Dataset Information

Guidance on risk-benefit assessment of foods.

ABSTRACT: 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.

SUBMITTER: EFSA Scientific Committee

PROVIDER: S-EPMC11250173 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature

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Guidance on risk-benefit assessment of foods.

More Simon John SJ Benford Diane D Hougaard Bennekou Susanne S Bampidis Vasileios V Bragard Claude C Halldorsson Thorhallur Ingi TI Hernández-Jerez Antonio F AF Koutsoumanis Kostas K Lambré Claude C Machera Kyriaki K Mullins Ewen E Nielsen Søren Saxmose SS Schlatter Josef J Schrenk Dieter D Turck Dominique D Naska Androniki A Poulsen Morten M Ranta Jukka J Sand Salomon S Wallace Heather H Bastaki Maria M Liem Djien D Smith Anthony A Ververis Ermolaos E Zamariola Giorgia G Younes Maged M

EFSA journal. European Food Safety Authority 20240716 7

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 ...[more]

PMID: 39015302

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Project description:Investigating the impact of diet on public health using risk-benefit assessment (RBA) methods that simultaneously consider both beneficial and adverse health outcomes could be useful for shaping dietary policies and guidelines. In the field of food safety and nutrition, RBA is a relatively new approach facing methodological challenges and being subject to further developments. One of the methodological aspects calling for improvement is the selection of components to be considered in the assessment, currently based mainly on non-harmonized unstandardized experts' judgment. Our aim was to develop a harmonized, transparent, and documented methodological framework for selecting nutritional, microbiological, and toxicological RBA components. The approach was developed under the Novel foods as red meat replacers-an insight using Risk-Benefit Assessment methods (NovRBA) case study, which attempted to estimate the overall health impact of replacing red meat with an edible insect species, Acheta domesticus. Starting from the compositional profiles of both food items, we created a "long list" of food components. By subsequently applying a series of predefined criteria, we proceeded from the "long" to the "short list." These criteria were established based on the occurrence and severity of health outcomes related to these components. For nutrition and microbiology, the occurrence of health outcomes was evaluated considering the presence of a component in the raw material, as well as the effect of processing on the respective component. Regarding toxicology, the presence and exposure relative to reference doses and the contribution to total exposure were considered. Severity was graded with the potential contribution to the background diet alongside bioavailability aspects (nutrition), the disability-adjusted life years per case of illness of each hazard (microbiology), and disease incidence in the population, potential fatality, and lifelong disability (toxicology). To develop the "final list" of components, the "short list" was refined by considering the availability and quality of data for a feasible inclusion in the RBA model. The methodology developed can be broadly used in food RBA, to guide and reinforce a harmonized selection of nutritional, microbiological, and toxicological components and will contribute to facilitating RBA implementation, enabling the generation of transparent, robust, and comparable outcomes.

Dataset Information

Guidance on risk-benefit assessment of foods.

Publications

Guidance on risk-benefit assessment of foods.

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