Final Rules: Food Additives and Color Additives
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Petition(s): CAP 8C0287
Listing of Color Additives Exempt From Certification; Reactive Blue 69
Petitioner: | Sauflon Pharmaceuticals Ltd. |
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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)
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