Chemical name: ethyl N-[2,3-dihydro-2,2-dimethylbenzofuran-7-yloxycarbonyl(methyl)aminothio]-N-isopropyl-ß-alaninate 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 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 benfuracarb. Benfuracarb 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 Authorisations for plant protection products containing benfuracarb had to be withdrawn by 20 March 2008. As of 21 September 2007 no authorisations for plant protection products containing benfuracarb were allowed to be granted or renewed by the Member States and all uses of plant p'rotection products containing benfuracarb were prohibited as from 20 March 2009. 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 benfuracarb was not demonstrated to fulfil the safety requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC. The use of benfuracarb leads to the presence of the metabolite carbofuran which is considerably more toxic than the parent compound benfuracarb. For the carbofuran residues resulting from The use of benfuracarb, the assessment has raised a concern about the acute exposure of vulnerable groups of consumer in particular children. Due to the lack of data presented by the notifier, the assessment of the risks to consumers is not complete. In order to be protected from potential adverse effects, operators need to use personal as well as respiratory protective equipment (20 ha/day is considered). In a further review in 2009, an updated assessment of acute exposure and risk identified risks for adults and children for exposure to carbofuran and 3-hydroxycarbofuran from consuming flowering, leafy and head brassica (EFSA, 2009). 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 benfuracarb 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 mainly regarding the risks of groundwater contamination from metabolites other than carbofuran, which could not be sufficiently assessed due to lack of data. Furthermore, based on available data, the evaluation underlines that it has not been demonstrated that the risks to birds and mammals, aquatic organisms, ground dwelling organisms, earthworms and other non-target organisms is acceptable. In a further review in 2009, the risk assessment identified a concern for groundwater contamination by the metabolite carbofuran and a high risk to the aquatic environment that could not be excluded for some scenarios. Granules needed to be covered by soil to mitigate the risk to birds from uptake of granules. A high risk to bees could not be excluded if the product was applied to flowering brassicas attractive to bees (EFSA, 2009). Expected effect of the final regulatory action in relation to the environment: Reduction of risk from the use of plant protection products. Date of entry into force of the final regulatory action: 20/03/2009 Complete entry in force of all provisions of Commission Decision 2007/615/EC of 20 September 2007 is 20 March 2009 since all uses of plant products containing benfuracarb were prohibited from that date at the latest. |