The US Food and Drug Administration is planning a rule that will require all food and beverage companies to submit Generally Recognized As Safe (GRAS) notices for human and animal food ingredients starting in 2026. Currently, companies can self-affirm GRAS status and may voluntarily share supporting data with the FDA to receive confirmation.
The proposed rule will formalise the FDA’s GRAS notice inventory and establish a clear process for determining if a substance does not qualify as GRAS. Substances already listed in the inventory or those that have received a “no questions” letter will be exempt. The FDA maintains a GRAS inventory page with details on more than 1,200 substances, a system in place since 1998 when the agency replaced the GRAS affirmation process with a notification procedure.
The rule follows a directive from the US Department of Health and Human Services to phase out self-affirmed GRAS status, creating a more consistent regulatory framework for ingredient safety assessment.