Chemical name: (2RS)-5-methylamino-2-phenyl-4-(a,a,a-trifluoro-mtolyl)furan-3(2H)-one 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 flurtamone because flurtamone 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 flurtamone as active substance by 27 June 2019 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing flurtamone is prohibited as of 27 March 2020. 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 flurtamone 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 human health the following concerns were identified: - The derivation of the health-based reference values could not be concluded for flurtamone as long as its mutagenic potential cannot be excluded. - The operator, worker, bystander and resident exposure risk assessment could not be conducted since non-dietary reference values could not be derived for flurtamone. - The consumer risk assessment could not be conducted with regard to flurtamone and the major plant metabolite trifluoroacetic acid included in the residue definition for risk assessment considering that toxicological reference values could not be derived for flurtamone and the identified data gaps in regards to trifluoroacetic acid. - The metabolite TFA (trifluoroacetic acid) is predicted to be present in groundwater at concentrations exceeding 0.1 g/L in all the relevant FOCUS groundwater scenarios. In fact the predicted levels of TFA are above 0.75 g/L in all scenarios (in the range of 3.62-22.13 g/L). Based on the studies assessed EFSA suggested that flurtamone should be classified as a category 2 carcinogen, however, a harmonised classification in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council does not currently exist for carcinogenicity. The presence of this metabolite in groundwater is therefore of concern since it has not been demonstrated that it does not share the same intrinsic properties as flurtamone. Therefore it cannot currently be established that the presence of the metabolite in groundwater will not result in unacceptable effects on groundwater or in harmful effects on human health; furthermore, the risk to consumers from total exposure to TFA cannot be concluded due to data gaps identified. 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: - With regard to the screening of endocrine-disrupting properties for flurtamone, since sensitive parameters for endocrine disruption were not all investigated in the studies submitted and thyroid follicular adenomas were observed in male rats without mechanistic clarifications, further investigations are requested according to the OECD Conceptual Framework (OECD, 2012) and the EFSA Scientific Opinion on the hazard assessment of endocrine disruptors (EFSA Scientific Committee, 2013). - The consumer risk assessment with regard to the residues that might be present in drinking water consequent to water treatment following abstraction for drinking water could not be finalised. 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 flurtamone. 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 flurtamone 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 the environment the following concerns were identified: - A high risk (5 out of 9 FOCUS scenarios) was identified for aquatic organisms for the representative use of flurtamone. 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 flurtamone. Date of entry into force of the final regulatory action: 27/12/2018 Complete entry into force of all provisions of Commission Implementing Regulation (EU) No 2018/1917 of 6 December 2018 concerning the non-renewal of approval of the active substance flurtamone, in accordance with Regulation (EC) No 1107/2009 was by 27 December 2018. |