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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 2016.

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2016]
[CITE: 21CFR178.3400]



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. 178.3400 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 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 [alpha]-alkylaryl-omega-hydroxypoly(oxyethylene) mixture consisting of 30 weight pct of [alpha]-(2,4,6-triisobutylphenyl)-omega-hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 7 moles and 70 weight pct of a 1:1 weight ratio mixture of [alpha]-(Z)-9-octadecenyl-omega-hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 18 moles and [alpha]-alkyl(C16-C18)-omega-hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 18 molesFor use only at levels not to exceed 0.5 pct by weight of coatings complying with 175.320 of this chapter and limited to use as an emulsifier for polyhydric alcohol diesters used as provided in 178.3770(b). The weight of the finished coating shall not exceed 2 milligrams per square inch of food-contact surface.
n-Alkylbenzenesulfonic acid (alkyl group consisting of not less than 95 percent C10 to C16) and its ammonium, calcium, magnesium, potassium, and sodium saltsFor use only as emulsifiers and/or surface active agents as components of nonfood articles complying with 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 178.3120.
Alkyl mono- and disulfonic acids, sodium salts (produced from n-alkanes in the range of C10-C18 with not less than 50 percent C14-C16)For use only:
1. As provided in 176.170 of this chapter.
2. At levels not to exceed 2 percent by weight of polyvinyl chloride and/or vinyl chloride copolymers complying with 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 176.170(c) of this chapter, and limited to conditions of use E, F, and G described in table 2 of 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 177.1640(c) of this chapter under conditions of use B through H described in table 2 of 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 in the range of C10-C18 with not less than 50 percent C14-C16], ammonium, calcium, magnesium, potassium, and sodium saltsFor use only:
1. In acrylonitrile-butadiene copolymers identified in 177.2600(c)(4)(i) of this chapter.
2. At levels not to exceed 1 percent by weight of acrylic coatings complying with 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 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 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 176.170(c) of this chapter.
4. As provided in 175.105 of this chapter.
Alpha-sulfo-omega-(dodecyloxy)poly(oxyethylene) ammonium salt (CAS Reg. No. 32612-48-9)For use only as an emulsifier at levels not to exceed 0.3 percent by weight of styrene-butadiene copolymer coatings for paper and paperboard complying with 176.170 of this chapter.
Ammonium salt of epoxidized oleic acid, produced from epoxidized oleic acid (predominantly dihydroxystearic and acetoxyhydroxystearic acids) meeting the following specifications: Acid number 160-180, saponification number 210-235, iodine number 2-15, and epoxy groups 0-0.4 percentFor use only:
1. As a polymerization emulsifier at levels not to exceed 1.5 pct by weight of vinyl chloride polymers used as components of nonfood articles complying with 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 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 175.105, 175.300, 176.170, 176.180, and 177.1210 of this chapter.
Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-9]).For use as a surface active agent as provided in 175.105, 175.125, 176.170, and 176.180 of this 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 Reg. No. 37294-49-8)For use only as an emulsifier 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
[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 condensate, sodium salt (CAS Reg. No. 9084-06-4)For use only:
1. At levels not to exceed 10 micrograms/in 2 (0.16 mg/dm 2) in vinylidene chloride copolymer or homopolymer coatings applied to films of propylene polymers complying with 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 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 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 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 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 sulfosuccinate, disodium salt (CAS Reg. No. 68954-91-6)For use only at levels not to exceed 5 percent by weight of 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) poly(oxypropylene)(4-12 moles) propanol] of minimum molecular weight 3500For use in coatings at levels not to exceed 1 mg per square foot of food-contact surface.
Poly(oxypropylene) (45-48 moles) block polymer with poly(oxyethylene). The finished block polymers meet the following specifications: Average molecular weight 11,000-18,000; hydroxyl number 6.2-10.2; .cloud point above 100 deg. C. for 10 pct solutionFor use only as a surface-active agent at levels not to exceed 0.5 percent by weight of polyolefin film or polyolefin coatings. Such polyolefin film and polyolefin coatings shall have an average 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 172.836 of this chapter
Polysorbate 65 conforming to the identity prescribed in 172.838 of this chapter
Polysorbate 80 conforming to the identity prescribed in 172.840 of this chapter
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 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 polyethylene glycol dodecyl ether, disodium salt (CAS Reg. No. 39354-45-5)For use only at levels not to exceed 5 percent by weight of total monomers used in the emulsion polymerization of polyvinyl acetate, acrylic, and vinyl/acrylic polymers intended for use as coatings for paper and paperboard.
Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl ether, disodium salt (alcohol moiety produced by condensation of 1 mole nonylphenol and an average of 9-10 moles of ethylene oxide) (CAS Reg. No. 9040-38-4)For use only at levels not to exceed 5 percent by weight of the total coating monomers used in the emulsion polymerization of polyvinyl acetate and vinyl-acrylate 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-octadecyl-sulfosuccinateFor use only as a 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 175.105(c)(5) of this chapter and used in food-packaging adhesives complying with 175.105 of this chapter.

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