Food
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of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.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.
Overview
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
Inventories
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
FDA proposed simplified GRAS notification system - 62 FR 18937 - April 17, 1997How to Submit a GRAS Notice
Excerpted from 62 FR 18937 - April 17, 1997
Guidance
Guidance for Industry: Frequently Asked Questions About GRAS Frequently Asked Questions about FDA's Regulation of Infant Formula SUPERCEDED July 2010 - Guidance for Industry: Enzyme Preparations: Chemistry Recommendations for Food Additive and GRAS Affirmation Petitions Estimating Dietary Intake of Substances in Food SUPERCEDED March 2009--Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions Guidance for Industry: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
Regulations
21 CFR Part 181
Prior Sanctioned Food Ingredients21 CFR Part 182
Substances Generally Recognized as Safe21 CFR Part 184
Direct Food Substances Affirmed As GRAS21 CFR Part 186
Indirect Food Substances Affirmed As GRAS
Contact Us
GRAS Notification Program
- (301)-436-1192
- premarkt@fda.hhs.gov
Office of Food Additive Safety
5100 Paint Branch Parkway
College Park, MD 20740