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The main objectives of EFSA's activities on emerging risks are: (i) to carry out activities to identify emerging risks; (ii) to develop and improve emerging risk identification (ERI) methodologies and approaches; and iii) to communicate on identified issues and risks. The outcome of these activities allows EFSA to prepare for future risk assessment challenges. EFSA networks of knowledge contributing to the ERI activity include the Emerging Risks Exchange Network, the Stakeholder Discussion Group on Emerging Risks, EFSA's scientific units, scientific panels and the Scientific Committee and its working groups. The current technical report summarises the activities of all groups involved in the ERI procedure and the issues identified in the course of 2021; it also describes the methodologies being developed and the collaborative activities. In total, 18 potential emerging issues were discussed in 2021. Eight were concluded to be emerging risks. The potential issues were classified according to the hazard and/or driver identified. In more than half of the issues discussed in 2021, a change in consumer trends was identified as a driver. A better understanding of these trends is particularly relevant for EFSA to improve preparedness. In addition, in 2021 the Emerging Risks Exchange Network members presented and discussed a total of 35 signals/potential emerging issues identified by their own horizon‐scanning activities. Several Member States representatives shared their work on signal identification with the objective of collecting additional information that can be used for a better characterisation of the retrieved signals. Finally, several procurements are ongoing in EFSA to develop methodologies for ERI in specific areas of interest. The implementation of more effective and comprehensive methods to proactively collect, share and disseminate knowledge in the landscape of emerging risks is crucial for EFSA's preparedness risk assessment scheme. [ABSTRACT FROM AUTHOR]

The main objectives of EFSA's activities on emerging risks are: (i) to carry out activities to identify emerging risks; (ii) to develop and improve emerging risk identification (ERI) methodologies and approaches; and (iii) communicate the issues and risks identified. The outcome of these activities also allows EFSA to prepare for future risk assessment challenges. The current technical report summarises the activities of all groups involved in the ERI procedure, the issues identified in the course of 2020, a description of the methodologies that have been considered, and collaborative activities. EFSA networks of knowledge contributing to the ERI activity include the Emerging Risks Exchange Network (EREN), the Stakeholder Discussion Group on Emerging Risks, EFSA's scientific units, scientific panels and the Scientific Committee. In total, 13 potential emerging issues were discussed in 2020. Six were concluded to be emerging issues. The potential issues were organised according to the hazard or driver identified. In addition, in 2020, EREN network members presented and discussed a total of 35 signals/potential emerging issues that had been identified by their own horizon‐scanning activities. Member State representatives shared their work on signal identification with the objective of collecting additional information that could be used for better characterisation. It is crucial to introduce more dynamic and interactive approaches to gather and disseminate knowledge, while also taking into consideration the potential risks that may arise in new areas. [ABSTRACT FROM AUTHOR]

To provide sound scientific advice in support of the European decision-making process in food and feed safety, the European Food Safety Authority (EFSA) has defined the principles for producing "evidence-based scientific assessments" (impartiality, methodological rigor, transparency, and engagement) and, to help fulfil them, has developed cross-cutting methodological approaches. This paper focusses on two of these approaches: conducting scientific assessments in four steps - with an emphasis on developing a protocol for the assessment a priori - and analyzing uncertainty. An overview of the 4-step approach and of the methods for addressing uncertainty is given, and a case study on uncertainty analysis, developed in collaboration with the German Federal Institute for Risk Assessment, is illustrated. The main advantage related to the implementation of protocols and uncertainty analysis is improvement of the scientific value of the outputs. However, experience and further capacity-building is needed to better incorporate uncertainty analysis into the planning phase (protocol) of the scientific assessment process. The case study is based on exposure in humans. Nonetheless it provides an example of a framework for evidence-based scientific assessments that is applicable also to other types of evidence, including evidence arising from new approach methodologies. Adopting the proposed framework, which covers an analysis of uncertainties in the planning and implementation phase, is expected to foster the integration of multiple evidence sources, including alternative methods and testing strategies, in the regulatory scientific assessment process. [ABSTRACT FROM AUTHOR]

During 2014‐2018, EFSA defined a series of principles for the scientific assessment process (impartiality, methodological rigour, transparency and engagement) and developed a 4‐stepapproach (plan/do/verify/report)to facilitate their fulfilment. According to the approach, the methods for the scientific assessmentmust be planned upfront in aprotocol to prevent data‐driven decisions and to increase rigour and transparency of the process.Following the decision to gradually implement the 4‐step approach in all EFSA's non‐application scientific assessments, it was deemed necessary to set up recommendations for protocol development. This technical report provides these recommendations. The document is published as a draftbecause the framework for protocol development will be tested in EFSA's non‐application assessmentsover a one‐yearperiod and revised accordingly. [ABSTRACT FROM AUTHOR]

At EFSA, animal dietary exposure estimates are undertaken by several Panels/Units to assess the risk of feed contaminants, pesticide residues, genetically modified feed and feed additives. Guidance documents describing methodologies for animal dietary exposure assessment are available both at EFSA and international levels. Although appropriate within pertinent regulatory frameworks, the methodologies used to assess animal dietary exposure vary across risk assessment areas. There are different approaches ranging from quick worst‐case estimations to more refined methods assessing actual exposure, resulting from the use of a heterogeneous selection of animal populations and default values to estimate feed intake. Furthermore, current feed classification systems in place at international and national levels contain a large and heterogeneous number of feed materials, which may benefit from further harmonisation efforts. This technical report presents an overview of the current approaches in place at EFSA to assess the exposure to chemicals in feed. The possibility for a greater harmonisation of feed classification and terminology is also addressed by comparing the structure of the EU catalogue of feed materials and the Harmonised OECD tables of feedstuffs derived from field crops with the EFSA FoodEx2 system. [ABSTRACT FROM AUTHOR]

The main objectives of EFSA's activities on emerging risks are:(i) to identify emerging risks in the areas within the remit of EFSA;and (ii) to develop and improve emerging risk identification methodologies and approaches. The current technical report summarises the activities of all groups involved in the emerging risk identification procedure, the issues identified in the course of 2018, a description of methodologies being developed and collaborative activities. EFSA networks of knowledge contributing to the emerging risks identification activity include the Emerging Risks Exchange Network, the StakeholderDiscussion Group on Emerging Risks, EFSA's scientific units, scientific panels and the Scientific Committee and its working groups. Summaries of emerging risk identification procedures in use by different stakeholders are presented.In total, 18 potential emerging issues were discussed in 2018. The issues were classified according to hazard [microbiological hazard (10), chemical hazard (2), other (e.g. antimicrobial resistance and allergies) (1)] and/or the driver underlying the emerging issues identified [illegal activity (2), new consumer trends (2), climate changerelated (1) and new process or technology (3)]. The Standing Working Group Emerging Risks revised the Emerging Risks identification process to better describe the role of EFSA networks of knowledge in identifying potential issues, the drafting and reviewing briefing notes by consultation with different stakeholders and the characterisation of issues by the already established criteria (novelty, soundness severity imminence and scale), but also byproviding clear recommendations to other stakeholders. Communication is a fundamental part of the emerging risk identification procedure. The results of the EU insights study did not indicate that emerging risks triggered significantly greater levels of concern to the public than established risks and suggested that by communicating information about the nature of the risk and the level of uncertainty that surrounds it, a proportionate perception of risk is achieved. Food fraud was of greater concern to consumers than other types of emerging risks. Food fraud can be an important driver for food safety emerging risks and it is important to better integrate risk assessment work on food safety into food fraud investigations. The review of the emerging risk identification (ERI) procedure conducted by the SWG‐ER provided conclusions and recommendations that will guide the future developments of the procedure in alignment with EFSA strategic objectives [ABSTRACT FROM AUTHOR]

This document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's document: 'Guidance on uncertainty analysis in scientific assessments'. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. The document provides a template for identifying expressions of uncertainty in scientific assessments and locating the specific guidance for each expression. The guidance is structured according to EFSA's three broadly defined categories of target audience: 'entry', 'informed' and 'technical' levels. Communicators should use the guidance for entry and informed audiences, while assessors should use the guidance for the technical level. The guidance was formulated using evidence from the scientific literature, grey literature and two EFSA research studies, or based on judgement and reasoning where evidence was incomplete or missing. The limitations of the evidence sources inform the recommendations for further research on uncertainty communication. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1540/full [ABSTRACT FROM AUTHOR]

The first strategic objective of EFSA's strategy 2020 'Trusted science for safe food' is the prioritisation of public and stakeholder engagement in the development of scientific assessment. To achieve this, objective public consultations are a key step for such a strategic framework. The draft Guidance document on communication of uncertainty underwent a web‐based public consultation from 4 May to 24 June 2018. The document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's 'Guidance on uncertainty analysis in scientific assessments'. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. Overall, EFSA received 212 comments from 24 interested parties including academia, national agencies, nongovernmental organisations and communicators. This report lists the individual comments received and explains in detail how the comments were taken into account during the finalisation process of the 'Guidance on communication of uncertainty in scientific assessments'. EFSA wishes to thank all the commenters for their valuable contributions. This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5520/full [ABSTRACT FROM AUTHOR]

During the development of the EFSA guidance on uncertainty analysis, the literature was found to be equivocal about the best methods for communicating scientific uncertainties and there was a lack of empirical evidence on the best approaches for reaching non‐technical audiences. EFSA therefore commissioned a focus group study in 2016 on clear communication of uncertainty information to different target audiences, followed by a larger scale multilingual online survey in 2017 described in this report. The survey was open over a three‐week period, from 23 February until 15 March 2017. As a result, 1,913 people across the EU responded in six languages to questions about expressions of uncertainty: qualitative and quantitative wordings, approximate and precise probabilities, and positive or negative framings. The results showed that similarly large percentages of respondents ranked qualitative and quantitative expressions more helpful for understanding risk, and there was some preference for positively‐framed statements. Nearly all the respondents were positive about receiving uncertainty information. There were moderate differences between the preferences of respondents using different languages and from different professional backgrounds, but due to limitations of the survey method it was not possible to interpret the cause of these. The results are consistent with those of the earlier focus group study. Together they support using positively‐framed, qualitative and quantitative expressions for all audience groups, as in every group some people prefer one and some the other, and nearly all find them useful. These findings together with those in the scientific literature will inform development of an EFSA guidance document on communication of uncertainty in scientific assessments, and updating EFSA's handbook on risk communication. [ABSTRACT FROM AUTHOR]

The core food model was described more than three decades ago, and has been used ever since to identify main food contributors to dietary intakes for both nutrients and other food chemicals. The Sub-Saharan Africa Total Diet Study (SSA-TDS) uses this model to describe the food consumption habits of some selected populations of Benin, Cameroon, Mali, and Nigeria, prior to use in the completion of quantitative risk assessments with regard to food chemicals. Food consumption data were derived from food expenditure data contained in national household budget surveys that were provided by the national institutes of statistics in each country. A classification of African foods was established for the purpose of the study and core foods were selected, so as to reflect 96 ± 1% of the average national total diet expressed in weight. Populations from eight study centers were selected by national stakeholders. This approach involves the purchase of 4020 individual foods, prepared as consumed and pooled into 335 food composite samples, for analysis of mycotoxins, PAHs, PCBs and dioxins, pesticides, metals and trace elements, PFAs, and BFRs. This sampling plan aims to provide a representative, cost effective, and replicable approach for deterministic dietary exposure assessments in developing countries. [ABSTRACT FROM AUTHOR]

To meet the general requirement for transparency in EFSA's work, all its scientific assessments must consider uncertainty. Assessments must say clearly and unambiguously what sources of uncertainty have been identified and what is their impact on the assessment conclusion. This applies to all EFSA's areas, all types of scientific assessment and all types of uncertainty affecting assessment. This current Opinion describes the principles and methods supporting a concise Guidance Document on Uncertainty in EFSA's Scientific Assessment, published separately. These documents do not prescribe specific methods for uncertainty analysis but rather provide a flexible framework within which different methods may be selected, according to the needs of each assessment. Assessors should systematically identify sources of uncertainty, checking each part of their assessment to minimise the risk of overlooking important uncertainties. Uncertainty may be expressed qualitatively or quantitatively. It is neither necessary nor possible to quantify separately every source of uncertainty affecting an assessment. However, assessors should express in quantitative terms the combined effect of as many as possible of identified sources of uncertainty. The guidance describes practical approaches. Uncertainty analysis should be conducted in a flexible, iterative manner, starting at a level appropriate to the assessment and refining the analysis as far as is needed or possible within the time available. The methods and results of the uncertainty analysis should be reported fully and transparently. Every EFSA Panel and Unit applied the draft Guidance to at least one assessment in their work area during a trial period of one year. Experience gained in this period resulted in improved guidance. The Scientific Committee considers that uncertainty analysis will be unconditional for EFSA Panels and staff and must be embedded into scientific assessment in all areas of EFSA's work., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Uncertainty analysis is the process of identifying limitations in scientific knowledge and evaluating their implications for scientific conclusions. It is therefore relevant in all EFSA's scientific assessments and also necessary, to ensure that the assessment conclusions provide reliable information for decision-making. The form and extent of uncertainty analysis, and how the conclusions should be reported, vary widely depending on the nature and context of each assessment and the degree of uncertainty that is present. This document provides concise guidance on how to identify which options for uncertainty analysis are appropriate in each assessment, and how to apply them. It is accompanied by a separate, supporting opinion that explains the key concepts and principles behind this Guidance, and describes the methods in more detail., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Objective: To elucidate possible mechanisms leading to neurodegeneration in patients with glucocerebrosidase (GBA)-associated Parkinson disease (PD) using combined proton ((1)H) and phosphorus ((31)P) magnetic resonance spectroscopic imaging (MRSI) in vivo., Methods: (1)H and (1)H-decoupled (31)P MRSI was performed in 13 patients with PD with heterozygous GBA mutations (GBA-PD) and 19 age- and sex-matched healthy controls to investigate metabolite concentrations in the mesostriatal target regions of PD pathology. NAA as marker of neuronal integrity, choline and ethanolamine containing compounds as markers of membrane phospholipid metabolism, and energy metabolites (notably high-energy phosphates) were quantified., Results: Compared to controls, NAA was significantly reduced in the putamen (p = 0.012) and in the midbrain of GBA-PD (p = 0.05). The choline concentration obtained from (1)H MRSI was significantly decreased in the midbrain of GBA-PD (p = 0.010). The phospholipid degradation product glycerophosphoethalonamine was increased in the putamen of GBA-PD (p = 0.05). Changes of energy metabolism were not detected in any region of interest., Conclusion: The pattern of neurodegeneration in GBA-associated PD is more pronounced in the putamen than in the midbrain. Our MRSI findings suggest that the neurodegenerative process in GBA-PD is associated with alterations of membrane phospholipid metabolism which might be also involved in abnormal α-synuclein aggregation.