[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3130]
[Page 397-400]
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. 178.3130 Antistatic and/or anti fogging agents in food-packaging
materials.
The substances listed in paragraph (b) of this section may be safely
used as antistatic and/or antifogging agents in food-packaging
materials, subject to the provisions of this section:
(a) The quantity used shall not exceed the amount reasonably
required to accomplish the intended technical effect.
(b) List of substances:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
N-Acyl sarcosines where the acyl group For use only:
is lauroyl, oleoyl, or derived from 1. As antistatic and/or
the combined fatty acids of coconut antifogging agent at levels
oil. not to exceed a total of 0.15
pct by weight of polyolefin
film used for packaging meat,
fresh fruits, and fresh
vegetables. The average
thickness of such polyolefin
film shall not exceed 0.003
inch.
2. As antistatic and/or
antifogging agent at levels
not to exceed a total of 0.15
pct by weight of ethylene-
vinyl acetate copolymer film
complying with Sec. 177.1350
of this chapter and used for
packaging meat, fresh fruits,
fresh vegetables, and dry food
of Type VIII described in
table 1 of Sec. 176.170(c)
of this chapter. The average
thickness of such ethylene-
vinyl acetate copolymer film
shall not exceed 0.003 inch
when used for packaging meat,
fresh fruits, and fresh
vegetables.
[[Page 398]]
Alpha-(Carboxymethyl)-omega- For use only as an antistatic
(tetradecyloxy)polyoxyethylene). and/or antifogging agent at
levels not to exceed 0.2 pct
by weight in polyolefin film
not exceeding 0.001 inch
thickness.
Alkyl mono- and disulfonic acids, For use only:
sodium salts (produced from n-alkanes 1. As antistatic agents at
in the range of C10-C18 with not less levels not to exceed 0.1
than 50 percent C14-C16). percent by weight of
polyolefin films that comply
with Sec. 177.1520 of this
chapter: Provided, that the
finished olefin polymers
contact foods of Types I, II,
III, IV, V, VIA, VIB, VII,
VIII, and IX described in
table 1 of Sec. 176.170(c)
of this chapter, and under
conditions of use E, F, and G
described in table 2 of Sec.
176.170(c) of this chapter.
2. As antistatic agents at
levels not to exceed 3.0
percent by weight of
polystyrene or rubber-modified
polystyrene complying with
Sec. 177.1640(c) of this
chapter under conditions of
use B through H described in
table 2 of Sec. 176.170(c)
of this chapter.
Aluminum Borate For use only:
((9Al2O3)[middot]2(B2O3), CAS Reg. No. 1. At levels not to exceed 1
11121-16-7) produced by reaction percent by weight of
between aluminum oxide and/or aluminum polypropylene films complying
hydroxide with boric acid and/or with Sec. 177.1520(c) of
metaboric acid at temperatures in this chapter, item 1.1, of
excess of 1000 [deg]C. polyethylene films complying
with Sec. 177.1520(c) of
this chapter, items 2.1 and
2.2 and having a density
greater than 0.94 gram per
cubic centimeter, and of
polyolefin copolymer films
complying with Sec.
177.1520(c) of this chapter,
items 3.1(a), 3.1(b), 3.2(a),
and 3.2(b). The finished
polymers may be used in
contact with all food types
identified in Table 1 of Sec.
176.170(c) of this chapter,
under conditions of use A
through H as described in
Table 2 of Sec. 176.170(c)
of this chapter. The thickness
of the films shall not exceed
0.005 inch.
2. At levels not to exceed 2
percent by weight of
polypropylene films complying
with Sec. 177.1520(c) of
this chapter, item 1.1, of
polyethylene films complying
with Sec. 177.1520(c) of
this chapter, items 2.1 and
2.2 and having a density
greater than 0.94 gram per
cubic centimeter, and of
polyolefin copolymer films
complying with Sec.
177.1520(c) of this chapter,
items 3.1(a), 3.1(b), 3.2(a),
and 3.2(b). The finished
polymers may be used in
contact with all food types
identified in Table 1 of Sec.
176.170(c) of this chapter
under conditions of use B
through H as described in
Table 2 of Sec. 176.170(c)
of this chapter. The thickness
of the films shall not exceed
0.005 inch.
N,N-Bis(2-hydroxyethyl)alkyl(C12- For use only as an antistatic
C18)amine. agent at levels not to exceed
0.1 pct by weight of
polyolefin food-contact films.
N,N-bis(2-hydroxyethyl)alkyl (C13-C15) For use only:
amine (CAS Reg. No. 70955-14-5). 1. As an antistatic agent at
levels not to exceed 0.2
percent by weight in molded or
extruded high-density
polyethylene (having a density
=0.95 g/cm\3\ and
polypropylene containers that
contact food only of the types
identified in Sec.
176.170(c) of this chapter,
Table 1, under types I, VI-B,
VII-B, and VIII, under the
conditions of use E through G
described in Table 2 of Sec.
176.170(c) of this chapter,
provided such foods have a pH
above 5.0.
2. As an antistatic agent at
levels not to exceed 0.1
percent by weight in molded or
extruded polypropylene
homopolymers and copolymers
that contact food only of the
types identified in Sec.
176.170(c) of this chapter,
Table 1, under Types II, III,
IV, V, VII-A, and IX, under
the conditions of use C
through G described in Table 2
of Sec. 176.170(c) of this
chapter.
[[Page 399]]
N,N-Bis(2-hydroxyethyl) alkylamine, For use only:
where the alkyl groups (C1-C18) are 1. As an antistatic agent at
derived from tallow. levels not to exceed 0.15 pct
by weight in molded or
extruded polyethylene
containers that contact food
only of the types identified
in Sec. 176.170(c) of this
chapter, table 1, under Types
I, IV-B, VI-B, VII-B, and
VIII, under the conditions of
use E through G described in
table 2 of Sec. 176.170(c)
of this chapter provided such
foods have a pH above 5.0.
2. As an antistatic agent at
levels not to exceed 0.10 mg.
per square inch of food-
contact surface in vinylidene
chloride copolymer coatings
complying with Sec. 175.320,
Sec. 177.1200, or Sec.
177.1630 of this chapter,
provided that such coatings
contact food only of the types
identified in Sec.
176.170(c) of this chapter,
table 1, under Types I, IV,
VII, VIII, and IX under the
conditions of use E through G
described in table 2 of Sec.
176.170(c) of this chapter.
The finished copolymers shall
contain at least 70 weight pct
of polymer units derived from
vinylidene chloride; and shall
contain not more than 5 weight
pct of total polymer units
derived from acrylamide,
acrylic acid, fumaric acid,
itaconic acid, methacrylic
acid, octadecyl methacrylate,
and vinyl sulfonic acid.
N,N-Bis(2-hydroxyethyl)dodecanamide For use only:
produced when diethanolamine is made 1. As an antistatic agent at
to react with methyl laurate such that levels not to exceed 0.5
the finished product: Has a minimum percent by weight of molded or
melting point of 36 [deg]C; has a extruded polyethylene
minimum amide assay of 90 percent; containers intended for
contains no more than 2 percent by contact with honey, chocolate
weight of free diethanolamine; and syrup, liquid sweeteners,
contains no more than 0.5 percent by condiments, flavor extracts
weight of N,N, bis(2- and liquid flavor
hydroxyethyl)piperazine, as determined concentrates, grated cheese,
by paper chromatography method. light and heavy cream, yogurt,
and foods of Type VIII as
described in table 1 of Sec.
176.170(c) of this chapter.
2. As an antistatic agent at
levels not to exceed 0.2
percent by weight in
polypropylene films complying
with Sec. 177.1520 of this
chapter, and used in contact
with food of Types I, II, III,
IV, V, VI-B, VII, VIII, and IX
described in table 1 of Sec.
176.170(c) of this chapter,
and under conditions of use B
through H described in table 2
of Sec. 176.170(c) of this
chapter. The average thickness
of such polypropylene film
shall not exceed 0.001 inches
(30 micrometers).
N,N-Bis(2-hydroxyethyl) dodecanamide For use only as an antistatic
produced when diethanolamine is made agent at levels not to exceed
to react with methyl laurate such that 0.5 percent by weight of
the finished product: Has a minimum molded or extruded
melting point of 36 [deg]C; has a polyethylene containers
minimum amide assay of 90 percent; intended for contact with
contains no more than 2 percent by honey, chocolate syrup, liquid
weight of free diethanolamine; and sweeteners, condiments, flavor
contains no more than 0.5 percent by extracts and liquid flavor
weight of N,N'-bis(2-hydroxyethyl) concentrates, grated cheese,
piperazine, as determined by paper light and heavy cream, yogurt,
chromatography method. and foods of Type VIII as
described in table 1 of Sec.
176.170(c) of this chapter.
N,N-Bis(2-hydroxyethyl) octadecylamine, For use only as an antistatic
Chemical Abstracts Service Registry agent at levels not to exceed
No. 10213-78-2, N-(2-hydroxyethyl)-N- 0.45 percent by weight in
octadecylglycine (monosodium salt), polypropylene films complying
Chemical Abstracts Service Registry with Sec. 177.1520 of this
No. 66810-88-6, and N,N-Bis(2- chapter, and used for
hydroxyethyl)-N-(carboxymethyl) packaging food of Types I, II,
octadecanaminum hydroxide (inner III, IV, V, VI-B, VII, VIII,
salt), Chemical Abstracts Service and IX described in table 1 of
Registry No. 24170-14-7, as the major Sec. 176.170(c) of this
components of a mixture prepared by chapter, and under conditions
reacting ethylene oxide with of use B through H described
octadecylamine and further reacting in table 2 of Sec.
this product with sodium 176.170(c). The average
monochloroacetate and sodium thickness of such
hydroxide, such that the final product polypropylene film shall not
has: A nitrogen content of 3.3-3.8 exceed 0.002 inch.
percent; a melting point of 42[deg]-50
[deg]C; and a pH of 10.0-11.5 in a 1
percent by weight aqueous solution.
[alpha]-n-Dodecanol-omega-hydroxypoly For use only as an antistatic
(oxyethylene) produced by the agent at levels not to exceed
condensation of 1 mole of n-dodecanol 0.2 pct by weight in low-
with an average of 9.5 moles of density polyethylene film
ethylene oxide to form a condensate having an average thickness
having a hydroxyl content of 2.7 to not exceeding 0.005 inch.
2.9 pct and having a cloud point of 80
[deg]C to 92 [deg]C in 1 pct by weight
aqueous solution.
Glycerol ester mixtures of ricinoleic As an antifogging agent at
acid, containing not more than 50 levels not exceeding 1.5 pct
percent monoricinoleate, 45 pct by weight of permitted
diricinoleate, 10 pct triricinoleate, plasticized vinyl chloride
and 3.3 pct free glycerine. homo-and/or copolymers.
N-Methacryloyloxyethyl-N, N- For use only as an antistatic
dimethylammonium-[alpha]-N-methyl agent at levels not to exceed
carboxylate chloride sodium salt, 0.2 percent by weight of
octadecyl methacrylate, ethyl polyolefin films that contact
methacrylate, cyclohexyl methacrylate, foods under the conditions of
N-vinyl-2-pyrrolidone copolymer (CAS use B through H described in
Reg. No. 66822-60-4). table 2 of Sec. 176.170(c)
of this chapter. The average
thickness of such polyolefin
film shall not exceed 0.02
centimeter (0.008 inch).
[[Page 400]]
Octadecanoic acid 2-[2-hydroxy ethyl) For use only as an antistatic
octadecylamino]ethyl ester (CAS Reg. agent at levels such that the
No. 52497-24-2), (octadecylimino) product of film thickness in
diethyl ene distearate (CAS Reg. No. microns times the weight
94945-28-5), and octadecyl percent additive does not
bis(hydroxyethyl)amine (CAS Reg. No. exceed 16, in polypropylene
10213-78-2), as the major components films complying with Sec.
of a mixture prepared by reacting 177.1520(c)1.1 of this
ethylene oxide with octadecylamine and chapter, and used for
further reacting this product with packaging food (except for
octadecanoic acid, such that the final food containing more than 8
product has: a maximum acid value of 5 percent alcohol) under
mg KOH/g and total amine value of conditions of use B through H
866 mg KOH/g as described in table 2 of Sec.
determined by a method entitled 176.170(c) of this chapter.
``Total Amine Value,'' which is
incorporated by reference. Copies of
the method are available from the
Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or
available for inspection 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..
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[42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26, 1980;
45 FR 85727, Dec. 30, 1980; 46 FR 13688, Feb. 24, 1981; 47 FR 26824,
June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457, Aug. 21, 1991;
58 FR 57556, Oct. 26, 1993; 60 FR 54430, Oct. 24, 1995; 60 FR 18351,
Apr. 11, 1995; 62 FR 31511, June 10, 1997; 63 FR 38748, July 20, 1998;
64 FR 62585, Nov. 17, 1999]