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 phthalate........... For use only:
1. As provided in Secs. 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 Secs. 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.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..............
Polybutene, hydrogenated For use only:
(minimum viscosity at 99 F, 39 1. In polymeric substances used in
Saybolt Universal seconds, as contact with non-fatty food.
determined by ASTM methods D445- 2. In polyethylene complying with Sec.
82 (``Standard Test Method for 177.1520 of this chapter and used in
Kinematic Viscosity of contact with fatty food, provided
Transparent and Opaque Liquids that the hydrogenated polybutene is
(and the Calculation of Dynamic added in an amount not to exceed 0.5
Viscosity)'') and D2161-82 pct by weight of the polyethylene,
(``Standard Method for and further provided that such
Conversion of Kinematic plasticized polyethylene shall not be
Viscosity to Saybolt Universal used as a component of articles
Viscosity or to Saybolt Furol intended for packing or holding food
Viscosity''), and bromine during cooking.
number of 3 or less, as 3. In polystyrene complying with Sec.
determined by ASTM method D1492- 177.1640 of this chapter and used in
78 (``Standard Test Method for contact with fatty food, provided
Bromine Index of Aromatic that the hydrogenated polybutene is
Hydrocarbons by Coulometric added in an amount not to exceed 5
Titration''), which are pct by weight of the polystyrene, and
incorporated by reference. further provided that such
Copies may be obtained from the plasticized polystyrene shall not be
American Society for Testing used as a component of articles
Materials, 100 Barr Harbor Dr., intended for packing or holding food
West Conshohocken, during cooking.
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]