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178.3400 Emulsifiers and/or surface-active agents.

Home > Regulations > Indirect food additives: Adjuvants, production aids, and sanitizers > 178.3400 Emulsifiers and/or surface-active agents.



[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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3400


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