CIRS Supports Magic Health in Securing U.S. GRAS for PQQ!
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.
Navigating the U.S. FDA’s Proposed GRAS Rule Shift: What Food & Ingredient Companies Need to Know
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.
FDA Releases Updated NDI Guidance: Focus on Ingredient Identification & Detailed Submission Requirements
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.
In-Depth Analysis: The FDA Officially Explains the GRAS Reform System
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.
Summary of US FDA GRAS Status from July to October 2026
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.
China CFSA Recommends Not Granting Approval of Advantame and Neotame
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.
[Weekly Update] Latest Acceptance Updates on China’s “Three New” Foods
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 Revises Special Act on Imported Food Safety Management
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.
China CFSA Seeks Comments on Six Proposed Food Additive Applications
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.
China SAMR Seeks Public Comments on Draft Amendment to the Food Safety Law: Health Food Filing Process Expected to Be Simplified
On October 10, 2026, China’s State Administration for Market Regulation (SAMR) released the Draft Amendment to the Food Safety Law of the People’s Republic of China for public comment.
The proposed amendments introduce several notable regulatory updates for the health food sector, aimed at streamlining approvals and updating product labeling requirements.
US FDA GRAS Notice
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Genetically Modified Microorganism Food Additive Registration in China
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US FDA Dietary Supplement Structure/Function Claim Notification
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US FDA Registration of Food Facilities
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US Food Label/Advertisement Information Review
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EU Novel Food Application
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GACC Overseas Manufacturers Registration of Imported Food (GACC Decree No.248)
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MARA Imported Feed and Pet Food Registration
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US FDA GRAS Notice
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Genetically Modified Microorganism Food Additive Registration in China
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US FDA Dietary Supplement Structure/Function Claim Notification
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US FDA Registration of Food Facilities
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US Food Label/Advertisement Information Review
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EU Novel Food Application
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GACC Overseas Manufacturers Registration of Imported Food (GACC Decree No.248)
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MARA Imported Feed and Pet Food Registration
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