Changes in legislation on monakolins.

Changes in legislation on monakolins.

Publication of the new Regulation (EU) 2022/860


We already commented in one of our previous news the legislative status on the safe doses of Monakolin K. At that time, the safety of the ingredient had been studied by the EFSA without being able to determine a daily safe dose of monacolin, since adverse effects were detected even with doses of 3 mg/day of monacolin.

We were waiting to know the final evaluation resolution on the restriction at European level of this substance.

Well, the new news has arrived…

What legislative changes have there been on this monacolin K?

After several months of dispute, European legislation has finally restricted the use of all monacolins from red yeast fermented rice in food, applying to all foods, including food supplements.

It has been moved from levels of 10 mg/day to less than 3 mg/day of total monakolins, without the possibility to indicate 3 mg on the label. Therefore, this substance has been included in Part B «Substances subject to restriction» of Annex III to Regulation (CE) 1925/2006 and its addition to foods or its use in manufacture foods should only be allowed according to the specific conditions in the Annex III.

In addition to being included in Part B, monakolins from red yeast fermented rice are also included in Part C «Substances under Community scrutiny». Therefore, although it is currently possible to place on the market foods containing less than 3 mg/day of monakolins from red yeast fermented rice, this could change in future.

What about health claims?

Until now, the following claim for monacolin K was accepted: “Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels”. However, it is removed from the Register of health claims by the Commission.

This is because a daily intake of 10 mg of monakolin K from red yeast-fermented rice is required to obtain the beneficial effect, but by limiting its levels to less than 3 mg, it is no longer possible to indicate this claim on the labelling.

The publication of the new Commission Regulation (EU) 2022/860 of 1 June 2022 amending Annex III to Regulation (EC) 1925/2006 entered into force on 22 June 2022, without a transition period. Therefore, as of that date, the presence on the market of products that do not comply with the new legislation are not allowed, not only in the maximum level of monakolins, but also in the mandatory warnings that must be declared on the label.