The European Food Safety Authority (EFSA) has proposed revised maximum residue levels (MRLs) for the fungicide fluopyram across a range of crops and recommended setting an import tolerance of 0.9 mg/kg for limes, following the evaluation of confirmatory data submitted by Bayer AG Crop Science Division. In a reasoned opinion published on 7 August 2026, EFSA confirmed existing MRLs for grapefruits, oranges, lemons, mandarins and tomatoes, lowered MRLs for spring onions, melons, watermelons, globe artichokes and leeks, and raised MRLs for escaroles, land cresses and red mustards. The assessment found no consumer risk, with the highest chronic exposure reaching 94% of the acceptable daily intake in a scenario that also considered Codex maximum residue limits for certain cereals.
The opinion stems from a data-gap review conducted under Article 12 of Regulation (EC) No 396/2005, which in 2020 identified missing information for several fluopyram uses and set tentative MRLs. Those tentative levels were implemented in EU law by Commission Regulation (EU) No 2021/618, which required interested parties to submit confirmatory data by 16 April 2023. Bayer submitted its application on 14 April 2023 to the German competent authority, which assessed the dossier and declared it admissible on 26 February 2024. A public consultation ran from 16 March to 6 April 2024, drawing no additional data or comments. Germany's evaluation report was sent to the European Commission and EFSA on 9 January 2026, and the Commission mandated EFSA to assess it on 20 January 2026.
For crops where data gaps remain unaddressed, EFSA offers risk managers two options: for Chinese cabbages/pe-tsai, spinaches and chards/beet leaves, either lower the MRL to the enforcement limit of quantification (0.01 mg/kg) with appropriate risk mitigation measures, or set it at 0.15 mg/kg based on residues expected in rotational crops. For bananas, the existing MRL of 0.8 mg/kg is maintained because it matches a Codex maximum residue limit already implemented in EU law. The limes import tolerance was derived by extrapolation from residue trials on lemons and mandarins, reflecting a use pattern not previously assessed by EFSA.
The opinion notes that the peer review of fluopyram's renewal of approval under Regulation (EC) No 1107/2009 is ongoing, so conclusions may need revisiting in light of that outcome. EFSA's recommendations will feed into the Commission's decision on amending the MRL regulation, with the proposed changes affecting growers and importers of the commodities concerned. For EU producers of melons, watermelons and leafy vegetables, the revised MRLs could require adjustments to cultivation practices or monitoring, while importers of limes gain a clear legal threshold for residues. Consumers are not expected to face health risks, as exposure remains below the acceptable daily intake in all assessed scenarios.