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U.S. Department of Health and Human Services

Final Rules: Food Additives and Color Additives
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Petition(s): FAP 2A4345

Secondary Direct Food Additives Permitted in Food for Human Consumption; Alpha-Acetolactate Decarboxylase Enzyme Preparation

Petitioner: Novozymes North America, Inc.Bioindustrials, Inc.
(Formerly Novo Nordisk Bioindustrials, Inc.)
Docket number (legacy and/or former docket number(s)): (92F-0396)
Subject additive and intended use: amending the food additive regulations to provide for the safe use of alpha-acetolactate decarboxylase enzyme preparation from Bacillus subtilis modified by recombinant to contain gene coding for the enzyme from B. brevis used as an aid to produce alcoholic malt beverages and distilled liquors.
21 CFR* affected: 173.115; Alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis.
Substance(s)*, (CAS Registry® No.):
  • alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation
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    Federal Register publication history: Nov 30, 1992; 57 FR 56585; Notice
    May 16, 2001; 66 FR 27020; Final Rule; Effective date: May 16, 2001


     

    *Definitions

    • 21 CFR: Title 21 of the Code of Federal Regulations.
    • Substance: The name of the substance listed in the CFR.
    • CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
    • Petitions (see also Questions and Answers About the Petition Process)
      • FAP: Food Additive Petition
      • CAP: Color Additive Petition
      • GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 1998)
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