EFSA has concluded its peer review of the pesticide active substance fluazaindolizine, identifying several data gaps that prevent finalisation of the consumer risk assessment and groundwater relevance assessment, according to a conclusion published on 24 July 2026. The substance, a nematicide developed by Corteva Agriscience International Sàrl for use on cucurbits and carrots, was evaluated under EU Regulation (EC) No 1107/2009, with Malta serving as rapporteur Member State. While no critical areas of concern were identified in mammalian toxicology or ecotoxicology, and the substance was found not to meet endocrine disruption criteria, multiple unresolved issues remain, particularly regarding the potential formation of trifluoroacetic acid (TFA) in the environment and the toxicity of certain metabolites.
The peer review process began when Malta received Corteva's application on 15 March 2021, with the dossier deemed admissible on 13 May 2021. Malta submitted its draft assessment report (DAR) on 19 June 2023, and EFSA initiated the peer review on 11 September 2023, consulting Member States and the applicant. A telephone conference on 13 February 2024 between EFSA, Malta and ECHA determined the need for additional information and expert consultations in mammalian toxicology, residues, environmental fate and ecotoxicology. Final consultations with Member States took place via written procedures in November-December 2025 and April 2026, leading to the 22 June 2026 approval of the conclusion.
Key data gaps include the inability to finalise the reference specification due to identity issues, and the assessment of the groundwater metabolite IN-VM862's aneugenicity, leaving its groundwater relevance unresolved. The volatile metabolite IN-VM862 also lacks inhalation toxicity data, preventing a finalised human risk assessment. In the residue section, a very preliminary dietary exposure assessment was calculated only for primary crops and honey, and the consumer risk assessment from drinking water could not be finalised due to missing information on water treatment processes and the potential formation of TFA. The surface water exposure assessment was hampered by two unidentified chromatographic peaks in natural water samples from the aqueous photolysis study.
For stakeholders, the outcome has mixed implications. Corteva Agriscience faces potential delays in EU approval unless it supplies the missing data, which could affect its market access for fluazaindolizine. EU farmers growing cucurbits and carrots may lose a new nematicide option, potentially increasing reliance on existing products. EU consumers face unresolved dietary and drinking water risks, though no acute concerns were flagged. National regulatory authorities, particularly Malta as RMS, will need to follow up on data requirements, adding to their workload. The European Commission will now decide on approval based on EFSA's conclusions, weighing the identified uncertainties against the substance's efficacy.