Monacolins from red yeast rice: new restrictions

Jun 20, 2022
Sébastien Bouley

The conditions of use of the ingredient are now set by Regulation (EU) 2022/860.

In recent years, there has been much discussion about the safety of monacolins from red yeast rice. Red yeast rice is considered a novel food, with the exception of its use in food supplements. The ingredient contains, as a result of fermentation by the yeast Monascus purpureus, several compounds including the family of monacolins, represented by monacolin K. A health claim is associated with the latter: “contributes to the maintenance of normal blood cholesterol levels”, at daily intakes of 10 mg.

The regulatory context of the ingredient is about to change, following the publication of Regulation (EU) 2022/860 on June 1st. The Regulation amends Regulation (EU) 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods, by adding monacolins from red yeast rice to Part B (restricted substances) and Part C (substances under Community scrutiny) of Annex III (substances whose use in foods is prohibited, restricted or under community scrutiny). Restrictions of use introduced by the new Regulation include the establishment of a maximum daily portion (set at 3 mg, which precludes the possibility of using the health claim) and additional requirements on label warnings (mainly about the characteristics of the product and about the sub-populations for which the product is not recommended).

  • Restrictions on the use of monacolins from red yeast rice:

As for the addition of monacolins from red yeast rice to Part C of Annex III, this implies that within four years, new decisions regarding the ingredient could be made, possibly based on emerging evidence.

The Regulation will come into force on June 21st, without a transition period.

To provide context, it should be noted that Regulation (EU) 2022/860 was developed taking into account the EFSA Opinion of June 25th, 2018 on the safety of monacolins in red yeast rice, which was published following the initiative of the European Commission to open the procedure under Article 8 (substances subject to prohibitions, restrictions or under Community control) of Regulation (EU) 1925/2006, after the positions taken on the subject by national institutions, such as the ANSES Opinion on the risks associated with the presence of “red yeast rice” in food supplements* published in 2014. Last year, the application of the Article 8 procedure had led to restrictions on botanical species containing hydroxyanthracene derivatives through Regulation (EU) 2021/468 (see our article on the matter); the same course will most likely affect other ingredients in the future.


* : link in French.