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§177.1637 聚(氧-1,2-乙烷二基氧羧基-2,6-萘二基羧基)树脂
2011-10-11 16:01  点击:2441
发布单位:FDA
发布文号:61 FR 14965
发布日期:1996-04-04
生效日期:暂无
有效性状态:
废止日期:暂无
备注:聚(氧-1,2-乙烷二基氧羧基-2,6-萘二基羧基)树脂是有2,6-萘二甲酸二甲酯与乙二醇经催化交换作用后催化聚合制成的聚合物。聚(氧-1,2-乙烷二基氧羧基-2,6-萘二基羧基)树脂的密度为1.33~1.40g/cm3。接触食品的制品,其聚合物0.1g在100 mL的25/40/35的对氯苯酚/四氯乙烷/苯酚溶液中的最低比浓对数黏度为0.55dL/g。0.5mm的树脂薄片在121℃水中浸提2h,不挥发浸提物量不超过0.31mg/cm2浸提树脂表面积。本节还规定了聚(氧-1,2-乙烷二基氧羧基-2,6-萘二基羧基)树脂的使用条件。

  §177.1637 Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins.


     Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food in accordance with the following conditions:

  (a) Identity. For the purpose of this section, poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins (CAS Reg. No. 24968-11-4) are polymers formed by catalytic transesterification of 2,6-dimethylnaphthalene dicarboxylate with ethylene glycol followed by catalytic polycondensation.

  (b) Specifications— (1) Density. The density of poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins shall be between 1.33 and 1.40 grams per cubic centimeter.

  (2) Inherent viscosity. The finished food-contact article shall have a minimum inherent viscosity of 0.55 deciliter per gram in a solution of 0.1 gram of polymer in 100 milliliters of a 25/40/35 (weight/weight/weight) solution of p -chlorophenol/tetrachloroethane/phenol. The viscosity is determined by Eastman Chemical Co.'s method ECD-A-AC-G-V-1-5, “Determination of Dilute Solution Viscosity of Polyesters,” dated May 31, 1988, 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-215), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 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.

  (c) Extraction limitations. A 0.5 millimeter (0.02 inch) thick sheet of resin when extracted with water at 121 °C (250 °F) for 2 hours shall yield total nonvolatile extractives not exceeding 2.0 micrograms per square inch of exposed resin surface.

  (d) Conditions of use. The finished food contact article shall be:

  (1) Used in contact only with food of Types I, II, IVB, VIA, VIB, VIIB, and VIII identified in table 1 of § 176.170(c) of this chapter, under conditions of use A through H described in table 2 of § 176.170(c) of this chapter; and with food of Types III, IVA, V, VIC, VIIA, and IX identified in table 1 of § 176.170(c) of this chapter, under conditions of use C through H described in table 2 of § 176.170(c) of this chapter; and

  (2) Identified in a manner that will differentiate the article from articles made of other polymeric resins to facilitate collection and sorting.

    [61 FR 14965, Apr. 4, 1996]
 

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