"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 through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.
- Under 21 CFR 570.30(c) and 570.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of animals in the United States.
Information About the GRAS Proposal
How to Submit a GRAS Notice to CVM
- Federal Register Notice - the GRAS Proposal
FDA proposed simplified GRAS notification system - 62 FR 18938 - April 17, 1997
Federal Register Notice of Pilot Program; Substances GRAS Added to Food for Animals
75 FR 31800 - June 4, 2010