Conclusion on the peer review of the pesticide risk assessment of the active substance dicloran European Food Safety Authority

Dicloran is one of the 79 substances of the third stage part A of the review programme covered by Commission Regulation (EC) No. 1490/2002(3), as amended by Commission Regulation (EC) No. 1095/20074. In accordance with Article 10(1) of the Regulation, Spain, being the designated rapporteur Member State (RMS), provided an initial evaluation of dicloran in the format of a Draft Assessment Report (DAR), which was received by the EFSA on 22 July 2005. The Commission of the European Communities (hereafter referred to as 'the Commission') examined dicloran in accordance with Article 11a of the Regulation and it was concluded that there were clear indications of harmful effects, leading to the adoption of a decision on non-inclusion in Annex I to Council Directive 91/414/EEC, in accordance with Articles 11f and 12 of the Regulation. Following the Commission Decision of 18 September 2008 (2008/744/EC)(5) concerning the non-inclusion of dicloran in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant Gowan Comercio Internacional e Servicos, Limitada (Margarita International) made a resubmission application for the inclusion of dicloran 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 conclusions leading to the Decision on non-inclusion, as set out in the Review Report (SANCO/1340/08 - rev.0). In accordance with Article 18 of Commission Regulation (EC) No. 33/2008, Spain, 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 6 October 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 8 October 2009. The EFSA collated and forwarded all comments received to the Commission on 30 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 and fate and behaviour in the environment, and deliver its conclusions on dicloran. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of dicloran as a fungicide on tomatoes, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report. There are no critical areas of concern in the physical-chemical properties section. Data gaps are identified in relation to relevant impurities. Two critical areas of concern are identified in the section for mammalian toxicology: the compliance of batches tested in the data package submitted compared to the proposed specification could not be proven, and the estimated exposure for re-entry workers exceeds the acceptable operator exposure level (AOEL), even with the use of personal protective equipment. In the residues area, for the specific use on tomatoes, the pertinent issues for consumer risk assessment have been reasonably addressed for the primary crop. For rotational crops and food of animal origin further consideration is necessary. Further data are required to confirm residue levels in following crops, including fruit crops. A risk assessment considering residues in following crops and in animal commodities is required. The implications for the consumer risk assessment are currently unknown. The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses. However, the characterisation/identification of a fraction of unidentified degradates formed in the aqueous photolysis study was not available. The potential for groundwater contamination by dicloran above the parametric drinking water limit of 0.1 mu g/L consequent to the representative uses was assessed as low. The risk to aquatic organisms was assessed as low for the representative use on glasshouse tomatoes. Risk mitigation is required to address the risk to aquatic organisms for FOCUSsw scenario R2 and R3 for the representative use on outdoor tomatoes. It was not possible to identify a low risk for fish and invertebrates in the additional (relevant) FOCUSsw scenario R4 and D6, based on the data available. It was not possible to finalise the risk assessment for aquatic organisms from exposure to photodegradates of dicloran, based on the data available, for any of the representative uses. It remains to be verified whether the mixtures of photodegradates tested on fish, daphnia and algae are representative for field situations. It was not possible to finalise the risk assessment for non-target soil macro-invertebrates for the field use on tomatoes, based on the data available. The risk to birds, mammals, bees, earthworms, non-target soil micro-organisms, non-target plants, and the function of waste water treatment plants was assessed as low for the representative uses on tomatoes.