Chemical name: 5-Pyrimidinemethanol, .alpha.-(2-chlorophenyl)-.alpha.-(4-chlorophenyl)- 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 2006/134/EC provided for a list of uses (crops and maximum quantity of the active substance) that were in principle allowed, 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 quantities of the active substance, were prohibited. In addition, the following uses were not allowed to be authorised by Member States: - air application, - knapsack and hand-held applications by amateur users, - home gardening. Pesticide use or uses that remain allowed: The use of plant protection products containing fenarimol was only authorised as a fungicide on tomatoes, peppers in greenhouses, aubergines, cucumbers in greenhouses, melons and ornamentals, nursery trees and perennial plants. The rates were not allowed to exceed: - 0.058 kg a.s. per hectare per application for tomatoes in field and 0.072 kg a.s. per hectare per application for tomatoes in greenhouses, - 0.072 kg a.s. per hectare per application for peppers, - 0.038 kg a.s. per hectare per application for aubergines, - 0.048 kg a.s. per hectare per application for cucumbers, - 0.024 kg a.s. per hectare per application for melons in field and 0.048 kg a.s. per hectare per application for melons in greenhouse, - 0.054 kg a.s. per hectare per application for ornamentals, nursery trees and perennial plants in field and 0.042 kg a.s. per hectare per application for ornamentals in greenhouses. Member States had to ensure that all appropriate risk mitigation measures were applied. Particular attention had to be paid to the protection of: - aquatic organisms. Where relevant, an appropriate distance had to be kept between treated areas and surface water bodies; - earthworms. Conditions of authorisation had to include risk mitigation measures, - birds and mammals. Conditions of authorisation needed to include risk mitigation measures; - operators, who were required to wear suitable protective clothing during mixing, loading, application and cleaning of the equipment; - workers, who needed to wear suitable protective clothing, in particular gloves, if they had to enter a treated area before the specific re-entry period had expired. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Commission Directive 2006/134/EC of 11 December 2006 amending Directive 91/414/EEC severely restricted the placing on the market and use of plant protection products containing fenarimol. 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 fenarimol from 1 January 2007 to 30 June 2008. It also set in place restrictions on the use of fenarimol. The Directive imposed on the Member States a requirement to review all authorisations of fenarimol to ensure that the restrictions set in Directive 2006/134/EC were respected as of 30 June 2007. It also required a re-evaluation of all authorised plant protection products containing fenarimol by 30 June 2008. The restrictions limited the application of fenarimol to specific crops and defined maximum quantities. It also prohibited specific uses and limited the period of fenarimol's inclusion in Annex I to Directive 91/414/EEC to 18 months after entry into force of Directive 2006/134 on 1 January 2007. It should be noted that this period has now expired. As of 30 June 2008, fenarimol is no longer included in the list of authorised active substances in Annex I. Hence, fenarimol 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 fenarimol 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 fenarimol 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 were required to wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment; - workers, who needed to wear suitable protective clothing, in particular gloves, if they had to enter a treated area before the specific re-entry period has expired. Member States were requested to ensure that the authorisation holders reported at the latest on 31 December of each year on incidences of operator health problems. Member States could require that elements, such as sales data and a survey of use patterns, were provided so that a realistic picture of the use conditions and the possible toxicological impact of fenarimol could be obtained. It was concluded that the effects of fenarimol on male fertility seen in rats were relevant for human risk assessment, although man is less sensitive to aromatase inhibition. With fenarimol, there is a possible risk of impaired fertility, a possible risk of harm to the unborn child and fenarimol may cause harm to breastfed babies. Annex I Part B of the Commission Directive 2006/134/EC recognized that no internationally accepted method of test for endocrine disruptor properties had been agreed at that time. It provided that once the test guidelines on endocrine disruptors under discussion at OECD have been adopted, that Member States request the submission of additional studies on possible endocrine disruptor properties of the products. Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products containing fenarimol. Summary of known hazards and risks to the environment: It was concluded that it could be expected that plant protection products containing fenarimol 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 fenarimol containing plant protection product for which Member States would grant or review the authorisation. Therefore, Member States had to ensure that all appropriate risk mitigation measures were applied. Member States were requested to pay particular attention to the protection of - aquatic organisms. Where relevant, an appropriate distance needed to be kept between treated areas and surface water bodies. This distance could depend of the application or not of drift reducing techniques or devices; - earthworms. Conditions of authorisation had to include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of applications, rates of application, and, if necessary, the degree of concentration of the active substance; - birds and mammals. Conditions of authorisation had 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. In addition, Member States were requested to require further studies to address the potential endocrine disrupting properties of fenarimol within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). Expected effect of the final regulatory action in relation to the environment: Reduction of risk from the use of plant protection products containing fenarimol. Date of entry into force of the final regulatory action: 01/07/2007 Commission Directive 2006/134/EC of 11 December 2006 entered into force on 1 January 2007. However, Member States had to apply the provisions of this Directive as of 1 July 2007. |