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MOTION FOR A RESOLUTION (D113902/02 – 2026/2821((RPS))

On the draft Commission regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice

B-10-2026-0466

Plenary sitting · Rapporteur: Esther Herranz García, Pietro Fiocchi, Carlo Fidanza, Carlo Ciccioli, Alessandro Ciriani, Daniele Polato, Mariateresa Vivaldini, Francesco Torselli, Sergio Berlato, Marco Squarta, Paolo Inselvini, Michele Picaro, Stefano Cavedagna, Alberico Gambino, Elena Donazzan, Mario Mantovani, Lara Magoni, Gabriel Mato, Isabel Benjumea Benjumea, Letizia Moratti, Fernando Navarrete Rojas, Elena Nevado del Campo, Pablo Arias Echeverría, Pilar del Castillo Vera, Liesbet Sommen, Dolors Montserrat, Susana Solís Pérez, Ingeborg Ter Laak, Flavio Tosi, Adrián Vázquez Lázara, Juan Ignacio Zoido Álvarez, Pascal Arimont, Hildegard Bentele, Carmen Crespo Díaz, Raúl de la Hoz Quintano, Nicolás Pascual de la Parte, Alma Ezcurra Almansa, Gheorghe Falcă, Maravillas Abadía Jover, Javier Zarzalejos, Francisco José Millán Mon, Borja Giménez Larraz, Esteban González Pons, Antonio López-Istúriz White, Elżbieta Katarzyna Łukacijewska

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✦ In short · AI summary of this text, generated 8 Oct 2026

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Parliament opposes the draft Commission regulation that would move monacolins from red yeast rice to Part A of Annex III to Regulation (EC) No 1925/2006, banning their use in foods including food supplements. It says the draft exceeds the Commission's implementing powers under Article 8 and breaches proportionality, because a total prohibition was not shown to be the least restrictive measure. It asks the Commission to withdraw the draft and submit a new one, and to await the Court of Justice rulings in the pending appeals on Commission Regulation (EU) 2021/468. It also asks for a full impact assessment of a ban on public health, consumers and the existing market.

Key points

  1. Parliament opposes adoption of the draft Commission regulation on monacolins from red yeast rice.
  2. It considers the draft exceeds the implementing powers in Article 8 of Regulation (EC) No 1925/2006 because a prohibition was imposed without adequately assessing less restrictive measures.
  3. It considers the draft breaches proportionality, and that maximum daily intake levels, labelling, product standardisation, quality control including citrinin limits and post-marketing surveillance could be less restrictive alternatives.
  4. It says the scientific assessment, which found no safe daily intake threshold, does not by itself justify the most restrictive response, given product variability and population heterogeneity.
  5. It calls on the Commission to withdraw the draft regulation and submit a new one to the committee.
  6. It calls on the Commission to take due account of the judgments to be delivered by the Court of Justice in the pending appeals on Commission Regulation (EU) 2021/468 before adopting the draft.
  7. It calls on the Commission to carry out a comprehensive impact assessment of a prohibition, covering lost LDL-cholesterol benefits, consumer shifts to pharmaceuticals or non-Union products, and economic effects on the lawful market.

Who is affected

  • Consumers who use red yeast rice supplements to manage elevated LDL-cholesterol, including those not on statins, would lose that option.
  • The existing lawful market for red yeast rice food supplements in the Union would be disrupted by a prohibition.
  • The Commission is asked to withdraw the draft, await Court of Justice rulings and conduct an impact assessment.

Figures and deadlines

  • less than 3 mg of monacolins from red yeast rice per individual daily portion, required by Commission Regulation (EU) 2022/860
  • 3 mg per day, intake level at which severe adverse reactions requiring hospitalisation were reported
  • approximately 1,7 million deaths each year from cardiovascular disease in the European Union
  • an estimated 62 million people affected by cardiovascular disease
  • more than EUR 282 billion annually, estimated total societal cost of cardiovascular disease across the Union
  • 0,0007 % estimated reporting rate for suspected serious adverse events from red yeast rice supplements
  • 0,0002 % estimated reporting rate for serious adverse events assessed as potentially related to red yeast rice supplements