Pyraclostrobin was included in Annex I to Directive 91/414/EEC on 01 June 2004, which is before the entry into force of Regulation (EC) No 396/2005 on 02 September 2008. EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(2) of afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Germany, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 03 April 2009 and, after having considered several comments made by EFSA, the RMS provided on 19 January 2010 a revised PROFile. Based on the conclusions derived in the framework of Directive 91/414/EEC under the supervision of the European Commission, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS, EFSA issued on 23 February 2011 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 29 April 2011 were considered for finalisation of this reasoned opinion. The following conclusions are derived. The toxicological profile of pyraclostrobin was evaluated in the framework of Directive 91/414/EEC. The ADI and the ARfD were established at 0.03 mg/kg bw/d and 0.03 mg/kg bw respectively. Primary crop metabolism of pyraclostrobin was investigated in three different crop groups following foliar applications. Metabolic patterns in the different studies were shown to be similar and the relevant residue for enforcement and risk assessment in all plant commodities treated by foliar application could be defined as pyraclostrobin. Validated analytical methods for enforcement of this residue definition are available with a LOQ of at least 0.02 mg/kg in hops, high oil content, high water content, acidic and dry commodities. These methods were however not validated for coffee beans. Further validation in this commodity is therefore still required. Regarding the magnitude of residues in all crops reported by the RMS, at least one GAP or import tolerance was supported by a sufficient number of supervised residue trials, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive appropriate MRLs, except for peppers, cotton seed and celery. In these three crops, the number of residue trials was not compliant with the minimum data requirements defined by EU guidance documents. EFSA was therefore not able to derive reliable MRL proposals and further residues trials are required. Moreover, the MRL derived for coffee beans is considered tentative only because there is no analytical method available for enforcement of this commodity. In processed commodities, pyraclostrobin residues were shown to be stable during pasteurisation, cooking, brewing and sterilisation. The relevant residue for enforcement and risk assessment in processed commodities is therefore expected to be the same as for primary crops. Magnitude of residues in processed commodities was also investigated and reliable processing factors were derived for beer, peeled melons, several commodities derived from cherries (canned, juice), plums (prunes, jam) and wine grapes (juice, wet pomace, must, white wine). With regard to the risk assessment, further processing studies are not required because they are not expected to affect the outcome of the risk assessment. However, if there would be the intention from risk managers to derive more processing factors for enforcement purposes, additional processing studies might be required. The potential incorporation of soil residues into succeeding and rotational crops was investigated in radish, lettuce and wheat. These studies showed a comparable metabolism as the one in primary crops and significant residues in rotational crops are not expected, provided that pyraclostrobin is applied according to the GAPs supported in the framework of this review. Based on the uses reported by the RMS, significant exposures to pyraclostrobin are expected for dairy ruminant, meat ruminants and pigs. Metabolism in lactating ruminants and poultry was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant residue definition for enforcement was defined as pyraclostrobin. For risk assessment the relevant residue definition was therefore defined as the sum of pyraclostrobin and its metabolites containing the 1-(4-chlorophenyl)-1H-pyrazole moiety or the 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazole moiety, expressed as pyraclostrobin, with a conversion factor of 4 on ruminant liver and 1 on all other commodities. A validated analytical method for enforcement of this definition in foods of animal origin is also available with a LOQ of 0.01 mg/kg in milk and 0.05 mg/kg in animal tissues and eggs. Available studies also demonstrated that residues of pyraclostrobin are not expected in significant amounts and that MRLs in poultry, pigs and ruminants can be set at the se LOQs. Both chronic and acute consumer exposure resulting from the MRLs proposed in the framework of this review were calculated. For those crops where appropriate MRLs and risk assessment values could not be derived, the existing EU MRL was considered instead. Based on these calculations, an exceedance of the ARfD was identified for scarole, table grapes and peppers, representing 236.1 %, 166.3 % and 109.2 % of the ARfD respectively. Considering the fall-back MRLs resulting from the northern outdoor GAP for scarole, the southern outdoor GAP for table grapes, and a less critical indoor use for peppers, the highest chronic exposure represented 12.6 % of the ADI (German child) and the highest acute exposure amounted to 96.4 % of the ARfD (globe artichokes). Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for pyraclostrobin. Additional calculations of the consumer exposure, including these CXLs (except those for products of animal origin as they were established on the basis of the metabolism study), were therefore performed and exceedances of the ARfD were identified for the existing CXLs in grapes (180.7 %), kale (137.5 %) and peaches (124.6 %). Excluding CXLs for these commodities from the calculation, the highest chronic exposure represented 13.3 % of the ADI (German child) and the highest acute exposure amounted to 96.4 % of the ARfD (globe artichokes). Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with the decision tree reported in Appendix D (see table below for a summary). All MRL values listed as Recommended? in the table are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see table footnot es for details). In particular, certain existing EU MRLs still needs to be confirmed by submission of the following data: 8 residues trials complying with the import tolerance GAP on cotton seed; 8 trials supporting the southern FR GAP on grapes (data gap resulting from a fall back GAP); 4 residues trials complying with the import tolerance GAP on celery; a validated method for enforcement of pyraclostrobin in coffee beans. It is highlighted that some of the 'Recommended' MRLs resulted from a CXL or from a GAP in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the recommended MRLs but which might have an impact on national authorisations: 8 residues trials supporting the northern outdoor GAP and 8 residues trials supporting the indoor GAPs on strawberries; 2 residues trials on blueberries, gooseberries or currants supporting the northern outdoor GAP on blueberries, gooseberries and currants; 8 residues trials supporting each import tolerance GAP on pome fruits , carrots, tomatoes, aubergines, peppers and lettuce; 8 residues trials supporting the northern outdoor GAP on potatoes; 4 residues trials supporting the northern outdoor GAP on lamb's lettuce; 4 residues trials supporting the northern outdoor GAP and 4 residues trials supporting the southern outdoor GAP on cress, land cress, rocket, rucola, red mustard and leaves and sprouts of Brassica spp; 4 residues trials supporting the southern outdoor GAP on leek. If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level or to further monitor the import of products treated with pyraclostrobin from third countries. Minor deficiencies were also identified in the assessment but these deficiencies are not expected to impact either on the validity of the Recommended MRLs or on the national authorisations. The following actions and/or data are therefore considered desirable but not essential: 4 trials on apricots compliant with the outdoor GAPs on peaches and apricots (data gap resulting from a new extrapolation rule); reporting of the separate northern and southern residues trials datasets on apricots, peaches, cherries and plums; confirmation that residue trials samples and livestock feeding samples were stored in compliance with demonstrated storage stability; residue trials supporting the GAPs on mangoes and papaya carried out with analytical methods achieving a LOQ of 0.02 mg/kg. [GRAPHICS]
