[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1324]
[Page 510]
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. 184.1324 Glyceryl monostearate.
(a) Glyceryl monostearate, also known as monostearin, is a mixture
of variable proportions of glyceryl monostearate
(C21H42O4, CAS Reg. No. 31566-31-1),
glyceryl monopalmitate (C19H38O4, CAS
Reg. No. 26657-96-5) and glyceryl esters of fatty acids present in
commercial stearic acid. Glyceryl monostearate is prepared by
glycerolysis of certain fats or oils that are derived from edible
sources or by esterification, with glycerin, of stearic acid that is
derived from edible sources.
(b) FDA is developing food-grade specifications for glyceryl
monostearate in cooperation with the National Academy of Sciences. In
the interim, this ingredient must be of a purity suitable for its
intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not not exist or have been waived.
[54 FR 7403 Feb. 21, 1989]