[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: |
