Conclusion on the peer review of the pesticide risk assessment of the active substance imazalil European Food Safety Authority

Commission Regulation (EC) No 737/20073 (hereinafter referred to as 'the Regulation') lays down the procedure for the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishes the list of those substances. Imazalil is one of the first group of active substances listed in the Regulation. In accordance with Article 6 of the Regulation, the notifiers Janssen Pharmaceutica NV, Certis Europe B.V., Makhteshim Chemical Works Ltd., AgriChem B.V. and Laboratorios Agrochem S.L. submitted a dossier on imazalil to The Netherlands and Spain, being the designated rapporteur Member State (RMS), and co-rapporteur Member State (co-RMS), respectively. In accordance with Article 10 of the Regulation, The Netherlands prepared an Assessment Report in consultation with Spain, which was submitted to the EFSA and the Commission of the European Communities (hereafter referred to as 'the Commission'). The Assessment Report was received by the EFSA on 9 June 2009. In accordance with Article 11 of the Regulation, the EFSA distributed the Assessment Report to Member States and the notifiers for comments on 11 June 2009. The EFSA collated and forwarded all comments received to the Commission on 13 July 2009. In accordance with Article 12, following consideration of the Assessment Report and the comments received, the Commission requested the EFSA to arrange an expert consultation on the Assessment Report as appropriate and deliver its conclusions on imazalil The conclusions presented in this report were reached on the basis of the evaluation of the representative uses of imazalil as a fungicide on citrus post harvest, protected tomatoes grown on artificial substrate, and as a cereal seed treatment, as proposed by the notifiers. Full details of the representative uses can be found in Appendix A to this report. There is no agreed specification for imazalil. No areas of concern were identified in the mammalian toxicity section. The exposure/risk assessment for re-entry workers (scenario: tomatoes) with regard to the exposure to the individual enantiomers that make up the active substance residue on treated fruit was considered as a data gap. In plants, the residue was defined as imazalil for monitoring and sum of imazalil and metabolite R014821 for risk assessment, although this metabolite is of no concern for the currently supported uses. The residue definition for ruminant matrices could not be finalised and the notifier was asked to propose a residue definition for monitoring including at least the parent imazalil and the metabolites FK284 and/or FK772. No chronic concern was identified with the maximum refined TMDI (IEDI) being 4% of the ADI only. Acute concern can not be totally excluded since the maximum refined IESTI is 92% of the ARfD when calculations are performed using the mean processing factor (0.07) derived for citrus pulp, but 115% of the ARfD for grapefruit (DE, child) and 105% of the ARfD for orange (UK infant) when calculations are performed using the individual processing factors derived for grapefruit (0.13) and for orange (0.08). With regard to environmental fate and behaviour, for the representative use as a cereal seed treatment information is missing regarding the route of degradation in soil and natural surface water systems and consequently the groundwater exposure assessment for potential soil metabolites is not finalised. For the representative use on glasshouse tomatoes grown on artificial media, information is missing regarding the route of degradation in natural surface water systems. The assessment of the representative use post harvest on citrus is based on there being no soil or surface water exposure from this use, consequent from appropriate management measures to preclude such exposure being implemented. A data gap was identified to address the long-term risk to granivorous birds and mammals from uses of imazalil as a seed treatment. The potential endocrine disrupting effects of imazalil on fish should be addressed for uses on tomatoes in glasshouses and for seed treatment. A data gap was identified to assess the long-term effect of the metabolite R014821 on soil micro-organisms for the use as a seed treatment.