European Union

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.

The proposed draft Regulation concerns the review of existing MRLs for difenoconazole in certain food commodities. Some MRLs for this substance are increased and some MRLs in certain commodities are lowered. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union. The proposed draft Regulation also addresses import tolerances in various crops.

The content of the draft Regulation previously notified in G/SPS/N/EU/702 (12 December 2023) is partially changed.This new version of the proposed draft Regulation concerns the review of existing maximum residue levels (MRLs) for cypermethrins in certain food commodities. MRLs for these substances in certain commodities are lowered. Lower MRLs are set after deleting old uses which are not authorised anymore in the European Union. Additionally, corresponding MRLs are set separately for alpha-cypermethrin. This new version of the draft Regulation intends to set separate MRLs for the sum of cypermethrins and for alpha-cypermethrin, based on the latest EFSA Statement: EFSA Journal. 2025;23:e9386. Statement on MRLs for alpha-cypermethrin and screening of the existing EU MRLs for cypermethrin. https://doi.org/10.2903/j.efsa.2025.9386

Regulation (EU) 2019/1793 lays down rules concerning the temporary increase of official controls upon entry into the Union on certain food and feed of non-animal origin from certain third countries (in Annex I); special import conditions for certain food and feed from certain third countries due to the contamination risk by mycotoxins, including aflatoxins, pesticide residues, and microbiological contamination (in Annex II - increased official border controls and official certificate accompanied by the results of sampling and analysis in the third country). This Implementing Regulation amends Annex II to Implementing Regulation (EU) 2019/1793 by including arachidonic acid oil from China due to possible contamination by cereulide toxin (frequency set at 50%).

The proposal notified in G/SPS/N/EU/891 (31 October 2025) is now adopted by Commission Implementing Regulation (EU) 2026/318 of 12 February 2026 amending Annex III to Implementing Regulation (EU) 2020/2235 and Annex II to Implementing Regulation (EU) 2021/403 as regards model certificates for entry into the Union of consignments of certain products of domestic solipeds origin intended for human consumption and certain categories of equine animals (Text with EEA relevance).This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.