21 C.F.R. § 184.1324   Glyceryl monostearate.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
Subpart B—Listing of Specific Substances Affirmed as GRAS

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§ 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 §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]

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