[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
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
(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/
(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
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: