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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 7C0310

Listing of Color Additives Subject to Certification; D&C Black No. 4

Petitioner: DSM Biomedical
Docket number (legacy and/or former docket number(s)): FDA-2017-C-0935
Subject additive and intended use: amending the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures for use in general surgery.
21 CFR* affected: 74.3054; D&C Black No. 4.
Substance(s)*, (CAS Registry® No.):
  • D&C Black No. 4
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    Federal Register publication history: Mar 6, 2017; 82 FR 12531; Notice of petition
    Jun 7, 2018; 83 FR 26356; Final Rule; Effective date: Jul 10, 2018
    Sep 18, 2018; 83 FR 47069; Final Rule; Confirmation of Effective Date; Effective date: Jul 10, 2018

     

    *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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