date:Jun 08, 2015
s final rule as mica-based pearlescent pigments.
II. Safety Evaluation
A. Determination of Safety
Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (the FDC Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be listed for a particular use unless the data and information available to FDA establish that the color additive is safe for that use. FDA's color additive regulations in21 CFR 70.3(i) define safe to mean that there is convincing evidence that establishes with reason