DraftCommission Regulation 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)

This draft Commission Regulation aims to prohibit the use of monacolins from red yeast rice in food based on the scientific opinion of EFSA and following a period of Union scrutiny during which food business operators, or any other interested parties, may submit scientific data to demonstrate the safety of plant preparations in question.On 25 June 2018, EFSA adopted a scientific opinion on the safety of monacolins in red yeast rice. In that opinion, it considered that the available information on the adverse effects reported in humans was judged to be sufficient to conclude that monacolins from red yeast rice were of significant safety concern at intake levels as low as 3 mg/day. EFSA was unable to provide advice on a daily intake of monacolins from red yeast rice that does not give rise to concerns for human health. Considering the significant harmful effect on health associated with the use of monacolins at levels as low as 3 mg/day and that no safe daily intake level could be set, the use of the substance in food was restricted and at the same time placed under Union scrutiny by means of Regulation (EU) 2022/860 of 1 June 2022 for a period of four years from the entry into application of that Regulation. On 29 January 2025, EFSA adopted a scientific opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006. In its opinion, EFSA concluded that the data submitted by interested parties during the Union scrutiny period do not allow establishing the safety of monacolins from red yeast rice at intake levels below 3 mg/day or identifying a safe daily intake of monacolins from red yeast rice. Therefore, pursuant to the procedure of Article 8(5) of Regulation (EC) No 1925/2006, monacolins from red yeast rice should be included in Part A of Annex III to Regulation (EC) No 1925/2006, which means that their use in food will be prohibited.