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.

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

“…such example is the update of EFSA's scientific opinion on polybrominated diphenyl ethers (PBDEs) in food (EFSA CONTAM Panel, 2011) in 2024(EFSA CONTAM Panel, 2024, where more than 200 new human epidemiological studies had been published since the previous assessment and had to be assessed. The performed evidence mapping helped make important planning decisions related to the organisation and prioritisation of health outcome categories, the extent of multicongener exposure assessment, and the feasibility of quantitative evidence synthesis of the human data (and the required allocation of resources).…”