21 CFR § 177.1637 - Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins.

§ 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 Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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.

(c)Extraction limitations. A 0.5 millimeter (0.02 inch) thick sheet of resin when extracted with water at 121 °C (250 °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 § 176.170(c) of this chapter, under conditions of use A through H described in table 2 of § 176.170(c) of this chapter; and with food of Types III, IVA, V, VIC, VIIA, and IX identified in table 1 of § 176.170(c) of this chapter, under conditions of use C through H described in table 2 of § 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, as amended at 78 FR 14666, Mar. 7, 2013; 81 FR 5594, Feb. 3, 2016]