Fenpyroximate is one of the 79 substances of the third stage Part A of the review programme covered by Commission Regulation (EC) No 1490/2002(1). This Regulation requires the European Food Safety Authority (EFSA) to organise upon request of the EU-Commission a peer review of the initial evaluation, i.e. the draft assessment report (DAR), provided by the designated rapporteur Member State and to provide within six months a conclusion on the risk assessment to the EU-Commission. Germany being the designated rapporteur Member State submitted the DAR on fenpyroximate in accordance with the provisions of Article 10(1) of the Regulation (EC) No 1490/2002, which was received by the EFSA on 25 October 2005. The peer review was initiated on 5 May 2006 by dispatching the DAR for consultation of the Member States and the sole applicant Nihon Nohyaku Co. Ltd. Subsequently, the comments received on the DAR were examined by the rapporteur Member State and remaining issues were agreed on during a written procedure in April May 2007. The identified issues as well as further data made available by the applicant upon request were evaluated in a series of scientific meetings with Member State experts in October and December 2007. A final discussion of the outcome of the consultation of experts took place during a written procedure with the Member States in February-March 2008 leading to the conclusions as laid down in this report. The conclusion was initially finalised on 14 April 2008 (scientific report no. 143 refers) however, following an update to the Residues chapter, the conclusion is revised and re-issued in October 2008. The conclusion was reached on the basis of the evaluation of the representative uses as an acaricide on grapes, apples, pears and beans. Full details of the GAP can be found in the attached list of end points. The representative formulated product for the evaluation was "Kiron", a suspension concentrate formulation (SC). Only single methods for the determination of residues are available since a multi-residue-method like the German S19 or the Dutch MM1 is not applicable due to the nature of the residues. The method of analysis for products of animal origin is only validated for fenpyroximate but the residue definition includes metabolite M-3(2) and therefore a data gap has been identified. Also the residue definition for surface water has not been finalised. Sufficient analytical methods as well as methods and data relating to physical, chemical and technical properties are available to ensure that quality control measurements of the plant protection product are possible. The technical specification could not be concluded on. Regarding the mammalian metabolism, fenpyroximate showed a rapid but incomplete oral absorption and excretion, mainly via faeces; intensive enterohepatic circulation was observed. Fenpyroximate is harmful if swallowed and very toxic by inhalation; eye irritation and skin sensitisation were observed. Based on toxicokinetic properties and different toxicological profile of the substance via oral or inhalation, the meeting of experts concluded that the oral absorption was not representative of the bioavailability of fenpyroximate. Critical effects observed through short term and long term studies were decreased body weight and food consumption. The relevant oral short term NOAEL is 1.3 mg/kg bw/day from the 90-day, rat study and the relevant inhalation NOAEL is 0.54 mg/kg bw/day from the 4-week study in rats; relevant long-term NOAEL was the dose level of 0.97 mg/kg bw/day. No genotoxicity, carcinogenicity or neurotoxicity was observed; neither reproductive nor developmental parameters were affected by treatment with fenpyroximate. The acceptable daily intake (ADI) is set at 0.01 mg/kg bw/day; the acceptable operator exposure level (AOEL) is 0.005 mg/kg bw/day and the acute reference dose (ARfD) is 0.02 mg/kg bw considering an assessment factor of 100 for all reference values. Dermal absorption is 7% when handling the concentrate formulation and 24% when handling the spray dilution. Considering the representative uses of Kiron (pome fruits, grapes and beans), the estimated operator exposure exceeds the AOEL according to the UK POEM model; according to the German model calculations, exposure exceeds the AOEL for high crop, tractor mounted air blast sprayers (pome fruits and grapes); exposure resulting from high crop, hand held applications (grapes) and field crop, tractor mounted hydraulic sprayers (beans) is below the AOEL when the use of PPE as protective gloves during mixing/loading and gloves, protective garment and sturdy footwear during application is considered. Re-entry worker exposure is estimated to be below the AOEL only if additional protective clothing, as gloves, long sleeved shirt and long trousers is considered. Bystander's exposure exceeds the AOEL for high crop applications, either tractor mounted or hand held; however for field crop applications (beans), bystander's exposure is estimated to be below the AOEL. The plant metabolism of fenpyroximate is very slow. Only one metabolite, the (Z)-isomer of the active substance (M-1) (3) is included in the residue definition for risk assessment. Further information is required to ensure that the toxicological reference values allocated to fenpyroximate cover its (Z) isomer. Some insufficiencies were identified in the submitted residue trials and further data are required. These deficiencies do not allow proposing an MRL in pome fruits. Studies are also required to investigate the stability of residues under hydrolysis conditions simulating processing. Transfer of soil residues to succeeding crops cannot be excluded for the use evaluated on beans harvested fresh. Based on animal metabolism and feeding studies, one animal metabolite is expected to reach quantifiable residue levels in ruminant liver and kidney. A provisional consumer exposure assessment has shown potential for children exposure in the range of the ARfD for apples, pears and grapes. This may however be reconsidered on the basis of more appropriate residue data for pome fruits. For grapes an option for decision makers is to consider to set the MRL at 0.2mg/kg instead of 0.3mg/kg. In soil under aerobic conditions fenpyroximate exhibits moderate to high persistence forming the major soil metabolite M-3 (accounting for up to 10.8% of applied radioactivity (AR)) which exhibits moderate to medium persistence and the minor non transient metabolite M-11(4) (accounting for up to 8.8%AR). Mineralisation of both the pyrazole and benzyl rings to carbon dioxide accounted for 17% AR and 51-65% AR respectively after 112 days. The formation of unextractable residues was a significant sink, accounting for 23.5-58.3 % AR and 21-41%AR respectively after 100-112 days. Fenpyroximate is immobile in soil, M-3 exhibits medium to low mobility in soil whilst M-11 is estimated by quantitative structure activity relationship (QSAR) calculations to exhibit medium mobility. There was no indication that adsorption of any of these compound was pH dependent. In dark natural sediment water systems fenpyroximate degraded exhibiting moderate persistence but partitioned relatively rapidly from water to sediment where the major metabolite M-11 was formed. M-3 and M-8(5) were major metabolites in water. The terminal metabolite, CO2, was an insignificant sink for the pyrazole ring radiolabel in the material balance accounting for a maximum of 1.9 % AR at 105 days (study end). Unextracted sediment residues were a more significant sink representing up to 28 % AR at study end. As no experiment is available where the benzyl ring was investigated a data gap is identified for further information on the fate and behaviour of the benzyl moiety in natural sediment water systems. In laboratory aqueous photolysis studies the Z isomer of fenpyroximate (M1) was a major metabolite. The necessary surface water and sediment exposure assessments were appropriately carried out using the agreed FOCUS scenarios approach for fenpyroximate at steps 1-4, with spray drift mitigation being applied at step 4. For the metabolites M-3, M-11 and M-8 appropriate FOCUS step 1 and 2 calculations were carried out. These values are the basis for the risk assessment discussed in this conclusion. The potential for groundwater exposure from the applied for intended uses by fenpyroximate and its soil metabolites M-3 and M-11 above the parametric drinking water limit of 0.1 g/L, was concluded to be low in geoclimatic situations that are represented by all 9 FOCUS groundwater scenarios. The acute and short term risk to birds can be considered as low for all representative uses evaluated. The blue tit is accepted as a focal species to refine the risk to insectivorous birds in pome fruit and vines. The tier 1 long-term risk assessment to birds did not identify low risk for any of the uses. Both PD and PT were refined in the risk assessment for orchard use and the PD was refined in the vine scenario. However, the TER did not reach the Annex VI trigger and a data gap is identified to refine the risk assessment for insectivorous birds in both orchards and vines. The yellowhammer and the grey partridge are accepted as focal species to refine the assessment of the risk to insectivorous and herbivorous birds respectively in beans. An acceptable risk was identified with refinements of PD in both scenarios. Based on the first tier risk assessment the acute risk to herbivorous mammals can be considered as low for all representative uses evaluated.. A refined long term risk assessment was needed for all representative uses. In a refined risk assessment the hare is used as focal species in beans and the bank vole is used for the representative uses in pome fruit and grapevine. The risk to mammals in beans can be considered low based on the hare, unattractiveness of crop, and an interception factor of 0.7. The risk to bank vole is considered low for uses in orchards and vine yard, based on a refined PD. The risk from secondary earthworm and fish poisoning is considered low for both birds and mammals Furthermore the risk to birds and mammals from ingestion of contaminated drinking water is considered low. Fenpyroximate is very toxic to aquatic organisms both on an acute as on a chronic time scale. A similar toxicity to fish, algae and aquatic invertebrates was observed. The higher tier toxicity test with fish in the present of sediment was accepted as the relevant endpoint in the aquatic risk assessment. Based on the available data the risk to aquatic organisms is considered low in all FOCUSsw Step 4 scenarios for all uses if sufficient non spray buffer zones are included. Buffer zones of 70 m, 45 m and 20 m are required for pome fruit, vine and bean respectively. The conclusion of the aquatic risk assessment may however change, as a data gap was identified for a fish full life cycle study. The risk from M-3 and M-8 to aquatic organisms is considered low. A BCF of 1601 was experimentally derived for whole fish. The risk to bees is considered low. A data gap is identified for a study to address the in-field risk to A. rhopalosiphi. The in-field risk to T pyri is considered to be low, as the off-field risk is considered to be low for all non-target arthropods if buffer zones up to 5 meter are applied. The risk to earthworms is considered to be low both for the parent and the metabolites M-3 and M-11. Also the risk to non-target marcro-organisms, non-target micro-organisms and non-target plants is considered low.