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U.S. Department of Health and Human Services

Final Rules and Final Orders: Food Additives and Color Additives

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Petition(s): CAP 8C0213

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

Petitioner: Davis & Geck
Docket number (legacy and/or former docket number(s)): (89C-0304)
Subject additive and intended use: amending the color additive regulations to provide for the safe use of [phthalocyaninato(2-)] copper to color nonabsorbable monofilament sutures composed of polybutylene terephthalate for general and ophthalmic surgery
21 CFR* affected: 74.3045; [Phthalocyaninato(2-)] copper
Substance(s)*, (CAS Registry® No.):
  • [phthalocyaninato(2-)]copper, (147-14-8)
  • Federal Register publication history: Aug 10, 1989; 54 FR 32850; Notice
    May 10, 1990; 55 FR 19618; Final Rule; Effective date: Jun 12, 1990
    May 25, 1990; 55 FR 21674; Correction
    Aug 6, 1990; 55 FR 31824; Final Rule; confirmation of effective date; Effective date: Jun 12, 1990


     

    *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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