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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 5C0248

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

Petitioner: United States Surgical Corp.
Docket number (legacy and/or former docket number(s)): (95C-0399)
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 glycolide/dioxanone/trimethylene carbonate tripolymer absorbable sutures for general surgery
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: Oct 23, 1995 60 FR 54279 Notice
Apr 23, 1998 63 FR 20096 Final rule May 27, 1998
Aug 28, 1998 63 FR 45943 Final rule; confirmation of effective date May 27, 1998

 

*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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