Two draft guidance documents – on the weight of evidence approach and biological relevance of observed effects – are now available for comments from the public. These documents, together with the guidance on uncertainty assessment, will help to further harmonise methodologies across all the areas under EFSA’s remit. This work will increase the openness, robustness and transparency of our scientific assessments.
We are calling for feedback on these documents from the international scientific community, European and national risk assessors, risk communicators and risk managers, as well as EFSA’s stakeholders. EFSA’s Scientific Committee will review your contributions and consider them in developing the final versions of these documents.
How can I take part?
The draft documents are available for your review (links below). You can then submit your comments via an online form.
- Public consultation on draft Guidance for the identification of biological relevance of adverse/positive health effects from experimental animal and human studies
- Public consultation on draft Guidance on the use of the weight of evidence approach in scientific assessments
You can also join in the dedicated discussions on the draft guidance documents with our scientists on our @Methods_EFSA group on LinkedIn.
What do the guidance documents describe?
Draft guidance on biological relevance:
- provides generic issues and criteria when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a positive health effect) or not;
- clarifies definitions and concepts, such as, responses of a biological system to exposure, mode of action and adverse outcome pathways, thresholds, critical effect, modelling approaches, biomarkers.
Draft guidance on weight of evidence:
- addresses the use of the weight of evidence in scientific assessments using both qualitative and quantitative approaches;
- proposes a three-step approach for assembling, weighing and integrating evidence and defines reliability, relevance and consistency, in terms of their contributions to a weight of evidence assessment.