Part 177—Indirect Food Additives: Polymers

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Part 177—Indirect Food Additives: Polymers Pt. 177 21 CFR Ch. I (4±1±99 Edition) PART 177ÐINDIRECT FOOD 177.1570 Poly-1-butene resins and butene/ ethylene copolymers. ADDITIVES: POLYMERS 177.1580 Polycarbonate resins. 177.1585 Polyestercarbonate resins. Subpart A [Reserved] 177.1590 Polyester elastomers. 177.1595 Polyetherimide resin. Subpart BÐSubstances for Use as Basic 177.1600 Polyethylene resins, carboxyl modi- Components of Single and Repeated fied. Use Food Contact Surfaces 177.1610 Polyethylene, chlorinated. 177.1615 Polyethylene, fluorinated. Sec. 177.1620 Polyethylene, oxidized. 177.1010 Acrylic and modified acrylic plas- 177.1630 Polyethylene phthalate polymers. tics, semirigid and rigid. 177.1632 Poly (phenyleneterephthalamide) 177.1020 Acrylonitrile/butadiene/styrene co± resins. polymer. 177.1635 Poly(p-methylstyrene) and rubber- 177.1030 Acrylonitrile/butadiene/styrene/ modified poly(p-methylstyrene). methyl methacrylate copolymer. 177.1637 Poly(oxy-1,2- 177.1040 Acrylonitrile/styrene copolymer. ethanediyloxycarbonyl-2,6- 177.1050 Acrylonitrile/styrene copolymer naphthalenediylcarbonyl) resins. modified with butadiene/styrene elas- 177.1640 Polystyrene and rubber-modified tomer. polystyrene. 177.1060 n-Alkylglutarimide/acrylic copoly- 177.1650 Polysulfide polymer-polyepoxy res- mers. ins. 177.1200 Cellophane. 177.1655 Polysulfone resins. 177.1210 Closures with sealing gaskets for 177.1660 Poly (tetramethylene food containers. terephthalate). 177.1240 1,4-Cyclohexylene dimethylene 177.1670 Polyvinyl alcohol film. terephthalate and 1,4-cyclohexylene 177.1680 Polyurethane resins. dimethylene isophthalate copolymer. 177.1810 Styrene block polymers. 177.1820 Styrene-maleic anhydride copoly- 177.1310 Ethylene-acrylic acid copolymers. mers. 177.1312 Ethylene-carbon monoxide copoly- 177.1830 Styrene-methyl methacrylate co- mers. polymers. 177.1315 Ethylene-1,4-cyclohexylene 177.1850 Textryls. dimethylene terephthalate copolymers. 177.1900 Urea-formaldehyde resins in molded 177.1320 Ethylene-ethyl acrylate copoly- articles. mers. 177.1950 Vinyl chloride-ethylene copoly- 177.1330 Ionomeric resins. mers. 177.1340 Ethylene-methyl acrylate copoly- 177.1960 Vinyl chloride-hexene-1 copoly- mer resins. mers. 177.1345 Ethylene/1,3-phenylene oxyethylene 177.1970 Vinyl chloride-lauryl vinyl ether isophthalate/terephthalate copolymer. copolymers. 177.1350 Ethylene-vinyl acetate copolymers. 177.1980 Vinyl chloride-propylene copoly- 177.1360 Ethylene-vinyl acetate-vinyl alco- mers. hol copolymers. 177.1990 Vinylidene chloride/methyl acry- 177.1380 Fluorocarbon resins. late copolymers. 177.1390 Laminate structures for use at tem- 177.2000 Vinylidene chloride/methyl acry- ° peratures of 250 F and above. late/methyl methacrylate polymers. 177.1395 Laminate structures for use at tem- peratures between 120 °F and 250 °F. Subpart CÐSubstances for Use Only as 177.1400 Hydroxyethyl cellulose film, water- Components of Articles Intended for insoluble. 177.1420 Isobutylene polymers. Repeated Use 177.1430 Isobutylene-butene copolymers. 177.2210 Ethylene polymer, 177.1440 4,4′-Isopropylidenediphenol- chlorosulfonated. epichlorohydrin resins minimum molec- 177.2250 Filters, microporous polymeric. ular weight 10,000. 177.2260 Filters, resin-bonded. 177.1460 Melamine-formaldehyde resins in 177.2280 4,4′-Isopropylidenediphenol- molded articles. epichlorohydrin thermosetting epoxy 177.1480 Nitrile rubber modified acrylo- resins. nitrile-methyl acrylate copolymers. 177.2355 Mineral reinforced nylon resins. 177.1500 Nylon resins. 177.2400 Perfluorocarbon cured elastomers. 177.1520 Olefin polymers. 177.2410 Phenolic resins in molded articles. 177.1550 Perfluorocarbon resins. 177.2415 Poly(aryletherketone) resins. 177.1555 Polyarylate resins. 177.2420 Polyester resins, cross-linked. 177.1556 Polyaryletherketone resins. 177.2430 Polyether resins, chlorinated. 177.1560 Polyarylsulfone resins. 177.2440 Polyethersulfone resins. 218 VerDate 06<MAY>99 09:09 May 12, 1999 Jkt 183064 PO 00000 Frm 00214 Fmt 8010 Sfmt 8010 Y:\SGML\183064T.XXX pfrm03 PsN: 183064T Food and Drug Administration, HHS § 177.1010 177.2450 Polyamide-imide resins. more of the acrylic or methacrylic 177.2460 Poly(2,6-dimethyl-1,4-phenylene) monomers listed in paragraph (a)(1) of oxide resins. this section. 177.2465 Polymethylmethacrylate/poly(tri methoxysilylpropyl) methacrylate co- (1) Homopolymers and copolymers of polymers. the following monomers: 177.2470 Polyoxymethylene copolymer. n-Butyl acrylate. 177.2480 Polyoxymethylene homopolymer. n-Butyl methacrylate. 177.2490 Polyphenylene sulfide resins. Ethyl acrylate. 177.2510 Polyvinylidene fluoride resins. 2-Ethylhexyl acrylate. 177.2550 Reverse osmosis membranes. Ethyl methacrylate. 177.2600 Rubber articles intended for re- Methyl acrylate. peated use. Methyl methacrylate. 177.2710 Styrene-divinylbenzene resins, cross-linked. (2) Copolymers produced by copolym- 177.2800 Textiles and textile fibers. erizing one or more of the monomers 177.2910 Ultra-filtration membranes. listed in paragraph (a)(1) of this section AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. with one or more of the following monomers: SOURCE: 42 FR 14572, Mar. 15, 1977, unless otherwise noted. Acrylonitrile. EDITORIAL NOTE: Nomenclature changes to Methacrylonitrile. α part 177 appear at 61 FR 14482, Apr. 2, 1996. -Methylstyrene. Styrene. Vinyl chloride. Subpart A [Reserved] Vinylidene chloride. (3) Polymers identified in paragraphs Subpart BÐSubstances for Use as (a)(1) and (2) of this section containing Basic Components of Single no more than 5 weight-percent of total and Repeated Use Food Con- polymer units derived by copolym- tact Surfaces erization with one or more of the monomers listed in paragraph (a)(3)(i) § 177.1010 Acrylic and modified acrylic and (ii) of this section. Monomers list- plastics, semirigid and rigid. ed in paragraph (a)(3)(ii) of this section Semirigid and rigid acrylic and modi- are limited to use only in plastic arti- fied acrylic plastics may be safely used cles intended for repeated use in con- as articles intended for use in contact tact with food. with food, in accordance with the fol- (i) List of minor monomers: lowing prescribed conditions. The Acrylamide. acrylic and modified acrylic polymers Acrylic acid or plastics described in this section 1,3-Butylene glycol dimethacrylate. also may be safely used as components 1,4-Butylene glycol dimethacrylate. of articles intended for use in contact Diethylene glycol dimethacrylate. with food. Diproplylene glycol dimethacrylate. (a) The optional substances that may Divinylbenzene. be used in the formulation of the Ethylene glycol dimethacrylate. semirigid and rigid acrylic and modi- Itaconic acid. Methacrylic acid. fied acrylic plastics, or in the formula- N-Methylolacrylamide. tion of acrylic and modified acrylic N-Methylolmethacrylamide. components of articles, include sub- 4-Methyl-1,4-pentanediol dimethacrylate. stances generally recognized as safe in Propylene glycol dimethacrylate. food, substances used in accordance Trivinylbenzene. with a prior sanction or approval, sub- (ii) List of minor monomers limited stances permitted for use in such plas- to use only in plastic articles intended tics by regulations in parts 170 through for repeated use in contact with food: 189 of this chapter, and substances identified in this paragraph. At least 50 Allyl methacrylate [Chemical Abstracts weight-percent of the polymer content Service Registry No. 96±05±9] tert-Butyl acrylate. of the acrylic and modified acrylic ma- tert-Butylaminoethyl methacrylate. terials used as finished articles or as sec-Butyl methacrylate. components of articles shall consist of tert-Butyl methacrylate. polymer units derived from one or Cyclohexyl methacrylate. 219 VerDate 06<MAY>99 09:09 May 12, 1999 Jkt 183064 PO 00000 Frm 00215 Fmt 8010 Sfmt 8010 Y:\SGML\183064T.XXX pfrm03 PsN: 183064T § 177.1010 21 CFR Ch. I (4±1±99 Edition) Dimethylaminoethyl methacrylate. and oils, and fatty alcohols derived 2-Ethylhexyl methacrylate. from such acids. Hydroxyethyl methacrylate. (7) Surface active agent: Sodium Hydroxyethyl vinyl sulfide. Hydroxypropyl methacrylate. dodecylbenzenesulfonate. Isobornyl methacrylate. (8) Miscellaneous materials: Isobutyl methacrylate. Di(2-ethylhexyl) phthalate, for use only as a Isopropyl acrylate. flow promoter at a level not to exceed 3 Isopropyl methacrylate. weight-percent based on the monomers. Methacrylamide. Dimethyl phthalate. Methacrylamidoethylene urea. Oxalic acid, for use only as a polymerization Methacryloxyacetamidoethylethylene urea. catalyst aid. Methacryloxyacetic acid. Tetraethylenepentamine, for use only as a n-Propyl methacrylate. catalyst activator at a level not to exceed 3,5,5-Trimethylcyclohexyl methacrylate. 0.5 weight-percent based on the monomers. (4) Polymers identified in paragraphs Toluene. (a)(1), (2), and (3) of this section are Xylene. mixed together and/or with the fol- (b) The semirigid and rigid acrylic lowing polymers, provided that no and modified acrylic plastics, in the chemical reactions, other than addi- finished form in which they are to con- tion reactions, occur when they are tact food, when extracted with the sol- mixed: vent or solvents characterizing the type of food and under the conditions Butadiene-acrylonitrile copolymers. Butadiene-acrylonitrile-styrene copolymers. of time and temperature as determined Butadiene-acrylonitrile-styrene-methyl from tables 1 and 2 of § 176.170(c) of this methacrylic copolymers. chapter, shall yield extractives not to Butadiene-styrene copolymers. exceed the following,
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