Advisory Group on Biomarkers of Effect

Background

The Advisory Group on Biomarkers of Effect (AGoB) is a specialised group of experts established under the EFSA Advisory Forum with the primary aim of supporting guidance development on the use of biomarkers of effect in regulatory 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. Acting in an advisory capacity, the group seeks to promote knowledge sharing, align efforts across the EU and internationally, and provide scientific input to harmonise methodologies. The goal is to identify early and avoid duplication of activities and potential divergent views on this topic, aiming to streamline future risk assessment approaches.

The group comprises members or representatives of EFSA's Advisory Forum, EFSA staff and observers from the European Commission. It is chaired by a representative from a Member State, nominated by the EFSA Advisory Forum. Experts from 18 countries have been delegated to the group.

EFSA’s Scientific Committee is developing new guidance on the use of biomarkers of effect in regulatory risk assessment of chemicals. In the initial phase of the guidance development project, EFSA focused on exploring key concepts and creating a structured foundation for the guidance. The second phase includes co-creation mechanisms involving collaboration among EU agencies. AGoB’s advice is feeding into this process alongside working groups at and involving multiple agencies, international organisations and other relevant stakeholders.

Milestones

  1. 2025

    December

    The third AGoB meeting includes a workshop involving experts from the working group contributing to the guidance development.

  2. September

    The second AGoB meeting takes place.

  3. July

    AGoB’s kick-off meeting familiarises participants with the group’s mandate, objectives, and expectations, and provides an overview of the project and how AGoB’s advice will support the guidance development process.

  4. March

    EFSA’s Advisory Forum establishes the AGoB to foster collaboration in developing cross-cutting guidance on the use of biomarkers of effect in risk assessment.

Objectives and tasks

The objectives of AGoB are centered on promoting knowledge sharing and engagement to foster the exchange and transfer of knowledge and best practices in developing guidance for using biomarkers of effect in regulatory risk assessment. The group aims to align EU and international efforts, facilitating constructive dialogue and collaboratively addressing challenges related to use of biomarkers of effect. AGoB provides scientific and technical input, including both support and recommendations on methodologies for using biomarkers of effect in risk assessment of chemicals.

The tasks of AGoB include providing input to EFSA on documents, processes, and other actions related to developing guidance on the use of biomarkers of effect. The group is required to deliver progress updates at Advisory Forum meetings, and compile yearly reports to track and communicate the group's progress and contributions.

For more details, see the Terms of Reference below.

Documents