Chemical name: oxetan-3-yl 2-[(4,6-dimethylpyrimidin-2-yl)carbamoylsulfamoyl]benzoate 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 the active substance oxasulfuron because oxasulfuron is not approved as active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market. EU Member States had to withdraw all authorisations for plant protection products containing oxasulfuron as active substance by 8 November 2018 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing oxasulfuron is prohibited as of 8 November 2019. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: In conclusion from the assessments made on the basis of the submitted information, no plant protection products containing the active substance oxasulfuron 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 (EU) No 546/2011. The information available was insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009. In more detail: - The overall consumer exposure assessment could not be finalised in view of the outstanding data regarding the metabolism and magnitude of the relevant compounds in rotational crops and the consumer exposure assessment through drinking water. - The ground water exposure assessment could not be finalised considering the lack of data for metabolites MT6, M3 and CGA 171895 (M5). The groundwater relevance assessment regarding biological screening for herbicidal activity of oxetan-3-ol (CGA 297691) could not be finalised. The peer review proposes that oxasulfuron should be classified as toxic for reproduction category 2, in accordance with the provisions of Regulation (EC) No 1272/2008, and toxic effects in the endocrine organs have been observed in the available data. Therefore, the conditions of the interim provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the consideration of endocrine disrupting properties may be met. On the basis of the available data (endocrine-related findings observed at high doses in association with other toxic effects) and current knowledge (OECD Conceptual Framework, as analysed in the EFSA Scientific Opinion on the hazard assessment of endocrine disruptors, 2013), the potential endocrine-disrupting properties of oxasulfuron could not be excluded. Expected effect of the final regulatory action in relation to human health: Reduction of risk for human health from the use of plant protection products containing oxasulfuron. Summary of known hazards and risks to the environment: In conclusion from the assessments made on the basis of the submitted information, no plant protection products containing the active substance oxasulfuron 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 (EU) No 546/2011. According to the evaluation related to environment the following concerns were identified: - The risk to aquatic organisms (aquatic plants) was assessed as high for one out of the two relevant FOCUS surface water scenarios for the representative use of oxasulfuron. - A high risk to earthworms was identified for the metabolite saccharin (CGA 27913). Based on the toxicity for aquatic plants, the experts agreed during the peer review of the pesticide to propose the M factors = 100 for the harmonised classification of oxasulfuron with Aquatic Chronic 1 - H410 and Aquatic Acute 1 - H400 endpoints. The information available was 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 risk assessment for aquatic organisms could not be finalised considering the lack of exposure estimates for metabolites MT6 and CGA 171895. - The risk assessment for earthworms could not be finalised considering the lack of exposure estimates for metabolite MT6. - The risk assessment for soil macro-organisms other than earthworms could not be finalised due to the lack data for oxasulfuron and the pertinent soil metabolites. - The risk assessment for soil microorganisms could not be finalised for the pertinent soil metabolites due to the lack of data. - The risk assessment for non-target terrestrial plants could not be finalised to the lack of toxicity data on the vegetative vigour With regard to the endocrine-disrupting potential, further data might be needed to draw a firm conclusion. 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 oxasulfuron. Date of entry into force of the final regulatory action: 08/08/2018 Complete entry into force of all provisions of Commission Implementing Regulation (EU) No 2018/1019 of 18 July 2018 concerning the non-renewal of approval of the active substance oxasulfuron, in accordance with Regulation (EC) No 1107/2009 was by 8 August 2018. |