On June 2nd, 2022, Regulation 2022/860 was published on the Official Journal of the European Union. This Regulation establishes a daily limit for all monacolins from red yeast rice in foods and food supplements of less than 3 mg. Additionally, it requires labelling modifications in these products to include warnings to avoid consumption by lactating women, children below 18 years old, adults above 70 and people who are already taking cholesterol-lowering drugs, amongst others.
Monacolins are a group of chemical compounds produced by yeasts. In the food industry, the most popular of all of them is monacolin K produced by the yeast Monascus purpureus when fermenting rice, hence the popular name for the ingredient “red yeast rice” (a traditional Chinese food with blood lipid lowering capacity).
This traditional use and further clinical research led EFSA in 2011 to grant monacolin the health claim “Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels” for foods providing a daily intake of 10 mg of monacolin, which has been used extensively in food supplements in Europe since then.
However, in 2018, EFSA issued a scientific opinion in which it considered that monacolin K was identical to lovastatin, the active ingredient of several drugs for the treatment of hypercholesterolemia in the EU and elsewhere, and that the intake of monacolins from red yeast rice via food supplements could lead to estimated exposure to monacolin K within the range of the therapeutic doses of lovastatin, involving similar adverse effects. The Authority also stated that adverse effects derived from monacolin were identified at doses as low as 3 mg/day, and that actually any dose, whatever low, could lead to adverse effects.
Now, with the favourable vote of 25 EU Member States and 2 abstentions, the text will be passed onto the European Parliament and the Council for final approval. This process is likely not to introduce any changes and will take around 3 months. Since the Regulation does not contemplate any transitional period (which is extraordinary), the law will enter into force 20 days after its publication – so, a 4-month period from now. As the text has the status of Regulation, it will apply in all 27 EU Member States from that date.
Furthermore, since the 3mg-safety limit conflicts with the 10 mg-health claim requirement, the cholesterol-maintenance claim will no longer be authorized and will be removed from the Union list of permitted health claims.
In other geographies, such as the US and others, monacolins are already regarded as pharmaceutical ingredients and are therefore not authorized for use in foods or food supplements.