65217 2025 eng 1 35 1 23 article Wiley Hoboken, NJ European Food Safety Authority (EFSA) 1 -- -- -- The use of azoles in the European Union and European Economic Area (EU/EEA) other than as human medicines has raised concerns about emergence and spread of azole‐resistant Aspergillus species. EU agencies, with the support of JRC, reviewed the evidence and provided conclusions and recommendations on this topic. Although incomplete, data from 2010 to 2021 showed that around 120,000 tonnes of azoles were sold in EU/EEA for uses other than as human medicines. The majority are used as plant protection products (119,000 tonnes), with a stable temporal trend. Evidence supported a link between environmental azole exposure and cross‐resistance selection to medical azoles in Aspergillus species (primarily shown for A. fumigatus). Prevalence of azole‐resistant A. fumigatus in human A. fumigatus infections ranges from 0.7% to 63.6% among different disease presentations and geographic regions; mortality rates range from 36% to 100% for invasive aspergillosis (IA). It was concluded that azole usage outside the human domain is likely or very likely to contribute to selection of azole‐resistant A. fumigatus isolates that could cause severe disease like IA. Environmental hotspots for resistance selection were identified, including stockpiling of agricultural waste and their possible use as soil amendment/fertiliser for certain agricultural crops (for plant protection products) and freshly cut wood (for biocides). Recommendations were formulated on measures to prevent and control selection of azole resistance in A. fumigatus, including implementation of good agricultural/horticultural practices, proper agricultural and wood waste storage and management, and on approval of new azole fungicides or renewal of existing fungicides. Recommendations on topics to be covered by studies provided when submitting applications for the approval of azole fungicides were listed. For the evaluation of such studies within the approval procedure, a preliminary framework for risk assessment was developed and should be further refined. Data gaps and uncertainties were identified, alongside with respective recommendations to address them. EFSA Journal 1831-4732 10.2903/j.efsa.2025.9200 urn:nbn:de:kobv:b43-652175 true {"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T09:40:11Z","timestamp":1766050811966,"version":"3.35.0"},"reference-count":14,"publisher":"Wiley","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["EFS2","EFSA Journal"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:p>Abstract\r\n The use of azoles in the European Union and European Economic Area (EU\/EEA) other than as human medicines has raised concerns about emergence and spread of azole\u2010resistant Aspergillus species. EU agencies, with the support of JRC, reviewed the evidence and provided conclusions and recommendations on this topic. Although incomplete, data from 2010 to 2021 showed that around 120,000 tonnes of azoles were sold in EU\/EEA for uses other than as human medicines. The majority are used as plant protection products (119,000 tonnes), with a stable temporal trend. Evidence supported a link between environmental azole exposure and cross\u2010resistance selection to medical azoles in Aspergillus species (primarily shown for A. fumigatus). Prevalence of azole\u2010resistant A.\u2009fumigatus in human A. fumigatus infections ranges from 0.7% to 63.6% among different disease presentations and geographic regions; mortality rates range from 36% to 100% for invasive aspergillosis (IA). It was concluded that azole usage outside the human domain is likely or very likely to contribute to selection of azole\u2010resistant A.\u2009fumigatus isolates that could cause severe disease like IA. Environmental hotspots for resistance selection were identified, including stockpiling of agricultural waste and their possible use as soil amendment\/fertiliser for certain agricultural crops (for plant protection products) and freshly cut wood (for biocides). Recommendations were formulated on measures to prevent and control selection of azole resistance in A.\u2009fumigatus, including implementation of good agricultural\/horticultural practices, proper agricultural and wood waste storage and management, and on approval of new azole fungicides or renewal of existing fungicides. Recommendations on topics to be covered by studies provided when submitting applications for the approval of azole fungicides were listed. For the evaluation of such studies within the approval procedure, a preliminary framework for risk assessment was developed and should be further refined. Data gaps and uncertainties were identified, alongside with respective recommendations to address them. \r\n<\/jats:p>","DOI":"10.2903\/j.efsa.2025.9200","type":"journal-article","created":{"date-parts":[[2025,1,30]],"date-time":"2025-01-30T10:02:40Z","timestamp":1738231360000},"source":"Crossref","is-referenced-by-count":13,"title":["Impact of the use of azole fungicides, other than as human medicines, on the development of azole\u2010resistant Aspergillus spp."],"prefix":"10.2903","volume":"23","author":[{"name":"European Food Safety Authority (EFSA)","sequence":"first","affiliation":[]},{"name":"European Centre for Disease Prevention and Control (ECDC)","sequence":"additional","affiliation":[]},{"name":"European Chemicals Agency (ECHA)","sequence":"additional","affiliation":[]},{"name":"European Environment Agency (EEA)","sequence":"additional","affiliation":[]},{"name":"European Medicines Agency (EMA)","sequence":"additional","affiliation":[]},{"name":"European Commission's Joint Research Centre (JRC)","sequence":"additional","affiliation":[]}],"member":"311","reference":[{"key":"10.2903\/j.efsa.2025.9200_ref1","unstructured":"ANSES (French Agency for Food, Environmental and Occupational Health & Safety) . 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