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Peer review of the pesticide risk assessment of the active substance cyprodinil
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-02-06 DOI: 10.2903/j.efsa.2025.9209
European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, Monica Fittipaldi Broussarad, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Silvia Mazzega, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Alexandra Piti, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza
{"title":"Peer review of the pesticide risk assessment of the active substance cyprodinil","authors":"European Food Safety Authority (EFSA),&nbsp;Fernando Álvarez,&nbsp;Maria Arena,&nbsp;Domenica Auteri,&nbsp;Sofia Batista Leite,&nbsp;Marco Binaglia,&nbsp;Anna Federica Castoldi,&nbsp;Arianna Chiusolo,&nbsp;Angelo Colagiorgi,&nbsp;Mathilde Colas,&nbsp;Federica Crivellente,&nbsp;Chloe De Lentdecker,&nbsp;Isabella De Magistris,&nbsp;Mark Egsmose,&nbsp;Gabriella Fait,&nbsp;Franco Ferilli,&nbsp;Monica Fittipaldi Broussarad,&nbsp;German Giner Santonja,&nbsp;Varvara Gouliarmou,&nbsp;Katrin Halling,&nbsp;Alessio Ippolito,&nbsp;Frederique Istace,&nbsp;Samira Jarrah,&nbsp;Dimitra Kardassi,&nbsp;Aude Kienzler,&nbsp;Anna Lanzoni,&nbsp;Roberto Lava,&nbsp;Renata Leuschner,&nbsp;Alberto Linguadoca,&nbsp;Jochem Louisse,&nbsp;Christopher Lythgo,&nbsp;Oriol Magrans,&nbsp;Iris Mangas,&nbsp;Silvia Mazzega,&nbsp;Andrea Mioč,&nbsp;Ileana Miron,&nbsp;Tunde Molnar,&nbsp;Laura Padovani,&nbsp;Vincenzo Padricello,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Alexandra Piti,&nbsp;Simone Rizzuto,&nbsp;Anamarija Romac,&nbsp;Agnès Rortais,&nbsp;Miguel Santos,&nbsp;Rositsa Serafimova,&nbsp;Rachel Sharp,&nbsp;Csaba Szentes,&nbsp;Andrea Terron,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Giorgia Vianello,&nbsp;Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9209","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9209","url":null,"abstract":"<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State France and co-rapporteur Member State Bulgaria for the pesticide active substance cyprodinil are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of cyprodinil as a fungicide on apples and barley. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9209","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143248696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety evaluation of the food enzyme acylglycerol lipase from the genetically modified Penicillium sp. strain AE-LGS
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-02-05 DOI: 10.2903/j.efsa.2025.9228
EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L.M. Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Natália Kovalkovičová, Cristina Fernández-Fraguas, Roos Anna de Nijs, Sandra Rainieri, Yi Liu
{"title":"Safety evaluation of the food enzyme acylglycerol lipase from the genetically modified Penicillium sp. strain AE-LGS","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L.M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Natália Kovalkovičová,&nbsp;Cristina Fernández-Fraguas,&nbsp;Roos Anna de Nijs,&nbsp;Sandra Rainieri,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9228","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9228","url":null,"abstract":"<p>The food enzyme acylglycerol lipase (glycerol-ester acylhydrolase, EC 3.1.1.23) is produced with the genetically modified <i>Penicillium</i> sp. strain AE-LGS by Amano Enzyme Inc. The Panel could not conclude on the taxonomic identification of the production strain due to a lack of appropriate data. The genetic modifications do not give rise to safety concerns. The food enzyme was free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in two food manufacturing processes. The compositional data provided were insufficient to characterise the food enzyme batches for commercialisation and the batch used for toxicological testing. As a result, the suitability of the batch used in the toxicological tests could not be established. The toxicological studies were thus not considered and the dietary exposure not calculated. A search for the homology of the amino acid sequence of the acylglycerol lipase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Taken together, due to insufficient data regarding the production strain and the food enzyme composition, the Panel could not complete the safety assessment of the food enzyme.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9228","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143248386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Re-evaluation of butane (E 943a), isobutane (E 943b) and propane (E 944) as food additives
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-01-31 DOI: 10.2903/j.efsa.2025.9203
EFSA Panel on Food Additives and Flavourings (FAF), Laurence Castle, Monica Andreassen, Gabriele Aquilina, Maria Bastos, Polly Boon, Biagio Fallico, Reginald Fitzgerald, Maria Jose Frutos Fernandez, Bettina Grasl-Kraupp, Ursula Gundert-Remy, Rainer Gürtler, Eric Houdeau, Marcin Kurek, Henriqueta Louro, Patricia Morales, Sabina Passamonti, Gabriele Gagliardi, Salvatore Multari, Josef Daniel Rasinger, Ana Maria Rincon, Camilla Smeraldi
{"title":"Re-evaluation of butane (E 943a), isobutane (E 943b) and propane (E 944) as food additives","authors":"EFSA Panel on Food Additives and Flavourings (FAF),&nbsp;Laurence Castle,&nbsp;Monica Andreassen,&nbsp;Gabriele Aquilina,&nbsp;Maria Bastos,&nbsp;Polly Boon,&nbsp;Biagio Fallico,&nbsp;Reginald Fitzgerald,&nbsp;Maria Jose Frutos Fernandez,&nbsp;Bettina Grasl-Kraupp,&nbsp;Ursula Gundert-Remy,&nbsp;Rainer Gürtler,&nbsp;Eric Houdeau,&nbsp;Marcin Kurek,&nbsp;Henriqueta Louro,&nbsp;Patricia Morales,&nbsp;Sabina Passamonti,&nbsp;Gabriele Gagliardi,&nbsp;Salvatore Multari,&nbsp;Josef Daniel Rasinger,&nbsp;Ana Maria Rincon,&nbsp;Camilla Smeraldi","doi":"10.2903/j.efsa.2025.9203","DOIUrl":"10.2903/j.efsa.2025.9203","url":null,"abstract":"<p>The Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of butane (E 943a), isobutane (E 943b) and propane (E 944) as food additives. Butane, isobutane and propane are short-chain (C<sub>3</sub>–C<sub>4</sub>) alkanes, which are in gaseous state at room temperature. Their currently permitted use in food is in vegetable oil pan spray (for professional use only) and water-based emulsion spray as propellants at <i>quantum satis</i>. They can also be used in food colour preparations with a maximum residual limit of 1 mg/kg in food. Two interested business operators (IBOs) provided information in response to the call for data published by EFSA reporting typical and maximum use levels. The toxicological hazards of the three gases via inhalation are known, however this route of exposure is not considered relevant for their safety assessment as food additives. Existing EU specifications for the three food additives already contain limits for the toxic impurity 1,3-butadiene (1,3-BD), however due to a lack of information on the manufacturing processes used, uncertainties do remain regarding the potential presence of other impurities not listed in the current EU specifications for food additives. Based on their physicochemical properties, the three gases are considered by the Panel to be of low toxicological concern when used as food additives and their dietary exposure very low. The Panel concluded that the use of butane (E 943a), isobutane (E 943b) and propane (E 944) as food additives at the currently permitted uses and use levels does not raise a safety concern. The Panel made some recommendations for amending existing EU specifications for butane (E 943a), isobutane (E 943b) and propane (E 944).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783170/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety evaluation of the food enzyme α-amylase from the non-genetically modified Aspergillus sp. strain FUA
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-01-31 DOI: 10.2903/j.efsa.2025.9167
EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L. M. Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Cristina Fernàndez-Fraguas, Magdalena Andryszkiewicz, Natalia Kovalkovicova, Eleonora Marini, Yi Liu
{"title":"Safety evaluation of the food enzyme α-amylase from the non-genetically modified Aspergillus sp. strain FUA","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Magdalena Andryszkiewicz,&nbsp;Natalia Kovalkovicova,&nbsp;Eleonora Marini,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9167","DOIUrl":"10.2903/j.efsa.2025.9167","url":null,"abstract":"<p>The food enzyme α-amylase (4-α-<span>d</span>-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified <i>Aspergillus</i> sp. strain FUA by DSM Food Specialties B.V. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in four food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in the production of distilled alcohol, dietary exposure was calculated only for the remaining three food manufacturing processes. It was estimated to be up to 0.687 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 2911. A search for the homology of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found, one of which is also an oral allergen. Known sources of allergens were used in the food enzyme manufacturing process. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783166/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Flavouring group evaluation 418 (FGE. 418): 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-01-31 DOI: 10.2903/j.efsa.2025.9201
EFSA Panel on Food Additives and Flavourings (FAF), Laurence Castle, Monica Andreassen, Gabriele Aquilina, Maria Bastos, Polly Boon, Biagio Fallico, Reginald FitzGerald, Maria Jose Frutos Fernandez, Bettina Grasl-Kraupp, Ursula Gundert-Remy, Rainer Gürtler, Eric Houdeau, Marcin Kurek, Henriqueta Louro, Patricia Morales, Sabina Passamonti, Romualdo Benigni, Kevin Chipman, Eugenia Cordelli, Gisela Degen, Karl-Heinz Engel, Paul Fowler, Maria Carfí, Gabriele Gagliardi, Agnieszka Mech, Salvatore Multari, Carla Martino
{"title":"Flavouring group evaluation 418 (FGE. 418): 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester","authors":"EFSA Panel on Food Additives and Flavourings (FAF),&nbsp;Laurence Castle,&nbsp;Monica Andreassen,&nbsp;Gabriele Aquilina,&nbsp;Maria Bastos,&nbsp;Polly Boon,&nbsp;Biagio Fallico,&nbsp;Reginald FitzGerald,&nbsp;Maria Jose Frutos Fernandez,&nbsp;Bettina Grasl-Kraupp,&nbsp;Ursula Gundert-Remy,&nbsp;Rainer Gürtler,&nbsp;Eric Houdeau,&nbsp;Marcin Kurek,&nbsp;Henriqueta Louro,&nbsp;Patricia Morales,&nbsp;Sabina Passamonti,&nbsp;Romualdo Benigni,&nbsp;Kevin Chipman,&nbsp;Eugenia Cordelli,&nbsp;Gisela Degen,&nbsp;Karl-Heinz Engel,&nbsp;Paul Fowler,&nbsp;Maria Carfí,&nbsp;Gabriele Gagliardi,&nbsp;Agnieszka Mech,&nbsp;Salvatore Multari,&nbsp;Carla Martino","doi":"10.2903/j.efsa.2025.9201","DOIUrl":"10.2903/j.efsa.2025.9201","url":null,"abstract":"<p>The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester [FL-no: 16.136] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance has not been reported to occur naturally and it is chemically synthesised. The information provided on the manufacturing process, the composition and the stability of [FL-no: 16.136] was considered sufficient. The chronic dietary exposure to [FL-no: 16.136] estimated using the added portions exposure technique (APET) is calculated to be 860 μg/person per day for a 60-kg adult and 540 μg/person per day for a 15-kg 3-year-old child. [FL-no: 16.136] did not show genotoxic effects in bacterial mutagenicity and mammalian cell micronucleus assays in vitro. No ADME studies on [FL-no: 16.136] were provided. In a prenatal developmental toxicity study, no maternal or fetal toxicity was observed in rats dosed up to 1000 mg/kg body weight (bw) per day. In a 90-day toxicity study in rats, no adverse effects were observed. In this study, the Panel considered that the NOAEL is 777 and 923 mg/kg bw per day (the highest dose tested) for male and female rats, respectively. Considering the lowest NOAEL of 777 mg/kg bw per day, as a reference point, adequate margins of exposure of 55 × 10<sup>3</sup> and 21 × 10<sup>3</sup> were calculated for adults and children, respectively, when considering the chronic APET dietary exposure estimates. The Panel concluded that the use of 3-[3-(2-isopropyl-5-methylcyclohexyl)-ureido]-butyric acid ethyl ester [FL-no: 16.136] as a flavouring substance under the proposed conditions of use does not raise a safety concern at the dietary exposure estimates calculated using the APET approach.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783151/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Plain Language Summary of the Scientific report on azole resistance in Aspergillus spp.
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-01-30 DOI: 10.2903/j.efsa.2025.p230103
{"title":"Plain Language Summary of the Scientific report on azole resistance in Aspergillus spp.","authors":"","doi":"10.2903/j.efsa.2025.p230103","DOIUrl":"10.2903/j.efsa.2025.p230103","url":null,"abstract":"","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780317/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of the use of azole fungicides, other than as human medicines, on the development of azole-resistant Aspergillus spp.
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-01-30 DOI: 10.2903/j.efsa.2025.9200
European Food Safety Authority (EFSA), European Centre for Disease Prevention and Control (ECDC), European Chemicals Agency (ECHA), European Environment Agency (EEA), European Medicines Agency (EMA), European Commission's Joint Research Centre (JRC)
{"title":"Impact of the use of azole fungicides, other than as human medicines, on the development of azole-resistant Aspergillus spp.","authors":"European Food Safety Authority (EFSA),&nbsp;European Centre for Disease Prevention and Control (ECDC),&nbsp;European Chemicals Agency (ECHA),&nbsp;European Environment Agency (EEA),&nbsp;European Medicines Agency (EMA),&nbsp;European Commission's Joint Research Centre (JRC)","doi":"10.2903/j.efsa.2025.9200","DOIUrl":"10.2903/j.efsa.2025.9200","url":null,"abstract":"<p>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 <i>Aspergillus</i> 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 <i>Aspergillus</i> species (primarily shown for <i>A. fumigatus</i>). Prevalence of azole-resistant <i>A. fumigatus</i> in human <i>A. fumigatus</i> 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 <i>A. fumigatus</i> 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 <i>A. fumigatus</i>, 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.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780318/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Microbiological hazards associated with the use of water in the post-harvest handling and processing operations of fresh and frozen fruits, vegetables and herbs (ffFVH). Part 3 (Fresh-whole FVH process water management plan)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-01-30 DOI: 10.2903/j.efsa.2025.9170
EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), Ana Allende, Avelino Alvarez-Ordóñez, Valeria Bortolaia, Sara Bover-Cid, Alessandra De Cesare, Wietske Dohmen, Laurent Guillier, Lieve Herman, Liesbeth Jacxsens, Lapo Mughini-Gras, Maarten Nauta, Jakob Ottoson, Luisa Peixe, Fernando Perez-Rodriguez, Panagiotis Skandamis, Elisabetta Suffredini, Jen Banach, Bin Zhou, Maria Teresa da Silva Felício, Laura Martino, Winy Messens, Angela Botteon
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引用次数: 0
Microbiological hazards associated with the use of water in the post-harvest handling and processing operations of fresh and frozen fruits, vegetables and herbs (ffFVH). Part 4 (fresh-cut FVH process water management plan)
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-01-30 DOI: 10.2903/j.efsa.2025.9171
EFSA Panel on Biological Hazards (BIOHAZ), Ana Allende, Avelino Alvarez-Ordóñez, Valeria Bortolaia, Sara Bover-Cid, Alessandra De Cesare, Wietske Dohmen, Laurent Guillier, Lieve Herman, Liesbeth Jacxsens, Lapo Mughini-Gras, Maarten Nauta, Jakob Ottoson, Luisa Peixe, Fernando Perez-Rodriguez, Panagiotis Skandamis, Elisabetta Suffredini, Jen Banach, Bin Zhou, Maria Teresa da Silva Felício, Laura Martino, Winy Messens, Angela Botteon
{"title":"Microbiological hazards associated with the use of water in the post-harvest handling and processing operations of fresh and frozen fruits, vegetables and herbs (ffFVH). Part 4 (fresh-cut FVH process water management plan)","authors":"EFSA Panel on Biological Hazards (BIOHAZ),&nbsp;Ana Allende,&nbsp;Avelino Alvarez-Ordóñez,&nbsp;Valeria Bortolaia,&nbsp;Sara Bover-Cid,&nbsp;Alessandra De Cesare,&nbsp;Wietske Dohmen,&nbsp;Laurent Guillier,&nbsp;Lieve Herman,&nbsp;Liesbeth Jacxsens,&nbsp;Lapo Mughini-Gras,&nbsp;Maarten Nauta,&nbsp;Jakob Ottoson,&nbsp;Luisa Peixe,&nbsp;Fernando Perez-Rodriguez,&nbsp;Panagiotis Skandamis,&nbsp;Elisabetta Suffredini,&nbsp;Jen Banach,&nbsp;Bin Zhou,&nbsp;Maria Teresa da Silva Felício,&nbsp;Laura Martino,&nbsp;Winy Messens,&nbsp;Angela Botteon","doi":"10.2903/j.efsa.2025.9171","DOIUrl":"10.2903/j.efsa.2025.9171","url":null,"abstract":"<p>Water used in post-harvest handling and processing operations is an important risk factor for microbiological cross-contamination of fruits, vegetables and herbs (FVH). Industrial data indicated that the fresh-cut FVH sector is characterised by process water at cooled temperature, operational cycles between 1 and 15 h, and product volumes between 700 and 3000 kg. Intervention strategies were based on water disinfection treatments mostly using chlorine-based disinfectants. Water replenishment was not observed within studied industries. The industrial data, which included 19 scenarios were used to develop a guidance for a water management plan (WMP) for the fresh-cut FVH sector. A WMP aims to maintain the fit-for-purpose microbiological quality of the process water and consists of: (a) identification of microbial hazards and hazardous events linked to process water; (b) establishment of the relationship between microbiological and physico-chemical parameters; (c) description of preventive measures; (d) description of intervention measures, including their validation, operational monitoring and verification; and (e) record keeping and trend analysis. A predictive model was used to simulate water management outcomes, highlighting the need for water disinfection treatments to maintain the microbiological quality of the process water and the added value of water replenishment. Relying solely on water replenishment (at realistic feasible rates) does not avoid microbial accumulation in the water. Operational monitoring of the physico-chemical parameters ensures that the disinfection systems are operating effectively. Verification includes microbiological analysis of the process water linked to the operational monitoring outcomes of physico-chemical parameters. Although <i>Escherichia coli</i> and <i>Listeria</i> spp. could be indicators for assessing water quality, food business operators should set up and validate a tailored WMP to identify physico-chemical parameters, as well as microbial indicators and their threshold levels, as performance standards for maintaining the fit-for-purpose microbiological quality of the process water during post-harvest handling and processing operations.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780610/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Microbiological hazards associated with the use of water in the post-harvest handling and processing operations of fresh and frozen fruits, vegetables and herbs (ffFVH). Part 2 – A dynamic mass balance model for handling and processing operations in ffFVH using water
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-01-30 DOI: 10.2903/j.efsa.2025.9173
EFSA Panel on Biological Hazards (BIOHAZ), Ana Allende, Avelino Alvarez-Ordóñez, Valeria Bortolaia, Sara Bover-Cid, Alessandra De Cesare, Wietske Dohmen, Laurent Guillier, Lieve Herman, Liesbeth Jacxsens, Lapo Mughini-Gras, Maarten Nauta, Jakob Ottoson, Luisa Peixe, Fernando Perez-Rodriguez, Panagiotis Skandamis, Elisabetta Suffredini, Jen Banach, Bin Zhou, Maria Teresa da Silva Felício, Laura Martino, Winy Messens, Angela Botteon
{"title":"Microbiological hazards associated with the use of water in the post-harvest handling and processing operations of fresh and frozen fruits, vegetables and herbs (ffFVH). Part 2 – A dynamic mass balance model for handling and processing operations in ffFVH using water","authors":"EFSA Panel on Biological Hazards (BIOHAZ),&nbsp;Ana Allende,&nbsp;Avelino Alvarez-Ordóñez,&nbsp;Valeria Bortolaia,&nbsp;Sara Bover-Cid,&nbsp;Alessandra De Cesare,&nbsp;Wietske Dohmen,&nbsp;Laurent Guillier,&nbsp;Lieve Herman,&nbsp;Liesbeth Jacxsens,&nbsp;Lapo Mughini-Gras,&nbsp;Maarten Nauta,&nbsp;Jakob Ottoson,&nbsp;Luisa Peixe,&nbsp;Fernando Perez-Rodriguez,&nbsp;Panagiotis Skandamis,&nbsp;Elisabetta Suffredini,&nbsp;Jen Banach,&nbsp;Bin Zhou,&nbsp;Maria Teresa da Silva Felício,&nbsp;Laura Martino,&nbsp;Winy Messens,&nbsp;Angela Botteon","doi":"10.2903/j.efsa.2025.9173","DOIUrl":"10.2903/j.efsa.2025.9173","url":null,"abstract":"<p>A dynamic mass balance model was developed to simulate contamination dynamics in the process water of fresh and frozen fruits, vegetables and herbs (ffFVH) during processing and handling operations. The mass balance relates to the flux of water and product in a wash tank and the number of microbial cells released in the water, inactivated by the water disinfectant or transferred from the water back to the product. Critical variables describing microbial dynamics in water are: (i) the chemical oxygen demand (COD), as an indicator of the concentration of organic matter; (ii) free chlorine (FC) and particularly its antimicrobial fraction, hypochlorous acid (HOCl); and (iii) the microbial population levels. Model parameters include: (i) the dilution rate of the process water, representing the speed of system saturation, equal to the water flux divided by the tank volume; (ii) the transfer rates of total bacterial counts (TBC) and COD from product to water; and (iii) the specific inactivation rate of microorganisms due to HOCl. The protective effect of COD on microbial cells against FC is encompassed in the inactivation rate. HOCl is expressed as a function of temperature, pH and total chlorine. The model can simulate ‘<i>what if scenarios’</i>, based on user-defined process-specific and product/microorganism-specific parameters through a web R-based application. This model can help food business operators when selecting intervention strategies and conditions to maintain the microbiological quality of the process water or identify conditions that represent poor or proper water management practices. Testing alternative model structures and collecting data about operational conditions of handling and/or processing operations, microbial dynamics and the magnitude of the product-specific protective effect on microorganisms are recommended to improve the application of the model.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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