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. Ethofumesate 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), Austria, and co-rapporteur Member State (co-RMS), Denmark, received an application from United Phosphorus and the Task Force comprising Bayer CropScience and ADAMA for the renewal of approval of the active substance ethofumesate. In addition, United Phosphorus and the Task Force comprising Bayer CropScience and ADAMA, 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 applicants, the co-RMS (Denmark), the European Commission and the European Food Safety Authority (EFSA) about the admissibility.
The RMS provided its initial evaluation of the dossier on ethofumesate in the renewal assessment report (RAR), which was received by EFSA on 28 January 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 applicants, United Phosphorus and the Task Force comprising Bayer CropScience and ADAMA, for comments on 10 March 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 11 May 2015.
Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicants, and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, environmental fate and behaviour and ecotoxicology.
In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether ethofumesate 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 ethofumesate as a herbicide on sugar beet, fodder beet and red beet, as proposed by the applicants. MRLs were assessed in sugar beet, fodder beet and red beet. Full details of the representative uses and the proposed MRLs can be found in Appendix A of this report.
Sufficient data were provided to demonstrate the efficacy and crop safety of the formulations.
A data gap was identified for a search of the scientific peer-reviewed open literature on the active substance and its relevant metabolites for the sections on fate and behaviour and ecotoxicology.
In the area of identity, physical/chemical/technical properties and methods of analysis one data gap was identified for a new 5 batch study for one of the sources and one data gap was identified for the validation of the pre-registration methods in ecotoxicological studies. Insufficient information for methods of analysis 2 and 4 used in toxicity studies is presented to draw a conclusion. Therefore, a data gap was identified.
In the area of mammalian toxicology and non-dietary exposure further data are needed to define the photo-toxicity and photo-genotoxicity of ethofumesate, to establish maximum contents of relevant impurities EMS and iBMS and to address the endocrine potential of ethofumesate. Toxicity studies were not representative of the technical specification leading to a critical area of concern.
In the area of residues, data gaps were identified for additional storage stability data in order to fully validate all the relevant residue trials, and for information to address the MRL assessment for honey, since these data are triggered by the new data requirements. A chronic consumer dietary risk assessment conducted with EFSA PRIMo rev. 2 indicated that exposure related to the representative uses for peer review was less than 1% of the ADI.
The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses. For these representative uses the potential for groundwater exposure above the parametric drinking water limit of 0.1 µg/L by ethofumesate and its transformation products NC 8493 and NC 20645, was assessed as low in geoclimatic situations represented by all the relevant FOCUS groundwater scenarios.
A low risk to birds, terrestrial vertebrates, aquatic organisms (assuming risk mitigation measures in some scenarios), other soil macro organisms, soil microorganisms, non-target terrestrial plants and sewage treatment organisms was concluded for all representative uses. Following the risk assessment scheme according to the EFSA guidance document on bees, a low acute and chronic risk to bees was concluded for all scenarios. However, data gaps were identified to address the risk to honeybee brood from ethofumesate and to address the risk to honeybees from metabolites in pollen and nectar. A high chronic risk to earthworms was concluded for all representative uses of ethofumesate applied as ‘Ethofol 500 SC’. A low chronic risk to earthworms was concluded for all representative uses of ethofumesate applied as ‘Ethofumesate 500 SC’.