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184.1505 Mono- and diglycerides.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1505 Mono- and diglycerides.



[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: 21CFR184.1505]

[Page 544-545]
 
                        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.  184.1505  Mono- and diglycerides.

    (a) Mono- and diglycerides consist of a mixture of glyceryl mono- 
and diesters, and minor amounts of triesters, that are prepared from 
fats or oils or fat-forming acids that are derived from edible sources. 
The most prevalent fatty acids include lauric, linoleic, myristic, 
oleic, palmitic, and stearic. Mono- and diglycerides are manufactured by 
the reaction of glycerin with fatty acids or the reaction of glycerin 
with triglycerides in the presence of an alkaline catalyst. The products 
are further purified to obtain a mixture of glycerides, free fatty 
acids, and free glycerin that contains at least 90 percent-by-weight 
glycerides.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 201, 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 generally 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 dough strengthener as 
defined in Sec.  170.3(o)(6) of this chapter; an emulsifier and 
emulsifier salt as defined in Sec.  170.3(o)(8) of this chapter; a 
flavoring agent and adjuvant as defined in Sec.  170.3(o)(12) of this 
chapter; a formulation aid as defined in Sec.  170.3(o)(14) of this 
chapter; a lubricant and release agent as defined in Sec.  170.3(o)(18) 
of this chapter; a solvent and vehicle as defined in Sec.  170.3(o)(27) 
of this chapter; a stabilizer and thickener as defined in Sec.  
170.3(o)(28) of this chapter; a surface-active agent as defined in 
Sec. 170.3(o)(29) of this chapter; a surface-finishing

[[Page 545]]

agent as defined in Sec.  170.3(o)(30) of this chapter; and a texturizer 
as defined in Sec.  170.3(o)(32) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[54 FR 7403, Feb. 21, 1989, as amended at 57 FR 10616, Mar.27, 1992]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1505


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