Commission rejects health claim for monacolin K from red yeast fermented rice
European Union
Jul 31, 2024
With implementing Regulation (EU) 2024/2063 of 30 July 2024, the Commission refused to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children’s development and health.
As there is still a possibility of harmful effects on health associated with the use of monacolins from red yeast rice, but scientific uncertainty in this regard persists, and considering that monacolins from red yeast rice may only be used in food supplements and that the extent of use of those food supplements could not be determined by the Authority, the use of monacolins from red yeast rice in food supplements is placed under Union scrutiny and therefore included in Part C of Annex III to Regulation (EC) No 1925/2006. Interested parties have the possibility under Article 8(4) of Regulation (EC) No 1925/2006 to submit data demonstrating the safety of monacolins from red yeast rice to the Authority in accordance with Article 5 of Implementing Regulation (EU) No 307/2012. In accordance with Article 8(5) of Regulation (EC) No 1925/2006 the Commission should take a decision within four years from the entry into force of Commission Regulation (EU) 2022/860, whether to generally allow the use of monacolins from red yeast rice listed in Annex III, Part C or to list the substance in Annex III, Part A or Part B, as appropriate, taking into account the opinion of the Authority on any submitted data.
Therefore, the proposed health claim should not be authorised and included in the Union list of permitted health claims.
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