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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): CAP 4C0300

Listing of Color Additives Exempt From Certification; Spirulina Extract

Petitioner: Colorcon, Inc.
Docket number (legacy and/or former docket number(s)): FDA-2014-C-1552
Subject additive and intended use: amending the color additive regulations to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules.
21 CFR* affected: 73.1530; Spirulina extract.
Substance(s)*, (CAS Registry® No.):
  • Spirulina extract
  • Federal Register publication history: Oct 22, 2014; 79 FR 63062; Notice of petition
    Aug 21, 2015; 80 FR 50762; Final Rule; Effective date: Sep 22, 2015
    Oct 29, 2015; 80 FR 66415; Final Rule; Confirmation of Effective Date; Effective date: Sep 22, 2015

     

    *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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