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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 0C0226

Listing of Color Additives for Coloring Contact Lenses; 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers

Petitioner: Sola/Barnes-Hind (now Pilkington Barnes Hind)
Docket number (legacy and/or former docket number(s)): (91C-0189)
Subject additive and intended use: amending the color additive regulations to provide for the safe use of the colored reaction products formed by copolymerizing 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester either with glyceryl methacrylate/methyl methacrylate/ethylene glycol dimethacrylate monomers or with N,N-dimethyl acrylamide/methyl methacrylate/ethylene glycol dimethacrylate monomers to form 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.):
  • 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic) ester, (109561-07-1)
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    Federal Register publication history: Jun 14, 1991; 56 FR 27518; Notice
    Oct 3, 1996; 61 FR 51584; Final rule; Effective date: Nov 5, 1996
    Mar 19, 1997; 62 FR 51584; Final rule; confirmation of effective date; Effective date: Nov 5, 1996


     

    *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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