Commodities
Home›Commodities›Agriculture›FDA proposes mandatory GRAS notifications for food ing…
FDA proposes mandatory GRAS notifications for food ingredients
The proposal would add FDA review timelines, including an initial 45-day evaluation and a 180-day to 360-day decision window after a submission is accepted.
The US Food and Drug Administration has published a proposed rule that would change how the agency handles generally recognized as safe, or GRAS, determinations for food ingredients. Under the proposal published Aug. 11 in the Federal Register, the FDA would move the GRAS process from voluntary self-affirmed options toward a mandatory notification framework.
World Grain reports that if a manufacturer does not meet the notification requirement for a substance’s conditions of intended use, the FDA would treat that noncompliance as a factor when prioritizing the substance for post-market review. The agency said the main benefit is increased information made available to both the FDA and the public to help assess whether a use should be regulated as a food additive subject to premarket review and approval.
The proposal also sets review timelines. After receiving a submission, the FDA would conduct an initial evaluation to determine whether it is adequate to file, expected to be completed within 45 days, and that phase would not evaluate the GRAS status of the substance.
Once a notice is accepted and filed, the FDA would have between 180 days and 360 days to notify the filer of its decision. For substances already on the market under industry self-GRAS conclusions, the rule would create a time-limited streamlined submission pathway to let manufacturers provide information on existing uses, with the goal of prioritizing safety evaluations while minimizing unnecessary regulatory burden.