Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers
fda-food · Food and Drug Administration · Rule · Published 2013-04-01 · Effective 2013-05-02 · 78 FR 19413
Document
Document number
2013-07294
Federal Register citation
78 FR 19413
CFR reference
21 CFR 73
Type
Rule
Action
Final rule.
Category
fda-food
Sub-agency
Food and Drug Administration
Publication date
2013-04-01
Effective date
2013-05-02
HHS docket
Docket Nos. FDA-2011-C-0344 and FDA-2011-C-0463
Abstract
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and 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. This action is in response to two color additive petitions (CAPs) filed by CooperVision, Inc.