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:
Saponification number, 147-157
Acid number, 5-10
Hydroxyl number, 235-260
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.
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.
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.
The maximum amount of the additive or additives shall not exceed 0.4 percent by weight of the finished edible vegetable fat-water emulsion.
21 C.F.R. §172.842