cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
88 rows where part_number = 177 and title_number = 21 sorted by section_id
This data as json, CSV (advanced)
Suggested facets: subpart, subpart_name
| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:3.0.1.1.8.2.1.1 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1010 Acrylic and modified acrylic plastics, semirigid and rigid. | FDA | [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 43 FR 54927, Nov. 24, 1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796, Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR 13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985; 87 FR 31089, May 20, 2022] | Semirigid and rigid acrylic and modified acrylic plastics may be safely used as articles intended for use in contact with food, in accordance with the following prescribed conditions. The acrylic and modified acrylic polymers or plastics described in this section also may be safely used as components of articles intended for use in contact with food. (a) The optional substances that may be used in the formulation of the semirigid and rigid acrylic and modified acrylic plastics, or in the formulation of acrylic and modified acrylic components of articles, include substances generally recognized as safe in food, substances used in accordance with a prior sanction or approval, substances permitted for use in such plastics by regulations in parts 170 through 189 of this chapter, and substances identified in this paragraph. At least 50 weight-percent of the polymer content of the acrylic and modified acrylic materials used as finished articles or as components of articles shall consist of polymer units derived from one or more of the acrylic or methacrylic monomers listed in paragraph (a)(1) of this section. (1) Homopolymers and copolymers of the following monomers: n- Butyl acrylate. n- Butyl methacrylate. Ethyl acrylate. 2-Ethylhexyl acrylate. Ethyl methacrylate. Methyl acrylate. Methyl methacrylate. n- Butyl acrylate. n- Butyl methacrylate. Ethyl acrylate. 2-Ethylhexyl acrylate. Ethyl methacrylate. Methyl acrylate. Methyl methacrylate. (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: Acrylonitrile. Methacrylonitrile. α-Methylstyrene. Styrene. Vinyl chloride. Vinylidene chloride. Acrylonitrile. Methacrylonitrile. α-Methylstyrene. Styrene. Vinyl chloride. Vinylidene chloride. (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 mo… | |||
| 21:21:3.0.1.1.8.2.1.10 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1240 1,4-Cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymer. | FDA | [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, 1984, as amended at 55 FR 34555, Aug. 23, 1990] | Copolymer of 1,4-cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate may be safely used as an article or component of articles used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The copolymer is a basic polyester produced by the catalytic condensation of dimethyl terephthalate and dimethyl isophthalate with 1,4-cyclohexanedimethanol, to which may have been added certain optional substances required in its production or added to impart desired physical and technical properties. (b) The quantity of any optional substance employed in the production of the copolymer does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitation further provided. (c) Any substance employed in the production of the copolymer that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation. (d) Substances employed in the production of the copolymer include: (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. (e) The copolymer conforms with the following specifications: (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 e… | |||
| 21:21:3.0.1.1.8.2.1.11 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1310 Ethylene-acrylic acid copolymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 51 FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, 1988] | The ethylene-acrylic acid copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for use in contact with food subject to the provisions of this section. (a) The ethylene-acrylic acid copolymers consist of basic copolymers produced by the copolymerization of ethylene and acrylic acid such that the finished basic copolymers contain no more than: (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. (b) The finished food-contact articles made with no more than 10 percent total polymer units derived from acrylic acid, when extracted with the solvent or solvents characterizing the type of food and under the conditions of its intended use as determined from tables 1 and 2 of § 176.170(c) of this chapter, yield net acidified chloroform-soluble extractives not to exceed 0.5 milligram per square inch of food-contact surface when tested by the methods prescribed in § 177.1330(e)(1), (3)(i) through (iv), (4), (5), and (6), except that (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. (c) The finished food-contact layer made with basic copolymers containing more than 10 weight-percent but no more than 25 weight-percent of total polymer units derived from acrylic acid and with a maximum thickness of 0.0025 inch (2.5 mils) may … | |||
| 21:21:3.0.1.1.8.2.1.12 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1312 Ethylene-carbon monoxide copolymers. | FDA | [57 FR 32422, July 22, 1992] | The ethylene-carbon monoxide copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for use in contact with food subject to the provisions of this section. (a) Identity. For the purposes of this section, ethylene-carbon monoxide copolymers (CAS Reg. No. 25052-62-4) consist of the basic polymers produced by the copolymerization of ethylene and carbon monoxide such that the copolymers contain not more than 30 weight-percent of polymer units derived from carbon monoxide. (b) Conditions of use. (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). (c) Specifications. (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… | |||
| 21:21:3.0.1.1.8.2.1.13 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers. | FDA | [45 FR 39252, June 10, 1980, as amended at 47 FR 24288, June 4, 1982; 49 FR 25629, June 22, 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, Nov. 24, 1995] | Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymer may be safely used as articles or components of articles intended for use in contact with food subject to provisions of this section and of part 174 of this chapter. (a) Identity. For the purposes of this section, ethylene-1,4-cyclohexylene dimethylene terephthalate copolymers (1,4-benzene dicarboxylic acid, dimethyl ester, polymerized with 1,4-cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25640-14-6) or (1,4-benzenedicarboxylic acid, polymerized with 1,4-cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25038-91-9) are basic copolymers meeting the specifications prescribed in paragraph (b) of this section, to which may have been added certain optional substances required in their production or added to impart desired physical or technical properties. (b) Specifications: (c) Analytical method for determination of extractability. The total extracted terephthaloyl moieties can be determined in the extracts, without evaporation of the solvent, by measuring the ultraviolet (UV) absorbance at 240 nanometers. The spectrophotometer (Varian 635-D, or equivalent) is zeroed with a sample of the solvent taken from the same lot used in the extraction tests. The concentration of the total terephthaloyl moieties in water, 3 percent acetic acid, and in 8 percent aqueous alcohol is calculated as bis(2-hydroxyethyl terephthalate) by reference to standards prepared in the appropriate solvent. Concentration of the terephthaloyl moieties in heptane is calculated as cyclic trimer (C 6 H 4 CO 2 C 2 H 4 CO 2 ) 3 , by reference to standards prepared in 95:5 percent (v/v) heptane: tetrahydrofuran. | |||
| 21:21:3.0.1.1.8.2.1.14 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1320 Ethylene-ethyl acrylate copolymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10108, Mar. 19, 1984] | Ethylene-ethyl acrylate copolymers may be safely used to produce packaging materials, containers, and equipment intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) Ethylene-ethyl acrylate copolymers consist of basic resins produced by the catalytic copolymerization of ethylene and ethyl acrylate, to which may have been added certain optional substances to impart desired technological properties to the resin. Subject to any limitations prescribed in this section, the optional substances may include: (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. (b) The ethyl acrylate content of the copolymer does not exceed 8 percent by weight unless it is blended with polyethylene or with one or more olefin copolymers complying with § 177.1520 or with a mixture of polyethylene and one or more olefin copolymers, in such proportions that the ethyl acrylate content of the blend does not exceed 8 percent by weight, or unless it is used in a coating complying with § 175.300 or § 176.170 of this chapter, in such proportions that the ethyl acrylate content does not exceed 8 percent by weight of the finished coating. (c) Ethylene-ethyl acrylate copolymers or the blend shall conform to the specifications prescribed in paragraph (c)(1) of this section and shall meet the ethyl acrylate content limits prescribed in paragraph (b) of this section, and the extractability limits prescribed in paragraph (c)(2) of this section, when tested by the methods prescribed for polyethylene in § 177.1520. (1) Specifications —(i) Infrared identification. Ethylene-ethyl acrylate copolymers can be identified by their characteristic infrared spectra. (ii) Quantitative determination of ethyl acrylate content. The ethyl acrylate can be determined… | |||
| 21:21:3.0.1.1.8.2.1.15 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1330 Ionomeric resins. | FDA | [45 FR 22916, Apr. 4, 1980, as amended at 49 FR 10108, Mar. 19, 1984; 49 FR 37747, Sept. 26, 1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, June 12, 1989] | Ionomeric resins manufactured from either ethylene-methacrylic acid copolymers (and/or their ammonium, calcium, magnesium, potassium, sodium, and/or zinc partial salts), ethylene-methacrylic acid-vinyl acetate copolymers (and/or their ammonium, calcium, magnesium, potassium, sodium, and/or zinc partial salts,), or methacrylic acid polymers with ethylene and isobutyl acrylate (and/or their potassium, sodium and/or zinc partial salts) may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, the ethylene-methacrylic acid copolymers consist of basic copolymers produced by the copolymerization of ethylene and methacrylic acid such that the copolymers contain no more than 20 weight percent of polymer units derived from methacrylic acid, and the ethylene-methacrylic acid-vinyl acetate copolymers consist of basic copolymers produced by the copolymerization of ethylene, methacrylic acid, and vinyl acetate such that the copolymers contain no more than 15 weight percent of polymer units derived from methacrylic acid. (b) For the purpose of this section, the methacrylic acid copolymers with ethylene and isobutyl acrylate consist of basic copolymers produced by the copolymerization of methacrylic acid, ethylene, and isobutyl acrylate such that the copolymers contain no less than 70 weight percent of polymer units derived from ethylene, no more than 15 weight percent of polymer units derived from methacrylic acid, and no more than 20 weight percent of polymer units derived from isobutyl acrylate. From 20 percent to 70 percent of the carboxylic acid groups may optionally be neutralized to form sodium or zinc salts. (c) The finished food-contact article described 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 … | |||
| 21:21:3.0.1.1.8.2.1.16 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1340 Ethylene-methyl acrylate copolymer resins. | FDA | Ethylene-methyl acrylate copolymer resins may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, the ethylene-methyl acrylate copolymer resins consist of basic copolymers produced by the copolymerization of ethylene and methyl acrylate such that the copolymers contain no more than 25 weight percent of polymer units derived from methyl acrylate. (b) The finished food-contact article, 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 (corrected for zinc extractives as zinc oleate) in each extracting solvent not to exceed 0.5 milligram per square inch of food-contact surface when tested by the methods described in § 176.170(d) 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. In testing the finished food-contact article, use a separate test sample for each required extracting solvent. (c) The provisions of this section are not applicable to ethylene-methyl acrylate copolymer resins used in food-packaging adhesives complying with § 175.105 of this chapter. | ||||
| 21:21:3.0.1.1.8.2.1.17 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1345 Ethylene/1,3-phenylene oxyethylene isophthalate/ terephthalate copolymer. | FDA | [57 FR 43399, Sept. 21, 1992, as amended at 59 FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2, 1996; 62 FR 34628, June 27, 1997; 81 FR 5593, Feb. 3, 2016] | Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer (CAS Reg. No. 87365-98-8) identified in paragraph (a) of this section may be safely used, subject to the provisions of this section, as the non-food-contact layer of laminate structures subject to the provisions of § 177.1395, and in blends with polyethylene terephthalate polymers complying with § 177.1630. (a) Identity. For the purpose of this section, ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer consists of the basic copolymer produced by the catalytic polycondensation of isophthalic acid and terephthalic acid with ethylene glycol and 1,3-bis(2-hydroxyethoxy)benzene such that the finished resin contains between 42 and 48 mole-percent of isophthalic moieties, between 2 and 8 mole-percent of terephthalic moieties, and not more than 10 mole-percent of 1,3-bis(2-hydroxyethoxy)benzene moieties. (b) Specifications —(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… | |||
| 21:21:3.0.1.1.8.2.1.18 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1350 Ethylene-vinyl acetate copolymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 43 FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999; 78 FR 14665, Mar. 7, 2013; 81 FR 5593, Feb. 3, 2016] | Ethylene-vinyl acetate copolymers may be safely used as articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance with the following prescribed conditions: (a)(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: (i) Substances generally recognized as safe in food and food packaging. (ii) Substances the use of which is permitted under applicable regulations in parts 170 through 189 of this chapter, prior sanction, or approvals. (iii) Substances identified in § 175.300(b)(3)(xxv), (xxvii), (xxx), and (xxxiii) of this chapter, and colorants used in accordance with § 178.3297 of this chapter. (iv) Erucamide as identified in § 178.3860 of this chapter. (v) Xanthan gum as identified in § 172.695 for use as a thickening agent at a level not to exceed 1 percent by weight of coating solids in aqueous dispersions of ethylene-vinyl acetate copolymers, where such copolymers are used only as coatings or a component of coatings. (vi) The copolymer of vinylidene fluoride and hexafluoropropene (CAS Reg. No. 9011-17-0), containing 65 to 71 percent fluorine and having a Mooney Viscosity of at least 28, for use as a processing aid at a level not to exceed 0.2 percent by weight of ethylene-vinyl acetate copolymers. (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 m… | |||
| 21:21:3.0.1.1.8.2.1.19 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers. | FDA | [47 FR 41531, Sept. 21, 1982, as amended at 49 FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, 2000; 78 FR 14665, Mar. 7, 2013; 81 FR 5593, Feb. 3, 2016] | Ethylene-vinyl acetate-vinyl alcohol copolymers (CAS Reg. No. 26221-27-2) may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) Ethylene-vinyl acetate-vinyl alcohol copolymers are produced by the partial or complete alcoholysis or hydrolysis of those ethylene-vinyl acetate copolymers complying with § 177.1350. (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. (b) The finished food-contact article shall not exceed 0.013 centimeter (0.005 inch) thickness and shall contact foods only of the types identified in table 1 of § 176.170(c) of this chapter in Categories I, II, IV-B, VI, VII-B, and VIII under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. Film samples of 0.013 centimeter (0.005) inch thickness representing the finished article shall meet the following extractive limitation when tested by ASTM method F34-76 (Reapproved 1980), “Standard Test Method for Liquid Extraction of Flexible Barrier Materials,” 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. … | |||
| 21:21:3.0.1.1.8.2.1.2 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1020 Acrylonitrile/butadiene/styrene co-polymer. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, 1982; 54 FR 24897, June 12, 1989] | Acrylonitrile/butadiene/styrene copolymer identified in this section may be safely used as an article or component of articles intended for use with all foods, except those containing alcohol, under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. (a) Identity. For the purpose of this section, the acrylonitrile/butadiene/styrene copolymer consists of: (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. (b) Adjuvants. The copolymer identified in paragraph (a) of this section may contain adjuvant substances required in its production. Such adjuvants may include substances generally recognized as safe in food, substances used in accordance with prior sanction, substances permitted in this part, and the following: (c) Specifications. (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_regu… | |||
| 21:21:3.0.1.1.8.2.1.20 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1380 Fluorocarbon resins. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 57 FR 185, Jan. 3, 1992] | Fluorocarbon resins may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, fluorocarbon resins consist of basic resins produced as follows: (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. (b) Fluorocarbon resins that are identified in paragraph (a) of this section and that comply with extractive limitations prescribed in paragraph (c) of this section may be used as articles or components of articles intended for use in contact with food as follows: (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)(… | |||
| 21:21:3.0.1.1.8.2.1.21 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1390 Laminate structures for use at temperatures of 250 °F and above. | FDA | [45 FR 2843, Jan. 15, 1980, as amended at 47 FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983; 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22, 1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, 1999; 64 FR 46272, Aug. 25, 1999; 69 FR 15668, Mar. 26, 2004; 81 FR 5593, Feb. 3, 2016] | (a) The high-temperature laminates identified in this section may be safely used for food contact at temperatures not exceeding 135 °C (275 °F) unless otherwise specified. These articles are layered constructions that are optionally bonded with adhesives. The interior (food-contact) layer(s) may be separated from the exterior layer(s) by a functional barrier, such as aluminum foil. Upon review of the physical properties of a particular construction, the Food and Drug Administration may consider other layers to serve as functional barriers. This regulation is not intended to limit these constructions as to shape, degree of flexibility, thickness, or number of layers. These layers may be laminated, extruded, coextruded, or fused. (b) When containers subject to this regulation undergo heat sterilization to produce shelf-stable foods, certain control measures (in addition to the food additive requirements in paragraphs (c) and (d) of this section) are necessary to ensure proper food sterilization and package integrity. Refer to parts 108, 110, 113, and 114 of this chapter for details. (c) Subject to the provisions of this paragraph, food-contact articles produced from high-temperature laminates may be safely used to package all food types except those containing more than 8 percent ethyl alcohol. (1) Polymeric films/layers. Films or layers not separated from food by a functional barrier must meet the following requirements: (i) Films/layers may consist of the following: ( a ) Polyolefin resins complying with item 2.2 or 3.2 of the table in § 177.1520(c). ( b ) Polymeric resin blends formulated from a base polymer complying with item 2.2 or 3.2 of the table in § 177.1520(c) blended with no more than 10 percent by weight of a copolymer of ethylene and vinyl acetate complying with § 177.1350. ( c ) Polymeric resin blends formulated from a base polymer complying with item 2.2 or 3.2 of the table in § 177.1520(c) blended with no more than 38 percent by weight of a homopolymer of isobutylene complying with § 177.1… | |||
| 21:21:3.0.1.1.8.2.1.22 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1395 Laminate structures for use at temperatures between 120 °F and 250 °F. | FDA | [52 FR 33575, Sept. 4, 1987, as amended at 53 FR 19772, May 31, 1988; 57 FR 43399, Sept. 21, 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, Oct. 17, 1997] | (a) The laminates identified in this section may be safely used at the specified temperatures. These articles are layered structures that are optionally bonded with adhesives. In these articles, the food-contact layer does not function as a barrier to migration of components from non-food-contact layers. The layers may be laminated, extruded, coextruded, or fused. (b) Laminate structures may be manufactured from: (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: | |||
| 21:21:3.0.1.1.8.2.1.23 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1400 Hydroxyethyl cellulose film, water-insoluble. | FDA | Water-insoluble hydroxyethyl cellulose film may be safely used for packaging food in accordance with the following prescribed conditions: (a) Water-insoluble hydroxyethyl cellulose film consists of a base sheet manufactured by the ethoxylation of cellulose under controlled conditions, to which may be added certain optional substances of a grade of purity suitable for use in food packaging as constituents of the base sheet or as coatings applied to impart desired technological properties. (b) Subject to any limitations prescribed in parts 170 through 189 of this chapter, the optional substances used in the base sheet and coating may include: (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). (c) Any substance employed in the production of the water-insoluble hydroxyethyl cellulose film described in this section that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation. | ||||
| 21:21:3.0.1.1.8.2.1.24 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1420 Isobutylene polymers. | FDA | Isobutylene polymers may be safely used as components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) For the purpose of this section, isobutylene polymers are those produced as follows: (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. (b) The polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of the polymers. The optional adjuvant substances required in the production of the polymers may include substances generally recognized as safe in food, substances used in accordance with a prior sanction or approval, and aluminum chloride. (c) The provisions of this section are not applicable to polyisobutylene used in food-packaging adhesives complying with § 175.105 of this chapter. | ||||
| 21:21:3.0.1.1.8.2.1.25 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1430 Isobutylene-butene copolymers. | FDA | [52 FR 11641, Apr. 10, 1987, as amended at 63 FR 36175, July 2, 1998] | Isobutylene-butene copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for use in contact with food, subject to the provisions of this section. (a) For the purpose of this section, isobutylene-butene copolymers consist of basic copolymers produced by the copolymerization of isobutylene with mixtures of n -butenes such that the finished basic copolymers contain not less than 45 weight percent of polymer units derived from isobutylene and meet the specifications prescribed in paragraph (b) of this section when tested by the methods described in paragraph (c) of this section. (b) Specifications: (c) The analytical methods for determining whether isobutylene-butene copolymers conform to the specifications in paragraph (b) are as follows: (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… | |||
| 21:21:3.0.1.1.8.2.1.26 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1440 4,4′-Isopropylidenediphenol-epichlorohydrin resins minimum molecular weight 10,000. | FDA | 4,4′-Isopropylidenediphenol-epichlo-rohydrin resins having a minimum molecular weight of 10,000 may be safely used as articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance with the following prescribed conditions: (a) 4,4′-Isopropylidenediphenol-ep-ichlorohydrin resins consist of basic resins produced by the condensation of equimolar amounts of 4,4′-isopropylidenediphenol and epichlorohydrin terminated with phenol, to which may have been added certain optional adjuvant substances required in the production of the resins. (b) The optional adjuvant substances required in the production of the resins may include substances generally recognized as safe in food, substances used in accordance with a prior sanction or approval, and the following: (c) 4,4′-Isopropylidenediphenol-ep-ichlorohydrin resins shall meet the following nonvolatile extractives limitations: (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. (d) The provisions of this section are not applicable to 4,4′-isopropylidene-diphenol-epichlorohydrin resins listed in other sections of subchapter B of this chapter. | ||||
| 21:21:3.0.1.1.8.2.1.27 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1460 Melamine-formaldehyde resins in molded articles. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991; 87 FR 31089, May 20, 2022] | Melamine-formaldehyde resins may be safely used as the food-contact surface of molded articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance with the following prescribed conditions: (a) For the purpose of this section, melamine-formaldehyde resins are those produced when 1 mole of melamine is made to react with not more than 3 moles of formaldehyde in water solution. (b) The resins may be mixed with refined woodpulp and the mixture may contain other optional adjuvant substances which may include the following: (c) The molded melamine-formaldehyde articles in the finished form in which they are to contact food, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature as determined from tables 1 and 2 of § 175.300(d) of this chapter, shall yield net chloroform-soluble extractives not to exceed 0.5 milligram per square inch of food-contact surface. | |||
| 21:21:3.0.1.1.8.2.1.28 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate copolymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19, 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996] | Nitrile rubber modified acrylonitrile-methyl acrylate copolymers identified in this section may be safely used as components of articles intended for food-contact use under conditions of use D, E, F, or G described in table 2 of § 176.170(c) of this chapter, subject to the provisions of this section. (a) For the purpose of this section, nitrile rubber modified acrylonitrile-methyl acrylate copolymers consist of basic copolymers produced by the graft copolymerization of 73-77 parts by weight of acrylonitrile and 23-27 parts by weight of methyl acrylate in the presence of 8-10 parts by weight of butadiene-acrylonitrile copolymers containing approximately 70 percent by weight of polymer units derived from butadiene. (b) The nitrile rubber modified acrylonitrile-methyl acrylate basic copolymers meet the following specifications and extractives limitations: (1) Specifications. (i) Nitrogen content is in the range 16.5-19 percent as determined by Kjeldahl analysis. (ii) Intrinsic viscosity in acetonitrile at 25 °C is not less than 0.29 deciliter per gram as determined by ASTM method D1243-79, “Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,” 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. (iii) Residual acrylonitrile monomer content is not more than 11 parts per million as determined by gas chromatography. (iv) Acetonitrile-soluble fraction after refluxing the base polymer in acetonitrile for 1 hour is not greater than 95 percent by weight of the basic copolymers. (2) Extractives limitations. The following extractive limitations are determined by an infrared spectrophotometric method titled, “Inf… | |||
| 21:21:3.0.1.1.8.2.1.29 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1500 Nylon resins. | FDA | [42 FR 14572, Mar. 15, 1977] | The nylon resins listed in paragraph (a) of this section may be safely used to produce articles intended for use in processing, handling, and packaging food, subject to the provisions of this section: (a) The nylon resins are manufactured as described in this paragraph so as to meet the specifications prescribed in paragraph (b) of this section when tested by the methods described in paragraph (d) of this section. (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)(i) Impact modified Nylon MXD-6 resins (CAS Reg. No. 59655-05-9) manufactured by the condensation of adipic acid, 1,3-benzenedimethanamine, and alpha- (3-aminopropyl)- omega- (3-amino-propoxy)poly- oxyethylene under such conditions that the alpha -(3-amino-propyl)- omega- (3-aminopropoxy) polyoxyethylene monomer content does not exceed 7 percent by weight of the finished resin. (ii) Nylon MXD-6 resins (CAS Reg. No. 25718-70-1) manufactured by the condensation of adipic acid and 1,3-benzenedimethanamine. (11… | |||
| 21:21:3.0.1.1.8.2.1.3 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1030 Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, 1982; 54 FR 24898, June 12, 1989] | Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer identified in this section may be safely used as an article or component of articles intended for use with food identified in table 1 of § 176.170(c) of this chapter as Type I, II, III, IVA, IVB, V, VIB, (except bottles intended to hold carbonated beverages), VIIA, VIIB, VIII and IX, under conditions of use C, D, E, F, and G described in table 2 of § 176.170(c) of this chapter with a high temperature limitation of 190 °F. (a) Identity. For the purpose of this section, acrylonitrile/butadiene/styrene/methyl methacrylate copolymer consists of: (1) 73 to 79 parts by weight of a matrix polymer containing 64 to 69 parts by weight of acrylonitrile, 25 to 30 parts by weight of styrene and 4 to 6 parts by weight of methyl methacrylate; and (2) 21 to 27 parts by weight of a grafted rubber consisting of (i) 16 to 20 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) 5 to 10 parts by weight of a graft polymer having the same composition range as the matrix polymer. (b) Adjuvants. The copolymer identified in paragraph (a) of this section may contain adjuvant substances required in its production. Such 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 the following: (c) Specifications. (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 Campu… | |||
| 21:21:3.0.1.1.8.2.1.30 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1520 Olefin polymers. | FDA | [42 FR 14572, Mar. 15, 1977] | The olefin polymers listed in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food, subject to the provisions of this section. (a) For the purpose of this section, olefin polymers are basic polymers manufactured as described in this paragraph, so as to meet the specifications prescribed in paragraph (c) of this section, when tested by the methods described in paragraph (d) of this section. (1)(i) Polypropylene consists of basic polymers manufactured by the catalytic polymerization of propylene. (ii) Propylene homopolymer consists of basic polymers manufactured by the catalytic polymerization of propylene with a metallocene catalyst. (2)(i) Polyethylene consists of basic polymers manufactured by the catalytic polymerization of ethylene. (ii) Fumaric acid-grafted polyethylene (CAS Reg. No. 26877-81-6) consists of basic polymers manufactured by the catalytic polymerization of ethylene followed by reaction with fumaric acid in the absence of free radical initiators. Such polymers shall contain grafted fumaric acid at levels not to exceed 2 percent by weight of the finished polymer. (3) Olefin basic copolymers consist of basic copolymers manufactured by the catalytic copolymerization of: (i) Two or more of the 1-alkenes having 2 to 8 carbon atoms. Such olefin basic copolymers contain not less than 96 weight-percent of polymer units derived from ethylene and/or propylene, except that: ( a )( 1 ) Olefin basic copolymers manufactured by the catalytic copolymerization of ethylene and hexene-1 or ethylene and octene-1 shall contain not less than 90 weight-percent of polymer units derived from ethylene; ( 2 ) Olefin basic copolymers manufactured by the catalytic copolymerization of ethylene and hexene-1 shall contain not less than 80 but not more than 90 weight percent of polymer units derived from ethylene. ( 3 ) Olefin basic copolymers manufactured by the catalytic copolymerization of ethylene and pentene-1 shall contain not less than 90 wei… | |||
| 21:21:3.0.1.1.8.2.1.31 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1550 Perfluorocarbon resins. | FDA | [43 FR 44834, Sept. 29, 1978, as amended at 47 FR 11843, Mar. 19, 1982; 47 FR 14699, Apr. 6, 1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, Jan. 11, 1985; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996] | Perfluorocarbon resins identified in this section may be safely used as articles or components of articles intended to contact food, subject to the provisions of this section: (a) Identity. For the purpose of this section, perfluorocarbon resins are those produced by: (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. (b) Optional components. The perfluorocarbon resins identified in paragraph (a) of this section as well as articles or coating made from these resins may include the following optional components except that the resin identified in paragraph (a)(2) of this section may not be used with the optional component, lithium polysilicate, mentioned in paragraph (b)(4) 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: (c) Optional processing. Poly- tetrafluoroethylene resins may be irradiated by either a cobalt-60 sealed source, at a maximum dose of gamma radiation not to exceed 7.5 megarads, or an electron beam at energy levels not to exceed 2.5 million electron volts with a maximum dosage of 7.5 megarads, to produce lubricant powders having a particle diameter of not more than 20 microns for use only as components of articles intended for repeated use in contact with food. (d) Specifications —(1) Infrared identification. Perfluorocarbon resins can be identified by their characteristic infrared spectra. (2… | |||
| 21:21:3.0.1.1.8.2.1.32 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1555 Polyarylate resins. | FDA | [52 FR 35540, Sept. 22, 1987] | Polyarylate resins (CAS Reg. No. 51706-10-6) may be safely used as articles or components of articles intended for use in contact with food in accordance with the following prescribed conditions: (a) Identity. Polyarylate resins (1, 3-benzenedicarboxylic acid, diphenyl ester, polymer with diphenyl 1,4-benzenedicarboxylate and 4-4′-(1-methylethylidine) bis(phenol)) are formed by melt polycondensation of bisphenol-A with diphenylisophthalate and diphenylterephthalate. (b) Specifications. (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. (c) Extractive limitations. The finished polyarylate resins in sheet form at least 0.5 millimeter (0.020 inch) thick, when extracted with water at 121 °C (250 °F) for 2 hours, shall yield total nonvolatile extractives not to exceed 2.33 micrograms per square centimeter (15 micrograms per square inch) of the exposed resin surface. (d) Limitations. Polyarylate resin articles may be used in contact with all foods except beverages containing more than 8 volume percent ethanol under conditions of use A through H, described in table 2 of § 176.170(c) of this chapter. | |||
| 21:21:3.0.1.1.8.2.1.33 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1556 Polyaryletherketone resins. | FDA | [61 FR 42381, Aug. 15, 1996] | The poly(oxy-1,4-phenylenecarbonyl-1,4-phenyleneoxy-1,4-phenylenecarbonyl-1,4-phenylenecarbonyl-1,4-phenylene) resins (CAS Reg. No. 55088-54-5 and CAS Reg. No. 60015-05-6 and commonly referred to as polyaryletherketone resins) identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with food, subject to the provisions of this section. (a) Identity. Polyaryletherketone resins consist of basic resins produced by reacting 4,4′-diphenoxy benzophenone and terephthaloyl dichloride in such a way that the finished resins have a minimum weight average molecular weight of 20,000 grams per mole, as determined by light scattering measurements in sulfuric acid at room temperature. (b) Optional adjuvant substances. The basic polyaryletherketone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. These adjuvants may include substances used in accordance with § 174.5 of this chapter and the following: (1) Benzoyl chloride, poly(tetrafluoro ethylene). (2) [Reserved] (c) Extractive limitations. The finished food-contact article yields net total extractives in each extracting solvent not to exceed 0.052 milligram per square inch (corresponding to 0.008 milligram per square centimeter) of food-contact surface, when extracted at reflux temperature for 2 hours with the following solvents: Distilled water, 50 percent (by volume) ethyl alcohol in distilled water, 3 percent acetic acid (by weight) in distilled water, and n -heptane. (d) In testing the finished food-contact article made of polyaryletherketone resin, use a separate test sample for each required extracting solvent. | |||
| 21:21:3.0.1.1.8.2.1.34 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1560 Polyarylsulfone resins. | FDA | [50 FR 31046, July 24, 1985] | Polyarylsulfone resins (CAS Reg. No. 79293-56-4) may be safely used as articles or components of articles intended for use in contact with food, at temperatures up to and including normal baking temperatures, in accordance with the following prescribed conditions: (a) Identity. Polyarylsulfone resins are copolymers containing not more than 25 percent of oxy- p -phenylene-oxy- p -phenylenesulfonyl- p- phenylene polymer units and not less than 75 percent of oxy- p -phenylenesulfonyl- p -phenylene-oxy- p -phenylenesulfonyl- p -phenylene polymer units. The copolymers have a minimum reduced viscosity of 0.40 deciliter per gram in 1-methyl-2-pyrrolidinone in accordance with ASTM method D2857-70 (Reapproved 1977), “Standard Test Method for Dilute Solution Viscosity of Polymers,” which is incorporated by reference. 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 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. (b) Optional adjuvant substances. The basic polyarylsulfone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic copolymers. These optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 179 of this chapter, substances generally recognized as safe in food, substances used in accordance with a prior sanction of approval, and substances named in this paragraph and further identified as required: (c) Extractive limitations. The finished polyarylsulfone resin when extracted for 2 hours with the following solvents at the specified temperatures yields total extractives in each extracting solvent not to exceed 0.008 milligram per square centimeter of food-contact surface: distil… | |||
| 21:21:3.0.1.1.8.2.1.35 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1570 Poly-1-butene resins and butene/ethylene copolymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19, 1984; 50 FR 31349, Aug. 2, 1985] | The poly-1-butene resins and butene/ethylene copolymers identified in this section may be safely used as articles or components of articles intended for use in contact with food subject to the provisions of this section. (a) Identity. Poly-1-butene resins are produced by the catalytic polymerization of 1-butene liquid monomer. Butene/ethylene copolymers are produced by the catalytic polymerization of 1-butene liquid monomer in the presence of small amounts of ethylene monomer so as to yield no higher than a 6-weight percent concentration of polymer units derived from ethylene in the copolymer. (b) Specifications and limitations. Poly-1-butene resins and butene/ethylene copolymers shall conform to the specifications prescribed in paragraph (b)(1) of this section, and shall meet the extractability limits prescribed in paragraph (b)(2) of this section. (1) Specifications —(i) Infrared identification. Poly-1-butene resins and butene/ethylene copolymers can be identified by their characteristic infrared spectra. (ii) Viscosity. Poly-1-butene resins and the butene/ethylene copolymers have an intrinsic viscosity 1.0 to 3.2 as determined by ASTM method D1601-78, “Standard Test Method for Dilute Solution Viscosity of Ethylene Polymers,” 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. (iii) Density. Poly-1-butene resins have a density of 0.904 to 0.920 gms/cm 3 , and butene/ethylene copolymers have a density of 0.890 to 0.916 gms/cm 3 as 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. The availability… | |||
| 21:21:3.0.1.1.8.2.1.36 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1580 Polycarbonate resins. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 46 FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6, 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994; 77 FR 41902, July 17, 2012] | Polycarbonate resins may be safely used as articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) Polycarbonate resins are polyesters produced by: (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 a 2, a 6-bis (6-hydroxy -m- tolyl) mesitol to which may have been added certain optional adjuvant substances required in the production of branched polycarbonate resins. (b) The optional adjuvant substances required in the production of resins produced by the methods described in paragraph (a)(1) and (3) of this section may include substances generally recognized as safe in food, substances used in accordance with a prior sanction or approval, and the following: (c) Polycarbonate resins shall conform to the specification prescribed in paragraph (c)(1) of this section and shall meet the extractives limitations prescribed in paragraph (c)(2) of this section. (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. (i) Polycarbonate resins, when extracted with distilled water at reflux temperature for 6 hours, shall yield total extractives not to exceed 0.15 percent by weight of the resins. (ii) Polycarbonate resins, when extracted with 50 percent (by volume) ethyl alcohol in distilled wate… | |||
| 21:21:3.0.1.1.8.2.1.37 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1585 Polyestercarbonate resins. | FDA | [57 FR 3940, Feb. 3, 1992, as amended at 64 FR 27178, May 19, 1999; 81 FR 5594, Feb. 3, 2015] | Polyestercarbonate resins may be safely used as articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, or holding food, in accordance with the following prescribed conditions: (a) Polyestercarbonate resins (CAS Reg. No. 71519-80-7) are produced by the condensation of 4,4′-isopropylidenediphenol, carbonyl chloride, terephthaloyl chloride, and isophthaloyl chloride such that the finished resins are composed of 45 to 85 molepercent ester, of which up to 55 mole-percent is the terephthaloyl isomer. The resins are manufactured using a phthaloyl chloride/carbonyl chloride mole ratio of 0.81 to 5.7/1 and isophthaloyl chloride/terephthaloyl chloride mole ratio of 0.81/1 or greater. The resins are also properly identified by CAS Reg. No. 114096-64-9 when produced with the use of greater than 2 but not greater than 5 weight percent p -cumylphenol (CAS Reg. No. 599-64-4), as an optional adjuvant substance in accordance with paragraph (b)(2) of this section. (b) Optional adjuvants. The optional adjuvant substances required in the production of resins identified in paragraph (a) of this section may include: (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. (c) Polyestercarbonate resins shall conform to the specifications prescribed in paragraph (c)(1) of this section and shall meet the extractive limitations prescribed in paragraph (c)(2) of this section. (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: (i) The solution … | |||
| 21:21:3.0.1.1.8.2.1.38 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1590 Polyester elastomers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19, 1984; 87 FR 31089, May 20, 2022] | The polyester elastomers identified in paragraph (a) of this section may be safely used as the food-contact surface of articles intended for use in contact with bulk quantities of dry food of the type identified in § 176.170(c) of this chapter, table 1, under Type VIII, in accordance with the following prescribed conditions: (a) For the purpose of this section, polyester elastomers are those produced by the ester exchange reaction when one or more of the following phthalates—dimethyl terephthalate, and dimethyl isophthalate—is made to react with alpha-hydroomega-hydroxypoly (oxytetramethylene) and/or 1,4-butanediol such that the finished elastomer has a number average molecular weight between 20,000 and 30,000. (b) Optional adjuvant substances employed in the production of the polyester elastomers or added thereto to impart desired technical or physical properties may include the following substances: (c) An appropriate sample of the finished polyester elastomer in the form in which it contacts food when subjected to ASTM method D968-81, “Standard Test Methods for Abrasion Resistance of Organic Coatings by the Falling Abrasive Tester,” 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. ), using No. 50 emery abrasive in lieu of Ottawa sand, shall exhibit an abrasion coefficient of not less than 100 liters per mil of thickness. | |||
| 21:21:3.0.1.1.8.2.1.39 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1595 Polyetherimide resin. | FDA | [50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. 3, 1985] | The polyetherimide resin identified in this section may be safely used as an article or component of an article intended for use in contact with food, subject to the provisions of this section. (a) Identity. For the purpose of this section, the polyetherimide resin is 1,3-isobenzofurandione, 5,5′[(1-methyl-ethylidene)bis(4,1-phenyleneoxy)] bis-polymer with 1,3-benzenediamine (CAS Reg. No. 61128-46-9), and is derived from the condensation reaction of m -phenylenediamine and bisphenol A-dianhydride. (b) Optional adjuvants. The basic polymer identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of basic resins or finished food-contact articles. 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 and extractives limitations —(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 microg… | |||
| 21:21:3.0.1.1.8.2.1.4 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1040 Acrylonitrile/styrene copoly-mer. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, 1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, Sept. 8, 1987] | Acrylonitrile/styrene copolymers identified in this section may be safely used as a component of packaging materials subject to the provisions of this section. (a) Identity. For the purposes of this section acrylonitrile/styrene copoly-mers are basic copolymers meeting the specifications prescribed in paragraph (c) of this section. (b) Adjuvants. (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: (c) Specifications. 1 Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction, number average molecular weight, and solution viscosity, titled: “Determination of Residual Acrylonitrile and Styrene Monomers-Gas Chromatographic Internal Standard Method”; “Infrared Spectrophotometric Determination of Polymer Extracted from Barex 210 Resin Pellets”; “Procedure for the Determination of Molecular Weights of Acrylonitrile/Styrene Copolymers,” and “Analytical Method for 10% Solution Viscosity of Tyril,” which are incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), 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. 2 As determined by the method titled “Headspace Sampling… | |||
| 21:21:3.0.1.1.8.2.1.40 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1600 Polyethylene resins, carboxyl modified. | FDA | Carboxyl-modified polyethylene resins may be safely used as the food-contact surface of articles intended for use in contact with food in accordance with the following prescribed conditions: (a) For the purpose of this section, carboxyl-modified polyethylene resins consist of basic polymers produced when ethylene-methyl acrylate basic copolymers, containing no more than 25 weight percent of polymer units derived from methyl acrylate, are made to react in an aqueous medium with one or more of the following substances: Ammonium hydroxide. Calcium carbonate. Potassium hydroxide. Sodium hydroxide. Ammonium hydroxide. Calcium carbonate. Potassium hydroxide. Sodium hydroxide. (b) The finished food-contact article, 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 total extractives in each extracting solvent not to exceed 0.5 milligram per square inch of food-contact surface as determined by the methods described in § 176.170(d) of this chapter; and 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. In testing the finished food-contact articles, a separate test sample is to be used for each required extracting solvent. (c) The provisions of paragraph (b) of this section are not applicable to carboxyl-modified polyethylene resins used in food-packaging adhesives complying with § 175.105 of this chapter. | ||||
| 21:21:3.0.1.1.8.2.1.41 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1610 Polyethylene, chlorinated. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19, 1984; 59 FR 14550, Mar. 29, 1994] | Chlorinated polyethylene identified in this section may be safely used as articles or components of articles that contact food, except for articles used for packing or holding food during cooking, subject to the provisions of this section. (a) For the purpose of this section, chlorinated polyethylene consists of basic polymers produced by the direct chlorination of polyethylene conforming to the density, maximum n- hexane extractable fraction, and maximum xylene soluble fraction specifications prescribed under item 2.1 of the table in § 177.1520(c). Such chlorinated polyethylene contains a maximum of 60 percent by weight of total chlorine, as determined by ASTM 1method D1303-55 (Reapproved 1979), “Standard Test Method for Total Chlorine in Vinyl Chloride Polymers and Copolymers,” 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. ), and has a 7.0 percent maximum extractable fraction in n -hexane at 50 °C, as determined by the method described in § 177.1520(d)(3)(ii). (b) Chlorinated polyethylene may be used in contact with all types of food, except that when used in contact with fatty food of Types III, IV-A, V, VII-A, and IX described in table 1 of § 176.170(c) of this chapter, chlorinated polyethylene is limited to use only as a modifier admixed at levels not exceeding 15 weight percent in plastic articles prepared from polyvinyl chloride and/or from vinyl chloride copolymers complying with § 177.1980. | |||
| 21:21:3.0.1.1.8.2.1.42 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1615 Polyethylene, fluorinated. | FDA | [48 FR 39057, Aug. 29, 1983] | Fluorinated polyethylene, identified in paragraph (a) of this section, may be safely used as food-contact articles in accordance with the following prescribed conditions: (a) Fluorinated polyethylene food-contact articles are produced by modifying the surface of polyethylene articles through action of fluorine gas in combination with gaseous nitrogen as an inert diluent. Such modification affects only the surface of the polymer, leaving the interior unchanged. Fluorinated polyethylene articles are manufactured from basic resins containing not less than 85 weight-percent of polymer units derived from ethylene and identified in § 177.1520 (a)(2) and (3)(i). (b) Fluorinated polyethylene articles conform to the specifications and use limitations of § 177.1520(c), items 2.1 and 3.1. (c) The finished food-contact article, when extracted with the solvent or solvents characterizing the type of food and under 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 fluoride ion not to exceed 5 parts per million calculated on the basis of the volume of food held by the food-contact article. | |||
| 21:21:3.0.1.1.8.2.1.43 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1620 Polyethylene, oxidized. | FDA | Oxidized polyethylene identified in paragraph (a) of this section may be safely used as a component of food-contact articles, in accordance with the following prescribed conditions: (a) Oxidized polyethylene is the basic resin produced by the mild air oxidation of polyethylene conforming to the density, maximum n- hexane extractable fraction, and maximum xylene soluble fraction specifications prescribed under item 2.3 of the table in § 177.1520(c). Such oxidized polyethylene has a minimum number average molecular weight of 1,200, as determined by high temperature vapor pressure osmometry, contains a maximum of 5 percent by weight of total oxygen, and has an acid value of 9 to 19. (b) The finished food-contact article, 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 acidified chloroform-soluble extractives not to exceed 0.5 milligram per square inch of food-contact surface when tested by the methods described in § 177.1330(c), except that 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 such regulations. ( Note: In testing the finished food-contact article, use a separate test sample for each extracting solvent.) (c) The provisions of this section are not applicable to oxidized polyethylene used as provided in §§ 175.105 and 176.210 of this chapter, and § 177.2800. The provisions of paragraph (b) of this section are not applicable to oxidized polyethylene used as provided in §§ 175.125 and 176.170(a)(5) of this chapter a… | ||||
| 21:21:3.0.1.1.8.2.1.44 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1630 Polyethylene phthalate polymers. | FDA | [42 FR 14572, Mar. 15, 1977] | Polyethylene phthalate polymers identified in this section may be safely used as, or components of plastics (films, articles, or fabric) intended for use in contact with food in accordance with the following prescribed conditions: (a) Polyethylene phthalate films consist of a base sheet of ethylene terephthalate polymer, ethylene terephthalate-isophthalate copolymer, or ethylene-1,4-cyclohexylene dimethylene terephthalate copolyesters described in § 177.1315(b)(3), to which have been added optional substances, either as constituents of the base sheet or as constituents of coatings applied to the base sheet. (b) Polyethylene phthalate articles consist of a base polymer of ethylene terephthalate polymer, or ethylene-1,4-cyclohexylene dimethylene terephthalate copolyesters described in § 177.1315(b)(3), to which have been added optional substances, either as constituents of the base polymer or as constituents of coatings applied to the base polymer. (c)(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. (d) The quantity of any optional substance employed in the production of polyethylene phthalate plastics does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitations further provided. Any substance employed in the production of polyethylene phthalate plastics that is the subject of a regulation in parts 174, 175, 176, 177, 178 and 179 of this chapter conforms with any specif… | |||
| 21:21:3.0.1.1.8.2.1.45 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1632 Poly(phenyleneterephthalamide) resins. | FDA | [57 FR 3125, Jan. 28, 1992, as amended at 69 FR 24512, May 4, 2004] | Poly(phenyleneterephthalamide) resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated contact with food. (a) Identity. For the purpose of this section, the poly(phenylene- terephthalamide) resins (CAS Reg. No. 26125-61-1) are produced by the polymerization of terephthalolyl chloride with p -phenylenediamine. The poly(phenyleneterephthalamide) resin fibers and yarns may contain optional adjuvant substances required in their preparation and finishing. (b) Optional adjuvant substances. The poly(phenyleneterephthalamide) resins identified in paragraph (a) of this section may contain the following optional adjuvant substances, subject to any limitation on their use: (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: (c) Specifications. (1) Poly(phenyleneterephthalamide) resins in the form of continuous filament yarns or fibers that have been scoured in accordance with paragraph (d)(1) of this section, when refluxed in a 50 percent ethanol/water mixture for 24 hours, yields total extractables not exceeding 0.5 percent by weight of the sample. (2) Poly(phenyleneterephthalamide) resins in the form of pulp, when refluxed in a 50 percent ethanol/water mixture for 24 hours, yields total extractables not exceeding 0.65 percent by weight of the sample. (d) Conditions of use. (1) Poly(phenyleneterephthalamide) resins in the form of continuous filament yarns and fibers may be used as components of articles intended for repeated use in contact with food at temperatures not to exceed 260 °C (500 °F). All items are scoured prior to use by agitation in a water bath containing 0.5 gram/liter of tetrasodium pyrophosphate and 0.5 percent detergent. The items are agitated at 80 °C (180 °F) for 20 minutes, and then subjected to a cold water rinse. (2) Poly(phenyleneterephthalamide) resin… | |||
| 21:21:3.0.1.1.8.2.1.46 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1635 Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene). | FDA | [48 FR 31384, July 8, 1983, as amended at 54 FR 24898, June 12, 1989; 55 FR 52989, Dec. 26, 1990] | Poly( p -methylstyrene) and rubber-modified poly( p -methylstyrene) identified in this section may be safely used as components of articles intended for use in contact with food, subject to the provisions of this section: (a) Identity. For the purposes of this section, poly( p -methylstyrene) and rubber-modified poly( p -methylstyrene) are basic polymers, manufactured as described in this paragraph, meeting the specifications prescribed in paragraph (c) of this section. (1) Poly( p -methylstyrene) (CAS Reg. No. 24936-41-2) polymer produced by the polymerization of p -methylstyrene. (2) Rubber-modified poly( p -methylstyrene) (CAS Reg. No. 33520-88-6) polymer produced by combining styrene-butadiene copolymer and/or polybutadiene with poly( p -methylstyrene), either during or after polymerization of the poly( p -methylstyrene), such that the finished polymers contain not less than 75 weight percent of total polymer units derived from p -methylstyrene) monomer. (b) Optional adjuvants. The basic polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymers. Such optional adjuvant substances may include substances permitted for such use by applicable regulations in this chapter, substances generally recognized as safe in food, substances generally recognized as safe in indirect additives, and substances used in accordance with prior sanction or approval. (c) Specifications. (1) Poly( p -methylstyrene) basic polymers identified in paragraph (a)(1) of this section shall contain not more than 1 weight percent of total residual p -methystyrene monomer, as determined by a gas chromatographic method titled, “Gas Chromatographic Determination of PMS and PET in PPMS Basic Polymers,” 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 Rec… | |||
| 21:21:3.0.1.1.8.2.1.47 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1637 Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins. | FDA | [61 FR 14965, Apr. 4, 1996, as amended at 78 FR 14666, Mar. 7, 2013; 81 FR 5594, Feb. 3, 2016] | Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food in accordance with the following conditions: (a) Identity. For the purpose of this section, poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins (CAS Reg. No. 24968-11-4) are polymers formed by catalytic transesterification of 2,6-dimethylnaphthalene dicarboxylate with ethylene glycol followed by catalytic polycondensation. (b) Specifications —(1) Density. The density of poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins shall be between 1.33 and 1.40 grams per cubic centimeter. (2) Inherent viscosity. The finished food-contact article shall have a minimum inherent viscosity of 0.55 deciliter per gram in a solution of 0.1 gram of polymer in 100 milliliters of a 25/40/35 (weight/weight/weight) solution of p -chlorophenol/tetrachloroethane/phenol. The viscosity is determined by Eastman Chemical Co.'s method ECD-A-AC-G-V-1-5, “Determination of Dilute Solution Viscosity of Polyesters,” dated May 31, 1988, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from 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. (c) Extraction limitations. A 0.5 millimeter (0.02 inch) thick sheet of resin when extracted with water at 121 °C (250 °F) for 2 hours shall yield total nonvolatile extractives … | |||
| 21:21:3.0.1.1.8.2.1.48 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1640 Polystyrene and rubber-modified polystyrene. | FDA | Polystyrene and rubber-modified polystyrene identified in this section may be safely used as components of articles intended for use in contact with food, subject to the provisions of this section. (a) Identity. For the purposes of this section, polystyrene and rubber-modified polystyrene are basic polymers manufactured as described in this paragraph so as to meet the specifications prescribed in paragraph (c) of this section when tested by the method described in paragraph (d) of this section. (1) Polystyrene consists of basic polymers produced by the polymerization of styrene. (2) Rubber-modified polystyrene consists of basic polymers produced by combining styrene-butadiene copolymers and/or polybutadiene with polystyrene, either during or after polymerization of the polystyrene, such that the finished basic polymers contain not less than 75 weight percent of total polymer units derived from styrene monomer. (b) Optional adjuvants. The basic polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymers. Such optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. (c) Specifications. (1) Polystyrene basic polymers identified in paragraph (a)(1) of this section shall contain not more than 1 weight percent of total residual styrene monomer, as determined by the method described in paragraph (d) of this section, except that when used in contact with fatty foods of Types III, IV-A, V, VII-A, and IX described in table 1 of § 176.170(c) of this chapter, such polystyrene basic polymers shall contain not more than 0.5 weight percent of total residual styrene monomer. (2) Rubber-modified polystyrene basic polymers identified in paragraph (a)(2) of this section shall contain not more than 0.5 weight percent of total residual styrene monome… | ||||
| 21:21:3.0.1.1.8.2.1.49 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1650 Polysulfide polymer-polyepoxy resins. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984] | Polysulfide polymer-polyepoxy res- ins may be safely used as the food-contact surface of articles intended for packaging, transporting, holding, or otherwise contacting dry food, in accordance with the following prescribed conditions: (a) Polysulfide polymer-polyepoxy resins are the reaction products of liquid polysulfide polymers and polyfunctional epoxide resins, cured with the aid of tri(dimethylaminomethyl) phenol, to which have been added certain optional substances to impart desired technological properties to the resins. Subject to any limitations prescribed in this section, the optional substances may include: (1) Substances generally recognized as safe in food and food packaging. (2) Substances the use of which is permitted under applicable regulations in this part, prior sanctions, or approvals. (3) Substances named in this subparagraph and further identified as required: (b) The resins are used as the food-contact surface for dry food. (c) An appropriate sample of the finished resin in the form in which it contacts food, when subjected to ASTM method D968-81, “Standard Test Methods for Abrasion Resistance of Organic Coatings by the Falling Abrasive Tester,” 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. ), using No. 50 Emery abrasive in lieu of Ottawa sand, shall exhibit and abrasion coefficient of not less than 20 liters per mil of film thickness. | |||
| 21:21:3.0.1.1.8.2.1.5 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1050 Acrylonitrile/styrene copoly-mer modified with butadiene/styrene elastomer. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48544, Sept. 23, 1977; 47 FR 11841, Mar. 19, 1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898, June 12, 1989] | Acrylonitrile/styrene copolymer modified with butadiene/styrene elastomer identified in this section may be safely used as a component of bottles intended for use with foods identified in table I of § 176.170(c) of this chapter as Type VI-B under conditions for use E, F, or G described in table 2 of § 176.170(c) of this chapter. (a) Identity. For the purpose of this section, acrylonitrile/styrene copoly- mer modified with butadiene/styrene elastomer consists of a blend of: (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. (b) Adjuvants. The modified copoly-mer identified in paragraph (a) of this section may contain adjuvant substances required in its production. Such 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 the following: (c) Specifications. (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… | |||
| 21:21:3.0.1.1.8.2.1.50 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1655 Polysulfone resins. | FDA | [51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, 1986; 61 FR 29475, June 11, 1996] | Polysulfone resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, polysulfone resins are: (1) Poly(oxy- p -phenylenesulfonyl- p -phenyleneoxy- p -phenyleneisopropylidene- p -phenylene) resins (CAS Reg. No. 25154-01-2) consisting of basic resins produced when the disodium salt of 4,4′-isopropylidenediphenol is made to react with 4,4′-dichlorodiphenyl sulfone in such a way that the finished resins have a minimum number average molecular weight of 15,000, as determined by osmotic pressure in monochlorobenzene; or (2) 1,1′-Sulfonylbis[4-chlorobenzene] polymer with 4,4′-(1-methylethylidene)bis[phenol] (minimum 92 percent) and 4,4′-sulfonylbis[phenol] (maximum 8 percent) (CAS Reg. No. 88285-91-0) produced when a mixture of 4,4′-isopropylidenediphenol (minimum 92 percent) and 4,4′-sulfonylbis[phenol] (maximum 8 percent) is made to react with 4,4′-dichlorodiphenyl sulfone in such a way that the finished resin has a minimum number average molecular weight of 26,000, as determined by osmotic pressure in dimethylformamide. (b) The basic polysulfone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. The optional adjuvant substances required in the production of the basic polysulfone resins may include substances described in § 174.5(d) of this chapter and the following: (c) Polysulfone resins, when extracted at reflux temperatures for 6 hours with the solvents—distilled water, 50 percent (by volume) ethyl alcohol in distilled water, 3 percent acetic acid in distilled water, and n- heptane, yield total extractives in each extracting solvent not to exceed 0.0078 milligram per square centimeter (0.05 milligram per square inch) of resin surface. Note: In testing the finished polysulfone resins, use a separate resin test sample for each required extract… | |||
| 21:21:3.0.1.1.8.2.1.51 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1660 Poly (tetramethylene terephthalate). | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 50 FR 20748, May 20, 1985; 52 FR 20069, May 29, 1987] | Poly(tetramethylene terephthalate) (poly (oxytetramethyleneoxyter-ephthaloyl)) [Chemical Abstracts Service Registry No. 24968-12-5] identified in this section may be safely used as articles or components of articles intended to contact food, in accordance with the following prescribed conditions: (a) Identity. For the purpose of this section, poly (tetramethylene terephthalate) is the reaction product of dimethyl terephthalate with 1,4-butanediol to which may have been added certain optional substances to impart desired technological properties to the polymer. (b) Optional adjuvant substances. Poly(tetramethylene terephthalate) identified in paragraph (a) of this section may contain optional adjuvant substances. The quantity of any optional adjuvant substance employed in the production of the polymer does not exceed the amount reasonably required to accomplish the intended technical or physical effect. Such adjuvants may include substances generally recognized as safe in food, substances used in accordance with prior sanction, and substances permitted under applicable regulations in this part. (c) Specifications. (1) Inherent viscosity of a 0.50 percent solution of the polymer in phenol/tetrachloroethane (60/40 weight ratio) solvent is not less than 0.6 as determined using a Wagner viscometer (or equivalent) and calculated from the following equation: where: N r = Ratio of flow time of the polymer solution to that of the solvent and c = polymer concentration of the test solution in grams per 100 milliliters. where: N r = Ratio of flow time of the polymer solution to that of the solvent and c = polymer concentration of the test solution in grams per 100 milliliters. (2) Poly(tetramethylene terephthalate) in the finished form in which it is to contact food shall yield total extractives as follows: (i) Not to exceed 0.08 milligram per square inch of food contact surface when extracted for 2 hours at 250 °F with distilled water. (ii) Not to exceed 0.02 milligram per square inch of food contact sur… | |||
| 21:21:3.0.1.1.8.2.1.52 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1670 Polyvinyl alcohol film. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984] | Polyvinyl alcohol film may be safely used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Types V, VIII, and IX, in accordance with the following prescribed conditions: (a) The polyvinyl alcohol film is produced from polyvinyl alcohol having a minimum viscosity of 4 centipoises when a 4-percent aqueous solution is tested at 20 °C. (b) The finished food-contact film for use in contact with Food Types V or IX, when extracted with the solvent characterizing the type of food and under the conditions of time and temperature characterizing its intended use as determined from tables 1 and 2 of § 176.170(c) of this chapter, yields total extractives not to exceed 0.078 milligram per square centimeter (0.5 milligram per square inch) of food-contact surface when tested by ASTM method F34-76 (Reapproved 1980), “Standard Test Method for Liquid Extraction of Flexible Barrier Materials,” 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. (c) The finished food-contact film shall not be used as a component of food containers intended for use in contact with water. | |||
| 21:21:3.0.1.1.8.2.1.53 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1680 Polyurethane resins. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 46 FR 57033, Nov. 20, 1981; 49 FR 10110, Mar. 19, 1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991] | The polyurethane resins identified in paragraph (a) of this section may be safely used as the food-contact surface of articles intended for use in contact with bulk quantities of dry food of the type identified in § 176.170(c) of this chapter, table 1, under Type VIII, in accordance with the following prescribed conditions: (a) For the purpose of this section, polyurethane resins are those produced when one or more of the isocyanates listed in paragraph (a)(1) of this section is made to react with one or more of the substances listed in paragraph (a)(2) of this section: (1) Isocyanates: Bis(isocyanatomethyl) benzene (CAS Reg. No. 25854-16-4). Bis(isocyanatomethyl) cyclohexane (CAS Reg. No. 38661-72-2). 4,4′-Diisocyanato-3,3′-dimethylbiphenyl (bi-tolylene diisocyanate). Diphenylmethane diisocyanate. Hexamethylene diisocyanate. 3-Isocyanatomethyl - 3,5,5 - trimethylcyclohexyl isocyanate. 4,4-Methylenebis(cyclohexyl isocyanate). Toluene diisocyanate. Bis(isocyanatomethyl) benzene (CAS Reg. No. 25854-16-4). Bis(isocyanatomethyl) cyclohexane (CAS Reg. No. 38661-72-2). 4,4′-Diisocyanato-3,3′-dimethylbiphenyl (bi-tolylene diisocyanate). Diphenylmethane diisocyanate. Hexamethylene diisocyanate. 3-Isocyanatomethyl - 3,5,5 - trimethylcyclohexyl isocyanate. 4,4-Methylenebis(cyclohexyl isocyanate). Toluene diisocyanate. (2) List of substances: Adipic acid. 1,4-Butanediol. 1,3-Butylene glycol. 1,4-Cyclohexane dimethanol (CAS Reg. No. 105-08-8). 2,2-Dimethyl-1,3-propanediol. Ethylene glycol. 1,6-Hexanediol (CAS Reg. No. 629-11-8).α-Hydro-ω-hydroxypoly(oxy-1,4-butanediyl) (CAS Reg. No. 25190-06-1). α-Hydro- omega -hydroxypoly (oxytetramethylene). α,α′-(Isopropylidenedi- p- phenylene)bis[ omega- hydroxypoly (oxypropylene)(3-4 moles)], average molecular weight 675. Maleic anhydride. Methyl oxirane polymer with oxirane (CAS Reg. No. 9003-11-6). Methyl oxirane polymer with oxirane, ether with 1,2,3-propanetriol (CAS Reg. No. 9082-00-2). α,α′α″,α″′-Neopentanetetra… | |||
| 21:21:3.0.1.1.8.2.1.54 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1810 Styrene block polymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 42 FR 43621, Aug. 30, 1977; 47 FR 11844, Mar. 19, 1982; 51 FR 16828, May 7, 1986; 54 FR 24898, June 12, 1989; 58 FR 65546, Dec. 15, 1993] | The styrene block polymers identified in paragraph (a) of this section may be safely used as articles or as components of articles intended for use in contact with food, subject to provisions of this section. (a) For the purpose of this section, styrene block polymers are basic polymers manufactured as described in this paragraph, so that the finished polymers meet the specifications prescribed in paragraph (b) of this section, when tested by the methods described in paragraph (c) of this section. (1) Styrene block polymers with 1,3-butadiene are those produced by the catalytic solution polymerization of styrene and 1,3-butadiene. (2) Styrene block polymers with 2-methyl-1,3-butadiene are those produced by the catalytic solution polymerization of styrene and 2-methyl-1,3-butadiene. (3) Styrene block polymers with 1,3-butadiene, hydrogenated are those produced by the catalytic solution polymerization of styrene and 1,3-butadiene, and subsequently hydrogenated. (b) Specifications: (c) The analytical methods for determining whether styrene block polymers conform to the specifications prescribed in this section are as follows and are applicable to the finished polymer. (1) Molecular weight. Molecular weight shall be determined by intrinsic viscosity (or other suitable method). (2) Glass transition points. The glass transition points shall be determined by either of the following methods: (i) ASTM method D2236-70 (“Standard Method of Test for Dynamic Mechanical Properties of Plastics by Means of Torsional Pendulum,” 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. ) modified by using a forced resonant vibratio… | |||
| 21:21:3.0.1.1.8.2.1.55 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1820 Styrene-maleic anhydride copolymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11844, Mar. 19, 1982; 47 FR 14698, Apr. 6, 1982; 54 FR 24898, June 12, 1989] | Styrene-maleic anhydride copolymers identified in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food, subject to provisions of this section. (a) For the purpose of this section, styrene-maleic anhydride copolymers are those produced by the polymerization of styrene and maleic anhydride so that the finished polymers meet the specifications prescribed in paragraph (b) of this section, when tested by the methods described in paragraph (c) of this section. (b) Specifications: (c) The analytical methods for determining conformance with specifications for styrene-maleic anhydride copolymers prescribed in this section are as follows: (1) Molecular weight. Molecular weight shall be determined by membrane osmometry. (2) Residual styrene monomer content. Residual styrene monomer content shall be determined by the method described in § 177.1640(d). (3) Residual maleic anhydride monomer content. Residual maleic anhydride monomer content shall be determined by a gas chromatographic method titled “Determination of Residual Maleic Anhydride in Polymers by Gas Chromatography,” 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. (d) The provisions of this section are not applicable to styrene-maleic anhydride copolymers listed in other sections of this subpart. | |||
| 21:21:3.0.1.1.8.2.1.56 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1830 Styrene-methyl methacrylate copolymers. | FDA | Styrene-methyl methacrylate copolymers identified in this section may be safely used as components of plastic articles intended for use in contact with food, subject to the provisions of this section. (a) For the purpose of this section, styrene-methyl methacrylate copolymers consist of basic copolymers produced by the copolymerization of styrene and methyl methacrylate such that the finished basic copolymers contain more than 50 weight percent of polymer units derived from styrene. (b) The finished plastic food-contact article, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of intended use as determined from tables 1 and 2 of § 176.170(c) of this chapter, yields extractives not to exceed the following when tested by the methods prescribed in § 177.1010(c); (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 0.40. | ||||
| 21:21:3.0.1.1.8.2.1.57 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1850 Textryls. | FDA | Textryls identified in this section may be safely used as articles or components of articles, intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food, subject to the provisions of this section. (a) Textryls are nonwoven sheets prepared from natural or synthetic fibers, bonded with fibryl (Fibryl consists of a polymeric resin in fibrous form commingled with fiber to facilitate sheet formation and subsequently heat cured to fuse the fibryl and effect bonding). (b) Textryls are prepared from the fibers, fibryls, and adjuvants identified in paragraph (c) of this section, and subject to limitations prescribed in that paragraph, provided that any substance that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specifications in such regulation for that substance as a component of polymeric resins used as food contact surfaces. (c) The fibers, fibryls, and adjuvants permitted are as follows: (d) Textryls meeting the conditions of test prescribed in paragraph (d)(1) of this section are used as prescribed in paragraph (d)(2) of this section. (1) Conditions of test. Textryls, when extracted with distilled water at reflux temperature for 1 hour, yield total extractives not to exceed 1 percent. (2) Uses. Textryls are used for packaging or holding food at ordinary temperatures and in the brewing of hot beverages. | ||||
| 21:21:3.0.1.1.8.2.1.58 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1900 Urea-formaldehyde resins in molded articles. | FDA | Urea-formaldehyde resins may be safely used as the food-contact surface of molded articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, urea-formaldehyde resins are those produced when 1 mole of urea is made to react with not more than 2 moles of formaldehyde in water solution. (b) The resins may be mixed with refined wood pulp and the mixture may contain other optional adjuvant substances which may include the following: (c) The finished food-contact article, 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 § 175.300(d) of this chapter, yields total extractives in each extracting solvent not to exceed 0.5 milligram per square inch of food-contact surface as determined by the methods described in § 175.300(e) of this chapter. In testing the finished food-contact article, use a separate test sample for each required extracting solvent. | ||||
| 21:21:3.0.1.1.8.2.1.59 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1950 Vinyl chloride-ethylene copolymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984] | The vinyl chloride-ethylene copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for contact with food, under conditions of use D, E, F, or G described in table 2 of § 176.170 (c) of this chapter, subject to the provisions of this section. (a) For the purpose of this section, vinyl chloride-ethylene copolymers consist of basic copolymers produced by the copolymerization of vinyl chloride and ethylene such that the finished basic copolymers meet the specifications and extractives limitations prescribed in paragraph (c) of this section, when tested by the methods described in paragraph (d) of this section. (b) The basic vinyl chloride-ethylene copolymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic copolymers. The optional adjuvant substances required in the production of the basic vinyl chloride-ethylene copolymers may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. (c) The vinyl chloride-ethylene basic copolymers meet the following specifications and extractives limitations: (1) Specifications. (i) Total chlorine content is in the range of 53 to 56 percent as determined by any suitable analytical procedure of generally accepted applicability. (ii) Intrinsic viscosity in cyclohexanone at 30 °C is not less than 0.50 deciliter per gram as determined by ASTM method D1243-79, “Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,” 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.arc… | |||
| 21:21:3.0.1.1.8.2.1.6 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1060 | FDA | [54 FR 20382, May 11, 1989, as amended at 58 FR 17098, Apr. 1, 1993] | n -Alkylglutarimide/acrylic copolymers identified in this section may be safely used as articles or components of articles intended for use in contact with food subject to provisions of this section and part 174 of this chapter. (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. (1) The n- alkylglutarimide/acrylic copolymers in the finished form in which they shall contact food, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature described in tables 1 and 2 of § 176.170(c) of this chapter, shall yield extractives not to exceed the limitations of § 177.1010(b) of this chapter, when prepared as strips, as described in § 177.1010(c)(2) of this chapter. (2) The n- alkylglutarimide/acrylic copolymers shall not be used as polymer modifiers in vinyl chloride homo- or copolymers. (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. | |||
| 21:21:3.0.1.1.8.2.1.60 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1960 Vinyl chloride-hexene-1 copolymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984] | The vinyl chloride-hexene-1 copolymers identified in paragraph (a) of this section or as components of articles intended for use in contact with food, under conditions of use D, E, F, or G described in table 2 of § 176.170(c) of this chapter, subject to the provisions of this section. (a) Identity. For the purposes of this section vinyl chloride-hexene-1 copolymers consist of basic copolymers produced by the copolymerization of vinyl chloride and hexene-1 such that the finished copolymers contain not more than 3 mole-percent of polymer units derived from hexene-1 and meet the specifications and extractives limitations prescribed in paragraph (b) of this section. The copolymers may optionally contain hydroxypropyl methylcellulose and trichloroethylene used as a suspending agent and chain transfer agent, respectively, in their production. (b) Specifications and limitations. The vinyl chloride-hexene-1 basic copolymers meet the following specifications and extractives limitations: (1) Specifications. (i) Total chlorine content is 53 to 56 percent as determined by any suitable analytical procedure of generally accepted applicability. (ii) Inherent viscosity in cyclohexanone at 30 °C is not less than 0.59 deciliters per gram as determined by ASTM method D1243-79, “Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,” 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) Extractives limitations. The following extractives limitations are determined by the methods prescribed in § 177.1970(d). (i) Total extractives do not exceed 0.01 weight percent when extracted with water at 150 °F for 2 hours. (ii) … | |||
| 21:21:3.0.1.1.8.2.1.61 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1970 Vinyl chloride-lauryl vinyl ether copolymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984] | The vinyl chloride-lauryl vinyl ether copolymers identified in paragraph (a) of this section may be used as an article or as a component of an article intended for use in contact with food subject to the provisions of this section. (a) Identity. For the purposes of this section vinyl chloride-lauryl vinyl ether copolymers consist of basic copolymers produced by the copolymerization of vinyl chloride and lauryl vinyl ether such that the finished copolymers contain not more than 3 weight-percent of polymer units derived from lauryl vinyl ether and meet the specifications and extractives limitations prescribed in paragraph (c) of this section. (b) Optional adjuvant substances. The basic vinyl chloride-lauryl vinyl ether copolymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic copolymers. These optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. (c) Specifications and limitations. The vinyl chloride-lauryl vinyl ether basic copolymers meet the following specifications and extractives limitations: (1) Specifications. (i) Total chlorine content is 53 to 56 percent as determined by any suitable analytical procedure of generally accepted applicability. (ii) Inherent viscosity in cylcoHhexanone at 30 °C is not less than 0.60 deciliter per gram as determined by ASTM method D1243-79, “Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,” 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_re… | |||
| 21:21:3.0.1.1.8.2.1.62 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1980 Vinyl chloride-propylene copolymers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984] | The vinyl chloride-propylene copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for contact with food, subject to the provisions of this section. (a) For the purpose of this section, vinyl chloride-propylene copolymers consist of basic copolymers produced by the copolymezation of vinyl chloride and propylene such that the finished basic copolymers meet the specifications and extractives limitations prescribed in paragraph (c) of this section, when tested by the methods described in paragraph (d) of this section. (b) The basic vinyl chloride-propylene copolymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic copolymers. The optional adjuvant substances required in the production of the basic vinyl chloride-propylene copolymers may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. (c) The vinyl chloride-propylene basic copolymers meet the following specifications and extractives limitations: (1) Specifications. (i) Total chlorine content is in the range of 53 to 56 percent as determined by any suitable analytical procedure of generally accepted applicability. (ii) Intrinsic viscosity in cyclohexanone at 30 °C is not less than 0.50 deciliter per gram as determined by ASTM method D1243-79, “Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,” 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) Extracti… | |||
| 21:21:3.0.1.1.8.2.1.63 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1990 Vinylidene chloride/methyl acrylate copolymers. | FDA | [48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. 31, 1983, as amended at 53 FR 47185, Nov. 22, 1988; 54 FR 24898, June 12, 1989] | The vinylidene chloride/methyl acrylate copolymers (CAS Reg. No. 25038-72-6) identified in paragraph (a) of this section may be safely used as an article or as a component of an article intended for use in contact with food subject to the provisions of this section. (a) Identity. For the purposes of this section vinylidene chloride/methyl acrylate copolymers consist of basic copolymers produced by the copolymerization of vinylidene chloride and methyl acrylate such that the copolymers contain not more than 15 weight-percent of polymer units derived from methyl acrylate. (b) Optional adjuvant substances. The basic vinylidene chloride/methyl acrylate copolymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic copolymers. These optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 179 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. (c) Specifications. (1) The methyl acrylate content is determined by an infrared spectrophotometric method titled “Determination of Copolymer Ratio in Vinylidene Chloride/Methyl Acrylate Copolymers,” 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) The weight average molecular weight of the copolymer is not less than 50,000 when determined by gel permeation chromatography using tetrahydrofuran as the solvent. The gel permeation chromatograph is calibrated with polystyrene standards. The basic gel permeation chromatographic method is described in ANSI/AS… | |||
| 21:21:3.0.1.1.8.2.1.64 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.2000 Vinylidene chloride/methyl acrylate/methyl methacrylate polymers. | FDA | [49 FR 29578, July 23, 1984] | The vinylidene chloride/methyl acrylate/methyl methacrylate polymers (CAS Reg. No. 34364-83-5) identified in paragraph (a) of this section may be safely used as articles or as a component of articles intended for use in contact with food subject to the provisions of this section. (a) Identity. For the purpose of this section, vinylidene chloride/methyl acrylate/methyl methacrylate polymers consist of basic polymers produced by the copolymerization of vinylidene chloride/methyl acrylate/methyl methacrylate such that the basic polymers or the finished food-contact articles meet the specifications prescribed in paragraph (d) of this section. (b) Optional adjuvant substances. The basic vinylidene chloride/methyl acrylate/methyl methacrylate polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymers. These optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 179 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction of approval. (c) Conditions of use. The polymers may be safely used as articles or as components of articles intended for use in producing, manufacturing, processing, preparing, treating, packaging, transporting, or holding food, including processing of packaged food at temperatures up to 121 °C (250 °F). (d) Specifications and limitations. The vinylidene chloride/methyl acrylate/methyl methacrylate basic polymers and/or finished food-contact articles meet the following specifications and limitations: (1)(i) The basic vinylidene chloride/methyl acrylate/methyl methacrylate polymers contain not more than 2 weight percent of polymer units derived from methyl acrylate monomer and not more than 6 weight percent of polymer units derived from methyl methacrylate monomer. (ii) The basic polymers are limited to a thickness of not more than 0.005 centimeter (0.002 inches). (2) The weight averag… | |||
| 21:21:3.0.1.1.8.2.1.7 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1200 Cellophane. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11842, Mar. 19, 1982; 64 FR 57978, Oct. 28, 1999; 87 FR 31089, May 20, 2022] | Cellophane may be safely used for packaging food in accordance with the following prescribed conditions: (a) Cellophane consists of a base sheet made from regenerated cellulose to which have been added certain optional substances of a grade of purity suitable for use in food packaging as constituents of the base sheet or as coatings applied to impart desired technological properties. (b) Subject to any limitations prescribed in this part, the optional substances used in the base sheet and coating may include: (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. (c) List of substances: (d) Any optional component listed in this section covered by a specific food additive regulation must meet any specifications in that regulation. (e) Acrylonitrile copolymers identified in this section shall comply with the provisions of § 180.22 of this chapter. | |||
| 21:21:3.0.1.1.8.2.1.8 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1210 Closures with sealing gaskets for food containers. | FDA | [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 47 FR 22090, May 21, 1982; 49 FR 5748, Feb. 15, 1984; 55 FR 34555, Aug. 23, 1990; 61 FR 14480, Apr. 2, 1996; 65 FR 26745, May 9, 2000; 65 FR 52908, Aug. 31, 2000; 70 FR 67651, Nov. 8, 2005; 76 FR 59249, Sept. 26, 2011; 78 FR 14665, Mar. 7, 2013; 82 FR 20832, May 4, 2017] | Closures with sealing gaskets may be safely used on containers intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance with the following prescribed conditions: (a) Closures for food containers are manufactured from substances generally recognized as safe for contact with food; substances that are subject to the provisions of prior sanctions; substances authorized by regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter; and closure-sealing gaskets, as further prescribed in this section. (b) Closure-sealing gaskets and overall discs are formulated from substances identified in § 175.300(b) of this chapter, with the exception of paragraph (b)(3)(v), (xxxi), and (xxxii) of that section, and from other optional substances, including the following: (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: Table 1 Table 2—Maximum Extractives Tolerances [In parts per million] 1 Extractability tests not applicable. (c) The closure assembly to include the sealing gasket or sealing compound, together with any polymeric or resinous coating, film, foil, natura… | |||
| 21:21:3.0.1.1.8.2.1.9 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | B | Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces | § 177.1211 Cross-linked polyacrylate copolymers. | FDA | [64 FR 28098, May 25, 1999, as amended at 65 FR 16817, Mar. 30, 2000] | Cross-linked polyacrylate copolymers identified in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food in accordance with the following prescribed conditions: (a) Identity. For the purpose of this section, the cross-linked polyacrylate copolymers consist of: (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). (b) Adjuvants. The copolymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such copolymers. The optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 179 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. (c) Extractives limitations. The copolymers identified in paragraph (a) of this section, in the finished form in which they will contact food, must yield low molecular weight (less than 1,000 Daltons) extractives of no more than 0.15 percent by weight of the total polymer when extracted with 0.2 percent by weight of aqueous sodium chloride solution at 20 °C for 24 hours. The low molecular weight extractives shall be determined using size exclusion chromatography or an equivalent method. When conducting the extraction test, the copolymer, with no other absorptive media, shall be confined either in a finished absorbent pad or in any suitable flexible porous article, (such as a “tea bag” or infuser), under an applied pressure of 0.15 pounds per square inch (for example, a 4 × 6 inch square pad is subjected to a 1.6 kilograms applied mass). The solvent used shall be at least 60 milliliters … | |||
| 21:21:3.0.1.1.8.3.1.1 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2210 Ethylene polymer, chlorosulfonated. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, 1989] | Ethylene polymer, chlorosulfonated as identified in this section may be safely used as an article or component of articles intended for use in contact with food, subject to the provisions of this section. (a) Ethylene polymer, chlorosulfonated is produced by chlorosulfonation of a carbon tetrachloride solution of polyethylene with chlorine and sulfuryl chloride. (b) Ethylene polymer, chlorosulfonated shall meet the following specifications: (1) Chlorine not to exceed 25 percent by weight. (2) Sulfur not to exceed 1.15 percent by weight. (3) Molecular weight is in the range of 95,000 to 125,000. Methods for the specifications in this paragraph (b), titled “Chlorine and Bromine—Coulometric Titration Method by Aminco Chloridometer,” “Hypolon ® Synthetic Rubber—Determination of Sulfur by Parr Bomb,” and ASTM method D2857-70 (Reapproved 1977), “Standard Test Method for Dilute Solution Viscosity of Polymers,” are incorporated by reference. Copies of the ASTM method may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959. Copies of the other two methods are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Copies of all three methods 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. (c) The additive is used as the article, or a component of articles, intended for use as liners and covers for reservoirs intended for the storage of water for drinking purposes. (d) Substances permitted by § 177.2600 may be employed in the preparation of ethylene polymers, chlorosulfonated, subject to any limitations prescribed therein. (e) The finished ethylene copolymers, chlorosulfonated shall conform to § 177.2600(e) and (g). | |||
| 21:21:3.0.1.1.8.3.1.10 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2430 Polyether resins, chlorinated. | FDA | Chlorinated polyether resins may be safely used as articles or components of articles intended for repeated use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) The chlorinated polyether resins are produced by the catalytic polymerization of 3,3-bis(chloromethyl)-oxetane, and shall contain not more than 2 percent residual monomer. (b) In accordance with good manufacturing practice, finished articles containing the chlorinated polyether resins shall be thoroughly cleansed prior to their first use in contact with food. | ||||
| 21:21:3.0.1.1.8.3.1.11 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2440 Polyethersulfone resins. | FDA | [44 FR 34493, June 15, 1979, as amended at 47 FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, Sept. 20, 1995; 78 FR 14666, Mar. 7, 2013] | Polyethersulfone resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with food in accordance with the following prescribed conditions: (a) For the purpose of this section, polyethersulfone resins are: (1) Poly(oxy- p -phenylenesulfonyl- p -phenylene) resins (CAS Reg. No. 25667-42-9), which have a minimum number average molecular weight of 16,000. (2) 1,1′-sulfonylbis[4-chlorobenzene] polymer with 4,4′-(1-methylethylidene)bis[phenol] (maximum 8 percent) and 4,4′-sulfonylbis[phenol] (minimum 92 percent) (CAS Reg. No. 88285-91-0), which have a minimum number average molecular weight of 26,000. (3) In paragraphs (a)(1) and (a)(2) of this section, the minimum number average molecular weight is determined by reduced viscosity in dimethyl formamide in accordance with ASTM method D2857-70 (Reapproved 1977), “Standard Test Method for Dilute Solution Viscosity of Polymers,” 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 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 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. (b) The basic resins identified in paragraphs (a)(1) and (a)(2) of this section may contain optional adjuvant substances described in § 174.5(d) of this chapter and the following: (c) The finished food-contact article, when extracted at reflux temperatures for 2 hours with the following four solvents, yields net chloroform-soluble extractives in each extracting solvent not to exceed 0.02 milligram per square inch of food-contact surface: distilled w… | |||
| 21:21:3.0.1.1.8.3.1.12 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2450 Polyamide-imide resins. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 54 FR 43170, Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005] | Polyamide-imide resins identified in paragraph (a) of this section may be safely used as components of articles intended for repeated use in contact with food, in accordance with the following prescribed conditions: (a) Identity. (1) For the purpose of this section the polyamide-imide resins are derived from the condensation reaction of substantially equimolar parts of trimellitic anhydride and p , p ′-diphenylmethane diisocyanate. (2) The polyamide-imide resins (CAS Reg. No. 31957-38-7) derived from the condensation reaction of equimolar parts of benzoyl chloride-3,4-dicarboxylic anhydride and 4,4′-diphenylmethanediamine. (b) Specifications. (1) Polyamide-imide resins identified in paragraph (a)(1) of this section shall have a nitrogen content of not less than 7.8 weight percent and not more than 8.2 weight percent. Polyamide-imide resins identified in paragraph (a)(2) of this section shall have a nitrogen content of not less than 7.5 weight percent and not more than 7.8 weight percent. Nitrogen content is determined by the Dumas Nitrogen Determination as set forth in the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), sections 7.016-7.020, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, 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) Polyamide-imide resins identified in paragraph (a)(1) of this section shall have a solution viscosity of not less than 1.200. Polyamide-imide resins identified in paragraph (a)(2) of this section shall have a solution viscosity of not less than 1.190. Solution viscosity shall be determined by a method titled “Solution Viscosity” which is incorporated by reference in accordance… | |||
| 21:21:3.0.1.1.8.3.1.13 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984; 63 FR 8852, Feb. 23, 1998] | The poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in paragraph (a) of this section may be used as an article or as a component of an article intended for use in contact with food subject to the provisions of this section. (a) Identity. For the purposes of this section, poly(2,6-dimethyl-1,4-phenylene) oxide resins consist of basic resins produced by the oxidative coupling of 2,6-xylenol such that the finished basic resins meet the specifications and extractives limitations prescribed in paragraph (c) of this section. (b) Optional adjuvant substances. The basic poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. The optional adjuvant substances required in the production of the basic poly(2,6-dimethyl-1,4-phenylene) oxide resins may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, substances used in accordance with a prior sanction or approval, and the following: (c) Specifications and extractives limitations. The poly(2,6-dimethyl-1,4-phenylene) oxide basic resins meet the following: (1) Specifications. Intrinsic viscosity is not less than 0.30 deciliter per gram as determined by ASTM method D1243-79, “Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,” which is incorporated by reference, modified as follows. Copies of the incorporation by reference 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. (i) Solvent: Chloroform, reagent grade containing 0.01 percent tert- butylcatechol. (ii) Resin sampl… | |||
| 21:21:3.0.1.1.8.3.1.14 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2465 Polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers. | FDA | [59 FR 5948, Feb. 9, 1994] | Polymethylmethacrylate/poly(trimethoxysilylpropyl) methacrylate copolymers (CAS Reg. No. 26936-30-1) may be safely used as components of surface primers used in conjunction with silicone polymers intended for repeated use and complying with § 175.300 of this chapter and § 177.2600, in accordance with the following prescribed conditions. (a) Identity. For the purpose of this section, polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers are produced by the polymerization of methylmethacrylate and trimethoxysilylpropylmethacrylate. (b) Conditions of use. (1) The polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers are used at levels not to exceed 6.0 percent by weight of the primer formulation. (2) The copolymers may be used in food contact applications with all food types under conditions of use B through H as described in table 2 of § 176.170(c) of this chapter. | |||
| 21:21:3.0.1.1.8.3.1.15 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2470 Polyoxymethylene copolymer. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 48 FR 56204, Dec. 20, 1983; 49 FR 5748, Feb. 15, 1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR 24898, June 12, 1989] | Polyoxymethylene copolymer identified in this section may be safely used as an article or component of articles intended for food-contact use in accordance with the following prescribed conditions: (a) Identity. For the purpose of this section, polyoxymethylene copolymers are identified as the following: The reaction product of trioxane (cyclic trimer of formaldehyde) and ethylene oxide (CAS Reg. No. 24969-25-3) or the reaction product of trioxane (cyclic trimer of formaldehyde) and a maximum of 5 percent by weight of butanediol formal (CAS Reg. No. 25214 85-1). Both copolymers may have certain optional substances added to impart desired technological properties to the copolymer. (b) Optional adjuvant substances. The polyoxymethylene copolymer identified in paragraph (a) of this section may contain optional adjuvant substances required in its production. The quantity of any optional adjuvant substance employed in the production of the copolymer does not exceed the amount reasonably required to accomplish the intended technical or physical effect. Such adjuvants may include substances generally recognized as safe in food, substances used in accordance with prior sanction, substances permitted under applicable regulations in parts 170 through 189 of this chapter, and the following: (1) Stabilizers (total amount of stabilizers not to exceed 2.0 percent and amount of any one stabilizer not to exceed 1.0 percent of polymer by weight) Calcium ricinoleate. Cyanoguanidine. Hexamethylene bis(3,5-di- tert -butyl-4-hydroxyhydrocinnamate) (CAS Reg. No. 35074-77-2). Melamine-formaldehyde resin. 2,2′-Methylenebis(4-methyl-6- tert- butylphenol). Nylon 6/66, weight ratio 2/3. Tetrakis [methylene (3,5-di -tert- butyl-4-hydroxyhydrocinnamate)] methane. Calcium ricinoleate. Cyanoguanidine. Hexamethylene bis(3,5-di- tert -butyl-4-hydroxyhydrocinnamate) (CAS Reg. No. 35074-77-2). Melamine-formaldehyde resin. 2,2′-Methylenebis(4-methyl-6- tert- butylphenol). Nylon 6/66, weight ratio 2/3. Tetrakis [meth… | |||
| 21:21:3.0.1.1.8.3.1.16 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2480 Polyoxymethylene homopolymer. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 43 FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19, 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, 1989] | Polyoxymethylene homopolymer identified in this section may be safely used as articles or components of articles intended for food-contact use in accordance with the following prescribed conditions: (a) Identity. For the purpose of this section, polyoxymethylene homopolymer is polymerized formaldehyde [Chemical Abstracts Service Registry No. 9002-81-7]. Certain optional adjuvant substances, described in paragraph (b) of this section, may be added to impart desired technological properties to the homopolymer. (b) Optional adjuvant substances. The polyoxymethylene homopolymer identified in paragraph (a) of this section may contain optional adjuvant substances in its production. The quantity of any optional adjuvant substance employed in the production of the homopolymer does not exceed the amount reasonably required to accomplish the intended effect. Such 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 the following: (1) Stabilizers. The homopolymer may contain one or more of the following stabilizers. The total amount of stabilizers shall not exceed 1.9 percent of homopolymer by weight, and the quantity of individual stabilizer used shall not exceed the limitations set forth below: (2) Lubricant. N,N′ -Distearoylethyl-enediamine. (3) Molding assistant. Polyethylene glycol 6,000. (c) Specifications. (1) Polyoxymethylene homopolymer can be identified by its characteristic infrared spectrum. (2) Minimum number average molecular weight of the homopolymer is 25,000. (3) Density of the homopolymer is between 1.39 and 1.44 as 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 Nati… | |||
| 21:21:3.0.1.1.8.3.1.17 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2490 Polyphenylene sulfide resins. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, 1989] | Polyphenylene sulfide resins (poly(1,4-phenylene sulfide) resins) may be safely used as coatings or components of coatings of articles intended for repeated use in contact with food, in accordance with the following prescribed conditions. (a) Polyphenylene sulfide resins consist of basic resins produced by the reaction of equimolar parts of p- dichlorobenzene and sodium sulfide, such that the finished resins meet the following specifications as determined by methods titled “Oxygen Flask Combustion-Gravimetric Method for Determination of Sulfur in Organic Compounds,” “Determination of the Inherent Viscosity of Polyphenylene Sulfide,” and “Analysis for Dichlorobenzene in Ryton Polyphenylene Sulfide,” which are 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) Sulfur content: 28.2-29.1 percent by weight of finished resin. (2) Minimum inherent viscosity: 0.13 deciliters per gram. (3) Maximum residual p- dichlorobenzene: 0.8 ppm. (b) Subject to any limitations prescribed in parts 170 through 189 of this chapter, the following optional substances may be added to the polyphenylene sulfide basic resins in an amount not to exceed that reasonably required to accomplish the intended physical or technical effect. (1) Substances generally recognized as safe in food. (2) Substances used in accordance with prior sanction or approval. (3) Substances the use of which is permitted in coatings under regulations in parts 170 through 189 of this chapter. (c) The finished coatings are thermally cured at temperatures of 700 °F and above. (d) Polyphenylene sulfide resin coatings may be used in contact with food at temperature… | |||
| 21:21:3.0.1.1.8.3.1.18 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2500 Polyphenylene sulfone resins. | FDA | [65 FR 15058, Mar. 21, 2000] | The polyphenylene sulfone resins (CAS Reg. No. 31833-61-1) identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with food, subject to the provisions of this section. (a) Identity. For the purpose of this section, polyphenylene sulfone resins consist of basic resin produced by reacting polyphenylene sulfide with peracetic acid such that the finished resins meet the specifications set forth in paragraph (c) of this section. The polyphenylene sulfide used to manufacture polyphenylene sulfone is prepared by the reaction of sodium sulfide and p -dichlorobenzene, and has a minimum weight average molecular weight of 5,000 Daltons. (b) Optional adjuvant substances. The basic polyphenylene sulfone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. These optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, or substances used in accordance with a prior sanction or approval. (c) Specifications. The glass transition temperature of the polymer is 360±5 °C as determined by the use of differential scanning calorimetry. | |||
| 21:21:3.0.1.1.8.3.1.19 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2510 Polyvinylidene fluoride resins. | FDA | Polyvinylidene fluoride resins may be safely used as articles or components of articles intended for repeated use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, the polyvinylidene fluoride resins consist of basic resins produced by the polymerization of vinylidene fluoride. (b) The finished food-contact article, when extracted at reflux temperatures for 2 hours with the solvents distilled water, 50 percent (by volume) ethyl alcohol in distilled water, and n- heptane, yields total extractives in each extracting solvent not to exceed 0.01 milligram per square inch of food-contact surface tested; and 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. ( Note: In testing the finished food-contact article, use a separate test sample for each required extracting solvent.) (c) In accordance with good manufacturing practice, finished food-contact articles containing the polyvinylidene fluoride resins shall be thoroughly cleansed prior to their first use in contact with food. | ||||
| 21:21:3.0.1.1.8.3.1.2 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2250 Filters, microporous polymeric. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991] | Microporous polymeric filters identified in paragraph (a) of this section may be safely used, subject to the provisions of this section, to remove particles of insoluble matter in producing, manufacturing, processing, and preparing bulk quantities of liquid food. (a) Microporous polymeric filters consist of a suitably permeable, continuous, polymeric matrix of polyvinyl chloride, vinyl chloride-propylene, or vinyl chloride-vinyl acetate, in which finely divided silicon dioxide is embedded. Cyclohexanone may be used as a solvent in the production of the filters. (b) Any substance employed in the production of microporous polymeric filters that is the subject of a regulation in parts 170 through 189 of this chapter must conform with any specification in such regulation. (c) Cyclohexanone when used as a solvent in the production of the filters shall not exceed 0.35 percent by weight of the microporous polymeric filters. (d) The microporous polymeric filters may be colored with colorants used in accordance with § 178.3297 of this chapter. (e) The temperature of food being processed through the microporous polymeric filters shall not exceed 180 °F. (f) The microporous polymeric filters shall be maintained in a sanitary manner in accordance with good manufacturing practice so as to prevent potential microbial adulteration of the food. (g) To assure safe use of the microporous polymeric filters, the label or labeling shall include adequate directions for a pre-use treatment, consisting of washing with a minimum of 2 gallons of potable water at a temperature of 180 °F for each square foot of filter, prior to the filter's first use in contact with food. | |||
| 21:21:3.0.1.1.8.3.1.20 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2550 Reverse osmosis membranes. | FDA | [49 FR 49448, Dec. 20, 1984, as amended at 52 FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] | Substances identified in paragraph (a) of this section may be safely used as reverse osmosis membranes intended for use in processing bulk quantities of liquid food to separate permeate from food concentrate or in purifying water for food manufacturing under the following prescribed conditions: (a) Identity. For the purpose of this section, reverse osmosis membranes may consist of either of the following formulations: (1) A cross-linked high molecular weight polyamide reaction product of 1,3,5-benzenetricarbonyl trichloride with 1,3-benzenediamine (CAS Reg. No. 83044-99-9) or piperazine (CAS Reg. No. 110-85-0). The membrane is on the food-contact surface, and its maximum weight is 62 milligrams per square decimeter (4 milligrams per square inch) as a thin film composite on a suitable support. (2) A cross-linked polyetheramine (CAS Reg. No. 101747-84-6), identified as the copolymer of epichlorohydrin, 1,2-ethanediamine and 1,2-dichloroethane, whose surface is the reaction product of this copolymer with 2,4-toluenediisocyanate (CAS Reg. No. of the final polymer is 99811-80-0) for use as the food-contact surface of reverse osmosis membranes used in processing liquid food. The composite membrane is on the food-contact surface and its maximum weight is 4.7 milligrams per square decimeter (0.3 milligrams per square inch) as a thin film composite on a suitable support. The maximum weight of the 2,4-toluenediisocyanate component of the thin film composite is 0.47 milligrams per square decimeter (0.03 milligrams per square inch). (3) For the purpose of this section, the reverse osmosis membrane consists of a polyaramide identified as 2,4-diaminobenzenesulfonic acid, calcium salt (2:1) polymer with 1,3-benzenediamine, 1,3-benzenedicarbonyl dichloride, and 1,4-benzenedicarbonyl dichloride (CAS Reg. No. 39443-76-0). The membrane is the food contact surface and may be applied as a film on a suitable support. Its maximum weight is 512 milligrams per square decimeter (33 milligrams per square inch). (4) A cross-linked hi… | |||
| 21:21:3.0.1.1.8.3.1.21 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2600 Rubber articles intended for repeated use. | FDA | [42 FR 14572, Mar. 15, 1977] | Rubber articles intended for repeated use may be safely used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) The rubber articles are prepared from natural and/or synthetic polymers and adjuvant substances as described in paragraph (c) of this section. (b) The quantity of any substance employed in the production of rubber articles intended for repeated use shall not exceed the amount reasonably required to accomplish the intended effect in the rubber article and shall not be intended to accomplish any effect in food. (c) Substances employed in the preparation of rubber articles include the following, subject to any limitations prescribed: (1) Substances generally recognized as safe for use in food or food packaging. (2) Substances used in accordance with the provisions of a prior sanction or approval. (3) Substances that by regulation in parts 170 through 189 of this chapter may be safely used in rubber articles, subject to the provisions of such regulation. (4) Substances identified in this paragraph (c)(4), provided that any substance that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation. (i) Elastomers. Acrylonitrile-butadiene copolymer. Brominated isobutylene-isoprene copolymers complying with § 177.1210. Butadiene-acrylonitrile-ethylene glycol dimethacrylate copolymers containing not more than 5 weight percent of polymer units derived from ethylene glycol dimethacrylate. Butadiene-acrylonitrile-methacrylic acid copolymer. Butadiene-styrene-methacrylic acid copolymer. Chloroprene polymers. Chlorotrifluoroethylene-vinylidene fluoride copolymer. Ethylene-propylene copolymer elastomers which may contain not more than 5 weight-percent of total polymer units derived from 5-methylene-2-norbornene and/or 5-ethylidine-2-norbornene. Ethylene-propylene-dicyclopentadiene copolymer. … | |||
| 21:21:3.0.1.1.8.3.1.22 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2710 Styrene-divinylbenzene resins, cross-linked. | FDA | Styrene-divinylbenzene cross-linked copolymer resins may be safely used as articles or components of articles intended for repeated use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) The resins are produced by the copolymerization of styrene with divinylbenzene. (b) The resins meet the extractives limitations prescribed in this paragraph: (1) The resins to be tested are ground or cut into small particles that will pass through a U.S. standard sieve No. 3 and that will be held on a U.S. standard sieve No. 20. (2) A 100-gram sample of the resins, when extracted with 100 milliliters of ethyl acetate at reflux temperature for 1 hour, yields total extractives not to exceed 1 percent by weight of the resins. (c) In accordance with good manufacturing practice, finished articles containing the resins shall be thoroughly cleansed prior to their first use in contact with food. | ||||
| 21:21:3.0.1.1.8.3.1.23 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2800 Textiles and textile fibers. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 46 FR 37042, July 17, 1981; 49 FR 4372, Feb. 6, 1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, Aug. 30, 1991] | Textiles and textile fibers may safely be used as articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) The textiles and textile fibers are prepared from one or more of the fibers identified in paragraph (d) of this section and from certain other adjuvant substances required in the production of the textiles or textile fibers or added to impart desired properties. (b) The quantity of any adjuvant substance employed in the production of textiles or textile fibers does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitation further provided. (c) Any substance employed in the production of textiles or textile fibers that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation. (d) Substances employed in the production of or added to textiles and textile fibers may include: (1) Substances generally recognized as safe in food. (2) Substances subject to prior sanction or approval for use in textiles and textile fibers and used in accordance with such sanction or approval. (3) Substances generally recognized as safe for use in cotton and cotton fabrics used in dry-food packaging. (4) Substances that by regulation in this part may safely be used in the production of or as a component of textiles or textile fibers and subject to provisions of such regulation. (5) Substances identified in this paragraph (d)(5), subject to such limitations as are provided: (e) Textile and textile fibers are used as articles or components of articles that contact dry food only. (f) The provisions of this section are not applicable to jute fibers used as prescribed by § 178.3620(d)(2) of this chapter. | |||
| 21:21:3.0.1.1.8.3.1.24 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2910 Ultra-filtration membranes. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 53 FR 17925, May 19, 1988; 58 FR 48599, Sept. 17, 1993; 60 FR 54426, Oct. 24, 1995] | Ultra-filtration membranes identified in paragraphs (a)(1), (a)(2), (a)(3), and (a)(4) of this section may be safely used in the processing of food, under the following prescribed conditions; (a)(1) Ultra-filtration membranes that consist of paper impregnated with cured phenol-formaldehyde resin, which is used as a support and is coated with a vinyl chloride-acrylonitrile copolymer. (2) Ultra-filtration membranes that consist of a sintered carbon support that is coated with zirconium oxide (CAS Reg. No. 1314-23-4) containing up to 12 percent yttrium oxide (CAS Reg. No. 1314-36-9). (3) Ultra-filtration membranes that consist of an aluminum oxide support that is coated with zirconium oxide (CAS Reg. No. 1314-23-4) containing up to 5 percent yttrium oxide (CAS Reg. No. 1314-36-9). (4) Ultrafiltration membranes that consist of a microporous poly(vinylidene fluoride) membrane with a hydrophilic surface modifier consisting of hydroxypropyl acrylate/tetraethylene glycol diacrylate copolymer. (b) Any substance employed in the production of ultra-filtration membranes that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with the specifications of such regulation. (c) Ultra-filtration membranes are used in the physical separation of dissolved or colloidally suspended varying molecular size components of liquids during the commercial processing of bulk quantities of food. (d) Ultra-filtration membranes shall be maintained in a sanitary manner in accordance with good manufacturing practice so as to prevent potential microbial adulteration of the food. (e) Ultrafiltration membranes identified in paragraph (a)(4) may be used to filter aqueous or acidic foods containing up to 13 percent of alcohol at temperatures not to exceed 21 °C (70 °F). (f) To assure safe use of the ultra-filtration membranes, the label or labeling shall include adequate directions for a pre-use treatment, consisting of conditioning and washing with a minimum of 8 gallons of potable water prior … | |||
| 21:21:3.0.1.1.8.3.1.3 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2260 Filters, resin-bonded. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991] | Resin-bonded filters may be safely used in producing, manufacturing, processing, and preparing food, subject to the provisions of this section. (a) Resin-bonded filters are prepared from natural or synthetic fibers to which have been added substances required in their preparation and finishing, and which are bonded with resins prepared by condensation or polymerization of resin-forming materials, together with adjuvant substances required in their preparation, application, and curing. (b) The quantity of any substance employed in the production of the resin-bonded filter does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitation further provided. (c) Any substance employed in the production of resin-bonded filters that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation. (d) Substances employed in the production of resin-bonded filters include the following, subject to any limitations provided: (1) Fibers: Cellulose pulp. Cotton. Nylon. (From nylon resins complying with the provisions of applicable regulations in subchapter B of this chapter. Polyethylene terephthalate complying in composition with the provisions of § 177.1630; for use in inline filtration only as provided for in paragraphs (e) and (f) of this section. Rayon (viscose). Cellulose pulp. Cotton. Nylon. (From nylon resins complying with the provisions of applicable regulations in subchapter B of this chapter. Polyethylene terephthalate complying in composition with the provisions of § 177.1630; for use in inline filtration only as provided for in paragraphs (e) and (f) of this section. Rayon (viscose). (2) Substances employed in fiber finishing: BHT. Butyl (or isobutyl) palmitate or stearate. 2,5-Di- tert -butyl hydroquinone for use only in lubricant formulations for rayon fiber finishing and at a usage level not to exceed 0.1 percent by weight of the lubricant formu… | |||
| 21:21:3.0.1.1.8.3.1.4 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2280 4,4′-Isopropylidenediphenolepichlorohydrin thermosetting epoxy resins. | FDA | [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, 1984] | 4,4′-Isopropylidenediphenol-epichlo-rohydrin thermosetting epoxy resins may be safely used as articles or components of articles intended for repeated use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) The basic thermosetting epoxy resin is made by reacting 4,4′-isopropylidenediphenol with epichlorohydrin. (b) The resin may contain one or more of the following optional substances provided the quantity used does not exceed that reasonably required to accomplish the intended effect: (c) In accordance with good manufacturing practice, finished articles containing the resins shall be thoroughly cleansed prior to their first use in contact with food. (d) The provisions of this section are not applicable to 4,4′-isopropylidenedi-phenol-epichlorohydrin resins listed in other sections of parts 174, 175, 176, 177, 178 and 179 of this chapter. | |||
| 21:21:3.0.1.1.8.3.1.5 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2355 Mineral reinforced nylon resins. | FDA | [42 FR 54533, Oct. 7, 1977, as amended at 42 FR 61594, Dec. 6, 1977] | Mineral reinforced nylon resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with nonacidic food (pH above 5.0) and at use temperatures not exceeding 212 °F. in accordance with the following prescribed conditions: (a) For the purpose of this section the mineral reinforced nylon resins consist of nylon 66, as identified in and complying with the specifications of § 177.1500, reinforced with up to 40 weight percent of calcium silicate and up to 0.5 weight percent 3-(triethoxysilyl) propylamine (Chemical Abstracts Service Registry No. 000919302) based on the weight of the calcium silicate. (b) The mineral reinforced nylon resins may contain up to 0.2 percent by weight of titanium dioxide as an optional adjuvant substance. (c) The mineral reinforced nylon resins with or without the optional substance described in paragraph (b) of this section, and in the form of 1/8 -inch molded test bars, when extracted with the solvents, i.e., distilled water and 50 percent (by volume) ethyl alcohol in distilled water, at reflux temperature for 24 hours using a volume-to-surface ratio of 2 milliliters of solvent per square inch of surface tested, shall meet the following extractives limitations: (1) Total extractives not to exceed 5.0 milligrams per square inch of food-contact surface tested for each solvent. (2) The ash after ignition of the extractives described in paragraph (c)(1) of this section, not to exceed 0.5 milligram per square inch of food-contact surface tested. (d) In accordance with good manufacturing practice, finished articles containing the mineral reinforced nylon resins shall be thoroughly cleansed prior to their first use in contact with food. | |||
| 21:21:3.0.1.1.8.3.1.6 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2400 Perfluorocarbon cured elastomers. | FDA | [49 FR 43050, Oct. 26, 1984] | Perfluorocarbon cured elastomers identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with nonacid food (pH above 5.0), subject to the provisions of this section. (a) Identity. (1) For the purpose of this section, perfluorocarbon cured elastomers are produced by terpolymerizing tetrafluorethylene (CAS Reg. No. 116-14-3), perfluoromethyl vinyl ether (CAS Reg. No. 1187-93-5), and perfluoro-2-phenoxypropyl vinyl ether (CAS Reg. No. 24520-19-2) and subsequent curing of the terpolymer (CAS Reg. No. 26658-70-8) using the crosslinking agent, phenol, 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl) ethylidene] bis-,dipotassium salt (CAS Reg. No. 25088-69-1) and accelerator, 1,4,7,10,13,16-hexaoxacyclooctadecane (CAS Reg. No. 17455-13-9). (2) The perfluorocarbon base polymer shall contain no less than 40 weight-percent of polymer units derived from tetrafluoroethylene, no less than 40 weight-percent of polymer units derived from perfluoromethyl vinyl ether and no more than 5 weight-percent polymer units derived from perfluoro-2-phenoxy-propyl vinyl ether. (3) The composition limitations of the cured elastomer, calculated as parts per 100 parts of terpolymer, are as follows: Phenol, 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)-ethylidene] bis-,dipotassium salt—not to exceed 5 parts. 1,4,7,10,13,16-Hexaoxacyclo-octadecane—not to exceed 5 parts. Phenol, 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)-ethylidene] bis-,dipotassium salt—not to exceed 5 parts. 1,4,7,10,13,16-Hexaoxacyclo-octadecane—not to exceed 5 parts. (b) Optional adjuvant substances. The perfluorocarbon cured elastomer identified in paragraph (a) of this section may contain the following optional adjuvant substances, subject to any limitations cited on their use: (1) Substances generally recognized as safe (GRAS) in food or food packaging. (2) Substances used in accordance with a prior sanction. (3) Substances authorized under applicable regulations in this part and in part… | |||
| 21:21:3.0.1.1.8.3.1.7 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2410 Phenolic resins in molded articles. | FDA | Phenolic resins identified in this section may be safely used as the food-contact surface of molded articles intended for repeated use in contact with nonacid food (pH above 5.0), in accordance with the following prescribed conditions: (a) For the purpose of this section, the phenolic resins are those produced when one or more of the phenols listed in paragraph (a)(1) of this section are made to react with one or more of the aldehydes listed in paragraph (a)(2) of this section, with or without aniline and/or anhydro-formaldehyde aniline (hexahydro-1, 3,5-triphenyl-s-triazine): (1) Phenols: p-tert- Amylphenol. p-tert- Butylphenol. o-, m-, and p- Cresol. p- Octylphenol. Phenol. o- and p- Phenylethylphenol mixture produced when phenol is made to react with styrene in the presence of sulfuric acid catalyst. p-tert- Amylphenol. p-tert- Butylphenol. o-, m-, and p- Cresol. p- Octylphenol. Phenol. o- and p- Phenylethylphenol mixture produced when phenol is made to react with styrene in the presence of sulfuric acid catalyst. (2) Aldehydes: Acetaldehyde. Formaldehyde. Paraldehyde. Acetaldehyde. Formaldehyde. Paraldehyde. (b) Optional adjuvant substances employed in the production of the phenolic resins or added thereto to impart desired technical or physical properties include the following: (c) The finished food-contact article, when extracted with distilled water at reflux temperature for 2 hours, using a volume-to-surface ratio of 2 milliliters of distilled water per square inch of surface tested, shall meet the following extractives limitations: (1) Total extractives not to exceed 0.15 milligram per square inch of food-contact surface. (2) Extracted phenol not to exceed 0.005 milligram per square inch of food-contact surface. (3) No extracted aniline when tested by a spectrophotometric method sensitive to 0.006 milligram of aniline per-square inch of food-contact surface. (d) In accordance with good manufacturing practice, finished molded articles containing the pheno… | ||||
| 21:21:3.0.1.1.8.3.1.8 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2415 Poly(aryletherketone) resins. | FDA | [63 FR 20315, Apr. 24, 1998] | Poly(aryletherketone) resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with food subject to the provisions of this section. (a) Identity. For the purposes of this section, poly(aryletherketone) resins are poly( p -oxyphenylene p -oxyphenylene p -carboxyphenylene) resins (CAS Reg. No. 29658-26-2) produced by the polymerization of hydroquinone and 4,4′-difluorobenzophenone, and have a minimum weight-average molecular weight of 12,000, as determined by gel permeation chromatography in comparison with polystyrene standards, and a minimum mid-point glass transition temperature of 142 °C, as determined by differential scanning calorimetry. (b) Optional adjuvant substances. The basic resins identified in paragraph (a) may contain optional adjuvant substances used in their production. These adjuvants may include substances described in § 174.5(d) of this chapter and the following: (c) Extractive limitations. The finished food contact article, when extracted at reflux temperatures for 2 hours with the following four solvents, yields in each extracting solvent net chloroform soluble extractives not to exceed 0.05 milligrams per square inch of food contact surface: Distilled water, 50 percent (by volume) ethanol in distilled water, 3 percent acetic acid in distilled water, and n -heptane. In testing the final food contact article, a separate test sample shall be used for each extracting solvent. | |||
| 21:21:3.0.1.1.8.3.1.9 | 21 | Food and Drugs | I | B | 177 | PART 177—INDIRECT FOOD ADDITIVES: POLYMERS | C | Subpart C—Substances for Use Only as Components of Articles Intended for Repeated Use | § 177.2420 Polyester resins, cross-linked. | FDA | [42 FR 14572, Mar. 15, 1977, as amended at 48 FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, 1989; 87 FR 31089, May 20, 2022] | Cross-linked polyester resins may be safely used as articles or components of articles intended for repeated use in contact with food, in accordance with the following prescribed conditions: (a) The cross-linked polyester resins are produced by the condensation of one or more of the acids listed in paragraph (a)(1) of this section with one or more of the alcohols or epoxides listed in paragraph (a)(2) of this section, followed by copolymerization with one or more of the cross-linking agents listed in paragraph (a)(3) of this section: (1) Acids: Adipic. Fatty acids, and dimers thereof, from natural sources. Fumaric. Isophthalic. Maleic. Methacrylic. Orthophthalic. Sebacic. Terephthalic. Trimellitic. Adipic. Fatty acids, and dimers thereof, from natural sources. Fumaric. Isophthalic. Maleic. Methacrylic. Orthophthalic. Sebacic. Terephthalic. Trimellitic. (2) Polyols and polyepoxides: Butylene glycol. Diethylene glycol. 2,2-Dimethyl-1,3-propanediol. Dipropylene glycol. Ethylene glycol. Glycerol. 4,4′-Isopropylidenediphenol-epichlorohydrin. Mannitol. a- Methyl glucoside. Pentaerythritol. Polyoxypropylene ethers of 4,4′-isopropylide-nediphenol (containing an average of 2-7.5 moles of propylene oxide). Propylene glycol. Sorbitol. Trimethylol ethane. Trimethylol propane. 2,2,4-Trimethyl-1,3-pentanediol. Butylene glycol. Diethylene glycol. 2,2-Dimethyl-1,3-propanediol. Dipropylene glycol. Ethylene glycol. Glycerol. 4,4′-Isopropylidenediphenol-epichlorohydrin. Mannitol. a- Methyl glucoside. Pentaerythritol. Polyoxypropylene ethers of 4,4′-isopropylide-nediphenol (containing an average of 2-7.5 moles of propylene oxide). Propylene glycol. Sorbitol. Trimethylol ethane. Trimethylol propane. 2,2,4-Trimethyl-1,3-pentanediol. (3) Cross-linking agents: Butyl acrylate. Butyl methacrylate. Ethyl acrylate. Ethylhexyl acrylate. Methyl acrylate. Methyl methacrylate. Styrene. Triglycidyl isocyanurate (CAS Reg. … |
Advanced export
JSON shape: default, array, newline-delimited, object
CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);