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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 8G0337

Direct Food Substances Affirmed as Generally Recognized as Safe; Chymosin Enzyme Preparation Derived From Escherichia Coli K-12

Petitioner: Pfizer Central Research (Pfizer)
Docket number (legacy and/or former docket number(s)): (87G-0418, 87F-0416)
Subject additive and intended use: amending its regulations to affirm that the use of chymosin preparation derived by fermentation from Escherichia coli K-12 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, Escherichia coli K-12
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    Federal Register publication history: Feb 9, 1988; 53 FR 3792; Notice
    Mar 23, 1990; 55 FR 10932; Final rule; Effective date: Mar 23, 1990


     

    *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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