EFSA Supporting Publications最新文献

{"title":"Workshop for the revision of the terrestrial ecotoxicology guidance document for pesticides risk assessment and for the development of an approach on indirect effects","authors":"European Food Safety Authority (EFSA),&nbsp;European Commission (EC)","doi":"10.2903/sp.efsa.2025.EN-9215","DOIUrl":"https://doi.org/10.2903/sp.efsa.2025.EN-9215","url":null,"abstract":"<p>The workshop, co-organized by EFSA and the European Commission (DG SANTE) on 8-9 October 2024 in Brussels, was the first step in response to the mandates requesting EFSA to review the Guidance Document on Terrestrial Ecotoxicology and to develop a framework for assessing potential indirect effects on biodiversity through trophic interactions in agro-environmental conditions. The event featured three discussion rounds: Round 1 focused on identifying gaps in current practices, Round 2 provided deeper analysis of these gaps, and Round 3 examined data availability, feasibility, and potential methodologies for addressing the gaps identified in Rounds 1 and 2. The workshop's breakout sessions, central to the event, allowed participants to engage in in-depth discussions on five specialized topics: Exposure, Non-Target Arthropods, Non-Target Terrestrial Plants, in-soil organisms, and indirect effects. These sessions aimed to gather stakeholder input on the limitations of the current guidance, exchange knowledge on available data and test guidelines, and clarify expectations for the upcoming revision. Each group addressed specific aspects, such as exposure pathways, problem formulation, and effect assessment. The group on indirect effect, a topic currently lacking specific guidance, discussed what can be feasibly achieved in the course of the mandate timeframe. The plenary sessions, held at the end of each day, provided an opportunity for group rapporteurs to present the key findings from their breakout discussions, including identified gaps and suggestions for improvements. These presentations were followed by a Question &amp; Answer session with the audience and reflections from EFSA on the discussions. The outcomes of the breakout sessions were enriching, offering valuable insights that will inform the revision of the guidance document, ensuring it reflects emerging needs and challenges in environmental protection.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2025.EN-9215","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143116146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Plant Health Newsletter on Horizon Scanning–December 2024","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/sp.efsa.2025.EN-9214","DOIUrl":"https://doi.org/10.2903/sp.efsa.2025.EN-9214","url":null,"abstract":"","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2025.EN-9214","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143115644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"L’ORA – A Living One Health Risk Assessment tool to assess the incursion risk of zoonotic diseases.","authors":"C.J. De Vos,&nbsp;M.J. Counotte,&nbsp;E. Snary,&nbsp;M. Nauta,&nbsp;A. Acosta,&nbsp;M.A. Dolman,&nbsp;J. Ligtenberg,&nbsp;A. Boklund,&nbsp;H. Roberts,&nbsp;A. Comin,&nbsp;M. Swanenburg,&nbsp;M.A.P.M. Van Asseldonk,&nbsp;C. Hultén,&nbsp;J. Gonzales,&nbsp;E.J.G.M. Westerhof,&nbsp;D. Serwin,&nbsp;P. Jokelainen,&nbsp;C.T. Kirkeby,&nbsp;D. Evans,&nbsp;H. Kim,&nbsp;C. Cobbold,&nbsp;V. Horigan,&nbsp;R.R.L. Simons,&nbsp;D. Brown,&nbsp;F. Dórea","doi":"10.2903/sp.efsa.2025.EN-9115","DOIUrl":"https://doi.org/10.2903/sp.efsa.2025.EN-9115","url":null,"abstract":"<p>Safeguarding global health is a moving target, with changes in climate and human activity raising new threats to public health, animal health and animal welfare. Decision support in the context of health management requires tools capable of making sense of large volumes of complex and multidisciplinary evidence. A One Health living risk assessment tool, L'ORA, was developed to assess the incursion risk for zoonotic and animal diseases using a One Health approach and allowing for automatic updates of the risk assessment. L'ORA estimates the incursion risk as the resultant of four steps: 1) Disease occurrence in source areas based on the distribution of diseases worldwide; 2) Rate of incursion based on the individuals or products moved from source areas to target areas and their probability of infection or contamination and contact with susceptible hosts in target areas; 3) Extent of disease spread in target areas, considering both domestic and wild host populations, vectors if the disease is vector-borne, and humans if the disease is zoonotic; and 4) Impact of the disease outbreak and concurrent control measures on public health, animal health and animal welfare, accounting for economic, societal, and environmental impacts. L'ORA is a decision support tool that was built as a generic tool comparing the relative risks of multiple diseases across multiple target areas. L'ORA monthly evaluates the incursion risk for each NUTS2 region in the European Union. Results can be used to identify areas of greater risk for each of the diseases to inform risk managers on where to focus attention and resources, and to inform, e.g., risk-based surveillance.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2025.EN-9115","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143114833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pest survey card on Euwallacea fornicatus sensu lato, Fusarium ambrosium and F. euwallaceae","authors":"European Food Safety Authority (EFSA),&nbsp;Gabriele Rondoni,&nbsp;Niklas Björklund,&nbsp;Irene Vloutoglou,&nbsp;Laura Carotti,&nbsp;Giulia Mattion,&nbsp;Sybren Vos","doi":"10.2903/sp.efsa.2025.EN-9179","DOIUrl":"https://doi.org/10.2903/sp.efsa.2025.EN-9179","url":null,"abstract":"<p>This document provides the conclusions of the pest survey card that was prepared in the context of the EFSA mandate on plant pest surveillance (M-2020-0114) at the request of the European Commission. The full pest survey card for <i>Euwallacea fornicatus sensu lato</i> (<i>s.l.</i>), <i>Fusarium ambrosium</i> and <i>F. euwallaceae</i> surveys is published and available online in the EFSA Pest Survey Card gallery at the following link and will be updated whenever new information becomes available: https://efsa.europa.eu/plants/planthealth/monitoring/surveillance/euwallacea-fornicatus-fusarium-ambrosium-euwallaceae</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2025.EN-9179","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143113624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pest survey card on Ips typographus","authors":"European Food Safety Authority (EFSA),&nbsp;Gabriele Rondoni,&nbsp;Niklas Björklund,&nbsp;Laura Carotti,&nbsp;Giulia Mattion,&nbsp;Sybren Vos","doi":"10.2903/sp.efsa.2025.EN-9141","DOIUrl":"https://doi.org/10.2903/sp.efsa.2025.EN-9141","url":null,"abstract":"<p>This document provides the conclusions of the pest survey card that was prepared in the context of the EFSA mandate on plant pest surveillance (M-2020-0114) at the request of the European Commission. The full pest survey card for <i>Ips typographus</i> is published and available online in the EFSA Pest Survey Card gallery at the following link and will be updated whenever new information becomes available: https://efsa.europa.eu/plants/planthealth/monitoring/surveillance/ips-typographus</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2025.EN-9141","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143113626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Guidance for reporting 2024 laboratory data on avian influenza","authors":"European Food Safety Authority (EFSA),&nbsp;Catalin Iancu,&nbsp;Alexandra Papanikolaou,&nbsp;Roxani Aminalragia-Giamini,&nbsp;Gabriele Zancanaro,&nbsp;Elisa Fasanelli","doi":"10.2903/sp.efsa.2024.EN-9199","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9199","url":null,"abstract":"<p>This technical report aims at guiding the reporting of data on analytical test results, and related metadata, to EFSA in the context of the activities for the surveillance of avian influenza. The objective is to explain in detail the individual data elements that are included in the EFSA Standard Sample Description version 2 (SSD2) data model. The guidance is intended to support the reporting countries in data transmission using eXtensible Markup Language (XML) data file transfer through the Data Collection Framework (DCF) according to the protocol described in the EFSA Guidance on Data Exchange version 2 (GDE2). The data elements are explained, including information about data type, list of allowed terms and associated business rules. Instructions about how to report common sampling schemes are also provided to ensure harmonised reporting among countries.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9199","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Overall conclusions on the application for approval of Quassia amara L. wood as a basic substance to be used in plant protection as an insecticide and repellent in pome fruit, stone fruit, hop and ornamentals","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/sp.efsa.2024.EN-9161","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9161","url":null,"abstract":"<p>The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received in accordance with Article 23 of Regulation (EC) No 1107/2009 concerning basic substances. This evaluation was requested by way of a specific mandate from the European Commission following the submission of an application for approval of <i>Quassia amara</i> L. wood as a basic substance to be used in plant protection as an insecticide and repellent in pome fruit, stone fruit, hop and ornamentals. This report summarises the outcome of the public and targeted consultations with Member States and EFSA, and presents EFSA's scientific views on the individual comments received including the overall conclusions with the main findings on the application.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9161","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Generic kinetic and kinetic-dynamic modelling in human subgroups of the population and animal species to support transparency in food and feed safety: Case studies","authors":"Rémy Beaudoin,&nbsp;Emilio Benfenati,&nbsp;Pierre-André Billat,&nbsp;Franca Maria Buratti,&nbsp;Chiara Dall'Asta,&nbsp;Keyvin Darney,&nbsp;Gianni Galaverna,&nbsp;Luca Dellafiora,&nbsp;Lorenzo Pedroni,&nbsp;Ron Hoogenboom,&nbsp;Leonie Lautz,&nbsp;Jochem Louisse,&nbsp;Alessandra Roncaglioni,&nbsp;Emanuela Testai,&nbsp;Cleo Tebby,&nbsp;Élisa Thépaut,&nbsp;Susanna Vichi,&nbsp;Florence Zeman","doi":"10.2903/sp.efsa.2024.EN-9010","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9010","url":null,"abstract":"<p>The present report describes the work performed in the EFSA-project ‘Data collection, update and further development of biologically-based models for humans and animal species to support transparency in food and feed safety’. Here, Focus is given to case studies for food and feed chemicals to predict kinetic parameters and profiles using generic and substance-specific physiologically-based kinetic (PBK) models for humans, including human subgroups, laboratory animal species, farm animals and a kinetic-dynamic model in salmon. For humans, five case studies were conducted to compare kinetic predictions using the human generic PBK 6-compartment COSMOS/TKPlatewith i) in vivo data from human clinical or biomonitoring studies, ii) substance-specific model predictions using molecules relevant to food safety. Another five case studies assessed the impact of physiological variability (including pregnancy, renal excretion, metabolism variability, or ontogeny) and their impact on biomarkers of exposure. Case studies on laboratory and farm animals focused on theophylline, caffeine, cannabinoids, alkaloids and mycotoxins using the generic 11/12 PBK compartment models integrated in EFSA's TKPlate to assess predicted and experimental parameters i.e. plasma concentrations, excretion via milk or eggs. Overall, predictions from the human generic and substance-specific PBK models for parameters of chronic exposure were similar and robust compared to the available experimental data. For test species and farm animals, model predictions from the generic TKPlate PBK models also performed well and were mostly within 2-fold compared to available experimental <i>in vivo</i> data. In addition, 3D molecular modelling case studies were also conducted to investigate transport of chemicals (ochratoxin A, perfluoroalkyls) and cytochrome P450 metabolism (ochratoxin A, safrole and other alkenylbenzenes) as a useful tool to generate metabolism information at the molecular level. Conclusions and recommendations for future work are formulated to further develop generic PBK models for parent compounds and metabolites and further guidance to use and parameterise these models in next generation risk assessment.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9010","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EFSA's activities on Emerging Risks in 2023","authors":"European Food Safety Authority (EFSA),&nbsp;Gkrintzali Georgia,&nbsp;Georgiev Milen,&nbsp;Garcia Matas Raquel,&nbsp;Maggiore Angelo,&nbsp;Georganas Alexandros,&nbsp;Czerwiec Aurore,&nbsp;Eynard Clémentine,&nbsp;Verloo Didier,&nbsp;Bottex Bernard","doi":"10.2903/sp.efsa.2024.EN-9198","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9198","url":null,"abstract":"<p>The main objectives of EFSA's activities on environmental scanning encompass: (i) the identification and analysis of emerging risks as well as more forward-looking signals, drivers and trends that could affect EFSA's work programme; (ii) developing and improving emerging risk identification methodologies and approaches; and (iii) communicating issues and risks that have been identified. The outcome of these activities equips EFSA to anticipate forthcoming challenges in the continuously evolving landscape of risk assessment. EFSA networks of knowledge that contribute to the emerging risks identification activity include the Emerging Risks Exchange Network (EREN), the Stakeholder Discussion Group on Emerging Risks (StaDG-ER), EFSA's scientific units, the Scientific Panels, the Scientific Committee and their working groups. The current technical report summarises the activities of all groups involved in the environmental scanning process, the issues identified in the course of 2023, and the collaborative activities. In total, 32 potential emerging issues were discussed in 2023 and five were concluded to be emerging risks. The potential issues were classified according to the hazard.</p><p>In 2023, EFSA has further implemented its environmental scanning and strategic options definition process with the development of the Emerging Risks Exchange Platform (ERAP), which is intended to centralise all emerging risks analysis activities. Acknowledging the breadth and variety of the scientific areas to be covered, EFSA has also put in place a collaborative network for preparedness that goes beyond just the European Union. Finally, special attention has been given to increasing the visibility of EFSA's environmental scanning work, making use of FoodSafeR's digital hub to disseminate EFSA's activities to a worldwide community of professionals dealing with preparedness, and with the creation of the biannual EFSA newsletter “<i>Emerging Risks Update</i>,” which provides valuable insights into EREN's and StaDG-ER's meetings and discussions, recent news and publications, upcoming events and activities related to environmental scanning.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9198","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recommended DNT Reference Chemical Test Set For In Vitro Assay Development*","authors":"William R. Mundy,&nbsp;Kevin M. Crofton","doi":"10.2903/sp.efsa.2024.EN-9175","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9175","url":null,"abstract":"<p>New approach methodologies (NAMs) for developmental neurotoxicology are being developed and used to provide information on chemical hazard and risk for humans while limiting the use of animals. Recently OECD published an initial guidance document for use of the Developmental Neurotoxicity In Vitro Battery (DNT IVB), composed of in vitro assays that assess critical neurodevelopmental processes. To evaluate assay performance and develop new assays for inclusion in the DNT IVB, positive and negative control compounds with known actions neurodevelopmental processes are required. In contrast, to evaluate the ability of the battery of <i>in vitro</i> DNT assays to predict developmental neurotoxicity <i>in vivo</i> in mammals (and particularly in humans), a different set of positive and negative controls are required. These are DNT Reference Chemicals - chemicals with evidence for <i>in vivo</i> developmental neurotoxicity identified in studies of humans or experimental animals (positives), as well as chemicals with evidence that they do not result in developmental neurotoxicity <i>in vivo</i> (negatives). The OECD guidance proposed a draft list of approximately 100 chemicals for use as DNT Reference Chemicals. The importance of this common set of chemicals was to provide a basis for beginning the evaluation of the current DNT-IVB performance vs. the available <i>in vivo</i> DNT studies and determine the added value of possible new assays developed for inclusion in the DNT IVB. The purpose of the current report is to update Appendix A of OCED 337 (OECD, 2023) and provide a <i>Recommended DNT Reference Chemical Test Set</i> for use in <i>in vitro</i> DNT assay development and evaluation.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9175","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142851401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}