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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 9G0349

Direct Food Substances Affirmed as Generally Recognized as Safe; Chymosin Enzyme Preparation Derived From Genetically Modified Kluyveromyces Marxianus (Hansen) Van Der Walt Variety Lactis (Dombrowski) Johannsen et Van Der Walt

Petitioner: Gist-brocades, Inc.
Docket number (legacy and/or former docket number(s)): (89G-0126)
Subject additive and intended use: amending its regulations to affirm that the use of chymosin preparation derived by fermentation from genetically modified Kluyveromyces marxianus (Hansen) Van Der Walt variety lactis (Dombrowski) Johannsen et Van Der Walt (K. marxianus var. lactis) 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, Kluyveromyces marxianus var. lactis
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    Federal Register publication history: May 10, 1989; 54 FR 20203; Notice
    Feb 25, 1992; 57 FR 6476; Final Rule; Effective date: Feb 25, 1992


     

    *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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