[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. 184.1329 Glyceryl palmitostearate.
(a) Glyceryl palmitostearate is a mixture of mono-, di-, and
esters of palmitic and stearic acids made from glycerin, palmitic acid,
and stearic acid.
(b) The ingredient meets the following specifications:
(1) The substance is a mixture of mono-, di-, and triglycerides of
palmitic acid and stearic acid.
(2) Heavy metals (as lead): Not more than 10 parts per million.
(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 formulation aid, as defined in Sec.
170.3(o)(14) of this chapter.
(2) The ingredient is used in excipient formulations for use in
tablets at levels not to exceed good manufacturing practice.
[60 FR 63621, Dec. 12, 1995]
Additives that reference this regulation: