Source: http://www.ecfr.gov/cgi-bin/text-idx?node=21:3.0.1.1.6&rgn=div5
Timestamp: 2014-12-19 17:27:20
Document Index: 595225267

Matched Legal Cases: ['ART 175', 'art 175', '§175', '§176', '§178', '§178', '§178', '§176', '§176', '§175', '§175', '§175', '§177', '§172', '§172', '§176', '§175', '§177', '§175', '§175', '§175', 'arts 73', '§172', '§177', '§178', '§175', '§175', '§172', '§175', '§178', '§176', '§176', '§175', '§175', '§175', '§175', '§175', '§175', '§177', '§178', '§176', '§180', '§175', '§175', '§177', 'arts 170', 'arts 170', '§176', '§176', '§176', '§176', '§178', '§176', '§176', '§176', '§176', '§176', '§176', '§176', '§176', '§176', '§177', '§177', '§176', '§176', '§180', '§175', 'arts 174', '§179', '§175', '§177', '§176', '§176', '§180', '§175', '§177', '§174', '§176', '§176', '§180', '§175', '§175', '§176', '§175', '§176', '§175', '§175', '§175', '§175', '§175']

PART 175—INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGSContentsSubpart A [Reserved]
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, 66 FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. 1, 2005. Back to Top
§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 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.
SubstancesLimitationsAbietic acidAcetoneAcetone-formaldehyde condensate (CAS Reg. No. 25619-09-4)Acetone-urea-formaldehyde resinN-Acetyl ethanolamineAcetyl tributyl citrateAcetyl triethyl citrate2-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 sulfosuccinate1-Alkyl (C6-C18) amino-3-amino-propane monoacetateAlkylated (C4 and/or C8) phenolsAlkyl (C7-C12) benzeneAlkyl (C10-C20) dimethylbenzyl ammonium chloriden-Alkyl(C12, C14, C16, or C18) dimethyl (ethylbenzyl) ammonium cyclohexylsulfamateFor use as preservative only.Alkyl ketene dimers as described in §176.120 of this chapterAlkyl (C7-C12) naphthalenealpha 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 salts2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111-41-1)3-AminopropanediolFor use only in the preparation of polyurethane resins.AluminumAluminum acetateAluminum di(2-ethylhexoate)Aluminum potassium silicateN-β-Aminoethyl-gamma-aminopropyl trimethoxysilane3-(Aminomethyl)-3,5,5-trimethylcyclohexylamineAminomethylpropanolAmmonium benzoateFor use as preservative only.Ammonium bifluorideFor 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 borateAmmonium citrateAmmonium persulfateAmmonium polyacrylateAmmonium potassium hydrogen phosphateAmmonium silico-fluorideFor 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 sulfamateAmmonium thiocyanateAmmonium thiosulfateAmyl acetateAnhydroenneaheptitolAnimal glue as described in §178.3120 of this chapter2-Anthraquinone sulfonic acid, sodium saltFor use only as polymerization-control agent.Antimony oxideAsbestosAsphalt, paraffinic and naphthenicAzelaic acidAzo-bis-isobutyronitrileBalata rubberBarium acetateBarium peroxideBarium sulfateBentoniteBenzene (benzol)1,4-Benzenedicarboxylic acid, bis[2-(1,1-dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methyl-phenyl]ester (CAS Reg. No. 57569-40-1)For use as a stabilizer.1,2-Benzisothiazolin-3-one (CAS Registry No. 2634-33-5)For use as preservative only.Benzothiazyldisulfidep-BenzoxyphenolFor use as preservative only.Benzoyl peroxideBenzyl alcoholBenzyl benzoateBenzyl bromoacetateFor use as preservative only.p-Benzyloxyphenol Do.BHA (butylated hydroxyanisole)BHT (butylated hydroxytoluene)Bicyclo[2.2.1]hept-2-ene-6-methyl acrylate2-Biphenyl diphenyl phosphateBis(benzoate-O)(2-propanolato)aluminum (CAS Reg. No. 105442-85-1)For use only as a reactant in the preparation of polyester resins.1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hy-drazine (CAS Reg. No. 32687-78-8)For use at a level not to exceed 2 percent by weight of the adhesive.1,3-Bis(2-benzothiazolylmercaptomethyl) urea4,4′-Bis(α,α-dimethylbenzyl)diphenylamine2,6-Bis(1,1-dimethylethyl)-4-(1-methylpropyl)phenol (CAS Reg. No. 17540-75-9)For use as an antioxidant and/or stabilizer only.2,6-Bis (1-methylheptadecyl)-p-cresol4-[[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) oxideFor use as preservative only.Bis(trichloromethyl)sulfone C.A. Registry No. 3064-70-8 Do.BoraxBoric acid2-Bromo-2-nitro-1, 3-propanediol (CAS Reg. No. 52-51-7)For use only as an antibacterial preservative.Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-9]).For use as a surface active agent in adhesives.1,3-Butanediol1,4-Butanediol1,4-Butanediol modified with adipic acidButoxy polyethylene polyproplyene glycol (molecular weight 900-4,200)Butyl acetateButyl acetyl ricinoleateButyl alcoholButylated reaction product of p-cresol and dicyclopentadieneAs identified in §178.2010(b) of this chapter.Butylated, styrenated cresols identified in §178.2010(b) of this chapterButyl benzoateButyl benzyl phthalateButyldecyl phthalate1,3-Butylene glycoldiglycolic acid copolymertert-Butyl hydroperoxide4,4′-Butylidenebis(6-tert-butyl-m-cresol)Butyl lactateButyloctyl phthalatep-tert-Butylphenyl salicylateButyl phthalate butyl glycolatep-tert-ButylpyrocatecholFor use only as polymerization-control agent.Butyl ricinoleateButyl rubber polymerButyl stearateButyl titanate, polymerizedButyraldehydeCalcium ethyl acetoacetateCalcium nitrateCalcium metasilicateCamphorCamphor fatty acid estersCandelilla waxepsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymerCarbon black, channel processCarbon disulfide-1,1′-methylenedipiperidine reaction productCarbon tetrachlorideCarboxymethylcelluloseCastor oil, polyoxyethylated (4-84 moles ethylene oxide)Cellulose acetate butyrateCellulose acetate propionateCeresin wax (ozocerite)Cetyl alcoholChloracetamideChloral hydrateChlorinated liquid n-paraffins with chain lengths of C10-C17, containing 40-70 percent chlorine by weightChlorinated pyridine mixture with active ingredients consisting of 2,3,5,6-tetrachloro-4-(methylsulfonyl) pyridine, 2,3,5,6-tetrachloro-4-(methylsulfinyl) pyridine and pentachloropyridineFor use as preservative only.Chlorinated rubber polymer (natural rubber polymer containing approximately 67 percent chlorine)1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chlorideFor use as preservative only.Chlorobenzene4-Chloro-3,5-dimethylphenol (p-chloro-m-xylenol)For use as preservative only.4-Chloro-3-methylphenol Do.5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 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)For use only as an antimicrobial agent in polymer latex emulsions.ChloroformChloropreneChromium caseinateChromium nitrateChromium potassium sulfateCobaltous acetateCoconut fatty acid amine salt of tetrachlorophenolFor use as preservative only.CopalCopper 8-quinolinolateFor use as preservative only.Coumarone-indene resinCresyl diphenyl phosphateCumene hydroperoxideCyanoguanidineCyclized rubber as identified in §176.170(b)(2) of this chapterCyclohexane1,4-Cyclohexanedimethanoldibenzoate (CAS Reg. No. 35541-81-2)CyclohexanolCyclohexanone resinCyclohexanone-formaldehyde condensateN-Cyclohexyl p-toluene sulfonamide(η5-Cyclopentadienyl)-(η6-isopropylbenzene)iron(II) hexafluorophosphate (CAS Reg. No. 32760-80-8)For use only as a photoinitiator.DamarDefoaming agents as described in §176.210 of this chapterDehydroacetic acidDiacetone alcoholDiacetyl peroxideN,N′-Dialkoyl-4,4′-diaminodiphenylmethane mixtures where; the alkoyl groups are derived from marine fatty acids (C12-C24)2,5-Di-tert-amylhydroquinoneDiamines derived from dimerized vegetable oil acidsDiaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or xylyl1,2-Dibromo-2,4-dicyanobutane (CAS Registry No. 3569-65-7)For use as a preservative only.2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No. 10222-01-2).For use as a preservative only. Di(butoxyethyl) phthalate2,5-Di-tert-butylhydroquinoneDibutyl maleate2,6-Di-tert-butyl-4-methylphenolFor use as preservative only.Di(C7, C9-alkyl)adipateDibutyl phthalateDibutyl sebacateDibutyltin dilaurate for use only as a catalyst for polyurethane resins1,2-Dichloroethylene (mixed isomers)Dicumyl peroxideDicyclohexyl phthalateDiethanolamineDiethanolamine condensed with animal or vegetable fatty acidsDiethylamineDiethylene glycolDiethylene glycol adipic acid copolymerDiethylene glycol dibenzoateDiethylene glycol hydrogenated tallowate monoesterDiethylene glycol laurateDiethylene glycol monobutyl etherDiethylene glycol monobutyl ether acetateDiethylene glycol monoethyl etherDiethylene glycol monoethyl ether acetateDiethylene glycol monomethyl etherDiethylene glycol monooleateDiethylene glycol monophenyl etherDiethylene glycol copolymer of adipic acid and phthalic anhydrideDi(2-ethylhexyl) adipateDi(2-ethylhexyl)hexahydrophthalateDi(2-ethylhexyl)phthalateDiethyl oxalateDiethyl phthalateDihexyl phthalateDihydroabietylphthalateDi(2-hydroxy-5-tert-butylphenyl) sulfide2,2′-Dihydroxy-5,5′-dichlorodiphenylmethane (dichlorophene)4,5-Dihydroxy-2-imidazolidinone4-(Diiodomethylsulfonyl) toluene CA Registry No.: 20018-09-01For use as an antifungal preservative only.Diisobutyl adipateDiisobutyl ketoneDiisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chlorideDiisobutyl phthalateDiisodecyl adipateDiisodecyl phthalateDiisooctyl phthalateDiisopropylbenzene hydroperoxideN,N-Dimethylcyclohexylamine dibutyldithiocarbamateDimethyl formamideDimethyl hexynol2,2-Dimethyl-1,3-propanediol dibenzoateDimethyl octynediolN-(1,1-dimethyl-3-oxobutyl) acrylamideDimethyl phthalate3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thioneFor use as preservative only.Di-β-naphthyl-p-phenylenediamine4,6-Dinonyl-o-cresolDinonylphenolDi-n-octyldecyl adipateDioctyldiphenylamineDioctylphthalateDioctylsebacateDioxaneDipentaerythritol pentastearateDipentamethylene-thiuram-tetrasulfideDipenteneDipentene resinsDipentene-beta-pinene-styrene resinsDipentene-styrene resin (CAS Registry No. 64536-06-7)Diphenyl-2-ethylhexyl phosphateDiphenyl, hydrogen atedN,N′-Diphenyl-p-phenylenediamineDiphenyl phthalate1,3-Diphenyl-2-thioureaDipropylene glycolDipropylene glycol dibenzoateDipropylene glycol monomethyl etherDipropylene glycol copolymer of adipic acid and phthalic anhydrideDisodium cyanodithioimidocarbonateDisodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294-49-8)N,N′-DistearoylethylenediamineDistearyl thiodipropionate3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hydroxyethyl)-s-triazine-2,4,6(1H, 3H, 5H)-trioneFor use as antioxidant only.4,4′-Dithiodimorpholinen-Dodecylmercaptantert-DodecylmercaptanDodecylphenoxybenzene-disulfonic acid and/or its calcium, magnesium, and sodium saltsElemi gumEpichlorohydrin-4,4′-isopropylidenediphenol resinEpichlorohydrin-4,4′-sec-butylidenediphenol resinEpichlorohydrin-4,4′-isopropylidene-di-o-cresol resinEpichlorohydrin-phenolformaldehyde resinErucamide (erucylamide)EthanolamineEthoxylated 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 etherEthyl 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)EthylenediamineEthylenediaminetetra-acetic acid, calcium, ferric, potassium, or sodium salts, single or mixedEthylene dichlorideEthylene glycolEthylene glycol monobutyl etherEthylene glycol monobutyl ether acetateEthylene glycol monoethyl etherEthylene glycol monoethyl ether acetateEthylene glycol monoethyl ether ricinoleateEthylene glycol monomethyl etherEthylene glycol monophenyl etherEthylene-carbon monoxide copolymer (CAS Reg. No. 25052-62-4) containing not more than 30 weight percent of the units derived from carbon monoxideEthylene-maleic anhydride copolymer, ammonium or potassium saltEthylene-methacrylic acid copolymer partial salts: Ammonium, calcium, magnesium, sodium, and/or zincEthylene-methacrylic acid-vinyl acetate copolymer partial salts: Ammonium, calcium, magnesium, sodium, and/or zincEthylene-octene-1 copolymers containing not less than 70 weight percent ethylene (CAS Reg. No. 26221-73-8)Ethylene-propylene-dicyclopentadiene copolymer rubberEthylene, propylene, 1,4-hexadiene and 2,5-norbornadiene tetrapolymerEthylene-vinyl acetate carbon monoxide terpolymer (CAS Registry No. 26337-35-9) containing not more than 15 weight percent of units derived from carbon monoxide2,2′-Ethylidenebis (4,6-di-tert-butylphenol) (CAS Reg. No. 35958-30-6)Ethyl-p-hydroxybenzoateFor use as preservative only.Ethyl hydroxyethylcelluloseEthyl lactate2,2′-Ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite (CAS Reg. No. 118337-09-0)For use as an antioxidant and/or stabilizer only.Ethyl phthalyl ethyl glycolateEthyl-p-toluene sulfonamideFats and oils derived from animal or vegetable sources, and the hydrogenated, sulfated, or sulfonated forms of such fats and oilsFatty acids derived from animal or vegetable fats and oils; and salts of such acids, single or mixed, as follows:AluminumAmmoniumCalciumMagnesiumPotassiumSodiumZincFerric chlorideFluosilicic acid (hydrofluosilicic 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.FormaldehydeFormaldehyde o- and p-toluene sulfonamideFormamideFumaratochromium (III) nitrateFurfuralFurfuryl alcoholFumaric acidgamma-Aminopropyltrimethoxysilane (CAS Reg. No. 13822-56-5)GlutaraldehydeGlycerides, di- and monoestersGlycerol polyoxypropylene triol, minimum average molecular weight 250 (CAS Reg. No. 25791-96-2)For use only in the preparation of polyester and polyurethane resins in adhesives.Glyceryl borate (glycol boriborate resin)Glyceryl ester of damar, copal, elemi, and sandaracGlyceryl monobutyl ricinoleateGlyceryl monohydroxy stearateGlyceryl monohydroxy tallowateGlyceryl polyoxypropylene triol (average molecular weight 1,000)Glyceryl tribenzoateGlycol diacetateGlyoxalHeptaneHexamethylenetetramineHexaneHexanetriolsHexylene glycolHydroabietyl alcoholHydrocarbon 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 acidFor 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 peroxideHydrogenated dipentene resin (CAS Reg. No. 106168-39-2)Hydrogenated dipentene-styrene copolymer resin (CAS Reg. No. 106168-36-9)Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin (CAS Reg. No. 106168-37-0)a-Hydro-omega-hydroxypoly-(oxytetramethylene)For use only in the preparation of polyurethane resins.HydroquinoneHydroquinone monobenzyl etherHydroquinone monoethyl ether2(2′-Hydroxy-3′,5′ di-tert-amylphenyl) benzotriazoleHydroxyacetic acid7-HydroxycoumarinHydroxyethylcellulose2-Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone(CAS Reg. No. 106797-53-9)For use only as a photoinitiator at a level not to exceed 5 percent by weight of the adhesive.1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2 alkyl (C6-C17) imidazolinium chlorideHydroxyethyldiethylenetriamineβ-Hydroxyethyl pyridinium 2-mercaptobenzothiazolHydroxyethyl starchHydroxyethylureaHydroxylamine sulfate5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, 5-hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5-hydroxypoly-[methyleneoxy]methyl-1-aza-3,7-dioxabicyclo[3.3.0] octane mixtureFor use only as an antibacterial preservative.Hydroxypropyl methylcellulose2-(Hydroxymethyl)-2-methyl-1,3-propanediol tribenzoate2-Imidazolidinone3-Iodo-2-propynyl-N-butyl carbamate (CAS Reg. No. 55406-53-6)For use only as an antifungal preservative.IodoformFor use only as polymerization-control agent.Isoascorbic acidIsobutyl alcohol (isobutanol)Isobutylene-isoprene copolymerIsodecyl benzoate (CAS Reg. No. 131298-44-7)IsophoroneIsopropanolamine (mono-, di-, tri-)Isopropyl acetateIsopropyl alcohol (isopropanol)Isopropyl-m- and p-cresol (thymol derived)4,4′-Isopropylidenediphenol4,4′-Isopropylidenediphenol, polybutylated mixtureFor use as preservative only.Isopropyl peroxydicarbonatep-Isopropoxy diphenylamine4,4′-Isopropylidene-bis(p-phenyleneoxy)-di-2-propanolItaconic acidJapan waxKeroseneLauroyl peroxideLauroyl sulfate salts:AmmoniumMagnesiumPotassiumSodiumLauryl alcoholLauryl pyridinium 5-chloro-2-mercaptobenzothiazoleLignin calcium sulfonateLignin sodium sulfonateLinoleamide (linoleic acid amide)Magnesium fluorideFor 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 glycerophosphateMaleic acidMaleic anhydride-diisobutylene copolymer, ammonium or sodium saltManganese acetateMarine oil fatty acid soaps, hydrogenatedMelamineMelamine-formaldehyde copolymer2-Mercaptobenzothiazole2-Mercaptobenzothiazole and dimethyl dithiocarbamic acid mixture, sodium saltFor use as preservative only.2-Mercaptobenzothiazole, sodium or zinc saltFor use as preservative only.Methacrylate-chromic chloride complex, ethyl or methyl esterp-Menthane hydroperoxideMethyl acetateMethyl acetyl ricinoleateMethyl alcohol (methanol)MethylcelluloseMethylene chloride4,4′-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 ketoneMethyl ethyl ketone-formaldehyde condensate2-Methylhexane1-Methyl-2-hydroxy-4-isopropyl benzeneMethyl isobutyl ketoneMethyl oleateMethyl oleate-palmitate mixtureMethyl phthalyl ethyl glycolateMethyl ricinoleateMethyl salicylatea-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a methylstyrene to 3 vinyltoluene)Methyl tallowateMineral oilMonochloracetic acidMonooctyldiphenylamineMontan waxMorpholineMyristic acid-chromic chloride complexMyristyl alcoholNaphthaNaphthalene, monosulfonatedNaphthalene sulfonic acid-formaldehyde condensate, sodium saltα-Naphthylamineα,α′,α″,α″′-Neopentane tetrayltetrakis [omega-hydroxypoly (oxypropylene) (1-2 moles)], average molecular weight 400Nitric acidµ-NitrobiphenylNitrocellulose2-Nitropropaneα-(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 molesα(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 oxideα-(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 molesendo-cis-5-Norbornene-2,3-dicarboxylic anhydrideα-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the octadecenyl group is derived from oleyl alcohol and the poly (oxyethylene) content averages 20 molesOctadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamateOctyl alcoholOctyldecyl phthalateOctylphenolOctylphenoxyethanolsOctylphenoxypolyethoxy-polypropoxyethanol (13 moles of ethylene oxide and propylene oxide)Odorless light petroleum hydrocarbonsOleamide (oleic acid amide)Oleic acid, sulfated2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate] (CAS Reg. No. 70331-94-1)Oxazolineα-(oxiranylmethyl)-ω-(oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], (alternative name: epichlorohydrin-polypropylene glycol) (CAS Reg. No. 26142-30-3)For use as a reactant in the preparation of epoxy-based resins.2,2′-[oxybis[(methyl-2,1-ethanediyl)-oxymethylene]]bisoxirane, (alternative name: epichlorohydrin-dipropylene glycol) (CAS Reg. No. 41638-13-5)For use as a reactant in the preparation of epoxy-based resins.n-Oxydiethylene-benzothiazolePalmitamide (palmitic acid amide)Paraffin (C12-C20) sulfonateParaformaldehydePentachlorophenolPentaerythritol ester of maleic anhydridePentaerythritol monostearateFor use as preservative only.Pentaerythritol tetrabenzoate [CAS Registry No. 4196-86-5]Pentaerythritol tetrastearate2,4-PentanedionePentasodium diethylenetriaminepentaacetate (CAS Reg. No. 140-01-2)PerchloroethylenePetrolatumPetroleum hydrocarbon resin (cyclopentadiene type), hydrogenatedPetroleum 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)PhenolFor use as preservative only.Phenol-coumarone-indene resinPhenolic resins as described in §175.300(b)(3)(vi)PhenothiazineFor use only as polymerization-control agent.Phenyl-β-naphthylamine (free of β-naphthylamine)o-PhenylphenolFor use as preservative only.o-Phthalic acidPimaric acidPine oilPiperazinePiperidinium pentamethylenedithiocarbamatePoly(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 acidDimerized vegetable oil acidsAmines:Bis(hexamethylene) triamine and higher homologuesDiethylenetriamineDiphenylamineEthylenediamineHexamethylenediaminePoly(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)TetraethylenepentamineTriethylenetetraminePolybutene, hydrogenatedPolybutylene glycol (molecular weight 1,000)Poly [2(diethylamino) ethyl methacrylate] phosphatePolyester of adipic acid, phthalic acid, and propylene glycol, terminated with butyl alcoholPolyester of diglycolic acid and propylene glycol containing ethylene glycol monobutyl ether as a chain stopperPolyester 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 acidDimethyl 1,4-cyclohexanedicarboxylate (CAS Reg. No. 94-60-0)Dimethyl-5-sulfoisophthalic acid (CAS Reg. No. 50975-82-1) and/or its sodium salt (CAS Reg. No. 3965-55-7)Polybasic and monobasic acids identified in §175.300(b)(3)(vii)(a) and (b)5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt (CAS Reg. No. 6362-79-4)Tetrahydrophthalic acidAlcohols:1,4-Cyclohexanedimethanol2,2-Dimethyl-1,3-propanediol1,6-Hexanediol (CAS Reg. No. 629-11-8)Polyhydric and monohydric alcohols identified in §175.300(b)(3)(vii)(c) and (d)Polyethyleneadipate modified with ethanolamine with the molar ratio of the amine to the adipic acid less than 0.1 to 1For use only in the preparation of polyurethan resins.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, oxidizedPolyethylene resins, carboxyl modified, identified in §177.1600 of this chapterPolyethyleniminePolyethylenimine-epichlorohydrin resinsPoly(ethyloxazoline) (CAS Reg. No. 25805-17-8)PolyisoprenePolymeric 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 toluenePolymers: Homopolymers and copolymers of the following monomers:AcrylamideAcrylic acidAcrylonitrileAllylmethacrylate (CAS Reg. No. 00096-05-09)ButadieneButeneN-tert-ButylacrylamideButyl acrylate1,3-Butylene glycol dimethacrylateButyl methacrylateCrotonic acidDecyl acrylateDiallyl fumarateDiallyl maleateDiallyl phthalateDibutyl fumarateDibutyl itaconateDibutyl maleateDi(2-ethylhexyl) maleateDimethyl-α-methylstyreneDioctyl fumarateDioctyl maleateDivinylbenzeneEthyl acrylateEthyleneEthylene cyanohydrin2-Ethylhexyl acrylateEthyl methacrylateFatty 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 estersGlycidyl methacrylate1-Hexene (CAS Reg. No. 592-41-6)2-Hydroxyethyl acrylate2-Hydroxyethyl methacrylate2-Hydroxypropyl methacrylateIsobutyl acrylateIsobutyleneItaconic acidMaleic acid, diester with 2-hydroxyethanesulfonic acid, sodium saltMaleic anhydrideMethacrylic acidMethyl acrylateN,N′-MethylenebisacrylamideMethyl methacrylateN-MethylolacrylamideMethyl styrene-Methyl styreneMonoethyl maleateMonomethyl maleateMono (2-ethylhexyl) maleate5-Norbornene-2 3-dicarboxylic acid, mono-n-butyl ester1-Octene (CAS Reg. No. 111-66-0)Propyl acrylatePropyleneStyreneTriallyl cyanurateVinyl acetateVinyl alcohol (from alcoholysis or hydrolysis of vinyl acetate units)Vinyl butyrateVinyl chlorideVinyl crotonateVinyl ethyl etherVinyl hexoateVinylidene chlorideVinyl methyl etherVinyl pelargonateVinyl propionateVinyl pyrrolidoneVinyl stearatePolyoxyalkylated-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 saltPolyoxyethylene (20 mol)—anhydrous lanolin adductPolyoxyethylene (molecular weight 200) dibenzoatePolyoxyethylene (molecular weight 200-600) esters of fatty acids derived from animal or vegetable fats and oils (including tall oil)Polyoxyethylene (15 moles) ester of rosinPolyoxyethylene (4-5 moles) ether of phenolPolyoxyethylene (25 moles)—glycerol adductPolyoxyethylene (40 moles) stearatePolyoxyethylene (5-15 moles) tridecyl alcoholPolyoxypropylene (3 moles) tridecyl alcohol sulfatePolyoxypropylene (20 moles) butyl etherPolyoxypropylene (40 moles) butyl etherPolyoxypropylene (20 moles) oleate butyl etherPolyoxypropylene-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 730Polypropylene glycol dibenzoate (CAS Reg. No. 72245-46-6)For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive.Polypropylene, noncrystallinePolysiloxanes:Diethyl polysiloxaneDihydrogen polysiloxaneDimethyl polysiloxaneDiphenyl polysiloxaneEthyl hydrogen polysiloxaneEthyl phenyl polysiloxaneMethyl ethyl polysiloxaneMethyl hydrogen polysiloxaneMethyl phenyl polysiloxanePhenyl hydrogen polysiloxanePolysorbate 60Polysorbate 80Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate)Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate)Poly[styrene-co-disodium maleate-co-α-(p-nonyl-phenyl)-omega-(p-vinyl-benzyl)poly(oxyethylene)] terpolymerPolytetrafluoroethylene.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 atomsPolyvinyl butyralPolyvinyl formalPotassium ferricyanideFor use only as polymerization-control agent.Potassium N-methyldithiocarbamatePotassium pentachlorophenateFor use as preservative only.Potassium permanganatePotassium persulfatePotassium phosphates (mono-, di-, tribasic)Potassium tripolyphosphateα, α′, α″-1,2,3-Propanetriyltris [omega-(2,3-epoxypropoxy) poly (oxypropylene) (24 moles)]β-PropiolactonePropyl alcohol (propanol)Propylene carbonatePropylene glycol and p-p′-isopropylidenediphenol dietherPropylene glycol dibenzoate (CAS Reg. No. 19224-26-1)For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive.Propylene glycol esters of coconut fatty acidsPropylene glycol monolauratePropylene glycol monomethyl etherPropylene glycol monostearateα, α′, α″-[Propylidynetris (methylene)] tris [omega-hydroxypoly (oxypropylene) (1.5 moles minimum)], minimum molecular weight 400Quaternary ammonium chloride (hexadecyl, octadecyl derivative)For use as preservative only.Rosin (wood, gum, and tall oil rosin), rosin dimers, decarboxylated rosin (including rosin oil, disproportionated rosin, and these substances as modified by one or more of the following reactants:Alkyl (C1-C9) phenolformaldehydeAmmoniaAmmonium caseinate-p-CyclohexylphenolformaldehydeDiethylene glycolDipentaerythritolEthylene glycolFormaldehydeFumaric acidGlycerinHydrogenIsophthalic acid4,4′-Isopropylidenediphenol-epichlorohydrin (epoxy)4,4′-Isopropylidenediphenol-formaldehydeMaleic anhydrideMethyl alcoholPentaerythritolPhthalic anhydridePolyethylene glycolPhenol-formaldehydePhenyl μ-cresol-formaldehydep-Phenylphenol-formaldehydeSulfuric acidTriethylene glycolXylenol-formaldehydeRosin salts (salts of wood, gum, and tall oil rosin, and the dimers thereof, decarboxylated rosin disproportionated rosin, hydrogenated rosin):AluminumAmmoniumCalciumMagnesiumPotassiumSodiumZincRosin, gasoline-insoluble fractionRubber hydrochloride polymerRubber latex, naturalSalicylic acidFor use as preservative only.SandaracSebacic acidShellacSilicon dioxide as defined in §172.480(a) of this chapterSodium alkyl (C2-C13.5 aliphatic) benezenesulfonateSodium aluminum pyrophosphateSodium aluminum sulfateSodium bisulfateSodium calcium silicateSodium capryl polyphosphateSodium carboxymethylcelluloseSodium chlorateSodium chloriteSodium chromateSodium decylsulfateSodium dehydroacetateFor use as preservative only.Sodium di-(2-ethylhexoate)Sodium di-(2-ethylhexyl) pyrophosphateSodium dihexylsulfosuccinateSodium dissobutylphenoxydiethoxyethyl sulfonateSodium diisobutylphenoxymonoethoxyethyl sulfonateSodium diisopropyl- and triisopropylnaphthalenesulfonateSodium dimethyldithiocarbamateSodium dioctylsulfosuccinateSodium n-dodecylpolyethoxy (50 moles) sulfateSodium ethylene ether of nonylphenol sulfateSodium 2-ethylhexyl sulfateSodium fluorideFor 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 sulfoxylateSodium formateSodium heptadecylsulfateSodium hypochloriteSodium isododecylphenoxypolyethoxy (40 moles) sulfateSodium N-lauroyl sarcosinateSodium metaborateSodium α-naphthalene sulfonateSodium nitrateSodium nitriteSodium oleoyl isopropanolamide sulfosuccinateSodium pentachlorophenateFor use as preservative only.Sodium perborateSodium persulfateSodium μ-phenylphenateFor use as preservative only.Sodium polyacrylateSodium polymethacrylateSodium polystyrene sulfonateSodium salicylateFor use as preservative only.Sodium salt of 1-hydroxy 2(1H)-pyridine thione Do.Sodium tetradecylsulfateSodium thiocyanateSodium bis-tridecylsulfosuccinateSodium xylene sulfonateSorbitan monooleateSorbitan monostearateSoybean oil, epoxidizedSpermaceti waxSperm oil waxStannous 2-ethylhexanoateFor use only as a catalyst for polyurethane resins.Stannous stearateStarch hydrolysatesStarch or starch modified by one or more of the treatments described in §§172.892 and 178.3520 of this chapterStarch, reacted with a urea-formaldehyde resinStarch, reacted with formaldehydeStearamide (stearic acid amide)Stearic acidStearic acid-chromic chloride complexStearyl-cetyl alcohol, technical grade, approximately 65 percent-80 percent stearyl and 20 percent-35 percent cetylStrontium salicylateStyrenated phenolStyrene block polymers with 1,3-butadieneStyrene-maleic anhydride copolymer, ammonium or potassium saltStyrene-maleic anhydride copolymer (partially methylated) sodium saltStyrene-methacrylic acid copolymer, potassium saltSucrose acetate isobutyrateSucrose benzoateSucrose octaacetate2-sulfoethyl methacrylate (CAS Registry No. 10595-80-9)For use at levels not to exceed 2 percent by weight of the dry adhesive.α-Sulfo-omega-(dodecyloxy)poly (oxyethylene), ammonium saltSulfonated 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)SulfurSynthetic 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 §176.170(a)(5) of this chapterTall oilTall oil fatty acids, linoleic and oleicTall oil fatty acid methyl esterTall oil, methyl esterTall oil pitchTall oil soapsTallow alcohol (hydrogenated)Tallow amine, secondary (hexadecyl, octadecyl), of hard tallowTallow, blown (oxidized)Tallow, propylene glycol esterTerpene resins (α-and β-pinene) homopolymers, copolymers, and condensates with phenol, formaldehyde, coumarone, and/or indeneTerphenylTerphenyl, hydrogenatedTerpineolTetraethylene pentamineTetraethylthiuram disulfideTetrahydrofuranTetrahydrofurfuryl alcoholTetra-isopropyl titanateTetrakis[methylene (3,5-di-tert-butyl-4-hydroxy-hydro-cinnamate)] methanea[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 oxidea-[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 molesTetramethyl decanediolTetramethyl decynediolTetramethyl decynediol plus 1-30 moles of ethylene oxideTetramethylthiuram monosulfideTetrasodium N-(1,2-dicarboxyethyl)N-octadecylsulfosuccinamate4,4′-Thiobis-6-tert-butyl-m-cresolThiodiethylene-bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)2,2′-(2,5-Thiophenediyl) bis[5-tert-butylbenzoxazole]ThiramThymolFor use as preservative only.Titanium dioxideTitanium dioxide-barium sulfateTitanium dioxide-calcium sulfateTitanium dioxide-magnesium silicateTolueneToluene 2,4-diisocyanateToluene 2,6-diisocyanateo- and p-Toluene ethyl sulfonamideo- and p-Toluene sulfonamidep-Toluene sulfonic acidp-(p′-Toluene-sulfonylamide)-diphenylamideTriazine-formaldehyde resins as described in §175.300(b)(3)(xiii)Tributoxyethyl phosphateTributylcitrateTri-tert-butyl-p-phenyl phenolFor use as preservative only.Tributyl phosphateTributyltin chloride complex of ethylene oxide condensate of dehydroabietylamineFor use as preservative only.Tri-n-butyltin acetateFor use as preservative only.Tri-n-butyltin neodecanoate Do.1,1,1-Trichloroethane1,1,2-TrichloroethaneTrichloroethyleneTri-β-chloroethylphosphateTridecyl alcoholTriethanolamine3-(Triethoxysilyl) propylamineTriethylene glycolTriethylene glycol dibenzoateTriethylene glycol di(2-ethylhexoate)Triethylene glycol polyester of benzoic acid and phthalic acidTriethylhexyl phosphateTriethylphosphate2,4,5-Trihydroxy butyrophenoneTriisopropanolamineTrimethylol propane2,2,4-Trimethylpentanediol-1,3-diisobutyrateTrimeric aromatic amine resin from diphenylamine and acetone of molecular weight approximately 500Tri(nonylphenyl) phosphite-formaldehyde resinsAs identified in §177.2600(c)(4)(iii) of this chapter. For use only as a stabilizer.TriphenylphosphateTripropylene glycol monomethyl ether1,3,5-Tris (3,5-di-tert-butyl-4-hydroxy-benzyl)-triazine-2,4,6 (1H,3H,5H)-trioneTris (p-tertiary butyl phenyl) phosphateTris(2-methyl-4-hydroxy-5-tert-butyl-phenyl)butaneTrisodium N-hydroxyethylethylenediaminetriacetate (CAS Reg. No. 139-89-9)TurpentineUrea-formaldehyde resins as described in §175.300(b)(3)(xii)Vegetable oil, sulfonated or sulfated, potassium saltVinyl acetate-maleic anhydride copolymer, sodium saltWaxes, petroleumWax, petroleum, chlorinated (40% to 70% chlorine)Waxes, synthetic paraffin (Fischer-Tropsch process)3-(2-Xenolyl)-1,2-epoxypropaneXyleneXylene (or toluene) alkylated with dicyclopentadieneZeinZinc acetateZinc ammonium chlorideZinc dibenzyl dithiocarbamateZinc dibutyldithiocarbamateZinc diethyldithiocarbamateZinc di(2-ethylhexoate)Zinc formaldehyde sulfoxylateZinc naphthenate and dehydroabietylamine mixtureZinc nitrateZinc orthophosphateZinc resinateZinc sulfideZineb (zinc ethylenebis-dithiocarbamate)Ziram (zinc dimethyldithiocarbamate)
Editorial Note: For Federal Register citations affecting §175.105, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. Back to Top
§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 §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 §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 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:
Polybutene-1. Polybutene, hydrogenated; complying with the identity prescribed under §178.3740(b) of this chapter.
§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 substancesLimitationsAluminum stearateAmmonium lauryl sulfateBoraxNot to exceed the amount required as a preservative in emulsion defoamer.Disodium hydrogen phosphate Do.FormaldehydeGlyceryl monostearateMethyl celluloseMineral oilParaffin waxPotassium hydroxidePotassium persulfateTallowTetrasodium pyrophosphateTitanium 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 °F for 30 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 °F for 30 minutes shall yield total chloroform-soluble extractables not to exceed 0.5 milligram per square inch. Back to Top
§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 substancesLimitationsAcetylated monoglyceridesComplying with 172.828 of this chapter.Cellulose acetate butyrateCellulose acetate propionateMineral oil, whiteFor use only as a component of hot-melt strippable food coatings applied to frozen meats and complying with §172.878 of this chapter. Back to Top
§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 §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 °C when used in contact with food Types III, IVA, V, VIIA, and IX identified in table 1 of §176.170(c) of this chapter and under conditions of use E, F, and G described in table 2 of §176.170(c) of this chapter 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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (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 °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 §175.105.
§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 °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 §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 §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. Back to Top
§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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (1) Solvent. N,N-Dimethylacetamide, technical grade.(2) Solution. Powdered resin and solvent are heated at 120 °C until the resin is dissolved.(3) Temperature. Flow times of the solvent and solution are determined at 110 °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:
t=Solution efflux time.
to=Solvent efflux time.
c=Concentration of solution in terms of grams per deciliter.
§175.300 Resinous and polymeric coatings.Resinous and polymeric coatings may be safely used as the food-contact surface of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions:(a) The coating is applied as a continuous film or enamel over a metal substrate, or the coating is intended for repeated food-contact use and is applied to any suitable substrate as a continuous film or enamel that serves as a functional barrier between the food and the substrate. The coating is characterized by one or more of the following descriptions:(1) Coatings cured by oxidation.(2) Coatings cured by polymerization, condensation, and/or cross-linking without oxidation.(3) Coatings prepared from prepolymerized substances.(b) The coatings are formulated from optional substances that may include:(1) Substances generally recognized as safe in food.(2) Substances the use of which is permitted by regulations in this part or which are permitted by prior sanction or approval and employed under the specific conditions, if any, of the prior sanction or approval.(3) Any substance employed in the production of resinous and polymeric coatings that is the subject of a regulation in subchapter B of this chapter and conforms with any specification in such regulation. Substances named in this paragraph (b)(3) and further identified as required:(i) Drying oils, including the triglycerides or fatty acids derived therefrom:
Corn. Cottonseed.
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:
(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:
(vi) Phenolic resins as the basic polymer formed by reaction of phenols with formaldehyde:(a) Phenolic resins formed by reaction of formaldehyde with:
(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:
(viii) Epoxy resins, catalysts, and adjuncts:(a) Epoxy resins, as the basic polymer:
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 °F (82 °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.
(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:
(xii) Urea-formaldehyde, resins and their curing catalyst:(a) Urea-formaldehyde resins, as the basic polymer:
(xiii) Triazine-formaldehyde resins and their curing catalyst:(a) Triazine-formaldehyde resins, as the basic polymer:
Dimethylamine-2-methyl-1-propanol. Methylpropanolamine.
Styrene copolymerized with one or more of the following:Acrylonitrile.α-Methylstyrene.
Maleic anhydride adduct of polypropylene The polypropylene used in the manufacture of the adduct complies with §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 °C on a 0.1 percent solution of the modified polypropylene in decahydronaphthalene as determined by a method titled “Method for Determination of Intrinsic Viscosity of Maleic Anhydride Adduct of Polypropylene,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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:
(xxvi) Colorants used in accordance with §178.3297 of this chapter.(xxvii) Surface lubricants:
(xxviii) Silicones and their curing catalysts:(a) Silicones as the basic polymer:
Adipic. Azelaic.
(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 §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 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 2—Test Procedures for Determining Amount of Extractives From Resinous or Polymeric Coatings, Using Solvents Simulating Types of Foods and BeveragesCondition of useTypes of food(see Table 1)ExtractantWater(time and temperature)Heptane1 2(time and temperature)8% alcohol(time and temperature)A. High temperature heat-sterilized (e.g., over 212 °F)I, IV-B250 °F, 2 hr III, IV-A, VIIdo150 °F, 2 hrB. Boiling water-sterilizedII212 °F, 30 min III, VIIdo120 °F, 30 minC. Hot filled or pasteurized above 150 °FII, IV-BFill boiling, cool to 100 °F III, IV-Ado120 °F, 15 min VdoD. Hot filled or pasteurized below 150 °FII, IV-B, VI-B150 °F, 2 hr III, IV-Ado100 °F, 30 min Vdo VI-A150 °F, 2 hr.E. Room temperature filled and stored (no thermal treatment in the container)II, IV-B, VI-B120 °F, 24 hr III, IV-Ado70 °F, 30 min V, VIIdo VI-A120 °F, 24 hr.F. Refrigerated storage (no thermal treatment in the container)I, II, III, IV-A, IV-B, VI-B,VII70 °F, 48 hr VI-A70 °F, 48 hr.G. Frozen storage (no thermal treatment in the container)I, II, III, IV-B, VII70 °F, 24 hrH. Frozen storage: Ready-prepared foods intended to be reheated in container at time of use:1. Aqueous or oil in water emulsion of high or low fatI, II, IV-B212 °F, 30 min2. Aqueous, high or low free oil or fatIII, IV-A, VIIdo120 °F, 30 min1 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 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 °F-200 °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 °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 °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 °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 °F), simulating hot fill or pasteurization above 150 °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 °F-85 °F. When the temperature reads 100 °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° for 2 hours), simulating hot fill or pasteurization below 150 °F. Preheat demineralized distilled water to 150 °F in a clean Pyrex flask. Fill the container within 1⁄4 -inch of the top with a measured volume of the 150 °F water and cover with clean aluminum foil. Place the test container in an oven maintained at 150 °F. After 2 hours, remove the test container from the oven and immediately composite the water of each replicate in a clean Pyrex flask or beaker. Proceed with the determination of the amount of extractives by the method described in paragraph (e)(5) of this section.(v) Water (120 °F for 24 hours), simulating room temperature filling and storage. Preheat demineralized distilled water to 120 °F in a clean Pyrex flask. Fill the container within 1⁄4 -inch of the top with a measured volume of the 120 °F water and cover with clean aluminum foil. Place the test container in an incubator or oven maintained at 120 °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 °F for 48 hours), simulating refrigerated storage. Bring demineralized distilled water to 70 °F in a clean Pyrex flask. Fill the container within 1⁄4 -inch of the top with a measured volume of the 70 °F water, and cover with clean aluminum foil. Place the test container in a suitable room maintained at 70 °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 °F for 24 hours), simulating frozen storage. Bring demineralized distilled water to 70 °F in a clean Pyrex flask. Fill the container within 1⁄4 -inch of the top with a measured volume of the 70 °F water and cover with clean aluminum foil. Place the container in a suitable room maintained at 70 °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 °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 °F for 2 hours) simulating high-temperature heat sterilization for fatty foods only. Preheat redistilled reagent-grade heptane (boiling point 208 °F) carefully in a clean Pyrex flask on a water bath or nonsparking hot plate in a well-ventilated hood to 150 °F. At the same time preheat a pressure cooker or equivalent to 150 °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 °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 °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 °F for 30 minutes), simulating boiling water sterilization of fatty foods only. Preheat redistilled reagent-grade heptane (boiling point 208 °F) carefully in a clean Pyrex flask on a water bath or nonsparking hot plate in a well-ventilated hood to 120 °F. At the same time, preheat a pressure cooker or equivalent to 120 °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 °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 °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 °F for 15 minutes), simulating hot fill or pasteurization above 150 °F for fatty foods only. Preheat redistilled reagent-grade heptane (boiling point 208 °F) carefully in a clean Pyrex flask on a water bath or nonsparking hot plate in a well-ventilated hood to 120 °F. At the same time, preheat a pressure cooker or equivalent to 120 °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 °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 °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 °F for 30 minutes), simulating hot fill or pasteurization below 150 °F for fatty foods only. Preheat redistilled reagent-grade heptane (boiling point 208 °F) carefully in a clean Pyrex flask on a water bath or nonsparking hot plate in a well-ventilated hood to 100 °F. At the same time, preheat a pressure cooker or equivalent to 100 °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 °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 °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 °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 °F heptane and cover with clean aluminum foil. Place the test container in a suitable room maintained at 70 °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 °F for 30 minutes), simulating frozen fatty foods reheated in the container. Preheat redistilled reagent-grade heptane (boiling point 208 °F) carefully in a clean Pyrex flask on a water bath or hot plate in a well-ventilated hood to 120 °F. At the same time, preheat a pressure cooker to 120 °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 °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 °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 °F for 2 hours), simulating alcoholic beverages hot filled or pasteurized below 150 °F. Preheat 8 percent (by volume) ethyl alcohol in demineralized distilled water to 150 °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 °F. After 2 hours, remove the container from the oven and immediately composite the alcohol from each replicate in a clean Pyrex flask. Proceed with the determination of the amount of extractives by the method described in paragraph (e)(5) of this section.(xvi) Alcohol—8 percent (120 °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 °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 °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 °F for 48 hours), simulating alcoholic beverages in refrigerated storage. Bring 8 percent (by volume) ethyl alcohol in demineralized distilled water to 70 °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 °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 °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.
View or download PDF(b) Heptane.
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.
If when calculated by the equations in paragraph (e)(5)(i) (a) and (b) of this section, the concentration of extractives residue (Ex) exceeds 50 parts per million or the extractives in milligrams per square inch exceed the limitations prescribed in paragraph (c) of this section for the particular container size, proceed to paragraph (e)(5)(ii) of this section (method for determining the amount of chloroform-soluble extractives residue).(ii) Chloroform-soluble extractives residue. Add 50 milliliters of chloroform (freshly distilled reagent grade or a grade having an established consistently low blank) to the dried and weighed residue, (e), in the platinum dish, obtained in paragraph (e)(5)(i) of this section. Warm carefully, and filter through Whatman No. 41 filter paper in a Pyrex funnel, collecting the filtrate in a clean, tared platinum dish. Repeat the chloroform extraction, washing the filter paper with this second portion of chloroform. Add this filtrate to the original filtrate and evaporate the total down to a few milliliters on a low-temperature hotplate. The last few milliliters should be evaporated in an oven maintained at 212 °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 °F-200 °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 × 11 inches inside height, 20 pounds per square inch safe operating pressure.Oven, mechanical convection, range to include 120 °F-212 °F explosion-proof, inside dimensions (minimum), 19″ × 19″ × 19″, constant temperature to ±2 °F (water bath may be substituted).Incubator, inside dimensions (minimum) 19″ × 19″ × 19″ for use at 100 °F±2 °F explosion proof (water bath may be substituted).Constant-temperature room or chamber 70 °F±2 °F minimum inside dimensions 19″ × 19″ × 19″.Hot plate, nonsparking (explosion proof), top 12″ × 20″, 2,500 watts, with temperature control.Platinum dish, 100-milliliter capacity minimum.All glass, Pyrex or equivalent.
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 °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 §180.22 of this chapter.(i) Epoxy resins derived by the reaction of 4,4′-isopropylidenediphenol and epichlorohydrin, as described in paragraph (b)(3)(viii)(a) of this section, may be used in accordance with this section except as coatings in packaging for powdered and liquid infant formula.
Editorial Note: For Federal Register citations affecting §175.300, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. Back to Top
§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 §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 substancesLimitations(i) Resins and polymers:Acrylic acid polymer and its ethyl or methyl estersAcrylamide copolymerized with ethyl acrylate and/or styrene and/or methacrylic acid, and the copolymer subsequently reacted with formaldehyde and butanolButadiene-acrylonitrile copolymerButadiene-acrylonitrile-styrene terpolymerButyl rubberN,N′-Diphenyl-p-phenylenediamineFor use only as a polymerization inhibitor in 2-sulfoethyl methacrylate, sodium salt.2-Ethylhexyl acrylate copolymerized with one or more of the following:AcrylonitrileItaconic acidMethacrylonitrileMethyl acrylateMethyl methacrylate4,4′-Isopropylidenediphenolepichlorohydrin average molecular weight 900Melamine-formaldehyde as the basic polymer or chemically modified with methyl alcoholMethacrylic acid and its ethyl or methyl esters copolymerized with one or more of the following:Acrylic acidEthyl acrylateMethyl acrylateα-Methyl styrene polymerα-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 α-methylstyrene to 3 vinyltoluene)For use only in coatings that contact food under conditions of use D, E, F, or G described in table 2 of §176.170(c) of this chapter, provided that the concentration of α-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 resinsAs defined in §176.170 of 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. 68139-70-8), as the basic resin, derived from:For use only in coatings for polypropylene films that contact food at temperatures not to exceed room temperature.Dimerized vegetable oil or tall oil acids containing not more than 20 percent of monomer acidsAzelaic acid (CAS Reg. No. 123-99-9) in an amount not to exceed 3.7 percent by weight of the polyamide resinEthylenediamine (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 resinPolyamide resins, derived from dimerized vegetable oil acids (containing not more than 20% of monomer acids) and ethylenediamine, as the basic resinFor use only in coatings for polyolefin films that contact food at temperatures not to exceed room temperature.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 acids (in an amount not to exceed 10 percent by weight of said polyamide resins); as the basic resinFor 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.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:AdipicAzelaicFor use in forming polyester resins intended for use in coatings that contact food only of the type identified in §176.170(c) of this chapter, table 1, under Category VIII, and under conditions of use E, F, or G, described in table 2 of §176.170(c) of this chapter.Dimerized fatty acids derived from:Animal, marine or vegetable fats and oilsTall oilFumaricIsophthalicMaleico-PhthalicSebacicTerephthalicTrimelliticMonobasic acids:Fatty acids derived from:Animal, marine, or vegetable fats and oilsGum rosinAs defined in §178.3870 of this chapter. For use in forming polyester resins intended for use in coatings that contact food only of the type identified in §176.170(c) of this chapter, table 1, under Category VIII, and under conditions of use E, F, or G described in table 2 of §176.170(c) of this chapter.Polyhydric alcohols:1,3-Butylene glycolDiethylene glycol2,2-Dimethyl-1,3-propanediolDipropylene glycolEthylene glycolGlycerolMannitolα-Methyl glucosidePentaerythritolPropylene glycolSorbitolTrimethylol ethaneTrimethylol propanePolyethylenimineFor use only as a primer subcoat to anchor epoxy surface coatings to the base sheet.PolystyrenePolyvinyl acetatePolyvinyl chlorideSiloxanes and silicones: 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). The following substances may be used as optional polymerization inhibitors:Platinum content not to exceed 150 parts per million.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); andTetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554-06-5).Siloxanes and silicones; platinum-catalyzed reaction product of vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. 68083-19-2 and 68083-18-1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148-57-2). Dimethyl maleate (CAS Reg. No. 624-48-6) and vinyl acetate (CAS Reg. No. 108-05-4) may be used as optional polymerization inhibitorsPlatinum content not to exceed 100 parts per million. For use only as a surface coating under the following conditions:1. In coatings for olefin polymers provided the coating contacts food only of the types identified in §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 §176.170(c) of this chapter.2. In coatings for olefin polymers provided the coating contacts food only of the types identified in §176.170(c) of this 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 §176.170(c) of this chapter.Siloxanes and silicones; platinum-catalyzed reaction product of vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. 68083-19-2 and 68083-18-1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148-57-2). Dimethyl maleate (CAS Reg. No. 624-48-6), vinyl acetate (CAS Reg. No. 108-05-4), dibutyl maleate (CAS Reg. No. 105-76-0) and diallyl maleate (CAS Reg. No. 999-21-3) may be used as optional polymerization inhibitors. The polymer may also contain C16-C18 olefins (CAS Reg. No. 68855-60-7) as a control release agentPlatinum content not to exceed 100 parts per million. For use only as a release coating for pressure sensitive adhesives.Styrene copolymerized with one or more of the following:Acrylonitrileα-Methyl styreneStyrene 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 percentFor use only in contact with foods of Types IV-A, V, and VII in table 1 of §176.170(c) of this chapter, under use conditions E through G in table 2 of §176.170(c), and with foods of Types VIII and IX without use temperature restriction.Styrene-isobutylene copolymerTerpene resins consisting of polymers of α-pinene, β-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 solution2-Sulfoethyl methacrylate, sodium salt Chemical Abstracts Service No. 1804-87-1]For use only in copolymer coatings under conditions of use E, F, and G described in table 2 of §176.170(c) of this chapter and limited to use at a level not to exceed 2.0 percent by weight of the dry copolymer coating.Vinyl chloride-acetate, hydroxyl-modified copolymer or maleic acid-modified copolymerVinyl chloride copolymerized with one or more of the following:AcrvlonitrileVinyl acetateVinylidene chlorideVinylidene chloride copolymerized with one or more of the following:Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl estersAcrylonitrileItaconic acidMethacrylic acid and its methyl, ethyl, propyl, butyl, or octyl estersMethacrylonitrileVinyl chloride(ii) Plasticizers:Acetyl tributyl citrateAcetyl triethyl citrateButyl phthalyl butyl glycolateButyl stearateDibutyl sebacateDiethyl phthalate2-Ethylhexyl diphenyl phosphateEthyl phthalyl ethyl glycolateGlycerol monooleateGlycerol triacetateTriethyl citrate(iii) Adjuvants (release agents, waxes, and dispersants):AcetoneAmides (unsubstituted) of fatty acids from vegetable or animal oilsn-Butyl acetaten-Butyl alcoholCandelilla waxCarnauba wax5-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 formulation.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 coating.Ethyl acetateFatty acids from vegetable or animal oils and their aluminum, ammonium, calcium, magnesium, and sodium saltsHexaneMethyl ethyl ketoneN,N′-Dioleoylethylenediamine (CAS Reg. No. 110-31-6)For use only in ionomeric resins complying with §177.1330 of this chapter and in ethylene vinyl acetate copolymers complying with §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 chapterPolyvinyl alcohol, minimum viscosity of 4% aqueous solution at 20 °C of 4 centipoises and percent alcoholysis of 87-100For use only as a dispersing agent at levels not to exceed 6% of total coating weight in coatings for pol-yolefin films provided the finished polyolefin films contact food only of the types identified in §176.170(c) of this chapter, table 1, under Types V, VIII, and IX.Sodium dioctyl sulfosuccinateSodium dodecylbenzenesulfonateSodium lauryl sulfateSorbitan and sorbitol esters of fatty acids from vegetable or animal oilsSpermaceti waxTetrahydrofuranToluene(iv) Preservatives:Silver chloride-coated titanium dioxideFor 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.(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 §176.170(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 §180.22 of this chapter.
§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 §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 substancesLimitationsSilicaJapan 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 °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 °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. Back to Top
§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 §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 §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 tested by the methods described in §176.170(d) of this chapter.(e) Acrylonitrile copolymers identified in this section shall comply with the provisions of §180.22 of this chapter.
§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 §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 §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 §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 §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 §180.22 of this chapter. Back to Top
§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 §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 °F with food of Types I, II, VI-A and B, and VIII described in table 1 of §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 §175.300(e):(1) The coating when extracted with distilled water at 180 °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 °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 §176.170(c) of this chapter provided 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 §175.300(e):(1) The coating when extracted with distilled water at 180 °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 °F for 24 hours yields total extractives not to exceed 0.05 milligram per square inch. Back to Top
§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 §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 substancesLimitationsEthylene glycolAs a solvent removed by water washing.Iron oxideLithium hydroxideRemoved by water washing.Methyl orangeAs an acid-base indicator.Potassium dichromateRemoved by water washing.Silica gelSodium silicateZinc, 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 §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 §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. Back to Top