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FDA 21 CFR 177.1520-2007

21 CFR Ch. I (4–1–07 Edition) §177.1520

(which has been held in a vacuum des-iccator over anhydrous calcium sulfate until constant weight has been at-tained) and carefully evaporated to dryness. The weight of the solid residue is determined by difference after hold-ing in a vacuum desiccator over anhy-drous calcium sulfate until constant weight has been attained. The percent of solids extracted is calculated by di-viding the weight of the solid residue by the weight of the sample and multi-plying by 100.

(5) Viscosity number (VN). (i) The vis-cosity number (VN) for Nylon 6/12 resin in a 96 percent sulfuric acid solution (5 milligrams resin per milliliter) shall be determined at 25 °C (77 °F) by method ISO 307–1984(E), ‘‘Plastics-Polyamides- Determination of Viscosity Number,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra-tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspec-tion 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 l register/

code l of l federal l regulations/

ibr l locations.html.

(ii) The viscosity number (VN) for Nylon 6/69 and Nylon PA–6–3–T resins in a 99 percent cresol solution (5 milli-grams resin per milliliter) shall be de-termined at 25 °C (77 °F) by method ISO 307–1984(E), ‘‘Plastics-Polyamides-De-termination of Viscosity Number,’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (d)(5)(i) of this section.

[42 FR 14572, Mar. 15, 1977]

E DITORIAL N OTE: For

F EDERAL R EGISTER ci-tations affecting §177.1500, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§177.1520Olefin polymers.

The olefin polymers listed in para-graph (a) of this section may be safely used as articles or components of arti-cles 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 para-graph, so as to meet the specifications prescribed in paragraph (c) of this sec-tion, when tested by the methods de-scribed in paragraph (d) of this section.

(1)(i) Polypropylene consists of basic polymers manufactured by the cata-lytic 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 cata-lytic polymerization of ethylene.

(ii) Fumaric acid-grafted poly-ethylene (CAS Reg. No. 26877–81–6) con-sists of basic polymers manufactured by the catalytic polymerization of ethylene followed by reaction with fu-maric acid in the absence of free rad-ical 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 hav-ing 2 to 8 carbon atoms. Such olefin basic copolymers contain not less than 96 weight-percent of polymer units de-rived from ethylene and/or propylene, except that:

(a)(1) Olefin basic copolymers manu-factured by the catalytic copolym-erization 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 manufac-tured by the catalytic copolymeriza-tion of ethylene and hexene-1 shall con-tain not less than 80 but not more than 90 weight percent of polymer units de-rived from ethylene.

(3) Olefin basic copolymers manufac-tured by the catalytic copolymeriza-tion of ethylene and pentene-1 shall contain not less than 90 weight-percent of polymer units derived from ethyl-ene.

(4) Olefin basic copolymers manufac-tured by the catalytic polymerization of ethylene and octene-1 shall contain not less than 50 weight-percent of poly-mer units derived from ethylene.

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