21 C.F.R. § 178.3400 Emulsifiers and/or surface-active agents.
Title 21 - Food and Drugs
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: (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. [42 FR 14609, Mar. 15, 1977] Editorial Note: For
Title 21: Food and Drugs
PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
Subpart D—Certain Adjuvants and Production Aids
§ 178.3400 Emulsifiers and/or surface-active agents.
------------------------------------------------------------------------ List of substances Limitations------------------------------------------------------------------------α-Alkyl-, α-alkenyl-, and For use only at levels not to α-alkylaryl-omega- exceed 0.5 pct by weight of hydroxypoly(oxyethylene) mixture coatings complying with § consisting of 30 weight pct of α- 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 § weight ratio mixture of α-(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 α-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 §§ 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 § 178.3120.Alkyl mono- and disulfonic acids, For use only: sodium salts (produced from n-alkanes 1. As provided in § 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 § 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.α-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 calcium, magnesium, potassium, and § 177.2600(c)(4)(i) of sodium salts. 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- 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 § 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 groups 0-0.4 percent. §§ 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 For use as a surface active alkyl) ester, ammonium salt (also agent as provided in known as butanedioic acid, sulfo-1,4- §§ 175.105, 175.125, diisodecyl ester, ammonium salt [CAS 176.170, and 176.180 of this Reg. No. 144093-88-9]).. chapter.α-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.α-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.α-(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 § 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.α-(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.α-(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 [prime]-(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.α-(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 α-(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.α-(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.α-(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 ·cloud point above 100 °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 § 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 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.α-[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-sulfosuccinate. polymerization emulsifier for resins applied to tea-bag material.α-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.α-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.------------------------------------------------------------------------
