On 20 May 2021, the European Commission launched a consultation (until 17 June 2021) on a draft regulation as regards monacolins from red yeast rice, according to article 8 of Regulation (EC) 1925/2006 and following the opinion of EFSA in 2018.
This draft regulation would add:
- in Part B of Annex III to Regulation (EC) 1925/2006 (under restrictions): Dose of monacolins < 3 mg / day (to be indicated on the label: content of monacolins and number of individual portions of the product for maximum daily consumption). Mandatory warnings: Warning not to exceed daily amount of less than 3mg. “Should not be consumed by pregnant or lactating women, children below 18 years old and adults above 70 years old”. “Seek advice from a doctor on consumption of this product if you experience any health problems”; “Should not be consumed if you are taking cholesterol-lowering medication”; “Should not be consumed if you are already consuming other products containing red yeast rice”.
- and in Part C of Annex III to Regulation (EC) 1925/2006, i.e. under Union scrutiny (under scrutiny because of scientific uncertainty: the industry will have 18 months to submit additional scientific data demonstrating the safety of the substances for a possible new assessment by EFSA; and the Commission should take a decision within four years).
Concretely, it corresponds to a ban of monacolins from red yeast rice for a daily dose greater than or equal to 3 mg/day and placing under restrictions (warnings) and under Union scrutiny of lower doses. Note that these restrictions apply to monacolins in general (and not only monacolin K).
The final text could be published in the Official Journal of the European Union at the beginning of 2022 (with no transition period).