[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: 21CFR184.1323]
[Page 522-523]
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. 184.1323 Glyceryl monooleate.
(a) Glyceryl monooleate is prepared by esterification of commerical
oleic acid that is derived either from edible
[[Page 523]]
sources or from tall oil fatty acids meeting the requirements of Sec.
172.862 of this chapter. It contains glyceryl monooleate
(C21H40O4, CAS Reg. No. 25496-72-4) and
glyceryl esters of fatty acids present in commercial oleic acid.
(b) FDA is developing food-grade specifications for glyceryl
monooleate 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.
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 as a flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter and as a solvent and
vehicle as defined in Sec. 170.3(o)(27) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods and baking mixes
as defined in Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages
and beverage bases as defined in Sec. 170.3(n)(3) of this chapter;
chewing gum as defined in Sec. 170.3(n)(6) of this chapter; and meat
products as defined in Sec. 170.3(n)(29) of this chapter.
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
[54 FR 7403 Feb. 21, 1989]
Additives that reference this regulation: |
