CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 3]

[CITE: 21CFR184.1324]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

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) The ingredient must be of a purity suitable for its intended use.

(c) In accordance with § 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, as amended at 73 FR 8607, Feb. 14, 2008]