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175.300 Resinous and polymeric coatings.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.300]

[Page 171-189]
 
                        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

[[Page 172]]

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 pre poly merized 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:

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.


[[Page 173]]


    (c) Rosin esters (paragraph (b)(3) (v)(b) of this section) modified 
by reaction with:

Maleic anhydride.
o-, m-, and p-substituted phenol-form alde hydes 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.
[alpha]-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.
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

[[Page 174]]

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-trimethyl cyclo hexyl amine 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-amino propyl tri meth oxysilane (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 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).

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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-benzene di methan amine, 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 benzene di methan amine, 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 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-

[[Page 176]]

aminopropyltrimethoxy silane, mono hydro gen 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.
[alpha]-Pinene.
[beta]-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.
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.

[[Page 177]]

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.
[alpha]-Methyl styrene polymer.
Styrene copolymerized with one or more of the following:
    Acrylonitrile.
    [alpha]-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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.

    (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.
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

[[Page 178]]

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.
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.


[[Page 179]]


    (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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.), 
for use only as a suspending agent in the manufacture of vinyl chloride 
copolymers and limited to 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.

[[Page 180]]

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-[beta]-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).
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).

[[Page 181]]

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, 100 Barr Harbor Dr., 
West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. 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 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.

[[Page 182]]

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 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

[[Page 183]]

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.

    (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)

[[Page 184]]

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. 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.

[[Page 185]]

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 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

[[Page 186]]

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 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.

[[Page 187]]

    (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.
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.

[[Page 188]]

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 2 [deg]F (water bath may be substituted).
    Incubator, inside dimensions (minimum) 19 x 19 
x 19 for use at 100 [deg]F2 [deg]F 
explosion proof (water bath may be substituted).
    Constant-temperature room or chamber 70 [deg]F2 [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.

    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.


[[Page 189]]


    (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.





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 175, Section 300


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