In 2024, the European Food Safety Authority (EFSA) continued to work with a strong global network of organisations to strengthen its preparedness for future risk analysis needs. The work focused on the identification and analysis of emerging issues, weak signals, trends and policy developments related to food and feed safety, plant health and animal health. EFSA collected a total of 65 emerging issues, of which 38 were further characterised and seven identified as emerging risks. The majority of identified risks that required follow-up were in the area of contaminants and biological hazards. EFSA also conducted horizon-scanning and foresight activities, screening 19 reports and identifying 10 signals for further analysis. None of the signals required an update of EFSA's work programme or strategy. In 2025, EFSA will further strengthen collaboration with its partners through a multi-agency horizon scanning exercise. This initiative, involving several EU agencies and Commission services, will adopt a One Health approach to support preparedness and develop future-proof strategies.

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.

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. 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 “ Emerging Risks Update ,” 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.

This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8441/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8440/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8437/full.

In 2013, the Global Coalition for Regulatory Science Research (GCRSR) was established with members from over ten countries (www.gcrsr.net). One of the main objectives of GCRSR is to facilitate communication among global regulators on the rise of new technologies with regulatory applications through the annual conference Global Summit on Regulatory Science (GSRS). The 11th annual GSRS conference (GSRS21) focused on "Regulatory Sciences for Food/Drug Safety with Real-World Data (RWD) and Artificial Intelligence (AI)." The conference discussed current advancements in both AI and RWD approaches with a specific emphasis on how they impact regulatory sciences and how regulatory agencies across the globe are pursuing the adaptation and oversight of these technologies. There were presentations from Brazil, Canada, India, Italy, Japan, Germany, Switzerland, Singapore, the United Kingdom, and the United States. These presentations highlighted how various agencies are moving forward with these technologies by either improving the agencies' operation and/or preparing regulatory mechanisms to approve the products containing these innovations. To increase the content and discussion, the GSRS21 hosted two debate sessions on the question of "Is Regulatory Science Ready for AI?" and a workshop to showcase the analytical data tools that global regulatory agencies have been using and/or plan to apply to regulatory science. Several key topics were highlighted and discussed during the conference, such as the capabilities of AI and RWD to assist regulatory science policies for drug and food safety, the readiness of AI and data science to provide solutions for regulatory science. Discussions highlighted the need for a constant effort to evaluate emerging technologies for fit-for-purpose regulatory applications. The annual GSRS conferences offer a unique platform to facilitate discussion and collaboration across regulatory agencies, modernizing regulatory approaches, and harmonizing efforts.

The workshop titled “Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks” was co-organized by the Evidence-based Toxicology Collaboration and the European Food Safety Authority (EFSA) and hosted by EFSA at its headquarters in Parma, Italy on October 2 and 3, 2019. The goal was to explore integration of systematic review with mechanistic evidence evaluation. Participants were invited to work on concrete products to advance the exploration of how evidence-based approaches can support the development and application of adverse outcome pathways (AOP) in chemical risk assessment. The workshop discussions were centered around three related themes: 1) assessing certainty in AOPs, 2) literature-based AOP development, and 3) integrating certainty in AOPs and non-animal evidence into decision frameworks. Several challenges, mostly related to methodology, were identified and largely determined the workshop recommendations. The workshop recommendations included the comparison and potential alignment of processes used to develop AOP and systematic review methodology, including the translation of vocabulary of evidence-based methods to AOP and vice versa, the development and improvement of evidence mapping and text mining methods and tools, as well as a call for a fundamental change in chemical risk and uncertainty assessment methodology if to be conducted based on AOPs and new approach methodologies (NAM). The usefulness of evidence-based approaches for mechanism-based chemical risk assessments was stressed, particularly the potential contribution of the rigor and transparency inherent to such approaches in building stakeholders’ trust for implementation of NAM evidence and AOPs into chemical risk assessment.

EFSA Supporting PublicationsVolume 19, Issue 5 E200501E Technical reportOpen Access Theme (concept) paper - Artificial Intelligence in risk assessment European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) SPIDO@efsa.europa.eu Correspondence:SPIDO@efsa.europa.euSearch for more papers by this authorErmanno Cavalli, Ermanno CavalliSearch for more papers by this authorDidier Verloo, Didier VerlooSearch for more papers by this authorKonstantinos Paraskevopoulos, Konstantinos ParaskevopoulosSearch for more papers by this authorJuliane Kleiner, Juliane KleinerSearch for more papers by this authorClaudia Heppner, Claudia HeppnerSearch for more papers by this authorMarta Hugas, Marta HugasSearch for more papers by this author European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) SPIDO@efsa.europa.eu Correspondence:SPIDO@efsa.europa.euSearch for more papers by this authorErmanno Cavalli, Ermanno CavalliSearch for more papers by this authorDidier Verloo, Didier VerlooSearch for more papers by this authorKonstantinos Paraskevopoulos, Konstantinos ParaskevopoulosSearch for more papers by this authorJuliane Kleiner, Juliane KleinerSearch for more papers by this authorClaudia Heppner, Claudia HeppnerSearch for more papers by this authorMarta Hugas, Marta HugasSearch for more papers by this author First published: 31 May 2022 https://doi.org/10.2903/sp.efsa.2022.e200501 Amendment: : Authorship of this technical report was rearranged on the 27th of June 2022. Disclaimer: This document does not present future project calls as part of EFSA’s work programme, or any future position of EFSA. It aims to support the development of a roadmap for action and its content can be subject to change. AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Volume19, Issue5May 2022E200501E RelatedInformation

Abstract This paper presents selected highlights from the ‘Engaging with society’ session of EFSA's third Scientific Conference ‘Science, Food and Society’ (Parma, Italy, 18–21 September 2018). The social dimension for scientific advisory bodies largely concerns science communication and public engagement. The political, economic and technological transformation of contemporary societies is challenging conventional structures and approaches in these areas. The disintermediation of communication and the proliferation of misinformation, it is argued, herald the onset of the post‐truth society. A better understanding of the way individuals consume information today has led to the development of tools to guide mediators such as journalists and communication specialists in countering these trends. Public engagement can reinforce confidence in regulatory bodies and potentially contribute to the quality of the scientific process. Scientific advisory bodies in Europe have created strategies and mechanisms to engage the public that are designed to increase transparency and representativeness. To be effective, several engagement mechanisms are needed, although factors such as resource constraints, institutional culture and public/stakeholder attitudes may limit their development. In conclusion, a more vigorous role for social research is needed to place scientific risk assessment within broader socio‐economic and political contexts. Social science expertise can help to define more impactful public information strategies and to explore the potential opportunities that engaged stakeholders and citizens can make to sustain and strengthen regulatory science.

The European Food Safety Authority (EFSA) regularly collects recommendations from members of the Scientific Committee and Scientific Panels on EFSA’s research needs and priorities (EFSA, 2017). At the end of the 2015–2018 Scientific Panels mandate, we collected views of outgoing Panel members on what food safety research areas should be prioritised for the coming 5–10 years. The objective was, not only to capitalise on experience gained during the Panel mandate, but also to inform research agendas, such as the upcoming Horizon Europe – Research Programme. The identification of risk assessment research priorities and the communication of such priorities to the relevant actors is an important aspect of the ‘EFSA Strategy 2020: Trusted science for safe food’. In addition to the Panel members, EFSA staff and other EFSA partner organisations and stakeholders were consulted, including the following:

Data have been at the heart of EFSA's 2020 Strategy and activities, and we continually strive to widen our evidence base and maximise access to data. As we begin developing our next strategy cycle for 2021–2027, the process of reflecting on how we currently use data and what our data landscape will look like in the future is at the forefront of our thinking. Horizon scanning and consultations with EFSA staff, experts and stakeholders are ongoing. We have also taken account of current trends and predictions in the wider global context within which food safety data, and specifically European food safety data, are used, managed and evaluated. Four themes of evolution are foreseen in the recently documented ‘Concept paper on the future of data in EFSA’ (Gilsenan et al., 2018) derived initially from the experience of EFSA scientific staff and discussed with EFSA management and the EFSA Advisory Forum. In November, we took the opportunity to gain insights to this vital topic from the 2nd Annual EFSA Stakeholders’ Forum. Taking each of these themes individually and as part of a data analysis ecosystem, we encourage stakeholders to consider what they see as the future of data to underpin evidence-based risk assessment in food safety. Scientific innovation and new data streams It is widely acknowledged that the vast majority of worldwide data has been created in recent years and is unstructured. With this trend increasing exponentially, the data available for analysis will expand continuously in terms of all the ‘V's’ of big data1 – including velocity, volume, variety (Gartner Inc.) and many more. EFSA is actively engaged in working with the scientific community to identify how data are created and captured in innovative research and what new and currently unknown or unexplored data streams we should be accessing to further expand our evidence base. Making data openly available and accessible is a key principle of EFSA. We are actively establishing relationships with partners such as GODAN, IPCHEM, ECHA, EMA and European open data portals. 2018 has seen the finalisation of a technical report on the publication of scientific data from EU-coordinated monitoring programmes and surveys. This is the output of a working group composed of member state experts and is an essential step towards publication of open data sets through our curated, open repository for the exchange of evidence and supporting materials used in food and feed safety risk assessments (Knowledge Junction on Zenodo). We are looking into novel information streams, crowd-sourcing, real-time monitoring systems throughout the food chain, ‘Internet of Things’, combining standards to improve data exchange capability and much more to ensure we create a growing pool of large, complex scientific data sets accessible with minimal manual intervention. Distributed data: from ‘data collection’ to ‘data connection’ Increasingly, the nature of EFSA's scientific work requires access to data not traditionally collected by the agency and it is timely to consider a shift in focus from ‘data collection’ to ‘data connection’. An Application Processing Interface (API) is the back-end technology to facilitate this transition – effectively an electronic ‘shop front’ to EFSA's data for machines. APIs are becoming more mainstream in everyday consumer transactions and are increasingly being used by organisations to allow automatic exchange of information via the internet without the need for human intervention. In EFSA's context, the Knowledge Junction on Zenodo is an essential digital tool to improve accessibility to EFSA's data and evidence. Exploration of mechanisms to automatically connect to and retrieve data from outside EFSA is a logical next step. Ultimately, an ecosystem of APIs has the potential to provide EFSA with access to up to date, relevant data without duplication and storage overheads. Each data creator in the ecosystem could collect, validate, store, maintain and operate appropriate access controls. In addition, the availability of cloud computing will enable more effective processing of data. Quantitative and data-driven methods Having identified and accessed relevant new data sources, the next challenge will be to ensure the data quality (fitness for purpose) is adequate to ensure EFSA's standards of scientific rigour are maintained. Building on the conclusions of the Prometheus report, our quantitative methods for data appraisal and validation will need to continue to develop in parallel with changing approaches to data identification and retrieval so we ensure appropriate transformation of big data into sound scientific evidence. EFSA's work in advancing our approach to automation, machine learning and artificial intelligence will build on ongoing work towards interoperability standards and domain ontologies. We see enormous opportunity to work in collaboration with stakeholders to test complex predictive models and machine learning in the field of risk assessment, expert knowledge elicitation and the tracing of food contamination events throughout the food chain. Exploring the living opinion A key feature of data use in risk assessment is timeliness and this will continue to increase in importance in the future. Moving towards more real-time data analysis and risk communication is expected to be increasingly important. Making that analysis readily accessible to practitioners, scientists and consumers in a reproducible and transparent way will also be driven by modern data visualisation and dissemination services. EFSA's work towards more efficient and effective data use, sharing and analysis has already begun moving us towards what we see emerging as the future of data. The four thematic areas identified relating to scientific data are being explored as part of our evolving strategy renewal to ensure EFSA remains agile, relevant and connected to 2027 and beyond. We welcome the ongoing engagement of our stakeholders and partners in continually working towards improved approaches to our work to protect consumers.

This volume reviews the testing methods and strategies commonly applied by regulatory agencies to protect human health and the environment. The design and selection of studies may be quite different depending on the use of the chemical that is tested, and other data that may be available. For example, pesticides used on food or feed require substantially more data than pesticides that might be used in forestry. The toxicity studies are applied to protect human health and the environment from the specific exposure for a specific use. Similarly, protecting an employee from the occupational exposure that might occur during the production of pharmaceuticals requires different information from the exposure to a patient taking such a pharmaceutical. Chapters in this volume also address the evolution of toxicology testing. The volume provides insight into how toxicology studies are used currently to estimate risk, and to protect human health. Toxicology is moving away from whole animal testing as new study designs are able to provide data that protect human health, but can be accomplished while minimizing the use of animals.

In 2014, the European Food Safety Authority (EFSA) started the PROMETHEUS (PROmoting METHods for Evidence Use in Scientific assessments) project to improve further and increase the consistency of the methods it uses in its scientific assessments. The project defined a set of principles for the scientific assessment process and a 4-step approach (plan/carry out/verify/report) for their fulfilment, which was tested in ten case studies, one from each EFSA panel. The present report describes the benefits, issues, needs and solutions related to the implementation of the 4-step approach in EFSA, identified in a dedicated workshop in October 2017. The key benefits of the approach, which was deemed applicable to all types of EFSA scientific assessment including assessments of regulated products, are: 1) increased ‘scientific value’ of EFSA outputs, i.e. the extent of impartiality, methodological rigour, transparency and engagement; 2) guarantee of fitness-for-purpose, as it implies tailoring the methods to the specificities of each assessment; 3) efficiency gain, since preparing a protocol for the assessment upfront helps more streamlined processes throughout the implementation phase; 4) innovation, as the approach promotes the pioneering practice of ‘planning before doing’ (well established in primary research) for broad scientific assessments in regulatory science; and 5) increased harmonisation and consistency of EFSA assessments. The 4-step approach was also considered an effective system for detecting additional methodological and/or expertise needs and a useful basis for further defining a quality management system for EFSA's scientific processes. The identified issues and solutions related to the implementation of the approach are: a) lack of engagement and need for effective communication on benefits and added value; b) need for further advances especially in the field of problem formulation/protocol development, evidence appraisal and evidence integration; c) need for specialised expertise in the previous aspects; and specific needs for d) assessments of regulated products and e) outsourced projects.

Risk analysis and risk governance face a decline in social trust at both the scientific and policy levels. The involvement of society in the process has been proposed as an approach to increasing trust and engagement by making better use of available data and knowledge. In this session, EFSA explored the challenges in building trust and engagement and the latest thinking and methodologies for increasing openness that can help the organisation to move beyond traditional dialogue and towards a more sustainable stakeholder and society interaction. The discussion centred on the needs of EFSA and of target audiences throughout the process, from risk assessment initiation through societal decision-making and communication. The main focus of the session was on methodologies and approaches that would enable EFSA to increase its scientific rigour and build trust from additional inputs gained by opening up its risk assessments at the level of data gathering, data analysis, expertise and innovation. This will require an approach that moves beyond traditional risk assessment practices that rely on a long chain of static information and knowledge such as scientific articles, reviews, expert groups and committees. (C) 2016 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

The Evidence-based Toxicology Collaboration hosted a workshop on "The Emergence of Systematic Review and Related Evidence-based Approaches in Toxicology," on November 21, 2014 in Baltimore, Maryland. The workshop featured speakers from agencies and organizations applying systematic review approaches to questions in toxicology, speakers with experience in conducting systematic reviews in medicine and healthcare, and stakeholders in industry, government, academia, and non-governmental organizations. Based on the workshop presentations and discussion, here we address the state of systematic review methods in toxicology, historical antecedents in both medicine and toxicology, challenges to the translation of systematic review from medicine to toxicology, and thoughts on the way forward. We conclude with a recommendation that as various agencies and organizations adapt systematic review methods, they continue to work together to ensure that there is a harmonized process for how the basic elements of systematic review methods are applied in toxicology.

Bioaccumulation in fish is a function of competing rates of chemical uptake and elimination. For hydrophobic organic chemicals bioconcentration, bioaccumulation and biomagnification potential are high and the biotransformation rate constant is a key parameter. Few measured biotransformation rate constant data are available compared to the number of chemicals that are being evaluated for bioaccumulation hazard and for exposure and risk assessment. Three new Quantitative Structure–Activity Relationships (QSARs) for predicting whole body biotransformation half-lives (HLN) in fish were developed and validated using theoretical molecular descriptors that seek to capture structural characteristics of the whole molecule and three data set splitting schemes. The new QSARs were developed using a minimal number of theoretical descriptors (n = 9) and compared to existing QSARs developed using fragment contribution methods that include up to 59 descriptors. The predictive statistics of the models are similar thus further corroborating the predictive performance of the different QSARs; Q2ext ranges from 0.75 to 0.77, CCCext ranges from 0.86 to 0.87, RMSE in prediction ranges from 0.56 to 0.58. The new QSARs provide additional mechanistic insights into the biotransformation capacity of organic chemicals in fish by including whole molecule descriptors and they also include information on the domain of applicability for the chemical of interest. Advantages of consensus modeling for improving overall prediction and minimizing false negative errors in chemical screening assessments, for identifying potential sources of residual error in the empirical HLN database, and for identifying structural features that are not well represented in the HLN dataset to prioritize future testing needs are illustrated.

EFSA JournalVolume 13, Issue 3 e13031 EditorialOpen Access Editorial: Increasing robustness, transparency and openness of scientific assessments A Hardy, A HardySearch for more papers by this authorJLCM Dorne, JLCM DorneSearch for more papers by this authorE Aiassa, E AiassaSearch for more papers by this authorJ Alexander, J AlexanderSearch for more papers by this authorB Bottex, B BottexSearch for more papers by this authorQ Chaudhry, Q ChaudhrySearch for more papers by this authorA Germini, A GerminiSearch for more papers by this authorB Nørrung, B NørrungSearch for more papers by this authorJ Schlatter, J SchlatterSearch for more papers by this authorD Verloo, D VerlooSearch for more papers by this authorT Robinson, T RobinsonSearch for more papers by this author A Hardy, A HardySearch for more papers by this authorJLCM Dorne, JLCM DorneSearch for more papers by this authorE Aiassa, E AiassaSearch for more papers by this authorJ Alexander, J AlexanderSearch for more papers by this authorB Bottex, B BottexSearch for more papers by this authorQ Chaudhry, Q ChaudhrySearch for more papers by this authorA Germini, A GerminiSearch for more papers by this authorB Nørrung, B NørrungSearch for more papers by this authorJ Schlatter, J SchlatterSearch for more papers by this authorD Verloo, D VerlooSearch for more papers by this authorT Robinson, T RobinsonSearch for more papers by this author First published: 27 March 2015 https://doi.org/10.2903/j.efsa.2015.e13031Citations: 13 Correspondence: [email protected] Published date: 27 March 2015 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article. References EFSA (European Food Safety Authority), 2014. Discussion Paper Transformation to an ‘Open EFSA’ http://www.efsa.europa.eu/en/corporate/doc/openefsadiscussionpaper14.pdf EFSA (European Food Safety Authority), 2015. Outcome of the targeted consultation of the EFSA Journal Editorial ‘Increasing openness, robustness and transparency of scientific assessments’. EFSA supporting publication 2015: EN-785. 26 pp. EFSA SC (EFSA Scientific Committee), 2011. Statistical significance and biological relevance. EFSA Journal 2011; 9 (9): 2372. 17 pp. doi:10.2903/j.efsa.2011.2372 EFSA SC (EFSA Scientific Committee), 2013. Scientific Opinion on the hazard assessment of endocrine disruptors: scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment. EFSA Journal 2013; 11 (3): 3132. 84 pp. doi: 10.2903/j.efsa.2013.3132 WHO (World Health Organization), 2004. International Programme on Chemical Safety: IPCS risk assessment terminology. Part 2. IPCS glossary of key exposure assessment terminology. Geneva, WHO, International Programme on Chemical Safety (IPCS Harmonization Project Document No. 1; http://www.who.int/ipcs/methods/harmonization/areas/ipcsterminologyparts1and2.pdf). Citing Literature Volume13, Issue3March 2015e13031 ReferencesRelatedInformation

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their “key elements” [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.

We discuss different aspects of farm-to-fork risk assessment from a modelling perspective. Stochastic simulation models as they are presented today represent a mathematical representation of nature. In food safety risk assessment, a common modelling approach consists of a logic chain beginning at the source of the hazard and ending with the unwanted consequences of interest. This 'farm-to-fork' approach usually begins with the hazard on the farm, sometimes with different compartments presenting different parts of the production chain, and ends with the 'dose' received by the consumer or in case a dose response model is available the number of cases of illness. These models are typically implemented as Monte Carlo simulations, which are unidirectional in nature, and the link between statistics and simulation model is not interactive. A possible solution could be the use of Bayesian belief networks (BBNs) and this paper tries to discuss in an intuitive way the possibilities of using BBNs as an alternative for Monte Carlo modelling. An inventory is made of the strengths and weaknesses of both approaches, and an example is given showing an additional use of BBNs in biotracing problems.