21 CFR 177.1655
§ 177.1655 Polysulfone resins.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 177.1655, § 177.1655 Polysulfone resins, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85242
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Full text
Polysulfone 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 prescribed conditions:
(a) For the purpose of this section, polysulfone resins are:
(1) Poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-p-phenylene) resins (CAS Reg. No. 25154-01-2) consisting of basic resins produced when the disodium salt of 4,4′-isopropylidenediphenol is made to react with 4,4′-dichlorodiphenyl sulfone in such a way that the finished resins have a minimum number average molecular weight of 15,000, as determined by osmotic pressure in monochlorobenzene; or
(2) 1,1′-Sulfonylbis[4-chlorobenzene] polymer with 4,4′-(1-methylethylidene)bis[phenol] (minimum 92 percent) and 4,4′-sulfonylbis[phenol] (maximum 8 percent) (CAS Reg. No. 88285-91-0) produced when a mixture of 4,4′-isopropylidenediphenol (minimum 92 percent) and 4,4′-sulfonylbis[phenol] (maximum 8 percent) is made to react with 4,4′-dichlorodiphenyl sulfone in such a way that the finished resin has a minimum number average molecular weight of 26,000, as determined by osmotic pressure in dimethylformamide.
(b) The basic polysulfone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. The optional adjuvant substances required in the production of the basic polysulfone resins may include substances described in § 174.5(d) of this chapter and the following:
(c) Polysulfone resins, when extracted at reflux temperatures for 6 hours with the solvents—distilled water, 50 percent (by volume) ethyl alcohol in distilled water, 3 percent acetic acid in distilled water, and n-heptane, yield total extractives in each extracting solvent not to exceed 0.0078 milligram per square centimeter (0.05 milligram per square inch) of resin surface. Note: In testing the finished polysulfone resins, use a separate resin test sample for each required extracting solvent.
(d) Polysulfone resins intended for repeated use in contact with food may be used under conditions of use A through H in table 2 of § 176.170(c) of this chapter. The resins intended for single-service food-contact use may be used only under condition of use H described in table 2 of § 176.170(c) of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.