Chemical name: Acetamide, 2-chloro-N-(2,6-diethylphenyl)-N-(methoxymethyl)- 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 the applications as 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 alachlor. Alachlor is not included in the list of authorized active substances in Annex I to Directive 91/414/EEC. The authorizations for plant protection products containing alachlor have to be withdrawn by 18 June 2007. From 19 December 2006 no authorizations for plant protection products containing alachlor can 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: Exposure of operators, workers and bystanders has not been considered to be sufficiently addressed with the available information. Alachlor has been classified as carcinogenic category 3, R40. The PPR Panel considered that it was extremely unlikely that concentrations of an active metabolite, which was considered harmful, would be achieved to initiate the chain of events terminating in cancer. Though extremely unlikely, it cannot be discarded that nasal tumors are relevant to humans. The calculations based on the UK and German operator exposure assessment models gave values higher than the AOEL for all uses of Lasso EC and Reneur, even when adequate PPE is worn during the operation of mixing, loading and application. Therefore, these calculations indicate an unacceptable risk to the operator for all uses of alachlor for which data were submitted. General exposure has also been assessed using values generated by a biomonitoring study in which absorbed dose of Lasso EC was as follows: Table 1 Absorbed dose of Lasso EC obtained from Canadian biomonitoring study Work load (ha/day)Absorbed dose (mg/kg bw/day) 500.008 390.006 100.002 A workload of 39 and 50 ha/day, both give an absorbed dose of greater than the proposed AOEL of 0.0025 mg/kg bw/day. 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: During the evaluation of this active substance, some areas of concern have been identified. It was especially the case for its environmental fate and behaviour, in particular with the formation of a large variety of degradation products, some of which being of toxicological and/or ecotoxicological concern. Alachlor metabolites in groundwater are in this regard a concern since metabolites have been found in groundwater at concentrations higher than 1 and 10 g/l. The assessment of those soil metabolites by the PPR Panel showed no evidence of toxicity for some of them. However, the toxicity and genotoxicity of others (85, 76, 51 and 25) could not be adequately tested by the Panel, due to inadequate databases, meaning that uncertainty remains as to the danger of these metabolites. Alachlor has been proved to be very toxic for aquatic organisms, and may cause long-term adverse effects in the aquatic environment. Using PEC values for the most sensitive aquatic organism, fish, for various exposure scenarios for crop use in Europe (different applications rates and buffer zones and run-off), the Toxicity Exposure Ratios (TER) indicated a potential long-term risk to terrestrial vertebrates (large birds eating grass, mammals) and acute risk to fish, algae and aquatic plants (acute and mesocosm). 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: 19/12/2006 Any period of grace granted by the Member States under Article 4(6) of Directive 91/414/EEC shall be as short as possible and shall expire not later than 18 June 2008 |