[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1595]
[Page 306]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177 INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
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, 5100 Paint Branch Pkwy., 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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