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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 7C0311

Listing of Color Additives Subject to Certification; D&C Yellow No. 8

Petitioner: Glo Eyes, LLC
Docket number (legacy and/or former docket number(s)): FDA-2017-C-2902
Subject additive and intended use: amending the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution.
21 CFR* affected: 74.3708 D&C Yellow No. 8.
Substance(s)*, (CAS Registry® No.): D&C Yellow No. 8, (518-47-8)
Federal Register publication history: May 31, 2017 82 FR 24912 Notice of petition
Sep 25, 2018 83 FR 48373 Final Rule Oct 26, 2018
Dec 17, 2018 83 FR 64443 Final Rule; Confirmation of Effective Date Oct 26, 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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