Food and Drug Administration, HHS § 177.1320

Maximum extractable fractions of the copolymer in the fin- Ethylene-1,4- ished form at specified tem- cyclohexylene peratures and times (ex- Test for dimethylene Inherent viscosity pressed in micrograms of the orientability Conditions of use terephthalate copolymers terephthaloyl moletles/square centimeter of food-contact surface)

...... do ...... (5) 0.23 microgram per square ...... do ...... In contact with foods and centimeter (1.5 micrograms beverages containing per square inch) of food-con- up to 50 percent (by tact surface of oriented co- volume) alcohol. Con- polymer when extracted with ditions of fill and stor- 50 percent (by volume) age not exceeding aqueous ethanol at 48.9 °C 48.9 °C (120 °F). No (120 °F) for 24 hours. thermal treatment in the container. 3. Ethylene-1,4- No test required ... For each corresponding condi- No test required ... For each corresponding cyclohexylene tion of use, must meet speci- specification, may be dimethylene fications described in used as a base sheet terephthalate copoly- § 177.1630(f), (g), (h), or (j). and base polymer in mer is the reaction accordance with con- product of dimethyl ditions of use de- terephthalate or ter- scribed in ephthalic acid with a § 177.1630(f), (g), (h), mixture containing 99 or (j). to 95 mole percent of ethylene glycol and 1 to 5 mole percent of 1,4- cyclohexanedimethan- ol (70 percent trans isomer, 30 percent cis isomer).

(c) Analytical method for determination § 177.1320 Ethylene-ethyl acrylate co- of extractability. The total extracted polymers. terephthaloyl moieties can be deter- Ethylene-ethyl acrylate copolymers mined in the extracts, without evapo- may be safely used to produce pack- ration of the solvent, by measuring the aging materials, containers, and equip- ultraviolet (UV) absorbance at 240 ment intended for use in producing, nanometers. The spectrophotometer manufacturing, packing, processing, (Varian 635–D, or equivalent) is zeroed preparing, treating, packaging, trans- with a sample of the solvent taken porting, or holding food, in accordance from the same lot used in the extrac- with the following prescribed condi- tion tests. The concentration of the tions: total terephthaloyl moieties in water, 3 (a) Ethylene-ethyl acrylate copoly- percent acetic acid, and in 8 percent mers consist of basic resins produced aqueous alcohol is calculated as bis(2- by the catalytic copolymerization of hydroxyethyl terephthalate) by ref- ethylene and ethyl acrylate, to which erence to standards prepared in the ap- may have been added certain optional propriate solvent. Concentration of the substances to impart desired techno- terephthaloyl moieties in heptane is logical properties to the resin. Subject calculated as cyclic trimer to any limitations prescribed in this (C6H4CO2C2H4CO2)3, by reference to section, the optional substances may standards prepared in 95:5 percent (v/v) include: heptane: tetrahydrofuran. (1) Substances generally recognized as safe in food and food packaging. [45 FR 39252, June 10, 1980, as amended at 47 (2) Substances the use of which is FR 24288, June 4, 1982; 49 FR 25629, June 22, permitted under applicable regulations 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, Nov. 24, 1995] in parts 170 through 189 of this chapter, prior sanction, or approvals. (b) The ethyl acrylate content of the copolymer does not exceed 8 percent by

263

VerDate Nov<24>2008 14:38 May 05, 2009 Jkt 217067 PO 00000 Frm 00273 Fmt 8010 Sfmt 8010 Y:\SGML\217067.XXX 217067 cprice-sewell on PRODPC61 with CFR § 177.1330 21 CFR Ch. I (4–1–09 Edition)

weight unless it is blended with poly- used in contact with food except as a ethylene or with one or more olefin co- component of articles used for pack- polymers complying with § 177.1520 or aging or holding food during cooking with a mixture of polyethylene and one provided they meet the following or more olefin copolymers, in such pro- extractability limits: portions that the ethyl acrylate con- (i) Maximum soluble fraction of 11.3 tent of the blend does not exceed 8 per- percent in xylene after refluxing and cent by weight, or unless it is used in subsequent cooling to 25 °C. a coating complying with § 175.300 or (ii) Maximum extractable fraction of § 176.170 of this chapter, in such propor- 5.5 percent when extracted with n- tions that the ethyl acrylate content hexane at 50 °C. does not exceed 8 percent by weight of (d) The provisions of paragraphs (b) the finished coating. and (c)(2) of this section are not appli- (c) Ethylene-ethyl acrylate copoly- cable to ethylene-ethyl acrylate co- mers or the blend shall conform to the polymers used in the formulation of ad- specifications prescribed in paragraph hesives complying with § 175.105 of this (c)(1) of this section and shall meet the chapter. ethyl acrylate content limits pre- [42 FR 14572, Mar. 15, 1977, as amended at 49 scribed in paragraph (b) of this section, FR 10108, Mar. 19, 1984] and the extractability limits prescribed in paragraph (c)(2) of this sec- § 177.1330 Ionomeric resins. tion, when tested by the methods pre- Ionomeric resins manufactured from scribed for polyethylene in § 177.1520. either ethylene-methacrylic acid co- (1) Specifications—(i) Infrared identi- polymers (and/or their ammonium, cal- fication. Ethylene-ethyl acrylate co- cium, magnesium, potassium, sodium, polymers can be identified by their and/or zinc partial salts), ethylene- characteristic infrared spectra. methacrylic acid-vinyl acetate copoly- (ii) Quantitative determination of ethyl mers (and/or their ammonium, cal- acrylate content. The ethyl acrylate can cium, magnesium, potassium, sodium, be determined by the infrared spectra. and/or zinc partial salts,), or meth- Prepare a scan from 10.5 microns to 12.5 acrylic acid polymers with ethylene microns. Obtain a baseline absorbance and isobutyl acrylate (and/or their po- at 11.6 microns and divide by the tassium, sodium and/or zinc partial plaque thickness to obtain absorbance salts) may be safely used as articles or per mil. From a previously prepared components of articles intended for use calibration curve, obtain the amount of in contact with food, in accordance ethyl acrylate present. with the following prescribed condi- (iii) Specific gravity. Ethylene-ethyl tions: acrylate copolymers have a specific (a) For the purpose of this section, gravity of not less than 0.920 nor more the ethylene-methacrylic acid copoly- than 0.935, as determined by ASTM mers consist of basic copolymers pro- method D1505–68 (Reapproved 1979), duced by the copolymerization of ‘‘Standard Test Method for Density of ethylene and methacrylic acid such Plastics by the Density-Gradient Tech- that the copolymers contain no more nique,’’ which is incorporated by ref- than 20 weight percent of polymer erence. Copies may be obtained from units derived from methacrylic acid, the American Society for Testing Ma- and the ethylene-methacrylic acid- terials, 100 Barr Harbor Dr., West vinyl acetate copolymers consist of Conshohocken, Philadelphia, PA 19428- basic copolymers produced by the co- 2959, or may be examined at the Na- polymerization of ethylene, meth- tional Archives and Records Adminis- acrylic acid, and vinyl acetate such tration (NARA). For information on that the copolymers contain no more the availability of this material at than 15 weight percent of polymer NARA, call 202–741–6030, or go to: http:// units derived from methacrylic acid. www.archives.gov/federallregister/ (b) For the purpose of this section, codeloflfederallregulations/ the methacrylic acid copolymers with ibrllocations.html. ethylene and isobutyl acrylate consist (2) Limitations. Ethylene-ethyl acry- of basic copolymers produced by the late copolymers or the blend may be copolymerization of methacrylic acid,

264

VerDate Nov<24>2008 14:38 May 05, 2009 Jkt 217067 PO 00000 Frm 00274 Fmt 8010 Sfmt 8010 Y:\SGML\217067.XXX 217067 cprice-sewell on PRODPC61 with CFR