[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: 21CFR184.1328]
[Page 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. 184.1328 Glyceryl behenate.
(a) Glyceryl behenate is a mixture of glyceryl esters of behenic
acid made from glycerin and behenic acid (a saturated C22
fatty acid). The mixture contains predominately glyceryl dibehenate.
(b) The ingredient meets the following specifications:
(1) 10 to 20 percent monoglyceride, 47 to 59 percent diglyceride, 26
to 38 percent triglyceride, and not more than 2.5 percent free fatty
acids.
(2) Behenic acid. Between 80 and 90 percent of the total fatty acid
content.
(3) Acid value. Not more than 4.
(4) Saponification value. Between 145 and 165.
(5) Iodine number. Not more than 3.
(6) Heavy metals (as Pb). Not more than 10 parts per million.
(c) In accordance with Sec. 184.1(b)(1) of this chapter, the
ingredient is used in food with no limitation other than current good
manufacturing practice. The affirmation of this ingredient is 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.
[52 FR 42430, Nov. 5, 1987]
Additives that reference this regulation: |
