EU Revokes the Health Claim on Monacolin K from Red Yeast Rice

The European Union issued Commission Regulation (EU) 2024/2041 on July 30, 2024, to revoke the previously authorized health claim for monacolin K derived from red yeast rice used in foods—“Monacolin K from red yeast rice contributes to the maintenance of normal blood LDL-cholesterol concentrations”. On July 31, 2024, the EU issued Commission Regulation (EU) 2024/2063, stipulating that the health claim shall not be included in the Union list of permitted health claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.

Legislation Background

As per the Regulation, red yeast rice is made by fermentation of rice with yeasts, mainly Monascus purpureus, resulting in the production of monacolins, the most abundant of which is monacolin K. Traditionally used in China as a food coloring and a remedy to promote digestion and blood circulation, it is not authorized for use as a food colorant in the EU. Moreover, food supplements containing red yeast rice preparations were marketed and consumed significantly before May 15, 1997. As a result, they are exempt from regulations pertaining to novel foods. However, the utilization of red yeast rice preparations in other food categories necessitates authorization under the relevant novel foods regulations.

In 2011, the European Food Safety Authority (EFSA) approved a health claim on monacolin K from red yeast rice, authorized by Commission Regulation (EU) No 432/2012 in 2012. The claimed effect is that the consumption of 10 mg/d monacolin K from red yeast rice contributes to maintaining normal blood LDL cholesterol concentrations. To support this claim, consumers must be informed that the beneficial effect is achieved with a daily intake of 10 mg of monacolin K from fermented red yeast rice preparations.

Subsequently, EU Member States raised safety concerns about consuming foods containing monacolins from red yeast rice. In 2017, the Commission requested EFSA to review their safety. On June 25, 2018, the Authority adopted a scientific opinion on the safety of monacolins in red yeast rice. The Authority considered that the available information on adverse effects reported in humans was sufficient to conclude that monacolins from red yeast rice, when used as food supplements at a 10 mg/day level, raised significant safety concerns. Furthermore, individual cases of severe adverse reactions were reported for monacolins from red yeast rice at intake levels as low as 3 mg/day. Additionally, due to the information available and uncertainties highlighted in its opinion, the Authority could not provide advice on a daily intake of monacolins from red yeast rice that would not raise concerns about harmful health effects for the general population and vulnerable subgroups as requested by the Commission.

In 2022, the EU issued Commission Regulation (EU) 2022/860, establishing usage conditions and labeling requirements for monacolins from red yeast rice as a restricted substance. It specified that "individual portions of the product for daily consumption should provide less than 3 mg of monacolins from red yeast rice."

Therefore, considering the current prohibition on the use of monacolins from red yeast rice at levels of 3 mg in food, conflicting with the 10 mg health claim requirement, the Commission revoked the health claim on monacolin K from red yeast rice from the Union list of permitted health claims in July 2024.

The new regulations will come into effect on the twentieth day following their publication in the Official Journal of the European Union. Read the full text at Commission Regulation (EU) 2024/2041 and Commission Regulation (EU) 2024/2063.