EFSA proposes risk-benefit assessment of foods
The document, available here, focuses on human health risks and benefits, and does not take into account other considerations, such as cost effectiveness.
It recommends a ‘stepwise’ approach, which would ensure a thorough review of findings at the end of each step to allow for a comparison of risks and benefits in the assessment.
It also proposes a number of metrics that can be used in the assessment process, and recommends that these metrics should be internationally agreed upon in order to “ensure harmonisation and recognition of the assessments”.
EFSA also recommends a close collaboration between risk assessors and benefit assessors so that the data generated by both can be used in a broader risk-benefit assessment context.
Assessment steps
EFSA’s scientific committee recommended four steps for benefit assessment, which, it says, is less well-established than risk assessment. The tiered approach, which would mirror the risk assessment paradigm, would include: positive health effect identification, positive health effect characterisation (dose response assessment), exposure assessment and benefit characterisation.
Once agreement on the terms of reference is reached between the risk-benefit assessor and the risk-benefit manager, EFSA recommends the following three steps:
- Initial assessment, addressing the question whether the health risks far outweigh the health benefits or vice versa
- Refined assessment, aiming at providing semi-quantitative or quantitative estimates of risks and benefits at relevant exposure by using common metrics
- Comparison of risks and benefits using a composite metric such as DALYs or QALYs to express the outcome of the risk-benefit assessment as a single net health impact value.
Discussion
“After each step of the risk-benefit assessment, discussion should take place between the risk-benefit assessor and the risk-benefit manager on whether sufficient information has been provided or whether the terms of reference should be refined in order to proceed with the next step of the assessment,” writes EFSA.
The committee said that the outcome of each step of the assessment should also include a narrative of the strengths and weaknesses of the evidence base and its associated uncertainties.
“The overall magnitude of uncertainty associated with a risk-benefit assessment may often be large. This should not be regarded as implying a failure of the assessment; on the contrary, it provides essential information for decision-making and helps in identification of data needs.”
