Chemical name: 2,3-dihydro-2,2-dimethylbenzofuran-7-yl (dibutylaminothio)methylcarbamate Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All applications as a plant protection product. Pesticide use or uses that remain allowed: Not relevant. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: It is prohibited to place on the market or use plant protection products containing carbosulfan. Carbosulfan is not included in the list of approved active substances under Regulation (EC) No 1107/2009, which replaces Directive 91/414/EEC. Authorisations for plant protection products containing carbosulfan had to be withdrawn by 13 December 2007. As of 16 June 2007 no authorizations for plant protection products containing carbosulfan were allowed to be granted or renewed by the Member States and all uses of plant protection products containing carbosulfan were prohibited as from 13 December 2008. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: It was concluded that carbosulfan was not demonstrated to fulfil the safety requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC. Certain metabolites with a hazardous profile appear with the use of carbosulfan. Some of these metabolites could be genotoxic. Due to uncertainties on this issue, and based on the current knowledge and the available data, risks regarding the exposure of consumer could not be excluded. In addition, impurities, of which at least one is carcinogenic (N-nitrosodibutylamine) were found in the substance as sold in the market (technical substance) at levels raising concerns. Moreover, the presence of unknown levels of carcinogenic impurities in the technical substance may increase during storage. The data provided by the notifier were not sufficient to address concerns on this issue and thus to assess the risk for operators in an adequate manner. The further review in 2009 noted possible exceedance of the Acceptable Daily Intake by toddlers and acute risk to children and adults from consumption of a number of crops. Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products. Summary of known hazards and risks to the environment: It was concluded that carbosulfan was not demonstrated to fulfil the safety requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC. The evaluation raised concerns regarding a possible risk to groundwater, due to a potential contamination of groundwater by the parent substance and by a number of relevant metabolites. In addition, the risk to birds and mammals, aquatic organisms, bees and earthworms could not be sufficiently assessed due to a lack of substantial data. Therefore, concerns remain as regards the risk assessment for these species. Additional data were available in the 2009 review which allowed addressing further elements of the risk assessment. There was a risk to birds and mammals from the uptake of residues in contaminated food items. Carbosulfan is toxic to bees and non-target arthropods although the risk was considered low for the representative uses that were evaluated. The risk to aquatic organisms, soil microorganisms and plants was considered low for the representative uses that were evaluated. Expected effect of the final regulatory action in relation to the environment: Reduction of risk from the use of plant protection products containing carbosulfan. Date of entry into force of the final regulatory action: 13/12/2008 Complete entry into force of all provisions of Commission Decision 2007/415/EC of 13 June 2007 is 13 December 2008 since all uses of plant products containing carbosulfan were prohibited as from that date at the latest. |