Stakeholder Workshop on EFSA’s Genotoxicity Guidance Revision
Background
EFSA organised a Workshop with relevant stakeholders concerning the revision of its genotoxicity guidance framework for food and feed safety assessment. The purpose of this revision is to incorporate state-of-the-art scientific advancements, as well as enhance clarity, consistency, and applicability across different sectors and types of substances. EFSA also seek to address challenges encountered in the interpretation and integration of genotoxicity data, especially in complex cases.
This event provided a platform to inform stakeholders about the ongoing revision of EFSA’s genotoxicity guidance and to gather input on critical issues, such as the use of new approach methodologies (NAMs), genotoxicity assessment of chemical mixtures and quantitative genotoxicity assessment. As part of the event, three breakout group sessions were organised to discuss and receive feedback on key matters that will be addressed during the revision. The Workshop aimed to bring together partners and stakeholders to gather feedback on the genotoxicity guidance revision and discuss fundamental scientific aspects.
Objectives of the meeting
As part of this process, EFSA engaged with stakeholders – including regulatory authorities, industry representatives, NGOs, and academia – to ensure the revised guidance is scientifically robust, practically applicable and aligned with current international standards.
The objectives of the workshop were to:
- Present the scope and rationale of the ongoing revision of EFSA’s genotoxicity guidance framework.
- Share preliminary proposals and areas identified for guidance improvement.
- Facilitate dialogue with stakeholders to gather feedback on practical challenges and scientific considerations.
- Promote transparency and inclusiveness in the guidance development process.
- Ensure the revised guidance reflects current scientific knowledge and stakeholder needs.
Contact
Do not hesitate to contact the organising committee at events [at] efsa.europa.eu for more information.
Documents
Presentations
- 1.2 Revision of EFSA’s genotoxicity guidance framework and Stakeholder Workshop
- 1.3 Genotoxicity testing strategy draft proposal
- 1.4 Quantitative genotoxicity assessment draft proposal
- 1.5 Mutagenicity assessment under REACH and BPR
- 1.6 Relevant guidance documents, frameworks and on-going activities at other EU agencies – EMA’s view
- 1.7 OECD – New Test Guidelines for genotoxicity assessment assays
- 1.8 EU Roadmap towards phasing out animal testing with focus on genotoxicity and carcinogenicity
- 2.2 The core in vitro test battery – 2 tests or 3
- 2.3 Improving the performance of the in vivo comet assay and considerations for following up in vivo comet positive results
- 2.4 Assessment of genotoxicity in the food industry: pyrrolizidine alkaloids case study and emerging challenges
- 2.5 Genotoxicity testing to inform pathway analysis (Adverse Outcome Pathways) and mutagenic modes of action
- 3.2A Breakout Group 1 – Thematic presentation: Quantitative assessment of genotoxicity (perspective from pesticide and biocide safety)
- 3.2B Breakout Group 2 – Thematic presentation: Towards a global genotoxicity testing strategy for botanical mixtures
- 3.2C Breakout Group 3 – Thematic presentation: Mechanistic genotoxicity: NAM & QSAR approaches and error corrected sequencing