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172.836 Polysorbate 60.

Home > Regulations > Food additives permitted for direct addition to food for human consumption > 172.836 Polysorbate 60.



[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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 172, Section 836


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