21 CFR §184.1923

1. (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.
2. (b)The ingredient must be of a purity suitable for its intended use.
3. (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. (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. (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.
4. (d)Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.