Chemical name: O,O-Dimethyl O-4-nitrophenyl phosphorothioate 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 plant protection product. Use or uses that remain allowed: No known industrial uses. Pesticide use or uses that remain allowed: EC Member States may have granted a period of grace for disposal, storage, placing on the market and use of existing stocks, no longer than 18months from the date of adoption of Commission Decision 2003/166/EC (i.e. until 9 September 2004). 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 parathion-methyl. Parathion-methyl is not included as an authorised active ingredient in Annex I to Directive 91/414/EEC. The authorisations for plant protection products containing parathion-methyl had to be withdrawn within a period of 6 months from the date of adoption of the Commission Decision 2003/166/EC. From that date, no authorisations for plant protection products containing parathion-methyl could 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: Final regulatory action was taken to protect operators applying plant protection products containing parathion-methyl. The principal issues which lead to these overall conclusions relate mainly to concerns about operator exposure. Exposure scenarios using UK Predictive Operator Exposure Model demonstrated that operator exposure was unacceptable for the proposed uses within the European Community (grapevines and table grapes). The estimated exposure exceeded the acceptable operator exposure level (AOEL) during the mixing/loading and the application operations, even when personal protective equipment (PPE) was worn. Using the German Model, scenarios for high crops/tractor mounted applications were acceptable using PPE, but not for high crops/hand held scenarios. A safe use for consumers exposed to potential residues resulting from the use of these plant protection products was not demonstrated. No metabolism data relevant to grapes (and processed products) were available. The notifier provided data on several crop residues, from which no extrapolation was possible, thus preventing an adequate risk assessment . Moreover this was not considered necessary as it was already demonstrated that the use of parathion -methyl was not safe for operators, which was sufficient grounds to take the final regulatory action. Expected effect of the final regulatory action in relation to human health: Complete reduction of risk from plant protection uses. Summary of known hazards and risks to the environment: Final regulatory action was taken to protect non-target organisms. Concerns were identified with regard to: - Insectivorous birds: the acute and long-term risk was found unacceptable following the use of parathion-methyl on vines at the application rate of 0.3 kg a.s./ha, based on technical material data. - Herbivorous mammals: the acute risk was found unacceptable following the use of parathion-methyl on vines at the application rate of 0.3 kg a.s./ha, based on technical material data. The risk associated with the use of microencapsulated formulation was acceptable. - Aquatic vertebrates: The risk evaluation based on data from both technical material and formulations found an unacceptable risk at the application rate of 0.3 kg a.s./ha on vines. The risk could be acceptable when mitigation measures (buffer zone) were used. - Aquatic invertebrates: The acute and chronic risk associated with the use of both technical material and microencapsulated formulations was unacceptable at the application rate of 0.3 kg a.s./ha on vines, even when a buffer zone of 50 m was considered. - High toxicity was recorded for non-target arthropods, and the long-term risk to earthworms was unacceptable. Expected effect of the final regulatory action in relation to the environment: Complete reduction of risk from plant protection uses. Date of entry into force of the final regulatory action: 09/09/2003 Authorisations for plant protection products containing parathion-methyl had to be withdrawn within a period of six months from the date of the final regulatory action. |