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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 9C0266

Listing of Color Additives for Coloring Sutures; D&C Violet No. 2

Petitioner: Genzyme Surgical Products Corp.
Docket number (legacy and/or former docket number(s)): (99C-1455)
Subject additive and intended use: amending the color additive regulations to provide for the safe use of D&C Violet No. 2 as a color additive in absorbable sutures prepared from homopolymers of glycolide for general surgery. The agency is also revising the nomenclature polyglactin 910 (glycolic-lactic acid polyester) to the generic nomenclature copolymers of 90 percent glycolide and 10 percent L-lactide.
21 CFR* affected: 74.3602; D&C Violet No. 2.
Substance(s)*, (CAS Registry® No.):
  • D&C Violet No. 2, (81-48-1)
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    Federal Register publication history: Jun 3, 1999; 64 FR 29871; Notice
    Jul 28, 2000; 65 FR 46342; Final Rule; Effective date: Aug 29, 2000
    Sep 28, 2000; 65 FR 58221; Final Rule; Confirmation of Effective Date; Effective date: Aug 29, 2000


     

    *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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