[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.115]
[Page 130]
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
Subpart B Enzyme Preparations and Microorganisms
Sec. 173.115 Alpha-acetolactate decarboxylase ([alpha]-ALDC) enzyme
preparation derived from a recombinant Bacillus subtilis.
The food additive alpha-acetolactate decarboxylase ([alpha]-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
[alpha]-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, 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, 5100 Paint Branch Pkwy., College Park, MD
20740, or 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) 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]
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