Chemical name: Phosphoramidic acid, (1-methylethyl)-, ethyl 3-methyl-4-(methylthio)phenyl ester 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 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 fenamiphos because fenamiphos is not approved as an active substance under 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 authorisations for plant protection products containing fenamiphos as an active substance by 23 March 2021. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing fenamiphos is prohibited as of 23 September 2021. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: It has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance fenamiphos in accordance with Article 20(1)(b) of that Regulation. According to the evaluation related to human health, the following concerns were identified: The risk to consumers. The overall consumer risk assessment is provisional since the data package for the metabolites fenamiphos sulfoxide (M01) and fenamiphos sulfone (M02) on genotoxicity was incomplete and the expression of the risk assessment residue definition for primary crops is provisional. Moreover, the risk assessment residue definition in rotational crops is provisional. However, even if the consumer risk assessment could not be finalised, an acute consumer risk was identified for all fruiting vegetables representative uses while for the ornamentals and nursery stock, which may have grown in rotation with food crops, an acute consumer risk cannot be excluded. Furthermore, for the chronic intake consumer exposure, if the calculated Maximum Residue Levels (MRLs) resulting from the available residue dataset submitted for the renewal process are used in the exposure assessment, the maximum TMDI would account for 172% of the ADI. 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 risk assessment to unique human metabolites could not be finalised whilst an in vitro comparative metabolism study was not submitted; the potential for groundwater contamination and the consumer risk assessment through exposure to metabolites from drinking water. While monitoring data from three vulnerable regions in Greece indicate that the potential for groundwater exposure above the parametric drinking water limit of 0.1 g/L was concluded to be low for fenamiphos and metabolites M01, M02, fenamiphos-sulfoxide-phenol (M12), fenamiphos-sulfone-phenol (M13) and fenamiphos-sulfone-anisole (M14) in the geoclimatic conditions that are represented in Greece, modelling data indicates that there is potential for exceedance of the limit of 0.1 g/L by M14 (well above 10 g/L in all scenarios, even at the lower rate of application). An assessment of the consumer intake could not be carried out for this metabolite since an ADI could not be established based on the data submitted. 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 fenamiphos. Date of entry into force of the final regulatory action: 23/09/2020 Complete entry into force of all provisions of Commission Implementing Regulation (EU) 2020/1246 of 2 September 2020 concerning the non-renewal of the approval of the active substance fenamiphos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 was on 23 September 2020. |