Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 177.1345 - Ethylene/1,3-phenylene oxyethylene isophthalate/ terephthalate copolymer.

Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer (CAS Reg. No. 87365-98-8) identified in paragraph (a) of this section may be safely used, subject to the provisions of this section, as the non-food-contact layer of laminate structures subject to the provisions of § 177.1395, and in blends with polyethylene terephthalate polymers complying with § 177.1630.

(a) Identity. For the purpose of this section, ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer consists of the basic copolymer produced by the catalytic polycondensation of isophthalic acid and terephthalic acid with ethylene glycol and 1,3-bis(2-hydroxyethoxy)benzene such that the finished resin contains between 42 and 48 mole-percent of isophthalic moieties, between 2 and 8 mole-percent of terephthalic moieties, and not more than 10 mole-percent of 1,3-bis(2-hydroxyethoxy)benzene moieties.

(b) Specifications—(1) Density. Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer identified in paragraph (a) of this section has a density of 1.33±0.02 grams per cubic centimeter measured by ASTM Method D 1505-85 (Reapproved 1990), “Standard Test Method for Density of Plastics by the Density-Gradient Technique,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, 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, and 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) Softening point. Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer identified in paragraph (a) of this section has a softening point of 63±5 °C as measured by ASTM Method D 1525-87, “Standard Test Method for VICAT Softening Temperature of Plastics,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this material is provided in paragraph (b)(1) of this section.

(c) Optional adjuvant substances. Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer, identified in paragraph (a) of this section, may contain optional adjuvant substances required in their production. The optional adjuvants may include substances used in accordance with § 174.5 of this chapter.

(d) Limitations. Copolymer blends described above shall not exceed 30 percent by weight of ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer. The finished blend may be used in contact with food only under conditions of use C through G, as described in table 2 of § 176.170(c) of this chapter, except that with food identified as Type III, IV-A, V, VII-A, and IX in § 176.170(c), table 1, the copolymer may be used under condition of use C at temperatures not to exceed 160 °F (71 °C).

[57 FR 43399, Sept. 21, 1992, as amended at 59 FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2, 1996; 62 FR 34628, June 27, 1997; 81 FR 5593, Feb. 3, 2016]
authority: 21 U.S.C. 321,342,348,379e
source: 42 FR 14572, Mar. 15, 1977, unless otherwise noted.
cite as: 21 CFR 177.1345