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聚烯烃(聚乙烯、聚丙烯等)的 FDA 标准Code of Federal Regulations Title 21, Volume 3 Revised as of April 1, 2005 From the U.S. Government Printing Office via GPO Access CITE: 21CFR177.1520Page 283-298TITLE 21-FOOD AND DRUGSCHAPTER I-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)PART 177_INDIRECT FOOD ADDITIVES: POLYMERS-Table of ContentsSubpart B_Substances for Use as Basic Components of Single and Repeated Use Food Contact SurfacesSec. 177.1520 Olefin polymers.The olefin polymers listed in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food, subject to the provisions of this section.(a) For the purpose of this section, olefin polymers are basic polymers manufactured as described in this paragraph, so as to meet the specifications prescribed in paragraph (c) of this section, when tested by the methods described in paragraph (d) of this section.(1)(i) Polypropylene consists of basic polymers manufactured by the catalytic polymerization of propylene.(ii) Propylene homopolymer consists of basic polymers manufactured by the catalytic polymerization of propylene with a metallocene catalyst.(2)(i) Polyethylene consists of basic polymers manufactured by the catalytic polymerization of ethylene.(ii) Fumaric acid-grafted polyethylene (CAS Reg. No. 26877-81-6) consists of basic polymers manufactured by the catalytic polymerization of ethylene followed by reaction with fumaric acid in the absence of free radical initiators. Such polymers shall contain grafted fumaric acid at levels not to exceed 2 percent by weight of the finished polymer.(3) Olefin basic copolymers consist of basic copolymers manufactured by the catalytic copolymerization of:(i) Two or more of the 1-alkenes having 2 to 8 carbon atoms. Such olefin basic copolymers contain not less than 96 weight-percent of polymer units derived from ethylene and/or propylene, except that:(a)(1) Olefin basic copolymers manufactured by the catalytic copolymerization of ethylene and hexene-1 or ethylene and octene-1 shall contain not less than 90 weight-percent of polymer units derived from ethylene;(2) Olefin basic copolymers manufactured by the catalytic copolymerization of ethylene and hexene-1 shall contain not less than 80 but not more than 90 weight percent of polymer units derived from ethylene.(3) Olefin basic copolymers manufactured by the catalytic copolymerization of ethylene and pentene-1 shall contain not less than 90 weight-percent of polymer units derived from ethylene.(4) Olefin basic copolymers manufactured by the catalytic polymerization of ethylene and octene-1 shall contain not less than 50 weight-percent of polymer units derived from ethylene.Page 284(b) Olefin basic copolymers manufactured by the catalytic copolymerization of ethylene and 4-methylpentene-1 shall contain not less than 89 weight-percent of polymer units derived from ethylene;(c)(1) Olefin basic copolymers manufactured by the catalytic copolymerization of two or more of the monomers ethylene, propylene, butene-1, 2-methylpropene-1, and 2,4,4-trimethylpentene-1 shall contain not less than 85 weight-percent of polymer units derived from ethylene and/or propylene;(2) Olefin basic copolymers manufactured by the catalytic copolymerization of propylene and butene-1 shall contain greater than 15 but not greater than 35 weight percent of polymer units derived from butene-1 with the remainder being propylene.(d) Olefin basic terpolymers manufactured by the catalytic copolymerization of ethylene, hexene-1, and either propylene or butene- 1, shall contain not less than 85 weight percent polymer units derived from ethylene.(e) Olefin basic copolymers manufactured by the catalytic polymerization of ethylene and octene-1, or ethylene, octene-1, and either hexene-1, butene-1, propylene, or 4-methylpentene-1 shall contain not less than 80 weight percent of polymer units derived from ethylene.(ii) 4-Methylpentene-1 and 1-alkenes having from 6 to 18 carbon atoms. Such olefin basic copolymers shall contain not less than 95 molar percent of polymer units derived from 4-methylpentene-1, except that copolymers manufactured with 1-alkenes having from 12 to 18 carbon atoms shall contain not less than 97 molar percent of polymer units derived from 4-methylpentene-1; or(iii) Ethylene and propylene that may contain as modifiers not more than 5 weight-percent of total polymer units derived by copolymerization with one or more of the following monomers:5-Ethylidine-2-norbornene. 5-Methylene-2-norbornene.(iv) Ethylene and propylene that may contain as a modifier not more than 4.5 weight percent of total polymer units derived by copolymerization with 1,4-hexadiene.(v) Ethylene and butene-1 copolymers (CAS Reg. No. 25087-34-7) that shall contain not less than 80 weight percent of polymer units derived from ethylene.(vi) Olefin basic copolymers (CAS Reg. No. 61
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