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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 0C0271

Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments

Petitioner: Ciba Vision Corp.
Docket number (legacy and/or former docket number(s)): FDA-2000-C-0234; (2000C-1321); (00C-1321)
Subject additive and intended use: amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in contact lenses.
21 CFR* affected: 73.3128; Mica-based pearlescent pigments.
Substance(s)*, (CAS Registry® No.):
  • mica-based pearlescent pigments
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    Federal Register publication history: Jun 7, 2000; 65 FR 36148; Notice
    May 20, 2002; 67 FR 35551; Notice (Amendment)
    Oct 24, 2002; 67 FR 65311; Final Rule
    Feb 14, 2003; 68 FR 7416; Final Rule; Confirmation of Effective Date; Effective date: Nov 26, 2002


     

    *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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