table 2
of paragraph (d) of this section; or when such coatings are intended for
repeated use in contact with foods of the types identified in paragraph
(d) of this section, table 1, under Types V, VI, VII, and VIII, under
conditions of use E or F as described in table 2 of paragraph (d) of
this section. Use shall be limited to coatings for tanks of capacity
greater than 530,000 gallons.
Catalysts and cross-linking agents for epoxy resins:
3-Aminomethyl-3,5,5-trimethylcyclohexylamine (CAS Reg. No. 2855-
0913-092).
Cyanoguanidine.
Dibutyl phthalate, for use only in coatings for containers having a
capacity of 1,000 gallons or more when such containers are intended for
repeated use in contact with alcoholic beverages containing up to 8
percent of alcohol by volume.
3-Diethylaminopropylamine (CAS Reg. No. 104-78-9), for use in coatings
at a level not to exceed 6 percent by weight of the resin when such
coatings are intended for repeated use in contact with foods only of the
types identified in paragraph (d) of this section, table 1, under Types
I, II, and III, under conditions of use C, D, E, or F as described in
table 2 of paragraph (d) of this section; or when such coatings are
intended for repeated use in contact with foods of the types identified
in paragraph (d) of this section, table 1, under Types V, VI, VII, and
VIII, under conditions of use E or F as described in table 2 of
paragraph (d) of this section. Use shall be limited to
[[Page 163]]
coatings for tanks of capacity greater than 530,000 gallons.
Diethylenetriamine.
Diphenylamine.
Ethylenediamine.
Isophthalyl dihydrazide for use only in coatings subject to the
provisions of paragraph (c) (3) or (4) of this section.
4,4'-Methylenedianiline, for use only in coatings for containers having
a capacity of 1,000 gallons or more when such containers are intended
for repeated use in contact with alcoholic beverages containing up to 8
percent of alcohol by volume.
N-Oleyl-1,3-propanediamine with not more than 10 percent by weight of
diethylaminoethanol.
3-Pentadecenyl phenol mixture (obtained from cashew nutshell liquid)
reacted with formaldehyde and ethylenediamine in a ratio of 1:2:2 (CAS
Reg. No. 68413-28-5).
Polyamine produced when 1 mole of the chlorohydrin diether of
polyethylene glycol 400 is made to react under dehydrohalogenating
conditions with 2 moles of N-octadecyltrimethylenediamine for use only
in coatings that are subject to the provisions of paragraph (c) (3) or
(4) of this section and that contact food at temperatures not to exceed
room temperature.
Polyethylenepolyamine (CAS Reg. No. 68131-73-7), for use only in
coatings intended for repeated use in contact with food, at temperatures
not to exceed 180 deg.F (82 deg.C).
Salicylic acid, for use only in coatings for containers having a
capacity of 1,000 gallons or more when such containers are intended for
repeated use in contact with alcoholic beverages containing up to 8
percent of alcohol by volume.
Salicylic acid (CAS Reg. No. 69-72-7), for use only in coatings at a
level not to exceed 0.35 percent by weight of the resin when such
coatings are intended for repeated use in contact with foods only of the
types identified in paragraph (d) of this section, table 1, under Types
I, II, and III, under conditions of use C, D, E, or F as described in
table 2 of paragraph (d) of this section; or when such coatings are
intended for repeated use in contact with foods of the types identified
in paragraph (d) of this section, table 1, under Types V, VI, VII, and
VIII, under conditions of use E or F as described in table 2 of
paragraph (d) of this section. Use shall be limited to coatings for
tanks of capacity greater than 530,000 gallons.
Stannous 2-ethylhexanoate for use only as a catalyst at a level not to
exceed 1 percent by weight of the resin used in coatings that are
intended for contact with food under conditions of use D, E, F, and G
described in table 2 of paragraph (d) of this section.
Styrene oxide, for use only in coatings for containers having a capacity
of 1,000 gallons or more when such containers are intended for repeated
use in contact with alcoholic beverages containing up to 8 percent of
alcohol by volume.
Tetraethylenepentamine.
Tetraethylenepentamine reacted with equimolar quantities of fatty acids.
Tri(dimethylaminomethyl) phenol and its salts prepared from the fatty
acid moieties of the salts listed in paragraph (b)(3)(xxii)(b) of this
section, for use only in coatings subject to the provisions of paragraph
(c) (3) or (4) of this section.
Triethylenetetramine.
Trimellitic anhydride (CAS Reg. No. 552-30-7) for use only as a cross-
linking agent at a level not to exceed 15 percent by weight of the resin
in contact with food under all conditions of use, except that resins
intended for use with foods containing more than 8 percent alcohol must
contact such food only under conditions of use D, E, F, and G described
in table 2 of paragraph (d) of this section.
Trimellitic anhydride adducts of ethylene glycol and glycerol, prepared
by the reaction of 1 mole of trimellitic anhydride with 0.4-0.6 mole of
ethylene glycol and 0.04-0.12 mole of glycerol, for use only as a cross-
linking agent at a level not to exceed 10 percent by weight of the cured
coating, provided that the cured coating only contacts food containing
not more than 8 percent alcohol.
Meta-Xylylenediamine (1,3-benzenedimethanamine, CAS Reg. No. 1477-55-0),
for use only in coatings at a level not to exceed 3 percent by weight of
the resin when such coatings are intended for repeated use in contact
with foods only of the types identified in paragraph (d) of this
section, table 1, under Types I, II, and III, under conditions of use C,
D, E or F as described in table 2 of paragraph (d) of this section; or
when such coatings are intended for repeated use in contact with foods
of the types identified in paragraph (d) of this section, table 1, under
Types V, VI, VII, and VIII, under conditions of use E or F as described
in table 2 of paragraph (d) of this section. Use shall be limited to
coatings for tanks of capacity greater than 530,000 gallons.
Para-Xylylenediamine (1,4 benzenedimethanamine, CAS Reg. No. 539-48-0),
for use only in coatings at a level not to exceed 0.6 percent by weight
of the resin when such coatings are intended for repeated use in contact
with foods only of the types identified in paragraph (d) of this
section, table 1, under Types I, II, III, under conditions of use C, D,
E, or F as described in table 2 of paragraph (d) of this section; or
when such coatings are intended for repeated use in contact with foods
of the types identified in paragraph (d) of this section, table 1, under
Types V, VI, VII, and VIII, under conditions of use E and F as described
in
[[Page 164]]
table 2 of paragraph (d) of this section. Use shall be limited to
coatings for tanks of capacity greater than 530,000 gallons.
(c) Adjuncts for epoxy resins:
Aluminum butylate.
Benzoic acid, for use as a component in epoxy resins for coatings not
exceeding a coating weight of 4 milligrams per square inch and that are
intended for contact under conditions of use D, E, F or G described in
table 2 of paragraph (d) of this section with alcoholic beverages
containing less than 8 percent alcohol.
Polyamides from dimerized vegetable oils and the amine catalysts listed
in paragraph (b)(3)(viii)(b) of this section, as the basic polymer.
Silane coupled silica, prepared from the reaction of microcrystalline
quartz with N-beta-(N-vinylbenzylamino) ethyl-gamma-
aminopropyltrimethoxy silane, monohydrogen chloride, for use only in
coatings intended for repeated use in contact with foods only of the
types identified in paragraph (d) of this section, table 1, under
Category I and Category VIII, at temperatures not exceeding 88 deg.C
(190 deg.F).
Succinic anhydride, for use as a component in epoxy resins for coatings
not exceeding a coating weight of 4 milligrams per square inch, and that
are intended for contact under conditions of use D, E, F or G described
in table 2 of paragraph (d) of this section with alcoholic beverages
containing less than 8 percent alcohol.
(ix) Coumarone-indene resin, as the basic polymer.
(x) Petroleum hydrocarbon resin (cyclopentadiene type), as the basic
polymer.
(xi) Terpene resins, as the basic polymer, from one or more of the
following:
Dipentene.
Hydrogenated dipentene resin (CAS Reg. No. 106168-39-2). For use only
with coatings in contact with acidic and aqueous foods.
Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin (CAS
Reg. No. 106168-37-0). For use only with coatings in contact with acidic
and aqueous foods.
-Pinene.
-Pinene.
(xii) Urea-formaldehyde, resins and their curing catalyst:
(a) Urea-formaldehyde resins, as the basic polymer:
Urea-formaldehyde.
Urea-formaldehyde chemically modified with methyl, ethyl, propyl,
isopropyl, butyl, or isobutyl alcohol.
Urea-formaldehyde chemically modified with one or more of the amine
catalysts listed in paragraph (b)(3)(viii)(b) of this section.
(b) Curing (cross-linking) catalyst for urea-formaldehyde resins:
Dodecyl benzenesulfonic acid (C.A. Registry No. 27176-87-0).
(xiii) Triazine-formaldehyde resins and their curing catalyst:
(a) Triazine-formaldehyde resins, as the basic polymer:
Benzoguanamine-formaldehyde.
Melamine-formaldehyde.
Melamine-formaldehyde chemically modified with one or more of the
following amine catalysts:
Amine catalysts listed in paragraph (b)(3)(viii)(b) of this section.
Dimethylamine-2-methyl-1-propanol.
Methylpropanolamine.
Triethanolamine.
Melamine-formaldehyde chemically modified with methyl, ethyl, propyl,
isopropyl, butyl, or isobutyl alcohol.
(b) Curing (cross-linking) catalyst for triazine-formaldehyde
resins:
Dodecyl benzenesulfonic acid (C.A. Registry No. 27176-87-0).
(xiv) Modifiers (for oils and alkyds, including polyesters), as the
basic polymer:
Butyl methacrylate.
Cyclopentadiene.
Methyl, ethyl, butyl, or octyl esters of acrylic acid.
Methyl methacrylate.
Styrene.
Vinyl toluene.
(xv) Vinyl resinous substance, as the basic polymers:
Polyvinyl acetate.
Polyvinyl alcohol.
Polyvinyl butyral.
Polyvinyl chloride.
Polyvinyl formal.
Polyvinylidene chloride.
Polyvinyl pyrrolidone.
Polyvinyl stearate.
Vinyl chloride-acetate-2,3-epoxypropyl methacrylate copolymers
containing not more than 10 weight percent of total polymer units
derived from 2,3-epoxypropyl methacrylate and not more than 0.1 weight
percent of unreacted 2,3-epoxypropyl methacrylate monomer for use in
coatings for containers.
Vinyl chloride-acetate, hydroxyl-modified copolymer.
[[Page 165]]
Vinyl chloride-acetate, hydroxyl-modified copolymer, reacted with
trimellitic anhydride.
Vinyl chloride copolymerized with acrylamide and ethylene in 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; the acrylamide portion
may or may not be subsequently partially hydrolyzed.
Vinyl chloride copolymerized with one or more of the following
substances:
Acrylonitrile.
Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl, hexyl,
heptyl, or octyl esters.
Maleic acid and/or its methyl, ethyl, propyl, butyl, amyl, hexyl,
heptyl, or octyl esters.
5-Norbornene-2,3-dicarboxylic acid, mono-n-butyl ester; for use such
that the finished vinyl chloride copolymers contain not more than 4
weight percent of total polymer units derived from this comonomer.
Vinyl acetate.
Vinylidene chloride.
Vinyl chloride-vinylidene chloride-2,3-epoxypropyl methacrylate
copolymers containing not more than 10 weight percent of total polymer
units derived from 2,3-epoxypropyl methacrylate and not more than 0.05
weight percent of unreacted 2,3-epoxypropyl methacrylate monomer based
on polymer solids for use only in coatings for containers intended for
contact with foods under conditions B, C, D, E, F, G, or H described in
table 2 of paragraph (d) of this section.
(xvi) Cellulosics, as the basic polymer:
Carboxymethylcellulose.
Cellulose acetate.
Cellulose acetate-butyrate.
Cellulose acetate-propionate.
Ethylcellulose.
Ethyl hydroxyethylcellulose.
Hydroxyethylcellulose.
Hydroxypropyl methylcellulose.
Methylcellulose.
Nitrocellulose.
(xvii) Styrene polymers, as the basic polymer:
Polystyrene.
-Methyl styrene polymer.
Styrene copolymerized with one or more of the following:
Acrylonitrile.
-Methylstyrene.
(xviii) Polyethylene and its copolymers as the basic polymer:
Ethylene-ethyl acrylate copolymer.
Ethylene-isobutyl acrylate copolymers containing no more than 35 weight
percent of total polymer units derived from isobutyl acrylate.
Ethylene-vinyl acetate copolymer.
Polyethylene.
(xix) Polypropylene as the basic polymer:
Polypropylene.
Maleic anhydride adduct of polypropylene The polypropylene used in the
manufacture of the adduct complies with Sec. 177.1520(c), item 1.1; and
the adduct has a maximum combined maleic anhydride content of 0.8
percent and a minimum intrinsic viscosity of 0.9, determined at 135
deg.C on a 0.1 percent solution of the modified polypropylene in
decahydronaphthalene as determined by a method titled ``Method for
Determination of Intrinsic Viscosity of Maleic Anhydride Adduct of
Polypropylene,'' which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204,
or available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(xx) Acrylics and their copolymers, as the basic polymer:
Acrylamide with ethylacrylate and/or styrene and/or methacrylic acid,
subsequently reacted with formaldehyde and butanol.
Acrylic acid and the following esters thereof:
Ethyl.
Methyl.
Butyl acrylate-styrene-methacrylic acid-hydroxyethyl methacrylate
copolymers containing no more than 20 weight percent of total polymer
units derived from methacrylic acid and containing no more than 7 weight
percent of total polymer units derived from hydroxyethyl methacrylate;
for use only in coatings that are applied by electrodeposition to metal
substrates.
Butyl acrylate-styrene-methacrylic acid-hydroxypropyl methacrylate
copolymers containing no more than 20 weight percent of total polymer
units derived from methacrylic acid and containing no more than 7 weight
percent of total polymer units derived from hydroxypropyl methacrylate;
for use only in coatings that are applied by electrodeposition to metal
substrates and that are intended for contact, under condition of use D,
E, F, or G described in table 2 of paragraph (d) of this section, with
food containing no more than 8 percent of alcohol.
Ethyl acrylate-styrene-methacrylic acid copolymers for use only as
modifiers for epoxy resins listed in paragraph (b)(3)(viii)(a) of this
section.
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Ethyl acrylate-methyl methacrylate-styrene-methacrylic acid copolymers
for use only as modifiers for epoxy resins listed in paragraph
(b)(3)(viii)(a) of this section.
2-Ethylhexyl acrylate-ethyl acrylate copolymers prepared by
copolymerization of 2-ethylhexyl acrylate and ethyl acrylate in a 7/3
weight ratio and having a number average molecular weight range of 5,800
to 6,500 and a refractive index, nD25 deg. (40 percent in
2,2,4-trimethyl pentane) of 1.4130-1.4190; for use as a modifier for
nylon resins complying with Sec. 177.1500 of this chapter and for
phenolic and epoxy resins listed in paragraph (b)(3) (vi) and (viii) of
this section, respectively, at a level not to exceed 1.5 percent of the
coating.
2-Ethylhexyl acrylate-methyl methacrylate-acrylic acid copolymers for
use only as modifiers for epoxy resins listed in paragraph (b)(3)(viii)
of this section.
Methacrylic acid and the following esters thereof:
Butyl.
Ethyl.
Methyl.
Methacrylic acid or its ethyl and methyl esters copolymerized with one
or more of the following:
Acrylic acid.
Ethyl acrylate.
Methyl acrylate.
n-Butyl acrylate-styrene-methacrylic acid-hydroxyethyl methacrylate
copolymers containing no more than 2 weight percent of total polymer
units derived from methacrylic acid and containing no more than 9.5
weight percent of total polymer units derived from hydroxyethyl
methacrylate; for use only in coatings in contact with dry food (food
type VIII in table 1 of paragraph (d) of this section). 2-
(Dimethylamino) ethanol (C.A.S. Registry No. 108-01-0) may be employed
as an optional adjuvant substance limited to no more than 2 weight
percent based on polymer solids in the coating emulsion.
Styrene polymers made by the polymerization of any combination of
styrene or alpha methyl styrene with acrylic acid, methacrylic acid, 2-
ethyl hexyl acrylate, methyl methacrylate, and butyl acrylate. The
styrene and alpha methyl styrene, individually, 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
average molecular weight (Mn) shall be at least 2,000 (as
determined 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. The polymers are for use only in contact with food of Types
IV-A, V, VII in table 1 of paragraph (d) of this section, under use
conditions E through G in table 2 of paragraph (d), and with food of
Type VIII without use temperature restriction.
(xxi) Elastomers, as the basic polymer:
Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene copolymer.
Butadiene-styrene copolymer.
Butyl rubber.
Chlorinated rubber.
2-Chloro-1,3-butadiene (neoprene).
Natural rubber (natural latex or natural latex solids, smoked or
unsmoked).
Polyisobutylene.
Rubber hydrochloride.
Styrene-isobutylene copolymer.
(xxii) Driers made by reaction of a metal from paragraph
(b)(3)(xxii)(a) of this section with acid, to form the salt listed in
paragraph (b)(3)(xxii)(b) of this section:
(a) Metals:
Aluminum.
Calcium.
Cerium.
Cobalt.
Iron.
Lithium.
Magnesium.
Manganese.
Zinc.
Zirconium.
(b) Salts:
Caprate.
Caprylate.
Isodecanoate.
Linoleate.
Naphthenate.
Neodecanoate.
Octoate (2-ethylhexoate).
Oleate.
Palmitate.
Resinate.
Ricinoleate.
Soyate.
Stearate.
Tallate.
(xxiii) Waxes:
Paraffin, Type I.
Paraffin, Type II.
Polyethylene.
Sperm oil.
Spermaceti.
(xxiv) Plasticizers:
Acetyl tributyl citrate.
Acetyl triethyl citrate.
Butyl phthalyl butyl glycolate.
Butyl stearate.
p-tert-Butyl phenyl salicylate.
Dibutyl sebacate.
Diethyl phthalate.
[[Page 167]]
Diisobutyl adipate.
Diisooctyl phthalate.
Epoxidized soybean oil (iodine number maximum 14; oxirane oxygen content
6% minimum), as the basic polymer.
Ethyl phthalyl ethyl glycolate.
2-Ethylhexyl diphenyl phosphate.
di-2-Ethylhexyl phthalate.
Glycerol.
Glyceryl monooleate.
Glyceryl triacetate.
Monoisopropyl citrate.
Propylene glycol.
Sorbitol.
Mono-, di-, and tristearyl citrate.
Triethyl citrate.
Triethylene glycol.
3-(2-Xenolyl)-1,2-epoxypropane.
(xxv) Release agents, as the basic polymer, when applicable:
N,N'-Dioleoylethylenediamine (CAS Reg. No. 110-31-6) for use only in
ionomeric resins complying with Sec. 177.1330 of this chapter and in
ethylene vinyl acetate copolymers complying with Sec. 177.1350 of this
chapter at a level not to exceed 0.0085 milligram per square centimeter
(0.055 milligram per square inch) in the finished food-contact article.
N,N'-Distearoyl ethylenediamine.
Linoleic acid amide.
Oleic acid amide.
Palmitic acid amide.
Petrolatum.
Polyethylene wax.
Polyoxyethylene glycol monooleate (mol. wt. of the polyoxyethylene
glycol moiety greater than 300).
Polytetrafluoroethylene.
Silicones (not less than 300 centistokes viscosity):
Dimethylpolysiloxanes and/or methylphenylpolysiloxanes. The methyl-
phenylpolysiloxanes contain not more than 2.0 percent by weight of
cyclosiloxanes having up to and including 4 siloxy units.
Silicones (not less than 100 centistokes viscosity):
Dimethylpolysiloxanes and/or methylphenylpolysiloxanes limited to use
only on metal substrates. The methylphenylpolysiloxanes contain not more
than 2.0 percent by weight of cyclosiloxanes having up to and including
4 siloxy units.
(xxvi) Colorants used in accordance with Sec. 178.3297 of this
chapter.
(xxvii) Surface lubricants:
Cottonseed oil and other edible oils.
Dibutyl sebacate.
Dioctyl sebacate.
Glyceryl monostearate.
Lanolin.
Mineral oil, white.
Palm oil.
Paraffin, Type I.
Paraffin, Type II.
Petrolatum.
Stearic acid.
(xxviii) Silicones and their curing catalysts:
(a) Silicones as the basic polymer:
Siloxane resins originating from methyl hydrogen polysiloxane, dimethyl
polysiloxane, and methylphenyl polysiloxane.
Siloxane resins originating from the platinum-catalyzed reaction product
of 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), where the platinum content does not exceed 150 parts per million.
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).
(b) Curing (cross-linking) catalysts for silicones (the maximum
amount of tin catalyst used shall be that required to effect optimum
cure but shall not exceed 1 part of tin per 100 parts of siloxane resins
solids):
Dibutyltin dilaurate.
Stannous oleate.
Tetrabutyl titanate.
(xxix) Surface active agents:
Ethylene oxide adduct of 2,4,7,9-tetramethyl-5-decyn-4,7-diol (CAS Reg.
No. 9014-85-1).
Poly[2-(diethylamino) ethyl methacrylate] phosphate (minimum intrinsic
viscosity in water at 25 deg.C is not less than 9.0 deciliters per gram
as determined by ASTM method D1243-79, ``Standard Test Method for Dilute
Solution Viscosity of Vinyl Chloride Polymers,'' which is incorporated
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 Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408), for use only as a
suspending agent in the manufacture of vinyl chloride copolymers and
limited to
[[Page 168]]
use at levels not to exceed 0.1 percent by weight of the copolymers.
Sodium dioctyl sulfosuccinate.
Sodium dodecylbenzenesulfonate
Sodium lauryl sulfate.
2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. Reg. No. 126-86-3), for use
only in can coatings which are subsequently dried and cured at
temperatures of at least 193 deg.C (380 deg.F) for 4 minutes.
(xxx) Antioxidants:
Butylated hydroxyanisole.
Butylated hydroxytoluene.
Gum guaiac.
Dilauryl thiodipropionate.
Nordihydroguaiaretic acid.
Propyl gallate.
Distearyl thiodipropionate.
Thiodipropionic acid.
2,4,5-Trihydroxybutyrophenone.
(xxxi) Can end cements (sealing compounds used for sealing can ends
only): In addition to the substances listed in paragraph (b) of this
section and those listed in Sec. 177.1210(b)(5) of this chapter, the
following may be used:
Butadiene-styrene-divinylbenzene copolymer (CAS Reg. No. 26471-45-4) for
use only at levels not to exceed 23.8 percent by weight of the cement
solids in can end cements.
Butadiene-styrene-fumaric acid copolymer.
4,4'-Butylidenebis (6-tert-butyl-m-cresol).
Dibenzamido phenyl disulfide.
Di--naphthyl phenylenediamine.
Dipentamethylene thiuram tetrasulfide.
Isobutylene-isoprene-divinylbenzene copolymers for use only at levels
not to exceed 15 percent by weight of the dry cement composition.
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt, for use
only at levels not to exceed 0.6 percent by weight of the cement solids
in can end cements for containers having a capacity of not less than 5
gallons.
Sodium decylbenzene sulfonate.
Sodium nitrite for use only at levels not to exceed 0.3 percent by
weight of the cement solids in can end cements for containers having a
capacity of not less than 5 gallons.
Sodium pentachlorophenate for use as a preservative at 0.1 percent by
weight in can-sealing compounds on containers having a capacity of 5
gallons or more.
Sodium phenylphenate.
Styrene-maleic anhydride resin, partial methyl and butyl (sec- or iso-)
esters, for use only at levels not in excess of 3 percent of the cement
solids in can end cement formulations.
Tetrasodium EDTA (tetrasodium ethylene-diaminetetraacetate).
Tri (mixed mono- and dinonylphenyl) phosphite.
Zinc dibutyldithiocarbamate.
(xxxii) Side seam cements: In addition to the substances listed in
paragraph (b)(3) (i) to (xxx), inclusive, of this section, the following
may be used.
p-tert-Butyl perbenzoate as a catalyst for epoxy resin.
epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer.
Dicumyl peroxide for use only as polymerization catalyst.
4-(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018-09-1) for use as a
preservative at a level not to exceed 0.3 percent by weight in can-
sealing cements.
Diisodecyl phthalate for use only as plasticizer in side seam cements
for containers intended for use in contact with food only of the types
identified in paragraph (d) of this section, table 1, under Categories
I, II, and VI.
4,4'-Bis(alpha,alpha-dimethylbenzyl)diphenylamine, CAS Reg. No. 10081-
67-1.
Ethyl toluene sulfonamide.
N,N'-Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamide), CAS
Reg. No. 23128-74-7.
Polyamides consisting of the following:
Copolymer of omega-laurolactam and espilon-caprolactam, CAS Reg. No.
25191-04-2 (Nylon 12/6).
Homopolymer of omega-aminododecanoic acid, CAS Reg. No. 24937-16-4.
Homopolymer of omega-laurolactam, CAS Reg. No. 25038-74-8 (Nylon
12).
Polyamides derived from the following acids and amines:
Acids:
Adipic.
Azelaic.
Sebacic.
Vegetable oil acids (with or without dimerization).
Amines:
Diethylenetriamine.
Diphenylamine.
Ethylenediamine.
Hexamethylenediamine.
Tetraethylenepentamine.
Triethylenetetramine.
Polypropylene glycol CAS Reg. No. 25322-69-4.
Sodium pentachlorophenate for use as a preservative at 0.1 percent by
weight in can-sealing compounds on containers having a capacity of 5
gallons or more.
Tetrakis [methylene(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)]methane,
CAS Reg. No. 6683-19-8.
Toluene sulfonamide formaldehyde resin (basic polymer).
[[Page 169]]
Triethylene glycol methacrylate for use only as polymerization cross-
linking agent in side seam cements for containers intended for use in
contact with food only of the types identified in paragraph (d) of this
section, table 1, under Categories I, II, and VI.
Urea.
(xxxiii) Miscellaneous materials:
Ammonium citrate.
Ammonium potassium phosphate.
Bentonite, modified by reaction with benzyl dimethyl alkyl ammonium
chloride, where the alkyl groups are derived from hydrogenated tallow
(CAS Reg. No. 71011-24-0). For use only as a rheological agent in
coatings intended to contact food under repeated use conditions.
Bentonite, modified by reaction with sodium stearate and benzyl dimethyl
alkyl ammonium chloride, where the alkyl groups are derived from
hydrogenated tallow (CAS Reg. No. 121888-68-4). For use as a rheological
agent only in coatings intended to contact dry food under repeated-use
conditions.
Calcium acetate.
Calcium ethyl acetoacetate.
Calcium glycerophosphate.
Calcium, sodium, and potassium oleates.
Calcium, sodium, and potassium ricinoleates.
Calcium, sodium, and potassium stearates.
Castor oil, hydrogenated.
Castor oil, hydrogenated polymer with ethylenediamine, 12-
hydroxyoctadecanoic acid and sebacic acid (CAS Reg. No. 68604-06-8). The
condensation product formed by the reaction of hydrogenated castor oil
with polyamide derived from ethylenediamine, sebacic acid and 12-
hydroxystearic acid, for use only in coatings at a level not to exceed
3.2 percent by weight of the resin when such coatings are intended for
repeated use in contact with foods only of the types identified in
paragraph (d) of this section, table 1, under Types I, II, and III,
under conditions of use C, D, E, or F as described in table 2 of
paragraph (d) of this section; or when such coatings are intended for
repeated use in contact with foods of the types identified in paragraph
(d) of this section, table 1, under Types V, VI, VII, and VIII, under
conditions of use E or F as described in table 2 of paragraph (d) of
this section. Use shall be limited to coatings for tanks of capacity
greater than 530,000 gallons.
Castor oil, sulfated, sodium salt (CAS Reg. No. 68187-76-8), for use
only in coatings for containers intended for repeated use.
Cetyl alcohol.
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172-55-4) and 2-
methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) mixture, at a ratio
of 3 parts to 1 part, respectively, manufactured from methyl-3-
mercaptopropionate (CAS 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). For
use only as an antimicrobial agent in emulsion-based silicone coatings
at a level not to exceed 50 milligrams per kilogram (based on
isothiazolone active ingredient) in the coating formulations.
Cyclohexanone-formaldehyde resin produced when 1 mole of cyclohexanone
is made to react with 1.65 moles of formaldehyde such that the finished
resin has an average molecular weight of 600-610 as determined by ASTM
method D2503-82, ``Standard Test Method for Molecular Weight (Relative
Molecular Mass) of Hydrocarbons by Thermoelectric Measurement of Vapor
Pressure,'' which is incorporated 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 Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408. For use only in contact with nonalcoholic and nonfatty foods
under conditions of use E, F, and G, described in table 2 of paragraph
(d) this section.
Decyl alcohol.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg No. 35691-65-7). For use as an
antimicrobial agent at levels not to exceed 500 milligrams per kilogram
in emulsion-based silicone coatings.
Disodium hydrogen phosphate.
Ethyl acetoacetate.
Hectorite, modified by reaction with a mixture of benzyl methyl dialkyl
ammonium chloride and dimethyl dialkyl ammonium chloride, where the
alkyl groups are derived from hydrogenated tallow (CAS Reg. No. 121888-
67-3). For use as a rheological agent only in coatings intended to
contact dry food under repeated-use conditions.
Lauryl alcohol.
Lecithin.
Magnesium, sodium, and potassium citrate.
Magnesium glycerophosphate.
Magnesium stearate.
Mono-, di-, and tricalcium phosphate.
Monodibutylamine pyrophosphate as sequestrant for iron.
Mono-, di-, and trimagnesium phosphate.
Myristyl alcohol.
Octyl alcohol.
Phosphoric acid.
Polybutene, hydrogenated; complying with the identity and limitations
prescribed by Sec. 178.3740 of this chapter.
Poly(ethylene oxide).
Siloxanes and silicones, dimethyl, 3-hydroxypropyl group-terminated,
diesters with poly(2-oxepanone), diacetates (CAS
[[Page 170]]
Reg. No. 116810-47-0) at a level not to exceed 0.025 weight percent of
the finished coating having no greater than a 0.5 mil thickness for use
as a component of polyester, epoxy, and acrylic coatings complying with
paragraphs (b)(3)(vii), (viii), and (xx) of this section, respectively.
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 concentration) in the dry coating.
Sodium pyrophosphate.
Stannous chloride.
Stannous stearate.
Stannous sulfate.
Stearyl alcohol.
2-Sulfoethyl methacrylate, sodium salt (CAS Reg. No. 1804-87-1). For use
only in copolymer coatings on metal under conditions of use E, F, and G
described in table 2 of paragraph (d) of this section, and limited to
use at a level not to exceed 2.0 percent by weight of the dry copolymer
coating.
Tetrasodium pyrophosphate.
Tridecyl alcohol produced from tetrapropylene by the oxo process, for
use only as a processing aid in polyvinyl chloride resins.
Trimethylolpropane (CAS Reg. No. 77-99-6). For use as a pigment
dispersant at levels not to exceed 0.45 percent by weight of the
pigment.
Vinyl acetate-dibutyl maleate copolymers produced when vinyl acetate and
dibutyl maleate are copolymerized with or without one of the monomers:
Acrylic acid or glycidyl methacrylate. For use only in coatings for
metal foil used in contact with foods that are dry solids with the
surface containing no free fat or oil. The finished copolymers shall
contain at least 50 weight-percent of polymer units derived from vinyl
acetate and shall contain no more than 5 weight-percent of total polymer
units derived from acrylic acid or glycidyl methacrylate.
(xxxiv) Polyamide resins derived from dimerized vegetable oil acids
(containing not more than 20 percent of monomer acids) and
ethylenediamine, as the basic resin, for use only in coatings that
contact food at temperatures not to exceed room temperature.
(xxxv) Polyamide resins having a maximum acid value of 5 and a
maximum amine value of 8.5 derived from dimerized vegetable oil acids
(containing not more than 10 percent of monomer acids), ethylenediamine,
and 4,4-bis (4-hydroxyphenyl) pentanoic acid (in an amount not to exceed
10 percent by weight of said polyamide resins); as the basic resin, for
use only in coatings that contact food at temperatures not to exceed
room temperature provided that the concentration of the polyamide resins
in the finished food-contact coating does not exceed 5 milligrams per
square inch of food-contact surface.
(xxxvi) Methacrylonitrile grafted polybutadiene copolymers
containing no more than 41 weight percent of total polymer units derived
from methacrylonitrile; for use only in coatings that are intended for
contact, under conditions of use D, E, F, or G described in table 2 of
paragraph (d) of this section, with food containing no more than 8
percent of alcohol.
(xxxvii) Polymeric resin as a coating component prepared from
terephthalic acid, isophthalic acid, succinic anhydride, ethylene
glycol, diethylene glycol, and 2,2-dimethyl-1,3-propanediol for use in
contact with aqueous foods and alcoholic foods containing not more than
20 percent (by volume) of alcohol under conditions of use D, E, F, and G
described in table 2 of Sec. 176.170 of this chapter. The resin shall
contain no more than 30 weight percent of 2,2-dimethyl-1,3-propanediol.
(c) The coating in the finished form in which it is to contact food,
when extracted with the solvent or solvents characterizing the type of
food, and under conditions of time and temperature characterizing the
conditions of its intended use as determined from tables 1 and 2 of
paragraph (d) of this section, shall yield chloroform-soluble
extractives, corrected for zinc extractives as zinc oleate, not to
exceed the following:
(1) From a coating intended for or employed as a component of a
container not to exceed 1 gallon and intended for one-time use, not to
exceed 0.5 milligram per square inch nor to exceed that amount as
milligrams per square inch that would equal 0.005 percent of the water
capacity of the container, in milligrams, divided by the area of the
food-contact surface of the container in square inches. From a
fabricated container conforming with the description in this paragraph
(c)(1), the extractives shall not exceed 0.5 milligram per square inch
of food-contact surface nor exceed 50 parts per million of the water
capacity of the container
[[Page 171]]
as determined by the methods provided in paragraph (e) of this section.
(2) From a coating intended for or employed as a component of a
container having a capacity in excess of 1 gallon and intended for one-
time use, not to exceed 1.8 milligrams per square inch nor to exceed
that amount as milligrams per square inch that would equal 0.005 percent
of the water capacity of the container in milligrams, divided by the
area of the food-contact surface of the container in square inches.
(3) From a coating intended for or employed as a component of a
container for repeated use, not to exceed 18 milligrams per square inch
nor to exceed that amount as milligrams per square inch that would equal
0.005 percent of the water capacity of the container in milligrams,
divided by the area of the food-contact surface of the container in
square inches.
(4) From coating intended for repeated use, and employed other than
as a component of a container, not to exceed 18 milligrams per square
inch of coated surface.
(d) Tables:
Table 1--Types of Food
I. Nonacid (pH above 5.0), aqueous products; may contain salt or sugar
or both, and including oil-in-water emulsions of low- or high-fat
content.
II. Acidic (pH 5.0 or below), aqueous products; may contain salt or
sugar or both, and including oil-in-water emulsions of low- or high-fat
content.
III. Aqueous, acid or nonacid products containing free oil or fat; may
contain salt, and including water-in-oil emulsions of low- or high-fat
content.
IV. Dairy products and modifications:
A. Water-in-oil emulsion, high- or low-fat.
B. Oil-in-water emulsion, high- or low-fat.
V. Low moisture fats and oils.
VI. Beverages:
A. Containing alcohol.
B. Nonalcoholic.
VII. Bakery products.
VIII. Dry solids (no end test required).
Table 2--Test Procedures for Determining the Amount of Extractives From Resinous or Polymeric Coatings, Using
Solvents Simulating Types of Foods and Beverages
----------------------------------------------------------------------------------------------------------------
Extractant
-----------------------------------------------------------
Condition of use Types of food (see Heptane \1\ \2\ 8 percent alcohol
table 1) Water (time and (time and (time and
temperature) temperature) temperature)
----------------------------------------------------------------------------------------------------------------
A. High temperature heat- I, IV-B........... 250 deg.F, 2 hr.. ..................
sterilized (e.g., over 212 III, IV-A, VII.... ......do.......... 150 deg.F, 2 hr..
deg.F).
B. Boiling water sterilized..... II................ 212 deg.F, 30 min ..................
III, VII.......... ......do.......... 120 deg.F, 30 min
C. Hot filled or pasteurized II, IV-B.......... Fill boiling, cool ..................
above 150 deg.F. to 100 deg.F.
III, IV-A......... ......do.......... ..................
V................. 120 deg.F, 15 min
......do..........
D. Hot filled or pasteurized II, IV-B, VI-B.... 150 deg.F, 2 hr.. .................. ..................
below 150 deg.F. III, IV-A......... ......do.......... 100 deg.F, 30 min 150 deg.F, 2 hr
V................. ......do..........
VI-A..............
E. Room temperature filled and I, II, IV-B, VI-B. 120 deg.F, 24 hr. .................. ..................
stored (no thermal treatment in III, IV-A......... ......do.......... 70 deg.F, 30 min. 120 deg.F, 24 hr
the container). V, VII............ ......do..........
VI-A..............
F. Refrigerated storage, no I, II, III, IV-A, 70 deg.F, 48 hr.. .................. ..................
thermal treatment in the IV-B, VI-B, VII. 70 deg.F, 48 hr
container). VI-A..............
G. Frozen storage (no thermal I, II, III, IV-B, 70 deg.F, 24 hr.. ..................
treatment in the container). VII.
H. Frozen storage: Ready-
prepared foods intended to be
reheated in container at time
of use:.
1. Aqueous or oil in water I, II, IV-B....... 212 deg.F, 30 min
emulsion of high or low fat.
2. Aqueous, high or low free III, IV-A, VII.... ......do.......... 120 deg.F, 30 min
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.
[[Page 172]]
(e) Analytical methods--(1) Selection of extractability conditions.
First ascertain the type of food product (table 1, paragraph (d) of this
section) that is being packed commercially in the test container and the
normal conditions of thermal treatment used in packaging the type of
food involved. Using table 2 (paragraph (d) of this section), select the
food-simulating solvent or solvents (demineralized distilled water,
heptane, and/or 8 percent ethyl alcohol) and the time-temperature
exaggerations of the container-use conditions. Aqueous products (Types
I, II, IV-B, and VI-B) require only a water-extractability test at the
temperature and time conditions shown for the most severe ``conditions
of use.'' Aqueous products with free oil or fat, and water-oil emulsions
(types III, IV-A, and VII) will require determinations of both water
extractability and heptane extractability. Low-moisture fats and oils
(type V with no free water) require only the heptane extractability.
Alcoholic beverages (type VI-A) require only the 8 percent alcohol
extractant. Having selected the appropriate extractant or extractants
simulating various types of foods and beverages and the time-temperature
exaggerations over normal use, follow the applicable extraction
procedure. Adapt the procedure, when necessary, for containers having a
capacity of over 1 gallon.
(2) Selection of coated-container samples. For consumer-sized
containers up to 1 gallon, quadruplicate samples of representative
containers (using for each replicate sample the number of containers
nearest to an area of 180 square inches) should be selected from the lot
to be examined.
(3) Cleaning procedure preliminary to determining the amount of
extractables from coated containers. Quadruplicate samples of
representative containers should be selected from the lot to be examined
and must be carefully rinsed to remove extraneous material prior to the
actual extraction procedure. Soda fountain pressure-type hot water
rinsing equipment, consisting in its simplest form of a \1/8\-inch-\1/
4\-inch internal diameter metal tube attached to a hot water line and
bent so as to direct a stream of water upward, may be used. Be sure hot
water has reached a temperature of 190 deg.F-200 deg.F before starting
to rinse the container. Invert the container over the top of the
fountain and direct a strong stream of hot water against the bottom and
all sides for 1 minute, drain, and allow to dry.
(4) Exposure conditions--(i) Water (250 deg.F for 2 hours),
simulating high-temperature heat sterilization. Fill the container
within \1/4\-inch of the top with a measured volume of demineralized
distilled water. Cover the container with clean aluminum foil and place
the container on a rack in a pressure cooker. Add a small amount of
demineralized distilled water to the pressure cooker, but do not allow
the water to touch the bottom of the container. Close the cooker
securely and start to heat over a suitable burner. When a steady stream
of steam emerges from the vent, close the vent and allow the pressure to
rise to 15 pounds per square inch (250 deg.F) and continue to maintain
this pressure for 2 hours. Slowly release the pressure, open the
pressure cooker when the pressure reads zero, and composite the water of
each replicate immediately in a clean Pyrex flask or beaker. Proceed
with the determination of the amount of extractives by the method
described in paragraph (e)(5) of this section.
(ii) Water (212 deg.F for 30 minutes), simulating boiling water
sterilization. Fill the container within \1/4\-inch of the top with a
measured volume of boiling, demineralized distilled water. Cover the
container with clean aluminum foil and place the container on a rack in
a pressure cooker in which a small amount of demineralized distilled
water is boiling. Do not close the pressure vent, but operate at
atmospheric pressure so that there is a continuous escape of a small
amount of steam. Continue to heat for 30 minutes, then remove the test
container and composite the contents of each replicate immediately in a
clean Pyrex flask or beaker. Proceed with the determination of the
amount of extractives by the method described in paragraph (e)(5) of
this section.
(iii) Water (from boiling to 100 deg.F), simulating hot fill or
pasteurization above 150 deg.F. Fill the container within \1/4\-inch of
the top with a measured volume of boiling, demineralized distilled
water.
[[Page 173]]
Insert a thermometer in the water and allow the uncovered container to
stand in a room at 70 deg.F-85 deg.F. When the temperature reads 100
deg.F, composite the water from each replicate immediately in a clean
Pyrex flask or beaker. Proceed with the determination of the amount of
extractives by the method described in paragraph (e)(5) of this section.
(iv) Water (150 deg. for 2 hours), simulating hot fill or
pasteurization below 150 deg.F. Preheat demineralized distilled water
to 150 deg.F in a clean Pyrex flask. Fill the container within \1/4\-
inch of the top with a measured volume of the 150 deg.F water and cover
with clean aluminum foil. Place the test container in an oven maintained
at 150 deg.F. After 2 hours, remove the test container from the oven
and immediately composite the water of each replicate in a clean Pyrex
flask or beaker. Proceed with the determination of the amount of
extractives by the method described in paragraph (e)(5) of this section.
(v) Water (120 deg.F for 24 hours), simulating room temperature
filling and storage. Preheat demineralized distilled water to 120 deg.F
in a clean Pyrex flask. Fill the container within \1/4\-inch of the top
with a measured volume of the 120 deg.F water and cover with clean
aluminum foil. Place the test container in an incubator or oven
maintained at 120 deg.F. After 24 hours, remove the test container from
the incubator and immediately composite the water of each replicate in a
clean Pyrex flask or beaker. Proceed with the determination of the
amount of extractives by the method described in paragraph (e)(5) of
this section.
(vi) Water (70 deg.F for 48 hours), simulating refrigerated
storage. Bring demineralized distilled water to 70 deg.F in a clean
Pyrex flask. Fill the container within \1/4\-inch of the top with a
measured volume of the 70 deg.F water, and cover with clean aluminum
foil. Place the test container in a suitable room maintained at 70
deg.F. After 48 hours, immediately composite the water of each replicate
in a clean Pyrex flask or beaker. Proceed with the determination of the
amount of extractives by the method described in paragraph (e)(5) of
this section.
(vii) Water (70 deg.F for 24 hours), simulating frozen storage.
Bring demineralized distilled water to 70 deg.F in a clean Pyrex flask.
Fill the container within \1/4\-inch of the top with a measured volume
of the 70 deg.F water and cover with clean aluminum foil. Place the
container in a suitable room maintained at 70 deg.F. After 24 hours,
immediately composite the water of each replicate in a clean Pyrex flask
or beaker. Proceed with the determination of the amount of extractives
by the method described in paragraph (e)(5) of this section.
(viii) Water (212 deg.F for 30 minutes), simulating frozen foods
reheated in the container. Fill the container to within \1/4\-inch of
the top with a measured volume of boiling, demineralized distilled
water. Cover the container with clean aluminum foil and place the
container on a rack in a pressure cooker in which a small amount of
demineralized distilled water is boiling. Do not close the pressure
vent, but operate at atmospheric pressure so that there is a continuous
escape of a small amount of steam. Continue to heat for 30 minutes, then
remove the test container and composite the contents of each replicate
immediately in a clean Pyrex flask or beaker. Proceed with the
determination of the amount of extractives by the method described in
paragraph (e)(5) of this section.
(ix) Heptane (150 deg.F for 2 hours) simulating high-temperature
heat sterilization for fatty foods only. Preheat redistilled reagent-
grade heptane (boiling point 208 deg.F) carefully in a clean Pyrex
flask on a water bath or nonsparking hot plate in a well-ventilated hood
to 150 deg.F. At the same time preheat a pressure cooker or equivalent
to 150 deg.F in an incubator. This pressure cooker is to serve only as
a container for the heptane-containing test package inside the incubator
in order to minimize the danger of explosion. Fill the test container
within \1/4\-inch of the top with a measured volume of the 150 deg.F
heptane and cover with clean aluminum foil. Place the test container in
the preheated pressure cooker and then put the assembly into a 150
deg.F incubator. After 2 hours, remove the pressure cooker from the
incubator, open the assembly, and immediately composite
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the heptane of each replicate in a clean Pyrex flask or beaker. Proceed
with the determination of the amount of extractives by the method
described in paragraph (e)(5) of this section.
(x) Heptane (120 deg.F for 30 minutes), simulating boiling water
sterilization of fatty foods only. Preheat redistilled reagent-grade
heptane (boiling point 208 deg.F) carefully in a clean Pyrex flask on a
water bath or nonsparking hot plate in a well-ventilated hood to 120
deg.F. At the same time, preheat a pressure cooker or equivalent to 120
deg.F in an incubator. This pressure cooker is to serve only as a vented
container for the heptane-containing test package inside the incubator
in order to minimize the danger of explosion. Fill the test container
within \1/4\-inch of the top with a measured volume of the 120 deg.F
heptane and cover with clean aluminum foil. Place the test container in
the preheated pressure cooker and then put the assembly into a 120
deg.F incubator. After 30 minutes, remove the pressure cooker from the
incubator, open the assembly, and immediately composite the heptane of
each replicate in a clean Pyrex flask or beaker. Proceed with the
determination of the amount of extractives by the method described in
paragraph (e)(5) of this section.
(xi) Heptane (120 deg.F for 15 minutes), simulating hot fill or
pasteurization above 150 deg.F for fatty foods only. Preheat
redistilled reagent-grade heptane (boiling point 208 deg.F) carefully
in a clean Pyrex flask on a water bath or nonsparking hot plate in a
well-ventilated hood to 120 deg.F. At the same time, preheat a pressure
cooker or equivalent to 120 deg.F in an incubator. This pressure cooker
is to serve only as a container for the heptane-containing test package
inside the incubator in order to minimize the danger of explosion. Fill
the test container within \1/4\-inch of the top with a measured volume
of the 120 deg.F heptane and cover with clean aluminum foil. Place the
test container in the preheated pressure cooker and then put the
assembly into a 120 deg.F incubator. After 15 minutes, remove the
pressure cooker from the incubator, open the assembly, and immediately
composite the heptane of each replicate in a clean Pyrex flask or
beaker. Proceed with the determination of the amount of extractives by
the method described in paragraph (e)(5) of this section.
(xii) Heptane (100 deg.F for 30 minutes), simulating hot fill or
pasteurization below 150 deg.F for fatty foods only. Preheat
redistilled reagent-grade heptane (boiling point 208 deg.F) carefully
in a clean Pyrex flask on a water bath or nonsparking hot plate in a
well-ventilated hood to 100 deg.F. At the same time, preheat a pressure
cooker or equivalent to 100 deg.F in an incubator. This pressure cooker
is to serve only as a container for the heptane-containing test package
inside the incubator in order to minimize the danger of explosion. Fill
the test container within \1/4\-inch of the top with a measured volume
of the 100 deg.F heptane and cover with clean aluminum foil. Place the
test container in the preheated pressure cooker and then put the
assembly into a 100 deg.F incubator. After 30 minutes, remove the
pressure cooker from the incubator, open the assembly and immediately
composite the heptane of each replicate in a clean Pyrex flask or
beaker. Proceed with the determination of the amount of extractives by
the method described in paragraph (e)(5) of this section.
(xiii) Heptane (70 deg.F for 30 minutes), simulating room
temperature filling and storage of fatty foods only. Fill the test
container within \1/4\-inch of the top with a measured volume of the 70
deg.F heptane and cover with clean aluminum foil. Place the test
container in a suitable room maintained at 70 deg.F. After 30 minutes,
composite the heptane of each replicate in a clean Pyrex flask or
beaker. Proceed with the determination of the amount of extractives by
the method described in paragraph (e)(5) of this section.
(xiv) Heptane (120 deg.F for 30 minutes), simulating frozen fatty
foods reheated in the container. Preheat redistilled reagent-grade
heptane (boiling point 208 deg.F) carefully in a clean Pyrex flask on a
water bath or hot plate in a well-ventilated hood to 120 deg.F. At the
same time, preheat a pressure cooker to 120 deg.F in an incubator. This
pressure cooker is to serve only as a container for the heptane-
containing test package inside the incubator in order to minimize the
danger of explosion. Fill the test container within \1/4\-inch of the
top with a measured volume of the 120 deg.F
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heptane and cover with clean aluminum foil. Place the test container in
the preheated pressure cooker and then put the assembly into a 120
deg.F incubator. After 30 minutes, remove the pressure cooker from the
incubator, open the assembly and immediately composite the heptane from
each replicate into a clean Pyrex flask. Proceed with the determination
of the amount of extractives by the method described in paragraph (e)(5)
of this section.
(xv) Alcohol--8 percent (150 deg.F for 2 hours), simulating
alcoholic beverages hot filled or pasteurized below 150 deg.F. Preheat
8 percent (by volume) ethyl alcohol in demineralized distilled water to
150 deg.F in a clean Pyrex flask. Fill the test container with within
\1/4\-inch of the top with a measured volume of the 8 percent alcohol.
Cover the container with clean aluminum foil and place in an oven
maintained at 150 deg.F. After 2 hours, remove the container from the
oven and immediately composite the alcohol from each replicate in a
clean Pyrex flask. Proceed with the determination of the amount of
extractives by the method described in paragraph (e)(5) of this section.
(xvi) Alcohol--8 percent (120 deg.F for 24 hours), simulating
alcoholic beverages room-temperature filled and stored. Preheat 8
percent (by volume) ethyl alcohol in demineralized distilled water to
120 deg.F in a clean Pyrex flask. Fill the test container within \1/4\-
inch of the top with a measured volume of the 8 percent alcohol, cover
the container with clean aluminum foil and place in an oven or incubator
maintained at 120 deg.F. After 24 hours, remove the container from the
oven or incubator and immediately composite the alcohol from each
replicate into a clean Pyrex flask. Proceed with the determination of
the amount of extractives by the method described in paragraph (e)(5) of
this section.
(xvii) Alcohol--8 percent (70 deg.F for 48 hours), simulating
alcoholic beverages in refrigerated storage. Bring 8 percent (by volume)
ethyl alcohol in demineralized distilled water to 70 deg.F in a clean
Pyrex flask. Fill the test container within \1/4\-inch of the top with a
measured volume of the 8 percent alcohol. Cover the container with clean
aluminum foil. Place the test container in a suitable room maintained at
70 deg.F. After 48 hours, immediately composite the alcohol from each
replicate into a clean Pyrex flask. Proceed with the determination of
the amount of extractives by the method described in paragraph (e)(5) of
this section.
Note: The tests specified in paragraph (e)(4) (i) through (xvii) of
this section are applicable to flexible packages consisting of coated
metal contacting food, in which case the closure end is double-folded
and clamped with metal spring clips by which the package can be
suspended.
(5) Determination of amount of extractives--(i) Total residues.
Evaporate the food-simulating solvents from paragraph (e)(4) (i) to
(xvii), inclusive, of this section to about 100 milliliters in the Pyrex
flask and transfer to a clean, tared platinum dish, washing the flask
three times with the solvent used in the extraction procedure, and
evaporate to a few milliliters on a nonsparking low-temperature
hotplate. The last few milliliters should be evaporated in an oven
maintained at a temperature of 212 deg.F. Cool the platinum dish in a
desiccator for 30 minutes and weigh the residue to the nearest 0.1
milligram (e). Calculate the extractives in milligrams per square inch
and in parts per million for the particular size of container being
tested and for the specific food-simulating solvent used.
(a) Water and 8-percent alcohol.
[GRAPHIC] [TIFF OMITTED] TR01JA93.388
[GRAPHIC] [TIFF OMITTED] TR01JA93.389
(b) Heptane.
[GRAPHIC] [TIFF OMITTED] TR01JA93.390
[GRAPHIC] [TIFF OMITTED] TR01JA93.391
where:
Ex=Extractives residue in ppm for any container size.
e=Milligrams extractives per sample tested.
a=Total coated area, including closure in square inches.
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c=Water capacity of container, in grams.
s=Surface of coated area tested, in square inches.
F=Five, the ratio of the amount of extractives removed from a coated
container by heptane under exaggerated time-temperature test conditions
compared to the amount extracted by a fat or oil from a container tested
under exaggerated conditions of thermal sterilization and use.
e'=Chloroform-soluble extractives residue.
ee'=Zinc corrected chloroform-soluble extractive residue.
e' or ee' is substituted for e in the above equations when necessary.
If when calculated by the equations in paragraph (e)(5)(i) (a) and (b)
of this section, the concentration of extractives residue (Ex) exceeds
50 parts per million or the extractives in milligrams per square inch
exceed the limitations prescribed in paragraph (c) of this section for
the particular container size, proceed to paragraph (e)(5)(ii) of this
section (method for determining the amount of chloroform-soluble
extractives residue).
(ii) Chloroform-soluble extractives residue. Add 50 milliliters of
chloroform (freshly distilled reagent grade or a grade having an
established consistently low blank) to the dried and weighed residue,
(e), in the platinum dish, obtained in paragraph (e)(5)(i) of this
section. Warm carefully, and filter through Whatman No. 41 filter paper
in a Pyrex funnel, collecting the filtrate in a clean, tared platinum
dish. Repeat the chloroform extraction, washing the filter paper with
this second portion of chloroform. Add this filtrate to the original
filtrate and evaporate the total down to a few milliliters on a low-
temperature hotplate. The last few milliliters should be evaporated in
an oven maintained at 212 deg.F. Cool the platinum dish in a desiccator
for 30 minutes and weigh to the nearest 0.1 milligram to get the
chloroform-soluble extractives residue (e'). This e' is substituted for
e in the equations in paragraph (e)(5)(i) (a) and (b) of this section.
If the concentration of extractives (Ex) still exceeds 50 parts per
million or the extractives in milligrams per square inch exceed the
limitations prescribed in paragraph (c) of this section for the
particular container size, proceed as follows to correct for zinc
extractives (``C'' enamels only): Ash the residue in the platinum dish
by heating gently over a Meeker-type burner to destroy organic matter
and hold at red heat for about 1 minute. Cool in the air for 3 minutes,
and place the platinum dish in the desiccator for 30 minutes and weigh
to the nearest 0.1 milligram. Analyze this ash for zinc by standard
Association of Official Agricultural Chemists methods or equivalent.
Calculate the zinc in the ash as zinc oleate, and subtract from the
weight of chloroform-soluble extractives residue (e') to obtain the
zinc-corrected chloroform-soluble extractives residue (ee'). This ee' is
substituted for e in the formulas in paragraph (e)(5)(i) (a) and (b) of
this section. To comply with the limitations in paragraph (c) of this
section, the chloroform-soluble extractives residue (but after
correction for the zinc extractives in case of ``C'' enamels) must not
exceed 50 parts per million and must not exceed in milligrams per square
inch the limitations for the particular article as prescribed in
paragraph (c) of this section.
(f) Equipment and reagent requirements--(1) Equipment.
Rinsing equipment, soda fountain pressure-type hot water, consisting
in simplest form of a \1/8\-inch-\1/4\-inch inside diameter metal tube
attached to a hot water line delivering 190 deg.F-200 deg.F water and
bent so as to direct a stream of water upward.
Pressure cooker, 21-quart capacity with pressure gage, safety
release, and removable rack, 12.5 inches inside diameter x 11 inches
inside height, 20 pounds per square inch safe operating pressure.
Oven, mechanical convection, range to include 120 deg.F-212 deg.F
explosion-proof, inside dimensions (minimum), 19'' x 19'' x 19'',
constant temperature to plus-minus2 deg.F (water bath may be
substituted).
Incubator, inside dimensions (minimum) 19'' x 19'' x 19'' for
use at 100 deg.Fplus-minus2 deg.F explosion proof (water
bath may be substituted).
Constant-temperature room or chamber 70 deg.Fplus-minus2
deg.F minimum inside dimensions 19'' x 19'' x 19''.
Hot plate, nonsparking (explosion proof), top 12'' x 20'', 2,500
watts, with temperature control.
Platinum dish, 100-milliliter capacity minimum.
All glass, Pyrex or equivalent.
(2) Reagents.
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Water, all water used in extraction procedure should be freshly
demineralized (deionized) distilled water.
Heptane, reagent grade, freshly redistilled before use, using only
material boiling at 208 deg.F.
Alcohol, 8 percent (by volume), prepared from undenatured 95 percent
ethyl alcohol diluted with demineralized or distilled water.
Chloroform, reagent grade, freshly redistilled before use, or a
grade having an established, consistently low blank.
Filter paper, Whatman No. 41 or equivalent.
(g) In accordance with good manufacturing practice, finished
coatings intended for repeated food-contact use shall be thoroughly
cleansed prior to their first use in contact with food.
(h) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
[42 FR 14534, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting
Sec. 175.300, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.