Session
SETAC EU Vienna 2025
Thursday 15th May 2025 – 11:30am (Hall D3)
Despite progress in hazard and risk assessments of nanoforms (NFs) over the past decades, significant challenges remain. The development of AdMa adds complexity both scientifically and regulatorily. Scientific and technical issues still hinder robust assessment of physical-chemical, fate, and hazard properties of NMs (nanoforms, NFs) despite the progress made over the last decades, e.g. on how to approach assessment of NFs (e.g. concept of similar NFs), or on alternative testing strategies. These are compounded further by AdMa's in the nanoscale.
The progress of new approach methodologies (NAMs) in (eco)toxicology) is envisaged to aid characterising and assessing NMs and AdMa, where traditional toxicological tools, tailored for gauging conventional chemical safety, cannot fully capture the complexities of these materials.
More precise and predictive methods are missing to assess safety across the entire product life-cycle, considering complex interactions and variability across different habitats and species as well as life-stages of use.
This session will highlight the multifaceted approach required for managing NMs and AdMa and presentations will relate to:
- Hazard & Risk Assessment: Methodologies & tools for NMs and AdMa hazards and risks; case studies & research findings with focus on in vitro, in chemico and in silico NAMs.
- Regulatory Challenges & Progress: Current state of chemical legislation and regulatory frameworks discussing challenges on regulatory compliance for regulatory bodies and industry, focus on AdMa.
- Industrial Applications: Utilisation of NMs & AdMa across various industries (e.g. consumer products, agrochemicals); environmental policy and risk management implications.
- Risk Management (RM): Compare prospective RM (predicting effects and exposure) with retrospective RM (monitoring and mitigating effects); proposed best practices and innovative approaches.
- Communication Tools & Strategies: Effective science communication to convey research findings on NMs and AdMa to all stakeholders (including consumers); successful dissemination strategies and tools.
Session Co-Chair: Kai Paul
Kai is a Principal Consultant and Team Leader of the Animal-Free Regulatory Solutions and Nanomaterials Teams. Kai has experience in toxicology and ecotoxicology and worked in both ecotoxicological and toxicological research and consultancy. He has acted as an external expert advisor and stakeholder to many projects and holds a PhD in the ecotoxicity of nanomaterials. Kai has +15 years' experience working with nanoforms in a regulatory and academic capacity. He has worked on 100s of nanoforms since the inception of nanoform REACH requirements (2020) and is a known expert in the nanomaterial regulatory field.
Kai is a former Chair of the SETAC Nanotechnology Interest Group & current vice-chair of the Nanotechnology Industries Association Regulatory Committee.
If you're involved in the manufacture, importation or distribution of nanoforms, and have any queries relating to nanomaterial regulatory compliance, call or email and we'll arrange for you to speak directly with Kai.
