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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR184.1323]



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. 184.1323 Glyceryl monooleate.

(a) glyceryl monooleate is prepared by esterification of commerical oleic acid that is derived either from edible sources or from tall oil fatty acids meeting the requirements of 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) 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. 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 170.3(o)(12) of this chapter and as a solvent and vehicle as defined in 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 170.3(n)(1) of this chapter; nonalcoholic beverages and beverage bases as defined in 170.3(n)(3) of this chapter; chewing gum as defined in 170.3(n)(6) of this chapter; and meat products as defined in 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, as amended at 73 FR 8607, Feb. 14, 2008]

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