subchapter_subject: "FOOD FOR HUMAN CONSUMPTION (CONTINUED)"
part_code: "172"
part_subject: "FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION"
subpart_code: "I"
subpart_subject: "Multipurpose Additives"
section_number: "172.838"
section_subject: "Polysorbate 65."
cfr_reference: "21 CFR 172.838"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 170 to 199"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
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:
(a)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.
(b)The food additive meets the following specifications:
(c)The additive is used, or intended for use, as follows:
(1)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.
(2)As an emulsifier in cakes and cake mixes, with or without one or a combination of the following:
(4)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:
(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.