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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: 21CFR184.1923]



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. 184.1923 Urea.

(a) urea (CO(NH2)2, CAS Reg. No. 57-13-6) is the diamide of carbonic acid and is also known as carbamide. It is a white, odorless solid and is commonly produced from CO2 by ammonolysis or from cyanamide by hydrolysis.

(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 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 170.3(o)(14) of this chapter and as a fermentation aid.

(2) The ingredient is used in yeast-raised bakery products; in alcoholic beverages as defined in 170.3(n)(2) of this chapter; and in gelatin products.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[48 FR 51616, Nov. 10, 1983, as amended at 49 FR 19816, May 10, 1984; 73 FR 8608, Feb. 14, 2008]

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