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Ref. Ares(2023)1382162 - 24/02/2023 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Deputy Director General for food sustainability responsible for Directorates D, E, F and G Brussels, SANTE/E4/MW/gb(2023)2030285 Permanent Representations / Missions to the EU of all Member States and EEA countries Dear Sir, dear Madam, Subject: Survey on azole use in the EU launched by the European Food Safety Authority, the European Chemicals Agency and the European Medicines Agency Resistance to azole drugs used to treat human infections with Aspergillus is a serious and growing concern. Resistance may develop during treatment with azole medicines but may also develop in the environment. There is growing evidence that species belonging to Aspergillus can acquire resistance mutations when exposed to azoles in the environment (for example from use in plant protection products or biocidal products). Therefore, in January 2022, in the context of the One Health approach, the European Commission sent a joint mandate 1 to the European Food Safety Authority (EFSA), the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA) and the European Medicines Agency (EMA) to provide a scientific report on the impact on the use of azole fungicides, other than as human medicines, on the development of resistances in species belonging to Aspergillus. As part of the mandate given to the agencies, information is required on the types of use, trends in quantities, and geographical variation in use of azole fungicides in the EU and EEA. In the context of this mandate, on 9 February 2023 the agencies (EFSA for pesticides, ECHA for biocides and EMA for veterinary medicines) sent a survey to be completed by each Member State / EEA country requesting relevant information. Invitations were sent to the relevant sectorial contact points that the agencies have on plant protection products, biocides, and veterinary medicines. The instructions are to contribute to the survey with one submission per sector per country, i.e. three submissions per country (pesticides, biocides, and veterinary medicines). The survey is open until 7 April 2023 at 23:59 (CET) and should be submitted online. The agencies recommended that Member States allocate sufficient time for compiling the requested information (which may be demanding) before starting to fill in the survey. 1 The mandate can be accessed via OpenEFSA via the following link: https://open.efsa.europa.eu/study- inventory/EFSA-Q-2022-00040  I would kindly ask you for your support on this important task and invite you to ask the responsible authorities within your Member State / country to ensure that full responses to the survey are provided to the agencies, allowing them to have complete and accurate information to use in their work. I thank you in advance for raising the attention of your responsible authorities and for inviting them to participate in this survey, which I am sure you will agree is part of a highly important One Health project. In case of questions related to the survey you can contact: For EFSA: Dimitra Kardassi ([email protected]) or [email protected] For ECHA: Eva Valkovicova ([email protected]) For EMA: Helen Jukes ([email protected]) or Zoltan Kunsagi ([email protected]) Yours faithfully, Claire BURY c.c.: Ambassadors and Deputy Permanent Representatives of Member States Ambassadors of EEA countries Members of the Standing Committee on Plants, Animals, Food and Feed, Section Phytopharmaceuticals - Plant Protection Products - Legislation Member State and EEA Competent Authorities for Biocidal Products Members of the Standing Committee on Veterinary Medicinal Products Executive Directors of the European Food Safety Authority, the European Chemicals Agency and the European Medicines Agency Electronically signed on 24/02/2023 15:54 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121 Saatja: Webdesktop <[email protected]> Saadetud: 01.03.2023 18:05 Adressaat: <"SM Info">; <[email protected]>; <[email protected]>; <"info ravimiamet ee">; <"Elen Ohov"> Koopia: <[email protected]>; <[email protected]>; <[email protected]>; <=?utf-8?Q?Agne_Nettan- Sepp_Br=C3=BCsselis?=>; <[email protected]>; <[email protected]> Teema: Webdesktop: Kiri nr 10.2-11/197 / Survey on azole use in the EU launched by the EFSA, the ECHA and the EMA Manused: 197.pdf; 197_edastuse-kiri.pdf Tere! Edastan Komisjoni kirja. Reg. number: 10.2-11/197 Reg. kuupäev: 01.03.2023 Sisu: Survey on azole use in the EU launched by the European Food Safety Authority, the European Chemicals Agency and the European Medicines Agency. Heade soovidega Tiiu Noobel [email protected] sekretär, EV alaline esindus EL juures From: [email protected] <[email protected]> Sent: Tuesday, February 28, 2023 3:57 PM Subject: Survey on azole use in the EU launched by the European Food Safety Authority, the European Chemicals Agency and the European Medicines Agency Dear Sir, dear Madam, Please find enclosed our letter registered under reference Ares(2023)1382162, regarding the above mentioned subject. Please note this document is sent electronically only. Best regards, EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Food and feed safety, innovation Pesticides and Biocides Please note that the personal data provided in your correspondence is processed in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council of 11 December 2018. For more information please consult the following website: https://ec.europa.eu/dpo-register/detail/DPR-EC-04327