New uncertainty approach to make advice ‘more transparent and robust’

EFSA has developed a harmonised approach to assessing and taking account of uncertainties in food safety, and animal and plant health. This approach will boost the transparency of the resulting scientific advice and make it more robust for decision-making.

The EFSA Scientific Committee guidance on uncertainty Scientific concept used in risk assessment to describe all types of limitations in available knowledge at the time an assessment is conducted, with the agreed resources, that affect the probability of possible outcomes to the assessment. in scientific assessments offers a diverse toolbox of scientific methods and technical tools for uncertainty analysis A method of identifying the sources of uncertainty in a risk assessment calculation and estimating their size and direction so that errors can be taken into account.. It is sufficiently flexible to be implemented in such diverse areas as plant pests, microbiological hazards and chemical substances.

Learning from others, learning by doing

Prof Tony Hardy, Chair of the Scientific Committee said: “Since 2016, we have tested, refined and tailored our new approach to uncertainty analysis, benefiting from open consultations with EFSA’s partners and the wider public. Crucially, we learnt a great deal about how to apply the new approach by trialling it across all EFSA’s scientific areas of activity.

“We have concluded that EFSA will benefit from applying and adapting the approach across the wide variety of scientific areas and types of assessments it carries out.

“We focused on making the guidance concise, practical and easily adaptable to the different types of EFSA’s assessments.”

The approach is described in two separate documents: a short user-friendly guidance with practical instructions and tips, and a supporting scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment. with all the detailed scientific reasoning and methods.

Implementing the approach

The long-term goal is that the new guidance on uncertainty will be an integral step in all EFSA’s scientific assessments.

Prof Hans Verhagen is head of EFSA’s department for risk assessment  A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation.. He said: “The trial showed that in areas like plant health, an explicit uncertainty analysis is already being used, with positive feedback from risk managers who say this helps them with their decision-making. In other areas, where uncertainty analysis is not yet integrated in the assessment process, the testing phase has helped give a clearer idea how to develop tailored approaches.”

Staged roll-out

EFSA will implement the approach in two stages. In general scientific areas, the guidance will apply from autumn 2018 after the renewal of the Authority’s scientific panels.

In regulated products areas such as pesticides, food additives or food contact materials it will be phased in later on, in light of the experience gained in the ‘non-regulated’ areas.

Communicating uncertainty

In parallel, EFSA is developing practical guidance for communication specialists on how to communicate the results of uncertainty analysis to different target audiences, including the public. A public consultation will be held on a draft of the communication approach in 2018.

• Guidance on Uncertainty Analysis in Scientific Assessment
• Principles and methods behind EFSA’s Guidance on Uncertainty Analysis in Scientific Assessment
• Workshop on the trial of the EFSA guidance document on uncertainty analysis in scientific assessments 22 - 23 June 2017 Parma, Italy