Dazomet is one of the 84 substances of the third stage part B of the review programme covered by Commission Regulation (EC) No 1490/2002, as amended by Commission Regulation (EC) No 1095/20074. In accordance with the Regulation, at the request of the Commission of the European Communities (hereafter referred to as,he Commission"), the EFSA organised a peer review of the initial evaluation, i.e. the Draft Assessment Report (DAR), provided by Belgium, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicants decision, in accordance with Article lie, to withdraw support for the inclusion of dazomet in Annex Ito Council Directive 91/414/EEC. Following the Commission Decision of 5 December 2008 (2008/934/EC)5 concerning the non inclusion of dazomet in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant Kanesho Soil Treatment SPRL/BVBA made a resubmission application for the inclusion of dazomet in Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No. 33/20086. 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, Belgium, 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 10 December 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 11 December 2009. The EFSA collated and forwarded all comments received to the Commission on 25 January 2010. 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 environmental fate and behaviour and ecotoxicology, and deliver its conclusions on dazomet. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of dazomet as a soil fumigant (nematicide, fungicide, herbicide, insecticide) on lettuce, strawberries and soil-grown tomatoes, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report. No data gaps or critical areas of concern are identified in the section identity, physical and chemical properties and analytical methods. A critical area of concern (and a related data gap) is identified with regard to the compliance of the batches tested in mammalian toxicology with the proposed specification. In addition, the operator and worker exposure assessment in greenhouses could not be finalised. \ Based on the metabolism studies performed in fruit crops (tomato, strawberry), root crops (radish), and leafy crops (cabbage), the residue for monitoring and risk assessment was defined by default as methyl isothiocyanate (MITC) alone. No residues were detected in the supervised residue trials and MRLs were proposed at the LOQ (0.01 mg/kg) for all representative uses. The Theoretical Maximum Daily Intake (TMDI) is less than 1% of the Acceptable Daily Intake (ADI) for all diets included in the EFSA PRIMo model, and the maximum acute intake is less than 2 % of the Acute Reference Dose (ARfD). Reliable soil degradation half-lives and kinetic formation fractions for the relevant metabolite MITC are not available. This missing information combined with uncertainty in the available groundwater modelling due to the volatile nature of MITC results in a critical area of concern, as the available assessments provide less robust reassurance that groundwater contamination can be avoided from the representative uses assessed, than is the normal case for regulatory leaching assessments. A critical area of concern is also identified over the potential for long-range atmospheric transport of MITC. Two data gaps are identified in the ecotoxicology section. The acute risk assessment to insectivorous birds for the representative field uses could not be finalised with the available data. Risk mitigation measures are required to address the risk from MITC to aquatic organisms (exposure via deposition).
