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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): GRP 9G0352

Direct Food Substances Affirmed as Generally Recognized as Safe; Chymosin Enzyme Preparation Derived From Aspergillus Niger Van Tieghem Variety Awamori (Nakazawa) Al-Musallam

Petitioner: Genencor, Inc., now Genencor International, Inc.
Docket number (legacy and/or former docket number(s)): (89G-0384)
Subject additive and intended use: amending its regulations to affirm that the use of chymosin preparation derived by fermentation from genetically modified Aspergillus niger van Tieghem variety awamori (Nakazawa) Al-Musallam (A. niger var. awamori) is generally recognized as safe (GRAS)
21 CFR* affected: 184.1685; Rennet (animal-derived) and chymosin preparation (fermentation-derived)
Substance(s)*, (CAS Registry® No.):
  • chymosin preparation, Aspergillus awamori
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    Federal Register publication history: Oct 4, 1989; 54 FR 40910; Notice
    May 7, 1993; 58 FR 27197; Final Rule; Effective date: May 7, 1993


     

    *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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