Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA) to notified biological agents aiming at simplifying risk assessments ...across different scientific Panels and Units. The aim of this review is to outline the implementation and value of the QPS assessment for EFSA and to explain its principles such as the unambiguous identity of a taxonomic unit, the body of knowledge including potential safety concerns and how these considerations lead to a list of biological agents recommended for QPS which EFSA keeps updated through an annual scientific review and assessment.
Human health and animal health risk assessment of combined exposure to multiple chemicals use the same steps as single-substance risk assessment, namely problem formulation, exposure assessment, ...hazard assessment and risk characterisation. The main unique feature of combined RA is the assessment of combined exposure, toxicity and risk. Recently, the Scientific Committee of the European Food Safety Authority (EFSA) published two relevant guidance documents. The first one "Harmonised methodologies for the human health, animal health and ecological risk assessment of combined exposure to multiple chemicals" provides principles and explores methodologies for all steps of risk assessment together with a reporting table. This guidance supports also the default assumption that dose addition is applied for combined toxicity of the chemicals unless evidence for response addition or interactions (antagonism or synergism) is available. The second guidance document provides an account of the scientific criteria to group chemicals in assessment groups using hazard-driven criteria and prioritisation methods, i.e., exposure-driven and risk-based approaches. This manuscript describes such principles, provides a brief description of EFSA's guidance documents, examples of applications in the human health and animal health area and concludes with a discussion on future challenges in this field.
This report assesses peer‐reviewed and grey literature on risk communication concepts and practices, as requested by the European Commission to support the implementation of a ‘General Plan for Risk ...Communication’, i.e. an integrated framework for EU food safety risk assessors and risk managers at Union and national level, as required by the revised EU General Food Law Regulation. We conducted a scoping review of social research studies and official reports in relation to risk communication in the following areas: understanding and awareness of risk analysis roles and tasks, reducing misunderstanding of the different meaning of the terms ‘hazard’ and ‘risk’, tackling misinformation and disinformation, enhancing confidence in EU food safety, taking account of risk perceptions, key factors in trade‐offs about risks, audience segmentation and tools, channels and mechanisms for coordinated risk communications. We structured our findings as follows: i) definitions of key concepts, ii) audience analysis and information requirements, iii) risk profiling, models and mechanisms, iv) contributions to communication strategies. We make several recommendations for consideration by the Commission, both in terms of actions to support the design and implementation of the general plan, and research needs that we consider crucial to further inform appropriate risk communication in the EU. EFSA carried out a targeted consultation of experts and a public consultation open to all interested parties including the general public, in preparing and finalising this report.
This publication is linked to the following EFSA Journal articles: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.e190401/full and http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.e190402/full
The communities of microorganisms and their genomes in a defined environment are collectively referred to as microbiomes (Marchesi and Ravel, 2015). They include representatives from the Bacteria, ...Archaea, lower and higher Eukarya, and viruses, and are found in most environments such as soils, aquatic habitats, surfaces and specific lumen of plants, animals and humans. According to ongoing studies, microbiome structures and dynamics across the food system can have both direct and indirect effects on human and animal health, in addition to their impact on food quality, safety and sustainability (CNBBSV concept paper, 2019). Moreover, recent research projects have offered new insights into the associations between microbiomes and a wide range of human diseases as well as their possible impact in modulating the exposure to environmental chemicals. As one of the core tasks of EFSA is to assess risks to human and animal health and/or the environment from substances linked to food and feed production, the increasing understanding of the role of microbiomes in health calls for a prospective mapping of their roles into regulatory scientific assessment processes with a view to understanding their potential health impact.
The interplay between science, risk assessment and risk management has always been complex, and even more so in a world increasingly characterised by rapid technical innovation, new modes of ...communication, suspicion about authorities and experts, and demands for people to have a say in decisions that are made on their behalf. In this challenging era where scientific advice on food safety has never been in greater demand, risk managers should effectively navigate the interplay between facts and values and be able to rely on robust and fit‐for‐purpose risk assessments to aid them. The fact that societal resistance is often encountered when scientific advice on food safety operates at a distance from social values and fails to actively engage with citizens, has led to increasing emphasis on the need to advance forms of risk assessment that are more contextual, and socially sound and accountable. EFSA's third Scientific Conference explored how risk assessments could be constructed to most usefully meet society's needs and thus connect science with society, while remaining scientifically robust. Contributors to the conference highlighted the need to: (1) frame risk assessments by clear policy goals and decision‐making criteria; (2) begin risk assessments with an explicit problem formulation to identify relevant information; (3) make use of reliable risk assessment studies; (4) be explicit about value judgements; (5) address and communicate scientific uncertainty; (6) follow trustworthy processes; (7) publish the evidence and data, and report the way in which they are used in a transparent manner; (8) ensure effective communication throughout the risk analysis process; (9) involve society, as appropriate; and (10) weigh risks and benefits on request. Implementation of these recommendations would contribute to increased credibility and trustworthiness of food safety risk assessments.
According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the group of pesticide active substances ...dithiocarbamates. To assess the occurrence of metiram, ziram, maneb and mancozeb residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EU) No 1107/2009, the MRLs established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) as well as the European authorisations and the import tolerances reported by Member States and the UK (including the supporting residues data) for metiram and mancozeb. Propineb and thiram were not considered further in this assessment since it is expected that all uses for these compounds, including import tolerances, have been withdrawn after the lowering of all the MRLs to the limit of quantification (LOQ) following the EFSA MRLs reviews completed, respectively, in 2020 and 2021. When reviewing the MRLs for the common residue definition (determined and expressed as CS2), EFSA was requested to consider also the monitoring data from organic samples collected and made available by the EURLs, reflecting the sulfur naturally occurring in crops and not related to the uses of the dithiocarbamates. Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible chronic/acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.
From 18–21 September 2018, EFSA hosted its third Scientific Conference on Science, Food and Society in Parma, Italy. This paper summarises the overall recommendations on future actions and research ...priorities of the conference and complements the earlier multi‐authored papers in this issue. The conference started and closed with the plenary sessions ‘where science meets society: putting risk assessment in context’ and ‘staying relevant in a changing world’, respectively. In between, there were seven breakout sessions five of which aimed at advancing risk assessment science in the areas of human health, the environment, biological hazards, nutrition and managing evidence, and two of which were dedicated to the societal aspects of risk assessment: engaging with society and envisioning the expertise of the future. During the 4 days of the event, participants addressed the complex interplay between science, risk assessment, policy and society, and explored how to advance food safety risk assessment to address the challenges of a changing world and ensure preparedness. Acknowledging that good science alone is no longer sufficient to ensure fit‐for‐purpose food safety risk assessments, EFSA must further build on its current five Strategic Objectives. To ensure that its risk assessments remain scientifically robust and sound, EFSA should strive for robust and fit‐for‐purpose risk assessments; consider food in the context of safety, nutrition and sustainability; and explore further how EFSA can work with other organisations to achieve the One Health/One Environment goals. In addition, EFSA should base scientific risk assessments on reliable science while capitalising on scientific advances; address scientific uncertainties; and fully publish the evidence and data used. In line with societal expectations, EFSA, in coordination with risk managers, should frame risk assessments through clear policy goals and problem formulation; be explicit about value judgements; communicate clearly and consistently and in coordination with risk assessors and risk managers; involve society; avoid conflicts of interest; and follow trustworthy processes.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Certis Europe B.V. submitted a request to the competent national authority in the Netherlands to modify the existing maximum ...residue levels (MRLs) for the active substance imazalil in cucumbers, courgettes and gherkins. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 0.08 mg/kg for the whole group of cucurbits with edible peel. It is noted that the derived MRL is proposed to replace the existing tentative MRL of 0.1 mg/kg for courgettes, thus also addressing the data gap identified in the context of the MRL review. As regards to cucumbers and gherkins, it is noted that the MRL proposal derived in the current application is covered by the MRL of 0.5 mg/kg currently in place for these commodities. Nevertheless, it is also noted that the aforementioned MRLs are based on Codex maximum residue limits (CXLs) which were revoked in 2019 following the JMPR proposal. Should this proposal be implemented in the EU regulation in the future, the proposed MRL of 0.08 mg/kg as derived in the current application would be considered an appropriate fall‐back option for the whole group of cucurbits with edible peel. Further risk management considerations are therefore required. Adequate analytical methods for enforcement are available to control the residues of imazalil on the commodities under consideration at the validated limit of quantification (LOQ) of 0.005 mg/kg (QuEChERS method based on LC–MS/MS) and 0.01 mg/kg (HPLC–MS/MS method). Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of imazalil according to the reported agricultural practices is unlikely to present a risk to consumer health. However, it should be noted that a high degree of uncertainty on the overall long‐term exposure calculation remains due to the data gaps identified in the context of the MRL review on full toxicological assessment of the metabolite R014821, which is expected to occur following post‐harvest uses of imazalil, and animal metabolites FK‐772 and FK‐284.
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