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Food and Drug Administration, HHS § 177.1580 Food and Drug Administration, HHS § 177.1580 an intrinsic viscosity 1.0 to 3.2 as deter- contact with food under conditions of mined by ASTM method D1601–78, use B, C, D, E, F, G, or H described in ‘‘Standard Test Method for Dilute So- table 2 of § 176.170(c) of this chapter, lution Viscosity of Ethylene Poly- subject to the provisions of this section mers,’’ which is incorporated by ref- and provided that the maximum erence. Copies may be obtained from extractables from test films 0.1 to 0.2 the American Society for Testing Ma- millimeter (0.004 to 0.008 inch) in thick- terials, 100 Barr Harbor Dr., West ness do not exceed 0.80 percent by Conshohocken, Philadelphia, PA 19428- weight of the polymer when extracted 2959, or may be examined at the Na- in a soxhlet extractor for 6 hours with tional Archives and Records Adminis- refluxing 95 percent ethanol. tration (NARA). For information on (iii) Poly-1-butene resins may be used the availability of this material at as articles or components of articles NARA, call 202–741–6030, or go to: http:// intended for packaging or holding food www.archives.gov/federallregister/ during cooking, provided that the codeloflfederallregulations/ thickness of such polymers in the form ibrllocations.html. in which they contact food shall not (iii) Density. Poly-1-butene resins exceed 0.1 millimeter (0.004 inch) and have a density of 0.904 to 0.920 gms/cm3, yield maximum extractables of not and butene/ethylene copolymers have a more than 2.5 percent by weight of the density of 0.890 to 0.916 gms/cm3 as de- polymer when films are extracted for 2 termined by ASTM method D1505–68 hours at 50 °C (122 °F) in n-heptane. (Reapproved 1979), ‘‘Standard Test [42 FR 14572, Mar. 15, 1977, as amended at 49 Method for Density of Plastics by the FR 10109, Mar. 19, 1984; 50 FR 31349, Aug. 2, Density-Gradient Technique,’’ which is 1985] incorporated by reference. The avail- ability of this incorporation by ref- § 177.1580 Polycarbonate resins. erence is given in paragraph (b)(1)(ii) of Polycarbonate resins may be safely this section. used as articles or components of arti- (iv) Melt index. Poly-1-butene resins cles intended for use in producing, have a melt index of 0.1 to 24 and the manufacturing, packing, processing, butene/ethylene copolymers have a preparing, treating, packaging, trans- melt index of 0.1 to 20 as determined by porting, or holding food, in accordance ASTM method D1238–82, condition E, with the following prescribed condi- ‘‘Standard Test Method for Flow Rates tions: of Thermoplastics by Extrusion Plas- (a) Polycarbonate resins are poly- tometer,’’ which is incorporated by ref- esters produced by: erence. The availability of this incor- (1) The condensation of 4,4′-iso- poration by reference is given in para- propylidenediphenol and carbonyl chlo- graph (b)(1)(ii) of this section. ride to which may have been added cer- (2) Limitations. Poly-1-butene resins tain optional adjuvant substances re- and butene/ethylene copolymers for use quired in the production of the resins; in articles that contact food, and for or by articles used for packing or holding (2) The reaction of molten 4,4′-iso- food during cooking shall yield no propylidenediphenol with molten di- more than the following extractables: phenyl carbonate in the presence of the (i) Poly-1-butene resins may be used disodium salt of 4,4′-isopro- as articles or components of articles pylidenediphenol. intended for use in contact with food, (3) The condensation of 4,4′-isopro- provided that the maximum pylidenediphenol, carbonyl chloride, extractables do not exceed 2.5 percent and 0.5 percent weight maximum of by weight of the polymer when film or a2,a6-bis (6-hydroxy-m-tolyl) mesitol to molded samples are tested for 2 hours which may have been added certain op- at 50 °C (122 °F) in n-heptane. tional adjuvant substances required in (ii) Butene/ethylene copolymers con- the production of branched taining no more than 6 percent by polycarbonate resins. weight of polymer units derived from (b) The optional adjuvant substances ethylene may be used as articles or required in the production of resins components of articles intended for produced by the methods described in 305 VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00315 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 177.1585 21 CFR Ch. I (4–1–11 Edition) paragraph (a)(1) and (3) of this section extractives not to exceed 0.15 percent may include substances generally rec- by weight of the resins. ognized as safe in food, substances used [42 FR 14572, Mar. 15, 1977, as amended at 46 in accordance with a prior sanction or FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6, approval, and the following: 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994] List of substances Limitations p-tert-Butylphenol .................. § 177.1585 Polyestercarbonate resins. Chloroform ............................. Polyestercarbonate resins may be p-Cumylphenol (CAS Reg. For use only as a chain ter- No. 599–64–4). minator at a level not to ex- safely used as articles or components ceed 5 percent by weight of articles intended for use in pro- of the resin. ducing, manufacturing, packing, proc- Ethylene dichloride. essing, preparing, treating, packaging, Heptane. Methylene chloride. or holding food, in accordance with the Monochlorobenzene .............. Not to exceed 500 p.p.m. as following prescribed conditions: residual solvent in finished (a) Polyestercarbonate resins (CAS resin. Pentaerythritol tetrastearate For use only as a mold re- Reg. No. 71519–80–7) are produced by the (CAS Reg. No. 115–83–3). lease agent, at a level not condensation of 4,4′- to exceed 0.5 percent by isopropylidenediphenol, carbonyl chlo- weight of the finished resin. ride, terephthaloyl chloride, and Phenol (CAS Reg. No. 108– 95–2). isophthaloyl chloride such that the fin- Pyridine. ished resins are composed of 45 to 85 Toluene: (CAS Reg. No. Not to exceed 800 parts per molepercent ester, of which up to 55 108–88–3). million as residual solvent in finished resin. mole-percent is the terephthaloyl iso- Triethylamine. mer. The resins are manufactured using a phthaloyl chloride/carbonyl (c) Polycarbonate resins shall con- chloride mole ratio of 0.81 to 5.7/1 and form to the specification prescribed in isophthaloyl chloride/terephthaloyl paragraph (c)(1) of this section and chloride mole ratio of 0.81/1 or greater. shall meet the extractives limitations The resins are also properly identified prescribed in paragraph (c)(2) of this by CAS Reg. No. 114096–64–9 when pro- section. duced with the use of greater than 2 (1) Specification. Polycarbonate resins but not greater than 5 weight percent can be identified by their char- p-cumylphenol (CAS Reg. No. 599–64–4), acteristic infrared spectrum. as an optional adjuvant substance in (2) Extractives limitations. The accordance with paragraph (b)(2) of polycarbonate resins to be tested shall this section. be ground or cut into small particles (b) Optional adjuvants. The optional that will pass through a U.S. standard adjuvant substances required in the sieve No. 6 and that will be held on a production of resins identified in para- U.S. standard sieve No. 10. graph (a) of this section may include: (i) Polycarbonate resins, when ex- (1) Substances used in accordance tracted with distilled water at reflux with § 174.5 of this chapter. temperature for 6 hours, shall yield (2) Substances identified in total extractives not to exceed 0.15 per- § 177.1580(b). cent by weight of the resins. (3) Substances regulated in (ii) Polycarbonate resins, when ex- § 178.2010(b) of this chapter for use in tracted with 50 percent (by volume) polycarbonate resins complying with ethyl alcohol in distilled water at § 177.1580: reflux temperature for 6 hours, shall Provided, That the substances are used yield total extractives not to exceed in accordance with any limitation on 0.15 percent by weight of the resins. concentration, conditions of use, and (iii) Polycarbonate resins, when ex- food types specified in § 178.2010(b) of tracted with n-heptane at reflux tem- this chapter. perature for 6 hours, shall yield total 306 VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00316 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR.
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