Commission Implementing Regulation (EU) No 844/2012 (hereinafter referred to as ‘the Regulation’) lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012. Fenamidone is one of the active substances listed in Regulation (EU) No 686/2012.
In accordance with Article 1 of the Regulation, the rapporteur Member State (RMS), the Czech Republic, and co-rapporteur Member State (co-RMS), France, received an application from Bayer CropScience AG for the renewal of approval of the active substance fenamidone. In addition, Bayer CropScience AG submitted applications for maximum residue levels (MRLs), as referred to in Article 7 of Regulation (EC) No 396/2005. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co-RMS (France), the European Commission and the European Food Safety Authority (EFSA) about the admissibility.
The RMS provided its initial evaluation of the dossier on fenamidone in the renewal assessment report (RAR), which was received by EFSA on 12 February 2015. The RAR included a proposal to set MRLs, submitted as referred to in Article 7(1) of Regulation (EC) No 844/2012. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Bayer CropScience AG, for comments on 8 April 2015. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 10 June 2015.
Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicant and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues and ecotoxicology.
In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether fenamidone can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of fenamidone as a fungicide on potatoes and tomatoes, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.
Sufficient efficacy data were supplied to support the representative uses.
A data gap was identified for a more detailed description in the RAR of the search of the scientific peer-reviewed open literature on the active substance and its relevant metabolites, dealing with side effects on health
In the area of identity, physical/chemical/technical properties and methods of analysis a data gap was identified for a method of analysis for body fluids and tissues. During the finalisation of the conclusion it was realised that the residue definition for drinking water and ground water was to include the metabolite RPA 412708 and therefore a new data gap for a validated method is identified.
In the area of mammalian toxicology and non-dietary exposure data gaps, issues that could not be finalised and a critical area of concern were identified. Since no conclusion on the genotoxic potential of fenamidone could be drawn, the setting of reference values and the finalisation of human health risk assessment could not be conducted leading to a critical area of concern. The groundwater metabolite RPA 412708 was concluded as being relevant for groundwater. The compliance of the toxicity studies compared to the technical specification and the relevance of impurities should be reconsidered once the genotoxic potential of fenamidone is properly addressed. Data gaps concerning in vitro comparative metabolism studies and further data to address the endocrine disruption potential of fenamidone lead to issues that could not be finalised.
In the area of residues data gaps and issues that could not be finalised were identified. Most notably the consumer dietary risk assessment that could not be concluded in the absence of agreed residue definitions for risk assessment and toxicological reference values for fenamidone.
The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at the EU level for the representative uses, with the notable exception that information was not available regarding the effect of water treatment processes on the nature of residues that may be present in surface water and groundwater at the point of abstraction for drinking water purposes. This results in it not being possible to finalise the consumer exposure assessment. A critical area of concern was identified due to FOCUS groundwater modelling of annual or triannual average recharge concentrations leaving the top 1 m soil depth, indicating a high potential for groundwater exposure above the parametric drinking water limit of 0.1 µg/L, by the toxicologically relevant metabolite RPA 412708, for all the representative uses assessed, in geoclimatic situations represented by all the pertinent Focus groundwater scenarios, for all aquifers that are over laid by soils of predominantly pH 7 or above
In the area of ecotoxicology, data gaps were identified for mammals to further address the long-term risk, including the risk from secondary poisoning of two metabolites. Data gaps were also identified relating to bees to provide information for further assessing the chronic risk to adult honeybees and honeybee larvae. Also effect on HGP (hypopharygeal glands) developmental should be considered. The risk to aquatic organisms was low when mitigation measures are applied, except for the scenario R4 in tomatoes. The in-field risk to non-target arthropods was low when mitigation measures are applied.