[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1637]

[Page 300]
 
                        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. 177.1637  Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins.

    Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) 
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 conditions:
    (a) Identity. For the purpose of this section, poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins (CAS Reg. No. 
24968-11-4) are polymers formed by catalytic transesterification of 2,6-
dimethylnaphthalene dicarboxylate with ethylene glycol followed by 
catalytic polycondensation.
    (b) Specifications--(1) Density. The density of poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins shall be 
between 1.33 and 1.40 grams per cubic centimeter.
    (2) Inherent viscosity. The finished food-contact article shall have 
a minimum inherent viscosity of 0.55 deciliter per gram in a solution of 
0.1 gram of polymer in 100 milliliters of a 25/40/35 (weight/weight/
weight) solution of p-chlorophenol/tetrachloroethane/phenol. The 
viscosity is determined by Eastman Chemical Co.'s method ECD-A-AC-G-V-1-
5, ``Determination of Dilute Solution Viscosity of Polyesters,'' dated 
May 31, 1988, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of 
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
215), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or may be examined at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 200 C St. 
SW., Washington, DC, or at the Office of the Federal Register, 800 North 
Capitol St. NW., Washington, DC.
    (c) Extraction limitations. A 0.5 millimeter (0.02 inch) thick sheet 
of resin when extracted with water at 121  deg.C (250  deg.F) for 2 
hours shall yield total nonvolatile extractives not exceeding 2.0 
micrograms per square inch of exposed resin surface.
    (d) Conditions of use. The finished food contact article shall be:
    (1) Used in contact only with food of Types I, II, IVB, VIA, VIB, 
VIIB, and VIII identified in table 1 of Sec. 176.170(c) of this chapter, 
under conditions of use A through H described in table 2 of 
Sec. 176.170(c) of this chapter; and with food of Types III, IVA, V, 
VIC, VIIA, and IX identified in table 1 of Sec. 176.170(c) of this 
chapter, under conditions of use C through H described in table 2 of 
Sec. 176.170(c) of this chapter; and
    (2) Identified in a manner that will differentiate the article from 
articles made of other polymeric resins to facilitate collection and 
sorting.

[61 FR 14965, Apr. 4, 1996]