Petition(s): CAP 8C0287

Listing of Color Additives Exempt From Certification; Reactive Blue 69

• Petitioner: Sauflon Pharmaceuticals Ltd.
• Docket number (legacy and/or former docket number(s)): FDA-2009-C-0543
• Subject additive and intended use: amending the color additive regulations to provide for the safe use of disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (CAS Reg. No. 70209-99-3), also known as Reactive Blue 69, as a color additive in contact lenses.
• 21 CFR* affected: 73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate.
• Substance(s)*, (CAS Registry® No.): disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate, (70209-99-3)
• Federal Register publication history: Nov 18, 2009 74 FR 59560 Notice ; May 4, 2011 76 FR 25234 Final Rule Jun 6, 2011 ; Sep 27, 2011 76 FR 59503 Final Rule; Confirmation of Effective Date Jun 6, 2011

 

*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)