Chemical name: O,S-dimethyl phosphoramidothioate Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Severely Restricted Use or uses prohibited by the final regulatory action: Part A of the Annex to Commission Directive 2006/131/EC provided for one single use on potato that was in principle allowed in the European Union and specified a maximum application rate and number of applications of the active substance, which means that Member States were allowed to grant national authorisations within those limits. All other uses not included in that list, i.e. other crops and higher rates of the active substance, were prohibited. In addition, the following uses were not allowed to be authorised by Member States: - air application, - knapsack and all hand-held applications, neither by amateur nor by professional users, - home gardening. Pesticide use or uses that remain allowed: Methamidophos was only allowed to be used on potatoes. The following conditions of use had to be respected: - At rates not exceeding 0.5 kg active substance per hectare per application, - Maximum 3 applications per season. Member States were requested to ensure that all appropriate risk mitigation measures were applied. Particular attention had to be paid to the protection of: - birds and mammals. Conditions of authorisation needed to include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, - aquatic organisms and non-target arthropods. An appropriate distance had to be kept between treated areas and surface water bodies as well as margins of the crop. This distance could depend on the application or not of drift reducing techniques, - operators, who needed to wear suitable protective clothing, in particular gloves, coveralls, rubber boots and respiratory protective devices during mixing and loading, and gloves, coveralls, rubber boots and face protection or safety glasses during application and cleaning of equipment. The above measures had to be applied, unless the exposure to the substance was adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Commission Directive 2006/131/EC of 11 December 2006 amending Directive 94/414/EEC severely restricted the placing on the market and use of plant protection products containing methamidophos. The Commission Directive amended Annex I to Directive 91/414/EEC (which was replaced by Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market) to permit the use of methamidophos from 1 January 2007 to 30 June 2008. It also set in place restrictions on the use of methamidophos. The Directive imposed on the Member States a requirement to review all authorisations of methamidophos to ensure that the restrictions set in Directive 2006/131/EC were respected as of 30 June 2007. It also required a re-evaluation of products containing methamidophos by 30 June 2008. The restrictions limited the application of methamidophos to only one specific crop (potato) and defined a maximum application rate and number of applications. It also prohibited specific uses and limited the period of inclusion of methamidophos in Annex I to Directive 94/414/EEC to 18 months after entry into force of Directive 2006/131/EEC on 1 January 2007. It should be noted that this period has now expired. As of 30 June 2008, methamidophos is no longer included in the list of authorised substances in Annex I. Hence, methamidophos is no longer allowed to be used as plant protection product in the European Union. 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 could be expected that plant protection products containing methamidophos would fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. This conclusion was however subject to compliance with the particular requirements in sections 4, 5, 6 and 7 of the review report, as well as to the implementation of the provisions of Article 4(1) and the uniform principles laid down in Annex VI of Directive 91/414/EEC, for each methamidophos containing plant protection product for which Member States would grant or review the authorisation. Therefore, Member States were requested to pay particular attention to the protection of operators who had to wear suitable protective clothing during mixing-loading and gloves, coveralls, rubber boots and face protection or safety glasses during application and cleaning of equipment. The above measures had to be applied, unless the exposure to the substance was adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. Member States were requested to ensure that the authorisation holders report at the latest on 31 December of each year on any reported effect on operator health. Member States could require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of methamidophos could be obtained. Methamidophos is a cholinesterase inhibitor characterised by high acute toxicity. Methamidophos is classified "T+ - Very toxic" (Directive 67/548/EEC) and "Acute Tox. 2" (Regulation (EC) 1272/2008 implementing the GHS system). The use of methamidophos may entail certain risks for consumers. Deterministic models indicated high risk for chronic and acute dietary intake especially for toddlers (consumption values taken from UK diet). The highest contributions to chronic risk came from consumption of plum fruit and tomatoes and the acute risk (ARfD) was high for all crops except for broccoli, cauliflower, cabbage and potato. A probabilistic model showed no acute risk. Intended uses have been reduced and new processing factors added. Based on the new list of uses, the deterministic model for estimating the chronic and acute intake of methamidophos through the diet did not show any risk for the general population. Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products containing methamidophos. Summary of known hazards and risks to the environment: It was concluded that it could be expected that plant protection products containing methamidophos would fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. This conclusion was however subject to compliance with the particular requirements in sections 4, 5, 6 and 7 of the review report, as well as to the implementation of the provisions of Article 4(1) and the uniform principles laid down in Annex VI of Directive 91/414/EEC, for each methamidophos containing plant protection product for which Member States would grant or review the authorisation. Therefore, Member States were requested to ensure that all appropriate risk mitigation measures were applied. Member States were requested to pay particular attention to the protection of - birds and mammals. Conditions of authorisation needed to include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, - aquatic organisms and non-target arthropods. An appropriate distance had to be kept between treated areas and surface water bodies as well as margins of the crop. This distance could depend on the application or not of drift reducing techniques. The risk assessment revealed that toxicity/exposure ratios for a range of scenarios and aquatic and terrestrial organisms indicated acute and long-term concern for birds and acute risk for mammals for the use of methamidophos in potato fields. There was also acute and long-term risk for the aquatic organism, Daphnia magna, with methamidophos use in field and orchard crops and vegetables. The risk to beneficial arthropods was also high. Further evaluation was conducted as to the consumption of methamidophos in the field by yellow wagtails and wood mice after reduction of insects by the insecticide. It was considered that consumption of dead insects would still take place. The role of avoidance by these animals (reduced consumption) of food treated with methamidophos was also considered but it appeared possible that feeding might be rapid enough for mortality to occur in field conditions. Preliminary consideration also suggested that other routes of exposure (drinking, dermal exposure and overspray of nesting birds) might be higher than risk from dietary exposure. Expected effect of the final regulatory action in relation to the environment: Reduction of risk to the environment (e.g. birds, mammals and aquatic organisms) from the use of plant protection products containing methamidophos. Date of entry into force of the final regulatory action: 01/07/2007 Commission Directive 2006/131/EC entered into force on 1 January 2007. However, Member States had to apply the provisions of this Directive from 1 July 2007. |