EFSA’s Scientific Committee recommends a three-step approach consisting of: an initial assessment which considers whether a risk-benefit assessment is actually needed or, alternatively, if the health risk clearly outweighs the health benefit (or vice versa); a refined assessment aimed at quantifying estimates of risk and benefit at relevant exposure levels; and finally, a full comparison of the combined risk and benefit to establish a net health impact value.

The Scientific Committee specifies that risk-benefit assessments should be based on clearly defined objectives to be agreed beforehand between risk-benefit assessors and decision-makers. The outlined approach should help to save time and resources as the assessors would report to decision-makers after each stage of the process, enabling the latter to decide whether sufficient information is already available for decisions to be taken without having to proceed through all of the steps.

The guidance document highlights that risk-benefit assessment is a complex process that presents many challenges, such as limited data on benefit assessment. It focuses on risk-benefit assessment with regard to human health and does not address other aspects which decision-makers may need to take into account such as social, economic, environmental or ethical considerations.

All stakeholders and interested parties will be able to provide their comments by 15 April 2010. In line with its policy on openness and transparency, EFSA will publish a summary report of the comments received on its website and will take these comments into consideration before finalising the guidance document.