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) ; endo-1,3(4)-beta-glucanase, (62213-14-3) ; carbohydrase, Bacillus Amyloliquefaciens ; carbohydrase, Bacillus Subtilis ; protease, Bacillus Amyloliquefaciens ; protease, Bacillus Subtilis, (51931-23-8) ; neutral proteinase ; subtilisin, (9014-01-1)
• 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 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)