EFSA Supporting Publications最新文献

{"title":"EFSA's activities on emerging risks in 2022","authors":"European Food Safety Authority (EFSA),&nbsp;Georgia Gkrintzali,&nbsp;Milen Georgiev,&nbsp;Raquel Garcia Matas,&nbsp;Angelo Maggiore,&nbsp;Roberta Giarnecchia,&nbsp;Didier Verloo,&nbsp;Bernard Bottex","doi":"10.2903/sp.efsa.2024.EN-8995","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8995","url":null,"abstract":"<p>The main objectives of EFSA's activities on emerging risks encompass: (i) conducting activities to identify emerging risks; (ii) developing and improving emerging risk identification (ERI) methodologies and approaches; and (iii) communicating identified issues and risks. The outcome of these activities equips EFSA to anticipate forthcoming challenges in the continuously evolving landscape of risk assessment. EFSA networks of knowledge contributing 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 emerging risk identification procedure, the issues identified in the course of 2022, the emerging risk identification methodologies being developed, and the collaborative activities. In total, 13 potential emerging issues were discussed in 2022 and two were concluded to be emerging risks. The potential issues were classified according to the hazard. The year 2022 marks a turn in EFSA's activities on emerging risk identification. To achieve strategic objective no. 2 ‘Ensure preparedness for future risks analysis needs’ of the EFSA Strategy 2027, a new process ‘Environmental scanning and strategic options definition’ has been developed. The process adds to the already existing emerging risks analysis workflow a second workflow that is more forward-looking, to deal with horizon scanning in the areas of food and feed safety, plant health and animal health. Similarly to the emerging risks analysis workflow, the new workflow for horizon scanning strongly relies on partnership to be prepared for future challenges, build resilience, and proactively shape the future in a one-health approach.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8995","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142123206","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 Project on the use of NAMs to explore the immunotoxicity of PFAS","authors":"Emanuela Corsini,&nbsp;Martina Iulini,&nbsp;Valentina Galbiati,&nbsp;Ambra Maddalon,&nbsp;Francesco Pappalardo,&nbsp;Giulia Russo,&nbsp;Ron L.A.P. Hoogenboom,&nbsp;Karsten Beekmann,&nbsp;Aafke W.F. Janssen,&nbsp;Jochem Louisse,&nbsp;Styliani Fragki,&nbsp;Alicia Paini","doi":"10.2903/sp.efsa.2024.EN-8926","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8926","url":null,"abstract":"<p>Perfluorinated substances (PFAS) are a class of synthetic chemicals widely used in industry, to which people and ecosystems are exposed. Epidemiological studies have shown that PFAS can cause immunosuppression, increased risk of infections and decreased response to vaccination, with the underlying mechanism(s) of action still remaining elusive. The aim of this project was to fill some of the data gaps identified in the 2020 EFSA Opinion, using new approach methodologies (NAMs). In particular, we aimed to get information on the mode of action for the immunosuppression effects observed in epidemiological studies (i.e., reduction in the vaccination efficacy and possible increase in the susceptibility to infectious disease), and to address the immunotoxicity of PFAS other than PFOS and PFOA (PFNA and PFHxS), including the assessment of a possible common mode of action and to provide insight into the relative potencies of the tested PFAS. To reach these goals, an integrated testing strategy (ITS) consisting of <i>in vitro</i> and <i>in silico</i> methods was developed. The effects of PFAS were investigated using target immune human cell-based <i>in vitr</i>o models, suitable to assess the relevant immunotoxic parameters observed in epidemiological studies (i.e. decreased antibody production). Results obtained fully support the evidence from human epidemiological studies. Furthermore, mathematical fate and distribution models were used to identify nominal concentration of PFAS in the <i>in vitro</i> cell system and physiologically based kinetic (PBK) models were used to perform quantitative <i>in vitro</i> to <i>in vivo</i> extrapolation. The ‘Universal Immune System Simulator’ was used to complete the ITS and investigate the reduced response to vaccination also on vulnerable populations. The use of these selected NAMs may provide a tool to support, by providing mechanistic information, regulatory risk assessment and to study the immunotoxic potential of other PFAS. The participation of immunotoxicologists, molecular biologists, risk assessors, and computational experts within the Consortium, together with EFSA's engagement, ensured the successful performance of this project and delivery of a NAMs-based strategy that allows generating mechanistic information on PFAS immunotoxicity and support risk assessment.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8926","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142045304","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":"Emerging chemical risks in food and feed","authors":"European Food Safety Authority (EFSA),&nbsp;Alexandros Georganas,&nbsp;Angelo Maggiore,&nbsp;Bernard Bottex","doi":"10.2903/sp.efsa.2024.EN-8992","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8992","url":null,"abstract":"<p>The EFSA process of Environmental Scanning and Strategic Options Definition aims at identifying knowledge gaps and opportunities to fulfil EFSA's mission more efficiently and contribute to the definition of EFSA's work programme and long-term strategy. The identification of trends, drivers of change and emerging risks in the fields within EFSA's mission is one of the objectives of this process. The Member States and stakeholders in the EFSA knowledge networks for emerging risks, namely the Emerging Risks Exchange Network (EREN) and the Stakeholder Discussion Group on Emerging Risks (StaDG-ER), have identified several emerging chemical issues/risks and analysed them according to the EFSA definition of emerging risks and characterisation criteria. In addition, various EFSA projects have been conducted for the identification of emerging chemical issues/risks using a wide range of methodologies and tools, like text and data mining, drivers’ analysis, foresight and chemical analysis (suspect screening, non-target analysis). In these projects, a variety of specific emerging chemical issues/risks have been identified and drivers of emerging risks explored (climate change, blue economy, circular economy). This technical report provides an overview of EFSA's activities related to emerging chemicals in the period 2020-2023. Identified emerging chemicals as well as the analysis of the strengths and weaknesses of the overall identification process in place, with a particular focus on its sustainability in the long term, are reported. In the context of the latest regulatory developments related to the set-up of an early warning system for emerging chemicals, actions to maximise opportunities and minimise weaknesses are described. They focus on collaborative efforts with a wide range of organisations for a permanent and sustainable emerging chemical risks identification system and developments to support the exchange of information on emerging chemical risks via specialised platforms.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8992","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141980245","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":"Use and underlying principles of the EFSA Pesticide Residue Intake Model (PRIMo), revision 4","authors":"European Food Safety Authority (EFSA),&nbsp;Bruno Dujardin,&nbsp;Zsuzsanna Horváth,&nbsp;Hermine Reich,&nbsp;Violetta Costanzo","doi":"10.2903/sp.efsa.2024.EN-8990","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8990","url":null,"abstract":"<p>The EFSA Pesticide Residue Intake Model (PRIMo) has, since its first version in 2007, become the standard tool used at the EU level to estimate the short- and long-term dietary exposure to pesticide residues. It is a deterministic model and is primarily used as a prospective screening tool for dietary risk assessment in the framework of Regulation (EC) No 396/2005 and Regulation (EU) No 1107/2009. Unlike its previous Excel-based versions, PRIMo 4 has been converted to an online web-application. The aim of the present report is to describe the features and functionalities of the latest version of PRIMo and provide guidance to its future users. One of the main novelties is that the model uses individual consumption data from the Comprehensive Food Consumption Database of EFSA, where the foods reported as consumed were disaggregated to their ingredients and converted to their raw primary commodity (RPC) equivalents by means of the EFSA RPC model. This innovation allows to have more detailed exposure assessment results, including results for minor products and processed foods.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8990","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141967175","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 the standard regulatory actions for prospective and retrospective cumulative dietary risk assessment of pesticides in MCRA","authors":"Jasper Engel,&nbsp;Johannes W. Kruisselbrink,&nbsp;Tijmen van Voorthuijsen,&nbsp;Waldo J. de Boer,&nbsp;Marco S. van Lenthe,&nbsp;Gerda van Donkersgoed,&nbsp;Hannah P. McKeon,&nbsp;Anne Zwartsen,&nbsp;Jacob D. van Klaveren","doi":"10.2903/sp.efsa.2024.EN-8942","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8942","url":null,"abstract":"<p>Chemical risk assessment typically focusses on individual substances. However, people are exposed daily to multiple chemicals from diverse sources. The Monte Carlo Risk Assessment (MCRA) platform, developed by Wageningen University &amp; Research (WUR, Biometris) for the Dutch Institute for Public Health and the Environment (RIVM), addresses this issue by enabling cumulative risk assessment (CRA). Recognising the need for mixture risk assessment (MRA), the European Food Safety Authority (EFSA) and RIVM collaborated under a Framework Partnership Agreement (FPA) to enhance the MCRA software for user-friendly and transparent MRA. These enhancements include the development of a new standard regulatory action (SRA) and the refinement of existing retrospective SRAs. The new prospective SRA enables the evaluation of scenarios for new (proposed) maximum residue levels (MRL) for substances within existing cumulative assessment groups (CAG), with the potential for future application to new substances. Regarding the updates of existing retrospective SRAs, more recent occurrence data, food consumption data from more countries compared to the previous version of the SRA, and additional health effects/CAGs were included. Future actions may include further development and periodic updates of the current retrospective SRAs in MCRA, incorporating new considerations and data. These improvements facilitate compliance with regulatory methods and support efficient risk assessment.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8942","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141967176","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 Entoleuca mammata","authors":"European Food Safety Authority (EFSA),&nbsp;Alessandra Gionni,&nbsp;Francesco Pecori,&nbsp;Alberto Santini,&nbsp;Cécile Robin,&nbsp;Melanie Camilleri","doi":"10.2903/sp.efsa.2024.EN-8531","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8531","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>Entoleuca mammata</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/entoleuca-mammata</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8531","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141967010","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":"Methodology for the data flow mapping and analysis in the European Member States","authors":"Nikolaos Kollaros,&nbsp;Dimitra Oikonomidou,&nbsp;Konstantinos Theofilopoulos,&nbsp;Network Research Belgium (NRB) S.A.","doi":"10.2903/sp.efsa.2024.EN-8983","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8983","url":null,"abstract":"<p>The aim of this project is an investigation into the existing national data flows of the MSs that collect data to be submitted to EFSA. Through a process of data flows identification, engagement with the MSs and analysis of the provided information, the purpose is to identify challenges and possible solutions at national level but also in a common European level with the usage of, a business data collection and country agnostic, methodology. This technical report describes the details of the methodology implemented by NRB in close collaboration with the participating MSs and EFSA. The methodology includes eight steps which are, the first interview with the MS, the creation of the Stakeholder's Map, the execution of the survey by the MS, the post-survey workshop with the MS, the production of data flow mapping and analysis country report, along with the country report validation, acceptance, and publication. The methodology is applied to one data collection per country.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8983","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141966958","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":"Administrative guidance for the preparation of applications for the authorisation of individual recycling processes to produce recycled plastics materials and articles intended to come into contact with food1","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/sp.efsa.2024.EN-8968","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8968","url":null,"abstract":"<p>This document provides guidance to applicants submitting applications for the authorisation of individual recycling processes that use a suitable technology to produce recycled plastic materials and articles intended to come into contact with food, which are to be evaluated by EFSA. Currently post-consumer mechanical PET recycling is the only suitable technology listed in Annex I to Commission Regulation (EU) 2022/1616 that requires individual authorisation. Consequently, this guidance describes the administrative requirements for the preparation and online submission of the dossier to support applications, submitted to the competent authority of a Member State for a new authorisation or for the modification of an authorisation of an individual recycling process based on post-consumer mechanical PET recycling as technology. It does not apply to novel technologies developed in accordance with Chapter IV of Commission Regulation (EU) 2022/1616. The Transparency Regulation amended the General Food Law by introducing new provisions in the pre-submission phase and in the application procedure: general pre-submission advice, notification of information related to studies commissioned or carried out to support an application, public disclosure of non-confidential version of all information submitted in support of the application and related confidentiality decision-making process, public consultation on submitted applications. These new requirements, as implemented by the Practical Arrangements laid down by EFSA, are reflected in this guidance. The guidance describes the procedure and the associated timelines for handling applications on individual recycling processes that use a suitable technology, the different possibilities to interact with EFSA and the support initiatives available from the preparation of the application (pre-submission phase) to the adoption and publication of EFSA's scientific opinion.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8968","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141968341","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":"Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for etoxazole in light of confirmatory information","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/sp.efsa.2024.EN-8974","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8974","url":null,"abstract":"<p>The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory information requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory information and their use in the risk assessment for etoxazole are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Greece and presents EFSA's scientific views and conclusions on the individual comments received.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8974","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141968300","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 the MCRA platform: enhancing data connectivity, security, interoperability, and accessibility","authors":"Jacob D. van Klaveren,&nbsp;Johannes W. Kruisselbrink,&nbsp;Jasper Engel,&nbsp;Tijmen van Voorthuijsen,&nbsp;Marco S. van Lenthe,&nbsp;Waldo J. de Boer,&nbsp;Gerda van Donkersgoed,&nbsp;Hannah P. McKeon,&nbsp;Anne Zwartsen","doi":"10.2903/sp.efsa.2024.EN-8941","DOIUrl":"10.2903/sp.efsa.2024.EN-8941","url":null,"abstract":"<p>Current risk assessment practices for chemicals primarily focus on individual substances or predefined mixtures. However, people are exposed daily to multiple chemicals from diverse sources. The Monte Carlo Risk Assessment (MCRA) platform, an open web-based tool, facilitates cumulative risk assessment (CRA) of chemicals. It is developed by Wageningen University &amp; Research (WUR, Biometris) for the Dutch Institute for Public Health and the Environment (RIVM). The a (EFSA) and RIVM have initiated a Framework Partnership Agreement (FPA) to enhance mixture risk assessment (MRA) capabilities in MCRA. This report describes the collaborative efforts of EFSA and RIVM to make the MCRA platform more interoperable and accessible, focusing on data connectivity and security. Emphasis is placed on integrating relevant data used in Standard Regulatory Actions (SRA) implemented in MCRA, ensuring up-to-date and relevant information. RIVM's security measures, including a security quick-scan and subsequent risk management plan, ensure a secure information and communications technology (ICT) and data hosting environment, especially for privacy sensitive data (e.g., food consumption data). A workflow for data exchange from EFSA to MCRA is proposed, focusing on standardisation and automation to minimise manual operations. This workflow builds on EFSA's established yearly pesticide data collection and reporting cycle. Additionally, efforts to align MCRA with other modelling software are explored. Ensuring Open MCRA's accessibility, various user groups are defined, enhancing the platform's usability for diverse stakeholders.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8941","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141853057","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}