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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 2G0282

Direct Food Substances Affirmed as Generally Recognized as Safe; Lactase Enzyme Preparation From Candida Pseudotropicalis

Petitioner: Pfizer, Inc.
Docket number (legacy and/or former docket number(s)): (83G-0062)
Subject additive and intended use: amending its regulations to affirm that lactase enzyme preparation derived from Candida pseudotropicalis for use in milk and milk-derived products to hydrolyze lactose is generally recognized as safe (GRAS)
21 CFR* affected: 184.1387; Lactase enzyme preparation from Candida pseudotropicalis
Substance(s)*, (CAS Registry® No.):
  • lactase, Candida pseudotropicalis
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  • lactase (beta-D-galactoside galactohydrolase; β-galactosidase), (9031-11-2)
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    Federal Register publication history: Mar 29, 1983; 48 FR 13098; Notice
    Feb 29, 1996; 61 FR 7702; Final rule; Effective date: Feb 29, 1996


     

    *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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