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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 6C0305

Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper

Petitioner: Milton W. Chu, M.D.
Docket number (legacy and/or former docket number(s)): FDA-2016-F-0821
Subject additive and intended use: amending the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses (IOLs).
21 CFR* affected: 73.3126; Titanium dioxide.
74.3045; [Phthalocyaninato (2-)] copper.
Substance(s)*, (CAS Registry® No.):
  • titanium dioxide, (13463-67-7)
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  • [phthalocyaninato (2-)] copper, (147-14-8)
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    Federal Register publication history: Mar 22, 2016; 81 FR 15173; Notice of petition
    Nov 1, 2016; 81 FR 75689; Final Rule; Effective date: Dec 2, 2016
    Jan 23, 2017; 82 FR 7648; Final Rule; Confirmation of Effective Date; Effective date: Dec 2, 2016

     

    *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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