The Commission Regulation (EU) 2022/860 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice has been published on 2nd June 2022.

This Regulation entered into force on 22nd June 2022. From this date it is prohibited to place food supplements containing more than or equal to 3 mg/day of monacolins from red yeast rice on the market.

For products containing less than 3 mg for daily consumption, labelling requirements are applicable.

Monacolins from red yeast rice was also added in the table in Part C ‘Substances under Community scrutiny’. Within four years a decision designed to amend non-essential elements of this Regulation shall be taken in accordance with the regulatory procedure with scrutiny, to generally allow the use of the substance or to list it in Annex III, Part A (Prohibited substances) or B (Restricted substances), as appropriate.

Source: EUR-Lex – 32022R0860 – EN – EUR-Lex (

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