[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
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: