Chemical name: Benzamide, 2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]- 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 uses. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: After an evaluation, the Norwegian Food Safety Authority has decided to deny the application for authorization of the plant protection product Infinito (containing fluopicolide and propamocarb-HCl) according to the Regulation of July 26 2004 # 1138 on pesticides. The reason for this decision was both fluopicolide and the metabolite M01 (BAM)'s adverse environmental properties regarding persistence and mobility. The reasons for the final regulatory action were relevant to: Environment Summary of known hazards and risks to the environment: Both fluopicolide and the metabolite M01 are very persistent in soil under laboratory conditions. Both fluopikolid and the metabolite M01 are also persistent in water. There are indications that the metabolite M01 will accumulate in soil in Norway even if Infinito is only used every third year. Norwegian experiments in laboratory and in the field indicate that many fungicides have slower degradation under Norwegian conditions compared to other countries. Estimates of the potential for accumulation are very dependent on the input parameters for degradation that are entered into the model. The Norwegian Food Safety Authority has chosen rather conservative endpoints (worst case normalized DT50 from laboratory studies) and calculations indicate that M01 accumulates in soil. The ground water modelling submitted by the applicant with Swedish scenarios and modelling with MACRO 4.4.2 indicates that fluopikolide will not leach to ground water in concentrations above 0.1 g/L. However, modelling conducted by the Norwegian Food Safety Authority with Norwegian and Swedish scenarios and the model MACRO 5.5.3, indicates that the metabolite M01 will leach to groundwater in concentrations above 0.1 g/L, even with use only every third year. The metabolite M01 (BAM) is also a metabolite from another active substance (diklobenil) and monitoring data from both Norway and other Nordic countries indicate that M01 (BAM) is very persistent under Nordic conditions as it has been found in groundwater up to 12 years after the use of the plant protection product dichlobenil. Even though this product had another GAP these data clearly indicate that this metabolite may persist in the environment. In addition, it is worth mentioning that fluopicolid has the potential to long range transport. Fluopicolide is also toxic to aquatic organisms even if the risk evaluation shows acceptable risk with correct use of the product. Expected effect of the final regulatory action in relation to the environment: Reduction of risk as this product is not allowed on the market. Date of entry into force of the final regulatory action: 22/09/2015 3 weeks appeal period after the decision. |