The European Commission has proposed new regulation to ban the use of monacolin K in food supplements for dosages equal to and higher than 3 mg. The red yeast rice (‘RYR’) component is currently being evaluated at the European level under the infamous Article 8 procedure of Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. The EC is also considering to put doses under 3 mg under scrutiny and the inclusion of warning statements for food products.
In 2018 the EFSA adopted a scientific opinion on the safety of monacolins in red yeast rice. The EFSA concluded that intake of monacolins from RYR via food supplements could lead to estimated exposure to monacolin K within the range of the therapeutic doses of lovastatin. The EFSA also concluded that monacolins from RYR when used as food supplements were of significant safety concern at the use level of 10 mg/day. The Panel further considered that individual cases of severe adverse reactions have been reported for monacolins from RYR at intake levels as low as 3 mg/day.
Although a final decision has not yet been taken, based on this EFSA opinion the EC intends to amend Annex III to Regulation (EC) No 1925/2006 as follows:
- Add in Part B, monacolin K in Red Yeast Rice at a dosage lower than 3 mg and include the following mandatory warnings on the label:
– “Consult a physician before use”;
– “Consult a physician if problems occur to the liver, the kidneys or muscles”;
– “The product should not be consumed if you are already taking other cholesterol-lowering medications or if you have an intolerance to statins”;
– “The product should not be consumed if you are already taking other products containing red yeast rice”.
- Add monacolin K in Part C.
Food business operators, or any other interested parties, may at any time submit for evaluation to the EFSA scientific data demonstrating the safety of a substance listed in Part C. Within four years the EC will decide to prohibit these substances or authorize them under conditions.
In case this proposition is adopted, the authorized monacolin K health claim on maintenance of normal blood cholesterol levels requiring a minimum amount of 10 mg of the substance, will no longer be permitted.
The text of the EC’s draft regulatory proposal is available at the following link:
 Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R1925-20190515
 Scientific opinion on the safety of monacolins in red yeast rice. Available at: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5368