Wire · regulatory
FDA Publishes Proposed Rule to Mandate GRAS Notification
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Fusion42 · 22 August 2026 · Fusion42 review
The FDA proposed a rule to mandate notification for substances considered Generally Recognised as Safe (GRAS), shifting from the current voluntary system to compulsory notification for both food ingredients and food contact substances in the U.S., aiming to enhance safety transparency without requiring premarket approval.
This Wire brief sits within Fusion42's coverage of Foodtech.
◆ ◆ The Wire takeaway
You must prepare your product files and submission plans now because the FDA’s mandatory GRAS notification rule will soon make voluntary filings obsolete. This is your chance to secure market access by documenting your safety case before the December 2027 compliance deadline.
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1 source · 13 Aug 2026
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