[Código de regulamentos federais][Título 21, Volume 3][Revisto a partir de 1 de abril de 2013.[CITE: 21CFR177.2600]TÍTULO 21 - ALIMENTOS E DROGASCAPÍTULO I - FOOD AND DRUG ADMINISTRATIONDEPARTAMENTO DE SAÚDE E SERVIÇOS HUMANOSSUBCAPÍTULO B - ALIMENTO PARA CONSUMO HUMANO (CONTINUADO)PARTE 177 - ADITIVOS ALIMENTARES INDIRETA: POLÍMEROSSUBPARTE C - substâncias para uso somente como componentes de artigos destinam ao uso repetidoSEC. 177.2600 artigos de borracha destinados a uso repetido.Artigos de borracha destinados a uso repetido podem ser utilizados com segurança em produzindo, fabricação, embalagem, processamento, preparação, tratamento, embalagem, transportando ou segurando comida, sob reserva das disposições da presente secção.(a) os artigos de borracha são preparados a partir de polímeros sintéticos ou naturais e substâncias adjuvantes como descrito no parágrafo (c) desta seção.(b) a quantidade de qualquer substância utilizada na produção de artigos de borracha destinados a uso repetido não pode exceder a quantidade razoavelmente necessária para realizar o efeito pretendido no artigo de borracha e não deve ser destinada para realizar qualquer efeito na comida.(c) substâncias empregadas na preparação de artigos de borracha incluem o seguinte, sujeita a quaisquer limitações prescritas:(1) as substâncias geralmente reconhecidas como seguro para utilização em alimentos ou embalagens de alimentos.(2) substâncias utilizadas em conformidade com as disposições de uma sanção prévia ou aprovação.(3) substâncias que, pelo Regulamento em partes 170 através de 189 do presente capítulo, podem ser utilizadas com segurança em artigos de borracha, sob reserva das disposições de tal regulamento.(4) substâncias identificadas neste parágrafo (c) (4), desde que qualquer substância que é objecto de um regulamento em partes, 174, 175, 176, 177, 178 e 179.45 deste capítulo está de acordo com qualquer especificação em tal regulamentação.(i) Elastômeros.Copolímero de acrilonitrila-butadieno.Copolímeros de isobuteno-isopreno retardadores cumprimento 177.1210.Copolímeros de acrilonitrila-butadieno-etileno glicol Dimetacrilato contendo não mais que 5 por cento do peso das unidades derivadas de polímero de dimetacrilato de etilenoglicol.Copolímero de ácido metacrílico-acrilonitrila-butadieno.Copolímero de ácido metacrílico-butadieno-estireno.Polímeros de borracha de cloropreno.Copolímero de fluoreto de vinilideno-clorotrifluoretileno.Elastômeros de copolímero de etileno-propileno que possam conter não mais de 5% peso de unidades total polímero derivado 5-metileno-2-Norborne e/ou 5-ethylidine-2-Norborne.Copolímero de etileno-propileno-dicyclopentadiene.Etileno-propileno-1, 4-hexadiene copolímeros contendo não mais do que 8 por cento das unidades total polímero derivados de 1 peso, hexadiene-4.Hydrogenated butadiene/acrylonitrile copolymers (CAS Reg. No. 88254-10-8) produced when acrylonitrile/butadiene copolymers are modified by hydrogenation of the olefinic unsaturation to leave either: (1) Not more than 10 percenttrans olefinic unsaturation and no [alpha], [beta]-olefinic unsaturation as determined by a method entitled "Determination of Residual [alpha], [beta]-Olefinic and Trans Olefinic Unsaturation Levels in HNBR," developed October 1, 1991, by Polysar Rubber Corp., 1256 South Vidal St., Sarnia, Ontario, Canada N7T 7MI; or (2) 0.4 percent to 20 percent olefinic unsaturation and Mooney viscosities greater than 45 (ML 1 + 4 @ 100 deg. C), as determined by ASTM Standard Method D1646-92, "Standard Test Method for Rubber--Viscosity and Vulcanization Characteristics (Mooney Viscometer)," which are both incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of these methods may be obtained from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1200, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. A copy of ASTM Standard Method D1646-92 may also be obtained from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428-2959.Isobutylene-isoprene copolymer.Polyamide/polyether block copolymers (CAS Reg. No. 77402-38-1 prepared by reacting a copolymer ofomega -laurolactam and adipic acid with poly(tetramethylene ether glycol). The polyamide and polyether components are reacted in ratios such that the polyamide component constitutes a minimum of 30 weight-percent of total polymer units. The copolymers may be used in contact with foods of Types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of 176.170(c) of this chapter at temperatures not to exceed 150 deg. F except that those copolymers prepared with less than 50 weight-percent of polyamide are limited to use in contact with such foods at temperatures not to exceed 100 deg. F.Polybutadiene.Polyester elastomers derived from the reaction of dimethyl terephthalate, 1,4-butanediol, and [alpha]-hydro-omega-hydroxypoly (oxytetramethylene). Additionally, trimethyl trimellitate may be used as a reactant. The polyester elastomers may be used only in contact with foods containing not more than 8 percent alcohol and limited to use in contact with food at temperatures not exceeding 150 deg. F.Polyisoprene.Polyurethane resins (CAS Reg. Nos. 37383-28-1 or 9018-04-6) derived from the reaction of diphenylmethane diisocyanate with 1,4-butanediol and polytetramethylene ether glycol.Polyurethane resins derived from reactions of diphenylmethane diisocyanate with adipic acid and 1,4-butanediol.Rubber, natural.Silicone basic polymer as described in ASTM method D1418-81, "Standard Practice for Rubber and Rubber Latices--Nomenclature," which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.Silicone (Si) elastomers containing methyl groups.Silicone (Psi) elastomers containing methyl and phenyl groups.Silicone (Vsi) elastomers containing methyl and vinyl groups.Silicone (Fsi) elastomers containing methyl and fluorine groups.Silicone (PVsi) elastomers containing phenyl, methyl, and vinyl groups.Styrene-butadiene copolymer.Vinylidene fluoride-hexafluoropropylene copolymers (minimum number average molecular weight 70,000 as determined by osmotic pressure in methyl ethyl ketone).Vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene copolymers (minimum number average molecular weight 100,000 as determined by osmotic pressure in methyl ethyl ketone).(ii)Vulcanization materials --(a )Vulcanizing agents.4,4'-Bis(aminocyclohexyl)methane carbamate for use only as cross-linking agent in the vulcanization of vinylidene fluoridehexafluoropropylene copolymer and vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene copolymer elastomers identified under paragraph (c)(4)(i) of this section and limited to use at levels not to exceed 2.4 percent by weight of such copolymers.
Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate) for use as a cross linking agent in the vulcanization of natural rubber, styrene-butadiene copolymer, acrylonitrile-butadiene copolymer, and ethylene-propylene terpolymers identified under paragraph (c)(4)(i) of this section and limited to use at levels not to exceed 2.4 percent by weight of such copolymers.
Hexamethylenediamine carbamate for use only as cross-linking agent in the vulcanization of vinylidene fluoride-hexafluoropropylene copolymer and vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene copolymer elastomers identified under paragraph (c)(4)(i) of this section and limited to use at levels not to exceed 1.5 percent by weight of such copolymers.
Sulfur, ground.
(b )Accelerators (total not to exceed 1.5 percent by weight of rubber product).
2-Benzothiazyl-N,N -diethylthiocarbamyl-sulfide.
Benzoyl peroxide.
1,3-Bis(2-benzothiazolylmercaptomethyl) urea.
N-tert- Butyl-2-benzothiazole sulfenamide.
Butyraldehyde-aniline resin (iodine number 670-705).
Carbon disulfide-1,1'-methylenedipiperidine reaction product.
Copper dimethyldithiocarbamate.
N- Cyclohexyl-2-benzothiazole sulfenamide.
Dibenzoyl-p- quinone dioxime.
Dibenzylamine.
Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate).
Di (4-methylbenzoyl) peroxide (CAS Reg. No. 895-85-2) for use only as a crosslinking agent in silicone polymers and elastomers identified under paragraph (c)(4)(i) of this section at levels not to exceed 1 percent by weight of such polymers and elastomers where the total of all accelerators does not exceed 1.5 percent by weight of rubber product.
Di-tert- butyl peroxide.
Dibutyl xanthogen disulfide.
2,4-Dichlorobenzoyl peroxide.
Dicumyl peroxide.
N,N- Dimethylcyclohexylamine salt of dibutyldithiocarbamic acid.
2,6-Dimethylmorpholine thiobenzothiazol.
Dipentamethylenethiuram hexasulfide (CAS Reg. No. 971-15-3).
Diphenylguanidine.
Diphenylguanidine phthalate.
1,3-Diphenyl-2-thiourea.
2,2'-Dithiobis[benzothiazole].
4,4'-Dithiodimorpholine.
N,N'- Di-o- tolylguanidine.
Di-o- tolylguanidine salt of pyroc
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