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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 9C0217

Listing of Color Additives for Coloring Contact Lenses; Vinyl Alcohol/Methyl Methacrylate-C.I. Reactive Red 180 Reaction Product

Petitioner: Ciba Vision Corp.
Docket number (legacy and/or former docket number(s)): (89C-0480)
Subject additive and intended use: amending the color additive regulations to provide for the safe use in coloring contact lenses of the reaction product formed by chemically bonding the dye C.I. Reactive Red 180 [5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-((2-(sulfooxy)ethyl)sulfonyl)-2-naphthalenyl)azo)-2,7-naphthalenedisulfonic acid, tetrasodium salt] )CAS Reg. No. 98114-32-0) to the vinyl alcohol/methyl methacrylate copolymeric lens material
21 CFR* affected: 73.3127; Vinyl alcohol/methyl methacrylate-dye reaction products
Substance(s)*, (CAS Registry® No.):
  • poly(methyl methacrylate-co-vinyl alcohol)-C.I. Reactive Red 180 reaction product
  • Federal Register publication history: Dec 19, 1989; 54 FR 51945; Notice
    Jan 8, 1993; 58 FR 3225; Final Rule; Effective date: Feb 9, 1993
    Apr 5, 1993; 58 FR 17508; Final Rule; amendment; Effective date: May 6, 1993
    Jun 22, 1993; 58 FR 33909; Final Rule; confirmation of effective date; Effective date: Feb 9, 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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