FDA consults on rule to make GRAS safety notifications mandatory for food substances in US

• FDA opened a 120-day consultation on Aug. 11, 2026 to mandate GRAS notices for substances marketed as generally recognized as safe.
• 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.
• Proposal also updates the threshold-of-regulation framework, potentially changing exemption eligibility for low-exposure food-contact substance uses.

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