GrokFood Home
Loading

178.3740 Plasticizers in polymeric substances.

Home > Regulations > Indirect food additives: Adjuvants, production aids, and sanitizers > 178.3740 Plasticizers in polymeric substances.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3740]

[Page 428-431]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 178_INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS--Table of Contents
 
             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:

[[Page 429]]



------------------------------------------------------------------------
           Substances                           Limitations
------------------------------------------------------------------------
Butylbenzyl phthalate...........  For use only:
                                  1. As provided in Sec.  Sec.   175.105
                                   and 176.180 of this chapter.
                                  2. In polymeric substances used in
                                   food-contact articles complying with
                                   Sec.   175.300, Sec.   175.320, or
                                   Sec.   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
                                   Sec.   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 Sec.
                                   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 Sec.   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 Sec.
                                   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 Sec.
                                   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 Sec.      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 Sec.
                                   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 Sec.
                                   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 Sec.  Sec.
                                   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
                                   Sec.   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.

[[Page 430]]


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 Sec.
                                   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 Sec.
                                   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 Sec.   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 Sec.
                                   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 Sec.   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 Sec.   175.105 of
                                   this chapter.
                                  2. In articles that contact food only
                                   of the types identified in Sec.
                                   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 Sec.   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
                                   Sec.   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..............

[[Page 431]]


Polybutene, hydrogenated          For use only:
 (minimum viscosity at 99         1. In polymeric substances used in
 [deg]F, 39 Saybolt Universal      contact with non-fatty food.
 seconds, as determined by ASTM   2. In polyethylene complying with Sec.
 methods D445-82 (``Standard         177.1520 of this chapter and used
 Test Method for Kinematic         in contact with fatty food, provided
 Viscosity of Transparent and      that the hydrogenated polybutene is
 Opaque Liquids (and the           added in an amount not to exceed 0.5
 Calculation of Dynamic            pct by weight of the polyethylene,
 Viscosity)'') and D2161-82        and further provided that such
 (``Standard Method for            plasticized polyethylene shall not be
 Conversion of Kinematic           used as a component of articles
 Viscosity to Saybolt Universal    intended for packing or holding food
 Viscosity or to Saybolt Furol     during cooking.
 Viscosity''), and bromine        3. In polystyrene complying with Sec.
 number of 3 or less, as            177.1640 of this chapter and used in
 determined by ASTM method D1492-  contact with fatty food, provided
 78 (``Standard Test Method for    that the hydrogenated polybutene is
 Bromine Index of Aromatic         added in an amount not to exceed 5
 Hydrocarbons by Coulometric       pct by weight of the polystyrene, and
 Titration''), which are           further provided that such
 incorporated by reference.        plasticized polystyrene shall not be
 Copies may be obtained from the   used as a component of articles
 American Society for Testing      intended for packing or holding food
 Materials, 100 Barr Harbor Dr.,   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: http://
 www.archives.gov/federal--
 register/code--of--federal--
 regulations/ibr--
 locations.html..
Polyisobutylene (mol weight 300-  For use in polyethylene complying with
 5,000).                           Sec.   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
 Sec.   177.1420 of this chapter.
Polypropylene glycol (CAS         For use only in polystyrene plastics,
 registry No. 25322-69-4)          identified in Sec.   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 Sec.   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 Sec.
                                   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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3740


Home | About | Search