6, 1982; 49 FR 10109, Mar. Polypropylene, noncrystalline; for use only to plasticize polyethylene described under items 2.1 and 2.2 of this table, provided that such plasticized polymers meet the maximum extractable fraction and maximum soluble fraction specifications prescribed for such basic polyethylene, 1.3. 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. The optional adjuvant substances required in the production of the basic olefin polymers or finished food-contact articles may include substances permitted for such use by applicable regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food and food packaging, substances used in accordance with a prior sanction or approval, and the following: (d) The analytical methods for determining whether olefin polymers conform to the specifications prescribed in this section are as follows, and are applicable to the basic polymer in film form not exceeding 4 mils in thickness. Food Contact Material Regulations - USA | SGS Greece (1) The polymers may be safely used as components of the food-contact or interior core layer of multilaminate food-contact articles. No. a regulation listed in Title 21 Code of Federal Regulations; (Note: In testing the finished food-contact article, use a separate test sample for each required extracting solvent.). Mineral oil; (1) In rubber articles complying with this section, not to exceed 30 percent by weight; (2) Alone or in combination with waxes, petroleum, total not to exceed 45 percent by weight of rubber articles that contain at least 20 percent by weight of ethylene-propylene copolymer elastomer complying with paragraph (c)(4)(i) of this section, in contact with foods of Types I, II, III, IV, VI, VII, VIII, and IX identified in table 1 of 176.170(c) of this chapter. Two-liter extraction vessel, such as a resin kettle or round bottom flask, fitted with an Allihn condenser (size C), a 45/50 male joint with a Teflon sleeve, and a Teflon coated stir bar. Exactly 2 hours after the solvent temperature has reached 50 C, disconnect the heater, remove the resin kettle from the heating jacket, and decant the solvent, while still warm, through a coarse filter paper placed on top of a fritted-glass funnel, collecting the filtrate in a tared, glass-stoppered Erlenmeyer flask of 1-liter capacity. (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. Preformed overall discs or annular rings of polymeric or resinous-coated paper, paperboard, plastic, or metal foil substrates, 5. (c) Optional adjuvant substances. View the most recent official publication: These links go to the official, published CFR, which is updated annually. (d) Analytical method for determination of total residual styrene monomer content . (2) Perfluorocarbon resins identified in paragraphs (a)(1) and (2) of this section and intended for use as coatings or components of coatings shall meet extractability limits prescribed in paragraph (e)(3) of this section when the resins in the form of coatings described in paragraphs (e)(2)(i) and (ii) of this section are extracted at reflux temperatures for 2 hours separately with distilled water, 8 percent ethanol, and n-heptane: (i) Perfluorocarbon resin coatings based on resins identified in paragraph (a)(1) of this section shall be applied to both sides of a 0.025-millimeter (0.001 inch) thick aluminum foil to a thickness of 0.025 millimeter (0.001 inch) after thermal curing at 399 C (750 F) for 10 minutes. 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. The absorbance in the region 544552 m should be 0.25 but must be not less than 0.12 nor more than 0.38. e is substituted for e in the above equations when necessary (See paragraph (e)(6)(ii) of this section for method to obtain e). 4098719) and/or 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. Mooney viscosity is determined by ASTM method D164681, Standard Test Method for RubberViscosity and Vulcanization Characteristics (Mooney Viscometer), which is incorporated by reference (the availability of this incorporation by reference is given in paragraph (d)(1) of this section), using the large rotor at a temperature of 100 C, except that a temperature of 127 C shall be used for those copolymers whose Mooney viscosity cannot be determined at 100 C. Styrene-divinylbenzene resins, cross-linked. The viscosity average molecular weight shall be determined from the kinematic viscosity (using ASTM method D44574, Test for Kinematic Viscosity of Transparent and Opaque Liquids (Revised 1974), which is incorporated by reference; copies are available from American Society for Testing and Materials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection at the National Archives and Records Administration (NARA). 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 (HFS200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 2404021200 or at the National Archives and Records Administration (NARA). The film to be tested shall be cut into approximately 1-inch squares by any convenient method that avoids contamination by dust, dirt, or grease (Note: Do not touch samples with bare fingersuse forceps to hold or transfer samples). For information on the availability of this material at NARA, call 2027416030, or go to: Distearic acid ester of di(hydroxyethyl) diethylenetriamine monoacetate. (b) Vinyl chloride-propylene copolymer content. (b) Optional adjuvant substances. 22, 1983; 49 FR 7558, Mar. Polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers. 4,4-Isopropylidenediphenol-epichlorohydrin resins minimum molecular weight 10,000. The finished filter, when exposed to 8 percent (by volume) ethyl alcohol in distilled water for 2 hours at a temperature equivalent to, or higher than, the filtration temperature of the alcoholic beverage, yields total extractives not to exceed 4 percent, by weight, of the filter. (5) Tetrafluoroethylene-resin-coated stirring bar, 1-inch long. The basic resins identified in paragraph (a) may contain optional adjuvant substances used in their production. (ii) The viscosity number (VN) for Nylon 6/69 and Nylon PA63T resins in a 99 percent cresol solution (5 milligrams resin per milliliter) shall be determined at 25 C (77 F) by method ISO 3071984(E), Plastics-Polyamides-Determination of Viscosity Number, which is incorporated by reference. No. Acrylonitrile/styrene copolymers identified in this section may be safely used as a component of packaging materials subject to the provisions of this section. Carboxymethyl hydroxyethylcellulose polymer. 21 CFR 177.1200 - Cellophane. - Content Details - CFR-2011-title21-vol3 3634831). 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. At a maximum level of 1.5 percent by weight of homopolymer. As a solvent in the preparation of fibryl. (2) Conditions of use. All Titles Title 21 Chapter I Part 177 Subpart B . Choosing an item from (6) Ethylene-maleic anhydride copolymers (CAS Reg. 20. An expanded scale recording titrimeter. (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. (ii) For films of greater than 2 mils (0.002 inch) thickness, extractives shall not exceed 0.40 milligram/square inch1 (0.062 milligram/square centimeter) of food-contact surface (n-heptane extractions) when extracted by the abbreviated method cited in paragraph (e)(2)(i) of this section, or. (e) Acrylonitrile copolymers identified in this section shall comply with the provisions of 180.22 of this chapter. eCFR :: 21 CFR Part 175 -- Indirect Food Additives: Adhesives and 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. 1,2-Dihydro-2,2,4-trimethyl-6-dodecylquinoline. Transfer 5 grams 0.001 gram of sample to the resin kettle, add 1,000 milliliters (840 grams) of xylene, and clamp top in position after inserting a piece of glass rod to prevent bumping during reflux. (h) Resin-bonded filters conforming with the specifications of paragraph (h)(1) of this section are used as provided in paragraph (h)(2) of this section: (1) Total extractives. 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 of the ASTM method may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959. 552(a) and 1 CFR part 51. Reweigh the Erlenmeyer flask and calculate the weight of the filtrate obtained to the nearest 0.1 gram. Used as plasticizers in polyethylene or polypropylene complying with, 3. The solution is cooled and an equal volume of acetone is added. No. (f) Nonapplicability. (6) Release agents: Fatty acids derived from animal and vegetable fats and oils, and fatty alcohols derived from such acids. 19, 1984; 63 FR 8852, Feb. 23, 1998]. Evaporate the filtrate on a stream bath with the aid of a stream of nitrogen. Break up any precipitated polymers that may have formed, and decant the xylene solution successively through a fast filter paper and then through a fritted-glass filter into a tared 1-liter Erlenmeyer flask, collecting only the first 450 milliliters500 milliliters of filtrate (any attempt to collect more of the xylene solution usually results in clogging the filter and risking losses). For information on the availability of this material at NARA, call 2027416030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Nylon resins PA 63T for repeated-use (excluding bottles) in contact with food of type VIA and VIB described in table 1 of, Aromatic petroleum hydrocarbon resin, hydrogenated (CAS Reg. Cool the evaporating dish in a desiccator for 30 minutes and weigh to the nearest 0.1 milligram to get the acidified chloroform-soluble extractives residue, e. (Note: If the residue value seems high, redry in the vacuum oven for one-half hour to ensure complete removal of all xylene solvent.) 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. 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. (i) Copolyester-graft acrylate copolymer described in paragraph (c)(1) of this section is intended to improve the adhesive qualities of film. (c) Specifications and limitations. (d) Analytical methods: The analytical methods for determining whether vinyl chloride-propylene basic copolymers conform to the extractives limitations prescribed in paragraph (c) of this section are as follows and are applicable to the basic copolymers in powder form having a particle size such that 100 percent will pass through a U.S. Standard Sieve No. 68937542), For use as an extrusion aid in the production of extruded olefin polymers that comply with, Triisopropanolamine (CAS Reg. (f) Acrylonitrile copolymers identified in this section are not authorized to be used to fabricate beverage containers. 15, 1977, as amended at 49 FR 10109, Mar. [42 FR 14572, Mar. 552(a) and 1 CFR part 51. 552(a) and 1 CFR part 51. For information on the availability of this material at NARA, call 2027416030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Food and Drug Administration - Wikipedia (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. 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). (iii) Antioxidants and antiozonants (total not to exceed 5 percent by weight of rubber product). [42 FR 14572, Mar. When the volume of solvent in the beaker has been reduced to 3050 milliliters, transfer the concentrated extractive to a suitable weighing dish that has been previously tared (dry). Background and more details are available in the 177.1330 - Ionomeric resins. Place an accurately weighed sample of suitable size in a clean borosilicate flask, and for each gram of sample add 3 milliliters of solvent previously heated to 150 F. As the basic polymer, and used as a resin to anchor coatings to substrate. 19, 1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, Apr. No. 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. The beaker with gas cover is inserted in an electric heating mantle equipped with a variable-voltage transformer. (2) Determination of total amount of extractives. (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. 2,2-Methylenebis(4-methyl-6-nonylphenol). 7, 1990; 59 FR 9925, Mar. As a Copies are available from the Center for Food Safety and Applied Nutrition (HFS200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). T = Milliliters of silver nitrate (sample minus blank) normality of silver nitrate. Closures with sealing gaskets or sealing compositions as described in 1, 2, 3, and 4, and including paper, paperboard, and glassine used for dry foods only, A. Silicone (Fsi) elastomers containing methyl and fluorine groups. When the xylene starts to boil, reduce the voltage to a level just sufficient to maintain reflux. 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 and 177.1200. (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. The finished polymers may be used only under the conditions described in, Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a vulcanizing agent in vulcanized natural or synthetic rubber gasket compositions at a level not to exceed 4 percent by weight of the elastomer content of the rubber gasket composition. No. Milliequivalents of organic chlorine in aqueous extract of 100 grams of sample equal milliequivalents of total chlorine in aqueous extract of 100 grams of sample (as calculated in paragraph (d)(3)(ii) of this section) minus milliequivalents of ionic chlorine in aqueous extract of 100 grams of sample (as calculated in paragraph (d)(3)(iii) of this section). 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. It is not an official legal edition of the CFR. 25854164) adduct of trimethylol propane. Compressed air, purified; helium gas; hydrogen gas; methylene chloride, redistilled; and styrene monomer, redistilled. [42 FR 14572, Mar. (a) For the purpose of this section, nitrile rubber modified acrylonitrile-methyl acrylate copolymers consist of basic copolymers produced by the graft copolymerization of 7377 parts by weight of acrylonitrile and 2327 parts by weight of methyl acrylate in the presence of 810 parts by weight of butadiene-acrylonitrile copolymers containing approximately 70 percent by weight of polymer units derived from butadiene. The information on this page is current as of Jun 07, 2023. Start a flow of nitrogen (2 to 3 liters per minute) into the gas cover and connect an aspirator to the receiver using a free-flow rate equivalent to 67 liters of air per minute. Resin-bonded filters may be safely used in producing, manufacturing, processing, and preparing food, subject to the provisions of this section. Fine particles should be separated from the cut resin by screening through a 20-mesh screen. No. (e) Nylon MXD6 resins that comply with item 10.3 of the table in 177.1500(b) of this chapter when extracted with water and heptane under the conditions of time and temperature specified for condition of use A, as set forth in Table 2 of 176.170(c) of this chapter. For information on the availability of this material at NARA, call 2027416030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. 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. Transfer the weighing dish to a vacuum desiccator at room temperature and allow to remain under reduced pressure for at least 12 hours (overnight), after which determine the net weight of the residue to the nearest 0.0001 gram. The solvent used shall be at least 60 milliliters aqueous sodium chloride solution per gram of copolymer. (v) Duplicate permanganate test determinations shall be run on samples of distilled water and 8 and 50 percent alcohol solvents that have been exposed to the temperature-time conditions of the extraction test without the plastic sample. Note: In testing the finished polysulfone resins, use a separate resin test sample for each required extracting solvent. Conditions of fill and storage not exceeding 48.9 C (120 F). Poly(oxyethylene) sorbitol monolaurate tetraoleate (CAS Reg. Copies are available from the Center for Food Safety and Applied Nutrition (HFS200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). (ii) Fluoride extractives calculated as fluorine not to exceed 0.46 milligram per square decimeter (0.03 milligram per square inch). The polycarbonate resins to be tested shall be ground or cut into small particles that will pass through a U.S. standard sieve No. (b) The polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of the polymers. (a) Identity. For information on the availability of this material at NARA, call 2027416030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. FDA regulations 21 CFR 177.2470 "Polyoxymethylene copolymer", 21 CFR 178.3297 . 121510096), methyl methacrylate/butyl acrylate copolymer (CAS Reg. (7) Surface active agent: Sodium dodecylbenzenesulfonate. Vinyl chloride-lauryl vinyl ether copolymers. 15, 1977, as amended at 57 FR 185, Jan. 3, 1992]. Copies are available from the Center for Food Safety and Applied Nutrition (HFS200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). Alternatively, the sample is reweighed after the extraction period to give a measure of the solvent extractable fraction. The availability of this incorporation by reference is given in paragraph (b) of this section. Polybutadiene resin (molecular weight range 2,00010,200; bromine number range 210320). 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). Tri(mixed mono- and dinonylphenyl) phosphite. The vinyl chloride-propylene copolymer content of the aqueous extract can be determined by determining the organic chlorine content and calculating the amount of copolymer equivalent to the organic chlorine content. Nitrile rubber modified acrylonitrile-methyl acrylate copolymers. The following extractives limitations are determined by the methods described in paragraph (d) of this section: (i) Total extractives do not exceed 0.10 weight-percent when extracted with n-heptane at 150 F for 2 hours. 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. The gelatin so used shall be technical grade or better. The test shall be run on a sample approximately the size of a 18-inch cube in at least 25 milliliters of 4.2 normal hydrochloric acid. (c) Acrylonitrile copolymers identified in this section shall comply with the provisions of 180.22 of this chapter. (1) Perfluorocarbon-molded articles having a surface area of 6.45 square decimeters (100 square inches) or more and at least 1.27 millimeters (0.05 inch) thick shall be extracted at reflux temperatures for 2 hours separately with distilled water, 50 percent ethanol, n-heptane, and ethyl acetate. 10, shall yield total extractives as follows: (i) Not to exceed 0.20 percent by weight of the copolymer when extracted for 6 hours with distilled water at reflux temperature. Laminate structures for use at temperatures of 250 F and above. Turn on heating jacket with transformer set at a predetermined voltage to bring the temperature of the contents to 50 C within 2025 minutes. Apply suction, and draw 3040 milliliters of filtrate through, adding more slurry to the funnel, and catching the filtrate in a large test tube. The finished polymer may be used in contact with food Types I, II, IV-B, VI-A through VI-C, VII-B, and VIII identified in table 1 of, For use as an initiator in the production of propylene homopolymer complying with, Methyl methacrylate/butyl acrylate-grafted polypropylene copolymer containing methyl methacrylate/butyl acrylate-grafted polypropylene (CAS Reg. 77996) adducts of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg. [43 FR 44834, Sept. 29, 1978, as amended at 47 FR 11843, Mar. (i) Principle. 114096649 when produced with the use of greater than 2 but not greater than 5 weight percent p-cumylphenol (CAS Reg. Correct the sample residue for this blank if significant. (4) Substances identified in this paragraph (b)(4) subject to such limitations as are provided: (1) Infrared identification. (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. Used as production aids in the manufacture of expanded (foamed) polystyrene articles complying with, Less than 20,000 seconds Saybolt at 200 F, 5. On exposure to distilled water at 250 F (121 C) for 2 hours, extractives from the food-contact side of the nylon 12 multilayered construction shall not exceed 0.05 milligram per square inch (0.0078 milligram per square centimeter) as total nonvolatile extractives. This document is available in the following developer friendly formats: Information and documentation can be found in our Ethylenediaminetetraacetic acid, sodium salt, 4-Ethyl-4-hexadecyl morpholinium ethyl sulfate, For use only as a lubricant in the manufacture of polyethylene terephthalate fibers specified in.
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