Chemical name: (S)-1-anilino-4-methyl-2-methylthio-4-phenylimidazolin-5-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 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 fenamidone because fenamidone 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 fenamidone as active substance by 14 February 2019 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing fenamidone is prohibited as of 14 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 fenamidone 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: - Health-based reference values could not be set based on the incomplete genotoxicity assessment. - The consumer and the non-dietary risk assessments cannot be conducted as healthbased reference values have not been set. - A high potential for groundwater exposure above the parametric drinking water limit of 0.1 g/L by the toxicologically relevant metabolite RPA 412708 was indicated for all the representative uses assessed, in geoclimatic situations represented by all pertinent (5 for tomatoes and 9 potatoes) Focus groundwater scenarios, for all aquifers that are over laid by soils of predominantly pH 7 or above. 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 compliance of the toxicity studies compared to the technical specification and the relevance of impurities should be reconsidered once the genotoxic potential of fenamidone is properly addressed. - The need for further tests and risk assessment to unique human metabolites could not be finalised whilst an in vitro comparative metabolism study was not submitted - Fenamidone is not classified or proposed to be classified as carcinogenic category 2 or as toxic for reproduction category 2, in accordance with the provisions of Regulation (EC) No 1272/20086 and 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 are not met. With regard to the scientific risk assessment in vivo studies provide evidence for endocrine effects produced by fenamidone exposure on the thyroid in rats. There was no indication of potential androgenic, anti-androgenic, oestrogenic or correlated adverse effects on the reproduction and reproductive organs. Further data on the endocrine disruptive pathways regarding rat thyroid are needed to conclude. - The consumer risk assessment from consumption of drinking water could not be finalised whilst the nature of residues in drinking water following water treatment had not been addressed. - The relevance assessment for metabolite RPA 41263 in groundwater could not be finalised whilst consumer exposure to RPA 412636 from other routes (food of plant and animal origin) had not been assessed but is required to be taken into account. - The consumer dietary risk assessment could not be conducted because the residue definitions for risk assessment in plant and livestock commodities are not finalised in terms of the inclusion of potentially relevant metabolites. 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 fenamidone 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 fenamidone 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 long-term risk to mammals (relevant for all representative field uses) was identified for fenamidone at the tier I assessment. A high risk from secondary poisoning was also not excluded for mammals. - A high risk to aquatic organisms (relevant for all representative field uses) from the metabolite acetophenone could not be excluded because no toxicity data were available. 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 fenamidone. Date of entry into force of the final regulatory action: 14/08/2018 |