[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. 184.1924 Urease enzyme preparation from Lactobacillus fermentum.
(a) This enzyme preparation is derived from the nonpathogenic,
nontoxicogenic bacterium Lactobacillus
fermentum. It contains the enzyme urease (CAS Reg. No. 9002-13-5), which
facilitates the hydrolysis of urea to ammonia and carbon dioxide. It is
produced by a pure culture fermentation process and by using materials
that are generally recognized as safe (GRAS) or are food additives that
have been approved for this use by the Food and Drug Administration
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the ``Food Chemicals Codex,'' 3d ed. (1981), pp.
107-110, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the National Academy
Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available
for inspection at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: http://www.archives.gov/federal--register/
(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 GRAS as a direct human food
ingredient is based upon the following current good manufacturing
practice conditions of use:
(1) The ingredient is used in wine, as defined in 27 CFR 2.5 and
4.10, as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to
convert urea to ammonia and carbon dioxide.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Current good manufacturing practice is
limited to use of this ingredient in wine to inhibit formation of ethyl
[57 FR 60473, Dec. 21, 1992]
Additives that reference this regulation: