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)

Annex III to Regulation (EC) No 1925/2006 is amended as follows: 1. The following entry is added in the table in Part B ‘Restricted substances’ in alphabetical order: Restricted substanceConditions of useAdditional requirements‘Monacolins from red yeast riceIndividual portion of the product for daily consumption shall provide less than 3 mg of monacolins from red yeast rice. 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. The label shall indicate the content of monacolins per portion of the product. 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”.’ 2. The following entry is added in the table in Part C ‘Substances under Community scrutiny’ in alphabetical order: ‘Monacolins from red yeast rice’

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.