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184.1903 Tributyrin.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1903 Tributyrin.



[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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1903


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