Chemical name: 1,3-Benzenedicarbonitrile, 2,4,5,6-tetrachloro- 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 chlorothalonil because chlorothalonil 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. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing chlorothalonil is prohibited as of 20 May 2020. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: The evaluation of the active substance chlorothalonil, following the submission of an application to renew its approval for the use in plant protection products, was made in the context of the work provided for in Articles 7 to 13 of Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. A Member State was designated to undertake a hazard and risk assessment based on the information submitted by the applicant and to establish a draft assessment report, which was subject to European Union peer review during which the European Food Safety Authority (EFSA) undertook consultations with experts from Member States as well as with the applicant. The risk evaluation was done inter alia by means of simulation models (e.g. FOCUS groundwater and surface water models) that have been developed for the EU risk evaluation and/or with data generated in the EU in order to represent the conditions that prevail in the EU. Detailed information on the risk evaluation can also be found in the respective guidance produced by EFSA. Based on the results of the evaluation, the European Commission established a review report, which was finalised in the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee). The PAFF Committee concluded that no plant protection product containing the active substance chlorothalonil 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 (EC) 546/2011. Therefore, chlorothalonil should not be approved in accordance with Regulation (EC) No 1107/2009. Final Renewal report for the active substance chlorothalonil finalised in the Standing Committee on Plants, Animals, Food and Feed at its meeting on 22 March 2019 in view of the non-renewal of the approval of chlorothalonil as active substance in accordance with Regulation (EC) No 1107/2009. European Commission, SANTE/10186/2018 Rev 1, 22 March 2019. Peer review of the pesticide risk assessment of the active substance chlorothalonil. EFSA Journal 2018;16(1):5126 https://www.efsa.europa.eu/en/efsajournal/pub/5126 It was concluded that no plant protection product containing the active substance chlorothalonil 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 (EC) 546/2011. According to the evaluation related to human health the following concerns were identified: - The proposed classification of chlorothalonil by the peer review as carcinogen category 1B in accordance to the provisions of Regulation (EC) No 1272/2008 (while harmonised classification is category 2) does not fulfil the approval criteria of Annex II, point 3.6.3 of Regulation (EC) No 1107/2009. - Chlorothalonil metabolites (except metabolite R611965) are relevant groundwater metabolites should they be predicted to occur in groundwater above the parametric drinking water limit of 0.1 ?g/L due to the proposed re-classification. - A genotoxicity concern cannot be excluded for residues to which consumers will be exposed. 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 analytical methods used in the toxicological studies were not identified and therefore not validated, these questions the validity of the studies, in particular repeated-dose dietary studies. - The need for further tests and risk assessment to unique human metabolites could not be finalised while an in vitro comparative metabolism study was not submitted. - The consumer risk assessment from the consumption of water could not be finalised, whilst satisfactory information was not available to address the effect of water treatment processes on the nature of the residues that might be present in surface water, when surface water is abstracted for drinking water. The consumer risk assessment is not finalised. The residue definitions for risk assessment in plant and animal commodities are preliminary. In the absence of toxicological reference values for R182281, even an indicative consumer risk assessment using the preliminary residue definitions cannot be conducted. 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 chlorothalonil. Summary of known hazards and risks to the environment: It was concluded that no plant protection product containing the active substance chlorothalonil 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 (EC) 546/2011. According to the evaluation related to the environment the following concerns were identified: - High risk to amphibians (acute and chronic) and to fish (chronic) for chlorothalonil was identified for all the representative uses. 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 chronic risk to amphibians 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 chlorothalonil. Date of entry into force of the final regulatory action: 20/05/2019 |