2022 New EU regulation as regards monacolins from red yeast rice

The latest EU regulations on red yeast rice in 2022 have come into effect on 1st, June. The new regulations impose stricter restrictions on using conditions of red yeast rice. It has already had a huge impact on the supplement market.

The core change is that, individual portion of the product for daily consumption shall provide less than 3 mg of monacolins from red yeast rice, which was 10mg for many years.

Additional requirements as below

  1. The label shall provide the number of individual portions of the product for maximum daily consumption and a warning not to consume a daily amount of 3 mg of monacolins from red yeast rice or more.
  2. The label shall indicate the content of monacolins per portion of the product.
  3. The label shall include the following warnings:
    • “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”.

For more details, please check below original regulation, or contact us.

Commission Regulation (EU) 2022/860 of 1 June 2022 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice (Text with EEA relevance)