FDA consults on rule to make GRAS safety notifications mandatory for food substances in US
XLP•Threshold-of-regulation framework also updated
The proposal also updates the threshold-of-regulation framework, potentially changing exemption eligibility for low-exposure food-contact substance uses.
FDA opens consultation on mandatory GRAS notices
FDA opened a 120-day consultation on Aug. 11, 2026 to mandate GRAS notices for substances marketed as generally recognized as safe.
Proposal would replace voluntary program and tighten compliance
The rule would replace the voluntary GRAS program, increasing compliance and documentation demands across the US food and food-contact supply chain.
Comments are due by Dec. 9, 2026; most provisions would take effect 60 days after publication of a final rule.
Mandatory GRAS notice submissions would start 18 months after the final rule’s effective date, setting a transition timeline for affected products.
