Chemical name: Dipyrido[1,2-a:2',1'-c]pyrazinediium, 6,7-dihydro-, dibromide 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 diquat because diquat 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 4 May 2019 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing diquat is prohibited as of 4 February 2020. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: It was concluded that no plant protection product containing the active substance diquat 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: - The estimated operator, bystander and resident exposure to diquat in 'Diquat 20% SL', exceed the AOEL even when the use of PPE is considered. - The estimated bystander and resident exposure to diquat in 'A1412A' exceed the AOEL. - Diquat dibromide may be considered to have endocrine disrupting properties according to the interim criteria for the determination of endocrine disrupting properties since it has toxic effects on endocrine organs and it is proposed to be classified as toxic for reproduction category 2 by the EFSA peer review, requiring consideration by risk managers. However, when assessing this concern, it should be noted that according to the available toxicological data, although there were some shortcomings in the reproductive and developmental experimental studies design, the results from existing data did not indicate a clear potential endocrine disruption activity of diquat on the tested animals.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: - Non-dietary risk assessment to diquat in 'Diquat 20% SL' was not performed on the use side-shoot control with spray on grapevines (lower plant parts, 0.2 kg a.s./ha). - No risk assessment in all the sections was performed on the use "field crop" (herbicide use, 0.4 kg a.s./ha). - The consumer risk assessment could not be finalised for the representative uses as a desiccant in potato and oilseed rape due to lack of data on the nature of residues upon processing that may result in relevant degradation products and due to lack of appropriate residue data in food of animal origin. The consumer risk assessment could also not be finalised for all the remaining representative uses exclusively applied for by the applicant Sharda since sufficient residue trials are not available that would permit dietary exposure considerations. 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 diquat. Summary of known hazards and risks to the environment: It was concluded that no plant protection product containing the active substance diquat 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 risk was identified for birds exposed to diquat via dietary consumption for all the representative uses of diquat. 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 aquatic risk assessment for the metabolite AQ1 could not be finalised due to the lack of any ecotoxicological data. The screening assessment considering the metabolite as 10 times more toxic than the parent was not sufficient to demonstrate a low risk to algae and macrophytes. - A proper identification/characterisation of the unidentified material in the SPE eluate in one soil photolysis study. In case the quantitative determination makes a metabolite occur at more than 5 % at two consecutive time points, then a groundwater assessment for this metabolite would be needed. - Potential long term consequences of the use of diquat regarding groundwater exposure. 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 diquat. Date of entry into force of the final regulatory action: 02/11/2018 Complete entry into force of all provisions of Commission Implementing Regulation (EU) No 2018/1532 of 12 October 2018 concerning the non-renewal of approval of the active substance diquat, in accordance with Regulation (EC) No 1107/2009 was by 2 November 2018. |