Pyridaben is one of the 84 substances of the third stage part B of the review programme covered by Commission Regulation (EC) No 1490/2002, 3 as amended by Commission Regulation (EC) No 1095/2007. 4 In accordance with the Regulation, at the request of the Commission of the European Communities (hereafter referred to as' the Commission'), the EFSA organised a peer review of the initial evaluation, i.e. the Draft Assessment Report (DAR), provided by the Netherlands, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicant's decision, in accordance with Article lIe, to withdraw support for the inclusion of pyridaben in Annex I to Council Directive 91/414/EEC. Following the Commission Decision of 5 December 2008 (2008/934/EC) 5 concerning the noninclusion of pyridaben in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant Nissan Chemical Europe S.A.R.L. made a resubmission application for the inclusion of pyridaben in Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No. 33/2008.6 The resubmission dossier included further data in response to the issues identified in the DAR. In accordance with Article 18 of Commission Regulation (EC) No. 33/2008, the Netherlands, being the designated RMS, submitted an evaluation of the additional data in the format of an Additional Report. The Additional Report was received by the EFSA on 15 June 2009. In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the Additional Report to Member States and the applicant for comments on 19 June 2009. The EFSA collated and forwarded all comments received to the Commission on 3 August 2009. In accordance with Article 20, following consideration of the Additional Report, the comments received, and where necessary the DAR, the Commission requested the EFSA to conduct a focused peer review in the areas of mammalian toxicology and environmental fate and behaviour and deliver its conclusions on pyridaben. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of pyridaben as an insecticide on tomato and citrus, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report. No areas of concern were identified in the physical-chemical properties section. However, there are the following data gaps: vapour pressure, Henry's law constant, a sprayability study, and validation of the plant method for acidic matrices. No areas of concern or data gaps were identified in the mammalian toxicology section. In the residues area, for the specific use on citrus and tomato, the pertinent issues for consumer risk assessment have been reasonably addressed. However further data gaps are identified for the use in citrus to confirm residue levels across the citrus crop group and to clarify the identity of fat soluble residues in animal commodities. The implications for the consumer risk assessment are expected to be minor, therefore this is not considered a critical area of concern. The data available on fate and behaviour in the environment are sufficient to carry out the required environmental exposure assessments at the EU level for the representative uses assessed. The potential for groundwater contamination consequent to these uses from pyridaben or its metabolites PB-22, PB-4 and PB-7 above the parametric drinking water limit of 0.1 tg/L was assessed as low. The risk to birds and mammals was assessed as low, after the refinement presented, except for the long-term risk to mammals arising from the use in citrus, where further information is required to address the risk. A high risk was identified for the aquatic environment arising from the use in citrus; no-spray buffer zones up to 30 m were insufficient to address the risk. A high risk was identified for bees for the use in citrus and further information is required. Risk mitigation measures such as 10 m no-spray buffer zones are required to protect non-target arthropods. The risk to earthworms, soil-dwelling macro- and micro-organisms, non-target plants and biological methods of sewage treatment was assessed as low.
