[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1595]

[Page 298-299]
 
                        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.

[[Page 299]]

    (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 Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (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]