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:
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n- F). The . ° . F) in contact ° . . C (120 ° F) F) and allowed to ° ° F) in contact with the C (120 ° ° F) and allowed to cool ° C (120 ° C (180 C (120 ° ° pressed in micrograms of the meter of food-contact surface) C (180 copolymer in the finished form at meter (1.5 micrograms per square inch) of food-contact surface when extracted with water added at 82.2 ° 48.9 meter (1.5 micrograms per square inch) of food-contact surface when extracted with 3 percent (by vol- ume) aqueous acetic acid added at 82.2 meter (0.5 microgram per square inch) of food-contact surface when extracted for 2 hours with heptane at 48.9 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 food-contact article cool to 48.9 heptane extractable results are to be divided by a factor of 5 with the food-contact article terephthaloyl moletles/square centi- Maximum extractable fractions of the specified temperatures and times (ex- (1) 0.23 microgram per square centi- (2) 0.23 microgram per square centi- (3) 0.08 microgram per square centi- (4) 0.16 microgram per square centi- =Ratio of r )/(c) where: N r Inherent viscosity ...... 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 solution of the copolymer in phenol- tet rachloroethane (60:40 ratio wt/ wt) solvent is not less than 0.669 as determined by using a Wagner vis- cometer (or equivalent) and cal- culated from the following equation: Inherent viscosity=(Natural loga- rithm of (N ...... do ...... do ...... do Inherent viscosity of a 0.50 percent
trans . ethylene-1,4- isomer)
cls
Non-oriented Ethylene-1,4-cyclohexylene cyclohexylene dimethylene terephthalate copolymer is the reac- tion product of dimethyl terephthalate or terephthalic acid with a mixture containing 99 to 66 mole percent of ethylene glycol and 1 to 34 mole percent of 1,4-cyclo- hexanedimethanol (70 percent isomer, 30 percent dimethylene terephthalate copolymers 1.
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n- C (120 . ° . F). The heptane extractable F) in contact with the food- F) in contact with the food- ° ° ° . F) and allowed to cool 48.9 F) and allowed to cool 48.9 F) for 20 minutes and allowed to meter (1.5 micrograms per square inch) of food-contact surface the oriented copolymer when extracted with water added at 87.8 ° (120 meter (1.5 micrograms per square inch) of food-contact surface ori- ented copolymer when extracted with 3 percent (by volume) aqueous acetic acid added at 87.8 ° meter (0.5 microgram per square inch) of food-contact surface ori- ented copolymer when extracted for 2 hours with meter (1.5 micrograms per square inch) of food-contact surface ori- ented copolymer when extracted with 20 percent (by volume) aque- ous ethanol heated to 65.6 ° cool to 48.9 meter (1.5 micrograms per square inch) of food-contact surface ori- ented copolymer when extracted with 50 percent (by volume) aque- ous ethanol at 48.9 contact article (120 (120 results are to be divided by a factor of 5 with the food-contact article 24 hours contact article. (1) 0.23 microgram per square centi- (2) 0.23 microgram per square centi- (3) 0.08 microgram per square centi- (4) 0.23 microgram per square centi- (5) 0.23 microgram per square centi- ...... do ...... do ...... do ...... do ...... do
cls ethylene-1,4- isomer, 30 percent
Oriented .
trans isomer) cyclohexylene dimethylene terephthalate copolymer is the reac- tion product of dimethyl terephthalate or terephthalic acid with a mixture containing 99 to 85 mole percent ethylene glycol and 1 to 15 mole percent of 1,4- cyclohexane-di-methanol (70 per- cent 2.
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cis isomer, 30 percent . Ethylene-1,4-cyclohexylene mer). dimethylene terephthalate copoly- mer is the reaction product of di- methyl terephthalate or terephthalic acid with a mixture containing 99 to 95 mole percent of ethylene glycol and 1 to 5 mole percent of 1,4- cyclohexanedimethanol (70 percent trans dimethylene terephthalate copolymers 3. Ethylene-1,4-cyclohexylene
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(c) Analytical method for determination with a mixture of polyethylene and one of extractability. The total extracted or more olefin copolymers, in such pro- terephthaloyl moieties can be deter- portions that the ethyl acrylate con- mined in the extracts, without evapo- tent of the blend does not exceed 8 per- ration of the solvent, by measuring the cent by weight, or unless it is used in ultraviolet (UV) absorbance at 240 a coating complying with § 175.300 or nanometers. The spectrophotometer § 176.170 of this chapter, in such propor- (Varian 635–D, or equivalent) is zeroed tions that the ethyl acrylate content with a sample of the solvent taken does not exceed 8 percent by weight of from the same lot used in the extrac- the finished coating. tion tests. The concentration of the (c) Ethylene-ethyl acrylate copoly- total terephthaloyl moieties in water, 3 mers or the blend shall conform to the percent acetic acid, and in 8 percent specifications prescribed in paragraph aqueous alcohol is calculated as bis(2- (c)(1) of this section and shall meet the hydroxyethyl terephthalate) by ref- ethyl acrylate content limits pre- erence to standards prepared in the ap- scribed in paragraph (b) of this section, propriate solvent. Concentration of the and the extractability limits pre- terephthaloyl moieties in heptane is scribed in paragraph (c)(2) of this sec- calculated as cyclic trimer tion, when tested by the methods pre- (C6H4CO2C2H4CO2)3, by reference to scribed for polyethylene in § 177.1520. standards prepared in 95:5 percent (v/v) (1) Specifications—(i) Infrared identi- heptane: tetrahydrofuran. fication. Ethylene-ethyl acrylate co- polymers can be identified by their [45 FR 39252, June 10, 1980, as amended at 47 FR 24288, June 4, 1982; 49 FR 25629, June 22, characteristic infrared spectra. 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, (ii) Quantitative determination of ethyl Nov. 24, 1995] acrylate content. The ethyl acrylate can be determined by the infrared spectra. § 177.1320 Ethylene-ethyl acrylate co- Prepare a scan from 10.5 microns to 12.5 polymers. microns. Obtain a baseline absorbance Ethylene-ethyl acrylate copolymers at 11.6 microns and divide by the may be safely used to produce packag- plaque thickness to obtain absorbance ing materials, containers, and equip- per mil. From a previously prepared ment intended for use in producing, calibration curve, obtain the amount of manufacturing, packing, processing, ethyl acrylate present. preparing, treating, packaging, trans- (iii) Specific gravity. Ethylene-ethyl porting, or holding food, in accordance acrylate copolymers have a specific with the following prescribed condi- gravity of not less than 0.920 nor more tions: than 0.935, as determined by ASTM (a) Ethylene-ethyl acrylate copoly- method D1505–68 (Reapproved 1979), mers consist of basic resins produced ‘‘Standard Test Method for Density of by the catalytic copolymerization of Plastics by the Density-Gradient Tech- ethylene and ethyl acrylate, to which nique,’’ which is incorporated by ref- may have been added certain optional erence. Copies may be obtained from substances to impart desired techno- the American Society for Testing Ma- logical properties to the resin. Subject terials, 1916 Race St., Philadelphia, PA to any limitations prescribed in this 19103, or may be examined at the Office section, the optional substances may of the Federal Register, 800 North Cap- include: itol Street, NW., suite 700, Washington, (1) Substances generally recognized DC 20408. as safe in food and food packaging. (2) Limitations. Ethylene-ethyl acry- (2) Substances the use of which is late copolymers or the blend may be permitted under applicable regulations used in contact with food except as a in parts 170 through 189 of this chapter, component of articles used for packag- prior sanction, or approvals. ing or holding food during cooking pro- (b) The ethyl acrylate content of the vided they meet the following copolymer does not exceed 8 percent by extractability limits: weight unless it is blended with poly- (i) Maximum soluble fraction of 11.3 ethylene or with one or more olefin co- percent in xylene after refluxing and polymers complying with § 177.1520 or subsequent cooling to 25° C.
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