Petition(s): FAP 9A4175

Secondary Direct Food Additives Permitted for Direct Addition to Food for Human Consumption; Materials Used as Fixing Agents in the Immobilization of Enzyme Preparations

• Petitioner: Enzyme Bio-Systems Ltd.
• Docket number (legacy and/or former docket number(s)): FDA-1989-F-0009 (1989F-0452) (89F-0452)
• Subject additive and intended use: amending the food additive regulations to provide for the safe use of dimethylamine-epichlorohydrin and acrylamide-acrylic acid resins, individually or together, as fixing agents for the immobilization of glucose isomerase enzyme preparations.
• 21 CFR* affected: 173.357 Materials used as fixing agents in the immobilization of enzyme preparations.
• Substance(s)*, (CAS Registry® No.): dimethylamine-epichlorohydrin copolymer (DEC), (25988-97-0) ; acrylamide-acrylic acid resin (AAR), (9003-06-9)
• Federal Register publication history: Nov 17, 1989 54 FR 47828 Notice ; Jun 25, 2002 67 FR 42714 Final Rule Jun 25, 2002

 

*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)