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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
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
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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