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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 1C0236

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

Petitioner: Ethicon, Inc.
Docket number (legacy and/or former docket number(s)): (91C-0432)
Subject additive and intended use: amending the color additive regulations to provide for the safe use of D&C Violet No. 2 to color poliglecaprone 25 (ε-caprolactone/glycolide copolymer) 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)
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    Federal Register publication history: Dec 2, 1991; 56 FR 61253; Notice
    Nov 15, 1993; 58 FR 60106; Final Rule; Effective date: Dec 16, 1993
    Jan 28, 1994; 59 FR 3998; Final Rule; confirmation of effective date; Effective date: Dec 16, 1993


     

    *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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