"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 excepted from the definition of a food additive.
- Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance 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 170.30(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. General recognition of safety through scientific procedures 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are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.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 170.30(c) and 170.3(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 consumers.
About the GRAS Notification Program How U.S. FDA's GRAS Notification Program Works FDA's Approach to the GRAS Provision: A History of Processes
Excerpted from Poster Presentation at the FDA Science Forum - April 2006
GRAS Final Rule
Inventory for Human Food
Regulatory and Policy Guidance
Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food
for Substances Intended for Use in Human or Animal Food (Updated 2016)
Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives
Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety
Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula
Guidance for Industry: Enzyme Preparations: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices
(January 1993, revised July 2010)
Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions
(March 2006, revised March 2009)
Guidance for Industry: Estimating Dietary Intake of Substances in Food
Guidance for Industry: Summary Table of Recommended Toxicological Testing for Additives Used in Food