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21 CFR 177.1315

§ 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 177.1315, § 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85205
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Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymer may be safely used as articles or components of articles intended for use in contact with food subject to provisions of this section and of part 174 of this chapter. (a) Identity. For the purposes of this section, ethylene-1,4-cyclohexylene dimethylene terephthalate copolymers (1,4-benzene dicarboxylic acid, dimethyl ester, polymerized with 1,4-cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25640-14-6) or (1,4-benzenedicarboxylic acid, polymerized with 1,4-cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25038-91-9) are basic copolymers meeting the specifications prescribed in paragraph (b) of this section, to which may have been added certain optional substances required in their production or added to impart desired physical or technical properties. (b) Specifications: (c) Analytical method for determination of extractability. The total extracted terephthaloyl moieties can be determined in the extracts, without evaporation of the solvent, by measuring the ultraviolet (UV) absorbance at 240 nanometers. The spectrophotometer (Varian 635-D, or equivalent) is zeroed with a sample of the solvent taken from the same lot used in the extraction tests. The concentration of the total terephthaloyl moieties in water, 3 percent acetic acid, and in 8 percent aqueous alcohol is calculated as bis(2-hydroxyethyl terephthalate) by reference to standards prepared in the appropriate solvent. Concentration of the terephthaloyl moieties in heptane is calculated as cyclic trimer (C6H4CO2C2H4CO2)3, by reference to standards prepared in 95:5 percent (v/v) heptane: tetrahydrofuran.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.