Petition(s): GRP 3G0016

Enzyme Preparations From Animal and Plant Sources; 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 certain enzyme preparations derived from animal and plant sources are generally recognized as safe (GRAS) for use as direct food ingredients
• 21 CFR* affected: 184.1024 Bromelain ; 184.1034 Catalase (bovine liver) ; 184.1316 Ficin ; 184.1415 Animal lipase ; 184.1443a Malt ; 184.1583 Pancreatin ; 184.1595 Pepsin ; 184.1914 Trypsin
• Substance(s)*, (CAS Registry® No.): bromelain, (9001-00-7) ; catalase, bovine liver, (81457-95-6) ; ficin, (9001-33-6) ; lipase (triacylglycerol lipase), (9001-62-1) ; malt ; pancreatin, (8049-47-6) ; pepsin, (9001-75-6) ; trypsin, (9002-07-7)
• 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 ; Sep 20, 1993 58 FR 48889 Notice of withdrawal ; Jun 26, 1995 60 FR 32904 Final Rule Jun 26, 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)