Regardless of whether the use of a substance is a food additive use or is GRAS, there must be evidence that the substance is safe under the conditions of its intended use. FDA has defined “safe” (21 CFR 170.3(i) and 21 CFR 570.3(i)) as a reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use. The specific data and information that demonstrate safety depend on the characteristics of the substance, the estimated dietary exposure 3, the population that will consume the substance, and other relevant considerations.
