Chemical name: Acetamide, 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)- 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: No Summary of the final regulatory action: It is prohibited to place on the market or use plant protection products containing acetochlor in the European Union. Acetochlor is not approved for placing on the market pursuant to Regulation (EC) No 1107/2009 concerning the placing of the plant protection products on the market (which replaces Directive 91/414/EEC). All authorisations for plant protection products containing acetochlor had to be withdrawn by the Member States by 23 June 2012 and all uses of plant protection products containing acetochlor are prohibited as of 23 June 2013 at the latest. 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 plant protection products containing acetochlor satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC. According to the risk assessment related to human health the followin concerns were identified: - The potential human exposure is above 100% of the ADI when predicted concentrations of the ground water metabolites t-oxanilic acid, t-sulfinylacetic acid, t-sulfonic acid and s-sulfonic acid that have been concluded as relevant metabolites are taken into account. - There is a potential human exposure to metabolite t-norchloro acetochlor when surface water is abstracted for drinking water, which has been concluded as relevant from a toxicological hazard assessment perspective. In addition, the toxicological data for t-norchloro acetochlor indicate that it is genotoxic. -A high potential for groundwater contamination has been identified over significant areas of the EU by the metabolites t-oxanilic acid, t-sulfinylacetic acid, t-sulfonic acid and s-sulfonic acid, which have been concluded as relevant metabolites. -No valid method is available to quantity residues in food of plant origin. Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products containing acetochlor. Summary of known hazards and risks to the environment: It was concluded that it was not demonstrated that it may be expected that plant protection products containing acetochlor satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC. Pursuant the risk assessment related to the environment the following concerns were identified: - Acetochlor is very toxic to all groups of aquatic organisms. - A high acute risk to birds from uptake of contaminated drinking water was indicated for the post emergence applications. - There is a high risk to non-target terrestrial plants. The risk assessment suggests that an in-field no spray buffer zone of 5m is required to protect non target plants in the off-field area. - A high long term risk for herbivorous birds has been identified. Expected effect of the final regulatory action in relation to the environment: Reduction of risk from the use of plant protection products containing acetochlor. Date of entry into force of the final regulatory action: 23/06/2013 |