Chemical name: 4-methylthio-3,5-xylyl methylcarbamate 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 methiocarb because methiocarb is not approved as an active substance pursuant to Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. EU Member States had to withdraw all authorisations for plant protection products containing methiocarb as active substance by 3 January 2020 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing methiocarb is prohibited as of 4 April 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 product containing the active substance methiocarb 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) 546/2011. According to the evaluation related to human health, the following concerns were identified: Exposure for workers loading and sowing the treated seed was above the AOEL (628% of the AOEL) and AAOEL (826% of the AAOEL) even with the use of workwear, gloves and FFP3 Respiratory Protective Equipment. The information available is insufficient to satisfy the requirements set out in Article4(1) to (3) of Regulation (EC) No 1107/2009, in particular with regard to: The consumer risk assessment could not be conducted because the residue definition for risk assessment in plant commodities is not finalised due to the lack of outstanding toxicity data to rule out the genotoxic potential for the metabolite methiocarb sulfoxide; Information on the analytical methods used in all dietary toxicity studies, including the assessment of their validity was not provided. 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 methiocarb 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 product containing the active substance methiocarb 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) 546/2011. According to the evaluation related to the environment, the following concerns were identified: A high acute and chronic risk to birds has been identified; A high acute and chronic risk to mammals has been identified; A high risk to earthworms has been identified from exposure to methiocarb and its metabolite methiocarb sulfoxide. 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 for bees could not be finalised. 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 methiocarb Date of entry into force of the final regulatory action: 27/09/2019 Complete entry into force of all provisions of Commission Implementing Regulation (EU) 2019/1606 of 27 September 2019 concerning the non-renewal of the approval of the active substance methiocarb was on 3 October 2019. |