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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
{"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 3 (Fresh-whole FVH process water management plan)","authors":"EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards),&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.2025.9170","DOIUrl":"10.2903/j.efsa.2025.9170","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-whole FVH sector is characterised by very variable operational cycle duration (between 8 and 900 h), large product volumes (e.g. more than 6000 tonnes) and process water at 2.8–25.0°C. 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 29 scenarios were used to develop a guidance for a water management plan (WMP) for the fresh-whole 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. Food business operators (FBOps) 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/PMC11780612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064526","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 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
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 5 (Frozen 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.2025.9172
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 5 (Frozen 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.2025.9172","DOIUrl":"10.2903/j.efsa.2025.9172","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 frozen FVH sector is characterised by operational cycles between 8 and 120 h, variable product volumes and no control of the temperature of process water. Intervention strategies were limited to the use of water disinfection treatments such as peroxyacetic acid and hydrogen peroxide. Chlorine-based disinfectants were not used, and water replenishment was not observed within studied industries. The industrial data, which included 13 scenarios, were used to develop a guidance for a water management plan (WMP) for the frozen 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. 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/PMC11780613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064536","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
Coordinated One Health investigation and management of outbreaks in humans and animals caused by zoonotic avian influenza viruses
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-01-29 DOI: 10.2903/j.efsa.2025.9183
Theresa Enkirch, Andrea Gervelmeyer, Luisa Hallmaier-Wacker, Angeliki Melidou, Katriina Willgert
{"title":"Coordinated One Health investigation and management of outbreaks in humans and animals caused by zoonotic avian influenza viruses","authors":"Theresa Enkirch,&nbsp;Andrea Gervelmeyer,&nbsp;Luisa Hallmaier-Wacker,&nbsp;Angeliki Melidou,&nbsp;Katriina Willgert","doi":"10.2903/j.efsa.2025.9183","DOIUrl":"10.2903/j.efsa.2025.9183","url":null,"abstract":"<div>\u0000 \u0000 <p>When investigating and controlling outbreaks caused by zoonotic avian influenza viruses (AIV), a One Health approach is key. However, knowledge-sharing on AIV-specific One Health strategies, tools and action plans remains limited across the EU/EEA. It is crucial to establish responsibilities, capacity requirements, and collaboration mechanisms during 'peace time' to enable timely and effective outbreak investigations and management.</p>\u0000 <p>This report focuses on five scenarios for outbreak investigation and management of zoonotic AIV at the human-animal-environment interface, emphasising key actions for the stakeholders involved. The document primarily highlights the collaborative framework necessary for interdisciplinary coordinated responses, referring to more detailed guidance and technical reports published elsewhere when applicable. Three scenarios are triggered by suspected outbreaks in animals, including kept animals of listed species, non-listed species, companion animals and wild birds/mammals. The other two scenarios are initiated by a probable human case or detection of the virus in wastewater or environmental samples (e.g. surface water or other sources).</p>\u0000 <p>All scenarios require cross-sectoral coordination and a One Health approach. While the specific sequence of actions and communication needs may differ across scenarios, the overarching response mechanisms for outbreak investigations and management remain consistent. By presenting each scenario alongside the integrated actions of stakeholders, the report identifies critical development needs, such as tools (e.g. communication and data sharing platforms); key points for information exchange across sectors, triggers for joint risk assessments, and gaps in existing knowledge.</p>\u0000 <p>The document should assist in developing guidance documents to facilitate coordinated One Health investigations and the management of outbreaks in humans and animals caused by zoonotic avian influenza viruses.</p>\u0000 </div>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11775912/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064456","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
Preparedness, prevention and control related to zoonotic avian influenza
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-01-29 DOI: 10.2903/j.efsa.2025.9191
EFSA Panel on Animal Health and Animal Welfare (AHAW), ECDC, Julio Alvarez, Anette Boklund, Sabine Dippel, Fernanda Dórea, Jordi Figuerola, Mette S. Herskin, Virginie Michel, Miguel Ángel Miranda Chueca, Eleonora Nannoni, Søren Saxmose Nielsen, Romolo Nonno, Anja B. Riber, Jan Arend Stegeman, Karl Ståhl, Hans-Hermann Thulke, Frank Tuyttens, Christoph Winckler, Claire Brugerolles, Thorsten Wolff, Anna Parys, Erika Lindh, Neus Latorre-Margalef, Marie-Anne Rameix Welti, Ralf Dürrwald, Ramona Trebbien, Sylvie Van der Werf, Magnus Gisslén, Isabella Monne, Alice Fusaro, Claire Guinat, Alessio Bortolami, Leonidas Alexakis, Theresa Enkirch, Olov Svartstrom, Katriina Willgert, Francesca Baldinelli, Ludovica Preite, Malin Grant, Alessandro Broglia, Angeliki Melidou
{"title":"Preparedness, prevention and control related to zoonotic avian influenza","authors":"EFSA Panel on Animal Health and Animal Welfare (AHAW),&nbsp;ECDC,&nbsp;Julio Alvarez,&nbsp;Anette Boklund,&nbsp;Sabine Dippel,&nbsp;Fernanda Dórea,&nbsp;Jordi Figuerola,&nbsp;Mette S. Herskin,&nbsp;Virginie Michel,&nbsp;Miguel Ángel Miranda Chueca,&nbsp;Eleonora Nannoni,&nbsp;Søren Saxmose Nielsen,&nbsp;Romolo Nonno,&nbsp;Anja B. Riber,&nbsp;Jan Arend Stegeman,&nbsp;Karl Ståhl,&nbsp;Hans-Hermann Thulke,&nbsp;Frank Tuyttens,&nbsp;Christoph Winckler,&nbsp;Claire Brugerolles,&nbsp;Thorsten Wolff,&nbsp;Anna Parys,&nbsp;Erika Lindh,&nbsp;Neus Latorre-Margalef,&nbsp;Marie-Anne Rameix Welti,&nbsp;Ralf Dürrwald,&nbsp;Ramona Trebbien,&nbsp;Sylvie Van der Werf,&nbsp;Magnus Gisslén,&nbsp;Isabella Monne,&nbsp;Alice Fusaro,&nbsp;Claire Guinat,&nbsp;Alessio Bortolami,&nbsp;Leonidas Alexakis,&nbsp;Theresa Enkirch,&nbsp;Olov Svartstrom,&nbsp;Katriina Willgert,&nbsp;Francesca Baldinelli,&nbsp;Ludovica Preite,&nbsp;Malin Grant,&nbsp;Alessandro Broglia,&nbsp;Angeliki Melidou","doi":"10.2903/j.efsa.2025.9191","DOIUrl":"10.2903/j.efsa.2025.9191","url":null,"abstract":"<p>A risk assessment framework was developed to evaluate the zoonotic potential of avian influenza (AI), focusing on virus mutations linked to phenotypic traits related to mammalian adaptation identified in the literature. Virus sequences were screened for the presence of these mutations and their geographical, temporal and subtype-specific trends. Spillover events to mammals (including humans) and human seroprevalence studies were also reviewed. Thirty-four mutations associated with five phenotypic traits (increased receptor specificity, haemagglutinin stability, neuraminidase specificity, enhanced polymerase activity and evasion of innate immunity) were shortlisted. AI viruses (AIVs) carrying multiple adaptive mutations and traits belonged to both low and highly pathogenic subtypes, mainly to A(H9N2), A(H7N9), A(H5N6) and A(H3N8), were sporadic and primarily detected in Asia. In the EU/EEA, H5Nx viruses of clade 2.3.4.4b, which have increased opportunities for evolution due to widespread circulation in birds and occasional cases/outbreaks in mammals, have acquired the highest number of zoonotic traits. Adaptive traits, such as enhanced polymerase activity and immune evasion, were frequently acquired, while receptor-specific mutations remained rare. Globally, human cases remain rare, with the majority overall due to A(H5N1), A(H5N6), A(H7N9) and A(H9N2) that are among the subtypes that tend to have a higher number of adaptive traits. The main drivers of mammalian adaptation include virus and host characteristics, and external factors increasing AIV exposure of mammals and humans to wild and domestic birds (e.g. human activities and ecological factors). Comprehensive surveillance of AIVs targeting adaptive mutations with whole genome sequencing in animals and humans is essential for early detection of zoonotic AIVs and efficient implementation of control measures. All preparedness, preventive and control measures must be implemented under a One Health framework and tailored to the setting and the epidemiological situation; in particular, enhanced monitoring, biosecurity, genomic surveillance and global collaboration are critical for mitigating the zoonotic risks of AIV.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11775931/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064496","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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