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Food and Drug Administration, HHS § 177.2600 Food and Drug Administration, HHS § 177.2600 (2) Reverse osmosis membranes de- tion in parts 174, 175, 176, 177, 178 and scribed in paragraph (a)(4) of this sec- § 179.45 of this chapter conforms with tion may be used in contact with all any specification in such regulation. types of liquid food, except food con- (i) Elastomers. taining more than 8 percent alcohol, at Acrylonitrile-butadiene copolymer. temperatures up to 80 °C (176 °F). Brominated isobutylene-isoprene copolymers (3) Reverse osmosis membranes shall complying with § 177.1210. be maintained in a sanitary manner in Butadiene-acrylonitrile-ethylene glycol accordance with current good manufac- dimethacrylate copolymers containing not turing practice so as to prevent micro- more than 5 weight percent of polymer bial adulteration of food. units derived from ethylene glycol dimethacrylate. (4) To assure their safe use, reverse Butadiene-acrylonitrile-methacrylic acid co- osmosis membranes and their supports polymer. shall be thoroughly cleaned prior to Butadiene-styrene-methacrylic acid copoly- their first use in accordance with cur- mer. rent good manufacturing practice. Chloroprene polymers. Chlorotrifluoroethylene-vinylidene fluoride [49 FR 49448, Dec. 20, 1984, as amended at 52 copolymer. FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, Ethylene-propylene copolymer elastomers 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, which may contain not more than 5 Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] weight-percent of total polymer units de- rived from 5-methylene-2-norbornene and/ § 177.2600 Rubber articles intended for or 5-ethylidine-2-norbornene. repeated use. Ethylene-propylene-dicyclopentadiene co- Rubber articles intended for repeated polymer. use may be safely used in producing, Ethylene-propylene-1,4-hexadiene copoly- mers containing no more than 8 weight manufacturing, packing, processing, percent of total polymer units derived preparing, treating, packaging, trans- from 1,4-hexadiene. porting, or holding food, subject to the Hydrogenated butadiene/acrylonitrile co- provisions of this section. polymers (CAS Reg. No. 88254–10–8) pro- (a) The rubber articles are prepared duced when acrylonitrile/butadiene copoly- from natural and/or synthetic polymers mers are modified by hydrogenation of the and adjuvant substances as described olefinic unsaturation to leave either: (1) Not more than 10 percent trans olefinic in paragraph (c) of this section. unsaturation and no a, b-olefinic (b) The quantity of any substance unsaturation as determined by a method employed in the production of rubber entitled ‘‘Determination of Residual a, b- articles intended for repeated use shall Olefinic and Trans Olefinic Unsaturation not exceed the amount reasonably re- Levels in HNBR,’’ developed October 1, quired to accomplish the intended ef- 1991, by Polysar Rubber Corp., 1256 South fect in the rubber article and shall not Vidal St., Sarnia, Ontario, Canada N7T 7MI; or (2) 0.4 percent to 20 percent olefinic be intended to accomplish any effect in unsaturation and Mooney viscosities great- food. er than 45 (ML 1 + 4 @ 100 °C), as deter- (c) Substances employed in the prep- mined by ASTM Standard Method D1646– aration of rubber articles include the 92, ‘‘Standard Test Method for Rubber— following, subject to any limitations Viscosity and Vulcanization Characteris- prescribed: tics (Mooney Viscometer),’’ which are both (1) Substances generally recognized incorporated by reference in accordance as safe for use in food or food pack- with 5 U.S.C. 552(a) and 1 CFR part 51. Cop- ies of these methods may be obtained from aging. the Division of Petition Control (HFS–215), (2) Substances used in accordance Center for Food Safety and Applied Nutri- with the provisions of a prior sanction tion, Food and Drug Administration, 5100 or approval. Paint Branch Pkwy., College Park, MD (3) Substances that by regulation in 20740, or may be examined at the Center for parts 170 through 189 of this chapter Food Safety and Applied Nutrition’s Li- may be safely used in rubber articles, brary, 5100 Paint Branch Pkwy., College subject to the provisions of such regu- Park, MD 20740, or at the National Ar- chives and Records Administration lation. (NARA). For information on the avail- (4) Substances identified in this para- ability of this material at NARA, call 202– graph (c)(4), provided that any sub- 741–6030, or go to: http://www.archives.gov/ stance that is the subject of a regula- federallregister/ 355 VerDate Mar<15>2010 10:14 May 14, 2012 Jkt 226069 PO 00000 Frm 00365 Fmt 8010 Sfmt 8010 Y:\SGML\226069.XXX 226069 erowe on DSK2VPTVN1PROD with CFR § 177.2600 21 CFR Ch. I (4–1–12 Edition) codeloflfederallregulations/ Silicone (Fsi) elastomers containing meth- ibrllocations.html. A copy of ASTM Stand- yl and fluorine groups. ard Method D1646–92 may also be obtained Silicone (PVsi) elastomers containing from the American Society for Testing and phenyl, methyl, and vinyl groups. Materials, 100 Barr Harbor Dr., West Styrene-butadiene copolymer. Conshohocken, PA 19428–2959. Vinylidene fluoride-hexafluoropropylene co- Isobutylene-isoprene copolymer. polymers (minimum number average mo- Polyamide/polyether block copolymers (CAS lecular weight 70,000 as determined by os- Reg. No. 77402–38–1 prepared by reacting a motic pressure in methyl ethyl ketone). copolymer of omega-laurolactam and adipic Vinylidene fluoride-hexafluoropropylene- acid with poly(tetramethylene ether gly- tetrafluoroethylene copolymers (minimum col). The polyamide and polyether compo- number average molecular weight 100,000 nents are reacted in ratios such that the as determined by osmotic pressure in polyamide component constitutes a min- methyl ethyl ketone). imum of 30 weight-percent of total polymer units. The copolymers may be used in con- (ii) Vulcanization materials—(a) Vul- tact with foods of Types I, II, III, IV, V, VI, canizing agents. VII, VIII, and IX identified in table 1 of ′ § 176.170(c) of this chapter at temperatures 4,4 -Bis(aminocyclohexyl)methane carbamate not to exceed 150 °F except that those co- for use only as cross-linking agent in the polymers prepared with less than 50 vulcanization of vinylidene weight-percent of polyamide are limited to fluoridehexafluoropropylene copolymer use in contact with such foods at tempera- and vinylidene fluoride- tures not to exceed 100 °F. hexafluoropropylene-tetrafluoroethylene Polybutadiene. copolymer elastomers identified under Polyester elastomers derived from the reac- paragraph (c)(4)(i) of this section and lim- tion of dimethyl terephthalate, 1,4- ited to use at levels not to exceed 2.4 per- butanediol, and a-hydro-omega- cent by weight of such copolymers. hydroxypoly (oxytetramethylene). Addi- Diisopropyl xanthogen polysulfide (a 1:2:1 tionally, trimethyl trimellitate may be mixture of O,O-di(1-methylethyl)trithio- used as a reactant. The polyester bis-thioformate, O,O-di(1- elastomers may be used only in contact methylethyl)tetrathio-bis-thioformate, with foods containing not more than 8 per- and O,O-di(1-methylethyl)pentathio-bis- cent alcohol and limited to use in contact thioformate) for use as a cross linking with food at temperatures not exceeding agent in the vulcanization of natural rub- 150 °F. ber, styrene-butadiene copolymer, acrylo- Polyisoprene. nitrile-butadiene copolymer, and ethylene- Polyurethane resins (CAS Reg. Nos. 37383–28– propylene terpolymers identified under 1 or 9018–04–6) derived from the reaction of paragraph (c)(4)(i) of this section and lim- diphenylmethane diisocyanate with 1,4- ited to use at levels not to exceed 2.4 per- butanediol and polytetramethylene ether cent by weight of such copolymers. glycol. Hexamethylenediamine carbamate for use Polyurethane resins derived from reactions only as cross-linking agent in the vul- of diphenylmethane diisocyanate with canization of vinylidene fluoride- adipic acid and 1,4-butanediol. hexafluoropropylene copolymer and vinyli- Rubber, natural. dene fluoride-hexafluoropropylene-tetra- Silicone basic polymer as described in ASTM fluoroethylene copolymer elastomers iden- method D1418–81, ‘‘Standard Practice for tified under paragraph (c)(4)(i) of this sec- Rubber and Rubber Latices—Nomen- tion and limited to use at levels not to ex- clature,’’ which is incorporated by ref- ceed 1.5 percent by weight of such copoly- erence. Copies may be obtained from the mers. American Society for Testing Materials, Sulfur, ground. 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be ex- (b) Accelerators (total not to exceed 1.5 amined at the National Archives and percent by weight of rubber product). Records Administration (NARA). For in- 2-Benzothiazyl-N,N-diethylthiocarbamyl-sul- formation on the availability of this mate- fide. rial at NARA, call 202–741–6030, or go to: Benzoyl peroxide. http://www.archives.gov/federallregister/ 1,3-Bis(2-benzothiazolylmercaptomethyl) codeloflfederallregulations/ urea. ibrllocations.html. N-tert-Butyl-2-benzothiazole sulfenamide. Silicone (Si) elastomers containing methyl Butyraldehyde-aniline resin (iodine number groups. 670–705). Silicone (Psi) elastomers containing meth- Carbon disulfide-1,1′-methylenedipiperidine yl and phenyl groups. reaction product. Silicone (Vsi) elastomers containing meth- Copper dimethyldithiocarbamate. yl and vinyl groups. N-Cyclohexyl-2-benzothiazole sulfenamide. 356 VerDate Mar<15>2010 10:14 May 14, 2012 Jkt 226069 PO 00000 Frm 00366 Fmt 8010 Sfmt 8010 Y:\SGML\226069.XXX 226069 erowe on DSK2VPTVN1PROD with CFR Food and Drug Administration, HHS § 177.2600 Dibenzoyl-p-quinone dioxime. (c) Retarders (total not to exceed 10 per- Dibenzylamine. cent of weight of rubber product). Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-methylethyl)trithio- Cyanoguanidine. bis-thioformate, O,O-di(1- Phthalic anhydride. methylethyl)tetrathio-bis-thioformate, Salicylic acid. and O,O-di(1-methylethyl)pentathio-bis- thioformate). (d) Activators (total not to exceed 5 per- Di(4-methylbenzoyl) peroxide (CAS Reg. No. cent by weight of rubber product except 895–85–2) for use only as a crosslinking magnesium oxide may be used at higher agent in silicone polymers and elastomers levels).
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