§ 175.210 21 CFR Ch. I (4–1–13 Edition)

not to exceed 0.05 percent by weight of Rubber hydrochloride. the finished pressure-sensitive adhe- Rubber (natural latex solids or crepe, sive. smoked or unsmoked). (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy) Terpene resins (a- and b-pinene), homopolymers, copolymers, and conden- phenyl]-2-methyl-1-propanone (CAS sates with phenol, formaldehyde, cou- Reg. No. 106797–53–9) as a photoinitiator marone, and/or indene. at a level not to exceed 5 percent by Tetrasodium ethylenediaminetetraacetate. weight of the pressure-sensitive adhe- Tri(mixed mono- and dinonylphenyl) sive. phosphite (which may contain not more than 1 percent by weight of (9) Butanedioic acid, sulfo-1,4-di-(C9- triisopropanolamine). C11 alkyl) ester, ammonium salt (also known as butanedioic acid sulfo-1, 4- (c) Acrylonitrile copolymers identi- diisodecyl ester, ammonium salt [CAS fied in this section shall comply with Reg. No. 144093–88–9]) as a surface ac- the provisions of § 180.22 of this chap- tive agent at a level not to exceed 3.0 ter. percent by weight of the finished pres- sure-sensitive adhesive. [42 FR 14534, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12, (b) Pressure-sensitive adhesives pre- 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, pared from one or a mixture of two or Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999] more of the substances listed in this paragraph may be used as the food-con- Subpart C—Substances for Use as tact surface of labels and/or tapes ap- plied to raw fruit and raw vegetables. Components of Coatings (1) Substances listed in paragraphs § 175.210 Acrylate ester copolymer (a)(1), (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), coating. (a)(8), and (a)(9) of this section, and those substances prescribed by para- Acrylate ester copolymer coating graph (a)(4) of this section that are not may safely be used as a food-contact identified in paragraph (b)(2) of this surface of articles intended for pack- section. aging and holding food, including heat- (2) Substances identified in this sub- ing of prepared food, subject to the pro- paragraph and subject to the limita- visions of this section: tions provided: (a) The acrylate ester copolymer is a fully polymerized copolymer of ethyl BHA. acrylate, methyl methacrylate, and BHT. methacrylic acid applied in emulsion Butadiene-acrylonitrile copolymer. form to molded virgin fiber and heat- Butadiene-acrylonitrile-styrene copolymer. Butadiene-styrene copolymer. cured to an insoluble resin. Butyl rubber. (b) Optional substances used in the Butylated reaction product of p-cresol and preparation of the polymer and in the dicyclopentadiene produced by reacting p- preparation and application of the cresol and dicyclopentadiene in an approxi- emulsion may include substances mate mole ratio of 1.5 to 1.0, respectively, named in this paragraph, in an amount followed by alkylation with isobutylene so not to exceed that required to accom- that the butyl content of the final product plish the desired technical effect and is not less than 18 percent, for use at levels not to exceed 1.0 percent by weight of the subject to any limitation prescribed: adhesive formulation. Provided, however, That any substance Chlorinated natural rubber. named in this paragraph and covered Isobutylene-styrene copolymer. by a specific regulation in subchapter Petrolatum. B of this chapter must meet any speci- Polybutene-1. fications in such regulation. Polybutene, hydrogenated; complying with the identity prescribed under § 178.3740(b) of List of substances Limitations this chapter. Polyisobutylene. Aluminum stearate. cis-1,4-Polyisoprene. Ammonium lauryl sulfate. Polystyrene. Borax ...... Not to exceed the amount required as a Propyl gallate. preservative in emul- Rapeseed oil, vulcanized. sion defoamer. Rosins and rosin derivatives as provided in Disodium hydrogen phosphate ..... Do. § 178.3870 of this chapter. Formaldehyde.

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List of substances Limitations (a) The additive is synthesized by the Fischer-Tropsch process from carbon Glyceryl monostearate. Methyl cellulose. monoxide and hydrogen, which are cat- Mineral oil. alytically converted to a mixture of Paraffin wax. paraffin hydrocarbons. Lower molec- Potassium hydroxide. Potassium persulfate. ular-weight fractions are removed by Tallow. distillation. The residue is hydro- Tetrasodium pyrophosphate. genated and may be further treated by Titanium dioxide. percolation through activated char- (c) The coating in the form in which coal. This mixture can be fractionated it contacts food meets the following into its components by a solvent sepa- tests: ration method, using synthetic (1) An appropriate sample when ex- isoparaffinic petroleum hydrocarbons posed to distilled water at 212 °F for 30 complying with § 178.3530 of this chap- minutes shall yield total chloroform- ter. soluble extractables not to exceed 0.5 (b) Synthetic paraffin shall conform milligram per square inch. to the following specifications: (2) An appropriate sample when ex- (1) Congealing point. There is no speci- posed to n-heptane at 120 °F for 30 min- fication for the congealing point of utes shall yield total chloroform-solu- synthetic paraffin components, except ble extractables not to exceed 0.5 milli- those components that have a con- gram per square inch. gealing point below 50 °C when used in contact with food Types III, IVA, V, § 175.230 Hot-melt strippable food VIIA, and IX identified in table 1 of coatings. § 176.170(c) of this chapter and under Hot-melt strippable food coatings conditions of use E, F, and G described may be safely applied to food, subject in table 2 of § 176.170(c) of this chapter to the provisions of this section. shall be limited to a concentration not (a) The coatings are applied to and exceeding 15 percent by weight of the used as removable coatings for food. finished coating. The congealing point (b) The coatings may be prepared, as shall be determined by ASTM method mixtures, from the following sub- D938–71 (Reapproved 1981), ‘‘Standard stances: Test Method for Congealing Point of (1) Substances generally recognized Petroleum Waxes, Including Petro- as safe in food. latum,’’ which is incorporated by ref- (2) Substances identified in this sub- erence. Copies may be obtained from paragraph. the American Society for Testing Ma- terials, 100 Barr Harbor Dr., West List of substances Limitations Conshohocken, Philadelphia, PA 19428- Acetylated monoglycerides ...... Complying with 172.828 2959, or may be examined at the Na- of this chapter. tional Archives and Records Adminis- Cellulose acetate butyrate. Cellulose acetate propionate. tration (NARA). For information on Mineral oil, white ...... For use only as a com- the availability of this material at ponent of hot-melt NARA, call 202–741–6030, or go to: http:// strippable food coat- ings applied to frozen www.archives.gov/federallregister/ meats and complying codeloflfederallregulations/ with § 172.878 of this ibrllocations.html. chapter. (2) Oil content. The substance has an oil content not exceeding 2.5 percent as § 175.250 Paraffin (synthetic). determined by ASTM method D721–56T, Synthetic paraffin may be safely ‘‘Tentative Method of Test for Oil Con- used as an impregnant in, coating on, tent of Petroleum Waxes’’ (Revised or component of coatings on articles 1956), which is incorporated by ref- used in producing, manufacturing, erence. See paragraph (b)(1) of this sec- packing, processing, preparing, treat- tion for availability of the incorpora- ing, packaging, transporting, or hold- tion by reference. ing food in accordance with the fol- (3) Absorptivity. The substance has an lowing prescribed conditions: absorptivity at 290 millimicrons in

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decahydronaphthalene at 88 °C not ex- § 175.270 Poly(vinyl fluoride) resins. ceeding 0.01 as determined by ASTM Poly(vinyl fluoride) resins identified method E131–81a, ‘‘Standard Defini- in this section may be safely used as tions of Terms and Symbols Relating to Molecular-Spectroscopy,’’ which is components of food-contact coatings incorporated by reference. See para- for containers having a capacity of not graph (b)(1) of this section for avail- less than 5 gallons, subject to the pro- ability of the incorporation by ref- visions of this section. erence. (a) For the purpose of this section, (c) The provisions of this section are poly(vinyl fluoride) resins consist of not applicable to synthetic paraffin basic resins produced by the polym- used in food-packaging adhesives com- erization of vinyl fluoride. plying with § 175.105. (b) The poly(vinyl fluoride) basic res- ins have an intrinsic viscosity of not [42 FR 14534, Mar. 15, 1977, as amended at 47 less than 0.75 deciliter per gram as de- FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19, 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, termined by ASTM method D1243–79, Aug. 3, 1995] ‘‘Standard Test Method for Dilute So- lution Viscosity of Vinyl Chloride § 175.260 Partial phosphoric acid Polymers,’’ which is incorporated by esters of polyester resins. reference. Copies may be obtained from Partial phosphoric acid esters of pol- the American Society for Testing Ma- yester resins identified in this section terials, 100 Barr Harbor Dr., West and applied on aluminum may be safely Conshohocken, Philadelphia, PA 19428- used as food-contact coatings, in ac- 2959, or may be examined at the Na- cordance with the following prescribed tional Archives and Records Adminis- conditions: tration (NARA). For information on (a) For the purpose of this section, the availability of this material at partial phosphoric acid esters of poly- NARA, call 202–741–6030, or go to: http:// ester resins are prepared by the reac- www.archives.gov/federallregister/ tion of trimellitic anhydride with 2,2- codeloflfederallregulations/ dimethyl-1,3-propanediol followed by ibrllocations.html. reaction of the resin thus produced (1) Solvent. N,N-Dimethylacetamide, with phosphoric acid anhydride to technical grade. produce a resin having an acid number (2) Solution. Powdered resin and sol- of 81 to 98 and a phosphorus content of vent are heated at 120 °C until the resin 4.05 to 4.65 percent by weight. is dissolved. (b) The coating is chemically bonded (3) Temperature. Flow times of the to the metal and cured at temperatures solvent and solution are determined at ° exceeding 450 F. 110 °C. (c) The finished food-contact coating, (4) Viscometer. Cannon-Ubbelohde size when extracted with the solvent or sol- 50 semimicro dilution viscometer (or vents characterizing the type of food equivalent). and under the conditions of time and (5) Calculation. The calculation meth- temperature characterizing the condi- tions of its intended use, as determined od used is that described in appendix X from tables 1 and 2 of § 175.300(d), yields 1.3 (ASTM method D1243–79, ‘‘Standard total extractives in each extracting Test Method for Dilute Solution Vis- solvent not to exceed 0.3 milligrams cosity of Vinyl Chloride Polymers,’’ per square inch of food-contact surface, which is incorporated by reference; see as determined by the methods de- paragraph (b) of this section for avail- scribed in § 175.300(e), and the coating ability of the incorporation by ref- yields 2,2-dimethyl-1,3-propanediol in erence) with the reduced viscosity de- each extracting solvent not to exceed termined for three concentration levels 0.3 micrograms per square inch of food- not greater than 0.5 gram per deciliter contact surface. In testing the finished and extrapolated to zero concentration food-contact articles, a separate test for intrinsic viscosity. The following sample is to be used for each required formula is used for determining re- extracting solvent. duced viscosity:

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− Beechnut. Reduced viscosity in terms = tto Candlenut. of deciliters per gram × Castor (including dehydrated). to c Chinawood (tung). where: Coconut. t=Solution efflux time. Corn. to=Solvent efflux time. Cottonseed. c=Concentration of solution in terms of Fish (refined). grams per deciliter. Hempseed. [42 FR 14534, Mar. 15, 1977, as amended at 47 Linseed. FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19, Oiticica. 1984] Perilla. Poppyseed. § 175.300 Resinous and polymeric coat- Pumpkinseed. ings. Safflower. Sesame. Resinous and polymeric coatings Soybean. may be safely used as the food-contact Sunflower. surface of articles intended for use in Tall oil. producing, manufacturing, packing, Walnut. processing, preparing, treating, pack- aging, transporting, or holding food, in The oils may be raw, heat-bodied, or accordance with the following pre- blown. They may be refined by filtra- scribed conditions: tion, degumming, acid or alkali wash- (a) The coating is applied as a contin- ing, bleaching, distillation, partial de- uous film or enamel over a metal sub- hydration, partial polymerization, or strate, or the coating is intended for solvent extraction, or modified by com- repeated food-contact use and is ap- bination with maleic anhydride. plied to any suitable substrate as a (ii) Reconstituted oils from continuous film or enamel that serves triglycerides or fatty acids derived as a functional barrier between the from the oils listed in paragraph food and the substrate. The coating is (b)(3)(i) of this section to form esters characterized by one or more of the fol- with: lowing descriptions: Butylene glycol. (1) Coatings cured by oxidation. Ethylene glycol. (2) Coatings cured by polymerization, Pentaerythritol. condensation, and/or cross-linking Polyethylene glycol. without oxidation. Polypropylene glycol. (3) Coatings prepared from prepoly- Propylene glycol. merized substances. Sorbitol. (b) The coatings are formulated from Trimethylol ethane. Trimethylol propane. optional substances that may include: (1) Substances generally recognized (iii) Synthetic drying oils, as the as safe in food. basic polymer: (2) Substances the use of which is Butadiene and methylstyrene copolymer. permitted by regulations in this part Butadiene and styrene copolymer, blown or or which are permitted by prior sanc- unblown. tion or approval and employed under Maleic anhydride adduct of butadiene sty- the specific conditions, if any, of the rene. prior sanction or approval. Polybutadiene. (3) Any substance employed in the (iv) Natural fossil resins, as the basic production of resinous and polymeric resin: coatings that is the subject of a regula- tion in subchapter B of this chapter Copal. and conforms with any specification in Damar. such regulation. Substances named in Elemi. Gilsonite. this paragraph (b)(3) and further identi- Glycerol ester of damar, copal, elemi, and fied as required: sandarac. (i) Drying oils, including the Sandarac. triglycerides or fatty acids derived Shellac. therefrom: Utah coal resin.

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(v) Rosins and rosin derivatives, with formed as esters of acids listed in para- or without modification by polymeriza- graph (b)(3)(vii) (a) and (b) of this sec- tion, isomerization, incidental tion by reaction with alcohols in para- decarboxylation, and/or hydrogenation, graph (b)(3)(vii) (c) and (d) of this sec- as follows: tion. (a) Rosins, refined to color grade of K (a) Polybasic acids: or paler: Adipic. Gum rosin. 1,4-cyclohexanedicarboxylic (CAS Reg. No. Tall oil rosin. 1076–97–7). Wood rosin. Dimerized fatty acids derived from oils listed in paragraph (b)(3)(i) of this section. (b) Rosin esters formed by reacting Fumaric. rosin (paragraph (b)(3)(v)(a) of this sec- Isophthalic. tion) with: Maleic. 2,6-Naphthalenedicarboxylic. 4,4′-sec-Butylidenediphenol-epichlorohydrin 2,6-Naphthalenedicarboxylic, dimethyl ester. (epoxy). Diethylene glycol. Orthophthalic. Ethylene glycol. Sebacic. Glycerol. Terephthalic. 4,4′-Isopropylidenediphenol-epichlorohydrin Terpene-maleic acid adduct. (epoxy). Trimellitic. Methyl alcohol. (b) Monobasic acids: Pentaerythritol. Benzoic acid. (c) Rosin esters (paragraph (b)(3)(v)(b) 4,4-Bis(4′-hydroxyphenyl)-pentanoic acid. of this section) modified by reaction tert-Butyl benzoic acid. with: Fatty acids derived from oils listed in para- graph (b)(3)(i) of this section. Maleic anhydride. Rosins listed in paragraph (b)(3)(v)(a) of this o-, m-, and p-substituted phenol-formalde- section, for use only as reactants in oil- hydes listed in paragraph (b)(3)(vi) of this based or fatty acid-based alkyd resins. section. Phenol-formaldehyde. (c) Polyhydric alcohols: (d) Rosin salts: Butylene glycol. Diethylene glycol. Calcium resinate (limed rosin). 2,2-Dimethyl-1,3-propanediol for use only in Zinc resinate. forming polyester resins for coatings in- (vi) Phenolic resins as the basic poly- tended for use in contact with non-alco- mer formed by reaction of phenols with holic foods. formaldehyde: Ethylene glycol. (a) Phenolic resins formed by reac- Glycerol. Mannitol. tion of formaldehyde with: a-Methyl glucoside. Alkylated (methyl, ethyl, propyl, isopropyl, Pentaerythritol. butyl) phenols. Propylene glycol. p-tert-Amylphenol. Sorbitol. 4,4′-sec-Butylidenediphenol. Triethylene glycol, for use as a component in p-tert-Butylphenol. polyester resins for coatings not exceeding o-, m-, and p-Cresol. a coating weight of 4 milligrams per square p-Cyclohexylphenol. inch and that are intended for contact 4,4′-Isopropylidenediphenol. under conditions of use D, E, F or G de- p-Nonylphenol. scribed in table 2 of paragraph (d) of this p-Octylphenol. section with alcoholic beverages con- 3-Pentadecyl phenol mixture obtained from taining less than 8 percent alcohol. cashew nut shell liquid. Trimethylol ethane. Phenol. Trimethylol propane. Phenyl o-cresol. (d) Monohydric alcohols: p-Phenylphenol. Xylenol. Cetyl alcohol. Decyl alcohol. (b) Adjunct for phenolic resins: Alu- Lauryl alcohol. minum butylate. Myristyl alcohol. (vii) Polyester resins (including Octyl alcohol. alkyd-type), as the basic polymers, Stearyl alcohol.

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(e) Catalysts: 3-(Aminomethyl)-3,5,5-trimethylcyclohexyl- amine reacted with phenol and formalde- Dibutyltin oxide (CAS Reg. No. 818–08–6), not hyde in a ratio of 2.6:1.0:2.0, for use only in to exceed 0.2 percent of the polyester resin. coatings intended for repeated use in con- Hydroxybutyltin oxide (CAS Reg. No. 2273– tact with foods only of the types identified 43–0), not to exceed 0.2 percent of the poly- in paragraph (d) of this section, table 1, ester resin. under Category I and Category VIII, at Monobutyltin tris(2-ethylhexoate) (CAS Reg. temperatures not exceeding 88 °C (190 °F). No. 23850–94–4), not to exceed 0.2 percent of N-Beta-(aminoethyl)-gamma-aminopropyltri- the polyester resin. methoxysilane (CAS Reg. No. 1760–24–3), for (viii) Epoxy resins, catalysts, and ad- use only in coatings at a level not to ex- juncts: ceed 1.3 percent by weight of the resin when such coatings are intended for re- (a) Epoxy resins, as the basic poly- peated use in contact with foods only of mer: the types identified in paragraph (d) of this section, table 1, under Types I, II, and III, (Alkoxy C10-C16)-2,3-epoxypropane, in which the alkyl groups are even numbered and under conditions of use C, D, E, or F as de- consist of a maximum of 1 percent C car- scribed in table 2 of paragraph (d) of this 10 section; or when such coatings are in- bon atoms and a minimum of 48 percent C12 carbon atoms and a minimum of 18 percent tended for repeated use in contact with foods of the types identified in paragraph C14 carbon atoms, for use only in coatings that are intended for contact with dry bulk (d) of this section, table 1, under Types V, foods at room temperature. VI, VII, and VIII, under conditions of use E 4,4′-sec-Butylidenediphenol-epichlorohydrin. or F as described in table 2 of paragraph (d) 4,4′-sec-Butylidenediphenol-epichlorohydrin of this section. Use shall be limited to reacted with one or more of the drying oils coatings for tanks of capacity greater than or fatty acids listed in paragraph (b)(3)(i) 530,000 gallons. of this section. Benzyl alcohol (CAS Reg. No. 100–51–6), for 4,4′-sec-Butylidenediphenol-epichlorohydrin use only in coatings at a level not to ex- chemically treated with one or more of ceed 4 percent by weight of the resin when the following substances: such coatings are intended for repeated use Allyl ether of mono-, di-, or trimethylol in contact with foods only of the types phenol. identified in paragraph (d) of this section, 4,4′-sec-Butylidenediphenol-formaldehyde. table 1, under Types I, II, and III, under 4,4′-Isopropylidenediphenol-formaldehyde. conditions of use C, D, E, or F as described Melamine-formaldehyde. in table 2 of paragraph (d) of this section; Phenol-formaldehyde. or when such coatings are intended for re- Urea-formaldehyde. peated use in contact with foods of the types identified in paragraph (d) of this Epoxidized polybutadiene. section, table 1, under Types V, VI, VII, Glycidyl ethers formed by reacting and VIII, under conditions of use E or F as phenolnovolak resins with described in table 2 of paragraph (d) of this epichlorohydrin. section. Use shall be limited to coatings 4,4′-Isopropylidenediphenol-epichlorohydrin. for tanks of capacity greater than 530,000 4,4′-Isopropylidenediphenol-epichlorohydrin gallons. reacted with one or more of the drying oils or fatty acids listed in paragraph (b)(3)(i) Catalysts and cross-linking agents for epoxy of this section. resins: 4,4′-Isopropylidenediphenol-epichlorohydrin 3-Aminomethyl-3,5,5- chemically treated with one or more of trimethylcyclohexylamine (CAS Reg. No. the following substances: 2855–0913–092). Allyl ether of mono-, di-, or trimethylol Cyanoguanidine. phenol. Dibutyl phthalate, for use only in coatings 4,4′-sec-Butylidenediphenol-formaldehyde. for containers having a capacity of 1,000 4,4′-Isopropylidenediphenol-formaldehyde. gallons or more when such containers are Melamine-formaldehyde. intended for repeated use in contact with 2,2′-[(1-methylethylidene)bis[4,1- alcoholic beverages containing up to 8 per- phenyleneoxy[1-(butoxymethyl)-2,1- cent of alcohol by volume. ethanediyl]oxymethylene]]bisoxirane, 3-Diethylaminopropylamine (CAS Reg. No. CAS Reg. No. 71033–08–4, for use only in 104–78–9), for use in coatings at a level not coatings intended for contact with bulk to exceed 6 percent by weight of the resin dry foods at temperatures below 100 °F. when such coatings are intended for re- Phenol-formaldehyde. peated use in contact with foods only of Urea-formaldehyde. the types identified in paragraph (d) of this section, table 1, under Types I, II, and III, (b) Catalysts and cross-linking agents under conditions of use C, D, E, or F as de- for epoxy resins: scribed in table 2 of paragraph (d) of this

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section; or when such coatings are in- by weight of the resin used in coatings that tended for repeated use in contact with are intended for contact with food under foods of the types identified in paragraph conditions of use D, E, F, and G described (d) of this section, table 1, under Types V, in table 2 of paragraph (d) of this section. VI, VII, and VIII, under conditions of use E Styrene oxide, for use only in coatings for or F as described in table 2 of paragraph (d) containers having a capacity of 1,000 gal- of this section. Use shall be limited to lons or more when such containers are in- coatings for tanks of capacity greater than tended for repeated use in contact with al- 530,000 gallons. coholic beverages containing up to 8 per- Diethylenetriamine. cent of alcohol by volume. Diphenylamine. Tetraethylenepentamine. Ethylenediamine. Tetraethylenepentamine reacted with Isophthalyl dihydrazide for use only in coat- equimolar quantities of fatty acids. ings subject to the provisions of paragraph Tri(dimethylaminomethyl) phenol and its (c) (3) or (4) of this section. salts prepared from the fatty acid moieties 4,4′-Methylenedianiline, for use only in coat- of the salts listed in paragraph ings for containers having a capacity of (b)(3)(xxii)(b) of this section, for use only 1,000 gallons or more when such containers in coatings subject to the provisions of are intended for repeated use in contact paragraph (c) (3) or (4) of this section. with alcoholic beverages containing up to 8 Triethylenetetramine. percent of alcohol by volume. Trimellitic anhydride (CAS Reg. No. 552–30– N-Oleyl-1,3-propanediamine with not more 7) for use only as a cross-linking agent at than 10 percent by weight of a level not to exceed 15 percent by weight diethylaminoethanol. of the resin in contact with food under all 3-Pentadecenyl phenol mixture (obtained conditions of use, except that resins in- from cashew nutshell liquid) reacted with tended for use with foods containing more formaldehyde and ethylenediamine in a than 8 percent alcohol must contact such ratio of 1:2:2 (CAS Reg. No. 68413–28–5). food only under conditions of use D, E, F, Polyamine produced when 1 mole of the and G described in table 2 of paragraph (d) chlorohydrin diether of polyethylene gly- of this section. col 400 is made to react under Trimellitic anhydride adducts of ethylene dehydrohalogenating conditions with 2 glycol and glycerol, prepared by the reac- moles of N-octadecyltrimethylenediamine tion of 1 mole of trimellitic anhydride with for use only in coatings that are subject to 0.4–0.6 mole of ethylene glycol and 0.04–0.12 the provisions of paragraph (c) (3) or (4) of mole of glycerol, for use only as a cross- this section and that contact food at tem- linking agent at a level not to exceed 10 peratures not to exceed room temperature. percent by weight of the cured coating, Polyethylenepolyamine (CAS Reg. No. 68131– provided that the cured coating only con- 73–7), for use only in coatings intended for tacts food containing not more than 8 per- repeated use in contact with food, at tem- cent alcohol. peratures not to exceed 180 °F (82 °C). Meta-Xylylenediamine (1,3-benzenedi- Salicylic acid, for use only in coatings for methanamine, CAS Reg. No. 1477–55–0), for containers having a capacity of 1,000 gal- use only in coatings at a level not to ex- lons or more when such containers are in- ceed 3 percent by weight of the resin when tended for repeated use in contact with al- such coatings are intended for repeated use coholic beverages containing up to 8 per- in contact with foods only of the types cent of alcohol by volume. identified in paragraph (d) of this section, Salicylic acid (CAS Reg. No. 69–72–7), for use table 1, under Types I, II, and III, under only in coatings at a level not to exceed conditions of use C, D, E or F as described 0.35 percent by weight of the resin when in table 2 of paragraph (d) of this section; such coatings are intended for repeated use or when such coatings are intended for re- in contact with foods only of the types peated use in contact with foods of the identified in paragraph (d) of this section, types identified in paragraph (d) of this table 1, under Types I, II, and III, under section, table 1, under Types V, VI, VII, conditions of use C, D, E, or F as described and VIII, under conditions of use E or F as in table 2 of paragraph (d) of this section; described in table 2 of paragraph (d) of this or when such coatings are intended for re- section. Use shall be limited to coatings peated use in contact with foods of the for tanks of capacity greater than 530,000 types identified in paragraph (d) of this gallons. section, table 1, under Types V, VI, VII, Para-Xylylenediamine (1,4 benzenedimethan- and VIII, under conditions of use E or F as amine, CAS Reg. No. 539–48–0), for use only described in table 2 of paragraph (d) of this in coatings at a level not to exceed 0.6 per- section. Use shall be limited to coatings cent by weight of the resin when such coat- for tanks of capacity greater than 530,000 ings are intended for repeated use in con- gallons. tact with foods only of the types identified Stannous 2-ethylhexanoate for use only as a in paragraph (d) of this section, table 1, catalyst at a level not to exceed 1 percent under Types I, II, III, under conditions of

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use C, D, E, or F as described in table 2 of Urea-formaldehyde. paragraph (d) of this section; or when such Urea-formaldehyde chemically modified with coatings are intended for repeated use in methyl, ethyl, propyl, isopropyl, butyl, or contact with foods of the types identified isobutyl alcohol. in paragraph (d) of this section, table 1, Urea-formaldehyde chemically modified with under Types V, VI, VII, and VIII, under one or more of the amine catalysts listed conditions of use E and F as described in in paragraph (b)(3)(viii)(b) of this section. table 2 of paragraph (d) of this section. Use shall be limited to coatings for tanks of ca- (b) Curing (cross-linking) catalyst for pacity greater than 530,000 gallons. urea-formaldehyde resins: (c) Adjuncts for epoxy resins: Dodecyl benzenesulfonic acid (C.A. Registry No. 27176–87–0). Aluminum butylate. Benzoic acid, for use as a component in (xiii) Triazine-formaldehyde resins epoxy resins for coatings not exceeding a and their curing catalyst: coating weight of 4 milligrams per square (a) Triazine-formaldehyde resins, as inch and that are intended for contact the basic polymer: under conditions of use D, E, F or G de- scribed in table 2 of paragraph (d) of this Benzoguanamine-formaldehyde. section with alcoholic beverages con- Melamine-formaldehyde. taining less than 8 percent alcohol. Melamine-formaldehyde chemically modified Polyamides from dimerized vegetable oils with one or more of the following amine and the amine catalysts listed in para- catalysts: graph (b)(3)(viii)(b) of this section, as the Amine catalysts listed in paragraph basic polymer. (b)(3)(viii)(b) of this section. Silane coupled silica, prepared from the re- Dimethylamine-2-methyl-1-propanol. action of microcrystalline quartz with N- Methylpropanolamine. beta-(N-vinylbenzylamino) ethyl-gamma- Triethanolamine. aminopropyltrimethoxy silane, mono- Melamine-formaldehyde chemically modified hydrogen chloride, for use only in coatings with methyl, ethyl, propyl, isopropyl, intended for repeated use in contact with butyl, or isobutyl alcohol. foods only of the types identified in para- (b) Curing (cross-linking) catalyst for graph (d) of this section, table 1, under triazine-formaldehyde resins: Category I and Category VIII, at tempera- tures not exceeding 88 °C (190 °F). Dodecyl benzenesulfonic acid (C.A. Registry Succinic anhydride, for use as a component No. 27176–87–0). in epoxy resins for coatings not exceeding a coating weight of 4 milligrams per square (xiv) Modifiers (for oils and alkyds, inch, and that are intended for contact including polyesters), as the basic poly- under conditions of use D, E, F or G de- mer: scribed in table 2 of paragraph (d) of this section with alcoholic beverages con- Butyl methacrylate. taining less than 8 percent alcohol. Cyclopentadiene. Methyl, ethyl, butyl, or octyl esters of acryl- (ix) Coumarone-indene resin, as the ic acid. basic polymer. Methyl methacrylate. (x) Petroleum hydrocarbon resin Styrene. (cyclopentadiene type), as the basic Vinyl toluene. polymer. (xv) Vinyl resinous substance, as the (xi) Terpene resins, as the basic poly- basic polymers: mer, from one or more of the following: Polyvinyl acetate. Dipentene. Polyvinyl alcohol. Hydrogenated dipentene resin (CAS Reg. No. Polyvinyl butyral. 106168–39–2). For use only with coatings in Polyvinyl chloride. contact with acidic and aqueous foods. Polyvinyl formal. Hydrogenated-beta-pinene-alpha-pinene- Polyvinylidene chloride. dipentene copolymer resin (CAS Reg. No. Polyvinyl pyrrolidone. 106168–37–0). For use only with coatings in Polyvinyl stearate. contact with acidic and aqueous foods. Vinyl chloride-acetate-2,3-epoxypropyl meth- a-Pinene. acrylate copolymers containing not more b-Pinene. than 10 weight percent of total polymer units derived from 2,3-epoxypropyl meth- (xii) Urea-formaldehyde, resins and acrylate and not more than 0.1 weight per- their curing catalyst: cent of unreacted 2,3-epoxypropyl meth- (a) Urea-formaldehyde resins, as the acrylate monomer for use in coatings for basic polymer: containers.

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Vinyl chloride-acetate, hydroxyl-modified Ethylene-ethyl acrylate copolymer. copolymer. Ethylene-isobutyl acrylate copolymers con- Vinyl chloride-acetate, hydroxyl-modified taining no more than 35 weight percent of copolymer, reacted with trimellitic anhy- total polymer units derived from isobutyl dride. acrylate. Vinyl chloride copolymerized with acryl- Ethylene-vinyl acetate copolymer. amide and ethylene in such a manner that Polyethylene. the finished copolymers have a minimum (xix) Polypropylene as the basic poly- weight average molecular weight of 30,000 and contain not more than 3.5 weight per- mer: cent of total polymer units derived from Polypropylene. acrylamide; the acrylamide portion may or Maleic anhydride adduct of polypropylene may not be subsequently partially The polypropylene used in the manufac- hydrolyzed. ture of the adduct complies with Vinyl chloride copolymerized with one or § 177.1520(c), item 1.1; and the adduct has a more of the following substances: maximum combined maleic anhydride con- Acrylonitrile. tent of 0.8 percent and a minimum intrin- Fumaric acid and/or its methyl, ethyl, sic viscosity of 0.9, determined at 135 °C on propyl, butyl, amyl, hexyl, heptyl, or octyl a 0.1 percent solution of the modified poly- esters. propylene in decahydronaphthalene as de- Maleic acid and/or its methyl, ethyl, propyl, termined by a method titled ‘‘Method for butyl, amyl, hexyl, heptyl, or octyl esters. Determination of Intrinsic Viscosity of 5-Norbornene-2,3-dicarboxylic acid, mono-n- Maleic Anhydride Adduct of Poly- butyl ester; for use such that the finished propylene,’’ which is incorporated by ref- vinyl chloride copolymers contain not erence. Copies are available from the Cen- more than 4 weight percent of total poly- ter for Food Safety and Applied Nutrition mer units derived from this comonomer. (HFS–200), Food and Drug Administration, Vinyl acetate. 5100 Paint Branch Pkwy., College Park, Vinylidene chloride. MD 20740, or available for inspection at the Vinyl chloride-vinylidene chloride-2,3- National Archives and Records Adminis- epoxypropyl methacrylate copolymers con- tration (NARA). For information on the taining not more than 10 weight percent of availability of this material at NARA, call total polymer units derived from 2,3- 202–741–6030, or go to: http:// epoxypropyl methacrylate and not more www.archives.gov/federallregister/ than 0.05 weight percent of unreacted 2,3- codeloflfederallregulations/ epoxypropyl methacrylate monomer based ibrllocations.html. on polymer solids for use only in coatings for containers intended for contact with (xx) Acrylics and their copolymers, foods under conditions B, C, D, E, F, G, or as the basic polymer: H described in table 2 of paragraph (d) of this section. Acrylamide with ethylacrylate and/or sty- rene and/or methacrylic acid, subsequently (xvi) Cellulosics, as the basic poly- reacted with formaldehyde and butanol. mer: Acrylic acid and the following esters thereof: Ethyl. Carboxymethylcellulose. Methyl. Cellulose acetate. Butyl acrylate-styrene-methacrylic acid-hy- Cellulose acetate-butyrate. droxyethyl methacrylate copolymers con- Cellulose acetate-propionate. taining no more than 20 weight percent of Ethylcellulose. total polymer units derived from meth- Ethyl hydroxyethylcellulose. acrylic acid and containing no more than 7 Hydroxyethylcellulose. weight percent of total polymer units de- Hydroxypropyl methylcellulose. rived from hydroxyethyl methacrylate; for Methylcellulose. use only in coatings that are applied by Nitrocellulose. electrodeposition to metal substrates. (xvii) Styrene polymers, as the basic Butyl acrylate-styrene-methacrylic acid- hydroxypropyl methacrylate copolymers polymer: containing no more than 20 weight percent Polystyrene. of total polymer units derived from meth- a-Methyl styrene polymer. acrylic acid and containing no more than 7 Styrene copolymerized with one or more of weight percent of total polymer units de- the following: rived from hydroxypropyl methacrylate; Acrylonitrile. for use only in coatings that are applied by a-Methylstyrene. electrodeposition to metal substrates and that are intended for contact, under condi- (xviii) Polyethylene and its copoly- tion of use D, E, F, or G described in table mers as the basic polymer: 2 of paragraph (d) of this section, with food

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containing no more than 8 percent of alco- 250. The monomer content shall be less hol. than 0.5 percent. The polymers are for use Ethyl acrylate-styrene-methacrylic acid co- only in contact with food of Types IV-A, V, polymers for use only as modifiers for VII in table 1 of paragraph (d) of this sec- epoxy resins listed in paragraph tion, under use conditions E through G in (b)(3)(viii)(a) of this section. table 2 of paragraph (d), and with food of Ethyl acrylate-methyl methacrylate-sty- Type VIII without use temperature restric- rene-methacrylic acid copolymers for use tion. only as modifiers for epoxy resins listed in paragraph (b)(3)(viii)(a) of this section. (xxi) Elastomers, as the basic poly- 2-Ethylhexyl acrylate-ethyl acrylate copoly- mer: mers prepared by copolymerization of 2- Butadiene-acrylonitrile copolymer. ethylhexyl acrylate and ethyl acrylate in a Butadiene-acrylonitrile-styrene copolymer. 7/3 weight ratio and having a number aver- Butadiene-styrene copolymer. age molecular weight range of 5,800 to 6,500 Butyl rubber. and a refractive index, n ° (40 percent in D25 Chlorinated rubber. 2,2,4-trimethyl pentane) of 1.4130–1.4190; for 2-Chloro-1,3-butadiene (neoprene). use as a modifier for nylon resins com- Natural rubber (natural latex or natural plying with § 177.1500 of this chapter and for latex solids, smoked or unsmoked). phenolic and epoxy resins listed in para- Polyisobutylene. graph (b)(3) (vi) and (viii) of this section, Rubber hydrochloride. respectively, at a level not to exceed 1.5 Styrene-isobutylene copolymer. percent of the coating. 2-Ethylhexyl acrylate-methyl methacrylate- (xxii) Driers made by reaction of a acrylic acid copolymers for use only as metal from paragraph (b)(3)(xxii)(a) of modifiers for epoxy resins listed in para- this section with acid, to form the salt graph (b)(3)(viii) of this section. Methacrylic acid and the following esters listed in paragraph (b)(3)(xxii)(b) of this thereof: section: Butyl. (a) Metals: Ethyl. Aluminum. Methyl. Calcium. Methacrylic acid or its ethyl and methyl Cerium. esters copolymerized with one or more of Cobalt. the following: Iron. Acrylic acid. Lithium. Ethyl acrylate. Magnesium. Methyl acrylate. Manganese. n-Butyl acrylate-styrene-methacrylic acid- Zinc. hydroxyethyl methacrylate copolymers Zirconium. containing no more than 2 weight percent of total polymer units derived from meth- (b) Salts: acrylic acid and containing no more than 9.5 weight percent of total polymer units Caprate. derived from hydroxyethyl methacrylate; Caprylate. for use only in coatings in contact with dry Isodecanoate. food (food type VIII in table 1 of paragraph Linoleate. (d) of this section). 2-(Dimethylamino) eth- Naphthenate. anol (C.A.S. Registry No. 108–01–0) may be Neodecanoate. employed as an optional adjuvant sub- Octoate (2-ethylhexoate). stance limited to no more than 2 weight Oleate. percent based on polymer solids in the Palmitate. coating emulsion. Resinate. Styrene polymers made by the polymeriza- Ricinoleate. tion of any combination of styrene or Soyate. alpha methyl styrene with acrylic acid, Stearate. methacrylic acid, 2-ethyl hexyl acrylate, Tallate. methyl methacrylate, and butyl acrylate. (xxiii) Waxes: The styrene and alpha methyl styrene, in- dividually, may constitute from 0 to 80 Paraffin, Type I. weight percent of the polymer. The other Paraffin, Type II. monomers, individually, may be from 0 to Polyethylene. 40 weight percent of the polymer. The poly- Sperm oil. Spermaceti. mer number average molecular weight (Mn) shall be at least 2,000 (as determined by gel (xxiv) Plasticizers: permeation chromatography). The acid number of the polymer shall be less than Acetyl tributyl citrate.

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Acetyl triethyl citrate. Dioctyl sebacate. Butyl phthalyl butyl glycolate. Glyceryl monostearate. Butyl stearate. Lanolin. p-tert-Butyl phenyl salicylate. Mineral oil, white. Dibutyl sebacate. Palm oil. Diethyl phthalate. Paraffin, Type I. Diisobutyl adipate. Paraffin, Type II. Diisooctyl phthalate. Petrolatum. Epoxidized soybean oil (iodine number max- Stearic acid. imum 14; oxirane oxygen content 6% min- imum), as the basic polymer. (xxviii) Silicones and their curing Ethyl phthalyl ethyl glycolate. catalysts: 2-Ethylhexyl diphenyl phosphate. (a) Silicones as the basic polymer: di-2-Ethylhexyl phthalate. Siloxane resins originating from methyl hy- Glycerol. drogen polysiloxane, dimethyl Glyceryl monooleate. Glyceryl triacetate. polysiloxane, and methylphenyl Monoisopropyl citrate. polysiloxane. Propylene glycol. Siloxane resins originating from the plat- Sorbitol. inum-catalyzed reaction product of vinyl- Mono-, di-, and tristearyl citrate. containing dimethylpolysiloxane (CAS Triethyl citrate. Reg. No. 68083–18–1 and CAS Reg. No. 68083– Triethylene glycol. 19–2) with methylhydrogen polysiloxane 3-(2-Xenolyl)-1,2-epoxypropane. (CAS Reg. No. 63148–57–2) and dimethylmethylhydrogen polysiloxane (xxv) Release agents, as the basic (CAS Reg. No. 68037–59–2), where the plat- polymer, when applicable: inum content does not exceed 150 parts per million. The following substances may be N,N′-Dioleoylethylenediamine (CAS Reg. No. used as optional polymerization inhibitors: 110–31–6) for use only in ionomeric resins 3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. complying with § 177.1330 of this chapter 107–54–0), at a level not to exceed 0.53 and in ethylene vinyl acetate copolymers weight-percent; complying with § 177.1350 of this chapter at 1-Ethynylcyclohexene (CAS Reg. No. 931–49– a level not to exceed 0.0085 milligram per 7), at a level not to exceed 0.64 weight-per- square centimeter (0.055 milligram per cent; square inch) in the finished food-contact Bis(methoxymethyl)ethyl maleate (CAS Reg. article. No. 102054–10–4), at a level not to exceed 1.0 N,N′-Distearoyl ethylenediamine. weight-percent; Linoleic acid amide. Methylvinyl cyclosiloxane (CAS Reg. No. Oleic acid amide. 68082–23–5); and Palmitic acid amide. Tetramethyltetravinylcyclotetrasiloxane Petrolatum. (CAS Reg. No. 2554–06–5). Polyethylene wax. Polyoxyethylene glycol monooleate (mol. (b) Curing (cross-linking) catalysts wt. of the polyoxyethylene glycol moiety for silicones (the maximum amount of greater than 300). tin catalyst used shall be that required Polytetrafluoroethylene. to effect optimum cure but shall not Silicones (not less than 300 centistokes vis- exceed 1 part of tin per 100 parts of si- cosity): Dimethylpolysiloxanes and/or methylphenylpolysiloxanes. The methyl- loxane resins solids): phenylpolysiloxanes contain not more than Dibutyltin dilaurate. 2.0 percent by weight of cyclosiloxanes Stannous oleate. having up to and including 4 siloxy units. Tetrabutyl titanate. Silicones (not less than 100 centistokes vis- cosity): Dimethylpolysiloxanes and/or (xxix) Surface active agents: methylphenylpolysiloxanes limited to use Ethylene oxide adduct of 2,4,7,9-tetramethyl- only on metal substrates. The 5-decyn-4,7-diol (CAS Reg. No. 9014–85–1). methylphenylpolysiloxanes contain not Poly[2-(diethylamino) ethyl methacrylate] more than 2.0 percent by weight of phosphate (minimum intrinsic viscosity in cyclosiloxanes having up to and including 4 water at 25 °C is not less than 9.0 deciliters siloxy units. per gram as determined by ASTM method (xxvi) Colorants used in accordance D1243–79, ‘‘Standard Test Method for Dilute with § 178.3297 of this chapter. Solution Viscosity of Vinyl Chloride Poly- (xxvii) Surface lubricants: mers,’’ which is incorporated by reference (Copies may be obtained from the Amer- Cottonseed oil and other edible oils. ican Society for Testing Materials, 100 Dibutyl sebacate. Barr Harbor Dr., West Conshohocken,

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Philadelphia, PA 19428-2959, or may be ex- sealing compounds on containers having a amined at the National Archives and capacity of 5 gallons or more. Records Administration (NARA). For in- Sodium phenylphenate. formation on the availability of this mate- Styrene-maleic anhydride resin, partial rial at NARA, call 202–741–6030, or go to: methyl and butyl (sec- or iso-) esters, for http://www.archives.gov/federallregister/ use only at levels not in excess of 3 percent codeloflfederallregulations/ of the cement solids in can end cement for- ibrllocations.html.), for use only as a sus- mulations. pending agent in the manufacture of vinyl Tetrasodium EDTA (tetrasodium ethylene- chloride copolymers and limited to use at diaminetetraacetate). levels not to exceed 0.1 percent by weight Tri (mixed mono- and dinonylphenyl) of the copolymers. phosphite. Sodium dioctyl sulfosuccinate. Zinc dibutyldithiocarbamate. Sodium dodecylbenzenesulfonate (xxxii) Side seam cements: In addi- Sodium lauryl sulfate. 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. tion to the substances listed in para- Reg. No. 126-86-3), for use only in can coat- graph (b)(3) (i) to (xxx), inclusive, of ings which are subsequently dried and this section, the following may be used. cured at temperatures of at least 193 °C (380 p-tert-Butyl perbenzoate as a catalyst for °F) for 4 minutes. epoxy resin. (xxx) Antioxidants: epsilon-Caprolactam-(ethylene-ethyl acry- late) graft polymer. Butylated hydroxyanisole. Dicumyl peroxide for use only as polymeriza- Butylated hydroxytoluene. tion catalyst. Gum guaiac. 4–(Diiodomethylsulfonyl) toluene (CAS Reg. Dilauryl thiodipropionate. No. 20018–09–1) for use as a preservative at Nordihydroguaiaretic acid. a level not to exceed 0.3 percent by weight Propyl gallate. in can-sealing cements. Distearyl thiodipropionate. Diisodecyl phthalate for use only as plasti- Thiodipropionic acid. cizer in side seam cements for containers 2,4,5-Trihydroxybutyrophenone. intended for use in contact with food only of the types identified in paragraph (d) of (xxxi) Can end cements (sealing com- this section, table 1, under Categories I, II, pounds used for sealing can ends only): and VI. In addition to the substances listed in 4,4′-Bis(alpha,alpha-dimethyl- paragraph (b) of this section and those benzyl)diphenylamine, CAS Reg. No. 10081– listed in § 177.1210(b)(5) of this chapter, 67–1. the following may be used: Ethyl toluene sulfonamide. N,N′-Hexamethylenebis(3,5-di-tert-butyl-4- Butadiene-styrene-divinylbenzene copolymer hydroxyhydrocinnamide), CAS Reg. No. (CAS Reg. No. 26471–45–4) for use only at 23128–74–7. levels not to exceed 23.8 percent by weight Polyamides consisting of the following: of the cement solids in can end cements. Copolymer of omega-laurolactam and Butadiene-styrene-fumaric acid copolymer. espilon-caprolactam, CAS Reg. No. 25191– 4,4′-Butylidenebis (6-tert-butyl-m-cresol). 04–2 (Nylon 12/6). Dibenzamido phenyl disulfide. Homopolymer of omega-aminododecanoic Di-b-naphthyl phenylenediamine. acid, CAS Reg. No. 24937–16–4. Dipentamethylene thiuram tetrasulfide. Homopolymer of omega-laurolactam, CAS Isobutylene-isoprene-divinylbenzene copoly- Reg. No. 25038–74–8 (Nylon 12). mers for use only at levels not to exceed 15 Polyamides derived from the following acids percent by weight of the dry cement com- and amines: position. Acids: Naphthalene sulfonic acid-formaldehyde con- Adipic. densate, sodium salt, for use only at levels Azelaic. not to exceed 0.6 percent by weight of the Sebacic. cement solids in can end cements for con- Vegetable oil acids (with or without tainers having a capacity of not less than dimerization). 5 gallons. Amines: Sodium decylbenzene sulfonate. Diethylenetriamine. Sodium nitrite for use only at levels not to Diphenylamine. exceed 0.3 percent by weight of the cement Ethylenediamine. solids in can end cements for containers Hexamethylenediamine. having a capacity of not less than 5 gal- Tetraethylenepentamine. lons. Triethylenetetramine. Sodium pentachlorophenate for use as a pre- Polypropylene glycol CAS Reg. No. 25322–69– servative at 0.1 percent by weight in can- 4.

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Sodium pentachlorophenate for use as a pre- coatings for tanks of capacity greater than servative at 0.1 percent by weight in can- 530,000 gallons. sealing compounds on containers having a Castor oil, sulfated, sodium salt (CAS Reg. capacity of 5 gallons or more. No. 68187–76–8), for use only in coatings for Tetrakis [methylene(3,5-di-tert-butyl-4- containers intended for repeated use. hydroxyhydrocinnamate)]methane, CAS Cetyl alcohol. Reg. No. 6683–19–8. 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Toluene sulfonamide formaldehyde resin Reg. No. 26172–55–4) and 2-methyl-4- (basic polymer). isothiazolin-3-one (CAS Reg. No. 2682–20–4) Triethylene glycol methacrylate for use only mixture, at a ratio of 3 parts to 1 part, re- as polymerization cross-linking agent in spectively, manufactured from methyl-3- side seam cements for containers intended mercaptopropionate (CAS Reg. No. 2935–90– for use in contact with food only of the 2) and optionally containing magnesium types identified in paragraph (d) of this nitrate (CAS Reg. No. 10377–60–3) at a con- section, table 1, under Categories I, II, and centration equivalent to the isothiazolone VI. active ingredients (weight/weight). For use Urea. only as an antimicrobial agent in emul- sion-based silicone coatings at a level not (xxxiii) Miscellaneous materials: to exceed 50 milligrams per kilogram (based on isothiazolone active ingredient) Ammonium citrate. in the coating formulations. Ammonium potassium phosphate. Cyclohexanone-formaldehyde resin produced Bentonite, modified by reaction with benzyl when 1 mole of cyclohexanone is made to dimethyl alkyl ammonium chloride, where react with 1.65 moles of formaldehyde such the alkyl groups are derived from hydro- that the finished resin has an average mo- genated tallow (CAS Reg. No. 71011–24–0). lecular weight of 600–610 as determined by For use only as a rheological agent in coat- ASTM method D2503–82, ‘‘Standard Test ings intended to contact food under re- Method for Molecular Weight (Relative peated use conditions. Molecular Mass) of Hydrocarbons by Ther- Bentonite, modified by reaction with sodium moelectric Measurement of Vapor Pres- stearate and benzyl dimethyl alkyl ammo- sure,’’ which is incorporated by reference. nium chloride, where the alkyl groups are Copies may be obtained from the American derived from hydrogenated tallow (CAS Society for Testing Materials, 100 Barr Reg. No. 121888–68–4). For use as a Harbor Dr., West Conshohocken, Philadel- rheological agent only in coatings in- phia, PA 19428-2959, or may be examined at tended to contact dry food under repeated- the National Archives and Records Admin- use conditions. istration (NARA). For information on the Calcium acetate. availability of this material at NARA, call Calcium ethyl acetoacetate. 202–741–6030, or go to: http:// Calcium glycerophosphate. www.archives.gov/federallregister/ Calcium, sodium, and potassium oleates. codeloflfederallregulations/ Calcium, sodium, and potassium ibrllocations.html. For use only in contact ricinoleates. with nonalcoholic and nonfatty foods Calcium, sodium, and potassium stearates. under conditions of use E, F, and G, de- Castor oil, hydrogenated. scribed in table 2 of paragraph (d) this sec- Castor oil, hydrogenated polymer with ethyl- tion. enediamine, 12-hydroxyoctadecanoic acid Decyl alcohol. and sebacic acid (CAS Reg. No. 68604–06–8). 1,2-Dibromo-2,4-dicyanobutane (CAS Reg No. The condensation product formed by the 35691–65–7). For use as an antimicrobial reaction of hydrogenated castor oil with agent at levels not to exceed 500 milli- polyamide derived from ethylenediamine, grams per kilogram in emulsion-based sili- sebacic acid and 12-hydroxystearic acid, for cone coatings. use only in coatings at a level not to ex- Disodium hydrogen phosphate. ceed 3.2 percent by weight of the resin Ethyl acetoacetate. when such coatings are intended for re- Hectorite, modified by reaction with a mix- peated use in contact with foods only of ture of benzyl methyl dialkyl ammonium the types identified in paragraph (d) of this chloride and dimethyl dialkyl ammonium section, table 1, under Types I, II, and III, chloride, where the alkyl groups are de- under conditions of use C, D, E, or F as de- rived from hydrogenated tallow (CAS Reg. scribed in table 2 of paragraph (d) of this No. 121888–67–3). For use as a rheological section; or when such coatings are in- agent only in coatings intended to contact tended for repeated use in contact with dry food under repeated-use conditions. foods of the types identified in paragraph Lauryl alcohol. (d) of this section, table 1, under Types V, Lecithin. VI, VII, and VIII, under conditions of use E Magnesium, sodium, and potassium citrate. or F as described in table 2 of paragraph (d) Magnesium glycerophosphate. of this section. Use shall be limited to Magnesium stearate.

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Mono-, di-, and tricalcium phosphate. ings that contact food at temperatures Monodibutylamine pyrophosphate as not to exceed room temperature. sequestrant for iron. Mono-, di-, and trimagnesium phosphate. (xxxv) Polyamide resins having a Myristyl alcohol. maximum acid value of 5 and a max- Octyl alcohol. imum amine value of 8.5 derived from Phosphoric acid. dimerized vegetable oil acids (con- Polybutene, hydrogenated; complying with taining not more than 10 percent of the identity and limitations prescribed by monomer acids), ethylenediamine, and § 178.3740 of this chapter. 4,4-bis (4-hydroxyphenyl) pentanoic Poly(ethylene oxide). Siloxanes and silicones, dimethyl, 3- acid (in an amount not to exceed 10 hydroxypropyl group-terminated, diesters percent by weight of said polyamide with poly(2-oxepanone), diacetates (CAS resins); as the basic resin, for use only Reg. No. 116810–47–0) at a level not to ex- in coatings that contact food at tem- ceed 0.025 weight percent of the finished peratures not to exceed room tempera- coating having no greater than a 0.5 mil ture provided that the concentration of thickness for use as a component of poly- ester, epoxy, and acrylic coatings com- the polyamide resins in the finished plying with paragraphs (b)(3)(vii), (viii), food-contact coating does not exceed 5 and (xx) of this section, respectively. milligrams per square inch of food-con- Silver chloride-coated titanium dioxide for tact surface. use only as a preservative in latex emul- (xxxvi) Methacrylonitrile grafted sions at a level not to exceed 2.2 parts per polybutadiene copolymers containing million (based on silver ion concentration) in the dry coating. no more than 41 weight percent of total Sodium pyrophosphate. polymer units derived from Stannous chloride. methacrylonitrile; for use only in coat- Stannous stearate. ings that are intended for contact, Stannous sulfate. under conditions of use D, E, F, or G Stearyl alcohol. described in table 2 of paragraph (d) of 2-Sulfoethyl methacrylate, sodium salt (CAS Reg. No. 1804–87–1). For use only in copoly- this section, with food containing no mer coatings on metal under conditions of more than 8 percent of alcohol. use E, F, and G described in table 2 of para- (xxxvii) Polymeric resin as a coating graph (d) of this section, and limited to use component prepared from terephthalic at a level not to exceed 2.0 percent by acid, isophthalic acid, succinic anhy- weight of the dry copolymer coating. dride, ethylene glycol, diethylene gly- Tetrasodium pyrophosphate. Tridecyl alcohol produced from col, and 2,2-dimethyl-1,3-propanediol tetrapropylene by the oxo process, for use for use in contact with aqueous foods only as a processing aid in polyvinyl chlo- and alcoholic foods containing not ride resins. more than 20 percent (by volume) of al- Trimethylolpropane (CAS Reg. No. 77–99–6). cohol under conditions of use D, E, F, For use as a pigment dispersant at levels and G described in table 2 of § 176.170 of not to exceed 0.45 percent by weight of the this chapter. The resin shall contain no pigment. Vinyl acetate-dibutyl maleate copolymers more than 30 weight percent of 2,2-di- produced when vinyl acetate and dibutyl methyl-1,3-propanediol. maleate are copolymerized with or without (c) The coating in the finished form one of the monomers: Acrylic acid or in which it is to contact food, when ex- glycidyl methacrylate. For use only in tracted with the solvent or solvents coatings for metal foil used in contact with characterizing the type of food, and foods that are dry solids with the surface under conditions of time and tempera- containing no free fat or oil. The finished copolymers shall contain at least 50 ture characterizing the conditions of weight-percent of polymer units derived its intended use as determined from ta- from vinyl acetate and shall contain no bles 1 and 2 of paragraph (d) of this sec- more than 5 weight-percent of total poly- tion, shall yield chloroform-soluble ex- mer units derived from acrylic acid or tractives, corrected for zinc extractives glycidyl methacrylate. as zinc oleate, not to exceed the fol- (xxxiv) Polyamide resins derived lowing: from dimerized vegetable oil acids (1) From a coating intended for or (containing not more than 20 percent of employed as a component of a con- monomer acids) and ethylenediamine, tainer not to exceed 1 gallon and in- as the basic resin, for use only in coat- tended for one-time use, not to exceed

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0.5 milligram per square inch nor to ex- square inch that would equal 0.005 per- ceed that amount as milligrams per cent of the water capacity of the con- square inch that would equal 0.005 per- tainer in milligrams, divided by the cent of the water capacity of the con- area of the food-contact surface of the tainer, in milligrams, divided by the container in square inches. area of the food-contact surface of the (4) From coating intended for re- container in square inches. From a fab- peated use, and employed other than as ricated container conforming with the a component of a container, not to ex- description in this paragraph (c)(1), the ceed 18 milligrams per square inch of extractives shall not exceed 0.5 milli- coated surface. gram per square inch of food-contact (d) Tables: surface nor exceed 50 parts per million of the water capacity of the container TABLE 1—TYPES OF FOOD as determined by the methods provided I. Nonacid (pH above 5.0), aqueous products; in paragraph (e) of this section. may contain salt or sugar or both, and in- (2) From a coating intended for or cluding oil-in-water emulsions of low- or employed as a component of a con- high-fat content. tainer having a capacity in excess of 1 II. Acidic (pH 5.0 or below), aqueous prod- gallon and intended for one-time use, ucts; may contain salt or sugar or both, and including oil-in-water emulsions of not to exceed 1.8 milligrams per square low- or high-fat content. inch nor to exceed that amount as mil- III. Aqueous, acid or nonacid products con- ligrams per square inch that would taining free oil or fat; may contain salt, equal 0.005 percent of the water capac- and including water-in-oil emulsions of ity of the container in milligrams, di- low- or high-fat content. vided by the area of the food-contact IV. Dairy products and modifications: surface of the container in square A. Water-in-oil emulsion, high- or low-fat. inches. B. Oil-in-water emulsion, high- or low-fat. V. Low moisture fats and oils. (3) From a coating intended for or VI. Beverages: employed as a component of a con- A. Containing alcohol. tainer for repeated use, not to exceed B. Nonalcoholic. 18 milligrams per square inch nor to VII. Bakery products. exceed that amount as milligrams per 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

Extractant Condition of use Types of food (see Table 1) Water Heptane1,2 8% alcohol (time and temperature) (time and temperature) (time and temperature)

A. High temperature I, IV–B ...... 250 °F, 2 hr ...... heat-sterilized (e.g., over 212 °F). 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- II, IV–B ...... Fill boiling, cool to 100 . ized above 150 °F. °F. III, IV–A ...... do ...... 120 °F, 15 min. V ...... do. D. Hot filled or pasteur- II, IV–B, VI–B ...... 150 °F, 2 hr ...... ized below 150 °F. III, IV–A ...... do ...... 100 °F, 30 min. V ...... do. VI–A ...... 150 °F, 2 hr. E. Room temperature II, IV–B, VI–B ...... 120 °F, 24 hr ...... filled and stored (no thermal treatment in the container). III, IV–A ...... do ...... 70 °F, 30 min. V, VII ...... do. VI–A ...... 120 °F, 24 hr. F. Refrigerated storage I, II, III, IV–A, IV–B, 70 °F, 48 hr ...... (no thermal treatment VI–B,VII. in the container). VI–A ...... 70 °F, 48 hr.

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TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES—Contin- ued

Extractant Condition of use Types of food (see Table 1) Water Heptane1,2 8% alcohol (time and temperature) (time and temperature) (time and temperature)

G. Frozen storage (no I, II, III, IV–B, VII ... 70 °F, 24 hr ...... thermal treatment in the container). H. Frozen storage: Ready-prepared foods intended to be re- heated in container at time of use: 1. Aqueous or oil in I, II, IV–B ...... 212 °F, 30 min ...... water emulsion of high or low fat. 2. Aqueous, high or III, IV–A, VII ...... do ...... 120 °F, 30 min. low free oil or fat. 1 Heptane extractant not to be used on wax-lined containers. 2 Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.

(e) Analytical methods—(1) Selection of to 1 gallon, quadruplicate samples of extractability conditions. First ascertain representative containers (using for the type of food product (table 1, para- each replicate sample the number of graph (d) of this section) that is being containers nearest to an area of 180 packed commercially in the test con- square inches) should be selected from tainer and the normal conditions of the lot to be examined. thermal treatment used in packaging (3) Cleaning procedure preliminary to the type of food involved. Using table 2 determining the amount of extractables (paragraph (d) of this section), select from coated containers. Quadruplicate the food-simulating solvent or solvents samples of representative containers (demineralized distilled water, should be selected from the lot to be heptane, and/or 8 percent ethyl alcohol) examined and must be carefully rinsed and the time-temperature exaggera- to remove extraneous material prior to tions of the container-use conditions. the actual extraction procedure. Soda Aqueous products (Types I, II, IV-B, fountain pressure-type hot water rins- and VI-B) require only a water- ing equipment, consisting in its sim- extractability test at the temperature plest form of a 1⁄8-inch–1⁄4-inch internal and time conditions shown for the diameter metal tube attached to a hot most severe ‘‘conditions of use.’’ Aque- water line and bent so as to direct a ous products with free oil or fat, and stream of water upward, may be used. water-oil emulsions (types III, IV-A, Be sure hot water has reached a tem- and VII) will require determinations of perature of 190 °F–200 °F before starting both water extractability and heptane to rinse the container. Invert the con- extractability. Low-moisture fats and tainer over the top of the fountain and oils (type V with no free water) require direct a strong stream of hot water only the heptane extractability. Alco- against the bottom and all sides for 1 holic beverages (type VI-A) require minute, drain, and allow to dry. only the 8 percent alcohol extractant. (4) Exposure conditions—(i) Water (250 Having selected the appropriate ex- °F for 2 hours), simulating high-tempera- tractant or extractants simulating var- ture heat sterilization. Fill the container ious types of foods and beverages and within 1⁄4-inch of the top with a meas- the time-temperature exaggerations ured volume of demineralized distilled over normal use, follow the applicable water. Cover the container with clean extraction procedure. Adapt the proce- aluminum foil and place the container dure, when necessary, for containers on a rack in a pressure cooker. Add a having a capacity of over 1 gallon. small amount of demineralized dis- (2) Selection of coated-container sam- tilled water to the pressure cooker, but ples. For consumer-sized containers up do not allow the water to touch the

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bottom of the container. Close the foil. Place the test container in an cooker securely and start to heat over oven maintained at 150 °F. After 2 a suitable burner. When a steady hours, remove the test container from stream of steam emerges from the the oven and immediately composite vent, close the vent and allow the pres- the water of each replicate in a clean sure to rise to 15 pounds per square Pyrex flask or beaker. Proceed with inch (250 °F) and continue to maintain the determination of the amount of ex- this pressure for 2 hours. Slowly re- tractives by the method described in lease the pressure, open the pressure paragraph (e)(5) of this section. cooker when the pressure reads zero, (v) Water (120 °F for 24 hours), simu- and composite the water of each rep- lating room temperature filling and stor- licate immediately in a clean Pyrex age. Preheat demineralized distilled flask or beaker. Proceed with the de- water to 120 °F in a clean Pyrex flask. termination of the amount of extrac- Fill the container within 1⁄4-inch of the tives by the method described in para- top with a measured volume of the 120 graph (e)(5) of this section. °F water and cover with clean alu- (ii) Water (212 °F for 30 minutes), simu- minum foil. Place the test container in lating boiling water sterilization. Fill the an incubator or oven maintained at 120 container within 1⁄4-inch of the top °F. After 24 hours, remove the test con- with a measured volume of boiling, tainer from the incubator and imme- demineralized distilled water. Cover diately composite the water of each the container with clean aluminum foil replicate in a clean Pyrex flask or and place the container on a rack in a beaker. Proceed with the determina- pressure cooker in which a small tion of the amount of extractives by amount of demineralized distilled the method described in paragraph water is boiling. Do not close the pres- (e)(5) of this section. sure vent, but operate at atmospheric (vi) Water (70 °F for 48 hours), simu- pressure so that there is a continuous lating refrigerated storage. Bring escape of a small amount of steam. demineralized distilled water to 70 °F Continue to heat for 30 minutes, then in a clean Pyrex flask. Fill the con- remove the test container and com- tainer within 1⁄4-inch of the top with a posite the contents of each replicate measured volume of the 70 °F water, immediately in a clean Pyrex flask or and cover with clean aluminum foil. beaker. Proceed with the determina- Place the test container in a suitable tion of the amount of extractives by room maintained at 70 °F. After 48 the method described in paragraph hours, immediately composite the (e)(5) of this section. water of each replicate in a clean (iii) Water (from boiling to 100 °F), sim- Pyrex flask or beaker. Proceed with ulating hot fill or pasteurization above 150 the determination of the amount of ex- °F. Fill the container within 1⁄4-inch of tractives by the method described in the top with a measured volume of paragraph (e)(5) of this section. boiling, demineralized distilled water. (vii) Water (70 °F for 24 hours), simu- Insert a thermometer in the water and lating frozen storage. Bring allow the uncovered container to stand demineralized distilled water to 70 °F in a room at 70 °F–85 °F. When the tem- in a clean Pyrex flask. Fill the con- perature reads 100 °F, composite the tainer within 1⁄4-inch of the top with a water from each replicate immediately measured volume of the 70 °F water in a clean Pyrex flask or beaker. Pro- and cover with clean aluminum foil. ceed with the determination of the Place the container in a suitable room amount of extractives by the method maintained at 70 °F. After 24 hours, im- described in paragraph (e)(5) of this mediately composite the water of each section. replicate in a clean Pyrex flask or (iv) Water (150° for 2 hours), simulating beaker. Proceed with the determina- hot fill or pasteurization below 150 °F. tion of the amount of extractives by Preheat demineralized distilled water the method described in paragraph to 150 °F in a clean Pyrex flask. Fill (e)(5) of this section. the container within 1⁄4-inch of the top (viii) Water (212 °F for 30 minutes), sim- with a measured volume of the 150 °F ulating frozen foods reheated in the con- water and cover with clean aluminum tainer. Fill the container to within 1⁄4-

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inch of the top with a measured volume of explosion. Fill the test container of boiling, demineralized distilled within 1⁄4-inch of the top with a meas- water. Cover the container with clean ured volume of the 120 °F heptane and aluminum foil and place the container cover with clean aluminum foil. Place on a rack in a pressure cooker in which the test container in the preheated a small amount of demineralized dis- pressure cooker and then put the as- tilled water is boiling. Do not close the sembly into a 120 °F incubator. After 30 pressure vent, but operate at atmos- minutes, remove the pressure cooker pheric pressure so that there is a con- from the incubator, open the assembly, tinuous escape of a small amount of and immediately composite the steam. Continue to heat for 30 minutes, heptane of each replicate in a clean then remove the test container and Pyrex flask or beaker. Proceed with composite the contents of each rep- the determination of the amount of ex- licate immediately in a clean Pyrex tractives by the method described in flask or beaker. Proceed with the de- paragraph (e)(5) of this section. termination of the amount of extrac- (xi) Heptane (120 °F for 15 minutes), tives by the method described in para- simulating hot fill or pasteurization above graph (e)(5) of this section. 150 °F for fatty foods only. Preheat re- (ix) Heptane (150 °F for 2 hours) simu- distilled reagent-grade heptane (boiling lating high-temperature heat sterilization point 208 °F) carefully in a clean Pyrex for fatty foods only. Preheat redistilled flask on a water bath or nonsparking reagent-grade heptane (boiling point hot plate in a well-ventilated hood to 208 °F) carefully in a clean Pyrex flask 120 °F. At the same time, preheat a on a water bath or nonsparking hot pressure cooker or equivalent to 120 °F plate in a well-ventilated hood to 150 in an incubator. This pressure cooker °F. At the same time preheat a pres- is to serve only as a container for the sure cooker or equivalent to 150 °F in heptane-containing test package inside an incubator. This pressure cooker is the incubator in order to minimize the to serve only as a container for the danger of explosion. Fill the test con- heptane-containing test package inside tainer within 1⁄4-inch of the top with a the incubator in order to minimize the measured volume of the 120 °F heptane danger of explosion. Fill the test con- and cover with clean aluminum foil. tainer within 1⁄4-inch of the top with a Place the test container in the measured volume of the 150 °F heptane preheated pressure cooker and then put and cover with clean aluminum foil. the assembly into a 120 °F incubator. Place the test container in the After 15 minutes, remove the pressure preheated pressure cooker and then put cooker from the incubator, open the as- the assembly into a 150 °F incubator. sembly, and immediately composite After 2 hours, remove the pressure the heptane of each replicate in a clean cooker from the incubator, open the as- Pyrex flask or beaker. Proceed with sembly, and immediately composite the determination of the amount of ex- the heptane of each replicate in a clean tractives by the method described in Pyrex flask or beaker. Proceed with paragraph (e)(5) of this section. the determination of the amount of ex- (xii) Heptane (100 °F for 30 minutes), tractives by the method described in simulating hot fill or pasteurization below paragraph (e)(5) of this section. 150 °F for fatty foods only. Preheat re- (x) Heptane (120 °F for 30 minutes), sim- distilled reagent-grade heptane (boiling ulating boiling water sterilization of fatty point 208 °F) carefully in a clean Pyrex foods only. Preheat redistilled reagent- flask on a water bath or nonsparking grade heptane (boiling point 208 °F) hot plate in a well-ventilated hood to carefully in a clean Pyrex flask on a 100 °F. At the same time, preheat a water bath or nonsparking hot plate in pressure cooker or equivalent to 100 °F a well-ventilated hood to 120 °F. At the in an incubator. This pressure cooker same time, preheat a pressure cooker is to serve only as a container for the or equivalent to 120 °F in an incubator. heptane-containing test package inside This pressure cooker is to serve only as the incubator in order to minimize the a vented container for the heptane-con- danger of explosion. Fill the test con- taining test package inside the incu- tainer within 1⁄4-inch of the top with a bator in order to minimize the danger measured volume of the 100 °F heptane

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and cover with clean aluminum foil. test container with within 1⁄4-inch of Place the test container in the the top with a measured volume of the preheated pressure cooker and then put 8 percent alcohol. Cover the container the assembly into a 100 °F incubator. with clean aluminum foil and place in After 30 minutes, remove the pressure an oven maintained at 150 °F. After 2 cooker from the incubator, open the as- hours, remove the container from the sembly and immediately composite the oven and immediately composite the heptane of each replicate in a clean alcohol from each replicate in a clean Pyrex flask or beaker. Proceed with Pyrex flask. Proceed with the deter- the determination of the amount of ex- mination of the amount of extractives tractives by the method described in by the method described in paragraph paragraph (e)(5) of this section. (e)(5) of this section. (xiii) Heptane (70 °F for 30 minutes), (xvi) Alcohol—8 percent (120 °F for 24 simulating room temperature filling and hours), simulating alcoholic beverages storage of fatty foods only. Fill the test room-temperature filled and stored. Pre- container within 1⁄4-inch of the top heat 8 percent (by volume) ethyl alco- with a measured volume of the 70 °F hol in demineralized distilled water to heptane and cover with clean alu- 120 °F in a clean Pyrex flask. Fill the minum foil. Place the test container in test container within 1⁄4-inch of the top a suitable room maintained at 70 °F. with a measured volume of the 8 per- After 30 minutes, composite the cent alcohol, cover the container with heptane of each replicate in a clean clean aluminum foil and place in an Pyrex flask or beaker. Proceed with oven or incubator maintained at 120 °F. the determination of the amount of ex- After 24 hours, remove the container tractives by the method described in from the oven or incubator and imme- paragraph (e)(5) of this section. diately composite the alcohol from (xiv) Heptane (120 °F for 30 minutes), each replicate into a clean Pyrex flask. simulating frozen fatty foods reheated in Proceed with the determination of the the container. Preheat redistilled rea- amount of extractives by the method gent-grade heptane (boiling point 208 described in paragraph (e)(5) of this °F) carefully in a clean Pyrex flask on section. a water bath or hot plate in a well-ven- (xvii) Alcohol—8 percent (70 °F for 48 tilated hood to 120 °F. At the same hours), simulating alcoholic beverages in time, preheat a pressure cooker to 120 refrigerated storage. Bring 8 percent (by °F in an incubator. This pressure cook- volume) ethyl alcohol in demineralized er is to serve only as a container for distilled water to 70 °F in a clean Pyrex the heptane-containing test package flask. Fill the test container within 1⁄4- inside the incubator in order to mini- inch of the top with a measured volume mize the danger of explosion. Fill the of the 8 percent alcohol. Cover the con- test container within 1⁄4-inch of the top tainer with clean aluminum foil. Place with a measured volume of the 120 °F the test container in a suitable room heptane and cover with clean alu- maintained at 70 °F. After 48 hours, im- minum foil. Place the test container in mediately composite the alcohol from the preheated pressure cooker and then each replicate into a clean Pyrex flask. put the assembly into a 120 °F incu- Proceed with the determination of the bator. After 30 minutes, remove the amount of extractives by the method pressure cooker from the incubator, described in paragraph (e)(5) of this open the assembly and immediately section. composite the heptane from each rep- NOTE: The tests specified in paragraph licate into a clean Pyrex flask. Proceed (e)(4) (i) through (xvii) of this section are ap- with the determination of the amount plicable to flexible packages consisting of of extractives by the method described coated metal contacting food, in which case in paragraph (e)(5) of this section. the closure end is double-folded and clamped (xv) Alcohol—8 percent (150 °F for 2 with metal spring clips by which the package hours), simulating alcoholic beverages hot can be suspended. filled or pasteurized below 150 °F. Pre- (5) Determination of amount of extrac- heat 8 percent (by volume) ethyl alco- tives—(i) Total residues. Evaporate the hol in demineralized distilled water to food-simulating solvents from para- 150 °F in a clean Pyrex flask. Fill the graph (e)(4) (i) to (xvii), inclusive, of

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this section to about 100 milliliters in grams per square inch exceed the limi- the Pyrex flask and transfer to a clean, tations prescribed in paragraph (c) of tared platinum dish, washing the flask this section for the particular con- three times with the solvent used in tainer size, proceed to paragraph the extraction procedure, and evapo- (e)(5)(ii) of this section (method for de- rate to a few milliliters on a non- termining the amount of chloroform- sparking low-temperature hotplate. soluble extractives residue). The last few milliliters should be evap- (ii) Chloroform-soluble extractives res- orated in an oven maintained at a tem- idue. Add 50 milliliters of chloroform perature of 212 °F. Cool the platinum (freshly distilled reagent grade or a dish in a desiccator for 30 minutes and grade having an established consist- weigh the residue to the nearest 0.1 ently low blank) to the dried and milligram (e). Calculate the extractives weighed residue, (e), in the platinum in milligrams per square inch and in dish, obtained in paragraph (e)(5)(i) of parts per million for the particular size this section. Warm carefully, and filter of container being tested and for the through Whatman No. 41 filter paper in specific food-simulating solvent used. a Pyrex funnel, collecting the filtrate (a) Water and 8-percent alcohol. in a clean, tared platinum dish. Repeat the chloroform extraction, washing the Milligrams extractives = e filter paper with this second portion of per square inch chloroform. Add this filtrate to the s original filtrate and evaporate the Ex= ( e )( a )(1000) total down to a few milliliters on a Extractives residue = low-temperature hotplate. The last few ()()cs milliliters should be evaporated in an oven maintained at 212 °F. Cool the (b) Heptane. platinum dish in a desiccator for 30 e minutes and weigh to the nearest 0.1 Milligrams extractives = milligram to get the chloroform-solu- per square inch ()()sF ble extractives residue (e′). This e′ is substituted for e in the equations in Ex= ( e )( a )(1000) paragraph (e)(5)(i) (a) and (b) of this Extractives residue = section. If the concentration of extrac- ()()()csF tives (Ex) still exceeds 50 parts per mil- lion or the extractives in milligrams where: per square inch exceed the limitations Ex=Extractives residue in ppm for any con- tainer size. prescribed in paragraph (c) of this sec- e=Milligrams extractives per sample tested. tion for the particular container size, a=Total coated area, including closure in proceed as follows to correct for zinc square inches. extractives (‘‘C’’ enamels only): Ash c=Water capacity of container, in grams. the residue in the platinum dish by s=Surface of coated area tested, in square heating gently over a Meeker-type inches. burner to destroy organic matter and F=Five, the ratio of the amount of extrac- hold at red heat for about 1 minute. tives removed from a coated container by heptane under exaggerated time-tempera- Cool in the air for 3 minutes, and place ture test conditions compared to the the platinum dish in the desiccator for amount extracted by a fat or oil from a 30 minutes and weigh to the nearest 0.1 container tested under exaggerated condi- milligram. Analyze this ash for zinc by tions of thermal sterilization and use. standard Association of Official Agri- e′=Chloroform-soluble extractives residue. cultural Chemists methods or equiva- ee′=Zinc corrected chloroform-soluble ex- lent. Calculate the zinc in the ash as tractive residue. zinc oleate, and subtract from the e′ or ee′ is substituted for e in the above equa- tions when necessary. weight of chloroform-soluble extrac- tives residue (e′) to obtain the zinc-cor- If when calculated by the equations in rected chloroform-soluble extractives paragraph (e)(5)(i) (a) and (b) of this residue (ee′). This ee′ is substituted for section, the concentration of extrac- e in the formulas in paragraph (e)(5)(i) tives residue (Ex) exceeds 50 parts per (a) and (b) of this section. To comply million or the extractives in milli- with the limitations in paragraph (c) of

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this section, the chloroform-soluble ex- Filter paper, Whatman No. 41 or equiva- tractives residue (but after correction lent. for the zinc extractives in case of ‘‘C’’ (g) In accordance with good manufac- enamels) must not exceed 50 parts per turing practice, finished coatings in- million and must not exceed in milli- tended for repeated food-contact use grams per square inch the limitations shall be thoroughly cleansed prior to for the particular article as prescribed their first use in contact with food. in paragraph (c) of this section. (h) Acrylonitrile copolymers identi- (f) Equipment and reagent require- fied in this section shall comply with ments—(1) Equipment. the provisions of § 180.22 of this chap- Rinsing equipment, soda fountain pressure- ter. type hot water, consisting in simplest form [42 FR 14534, Mar. 15, 1977] of a 1⁄8-inch–1⁄4-inch inside diameter metal tube attached to a hot water line delivering EDITORIAL NOTE: For FEDERAL REGISTER ci- 190 °F–200 °F water and bent so as to direct tations affecting § 175.300, see the List of CFR a stream of water upward. Sections Affected, which appears in the Pressure cooker, 21-quart capacity with Finding Aids section of the printed volume pressure gage, safety release, and removable and at www.fdsys.gov. rack, 12.5 inches inside diameter × 11 inches inside height, 20 pounds per square inch safe § 175.320 Resinous and polymeric coat- operating pressure. ings for polyolefin films. Oven, mechanical convection, range to in- Resinous and polymeric coatings clude 120 °F–212 °F explosion-proof, inside di- may be safely used as the food-contact ″ × ″ × ″ mensions (minimum), 19 19 19 , constant surface of articles intended for use in temperature to ±2 °F (water bath may be substituted). producing, manufacturing, packing, Incubator, inside dimensions (minimum) processing, preparing, treating, pack- 19″ × 19″ × 19″ for use at 100 °F±2 °F explosion aging, transporting, or holding food, in proof (water bath may be substituted). accordance with the following pre- Constant-temperature room or chamber 70 scribed conditions: °F±2 °F minimum inside dimensions 19″ × 19″ (a) The coating is applied as a contin- × 19″. uous film over one or both sides of a Hot plate, nonsparking (explosion proof), base film produced from one or more of top 12″ × 20″, 2,500 watts, with temperature the basic olefin polymers complying control. with § 177.1520 of this chapter. The base Platinum dish, 100-milliliter capacity min- imum. polyolefin film may contain optional All glass, Pyrex or equivalent. adjuvant substances permitted for use in polyolefin film by applicable regula- (2) Reagents. tions in parts 170 through 189 of this Water, all water used in extraction proce- chapter. dure should be freshly demineralized (deion- (b) The coatings are formulated from ized) distilled water. optional substances which are: Heptane, reagent grade, freshly redistilled (1) Substances generally recognized before use, using only material boiling at 208 as safe for use in or on food. °F. (2) Substances the use of which is Alcohol, 8 percent (by volume), prepared permitted under applicable regulations from undenatured 95 percent ethyl alcohol in parts 170 through 189 of this chapter, diluted with demineralized or distilled water. by prior sanctions, or approvals. Chloroform, reagent grade, freshly redis- (3) Substances identified in this para- tilled before use, or a grade having an estab- graph (b)(3) and subject to such limita- lished, consistently low blank. 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.

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List of substances Limitations

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 For use only in coatings that contact food under conditions of 1 a-methylstyrene to 3 vinyltoluene). 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 For use only in coatings for polypropylene films that contact basic resin, derived from: 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 For use only in coatings for polyolefin films that contact food at acids (containing not more than 20% of monomer acids) temperatures not to exceed room temperature. and ethylenediamine, as the basic resin. Polyamide resins having a maximum acid value of 5 and a For use only in coatings that contact food at temperatures not maximum amine value of 8.5 derived from dimerized to exceed room temperature provided that the concentration vegetable oil acids (containing not more than 10 percent of the polyamide resins in the finished food-contact coating of monomer acids), ethylenediamine, and 4,4-bis (4- does not exceed 5 milligrams per square inch of food-con- hydroxyphenyl) pentanoic acids (in an amount not to ex- tact surface. ceed 10 percent by weight of said polyamide resins); as the basic resin. Polyester resins formed by reaction of one or more of the following polybasic acids and monobasic acids with one or more of the following polyhydric alcohols: Polybasic acids: Adipic. Azelaic ...... For use in forming polyester resins intended for use in coatings that contact food only of the type identified in § 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.

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List of substances Limitations

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 Platinum content not to exceed 150 parts per million. 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:. 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).. Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a surface coating under the following conditions: 68083–19–2 and 68083–18–1), with methyl hydrogen 1. In coatings for olefin polymers provided the coating contacts polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate food only of the types identified in § 176.170(c) of this chap- (CAS Reg. No. 624–48–6) and vinyl acetate (CAS Reg. No. ter, table 1, under Types I, II, VI, and VII-B when used under 108–05–4) may be used as optional polymerization inhibitors. 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 Platinum content not to exceed 100 parts per million. For use vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives. 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. Styrene copolymerized with one or more of the following: Acrylonitrile. a-Methyl styrene.

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List of substances Limitations

Styrene polymers made by the polymerization of any com- For use only in contact with foods of Types IV-A, V, and VII in bination of styrene or alpha methyl styrene with acrylic table 1 of § 176.170(c) of this chapter, under use conditions acid, methacrylic acid, 2-ethyl hexyl acrylate, methyl E through G in table 2 of § 176.170(c), and with foods of methacrylate, and butyl acrylate. The styrene and alpha Types VIII and IX without use temperature restriction. 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. 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 For use only in copolymer coatings under conditions of use E, Service No. 1804–87–1]. 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 ...... 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– For use only as an antimicrobial agent in emulsion-based sili- 55–4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. cone coatings at a level not to exceed 50 milligrams per kilo- 2682–20–4) mixture, at a ratio of 3 parts to 1 part, respec- gram (based on isothiazolone active ingredient) in the coat- tively, manufactured from methyl-3-mercaptopropionate (CAS ing formulation. 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).. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65– For use as an antimicrobial agent at levels not to exceed 500 7). 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.

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List of substances Limitations

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- For use only as a dispersing agent at levels not to exceed 6% tion at 20 °C of 4 centipoises and percent alcoholysis of of total coating weight in coatings for pol-yolefin films pro- 87–100. 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 (b) The quantity of any optional sub- in which it is to contact food, when ex- stance does not exceed the amount rea- tracted with the solvent or solvents sonably required to accomplish the in- characterizing the type of food, and tended physical or technical effect nor under conditions of time and tempera- any limitations further provided. ture characterizing the conditions of (c) Any optional substance that is its intended use as determined from ta- the subject of a regulation in parts 174, bles 1 and 2 of § 176.17(c) of this chapter, 175, 176, 177, 178, and § 179.45 of this shall yield net chloroform-soluble ex- chapter conforms with any specifica- tractives not to exceed 0.5 milligram tions in such regulation. per square inch of coated surface. (d) Optional substances as provided (d) Acrylonitrile copolymers identi- in paragraph (a) of this section include: fied in this section shall comply with (1) Substances generally recognized the provisions of § 180.22 of this chap- as safe in food. ter. (2) Substances subject to prior sanc- tion or approval for uses with a copoly- [42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29, mer of vinyl acetate and crotonic acid 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, and used in accordance with such sanc- Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR tion or approval. 49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 (3) Substances identified in this sub- FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, paragraph and subject to such limita- 1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, tions as are provided: June 13, 2000] List of substances Limitations § 175.350 Vinyl acetate/crotonic acid copolymer. Silica. Japan wax. A copolymer of vinyl acetate and crotonic acid may be safely used as a (e) Copolymer of vinyl acetate and coating or as a component of a coating crotonic acid used as a coating or as a which is the food-contact surface of component of a coating conforming polyolefin films intended for packaging with the specifications of paragraph food, subject to the provisions of this (e)(1) of this section are used as pro- section. vided in paragraph (e)(2) of this sec- (a) The copolymer may contain added tion. optional substances to impart desired (1) Specifications. (i) The chloroform- properties. soluble portion of the water extractives

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of the coated film obtained with dis- (d) The coating in the finished form tilled water at 120 °F for 24 hours does in which it is to contact food, when ex- not exceed 0.5 milligram per square tracted with the solvent or solvents inch of coated surface. characterizing the type of food, and (ii) The chloroform-soluble portion of under conditions of time and tempera- the n-heptane extractives of the coated ture characterizing the conditions of film obtained with n-heptane at 70 °F its intended use as determined from ta- for 30 minutes does not exceed 0.5 milli- bles 1 and 2 of § 176.170(c) of this chap- gram per square inch of coated surface. ter, shall yield net chloroform-soluble (2) Conditions of use. The copolymer extractives not to exceed 0.5 milligram of vinyl acetate and crotonic acid is per square inch of coated surface when used as a coating or as a component of tested by the methods described in a coating for polyolefin films for pack- § 176.170(d) of this chapter. aging bakery products and confec- (e) Acrylonitrile copolymers identi- tionery. fied in this section shall comply with the provisions of § 180.22 of this chap- § 175.360 Vinylidene chloride copoly- ter. mer coatings for nylon film. [42 FR 14534, Mar. 15, 1977, as amended at 43 Vinylidene chloride copolymer coat- FR 7206, Feb. 21, 1978; 45 FR 76998, Nov. 21, ings identified in this section and ap- 1980; 47 FR 54430, Dec. 3, 1982] plied on nylon film may be safely used § 175.365 Vinylidene chloride copoly- as food-contact surfaces, in accordance mer coatings for polycarbonate with the following prescribed condi- film. tions: Vinylidene chloride copolymer coat- (a) The coating is applied as a contin- ings identified in this section and ap- uous film over one or both sides of a plied on polycarbonate film may be base film produced from nylon resins safely used as food-contact surfaces, in complying with § 177.1500 of this chap- accordance with the following pre- ter. scribed conditions: (b) The coatings are prepared from (a) The coating is applied as a contin- vinylidene chloride copolymers pro- uous film over one or both sides of a duced by copolymerizing vinylidene base film produced from polycarbonate chloride with one or more of the mono- resins complying with § 177.1580 of this mers acrylic acid, acrylonitrile, ethyl chapter. acrylate, methacrylic acid, methyl ac- (b) The coatings are prepared from rylate, methyl methacrylate (CAS Reg. vinylidene chloride copolymers pro- No. 80–62–6; maximum use level 6 duced by copolymerizing vinylidene weight percent) and 2-sulfoethyl meth- chloride with acrylonitrile, methyl ac- acrylate (CAS Reg. No. 10595–80–9; max- rylate, and acrylic acid. The finished imum use level 1 weight percent). The copolymers contain at least 50 weight- finished copolymers contain at least 50 percent of polymer units derived from weight percent of polymer units de- vinyldene chloride. rived from vinylidene chloride. The fin- (c) Optional adjuvant substances em- ished coating produced from vinylidene ployed in the production of the coat- chloride copolymers produced by co- ings or added thereto to impart desired polymerizing vinylidene chloride with properties may include sodium methyl methacrylate and/or 2- dodecylbenzenesulfonate in addition to sulfoethyl methacrylate, or with meth- substances described in § 174.5(d) of this yl methacrylate and/or 2-sulfoethyl chapter. methacrylate together with one or (d) The coating in the finished form more of the other monomers from this in which it is to contact food, when ex- section, is restricted to use at or below tracted with the solvent or solvents room temperature. characterizing the type of food, and (c) Optional adjuvant substances em- under the conditions of time and tem- ployed in the production of the coat- perature characterizing the conditions ings or added thereto to impart desired of its intended use as determined from properties may include sodium tables 1 and 2 of § 176.170(c) of this chap- dodecylbenzenesulfonate. ter, shall yield net chloroform-soluble

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extractives in each extracting solvent 0.05 milligram per square inch of food- not to exceed 0.5 milligram per square contact surface. inch of coated surface as determined by (c) The resins identified in paragraph the methods described in § 176.170(d) of (a) of this section may be used as a this chapter. In testing the finished food-contact coating for articles in- food-contact articles, a separate test tended for contact at temperatures not sample is to be used for each required to exceed room temperature with food extracting solvent. of Type VI-C described in table 1 of (e) Acrylonitrile copolymers identi- § 176.170(c) of this chapter provided the fied in this section shall comply with coating in the finished form in which it the provisons of § 180.22 of this chapter. is to contact food meets the following extractives limitations when tested by § 175.380 Xylene-formaldehyde resins the methods provided in § 175.300(e): condensed with 4,4′- (1) The coating when extracted with isopropylidenediphenol- distilled water at 180 °F for 24 hours epichlorohydrin epoxy resins. yields total extractives not to exceed The resins identified in paragraph (a) 0.05 milligram per square inch of food- of this section may be safely used as a contact surface. food-contact coating for articles in- (2) The coating when extracted with tended for use in contact with food, in 50 percent (by volume) ethyl alcohol in accordance with the following pre- distilled water at 180 °F for 24 hours scribed conditions. yields total extractives not to exceed (a) The resins are produced by the 0.05 milligram per square inch. condensation of xylene-formaldehyde resin and 4,4′-isopropylidenediphenol- § 175.390 Zinc-silicon dioxide matrix epichlorohydrin epoxy resins, to which coatings. may have been added certain optional Zinc-silicon dioxide matrix coatings adjuvant substances required in the may be safely used as the food-contact production of the resins or added to im- surface of articles intended for use in part desired physical and technical producing, manufacturing, packing, properties. The optional adjuvant sub- processing, preparing, treating, pack- stances may include resins produced by aging, transporting, or holding food, the condensation of allyl ether of subject to the provisions of this sec- mono-, di-, or trimethylol phenol and tion; capryl alcohol and also may include (a) The coating is applied to a metal substances identified in § 175.300(b)(3), surface, cured, and washed with water with the exception of paragraph (b)(3) to remove soluble substances. (xxxi) and (xxxii) of that section. (b) The coatings are formulated from (b) The resins identified in paragraph optional substances which include: (a) of this section may be used as a (1) Substances generally recognized food-contact coating for articles in- as safe. tended for contact at temperatures not (2) Substances for which safe condi- to exceed 160 °F with food of Types I, tions of use have been prescribed in II, VI-A and B, and VIII described in § 175.300. table 1 of § 176.170(c) of this chapter (3) Substances identified in para- provided that the coating in the fin- graph (c) of this section, subject to the ished form in which it is to contact limitations prescribed. food meets the following extractives (c) The optional substances per- limitations when tested by the meth- mitted are as follows: ods provided in § 175.300(e): (1) The coating when extracted with List of substances Limitations ° distilled water at 180 F for 24 hours Ethylene glycol ...... As a solvent removed by yields total extractives not to exceed water washing. 0.05 milligram per square inch of food- Iron oxide. contact surface. Lithium hydroxide ...... Removed by water washing. Methyl orange ...... As an acid-base indicator. (2) The coating when extracted with 8 Potassium dichromate ...... Removed by water washing. percent (by volume) ethyl alcohol in Silica gel. distilled water at 160 °F for 4 hours Sodium silicate. yields total extractives not to exceed Zinc, as particulate metal.

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(d) The coating in the finished form Subpart A [Reserved] in which it is to contact food, when ex- tracted with the solvent or solvents Subpart B—Substances for Use characterizing the type of food, and under the conditions of its intended use Only as Components of Paper as shown in table 1 and 2 of § 175.300(d) and Paperboard (using 20 percent alcohol as the solvent § 176.110 Acrylamide-acrylic acid res- when the type of food contains approxi- ins. mately 20 percent alcohol) shall yield total extractives not to exceed those Acrylamide-acrylic acid resins may prescribed in § 175.300(c)(3); lithium ex- be safely used as components of arti- tractives not to exceed 0.025 milligram cles intended for use in producing, per square inch of surface; and chro- manufacturing, packing, processing, mium extractives not to exceed 0.05 preparing, treating, packaging, trans- microgram per square inch of surface. porting, or holding food, subject to the (e) The coatings are used as food-con- provisions of this section. tact surfaces for bulk reusable con- (a) Acrylamide-acrylic acid resins are tainers intended for storing, handling, produced by the polymerization of ac- and transporting food. rylamide with partial hydrolysis or by the copolymerization of acrylamide and acrylic acid. PART 176—INDIRECT FOOD ADDI- (b) The acrylamide-acrylic acid res- TIVES: PAPER AND PAPERBOARD ins contain less than 0.2 percent resid- COMPONENTS ual monomer. (c) The resins are used as adjuvants Subpart A [Reserved] in the manufacture of paper and paper- board in amounts not to exceed that Subpart B—Substances for Use Only as necessary to accomplish the technical Components of Paper and Paperboard effect and not to exceed 2 percent by Sec. weight of the paper or paperboard. 176.110 Acrylamide-acrylic acid resins. 176.120 Alkyl ketene dimers. § 176.120 Alkyl ketene dimers. 176.130 Anti-offset substances. Alkyl ketene dimers may be safely 176.150 Chelating agents used in the manu- used as a component of articles in- facture of paper and paperboard. tended for use in producing, manufac- 176.160 Chromium (Cr III) complex of N- turing, packing, processing, preparing, ethyl-N-heptadecylfluoro-octane sulfonyl treating, packaging, transporting, or glycine. holding food, subject to the provisions 176.170 Components of paper and paperboard of this section. in contact with aqueous and fatty foods. 176.180 Components of paper and paperboard (a) The alkyl ketene dimers are man- in contact with dry food. ufactured by the dehydrohalogenation 176.200 Defoaming agents used in coatings. of the acyl halides derived from the 176.210 Defoaming agents used in the manu- fatty acids of animal or vegetable fats facture of paper and paperboard. and oils. 176.230 3,5-Dimethyl-1,3,5,2H- (b) The alkyl ketene dimers are used tetrahydrothiadiazine-2-thione. as an adjuvant in the manufacture of 176.250 Poly-1,4,7,10,13-pentaaza-15- paper and paperboard under such condi- hydroxyhexadecane. tions that the alkyl ketene dimers and 176.260 Pulp from reclaimed fiber. their hydrolysis products dialkyl 176.300 Slimicides. ketones do not exceed 0.4 percent by 176.320 Sodium nitrate-urea complex. weight of the paper or paperboard. 176.350 Tamarind seed kernel powder. (c) The alkyl ketene dimers may be AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. used in the form of an aqueous emul- SOURCE: 42 FR 14554, Mar. 15, 1977, unless sion which may contain sodium otherwise noted. lignosulfonate as a dispersant. EDITORIAL NOTE: Nomenclature changes to § 176.130 Anti-offset substances. part 176 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. Substances named in paragraphs (b) 1, 2005. and (c) of this section may be safely

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