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Magic Health’s flagship ingredient, PERFQUQ™ (Pyrroloquinoline Quinone Disodium Salt), has officially earned Self-GRAS (Generally Recognized as Safe) status in the United States following unanimous approval from an independent expert panel. This key regulatory milestone confirms the ingredient's safety for use in U.S. foods and beverages, marking a significant step forward in Magic Health’s international expansion. CIRS Group provided end-to-end support throughout the GRAS assessment.
The U.S. FDA proposes making the voluntary Generally Recognized as Safe (GRAS) notification mandatory while preserving "Self-GRAS" statutory status. If finalized, companies face mandatory filing timelines: a one-year window to submit abbreviated notices for existing unnotified ingredients, exemptions for current "no questions" letters, and required pre-market FDA submissions for new ingredients.
On October 19, 2026, the FDA simultaneously issued two NDI guidance documents to further refine the requirements for submitting New Dietary Ingredients (NDI) for dietary supplements. CIRS Group provides an in-depth analysis of the key changes in the guidance to assist companies in conducting NDI compliance assessments and filing submissions for the U.S. market.
The FDA is modernizing its 30-year-old GRAS system by replacing voluntary notifications with a mandatory regime to close safety blind spots. Companies using human or animal food ingredients under GRAS provisions must notify the agency, though existing marketed ingredients benefit from a one-year simplified submission window and an 18-month overall compliance grace period.
CIRS Group Korea will take part in the 2026 Alternative Food Industry Expert Training Program (Cell-Cultured Food) run by the World Food Tech Council, delivering a session on the regulatory status and practice for novel food ingredients in overseas markets.
The Generally Recognized as Safe (GRAS) notification pathway remains a critical route for food ingredient regulatory compliance and commercialization in the United States. Following our previous reviews for Q1 and H1 2026, CIRS Group compiled the latest GRAS notification updates published on the official U.S. Food and Drug Administration (FDA) website from July through October 15, 2026.
Recently, China's National Health Commission (NHC) issued notifications regarding the approval and review of “Three new foods” (new food raw materials, new food additives, and new food-related products). The notifications included: 5 notifications of extension notice; 7 notifications of review opinions. 1 non-approval decisions.
China NHC issued notifications regarding the acceptance of “three new foods”. The applications for 1 new food materials and 4 new food additives have been received.
South Korea’s Amendment No. 21948 to the Special Act on Imported Food Safety Management takes effect March 16, 2027. It mandates the revocation of overseas facility registrations extended through fraudulent means and switches the distribution traceability threshold for imported health functional foods from domestic sales amount to customs import value.
On October 12, 2026, China’s CFSA opened a public consultation through November 12, 2026, on six safety-approved food additives. Proposals include new enzyme D-Allulose 3-epimerase, new fortifiers UPU and LNT, expanded uses for white mineral oil and calcium 6S-5-methyltetrahydrofolate, and updated specifications for synthetic Vitamin E.
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