Regulators, scientists, and industry stakeholders came together at EFSA’s 2025 nanomaterials workshop to align on the future of nano risk assessment in food and feed. While no major scientific breakthroughs emerged, improved dialogue, regulatory clarity, and a roadmap for unified guidance marked meaningful progress.
Why the EFSA Workshop on Nanomaterials Mattered
The EFSA Workshop on Nanomaterials in Risk Assessment for Food and Feed, held in Brussels on 11-12 June 2025, brought together key stakeholders – including regulatory bodies, industry representatives, consultants, and researchers – to discuss the ongoing development of updated EFSA guidance on nanomaterials. The workshop addressed both scientific and regulatory challenges related to assessing nanomaterials and small particles in the food and feed chain. It built upon the 2021 EFSA guidance documents on particle technical requirements and nanomaterial risk assessment.
A Roadmap to 2029: Phased Guidance Updates in Progress
EFSA has initiated a self-task mandate to merge and update the existing guidance into a unified document. This effort involves stakeholder engagement, a phased development plan extending to 2029, and integration of results from EFSA-funded research on new approach methodologies (NAMs). The phased approach includes clarifying current guidance structure (by 2026), integrating major scientific updates including advanced materials and nanocarriers (by 2027), and finally incorporating results from ongoing NAMs projects (by 2029). These include hazard assessments of nanofibers, gut-on-a-chip models, and the development of tools for integrating NAMs into regulatory assessments.
Scientific Challenges in Focus: Particle Characterisation, Definitions, & Data Gaps
Workshop sessions highlighted persistent scientific issues: particle characterisation (especially solubility, dispersion stability, and particle count methodology), variability in regulatory definitions between jurisdictions (EU vs. US), and concerns about measurement methods and metadata transparency. Key takeaways emphasized the need to standardise what particles are counted (single particles vs. agglomerates/aggregates or constituent particles in agglomerates/aggregates), which sizes are relevant, how to measure them, and how definitions differ internationally.
Cross-Agency Collaboration: EMA, OECD, FDA, & Blue Frog in the Spotlight
Contributions from EMA, OECD, and FDA shed light on regulatory frameworks and policy lines beyond EFSA. EMA is progressing on a nano-specific guideline for veterinary medicines, addressing concerns such as particle size cut-offs (e.g. applying same 250 nm cut off as EFSA (GI barrier maximum) ) and inclusion of biological entities. OECD is focusing on advanced materials and SSbD. The ECHA funded project Consortium, lead by Blue Frog Scientific, on ‘Nanomaterial Risk Assessment: a regulatory way forward for sameness and grouping approaches’ was mentioned several times and interest in results was high.
Read-Across & SSbD: Building Smarter Risk Assessment Models
Discussions also covered scientific issues such as aggregation/agglomeration measurement challenges, the applicability of historical data, advancing Safe & Sustainable by Design (SSbD), and the use of read-across approaches for data-poor nanomaterials. The read-across topic revealed the importance of expert judgment in defining similarity, particularly in the context of particle size distributions and compositional boundaries.
Takeaways: No Breakthroughs – But Real Progress Toward Harmonisation
The workshop reinforced existing scientific understanding, but significantly advanced regulatory alignment and stakeholder communication. While no major scientific breakthroughs were reported, the improved transparency and dialogue between the stakeholders, were seen as crucial steps toward harmonised and future-ready nano risk assessment.
Expert Guidance on Nanomaterial Risk Assessment
At Blue Frog Scientific, we’re at the forefront of regulatory science, with deep expertise in nanomaterials and particle characterisation. Whether you're navigating EFSA, ECHA, or cross-agency requirements, our nano-experts can help. Call or message and speak directly with one of our nanomaterial regulatory consultants.
