The food additive polysorbate 65 (polyoxyethylene (20) sorbitan tristearate), which is a mixture of polyoxyethylene ethers of mixed stearic acid esters of sorbitol anhydrides and related compounds, may be safely used in 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 a product with a maximum acid number of 15 and a maximum water content of 0.2 percent, which is then reacted with ethylene oxide.

The food additive meets the following specifications:

The additive is used, or intended for use, as follows:

As an emulsifier in ice cream, frozen custard, ice milk, fruit sherbet and nonstandardized frozen desserts when used alone or in combination with polysorbate 80, whereby the maximum amount of the additives, alone or in combination, does not exceed 0.1 percent of the finished frozen dessert.

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

Sorbitan monostearate.

Polysorbate 60.

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

Sorbitan monostearate;

Polysorbate 60;

Polysorbate 80;

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:

Sorbitan monostearate.

Polysorbate 60.

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

Sorbitan monostearate.

Polysorbate 60.

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.