Chemical name: 6-methyl-4-{(E)-pyridin-3-ylmethylidene]amino}-4,5-dihydro-1,2,4-triazin-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 pymetrozine because pymetrozine 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 diquat as active substance by 30 April 2019 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing pymetrozine is prohibited as of 30 January 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 pymetrozine 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: - Considering the harmonised classification of pymetrozine as carcinogen category 2 and the proposed classification as reproductive toxicant category 2 by the EFSA peer review, and that pymetrozine produced adverse effects on endocrine organs across different species and timelines, a critical area of concern was identified with regard to Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 interim provisions for active substances that shall be considered to have endocrine disrupting properties. However, it is noted that the scientific assessment for potential endocrine disruption properties of pymetrozine could not be finalised. - The potential for groundwater exposure above the parametric drinking water limit of 0.1 g/L by the relevant metabolite CGA371075 (4,6-dimethyl-1,2,4-triazine-3,5(2H,4H)-dione) in all the pertinent groundwater scenarios for all four representative uses assessed (assessed as relevant from the toxicological point of view according to the guidance document on the assessment of the relevance of metabolites in groundwater (European Commission, 2003, Sanco/221/2000 -rev.10- final 25 February 2003, https://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_appproc_guide_fate_metabolites-groundwtr.pdf) consequent to the harmonised classification of pymetrozine as carcinogen category 2. Note that the EFSA peer review also proposed classification as reproductive toxicant category 2.) 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 consumer risk assessment for the tomato/aubergine use cannot be finalised as new residue trials are required. Expected effect of the final regulatory action in relation to human health: Reduction of risk for the environment from the use of plant protection products containing pymetrozine 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 pymetrozine 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. The information available was 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 assessments for soil dwelling and aquatic organisms and the potential for impacts on groundwater quality for the anaerobic soil metabolites CGA180777(nicotinic acid) and GS23199 (6-methyl-1,2,4-triazine-3,5(2H,4H)-dione) and the soil dwelling organism risk assessment and the potential for impacts on groundwater quality for the anaerobic soil metabolite CGA249257 (6-methyl-4,5-dihydro-1,2,4-triazin-3(2H)-one) could not be finalised, which is relevant for the use on oilseed rape in territories where anaerobic soil conditions can occur. - The risk assessment for aquatic organisms for the groundwater metabolite M3MF 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 pymetrozine. Date of entry into force of the final regulatory action: 30/10/2018 Complete entry into force of all provisions of Commission Implementing Regulation (EU) No 2018/1501 of 9 October 2018 concerning the non-renewal of approval of the active substance pymetrozine, in accordance with Regulation (EC) No 1107/2009 was by 30 October 2018. |