2016-19164: Substances Generally Recognized as Safe

Summary

The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status.

The agency’s own summary, as published.

What this changes

Amends 6 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 20 Public Information
• 21 CFR 25 Environmental Impact Considerations
• 21 CFR 170 Food Additives
• 21 CFR 184 Direct Food Substances Affirmed as Generally Recognized as Safe
• 21 CFR 186 Indirect Food Substances Affirmed as Generally Recognized as Safe
• 21 CFR 570 Food Additives