21 C.F.R. § 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers.
Title 21 - Food and Drugs
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. [45 FR 39252, June 10, 1980, as amended at 47 FR 24288, June 4, 1982; 49 FR 25629, June 22, 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, Nov. 24, 1995]
Title 21: Food and Drugs
PART 177—INDIRECT FOOD ADDITIVES: POLYMERS
Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces
§ 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers.
---------------------------------------------------------------------------------------------------------------- Maximum extractable fractions of the copolymer in the finished form at Ethylene-1,4-cyclohexylene specified dimethylene terephthalate Inherent viscosity temperatures and Test for Conditions of use copolymers times (expressed orientability in micrograms of the terephthaloyl moletles/square centimeter of food- contact surface)----------------------------------------------------------------------------------------------------------------1. Non-oriented ethylene-1,4- Inherent viscosity (1) 0.23 microgram No test required.. In contact with cyclohexylene dimethylene of a 0.50 percent per square foods, including terephthalate copolymer is the solution of the centimeter (1.5 foods containing reaction product of dimethyl copolymer in micrograms per not more than 25 terephthalate or terephthalic phenol- square inch) of percent (by acid with a mixture containing tetrachloroethane food-contact volume) aqueous 99 to 66 mole percent of (60:40 ratio wt/ surface when alcohol, ethylene glycol and 1 to 34 wt) solvent is extracted with excluding mole percent of 1,4-cyclo- not less than water added at carbonated hexanedimethanol (70 percent 0.669 as 82.2 °C (180 beverages and trans isomer, 30 percent cls determined by °F) and beer. Conditions isomer). using a Wagner allowed to cool of hot fill not viscometer (or to 48.9 °C to exceed 82.2 equivalent) and (120 °F) in °C (180 calculated from contact with the °F), storage the following food-contact at temperatures equation: article. not in excess of Inherent 48.9 °C (120 viscosity = °F). No (Natural thermal treatment logarithm of (Nr)/ in the container. (c) where: Nr=Ratio of flow time of the polymer solution to that of the solvent, and c=concentration of the test solution expressed in grams per 100 milliliters. ......do.......... (2) 0.23 microgram ......do.......... Do. per square centimeter (1.5 micrograms per square inch) of food-contact surface when extracted with 3 percent (by volume) aqueous acetic acid added at 82.2 °C (180 °F) and allowed to cool to 48.9 °C (120 °F) in contact with the food-contact article. ......do.......... (3) 0.08 microgram ......do.......... Do. per square centimeter (0.5 microgram per square inch) of food-contact surface when extracted for 2 hours with n- heptane at 48.9 °C (120 °F). The heptane extractable results are to be divided by a factor of 5. ......do.......... (4) 0.16 microgram ......do.......... Do. per square centimeter (1.0 microgram per square inch) of food-contact surface when extracted for 24 hours with 25 percent (by volume) aqueous ethanol at 48.9 °C (120 °F).2. Oriented ethylene-1,4- ......do.......... (1) 0.23 microgram When extracted In contact with cyclohexylene dimethylene per square with heptane at nonalcoholic terephthalate copolymer is the centimeter (1.5 65.6 °C (150 foods including reaction product of dimethyl micrograms per °F) for 2 carbonated terephthalate or terephthalic square inch) of hours: beverages. acid with a mixture containing food-contact terephthaloyl Conditions of hot 99 to 85 mole percent ethylene surface of the moieties do not fill not glycol and 1 to 15 mole percent oriented exceed 0.09 exceeding 87.8 of 1,4-cyclohexane-di-methanol copolymer when microgram per °C (190 (70 percent trans isomer, 30 extracted with square centimeter °F), storage percent cls isomer). water added at (0.60 microgram at temperatures 87.8 °C (190 per square inch) not in excess of °F) and of food-contact 48.9 °C (120 allowed to cool surface. °F). No to 48.9 °C thermal treatment (120 °F) in in the container. contact with the food-contact article. ......do.......... (2) 0.23 microgram ......do.......... Do. per square centimeter (1.5 micrograms per square inch) of food-contact surface of oriented copolymer when extracted with 3 percent (by volume) aqueous acetic acid added at 87.8 °C (190 °F) and allowed to cool to 48.9 °C (120 °F) in contact with the food-contact article. ......do.......... (3) 0.08 microgram ......do.......... Do. per square centimeter (0.5 microgram per square inch) of food-contact surface of oriented copolymer when extracted for 2 hours with n- heptane at 48.9 °C (120 °F). The heptane extractable results are to be divided by a factor of 5. ......do.......... (4) 0.23 microgram ......do.......... In contact with per square foods and centimeter (1.5 beverages micrograms per containing up to square inch) of 20 percent (by food-contact volume) alcohol. surface of Conditions of oriented thermal treatment copolymer when in the container extracted with 20 not exceeding percent (by 65.6 °C (150 volume) aqueous °F) for 20 ethanol heated to minutes. Storage 65.6 °C (150 at temperatures °F) for 20 not in excess of minutes and 48.9 °C (120 allowed to cool °F). to 48.9 °C (120 °F) in contact with the food-contact article. ......do.......... (5) 0.23 microgram ......do.......... In contact with per square foods and centimeter (1.5 beverages micrograms per containing up to square inch) of 50 percent (by food-contact volume) alcohol. surface of Conditions of oriented fill and storage copolymer when not exceeding extracted with 50 48.9 °C (120 percent (by °F). No volume) aqueous thermal treatment ethanol at 48.9 in the container. °C (120 °F) for 24 hours.3. Ethylene-1,4-cyclohexylene No test required.. For each No test required.. For each dimethylene terephthalate corresponding corresponding copolymer is the reaction condition of use, specification, product of dimethyl must meet may be used as a terephthalate or terephthalic specifications base sheet and acid with a mixture containing described in base polymer in 99 to 95 mole percent of § accordance with ethylene glycol and 1 to 5 mole 177.1630(f), (g), conditions of use percent of 1,4- (h), or (j). described in cyclohexanedimethanol (70 § percent trans isomer, 30 177.1630(f), (g), percent cis isomer). (h), or (j).----------------------------------------------------------------------------------------------------------------
