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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 4A4406

Secondary Direct Food Additives Permitted in Food for Human Consumption; Milk-Clotting Enzymes

Petitioner: Novo Nordisk Bioindustrials, Inc.
Docket number (legacy and/or former docket number(s)): (93F-0461)
Subject additive and intended use: amending the food additive regulations to provide for the safe use of aspartic proteinase enzyme preparation produced by pure culture fermentation of Aspergillus oryzae modified by recombinant deoxyribonucleic (DNA) techniques to contain the gene for aspartic proteinase enzyme from Rhizomucor miehei for use as a milk-clotting enzyme in the production of cheese
21 CFR* affected: 173.150; Milk-clotting enzymes, microbial
Substance(s)*, (CAS Registry® No.):
  • microbial rennet, aspergillus oryzae recombinant
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    Federal Register publication history: Jan 21, 1994; 59 FR 3365; Notice
    Nov 3, 1997; 62 FR 59281; Final Rule; Effective date: Nov 2, 1997


     

    *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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