TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION

PART 173 - SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

subpart b - ENZYME PREPARATIONS AND MICROORGANISMS

173.115 - Alpha - acetolactate decarboxylase (α - 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, pp. 133134, 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 2027416030, 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]