Purpose: Development of a guidance document providing a harmonised framework applicable to all relevant working areas of EFSA on how to characterise, document and explain uncertainties in the various steps of risk assessment.
Methods: The EFSA Scientific Committee set-up an overarching Working Group with representatives from all EFSA Panels and the support of relevant external experts. During the development of the GD, the WG consulted the EFSA Panels, risk managers from DG SANTE, national authorities, EU sister agencies, and international organisations, and published the document for public consultation. In light of all the comments received a revised version of the GD is currently being tested by all EFSA Panels on selected opinions. At the end of the testing phase the GD will be further revised and finalised.
Results: The GD proposes a methodological framework for analysing uncertainties in all EFSA scientific assessments and provides a tool-box of qualitative and quantitative methodologies that can be used to perform the analysis. The approach aims to be sufficiently flexible to adapt to the needs of the different EFSA Panels and to the circumstances of each assessment, e.g., from urgent advices to longer-term comprehensive reviews of all available scientific knowledge.
Significance: The GD will contribute to increase transparency in the risk assessment process carried out by EFSA and further strengthen the basis for an informed decision-making process in the area of food safety.