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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 8C0253

Listing of Color Additives for Coloring Sutures; [Phthalocyaninato(2-)] Copper

Petitioner: Ethicon, Inc.
Docket number (legacy and/or former docket number(s)): (98C-0041)
Subject additive and intended use: amending the color additive regulations to provide for the safe use of [phthalocyaninato(2-)] copper in coloring nonabsorbable sutures for general and ophthalmic surgery made from a blend of poly(vinylidene fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene)
21 CFR* affected: 74.3045; [Phthalocyaninato(2-)] copper
Substance(s)*, (CAS Registry® No.):
  • [phthalocyaninato(2-)]copper, (147-14-8)
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    Federal Register publication history: Feb 2, 1998; 63 FR 5387; Notice
    Apr 30, 1999; 64 FR 23185; Final rule; Effective date: Jun 2, 1999
    Jul 22, 1999; 64 FR 39414; Final rule; confirmation of effective date; Effective date: Jun 2, 1999


     

    *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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