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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 3G0016

Carbohydrase and Protease Enzyme Preparations Derived From Bacillus Subtilis or Bacillus Amyloliquefaciens; Affirmation of GRAS Status as Direct Food Ingredients

Petitioner: Ad Hoc Enzyme Technical Committee (now the Enzyme Technical Association)
Docket number (legacy and/or former docket number(s)): (84G-0257)
Subject additive and intended use: affirming that carbohydrase enzyme preparations derived from either Bacillus subtilis or B. amyloliquefaciens and protease enzyme preparations derived from either B. subtilis or B. amyloliquefaciens are generally recognized as safe (GRAS) for use as direct food ingredients
21 CFR* affected: 184.1148; Bacterially-derived carbohydrase enzyme preparation
184.1150; Bacterially-derived protease enzyme preparation
Substance(s)*, (CAS Registry® No.):
  • alpha-amylase, (9000-90-2)
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  • endo-1,3(4)-beta-glucanase, (62213-14-3)
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  • carbohydrase, Bacillus Amyloliquefaciens
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  • carbohydrase, Bacillus Subtilis
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  • protease, Bacillus Amyloliquefaciens
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  • protease, Bacillus Subtilis, (51931-23-8)
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  • neutral proteinase
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  • subtilisin, (9014-01-1)
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    Federal Register publication history: Apr 12, 1973; 38 FR 9256; Notice
    Jun 12, 1973; 38 FR 15471; Notice
    Aug 29, 1984; 49 FR 34305; Notice (amended notice of filing)
    Jun 23, 1987; 52 FR 23607; Notice (amended notice of filing)
    Sep 20, 1993; 58 FR 48889; Notice (withdrawal)
    Aug 5, 1996; 61 FR 40648; Notice (amended notice of filing)
    Apr 23, 1999; 64 FR 19887; Final rule; Effective date: Apr 23, 1999


     

    *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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