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§177.2440 聚醚砜树脂(Polyethersulfone resins)
2011-10-14 19:54  点击:12791
发布单位:FDA
发布文号:60 FR 48648
发布日期:1995-09-20
生效日期:暂无
有效性状态:
废止日期:暂无
备注:在符合本节中各项规定的条件下,本节(a)中所指的聚醚砜树脂,可用做重复接触食品的制品或制品组分。本节(a)(1)和(a)(2)中所指的基本树脂,可含有本章174.5(d)中所指的辅料以及二苯砜、二甲基亚砜、N-甲基-2-吡咯烷酮。与食品接触的制品,用规定溶剂在回流温度下浸提2h,在每一种浸提溶剂中所得的净氯仿可溶性浸提物,不得超过0.02mg/in2。与食品接触的聚醚砜树脂制品,在初次用于接触食品前,按良好生产操作规定清洗。

     §177.2440 Polyethersulfone resins


        Polyethersulfone resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with food in accordance with the following prescribed conditions:

  (a) For the purpose of this section, polyethersulfone resins are:

  (1) Poly(oxy-p -phenylenesulfonyl-p -phenylene) resins (CAS Reg. No. 25667-42-9), which have a minimum number average molecular weight of 16,000.

  (2) 1,1′-sulfonylbis[4-chlorobenzene] polymer with 4,4′-(1-methyl-ethyl-idene)bis[phenol] (maximum 8 percent) and 4,4′-sulfonylbis[phenol] (minimum 92 percent) (CAS Reg. No. 88285-91-0), which have a minimum number average molecular weight of 26,000.

  (3) In paragraphs (a)(1) and (a)(2) of this section, the minimum number average molecular weight is determined by reduced viscosity in dimethyl formamide in accordance with ASTM method D2857-70 (Reapproved 1977), “Standard Test Method for Dilute Solution Viscosity of Polymers,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the Division of Petition Control (HFS-215), Center for Food Safety and Applied Nutrition, 1110 Vermont Ave. NW., suite 1200, Washington, DC, 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.

  (b) The basic resins identified in paragraphs (a)(1) and (a)(2) of this section may contain optional adjuvant substances described in § 174.5(d) of this chapter and the following:

List of substances  Limitations
 Diphenylsulfone .Not to exceed 0.2 percent as residual solvent in the finished basic resin described in paragraph (a)(1) of this section
 Dimethyl sulfoxide Not to exceed 0.01 percent as residual solvent in the finished basic resin described in paragraph (a)(1) of this section. 
N-methyl-2-pyrrolidone   Not to exceed 0.01 percent as residual solvent in the finished basic resin described in paragraph (a)(2) of this section.


  (c) The finished food-contact article, when extracted at reflux temperatures for 2 hours with the following four solvents, yields net chloroform-soluble extractives in each extracting solvent not to exceed 0.02 milligram per square inch of food-contact surface: distilled water, 50 percent (by volume) ethyl alcohol in distilled water, 3 percent acetic acid in distilled water, and n -heptane. (Note: In testing the finished food-contact article, use a separate test sample for each required extracting solvent.)

  (d) In accordance withgood manufacturing practice, finished food-contact articles containing the polyethersulfone resins shall be thoroughly cleansed before their first use in contact with food.

   [44 FR 34493, June 15, 1979, as amended at 47 FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, Sept. 20, 1995]

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