Generally Recognized as Safe (GRAS)
“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 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of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.
- 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 Notice Inventory
List of all GRAS notices (includes the subject of each notice, the FDA-assigned number and FDA’s response letter)
Information about the GRAS Proposal
- Federal Register Notice – the GRAS Proposal (PDF – 272KB)
FDA proposed simplified GRAS notification system – 62 FR 18937 – April 17, 1997
- How to Submit a GRAS Notice
Adapted from 62 FR 18937 – April 17, 1997
- Federal Register Notice – Substances Generally Recognized as Safe; Reopening of the Comment Period
FDA reopened comment period for GRAS proposed rule
75 FR 81536 – Dec 28, 2010
Comment period closed March 28, 2011
- Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
- Regulatory Submissions
- Guidance for Industry: Frequently Asked Questions About GRAS
- 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
- Guidance for Industry: Estimating Dietary Intake of Substances in Food
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions
- Guidance for Industry: Summary Table of Recommended Toxicological Testing for Additives Used in Food