Hymexazol 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 Finland being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicant's decision, in accordance with Article 11e, to withdraw support for the inclusion of hymexazol in Annex I to Council Directive 91/414/EEC. Following the Commission Decision of 11 December 2008 (2008/934/EC)(5) concerning the non-inclusion of hymexazol in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant Mitsui Chemicals Agro INC. made a resubmission application for the inclusion of hymexazol 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, Finland 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 17 September 2009. In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the Additional Report to Member States for comments on 22 September 2009. The DAR was also distributed to Member States and the applicant for comments in view of the fact that the original peer review had been terminated following the applicant's notification of withdrawal of support. The EFSA collated and forwarded all comments received to the Commission on 5 November 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, residues, and ecotoxicology and deliver its conclusions on hymexazol. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of hymexazol as a fungicide on sugar beet and tomato, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report. In the mammalian toxicology section, no data gap or area of concern were identified. Insufficient residues data were available to finalise a risk assessment for the use on sugar beet. The residues data available for greenhouse tomato uses indicated no chronic or acute concern for soil grown tomatoes, however an exceedance of the ARfD was noted for hydroponically grown tomatoes. Hydrolysis studies to confirm the nature of residues in processed commodities are required for all tomato uses. Rotational crop studies are required to finalise the risk assessment for outdoor uses on tomatoes. The data available on environmental fate and behaviour in the environment are sufficient to carry out the required environmental exposure assessments at the EU level for the representative uses. The potential for groundwater exposure above the parametric drinking water limit of 0.1 mu g/L was assessed as low for the use as a sugar beet seed treatment. For the uses on tomatoes, a high potential for groundwater contamination by the active substance hymexazol was identified in vulnerable situations, with 3 out of the 4 pertinent FOCUS groundwater scenarios being predicted to exceed the parametric drinking water limit of 0.1 mu g/L. Only in the Porto scenario concentrations were <0.1 mu g/L. In the other 3 scenarios concentrations in the range 0.3-9.898 mu g/L were estimated. An assessment representing actual hydrological conditions in glasshouses has not been submitted, however, with the information available, it also has to be concluded that there is a high potential for groundwater contamination by hymexazol, from the uses on glasshouse tomatoes. The first tier short-term TER values for insectivorous birds were above the Annex VI trigger of 10, indicating a low short-term risk for the representative uses. The first-tier acute and long-term TER values were below the Annex VI triggers, indicating a potential high acute and long-term risk to insectivorous birds for the use in tomato. The refinement of the acute and long-term risk assessment for insectivorous birds was based on a refined RUD. The acute TER values were above the trigger values, indicating a low acute risk for insectivorous birds. However, the long-term TER values were below the Annex VI trigger values, indicating a high long-term risk for insectivorous birds for the outdoor use in tomato. The first tier acute and short-term TER values for granivorous birds and mammals were below the Annex VI trigger values, indicating a potential high risk for the use in sugar beet. The Member State experts agreed that the restriction phrases SP5 and SP6 are necessary for the use in sugar beet in order to address the acute and short-term risk for granivorous birds and mammals. The long-term risk to granivorous birds and mammals was not addressed in the DAR. Member State experts identified a data gap for the long-term risk for granivorous birds and mammals for the use in sugar beet. The acute and chronic risk to mammals for the use in tomato was assessed as low. The TER values for aquatic organisms were above the Annex VI trigger values, indicating a low risk to aquatic organisms for the use in tomato and in sugar beet. However, with respect to the metabolite 5-methyl-2(3H)-oxazolone, a high risk was identified for aquatic invertebrates and sediment-dwelling organisms for the outdoor tomato use, and a data gap is identified. The risk to bees, non-target arthropods, earthworms, soil non-target micro-organisms, non-target plants and biological methods of sewage treatment was assessed as low.
