Chemical name: Benzamide, N-[[[4-[2-chloro-4-(trifluoromethyl)phenoxy]-2-fluorophenyl]amino]carbonyl]-2,6-difluoro- 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 flufenoxuron. Flufenoxuron is not included in the list of approved active substances under Regulation (EC) No 1107/2009, which replaces Directive 91/414/EEC. As a consequence, flufenoxuron is not approved for placing on the market pursuant to Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing flufenoxuron was prohibited as of 31 December 2012. 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 it was not demonstrated that it may be expected that,under the proposed conditions of use, plant protection products containing flufenoxuron satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC. During the risk assessment concerns were identified, in particular, as regards the consumer risk assessment. It was not possible to finalise the consumer risk assessment because consumer exposure could not be assessed reliably, in particular, with respect to magnitude and toxicoiogical relevance of different metabolites. Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products containing flufenoxuron. Summary of known hazards and risks to the environment: It was concluded that it was not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing flufenoxuron satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC. The risk assessment on the environment identified a high long-term risk to small herbivorous mammals and a data gap to further address the risk for the representative use on grapevines. A low risk to terrestrial vertebrates through the food chain could not be demonstrated for the use on grapevines. Furthermore the risk to aquatic organisms is considered high for all representative uses; in the case of grapevines even when applying the maximum admissible drift reduction. According to the risk evaluation the potential risk for bioaccumulation along the aquatic food chain could not be considered fully addressed by the available data. Further risk refinement and data were required to assess the risk of flufenoxuron for aquatic organisms. The risk for bees needs to be further assessed and mitigation measures would be needed to avoid any exposure of bees. The risk assessment for non-target arthropods could not be finalised since in-field and off-field recovery of C. carnea was not demonstrated for the representative use on grapevines and needs to be further addressed. A high long-term risk is observed for soil-living organisms (collembola) on the basis of the accumulation in soil, and there is a data gap for the representative use on grapevines. Expected effect of the final regulatory action in relation to the environment: Reduction of risk from the use of plant protection products containing flufenoxuron. Date of entry into force of the final regulatory action: 31/12/2012 Complete entry into force of all provisions of Regulation (EU) No 942/2011 of 22 September 2011 concerning the non-approval of the active substance flufenoxuron, in accordance with Regulation (EC) No 1107/2009 was by 31 December 2012. |