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Food and Drug Administration, HHS § 177.1315

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Food and Drug Administration, HHS § 177.1315 Food and Drug Administration, HHS § 177.1315 under conditions of use E through G as Food Safety and Applied Nutrition described in table 2 of § 176.170(c) of this (HFS±200), Food and Drug Administra- chapter. tion, 200 C St. SW., Washington, DC, or (d) The provisions of this section are at the Office of the Federal Register, not applicable to ethylene-acrylic acid 800 North Capitol St. NW., suite 700, copolymers used in food-packaging ad- Washington, DC. hesives complying with § 175.105 of this (3) The basic copolymer identified in chapter. paragraph (a) of this section, when ex- [42 FR 14572, Mar. 15, 1977, as amended at 51 tracted with the solvent or solvents FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, characterizing the type of food and 1988] under the conditions of time and tem- perature characterizing the conditions § 177.1312 Ethylene-carbon monoxide of its intended use, as determined from copolymers. Tables 1 and 2 of § 176.170(c) of this The ethylene-carbon monoxide co- chapter, yields net chloroform-soluble polymers identified in paragraph (a) of extractives in each extracting solvent this section may be safely used as com- not to exceed 0.5 milligram per square ponents of articles intended for use in inch of food-contact surface when test- contact with food subject to the provi- ed by methods described in § 176.170(d) sions of this section. of this chapter. (a) Identity. For the purposes of this (4) The provisions of this section are section, ethylene-carbon monoxide co- not applicable to ethylene-carbon mon- polymers (CAS Reg. No. 25052±62±4) con- oxide copolymers complying with sist of the basic polymers produced by § 175.105 of this chapter. the copolymerization of ethylene and carbon monoxide such that the copoly- [57 FR 32422, July 22, 1992] mers contain not more than 30 weight- percent of polymer units derived from § 177.1315 Ethylene-1, 4-cyclohexylene carbon monoxide. dimethylene terephthalate copoly- mers. (b) Conditions of use. (1) The polymers may be safely used as components of Ethylene-1, 4-cyclohexylene the food-contact or interior core layer dimethylene terephthalate copolymer of multilaminate food-contact articles. may be safely used as articles or com- (2) The polymers may be safely used ponents of articles intended for use in as food-contact materials at tempera- contact with food subject to provisions tures not to exceed 121 °C (250 °F). of this section and of part 174 of this (c) Specifications. (1) Food-contact chapter. layers formed from the basic copoly- (a) Identity. For the purposes of this mer identified in paragraph (a) of this section, ethylene-1,4-cyclohexylene section shall be limited to a thickness dimethylene terephthalate copolymers of not more than 0.01 centimeter (0.004 (1,4-benzene dicarboxylic acid, di- inch). methyl ester, polymerized with 1,4- (2) The copolymers identified in para- cyclohexanedimethanol and 1,2- graph (a) of this section shall have a ethanediol) (CAS Reg. No. 25640±14±6) or melt index not greater than 500 as de- (1,4-benzenedicarboxylic acid, polym- termined by ASTM method D1238±82, erized with 1,4-cyclohexanedimethanol condition E ``Standard Test Method for and 1,2-ethanediol) (CAS Reg. No. Flow Rates of Thermoplastics by Ex- 25038±91±9) are basic copolymers meet- trusion Plastometer,'' which is incor- ing the specifications prescribed in porated by reference in accordance paragraph (b) of this section, to which with 5 U.S.C. 552(a) and 1 CFR part 51. may have been added certain optional Copies may be obtained from the Amer- substances required in their production ican Society for Testing Materials, 1916 or added to impart desired physical or Race St., Philadelphia, PA 19103, or technical properties. may be examined at the Center for (b) Specifications: 235 VerDate 25<JUL>96 14:53 Jul 31, 1996 Jkt 167067 PO 00000 Frm 00231 Fmt 8010 Sfmt 8010 C:\CFR\21V3C1SB.TXT pfrm13 VerDate 25<JUL>96 14:53Jul31,1996 Jkt167067 PO00000 Frm00232 Fmt8010 Sfmt8010 C:\CFR\21V3C1SB.TXT pfrm13 § Maximum extractable fractions of the 177.1315 copolymer in the finished form at Ethylene-1,4-cyclohexylene specified temperatures and times (ex- dimethylene terephthalate copolymers Inherent viscosity pressed in micrograms of the Test for orientability Conditions of use terephthaloyl moletles/square centi- meter of food-contact surface) 1. Non-oriented ethylene-1,4- Inherent viscosity of a 0.50 percent (1) 0.23 microgram per square centi- No test required .............. In contact with foods, including foods cyclohexylene dimethylene solution of the copolymer in phenol- meter (1.5 micrograms per square containing not more than 25 per- terephthalate copolymer is the reac- tet rachloroethane (60:40 ratio wt/ inch) of food-contact surface when cent (by volume) aqueous alcohol, tion product of dimethyl wt) solvent is not less than 0.669 as extracted with water added at 82.2 excluding carbonated beverages terephthalate or terephthalic acid determined by using a Wagner vis- °C (180 °F) and allowed to cool to and beer. Conditions of hot fill not with a mixture containing 99 to 66 cometer (or equivalent) and cal- 48.9 °C (120 °F) in contact with the to exceed 82.2 °C (180 °F), storage mole percent of ethylene glycol and culated from the following equation: food-contact article. at temperatures not in excess of 1 to 34 mole percent of 1,4-cyclo- Inherent viscosity=(Natural loga- 48.9 °C (120 °F). No thermal treat- hexanedimethanol (70 percent trans rithm of (Nr)/(c) where: Nr=Ratio of ment in the container. isomer, 30 percent cls isomer). flow time of the polymer solution to that of the solvent, and c=concentration of the test solution expressed in grams per 100 milli- liters. ......do .................................................. (2) 0.23 microgram per square centi- ......do .............................. Do. meter (1.5 micrograms per square inch) of food-contact surface when 236 extracted with 3 percent (by vol- ume) 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 per square centi- ......do .............................. Do. meter (0.5 microgram per square inch) of food-contact surface when extracted for 2 hours with n- 21 CFRCh.I(4±1±96Edition) 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 per square centi- ......do .............................. Do. meter (1.0 microgram per square inch) of food-contact surface when extracted for 24 hours with 25 per- cent (by volume) aqueous ethanol at 48.9 °C (120 °F). VerDate 25<JUL>96 14:53Jul31,1996 Jkt167067 PO00000 Frm00233 Fmt8010 Sfmt8010 C:\CFR\21V3C1SB.TXT pfrm13 Food andDrugAdministration,HHS 2. Oriented ethylene-1,4- ......do .................................................. (1) 0.23 microgram per square centi- When extracted with In contact with nonalcoholic foods in- cyclohexylene dimethylene meter (1.5 micrograms per square heptane at 65.6 °C cluding carbonated beverages. terephthalate copolymer is the reac- inch) of food-contact surface of the (150 °F) for 2 hours: Conditions of hot fill not exceeding tion product of dimethyl oriented copolymer when extracted terephthaloyl moieties 87.8 °C (190 °F), storage at tem- terephthalate or terephthalic acid with water added at 87.8 °C (190 do not exceed 0.09 peratures not in excess of 48.9 °C with a mixture containing 99 to 85 °F) and allowed to cool to 48.9 °C microgram per square (120 °F). No thermal treatment in mole percent ethylene glycol and 1 (120 °F) in contact with the food- centimeter (0.60 the container. to 15 mole percent of 1,4- contact article. microgram per square cyclohexane-di-methanol (70 per- inch) of food-contact cent trans isomer, 30 percent cls surface. isomer). ......do .................................................. (2) 0.23 microgram per square centi- ......do .............................. Do. meter (1.5 micrograms per square inch) of food-contact surface of ori- ented 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 per square centi- ......do .............................. Do. meter (0.5 microgram per square inch) of food-contact surface of ori- 237 ented 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 per square centi- ......do .............................. In contact with foods and beverages meter (1.5 micrograms per square containing up to 20 percent (by vol- inch) of food-contact surface of ori- ume) alcohol. Conditions of thermal ented copolymer when extracted treatment in the container not ex- with 20 percent (by volume) aque- ceeding 65.6 °C (150 °F) for 20 ous ethanol heated to 65.6 °C (150 minutes. Storage at temperatures °F) for 20 minutes and allowed to not in excess of 48.9 °C (120 °F). cool to 48.9 °C (120 °F) in contact with the food-contact article. ......do .................................................. (5) 0.23 microgram per square centi- ......do .............................. In contact with foods and beverages meter (1.5 micrograms per square containing up to 50 percent (by vol- inch) of food-contact surface of ori- ume) alcohol. Conditions of fill and ented copolymer when extracted storage not exceeding 48.9 °C (120 with 50 percent (by volume) aque- °F). No thermal treatment in the ° ° ous ethanol at 48.9 C (120 F) for container.
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