Flupyradifurone is a new active substance for which in accordance with Article 7 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (hereinafter referred to as ‘the Regulation’), the rapporteur Member State (RMS), the Netherlands, received an application from Bayer CropScience AG for approval. In accordance with Article 8(1)(g) of the Regulation, Bayer CropScience AG submitted applications for maximum residue levels as referred to in Article 7 of Regulation (EC) No 396/2005. Complying with Article 9 of the Regulation, the completeness of the dossier was checked by the RMS and the date of admissibility of the application was recognised as being 21 June 2012.
The RMS provided its initial evaluation of the dossier on flupyradifurone in the Draft Assessment Report (DAR), which was received by the EFSA on 1 February 2014. The DAR included a proposal to set maximum residue levels, in accordance with Article 11(2) of the Regulation. The peer review was initiated on 5 February 2014 by dispatching the DAR for consultation of the Member States and the applicant Bayer CropScience AG.
Following consideration of the comments received on the DAR, it was concluded that additional information should be requested from the applicant, and that the EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues, environmental fate and behaviour and ecotoxicology.
In accordance with Article 12 of the Regulation, the EFSA should adopt a conclusion on whether flupyradifurone can be expected to meet the approval criteria provided for in Article 4 of the Regulation taking into consideration recital (10) of the Regulation. Furthermore, this conclusion also addresses the assessment required from EFSA under Article 12 of Regulation (EC) No 396/2005, provided the active substance will be approved under Regulation (EC) No 1107/2009 without restrictions affecting the residue assessment.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of flupyradifurone as an insecticide in hops and field and glasshouse lettuce as proposed by the applicant. MRLs were assessed in apples/pears, grapes, tomatoes, peppers, cucurbits, watermelon and lettuce. Full details of the representative uses and the proposed MRLs can be found in Appendix A to this report.
A data gap was identified in relation to the search of the scientific peer-reviewed open literature on the active substance and its relevant metabolites.
Sufficient information was provided to confirm the effectiveness of flupyradifurone against the target insects when applied according to the GAPs reported under the representative uses.
No data gaps were identified in the area of identity, physical/chemical/technical properties and methods of analysis.
In the mammalian toxicology area, data gaps were identified to address the relevance of the individual impurities present in the technical specification in comparison with the toxicological profile of the parent compound. The interim provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the consideration of endocrine disrupting properties are not met. However, data gaps were identified for Level 2 tests currently indicated in the OECD Conceptual Framework, to address the potential for endocrine-mediated mode of action regarding the reproductive effects observed in a 2-generation reproductive toxicity in rats (reduced number of implantation sites and oestrus cycle, reduced litter size -reduced number of pups born and higher number of stillborn), and noting that further tests might be necessary pending on the outcome (issue not finalised).
Based on the available information, plant and animal residue definitions were proposed for enforcement and risk assessment. The GAP supporting the representative use of flupyradifurone on lettuce under greenhouse conditions result in an exceedance of the ARfD and therefore, the MRL for lettuce was derived from the outdoor GAP reported in the MRL application. Data gaps were identified for the submission of new animal feeding studies conducted with the metabolite DFA and of additional field rotational crop studies.
The import tolerance requests, reported in the MRL application, were not considered, pending the submission of documentations providing evidence for the registration of the active substance in the exporting countries. In contrast, maximum residue level requests related to the EU GAPs were fully supported by the available data and separate MRLs were proposed for flupyradifurone and DFA respectively. In addition, default MRL values were proposed to cover the residues of flupyradifurone and DFA expected in rotational crops.
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. A critical area of concern was identified, the active substance flupyradifurone has a high potential to exceed the parametric drinking water limit of 0.1µg/L in groundwater as represented by the 80th percentile annual average concentration moving below 1m depth, in geoclimatic situations represented by the FOCUS scenarios in hops (4 out of 7 scenarios), field lettuce (4 out of 7 scenarios) and protected lettuce (6 out of 7 scenarios). A data gap was proposed for information to address the effect of water treatment processes on the nature of residues of the active substance and metabolites when surface water is abstracted for drinking water and metabolites when groundwater is abstracted for drinking water to address Article 4 (approval criteria for active substances) 3(b) of Regulation (EC) No 1107/2009. Whilst robust information regarding this was not available, the consumer risk assessment is considered not finalised.
Data gaps were identified in the ecotoxicology section: to further address the potential for endocrine disruption of flupyradifurone; to further address a scientific peer-reviewed open literature search on the active substance and its relevant metabolites; to further address the long-term risk to small herbivorous mammals from dietary routes in lettuce and to further address the chronic risk to aquatic invertebrates for the representative field uses in lettuce. A data gap was proposed for the submission of the studies found by the applicant during the search of the scientific peer-reviewed open literature on the active substance and its relevant metabolites.