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184.1923 Urea.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1923 Urea.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1923]

[Page 574]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        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) FDA is developing food-grade specifications for urea 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 Sec.  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 Sec.  
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 Sec.  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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1923


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