Chemical name: 2-[(4,6-dimethoxypyrimidin-2-yl)carbamoylsulfamoyl]-6-(trifluoromethyl)pyridine-3-carboxylic acid 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 a plant protection product. Pesticide use or uses that remain allowed: Not relevant. 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 DPX KE 459 (flupyrsulfuron-methyl). DPX KE 459 (flupyrsulfuron-methyl) is not included in the list of approved active substances under Regulation (EC) No 1107/2009. As a consequence, DPX KE 459 (flupyrsulfuron-methyl) Is not approved for placing on the market pursuant to Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. Authorisations for plant protection products containing DPX KE 459 (flupyrsulfuron-methyl) as active substance had to be withdrawn by Member States by 13 December 2017 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing DPX KE 459 (flupyrsulfuron-methyl) is prohibited as of 14 December 2018. 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 no plant protection products containing the active substance DPX KE 459 (flupyrsulfuron-methyl) is expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EC) 546/2011. According to the evaluation related to human health the following concerns were identified: - the potential for groundwater exposure above the parametric drinking water limit of 0.1 flupyrsulfuron g/L by the metabolites IN-JV460, IN-KY374 and IN-KC576. In particular, for metabolites IN-KC576 and IN-KY374 the predicted concentrations exceed 0.75 flupyrsulfuron flupyrsulfuron g/L for the majority of the FOCUS groundwater scenarios. The presence of these metabolites in groundwater is of particular concern since it has not been demonstrated that these metabolites do not share the same intrinsic properties as the parent substance (based on the studies assessed, EFSA concluded that the parent substance has certain intrinsic toxicological properties, in particular as regards to carcinogenicity and reproductive toxicity). Therefore it cannot currently be established that the presence of the metabolites in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health. The information available is insufficient to satisfy the requirements set out in Article 4(1 ) to (3) of Regulation (EC) No 1107/2009, in particular with regard to: - the assessment of the possible exposure of groundwater to several metabolites (IN-JE127 and IN KF311). For IN-JE127 the genotoxic potential cannot be concluded based on the data available and therefore unacceptable effects on groundwater and harmful effects on human health cannot currently be excluded for this metabolite. - with regards to metabolite IN-JE127, although no significant residues above 0.01 mg/kg of parent or metabolites were present at harvest, based on the available data a genotoxic potential could not be excluded, nor can it be ruled out that consumers could be exposed to this metabolite via food and drinking water even though the levels might be very low. Additionally, during the peer review it was proposed that DPX KE 459 (flupyrsulfuron-methyl) should be classified as carcinogen category 2 and as toxic for reproduction category 2 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council. According to this proposal, and following the interim criteria from Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009, DPX KE 459 (flupyrsulfuron-methyl) shall be considered to have endocrine disrupting properties. However, when assessing this concern, it should be noted that according to the available toxicological data and the current scientific state-of-play, flupyrsulfuron-methyl-sodium is considered unlikely to have endocrine disrupting effects in mammals. Expected effect of the final regulatory action in relation to human health: Reduction of risk for the human health from the use of plant protection products containing DPX KE 459 (flupyrsulfuron-methyl). Summary of known hazards and risks to the environment: It was concluded that no plant protection products containing the active substance DPX KE 459 (flupyrsulfuron-methyl) is expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EC) 546/2011. According to the evaluation related to environment the following concerns were identified: - the high risk to aquatic organisms, in particular algae and aquatic plants. - the assessment of the possible exposure of groundwater to several metabolites (IN-JE127 and IN-KF311). For IN-JE127 the genotoxic potential cannot be concluded based on the data available and therefore unacceptable effects on groundwater and harmful effects on human health cannot currently be excluded for this metabolite. Expected effect of the final regulatory action in relation to the environment: Reduction of risk for the environment from the use of plant protection products containing DPX KE 459 (flupyrsulfuron-methyl). Date of entry into force of the final regulatory action: 12/09/2017 |