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172.842 Sorbitan monostearate.

Home > Regulations > Food additives permitted for direct addition to food for human consumption > 172.842 Sorbitan monostearate.



[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: 21CFR172.842]

[Page 94-95]
 
                        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.  172.842  Sorbitan monostearate.

    The food additive sorbitan monostearate, which is a mixture of 
partial stearic and palmitic acid esters of sorbitol anhydrides, may be 
safely used in or on 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 essentially a mixture of esters.
    (b) The food additive meets the following specifications:

Saponification number, 147-157
Acid number, 5-10
Hydroxyl number, 235-260

    (c) It is used or intended for use, alone or in combination with 
polysorbate 60 as follows:
    (1) As an emulsifier in whipped edible oil topping with or without 
one or a combination of the following:
    (i) Polysorbate 60;
    (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 polysorbate 60 
may be used in excess of 0.4 percent: Provided, That the amount of the 
additive does not exceed 0.27 percent and the amount of polysorbate 60 
does not exceed 0.77 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) Polysorbate 60.


When used alone, the maximum amount of sorbitan monostearate shall not 
exceed 0.61 percent of the cake or cake mix, on a dry-weight basis. When 
used with polysorbate 65 and/or polysorbate 60, it shall not exceed 0.61 
percent, nor shall the polysorbate 65 exceed 0.32 percent or the 
polysorbate 60 exceed 0.46 percent, and no combination of the 
emulsifiers shall exceed 0.66 percent of the weight of the cake or cake 
mix, calculated on a dry-weight basis.
    (3) As an emulsifier, alone or in combination with polysorbate 60 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 1 percent of the 
weight of the finished nonstandardized confectionery coating or 
standardized cacao product.
    (ii) It is used with polysorbate 60 in any combination of up to 1 
percent sorbitan monostearate and up to 0.5 percent polysorbate 60 
provided that the total combination does not exceed 1 percent of the 
weight of the finished nonstandardized confectionery coating or 
standardized cacao product.
    (4) As an emulsifier in cake icings and cake fillings, with or 
without one or a combination of the following:
    (i) Polysorbate 65.
    (ii) Polysorbate 60.


When used alone, the maximum amount of sorbitan monostearate shall not 
exceed 0.7 percent of the weight of the cake icing or cake filling. When 
used with polysorbate 65 and/or polysorbate 60, it shall not exceed 0.7 
percent, nor shall the polysorbate 65 exceed 0.32 percent or the 
polysorbate 60 exceed 0.46 percent, and no combination of these 
emulsifiers shall exceed 1 percent of the weight of the cake icing or 
cake filling.
    (5) 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 60.
    (ii) Polysorbate 65.


The maximum amount of the additive or additives shall not exceed 0.4 
percent by weight of the finished edible vegetable fat-water emulsion.
    (6) It is used alone as a rehydration aid in the production of 
active dry yeast in an amount not to exceed 1 percent by weight of the 
dry yeast.

[[Page 95]]

    (7) As an emulsifier, alone or in combination with polysorbate 60, 
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.
    (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. 20, 1978]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 172, Section 842


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