[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: 21CFR178.3400]
[Page 407-410]
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. 178.3400 Emulsifiers and/or surface-active agents.
The substances listed in paragraph (c) of this section may be safely
used as emulsifiers and/or surface-active agents in the manufacture of
articles or components of articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, subject to the provisions of this
section.
(a) The quantity used shall not exceed the amount reasonably
required to accomplish the intended technical effect; and the quantity
that may become a component of food as a result of such use shall not be
intended to, nor in fact, accomplish any physical or technical effect in
the food itself.
(b) The use as an emulsifier and/or surface-active agent in any
substance or article that is the subject of a regulation in parts 174,
175, 176, 177, 178 and Sec. 179.45 of this chapter conforms with any
specifications and limitations prescribed by such regulation for the
finished form of the substance or article.
(c) List of substances:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
[alpha]-Alkyl-, [alpha]-alkenyl-, and For use only at levels not to
[alpha]-alkylaryl-omega- exceed 0.5 pct by weight of
hydroxypoly(oxyethylene) mixture coatings complying with Sec.
consisting of 30 weight pct of [alpha]- 175.320 of this chapter and
(2,4,6-triisobutylphenyl)-omega- limited to use as an
hydroxypoly(oxyethylene) having an emulsifier for polyhydric
average poly(oxyethylene) content of 7 alcohol diesters used as
moles and 70 weight pct of a 1:1 provided in Sec.
weight ratio mixture of [alpha]-(Z)-9- 178.3770(b). The weight of the
octadecenyl-omega- finished coating shall not
hydroxypoly(oxyethylene) having an exceed 2 milligrams per square
average poly(oxyethylene) content of inch of food-contact surface.
18 moles and [alpha]-alkyl(C16-C18)-
omega-hydroxypoly(oxyethylene) having
an average poly(oxyethylene) content
of 18 moles.
n-Alkylbenzenesulfonic acid (alkyl For use only as emulsifiers and/
group consisting of not less than 95 or surface active agents as
percent C10 to C16) and its ammonium, components of nonfood articles
calcium, magnesium, potassium, and complying with Sec. Sec.
sodium salts. 175.300, 175.320, 175.365,
175.380, 176.170, 176.180,
177.1010, 177.1200, 177.1210,
177.1630, 177.2600, and
177.2800 of this chapter and
Sec. 178.3120.
[[Page 408]]
Alkyl mono- and disulfonic acids, For use only:
sodium salts (produced from n-alkanes 1. As provided in Sec.
in the range of C10-C18 with not less 176.170 of this chapter.
than 50 percent C14-C16). 2. At levels not to exceed 2
percent by weight of polyvinyl
chloride and/or vinyl chloride
copolymers complying with Sec.
177.1980 of this chapter.
3. As emulsifiers in vinylidene
chloride copolymer or
homopolymer coatings at levels
not to exceed a total of 2.6
percent by weight of coating
solids. The finished polymer
contacts food only of the
Types I, II, III, IV, V, VIA,
VIB, VII, VIII, and IX as
identified in table 1 of Sec.
176.170(c) of this chapter,
and limited to conditions of
use E, F, and G described in
table 2 of Sec. 176.170 of
this chapter.
4. As emulsifiers and/or
surface-active 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.
[alpha]-Alkyl-omega-
hydroxypoly(oxyethylene) produced by
condensation of 1 mole of C11-C15
straight-chain randomly substitued
secondary alcohols with an average of
7-20 moles of ethylene oxide.
alpha Olefin sulfonate [alkyl group is For use only:
in the range of C10-C18 with not less 1. In acrylonitrile-butadiene
than 50 percent C14-C16], ammonium, copolymers identified in Sec.
calcium, magnesium, potassium, and 177.2600(c)(4)(i) of this
sodium salts. chapter.
2. At levels not to exceed 1
percent by weight of acrylic
coatings complying with Sec.
175.300(b)(3)(xx) of this
chapter and having a maximum
thickness of 0.051 millimeter
(0.002 inch). The finished
polymers contact food only of
the Types V, VIII, and IX as
identified in table 1 of Sec.
176.170(c) of this chapter.
3. At levels not to exceed 2
percent by weight of vinyl
chloride copolymer coatings
having a maximum thickness of
0.051 millimeter (0.002 inch)
and complying with Sec.
175.300(b)(3)(xv) of this
chapter. The finished polymers
contact food only of the Types
V, VIII, and IX as identified
in table 1 of Sec.
176.170(c) of this chapter.
4. As provided in Sec.
175.105 of this chapter.
Alpha-sulfo-omega- For use only as an emulsifier
(dodecyloxy)poly(oxyethylene) ammonium at levels not to exceed 0.3
salt (CAS Reg. No. 32612-48-9). percent by weight of styrene-
butadiene copolymer coatings
for paper and paperboard
complying with Sec. 176.170
of this chapter.
Ammonium salt of epoxidized oleic acid, For use only:
produced from epoxidized oleic acid 1. As a polymerization
(predominantly dihydroxystearic and emulsifier at levels not to
acetoxyhydroxystearic acids) meeting exceed 1.5 pct by weight of
the following specifications: Acid vinyl chloride polymers used
number 160-180, saponification number as components of nonfood
210-235, iodine number 2-15, and epoxy articles complying with Sec.
groups 0-0.4 percent. Sec. 175.105, 175.300,
176.170, 176.180, and 177.1210
of this chapter. Such vinyl
chloride polymers are limited
to polyvinyl chloride and/or
vinyl chloride copolymers
complying with Sec. 177.1980
of this chapter.
2. As a polymerization
emulsifier at levels not to
exceed 1.5 pct by weight of
vinyl chloride-vinyl acetate
copolymers used as components
of nonfood articles complying
with Sec. Sec. 175.105,
175.300, 176.170, 176.180, and
177.1210 of this chapter.
Butanedioic acid, sulfo-1,4-di-(C9-C11 For use as a surface active
alkyl) ester, ammonium salt (also agent as provided in Sec.
known as butanedioic acid, sulfo-1,4- Sec. 175.105, 175.125,
diisodecyl ester, ammonium salt [CAS 176.170, and 176.180 of this
Reg. No. 144093-88-9]).. chapter.
[alpha]-Di-sec-butylphenyl-omega-
hydroxypoly(oxyethylene) produced by
the condensation of 1 mole of di-sec-
butylphenol with an average of 4-14 or
30-50 moles of ethylene oxide; if a
blend of products is used, the average
number of moles of ethylene oxide
reacted to produce any product that is
a component of the blend shall be in
the range 4-14 or 30-50; sec-butyl
groups are predominantly (90 percent
or more) o-, p-substituents.
Disodium 4-isodecyl sulfosuccinate (CAS For use only as an emulsifier
Reg. No. 37294-49-8). at levels not to exceed 5
percent by weight of polymers
intended for use in coatings.
[alpha]-Dodecyl-omega-hydroxpoly
(oxyethylene) mixture of dihydrogen
phosphate and monohydrogen phosphate
esters that have an acid number (to pH
5.2) of 103-111 and that are produced
by the esterification of the
condensation product of 1 mole of n-
dodecyl alcohol with 4-4.5 moles of
ethylene oxide.
[[Page 409]]
[alpha]-(p-Dodecylphenyl)-omega-
hydroxypoly (oxyethylene) produced by
the condensation of 1 mole of
dodecylphenol (dodecyl group is a
propylene tetramer isomer) with an
average of 4-14 or 30-50 moles of
ethylene oxide; if a blend of products
is used, the average number of moles
of ethylene oxide reacted to produce
any product that is a component of the
blend shall be in the range 4-14 or 30-
50.
Naphthalene sulfonic acid-formaldehyde For use only:
condensate, sodium salt (CAS Reg. No. 1. At levels not to exceed 10
9084-06-4). micrograms/in\2\ (0.16 mg/
dm\2\) in vinylidene chloride
copolymer or homopolymer
coatings applied to films of
propylene polymers complying
with Sec. 177.1520 of this
chapter.
2. At levels not to exceed 14
micrograms/in\2\ (0.21 mg/
dm\2\) in vinylidene chloride
copolymer or homopolymer
coatings applied to films of
polyethylene phthalate
polymers complying with Sec.
177.1630 of this chapter.
[alpha]-(p-nonylphenyl)-omega-
hydroxypoly (oxyethylene) mixture of
dihydrogen phosphate and monohydrogen
phosphate esters that have an acid
number (to pH 5.2) of 49-59 and that
are produced by the esterification of
a-(p-nonylphenyl)-omega-hydroxypoly
(oxyethylene) complying with the
identity prescribed in Sec.
178.3400(c) and having an average
poly(oxyethylene) content of 5.5-6.5
moles.
[alpha]-(p-Nonylphenyl)-omega-
hydroxypoly (oxyethylene) mixture of
dihydrogen phosphate and monohydrogen
phosphate esters that have an acid
number (to pH 5.2) of 62-72 and that
are produced by the esterification of
'-(p-nonylphenyl)omega-hydroxypoly
(oxyethylene) complying with the
identity prescribed in Sec.
178.3400(c) and having an average
poly(oxyethylene) content of 9-10
moles.
[alpha]-(p-Nonylphenyl)-omega-
hydroxypoly (oxyethylene) mixture of
dihydrogen phosphate and monohydrogen
phosphate esters that have an acid
number (to pH 5.2) of 98-110 and that
are produced by the esterification of
[alpha]-(p-nonylphenyl)-omega-
hydroxypoly (oxyethylene) complying
with the identity prescribed in Sec.
178.3400(c) and having an average
poly(oxyethylene) content of 45-55
moles.
[alpha]-(p-Nonylphenyl)-omega-
hydroxypoly (oxyethylene) produced by
the condensation of 1 mole of
nonylphenol (nonyl group is a
propylene trimer isomer) with an
average of 4-14 or 30-50 moles of
ethylene oxide: if a blend of products
is used, the average number of moles
of ethylene oxide reacted to produce
any product that is a component of the
blend shall be in the range 4-14 or 30-
50.
[alpha]-(p-Nonylphenyl)-omega-
hydroxypoly (oxyethylene) sulfate,
ammonium or sodium salt: the nonyl
group is a propylene trimer isomer and
the poly (oxyethylene) content average
4 moles.
Polyethyleneglycol alkyl(C10-C12) ether For use only at levels not to
sulfosuccinate, disodium salt (CAS exceed 5 percent by weight of
Reg. No. 68954-91-6). total monomers used in the
emulsion polymerization of
polyvinyl acetate, acrylic,
and vinyl/acrylic polymers
intended for use as coatings
for paper and paperboard.
Poly[(methylene-p-nonylphenoxy) For use in coatings at levels
poly(oxypropylene)(4-12 moles) not to exceed 1 mg per square
propanol] of minimum molecular weight foot of food-contact surface.
3500.
Poly(oxypropylene) (45-48 moles) block For use only as a surface-
polymer with poly(oxyethylene). The active agent at levels not to
finished block polymers meet the exceed 0.5 percent by weight
following specifications: Average of polyolefin film or
molecular weight 11,000-18,000; polyolefin coatings. Such
hydroxyl number 6.2-10.2; polyolefin film and polyolefin
[middot]cloud point above 100 [deg]C. coatings shall have an average
for 10 pct solution. thickness not to exceed 0.005
inch and shall be limited to
use in contact with foods that
have a pH above 5.0 and that
contain no more than 8 pct of
alcohol.
Polysorbate 20 (polyoxyethylene (20)
sorbitan monolaurate) meeting the
following specifications:
Saponification number 40-50, acid
number 0-2, hydroxyl number 60-108,
oxyethylene content 70-74 pct.
Polysorbate 40 (polyoxyethylene (20)
sorbitan monopalmitate) meeting the
following specifications:
Saponification number 41-52,
oxyethylene content 66-70.5 pct.
Polysorbate 60 conforming to the
identity prescribed in Sec. 172.836
of this chapter.
Polysorbate 65 conforming to the
identity prescribed in Sec. 172.838
of this chapter.
Polysorbate 80 conforming to the
identity prescribed in Sec. 172.840
of this chapter.
[[Page 410]]
Polysorbate 85 (polyoxyethylene (20)
sorbitan trioleate) meeting the
following specifications:
Saponification number 80-95,
oxyethylene content 46-50 percent.
Sodium 1,4-dicylcohexyl sulfosuccinate.
Sodium 1,4-dihexyl sulfosuccinate......
Sodium 1,4 diisobutyl sulfosuccinate...
Sodium dioctyl sulfosuccinate..........
Sodium 1,4-dipentyl sulfosuccinate.....
Sodium 1,4-ditridecyl sulfosuccinate...
Sodium lauryl sulfate..................
Sodium
monoalkylphenoxybenzenedisulfonate and
sodium
dialkylphenoxybenzenedisulfonate
mixtures containing not less than 70
pct of the monoalkylated product where
the alkyl group is C8C16.
Sorbitan monolaurate meeting the
following specifications.
Saponification number 153-170; and
hydroxyl number 330-360.
Sorbitan monooleate meeting the
following specifications:
Saponification number 145-160,
hydroxyl number 193-210.
Sorbitan monopalmitate meeting the
following specifications:
Saponification No. 140-150; and
hydroxyl No. 275-305.
Sorbitan monostearate conforming to the
identity prescribed in Sec. 172.842
of this chapter.
Sorbitan trioleate meeting the
following specifications:
Saponification No. 170-190; and
hydroxyl No. 55-70.
Sorbitan tristearate meeting the
following specifications:
Saponification No. 176-188; and
hydroxyl No. 66-80.
Sulfosuccinic acid 4-ester with For use only at levels not to
polyethylene glycol dodecyl ether, exceed 5 percent by weight of
disodium salt (CAS Reg. No. 39354-45- total monomers used in the
5). emulsion polymerization of
polyvinyl acetate, acrylic,
and vinyl/acrylic polymers
intended for use as coatings
for paper and paperboard.
Sulfosuccinic acid 4-ester with For use only at levels not to
polyethylene glycol nonylphenyl ether, exceed 5 percent by weight of
disodium salt (alcohol moiety produced the total coating monomers
by condensation of 1 mole nonylphenol used in the emulsion
and an average of 9-10 moles of polymerization of polyvinyl
ethylene oxide) (CAS Reg. No. 9040-38- acetate and vinyl-acrylate
4). copolymers intended for use as
coatings for paper and
paperboard.
[alpha]-[p-(1,1,3,3-
Tetramethylbutyl)phenyl] omega-
hydroxypoly(oxyethylene) produced by
the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with
an average of 4-14 or 30-40 moles of
ethylene oxide; if a blend of products
is used, the average number of moles
of ethylene oxide reacted to produce
any product that is a component of the
blend shall be in the range 4-14 or 30-
50.
Tetrasodium N-(1,2-dicarboxyethyl)-N- For use only as a
octadecyl-sulfosuccin ate. polymerization emulsifier for
resins applied to tea-bag
material.
[alpha]-Tridecyl-omega-hydroxypoly
(oxyethylene) mixture of dihydrogen
phosphate and monohydrogen phosphate
esters that have an acid number (to pH
5.2) of 75-85 and that are produced by
the esterification of the condensation
product of one mole of ``oxo'' process
tridecyl alcohol with 5.5-6.5 moles of
ethylene oxide.
[alpha]-Tridecyl-omega-hydroxypoly
(oxyethyl-ene) mixture of dihydrogen
phosphate and monohydrogen phosphate
esters that have an acid number (to pH
5.2) of 58-70 and that are produced by
the esterification of the condensation
product of one mole of ``oxo'' process
tridecyl alcohol with 9-10 moles of
ethylene oxide.
------------------------------------------------------------------------
(d) The provisions of this section are not applicable to emulsifiers
and/or surface-active agents listed in Sec. 175.105(c)(5) of this
chapter and used in food-packaging adhesives complying with Sec.
175.105 of this chapter.
[42 FR 14609, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting Sec.
178.3400, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
Additives that reference this regulation: |
