(1) Homopolymers and copolymers of the following monomers:

(2) Copolymers produced by copolymerizing one or more of the monomers listed in paragraph (a)(1) of this section with one or more of the following monomers:

(3) Polymers identified in paragraphs (a)(1) and (2) of this section containing no more than 5 weight-percent of total polymer units derived by copolymerization with one or more of the monomers listed in paragraph (a)(3)(i) and (ii) of this section. Monomers listed in paragraph (a)(3)(ii) of this section are limited to use only in plastic articles intended for repeated use in contact with food.

(4) Polymers identified in paragraphs (a)(1), (2), and (3) of this section are mixed together and/or with the following polymers, provided that no chemical reactions, other than addition reactions, occur when they are mixed:

(5) Antioxidants and stabilizers identified in § 175.300(b)(3)(xxx) of this chapter and the following:

(6) Release agents: Fatty acids derived from animal and vegetable fats and oils, and fatty alcohols derived from such acids.

(7) Surface active agent: Sodium dodecylbenzenesulfonate.

(8) Miscellaneous materials:

(1) Total nonvolatile extractives not to exceed 0.3 milligram per square inch of surface tested.

(2) Potassium permanganate oxidizable distilled water and 8 and 50 percent alcohol extractives not to exceed an absorbance of 0.15.

(3) Ultraviolet-absorbing distilled water and 8 and 50 percent alcohol extractives not to exceed an absorbance of 0.30.

(4) Ultraviolet-absorbing n-heptane extractives not to exceed an absorbance of 0.10.

(1) Selection of extractability conditions. These are to be chosen as provided in § 176.170(c) of this chapter.

(2) Preparation of samples. Sufficient samples to allow duplicates of all applicable tests shall be cut from the articles or formed from the plastic composition under tests, as strips about 2.5 inches by about 0.85-inch wide by about 0.125-inch thick. The total exposed surface should be 5 square inches ±0.5-square inch. The samples, after preparation, shall be washed with a clean brush under hot tapwater, rinsed under running hot tapwater (140 °F minimum), rinsed with distilled water, and air-dried in a dust-free area or in a desiccator.

(3) Preparation of solvents. The water used shall be double-distilled water, prepared in a still using a block tin condenser. The 8 and 50 percent (by volume) alcohol solvents shall be prepared from ethyl alcohol meeting the specifications of the United States Pharmacopeia XX and diluted with double-distilled water that has been prepared in a still using a tin block condenser. The n-heptane shall be spectrophotometric grade. Adequate precautions must be taken to keep all solvents dust-free.

(4) Blank values on solvents.

(5) Extraction procedure. For each extraction, place a plastic sample in a clean 25 millimeters × 200 millimeters hard-glass test tube and add solvent equal to 10 milliliters of solvent per square inch of plastic surface. This amount will be between 45 milliliters and 55 milliliters. The solvent must be preequilibrated to the temperature of the extraction test. Close the test tube with a ground-glass stopper and expose to the specified temperature for the specified time. Cool the tube and contents to room temperature if necessary.

(6) Determination of total nonvolatile extractives. Remove the plastic strip from the solvent with a pair of clean forceps and wash the strip with 5 milliliters of the appropriate solvent, adding the washings to the contents of the test tube. Pour the contents of the test tube into a clean, weighed platinum dish. Wash the tube with 5 milliliters of the appropriate solvent and add the solvent to the platinum dish. Evaporate the solvent to 2-5 milliliters on a nonsparking, low-temperature hotplate. Complete the evaporation in a 212 °F oven for 30 minutes. Cool the dish in a desiccator for 30 minutes and weigh to the nearest 0.1 milligram. Calculate the total nonvolatile extractives as follows:

(7) Determination of potassium permanganate oxidizable extractives.

(i) Pipette 25 milliliters of distilled water into a clean 125-milliliter Erlenmeyer flask that has been rinsed several times with aliquots of distilled water. This is the blank. Prepare a distilled water solution containing 1.0 part per million of p-methoxyphenol (melting point 54-56 °C, Eastman grade or equivalent). Pipette 25 milliliters of this p-methoxyphenol solution into a rinsed Erlenmeyer flask. Pipette exactly 3.0 milliliters of 154 parts per million aqueous potassium permanganate solution into the p-methoxyphenol and exactly 3.0 milliliters into the blank, in that order. Swirl both flasks to mix the contents and then transfer aliquots from each flask into matched 5-centimeter spectrophotometric absorption cells. The cells are placed in the spectrophotometer cell compartment with the p-methoxyphenol solution in the reference beam. Spectrophotometric measurement is conducted as in paragraph (c)(7)(iv) of this section. The absorbance reading in the region 544-552 mµ should be 0.24 but must be not less than 0.12 nor more than 0.36. This test shall be run in duplicate. For the purpose of ascertaining compliance with the limitations in paragraph (b)(2) of this section, the absorbance measurements obtained on the distilled water extracts according to paragraph (c)(7)(iv) of this section shall be multiplied by a correction factor, calculated as follows:

(ii) The procedure in paragraph (c)(7)(i) of this section is repeated except that, in this instance, the solvent shall be 8 percent alcohol. The absorbance in the region 544-552 mµ should be 0.26 but must be not less than 0.13 nor more than 0.39. This test shall be run in duplicate. For the purpose of ascertaining compliance with the limitations prescribed in paragraph (b)(2) of this section, the absorbance measurements obtained on the 8 percent alcohol extracts according to paragraph (c)(7)(iv) of this section shall be multiplied by a correction factor, calculated as follows:

(iii) The procedure in paragraph (c)(7)(i) of this section is repeated except that, in this instance, the solvent shall be 50 percent alcohol. The absorbance in the region 544-552 mµ should be 0.25 but must be not less than 0.12 nor more than 0.38. This test shall be run in duplicate. For the purpose of ascertaining compliance with the limitations prescribed in paragraph (b)(2) of this section, the absorbance measurements obtained on the 50 percent alcohol extracts according to paragraph (c)(7)(iv) of this section shall be multiplied by a correction factor, calculated as follows:

(8) Determination of ultraviolet-absorbing extractives.

(i) A distilled water solution containing 1.0 part per million of p-methoxyphenol (melting point 54 °C-56 °C. Eastman grade or equivalent) shall be scanned in the region 360 to 220 mµ in 5-centimeter silica spectrophotometric absorption cells versus a distilled water reference. The absorbance at the wavelength of maximum absorbance (should be about 285 mµ) is about 0.11 but must be not less than 0.08 nor more than 0.14. This test shall be run in duplicate. For the purpose of ascertaining compliance with the limitations prescribed in paragraph (b)(3) and (4) of this section, the absorbance obtained on the extracts according to paragraph (c)(8)(ii) of this section shall be multiplied by a correction factor, calculated as follows:

(1) Eighty-four to eighty-nine parts by weight of a matrix polymer containing 73 to 78 parts by weight of acrylonitrile and 22 to 27 parts by weight of styrene; and

(2) Eleven to sixteen parts by weight of a grafted rubber consisting of (i) 8 to 13 parts of butadiene/styrene elastomer containing 72 to 77 parts by weight of butadiene and 23 to 28 parts by weight of styrene and (ii) 3 to 8 parts by weight of a graft polymer having the same composition range as the matrix polymer.

(1) Nitrogen content of the copolymer is in the range of 16 to 18.5 percent as determined by Micro-Kjeldahl analysis.

(2) Residual acrylonitrile monomer content of the finished copolymer articles is not more than 11 parts per million as determined by a gas chromatographic method titled “Determination of Residual Acrylonitrile and Styrene Monomers-Gas Chromatographic Internal Standard Method,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Total nonvolatile extractives not to exceed 0.0005 milligram per square inch surface area when the finished food contact article is exposed to distilled water, 3 percent acetic acid, or n-heptane for 8 days at 120 °F.

(2) The finished food-contact article shall yield not more than 0.0015 milligram per square inch of acrylonitrile monomer when exposed to distilled water and 3 percent acetic acid at 150 °F for 15 days when analyzed by a polarographic method titled “Extracted Acrylonitrile by Differential Pulse Polarography,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Nitrogen content of the copolymer is in the range of 13.0 to 16.0 percent as determined by Micro-Kjeldahl analysis.

(2) Residual acrylonitrile monomer content of the finished copolymer articles is not more than 11 parts per million as determined by a gas chromatographic method titled “Determination of Residual Acrylonitrile and Styrene Monomers-Gas Chromatographic Internal Standard Method,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Total nonvolatile extractives not to exceed 0.0005 milligram per square inch surface area of the food-contact article when exposed to distilled water, 3 percent acetic acid, 50 percent ethanol, and n-heptane for 10 days at 120 °F.

(2) The finished food-contact article shall yield not more than 0.0025 milligram per square inch of acrylonitrile monomer when exposed to distilled water, 3 percent acetic acid and n-heptane at 190 °F for 2 hours, cooled to 120 °F (80 to 90 minutes) and maintained at 120 °F for 10 days when analyzed by a polarographic method titled “Extracted Acrylonitrile by Differential Pulse Polarography,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) The copolymers identified in paragraph (c) of this section may contain adjuvant substances required in their production, with the exception that they shall not contain mercaptans or other substances which form reversible complexes with acryl-onitrile monomer. Permissible adjuvants may include substances generally recognized as safe in food, substances used in accordance with prior sanction, substances permitted under applicable regulations in this part, and those authorized in paragraph (b)(2) of this section.

(2) The optional adjuvants for the acrylonitrile/styrene copolymer identified in paragraphs (c)(1) and (3) of this section are as follows:

(1) 82-88 parts by weight of a matrix copolymer produced by polymerization of 77-82 parts by weight of acrylonitrile and 18-23 parts of styrene; and

(2) 12-18 parts by weight of a grafted rubber consisting of (i) 8-12 parts of butadiene/styrene elastomer containing 77-82 parts by weight of butadiene and 18-23 parts by weight of styrene and (ii) 4-6 parts by weight of a graft copolymer consisting of 70-77 parts by weight of acrylonitrile and 23-30 parts by weight of styrene.

(1) Nitrogen content of the modified copolymer is in the range of 17.7-19.8 percent.

(2) Intrinsic viscosity of the matrix copolymer in butyrolactone is not less than 0.5 deciliter/gram at 35 °C, as determined by the method titled “Molecular Weight of Matrix Copolymer by Solution Viscosity,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) Residual acrylonitrile monomer content of the modified copolymer articles is not more than 11 ppm as determined by a gas chromatographic method titled “Determination of Residual Acrylonitrile and Styrene Monomers-Gas Chromatographic Internal Standard Method,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) The extracted copolymer shall not exceed 2.0 ppm in aqueous extract obtained when a 100-gram sample of copolymer is extracted with 250 milliliters of freshly distilled water at reflux temperature for 2 hours.

(2) The extracted copolymer shall not exceed 0.5 ppm in n-heptane when a 100-gram sample of the basic copol-ymer is extracted with 250 milliliters spectral grade n-heptane at reflux temperature for 2 hours.

(1) The modified copolymer shall be in the form of eight strips 1⁄2 inch by 4 inches by .03 inch.

(2) The modified copolymer strips shall be immersed in 225 milliliters of 3 percent acetic acid in a Pyrex glass pressure bottle.

(3) The pyrex glass pressure bottle is then sealed and heated to 150 °F in either a circulating air oven or a thermostat controlled bath for a period of 8 days.

(4) The Pyrex glass pressure bottle is then removed from the oven or bath and cooled to room temperature. A sample of the extracting solvent is then withdrawn and analyzed for acrylonitrile monomer by a gas chromatographic method titled “Gas-Solid Chromatographic Procedure for Determining Acrylonitrile Monomer in Acrylonitrile-Containing Polymers and Food Simulating Solvents,” which is incorporated by reference. Copies, are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(a) Identity. For the purpose of this section, n-alkylglutarimide/acrylic copolymers are copolymers obtained by reaction of substances permitted by § 177.1010(a)(1), (2), and (3) with the following substance: Monomethylamine (CAS Reg. No. 74-89-5), to form n-methylglutarimide/acrylic copolymers.

(b) Adjuvants. The copolymers identified in paragraph (a) of this section may contain adjuvant substances required in their production. The optional adjuvant substances required in the production of the basic polymer may include substances permitted for such use by applicable regulations, as set forth in part 174 of this chapter.

(c) Specifications. Maximum nitrogen content of the copolymer determined by micro-Kjeldahl analysis, shall not exceed 8 percent.

(d) Limitations.

(e) Conditions of use. The n-alkylglutarimide/acrylic copolymers are used as articles or components of articles (other than articles composed of vinyl chloride homo- or copolymers) intended for use in contact with all foods except beverages containing more than 8 percent alcohol under conditions of use D, E, F, and G as described in table 2 of § 176.170(c) of this chapter.

(1) Substances generally recognized as safe in food.

(2) Substances for which prior approval or sanctions permit their use in cellophane, under conditions specified in such sanctions and substances listed in § 181.22 of this chapter.

(3) Substances that by any regulation promulgated under section 409 of the act may be safely used as components of cellophane.

(4) Substances named in this section and further identified as required.

(1) Substances generally recognized as safe in food.

(2) Substances used in accordance with the provisions of a prior sanction or approval within the meaning of section 201(s) of the act.

(3) Substances that are the subject of regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter and used in accordance with the conditions prescribed.

(4) Substances identified in paragraph (b)(5) of this section, used in amounts not to exceed those required to accomplish the intended physical or technical effect and in conformance with any limitation provided; and further provided that any substance employed in the production of closure-sealing gasket compositions that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with the identity or specifications prescribed.

(5) Substances that may be employed in the manufacture of closure-sealing gaskets include:

(1) The grafted copolymer of cross-linked sodium polyacrylate identified as 2-propenoic acid, polymers with N,N-di-2-propenyl-2-propen-1-amine and hydrolyzed polyvinyl acetate, sodium salts, graft (CAS Reg. No. 166164-74-5); or

(2) 2-propenoic acid, polymer with 2-ethyl-2-(((1-oxo-2-propenyl)oxy)methyl)-1,3-propanediyl di-2-propenoate and sodium 2-propenoate (CAS Reg. No. 76774-25-9).

(1) Substances generally recognized as safe in food.

(2) Substances subject to prior sanction or approval for use in the copoly-mer and used in accordance with such sanction or approval.

(3) Substances which by regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter may be safely used as components of resinous or polymeric coatings and film used as food-contact surfaces, subject to the provisions of such regulation.

(1) The copolymer, when extracted with distilled water at reflux temperature for 2 hours, yields total extractives not to exceed 0.05 percent.

(2) The copolymer, when extracted with ethyl acetate at reflux temperature for 2 hours, yields total extractives not to exceed 0.7 percent.

(3) The copolymer, when extracted with n-hexane at reflux temperature for 2 hours, yields total extractives not to exceed 0.05 percent.

(1) 10 weight-percent of total polymer units derived from acrylic acid when used in accordance with paragraph (b) of this section; and

(2) 25 weight-percent of total polymer units derived from acrylic acid when used in accordance with paragraph (c) of this section.

(1) The total residue method using 3 percent acetic acid, as prescribed in § 177.1330(e)(6)(i)(a), does not apply, and

(2) The net acidified chloroform-soluble extractives from paper and paperboard complying with § 176.170 of this chapter may be corrected for wax, petrolatum, and mineral oil as provided in § 176.170(d)(5)(iii)(b) of this chapter.

If the finished food-contact article is itself the subject of a regulation in parts 174, 175, 176, 177, 178, and § 179.45 of this chapter, it shall also comply with any specifications and limitations prescribed for it by that regulation.

(1) The polymers may be safely used as components of the food-contact or interior core layer of multilaminate food-contact articles.

(2) The polymers may be safely used as food-contact materials at temperatures not to exceed 121 °C (250 °F).

(1) Food-contact layers formed from the basic copolymer identified in paragraph (a) of this section shall be limited to a thickness of not more than 0.01 centimeter (0.004 inch).

(2) The copolymers identified in paragraph (a) of this section shall have a melt index not greater than 500 as determined by ASTM method D1238-82, condition E “Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) The basic copolymer identified in paragraph (a) of this section, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of its intended use, as determined from tables 1 and 2 of § 176.170(c) of this chapter, yields net chloroform-soluble extractives in each extracting solvent not to exceed 0.5 milligram per square inch of food-contact surface when tested by methods described in § 176.170(d) of this chapter.

(4) The provisions of this section are not applicable to ethylene-carbon monoxide copolymers complying with § 175.105 of this chapter.

(1) Substances generally recognized as safe in food and food packaging.

(2) Substances the use of which is permitted under applicable regulations in parts 170 through 189 of this chapter, prior sanction, or approvals.

(1) Specifications —

(2) Limitations. Ethylene-ethyl acrylate copolymers or the blend may be used in contact with food except as a component of articles used for packaging or holding food during cooking provided they meet the following extractability limits:

(1) For fatty food use.

(2) For aqueous foods.

(1) Selection of extractability conditions for ionomeric resins. First ascertain the type of food (table 1 of § 176.170(c) of this chapter) that is being packed or used in contact with the finished food-contact article described in paragraph (a) of this section, and also ascertain the normal conditions of thermal treatment used in packaging or contacting the type of food involved. Using table 2 of § 176.170 (c) of this chapter, select the food-simulating solvent or solvents and the time-temperature test conditions that correspond to the intended use of the finished food-contact article. Having selected the appropriate food-simulating solvent or solvents and time-temperature exaggeration over normal use, follow the applicable extraction procedure.

(2) Selection of extractability conditions for ionomeric resins. Using table I of paragraph (f) of this section ascertain the type of food that is being packed or used in contact with the finished food-contact article described in paragraph (b) of this section, and also ascertain the food-simulating solvent or solvents that correspond to the intended use of the finished food-contact article.

(3) Reagents —

(4) Selection of test method. The finished food-contact articles shall be tested either by the extraction cell described in the Journal of the Association of Official Agricultural Chemists, Vol. 47, No. 1, p. 177-179 (February 1964), also described in ASTM method F34-76 (Reapproved 1980), “Standard Test Method for Liquid Extraction of Flexible Barrier Materials,” which are incorporated by reference, or by adapting the in-container methods described in § 175.300(e) of this chapter. Copies of the material incorporated by reference are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, and the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, respectively, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(5) Selection of samples. Quadruplicate samples should be tested, using for each replicate sample the number of finished articles with a food-contact surface nearest to 100 square inches.

(6) Determination of amount of extractives —

(1) Density. Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer identified in paragraph (a) of this section has a density of 1.33±0.02 grams per cubic centimeter measured by ASTM Method D 1505-85 (Reapproved 1990), “Standard Test Method for Density of Plastics by the Density-Gradient Technique,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Softening point. Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer identified in paragraph (a) of this section has a softening point of 63±5 °C as measured by ASTM Method D 1525-87, “Standard Test Method for VICAT Softening Temperature of Plastics,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this material is provided in paragraph (b)(1) of this section.

(1) Ethylene-vinyl acetate copolymers consist of basic resins produced by the catalytic copolymerization of ethylene and vinyl acetate to which may have been added certain optional substances to impart desired technological or physical properties to the resin. Subject to any limitations prescribed in this section, the optional substances may include:

(2) Maleic anhydride-grafted ethylene-vinyl acetate copolymers (CAS Reg. No. 28064-24-6) consist of basic resins produced by the catalytic copolymerization of ethylene and vinyl acetate, followed by reaction with maleic anhydride. Such polymers shall contain not more than 11 percent of polymer units derived from vinyl acetate by weight of total polymer prior to reaction with maleic anhydride, and not more than 2 percent of grafted maleic anhydride by weight of the finished polymer. Optional adjuvant substances that may be added to the copolymers include substances generally recognized as safe in food and food packaging, substances the use of which is permitted under applicable regulations in parts 170 through 189 of this chapter, and substances identified in § 175.300(b)(3)(xxv), (xxvii), (xxxiii), and (xxx) of this chapter and colorants for polymers used in accordance with the provisions of § 178.3297 of this chapter.

(1) Ethylene-vinyl acetate copolymers, with or without the optional substances described in paragraph (a) of this section, when extracted with the solvent or solvents characterizing the type of food, and under conditions of time and temperature characterizing the conditions of their intended use as determined from tables 1 and 2 of § 176.170(c) of this chapter, shall yield net chloroform-soluble extractives corrected for zinc as zinc oleate not to exceed 0.5 milligram per square inch of an appropriate sample.

(2) Maleic anhydride grafted ethylene-vinyl acetate copolymers shall have a melt flow index not to exceed 2.1 grams per 10 minutes as determined by ASTM method D 1238-82, “Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer,” which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or at the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Compliance of the melt flow index specification shall be determined using conditions and procedures corresponding to those described in the method as Condition E, Procedure A). The copolymers shall be used in blends with other polymers at levels not to exceed 17 percent by weight of total polymer, subject to the limitation that when contacting food of types III, IV-A, V, VI-C, VII-A, and IX, identified in § 176.170(c) of this chapter, Table 1, the polymers shall be used only under conditions of use C, D, E, F, and G, described in § 176.170(c) of this chapter, Table 2.

(1) Electron beam source of ionizing radiation at a maximum energy of 3 million electron volts: Maximum absorbed dose not to exceed 150 kiloGray (15 megarads).

(2) The finished food-contact film shall meet the extractives limitations prescribed in paragraph (e)(2) of this section.

(3) The ethylene-vinyl acetate copolymer films may be further irradiated in accordance with the provisions of paragraph (e)(1) of this section: Provided, That the total accumulated radiation dose from both electron beam and gamma ray radiation does not exceed 150 kiloGray (15 megarads).

(1) Gamma photons emitted from a cobalt-60 sealed source in the dose range of 5-50 kiloGray (0.5-5.0 megarads).

(2) The irradiated ethylene-vinyl acetate copolymer films, when extracted with reagent grade n-heptane (freshly redistilled before use) according to methods described under § 176.170(d)(3) of this chapter, at 75 °F for 30 minutes shall yield total extractives not to exceed 4.5 percent by weight of the film.

(1) Those copolymers containing a minimum of 55 percent ethylene and a maximum of 30 percent vinyl alcohol units by weight may be used in contact with foods as described in paragraph (b) of this section.

(2) Those copolymers containing a minimum of 55 percent ethylene and a maximum of 15 percent vinyl alcohol units by weight may be used in contact with foods as described in paragraph (c) of this section.

(3) Those copolymers containing 17 to 40 percent ethylene and 60 to 83 percent vinyl alcohol units by weight may be used in contact with foods as described in paragraph (d) of this section.

(1) The film when extracted with distilled water at 21 °C (70 °F) for 48 hours yields total extractives not to exceed 0.0047 milligram per square centimeter (0.03 milligram per square inch) of food-contact surface.

(2) The film when extracted with 50 percent ethyl alcohol at 21 °C (70 °F) for 48 hours yields total extractives not to exceed 0.0062 milligram per square centimeter (0.04 milligram per square inch) of food-contact surface.

(1) Chlorotrifluoroethylene resins produced by the homopolymerization of chlorotrifluoroethylene.

(2) Chlorotrifluoroethylene-1,1-difluoroethylene copolymer resins produced by copolymerization of chlorotrifluoroethylene and 1,1-difluoroethylene.

(3) Chlorotrifluoroethylene-1,1-difluoroethylene-tetrafluoroethylene co-polymer resins produced by copolymerization of chlorotrifluoroethylene, 1,1-difluoroethylene, and tetrafluoroethylene.

(4) Ethylene-chlorotrifluoroethylene copolymer resins produced by copolymerization of nominally 50 mole percent of ethylene and 50 mole percent of chlorotrifluoroethylene. The copolymer shall have a melting point of 239 to 243 °C and a melt index of less than or equal to 20 as determined by ASTM Method D 3275-89 “Standard Specification for E-CTFE-Fluoroplastic Molding, Extrusion, and Coating Materials,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Society for Testing and Materials, 1916 Race St., Philadelphia, PA 19013, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Fluorocarbon resins that are identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section and that comply only with the extractive limitations prescribed in paragraphs (c)(1) and (c)(2) of this section may be used when such use is limited to articles or components of articles that are intended for repeated use in contact with food or that are intended for one-time use in contact with foods only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, VI, VII-B, and VIII.

(2) Fluorocarbon resins that are identified in paragraph (a)(4) of this section and that comply with the extractive limitations prescribed in paragraphs (c)(1) and (c)(2) of this section may be used only when such use is limited to articles or components of articles that are intended for repeated use in contact with food.

(3) In accordance with current good manufacturing practice, those food-contact articles intended for repeated use shall be thoroughly cleansed prior to their first use in contact with food.

(1) A 100-gram sample of the resin pellets, when extracted with 100 milliliters of distilled water at reflux temperature for 8 hours, shall yield total extractives not to exceed 0.003 percent by weight of the resins.

(2) A 100-gram sample of the resin pellets, when extracted with 100 milliliters of 50 percent (by volume) ethyl alcohol in distilled water at reflux temperature for 8 hours, shall yield total extractives not to exceed 0.003 percent by weight of the resins.

(3) A 100-gram sample of the resin pellets, when extracted with 100 milliliters of n-heptane at reflux temperature for 8 hours, shall yield total extractives not to exceed 0.01 percent by weight of the resins.

(1) Polymeric films/layers. Films or layers not separated from food by a functional barrier must meet the following requirements:

(2) Adhesives. The use of adhesives in these containers is optional. Adhesives may be formulated from the following substances, subject to the prescribed limitations:

(3) Test specifications. These specifications apply only to materials on the food-contact side of a functional barrier, if present. All tests must be performed on containers made under production conditions. Laminated structures submitted to extraction procedures must maintain complete structural integrity (particularly with regard to delamination) throughout the test.

(1) The container is constructed of aluminum foil to which nylon 12 film is fused. Prior to fusing the nylon 12, the aluminum foil may be optionally precoated with a coating complying with § 175.300 of this chapter.

(2) Nylon 12 resin complying with § 177.1500 and having an average thickness not to exceed 0.0016 inch (41 microns) may be used as the food-contact surface of the container.

(3) Container test specifications. On exposure to distilled water at 250 °F (121 °C) for 2 hours, extractives from the food-contact side of the nylon 12 multilayered construction shall not exceed 0.05 milligram per square inch (0.0078 milligram per square centimeter) as total nonvolatile extractives.

(1) Polymers and adjuvants complying with § 177.1390 of this chapter.

(2) Any polymeric resin listed in these regulations so long as the use of the resin in the structure complies with the conditions of use (food type and time/temperature) specified in the regulation for that resin.

(3) Optional adjuvant substances used in accordance with § 174.5 of this chapter.

(4) The following substances in non-food-contact layers only:

(1) Substances generally recognized as safe in food.

(2) Substances permitted to be used in water-insoluble hydroxyethyl cellulose film by prior sanction or approval and under conditions specified in such sanctions or approval, and substances listed in part 181, subpart B of this chapter.

(3) Substances that by any regulation promulgated under section 409 of the act may be safely used as components of water-insoluble hydroxyethyl cellulose film.

(4) Substances identified in and used in compliance with § 177.1200(c).

(1) Polyisobutylene produced by the homopolymerization of isobutylene such that the finished polymers have a molecular weight of 750,000 (Flory) or higher.

(2) Isobutylene-isoprene copolymers produced by the copolymerization of isobutylene with not more than 3 molar percent of isoprene such that the finished polymers have a molecular weight of 300,000 (Flory) or higher.

(3) Chlorinated isobutylene-isoprene copolymers produced when isobutylene-isoprene copolymers (molecular weight 300,000 (Flory) or higher) are modified by chlorination with not more than 1.3 weight-percent of chlorine.

(1) Molecular weight. Molecular weight shall be determined by American Society for Testing and Materials (ASTM) method D2503-82, “Standard Test Method for Molecular Weight (Relative Molecular Mass) of Hydrocarbons by Thermoelectric Measurement of Vapor Pressure,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Viscosity. Viscosity shall be determined by ASTM method D445-74, “Test for Kinematic Viscosity of Transparent and Opaque Liquids,” which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(3) Maximum bromine value. Maximum bromine value shall be determined by ASTM method D1492-78, “Standard Test Method for Bromine Index of Aromatic Hydrocarbons by Coulometric Titration,” which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(1) Maximum extractable nonvolatile fraction of 2 parts per million when extracted with distilled water at 70 °C for 2 hours, using a volume-to-surface ratio of 2 milliliters per square inch.

(2) Maximum extractable nonvolatile fraction of 3 parts per million when extracted with n-heptane at 70 °C for 2 hours, using a volume-to-surface ratio of 2 milliliters per square inch.

(3) Maximum extractable nonvolatile fraction of 6 parts per million when extracted with 10 percent (by volume) ethyl alcohol in distilled water at 70 °C for 2 hours, using a volume-to-surface ratio of 2 milliliters per square inch.

(1) Specifications.

(2) Extractives limitations. The following extractive limitations are determined by an infrared spectrophotometric method titled, “Infrared Spectrophotometric Determination of Polymer Extracted from Borex ® 210 Resin Pellets,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.Copies are applicable to the basic copolymers in the form of particles of a size that will pass through a U.S. standard sieve No. 6 and that will be held on a U.S. standard sieve No. 10:

(1) Nylon 66 resins are manufactured by the condensation of hexamethylene-diamine and adipic acid.

(2) Nylon 610 resins are manufactured by the condensation of hexamethylene-diamine and sebacic acid.

(3) Nylon 66/610 resins are manufactured by the condensation of equal-weight mixtures of nylon 66 salts and nylon 610 salts.

(4) Nylon 6/66 resins manufactured by the condensation and polymerization of Nylon 66 salts and epsilon-caprolactam.

(5) Nylon 11 resins are manufactured by the condensation of 11-aminoundecanoic acid.

(6) Nylon 6 resins are manufactured by the polymerization of epsilon-caprolactam.

(7) Nylon 66T resins are manufactured by the condensation of hexamethyl-enediamine, adipic acid, and terephthalic acid such that composition in terms of ingredients is 43.1±0.2 weight percent hexamethyl-enediamine, 35.3±1.2 weight percent adipic acid, and 21.6±1.2 weight percent terephthalic acid.

(8) Nylon 612 resins are manufactured by the condensation of hexamethylenediamine and dodecanedioic acid.

(9) Nylon 12 resins are manufactured by the condensation of omega-laurolactam.

(10)

(11) Nylon 12T resins are manufactured by the condensation of omega-laurolactam (CAS Reg. No. 0947-04-6), isophthalic acid (CAS Reg. No. 0121-91-5), and bis(4-amino-3-methylcycl-ohexyl)methane (CAS Reg. No. 6864-37-5) such that the composition in terms of ingredients is 34.4±1.5 weight percent omega-laurolactam, 26.8±0.4 weight percent isophthalic acid, and 38.8±0.5 weight percent bis(4-amino-3-methylcyclohexyl)-methane.

(12) Nylon 6I/6T resins (CAS Reg. No. 25750-23-6) are manufactured by the condensation of hexamethylenediamine, terephthalic acid, and isophthalic acid such that 65 to 80 percent of the polymer units are derived from hexamethylene isophthalamide.

(13)

(14) Nylon 6/69 resins (CAS Reg. No. 51995-62-1) are manufactured by the condensation of 49.5 + 0.5 weight percent epsilon-caprolactam, 19.4 + 0.2 weight percent hexamethylenediamine and 31.2 + 0.3 weight percent azelaic acid.

(15) Nylon 46 resins (CAS Reg. No. 50327-77-0) are manufactured by the condensation of 1,4-butanediamine and adipic acid.

(16) Nylon resins PA 6-3-T (CAS Registry No. 26246-77-5) are manufactured by the condensation of 50 mol percent 1,4-benzenedicarboxylic acid, dimethyl ester and 50 mol percent of an equimolar mixture of 2,2,4-trimethyl-1,6-hexanediamine and 2,4,4-trimethyl-1,6-hexanediamine.

(1) Identity. Copolyester-graft-acrylate copolymer is the substance 1,4-benzenedicarboxylic acid, polymer with 1,4-butanediol, (E)-2-butenedioic acid, 1,2-ethanediol, ethyl 2-propenoate, hexanedioic acid and 2-propenoic acid, graft (CAS Reg. No. 175419-23-5), and is derived from grafting of 25 weight percent of acrylic polymer with 75 weight percent of copolyester. The copolyester is polymerized terephthalic acid (55 mol%), adipic acid (40 mol%), and fumaric acid (5 mol%) with ethylene glycol (40 mol%) and 1,4-butanediol (60 mol%). The acrylic polymer is made from acrylic acid (70 mol%) and ethyl acrylate (30 mol%).

(2) Specifications. The finished copolyester-graft-acrylate copolymer shall meet the following specifications:

(3) Conditions of use.

(1) Specific gravity. Specific gravity shall be determined by weighing a 1-gram to 5-gram sample first in air and then in freshly boiled distilled water at 23 °C±2 °C.

(2) Melting point. The melting point shall be determined as follows: Use a hot-stage apparatus. The use of crossed nicol prisms with a microscope hot stage and reading of the thermometer when the birefringence disappears increases the accuracy. If the crossed nicol apparatus is not available, use the lowest temperature at which the sample becomes transparent or the sharp edges or corners of the sample become rounded as the melting point. In case of doubt as to the onset of melting, the sample is prodded with a sharp instrument. If it sticks to the heating block, it is considered to have melted. If the melting point is low, dry the sample in an oven at 85 °C for 24 hours in a nitrogen atmosphere then repeat the test.

(3) Solubility in boiling 4.2N HCl. The test shall be run on a sample approximately the size of a 1⁄8-inch cube in at least 25 milliliters of 4.2 normal hydrochloric acid.

(4) Maximum extractable fraction in selected solvents. The procedure for determining the maximum extractable fraction of the nylon resins in selected solvents is as follows:

(5) Viscosity number (VN).

(1)

(2)

(3) Olefin basic copolymers consist of basic copolymers manufactured by the catalytic copolymerization of:

(4) Poly(methylpentene) consists of basic polymers manufactured by the catalytic polymerization of 4-methylpentene-1.

(5) Polyethylene graft copolymers consist of polyethylene complying with item 2.2 of paragraph (c) of this section which subsequently has 3a,4,7,7a-tetrahydromethyl-4,7-methanoisobenzofuran-1,3-dione grafted onto it at a level not to exceed 1.7 percent by weight of the finished copolymer.

(6) Ethylene-maleic anhydride copolymers (CAS Reg. No. 9006-26-2) containing no more than 2 percent by weight of copolymer units derived from maleic anhydride.

(1) Density. Density shall be determined by ASTM method D1505-68 (Reapproved 1979), “Standard Test Method for Density of Plastics by the Density-Gradient Technique,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Melting point or softening point —

(3) Maximum extractable fraction in n-hexane —

(i) Olefin copolymers described in paragraph (a)(3)(ii) of this section, polypropylene, and poly(methylpentene). A sample is refluxed in the solvent for 2 hours and filtered at the boiling point. The filtrate is evaporated and the total residue weighed as a measure of the solvent extractable fraction.

(a) Apparatus.

(1) Erlenmeyer flasks, 250-milliliter, with ground joint.

(2) Condensers, Allihn, 400-millimeter jacket, with ground joint.

(3) Funnels, ribbed 75-millimeter diameter, stem cut to 40 millimeters.

(4) Funnels, Buchner type, with coarse-porosity fritted disc, 60-millimeter diameter.

(5) Bell jar for vacuum filtration into beaker.

(b) Reagent. n- Hexane, commercial grade, specific gravity 0.663-0.667 (20 °C/20 °C), boiling range 66 °C-69 °C, or equivalent.

(c) Procedure. Weigh 1 gram of sample accurately and place in a 250-milliliter Erlenmeyer flask containing two or three boiling stones. Add 100 milliliters of solvent, attach the flask to the condenser (use no grease), and reflux the mixture for 2 hours. Remove the flask from the heat, disconnect the condenser, and filter rapidly, while still hot, through a small wad of glass wool packed in a short-stem funnel into a tared 150-millimeter beaker. Rinse the flask and filter with two 10-milliliter portions of the hot solvent, and add the rinsings to the filtrate. Evaporate the filtrate on a stream bath with the aid of a stream of nitrogen. Dry the residue in a vacuum oven at 110 °C for 2 hours, cool in a desiccator, and weigh to the nearest 0.0001 gram. Determine the blank on 120 milliliters of solvent evaporated in a tared 150-milliliter beaker. Correct the sample residue for this blank if significant. Calculation:

(4) Maximum soluble fraction in xylene —

(i) Olefin copolymers described in paragraph (a)(3)(ii) of this section, polypropylene, and poly(methylpen-tene). A sample is dissolved completely in xylene by heating and stirring in a bottle with little free space. The solution is allowed to cool without stirring, whereupon the insoluble portion precipitates and is filtered off; the total solids content of the filtrate is then determined as a measure of the soluble fraction.

(a) Apparatus.

(1) Pyrex (or equivalent) reagent bottle, 125-milliliter, glass-stoppered.

(2) Heating mantle of size for 150-milliliter beaker (or suitable aluminum block to fit the 125-milliter bottle described in paragraph (d)(4)(i)(a)(1) of this section.

(3) Magnetic stirrer for use under the heating mantle (combination magnetic stirrer and hotplate may be used if aluminum block is used in place of heating mantle).

(4) Variable-voltage transformer, 7.5 amperes.

(5) Tetrafluoroethylene-resin-coated stirring bar, 1-inch long.

(6) Constant temperature water bath maintained at 25 °C±0.5 °C.

(7) Aluminum dishes, 18 millimeters × 60 millimeters, disposable.

(8) Funnel, Buchner type, with coarse-porosity fritted disc, 30-60 millimeter diameter.

(b) Reagent. Xylene with antioxidant. Dissolve 0.020 gram of phenyl-β- naphthylamine in 1 liter of industrial grade xylene having specific gravity 0.856-0.867 (20 °C/20 °C) and boiling range 123 °C-160 °C.

(c) Procedure. Weigh 1 to 2 grams of sample to the nearest 0.001 gram and place in a 125-milliliter Pyrex reagent bottle containing a 1-inch long tetrafluoroethylene-resin-coated stirring bar. Add 100 milliliters of solvent, set the stopper in lightly, and place the bottle in the heating mantle or aluminum block maintained at a temperature of 120 °C, and stir with a magnetic stirrer until the sample is completely dissolved. Remove the bottle from the heat and allow it to cool 1 hour in the air, without stirring. Then place the bottle in a water bath maintained at 25 °C ±0.5 °C, and allow to stand 1 hour without stirring. Next, remove the bottle from the water bath, shake, and pour part of the contents into the coarse-porosity fritted-glass funnel. Apply suction, and draw 30-40 milliliters of filtrate through, adding more slurry to the funnel, and catching the filtrate in a large test tube. (If the slurry is hard to filter, add 10 grams of diatomaceous earth filter aid to the bottle and shake vigorously just prior to the filtration.) Pipet a suitable aliquot (preferably 20 milliliters) of the filtrate into a tared aluminum disposable dish. Place the dish on a steam bath covered with a fresh sheet of aluminum foil and invert a short-stemmed 4-inch funnel over the dish. Pass nitrogen (heated if desired) down through the funnel at a rate sufficient to just ripple the surface of the solvent. When the liquid has evaporated, place the dish in a vacuum oven at 140 °C and less than 50 millimeters mercury pressure for 2 hours. Cool in a desiccator and weigh. (Note: If the residue value seems high, redry in the vacuum oven for one-half hour to ensure complete removal of all xylene solvent.) Calculation:

(5) Viscosity average molecular weight olefin copolymers described in paragraphs (a)(3)(iii) and (iv) of this section. The viscosity average molecular weight shall be determined from the kinematic viscosity (using ASTM method D445-74, “Test for Kinematic Viscosity of Transparent and Opaque Liquids” (Revised 1974), which is incorporated by reference; copies are available from American Society for Testing and Materials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.) of solutions of the copolymers in solvents and at temperatures as follows:

(6) Mooney viscosity—olefin copolymers described in paragraph (a)(3)(iii) of this section. Mooney viscosity is determined by ASTM method D1646-81, “Standard Test Method for Rubber—Viscosity and Vulcanization Characteristics (Mooney Viscometer),” which is incorporated by reference (the availability of this incorporation by reference is given in paragraph (d)(1) of this section), using the large rotor at a temperature of 100 °C, except that a temperature of 127 °C shall be used for those copolymers whose Mooney viscosity cannot be determined at 100 °C. The apparatus containing the sample is warmed for 1 minute, run for 8 minutes, and viscosity measurements are then made.

(7) Melt flow index. The melt flow index of olefin polymers described below shall be determined by ASTM method D-1238-82, “Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer,” which is incorporated by reference in accordance with 5 U.S.C. 552(a). The availability of this incorporation by reference is given in paragraph (d)(1) of this section. The olefin polymers and test conditions and procedures are as follows:

(8) Melting peak temperature. The melt temperature of the olefin polymers described in paragraph (a)(3)(ii) of this section shall be determined by ASTM method D 3418-82, “Standard Test Method for Transition Temperatures of Polymers by Thermal Analysis,” which is incorporated by reference in accordance with 5 U.S.C. 552(a). The availability of this incorporation by reference is given in paragraph (d)(1) of this section.

(9) Intrinsic viscosity. The intrinsic viscosity of the olefin polymers described in paragraph (a)(3)(ii) of this section shall be determined by ASTM method D 1601-78, “Standard Test Method for Dilute Solution Viscosity of Ethylene Polymers,” which is incorporated by reference in accordance with 5 U.S.C. 552(a). The availability of this incorporation by reference is given in paragraph (d)(1) of this section.

(1) The homopolymerization and/or copolymerization of hexafluoropropylene and tetrafluoroethylene, and

(2) the copolymerization of perfluoropropylvinylether and tetrafluoroethylene (CAS Reg. No. 26655-00-5). The resins shall meet the extractives limitations in paragraph (d) of this section.

(1) Substances generally recognized as safe (GRAS) in food or food packaging subject to any limitations cited on their use.

(2) Substances used in accordance with a prior sanction or approval, subject to any limitations cited in the prior sanction or approval.

(3) Substances authorized under applicable regulations in this part and in parts 175 and 178 of this chapter and subject to any limitations prescribed therein.

(4) The following substances, subject to any limitations prescribed:

(1) Infrared identification. Perfluorocarbon resins can be identified by their characteristic infrared spectra.

(2) Melt-viscosity.

(3) Thermal instability index. The thermal instability index of the tetrafluoroethylene homopolymer shall not exceed 50 as determined by ASTM method D1457-56T, “Test for Thermal Instablility index of Tetrafluoroethylene Homopolymer” (Revised 1956), which is incorporated by reference. Copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The requirements of this paragraph do not apply to polytetrafluoroethylene resin lubricant powders described in paragraph (c) of this section.

(1) Perfluorocarbon-molded articles having a surface area of 6.45 square decimeters (100 square inches) or more and at least 1.27 millimeters (0.05 inch) thick shall be extracted at reflux temperatures for 2 hours separately with distilled water, 50 percent ethanol, n-heptane, and ethyl acetate.

(2) Perfluorocarbon resins identified in paragraphs (a)(1) and (2) of this section and intended for use as coatings or components of coatings shall meet extractability limits prescribed in paragraph (e)(3) of this section when the resins in the form of coatings described in paragraphs (e)(2)(i) and (ii) of this section are extracted at reflux temperatures for 2 hours separately with distilled water, 8 percent ethanol, and n-heptane:

(3) The extracted surfaces shall meet the following extractability limits:

(1) The finished copolymers shall contain from 70 to 80 weight percent of polymer units derived from diphenylisophthalate and 20 to 30 weight percent of polymer units derived from diphenylterephthalate.

(2) Polyarylate resins shall have a minimum weight average molecular weight of 20,000.

(3) Polyarylate resins may be identified by their characteristic infrared spectra.

(1) Benzoyl chloride, poly(tetrafluoro ethylene).

(2) [Reserved]

(1) Specifications —

(2) Limitations. Poly-1-butene resins and butene/ethylene copolymers for use in articles that contact food, and for articles used for packing or holding food during cooking shall yield no more than the following extractables:

(1) The condensation of 4,4′-iso-propylidenediphenol and carbonyl chloride to which may have been added certain optional adjuvant substances required in the production of the resins; or by

(2) The reaction of molten 4,4′-iso-propylidenediphenol with molten diphenyl carbonate in the presence of the disodium salt of 4,4′-isopropylidenediphenol.

(3) The condensation of 4,4′-isopro- pylidenediphenol, carbonyl chloride, and 0.5 percent weight maximum of a2,a6-bis (6-hydroxy-m-tolyl) mesitol to which may have been added certain optional adjuvant substances required in the production of branched polycarbonate resins.

(1) Specification. Polycarbonate resins can be identified by their characteristic infrared spectrum.

(2) Extractives limitations. The polycarbonate resins to be tested shall be ground or cut into small particles that will pass through a U.S. standard sieve No. 6 and that will be held on a U.S. standard sieve No. 10.

(1) Substances used in accordance with § 174.5 of this chapter.

(2) Substances identified in § 177.1580(b).

(3) Substances regulated in § 178.2010(b) of this chapter for use in polycarbonate resins complying with § 177.1580:

Provided, That the substances are used in accordance with any limitation on concentration, conditions of use, and food types specified in § 178.2010(b) of this chapter.

(1) Specifications. Polyestercarbonate resins identified in paragraph (a) of this section can be identified by their characteristic infrared spectrum. The resins shall comply with either or both of the following specifications:

(2) Extractives limitations. The polyestercarbonate resins to be tested shall be ground or cut into small particles that will pass through a U.S. standard sieve No. 6 and that will be held on U.S. standard sieve No. 10.

(3) Residual methylene chloride levels in polyestercarbonate resins. Polyestercarbonate resin articles in the finished form shall not contain residual methylene chloride in excess of 5 parts per million as determined by a method titled “Analytical Method for Determination of Residual Methylene Chloride in Polyestercarbonate Resin,” developed by the General Electric Co., July 23, 1991, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Specifications. Polyetherimide resin identified in paragraph (a) of this section shall have an intrinsic viscosity in chloroform at 25 °C (77 °F) of not less than 0.35 deciliter per gram as determined by a method titled “Intrinsic Viscosity of ULTEM Polyetherimide Using Chloroform as the Solvent,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Extractive limitations. Extractive limitations are applicable to the basic polyetherimide resin in the form of molded discs of thickness 0.16 centimeter (0.063 inch). The resin discs when extracted with distilled water at 121 °C (250 °F) for 2 hours yield total nonvolatile extractives of not more than 12.3 micrograms per square centimeter.

(1) Polyethylene phthalate spunbonded nonwoven fabric consist of continuous filaments of ethylene terephthalate polymer and ethylene terephthalate-isophthalate copolymer to which may have been added optional adjuvant substances required in their preparation and finishing.

(2) The ethylene terephthalate-isophthalate copolymer component of the fabric shall not exceed 25 percent by weight. The filaments may be blended with other fibers regulated for the specific use and the spunbonded fabric may be further bonded by application of heat and/or pressure.

(3) The fabric shall be used only in accordance with paragraph (i) of this section.

(1) Substances generally recognized as safe in food.

(2) Substances subject to prior sanction or approval for use in polyethylene phthalate plastics and used in accordance with such sanction or approval.

(3) Substances which by regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter may be safely used as components of resinous or polymeric food-contact surfaces subject to the provisions of such regulation.

(4) Substances identified in this paragraph (e)(4) subject to the limitations prescribed:

List of Substances and Limitations

(1) Specifications.

(2) Conditions of use. The plastics are used for packaging, transporting, or holding food, excluding alcoholic beverages, at temperatures not to exceed 250 °F.

(1) Specifications.

(2) Conditions of use. The plastics are used for packaging, transporting, or holding alcoholic beverages that do not exceed 50 percent alcohol by volume.

(1) Specifications.

(2) Conditions of use. The plastics are used to contain foods during oven baking or oven cooking at temperatures above 250 °F.

(1) Specifications. Chloroform-soluble extractives shall not exceed 0.2 milligram/inch² of food-contact surface when exposed to the following solvents at temperatures and times indicated:

(2) Conditions of use. The plastics are intended for:

(1) Specifications.

(2) Conditions of use. The plastics are used for packaging, transporting, or holding alcoholic foods that do not exceed 95 percent alcohol by volume.

(1) Optional adjuvant substances authorized for this use in accordance with § 174.5 of this chapter.

(2) Optional finish components, total weight not to exceed 1 percent by weight of the base polymer, as follows: