Code of Federal Regulations Title 21. Food and Drugs § 21.184.1903 Tributyrin

(a) Tributyrin (C₁₅H₂₆O_6, CAS Reg. No. 60–01–5), also known as butyrin or glyceryl tributyrate, is the triester of glycerin and butyric acid. It is prepared by esterification of glycerin with excess butyric acid.

(b) The ingredient meets the specification of the Food Chemicals Codex, 3d Ed. (1981), p. 416, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:  http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.