FDA CFR21 177.1520

271 Food and Drug Administration, HHS § 177.1520 the size of the molding powder. This can be done conveniently by using a small-scale commercial plastics granulator and cutting the sample through a screen having 1⁄4-inch mesh. Fine particles should be separated from the cut resin by screening through a 20- mesh screen. The material retained on the screen is suitable for the extraction tests. (ii) The organic solvents must be of American Chemical Society analytical reagent grade; distilled water is used. Approximately 30 grams of the pre- pared sample is weighed to the nearest milligram. The weighed resin is trans- ferred to a 500-milliliter round-bottom flask equipped with a reflux condenser. Approximately 300-milliliters of sol- vent is added to the flask and the con- tents refluxed gently for 8 hours with a heating mantle. The solvent is then fil- tered off immediately while still hot, using a Buchner funnel approximately 5 inches in diameter, a suction flask, and a hardened filter paper (Whatman No. 50 or equivalent). The paper is wet with the solvent and a slight suction applied just before starting the filtra- tion. The resin is washed twice with approximately 100-milliliter portions of solvent and the combined filtrate and washings are reduced to approximately 25 milliliters by evaporation at reduced pressure (50 millimeters to 100 millime- ters of mercury, absolute), heating as necessary. The contents of the flask are transferred to an evaporation dish (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 Office of the Federal Reg- ister, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (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] EDITORIAL NOTE: ForFEDERAL REGISTER 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. § 177.1520 Olefin 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 VerDate Mar<13>2002 11:39 Apr 17, 2002 Jkt 197064 PO 00000 Frm 00271 Fmt 8010 Sfmt 8010 Y:\SGML\197064T.XXX pfrm03 PsN: 197064T 272 21 CFR Ch. I (4–1–02 Edition)§ 177.1520 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. (b) Olefin basic copolymers manufac- tured by the catalytic copolymeriza- tion 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 manu- factured by the catalytic copolym- erization of two or more of the mono- mers 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 pro- pylene; (2) Olefin basic copolymers manufac- tured by the catalytic copolymeriza- tion 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 manufac- tured by the catalytic copolymeriza- tion of ethylene, hexene-1, and either propylene or butene-1, shall contain not less than 85 weight percent poly- mer units derived from ethylene. (e) Olefin basic copolymers manufac- tured 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 ethyl- ene. (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 poly- mer units derived from 4- methylpentene-1, except that copoly- mers manufactured with 1-alkenes hav- ing 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 mono- mers: 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 ethyl- ene. (vi) Olefin basic copolymers (CAS Reg. No. 61615–63–2) manufactured by the catalytic copolymerization of ethylene and propylene with 1,4- hexadiene, followed by reaction with fumaric acid in the absence of free rad- ical initiators. Such polymers shall contain not more than 4.5 percent of polymer units deriving from 1,4- hexadiene by weight of total polymer prior to reaction with fumaric acid and not more than 2.2 percent of grafted fu- maric acid by weight of the finished polymer. (vii) Ethylene and 2-norbornene (CAS Reg. No. 26007–43–2) copolymers that shall contain not less than 30 and not VerDate Mar<13>2002 11:39 Apr 17, 2002 Jkt 197064 PO 00000 Frm 00272 Fmt 8010 Sfmt 8010 Y:\SGML\197064T.XXX pfrm03 PsN: 197064T 273 Food and Drug Administration, HHS § 177.1520 more than 70 mole percent of polymer units derived from 2-norbornene. (4) Poly(methylpentene) consists of basic polymers manufactured by the catalytic polymerization of 4- methylpentene-1. (5) Polyethylene graft copolymers consist of polyethylene complying with item 2.2 of paragraph (c) of this section which subsequently has 3a,4,7,7a- tetrahydromethyl-4,7- methanoisobenzofuran-1,3-dione graft- ed onto it at a level not to exceed 1.7 percent by weight of the finished co- polymer. (6) Ethylene-maleic anhydride co- polymers (CAS Reg. No. 9006–26–2) con- taining no more than 2 percent by weight of copolymer units derived from maleic anhydride. (b) The basic olefin polymers identi- fied in paragraph (a) of this section may contain optional adjuvant sub- stances required in the production of such basic olefin polymers. The op- tional adjuvant substances required in the production of the basic olefin poly- mers or finished food-contact articles may include substances permitted for such use by applicable regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food and food packaging, substances used in accordance with a prior sanc- tion or approval, and the following: Substance Limitations Aromatic petroleum hydrocarbon resin, hydrogenated (CAS Reg. No. 88526–47–0), produced by the catalytic polym- erization of aromatic-substituted olefins from distillates of cracked petroleum stocks with a boiling point no greater than 220 °C (428 °F), and the subsequent catalytic hydrogenation of the resulting aromatic petroleum hydrocarbon resin, hav- ing a minimum softening point of 110 °C (230 °F), as deter- mined by ASTM Method E 28–67 (Reapproved 1982), ‘‘Standard Test Method for Softening Point by Ring-and-Ball Apparatus,’’ and a minimum aniline point of 107 °C (225 °F), as determined by ASTM Method D 611–82, ‘‘Standard Test Methods for Aniline Point and Mixed Aniline Point of Petro- leum Products and Hydrocarbon Solvents,’’ both of which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the American Society for Testing and Materials, 1916 Race St., Philadelphia, PA 19103, or 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 may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC . For use only as an adjuvant at levels not to exceed 25 percent by weight in blends with polypropylene complying with para- graph (c), item 1.1 of this section. The finished polymer may be used in contact with food Types I, II, IV–B, VI–A through VI–C, VII–B, and VIII identified in table 1 of § 176.170(c) of this chapter and under conditions of use B through H de- scribed in table 2 of § 176.170(c) of this chapter; and with food Types III, IV–A, V, VII–A, and IX identified in table 1 of § 176.170(c) of this chapter and under conditions of use D through G described in table 2 of § 176.170(c) of this chap- ter. Colorants used in accordance with § 178.3297 of this chapter . 2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– 63–7) . For use as an initiator in the production of propylene homopolymer complying with § 177.1520(c), item 1.1 and olefin copolymers complying with § 177.1520(c), items 3.1 and 3.2 and containing not less than 75 weight percent of polymer units derived from propylene, provided that the max- imum concentration of tert-butyl alcohol in the polymer does not exceed 100 parts per million, as determined by a method titled ‘‘Determination of tert-Butyl Alcohol in Polypropylene,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. VerDate Mar<13>2002 11:39 Apr 17, 2002 Jkt 197064 PO 00000 Frm 00273 Fmt 8010 Sfmt 8010 Y:\SGML\197064T.XXX pfrm03 PsN: 197064T 274 21 CFR Ch. I (4–1–02 Edition)§ 177.1520 Substance Limitations Methyl methacrylate/butyl acrylate-grafted polypropylene co- polymer containing methyl methacrylate/butyl acrylate-grafted polypropylene (CAS Reg. No. 121510–09–6), methyl meth- acrylate/butyl acrylate copolymer (CAS Reg. No. 25852–37– 3), methyl methacrylate homopolymer (CAS Reg. No. 9011– 14–7), and polypropylene (CAS Reg. No. 9003–07–0), re- sulting from the reaction of a mixture of methyl methacrylate and butyl acrylate with polypropylene. The finished product contains no more than 55 percent by weight of polymer units derived from methyl methacrylate and butyl acrylate as de- termined by a method entitled, ‘‘Determination of the Total Acrylic in PP–MMA/BA Polymers,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be exam- ined at the Center for Food Safety and Applied Nutrition’s Li- brary, 200 C. St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC . For use only at levels not to exceed 6 percent by weight of olefin polymers complying with paragraph (c) of this section, items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com- plying with items 3.1a, 3.2a, and 3.2b contain not less than 85 weight-percent of polymer units derived from propylene. Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- genated (CAS Reg. No. 68132–00–3) produced by the ther- mal polymerization of dicyclopentadiene and cyclodiene codimers (consisting of a mixture of cyclopentadiene, methyl cyclopentadiene, and C4–C5 acyclic dienes), followed by hy- drogenation and having a ring-and-ball softening point of 119 °C minimum as determined by ASTM Method E 28–67 (Re- approved 1982), ‘‘Standard Test Method for Softening Point by Ring-and-Ball Apparatus,’’ and a minimum viscosity of 3,000 centipoise, measured at 160 °C, as determined by ASTM Method D 3236–88, ‘‘Standard Test Method for Ap- parent Viscosity of Hot Melt Adhesives and Coating Mate- rials,’’ both of which are incorporated by reference in accord- ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the American Society for Testing and Mate- rials, 1916 Race St., Philadelphia, PA 19103, or from the Center For Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC . For use only as an adjuvant at levels not to exceed 30 percent by weight in blends with: (1) Polypropylene complying with paragraph (c), item 1.1 of this section, or (2) a copolymer of propylene and ethylene containing not less than 94 weight percent propylene and complying with paragraph (c), item 3.2 of this section. The average thickness of the food-con- tact film is not to exceed 0.1 millimeter (0.004 inch). The fin- ished polymer may be used in contact with (1) Food types I, II, IV–B, VI–A, VI–B, VII–B, and VIII identified in table 1 of § 176.170(c) of this chapter and under conditions of use C through G described in table 2 of § 176.170(c) of this chap- ter; and (2) food types III, IV–A, V, VI–C, VII–A, and IX iden- tified in table 1 of § 176.170(c) of this chapter and under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. Polymethylsilsesquioxane (CAS Reg. No. 68554–70–1) ............ For use only as a surface lubricant or anti-blocking agent in films. Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– 79–9), having a melt viscosity of 6 to 37 kilopoise at a shear rate of 100¥1 seconds at 232 °C as determined by ASTM Method D 3835–79 (Reapproved 1983), ‘‘Standard Test Method for Rheological Properties of Thermoplastics with a Capillary Rheometer’’ using a capillary of 15:1 L/D, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC . For use only as a processing aid in the production of olefin polymers complying with paragraph (c) of this section at lev- els not to exceed 1.0 percent by weight of the polymer. The finished polymers may be used only under the conditions de- scribed in § 176.170(c) of this chapter, table 2, under condi- tions of use B though H. Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. 68937–54–2) . For use as an extrusion aid in the production of extruded olefin polymers that comply with § 177.1520(c) at levels not to ex- ceed 0.3 percent by weight of the polymer. The finished polymer is used in contact with foods under conditions of use B through H described in table 2 of § 176.170 of this chapter. VerDate Mar<13>2002 11:39 Apr 17, 2002 Jkt 197064 PO 00000 Frm 00274 Fmt 8010 Sfmt 8010 Y:\SGML\197064T.XXX pfrm03 PsN: 197064T 275 Food and Drug Administration, HHS § 177.1520 Substance Limitations Triisopropanolamine (CAS Reg. No. 122–20–3) ........................ For use as a Zeigler-Natta-type catalyst deactivator and anti- oxidant in the production of olefin polymers complying with § 177.1520(c), items 2.1, 2.2, and 2.3, and having a min- imum density of 0.94 grams per cubic centimeter, and co- polymers complying with § 177.1520(c), items 3.1 and 3.2, for use in contact with all foods under the following condi- tions of use: (a) films with a maximum thickness of 0.102 millimeter (0.004 inch) may be used under conditions A through H defined in table 2 of § 176.170(c) of this chapter; and (b) articles with thickness greater than 0.102 millimeter (0.004 inch) may be used under conditions C through G de- fined in table 2 of § 176.170(c) of this chapter. Trimethylpyridine and dimethylpyridine mixture having percent by weight composition as follows: 2,4,6-trimethylpyridine (CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- trimethylpyridine (CAS Reg. No. 1462–84–6), not more than 27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), not more than 12 percent; and other dimethylpyridines, not more than 6 percent . For use only as an adjuvant substance in the production of propylene homopolymers complying with items 1.1, 1.2, and 1.3, and propylene copolymers complying with items 3.1, and 3.2 of paragraph (c) of this section provided that the ad- juvant is used at a level not to exceed 20 parts per million by weight o