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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 1C0292

Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers

Petitioner: CooperVision, Inc.
Docket number (legacy and/or former docket number(s)): FDA-2011-C-0344
Subject additive and intended use: amending the color additive regulations to provide for the safe use of additional ... copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses.
21 CFR* affected: 73.3100 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers.
Substance(s)*, (CAS Registry® No.): C.I. Reactive Blue 247, (109561-07-1)
Federal Register publication history: Jun 28, 2011 76 FR 37690 Notice of petitions
Apr 1, 2013 78 FR 19413 Final Rule May 2, 2013
Jun 25, 2013 78 FR 37962 Final Rule; Confirmation of Effective Date May 2, 2013

 

*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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