21 C.F.R. § 178.3740 Plasticizers in polymeric substances.
Title 21 - Food and Drugs
Subject to the provisions of this regulation, the substances listed in paragraph (b) of this section may be safely used as plasticizers in polymeric substances used in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food. (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect. (b) List of substances: (c) The use of the plasticizers in any polymeric substance or article subject to any regulation in parts 174, 175, 176, 177, 178 and 179 of this chapter must comply with any specifications and limitations prescribed by such regulation for the finished form of the substance or article. [42 FR 14609, Mar. 15, 1977, as amended at 42 FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986]
Title 21: Food and Drugs
PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
Subpart D—Certain Adjuvants and Production Aids
§ 178.3740 Plasticizers in polymeric substances.
------------------------------------------------------------------------ Substances Limitations------------------------------------------------------------------------Butylbenzyl phthalate........... For use only: 1. As provided in §§ 175.105 and 176.180 of this chapter. 2. In polymeric substances used in food-contact articles complying with § 175.300, § 175.320, or § 176.170 of this chapter: Provided, That the butyl benzyl phthalate contains not more than 1 percent by weight of dibenzyl phthalate. 3. In polymeric substances used in other permitted food-contact articles: Provided, That the butyl benzyl phthalate contains not more than 1 percent by weight of dibenzyl phthalate; and Provided further, That 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, shall yield net chloroform-soluble extractives not to exceed 0.5 mg. per square inch, as determined by the methods prescribed in § 175.300(e) of this chapter.1,3-Butylene glycoladipic acid For use at levels not exceeding 33 polyester (1,700-2,200 percent by weight of polyvinyl molecular weight) terminated chloride homopolymers used in contact with a 16 percent by weight with food (except foods that contain mixture of myristic, palmitic, more than 8 percent of alcohol) at and stearic acids. temperatures not to exceed room temperature. The average thickness of such homopolymers in the form in which they contact food shall not exceed 0.004 inch.Di(C7, C9-alkyl) adipate, in For use only under the conditions which the C7, C9-alkyl groups listed below, and excluding use as a are derived from linear alpha component of resinous and polymeric olefins by the oxo process. coatings described in § 175.300 of this chapter. 1. At levels not to exceed 24 percent by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not to exceed 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymer in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch.Di-n-alkyl adipate made from C6 For use only: C8-C10 (predominately C8 and 1. At levels not exceeding 24 pct by C10) or C8-C10 synthetic fatty weight of permitted vinyl chloride alcohols complying with § homo- and/or copolymers used in 172.864 of this chapter. contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in which they contact food shall not exceed 0.002 inch.Dicyclohexyl phthalate.......... For use only: 1. As provided in §§ 175.105, 176.170, 176.180, and 177.1200 of this chapter. 2. Alone or in combination with other phthalates, in plastic film or sheet prepared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. Such plastic film or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pct by weight of total phthalates, calculated as phthalic acid.Di(2-ethylhexyl) adipate........ ......................................Diisononyl adipate.............. For use only: 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact under conditions of use F and G described in table 2 of § 176.170(c) of this chapter with fatty, nonalcoholic foods having a fat and oil content not exceeding a total of 30 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter with fatty, nonalcoholic foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch.Diisononyl phthalate............ For use only at levels not exceeding 43 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, and VIII, at temperatures not exceeding room temperature. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch.Di(2-ethylhexyl) azelate........ For use only: 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic food. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of § 176.170(c) of this chapter, with fatty, nonalcoholic food having a fat and oil content not exceeding a total of 30 percent by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch.Di-n-hexylazelate............... For use only: 1. In polymeric substances used in contact with nonfatty food. 2. In polymeric substances used in contact with fatty food and limited to use at levels not exceeding 15 pct by weight of such polymeric substance except as provided under limitation 3. 3. At levels greater than 15 but not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F or G described in table 2 of § 176.170(c) of this chapter, with fatty food having a fat and oil content not exceeding a total of 30 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch.Dihexyl phthalate............... For use only: 1. As provided in § 175.105 of this chapter. 2. In articles that contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI-B, and VIII.Diphenyl phthalate.............. For use only: 1. As provided in § 175.105 of this chapter. 2. Alone or in combination with other phthalates, in plastic film or sheet prepared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride copolymers complying with § 177.1980 of this chapter. Such plastic film or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pct by weight of total phthalates, calculated as phthalic acid.Epoxidized butyl esters of Iodine number, maximum 5; oxirane linseed oil fatty acids. oxygen, minimum 7.8 pct.Epoxidized linseed oil.......... Iodine number, maximum 5; oxirane oxygen, minimum 9-pct.Mineral oil, white..............Polybutene, hydrogenated For use only: (minimum viscosity at 99 1. In polymeric substances used in °F, 39 Saybolt Universal contact with non-fatty food. seconds, as determined by ASTM 2. In polyethylene complying with methods D445-82 (``Standard § 177.1520 of this chapter and Test Method for Kinematic used in contact with fatty food, Viscosity of Transparent and provided that the hydrogenated Opaque Liquids (and the polybutene is added in an amount not Calculation of Dynamic to exceed 0.5 pct by weight of the Viscosity)'') and D2161-82 polyethylene, and further provided (``Standard Method for that such plasticized polyethylene Conversion of Kinematic shall not be used as a component of Viscosity to Saybolt Universal articles intended for packing or Viscosity or to Saybolt Furol holding food during cooking. Viscosity''), and bromine 3. In polystyrene complying with number of 3 or less, as § 177.1640 of this chapter and determined by ASTM method D1492- used in contact with fatty food, 78 (``Standard Test Method for provided that the hydrogenated Bromine Index of Aromatic polybutene is added in an amount not Hydrocarbons by Coulometric to exceed 5 pct by weight of the Titration''), which are polystyrene, and further provided incorporated by reference. that such plasticized polystyrene Copies may be obtained from the shall not be used as a component of American Society for Testing articles intended for packing or Materials, 100 Barr Harbor Dr., holding food during cooking. 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: https:// www.archives.gov/ federal_register/ code_of_federal_regulations/ ibr_locations.html..Polyisobutylene (mol weight 300- For use in polyethylene complying with 5,000). § 177.1520 of this chapter, provided that the polyisobutylene is added in an amount not exceeding 0.5 pct by weight of the polyethylene, and further provided that such plasticized polyethylene shall not be used as a component of articles intended for packing or holding food during cooking.Polyisobutylene complying with § 177.1420 of this chapter.Polypropylene glycol (CAS For use only in polystyrene plastics, registry No. 25322-69-4) identified in § 177.1640(a)(1), (minimum mean molecular weight in an amount not to exceed 6 pct by 1,200). weight of the finished food-contact article.Propylene glycol azelate For use only at levels not exceeding (average mol. weight 3,000). 41 pct by weight of permitted polyvinyl chloride coatings. Such coatings shall be used only as bulk food contact surfaces of articles intended for repeated use, complying with § 177.2600 of this chapter.Triethylene glycol.............. Diethylene glycol content not to exceed 0.1 pct.2,2,4-Trimethyl-1,3-pentanediol For use only in cellulosic plastics in diisobutyrate. an amount not to exceed 15 pct by weight of the finished food-contact article, provided that the finished plastic article contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI-B, VII-B, and VIII.------------------------------------------------------------------------
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