On 13 May 2026, the Section ‘General Food Law’ of the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) delivered a favourable opinion on a draft Commission Regulation aimed at prohibiting the use of monacolins from red yeast rice in food.
The draft Regulation amends Annex III to Regulation (EC) No 1925/2006 and adds monacolins from red yeast rice to the list of substances in Part A whose use in food is prohibited.
The prohibition is based on a scientific opinion published by the European Food Safety Authority (EFSA) in February 2025 as part of the procedure laid down in Article 8 of Regulation (EC) No 1925/2006. Although several stakeholders submitted additional data, EFSA concluded that the safety of the substance could not be established on the basis of the additional data and reiterated its concerns regarding the safety of monacolins from red yeast rice.
The prohibition follows earlier measures that had already significantly restricted the use of monacolins from red yeast rice. In 2022, the European Commission already restricted the use of monacolins from red yeast rice to individual portions providing less than 3 mg of monacolins per day. In 2024, the corresponding health claim relating to monacolin K from red yeast rice was also removed from the Union list established by Regulation (EU) No 432/2012.
However, the prohibition does not yet apply. The Regulation must first be published in the Official Journal of the European Union. According to the current timetable, publication is expected towards the end of 2026. Furthermore, the draft also provides for a 12-month transitional period for products lawfully placed on the market before the entry into force of the Regulation.
