Chemical name: 2,3-dihydro-2,2-dimethylbenzofuran-7-yl 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 uses as plant protection products. 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 carbofuran. Carbofuran is not included in the list of approved active ingredients under Regulation (EC) No 1107/2009, which replaces Directive 91/414/EEC. The authorizations for plant protection products containing carbofuran had to be withdrawn by 13 December 2007. As of 16 June 2007, no authorisations for plant protection products containing carbofuran could be granted or renewed. 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 carbofuran was not demonstrated to fulfil the safety requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC (replaced by Regulation (EC) 1107/2009). The consumer risk assessment, which raised a concern about the acute exposure of vulnerable groups of consumers, in particular children, could not be finalised due to the lack of information as regards certain relevant residues (EFSA, 2006). The consumer risk assessment mentioned above has been superseded by an updated risk assessment based on new data. The sum of intakes of carbofuran and 3-hydroxy carbofuran from crops was compared with the toxicological reference values for carbofuran. An exceedance of the ADI was noted for toddlers in two models. The acute consumer risk assessment indicates that the ARfD is significantly exceeded for a number of crops consumed by children and by adults/the general population (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 carbofuran was not demonstrated to fulfil the safety requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC (replaced by Regulation (EC) 1107/2009). The environmental risk assessment identified a number of concerns with regard to ecotoxicology. The risk for ground water contamination was assessed to be high, but could not be concluded, in particular because the data did not provide sufficient information about a number of metabolites which have a hazardous profile. Furthermore, concerns remain as regards the risk assessment for birds and mammals, aquatic organisms, bees, non-target arthropods, earthworms, and soil non-target organisms. Expected effect of the final regulatory action in relation to the environment: Reduction of risk from the use of plant protection products containing carbofuran. Date of entry into force of the final regulatory action: 13/12/2008 Complete entry into force of all provisions of Commission Decision 2007/416/EC of 13 June 2007 was 13 December 2008 since all uses of plant protection products containing carbofuran were prohibited as from that date at the latest. |