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184.1924 Urease enzyme preparation from Lactobacillus fermentum.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1924 Urease enzyme preparation from Lactobacillus fermentum.



[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: 21CFR184.1924]

[Page 574-575]
 
                        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.  184.1924  Urease enzyme preparation from Lactobacillus fermentum.

    (a) This enzyme preparation is derived from the nonpathogenic, 
nontoxicogenic bacterium Lactobacillus

[[Page 575]]

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 
(FDA).
    (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/
code--of--federal--regulations/ibr--locations.html.
    (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 
carbamate.

[57 FR 60473, Dec. 21, 1992]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1924


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