Europe
The Commission Regulation (EU) 2024/2041, dated 29 July 2024, which amends Regulation (EU) No 432/2012 concerning the health claim for monacolin K from red yeast rice, was published in the Official Journal on 30 July.
The European Commission’s regulation addresses the safety and use of monacolins from red yeast rice, specifically monacolin K. Following scientific assessments by the European Food Safety Authority (EFSA), it was concluded that monacolin K, similar to lovastatin, poses significant health risks at certain intake levels, leading to the prohibition of its use in food supplements at doses of 3 mg or more per day. Consequently, the health claim regarding monacolin K’s ability to maintain normal blood cholesterol levels has been revoked from the Union list of permitted health claims.
Regulation 2024/2041 will enter into force on the twentieth day following that of its publication in the Official Journal.