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Europe: Publication of the regulation on monacolins from red yeast rice

Regulation (EU) 2022/860 of 1 June 2022 amending Annex III to Regulation (EC) 1925/2006 as regards monacolins from red yeast rice has been published on the Official Journal of the European Union on 2 June 2022 and will apply from 22 June 2022 (with no transition period).

This regulation adds monacolins from red yeast rice:

  • 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 per portion of the product and number of individual portions of the product for maximum daily consumption). 

Mandatory warnings: Warning not to consume a daily amount of 3 mg of monacolins from yeast rice or more. “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).

Recital 6 of this regulation reminds that the use of red yeast rice preparations in food categories other than food supplements is is not authorized (subject to an authorisation under Regulation (EU) 2015/2283 on novel foods).

In conclusion, from 22 June 2022, all food supplements with a daily dose of monacolins from red yeast rice greater than or equal to 3 mg/day will be banned at European level, and the mandatory mentions and warnings must be present on the labelling of food supplements with a daily dose of monacolins from red yeast rice lower than 3 mg/day.