Within the risk analysis framework, risk assessment has the critical role of setting health standards to protect humans, animals and the environment from hazards of a physical, chemical or biological nature.
The European Food Safety Authority adopted the ‘Open EFSA’ approach, which aspires to improve the overall quality of the available information and data used for its scientific outputs, and to comply with normative and societal expectations of openness and transparency. In line with these principles, EFSA is developing three separate but closely related guidance documents for its expert Panels to use in their scientific assessments. These documents address three key elements of any evidence-based scientific assessment: the analysis of Uncertainty, and the determination of Weight of Evidence and Biological Relevance.
The first document provides guidance on how to identify, characterise, document and explain all types of uncertainty arising within an individual assessment for all areas of EFSA’s remit. The draft Guidance provides a harmonised and flexible framework within which different described qualitative and quantitative methods may be selected from a toolbox of potential methods described according to the needs of each assessment.
The second document on weight of evidence provides a general framework for considering and documenting the approach used to evaluate and weigh the assembled evidence when addressing the main question of a given scientific assessment or questions that need to be answered in order to provide, in conjunction, an overall answer. This includes assessing the relevance, reliability and consistency of the available evidence. It also includes approaches to integrating the evidence.
The third draft document offers a general framework for establishing the biological relevance of observations at various stages of the assessment. It identifies generic issues related to biological relevance in the appraisal of pieces of evidence and specific criteria to consider when deciding on whether or not an observed effect is biologically relevant (i.e. is adverse or shows a positive health effect).
This symposium aims at summarising the work of the EFSA Scientific Committee on the development of harmonised methodologies on the three aforementioned topics in different areas of food safety, including chemical risk assessment, microbiological risk assessment and environmental risk assessment. Presentations will include, in addition to a general introduction, a description of the principles of each of the aspects addressed, as well as a presentation on reporting and communicating the outcomes, with emphasis on uncertainties.