Scientific Committee guidance on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments

,; More, Simon; Bampidis, Vasileios; Benford, Diane; Bragard, Claude; Hernandez‐Jerez, Antonio; Bennekou, Susanne Hougaard; Koutsoumanis, Konstantinos; Lambré, Claude; Machera, Kyriaki; Mennes, Wim; Mullins, Ewen; Nielsen, Soren Saxmose; Schlatter, Josef; Schrenk, Dieter; Turck, Dominique; Younes, Maged; Fletcher, Tony; Greiner, Matthias; Ntzani, Evangelia; Pearce, Neil; Vinceti, Marco; Vrijheid, Martine; Georgiadis, Marios; Gervelmeyer, Andrea; Halldorsson, Thorhallur I.

doi:10.2903/j.efsa.2024.8866

Cited by 3 publications

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References 205 publications

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“…multiple time points, different conditions, etc.). In epidemiological studies, interindividual and intraindividual variability in kinetics and dynamics are the main sources of variability and can be estimated and accounted for various degrees depending on study design and data collected (EFSA Scientific Committee, 2024 ).…”

Section: Conducting the Risk–benefit Assessmentmentioning

confidence: 99%

Guidance on risk–benefit assessment of foods

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Benford,

Hougaard Bennekou

et al. 2024

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The EFSA Scientific Committee has updated its 2010 Guidance on risk–benefit assessment (RBA) of foods. The update addresses methodological developments and regulatory needs. While it retains the stepwise RBA approach, it provides additional methods for complex assessments, such as multiple chemical hazards and all relevant health effects impacting different population subgroups. The updated guidance includes approaches for systematic identification, prioritisation and selection of hazardous and beneficial food components. It also offers updates relevant to characterising adverse and beneficial effects, such as measures of effect size and dose–response modelling. The guidance expands options for characterising risks and benefits, incorporating variability, uncertainty, severity categorisation and ranking of different (beneficial or adverse) effects. The impact of different types of health effects is assessed qualitatively or quantitatively, depending on the problem formulation, scope of the RBA question and data availability. The integration of risks and benefits often involves value‐based judgements and should ideally be performed with the risk–benefit manager. Metrics such as Disability‐Adjusted Life Years (DALYs) and Quality‐Adjusted Life Years (QALYs) can be used. Additional approaches are presented, such as probability of all relevant effects and/or effects of given severities and their integration using severity weight functions. The update includes practical guidance on reporting results, interpreting outcomes and communicating the outcome of an RBA, considering consumer perspectives and responses to advice.

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Section: Conducting the Risk–benefit Assessmentmentioning

confidence: 99%

Guidance on risk–benefit assessment of foods

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Benford,

Hougaard Bennekou

et al. 2024

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Guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals

Turck,

Bohn,

Cámara

et al. 2024

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Vitamins and essential minerals are micronutrients that are required for the normal functioning of the human body. However, they may lead to adverse health effects if consumed in excess. A tolerable upper intake level (UL) is a science‐based reference value that supports policy‐makers and other relevant actors in managing the risks of excess nutrient intake. EFSA's principles for establishing ULs for vitamins and minerals were originally developed by the Scientific Committee on Food in 2000. This guidance from the EFSA Panel on Nutrition, Novel Foods and Food Allergens provides an updated framework for UL assessments. A draft was published in 2022 and underwent a 2‐year piloting period. The present document incorporates revisions based on the experience gained through its practical implementation. It covers aspects related to the planning of the risk assessment (problem formulation and definition of methods) and its implementation (evidence retrieval, appraisal, synthesis, integration, uncertainty analysis). As in the previous framework, the general principles developed for the risk assessment of chemicals in food are applied, i.e. hazard identification, hazard characterisation, intake assessment, risk characterisation. Specific to nutrients are their biochemical and physiological roles and the specific and selective mechanisms that maintain the systemic homeostasis and accumulation of the nutrient in the body. Such considerations must also be taken into account when conducting risk assessments of nutrients.

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Conceptual basis for the development of guidance for the use of biomarkers of effect in regulatory risk assessment of chemicals

Hernández‐Jerez,

Hougaard Bennekou,

Hoogenboom

et al. 2024

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This Scientific Report was carried out in the context of the self‐task mandate (M‐2023‐00097) of the EFSA's Scientific Committee on ‘Guidance on the use of biomarkers of effect in regulatory risk assessment of chemicals’. In the first phase, the project on biomarkers of effect started with a feasibility study (EFSA‐Q‐2024‐00128), with the intention to look closer at definitions and descriptions of biomarkers of effect, as well as to explore several concepts related to the context of application and other scientific principles to be further considered for its development. In addition, relevant activities, initiatives and knowledge in this area were collected and analysed within a complementary mapping study. The outcome of this phase aimed to create a structured basis for future guidance, to identify challenges and to recommend a way forward for its development. The recommendations refer especially to terminologies, the scope of the guidance and several scientific and technical aspects of the selection and interpretation of biomarkers of effect that need to be addressed in future guidance. Moreover, further recommendation refers to the collaborative process to be established with other regulatory organisations that should support the harmonisation and reduce divergencies in the application of methodologies across organisations or sectors.

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Scientific Committee guidance on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments

Cited by 3 publications

References 205 publications

Guidance on risk–benefit assessment of foods

Guidance on risk–benefit assessment of foods

Guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals

Conceptual basis for the development of guidance for the use of biomarkers of effect in regulatory risk assessment of chemicals

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