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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): 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)
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  • acrylamide-acrylic acid resin (AAR), (9003-06-9)
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    Federal Register publication history: Nov 17, 1989; 54 FR 47828; Notice
    Jun 25, 2002; 67 FR 42714; Final Rule; Effective date: 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)
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