Chemical name: manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt 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 mancozeb because mancozeb 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 mancozeb as active substance by 4 July 2021 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing mancozeb is prohibited as of 4 January 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 submitted information, no plant protection product containing the active substance mancozeb 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: Mancozeb has to be classified as toxic for reproduction category 1B (R1B) in accordance with the criteria set out in Commission Regulation (EC) No 1272/2008 as recommended in the opinion of the Risk Assessment Committee of the European Chemicals Agency published in March 2019. Substances which are classified as R1B cannot be approved unless negligible exposure is demonstrated, or information is provided in the application to demonstrate that the active substances is necessary to control a serious danger to plant health which cannot be controlled via other available means (Art 4.7 of Regulation (EC) No 1107/2009). Mancozeb meets the criteria to be identified as having endocrine disrupting properties for humans -according to the T (thyroid) modality-, which has similar consequences for approval as the classification as R1B. Estimates of non-dietary exposure exceed the reference values for tomatoes, potatoes, cereals (for some kinds of applications) and grapevines, which are the sole uses proposed by the applicant in its application. 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 mancozeb 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 mancozeb 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: -Mancozeb meets the criteria to be identified as having endocrine disrupting properties for non-target organisms -according to the T (thyroid) modality. -Mancozeb poses a high risk to birds, mammals, non-target arthropods, soil macro- organisms for all representative uses (except for tomatoes grown in high technology permanent greenhouses) as well as for aquatic organisms, except for the use on potatoes. 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 mancozeb Date of entry into force of the final regulatory action: 14/12/2020 Complete entry into force of all provisions of Commission Implementing Regulation (EU) 2020/2087 of 14 December 2020 concerning the non-renewal of the approval of the active substance mancozeb was 4 January 2021. |