[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.115]

[Page 121-122]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION--Table of Contents
 
            Subpart B--Enzyme Preparations and Microorganisms
 
Sec. 173.115  Alpha-acetolactate decarboxylase (-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis.

    The food additive alpha-acetolactate decarboxylase (-ALDC) 
enzyme preparation, may be safely used in accordance with the following 
conditions:
    (a) The food additive is the enzyme preparation derived from a 
modified Bacillus subtilis strain that contains the gene coding for 
-ALDC from Bacillus brevis.
    (b)(1) The manufacturer produces the additive from a pure culture 
fermentation of a strain of Bacillus subtilis that is nonpathogenic and 
nontoxigenic in man or other animals.
    (2) The manufacturer may stabilize the enzyme preparation with 
glutaraldehyde or with other suitable approved food additives or 
generally recognized as safe substances.
    (3) The enzyme preparation must meet the general and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 4th 
ed., 1996,

[[Page 122]]

pp. 133-134, which is incorporated by reference. The Director of the 
Office of the Federal Register approves this incorporation by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be 
obtained from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20055, or may be examined at the Center for Food Safety 
and Applied Nutrition, 200 C St. SW., Washington, DC, or at the Office 
of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (c) The additive is used in an amount not in excess of the minimum 
required to produce its intended effect as a processing aid in the 
production of alcoholic malt beverages and distilled liquors.

[66 FR 27022, May 16, 2001]