EU Proposes to Completely Ban Monacolins from Red Yeast Rice in Food Products

Mar 05, 2026

Lennie Tao

1. The EU plans to completely prohibit the use of monacolins from red yeast rice in foods and food supplements by adding them to Part A (prohibited substances) of Annex III to Regulation (EC) No 1925/2006.
2. EFSA’s 2025 opinion concluded that monacolins from red yeast rice cannot be considered safe even below 3 mg/day, prompting removal from the restricted and Union scrutiny lists.
3. Products lawfully on the EU market before entry into force may continue to be sold for 12 months after the regulation becomes applicable.

On March 4, 2026, the European Union notified the World Trade Organization (WTO) of a Draft Commission Regulation aimed at amending Annex III to Regulation (EC) No 1925/2006. The draft proposes a complete prohibition on the use of monacolins from red yeast rice in foods. The public consultation for this draft is currently open, with a feedback deadline of May 3, 2026, and the regulation is expected to be adopted in the third quarter of 2026.

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Tags : Health Supplement Prepackaged Food Regulation & Standard Importation Food Safety Food Ingredients EU

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Lennie Tao
ChemLinked Regulatory Analyst

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