EFSA Supporting Publications最新文献

{"title":"Governance Model for Ontologies","authors":"Yannis Tzitzikas,&nbsp;Yannis Marketakis,&nbsp;Pavlos Fafalios,&nbsp;Athina Kritsotaki,&nbsp;Anastasia Axaridou,&nbsp;Michalis Mountantonakis,&nbsp;Chryssoula Bekiari,&nbsp;Maria Theodoridou","doi":"10.2903/sp.efsa.2024.EN-9119","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9119","url":null,"abstract":"<p>This report proposes a governance model for managing the activities involving ontologies at EFSA. It contains recommendations about (a) the scoping of the ontology development activities at EFSA (purpose and subject matter), (b) external and internal consistency and interoperability, (c) maintenance and evolution, (d) access policies, (e) IT considerations (aligned with Deliverable D4), (f) outsourcing strategy, (g) training needs related to ontologies. The proposed model is aligned with the existing governance activities of EFSA, such as Rebuild DF. The document is complemented with the adopted governance model of other ontologies.</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-9119","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861839","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":"Compendium of Information on the Use of Guideline-Based Developmental Neurotoxicity Studies*","authors":"Kevin M. Crofton,&nbsp;William R. Mundy","doi":"10.2903/sp.efsa.2024.EN-9174","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9174","url":null,"abstract":"<p>Recent regulatory use of in vitro assays for developmental neurotoxicity have promulgated the development of initial OECD guidance for use of data from the developmental neurotoxicity in vitro battery (DNT IVB). One limitation in use of data from NAMs like the DNT IVB are the uncertainties of in vitro to predict in vivo effects. The lack of any curated database of in vivo DNT studies hampers such a comparison. The goal of the current effort was construction of a repository of all DNT studies defined as publicly available studies that followed DNT and/or reproductive guidelines containing a DNT cohort. The first specific aim was construction of a dataset that identified published studies and regulatory documents that mention completed, underway or planned DNT studies. This included documents which use read across as well agency waivers for DNT studies. The second aim identified those documents from Aim 1 that report the results of completed DNT studies. The third aim identified DNT studies that provide regulatory reviews with summary data. A total of 1648 documents were found from the overall search that had evidence of, 1) a completed, ongoing, or planned DNT study; 2) a read-across or planned read-across; or 3) a waiver. The 1648 documents included 324 DNT study citations. Final filtering of these data yielded a list of 153 DNT studies conducted on 144 chemicals and one stressor (diet restriction) for which there were both extensive data summaries and regulatory reviews. These results likely undercount the number of conducted studies due to the limited release of information from many regulatory agencies. In addition, the amount of information provided publicly available reviews ranges widely, from a one sentence summary to an extensive review with summaries of the methods, results and data interpretations. It is hoped that this paper will persuade regulatory agencies to release more DNT studies that provide comprehensive information. This will foster transparency and ensure public confidence in regulatory decisions. In addition, these results should provide data that promotes comparisons between in vitro and in vivo DNT methods.</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-9174","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861837","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":"Ontologies and Case Studies","authors":"Yannis Tzitzikas,&nbsp;Yannis Marketakis,&nbsp;Pavlos Fafalios,&nbsp;Athina Kritsotaki,&nbsp;Anastasia Axaridou,&nbsp;Michalis Mountantonakis,&nbsp;Maria Theodoridou,&nbsp;Chryssoula Bekiari","doi":"10.2903/sp.efsa.2024.EN-9120","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9120","url":null,"abstract":"<p>Ontologies define the main concepts and relations of a domain and can play the role of common language between domain experts, software developers and computer systems, allowing for easier and more comprehensive data management. Ontologies can provide a structure and context for data, enabling better analysis and decision-making. Ontologies can be leveraged for improving various Machine Learning-based tasks (they can be used for improving the accuracy and consistency of training data, and we can combine ML-based predictions with ontology-based reasoning). Ontologies are key components for achieving semantic data integration. In the context of this deliverable, we have surveyed 40 ontologies and 7 other knowledge organization systems related to food safety and we have categorized them according to a set of appropriate criteria. Subsequently we analysed the 18 case studies, that could involve ontologies, and for each one we have described the possible use of ontologies and what would be the benefit. Finally the identified case studies have been evaluated with respect to a set of criteria regarding benefits, cost and maturity.</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-9120","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861549","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":"Architectural Suggestions for Ontology Management","authors":"Yannis Tzitzikas,&nbsp;Yannis Marketakis,&nbsp;Michalis Mountantonakis,&nbsp;Pavlos Fafalios,&nbsp;Maria Theodoridou,&nbsp;Anastasia Axaridou,&nbsp;Athina Kritsotaki,&nbsp;Chryssoula Bekiari","doi":"10.2903/sp.efsa.2024.EN-9118","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9118","url":null,"abstract":"<p>This document describes the steps that required for creating and maintaining an ontology; for exploiting an ontology in order to describe data from one or more data sources; and for developing services and applications that provide unified access and insightful analysis on the data. The document provides the state of the art of the various tools and software components that exist and can be used for carrying out various tasks of the overall process. The components are grouped based on their intended use and for each one of them a concise description, as well as other useful details (i.e. if they are open-source, their license, etc.), are provided. For each step or task, the involved software components are also described in a table presenting their details with respect to various dimensions (e.g. open-source, license, available online, key advantages, etc.), in order to enable their quick comparison. Moreover, successful examples of semantic data integration are presented, i.e., for cases where a top-level ontology is used for integrating data for the cultural and biodiversity domain, and services for large-scale semantic data integration (including hundreds of datasets from several domains). Furthermore, it provides the high-level architectural suggestions that can be used as a basis for the actual implementation of any ontology-based system; the described processes and tools can be exploited for the development of the ontology-based functionality. Finally, it offers the adaptations of the proposed architecture for the EFSA case studies, by providing details about their components and indicative pipelines and tools.</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-9118","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861841","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 the 2025 national control plans for Veterinary Medicinal Product Residues","authors":"European Food Safety Authority (EFSA),&nbsp;Stefania Salvatore,&nbsp;Marta Vericat Ferrer,&nbsp;Valentina Bocca","doi":"10.2903/sp.efsa.2024.EN-9184","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9184","url":null,"abstract":"<p>This document should be used for reporting to EFSA samples planned under the national control plans for residues of veterinary medicinal product. It provides guidance on how to use the data model for submission to the EU of such data and related information.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9184","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861068","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 Massicus raddei","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.2024.EN-9159","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9159","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>Massicus raddei</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/massicus-raddei</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9159","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861020","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":"2024 crisis preparedness training: Annual Report","authors":"European Food Safety Authority (EFSA),&nbsp;Julia Johnson,&nbsp;Amy Drawbell,&nbsp;Bernard Bottex,&nbsp;Georgia Gkrintzali","doi":"10.2903/sp.efsa.2024.EN-9185","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9185","url":null,"abstract":"<p>In 2024, the European Food Safety Authority (EFSA) organised two crisis preparedness sessions. The internal crisis workshop focused on EFSA's preparedness to respond under the Serious Cross-Border Threats to Health (SCBTH) Regulation (EU) 2022/2371 and especially the requirement for a Joint Risk Assessment (JRA) with other EU agencies. EFSA's crisis training contractor, Instinctif Partners, developed the internal workshop for EFSA's Senior Management Team to increase awareness of the implications, roles and responsibilities in a JRA, as well as identifying required amendments for EFSA's internal crisis response procedures and the draft Interagency Working Arrangement under article 20 of the SCBTH Regulation. The workshop was mainly discussion-based, with a series of exercises focusing on identifying areas for process amendment, following three context-setting presentations. The external crisis exercise was co-developed by the Food Safety Authority of Ireland (FSAI), EFSA and Instinctif Partners to rehearse a multi-agency, multi-Member State response under the SCBTH regulation. Lasting 2.5-days, the preparedness training event comprised an overview of the Regulation on SCBTH, a role-played, 1.5-day simulation exercise and a half-day debrief session. The event was held in person at the Convention Centre, Dublin, and also involved multiple participants joining online. In addition to rehearsing the development of a multi-agency JRA in response to a SCBTH, the training also aimed to clarify Member States’ interaction during such a response. The objectives of both events were achieved, based on recorded outcomes and feedback provided by participants in evaluation surveys. This Annual Report summarises the external crisis exercise and provides a detailed overview of the development, running, and outcomes of the internal workshop, along with the participants’ feedback.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9185","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861266","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":"Refining the methodology for verifying GLP studies submitted within an application for regulated products","authors":"T. Coja,&nbsp;A Charistou,&nbsp;S. Anagnos,&nbsp;C. Anagnostopoulos,&nbsp;N. Arapaki,&nbsp;R. Bauer,&nbsp;D. Bournele,&nbsp;S. Galazka,&nbsp;P. Gatos,&nbsp;D. Hofstädter,&nbsp;I. Kandris,&nbsp;E. Karanasios,&nbsp;M. Kuffner,&nbsp;K. Machera,&nbsp;K. Marchart,&nbsp;U. Mayerhofer,&nbsp;S. Mirmigkou,&nbsp;I. Moschou,&nbsp;V. Plichta,&nbsp;E. Rauscher-Gabernig,&nbsp;J. Steinwider,&nbsp;W. Stepanek,&nbsp;H. Sun,&nbsp;E. Tzanetou,&nbsp;K. Vejdovszky,&nbsp;E. Vogiatzi,&nbsp;A. Weninger,&nbsp;M. Wögerbauer","doi":"10.2903/sp.efsa.2024.EN-9004","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9004","url":null,"abstract":"<p>OECD Good Laboratory Practice (GLP) principles were developed by governments as a regulatory control mechanism to ensure that safety studies would be of acceptable quality and integrity. EU Directives 2004/09/EC and 2004/10/EC incorporate the OECD GLP principles into the EU regulatory framework, requiring that studies submitted for the assessment and authorization adhere to the principles of GLP. In its role as European risk assessor authority, EFSA launched a project to strengthen the methodology for verifying GLP studies for all regulated product areas under its remit, with three main objectives: to establish verification methodology and tools through a fit for purpose GLP verification checklist, to test the methodology by applying it to substantial amount of studies across different regulatory areas and different study types and to develop a hands-on training program for GLP assessors and scientific units/risk assessors for the use and understanding of the created GLP checklist. Following these objectives, the study evaluation had two levels of assessment: identification of GLP observations and assessing scientific reliability of studies where GLP observations were made. Around 1,000 studies were investigated to examine the developed methodology. The GLP verification checklist proved to be fit for purpose for verifying GLP studies. Hands-on training was made available on the EU academy platform (https://academy.europa.eu/).</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142860844","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 Nemorimyza maculosa","authors":"European Food Safety Authority (EFSA),&nbsp;Mladen Šimala,&nbsp;Luka Mustapić,&nbsp;Josep Anton Jaques Miret,&nbsp;Laura Carotti,&nbsp;Giulia Mattion,&nbsp;Sybren Vos","doi":"10.2903/sp.efsa.2024.EN-9109","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9109","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>Nemorimyza maculosa</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/nemorimyza-maculosa</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9109","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142851464","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":"Update of a database of toxicological effects of pesticides in view of performing cumulative risk assessments. Part 1: Catalogue of toxicity endpoints and data model for the collection of toxicity endpoints.","authors":"Lea Bredsdorff,&nbsp;Karin Nørby,&nbsp;Annika Boye Petersen,&nbsp;Vibe Beltoft,&nbsp;Julie Boberg","doi":"10.2903/sp.efsa.2024.EN-9137","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9137","url":null,"abstract":"<p>A catalogue of toxicity endpoints was developed for a consistent collection of toxicological information. The toxicity endpoints of relevance for cumulative risk assessment were organised in a table for each target organ/tissue/system (cumulative assessment group (CAG) at level 1) including information on specific toxicological effect(s) (CAG at level 2), indicators that reflect the relevance for the CAG at level 2, and descriptions/interpretations that allow an understanding of the CAG at level 2. A data model for the collection of toxicity endpoints was developed to ensure the possibility of integration of the collected data to the EFSA OpenFoodTox database, in order to extend it to non-critical endpoints. The collection of toxicity endpoints and grouping of active substances were performed for a total of 328 active substances and 165 of their metabolites. The data model was filled in for all the OpenFoodTox columns as far as possible and essential information which could not be entered in the OpenFoodTox columns were noted in the ‘Remark column’. In total, 29 CAGs at level 1 have been evaluated for inclusion of specific toxicological effects (CAGs at level 2), whereas four CAG1 targets (gastrointestinal tract, immune system, lungs and skin) were not evaluated as the effects observed in these CAG1 targets were not considered relevant for CAGs at level 2. A number of toxicological effects considered adverse and of relevance for human risk assessment, but generally not relevant for CAGs at level 2, include mortality, clinical signs of toxicity, changes in bodyweight and body weight gain, changes in food consumption and water consumption, changes in clinical biochemistry and urinalysis parameters and changes in organ weights without histopathological changes. © National Food Institute, Technical University of Denmark, 2024</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9137","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142860498","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}