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:

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.

The food additive meets the following specifications:

It is used or intended for use, alone or in combination with polysorbate 60 as follows:

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

Polysorbate 60;

Polysorbate 65;

Polysorbate 80;

As an emulsifier in cakes and cake mixes, with or without one or a combination of the following:

Polysorbate 65.

Polysorbate 60.

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:

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.

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.

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

Polysorbate 65.

Polysorbate 60.

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:

Polysorbate 60.

Polysorbate 65.

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.

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.

To assure safe use of the additive, in addition to the other information required by the Act:

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

The name of the additive.

A statement of the concentration or strength of the additive in any intermediate premixes.

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.