GRAS Notification Program

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A substance that will be added to food is subject to premarket approval by FDA unless its use is generally recognized as safe (GRAS) by qualified experts.(1) On April 17, 1997, FDA issued a proposed rule (the GRAS proposal; 62 FR 18938) that would establish a notification procedure whereby any person may notify FDA of a determination by that person that a particular use of a substance is GRAS. Although the proposed notification procedure is not yet final, FDA has already received several notices. As described in the GRAS proposal, the agency is evaluating whether each submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS. Following this evaluation, FDA responds to the notifier by letter. In general, FDA's response has been in one of three categories: The agency does not question the basis for the notifier's GRAS determination; The agency concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information or because the available data and information raise questions about the safety of the notified substance); or The response letter states that the agency has, at the notifier's request, ceased to evaluate the GRAS notice. In the GRAS proposal, FDA announced its intention to maintain an Inventory of GRAS Notices and the agency's response to those notices. The "Summary of All GRAS notices" table below is the main page of that inventory. Importantly, the Inventory of GRAS Notices includes all GRAS notices, regardless of whether the notice is pending at FDA or has come to closure, and regardless of the nature of FDA's response. Summary of all GRAS Notices FDA Proposes Simplified GRAS Notification System (April 17, 1997): Summary paper Federal Register Notice How to Submit a GRAS Notice Guidance Documents that are Relevant to the Preparation of a GRAS Notice: Enzyme Preparations: Chemistry Recommendations for Food Additive and GRAS Affirmation Petitions Estimating Exposure To Direct Food Additives And Chemical Contaminants in the Diet Recommendations for Submission of Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions Statement of Policy: Foods Derived from New Plant Varieties Toxicological Testing of Food Additives Related Links Contact Information