Indirect food additives: adhesives and components of coatings (21 CFR 175.105-175.390)

158 21 CFR Ch. I (4–1–16 Edition) § 174.6 (c) The existence in this subchapter B of a regulation prescribing safe condi tions for the use of a substance as an article or component of articles that contact food shall not be construed as implying that such substance may be safely used as a direct additive in food. (d) Substances that under conditions of good manufacturing practice may be safely used as components of articles that contact food include the fol lowing, subject to any prescribed limi tations: (1) Substances generally recognized as safe in or on food. (2) Substances generally recognized as safe for their intended use in food packaging. (3) Substances used in accordance with a prior sanction or approval. (4) Substances permitted for use by regulations in this part and parts 175, 176, 177, 178 and § 179.45 of this chapter. (5) Food contact substances used in accordance with an effective pre market notification for a food contact substance (FCN) submitted under sec tion 409(h) of the act. [42 FR 14534, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002] § 174.6 Threshold of regulation for substances used in food-contact ar ticles. Substances used in food-contact arti cles (e.g., food-packaging or food-proc essing equipment) that migrate, or that may be expected to migrate, into food at negligible levels may be re viewed under § 170.39 of this chapter. The Food and Drug Administration will exempt substances whose uses it determines meet the criteria in § 170.39 of this chapter from regulation as food additives and, therefore, a food addi tive petition will not be required for the exempted use. [60 FR 36596, July 17, 1995] PART 175—INDIRECT FOOD ADDI TIVES: ADHESIVES AND COMPO NENTS OF COATINGS Subpart A [Reserved] Subpart B—Substances for Use Only as Components of Adhesives Sec. 175.105 Adhesives. 175.125 Pressure-sensitive adhesives. Subpart C—Substances for Use as Components of Coatings 175.210 Acrylate ester copolymer coating. 175.230 Hot-melt strippable food coatings. 175.250 Paraffin (synthetic). 175.260 Partial phosphoric acid esters of pol yester resins. 175.270 Poly(vinyl fluoride) resins. 175.300 Resinous and polymeric coatings. 175.320 Resinous and polymeric coatings for polyolefin films. 175.350 Vinyl acetate/crotonic acid copoly mer. 175.360 Vinylidene chloride copolymer coat ings for nylon film. 175.365 Vinylidene chloride copolymer coat ings for polycarbonate film. 175.380 Xylene-formaldehyde resins con densed with 4,4′-isopropylidenediphenol epichlorohydrin epoxy resins. 175.390 Zinc-silicon dioxide matrix coatings. AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. SOURCE: 42 FR 14534, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 175 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. 1, 2005. Subpart A [Reserved] Subpart B—Substances for Use Only as Components of Adhesives § 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 adhe sive 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00168 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 159 Food and Drug Administration, HHS § 175.105 packaged fatty and aqueous foods shall not exceed the trace amount at seams and at the edge exposure between pack aging laminates that may occur within the limits of good manufacturing prac tice. (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 con tainer shall bear the statement ‘‘food packaging adhesive’’. (c) Subject to any limitation pre scribed 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 ad hesives, the optional substances used in the formulation of adhesives may in clude the following: (1) Substances generally recognized as safe for use in food or food pack aging. (2) Substances permitted for use in adhesives by prior sanction or approval and employed under the specific condi tions of use prescribed by such sanc tion or approval. (3) Flavoring substances permitted for use in food by regulations in this part, provided that such flavoring sub stances are volatilized from the adhe sives 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 regula tion. Substances Limitations Abietic acid. Acetone. Acetone-formaldehyde condensate (CAS Reg. No. 25619–09–4). Acetone-urea-formaldehyde resin. N-Acetyl ethanolamine. Acetyl tributyl citrate. Acetyl triethyl citrate. 2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, sodium salt (CAS Reg. No. 35641–59–9). Albumin, blood. (2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983–55–0). 4-[2-[2-2-(Alkoxy (C12-C15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate. 1-Alkyl (C6-C18) amino-3-amino-propane monoacetate. Alkylated (C4 and/or C8) phenols. Alkyl (C7-C12) benzene. Alkyl (C10-C20) dimethylbenzyl ammonium chloride. n-Alkyl(C12, C14, C16, or C18) dimethyl (ethylbenzyl) ammonium cyclohexylsulfamate. For use as preservative only. Alkyl ketene dimers as described in § 176.120 of this chapter. Alkyl (C7-C12) naphthalene. alpha Olefin sulfonate [alkyl group is in the range of C10-C18 with not less than 50 percent C14-C16], ammonium, calcium, magnesium, po tassium, and sodium salts. 2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111–41–1). 3-Aminopropanediol .................................................................................... For use only in the preparation of polyurethane res ins. Aluminum. Aluminum acetate. Aluminum di(2-ethylhexoate). Aluminum potassium silicate. N-b-Aminoethyl-gamma-aminopropyl trimethoxysilane. 3-(Aminomethyl)-3,5,5-trimethylcyclohexylamine. Aminomethylpropanol. Ammonium benzoate .................................................................................. For use as preservative only. Ammonium bifluoride .................................................................................. For use only as bonding agent for aluminum foil, sta bilizer or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Ammonium borate. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00169 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 160 21 CFR Ch. I (4–1–16 Edition) § 175.105 Substances Limitations Ammonium citrate. Ammonium persulfate. Ammonium polyacrylate. Ammonium potassium hydrogen phosphate. Ammonium silico-fluoride ............................................................................ For use only as bonding agent for aluminum foil, sta bilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Ammonium sulfamate. Ammonium thiocyanate. Ammonium thiosulfate. Amyl acetate. Anhydroenneaheptitol. Animal glue as described in § 178.3120 of this chapter. 2-Anthraquinone sulfonic acid, sodium salt ................................................ For use only as polymerization-control agent. Antimony oxide. Asbestos. Asphalt, paraffinic and naphthenic. Azelaic acid. Azo-bis-isobutyronitrile. Balata rubber. Barium acetate. Barium peroxide. Barium sulfate. Bentonite. Benzene (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. Benzothiazyldisulfide. p-Benzoxyphenol ......................................................................................... For use as preservative only. Benzoyl peroxide. Benzyl alcohol. Benzyl benzoate. Benzyl bromoacetate .................................................................................. For use as preservative only. p-Benzyloxyphenol ...................................................................................... Do. BHA (butylated hydroxyanisole). BHT (butylated hydroxytoluene). Bicyclo[2.2.1]hept-2-ene-6-methyl acrylate. 2-Biphenyl diphenyl phosphate. Bis(benzoate-O)(2-propanolato)aluminum (CAS Reg. No. 105442–85–1) For use only as a reactant in the preparation of poly ester 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) urea. 4,4′-Bis(a,a-dimethylbenzyl)diphenylamine. 2,6-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-cresol. 4-[[4, 6-Bis(octylthio)6-Bis(octylthio)6-Bis(octylthio)-s-triazin-2-yl]amino] 2,6-di-tert-butylphenol (CAS Reg. No. 991–84–4). Bis(tri-n-butyltin) oxide ................................................................................ For use as preservative only. Bis(trichloromethyl)sulfone C.A. Registry No. 3064–70–8 ......................... Do. Borax. Boric acid. 2-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-Butanediol. 1,4-Butanediol. 1,4-Butanediol modified with adipic acid. Butoxy polyethylene polyproplyene glycol (molecular weight 900–4,200). Butyl acetate. Butyl acetyl ricinoleate. Butyl alcohol. Butylated reaction product of p-cresol and dicyclopentadiene ................... As identified in § 178.2010(b) of this chapter. Butylated, styrenated cresols identified in § 178.2010(b) of this chapter. Butyl benzoate. Butyl benzyl phthalate. Butyldecyl phthalate .................................................................................... 1,3-Butylene glycoldiglycolic acid copolymer. tert-Butyl hydroperoxide. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00170 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 161 Food and Drug Administration, HHS § 175.105 Substances Limitations 4,4′-Butylidenebis(6-tert-butyl-m-cresol). Butyl lactate. Butyloctyl phthalate. p-tert-Butylphenyl salicylate. Butyl phthalate butyl glycolate. p-tert-Butylpyrocatechol .............................................................................. For use only as polymerization-control agent. Butyl ricinoleate. Butyl rubber polymer. Butyl stearate. Butyl titanate, polymerized. Butyraldehyde. Calcium ethyl acetoacetate. Calcium nitrate. Calcium metasilicate. Camphor. Camphor fatty acid esters. Candelilla wax. epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer. Carbon black, channel process. Carbon disulfide-1,1′-methylenedipiperidine reaction product. Carbon tetrachloride. Carboxymethylcellulose. Castor oil, polyoxyethylated (4–84 moles ethylene oxide). Cellulose acetate butyrate. Cellulose acetate propionate. Ceresin wax (ozocerite). Cetyl alcohol. Chloracetamide. Chloral hydrate. Chlorinated liquid n-paraffins with chain lengths of C10-C17, containing 40–70 percent chlorine by weight. Chlorinated pyridine mixture with active ingredients consisting of 2,3,5,6 tetrachloro-4-(methylsulfonyl) pyridine, 2,3,5,6-tetrachloro-4 (methylsulfinyl) pyridine and pentachloropyridine. For use as preservative only. Chlorinated rubber polymer (natural rubber polymer containing approxi mately 67 percent chlorine). 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ....................... For use as preservative only. Chlorobenzene. 4-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 con centration equivalent to the isothiazolone active ingredients (weight/ weight). For use only as an antimicrobial agent in polymer latex emulsions. Chloroform. Chloroprene. Chromium caseinate. Chromium nitrate. Chromium potassium sulfate. Cobaltous acetate. Coconut fatty acid amine salt of tetrachlorophenol .................................... For use as preservative only. Copal. Copper 8-quinolinolate ................................................................................ For use as preservative only. Coumarone-indene resin. Cresyl diphenyl phosphate. Cumene hydroperoxide. Cyanoguanidine. Cyclized rubber as identified in § 176.170(b)(2) of this chapter. Cyclohexane. 1,4-Cyclohexanedimethanoldibenzoate (CAS Reg. No. 35541–81–2). Cyclohexanol. Cyclohexanone resin. Cyclohexanone-formaldehyde condensate. N-Cyclohexyl p-toluene sulfonamide. (h5-Cyclopentadienyl)-(h6-isopropylbenzene)iron(II) hexafluorophosphate (CAS Reg. No. 32760–80–8). For use only as a photoinitiator. Damar. Defoaming agents as described in § 176.210 of this chapter. Dehydroacetic acid ...................................................................................... Diacetone alcohol. Diacetyl peroxide. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00171 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 162 21 CFR Ch. I (4–1–16 Edition) § 175.105 Substances Limitations N,N′-Dialkoyl-4,4′-diaminodiphenylmethane mixtures where; the alkoyl groups are derived from marine fatty acids (C12-C24). 2,5-Di-tert-amylhydroquinone. Diamines derived from dimerized vegetable oil acids. Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or xylyl. 1,2–Dibromo–2,4–dicyanobutane (CAS 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) phthalate. 2,5-Di-tert-butylhydroquinone. Dibutyl maleate. 2,6-Di-tert-butyl-4-methylphenol .................................................................. For use as preservative only. Di(C7, C9-alkyl)adipate. Dibutyl phthalate. Dibutyl sebacate. Dibutyltin dilaurate for use only as a catalyst for polyurethane resins. 1,2-Dichloroethylene (mixed isomers). Dicumyl peroxide. Dicyclohexyl phthalate. Diethanolamine. Diethanolamine condensed with animal or vegetable fatty acids. Diethylamine. Diethylene glycol. Diethylene glycol adipic acid copolymer. Diethylene glycol dibenzoate. Diethylene glycol hydrogenated tallowate monoester. Diethylene glycol laurate. Diethylene glycol monobutyl ether. Diethylene glycol monobutyl ether acetate. Diethylene glycol monoethyl ether. Diethylene glycol monoethyl ether acetate. Diethylene glycol monomethyl ether. Diethylene glycol monooleate. Diethylene glycol monophenyl ether. Diethylene glycol copolymer of adipic acid and phthalic anhydride. Di(2-ethylhexyl) adipate. Di(2-ethylhexyl)hexahydrophthalate. Di(2-ethylhexyl)phthalate. Diethyl oxalate. Diethyl phthalate. Dihexyl phthalate. Dihydroabietylphthalate. Di(2-hydroxy-5-tert-butylphenyl) sulfide. 2,2′-Dihydroxy-5,5′-dichlorodiphenylmethane (dichlorophene). 4,5-Dihydroxy-2-imidazolidinone. 4-(Diiodomethylsulfonyl) toluene CA Registry No.: 20018–09–01 ............. For use as an antifungal preservative only. Diisobutyl adipate. Diisobutyl ketone. Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride. Diisobutyl phthalate. Diisodecyl adipate. Diisodecyl phthalate. Diisooctyl phthalate. Diisopropylbenzene hydroperoxide. N,N-Dimethylcyclohexylamine dibutyldithiocarbamate. Dimethyl formamide. Dimethyl hexynol. 2,2-Dimethyl-1,3-propanediol dibenzoate. Dimethyl octynediol. N-(1,1-dimethyl-3-oxobutyl) acrylamide. Dimethyl phthalate. 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione ................................. For use as preservative only. Di-b-naphthyl-p-phenylenediamine. 4,6-Dinonyl-o-cresol. Dinonylphenol. Di-n-octyldecyl adipate. Dioctyldiphenylamine. Dioctylphthalate. Dioctylsebacate. Dioxane. Dipentaerythritol pentastearate. Dipentamethylene-thiuram-tetrasulfide. Dipentene .................................................................................................... Dipentene resins. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00172 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 163 Food and Drug Administration, HHS § 175.105 Substances Limitations Dipentene-beta-pinene-styrene resins. Dipentene-styrene resin (CAS Registry No. 64536–06–7). Diphenyl-2-ethylhexyl phosphate. Diphenyl, hydrogen ated. N,N′-Diphenyl-p-phenylenediamine. Diphenyl phthalate. 1,3-Diphenyl-2-thiourea. Dipropylene glycol. Dipropylene glycol dibenzoate. Dipropylene glycol monomethyl ether. Dipropylene glycol copolymer of adipic acid and phthalic anhydride. Disodium cyanodithioimidocarbonate. Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49–8). N,N′-Distearoylethylenediamine. Distearyl thiodipropionate. 3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hy droxyethyl)-s-triazine-2,4,6(1H, 3H, 5H)-trione. For use as antioxidant only. 4,4′-Dithiodimorpholine. n-Dodecylmercaptan. tert-Dodecylmercaptan. Dodecylphenoxybenzene-disulfonic acid and/or its calcium, magnesium, and sodium salts. Elemi gum. Epichlorohydrin-4,4′-isopropylidenediphenol resin. Epichlorohydrin-4,4′-sec-butylidenediphenol resin. Epichlorohydrin-4,4′-isopropylidene-di-o-cresol resin. Epichlorohydrin-phenolformaldehyde resin. Erucamide (erucylamide). Ethanolamine. Ethoxylated primary linear alcohols of greater than 10 percent ethylene oxide by weight having molecular weights of 390 to 7,000 (CAS Reg. No. 97953–22–5). Ethoxypropanol butyl ether. Ethyl alcohol (ethanol). 5-Ethyl-1,3-diglycidyl-5-methylhydantoin (CAS Reg. No. 15336–82–0). Ethylene-acrylic acid-carbon monoxide copolymer (CAS Reg. No. 97756–27–9). Ethylene-acrylic acid copolymer, partial sodium salt containing no more than 20 percent acrylic acid by weight, and no more than 16 percent of the acrylic acid as the sodium salt (CAS Reg. No. 25750–82–7). Ethylenediamine. Ethylenediaminetetra-acetic acid, calcium, ferric, potassium, or sodium salts, single or mixed. Ethylene dichloride. Ethylene glycol. Ethylene glycol monobutyl ether. Ethylene glycol monobutyl ether acetate. Ethylene glycol monoethyl ether. Ethylene glycol monoethyl ether acetate. Ethylene glycol monoethyl ether ricinoleate. Ethylene glycol monomethyl ether. Ethylene glycol monophenyl ether. Ethylene-carbon monoxide copolymer (CAS Reg. No. 25052–62–4) con taining not more than 30 weight percent of the units derived from car bon monoxide. Ethylene-maleic anhydride copolymer, ammonium or potassium salt. Ethylene-methacrylic acid copolymer partial salts: Ammonium, calcium, magnesium, sodium, and/or zinc. Ethylene-methacrylic acid-vinyl acetate copolymer partial salts: Ammo nium, calcium, magnesium, sodium, and/or zinc. Ethylene-octene-1 copolymers containing not less than 70 weight per cent ethylene (CAS Reg. No. 26221–73–8). Ethylene-propylene-dicyclopentadiene copolymer rubber. Ethylene, propylene, 1,4-hexadiene and 2,5-norbornadiene tetrapolymer. Ethylene-vinyl acetate carbon monoxide terpolymer (CAS Registry No. 26337–35–9) containing not more than 15 weight percent of units de rived from carbon monoxide. 2,2′-Ethylidenebis (4,6-di-tert-butylphenol) (CAS Reg. No. 35958–30–6). Ethyl-p-hydroxybenzoate ............................................................................. For use as preservative only. Ethyl hydroxyethylcellulose. Ethyl lactate. 2,2′-Ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite (CAS Reg. No. 118337–09–0). For use as an antioxidant and/or stabilizer only. Ethyl phthalyl ethyl glycolate. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00173 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 164 21 CFR Ch. I (4–1–16 Edition) § 175.105 Substances Limitations Ethyl-p-toluene sulfonamide ........................................................................ Fats and oils derived from animal or vegetable sources, and the hydro genated, sulfated, or sulfonated forms of such fats and oils. Fatty acids derived from animal or vegetable fats and oils; and salts of such acids, single or mixed, as follows: Aluminum. Ammonium. Calcium. Magnesium. Potassium. Sodium. Zinc. Ferric chloride. Fluosilicic acid (hydrofluosilicic acid) .......................................................... For use only as bonding agent for aluminum foil, sta bilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Formaldehyde. Formaldehyde o- and p-toluene sulfonamide. Formamide. Fumaratochromium (III) nitrate. Furfural. Furfuryl alcohol. Fumaric acid. gamma-Aminopropyltrimethoxysilane (CAS Reg. No. 13822–56–5). Glutaraldehyde. Glycerides, di- and monoesters. Glycerol polyoxypropylene triol, minimum average molecular weight 250 (CAS Reg. No. 25791–96–2). For use only in the preparation of polyester and poly urethane resins in adhesives. Glyceryl borate (glycol boriborate resin). Glyceryl ester of damar, copal, elemi, and sandarac. Glyceryl monobutyl ricinoleate. Glyceryl monohydroxy stearate. Glyceryl monohydroxy tallowate. Glyceryl polyoxypropylene triol (average molecular weight 1,000). Glyceryl tribenzoate. Glycol diacetate. Glyoxal. Heptane. Hexamethylenetetramine. Hexane. Hexanetriols. Hexylene glycol. Hydroabietyl alcohol. Hydrocarbon resins (produced by polymerization of mixtures of mono and di-unsaturated hydrocarbons of the aliphatic, alicyclic, and monobenzenoid type derived both from cracked petroleum and ter pene stocks) (CAS Reg. No. 68239–99–6). Hydrocarbon resins (produced by the polymerization of styrene and alpha-methyl styrene), hydrogenated (CAS Reg. No. 68441–37–2). Hydrofluoric acid ......................................................................................... For use only as bonding agent for aluminum foil, sta bilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Hydrogen peroxide. Hydrogenated dipentene resin (CAS Reg. No. 106168–39–2). Hydrogenated dipentene-styrene copolymer resin (CAS Reg. No. 106168–36–9). Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin (CAS Reg. No. 106168–37–0). a-Hydro-omega-hydroxypoly-(oxytetramethylene) ...................................... For use only in the preparation of polyurethane res ins. Hydroquinone. Hydroquinone monobenzyl ether. Hydroquinone monoethyl ether. 2(2′-Hydroxy-3′,5′ di-tert-amylphenyl) benzotriazole. Hydroxyacetic acid. 7-Hydroxycoumarin. Hydroxyethylcellulose. 2–Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone(CAS Reg. No. 106797–53–9). For use only as a photoinitiator at a level not to ex ceed 5 percent by weight of the adhesive. 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2 alkyl (C6-C17) imidazolinium chlo ride. Hydroxyethyldiethylenetriamine. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00174 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 165 Food and Drug Administration, HHS § 175.105 Substances Limitations b-Hydroxyethyl pyridinium 2-mercaptobenzothiazol. Hydroxyethyl starch. Hydroxyethylurea ........................................................................................ Hydroxylamine sulfate. 5-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 mixture. For use only as an antibacterial preservative. Hydroxypropyl methylcellulose. 2-(Hydroxymethyl)-2-methyl-1,3-propanediol tribenzoate. 2-Imidazolidinone. 3–Iodo–2–propynyl-N-butyl carbamate (CAS Reg. No. 55406–53–6) ....... For use only as an antifungal preservative. Iodoform ...................................................................................................... For use only as polymerization-control agent. Isoascorbic acid. Isobutyl alcohol (isobutanol). Isobutylene-isoprene copolymer. Isodecyl benzoate (CAS Reg. No. 131298–44–7). Isophorone. Isopropanolamine (mono-, di-, tri-). Isopropyl acetate. Isopropyl alcohol (isopropanol). Isopropyl-m- and p-cresol (thymol derived). 4,4′-Isopropylidenediphenol. 4,4′-Isopropylidenediphenol, polybutylated mixture .................................... For use as preservative only. Isopropyl peroxydicarbonate. p-Isopropoxy diphenylamine. 4,4′-Isopropylidene-bis(p-phenyleneoxy)-di-2-propanol. Itaconic acid. Japan wax. Kerosene. Lauroyl peroxide. Lauroyl sulfate salts: Ammonium. Magnesium. Potassium. Sodium. Lauryl alcohol. Lauryl pyridinium 5-chloro-2-mercaptobenzothiazole. Lignin calcium sulfonate. Lignin sodium sulfonate. Linoleamide (linoleic acid amide). Magnesium fluoride ..................................................................................... For use only as bonding agent for aluminum foil, sta bilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesives. Magnesium glycerophosphate. Maleic acid. Maleic anhydride-diisobutylene copolymer, ammonium or sodium salt. Manganese acetate. Marine oil fatty acid soaps, hydrogenated. Melamine. Melamine-formaldehyde copolymer. 2-Mercaptobenzothiazole. 2-Mercaptobenzothiazole and dimethyl dithiocarbamic acid mixture, so dium salt. For use as preservative only. 2-Mercaptobenzothiazole, sodium or zinc salt ........................................... For use as preservative only. Methacrylate-chromic chloride complex, ethyl or methyl ester. p-Menthane hydroperoxide. Methyl acetate. Methyl acetyl ricinoleate. Methyl alcohol (methanol). Methylcellulose. Methylene chloride. 4,4′-Methylenebis(2,6-di-tert-butylphenol). 2,2-Methylenebis (4-ethyl-6-tert-butylphenol). 2,2-Methylenebis (4-methyl-6-nonylphenol). 2,2-Methylenebis (4-methyl-6-tert-butylphenol). Methyl ethyl ketone. Methyl ethyl ketone-formaldehyde condensate. 2-Methylhexane. 1-Methyl-2-hydroxy-4-isopropyl benzene. Methyl isobutyl ketone. Methyl oleate. Methyl oleate-palmitate mixture. Methyl phthalyl ethyl glycolate. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00175 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 166 21 CFR Ch. I (4–1–16 Edition) § 175.105 Substances Limitations Methyl ricinoleate. Methyl salicylate. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a methylstyrene to 3 vinyltoluene). Methyl tallowate. Mineral oil. Monochloracetic acid. Monooctyldiphenylamine. Montan wax. Morpholine. Myristic acid-chromic chloride complex. Myristyl alcohol. Naphtha. Naphthalene, monosulfonated. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt. a-Naphthylamine. a,a′,a″,a″′-Neopentane tetrayltetrakis [omega-hydroxypoly (oxypropylene) (1–2 moles)], average molecular weight 400. Nitric acid. μ-Nitrobiphenyl. Nitrocellulose. 2-Nitropropane. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydro gen phosphate and monohydrogen phosphate esters; the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content aver ages 6–9 moles or 50 moles. a(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of p-nonylphenol (nonyl group is a propylene trimer isomer) with an average of 1–40 moles of ethylene oxide. a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium salt: the nonyl group is a propylene trimer isomer and the poly (oxy ethylene) content averages 9 or 30 moles. endo-cis-5-Norbornene-2,3-dicarboxylic anhydride. a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the octadecenyl group is derived from oleyl alcohol and the poly (oxyethylene) content averages 20 moles. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate. Octyl alcohol. Octyldecyl phthalate. Octylphenol. Octylphenoxyethanols. Octylphenoxypolyethoxy-polypropoxyethanol (13 moles of ethylene oxide and propylene oxide). Odorless light petroleum hydrocarbons. Oleamide (oleic acid amide). Oleic acid, sulfated. 2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate] (CAS Reg. No. 70331–94–1). Oxazoline. a-(oxiranylmethyl)-w-(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-benzothiazole. Palmitamide (palmitic acid amide). Paraffin (C12-C20) sulfonate. Paraformaldehyde. Pentachlorophenol. Pentaerythritol ester of maleic anhydride. Pentaerythritol monostearate ...................................................................... For use as preservative only. Pentaerythritol tetrabenzoate [CAS Registry No. 4196–86–5]. Pentaerythritol tetrastearate. 2,4-Pentanedione. Pentasodium diethylenetriaminepentaacetate (CAS Reg. No. 140–01–2). Perchloroethylene. Petrolatum. Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated. Petroleum hydrocarbon resin (produced by the catalytic polymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked petroleum stocks). VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00176 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 167 Food and Drug Administration, HHS § 175.105 Substances Limitations Petroleum hydrocarbon resins (produced by the homo-and copolymeriza tion of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid arylalkene types from distillates of cracked petroleum stocks). Phenol ......................................................................................................... For use as preservative only. Phenol-coumarone-indene resin. Phenolic resins as described in § 175.300(b)(3)(vi). Phenothiazine .............................................................................................. For use only as polymerization-control agent. Phenyl-b-naphthylamine (free of b-naphthylamine). o-Phenylphenol ........................................................................................... For use as preservative only. o-Phthalic acid. Pimaric acid ................................................................................................. Pine oil. Piperazine. Piperidinium pentamethylenedithiocarbamate. Poly(acrylamide-[2-acrylamide-2-methylpropylsulfonate]-dimethylidiallyl ammonium chloride) sodium salt (CAS Reg. No. 72275-68-4). Polyamides derived from reaction of one or more of the following acids with one or more of the following amines: Acids: Azelaic acid. Dimerized vegetable oil acids. Amines: Bis(hexamethylene) triamine and higher homologues. Diethylenetriamine. Diphenylamine. Ethylenediamine. Hexamethylenediamine. Poly(oxypropylene)diamine (weight average molecular weight 2010) (CAS Reg. No. 9046–10–0). Poly(oxypropylene)diamine (weight average molecular weight 440) (CAS Reg. No. 9046–10–0). Tetraethylenepentamine. Triethylenetetramine. Polybutene, hydrogenated. Polybutylene glycol (molecular weight 1,000). Poly [2(diethylamino) ethyl methacrylate] phosphate. Polyester of adipic acid, phthalic acid, and propylene glycol, terminated with butyl alcohol. Polyester of diglycolic acid and propylene glycol containing ethylene gly col monobutyl ether as a chain stopper. Polyester resins (including alkyd type), as the basic polymer, formed as esters when one or more of the following acids are made to react with one or more of the following alcohols: Acids: Azelaic acid. Dimethyl 1,4-cyclohexanedicarboxylate (CAS Reg. No. 94–60–0). Dimethyl-5-sulfoisophthalic acid (CAS Reg. No. 50975–82–1) and/or its sodium salt (CAS Reg. No. 3965–55–7). Polybasic and monobasic acids identified in § 175.300(b)(3)(vii)(a) and (b). 5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt (CAS Reg. No. 6362–79–4). Tetrahydrophthalic acid. Alcohols: 1,4-Cyclohexanedimethanol. 2,2-Dimethyl-1,3-propanediol. 1,6-Hexanediol (CAS Reg. No. 629–11–8). Polyhydric and monohydric alcohols identified in § 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 1. For 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, oxidized. Polyethylene resins, carboxyl modified, identified in § 177.1600 of this chapter. Polyethylenimine. Polyethylenimine-epichlorohydrin resins. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00177 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 168 21 CFR Ch. I (4–1–16 Edition) § 175.105 Substances Limitations Poly(ethyloxazoline) (CAS Reg. No. 25805-17-8). Polyisoprene. Polymeric esters of polyhydric alcohols and polycarboxylic acids pre pared from glycerin and phthalic anhydride and modified with benzoic acid, castor oil, coconut oil, linseed oil, rosin, soybean oil, styrene, and vinyl toluene. Polymers: Homopolymers and copolymers of the following monomers:. Acrylamide. Acrylic acid. Acrylonitrile. Allylmethacrylate (CAS Reg. No. 00096–05–09). Butadiene. Butene. N-tert-Butylacrylamide. Butyl acrylate. 1,3-Butylene glycol dimethacrylate. Butyl methacrylate. Crotonic acid. Decyl acrylate. Diallyl fumarate. Diallyl maleate. Diallyl phthalate. Dibutyl fumarate. Dibutyl itaconate. Dibutyl maleate. Di(2-ethylhexyl) maleate. Dimethyl-a-methylstyrene. Dioctyl fumarate. Dioctyl maleate. Divinylbenzene. Ethyl acrylate. Ethylene. Ethylene cyanohydrin. 2-Ethylhexyl acrylate. Ethyl methacrylate. Fatty acids, C10-13-branched, vinyl esters (CAS Reg. No. 184785– 38–4). Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl hexyl, heptyl and octyl esters. Glycidyl methacrylate. 1–Hexene (CAS Reg. No. 592–41–6). 2-Hydroxyethyl acrylate. 2-Hydroxyethyl methacrylate. 2-Hydroxypropyl methacrylate. Isobutyl acrylate. Isobutylene. Itaconic acid. Maleic acid, diester with 2-hydroxyethanesulfonic acid, sodium salt. Maleic anhydride. Methacrylic acid. Methyl acrylate. N,N′-Methylenebisacrylamide. Methyl methacrylate. N-Methylolacrylamide. Methyl styrene. Methyl styrene. Monoethyl maleate. Monomethyl maleate. Mono (2-ethylhexyl) maleate. 5-Norbornene-2 3-dicarboxylic acid, mono-n-butyl ester. 1-Octene (CAS Reg. No. 111–66–0). Propyl acrylate. Propylene. Styrene. Triallyl cyanurate. Vinyl acetate. Vinyl alcohol (from alcoholysis or hydrolysis of vinyl acetate units). Vinyl butyrate. Vinyl chloride. Vinyl crotonate. Vinyl ethyl ether. Vinyl hexoate. Vinylidene chloride. Vinyl methyl ether. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00178 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 169 Food and Drug Administration, HHS § 175.105 Substances Limitations Vinyl pelargonate. Vinyl propionate. Vinyl pyrrolidone. Vinyl stearate. Polyoxyalkylated-phenolic resin (phenolic resin obtained from formalde hyde plus butyl- and/or amylphenols, oxyalkylated with ethylene oxide and/or propylene oxide). Poly(oxycaproyl) diols and triols (minimum molecular weight 500). Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt. Polyoxyethylene (20 mol)—anhydrous lanolin adduct. Polyoxyethylene (molecular weight 200) dibenzoate. Polyoxyethylene (molecular weight 200–600) esters of fatty acids derived from animal or vegetable fats and oils (including tall oil). Polyoxyethylene (15 moles) ester of rosin. Polyoxyethylene (4–5 moles) ether of phenol. Polyoxyethylene (25 moles)—glycerol adduct. Polyoxyethylene (40 moles) stearate. Polyoxyethylene (5–15 moles) tridecyl alcohol. Polyoxypropylene (3 moles) tridecyl alcohol sulfate. Polyoxypropylene (20 moles) butyl ether. Polyoxypropylene (40 moles) butyl ether. Polyoxypropylene (20 moles) oleate butyl ether. Polyoxypropylene-polyoxyethylene condensate (minimum molecular weight 1,900). Polypropylene glycol (minimum molecular weight 150). Polypropylene glycol (3–4 moles) triether with 2-ethyl-2-(hydroxymethyl) 1,3-propane-diol, average molecular weight 730. Polypropylene glycol dibenzoate (CAS Reg. No. 72245–46–6) ................. For use as a plasticizer at levels not to exceed 20 percent by weight of the finished adhesive. Polypropylene, noncrystalline. Polysiloxanes: Diethyl polysiloxane. Dihydrogen polysiloxane. Dimethyl polysiloxane. Diphenyl polysiloxane. Ethyl hydrogen polysiloxane. Ethyl phenyl polysiloxane. Methyl ethyl polysiloxane. Methyl hydrogen polysiloxane. Methyl phenyl polysiloxane. Phenyl hydrogen polysiloxane. Polysorbate 60. Polysorbate 80. Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate). Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate). Poly[styrene-co-disodium maleate-co-a-(p-nonyl-phenyl)-omega-(p-vinyl benzyl)poly(oxyethylene)] terpolymer. Polytetrafluoroethylene.. Polyurethane resins produced by: (1) reacting diisocyanates with one or more of the polyols or polyesters named in this paragraph, or (2) re acting 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 poly propylene 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 per cent of comonomer units derived from 1-alkenes having 12 to 20 car bon atoms. Polyvinyl butyral. Polyvinyl formal. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00179 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 170 21 CFR Ch. I (4–1–16 Edition) § 175.105 Substances Limitations Potassium ferricyanide ................................................................................ For use only as polymerization-control agent. Potassium N-methyldithiocarbamate. Potassium pentachlorophenate ................................................................... For use as preservative only. Potassium permanganate. Potassium persulfate. Potassium phosphates (mono-, di-, tribasic). Potassium tripolyphosphate. a, a′, a″-1,2,3-Propanetriyltris [omega-(2,3-epoxypropoxy) poly (oxypropylene) (24 moles)]. b-Propiolactone. Propyl alcohol (propanol). Propylene carbonate. Propylene glycol and p-p′-isopropylidenediphenol diether. Propylene 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 acids. Propylene glycol monolaurate. Propylene glycol monomethyl ether. Propylene glycol monostearate. a, a′, a″-[Propylidynetris (methylene)] tris [omega-hydroxypoly (oxypropylene) (1.5 moles minimum)], minimum molecular weight 400. Quaternary 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) phenolformaldehyde. Ammonia. Ammonium caseinate-p-Cyclohexylphenolformaldehyde. Diethylene glycol. Dipentaerythritol. Ethylene glycol. Formaldehyde. Fumaric acid. Glycerin. Hydrogen. Isophthalic acid. 4,4′-Isopropylidenediphenol-epichlorohydrin (epoxy). 4,4′-Isopropylidenediphenol-formaldehyde. Maleic anhydride. Methyl alcohol. Pentaerythritol. Phthalic anhydride. Polyethylene glycol. Phenol-formaldehyde. Phenyl μ-cresol-formaldehyde. p-Phenylphenol-formaldehyde. Sulfuric acid. Triethylene glycol. Xylenol-formaldehyde. Rosin salts (salts of wood, gum, and tall oil rosin, and the dimers there of, decarboxylated rosin disproportionated rosin, hydrogenated rosin): Aluminum. Ammonium. Calcium. Magnesium. Potassium. Sodium. Zinc. Rosin, gasoline-insoluble fraction. Rubber hydrochloride polymer. Rubber latex, natural. Salicylic acid ................................................................................................ For use as preservative only. Sandarac. Sebacic acid. Shellac. Silicon dioxide as defined in § 172.480(a) of this chapter. Sodium alkyl (C2-C13.5 aliphatic) benezenesulfonate. Sodium aluminum pyrophosphate. Sodium aluminum sulfate. Sodium bisulfate. Sodium calcium silicate. Sodium capryl polyphosphate. Sodium carboxymethylcellulose. Sodium chlorate. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00180 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 171 Food and Drug Administration, HHS § 175.105 Substances Limitations Sodium chlorite. Sodium chromate. Sodium decylsulfate. Sodium dehydroacetate .............................................................................. For use as preservative only. Sodium di-(2-ethylhexoate). Sodium di-(2-ethylhexyl) pyrophosphate. Sodium dihexylsulfosuccinate. Sodium dissobutylphenoxydiethoxyethyl sulfonate. Sodium diisobutylphenoxymonoethoxyethyl sulfonate. Sodium diisopropyl- and triisopropylnaphthalenesulfonate. Sodium dimethyldithiocarbamate. Sodium dioctylsulfosuccinate. Sodium n-dodecylpolyethoxy (50 moles) sulfate. Sodium ethylene ether of nonylphenol sulfate. Sodium 2-ethylhexyl sulfate. Sodium fluoride ........................................................................................... For use only as bonding agent for aluminum foil, sta bilizer, or preservative. Total fluoride for all sources not to exceed 1 percent by weight of the finished adhesive. Sodium formaldehyde sulfoxylate. Sodium formate. Sodium heptadecylsulfate. Sodium hypochlorite. Sodium isododecylphenoxypolyethoxy (40 moles) sulfate. Sodium N-lauroyl sarcosinate. Sodium metaborate. Sodium a-naphthalene sulfonate. Sodium nitrate. Sodium nitrite. Sodium oleoyl isopropanolamide sulfosuccinate. Sodium pentachlorophenate ....................................................................... For use as preservative only. Sodium perborate. Sodium persulfate. Sodium μ-phenylphenate ............................................................................ For use as preservative only. Sodium polyacrylate. Sodium polymethacrylate. Sodium polystyrene sulfonate. Sodium salicylate ........................................................................................ For use as preservative only. Sodium salt of 1-hydroxy 2(1H)-pyridine thione ......................................... Do. Sodium tetradecylsulfate. Sodium thiocyanate. Sodium bis-tridecylsulfosuccinate. Sodium xylene sulfonate. Sorbitan monooleate. Sorbitan monostearate. Soybean oil, epoxidized. Spermaceti wax. Sperm oil wax. Stannous 2-ethylhexanoate ........................................................................ For use only as a catalyst for polyurethane resins. Stannous stearate. Starch hydrolysates. Starch or starch modified by one or more of the treatments described in §§ 172.892 and 178.3520 of this chapter. Starch, reacted with a urea-formaldehyde resin. Starch, reacted with formaldehyde. Stearamide (stearic acid amide). Stearic acid. Stearic acid-chromic chloride complex. Stearyl-cetyl alcohol, technical grade, approximately 65 percent–80 per cent stearyl and 20 percent–35 percent cetyl. Strontium salicylate. Styrenated phenol. Styrene block polymers with 1,3-butadiene. Styrene-maleic anhydride copolymer, ammonium or potassium salt. Styrene-maleic anhydride copolymer (partially methylated) sodium salt. Styrene-methacrylic acid copolymer, potassium salt. Sucrose acetate isobutyrate. Sucrose benzoate. Sucrose octaacetate. 2–sulfoethyl methacrylate (CAS Registry No. 10595–80–9) ...................... For use at levels not to exceed 2 percent by weight of the dry adhesive. a-Sulfo-omega-(dodecyloxy)poly (oxyethylene), ammonium salt. Sulfonated octadecylene (sodium form). VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00181 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 172 21 CFR Ch. I (4–1–16 Edition) § 175.105 Substances Limitations Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether diso dium 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, di sodium salt (alcohol moiety produced by condensation of 1 mole of nonylphenol and an average of 9–10 moles of ethylene oxide) (CAS Reg. No. 9040–38–4). Sulfur. Synthetic primary linear aliphatic alcohols whose weight average molec ular weight is greater than 400 (CAS Reg. No. 71750–71–5). Synthetic wax polymer as described in § 176.170(a)(5) of this chapter. Tall oil. Tall oil fatty acids, linoleic and oleic. Tall oil fatty acid methyl ester. Tall oil, methyl ester. Tall oil pitch. Tall oil soaps. Tallow alcohol (hydrogenated). Tallow amine, secondary (hexadecyl, octadecyl), of hard tallow. Tallow, blown (oxidized). Tallow, propylene glycol ester. Terpene resins (a-and b-pinene) homopolymers, copolymers, and con densates with phenol, formaldehyde, coumarone, and/or indene. Terphenyl. Terphenyl, hydrogenated. Terpineol. Tetraethylene pentamine. Tetraethylthiuram disulfide. Tetrahydrofuran. Tetrahydrofurfuryl alcohol. Tetra-isopropyl titanate. Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxy-hydro-cinnamate)] meth ane. A[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly-(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average of 1–40 moles of ethylene oxide. A-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxy-poly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and their sodium, potassium, and ammonium salts having a poly(oxyethylene) content averaging 6–9 or 40 moles. Tetramethyl decanediol. Tetramethyl decynediol. Tetramethyl decynediol plus 1–30 moles of ethylene oxide. Tetramethylthiuram monosulfide. Tetrasodium N-(1,2-dicarboxyethyl)N-octadecylsulfosuccinamate. 4,4′-Thiobis-6-tert-butyl-m-cresol. Thiodiethylene-bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate). 2,2′-(2,5-Thiophenediyl) bis[5-tert-butylbenzoxazole]. Thiram. Thymol ......................................................................................................... For use as preservative only. Titanium dioxide. Titanium dioxide-barium sulfate. Titanium dioxide-calcium sulfate. Titanium dioxide-magnesium silicate. Toluene. Toluene 2,4-diisocyanate. Toluene 2,6-diisocyanate. o- and p-Toluene ethyl sulfonamide. o- and p-Toluene sulfonamide. p-Toluene sulfonic acid. p-(p′-Toluene-sulfonylamide)-diphenylamide. Triazine-formaldehyde resins as described in § 175.300(b)(3)(xiii). Tributoxyethyl phosphate. Tributylcitrate. Tri-tert-butyl-p-phenyl phenol ...................................................................... For use as preservative only. Tributyl phosphate. Tributyltin chloride complex of ethylene oxide condensate of dehydroabietylamine. For use as preservative only. Tri-n-butyltin acetate ................................................................................... For use as preservative only. Tri-n-butyltin neodecanoate ........................................................................ Do. 1,1,1-Trichloroethane. 1,1,2-Trichloroethane. Trichloroethylene. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00182 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 173 Food and Drug Administration, HHS § 175.125 Substances Limitations Tri-b-chloroethylphosphate. Tridecyl alcohol. Triethanolamine. 3-(Triethoxysilyl) propylamine. Triethylene glycol. Triethylene glycol dibenzoate. Triethylene glycol di(2-ethylhexoate). Triethylene glycol polyester of benzoic acid and phthalic acid. Triethylhexyl phosphate. Triethylphosphate. 2,4,5-Trihydroxy butyrophenone. Triisopropanolamine. Trimethylol propane. 2,2,4-Trimethylpentanediol-1,3-diisobutyrate. Trimeric aromatic amine resin from diphenylamine and acetone of mo lecular weight approximately 500. Tri(nonylphenyl) phosphite-formaldehyde resins ........................................ As identified in § 177.2600(c)(4)(iii) of this chapter. For use only as a stabilizer. Triphenylphosphate. Tripropylene glycol monomethyl ether. 1,3,5-Tris (3,5-di-tert-butyl-4-hydroxy-benzyl)-triazine-2,4,6 (1H,3H,5H) trione. Tris (p-tertiary butyl phenyl) phosphate. Tris(2-methyl-4-hydroxy-5-tert-butyl-phenyl)butane. Trisodium N-hydroxyethylethylenediaminetriacetate (CAS Reg. No. 139– 89–9). Turpentine. Urea-formaldehyde resins as described in § 175.300(b)(3)(xii). Vegetable oil, sulfonated or sulfated, potassium salt. Vinyl acetate-maleic anhydride copolymer, sodium salt. Waxes, petroleum. Wax, petroleum, chlorinated (40% to 70% chlorine). Waxes, synthetic paraffin (Fischer-Tropsch process). 3-(2-Xenolyl)-1,2-epoxypropane. Xylene. Xylene (or toluene) alkylated with dicyclopentadiene. Zein. Zinc acetate. Zinc ammonium chloride. Zinc dibenzyl dithiocarbamate. Zinc dibutyldithiocarbamate. Zinc diethyldithiocarbamate. Zinc di(2-ethylhexoate). Zinc formaldehyde sulfoxylate. Zinc naphthenate and dehydroabietylamine mixture. Zinc nitrate. Zinc orthophosphate. Zinc resinate. Zinc sulfide. Zineb (zinc ethylenebis-dithiocarbamate). Ziram (zinc dimethyldithiocarbamate). [42 FR 14534, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977] EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 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. § 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 pre scribed conditions: (a) Pressure-sensitive adhesives pre pared from one or a mixture of two or more of the substances listed in this paragraph may be used as the food-con tact surface of labels and/or tapes ap plied to poultry, dry food, and proc essed, frozen, dried, or partially dehy drated fruits or vegetables. (1) Substances generally recognized as safe in food. (2) Substances used in accordance with a prior sanction or approval. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00183 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 174 21 CFR Ch. I (4–1–16 Edition) § 175.210 (3) Color additives listed for use in or on food in parts 73 and 74 of this chap ter. (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 pres sure-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 adhe sive. (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 adhe sive. (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 ac tive agent at a level not to exceed 3.0 percent by weight of the finished pres sure-sensitive adhesive. (b) Pressure-sensitive adhesives pre pared from one or a mixture of two or more of the substances listed in this paragraph may be used as the food-con tact surface of labels and/or tapes ap plied 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 para graph (a)(4) of this section that are not identified in paragraph (b)(2) of this section. (2) Substances identified in this sub paragraph and subject to the limita tions provided: BHA. BHT. Butadiene-acrylonitrile copolymer. Butadiene-acrylonitrile-styrene copolymer. Butadiene-styrene copolymer. Butyl rubber. Butylated reaction product of p-cresol and dicyclopentadiene produced by reacting p cresol and dicyclopentadiene in an approxi mate mole ratio of 1.5 to 1.0, respectively, followed by alkylation with isobutylene so that the butyl content of the final product is not less than 18 percent, for use at levels not to exceed 1.0 percent by weight of the adhesive formulation. Chlorinated natural rubber. Isobutylene-styrene copolymer. Petrolatum. Polybutene-1. Polybutene, hydrogenated; complying with the identity prescribed under § 178.3740(b) of this chapter. Polyisobutylene. cis-1,4-Polyisoprene. Polystyrene. Propyl gallate. Rapeseed oil, vulcanized. Rosins and rosin derivatives as provided in § 178.3870 of this chapter. Rubber hydrochloride. Rubber (natural latex solids or crepe, smoked or unsmoked). Terpene resins (a- and b-pinene), homopolymers, copolymers, and conden sates with phenol, formaldehyde, cou marone, and/or indene. Tetrasodium ethylenediaminetetraacetate. Tri(mixed mono- and dinonylphenyl) phosphite (which may contain not more than 1 percent by weight of triisopropanolamine). (c) Acrylonitrile copolymers identi fied in this section shall comply with the provisions of § 180.22 of this chap ter. [42 FR 14534, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12, 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999] Subpart C—Substances for Use as Components of Coatings § 175.210 Acrylate ester copolymer coating. Acrylate ester copolymer coating may safely be used as a food-contact surface of articles intended for pack aging and holding food, including heat ing of prepared food, subject to the pro visions 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00184 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 175 Food and Drug Administration, HHS § 175.250 emulsion may include substances named in this paragraph, in an amount not to exceed that required to accom plish 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 speci fications in such regulation. List of substances Limitations Aluminum stearate. Ammonium lauryl sulfate. Borax ............................................ Not to exceed the amount required as a preservative in emul sion defoamer. Disodium hydrogen phosphate ..... Do. Formaldehyde. Glyceryl monostearate. Methyl cellulose. Mineral oil. Paraffin wax. Potassium hydroxide. Potassium persulfate. Tallow. Tetrasodium pyrophosphate. Titanium dioxide. (c) The coating in the form in which it contacts food meets the following tests: (1) An appropriate sample when ex posed 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 ex posed to n-heptane at 120 °F for 30 min utes shall yield total chloroform-solu ble extractables not to exceed 0.5 milli gram per square inch. § 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 sub stances: (1) Substances generally recognized as safe in food. (2) Substances identified in this sub paragraph. List of substances Limitations Acetylated monoglycerides ........... Complying with 172.828 of this chapter. Cellulose acetate butyrate. List of substances Limitations Cellulose acetate propionate. Mineral oil, white ........................... For use only as a com ponent of hot-melt strippable food coat ings applied to frozen meats and complying with § 172.878 of this chapter. § 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, treat ing, packaging, transporting, or hold ing food in accordance with the fol lowing prescribed conditions: (a) The additive is synthesized by the Fischer-Tropsch process from carbon monoxide and hydrogen, which are cat alytically converted to a mixture of paraffin hydrocarbons. Lower molec ular-weight fractions are removed by distillation. The residue is hydro genated and may be further treated by percolation through activated char coal. This mixture can be fractionated into its components by a solvent sepa ration method, using synthetic isoparaffinic petroleum hydrocarbons complying with § 178.3530 of this chap ter. (b) Synthetic paraffin shall conform to the following specifications: (1) Congealing point. There is no speci fication for the congealing point of synthetic paraffin components, except those components that have a con gealing 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 Petro latum,’’ which is incorporated by ref erence. Copies may be obtained from the American Society for Testing Ma terials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00185 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 176 21 CFR Ch. I (4–1–16 Edition) § 175.260 2959, or may be examined at the Na tional Archives and Records Adminis tration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.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 Con tent of Petroleum Waxes’’ (Revised 1956), which is incorporated by ref erence. See paragraph (b)(1) of this sec tion for availability of the incorpora tion by reference. (3) Absorptivity. The substance has an absorptivity at 290 millimicrons in decahydronaphthalene at 88 °C not ex ceeding 0.01 as determined by ASTM method E131–81a, ‘‘Standard Defini tions of Terms and Symbols Relating to Molecular-Spectroscopy,’’ which is incorporated by reference. See para graph (b)(1) of this section for avail ability of the incorporation by ref erence. (c) The provisions of this section are not applicable to synthetic paraffin used in food-packaging adhesives com plying with § 175.105. [42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19, 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, Aug. 3, 1995] § 175.260 Partial phosphoric acid esters of polyester resins. Partial phosphoric acid esters of pol yester resins identified in this section and applied on aluminum may be safely used as food-contact coatings, in ac cordance with the following prescribed conditions: (a) For the purpose of this section, partial phosphoric acid esters of poly ester resins are prepared by the reac tion 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 sol vents characterizing the type of food and under the conditions of time and temperature characterizing the condi tions 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 de scribed 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. § 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 pro visions of this section. (a) For the purpose of this section, poly(vinyl fluoride) resins consist of basic resins produced by the polym erization of vinyl fluoride. (b) The poly(vinyl fluoride) basic res ins have an intrinsic viscosity of not less than 0.75 deciliter per gram as de termined by ASTM method D1243–79, ‘‘Standard Test Method for Dilute So lution Viscosity of Vinyl Chloride Polymers,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Ma terials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428 2959, or may be examined at the Na tional Archives and Records Adminis tration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (1) Solvent. N,N-Dimethylacetamide, technical grade. (2) Solution. Powdered resin and sol vent are heated at 120 °C until the resin is dissolved. (3) Temperature. Flow times of the solvent and solution are determined at 110 °C. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00186 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 177 Food and Drug Administration, HHS § 175.300 (4) Viscometer. Cannon-Ubbelohde size 50 semimicro dilution viscometer (or equivalent). (5) Calculation. The calculation meth od used is that described in appendix X 1.3 (ASTM method D1243–79, ‘‘Standard Test Method for Dilute Solution Vis cosity of Vinyl Chloride Polymers,’’ which is incorporated by reference; see paragraph (b) of this section for avail ability of the incorporation by ref erence) with the reduced viscosity de termined 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 re duced viscosity: Reduced viscosity in terms of deciliters per gram = − × t to to c where: t = Solution efflux time. to = Solvent efflux time. c = Concentration of solution in terms of grams per deciliter. [42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19, 1984] § 175.300 Resinous and polymeric coat ings. 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, pack aging, transporting, or holding food, in accordance with the following pre scribed conditions: (a) The coating is applied as a contin uous film or enamel over a metal sub strate, or the coating is intended for repeated food-contact use and is ap plied 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 fol lowing descriptions: (1) Coatings cured by oxidation. (2) Coatings cured by polymerization, condensation, and/or cross-linking without oxidation. (3) Coatings prepared from prepoly merized substances. (b) The coatings are formulated from optional substances that may include: (1) Substances generally recognized as safe in food. (2) Substances the use of which is permitted by regulations in this part or which are permitted by prior sanc tion 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 regula tion in subchapter B of this chapter and conforms with any specification in such regulation. Substances named in this paragraph (b)(3) and further identi fied as required: (i) Drying oils, including the triglycerides or fatty acids derived therefrom: Beechnut. Candlenut. Castor (including dehydrated). Chinawood (tung). Coconut. Corn. Cottonseed. Fish (refined). Hempseed. Linseed. Oiticica. Perilla. Poppyseed. Pumpkinseed. Safflower. Sesame. Soybean. Sunflower. Tall oil. Walnut. The oils may be raw, heat-bodied, or blown. They may be refined by filtra tion, degumming, acid or alkali wash ing, bleaching, distillation, partial de hydration, partial polymerization, or solvent extraction, or modified by com bination with maleic anhydride. (ii) Reconstituted oils from triglycerides or fatty acids derived from the oils listed in paragraph (b)(3)(i) of this section to form esters with: Butylene glycol. Ethylene glycol. Pentaerythritol. Polyethylene glycol. Polypropylene glycol. Propylene glycol. Sorbitol. Trimethylol ethane. Trimethylol propane. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00187 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072 ER 0 1 JA 9 3 .3 8 7 < /G P H > js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 178 21 CFR Ch. I (4–1–16 Edition) § 175.300 (iii) Synthetic drying oils, as the basic polymer: Butadiene and methylstyrene copolymer. Butadiene and styrene copolymer, blown or unblown. Maleic anhydride adduct of butadiene sty rene. Polybutadiene. (iv) Natural fossil resins, as the basic resin: Copal. Damar. Elemi. Gilsonite. Glycerol ester of damar, copal, elemi, and sandarac. Sandarac. Shellac. Utah coal resin. (v) Rosins and rosin derivatives, with or without modification by polymeriza tion, isomerization, incidental decarboxylation, and/or hydrogenation, as follows: (a) Rosins, refined to color grade of K or paler: Gum rosin. Tall oil rosin. Wood rosin. (b) Rosin esters formed by reacting rosin (paragraph (b)(3)(v)(a) of this sec tion) with: 4,4′-sec-Butylidenediphenol-epichlorohydrin (epoxy). Diethylene glycol. Ethylene glycol. Glycerol. 4,4′-Isopropylidenediphenol-epichlorohydrin (epoxy). Methyl alcohol. Pentaerythritol. (c) Rosin esters (paragraph (b)(3)(v)(b) of this section) modified by reaction with: Maleic anhydride. o-, m-, and p-substituted phenol-formalde hydes listed in paragraph (b)(3)(vi) of this section. Phenol-formaldehyde. (d) Rosin salts: Calcium resinate (limed rosin). Zinc resinate. (vi) Phenolic resins as the basic poly mer formed by reaction of phenols with formaldehyde: (a) Phenolic resins formed by reac tion of formaldehyde with: Alkylated (methyl, ethyl, propyl, isopropyl, butyl) phenols. p-tert-Amylphenol. 4,4′-sec-Butylidenediphenol. p-tert-Butylphenol. o-, m-, and p-Cresol. p-Cyclohexylphenol. 4,4′-Isopropylidenediphenol. p-Nonylphenol. p-Octylphenol. 3-Pentadecyl phenol mixture obtained from cashew nut shell liquid. Phenol. Phenyl o-cresol. p-Phenylphenol. Xylenol. (b) Adjunct for phenolic resins: Alu minum butylate. (vii) Polyester resins (including alkyd-type), as the basic polymers, formed as esters of acids listed in para graph (b)(3)(vii) (a) and (b) of this sec tion by reaction with alcohols in para graph (b)(3)(vii) (c) and (d) of this sec tion. (a) Polybasic acids: Adipic. 1,4-cyclohexanedicarboxylic (CAS Reg. No. 1076–97–7). Dimerized fatty acids derived from oils listed in paragraph (b)(3)(i) of this section. Fumaric. Isophthalic. Maleic. 2,6-Naphthalenedicarboxylic. 2,6-Naphthalenedicarboxylic, dimethyl ester. Orthophthalic. Sebacic. Terephthalic. Terpene-maleic acid adduct. Trimellitic. (b) Monobasic acids: Benzoic acid. 4,4-Bis(4′-hydroxyphenyl)-pentanoic acid. tert-Butyl benzoic acid. Fatty acids derived from oils listed in para graph (b)(3)(i) of this section. Rosins listed in paragraph (b)(3)(v)(a) of this section, for use only as reactants in oil based or fatty acid-based alkyd resins. (c) Polyhydric alcohols: Butylene glycol. Diethylene glycol. 2,2-Dimethyl-1,3-propanediol for use only in forming polyester resins for coatings in tended for use in contact with non-alco holic foods. Ethylene glycol. Glycerol. Mannitol. a-Methyl glucoside. Pentaerythritol. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00188 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 179 Food and Drug Administration, HHS § 175.300 Propylene glycol. Sorbitol. Triethylene glycol, for use as a component in polyester resins for coatings not exceeding a coating weight of 4 milligrams per square inch and that are intended for contact under conditions of use D, E, F or G de scribed in table 2 of paragraph (d) of this section with alcoholic beverages con taining less than 8 percent alcohol. Trimethylol ethane. Trimethylol propane. (d) Monohydric alcohols: Cetyl alcohol. Decyl alcohol. Lauryl alcohol. Myristyl alcohol. Octyl alcohol. Stearyl alcohol. (e) Catalysts: Dibutyltin oxide (CAS Reg. No. 818–08–6), not to exceed 0.2 percent of the polyester resin. Hydroxybutyltin oxide (CAS Reg. No. 2273– 43–0), not to exceed 0.2 percent of the poly ester resin. Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850–94–4), not to exceed 0.2 percent of the polyester resin. (viii) Epoxy resins, catalysts, and ad juncts: (a) Epoxy resins, as the basic poly mer: (Alkoxy C10-C16)-2,3-epoxypropane, in which the alkyl groups are even numbered and consist of a maximum of 1 percent C10 car bon atoms and a minimum of 48 percent C12 carbon atoms and a minimum of 18 percent C14 carbon atoms, for use only in coatings that are intended for contact with dry bulk foods at room temperature. 4,4′-sec-Butylidenediphenol-epichlorohydrin. 4,4′-sec-Butylidenediphenol-epichlorohydrin reacted with one or more of the drying oils or fatty acids listed in paragraph (b)(3)(i) of this section. 4,4′-sec-Butylidenediphenol-epichlorohydrin chemically treated with one or more of the following substances: Allyl ether of mono-, di-, or trimethylol phenol. 4,4′-sec-Butylidenediphenol-formaldehyde. 4,4′-Isopropylidenediphenol-formaldehyde. Melamine-formaldehyde. Phenol-formaldehyde. Urea-formaldehyde. Epoxidized polybutadiene. Glycidyl ethers formed by reacting phenolnovolak resins with epichlorohydrin. 4,4′-Isopropylidenediphenol-epichlorohydrin. 4,4′-Isopropylidenediphenol-epichlorohydrin reacted with one or more of the drying oils or fatty acids listed in paragraph (b)(3)(i) of this section. 4,4′-Isopropylidenediphenol-epichlorohydrin chemically treated with one or more of the following substances: Allyl ether of mono-, di-, or trimethylol phenol. 4,4′-sec-Butylidenediphenol-formaldehyde. 4,4′-Isopropylidenediphenol-formaldehyde. Melamine-formaldehyde. 2,2′-[(1-methylethylidene)bis[4,1 phenyleneoxy[1-(butoxymethyl)-2,1 ethanediyl]oxymethylene]]bisoxirane, CAS Reg. No. 71033–08–4, for use only in coatings intended for contact with bulk dry foods at temperatures below 100 °F. Phenol-formaldehyde. Urea-formaldehyde. (b) Catalysts and cross-linking agents for epoxy resins: 3-(Aminomethyl)-3,5,5-trimethylcyclohexyl amine reacted with phenol and formalde hyde in a ratio of 2.6:1.0:2.0, for use only in coatings intended for repeated use in con tact with foods only of the types identified in paragraph (d) of this section, table 1, under Category I and Category VIII, at temperatures not exceeding 88 °C (190 °F). N-Beta-(aminoethyl)-gamma-aminopropyltri methoxysilane (CAS Reg. No. 1760–24–3), for use only in coatings at a level not to ex ceed 1.3 percent by weight of the resin when such coatings are intended for re peated use in contact with foods only of the types identified in paragraph (d) of this section, table 1, under Types I, II, and III, under conditions of use C, D, E, or F as de scribed in table 2 of paragraph (d) of this section; or when such coatings are in tended for repeated use in contact with foods of the types identified in paragraph (d) of this section, table 1, under Types V, VI, VII, and VIII, under conditions of use E or F as described in table 2 of paragraph (d) of this section. Use shall be limited to coatings for tanks of capacity greater than 530,000 gallons. Benzyl alcohol (CAS Reg. No. 100–51–6), for use only in coatings at a level not to ex ceed 4 percent by weight of the resin when such coatings are intended for repeated use in contact with foods only of the types identified in paragraph (d) of this section, table 1, under Types I, II, and III, under conditions of use C, D, E, or F as described in table 2 of paragraph (d) of this section; or when such coatings are intended for re peated use in contact with foods of the types identified in paragraph (d) of this section, table 1, under Types V, VI, VII, and VIII, under conditions of use E or F as described in table 2 of paragraph (d) of this section. Use shall be limited to coatings for tanks of capacity greater than 530,000 gallons. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00189 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 180 21 CFR Ch. I (4–1–16 Edition) § 175.300 Catalysts and cross-linking agents for epoxy resins: 3-Aminomethyl-3,5,5 trimethylcyclohexylamine (CAS Reg. No. 2855–0913–092). Cyanoguanidine. Dibutyl phthalate, for use only in coatings for containers having a capacity of 1,000 gallons or more when such containers are intended for repeated use in contact with alcoholic beverages containing up to 8 per cent of alcohol by volume. 3-Diethylaminopropylamine (CAS Reg. No. 104–78–9), for use in coatings at a level not to exceed 6 percent by weight of the resin when such coatings are intended for re peated use in contact with foods only of the types identified in paragraph (d) of this section, table 1, under Types I, II, and III, under conditions of use C, D, E, or F as de scribed in table 2 of paragraph (d) of this section; or when such coatings are in tended for repeated use in contact with foods of the types identified in paragraph (d) of this section, table 1, under Types V, VI, VII, and VIII, under conditions of use E or F as described in table 2 of paragraph (d) of this section. Use shall be limited to coatings for tanks of capacity greater than 530,000 gallons. Diethylenetriamine. Diphenylamine. Ethylenediamine. Isophthalyl dihydrazide for use only in coat ings subject to the provisions of paragraph (c) (3) or (4) of this section. 4,4′-Methylenedianiline, for use only in coat ings for containers having a capacity of 1,000 gallons or more when such containers are intended for repeated use in contact with alcoholic beverages containing up to 8 percent of alcohol by volume. N-Oleyl-1,3-propanediamine with not more than 10 percent by weight of diethylaminoethanol. 3-Pentadecenyl phenol mixture (obtained from cashew nutshell liquid) reacted with formaldehyde and ethylenediamine in a ratio of 1:2:2 (CAS Reg. No. 68413–28–5). Polyamine produced when 1 mole of the chlorohydrin diether of polyethylene gly col 400 is made to react under dehydrohalogenating conditions with 2 moles of N-octadecyltrimethylenediamine for use only in coatings that are subject to the provisions of paragraph (c) (3) or (4) of this section and that contact food at tem peratures not to exceed room temperature. Polyethylenepolyamine (CAS Reg. No. 68131– 73–7), for use only in coatings intended for repeated use in contact with food, at tem peratures not to exceed 180 °F (82 °C). Salicylic acid, for use only in coatings for containers having a capacity of 1,000 gal lons or more when such containers are in tended for repeated use in contact with al coholic beverages containing up to 8 per cent of alcohol by volume. Salicylic acid (CAS Reg. No. 69–72–7), for use only in coatings at a level not to exceed 0.35 percent by weight of the resin when such coatings are intended for repeated use in contact with foods only of the types identified in paragraph (d) of this section, table 1, under Types I, II, and III, under conditions of use C, D, E, or F as described in table 2 of paragraph (d) of this section; or when such coatings are intended for re peated use in contact with foods of the types identified in paragraph (d) of this section, table 1, under Types V, VI, VII, and VIII, under conditions of use E or F as described in table 2 of paragraph (d) of this section. Use shall be limited to coatings for tanks of capacity greater than 530,000 gallons. Stannous 2-ethylhexanoate for use only as a catalyst at a level not to exceed 1 percent by weight of the resin used in coatings that are intended for contact with food under conditions of use D, E, F, and G described in table 2 of paragraph (d) of this section. Styrene oxide, for use only in coatings for containers having a capacity of 1,000 gal lons or more when such containers are in tended for repeated use in contact with al coholic beverages containing up to 8 per cent of alcohol by volume. Tetraethylenepentamine. Tetraethylenepentamine reacted with equimolar quantities of fatty acids. Tri(dimethylaminomethyl) phenol and its salts prepared from the fatty acid moieties of the salts listed in paragraph (b)(3)(xxii)(b) of this section, for use only in coatings subject to the provisions of paragraph (c) (3) or (4) of this section. Triethylenetetramine. Trimellitic anhydride (CAS Reg. No. 552–30– 7) for use only as a cross-linking agent at a level not to exceed 15 percent by weight of the resin in contact with food under all conditions of use, except that resins in tended for use with foods containing more than 8 percent alcohol must contact such food only under conditions of use D, E, F, and G described in table 2 of paragraph (d) of this section. Trimellitic anhydride adducts of ethylene glycol and glycerol, prepared by the reac tion of 1 mole of trimellitic anhydride with 0.4–0.6 mole of ethylene glycol and 0.04–0.12 mole of glycerol, for use only as a cross linking agent at a level not to exceed 10 percent by weight of the cured coating, provided that the cured coating only con tacts food containing not more than 8 per cent alcohol. Meta-Xylylenediamine (1,3-benzenedi methanamine, CAS Reg. No. 1477–55–0), for use only in coatings at a level not to ex ceed 3 percent by weight of the resin when such coatings are intended for repeated use VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00190 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 181 Food and Drug Administration, HHS § 175.300 in contact with foods only of the types identified in paragraph (d) of this section, table 1, under Types I, II, and III, under conditions of use C, D, E or F as described in table 2 of paragraph (d) of this section; or when such coatings are intended for re peated use in contact with foods of the types identified in paragraph (d) of this section, table 1, under Types V, VI, VII, and VIII, under conditions of use E or F as described in table 2 of paragraph (d) of this section. Use shall be limited to coatings for tanks of capacity greater than 530,000 gallons. Para-Xylylenediamine (1,4 benzenedimethan amine, CAS Reg. No. 539–48–0), for use only in coatings at a level not to exceed 0.6 per cent by weight of the resin when such coat ings are intended for repeated use in con tact with foods only of the types identified in paragraph (d) of this section, table 1, under Types I, II, III, under conditions of use C, D, E, or F as described in table 2 of paragraph (d) of this section; or when such coatings are intended for repeated use in contact with foods of the types identified in paragraph (d) of this section, table 1, under Types V, VI, VII, and VIII, under conditions of use E and F as described in table 2 of paragraph (d) of this section. Use shall be limited to coatings for tanks of ca pacity greater than 530,000 gallons. (c) Adjuncts for epoxy resins: Aluminum butylate. Benzoic acid, for use as a component in epoxy resins for coatings not exceeding a coating weight of 4 milligrams per square inch and that are intended for contact under conditions of use D, E, F or G de scribed in table 2 of paragraph (d) of this section with alcoholic beverages con taining less than 8 percent alcohol. Polyamides from dimerized vegetable oils and the amine catalysts listed in para graph (b)(3)(viii)(b) of this section, as the basic polymer. Silane coupled silica, prepared from the re action of microcrystalline quartz with N beta-(N-vinylbenzylamino) ethyl-gamma aminopropyltrimethoxy silane, mono hydrogen chloride, for use only in coatings intended for repeated use in contact with foods only of the types identified in para graph (d) of this section, table 1, under Category I and Category VIII, at tempera tures not exceeding 88 °C (190 °F). Succinic anhydride, for use as a component in epoxy resins for coatings not exceeding a coating weight of 4 milligrams per square inch, and that are intended for contact under conditions of use D, E, F or G de scribed in table 2 of paragraph (d) of this section with alcoholic beverages con taining less than 8 percent alcohol. (ix) Coumarone-indene resin, as the basic polymer. (x) Petroleum hydrocarbon resin (cyclopentadiene type), as the basic polymer. (xi) Terpene resins, as the basic poly mer, from one or more of the following: Dipentene. Hydrogenated dipentene resin (CAS Reg. No. 106168–39–2). For use only with coatings in contact with acidic and aqueous foods. Hydrogenated-beta-pinene-alpha-pinene dipentene copolymer resin (CAS Reg. No. 106168–37–0). For use only with coatings in contact with acidic and aqueous foods. a-Pinene. b-Pinene. (xii) Urea-formaldehyde, resins and their curing catalyst: (a) Urea-formaldehyde resins, as the basic polymer: Urea-formaldehyde. Urea-formaldehyde chemically modified with methyl, ethyl, propyl, isopropyl, butyl, or isobutyl alcohol. Urea-formaldehyde chemically modified with one or more of the amine catalysts listed in paragraph (b)(3)(viii)(b) of this section. (b) Curing (cross-linking) catalyst for urea-formaldehyde resins: Dodecyl benzenesulfonic acid (C.A. Registry No. 27176–87–0). (xiii) Triazine-formaldehyde resins and their curing catalyst: (a) Triazine-formaldehyde resins, as the basic polymer: Benzoguanamine-formaldehyde. Melamine-formaldehyde. Melamine-formaldehyde chemically modified with one or more of the following amine catalysts: Amine catalysts listed in paragraph (b)(3)(viii)(b) of this section. Dimethylamine-2-methyl-1-propanol. Methylpropanolamine. Triethanolamine. Melamine-formaldehyde chemically modified with methyl, ethyl, propyl, isopropyl, butyl, or isobutyl alcohol. (b) Curing (cross-linking) catalyst for triazine-formaldehyde resins: Dodecyl benzenesulfonic acid (C.A. Registry No. 27176–87–0). (xiv) Modifiers (for oils and alkyds, including polyesters), as the basic poly mer: Butyl methacrylate. Cyclopentadiene. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00191 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 182 21 CFR Ch. I (4–1–16 Edition) § 175.300 Methyl, ethyl, butyl, or octyl esters of acryl ic acid. Methyl methacrylate. Styrene. Vinyl toluene. (xv) Vinyl resinous substance, as the basic polymers: Polyvinyl acetate. Polyvinyl alcohol. Polyvinyl butyral. Polyvinyl chloride. Polyvinyl formal. Polyvinylidene chloride. Polyvinyl pyrrolidone. Polyvinyl stearate. Vinyl chloride-acetate-2,3-epoxypropyl meth acrylate copolymers containing not more than 10 weight percent of total polymer units derived from 2,3-epoxypropyl meth acrylate and not more than 0.1 weight per cent of unreacted 2,3-epoxypropyl meth acrylate monomer for use in coatings for containers. Vinyl chloride-acetate, hydroxyl-modified copolymer. Vinyl chloride-acetate, hydroxyl-modified copolymer, reacted with trimellitic anhy dride. Vinyl chloride copolymerized with acryl amide and ethylene in such a manner that the finished copolymers have a minimum weight average molecular weight of 30,000 and contain not more than 3.5 weight per cent of total polymer units derived from acrylamide; the acrylamide portion may or may not be subsequently partially hydrolyzed. Vinyl chloride copolymerized with one or more of the following substances: Acrylonitrile. Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, or octyl esters. Maleic acid and/or its methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, or octyl esters. 5-Norbornene-2,3-dicarboxylic acid, mono-n butyl ester; for use such that the finished vinyl chloride copolymers contain not more than 4 weight percent of total poly mer units derived from this comonomer. Vinyl acetate. Vinylidene chloride. Vinyl chloride-vinylidene chloride-2,3 epoxypropyl methacrylate copolymers con taining not more than 10 weight percent of total polymer units derived from 2,3 epoxypropyl methacrylate and not more than 0.05 weight percent of unreacted 2,3 epoxypropyl methacrylate monomer based on polymer solids for use only in coatings for containers intended for contact with foods under conditions B, C, D, E, F, G, or H described in table 2 of paragraph (d) of this section. (xvi) Cellulosics, as the basic poly mer: Carboxymethylcellulose. Cellulose acetate. Cellulose acetate-butyrate. Cellulose acetate-propionate. Ethylcellulose. Ethyl hydroxyethylcellulose. Hydroxyethylcellulose. Hydroxypropyl methylcellulose. Methylcellulose. Nitrocellulose. (xvii) Styrene polymers, as the basic polymer: Polystyrene. a-Methyl styrene polymer. Styrene copolymerized with one or more of the following: Acrylonitrile. a-Methylstyrene. (xviii) Polyethylene and its copoly mers as the basic polymer: Ethylene-ethyl acrylate copolymer. Ethylene-isobutyl acrylate copolymers con taining no more than 35 weight percent of total polymer units derived from isobutyl acrylate. Ethylene-vinyl acetate copolymer. Polyethylene. (xix) Polypropylene as the basic poly mer: Polypropylene. Maleic anhydride adduct of polypropylene The polypropylene used in the manufac ture of the adduct complies with § 177.1520(c), item 1.1; and the adduct has a maximum combined maleic anhydride con tent of 0.8 percent and a minimum intrin sic viscosity of 0.9, determined at 135 °C on a 0.1 percent solution of the modified poly propylene in decahydronaphthalene as de termined by a method titled ‘‘Method for Determination of Intrinsic Viscosity of Maleic Anhydride Adduct of Poly propylene,’’ which is incorporated by ref erence. Copies are available from the Cen ter 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 Adminis tration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (xx) Acrylics and their copolymers, as the basic polymer: VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00192 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 183 Food and Drug Administration, HHS § 175.300 Acrylamide with ethylacrylate and/or sty rene and/or methacrylic acid, subsequently reacted with formaldehyde and butanol. Acrylic acid and the following esters thereof: Ethyl. Methyl. Butyl acrylate-styrene-methacrylic acid-hy droxyethyl methacrylate copolymers con taining no more than 20 weight percent of total polymer units derived from meth acrylic acid and containing no more than 7 weight percent of total polymer units de rived from hydroxyethyl methacrylate; for use only in coatings that are applied by electrodeposition to metal substrates. Butyl acrylate-styrene-methacrylic acid hydroxypropyl methacrylate copolymers containing no more than 20 weight percent of total polymer units derived from meth acrylic acid and containing no more than 7 weight percent of total polymer units de rived from hydroxypropyl methacrylate; for use only in coatings that are applied by electrodeposition to metal substrates and that are intended for contact, under condi tion 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 alco hol. Ethyl acrylate-styrene-methacrylic acid co polymers for use only as modifiers for epoxy resins listed in paragraph (b)(3)(viii)(a) of this section. Ethyl acrylate-methyl methacrylate-sty rene-methacrylic acid copolymers for use only as modifiers for epoxy resins listed in paragraph (b)(3)(viii)(a) of this section. 2-Ethylhexyl acrylate-ethyl acrylate copoly mers prepared by copolymerization of 2 ethylhexyl acrylate and ethyl acrylate in a 7/3 weight ratio and having a number aver age molecular weight range of 5,800 to 6,500 and a refractive index, nD25° (40 percent in 2,2,4-trimethyl pentane) of 1.4130–1.4190; for use as a modifier for nylon resins com plying with § 177.1500 of this chapter and for phenolic and epoxy resins listed in para graph (b)(3) (vi) and (viii) of this section, respectively, at a level not to exceed 1.5 percent of the coating. 2-Ethylhexyl acrylate-methyl methacrylate acrylic acid copolymers for use only as modifiers for epoxy resins listed in para graph (b)(3)(viii) of this section. Methacrylic acid and the following esters thereof: Butyl. Ethyl. Methyl. Methacrylic acid or its ethyl and methyl esters copolymerized with one or more of the following: Acrylic acid. Ethyl acrylate. Methyl acrylate. n-Butyl acrylate-styrene-methacrylic acid hydroxyethyl methacrylate copolymers containing no more than 2 weight percent of total polymer units derived from meth acrylic acid and containing no more than 9.5 weight percent of total polymer units derived from hydroxyethyl methacrylate; for use only in coatings in contact with dry food (food type VIII in table 1 of paragraph (d) of this section). 2-(Dimethylamino) eth anol (C.A.S. Registry No. 108–01–0) may be employed as an optional adjuvant sub stance limited to no more than 2 weight percent based on polymer solids in the coating emulsion. Styrene polymers made by the polymeriza tion 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, in dividually, 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 poly mer number average molecular weight (Mn) shall be at least 2,000 (as determined by gel permeation chromatography). The acid number of the polymer shall be less than 250. The monomer content shall be less than 0.5 percent. The polymers are for use only in contact with food of Types IV-A, V, VII in table 1 of paragraph (d) of this sec tion, under use conditions E through G in table 2 of paragraph (d), and with food of Type VIII without use temperature restric tion. (xxi) Elastomers, as the basic poly mer: Butadiene-acrylonitrile copolymer. Butadiene-acrylonitrile-styrene copolymer. Butadiene-styrene copolymer. Butyl rubber. Chlorinated rubber. 2-Chloro-1,3-butadiene (neoprene). Natural rubber (natural latex or natural latex solids, smoked or unsmoked). Polyisobutylene. Rubber hydrochloride. Styrene-isobutylene copolymer. (xxii) Driers made by reaction of a metal from paragraph (b)(3)(xxii)(a) of this section with acid, to form the salt listed in paragraph (b)(3)(xxii)(b) of this section: (a) Metals: Aluminum. Calcium. Cerium. Cobalt. Iron. Lithium. Magnesium. Manganese. Zinc. Zirconium. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00193 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 184 21 CFR Ch. I (4–1–16 Edition) § 175.300 (b) Salts: Caprate. Caprylate. Isodecanoate. Linoleate. Naphthenate. Neodecanoate. Octoate (2-ethylhexoate). Oleate. Palmitate. Resinate. Ricinoleate. Soyate. Stearate. Tallate. (xxiii) Waxes: Paraffin, Type I. Paraffin, Type II. Polyethylene. Sperm oil. Spermaceti. (xxiv) Plasticizers: Acetyl tributyl citrate. Acetyl triethyl citrate. Butyl phthalyl butyl glycolate. Butyl stearate. p-tert-Butyl phenyl salicylate. Dibutyl sebacate. Diethyl phthalate. Diisobutyl adipate. Diisooctyl phthalate. Epoxidized soybean oil (iodine number max imum 14; oxirane oxygen content 6% min imum), as the basic polymer. Ethyl phthalyl ethyl glycolate. 2-Ethylhexyl diphenyl phosphate. di-2-Ethylhexyl phthalate. Glycerol. Glyceryl monooleate. Glyceryl triacetate. Monoisopropyl citrate. Propylene glycol. Sorbitol. Mono-, di-, and tristearyl citrate. Triethyl citrate. Triethylene glycol. 3-(2-Xenolyl)-1,2-epoxypropane. (xxv) Release agents, as the basic polymer, when applicable: N,N′-Dioleoylethylenediamine (CAS Reg. No. 110–31–6) for use only in ionomeric resins complying with § 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. N,N′-Distearoyl ethylenediamine. Linoleic acid amide. Oleic acid amide. Palmitic acid amide. Petrolatum. Polyethylene wax. Polyoxyethylene glycol monooleate (mol. wt. of the polyoxyethylene glycol moiety greater than 300). Polytetrafluoroethylene. Silicones (not less than 300 centistokes vis cosity): Dimethylpolysiloxanes and/or methylphenylpolysiloxanes. The methyl phenylpolysiloxanes contain not more than 2.0 percent by weight of cyclosiloxanes having up to and including 4 siloxy units. Silicones (not less than 100 centistokes vis cosity): Dimethylpolysiloxanes and/or methylphenylpolysiloxanes limited to use only on metal substrates. The methylphenylpolysiloxanes contain not more than 2.0 percent by weight of cyclosiloxanes having up to and including 4 siloxy units. (xxvi) Colorants used in accordance with § 178.3297 of this chapter. (xxvii) Surface lubricants: Cottonseed oil and other edible oils. Dibutyl sebacate. Dioctyl sebacate. Glyceryl monostearate. Lanolin. Mineral oil, white. Palm oil. Paraffin, Type I. Paraffin, Type II. Petrolatum. Stearic acid. (xxviii) Silicones and their curing catalysts: (a) Silicones as the basic polymer: Siloxane resins originating from methyl hy drogen polysiloxane, dimethyl polysiloxane, and methylphenyl polysiloxane. Siloxane resins originating from the plat inum-catalyzed reaction product of vinyl containing dimethylpolysiloxane (CAS Reg. No. 68083–18–1 and CAS Reg. No. 68083– 19–2) with methylhydrogen polysiloxane (CAS Reg. No. 63148–57–2) and dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037–59–2), where the plat inum content does not exceed 150 parts per million. The following substances may be used as optional polymerization inhibitors: 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107–54–0), at a level not to exceed 0.53 weight-percent; 1-Ethynylcyclohexene (CAS Reg. No. 931–49– 7), at a level not to exceed 0.64 weight-per cent; Bis(methoxymethyl)ethyl maleate (CAS Reg. No. 102054–10–4), at a level not to exceed 1.0 weight-percent; Methylvinyl cyclosiloxane (CAS Reg. No. 68082–23–5); and VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00194 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 185 Food and Drug Administration, HHS § 175.300 Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554–06–5). (b) Curing (cross-linking) catalysts for silicones (the maximum amount of tin catalyst used shall be that required to effect optimum cure but shall not exceed 1 part of tin per 100 parts of si loxane resins solids): Dibutyltin dilaurate. Stannous oleate. Tetrabutyl titanate. (xxix) Surface active agents: Ethylene oxide adduct of 2,4,7,9-tetramethyl 5-decyn-4,7-diol (CAS Reg. No. 9014–85–1). Poly[2-(diethylamino) ethyl methacrylate] phosphate (minimum intrinsic viscosity in water at 25 °C is not less than 9.0 deciliters per gram as determined by ASTM method D1243–79, ‘‘Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Poly mers,’’ which is incorporated by reference (Copies may be obtained from the Amer ican Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be ex amined at the National Archives and Records Administration (NARA). For in formation on the availability of this mate rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.), for use only as a sus pending agent in the manufacture of vinyl chloride copolymers and limited to use at levels not to exceed 0.1 percent by weight of the copolymers. Sodium dioctyl sulfosuccinate. Sodium dodecylbenzenesulfonate Sodium lauryl sulfate. 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. Reg. No. 126-86-3), for use only in can coat ings which are subsequently dried and cured at temperatures of at least 193 °C (380 °F) for 4 minutes. (xxx) Antioxidants: Butylated hydroxyanisole. Butylated hydroxytoluene. Gum guaiac. Dilauryl thiodipropionate. Nordihydroguaiaretic acid. Propyl gallate. Distearyl thiodipropionate. Thiodipropionic acid. 2,4,5-Trihydroxybutyrophenone. (xxxi) Can end cements (sealing com pounds used for sealing can ends only): In addition to the substances listed in paragraph (b) of this section and those listed in § 177.1210(b)(5) of this chapter, the following may be used: Butadiene-styrene-divinylbenzene copolymer (CAS Reg. No. 26471–45–4) for use only at levels not to exceed 23.8 percent by weight of the cement solids in can end cements. Butadiene-styrene-fumaric acid copolymer. 4,4′-Butylidenebis (6-tert-butyl-m-cresol). Dibenzamido phenyl disulfide. Di-b-naphthyl phenylenediamine. Dipentamethylene thiuram tetrasulfide. Isobutylene-isoprene-divinylbenzene copoly mers for use only at levels not to exceed 15 percent by weight of the dry cement com position. Naphthalene sulfonic acid-formaldehyde con densate, sodium salt, for use only at levels not to exceed 0.6 percent by weight of the cement solids in can end cements for con tainers having a capacity of not less than 5 gallons. Sodium decylbenzene sulfonate. Sodium nitrite for use only at levels not to exceed 0.3 percent by weight of the cement solids in can end cements for containers having a capacity of not less than 5 gal lons. Sodium pentachlorophenate for use as a pre servative at 0.1 percent by weight in can sealing compounds on containers having a capacity of 5 gallons or more. Sodium phenylphenate. Styrene-maleic anhydride resin, partial methyl and butyl (sec- or iso-) esters, for use only at levels not in excess of 3 percent of the cement solids in can end cement for mulations. Tetrasodium EDTA (tetrasodium ethylene diaminetetraacetate). Tri (mixed mono- and dinonylphenyl) phosphite. Zinc dibutyldithiocarbamate. (xxxii) Side seam cements: In addi tion to the substances listed in para graph (b)(3) (i) to (xxx), inclusive, of this section, the following may be used. p-tert-Butyl perbenzoate as a catalyst for epoxy resin. epsilon-Caprolactam-(ethylene-ethyl acry late) graft polymer. Dicumyl peroxide for use only as polymeriza tion catalyst. 4–(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018–09–1) for use as a preservative at a level not to exceed 0.3 percent by weight in can-sealing cements. Diisodecyl phthalate for use only as plasti cizer in side seam cements for containers intended for use in contact with food only of the types identified in paragraph (d) of this section, table 1, under Categories I, II, and VI. 4,4′-Bis(alpha,alpha-dimethyl benzyl)diphenylamine, CAS Reg. No. 10081– 67–1. Ethyl toluene sulfonamide. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00195 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 186 21 CFR Ch. I (4–1–16 Edition) § 175.300 N,N′-Hexamethylenebis(3,5-di-tert-butyl-4 hydroxyhydrocinnamide), CAS Reg. No. 23128–74–7. Polyamides consisting of the following: Copolymer of omega-laurolactam and espilon-caprolactam, CAS Reg. No. 25191– 04–2 (Nylon 12/6). Homopolymer of omega-aminododecanoic acid, CAS Reg. No. 24937–16–4. Homopolymer of omega-laurolactam, CAS Reg. No. 25038–74–8 (Nylon 12). Polyamides derived from the following acids and amines: Acids: Adipic. Azelaic. Sebacic. Vegetable oil acids (with or without dimerization). Amines: Diethylenetriamine. Diphenylamine. Ethylenediamine. Hexamethylenediamine. Tetraethylenepentamine. Triethylenetetramine. Polypropylene glycol CAS Reg. No. 25322–69– 4. Sodium pentachlorophenate for use as a pre servative at 0.1 percent by weight in can sealing compounds on containers having a capacity of 5 gallons or more. Tetrakis [methylene(3,5-di-tert-butyl-4 hydroxyhydrocinnamate)]methane, CAS Reg. No. 6683–19–8. Toluene sulfonamide formaldehyde resin (basic polymer). Triethylene glycol methacrylate for use only as polymerization cross-linking agent in side seam cements for containers intended for use in contact with food only of the types identified in paragraph (d) of this section, table 1, under Categories I, II, and VI. Urea. (xxxiii) Miscellaneous materials: Ammonium citrate. Ammonium potassium phosphate. Bentonite, modified by reaction with benzyl dimethyl alkyl ammonium chloride, where the alkyl groups are derived from hydro genated tallow (CAS Reg. No. 71011–24–0). For use only as a rheological agent in coat ings intended to contact food under re peated use conditions. Bentonite, modified by reaction with sodium stearate and benzyl dimethyl alkyl ammo nium chloride, where the alkyl groups are derived from hydrogenated tallow (CAS Reg. No. 121888–68–4). For use as a rheological agent only in coatings in tended to contact dry food under repeated use conditions. Calcium acetate. Calcium ethyl acetoacetate. Calcium glycerophosphate. Calcium, sodium, and potassium oleates. Calcium, sodium, and potassium ricinoleates. Calcium, sodium, and potassium stearates. Castor oil, hydrogenated. Castor oil, hydrogenated polymer with ethyl enediamine, 12-hydroxyoctadecanoic acid and sebacic acid (CAS Reg. No. 68604–06–8). The condensation product formed by the reaction of hydrogenated castor oil with polyamide derived from ethylenediamine, sebacic acid and 12-hydroxystearic acid, for use only in coatings at a level not to ex ceed 3.2 percent by weight of the resin when such coatings are intended for re peated use in contact with foods only of the types identified in paragraph (d) of this section, table 1, under Types I, II, and III, under conditions of use C, D, E, or F as de scribed in table 2 of paragraph (d) of this section; or when such coatings are in tended for repeated use in contact with foods of the types identified in paragraph (d) of this section, table 1, under Types V, VI, VII, and VIII, under conditions of use E or F as described in table 2 of paragraph (d) of this section. Use shall be limited to coatings for tanks of capacity greater than 530,000 gallons. Castor oil, sulfated, sodium salt (CAS Reg. No. 68187–76–8), for use only in coatings for containers intended for repeated use. Cetyl alcohol. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172–55–4) and 2-methyl-4 isothiazolin-3-one (CAS Reg. No. 2682–20–4) mixture, at a ratio of 3 parts to 1 part, re spectively, manufactured from methyl-3 mercaptopropionate (CAS Reg. No. 2935–90– 2) and optionally containing magnesium nitrate (CAS Reg. No. 10377–60–3) at a con centration equivalent to the isothiazolone active ingredients (weight/weight). For use only as an antimicrobial agent in emul sion-based silicone coatings at a level not to exceed 50 milligrams per kilogram (based on isothiazolone active ingredient) in the coating formulations. Cyclohexanone-formaldehyde resin produced when 1 mole of cyclohexanone is made to react with 1.65 moles of formaldehyde such that the finished resin has an average mo lecular weight of 600–610 as determined by ASTM method D2503–82, ‘‘Standard Test Method for Molecular Weight (Relative Molecular Mass) of Hydrocarbons by Ther moelectric Measurement of Vapor Pres sure,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadel phia, PA 19428-2959, or may be examined at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00196 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 187 Food and Drug Administration, HHS § 175.300 codeloflfederallregulations/ ibrllocations.html. For use only in contact with nonalcoholic and nonfatty foods under conditions of use E, F, and G, de scribed in table 2 of paragraph (d) this sec tion. Decyl alcohol. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg No. 35691–65–7). For use as an antimicrobial agent at levels not to exceed 500 milli grams per kilogram in emulsion-based sili cone coatings. Disodium hydrogen phosphate. Ethyl acetoacetate. Hectorite, modified by reaction with a mix ture of benzyl methyl dialkyl ammonium chloride and dimethyl dialkyl ammonium chloride, where the alkyl groups are de rived from hydrogenated tallow (CAS Reg. No. 121888–67–3). For use as a rheological agent only in coatings intended to contact dry food under repeated-use conditions. Lauryl alcohol. Lecithin. Magnesium, sodium, and potassium citrate. Magnesium glycerophosphate. Magnesium stearate. Mono-, di-, and tricalcium phosphate. Monodibutylamine pyrophosphate as sequestrant for iron. Mono-, di-, and trimagnesium phosphate. Myristyl alcohol. Octyl alcohol. Phosphoric acid. Polybutene, hydrogenated; complying with the identity and limitations prescribed by § 178.3740 of this chapter. Poly(ethylene oxide). Siloxanes and silicones, dimethyl, 3 hydroxypropyl group-terminated, diesters with poly(2-oxepanone), diacetates (CAS Reg. No. 116810–47–0) at a level not to ex ceed 0.025 weight percent of the finished coating having no greater than a 0.5 mil thickness for use as a component of poly ester, epoxy, and acrylic coatings com plying with paragraphs (b)(3)(vii), (viii), and (xx) of this section, respectively. Silver chloride-coated titanium dioxide for use only as a preservative in latex emul sions at a level not to exceed 2.2 parts per million (based on silver ion concentration) in the dry coating. Sodium pyrophosphate. Stannous chloride. Stannous stearate. Stannous sulfate. Stearyl alcohol. 2-Sulfoethyl methacrylate, sodium salt (CAS Reg. No. 1804–87–1). For use only in copoly mer coatings on metal under conditions of use E, F, and G described in table 2 of para graph (d) of this section, and limited to use at a level not to exceed 2.0 percent by weight of the dry copolymer coating. Tetrasodium pyrophosphate. Tridecyl alcohol produced from tetrapropylene by the oxo process, for use only as a processing aid in polyvinyl chlo ride resins. Trimethylolpropane (CAS Reg. No. 77–99–6). For use as a pigment dispersant at levels not to exceed 0.45 percent by weight of the pigment. Vinyl acetate-dibutyl maleate copolymers produced when vinyl acetate and dibutyl maleate are copolymerized with or without one of the monomers: Acrylic acid or glycidyl methacrylate. For use only in coatings for metal foil used in contact with foods that are dry solids with the surface containing no free fat or oil. The finished copolymers shall contain at least 50 weight-percent of polymer units derived from vinyl acetate and shall contain no more than 5 weight-percent of total poly mer units derived from acrylic acid or glycidyl methacrylate. (xxxiv) Polyamide resins derived from dimerized vegetable oil acids (containing not more than 20 percent of monomer acids) and ethylenediamine, as the basic resin, for use only in coat ings that contact food at temperatures not to exceed room temperature. (xxxv) Polyamide resins having a maximum acid value of 5 and a max imum amine value of 8.5 derived from dimerized vegetable oil acids (con taining 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 tem peratures not to exceed room tempera ture provided that the concentration of the polyamide resins in the finished food-contact coating does not exceed 5 milligrams per square inch of food-con tact surface. (xxxvi) Methacrylonitrile grafted polybutadiene copolymers containing no more than 41 weight percent of total polymer units derived from methacrylonitrile; for use only in coat ings 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 anhy dride, ethylene glycol, diethylene gly col, and 2,2-dimethyl-1,3-propanediol VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00197 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 188 21 CFR Ch. I (4–1–16 Edition) § 175.300 for use in contact with aqueous foods and alcoholic foods containing not more than 20 percent (by volume) of al cohol 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-di methyl-1,3-propanediol. (c) The coating in the finished form in which it is to contact food, when ex tracted with the solvent or solvents characterizing the type of food, and under conditions of time and tempera ture characterizing the conditions of its intended use as determined from ta bles 1 and 2 of paragraph (d) of this sec tion, shall yield chloroform-soluble ex tractives, corrected for zinc extractives as zinc oleate, not to exceed the fol lowing: (1) From a coating intended for or employed as a component of a con tainer not to exceed 1 gallon and in tended for one-time use, not to exceed 0.5 milligram per square inch nor to ex ceed that amount as milligrams per square inch that would equal 0.005 per cent of the water capacity of the con tainer, in milligrams, divided by the area of the food-contact surface of the container in square inches. From a fab ricated container conforming with the description in this paragraph (c)(1), the extractives shall not exceed 0.5 milli gram 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 con tainer 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 mil ligrams per square inch that would equal 0.005 percent of the water capac ity of the container in milligrams, di vided 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 con tainer 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 per cent of the water capacity of the con tainer in milligrams, divided by the area of the food-contact surface of the container in square inches. (4) From coating intended for re peated use, and employed other than as a component of a container, not to ex ceed 18 milligrams per square inch of coated surface. (d) Tables: TABLE 1—TYPES OF FOOD I. Nonacid (pH above 5.0), aqueous products; may contain salt or sugar or both, and in cluding oil-in-water emulsions of low- or high-fat content. II. Acidic (pH 5.0 or below), aqueous prod ucts; may contain salt or sugar or both, and including oil-in-water emulsions of low- or high-fat content. III. Aqueous, acid or nonacid products con taining free oil or fat; may contain salt, and including water-in-oil emulsions of low- or high-fat content. IV. Dairy products and modifications: A. Water-in-oil emulsion, high- or low-fat. B. Oil-in-water emulsion, high- or low-fat. V. Low moisture fats and oils. VI. Beverages: A. Containing alcohol. B. Nonalcoholic. VII. Bakery products. VIII. Dry solids (no end test required). TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES Condition of use Types of food (see Table 1) Extractant Water (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–B ................... 250 °F, 2 hr ................... . III, IV–A, VII ........... do .................................. 150 °F, 2 hr. B. Boiling water-sterilized II ............................ 212 °F, 30 min .............. . III, VII ..................... do .................................. 120 °F, 30 min. C. Hot filled or pasteur ized above 150 °F. II, IV–B .................. Fill boiling, cool to 100 °F. . III, IV–A ................. do .................................. 120 °F, 15 min. V ............................ ....................................... do. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00198 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 189 Food and Drug Administration, HHS § 175.300 TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES—Contin ued Condition of use Types of food (see Table 1) Extractant Water (time and temperature) Heptane1 2 (time and temperature) 8% alcohol (time and temperature) D. Hot filled or pasteur ized below 150 °F. II, IV–B, VI–B ........ 150 °F, 2 hr ................... . III, IV–A ................. do .................................. 100 °F, 30 min. V ............................ ....................................... do. VI–A ...................... ....................................... ....................................... 150 °F, 2 hr. E. Room temperature filled and stored (no thermal treatment in the container). II, IV–B, VI–B ........ 120 °F, 24 hr ................. . III, IV–A ................. do .................................. 70 °F, 30 min. V, VII ..................... ....................................... do. VI–A ...................... ....................................... ....................................... 120 °F, 24 hr. F. Refrigerated storage (no thermal treatment in the container). I, II, III, IV–A, IV–B, VI–B,VII. 70 °F, 48 hr ................... . VI–A ...................... ....................................... ....................................... 70 °F, 48 hr. G. Frozen storage (no thermal treatment in the container). I, II, III, IV–B, VII ... 70 °F, 24 hr ................... . H. Frozen storage: Ready-prepared foods intended to be re heated in container at time of use: 1. Aqueous or oil in water emulsion of high or low fat. I, II, IV–B ............... 212 °F, 30 min .............. . 2. Aqueous, high or low free oil or fat. III, IV–A, VII ........... do .................................. 120 °F, 30 min. 1 Heptane extractant not to be used on wax-lined containers. 2 Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product. (e) Analytical methods—(1) Selection of extractability conditions. First ascertain the type of food product (table 1, para graph (d) of this section) that is being packed commercially in the test con tainer 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 exaggera tions 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.’’ Aque ous 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. Alco holic beverages (type VI-A) require only the 8 percent alcohol extractant. Having selected the appropriate ex tractant or extractants simulating var ious types of foods and beverages and the time-temperature exaggerations over normal use, follow the applicable extraction procedure. Adapt the proce dure, when necessary, for containers having a capacity of over 1 gallon. (2) Selection of coated-container sam ples. 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00199 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 190 21 CFR Ch. I (4–1–16 Edition) § 175.300 to remove extraneous material prior to the actual extraction procedure. Soda fountain pressure-type hot water rins ing equipment, consisting in its sim plest 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 tem perature of 190 °F–200 °F before starting to rinse the container. Invert the con tainer 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-tempera ture heat sterilization. Fill the container within 1⁄4-inch of the top with a meas ured 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 dis tilled 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 pres sure to rise to 15 pounds per square inch (250 °F) and continue to maintain this pressure for 2 hours. Slowly re lease the pressure, open the pressure cooker when the pressure reads zero, and composite the water of each rep licate immediately in a clean Pyrex flask or beaker. Proceed with the de termination of the amount of extrac tives by the method described in para graph (e)(5) of this section. (ii) Water (212 °F for 30 minutes), simu lating 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 pres sure 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 com posite the contents of each replicate immediately in a clean Pyrex flask or beaker. Proceed with the determina tion of the amount of extractives by the method described in paragraph (e)(5) of this section. (iii) Water (from boiling to 100 °F), sim ulating 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 tem perature reads 100 °F, composite the water from each replicate immediately in a clean Pyrex flask or beaker. Pro ceed 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 ex tractives by the method described in paragraph (e)(5) of this section. (v) Water (120 °F for 24 hours), simu lating room temperature filling and stor age. 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 alu minum foil. Place the test container in an incubator or oven maintained at 120 °F. After 24 hours, remove the test con tainer from the incubator and imme diately composite the water of each replicate in a clean Pyrex flask or beaker. Proceed with the determina tion of the amount of extractives by the method described in paragraph (e)(5) of this section. (vi) Water (70 °F for 48 hours), simu lating refrigerated storage. Bring demineralized distilled water to 70 °F in a clean Pyrex flask. Fill the con tainer within 1⁄4-inch of the top with a measured volume of the 70 °F water, and cover with clean aluminum foil. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00200 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 191 Food and Drug Administration, HHS § 175.300 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 ex tractives by the method described in paragraph (e)(5) of this section. (vii) Water (70 °F for 24 hours), simu lating frozen storage. Bring demineralized distilled water to 70 °F in a clean Pyrex flask. Fill the con tainer 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, im mediately composite the water of each replicate in a clean Pyrex flask or beaker. Proceed with the determina tion of the amount of extractives by the method described in paragraph (e)(5) of this section. (viii) Water (212 °F for 30 minutes), sim ulating frozen foods reheated in the con tainer. 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 dis tilled water is boiling. Do not close the pressure vent, but operate at atmos pheric pressure so that there is a con tinuous escape of a small amount of steam. Continue to heat for 30 minutes, then remove the test container and composite the contents of each rep licate immediately in a clean Pyrex flask or beaker. Proceed with the de termination of the amount of extrac tives by the method described in para graph (e)(5) of this section. (ix) Heptane (150 °F for 2 hours) simu lating 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 pres sure 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 con tainer 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 as sembly, and immediately composite the heptane of each replicate in a clean Pyrex flask or beaker. Proceed with the determination of the amount of ex tractives by the method described in paragraph (e)(5) of this section. (x) Heptane (120 °F for 30 minutes), sim ulating 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-con taining test package inside the incu bator in order to minimize the danger of explosion. Fill the test container within 1⁄4-inch of the top with a meas ured 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 as sembly 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 ex tractives 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 re distilled 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 con tainer 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00201 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 192 21 CFR Ch. I (4–1–16 Edition) § 175.300 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 as sembly, and immediately composite the heptane of each replicate in a clean Pyrex flask or beaker. Proceed with the determination of the amount of ex tractives 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 re distilled 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 con tainer 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 as sembly and immediately composite the heptane of each replicate in a clean Pyrex flask or beaker. Proceed with the determination of the amount of ex tractives 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 alu minum 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 ex tractives 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 rea gent-grade heptane (boiling point 208 °F) carefully in a clean Pyrex flask on a water bath or hot plate in a well-ven tilated hood to 120 °F. At the same time, preheat a pressure cooker to 120 °F in an incubator. This pressure cook er is to serve only as a container for the heptane-containing test package inside the incubator in order to mini mize 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 alu minum foil. Place the test container in the preheated pressure cooker and then put the assembly into a 120 °F incu bator. After 30 minutes, remove the pressure cooker from the incubator, open the assembly and immediately composite the heptane from each rep licate 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. Pre heat 8 percent (by volume) ethyl alco hol 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 deter mination 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. Pre heat 8 percent (by volume) ethyl alco hol 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 per cent 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 imme diately 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00202 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 193 Food and Drug Administration, HHS § 175.300 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 con tainer with clean aluminum foil. Place the test container in a suitable room maintained at 70 °F. After 48 hours, im mediately 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 ap plicable 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 extrac tives—(i) Total residues. Evaporate the food-simulating solvents from para graph (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 evapo rate to a few milliliters on a non sparking low-temperature hotplate. The last few milliliters should be evap orated in an oven maintained at a tem perature 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. Milligrams extractives per square inch = e s Extractives residue = =Ex e a c s ( )( )(1000) ( )( ) (b) Heptane. Milligrams extractives per square inch = e s F( )( ) Extractives residue = =Ex e a c s F ( )( )(1000) ( )( )( ) where: Ex = Extractives residue in ppm for any con tainer 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 extrac tives removed from a coated container by heptane under exaggerated time-tempera ture test conditions compared to the amount extracted by a fat or oil from a container tested under exaggerated condi tions of thermal sterilization and use. e′ = Chloroform-soluble extractives residue. ee′ = Zinc corrected chloroform-soluble ex tractive residue. e′ or ee′ is substituted for e in the above equa tions when necessary. If when calculated by the equations in paragraph (e)(5)(i) (a) and (b) of this section, the concentration of extrac tives residue (Ex) exceeds 50 parts per million or the extractives in milli grams per square inch exceed the limi tations prescribed in paragraph (c) of this section for the particular con tainer size, proceed to paragraph (e)(5)(ii) of this section (method for de termining the amount of chloroform soluble extractives residue). (ii) Chloroform-soluble extractives res idue. Add 50 milliliters of chloroform (freshly distilled reagent grade or a grade having an established consist ently 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-solu ble extractives residue (e′). This e′ is substituted for e in the equations in VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00203 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072 ER 0 1 JA 9 3 .3 8 8 < /G P H > E R 0 1 JA 9 3 .3 8 9 < /G P H > E R 0 1 JA 9 3 .3 9 0 < /G P H > E R 0 1 JA 9 3 .3 9 1 < /G P H > js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 194 21 CFR Ch. I (4–1–16 Edition) § 175.320 paragraph (e)(5)(i) (a) and (b) of this section. If the concentration of extrac tives (Ex) still exceeds 50 parts per mil lion or the extractives in milligrams per square inch exceed the limitations prescribed in paragraph (c) of this sec tion 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 Agri cultural Chemists methods or equiva lent. Calculate the zinc in the ash as zinc oleate, and subtract from the weight of chloroform-soluble extrac tives residue (e′) to obtain the zinc-cor rected 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 ex tractives 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 milli grams per square inch the limitations for the particular article as prescribed in paragraph (c) of this section. (f) Equipment and reagent require ments—(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 in clude 120 °F–212 °F explosion-proof, inside di mensions (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 min imum. All glass, Pyrex or equivalent. (2) Reagents. Water, all water used in extraction proce dure should be freshly demineralized (deion ized) 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 redis tilled before use, or a grade having an estab lished, consistently low blank. Filter paper, Whatman No. 41 or equiva lent. (g) In accordance with good manufac turing practice, finished coatings in tended for repeated food-contact use shall be thoroughly cleansed prior to their first use in contact with food. (h) Acrylonitrile copolymers identi fied in this section shall comply with the provisions of § 180.22 of this chap ter. (i) Epoxy resins derived by the reac tion of 4,4′-isopropylidenediphenol and epichlorohydrin, as described in para graph (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. [42 FR 14534, Mar. 15, 1977] EDITORIAL NOTE: For FEDERAL REGISTER ci tations 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. § 175.320 Resinous and polymeric coat ings 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, pack aging, transporting, or holding food, in accordance with the following pre scribed conditions: (a) The coating is applied as a contin uous 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00204 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 195 Food and Drug Administration, HHS § 175.320 polyolefin film may contain optional adjuvant substances permitted for use in polyolefin film by applicable regula tions 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 para graph (b)(3) and subject to such limita tions as are provided: List of substances Limitations (i) Resins and polymers: Acrylic acid polymer and its ethyl or methyl esters. Acrylamide copolymerized with ethyl acrylate and/or sty rene and/or methacrylic acid, and the copolymer subse quently reacted with formaldehyde and butanol. Butadiene-acrylonitrile copolymer. Butadiene-acrylonitrile-styrene terpolymer. Butyl rubber. N,N′-Diphenyl-p-phenylenediamine ...................................... For use only as a polymerization inhibitor in 2-sulfoethyl meth acrylate, sodium salt. 2-Ethylhexyl acrylate copolymerized with one or more of the following: Acrylonitrile. Itaconic acid. Methacrylonitrile. Methyl acrylate. Methyl methacrylate. 4,4′-Isopropylidenediphenolepichlorohydrin average molec ular weight 900. Melamine-formaldehyde as the basic polymer or chemi cally modified with methyl alcohol. Methacrylic acid and its ethyl or methyl esters copolym erized with one or more of the following: Acrylic acid. Ethyl acrylate. Methyl acrylate. a-Methyl styrene polymer. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a-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 a-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 resins ................................ As defined in § 176.170 of this chapter. Blended with butyl rub ber 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 coat ing 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 acids. Azelaic acid (CAS Reg. No. 123–99–9) in an amount not to exceed 3.7 percent by weight of the poly amide resin. Ethylenediamine (CAS Reg. No. 107–15–3). Piperazine (CAS Reg. No. 110–85–0) in an amount not to exceed 6.4 percent by weight of the poly amide resin. Polyamide resins, derived from dimerized vegetable oil acids (containing not more than 20% of monomer acids) and ethylenediamine, as the basic resin. For 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 ex ceed 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-con tact surface. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00205 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 196 21 CFR Ch. I (4–1–16 Edition) § 175.320 List of substances Limitations Polyester resins formed by reaction of one or more of the following polybasic acids and monobasic acids with one or more of the following polyhydric alcohols: Polybasic acids: Adipic. Azelaic .................................................................... For use in forming polyester resins intended for use in coatings that contact food only of the type identified in § 176.170(c) of this chapter, table 1, under Category VIII, and under condi tions 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 oils. Tall oil. Fumaric. Isophthalic. Maleic. o-Phthalic. Sebacic. Terephthalic. Trimellitic. Monobasic acids: Fatty acids derived from: Animal, marine, or vegetable fats and oils. Gum rosin ....................................................... As defined in § 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 chap ter, table 1, under Category VIII, and under conditions of use E, F, or G described in table 2 of § 176.170(c) of this chap ter. Polyhydric alcohols: 1,3-Butylene glycol. Diethylene glycol. 2,2-Dimethyl-1,3-propanediol. Dipropylene glycol. Ethylene glycol. Glycerol. Mannitol. a-Methyl glucoside. Pentaerythritol. Propylene glycol. Sorbitol. Trimethylol ethane. Trimethylol propane. Polyethylenimine .................................................................. For use only as a primer subcoat to anchor epoxy surface coatings to the base sheet. Polystyrene. Polyvinyl acetate. Polyvinyl chloride .................................................................. Siloxanes and silicones: platinum-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); and. Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554–06–5).. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00206 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 197 Food and Drug Administration, HHS § 175.320 List of substances Limitations 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 inhibitors. Platinum 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 chap ter, 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 chap ter, 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 agent. Platinum 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: Acrylonitrile. a-Methyl styrene. Styrene polymers made by the polymerization of any com bination 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, in dividually, 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 per meation chromatography). The acid number of the poly mer shall be less than 250. The monomer content shall be less than 0.5 percent. For 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 copolymer. Terpene resins consisting of polymers of a-pinene, b-pi nene, and/or dipentene; acid value less than 5, saponi fication number less than 5, and color less than 4 on the Gardner scale as measured in 50 percent mineral spirits solution. 2-Sulfoethyl methacrylate, sodium 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 ma leic acid-modified copolymer. Vinyl chloride copolymerized with one or more of the fol lowing: Acrvlonitrile. Vinyl acetate. Vinylidene chloride. Vinylidene chloride copolymerized with one or more of the following: Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters. Acrylonitrile. Itaconic acid. Methacrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters. Methacrylonitrile. Vinyl chloride. (ii) Plasticizers: Acetyl tributyl citrate. Acetyl triethyl citrate. Butyl phthalyl butyl glycolate. Butyl stearate. Dibutyl sebacate. Diethyl phthalate. 2-Ethylhexyl diphenyl phosphate. Ethyl phthalyl ethyl glycolate. Glycerol monooleate ............................................................ VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00207 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 198 21 CFR Ch. I (4–1–16 Edition) § 175.350 List of substances Limitations Glycerol triacetate. Triethyl citrate. (iii) Adjuvants (release agents, waxes, and dispersants): Acetone. Amides (unsubstituted) of fatty acids from vegetable or animal oils. n-Butyl acetate. n-Butyl alcohol. Candelilla wax. Carnauba wax. 5-Chloro-2-methyl-4-isothiazolin-3-one (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, respec tively, 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 sili cone coatings at a level not to exceed 50 milligrams per kilo gram (based on isothiazolone active ingredient) in the coat ing 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 acetate. Fatty acids from vegetable or animal oils and their alu minum, ammonium, calcium, magnesium, and sodium salts. Hexane. Methyl ethyl ketone. N,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 com plying with § 177.1350 of this chapter at a level not to ex ceed 0.0085 milligram per square centimeter (0.055 milli gram per square inch) in the finished food-contact article. Petroleum waxes conforming to specifications included in a regulation in subchapter B of this chapter. Polyvinyl alcohol, minimum viscosity of 4% aqueous solu tion at 20 °C of 4 centipoises and percent alcoholysis of 87–100. For use only as a dispersing agent at levels not to exceed 6% of total coating weight in coatings for pol-yolefin films pro vided 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 sulfosuccinate. Sodium dodecylbenzenesulfonate. Sodium lauryl sulfate. Sorbitan and sorbitol esters of fatty acids from vegetable or animal oils. Spermaceti wax. Tetrahydrofuran. Toluene. (iv) Preservatives: Silver chloride-coated titanium dioxide ................................ For use only as a preservative in latex emulsions at a level not to exceed 2.2 parts per million (based on silver ion con centration) in the dry coating. (c) The coating in the finished form in which it is to contact food, when ex tracted with the solvent or solvents characterizing the type of food, and under conditions of time and tempera ture characterizing the conditions of its intended use as determined from ta bles 1 and 2 of § 176.170(c) of this chap ter, shall yield net chloroform-soluble extractives not to exceed 0.5 milligram per square inch of coated surface. (d) Acrylonitrile copolymers identi fied in this section shall comply with the provisions of § 180.22 of this chap ter. [42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29, 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR 49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, 1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, June 13, 2000] § 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00208 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 199 Food and Drug Administration, HHS § 175.360 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 sub stance does not exceed the amount rea sonably required to accomplish the in tended 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 specifica tions 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 sanc tion or approval for uses with a copoly mer of vinyl acetate and crotonic acid and used in accordance with such sanc tion or approval. (3) Substances identified in this sub paragraph and subject to such limita tions as are provided: List of substances Limitations Silica. Japan wax. (e) Copolymer of vinyl acetate and crotonic acid used as a coating or as a component of a coating conforming with the specifications of paragraph (e)(1) of this section are used as pro vided in paragraph (e)(2) of this sec tion. (1) Specifications. (i) The chloroform soluble portion of the water extractives of the coated film obtained with dis tilled 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 milli gram 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 pack aging bakery products and confec tionery. § 175.360 Vinylidene chloride copoly mer coatings for nylon film. Vinylidene chloride copolymer coat ings identified in this section and ap plied on nylon film may be safely used as food-contact surfaces, in accordance with the following prescribed condi tions: (a) The coating is applied as a contin uous film over one or both sides of a base film produced from nylon resins complying with § 177.1500 of this chap ter. (b) The coatings are prepared from vinylidene chloride copolymers pro duced by copolymerizing vinylidene chloride with one or more of the mono mers acrylic acid, acrylonitrile, ethyl acrylate, methacrylic acid, methyl ac rylate, methyl methacrylate (CAS Reg. No. 80–62–6; maximum use level 6 weight percent) and 2-sulfoethyl meth acrylate (CAS Reg. No. 10595–80–9; max imum use level 1 weight percent). The finished copolymers contain at least 50 weight percent of polymer units de rived from vinylidene chloride. The fin ished coating produced from vinylidene chloride copolymers produced by co polymerizing vinylidene chloride with methyl methacrylate and/or 2 sulfoethyl methacrylate, or with meth yl 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 em ployed in the production of the coat ings 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 ex tracted with the solvent or solvents characterizing the type of food, and under conditions of time and tempera ture characterizing the conditions of its intended use as determined from ta bles 1 and 2 of § 176.170(c) of this chap ter, 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 identi fied in this section shall comply with VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00209 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 200 21 CFR Ch. I (4–1–16 Edition) § 175.365 the provisions of § 180.22 of this chap ter. [42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 FR 76998, Nov. 21, 1980; 47 FR 54430, Dec. 3, 1982] § 175.365 Vinylidene chloride copoly mer coatings for polycarbonate film. Vinylidene chloride copolymer coat ings identified in this section and ap plied on polycarbonate film may be safely used as food-contact surfaces, in accordance with the following pre scribed conditions: (a) The coating is applied as a contin uous 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 pro duced by copolymerizing vinylidene chloride with acrylonitrile, methyl ac rylate, and acrylic acid. The finished copolymers contain at least 50 weight percent of polymer units derived from vinyldene chloride. (c) Optional adjuvant substances em ployed in the production of the coat ings 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 ex tracted with the solvent or solvents characterizing the type of food, and under the conditions of time and tem perature characterizing the conditions of its intended use as determined from tables 1 and 2 of § 176.170(c) of this chap ter, 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 identi fied in this section shall comply with the provisons of § 180.22 of this chapter. § 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 in tended for use in contact with food, in accordance with the following pre scribed 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 im part desired physical and technical properties. The optional adjuvant sub stances 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 in tended 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 fin ished form in which it is to contact food meets the following extractives limitations when tested by the meth ods 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 in tended 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00210 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 201 Food and Drug Administration, HHS § 176.110 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. § 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, pack aging, transporting, or holding food, subject to the provisions of this sec tion; (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 condi tions of use have been prescribed in § 175.300. (3) Substances identified in para graph (c) of this section, subject to the limitations prescribed. (c) The optional substances per mitted are as follows: List of substances Limitations Ethylene glycol ...................... As a solvent removed by water washing. Iron oxide. Lithium hydroxide .................. Removed by water washing. Methyl orange ........................ As an acid-base indicator. Potassium dichromate ........... Removed by water washing. Silica gel. Sodium silicate. Zinc, as particulate metal. (d) The coating in the finished form in which it is to contact food, when ex tracted 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 approxi mately 20 percent alcohol) shall yield total extractives not to exceed those prescribed in § 175.300(c)(3); lithium ex tractives not to exceed 0.025 milligram per square inch of surface; and chro mium extractives not to exceed 0.05 microgram per square inch of surface. (e) The coatings are used as food-con tact surfaces for bulk reusable con tainers intended for storing, handling, and transporting food. PART 176—INDIRECT FOOD ADDI TIVES: PAPER AND PAPERBOARD COMPONENTS Subpart A [Reserved] Subpart B—Substances for Use Only as Components of Paper and Paperboard Sec. 176.110 Acrylamide-acrylic acid resins. 176.120 Alkyl ketene dimers. 176.130 Anti-offset substances. 176.150 Chelating agents used in the manu facture of paper and paperboard. 176.160 Chromium (Cr III) complex of N ethyl-N-heptadecylfluoro-octane sulfonyl glycine. 176.170 Components of paper and paperboard in contact with aqueous and fatty foods. 176.180 Components of paper and paperboard in contact with dry food. 176.200 Defoaming agents used in coatings. 176.210 Defoaming agents used in the manu facture of paper and paperboard. 176.230 3,5-Dimethyl-1,3,5,2H tetrahydrothiadiazine-2-thione. 176.250 Poly-1,4,7,10,13-pentaaza-15 hydroxyhexadecane. 176.260 Pulp from reclaimed fiber. 176.300 Slimicides. 176.320 Sodium nitrate-urea complex. 176.350 Tamarind seed kernel powder. AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. SOURCE: 42 FR 14554, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 176 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. 1, 2005. Subpart A [Reserved] Subpart B—Substances for Use Only as Components of Paper and Paperboard § 176.110 Acrylamide-acrylic acid res ins. Acrylamide-acrylic acid resins may be safely used as components of arti cles intended for use in producing, VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00211 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R