FDA has incorporated this concept of safety into its color additive regulations. Under 21 CFR 70.3(i), a color additive is ―safe‖ if there is ―convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.‖ Therefore, the general safety clause prohibits the listing of a color additive unless it is safe, as defined in 21 CFR 70.3(i).