Conclusion on the peer review of the pesticide risk assessment of the active substance beta-cypermethrin
Beta-cypermethrin is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC the United Kingdom (hereinafter referred to as the ‘RMS’) received an application from Cerexagri S.A.S. (subsidiary of United Phosphorus Ltd.) for approval. Complying with Article 6(3) of Directive 91/414/EEC, the completeness of the dossier was checked by the RMS. The European Commission recognised in principle the completeness of the dossier by Commission Decision 2011/266/EU.
The RMS provided its initial evaluation of the dossier on beta-cypermethrin in the Draft Assessment Report (DAR), which was received by the EFSA on 5 April 2013. The peer review was initiated on 18 April 2013 by dispatching the DAR for consultation of the Member States and the applicant Cerexagri S.A.S.
Following consideration of the comments received on the DAR, it was concluded that additional information should be requested from the applicant and EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues, environmental fate and behaviour and ecotoxicology, and EFSA should adopt a conclusion on whether beta-cypermethrin can be expected to meet the conditions provided for in Article 5 of Directive 91/414/EEC, in accordance with Article 8 of Commission Regulation (EU) No 188/2011.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of beta-cypermethrin as an insecticide in oilseed rape, wheat and maize, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.
Data gaps were identified for the section physical and chemical properties and analytical methods.
In the mammalian toxicology section, two data gaps were identified: the first one for medical data, and the second one for information/data to address the toxicological profile of the metabolite PBA.
Based on the available information a residue definition was proposed for the cereal group only. Provisionally, the same residue definition was proposed for products of animal origin, pending on the submission of additional information on the fate of the cyclopropyl moiety of beta-cypermethrin and on the toxicity of the metabolite PBA. In addition, data gaps were identified to submit a metabolism study on pulses/oilseeds and residue trials on oilseed rape and maize silage. Based on the available data, no chronic or acute concerns were identified for the consumers. The consumer risk assessment should be considered provisional pending on the submission of the requested data.
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 assessed, with the exception of a satisfactory characterisation of the route of degradation of beta-cypermethrin in soil under illuminated conditions. Therefore the residue definitions set for soil, groundwater and surface water are uncertain (might not be complete). Another data gap was identified to address the impact of the enantiomeric composition of beta-cypermethrin and its metabolite cyperamide in the environment (aquatic compartment only). For the representative uses, the potential for groundwater exposure above the parametric drinking water limit of 0.1 μg/L was assessed as low for beta-cypermethrin and its metabolites PBA, CPA and cyperamide.
Several data gaps were identified in the ecotoxicology section, i.e. to further address the risk to aquatic organisms, bees, non-target arthropods and soil organisms. A critical area of concern was identified for aquatic organisms, bees and non-target arthropods.