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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): GRP 3G0284

alpha-Amylase Enzyme Preparation; Affirmation of GRAS Status as Direct Human Food Ingredient

Petitioner: CPC International, Inc.
Docket number (legacy and/or former docket number(s)): (83G-0277)
Subject additive and intended use: affirming that α-amylase enzyme preparation derived from Bacillus stearothermophilus is generally recognized as safe (GRAS) for use in the processing of starch to make maltodextrins and nutritive carbohydrate sweeteners
21 CFR* affected: 184.1012; [alpha]-Amylase enzyme preparation from Bacillus stearothermophilus
Substance(s)*, (CAS Registry® No.):
  • alpha-amylase enzyme preparation from Bacillus stearothermophilus, (98002-53-0)
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  • α-amylase (alpha-amylase; 1,4-alpha-D-glucan glucanohydrolase), (9000-90-2)
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    Federal Register publication history: Sep 21, 1983; 48 FR 43096; Notice
    Dec 5, 1994; 59 FR 62366; Tentative Final Rule; Effective date: Dec 5, 1994
    Nov 3, 1995; 60 FR 55788; Final Rule; Effective date: Nov 3, 1995


     

    *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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