Chemical name: Benzenamine, 2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- 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 trifluralin. Trifluralin is not included in the list of approved active substances under Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, which replaces Directive 91/414/EEC. A first decision not to include trifluralin in Annex I to Directive 91/414/EEC (i.e. the list of approved active substances) was adopted in 2007 (Commission Decision 2007/629/EC). The original notifier submitted a new application for approval of the active substance. A second decision (Commission Decision 2010/355/EU) confirmed the non-inclusion of trifluralin in the list of approved active substances in Annex I to Directive 91/414/EEC. No authorisations for plant protection products containing trifluralin are allowed to be granted by the Member States and all uses of plant protection products containing trifluralin are prohibited. The reasons for the final regulatory action were relevant to: Environment Summary of known hazards and risks to human health: The initial review report established in 2007 refers to concerns about the consumer exposure for non-cereal applications since the information available was insufficient to satisfy the requirements set out in Annex II and Annex III Directive 91/414/EEC. In order to reduce the risk to consumers, the notifier only supported applications on oil-seed rape during the re-submission procedure. The estimated operator exposure was below the AOEL only if PPE (gloves) is used during mixing and loading as well as during application (gloves and coverall) (EFSA, 2009). Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products containing trifluralin. Summary of known hazards and risks to the environment: The initial evaluation raised concerns on: - high risk for aquatic organisms (especially fish), - toxicity of certain metabolites to sediment dwelling organisms, - high persistence in soil, - high potential for bioaccumulation, and - the potential for long range transport via air. The additional data and information provided in the second application did not permit the elimination of all these concerns, except the risk for sediment dwelling organisms through certain metabolites which was assessed as low. The potential high risk for aquatic organisms, especially the chronic risk to fish, could not be solved due to shortcomings in the newly submitted studies. No data on the exposure pattern were available, which did not make it possible to conclude the chronic risk assessment for fish; and the surface water risk assessment could not be finalised. In addition, the potential for long range transport via air was not adequately elucidated, as the information produced was of an obsolete nature, and the assessment could thus not be finalised. Expected effect of the final regulatory action in relation to the environment: Reduction of risk from the use of plant protection products containing trifluralin. Date of entry into force of the final regulatory action: 26/06/2010 Entry into force of Commission Decision 2010/455/EU of 25 June 2010 is 26 June 2010. The initial decision of non-inclusion of 2007 entered into force completely on 29 March 2009 when all uses of plant products containing trifluralin were prohibited as from that date at the latest. |