[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1903]
[Page 573]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
SAFE--Table of Contents
Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec. 184.1903 Tributyrin.
(a) Tributyrin (C15H26O6, 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 Sec. 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 generaly recognized as safe (GRAS)
as a direct human food ingredient is based upon the following current
good manufacturing practice conditions of use:
(1) The ingredient is used in food as a flavoring agent and adjuvant
as defined in Sec. 170.3(o)(12) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice; baked goods as defined in
Sec. 170.3(n)(1) of this chapter; alcoholic beverages as defined in
Sec. 170.3(n)(2) of this chapter; nonalcoholic beverages as defined in
Sec. 170.3(n)(3) of this chapter; fats and oils as defined in Sec.
170.3(n)(12) of this chapter; frozen dairy desserts and mixes as defined
in Sec. 170.3(n)(20) of this chapter; gelatins, puddings and fillngs as
defined in Sec. 170.3(n)(22) of this chapter; and soft candy as defined
in Sec. 170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, 1989]
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