Chemical name: N-(dimethoxyphosphinothioylthiomethyl)phatalimide 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. Not relevant Use or uses that remain allowed: Not relevant 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 phosmet because phosmet is not approved as an 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 phosmet as active substance by 1 May 2022 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing phosmet is prohibited as of 1 November 2022. 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 available information, no plant protection product containing the active substance phosmet 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 evaluations related to human health the following concerns were identified: Non-dietary exposure estimates (i.e. for operator, worker, bystander and resident) for all representative uses applied for were above the acceptable operator exposure level (AOEL) and the acute acceptable operator exposure level (AAOEL) even with the use of personal protective equipment or application of available mitigation measures (in accordance with the EFSA calculator). The provisional dietary exposure estimates for consumers exceeded the acceptable daily intake (ADI) and the acute reference dose (ARfD) for the representative uses assessed. Moreover, residues at the level of the default value of 0.01 mg/kg would also exceed the ARfD for several edible commodities assessed as part of the representative uses. - 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: Developmental neurotoxicity (DNT) - experts during the peer-review agreed that the DNT of phosmet should have been further investigated by the applicant, in particular since epidemiological evidence was available from organophosphates in general (a DNT study on phosmet was not submitted); The consumer risk assessment could only be provisionally conducted and is likely underestimating the actual dietary exposure and risk, since neither all commodities nor all potentially relevant metabolites could be assessed due to several data gaps.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 phosmet. Summary of known hazards and risks to the environment: In conclusion from the assessment made on the basis of the available information, no plant protection product containing the active substance phosmet 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 reproductive risk was identified for birds and wild mammals for all uses of phosmet. A high acute and chronic risk to aquatic invertebrates was identified for all uses of phosmet. A high risk to honey bees and to non-target arthropods was identified for all uses of phosmet.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 phosmet. Date of entry into force of the final regulatory action: 01/02/2022 |