"GRAS" is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.
Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 570.3 and 21 CFR 570.30, the use of a food additive may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.
- Under 21 CFR 570.30(b), general recognition of safety based upon scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of a food additive. General recognition of safety through scientific procedures must address safety for both the target animal and for humans consuming human food derived from food-producing animals and is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
- Under 21 CFR 570.30(c) and 570.3(f), general recognition of safety through experience based on common use in food requires a substantial history of consumption of a substance by a significant number of animals of the species to which the substance is intended to be fed (and, for food-producing animals fed with such substance, also means a substantial history of consumption by humans consuming human foods derived from those food-producing animals).