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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR177.2415]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 177 -- INDIRECT FOOD ADDITIVES: POLYMERS

Subpart C - Substances for Use Only as Components of Articles Intended for Repeated Use

Sec. 177.2415 Poly(aryletherketone) resins.

Poly(aryletherketone) 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 subject to the provisions of this section.

(a) Identity. For the purposes of this section, poly(aryletherketone) resins are poly(p -oxyphenylene p -oxyphenylene p -carboxyphenylene) resins (CAS Reg. No. 29658-26-2) produced by the polymerization of hydroquinone and 4,4'-difluorobenzophenone, and have a minimum weight-average molecular weight of 12,000, as determined by gel permeation chromatography in comparison with polystyrene standards, and a minimum mid-point glass transition temperature of 142 deg.C, as determined by differential scanning calorimetry.

(b) Optional adjuvant substances. The basic resins identified in paragraph (a) may contain optional adjuvant substances used in their production. These adjuvants may include substances described in § 174.5(d) of this chapter and the following:

Substance Limitations
Diphenyl sulfoneNot to exceed 0.2 percent by weight as a residual solvent in the finished basic resin.

(c) Extractive limitations. The finished food contact article, when extracted at reflux temperatures for 2 hours with the following four solvents, yields in each extracting solvent net chloroform soluble extractives not to exceed 0.05 milligrams per square inch of food contact surface: Distilled water, 50 percent (by volume) ethanol in distilled water, 3 percent acetic acid in distilled water, and n -heptane. In testing the final food contact article, a separate test sample shall be used for each extracting solvent.

[63 FR 20315, Apr. 24, 1998]

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