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)
• Federal Register publication history: Jun 3, 1999 64 FR 29871 Notice ; Jul 28, 2000 65 FR 46342 Final Rule Aug 29, 2000 ; Sep 28, 2000 65 FR 58221 Final Rule; Confirmation of 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)