Three ais gain EU re-registration

Date:08-12-2011

Under the support of EU Standing Committee on the Food Chain and Animal Health, European Commission has renewed registrations for three ais: Syngenta’s herbicide oxyfluorfen; Dow AgroScience and MAI’s insecticide tefluthrin and Bayer’s fungicide spiroxamine. The tefluthrin and oxyfluorfen had been temporarily withdrawn from the EU review list of existing ais and their applicants have resubmitted additional data in 2009.

The oxyfluorfen can be only used for banded applications close to ground from autumn to early spring, and Member State shall pay particular attention to: the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate and the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants and conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit below confirmatory information by 30 June 2012: the specification of the technical material, as commercially manufactured including information on the relevance of the impurities; the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies. And information regarding: the potential risk to aquatic organisms for the active substance and for the metabolites 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino] phenol, 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy] benzoic acid, 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl) benzene, 4-(3-ethoxy-4-hydroxyphenoxy) benzoic acid and for the unidentified metabolite Deg 27 and potential risk from bioaccumulation and biomagnification in the aquatic food chain, including sediment dwellers; exposure data for banded application adequate for use as drift mitigation values should be submited by 31 December 2013.

For tefluthrin, the seed coating products shall only be performed in profession seed treatment facilities and the facilities shall apply the best available techniques in order to exclude the release of dust clouds during storage, transport and application. Member states shall pay particular attention to: pay particular attention to the operators and workers safety and include among the authorised conditions of use the application of adequate personal protective equipment as well as respiratory protective equipment; the risk to birds and mammals, risk mitigation measures should be applied to grant a high degree of incorporation in soil and avoidance of spillage; ensure that the label of treated seed includes the indication that the seeds were treated with tefluthrin and sets out the risk mitigation measures provided for in the authorization. The applicant shall submit confirmatory information regarding: the specification of the technical material, as commercially manufactured by 30 June 2012; validated analytical method for water by 31 December 2012; and the possible environmental impact of the preferential degradation/conversion of the isomers and an estimation of the relative toxicity and risk assessment for the workers two years after the adoption of a specific guidance document on evaluation of isomers mixture.

For spiroxamine approval, Member States shall pay particular attention to: the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment; the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; the risk to aquatic organisms and conditions of authorization shall include risk mitigation measures where appropriate. The notifier shall submit confirmatory information regarding the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment by two year after the adoption of specific guidance and information regarding: the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities; the groundwater exposure assessment for metabolite [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide; the risk to aquatic organisms by 31 December 2013.