On the basis of a scientific opinion from the European Food Safety Authority (EFSA), the European Commission adopted a regulation on Wednesday, 1 June, to restrict the use of monacolins from red yeast rice in food supplements.
Consumers use these supplements to control and maintain normal blood cholesterol levels. Yet, EFSA concluded in 2018 that there was a significant safety concern with monacolins when used at the dose of 10 mg/day (see EUROPE 12727/30).
Under the Commission Regulation, individual portions of a food or food supplement intended for daily consumption must provide less than 3 mg of monacolins from red yeast rice.
Moreover, product labels will have to contain warnings such as ‘Should not be consumed by women who are pregnant or breastfeeding, children under the age of 18, and adults over the age of 70’; ‘Seek advice from a doctor on the consumption of this product if you have health problems’; ‘Should not be consumed if you are taking cholesterol-lowering medication’; and ‘Should not be consumed if you are already consuming other products containing red yeast rice’.
This regulation amends Annex III to Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. (Original version in French by Aminata Niang)