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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR178.3740]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

Subpart D--Certain Adjuvants and Production Aids

Sec. 178.3740 Plasticizers in polymeric substances.

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:

Substances Limitations
Butylbenzyl phthalateFor 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 polyester (1,700-2,200 molecular weight) terminated with a 16 percent by weight mixture of myristic, palmitic, and stearic acidsFor use at levels not exceeding 33 percent by weight of polyvinyl chloride homopolymers used in contact with food (except foods that contain more than 8 percent of alcohol) at 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 which the C7, C9-alkyl groups are derived from linear alpha olefins by the oxo processFor use only under the conditions listed below, and excluding use as a component of resinous and polymeric 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 C8-C10 (predominately C8 and C10) or C8-C10 synthetic fatty alcohols complying with 172.864 of this chapterFor use only:
1. At levels not exceeding 24 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 0.005 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 phthalateFor 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 adipateFor 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 phthalateFor 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) azelateFor 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-hexylazelateFor 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 phthalateFor 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 phthalateFor 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 linseed oil fatty acidsIodine number, maximum 5; oxirane oxygen, minimum 7.8 pct.
Epoxidized linseed oilIodine number, maximum 5; oxirane oxygen, minimum 9-pct.
Mineral oil, white
Polybutene, hydrogenated (minimum viscosity at 99 deg. F, 39 Saybolt Universal seconds, as determined by ASTM methods D445-82 ("Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (and the Calculation of Dynamic Viscosity)") and D2161-82 ("Standard Method for Conversion of Kinematic Viscosity to Saybolt Universal Viscosity or to Saybolt Furol Viscosity"), and bromine number of 3 or less, as determined by ASTM method D1492-78 ("Standard Test Method for Bromine Index of Aromatic Hydrocarbons by Coulometric Titration"), which are 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.For use only:
1. In polymeric substances used in contact with non-fatty food.
2. In polyethylene complying with 177.1520 of this chapter and used in contact with fatty food, provided that the hydrogenated polybutene is added in an amount not to exceed 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.
3. In polystyrene complying with 177.1640 of this chapter and used in contact with fatty food, provided that the hydrogenated polybutene is added in an amount not to exceed 5 pct by weight of the polystyrene, and further provided that such plasticized polystyrene shall not be used as a component of articles intended for packing or holding food during cooking.
Polyisobutylene (mol weight 300-5,000)For use in polyethylene complying with 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 registry No. 25322-69-4) (minimum mean molecular weight 1,200)For use only in polystyrene plastics, identified in 177.1640(a)(1), in an amount not to exceed 6 pct by weight of the finished food-contact article.
Propylene glycol azelate (average mol. weight 3,000)For use only at levels not exceeding 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 glycolDiethylene glycol content not to exceed 0.1 pct.
2,2,4-Trimethyl-1,3-pentanediol diisobutyrateFor use only in cellulosic plastics in 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.

(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]

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