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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 April 1 2020.

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]
[Revised as of April 1, 2020]
[CITE: 21CFR177.1595]



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 B - Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces

Sec. 177.1595 Polyetherimide resin.

The polyetherimide resin identified in this section may be safely used as an article or component of an article intended for use in contact with food, subject to the provisions of this section.

(a) Identity. For the purpose of this section, the polyetherimide resin is 1,3-isobenzofurandione, 5,5'[(1-methyl-ethylidene)bis(4,1-phenyleneoxy)] bis-polymer with 1,3-benzenediamine (CAS Reg. No. 61128-46-9), and is derived from the condensation reaction of m -phenylenediamine and bisphenol A-dianhydride.

(b) Optional adjuvants. The basic polymer identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of basic resins or finished food-contact articles. The optional adjuvant substances required in the production of the basic polymer may include substances permitted for such use by applicable regulations as set forth in part 174 of this chapter.

(c) Specifications and extractives limitations - (1) Specifications. Polyetherimide resin identified in paragraph (a) of this section shall have an intrinsic viscosity in chloroform at 25 deg.C (77 deg.F) of not less than 0.35 deciliter per gram as determined by a method titled "Intrinsic Viscosity of ULTEM Polyetherimide Using Chloroform as the Solvent," which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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.

(2) Extractive limitations. Extractive limitations are applicable to the basic polyetherimide resin in the form of molded discs of thickness 0.16 centimeter (0.063 inch). The resin discs when extracted with distilled water at 121 deg.C (250 deg.F) for 2 hours yield total nonvolatile extractives of not more than 12.3 micrograms per square centimeter.

[50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. 3, 1985]

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