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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 6G0077

Direct Food Substances Affirmed as Generally Recognized as Safe; Lactase Enzyme Preparation From Kluyveromyces Lactis

Petitioner: SugarLo Co.
Docket number (legacy and/or former docket number(s)): (77G-0007)
Subject additive and intended use: affirming that a lactase enzyme preparation derived from the yeast Kluyveromyces lactis is generally recognized as safe (GRAS) for use in the production of lactase-treated milk and lactose-reduced milk
21 CFR* affected: 184.1388; Lactase enzyme preparation from Kluyveromyces lactis
Substance(s)*, (CAS Registry® No.):
  • beta-galactoside galactohydrase, Kluyveromyces lactis
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    Federal Register publication history: Apr 19, 1977; 42 FR 20348; Notice
    Dec 4, 1984; 49 FR 47384; Final Rule; Effective date: Dec 4, 1984


     

    *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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