This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175]
[Page 148]
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 A [Reserved]
Subpart B--Substances for Use Only as Components of Adhesives
Sec.
175.105 Adhesives.
175.125 Pressure-sensitive adhesives.
Subpart C--Substances for Use as Components of Coatings
175.210 Acrylate ester copolymer coating.
175.230 Hot-melt strippable food coatings.
175.250 Paraffin (synthetic).
175.260 Partial phosphoric acid esters of polyester resins.
175.270 Poly(vinyl fluoride) resins.
175.300 Resinous and polymeric coatings.
175.320 Resinous and polymeric coatings for polyolefin films.
175.350 Vinyl acetate/crotonic acid copolymer.
175.360 Vinylidene chloride copolymer coatings for nylon film.
175.365 Vinylidene chloride copolymer coatings for polycarbonate film.
175.380 Xylene-formaldehyde resins condensed with 4,4'-
isopropylidenediphenol-epichlorohydrin epoxy resins.
175.390 Zinc-silicon dioxide matrix coatings.
Authority: 21 U.S.C. 321, 342, 348, 379e.
Source: 42 FR 14534, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 175 appear at 61 FR
14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001.
Subpart A [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.105]
[Page 148-163]
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 B--Substances for Use Only as Components of Adhesives
Sec. 175.105 Adhesives.
(a) Adhesives may be safely used as components of articles intended
for use in packaging, transporting, or holding food in accordance with
the following prescribed conditions:
(1) The adhesive is prepared from one or more of the optional
substances named in paragraph (c) of this section, subject to any
prescribed limitations.
(2) The adhesive is either separated from the food by a functional
barrier or used subject to the following additional limitations:
(i) In dry foods. The quantity of adhesive that contacts packaged
dry food shall not exceed the limits of good manufacturing practice.
(ii) In fatty and aqueous foods. (a) The quantity of adhesive that
contacts packaged fatty and aqueous foods shall not exceed the trace
amount at seams and at the edge exposure between packaging laminates
that may occur within the limits of good manufacturing practice.
(b) Under normal conditions of use the packaging seams or laminates
will remain firmly bonded without visible separation.
(b) To assure safe usage of adhesives, the label of the finished
adhesive container shall bear the statement "food-packaging adhesive".
(c) Subject to any limitation prescribed in this section and in any
other regulation promulgated under section 409 of the Act which
prescribes safe conditions of use for substances that may be employed as
constituents of adhesives, the optional substances used in the
formulation of adhesives may include the following:
(1) Substances generally recognized as safe for use in food or food
packaging.
(2) Substances permitted for use in adhesives by prior sanction or
approval
[[Page 149]]
and employed under the specific conditions of use prescribed by such
sanction or approval.
(3) Flavoring substances permitted for use in food by regulations in
this part, provided that such flavoring substances are volatilized from
the adhesives during the packaging fabrication process.
(4) Color additives approved for use in food.
(5) Substances permitted for use in adhesives by other regulations
in this subchapter and substances named in this subparagraph: Provided,
however, That any substance named in this paragraph and covered by a
specific regulation in this subchapter, must meet any specifications in
such regulation.
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Abietic acid...........................
Acetone................................
Acetone-formaldehyde condensate (CAS
Reg. No. 25619-09-4).
Acetone-urea-formaldehyde resin........
N-Acetyl ethanolamine..................
Acetyl tributyl citrate................
Acetyl triethyl citrate................
2-Acrylamido-2-methyl-propanesulfonic
acid, homopolymer, sodium salt (CAS
Reg. No. 35641-59-9).
Albumin, blood.........................
(2-Alkenyl) succinic anhydrides in
which the alkenyl groups are derived
from olefins which contain not less
than 78 percent C30 and higher groups
(CAS Reg. No. 70983-55-0).
4-[2-[2-2-(Alkoxy (C12-C15) ethoxy)
ethoxy]ethyl] disodium sulfosuccinate.
1-Alkyl (C6-C18) amino-3-amino-propane
monoacetate.
Alkylated (C4 and/or C8) phenols.......
Alkyl (C7-C12) benzene.................
Alkyl (C10-C20) dimethylbenzyl ammonium
chloride.
n-Alkyl(C12, C14, C16, or C18) dimethyl For use as preservative only.
(ethylbenzyl) ammonium
cyclohexylsulfamate.
Alkyl ketene dimers as described in
Sec. 176.120 of this chapter.
Alkyl (C7-C12) naphthalene.............
alpha Olefin sulfonate [alkyl group is
in the range of C10-C18 with not less
than 50 percent C14-C16], ammonium,
calcium, magnesium, potassium, and
sodium salts.
2-[(2-aminoethyl)amino]ethanol (CAS
Reg. No. 111-41-1).
3-Aminopropanediol..................... For use only in the preparation
of polyurethane resins.
Aluminum...............................
Aluminum acetate.......................
Aluminum di(2-ethylhexoate)............
Aluminum potassium silicate............
N-[beta]-Aminoethyl-gamma-aminopropyl
trimethoxysilane.
3-(Aminomethyl)-3,5,5-
trimethylcyclohexylamine.
Aminomethylpropanol....................
Ammonium benzoate...................... For use as preservative only.
Ammonium bifluoride.................... For use only as bonding agent
for aluminum foil, stabilizer
or preservative. Total
fluoride from all sources not
to exceed 1 percent by weight
of the finished adhesive.
Ammonium borate........................
Ammonium citrate.......................
Ammonium persulfate....................
Ammonium polyacrylate..................
Ammonium potassium hydrogen phosphate..
Ammonium silico-fluoride............... For use only as bonding agent
for aluminum foil, stabilizer,
or preservative. Total
fluoride from all sources not
to exceed 1 percent by weight
of the finished adhesive.
Ammonium sulfamate.....................
Ammonium thiocyanate...................
Ammonium thiosulfate...................
Amyl acetate...........................
Anhydroenneaheptitol...................
Animal glue as described in Sec.
178.3120 of this chapter.
2-Anthraquinone sulfonic acid, sodium For use only as polymerization-
salt. control agent.
Antimony oxide.........................
Asbestos...............................
Asphalt, paraffinic and naphthenic.....
[[Page 150]]
Azelaic acid...........................
Azo-bis-isobutyronitrile...............
Balata rubber..........................
Barium acetate.........................
Barium peroxide........................
Barium sulfate.........................
Bentonite..............................
Benzene (benzol).......................
1,4-Benzenedicarboxylic acid, bis[2- For use as a stabilizer.
(1,1-dimethylethyl)-6-[[3-(1,1-
dimethylethyl)-2-hydroxy-5-
methylphenyl]methyl]-4-methyl-
phenyl]ester (CAS Reg. No. 57569-40-1).
1,2-Benzisothiazolin-3-one (CAS For use as preservative only.
Registry No. 2634-33-5).
Benzothiazyldisulfide..................
p-Benzoxyphenol........................ For use as preservative only.
Benzoyl peroxide.......................
Benzyl alcohol.........................
Benzyl benzoate........................
Benzyl bromoacetate.................... For use as preservative only.
p-Benzyloxyphenol...................... Do.
BHA (butylated hydroxyanisole).........
BHT (butylated hydroxytoluene).........
Bicyclo[2.2.1]hept-2-ene-6-methyl
acrylate.
2-Biphenyl diphenyl phosphate..........
Bis(benzoate-O)(2-propanolato)aluminum For use only as a reactant in
(CAS Reg. No. 105442-85-1). the preparation of polyester
resins.
1,2-Bis(3,5-di-tert-butyl-4- For use at a level not to
hydroxyhydrocinnamoyl)hy-drazine (CAS exceed 2 percent by weight of
Reg. No. 32687-78-8). the adhesive.
1,3-Bis(2-benzothiazolylmercaptomethyl)
urea.
4,4'-Bis([alpha],[alpha]-
dimethylbenzyl)diphenylamine.
2,6-Bis(1,1-dimethylethyl)-4-(1- For use as an antioxidant and/
methylpropyl)phenol (CAS Reg. No. or stabilizer only.
17540-75-9).
2,6-Bis (1-methylheptadecyl)-p-cresol..
4-[[4, 6-Bis(octylthio)6-
Bis(octylthio)6-Bis(octylthio)-s-
triazin-2-yl]amino]-2,6-di-tert-
butylphenol (CAS Reg. No. 991-84-4).
Bis(tri-n-butyltin) oxide.............. For use as preservative only.
Bis(trichloromethyl)sulfone C.A. Do.
Registry No. 3064-70-8.
Borax..................................
Boric acid.............................
2-Bromo-2-nitro-1, 3-propanediol (CAS For use only as an
Reg. No. 52-51-7). antibacterial preservative.
Butanedioic acid, sulfo-1,4-di-(C9-C11 For use as a surface active
alkyl) ester, ammonium salt (also agent in adhesives.
known as butanedioic acid, sulfo-1,4-
diisodecyl ester, ammonium salt [CAS
Reg. No. 144093-88-9])..
1,3-Butanediol.........................
1,4-Butanediol.........................
1,4-Butanediol modified with adipic
acid.
Butoxy polyethylene polyproplyene
glycol (molecular weight 900-4,200).
Butyl acetate..........................
Butyl acetyl ricinoleate...............
Butyl alcohol..........................
Butylated reaction product of p-cresol As identified in Sec.
and dicyclopentadiene. 178.2010(b) of this chapter.
Butylated, styrenated cresols
identified in Sec. 178.2010(b) of
this chapter.
Butyl benzoate.........................
Butyl benzyl phthalate.................
Butyldecyl phthalate................... ...............................
1,3-Butylene glycoldiglycolic acid
copolymer.
tert-Butyl hydroperoxide...............
4,4'-Butylidenebis(6-tert-butyl-m-
cresol).
Butyl lactate..........................
Butyloctyl phthalate...................
p-tert-Butylphenyl salicylate..........
Butyl phthalate butyl glycolate........
p-tert-Butylpyrocatechol............... For use only as polymerization-
control agent.
Butyl ricinoleate......................
Butyl rubber polymer...................
Butyl stearate.........................
Butyl titanate, polymerized............
Butyraldehyde..........................
Calcium ethyl acetoacetate.............
Calcium nitrate........................
Calcium metasilicate...................
Camphor................................
Camphor fatty acid esters..............
Candelilla wax.........................
epsilon-Caprolactam-(ethylene-ethyl
acrylate) graft polymer.
[[Page 151]]
Carbon black, channel process..........
Carbon disulfide-1,1'-
methylenedipiperidine reaction product.
Carbon tetrachloride...................
Carboxymethylcellulose.................
Castor oil, polyoxyethylated (4-84
moles ethylene oxide).
Cellulose acetate butyrate.............
Cellulose acetate propionate...........
Ceresin wax (ozocerite)................
Cetyl alcohol..........................
Chloracetamide.........................
Chloral hydrate........................
Chlorinated liquid n-paraffins with
chain lengths of C10-C17, containing
40-70 percent chlorine by weight.
Chlorinated pyridine mixture with For use as preservative only.
active ingredients consisting of
2,3,5,6-tetrachloro-4-(methylsulfonyl)
pyridine, 2,3,5,6-tetrachloro-4-
(methylsulfinyl) pyridine and
pentachloropyridine.
Chlorinated rubber polymer (natural
rubber polymer containing
approximately 67 percent chlorine).
1-(3-Chloroallyl)-3,5,7-triaza-1- For use as preservative only.
azoniaadamantane chloride.
Chlorobenzene..........................
4-Chloro-3,5-dimethylphenol (p-chloro-m- For use as preservative only.
xylenol).
4-Chloro-3-methylphenol................ Do.
5-Chloro-2-methyl-4-isothiazolin-3-one For use only as an
(CAS Reg. No. 26172-55-4) and 2-methyl- antimicrobial agent in polymer
4-isothiazolin-3-one (CAS Reg. No. latex emulsions.
2682-20-4) mixture at a ratio of 3
parts to 1 part, manufactured from
methyl-3-mercaptopropionate (CAS Reg.
No. 2935-90-2). The mixture may
contain magnesium nitrate (CAS Reg.
No. 10377-60-3) at a concentration
equivalent to the isothiazolone active
ingredients (weight/weight).
Chloroform.............................
Chloroprene............................
Chromium caseinate.....................
Chromium nitrate.......................
Chromium potassium sulfate.............
Cobaltous acetate......................
Coconut fatty acid amine salt of For use as preservative only.
tetrachlorophenol.
Copal..................................
Copper 8-quinolinolate................. For use as preservative only.
Coumarone-indene resin.................
Cresyl diphenyl phosphate..............
Cumene hydroperoxide...................
Cyanoguanidine.........................
Cyclized rubber as identified in Sec.
176.170(b)(2) of this chapter.
Cyclohexane............................
1,4-Cyclohexanedimethanoldibenzoate
(CAS Reg. No. 35541-81-2).
Cyclohexanol...........................
Cyclohexanone resin....................
Cyclohexanone-formaldehyde condensate..
N-Cyclohexyl p-toluene sulfonamide.....
([eta]\5\-Cyclopentadienyl)-([eta]\6\- For use only as a
isopropylbenzene)iron(II) photoinitiator.
hexafluorophosphate (CAS Reg. No.
32760-80-8).
Damar..................................
Defoaming agents as described in Sec.
176.210 of this chapter.
Dehydroacetic acid..................... ...............................
Diacetone alcohol......................
Diacetyl peroxide......................
N,N'-Dialkoyl-4,4'-
diaminodiphenylmethane mixtures where;
the alkoyl groups are derived from
marine fatty acids (C12-C24).
2,5-Di-tert-amylhydroquinone...........
Diamines derived from dimerized
vegetable oil acids.
Diaryl-p-phenylenediamine, where the
aryl group may be phenyl, tolyl, or
xylyl.
1,2-Dibromo-2,4-dicyanobutane (CAS For use as a preservative only.
Registry No. 3569-65-7).
2,2-Dibromo-3-nitrilopropionamide (CAS For use as a preservative only.
Reg. No. 10222-01-2)..
Di(butoxyethyl) phthalate..............
2,5-Di-tert-butylhydroquinone..........
Dibutyl maleate........................
2,6-Di-tert-butyl-4-methylphenol....... For use as preservative only.
Di(C7, C9-alkyl)adipate................
Dibutyl phthalate......................
Dibutyl sebacate.......................
Dibutyltin dilaurate for use only as a
catalyst for polyurethane resins.
1,2-Dichloroethylene (mixed isomers)...
Dicumyl peroxide.......................
[[Page 152]]
Dicyclohexyl phthalate.................
Diethanolamine.........................
Diethanolamine condensed with animal or
vegetable fatty acids.
Diethylamine...........................
Diethylene glycol......................
Diethylene glycol adipic acid copolymer
Diethylene glycol dibenzoate...........
Diethylene glycol hydrogenated
tallowate monoester.
Diethylene glycol laurate..............
Diethylene glycol monobutyl ether......
Diethylene glycol monobutyl ether
acetate.
Diethylene glycol monoethyl ether......
Diethylene glycol monoethyl ether
acetate.
Diethylene glycol monomethyl ether.....
Diethylene glycol monooleate...........
Diethylene glycol monophenyl ether.....
Diethylene glycol copolymer of adipic
acid and phthalic anhydride.
Di(2-ethylhexyl) adipate...............
Di(2-ethylhexyl)hexahydrophthalate.....
Di(2-ethylhexyl)phthalate..............
Diethyl oxalate........................
Diethyl phthalate......................
Dihexyl phthalate......................
Dihydroabietylphthalate................
Di(2-hydroxy-5-tert-butylphenyl)
sulfide.
2,2'-Dihydroxy-5,5'-
dichlorodiphenylmethane
(dichlorophene).
4,5-Dihydroxy-2-imidazolidinone........
4-(Diiodomethylsulfonyl) toluene CA For use as an antifungal
Registry No.: 20018-09-01. preservative only.
Diisobutyl adipate.....................
Diisobutyl ketone......................
Diisobutylphenoxyethoxyethyl dimethyl
benzyl ammonium chloride.
Diisobutyl phthalate...................
Diisodecyl adipate.....................
Diisodecyl phthalate...................
Diisooctyl phthalate...................
Diisopropylbenzene hydroperoxide.......
N,N-Dimethylcyclohexylamine
dibutyldithiocarbamate.
Dimethyl formamide.....................
Dimethyl hexynol.......................
2,2-Dimethyl-1,3-propanediol dibenzoate
Dimethyl octynediol....................
N-(1,1-dimethyl-3-oxobutyl) acrylamide.
Dimethyl phthalate.....................
3,5-Dimethyl-1,3,5,2H- For use as preservative only.
tetrahydrothiadiazine-2-thione.
Di-[beta]-naphthyl-p-phenylenediamine..
4,6-Dinonyl-o-cresol...................
Dinonylphenol..........................
Di-n-octyldecyl adipate................
Dioctyldiphenylamine...................
Dioctylphthalate.......................
Dioctylsebacate........................
Dioxane................................
Dipentaerythritol pentastearate........
Dipentamethylene-thiuram-tetrasulfide..
Dipentene.............................. ...............................
Dipentene resins.......................
Dipentene-beta-pinene-styrene resins...
Dipentene-styrene resin (CAS Registry
No. 64536-06-7).
Diphenyl-2-ethylhexyl phosphate........
Diphenyl, hydrogen ated................
N,N'-Diphenyl-p-phenylenediamine.......
Diphenyl phthalate.....................
1,3-Diphenyl-2-thiourea................
Dipropylene glycol.....................
Dipropylene glycol dibenzoate..........
Dipropylene glycol monomethyl ether....
Dipropylene glycol copolymer of adipic
acid and phthalic anhydride.
Disodium cyanodithioimidocarbonate.....
Disodium 4-isodecyl sulfosuccinate (CAS
Reg. No. 37294-49-8).
N,N'-Distearoylethylenediamine.........
Distearyl thiodipropionate.............
3,5-Di-tert-butyl-4- For use as antioxidant only.
hydroxyhydrocinnamic acid triester
with 1,3,5-tris(2-hydroxyethyl)-s-
triazine-2,4,6(1H, 3H, 5H)-trione.
4,4'-Dithiodimorpholine................
[[Page 153]]
n-Dodecylmercaptan.....................
tert-Dodecylmercaptan..................
Dodecylphenoxybenzene-disulfonic acid
and/or its calcium, magnesium, and
sodium salts.
Elemi gum..............................
Epichlorohydrin-4,4'-
isopropylidenediphenol resin.
Epichlorohydrin-4,4'-sec-
butylidenediphenol resin.
Epichlorohydrin-4,4'-isopropylidene-di-
o-cresol resin.
Epichlorohydrin-phenolformaldehyde
resin.
Erucamide (erucylamide)................
Ethanolamine...........................
Ethoxylated primary linear alcohols of
greater than 10 percent ethylene oxide
by weight having molecular weights of
390 to 7,000 (CAS Reg. No. 97953-22-5).
Ethoxypropanol butyl ether.............
Ethyl alcohol (ethanol)................
5-Ethyl-1,3-diglycidyl-5-
methylhydantoin (CAS Reg. No. 15336-82-
0).
Ethylene-acrylic acid-carbon monoxide
copolymer (CAS Reg. No. 97756-27-9).
Ethylene-acrylic acid copolymer,
partial sodium salt containing no more
than 20 percent acrylic acid by
weight, and no more than 16 percent of
the acrylic acid as the sodium salt
(CAS Reg. No. 25750-82-7).
Ethylenediamine........................
Ethylenediaminetetra-acetic acid,
calcium, ferric, potassium, or sodium
salts, single or mixed.
Ethylene dichloride....................
Ethylene glycol........................
Ethylene glycol monobutyl ether........
Ethylene glycol monobutyl ether acetate
Ethylene glycol monoethyl ether........
Ethylene glycol monoethyl ether acetate
Ethylene glycol monoethyl ether
ricinoleate.
Ethylene glycol monomethyl ether.......
Ethylene glycol monophenyl ether.......
Ethylene-carbon monoxide copolymer (CAS
Reg. No. 25052-62-4) containing not
more than 30 weight percent of the
units derived from carbon monoxide.
Ethylene-maleic anhydride copolymer,
ammonium or potassium salt.
Ethylene-methacrylic acid copolymer
partial salts: Ammonium, calcium,
magnesium, sodium, and/or zinc.
Ethylene-methacrylic acid-vinyl acetate
copolymer partial salts: Ammonium,
calcium, magnesium, sodium, and/or
zinc.
Ethylene-octene-1 copolymers containing
not less than 70 weight percent
ethylene (CAS Reg. No. 26221-73-8).
Ethylene-propylene-dicyclopentadiene
copolymer rubber.
Ethylene, propylene, 1,4-hexadiene and
2,5-norbornadiene tetrapolymer.
Ethylene-vinyl acetate carbon monoxide
terpolymer (CAS Registry No. 26337-35-
9) containing not more than 15 weight
percent of units derived from carbon
monoxide.
2,2'-Ethylidenebis (4,6-di-tert-
butylphenol) (CAS Reg. No. 35958-30-6).
Ethyl-p-hydroxybenzoate................ For use as preservative only.
Ethyl hydroxyethylcellulose............
Ethyl lactate..........................
2,2'-Ethylidenebis(4,6-di-tert- For use as an antioxidant and/
butylphenyl)fluorophosphonite (CAS or stabilizer only.
Reg. No. 118337-09-0).
Ethyl phthalyl ethyl glycolate.........
Ethyl-p-toluene sulfonamide............ ...............................
Fats and oils derived from animal or
vegetable sources, and the
hydrogenated, sulfated, or sulfonated
forms of such fats and oils.
Fatty acids derived from animal or
vegetable fats and oils; and salts of
such acids, single or mixed, as
follows:
Aluminum.............................
Ammonium.............................
Calcium..............................
Magnesium............................
Potassium............................
Sodium...............................
Zinc.................................
Ferric chloride........................
Fluosilicic acid (hydrofluosilicic For use only as bonding agent
acid). for aluminum foil, stabilizer,
or preservative. Total
fluoride from all sources not
to exceed 1 percent by weight
of the finished adhesive.
Formaldehyde...........................
[[Page 154]]
Formaldehyde o- and p-toluene
sulfonamide.
Formamide..............................
Fumaratochromium (III) nitrate.........
Furfural...............................
Furfuryl alcohol.......................
Fumaric acid...........................
gamma-Aminopropyltrimethoxysilane (CAS
Reg. No. 13822-56-5).
Glutaraldehyde.........................
Glycerides, di- and monoesters.........
Glycerol polyoxypropylene triol, For use only in the preparation
minimum average molecular weight 250 of polyester and polyurethane
(CAS Reg. No. 25791-96-2). resins in adhesives.
Glyceryl borate (glycol boriborate
resin).
Glyceryl ester of damar, copal, elemi,
and sandarac.
Glyceryl monobutyl ricinoleate.........
Glyceryl monohydroxy stearate..........
Glyceryl monohydroxy tallowate.........
Glyceryl polyoxypropylene triol
(average molecular weight 1,000).
Glyceryl tribenzoate...................
Glycol diacetate.......................
Glyoxal................................
Heptane................................
Hexamethylenetetramine.................
Hexane.................................
Hexanetriols...........................
Hexylene glycol........................
Hydroabietyl alcohol...................
Hydrocarbon resins (produced by
polymerization of mixtures of mono-
and di-unsaturated hydrocarbons of the
aliphatic, alicyclic, and
monobenzenoid type derived both from
cracked petroleum and terpene stocks)
(CAS Reg. No. 68239-99-6).
Hydrocarbon resins (produced by the
polymerization of styrene and alpha-
methyl styrene), hydrogenated (CAS
Reg. No. 68441-37-2).
Hydrofluoric acid...................... For use only as bonding agent
for aluminum foil, stabilizer,
or preservative. Total
fluoride from all sources not
to exceed 1 percent by weight
of the finished adhesive.
Hydrogen peroxide......................
Hydrogenated dipentene resin (CAS Reg.
No. 106168-39-2).
Hydrogenated dipentene-styrene
copolymer resin (CAS Reg. No. 106168-
36-9).
Hydrogenated-beta-pinene-alpha-pinene-
dipentene copolymer resin (CAS Reg.
No. 106168-37-0).
a-Hydro-omega-hydroxypoly- For use only in the preparation
(oxytetramethylene). of polyurethane resins.
Hydroquinone...........................
Hydroquinone monobenzyl ether..........
Hydroquinone monoethyl ether...........
2(2'-Hydroxy-3',5' di-tert-amylphenyl)
benzotriazole.
Hydroxyacetic acid.....................
7-Hydroxycoumarin......................
Hydroxyethylcellulose..................
2-Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]- For use only as a
2-methyl-1-propanone(CAS Reg. No. photoinitiator at a level not
106797-53-9). to exceed 5 percent by weight
of the adhesive.
1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2
alkyl (C6-C17) imidazolinium chloride.
Hydroxyethyldiethylenetriamine.........
[beta]-Hydroxyethyl pyridinium 2-
mercaptobenzothiazol.
Hydroxyethyl starch....................
Hydroxyethylurea....................... ...............................
Hydroxylamine sulfate..................
5-Hydroxymethoxymethyl-1-aza-3,7- For use only as an
dioxabicyclo[3.3.0]octane, 5- antibacterial preservative.
hydroxymethyl-1-aza-3,7-
dioxabicyclo[3.3.0]octane, and 5-
hydroxypoly-[methyleneoxy]methyl-1-aza-
3,7-dioxabicyclo[3.3.0] octane mixture.
Hydroxypropyl methylcellulose..........
2-(Hydroxymethyl)-2-methyl-1,3-
propanediol tribenzoate.
2-Imidazolidinone......................
3-Iodo-2-propynyl-N-butyl carbamate For use only as an antifungal
(CAS Reg. No. 55406-53-6). preservative.
Iodoform............................... For use only as polymerization-
control agent.
Isoascorbic acid.......................
Isobutyl alcohol (isobutanol)..........
Isobutylene-isoprene copolymer.........
Isodecyl benzoate (CAS Reg. No. 131298-
44-77).
Isophorone.............................
Isopropanolamine (mono-, di-, tri-)....
[[Page 155]]
Isopropyl acetate......................
Isopropyl alcohol (isopropanol)........
Isopropyl-m- and p-cresol (thymol
derived).
4,4'-Isopropylidenediphenol............
4,4'-Isopropylidenediphenol, For use as preservative only.
polybutylated mixture.
Isopropyl peroxydicarbonate............
p-Isopropoxy diphenylamine.............
4,4'-Isopropylidene-bis(p-phenyleneoxy)-
di-2-propanol.
Itaconic acid..........................
Japan wax..............................
Kerosene...............................
Lauroyl peroxide.......................
Lauroyl sulfate salts:
Ammonium.............................
Magnesium............................
Potassium............................
Sodium...............................
Lauryl alcohol.........................
Lauryl pyridinium 5-chloro-2-
mercaptobenzothiazole.
Lignin calcium sulfonate...............
Lignin sodium sulfonate................
Linoleamide (linoleic acid amide)......
Magnesium fluoride..................... For use only as bonding agent
for aluminum foil, stabilizer,
or preservative. Total
fluoride from all sources not
to exceed 1 percent by weight
of the finished adhesives.
Magnesium glycerophosphate.............
Maleic acid............................
Maleic anhydride-diisobutylene
copolymer, ammonium or sodium salt.
Manganese acetate......................
Marine oil fatty acid soaps,
hydrogenated.
Melamine...............................
Melamine-formaldehyde copolymer........
2-Mercaptobenzothiazole................
2-Mercaptobenzothiazole and dimethyl For use as preservative only.
dithiocarbamic acid mixture, sodium
salt.
2-Mercaptobenzothiazole, sodium or zinc For use as preservative only.
salt.
Methacrylate-chromic chloride complex,
ethyl or methyl ester.
p-Menthane hydroperoxide...............
Methyl acetate.........................
Methyl acetyl ricinoleate..............
Methyl alcohol (methanol)..............
Methylcellulose........................
Methylene chloride.....................
4,4'-Methylenebis(2,6-di-tert-
butylphenol).
2,2-Methylenebis (4-ethyl-6-tert-
butylphenol).
2,2-Methylenebis (4-methyl-6-
nonylphenol).
2,2-Methylenebis (4-methyl-6-tert-
butylphenol).
Methyl ethyl ketone....................
Methyl ethyl ketone-formaldehyde
condensate.
2-Methylhexane.........................
1-Methyl-2-hydroxy-4-isopropyl benzene.
Methyl isobutyl ketone.................
Methyl oleate..........................
Methyl oleate-palmitate mixture........
Methyl phthalyl ethyl glycolate........
Methyl ricinoleate.....................
Methyl salicylate......................
a-Methylstyrene-vinyltoluene copolymer ...............................
resins (molar ratio 1 a methylstyrene
to 3 vinyltoluene).
Methyl tallowate.......................
Mineral oil............................
Monochloracetic acid...................
Monooctyldiphenylamine.................
Montan wax.............................
Morpholine.............................
Myristic acid-chromic chloride complex.
Myristyl alcohol.......................
Naphtha................................
Naphthalene, monosulfonated............
Naphthalene sulfonic acid-formaldehyde
condensate, sodium salt.
[alpha]-Naphthylamine..................
[alpha],[alpha]',[alpha][dprime],[alpha
][dprime]'-Neopentane tetrayltetrakis
[omega-hydroxypoly (oxypropylene) (1-2
moles)], average molecular weight 400.
[[Page 156]]
Nitric acid............................
[mu]-Nitrobiphenyl.....................
Nitrocellulose.........................
2-Nitropropane.........................
[alpha]-(p-Nonylphenyl)-omega-
hydroxypoly (oxyethylene) mixture of
dihydrogen phosphate and monohydrogen
phosphate esters; the nonyl group is a
propylene trimer isomer and the poly
(oxyethylene) content averages 6-9
moles or 50 moles.
[alpha](p-Nonylphenyl)-omega-
hydroxypoly (oxyethylene) produced by
the condensation of 1 mole of p-
nonylphenol (nonyl group is a
propylene trimer isomer) with an
average of 1-40 moles of ethylene
oxide.
[alpha]-(p-Nonylphenyl)-omega-
hydroxypoly (oxyethylene) sulfate,
ammonium salt: the nonyl group is a
propylene trimer isomer and the poly
(oxyethylene) content averages 9 or 30
moles.
endo-cis-5-Norbornene-2,3-dicarboxylic
anhydride.
[alpha]-cis-9-Octadecenyl-omega-
hydroxypoly (oxyethylene); the
octadecenyl group is derived from
oleyl alcohol and the poly
(oxyethylene) content averages 20
moles.
Octadecyl 3,5-di-tert-butyl-4-
hydroxyhydrocinnamate.
Octyl alcohol..........................
Octyldecyl phthalate...................
Octylphenol............................
Octylphenoxyethanols...................
Octylphenoxypolyethoxy-
polypropoxyethanol (13 moles of
ethylene oxide and propylene oxide).
Odorless light petroleum hydrocarbons..
Oleamide (oleic acid amide)............
Oleic acid, sulfated...................
2,2'-Oxamidobis[ethyl 3-(3,5-di-tert-
butyl-4-hydroxyphenyl)propionate] (CAS
Reg. No. 70331-94-1).
Oxazoline..............................
[alpha]-(oxiranylmethyl)-[omega]- For use as a reactant in the
(oxiranylmethoxy)poly[oxy(methyl-1,2- preparation of epoxy-based
ethanediyl)], (alternative name: resins.
epichlorohydrin-polypropylene glycol)
(CAS Reg. No. 26142-30-3).
2,2'-[oxybis[(methyl-2,1-ethanediyl)- For use as a reactant in the
oxymethylene]]bisoxirane, (alternative preparation of epoxy-based
name: epichlorohydrin-dipropylene resins.
glycol) (CAS Reg. No. 41638-13-5).
n-Oxydiethylene-benzothiazole..........
Palmitamide (palmitic acid amide)......
Paraffin (C12-C20) sulfonate...........
Paraformaldehyde.......................
Pentachlorophenol......................
Pentaerythritol ester of maleic
anhydride.
Pentaerythritol monostearate........... For use as preservative only.
Pentaerythritol tetrabenzoate [CAS
Registry No. 4196-86-5].
Pentaerythritol tetrastearate..........
2,4-Pentanedione.......................
Pentasodium
diethylenetriaminepentaacetate (CAS
Reg. No. 140-01-2).
Perchloroethylene......................
Petrolatum.............................
Petroleum hydrocarbon resin
(cyclopentadiene type), hydrogenated.
Petroleum hydrocarbon resin (produced
by the catalytic polymerization and
subsequent hydrogenation of styrene,
vinyltoluene, and indene types from
distillates of cracked petroleum
stocks).
Petroleum hydrocarbon resins (produced
by the homo-and copolymerization of
dienes and olefins of the aliphatic,
alicyclic, and monobenzenoid
arylalkene types from distillates of
cracked petroleum stocks).
Phenol................................. For use as preservative only.
Phenol-coumarone-indene resin..........
Phenolic resins as described in Sec.
175.300(b)(3)(vi).
Phenothiazine.......................... For use only as polymerization-
control agent.
Phenyl-[beta]-naphthylamine (free of
[beta]-naphthylamine).
o-Phenylphenol......................... For use as preservative only.
o-Phthalic acid........................
Pimaric acid........................... ...............................
Pine oil...............................
Piperazine.............................
Piperidinium
pentamethylenedithiocarbamate.
Poly(acrylamide-[2-acrylamide-2-
methylpropylsulfonate]-
dimethylidiallyl ammonium chloride)
sodium salt (CAS Reg. No. 72275-68-4).
Polyamides derived from reaction of one
or more of the following acids with
one or more of the following amines:
Acids:
Azelaic acid...................
[[Page 157]]
Dimerized vegetable oil acids..
Amines:
Bis(hexamethylene) triamine and
higher homologues.
Diethylenetriamine.............
Diphenylamine..................
Ethylenediamine................
Hexamethylenediamine...........
Poly(oxypropylene)diamine
(weight average molecular
weight 2010) (CAS Reg. No.
9046-10-0).
Poly(oxypropylene)diamine
(weight average molecular
weight 440) (CAS Reg. No. 9046-
10-0).
Tetraethylenepentamine.........
Triethylenetetramine...........
Polybutene, hydrogenated...............
Polybutylene glycol (molecular weight
1,000).
Poly [2(diethylamino) ethyl
methacrylate] phosphate.
Polyester of adipic acid, phthalic
acid, and propylene glycol, terminated
with butyl alcohol.
Polyester of diglycolic acid and
propylene glycol containing ethylene
glycol monobutyl ether as a chain
stopper.
Polyester resins (including alkyd
type), as the basic polymer, formed as
esters when one or more of the
following acids are made to react with
one or more of the following alcohols:
Acids:
Azelaic acid...................
Dimethyl 1,4-
cyclohexanedicarboxylate (CAS
Reg. No. 94-60-0).
Dimethyl-5-sulfoisophthalic
acid (CAS Reg. No. 50975-82-1)
and/or its sodium salt (CAS
Reg. No. 3965-55-7).
Polybasic and monobasic acids
identified in Sec.
175.300(b)(3)(vii)(a) and (b).
5-sulfo-1,3-benzenedicarboxylic
acid, monosodium salt (CAS
Reg. No. 6362-79-4).
Tetrahydrophthalic acid........
Alcohols:
1,4-Cyclohexanedimethanol......
2,2-Dimethyl-1,3-propanediol...
1,6-Hexanediol (CAS Reg. No.
629-11-8).
Polyhydric and monohydric
alcohols identified in Sec.
175.300(b)(3)(vii)(c) and (d).
Polyethyleneadipate modified with For use only in the preparation
ethanolamine with the molar ratio of of polyurethan resins.
the amine to the adipic acid less than
0.1 to 1.
Polyethylene glycol (molecular weight
200-6,000).
Polyethylene glycol mono-isotridecyl
ether sulfate, sodium salt (CAS Reg.
No. 150413-26-6).
Polyethyleneglycol alkyl(C10-C12) ether
sulfosuccinate, disodium salt (CAS
Reg. No. 68954-91-6).
Polyethylene, oxidized.................
Polyethylene resins, carboxyl modified,
identified in Sec. 177.1600 of this
chapter.
Polyethylenimine.......................
Polyethylenimine-epichlorohydrin resins
Poly(ethyloxazoline) (CAS Reg. No.
25805-17-8).
Polyisoprene...........................
Polymeric esters of polyhydric alcohols
and polycarboxylic acids prepared from
glycerin and phthalic anhydride and
modified with benzoic acid, castor
oil, coconut oil, linseed oil, rosin,
soybean oil, styrene, and vinyl
toluene.
Polymers: Homopolymers and copolymers
of the following monomers:.
Acrylamide...........................
Acrylic acid.........................
Acrylonitrile........................
Allylmethacrylate (CAS Reg. No. 00096-
05-09).
Butadiene............................
Butene...............................
N-tert-Butylacrylamide...............
Butyl acrylate.......................
1,3-Butylene glycol dimethacrylate...
Butyl methacrylate...................
Crotonic acid........................
Decyl acrylate.......................
Diallyl fumarate.....................
Diallyl maleate......................
[[Page 158]]
Diallyl phthalate....................
Dibutyl fumarate.....................
Dibutyl itaconate....................
Dibutyl maleate......................
Di(2-ethylhexyl) maleate.............
Dimethyl-[alpha]-methylstyrene.......
Dioctyl fumarate.....................
Dioctyl maleate......................
Divinylbenzene.......................
Ethyl acrylate.......................
Ethylene.............................
Ethylene cyanohydrin.................
2-Ethylhexyl acrylate................
Ethyl methacrylate...................
Fatty acids, C10-13-branched, vinyl
esters (CAS Reg. No. 184785-38-4).
Fumaric acid and/or its methyl,
ethyl, propyl, butyl, amyl hexyl,
heptyl and octyl esters.
Glycidyl methacrylate................
1-Hexene (CAS Reg. No. 592-41-6).....
2-Hydroxyethyl acrylate..............
2-Hydroxyethyl methacrylate..........
2-Hydroxypropyl methacrylate.........
Isobutyl acrylate....................
Isobutylene..........................
Itaconic acid........................
Maleic acid, diester with 2-
hydroxyethanesulfonic acid, sodium
salt.
Maleic anhydride.....................
Methacrylic acid.....................
Methyl acrylate......................
N,N'-Methylenebisacrylamide..........
Methyl methacrylate..................
N-Methylolacrylamide.................
Methyl styrene.......................
-Methyl styrene......................
Monoethyl maleate....................
Monomethyl maleate...................
Mono (2-ethylhexyl) maleate..........
5-Norbornene-2 3-dicarboxylic acid,
mono-n-butyl ester.
1-Octene (CAS Reg. No. 111-66-0).....
Propyl acrylate......................
Propylene............................
Styrene..............................
Triallyl cyanurate...................
Vinyl acetate........................
Vinyl alcohol (from alcoholysis or
hydrolysis of vinyl acetate units).
Vinyl butyrate.......................
Vinyl chloride.......................
Vinyl crotonate......................
Vinyl ethyl ether....................
Vinyl hexoate........................
Vinylidene chloride..................
Vinyl methyl ether...................
Vinyl pelargonate....................
Vinyl propionate.....................
Vinyl pyrrolidone....................
Vinyl stearate.......................
Polyoxyalkylated-phenolic resin
(phenolic resin obtained from
formaldehyde plus butyl- and/or
amylphenols, oxyalkylated with
ethylene oxide and/or propylene oxide).
Poly(oxycaproyl) diols and triols
(minimum molecular weight 500).
Polyoxyethylated (40 moles) tallow
alcohol sulfate, sodium salt.
Polyoxyethylene (20 mol)--anhydrous
lanolin adduct.
Polyoxyethylene (molecular weight 200)
dibenzoate.
Polyoxyethylene (molecular weight 200-
600) esters of fatty acids derived
from animal or vegetable fats and oils
(including tall oil).
Polyoxyethylene (15 moles) ester of
rosin.
Polyoxyethylene (4-5 moles) ether of
phenol.
Polyoxyethylene (25 moles)--glycerol
adduct.
Polyoxyethylene (40 moles) stearate....
Polyoxyethylene (5-15 moles) tridecyl
alcohol.
Polyoxypropylene (3 moles) tridecyl
alcohol sulfate.
Polyoxypropylene (20 moles) butyl ether
Polyoxypropylene (40 moles) butyl ether
[[Page 159]]
Polyoxypropylene (20 moles) oleate
butyl ether.
Polyoxypropylene-polyoxyethylene
condensate (minimum molecular weight
1,900).
Polypropylene glycol (minimum molecular
weight 150).
Polypropylene glycol (3-4 moles)
triether with 2-ethyl-2-
(hydroxymethyl)-1,3-propane-diol,
average molecular weight 730.
Polypropylene glycol dibenzoate (CAS For use as a plasticizer at
Reg. No. 72245-46-6). levels not to exceed 20
percent by weight of the
finished adhesive.
Polypropylene, noncrystalline..........
Polysiloxanes:
Diethyl polysiloxane.................
Dihydrogen polysiloxane..............
Dimethyl polysiloxane................
Diphenyl polysiloxane................
Ethyl hydrogen polysiloxane..........
Ethyl phenyl polysiloxane............
Methyl ethyl polysiloxane............
Methyl hydrogen polysiloxane.........
Methyl phenyl polysiloxane...........
Phenyl hydrogen polysiloxane.........
Polysorbate 60.........................
Polysorbate 80.........................
Polysorbate 20 (polyoxyethylene (20)
sorbitan monolaurate).
Polysorbate 40 (polyoxyethylene (20)
sorbitan monopalmitate).
Poly[styrene-co-disodium maleate-co-
[alpha]-(p-nonyl-phenyl)-omega-(p-
vinyl-benzyl)poly(oxyethylene)]
terpolymer.
Polytretrafluoroethylene...............
Polyurethane resins produced by: (1)
reacting diisocyanates with one or
more of the polyols or polyesters
named in this paragraph, or (2)
reacting the chloroformate derivatives
of one or more of the polyols or
polyesters named in this paragraph
with one or more of the polyamines
named in this paragraph, or (3)
reacting toluene diisocyanate or 4,4'
methylenebis(cyclohexylisocyanate)
(CAS Reg. No. 5124-30-1) with: (i) one
or more of the polyols or polyesters
named in this paragraph and with
either N-methyldiethanolamine (CAS
Reg. No. 105-59-9) and dimethyl
sulfate (CAS Reg. No. 77-78-1) or
dimethylolpropionic acid (CAS Reg. No.
4767-03-7) and triethylamine (CAS Reg.
No. 121-44-8), or (ii) a fumaric acid-
modified polypropylene glycol or
fumaric acid-modified tripropylene
glycol), triethylamine (CAS Reg. No.
107-15-3), and ethylenediamine (CAS
Reg. No. 121-44-8), or (4) reacting
meta-tetramethylxylene diisocyanate
(CAS Reg. No. 2778-42-9) with one or
more of the polyols and polyesters
listed in this paragraph and with
dimethylolpropionic acid (CAS Reg. No.
4767-03-7) and triethylamine (CAS Reg.
No. 121-44-8), N-methyldiethanolamine
(CAS Reg. No. 105-59-9), 2-
dimethylaminoethanol (CAS Reg. No. 108-
01-0), 2-dimethylamino-2-methyl-1-
propanol (CAS Reg. No. 7005-47-2), and/
or 2-amino-2-methyl-1-propanol (CAS
Reg. No. 124-68-5).
Polyvinyl alcohol modified so as to
contain not more than 3 weight percent
of comonomer units derived from 1-
alkenes having 12 to 20 carbon atoms.
Polyvinyl butyral......................
Polyvinyl formal.......................
Potassium ferricyanide................. For use only as polymerization-
control agent.
Potassium N-methyldithiocarbamate......
Potassium pentachlorophenate........... For use as preservative only.
Potassium permanganate.................
Potassium persulfate...................
Potassium phosphates (mono-, di-,
tribasic).
Potassium tripolyphosphate.............
[alpha], [alpha]', [alpha][dprime]-
1,2,3-Propanetriyltris [omega-(2,3-
epoxypropoxy) poly (oxypropylene) (24
moles)].
[beta]-Propiolactone...................
Propyl alcohol (propanol)..............
Propylene carbonate....................
Propylene glycol and p-p'-
isopropylidenediphenol diether.
Propylene glycol dibenzoate (CAS Reg. For use as a plasticizer at
No. 19224-26-1). levels not to exceed 20
percent by weight of the
finished adhesive.
Propylene glycol esters of coconut
fatty acids.
Propylene glycol monolaurate...........
Propylene glycol monomethyl ether......
Propylene glycol monostearate..........
[alpha], [alpha]', [alpha][dprime]-
[Propylidynetris (methylene)] tris
[omega-hydroxypoly (oxypropylene) (1.5
moles minimum)], minimum molecular
weight 400.
[[Page 160]]
Quaternary ammonium chloride For use as preservative only.
(hexadecyl, octadecyl derivative).
Rosin (wood, gum, and tall oil rosin),
rosin dimers, decarboxylated rosin
(including rosin oil,
disproportionated rosin, and these
substances as modified by one or more
of the following reactants:.
Alkyl (C1-C9) phenolformaldehyde.....
Ammonia..............................
Ammonium caseinate-p-
Cyclohexylphenolformaldehyde.
Diethylene glycol....................
Dipentaerythritol....................
Ethylene glycol......................
Formaldehyde.........................
Fumaric acid.........................
Glycerin.............................
Hydrogen.............................
Isophthalic acid.....................
4,4'-Isopropylidenediphenol-
epichlorohydrin (epoxy).
4,4'-Isopropylidenediphenol-
formaldehyde.
Maleic anhydride.....................
Methyl alcohol.......................
Pentaerythritol......................
Phthalic anhydride...................
Polyethylene glycol..................
Phenol-formaldehyde..................
Phenyl [mu]-cresol-formaldehyde......
p-Phenylphenol-formaldehyde..........
Sulfuric acid........................
Triethylene glycol...................
Xylenol-formaldehyde.................
Rosin salts (salts of wood, gum, and
tall oil rosin, and the dimers
thereof, decarboxylated rosin
disproportionated rosin, hydrogenated
rosin):
Aluminum.............................
Ammonium.............................
Calcium..............................
Magnesium............................
Potassium............................
Sodium...............................
Zinc.................................
Rosin, gasoline-insoluble fraction.....
Rubber hydrochloride polymer...........
Rubber latex, natural..................
Salicylic acid......................... For use as preservative only.
Sandarac...............................
Sebacic acid...........................
Shellac................................
Silicon dioxide as defined in Sec.
172.480(a) of this chapter.
Sodium alkyl (C2-C13.5 aliphatic)
benezenesulfonate.
Sodium aluminum pyrophosphate..........
Sodium aluminum sulfate................
Sodium bisulfate.......................
Sodium calcium silicate................
Sodium capryl polyphosphate............
Sodium carboxymethylcellulose..........
Sodium chlorate........................
Sodium chlorite........................
Sodium chromate........................
Sodium decylsulfate....................
Sodium dehydroacetate.................. For use as preservative only.
Sodium di-(2-ethylhexoate).............
Sodium di-(2-ethylhexyl) pyrophosphate.
Sodium dihexylsulfosuccinate...........
Sodium dissobutylphenoxydiethoxyethyl
sulfonate.
Sodium diisobutylphenoxymonoethoxyethyl
sulfonate.
Sodium diisopropyl- and
triisopropylnaphthalenesulfonate.
Sodium dimethyldithiocarbamate.........
Sodium dioctylsulfosuccinate...........
Sodium n-dodecylpolyethoxy (50 moles)
sulfate.
Sodium ethylene ether of nonylphenol
sulfate.
Sodium 2-ethylhexyl sulfate............
Sodium fluoride........................ For use only as bonding agent
for aluminum foil, stabilizer,
or preservative. Total
fluoride for all sources not
to exceed 1 percent by weight
of the finished adhesive.
Sodium formaldehyde sulfoxylate........
Sodium formate.........................
[[Page 161]]
Sodium heptadecylsulfate...............
Sodium hypochlorite....................
Sodium isododecylphenoxypolyethoxy (40
moles) sulfate.
Sodium N-lauroyl sarcosinate...........
Sodium metaborate......................
Sodium [alpha]-naphthalene sulfonate...
Sodium nitrate.........................
Sodium nitrite.........................
Sodium oleoyl isopropanolamide
sulfosuccinate.
Sodium pentachlorophenate.............. For use as preservative only.
Sodium perborate.......................
Sodium persulfate......................
Sodium [mu]-phenylphenate.............. For use as preservative only.
Sodium polyacrylate....................
Sodium polymethacrylate................
Sodium polystyrene sulfonate...........
Sodium salicylate...................... For use as preservative only.
Sodium salt of 1-hydroxy 2(1H)-pyridine Do.
thione.
Sodium tetradecylsulfate...............
Sodium thiocyanate.....................
Sodium bis-tridecylsulfosuccinate......
Sodium xylene sulfonate................
Sorbitan monooleate....................
Sorbitan monostearate..................
Soybean oil, epoxidized................
Spermaceti wax.........................
Sperm oil wax..........................
Stannous 2-ethylhexanoate.............. For use only as a catalyst for
polyurethane resins.
Stannous stearate......................
Starch hydrolysates....................
Starch or starch modified by one or
more of the treatments described in
Secs. 172.892 and 178.3520 of this
chapter.
Starch, reacted with a urea-
formaldehyde resin.
Starch, reacted with formaldehyde......
Stearamide (stearic acid amide)........
Stearic acid...........................
Stearic acid-chromic chloride complex..
Stearyl-cetyl alcohol, technical grade,
approximately 65 percent-80 percent
stearyl and 20 percent-35 percent
cetyl.
Strontium salicylate...................
Styrenated phenol......................
Styrene block polymers with 1,3-
butadiene.
Styrene-maleic anhydride copolymer,
ammonium or potassium salt.
Styrene-maleic anhydride copolymer
(partially methylated) sodium salt.
Styrene-methacrylic acid copolymer,
potassium salt.
Sucrose acetate isobutyrate............
Sucrose benzoate.......................
Sucrose octaacetate....................
2-sulfoethyl methacrylate (CAS Registry For use at levels not to exceed
No. 10595-80-9). 2 percent by weight of the dry
adhesive.
[alpha]-Sulfo-omega-(dodecyloxy)poly
(oxyethylene), ammonium salt.
Sulfonated octadecylene (sodium form)..
Sulfosuccinic acid 4-ester with
polyethylene glycol dodecyl ether
disodium salt (alcohol moiety produced
by condensation of 1 mole of n-dodecyl
alcohol and an average of 5-6 moles of
ethylene oxide, Chemical Abstracts
Service Registry No. 039354-45-5).
Sulfosuccinic acid 4-ester with
polyethylene glycol nonylphenyl ether,
disodium salt (alcohol moiety produced
by condensation of 1 mole of
nonylphenol and an average of 9-10
moles of ethylene oxide) (CAS Reg. No.
9040-38-4).
Sulfur.................................
Synthetic primary linear aliphatic
alcohols whose weight average
molecular weight is greater than 400
(CAS Reg. No. 71750-71-5).
Synthetic wax polymer as described in
Sec. 176.170(a)(5) of this chapter.
Tall oil...............................
Tall oil fatty acids, linoleic and
oleic.
Tall oil fatty acid methyl ester.......
Tall oil, methyl ester.................
Tall oil pitch.........................
Tall oil soaps.........................
Tallow alcohol (hydrogenated)..........
Tallow amine, secondary (hexadecyl,
octadecyl), of hard tallow.
Tallow, blown (oxidized)...............
Tallow, propylene glycol ester.........
[[Page 162]]
Terpene resins ([alpha]-and [beta]- ...............................
pinene) homopolymers, copolymers, and
condensates with phenol, formaldehyde,
coumarone, and/or indene.
Terphenyl..............................
Terphenyl, hydrogenated................
Terpineol..............................
Tetraethylene pentamine................
Tetraethylthiuram disulfide............
Tetrahydrofuran........................
Tetrahydrofurfuryl alcohol.............
Tetra-isopropyl titanate...............
Tetrakis[methylene (3,5-di-tert-butyl-4-
hydroxy-hydro-cinnamate)] methane.
a[p-(1,1,3,3-Tetramethylbutyl) phenyl]-
omega-hydroxypoly-(oxyethylene)
produced by the condensation of 1 mole
of p-(1,1,3,3-tetramethylbutyl) phenol
with an average of 1-40 moles of
ethylene oxide.
a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-
omega-hydroxy-poly(oxyethylene)
mixture of dihydrogen phosphate and
monohydrogen phosphate esters and
their sodium, potassium, and ammonium
salts having a poly(oxyethylene)
content averaging 6-9 or 40 moles.
Tetramethyl decanediol.................
Tetramethyl decynediol.................
Tetramethyl decynediol plus 1-30 moles
of ethylene oxide.
Tetramethylthiuram monosulfide.........
Tetrasodium N-(1,2-dicarboxyethyl)N-
octadecylsulfosuccinamate.
4,4'-Thiobis-6-tert-butyl-m-cresol.....
Thiodiethylene-bis(3,5-di-tert-butyl-4-
hydroxyhydrocinnamate).
2,2'-(2,5-Thiophenediyl) bis[5-tert-
butylbenzoxazole].
Thiram.................................
Thymol................................. For use as preservative only.
Titanium dioxide.......................
Titanium dioxide-barium sulfate........
Titanium dioxide-calcium sulfate.......
Titanium dioxide-magnesium silicate....
Toluene................................
Toluene 2,4-diisocyanate...............
Toluene 2,6-diisocyanate...............
o- and p-Toluene ethyl sulfonamide.....
o- and p-Toluene sulfonamide...........
p-Toluene sulfonic acid................
p-(p'-Toluene-sulfonylamide)-
diphenylamide.
Triazine-formaldehyde resins as
described in Sec. 175.300(b)(3)(xiii).
Tributoxyethyl phosphate...............
Tributylcitrate........................
Tri-tert-butyl-p-phenyl phenol......... For use as preservative only.
Tributyl phosphate.....................
Tributyltin chloride complex of For use as preservative only.
ethylene oxide condensate of
dehydroabietylamine.
Tri-n-butyltin acetate................. For use as preservative only.
Tri-n-butyltin neodecanoate............ Do.
1,1,1-Trichloroethane..................
1,1,2-Trichloroethane..................
Trichloroethylene......................
Tri-[beta]-chloroethylphosphate........
Tridecyl alcohol.......................
Triethanolamine........................
3-(Triethoxysilyl) propylamine.........
Triethylene glycol.....................
Triethylene glycol dibenzoate..........
Triethylene glycol di(2-ethylhexoate)..
Triethylene glycol polyester of benzoic
acid and phthalic acid.
Triethylhexyl phosphate................
Triethylphosphate......................
2,4,5-Trihydroxy butyrophenone.........
Triisopropanolamine....................
Trimethylol propane....................
2,2,4-Trimethylpentanediol-1,3-
diisobutyrate.
Trimeric aromatic amine resin from
diphenylamine and acetone of molecular
weight approximately 500.
Tri(nonylphenyl) phosphite-formaldehyde As identified in Sec.
resins. 177.2600(c)(4)(iii) of this
chapter. For use only as a
stabilizer.
Triphenylphosphate.....................
Tripropylene glycol monomethyl ether...
1,3,5-Tris (3,5-di-tert-butyl-4-hydroxy-
benzyl)-triazine-2,4,6 (1H,3H,5H)-
trione.
[[Page 163]]
Tris (p-tertiary butyl phenyl)
phosphate.
Tris(2-methyl-4-hydroxy-5-tert-butyl-
phenyl)butane.
Trisodium N-
hydroxyethylethylenediaminetriacetate
(CAS Reg. No. 139-89-9).
Turpentine.............................
Urea-formaldehyde resins as described
in Sec. 175.300(b)(3)(xii).
Vegetable oil, sulfonated or sulfated,
potassium salt.
Vinyl acetate-maleic anhydride
copolymer, sodium salt.
Waxes, petroleum.......................
Wax, petroleum, chlorinated (40% to 70%
chlorine).
Waxes, synthetic paraffin (Fischer-
Tropsch process).
3-(2-Xenolyl)-1,2-epoxypropane.........
Xylene.................................
Xylene (or toluene) alkylated with
dicyclopentadiene.
Zein...................................
Zinc acetate...........................
Zinc ammonium chloride.................
Zinc dibenzyl dithiocarbamate..........
Zinc dibutyldithiocarbamate............
Zinc diethyldithiocarbamate............
Zinc di(2-ethylhexoate)................
Zinc formaldehyde sulfoxylate..........
Zinc naphthenate and
dehydroabietylamine mixture.
Zinc nitrate...........................
Zinc orthophosphate....................
Zinc resinate..........................
Zinc sulfide...........................
Zineb (zinc ethylenebis-
dithiocarbamate).
Ziram (zinc dimethyldithiocarbamate)...
------------------------------------------------------------------------
[42 FR 14534, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]
Editorial Note: For Federal Register citations affecting
Sec. 175.105, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.125]
[Page 163-164]
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 B--Substances for Use Only as Components of Adhesives
Sec. 175.125 Pressure-sensitive adhesives.
Pressure-sensitive adhesives may be safely used as the food-contact
surface of labels and/or tapes applied to food, in accordance with the
following prescribed conditions:
(a) Pressure-sensitive adhesives prepared from one or a mixture of
two or more of the substances listed in this paragraph may be used as
the food-contact surface of labels and/or tapes applied to poultry, dry
food, and processed, frozen, dried, or partially dehydrated fruits or
vegetables.
(1) Substances generally recognized as safe in food.
(2) Substances used in accordance with a prior sanction or approval.
(3) Color additives listed for use in or on food in parts 73 and 74
of this chapter.
(4) Substances identified in Sec. 172.615 of this chapter other than
substances used in accordance with paragraph (a)(2) of this section.
(5) Polyethylene, oxidized; complying with the identity prescribed
in Sec. 177.1620(a) of this chapter.
(6) 4-[[4, 6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di-tert-
butylphenol (CAS Reg. No. 991-84-4) as an antioxidant/stabilizer at a
level not to exceed 1.5 percent by weight of the finished pressure-
sensitive adhesive.
(7) 2,2'-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg.
No. 7128-64-5) as an optical brightener at a level not to exceed 0.05
percent by weight of the finished pressure-sensitive adhesive.
(8) 2-Hydroxy-1-[4-(2-hydroxyethoxy) phenyl]-2-methyl-1-propanone
(CAS Reg. No. 106797-53-9) as a photoinitiator at a level not to exceed
5 percent by weight of the pressure-sensitive adhesive.
(9) Butanedioic acid, sulfo-1,4-di-(C9-C11
alkyl) ester, ammonium salt (also known as butanedioic acid sulfo-1, 4-
diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-9]) as a surface
active agent at a level not to exceed 3.0
[[Page 164]]
percent by weight of the finished pressure-sensitive adhesive.
(b) Pressure-sensitive adhesives prepared from one or a mixture of
two or more of the substances listed in this paragraph may be used as
the food-contact surface of labels and/or tapes applied to raw fruit and
raw vegetables.
(1) Substances listed in paragraphs (a)(1), (a)(2), (a)(3), (a)(5),
(a)(6), (a)(7), (a)(8), and (a)(9) of this section, and those substances
prescribed by paragraph (a)(4) of this section that are not identified
in paragraph (b)(2) of this section.
(2) Substances identified in this subparagraph and subject to the
limitations provided:
BHA.
BHT.
Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene copolymer.
Butadiene-styrene copolymer.
Butyl rubber.
Butylated reaction product of p-cresol and dicyclopentadiene produced by
reacting p-cresol and dicyclopentadiene in an approximate mole ratio of
1.5 to 1.0, respectively, followed by alkylation with isobutylene so
that the butyl content of the final product is not less than 18 percent,
for use at levels not to exceed 1.0 percent by weight of the adhesive
formulation.
Chlorinated natural rubber.
Isobutylene-styrene copolymer.
Petrolatum.
Polybutene-1.
Polybutene, hydrogenated; complying with the identity prescribed under
Sec. 178.3740(b) of this chapter.
Polyisobutylene.
cis-1,4-Polyisoprene.
Polystyrene.
Propyl gallate.
Rapeseed oil, vulcanized.
Rosins and rosin derivatives as provided in Sec. 178.3870 of this
chapter.
Rubber hydrochloride.
Rubber (natural latex solids or crepe, smoked or unsmoked).
Terpene resins ([alpha]- and [beta]-pinene), homopolymers, copolymers,
and condensates with phenol, formaldehyde, coumarone, and/or indene.
Tetrasodium ethylenediaminetetraacetate.
Tri(mixed mono- and dinonylphenyl) phosphite (which may contain not more
than 1 percent by weight of triisopropanolamine).
(c) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
[42 FR 14534, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977;
48 FR 15617, Apr. 12, 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528,
Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.210]
[Page 164-165]
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. 175.210 Acrylate ester copolymer coating.
Acrylate ester copolymer coating may safely be used as a food-
contact surface of articles intended for packaging and holding food,
including heating of prepared food, subject to the provisions of this
section:
(a) The acrylate ester copolymer is a fully polymerized copolymer of
ethyl acrylate, methyl methacrylate, and methacrylic acid applied in
emulsion form to molded virgin fiber and heat-cured to an insoluble
resin.
(b) Optional substances used in the preparation of the polymer and
in the preparation and application of the emulsion may include
substances named in this paragraph, in an amount not to exceed that
required to accomplish the desired technical effect and subject to any
limitation prescribed: Provided, however, That any substance named in
this paragraph and covered by a specific regulation in subchapter B of
this chapter must meet any specifications in such regulation.
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Aluminum stearate.........................
Ammonium lauryl sulfate...................
Borax..................................... Not to exceed the amount
required as a preservative
in emulsion defoamer.
Disodium hydrogen phosphate............... Do.
Formaldehyde..............................
Glyceryl monostearate.....................
Methyl cellulose..........................
Mineral oil...............................
Paraffin wax..............................
Potassium hydroxide.......................
Potassium persulfate......................
Tallow....................................
Tetrasodium pyrophosphate.................
Titanium dioxide..........................
------------------------------------------------------------------------
(c) The coating in the form in which it contacts food meets the
following tests:
(1) An appropriate sample when exposed to distilled water at 212
deg.F for 30
[[Page 165]]
minutes shall yield total chloroform-soluble extractables not to exceed
0.5 milligram per square inch.
(2) An appropriate sample when exposed to n-heptane at 120 deg.F
for 30 minutes shall yield total chloroform-soluble extractables not to
exceed 0.5 milligram per square inch.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.230]
[Page 165]
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. 175.230 Hot-melt strippable food coatings.
Hot-melt strippable food coatings may be safely applied to food,
subject to the provisions of this section.
(a) The coatings are applied to and used as removable coatings for
food.
(b) The coatings may be prepared, as mixtures, from the following
substances:
(1) Substances generally recognized as safe in food.
(2) Substances identified in this subparagraph.
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Acetylated monoglycerides................. Complying with 172.828 of
this chapter.
Cellulose acetate butyrate................
Cellulose acetate propionate..............
Mineral oil, white........................ For use only as a component
of hot-melt strippable food
coatings applied to frozen
meats and complying with
Sec. 172.878 of this
chapter.
------------------------------------------------------------------------
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.250]
[Page 165]
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. 175.250 Paraffin (synthetic).
Synthetic paraffin may be safely used as an impregnant in, coating
on, or component of coatings on articles used in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food in accordance with the following
prescribed conditions:
(a) The additive is synthesized by the Fischer-Tropsch process from
carbon monoxide and hydrogen, which are catalytically converted to a
mixture of paraffin hydrocarbons. Lower molecular-weight fractions are
removed by distillation. The residue is hydrogenated and may be further
treated by percolation through activated charcoal. This mixture can be
fractionated into its components by a solvent separation method, using
synthetic isoparaffinic petroleum hydrocarbons complying with
Sec. 178.3530 of this chapter.
(b) Synthetic paraffin shall conform to the following
specifications:
(1) Congealing point. There is no specification for the congealing
point of synthetic paraffin components, except those components that
have a congealing point below 50 deg.C when used in contact with food
Types III, IVA, V, VIIA, and IX identified in table 1 of Sec. 176.170(c)
of this chapter and under conditions of use E, F, and G described in
table 2 of Sec. 176.170(c) of this chapter shall be limited to a
concentration not exceeding 15 percent by weight of the finished
coating. The congealing point shall be determined by ASTM method D938-71
(Reapproved 1981), "Standard Test Method for Congealing Point of
Petroleum Waxes, Including Petrolatum," 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.
(2) Oil content. The substance has an oil content not exceeding 2.5
percent as determined by ASTM method D721-56T, "Tentative Method of
Test for Oil Content of Petroleum Waxes" (Revised 1956), which is
incorporated by reference. See paragraph (b)(1) of this section for
availability of the incorporation by reference.
(3) Absorptivity. The substance has an absorptivity at 290
millimicrons in decahydronaphthalene at 88 deg.C not exceeding 0.01 as
determined by ASTM method E131-81a, "Standard Definitions of Terms and
Symbols Relating to Molecular-Spectroscopy," which is incorporated by
reference. See paragraph (b)(1) of this section for availability of the
incorporation by reference.
(c) The provisions of this section are not applicable to synthetic
paraffin used in food-packaging adhesives complying with Sec. 175.105.
[42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19, 1982;
49 FR 10106, Mar. 19, 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645,
Aug. 3, 1995]
[[Page 166]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.260]
[Page 166]
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. 175.260 Partial phosphoric acid esters of polyester resins.
Partial phosphoric acid esters of polyester resins identified in
this section and applied on aluminum may be safely used as food-contact
coatings, in accordance with the following prescribed conditions:
(a) For the purpose of this section, partial phosphoric acid esters
of polyester resins are prepared by the reaction of trimellitic
anhydride with 2,2-dimethyl-1,3-propanediol followed by reaction of the
resin thus produced with phosphoric acid anhydride to produce a resin
having an acid number of 81 to 98 and a phosphorus content of 4.05 to
4.65 percent by weight.
(b) The coating is chemically bonded to the metal and cured at
temperatures exceeding 450 deg.F.
(c) The finished food-contact coating, when extracted with the
solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of its
intended use, as determined from tables 1 and 2 of Sec. 175.300(d),
yields total extractives in each extracting solvent not to exceed 0.3
milligrams per square inch of food-contact surface, as determined by the
methods described in Sec. 175.300(e), and the coating yields 2,2-
dimethyl-1,3-propanediol in each extracting solvent not to exceed 0.3
micrograms per square inch of food-contact surface. In testing the
finished food-contact articles, a separate test sample is to be used for
each required extracting solvent.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.270]
[Page 166]
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. 175.270 Poly(vinyl fluoride) resins.
Poly(vinyl fluoride) resins identified in this section may be safely
used as components of food-contact coatings for containers having a
capacity of not less than 5 gallons, subject to the provisions of this
section.
(a) For the purpose of this section, poly(vinyl fluoride) resins
consist of basic resins produced by the polymerization of vinyl
fluoride.
(b) The poly(vinyl fluoride) basic resins have an intrinsic
viscosity of not less than 0.75 deciliter 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.
(1) Solvent. N,N-Dimethylacetamide, technical grade.
(2) Solution. Powdered resin and solvent are heated at 120 deg.C
until the resin is dissolved.
(3) Temperature. Flow times of the solvent and solution are
determined at 110 deg.C.
(4) Viscometer. Cannon-Ubbelohde size 50 semimicro dilution
viscometer (or equivalent).
(5) Calculation. The calculation method used is that described in
appendix X 1.3 (ASTM method D1243-79, "Standard Test Method for Dilute
Solution Viscosity of Vinyl Chloride Polymers," which is incorporated
by reference; see paragraph (b) of this section for availability of the
incorporation by reference) with the reduced viscosity determined for
three concentration levels not greater than 0.5 gram per deciliter and
extrapolated to zero concentration for intrinsic viscosity. The
following formula is used for determining reduced viscosity:
[GRAPHIC] [TIFF OMITTED] TR01JA93.387
where:
t=Solution efflux time.
to=Solvent efflux time.
c=Concentration of solution in terms of grams per deciliter.
[42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19, 1982;
49 FR 10107, Mar. 19, 1984]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.300]
[Page 166-184]
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 167]]
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:
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 168]]
(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.
[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 169]]
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 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).
[[Page 170]]
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 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 171]]
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.
[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 172]]
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 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.
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.
[[Page 173]]
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.
(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
[[Page 174]]
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 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):
[[Page 175]]
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). 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
[[Page 176]]
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 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.
[[Page 177]]
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 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
[[Page 178]]
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) 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
[[Page 179]]
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. 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
[[Page 180]]
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 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
[[Page 181]]
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.
(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
[[Page 182]]
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.
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
[[Page 183]]
(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.
(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
[[Page 184]]
Sections Affected, which appears in the Finding Aids section of the
printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.320]
[Page 184-187]
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. 175.320 Resinous and polymeric coatings for polyolefin films.
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 over one or both
sides of a base film produced from one or more of the basic olefin
polymers complying with Sec. 177.1520 of this chapter. The base
polyolefin film may contain optional adjuvant substances permitted for
use in polyolefin film by applicable regulations in parts 170 through
189 of this chapter.
(b) The coatings are formulated from optional substances which are:
(1) Substances generally recognized as safe for use in or on food.
(2) Substances the use of which is permitted under applicable
regulations in parts 170 through 189 of this chapter, by prior
sanctions, or approvals.
(3) Substances identified in this paragraph (b)(3) and subject to
such limitations as are provided:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
(i) Resins and polymers:
Acrylic acid polymer and its ethyl or
methyl esters.
Acrylamide copolymerized with ethyl
acrylate and/or styrene and/or
methacrylic acid, and the copolymer
subsequently reacted with
formaldehyde and butanol.
Butadiene-acrylonitrile copolymer....
Butadiene-acrylonitrile-styrene
terpolymer.
Butyl rubber.........................
N,N'-Diphenyl-p-phenylenediamine..... For use only as a
polymerization inhibitor in 2-
sulfoethyl methacrylate,
sodium salt.
2-Ethylhexyl acrylate copolymerized
with one or more of the following:
Acrylonitrile......................
Itaconic acid......................
Methacrylonitrile..................
Methyl acrylate....................
Methyl methacrylate................
4,4'-
Isopropylidenediphenolepichlorohydri
n average molecular weight 900.
Melamine-formaldehyde as the basic
polymer or chemically modified with
methyl alcohol.
Methacrylic acid and its ethyl or
methyl esters copolymerized with one
or more of the following:
Acrylic acid.......................
Ethyl acrylate.....................
Methyl acrylate....................
[alpha]-Methyl styrene polymer.......
[alpha]-Methylstyrene-vinyltoluene For use only in coatings that
copolymer resins (molar ratio 1 contact food under conditions
[alpha]-methylstyrene to 3 of use D, E, F, or G described
vinyltoluene). in table 2 of Sec. 176.170(c)
of this chapter, provided that
the concentration of [alpha]-
methylstyrene-vinyltoluene
copolymer resins in the
finished food-contact coating
does not exceed 1.0 milligram
per square inch of food-
contact surface.
Petroleum alicyclic hydrocarbon As defined in Sec. 176.170 of
resins. this chapter. Blended with
butyl rubber for use as a
component of coatings on
polyolefin fabric for bulk
packaging of raw fruits and
vegetables and used at a level
not to exceed 30 percent by
weight of the total coating
solids.
Polyamide resins (CAS Reg. No. 68139- For use only in coatings for
70-8), as the basic resin, derived polypropylene films that
from: contact food at temperatures
not to exceed room
temperature.
Dimerized vegetable oil or tall oil
acids containing not more than 20
percent of monomer acids.
Azelaic acid (CAS Reg. No. 123-99-
9) in an amount not to exceed 3.7
percent by weight of the polyamide
resin.
Ethylenediamine (CAS Reg. No. 107-
15-3).
Piperazine (CAS Reg. No. 110-85-0)
in an amount not to exceed 6.4
percent by weight of the polyamide
resin.
[[Page 185]]
Polyamide resins, derived from For use only in coatings for
dimerized vegetable oil acids polyolefin films that contact
(containing not more than 20% of food at temperatures not to
monomer acids) and ethylenediamine, exceed room temperature.
as the basic resin.
Polyamide resins having a maximum For use only in coatings that
acid value of 5 and a maximum amine contact food at temperatures
value of 8.5 derived from dimerized not to exceed room temperature
vegetable oil acids (containing not provided that the
more than 10 percent of monomer concentration of the polyamide
acids), ethylenediamine, and 4,4-bis resins in the finished food-
(4-hydroxyphenyl) pentanoic acids contact coating does not
(in an amount not to exceed 10 exceed 5 milligrams per square
percent by weight of said polyamide inch of food-contact surface.
resins); as the basic resin.
Polyester resins formed by reaction
of one or more of the following
polybasic acids and monobasic acids
with one or more of the following
polyhydric alcohols:
Polybasic acids:
Adipic...........................
Azelaic.......................... For use in forming polyester
resins intended for use in
coatings that contact food
only of the type identified in
Sec. 176.170(c) of this
chapter, table 1, under
Category VIII, and under
conditions of use E, F, or G,
described in table 2 of Sec.
176.170(c) of this chapter.
Dimerized fatty acids derived
from:
Animal, marine or vegetable
fats and oils.
Tall oil.......................
Fumaric..........................
Isophthalic......................
Maleic...........................
o-Phthalic.......................
Sebacic..........................
Terephthalic.....................
Trimellitic......................
Monobasic acids:
Fatty acids derived from:
Animal, marine, or vegetable
fats and oils.
Gum rosin...................... As defined in Sec. 178.3870 of
this chapter. For use in
forming polyester resins
intended for use in coatings
that contact food only of the
type identified in Sec.
176.170(c) of this chapter,
table 1, under Category VIII,
and under conditions of use E,
F, or G described in table 2
of Sec. 176.170(c) of this
chapter.
Polyhydric alcohols:
1,3-Butylene glycol..............
Diethylene glycol................
2,2-Dimethyl-1,3-propanediol.....
Dipropylene glycol...............
Ethylene glycol..................
Glycerol.........................
Mannitol.........................
[alpha]-Methyl glucoside.........
Pentaerythritol..................
Propylene glycol.................
Sorbitol.........................
Trimethylol ethane...............
Trimethylol propane..............
Polyethylenimine..................... For use only as a primer
subcoat to anchor epoxy
surface coatings to the base
sheet.
Polystyrene..........................
Polyvinyl acetate....................
Polyvinyl chloride................... ...............................
Siloxanes and silicones: platinum- Platinum content not to exceed
catalyzed reaction product of vinyl- 150 parts per million.
containing dimethylpolysiloxane (CAS
Reg. No. 68083-18-1 and CAS Reg. No.
68083-19-2) with methylhydrogen
polysiloxane (CAS Reg. No. 63148-57-2)
and dimethylmethylhydrogen
polysiloxane (CAS Reg. No. 68037-59-
2). The following substances may be
used as optional polymerization
inhibitors:.
3,5-Dimethyl-1-hexyne-3-ol (CAS Reg.
No. 107-54-0), at a level not to
exceed 0.53 weight percent;.
1-Ethynylcyclohexene (CAS Reg. No.
931-49-7), at a level not to exceed
0.64 weight percent;.
Bis(methoxymethyl)ethyl maleate
(CAS Reg. No. 102054-10-4), at a
level not to exceed 1.0 weight
percent;.
Methylvinyl cyclosiloxane (CAS Reg.
No. 68082-23-5); and.
[[Page 186]]
Tetramethyltetravinylcyclotetrasiloxa
ne (CAS Reg. No. 2554-06-5)..
Siloxanes and silicones; platinum- Platinum content not to exceed
catalyzed reaction product of vinyl- 100 parts per million. For use
containing dimethylpolysiloxane (CAS only as a surface coating
Reg. Nos. 68083-19-2 and 68083-18-1), under the following
with methyl hydrogen polysiloxane (CAS conditions:
Reg. No. 63148-57-2). Dimethyl maleate 1. In coatings for olefin
(CAS Reg. No. 624-48-6) and vinyl polymers provided the coating
acetate (CAS Reg. No. 108-05-4) may be contacts food only of the
used as optional polymerization types identified in Sec.
inhibitors. 176.170(c) of this chapter,
table 1, under Types I, II,
VI, and VII-B when used under
conditions of use E, F, and G
described in table 2 in Sec.
176.170(c) of this chapter.
2. In coatings for olefin
polymers provided the coating
contacts food only of the
types identified in Sec.
176.170(c) of this chapter,
table 1, under Types III, IV,
V, VII-A, VIII, and IX when
used under conditions of use A
through H described in table 2
in Sec. 176.170(c) of this
chapter.
Siloxanes and silicones; platinum- Platinum content not to exceed
catalyzed reaction product of vinyl- 100 parts per million. For use
containing dimethylpolysiloxane (CAS only as a release coating for
Reg. Nos. 68083-19-2 and 68083-18-1), pressure sensitive adhesives.
with methyl hydrogen polysiloxane (CAS
Reg. No. 63148-57-2). Dimethyl maleate
(CAS Reg. No. 624-48-6), vinyl acetate
(CAS Reg. No. 108-05-4), dibutyl
maleate (CAS Reg. No. 105-76-0) and
diallyl maleate (CAS Reg. No. 999-21-
3) may be used as optional
polymerization inhibitors. The polymer
may also contain C16-C18 olefins (CAS
Reg. No. 68855-60-7) as a control
release agent.
Styrene copolymerized with one or
more of the following:
Acrylonitrile......................
[alpha]-Methyl styrene.............
Styrene polymers made by the For use only in contact with
polymerization of any combination of foods of Types IV-A, V, and
styrene or alpha methyl styrene with VII in table 1 of Sec.
acrylic acid, methacrylic acid, 2- 176.170(c) of this chapter,
ethyl hexyl acrylate, methyl under use conditions E through
methacrylate, and butyl acrylate. G in table 2 of Sec.
The styrene and alpha methyl 176.170(c), and with foods of
styrene, individually, may Types VIII and IX without use
constitute from 0 to 80 weight temperature restriction.
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.
Styrene-isobutylene copolymer........
Terpene resins consisting of polymers
of [alpha]-pinene, [beta]-pinene,
and/or dipentene; acid value less
than 5, saponification number less
than 5, and color less than 4 on the
Gardner scale as measured in 50
percent mineral spirits solution.
2-Sulfoethyl methacrylate, sodium For use only in copolymer
salt Chemical Abstracts Service No. coatings under conditions of
1804-87-1]. use E, F, and G described in
table 2 of Sec. 176.170(c) of
this chapter and limited to
use at a level not to exceed
2.0 percent by weight of the
dry copolymer coating.
Vinyl chloride-acetate, hydroxyl-
modified copolymer or maleic acid-
modified copolymer.
Vinyl chloride copolymerized with one
or more of the following:
Acrvlonitrile......................
Vinyl acetate......................
Vinylidene chloride................
Vinylidene chloride copolymerized
with one or more of the following:
Acrylic acid and its methyl, ethyl,
propyl, butyl, or octyl esters.
Acrylonitrile......................
Itaconic acid......................
Methacrylic acid and its methyl,
ethyl, propyl, butyl, or octyl
esters.
Methacrylonitrile..................
Vinyl chloride.....................
(ii) Plasticizers:
Acetyl tributyl citrate..............
Acetyl triethyl citrate..............
Butyl phthalyl butyl glycolate.......
Butyl stearate.......................
Dibutyl sebacate.....................
Diethyl phthalate....................
2-Ethylhexyl diphenyl phosphate......
[[Page 187]]
Ethyl phthalyl ethyl glycolate.......
Glycerol monooleate.................. ...............................
Glycerol triacetate..................
Triethyl citrate.....................
(iii) Adjuvants (release agents, waxes,
and dispersants):
Acetone..............................
Amides (unsubstituted) of fatty acids
from vegetable or animal oils.
n-Butyl acetate......................
n-Butyl alcohol......................
Candelilla wax.......................
Carnauba wax.........................
5-Chloro-2-methyl-4-isothiazolin-3-one For use only as an
(CAS Reg. No. 26172-55-4) and 2-methyl- antimicrobial agent in
4-isothiazolin-3-one (CAS Reg. No. emulsion-based silicone
2682-20-4) mixture, at a ratio of 3 coatings at a level not to
parts to 1 part, respectively, exceed 50 milligrams per
manufactured from methyl-3- kilogram (based on
mercaptopropionate (CAS Reg. No. 2935- isothiazolone active
90-2) and optionally containing ingredient) in the coating
magnesium nitrate (CAS Reg. No. 10377- formulation.
60-3) at a concentration equivalent to
the isothiazolone active ingredients
(weight/weight)..
1,2-Dibromo-2,4-dicyanobutane (CAS For use as an antimicrobial
Reg. No. 35691-65-7). agent at levels not to exceed
500 milligrams per kilogram in
emulsion-based silicone
coating.
Ethyl acetate........................
Fatty acids from vegetable or animal
oils and their aluminum, ammonium,
calcium, magnesium, and sodium salts.
Hexane...............................
Methyl ethyl ketone..................
N,N'-Dioleoylethylenediamine (CAS For use only in ionomeric
Reg. No. 110-31-6). 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.
Petroleum waxes conforming to
specifications included in a
regulation in subchapter B of this
chapter.
Polyvinyl alcohol, minimum viscosity For use only as a dispersing
of 4% aqueous solution at 20 deg.C agent at levels not to exceed
of 4 centipoises and percent 6% of total coating weight in
alcoholysis of 87-100. coatings for pol-yolefin films
provided the finished
polyolefin films contact food
only of the types identified
in Sec. 176.170(c) of this
chapter, table 1, under Types
V, VIII, and IX.
Sodium dioctyl sulfosuccinate........
Sodium dodecylbenzenesulfonate.......
Sodium lauryl sulfate................
Sorbitan and sorbitol esters of fatty
acids from vegetable or animal oils.
Spermaceti wax.......................
Tetrahydrofuran......................
Toluene..............................
(iv) Preservatives:
Silver chloride-coated titanium For use only as a preservative
dioxide. in latex emulsions at a level
not to exceed 2.2 parts per
million (based on silver ion
concentration) in the dry
coating.
------------------------------------------------------------------------
(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
Sec. 176.17(c) of this chapter, shall yield net chloroform-soluble
extractives not to exceed 0.5 milligram per square inch of coated
surface.
(d) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
[42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45
FR 6541, Jan. 29, 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, Sept.
18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR 49674, Oct. 1, 1991; 61 FR
14246, Apr. 1, 1996; 63 FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15,
1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, June 13, 2000]
[[Page 188]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.350]
[Page 188]
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. 175.350 Vinyl acetate/crotonic acid copolymer.
A copolymer of vinyl acetate and crotonic acid may be safely used as
a coating or as a component of a coating which is the food-contact
surface of polyolefin films intended for packaging food, subject to the
provisions of this section.
(a) The copolymer may contain added optional substances to impart
desired properties.
(b) The quantity of any optional substance does not exceed the
amount reasonably required to accomplish the intended physical or
technical effect nor any limitations further provided.
(c) Any optional substance that is the subject of a regulation in
parts 174, 175, 176, 177, 178, and Sec. 179.45 of this chapter conforms
with any specifications in such regulation.
(d) Optional substances as provided in paragraph (a) of this section
include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for uses with a
copolymer of vinyl acetate and crotonic acid and used in accordance with
such sanction or approval.
(3) Substances identified in this subparagraph and subject to such
limitations as are provided:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Silica....................................
Japan wax.................................
------------------------------------------------------------------------
(e) Copolymer of vinyl acetate and crotonic acid used as a coating
or as a component of a coating conforming with the specifications of
paragraph (e)(1) of this section are used as provided in paragraph
(e)(2) of this section.
(1) Specifications. (i) The chloroform-soluble portion of the water
extractives of the coated film obtained with distilled water at 120
deg.F for 24 hours does not exceed 0.5 milligram per square inch of
coated surface.
(ii) The chloroform-soluble portion of the n-heptane extractives of
the coated film obtained with n-heptane at 70 deg.F for 30 minutes does
not exceed 0.5 milligram per square inch of coated surface.
(2) Conditions of use. The copolymer of vinyl acetate and crotonic
acid is used as a coating or as a component of a coating for polyolefin
films for packaging bakery products and confectionery.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.360]
[Page 188-189]
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. 175.360 Vinylidene chloride copolymer coatings for nylon film.
Vinylidene chloride copolymer coatings identified in this section
and applied on nylon film may be safely used as food-contact surfaces,
in accordance with the following prescribed conditions:
(a) The coating is applied as a continuous film over one or both
sides of a base film produced from nylon resins complying with
Sec. 177.1500 of this chapter.
(b) The coatings are prepared from vinylidene chloride copolymers
produced by copolymerizing vinylidene chloride with one or more of the
monomers acrylic acid, acrylonitrile, ethyl acrylate, methacrylic acid,
methyl acrylate, methyl methacrylate (CAS Reg. No. 80-62-6; maximum use
level 6 weight percent) and 2-sulfoethyl methacrylate (CAS Reg. No.
10595-80-9; maximum use level 1 weight percent). The finished copolymers
contain at least 50 weight percent of polymer units derived from
vinylidene chloride. The finished coating produced from vinylidene
chloride copolymers produced by copolymerizing vinylidene chloride with
methyl methacrylate and/or 2-sulfoethyl methacrylate, or with methyl
methacrylate and/or 2-sulfoethyl methacrylate together with one or more
of the other monomers from this section, is restricted to use at or
below room temperature.
(c) Optional adjuvant substances employed in the production of the
coatings or added thereto to impart desired properties may include
sodium dodecylbenzenesulfonate.
(d) 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
Sec. 176.170(c) of this chapter, shall yield net chloroform-soluble
extractives not to exceed 0.5 milligram per square inch of coated
surface when
[[Page 189]]
tested by the methods described in Sec. 176.170(d) of this chapter.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
[42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45
FR 76998, Nov. 21, 1980; 47 FR 54430, Dec. 3, 1982]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.365]
[Page 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. 175.365 Vinylidene chloride copolymer coatings for polycarbonate film.
Vinylidene chloride copolymer coatings identified in this section
and applied on polycarbonate film may be safely used as food-contact
surfaces, in accordance with the following prescribed conditions:
(a) The coating is applied as a continuous film over one or both
sides of a base film produced from polycarbonate resins complying with
Sec. 177.1580 of this chapter.
(b) The coatings are prepared from vinylidene chloride copolymers
produced by copolymerizing vinylidene chloride with acrylonitrile,
methyl acrylate, and acrylic acid. The finished copolymers contain at
least 50 weight-percent of polymer units derived from vinyldene
chloride.
(c) Optional adjuvant substances employed in the production of the
coatings or added thereto to impart desired properties may include
sodium dodecylbenzenesulfonate in addition to substances described in
Sec. 174.5(d) of this chapter.
(d) 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 the conditions of time and temperature characterizing
the conditions of its intended use as determined from tables 1 and 2 of
Sec. 176.170(c) of this chapter, shall yield net chloroform-soluble
extractives in each extracting solvent not to exceed 0.5 milligram per
square inch of coated surface as determined by the methods described in
Sec. 176.170(d) of this chapter. In testing the finished food-contact
articles, a separate test sample is to be used for each required
extracting solvent.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisons of Sec. 180.22 of this chapter.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.380]
[Page 189-190]
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. 175.380 Xylene-formaldehyde resins condensed with 4,4'-isopropylidenediphenol-epichlorohydrin epoxy resins.
The resins identified in paragraph (a) of this section may be safely
used as a food-contact coating for articles intended for use in contact
with food, in accordance with the following prescribed conditions.
(a) The resins are produced by the condensation of xylene-
formaldehyde resin and 4,4'-isopropylidenediphenol-epichlorohydrin epoxy
resins, to which may have been added certain optional adjuvant
substances required in the production of the resins or added to impart
desired physical and technical properties. The optional adjuvant
substances may include resins produced by the condensation of allyl
ether of mono-, di-, or trimethylol phenol and capryl alcohol and also
may include substances identified in Sec. 175.300(b)(3), with the
exception of paragraph (b)(3) (xxxi) and (xxxii) of that section.
(b) The resins identified in paragraph (a) of this section may be
used as a food-contact coating for articles intended for contact at
temperatures not to exceed 160 deg.F with food of Types I, II, VI-A and
B, and VIII described in table 1 of Sec. 176.170(c) of this chapter
provided that the coating in the finished form in which it is to contact
food meets the following extractives limitations when tested by the
methods provided in Sec. 175.300(e):
(1) The coating when extracted with distilled water at 180 deg.F
for 24 hours yields total extractives not to exceed 0.05 milligram per
square inch of food-contact surface.
(2) The coating when extracted with 8 percent (by volume) ethyl
alcohol in distilled water at 160 deg.F for 4 hours yields total
extractives not to exceed 0.05 milligram per square inch of food-contact
surface.
(c) The resins identified in paragraph (a) of this section may be
used as a food-contact coating for articles intended for contact at
temperatures not to exceed room temperature with food of Type VI-C
described in table 1 of Sec. 176.170(c) of this chapter provided the
coating in the finished form in which it is to contact food meets the
following
[[Page 190]]
extractives limitations when tested by the methods provided in
Sec. 175.300(e):
(1) The coating when extracted with distilled water at 180 deg.F
for 24 hours yields total extractives not to exceed 0.05 milligram per
square inch of food-contact surface.
(2) The coating when extracted with 50 percent (by volume) ethyl
alcohol in distilled water at 180 deg.F for 24 hours yields total
extractives not to exceed 0.05 milligram per square inch.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.390]
[Page 190]
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. 175.390 Zinc-silicon dioxide matrix coatings.
Zinc-silicon dioxide matrix 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, subject to the provisions of this
section;
(a) The coating is applied to a metal surface, cured, and washed
with water to remove soluble substances.
(b) The coatings are formulated from optional substances which
include:
(1) Substances generally recognized as safe.
(2) Substances for which safe conditions of use have been prescribed
in Sec. 175.300.
(3) Substances identified in paragraph (c) of this section, subject
to the limitations prescribed.
(c) The optional substances permitted are as follows:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Ethylene glycol........................... As a solvent removed by
water washing.
Iron oxide................................
Lithium hydroxide......................... Removed by water washing.
Methyl orange............................. As an acid-base indicator.
Potassium dichromate...................... Removed by water washing.
Silica gel................................
Sodium silicate...........................
Zinc, as particulate metal................
------------------------------------------------------------------------
(d) 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 the conditions of its intended use as shown in table 1
and 2 of Sec. 175.300(d) (using 20 percent alcohol as the solvent when
the type of food contains approximately 20 percent alcohol) shall yield
total extractives not to exceed those prescribed in Sec. 175.300(c)(3);
lithium extractives not to exceed 0.025 milligram per square inch of
surface; and chromium extractives not to exceed 0.05 microgram per
square inch of surface.
(e) The coatings are used as food-contact surfaces for bulk reusable
containers intended for storing, handling, and transporting food.
