Code of Federal Regulations Title 21. Food and Drugs § 21.172.842 Sorbitan monostearate

(1) As an emulsifier in whipped edible oil topping with or without one or a combination of the following:

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:

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 §§ 163.123, 163.130, 163.135, 163.140, 163.145, and 163.150 of this chapter, as follows:

(4) As an emulsifier in cake icings and cake fillings, with or without one or a combination of the following:

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:

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.

(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 § 172.878 and/or petroleum wax conforming with § 172.886 for use as protective coatings on raw fruits and vegetables.

(1) The label of the additive and any intermediate premixes shall bear:

(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.