Chemical name: 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 products. Pesticide use or uses that remain allowed: None. 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 dimethenamid. Dimethenamid is not included in the list of authorized active ingredients in Annex I to Directive 91/414/EEC. The authorizations for plant protection products containing dimethenamid had to be withdrawn by 22 June 2007. From 28 December 2006 no authorizations for plant protection products containing dimethenamid 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 consumers has not been considered to be sufficiently assessed. The lack of data observed on toxicity of breakdown products might also be an issue in term of endangerment to consumers and workers. The estimated operator exposure is above the AOEL for UK-POEM even with protective equipment (gloves during mixing and loading and application) but below the AOEL according to the German model when using appropriate protective equipment (gloves during mixing and loading and application and coverall during application). On the basis of the data submitted for the risk assessment under Directive 91/414/EEC, the following classification and labeling was proposed for dimethenamid: Xn (Harmful); R22 (harmful if swallowed), R43 (may cause sensitization by skin contact). Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection product Summary of known hazards and risks to the environment: A high first tier risks to insectivorous birds for both representative uses and to medium herbivorous mammals in maize were identified in the assessment according to the current guidance. A high risk was also identified for algae and aquatic macrophytes. Buffer zones of 20 m are required for the proposed application rates in maize. Although the acute toxicity is low, a long-term risk to earthworms cannot be excluded. The parent compound, dimethenamid, is unlikely to contaminate groundwater when used as recommended. However, metabolites could be present in shallow vulnerable groundwater at concentrations greater than 0.1 g/l, and could be expected at levels up >0.75 g/l. Under very extreme worst case leaching conditions, it could not be excluded that the metabolite M27 could be present in shallow vulnerable groundwater at >10 g/l 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: 28/12/2006 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 22 June 2008. |