Flufenacet not renewed: authorisations withdrawn by 10 December 2025, use of stocks until 10 December 2026; the metabolite TFA above 10 µg/L in groundwater in all 9 FOCUS scenarios at 160–240 g/ha, thyroid endocrine disruption; EFSA — HPLC-MS/MS with an LOQ of 0.01 mg/kg in plants and 0.05 µg/L in water
Commission Implementing Regulation (EU) 2025/910, published on 21 May 2025, does not renew the approval of the herbicide flufenacet, used in winter cereals. The Commission relies on the EFSA conclusions of 29 August 2024: flufenacet meets the criteria for an endocrine disruptor (thyroid) in humans and non-target organisms, and its metabolite trifluoroacetic acid (TFA) may contaminate groundwater well above 0.1 µg/L in all scenarios. Member States withdraw authorisations by 10 December 2025 and the grace period for using up stocks expires on 10 December 2026 at the latest.
- Reasoning of the act: TFA was considered a toxicologically relevant metabolite — some REACH registrants indicated classification as toxic for reproduction category 2, and Germany submitted a proposal for harmonised classification in category 1B; under guidance SANCO/221/2000 a metabolite qualifying for such classification, in any category, is relevant, so the 0.1 µg/L limit of Directive 2006/118/EC applies. EFSA also identified a high risk to algae in 8 of 9 scenarios. The act deletes flufenacet from the list of candidates for substitution (Regulation 2015/408).
- Monitoring methods (EFSA): the plant residue definition is the sum of metabolites containing the N-fluorophenyl-N-isopropyl moiety, expressed as flufenacet — HPLC-MS/MS, LOQ 0.05 mg/kg in straw and 0.01 mg/kg in the other groups; in animal products GC-MS after derivatisation of the common moiety 4-fluoro-N-isopropylaniline to 2,2,2-trifluoro-N-(4-fluorophenyl)-N-isopropylacetamide, LOQ 0.05 mg/kg (muscle, kidney, fat, eggs), 0.02 mg/kg (liver), 0.01 mg/kg (milk); soil HPLC-MS/MS 2 µg/kg, drinking and surface water 0.05 µg/L, body fluids 50 µg/L. Gaps: a method for air, for body tissues and for toluene (relevant impurity, max. 1 g/kg) in the formulation.
- Groundwater (PEARL and PELMO models, 9 FOCUS scenarios): TFA above 10 µg/L in all scenarios for autumn use at 240 and 160 g/ha and spring use at 160 g/ha, in 7 of 9 at 120 g/ha, and always above 0.1 µg/L; above 0.1 µg/L also FOE sulfonic acid (all scenarios), FOE oxalate, FOE methylsulfone and FOE trifluoroethanesulfonic acid. In soil TFA reached up to 81 % of applied radioactivity and is very highly persistent. The consumer risk assessment was not finalised — field trials for TFA in crops and data on chlorination products in drinking water were among the missing items.
- EFSA reference values: ADI 0.004 mg/kg bw per day (from the LOAEL of 1.2 mg/kg bw in the 2-year rat study, additional factor of 3), ARfD 0.017 mg/kg bw, AOEL 0.006 and AAOEL 0.017 mg/kg bw. The representative formulation ‘DFF+FFA SC 600’ contained 400 g/L flufenacet and 200 g/L diflufenican; minimum purity of the substance 970 g/kg. The approval period of flufenacet had been extended by Regulation 2023/1757 until 15 June 2025; the act does not preclude a new application for approval.