[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: 21CFR172.836]
[Page 89-90]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
CONSUMPTION--Table of Contents
Subpart I_Multipurpose Additives
Sec. 172.836 Polysorbate 60.
The food additive polysorbate 60 (polyoxyethylene (20) sorbitan
monostearate) which is a mixture of polyoxyethylene ethers of mixed
partial stearic and palmitic acid esters of sorbitol anhydrides and
related compounds, may be safely used in food in accordance with the
following prescribed conditions:
(a) The food additive is manufactured by reacting stearic acid
(usually containing associated fatty acids, chiefly palmitic) with
sorbitol to yield a product with a maximum acid number of 10 and a
maximum water content of 0.2 percent, which is then reacted with
ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 81-96.
Oxyethylene content 65 percent-69.5 percent.
(c) It is used or intended for use as follows:
(1) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 65;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping; except that a combination of the additive with sorbitan
monostearate may be used in excess of 0.4 percent, provided that the
amount of the additive does not exceed 0.77 percent and the amount of
sorbitan monostearate does not exceed 0.27 percent of the weight of the
finished whipped edible oil topping.
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
When used alone, the maximum amount of polysorbate 60 shall not exceed
0.46 percent of the cake or cake mix, on a dry-weight basis. When used
with polysorbate 65 and/or sorbitan monostearate, it shall not exceed
0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or the
sorbitan monostearate exceed 0.61 percent, and no combination of these
emulsifiers shall exceed 0.66 percent of the cake or cake mix, all
calculated on a dry-weight basis.
(3) As an emulsifier, alone or in combination with sorbitan
monostearate, in nonstandardized confectionery coatings and standardized
cacao products specified in Sec. Sec. 163.123, 163.130, 163.135,
163.140, 163.145, and 163.150 of this chapter, as follows:
(i) It is used alone in an amount not to exceed 0.5 percent of the
weight of the finished nonstandardized confectionery coating or
standardized cacao product.
(ii) It is used with sorbitan monostearate in any combination of up
to 0.5 percent of polysorbate 60 and up to 1 percent of sorbitan
monostearate: Provided, That the total combination does not exceed 1
percent of the weight of the finished nonstandardized confectionery
coating or standardized cacao product.
(4) [Reserved]
(5) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
When used alone, the maximum amount of polysorbate 60 shall not exceed
0.46 percent of the weight of the cake icings and cake fillings. When
used with polysorbate 65 and/or sorbitan monostearate, it shall not
exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or
the sorbitan monostearate exceed 0.7 percent, and no combination of
these emulsifiers shall exceed 1 percent of the weight of the cake icing
or cake filling.
(6) To impart greater opacity to sugar-type confection coatings
whereby the maximum amount of the additive does not exceed 0.2 percent
of the weight of the finished sugar coating.
[[Page 90]]
(7) As an emulsifier in nonstandardized dressings whereby the
maximum amount of the additive does not exceed 0.3 percent of the weight
of the finished dressings.
(8) As an emulsifier, alone or in combination with polysorbate 80,
in shortenings and edible oils intended for use in foods as follows,
when standards of identity established under section 401 of the act do
not preclude such use:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished shortening or oil.
(ii) It is used with polysorbate 80 in any combination providing no
more than 1 percent of polysorbate 60 and no more than 1 percent of
polysorbate 80, provided that the total combination does not exceed 1
percent of the finished shortening or oil.
(iii) The 1-percent limitation specified in paragraph (c)(8) (i) and
(ii) of this section may be exceeded in premix concentrates of
shortening or edible oil if the labeling complies with the requirements
of paragraph (d) of this section.
(9) As an emulsifier in solid-state, edible vegetable fat-water
emulsions intended for use as substitutes for milk or cream in beverage
coffee, with or without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(10) As a foaming agent in nonalcoholic mixes, to be added to
alcoholic beverages in the preparation of mixed alcoholic drinks, at a
level not to exceed 4.5 percent by weight of the nonalcoholic mix.
(11) As a dough conditioner in yeast-leavened bakery products in an
amount not to exceed 0.5 percent by weight of the flour used.
(12) As an emulsifier, alone or in combination with sorbitan
monostearate, in the minimum quantity required to accomplish the
intended effect, in formulations of white mineral oil conforming with
Sec. 172.878 and/or petroleum wax conforming with Sec. 172.886 for use
as protective coatings on raw fruits and vegetables.
(13) As a dispersing agent in artificially sweetened gelatin
desserts and in artificially sweetened gelatin dessert mixes, whereby
the amount of the additive does not exceed 0.5 percent on a dry-weight
basis.
(14) As an emulsifier in chocolate flavored syrups, whereby the
maximum amount of the additive does not exceed 0.05 percent in the
finished product.
(15) As a surfactant and wetting agent for natural and artificial
colors in food as follows:
(i) In powdered soft drink mixes in an amount not to exceed 4.5
percent by weight of the mix.
(ii) In sugar-based gelatin dessert mixes in an amount not to exceed
0.5 percent by weight of the mix.
(iii) In artificially sweetened gelatin dessert mixes in an amount
not to exceed 3.6 percent by weight of the mix.
(iv) In sugar-based pudding mixes in an amount not to exceed 0.5
percent by weight of the mix.
(v) In artificially sweetened pudding mixes in an amount not to
exceed 0.5 percent by weight of the mix.
(16) As an emulsifier in ice cream, frozen custard, fruit sherbet,
and nonstandardized frozen desserts when used alone or in combination
with polysorbate 65 and/or polysorbate 80, whereby the maximum amount of
the additives, alone or in combination, does not exceed 0.1 percent of
the finished frozen dessert.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide
a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 25, 1978; 45
FR 58836, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, Oct.
28, 1999]
Additives that reference this regulation: |
