Joint Regulatory Risk Assessors Summit – Advancing Safety & Sustainability Assessments of Advanced Materials

Advanced materials bring new challenges for safety and sustainability assessment. To address these, the EU Horizon Europe projects ACCORDs, iCARE, MACRAMÉ, and nanoPASS are hosting a Joint Summit to address the needs of industry and regulators in assessing the safety and sustainability of advanced materials.

The event will feature discussions, latest method developments, and direct engagement with regulators, scientists, and industry professionals. Key sessions will focus on regulatory challenges, scientific developments, and pathways towards advancing test methods for regulatory testing.

This summit is designed for those working at the intersection of materials innovation and regulatory compliance. Participants will have the opportunity to engage in panel discussions, breakout groups, and a poster session to help shape the future of test methods for advanced materials.

Agenda Highlights

📅 19 June 2025 – 9:00 – 20:00 CEST

  • Opening & Scene-Setting
  • Safety Testing Challenges – Stakeholder perspectives on key challenges & panel discussion
  • Advancing Regulatory Testing
    • Characterisation of advanced materials (in test systems and complex matrices)
    • Human health models to predict the safety of advanced materials
    • Ecotoxicity, release, fate and environmental testing of advanced materials
  • Poster Session & Networking

    📅 20 June 2025 – 9:00 – 15:30 CEST

    • Challenges and solutions in testing industrial relevant samples along the material lifecycle
    • Recommendations for developing Regulatory Test Methods – Breakout groups and panel discussion
    • Way forward – Key takeaways and next steps

      Who Should Attend?

      This summit is designed for:

      • Regulators integrating new methods into regulatory frameworks
      • OECD representatives exploring future Test Guidelines
      • Scientists developing methods for safety and sustainability assessments
      • Industry professionals, CROs, and SMEs targeting regulatory compliance
      • Standardisation bodies defining new testing standards

        This summit offers a unique opportunity to engage with peers and decision-makers on the evolving regulatory landscape. Join us to help shape the future of regulatory test methods for advanced materials.

        Practical Information:

        The Joint Summit held at the OECD Conference Centre in Paris (France); address:

        OECD Headquarters & Conference Centre
        2, rue André Pascal
        75016 Paris
        FRANCE
        Tel.: +33 1 45 24 82 00

        More information:

        Agenda

        (mouse over the chair/speaker for more information)

        DAY 1 (Thursday, 19. June 2025)

        Session I: Introduction and setting the scene

        09:00 – 09:30

        Welcome to the OECD

        Welcome by organisers: Short introduction to MACRAMÉ, iCare, nanoPASS and ACCORDs

        Mar Gonzalez (OECD)

        Mar Gonzalez is responsible for implementing the OECD’s nanosafety and advanced materials program. Her work focuses on enhancing regulatory preparedness and timely decision-making for nanomaterials and advanced materials. She coordinates the development of tools to assess the hazards of these materials, implements the Safer and Sustainable Innovation approach, and advances knowledge of emerging materials to improve anticipatory risk governance. This aligns with strategies for managing industrial chemicals.

        Steffi Friedrichs (AIST)

        Dr Steffi Friedrichs, Founder & Director of AcumenIST SRL, has been a leading expert, policy advisor and business representative for emerging technological innovation for over 20 years. Steffi made a name for herself as the founder and Director-General of the Nanotechnology Industries Association (NIA) group, where she established novel, collaborative approaches to the political representation of technology-based companies. Having thus initiated numerous large-scale public-private collaborations and created channels for industries’ contributions to both international and national regulatory processes, Steffi subsequently worked for the OECD, where she developed its definition, indicators and impact assessment of biotechnology, nanotechnology, and other converging technologies, and led two international technology policy workshops on genome editing. Wishing to support the advancement of transparent, science-based policy-making, Steffi gathered a strong track record in the establishment, development and representation of technology-based companies, and created and ran participatory technology assessment workshops. She initiated several outreach and communication initiatives to foster the public understanding of novel technologies. She was a Co-Founder and Member of the Board of Directors of the Chicago Micro- & Nanotechnology Community (CMNC), Director of the Master’s Programme in Micro- and Nanotechnology at the University of Cambridge, and Lecturer in Inorganic Chemistry and Solid State Chemistry at the University of Oxford.

        09:30 – 09:40

        Keynote: Needs of regulatory and policy frameworks to support safe and sustainable advanced materials

        Erik Bleeker (RIVM)

        Dr. Eric Bleeker is a senior scientist at the National Institute of Public Health and the Environment (RIVM) in the Netherlands. He has a PhD in ecotoxicology and previously worked as a post-doc researcher in ecotoxicology for about 8 years. Since 2008 he has been working on risk assessment of chemicals with a focus on nanomaterials, mainly focused on the European chemicals legislation REACH. His work on nanomaterials involves a broad range of topics. He provides policy advice and support, both on a national level (to several Dutch ministries), as well as on international levels (e.g. in adaptations of the REACH Regulation, the EU Recommendation on the definition of nanomaterials, and representing the Netherlands in ECHA’s NanoMaterials Expert Group and in the OECD Working Party on Manufactured Nanomaterials). He also contributes to guidance and test guidelines for nanomaterials (e.g. REACH Guidance at ECHA, OECD Test Guidelines and Guidance Documents) and recently became Dutch National Coordinator of the OECD Test Guidelines Programme. Furthermore, he has been and still is participating in several EU research projects that support risk assessment of nanomaterials (e.g. GRACIOUS, Gov4Nano, and NanoHarmony), which included advancing grouping approaches, test guideline developments, and governance. Currently, he expands his activities towards more advanced materials (e.g. in OECD-WPMN and the EU project MACRAMÉ).

        09:40 – 10:30

        Panel discussion: What are the issues in safety testing of advanced materials?

        Chair: Thomas Kuhlbusch (BAuA)

        Thomas Kuhlbusch is employed at the Federal Institute for Occupational Hygiene and Health (BAuA), Germany. He is chemist by background and received his PhD in analytical chemistry while working at the Max Planck Institute for Air Chemistry. During his post doc period (1994 – 97) he had a stipend by the American Academy of Sciences and worked at the US EPA on air chemistry and climate change. In 1997 he moved to the University of Duisburg-Essen to conduct research on particle science. In 2001 he moved with his team to a research institute, IUTA e.V., where he conducted research on (nano)particle measurement technology, environmental behaviour, exposure assessment, workplace safety, and related epidemiological and toxicological studies. In 2016 he moved to BAuA where he is now head of unit “Hazardous Substances and Biological Agents”. His focus is set to achieve safe handling and use of hazardous substances and biological agents at work by advising on regulatory issues on national and international level. Thomas Kuhlbusch has led the EU project NanoHarmony, is member of the German delegation to the OECD- WPMN and member of the Malta Initiative Board besides other..

        Erik Bleeker (RIVM)

        Dr. Eric Bleeker is a senior scientist at the National Institute of Public Health and the Environment (RIVM) in the Netherlands. He has a PhD in ecotoxicology and previously worked as a post-doc researcher in ecotoxicology for about 8 years. Since 2008 he has been working on risk assessment of chemicals with a focus on nanomaterials, mainly focused on the European chemicals legislation REACH. His work on nanomaterials involves a broad range of topics. He provides policy advice and support, both on a national level (to several Dutch ministries), as well as on international levels (e.g. in adaptations of the REACH Regulation, the EU Recommendation on the definition of nanomaterials, and representing the Netherlands in ECHA’s NanoMaterials Expert Group and in the OECD Working Party on Manufactured Nanomaterials). He also contributes to guidance and test guidelines for nanomaterials (e.g. REACH Guidance at ECHA, OECD Test Guidelines and Guidance Documents) and recently became Dutch National Coordinator of the OECD Test Guidelines Programme. Furthermore, he has been and still is participating in several EU research projects that support risk assessment of nanomaterials (e.g. GRACIOUS, Gov4Nano, and NanoHarmony), which included advancing grouping approaches, test guideline developments, and governance. Currently, he expands his activities towards more advanced materials (e.g. in OECD-WPMN and the EU project MACRAMÉ).

        Blanca Suarez Merino (TEMASOL)

        Dr Suarez-Merino (DPhil Oxford Biochemistry) is the Regulatory Affairs Director at the Nanotechnology Industries Association and Cofounder of TEMAS Solutions GmbH. Dr Suarez-Merino is Vice Chair of the BIAC Nanotechnology Committee at the OECD contributing to several groups under the OECD WPMN including the Steering Group on Advanced Materials and the Safe Innovation Approach. She also contributes to the Nanomaterial Expert Group under ECHA and the EFSA's Stakeholder Discussion Group on Emerging Risks (StadDG-ER). She is also a National Expert under the Nanotechnologies Standardisation Group (SNV) and routinely contributes to work under CEN/TC 352 Nanotechnologies, leading the SSbD standard. Dr Suarez-Merino is also a member of the Swiss National Platform on the safe handling of synthetic nanomaterials and co-authored the update of the Precautionary Matrix for Nanomaterials, and contributed to different testing guidelines for safety assessment of nanomaterials, the latest one being the adaptation of OECD TG 442D. She has been very active in European Projects focusing on Regulatory research and nanomaterials for several years. 

        Virginia Rodriguez (ECHA)

        Virginia Rodríguez Unamuno is a regulatory expert at the European Chemicals Agency (ECHA), with nearly two decades of experience in EU chemicals legislation, particularly in the regulation of biocides, industrial chemicals, and nanomaterials. Since 2013, she has contributed to the implementation of the Biocidal Products Regulation (BPR) and REACH, focusing on dossier evaluation, environmental risk assessment, technical guidance development, and the assessment of complex substances under compliance checks and testing proposals.

        Prior to joining ECHA, Virginia worked at the European Commission’s Joint Research Centre (JRC) and at INIA (National Institute for Agricultural and Food Research and Technology), supporting the Spanish Ministry of Environment in the implementation of the Biocidal Products Directive. She has also contributed to international regulatory cooperation, including activities under the OECD Working Party on Manufactured Nanomaterials.

        She holds a Doctorate in Applied Biological Sciences and a degree in Chemistry, along with a postgraduate qualification in Toxicology and Risk Assessment. Virginia combines scientific expertise with deep regulatory insight and strong project management skills, bringing a practical and forward-looking approach to complex chemical safety challenges.

        Mar Gonzalez (OECD)

        Mar Gonzalez is responsible for implementing the OECD’s nanosafety and advanced materials program. Her work focuses on enhancing regulatory preparedness and timely decision-making for nanomaterials and advanced materials. She coordinates the development of tools to assess the hazards of these materials, implements the Safer and Sustainable Innovation approach, and advances knowledge of emerging materials to improve anticipatory risk governance. This aligns with strategies for managing industrial chemicals.

        Tommaso Serchi (LIST)

        Dr. Tommaso Serchi is the head of the Environmental Health research group of the Luxembourg Institute of Science and Technology. He has a background in medicinal chemistry and technology. He obtained a PhD in medical biotechnology and he is an European Registered Toxicologist (Belgian Registry) and holds a habilitation from the Italian Ministry of Education and from the University of Luxembourg. He is a toxicologist with more than 10 years of experience in proteomics and in developing complex 3D in vitro models for a multitude of applications. He coordinates and is partners of several EU projectsn and EFSA projects.

        He is the Head of the Luxembourg delegation for the OECD Working Party on Manufactured Nanomaterials (WPMN) and deputy Head of the Luxembourg delegation for the OECD National co-ordinators of the Test Guidelines programme working group. He participates in OECD working groups and experts committees such as those for “Bioacumulation of NanoMaterials” or for “Intestinal fate of orally ingested Nanomaterials”. He is the co-chair of the OECD Steering Group on Testing and Assessment (SGTA).

        His scientific interests range from toxicology, cell biology and cellular/tissue engineering, regulatory toxicology and, especially, to the development of advanced New Approach Methodologies (NAMs) for bio-medical and toxicological applications. He is the coordinator of the H2020 project PHOENIX (Pharmaceutical Open Innovation Test Bed for Enabling Nono-pharmaceuticals Innovative Products) and of the Horizon Europe project CHIASMA (Accessible Innovative Methods for the Safety & Sustainability Assessment of Chemicals & Materials).

        He is co-author of 59 scientific publications and 5 patents, and Google scholar has registered >2200 citations and an h-index of 26.

        Anke Jesse (BMUKN)

        Dr. Anke Jesse holds a doctorate in law. She is Head of Division “Nanoscale Advanced Materials, OECD Chemicals Policy” at the German Federal Ministry for the Environment, Climate Action, Nature Conservation and Nuclear Safety in Berlin since December 2008. The division is in charge of regulatory issues relating to nanomaterials within the framework of European chemicals legislation (REACH Regulation (VO (EG) 1907/2006)), for the Test Methods Regulation (EU VO 440/2008) and the regulations on Good Manufacturing Practice (GLP). With regard to advanced materials, the division focuses on materials in the nano range (up to 1,000 nm) and possible measures to minimize risks to the environment and health from a regulatory perspective.
        Anke Jesse is also chair of the Malta Initiative, which she initiated in 2017. The Malta Initiative is a voluntary network without an official mandate, where representatives of European countries, European institutions, authorities, research institutions, NGOs, universities and industry work together to find possibilities for developing and amending the measurement and test methods required to enforce legislation (particularly in the field of chemicals). Prior to her current position Anke Jesse was, among others, Head of Division “Cabinet and Parliament” at the Federal Ministry for the Environment (Berlin), Head of the Representation of North Rhine-Westphalia to the Federation (Berlin) and Head of Minister’s Office at the Finance Ministry of North Rhine-Westphalia (Düsseldorf).

        10:30 – 11:00

        Tea, Coffee & Posters

        Session II: Characterisation of advanced materials (in test systems and complex matrices)

        11:00 – 11:05

        Introduction to the challenges by the chair

        Dan Hodoroaba (BAM)

        Dan Hodoroaba is head of the Division Surface and Thin Film Analysis at BAM and a representative of the Competence Center Advanced Materials@BAM. His current research activities focus on correlative approaches for accurate physico-chemical characterization of nano and advanced materials, mainly by means of electron and X-ray spectroscopies/microscopies with increased consideration of graphene-related 2D materials. Dan is author of more than 150 WoS articles, editor of the book Characterization of Nanoparticles, and has leading roles in European research projects on characterisation of nanomaterials as well as in national and international (pre-)standardisation bodies such as DIN, ISO and VAMAS.

        11:05 – 11:20

        Correlative Microscopy: identifying objects by combining technologies

        Maike Stange (BAuA)

        Maike Stange is a postdoctoral researcher at the German Federal Institute for Occupational Safety and Health (BAuA), focusing on Raman spectroscopy. She has been trained in various microscopy techniques and is well experienced in biomedical analyses methods and cell biology, based on her education in Biotechnology and Biochemistry. Before commencing her PhD studies in Biophysics, she was working at the University of Potsdam on a project investigating biological processes through mathematical modelling. The focus of her current research is the physico-chemical characterisation and identification of advanced materials in the EU project MACRAMÉ by using a confocal Raman microscope. In addition to her primary research, she is involved in identifying micro- and nanoplastics in air samples using correlative microscopy based on SEM and Raman spectroscopy, and further developing this technique.

        11:20 – 11:35

        Nanoinformatics methods and in silico characterisation of advanced materials for predictive toxicology

        Vladimir Lobaskin (UCD)

        Dr. Vladimir Lobaskin is an Associate Professor in the School of Physics, University College Dublin, National University of Ireland. His main research interests are in the field of physics of soft condensed matter and bionano interactions. His lab develops computational tools for in silico characterisation of materials and multiscale modelling methods for biological fluids and nanostructured matter, as well as models for nanomaterials toxicity assessment. He coordinated two research consortia in the field of nanosafety funded by European Commission’s FP7 and Horizon 2020 frameworks and took part in multiple other EU-funded projects on nanosafety and nanoinformatics. He is a contributor to the EU-US Roadmap Nanoinformatics 2030. He is representing European Union in the EU-US Communities of Research in Nano-EHS, coordinating the Characterisation CoR.

        11:35 – 11:50

        Advanced physico-chemical Characterisation & Correlation of Results with different Methods for GFMs

        Dan Hodoroaba (BAM)

        Dan Hodoroaba is head of the Division Surface and Thin Film Analysis at BAM and a representative of the Competence Center Advanced Materials@BAM. His current research activities focus on correlative approaches for accurate physico-chemical characterization of nano and advanced materials, mainly by means of electron and X-ray spectroscopies/microscopies with increased consideration of graphene-related 2D materials. Dan is author of more than 150 WoS articles, editor of the book Characterization of Nanoparticles, and has leading roles in European research projects on characterisation of nanomaterials as well as in national and international (pre-)standardisation bodies such as DIN, ISO and VAMAS.

        11:50 – 12:20

        Discussion

        12:20 – 12:30

        Poster pitches

        12:30 – 13:30

        Lunch & Posters

        Session III: Human health models to predict the safety of advanced materials

        13:30 – 13:35

        Introduction to the challenges by the chair

        Blanca Suarez Merino (TEMASOL)

        Dr Suarez-Merino (DPhil Oxford Biochemistry) is the Regulatory Affairs Director at the Nanotechnology Industries Association and Cofounder of TEMAS Solutions GmbH. Dr Suarez-Merino is Vice Chair of the BIAC Nanotechnology Committee at the OECD contributing to several groups under the OECD WPMN including the Steering Group on Advanced Materials and the Safe Innovation Approach. She also contributes to the Nanomaterial Expert Group under ECHA and the EFSA's Stakeholder Discussion Group on Emerging Risks (StadDG-ER). She is also a National Expert under the Nanotechnologies Standardisation Group (SNV) and routinely contributes to work under CEN/TC 352 Nanotechnologies, leading the SSbD standard. Dr Suarez-Merino is also a member of the Swiss National Platform on the safe handling of synthetic nanomaterials and co-authored the update of the Precautionary Matrix for Nanomaterials, and contributed to different testing guidelines for safety assessment of nanomaterials, the latest one being the adaptation of OECD TG 442D. She has been very active in European Projects focusing on Regulatory research and nanomaterials for several years. 

        13:35 – 13:50

        Development and Application of In Vitro Models to Assess Neurotoxicity of Advanced Materials, the iCare approach

        Ernesto Alfaro-Moreno (INL)

        The main interest of Ernesto Alfaro-Moreno lies in evaluating local and systemic effects induced by PM10, PM2.5, and nanoparticles. He has been focused on characterizing the toxicity of particles while evaluating the effects on epithelial, endothelial, and monocytic cells. He has been very active in the characterization of Cytotoxic, genotoxic, and proinflammatory effects. He also has been involved in the development and improvement of new In vitro models. His current interest in the Nanosafety area include the development of alveolo-vascular communication models, models for skin-on-a-chip, multi-sensing, C. elegans, and in silico assessments of nanoparticles and complex mixtures.

        13:50 – 14:05

        In vitro testing of advanced materials for effects on the lung

        Martin Wiemann (IBE) 

        Martin Wiemann (born 1960) studied biology and obtained his PhD in protozoology in 1990 at the University of Münster in Germany. Following postdoctoral studies in Ulm, San Diego, Münster and Essen, he became an assistant professor of human physiology at the University of Duisburg-Essen in 2000. Since 2007, he has been the CEO and Scientific Advisor of the IBE R&D Institute for Lung Health gGmbH, which develops cell-based in vitro assays to determine particle toxicity in the lung.

        14:05 – 14:20

        Validating animal-free in-vitro-learned digital twin for quantitative inflammation prediction from acute to chronic condition addressing 4 OECD TGs

        Janez Štrancar (Infinite Biotech)

        Prof. Dr. Janez Štrancar is co-founder, CEO and Head of R&D at Infinite biotech LLC (from 2019), as well as Head of Laboratory of Biophysics (from 2006) at Jozef Stefan Institute (Slovenia) and head of research program Experimental biophysics of complex systems, with expertise in Molecular biophysics, Molecular Spectroscopies, Advanced microscopies, Advanced photonics and On-chip technologies, as well as NAMs and digital twin in nanotoxicology. He obtained PhD in Physics at University of Ljubljana in 2000, and worked as a postdoc at Austrian Academy of Sciences (2001-2002), as well as visiting professor at University of Wageningen (The Netherlands, 2002), University of Provence (France, 2007) and at Politechnico Torino (Italy, 2013). He headed several national and international projects, including projects in 2 national centers of excellences, two MNT innovation projects, WPs in FP7, H2020 and HEurope collaborative projects, Smart Specialization innovation project as well as Photonics platform within industrial partnership Factories of the Future. He published more than 100 scientific papers with total 1800 pure citations and supervised 17 PhD students in last 18 years.

        14:20 – 14:35

        Advanced Insights into Cellular Internalization of 2D Materials

        Damjana Drobne (University of Ljubljana)

        Prof. Dr. Damjana Drobne is head of Bionanoteam, the Research group for nanobiology and nanotoxicology at the Biotechnical faculty, University of Ljubljana.

        14:35 – 14:50

        Discussion

        14:50 – 15:00

        Poster pitches

        15:00 – 15:30

        Tea, Coffee & Posters

        Session IV: Ecotoxicity, release, fate and environmental testing of advanced materials

        15:30 – 15:35

        Introduction to the challenges by the chair

        Iseult Lynch (UoB)

        Iseult Lynch is an Irish chemist and Professor of Enivornmental Nanoscience at the School of Geography, Earth and Environmental Sciences at the University of Birmingham. Her research focuses on the safety of nanoparticles in the environment and their interactions with biological entities.

        15:35 – 15:50

        Expanding the use of standardised in vitro ecotoxicity assays

        Alberto Katsumiti (GAIKER)

        Dr. Alberto Katsumiti is a researcher at the GAIKER Technology Centre. He has 20 years of experience in ecotoxicology and human health studies, and 14 years of experience in nanotoxicology. He holds a BSc in Biology, an MSc in Ecology and Conservation, a second MSc, and a PhD in Environmental Contamination and Environmental Toxicology. His research has focused on studying the mechanisms of toxicity of environmental pollutants—especially emerging contaminants (e.g., nanomaterials, advanced materials, microplastics)—on human health and the environment, using alternative methods and in vitro tools. He has also been actively involved in developing New Approach Methodologies (NAMs) for human and environmental hazard assessment. Dr. Katsumiti is a member of EU-NETVAL (the European Union Network of Laboratories for the Validation of Alternative Methods) and serves as GAIKER’s representative among EFSA Article 36 competent organizations.

        15:50 – 16:05

        C. elegans in Neuro-Nanosafety: A Translational Bridging Model and New Approach Methodology (NAM) Tool

        Nivedita Chatterjee (INL)

        Nivedita Chatterjee is a staff researcher in the nanosafety group at INL, Braga, Portugal. Her research focuses on the underlying mechanisms and molecular toxicology of nanomaterials, particularly genotoxicity, epigenetic alterations, and neurotoxicity. In the European Horizon project iCare, she is leading Work Package 3, using C. elegans as a model for neuro-nanosafety.

        16:05 – 16:20

        Material Flow Analysis: A basic pillar for regulatory risk assessment and beyond

        Luis Mauricio Ortiz-Galvez (EMPA)

        Luis Mauricio Ortiz-Galvez (he/him) received a BSc. in Nanotechnology and Molecular Engineering (2014-2018), from Univerisdad de las Américas Puebla, in Mexico, and an Erasmus Mundus Joint Master's Degree in Environmental Contamination and Toxicology (2020-2022), from the University of the Basque Country, in Spain. Now, he is doing his PhD at the Swiss Federal Laboratories for Material Science and Technology - Empa, St. Gallen, as part of the Environmental System Units department of ETH Zürich. His research focuses on the release of engineered nanomaterials and advanced materials and their prospective environmental impact, by using Material Flow Analysis, Life Cycle Assessment, Scenario Formation, and other methods. He is also participating in the MACRAMÉ project, and other international initiatives, such as the International Network Initiative on Safe and Sustainable Nanotechnologies (INISS-nano). His professional interests are environmental risk and sustainability assessment (including circular economy), science and risk communication to the public, risk governance, stakeholder engagement, international collaboration, science diplomacy, ethics in research, and transdisciplinary studies in the context of materials' and commercialized products' design methodologies.
        Email address: luism.ortizgalvez@empa.ch
        ORCID: https://orcid.org/0000-0002-5909-3235
        LinkedIn: https://www.linkedin.com/in/luismauricioortizgalvez/

        16:20 – 16:50

        Discussion

        16:50 – 17:00

        Poster pitches

        17:00 – 18:00 

        Session V: Poster Session

        18:00 – 20:00

        Networking Cocktails

        DAY 2 (Friday, 20. June 2025)

        Session VI: Challenges and solutions in testing industrial relevant samples along the material lifecycle

        09:00 – 09:05

        Introduction to the challenges by the chair

        Iztok Urbančič (US)

         

        Iztok Urbančič is project leader at Jožef Stefan Institute, Ljubljana, Slovenia (https://lbf.ijs.si), where they are applying advanced optical microscopy techniques and modelling to devise mechanisms of cellular responses to nano-sized particulate matter (engineered or environmental) leading to chronic diseases. Together with the spin-out company Infinite Biotech (https://www.infinite-biotech.com), they are developing in vitro/in silico tests for prediction of long-term health hazards. He coordinates the Horizon Europe project nanoPASS (https://www.nanopass.eu), aiming to calibrate and validate the NAMs for 4 adverse outcomes and demonstrate their applicability to diverse industrial materials for regulatory use.

        09:05 – 09:20

        Representing material life cycles in regulatory-relevant data

        Thomas Exner (7P9)

        Dr. Thomas Exner (M) is a founding partner and Chief Scientific Officer of the Slovenian-based SME Seven Past Nine d.o.o. Dr. Exner studied chemistry and did his PhD at the Technische Universität Darmstadt (Germany) followed by a postdoc at the University of Saskatchewan, Canada. After 12 years of independent academic research (University of Konstanz and University of Tübingen), he joined Edelweiss Connect in 2015 and finally moved on to Seven Past Nine in 2021. There, he is responsible for the scientific planning, execution, supervision and coordination of different projects in the area of safety and sustainability of advanced materials and the use of digital approaches therein.

        09:20 – 09:35

        Relevance and applicability of alternative (eco)toxicity methods in industrial settings

        Elise Morel (TEMASOL)

        Elise Morel (PhD) has a background in (nano)ecotoxicology and an interest in standardisation processes. In TEMAS Solutions GmbH, she supports the design of safe and sustainable innovative technologies, with a focus on safety assessments. In the iCare EU funded project, she facilitates the application of iCare methods and techniques on the industrial use cases. She is also looking at ways to feed the LCA assessment of graphene based 2D nanomaterials with the various hazard data generated by the project to produce environmental footprints in a cost-efficient manner.

        09:35 – 09:50

        In depth analysis of commercial functionalized graphene nanoplatelets towards structure-activity relationships

        Jörg Radnik (BAM)

        Dr. Jörg Radnik is Senior Scientist at the Federal Institute for Material Research and Testing, Berlin in the Division 6.1 “Surface analysis and Interfacial Chemistry” and working in the competence centre nano@BAM. His research focuses on the chemical analysis of nanostructured materials. He is currently involved in different nanosafety-related research projects (e.g. NanoSolveIt, ACCORDs) and in metrological projects (e.g. ISO-G-Scope). Since October 2023, he is leading the standardization and regulation task in the Graphene Flagship CSA. Furthermore, he is member of the Surface Analysis Working group of the consultative committee for amount of substance: metrology in chemistry and biology (CCQM) of the Bureau International des Poids et Mesure (BIPM) and one of the German representatives in the Versailles Project on Advanced Materials and Standards (VAMAS). In these functions, he leads different projects to enhance the accuracy and conformity of chemical methods in the field of nanomaterials. Furthermore, he is official delegate of the Deutsches Institut für Normung (DIN) in the technical committees for Surface Analytics and Nanotechnologies.

        09:50 – 10:05

        Sampling and testing industrially relevant materials: Possibilities and Pitfalls

        Christina Isaxon (Lund University)

        Associate professor and Senior lecturer Christina Isaxon works with airborne emission and exposure characterization in the Aerosol group at the Faculty of Engineering, Lund University, Sweden. Her research focus is the connection between particle properties and health effects in work environments as well as in the Global South. She is the main coordinator for Nanosafety and Sustainability at the Strategic Research Area NanoLund at Lund University. She is an elected co-coordinator of the Aerosols and Health working group in the European Aerosol Association and elected board member of the Nordic Society for Aerosol Research. Additionally, she is a member of the NASA MAIA (Multi-Angler Imager of Aerosols) Science Team, with special responsibility for air pollution characterization in the Primary Target area of Ethiopia. Isaxon is leading the work package 5, Industrial cases and exposure monitoring, in nanoPASS Bridging the gaps in nanosafety for animal-free prediction of adverse outcomes.

        10:05 – 10:20

        Progress towards standardisation of toxicity testing for SSBD of GFMs

        Mary Gulumian (NWU)

        Professor Mary Gulumian is appointed as an Extraordinary Professor at the North-West University. She is the founder member and President of TOXSA, and the founder member and President of SRA-Africa. She served as the vice-President of the Executive Committee of IUTOX. She has authored and co-authored numerous scientific publications and made a great number of keynote and invited presentations at local and overseas conferences. She has also provided expert consultation to industry and government departments on the toxicity of chemicals in the working and ambient environments. Professor Gulumian received in 2022 at the XVIth International Congress of Toxicology in Maastricht, the IUTOX Lifetime achievement Award in recognition of her services to toxicology in developing countries and in 2016 at the 11th International Particle Toxicology meeting in Singapore received “Lifetime Achievement Award for Outstanding Contributions to the Field of Particle Toxicology”. Her research interests include hazard identification and elucidation of mechanisms of toxicity of micro and nano particles. Professor Gulumian is also a member of the Specialty Chief Editor, Frontiers in Toxicology Editorial Board of the journal of Toxicology, and the journal Particle and Fibre Toxicology, and also the Associate Editor of the journal Inhalation Toxicology.

        10:20 – 10:50

        Discussion

        Session VII: Informed recommendations on needs for Test Guideline & standard developments

        10:50 – 11:00

        European Test Method and Validation Strategy

        Monique Groenewold (RIVM)

        11:00 -11:15

        Introduction to the informed recommendations on needs for Test Guideline and standard development

        Elisabeth Heunisch (BAuA)

        Dr. Elisabeth Heunisch is a scientist at the Federal Institute for Occupational Safety and Health (BAuA) in Germany with a background in Physical Chemistry. She has a PhD in Chemistry obtained at the Free University Berlin for her work at the Helmholtz-Zentrum Berlin on charge separation in quantum dot layers. Her work is dedicated towards the safety of nano- and advanced materials, with a strong focus on occupational safety towards fibrous aerosols. She is co-chairing the Malta Initiative and co-leaded the EU-funded project NanoHarmony, both dedicated to support the development of OECD Test Guidelines for nanomaterials. She is and was involved in several further research projects that support risk assessment of nano- and advanced materials (MACRAMÉ, Gov4Nano, NanoReg) and contributes to the OECD Test Guideline for dustiness testing of nanomaterials and the WPMN Guidance on Release Tests for Nanomaterials.

        11:15 – 11:30

        Tea, Coffee & Posters

        11:30 – 13:00

        Breakout Group Discussions

        13:00 – 14:00

        Lunch

        14:00 – 14:45

        Panel discussion:  With one representative from each breakout group

        Including a discussion with the audience

        Chair: Sean Kelly (NIA)

        Sean has worked at the Nanotechnology Industries Association (NIA) since 2015 when he joined as Senior Project Manager to lead on the Association’s funded project activities. He has worked on a range of EU funded projects related to safe and sustainable by design, regulatory issues and industry stakeholder engagement in activities. Currently he is responsible for leading the NIA as it goes through a strategic review of its work to ensure that it continues to serve the best interests of its members. He is also lead for the NIA’s non- regulatory policy work, most recently as a member of the EU’s Technology Council for Advanced Materials.

        Session VIII: Way forward and closing of the meeting

        14:45 – 15:05

        Setting the scene, Malta Initiative and key messages of summit

        New projects and next steps

        Chair: Thomas Kuhlbusch (BAuA)

        Thomas Kuhlbusch is employed at the Federal Institute for Occupational Hygiene and Health (BAuA), Germany. He is chemist by background and received his PhD in analytical chemistry while working at the Max Planck Institute for Air Chemistry. During his post doc period (1994 – 97) he had a stipend by the American Academy of Sciences and worked at the US EPA on air chemistry and climate change. In 1997 he moved to the University of Duisburg-Essen to conduct research on particle science. In 2001 he moved with his team to a research institute, IUTA e.V., where he conducted research on (nano)particle measurement technology, environmental behaviour, exposure assessment, workplace safety, and related epidemiological and toxicological studies. In 2016 he moved to BAuA where he is now head of unit “Hazardous Substances and Biological Agents”. His focus is set to achieve safe handling and use of hazardous substances and biological agents at work by advising on regulatory issues on national and international level. Thomas Kuhlbusch has led the EU project NanoHarmony, is member of the German delegation to the OECD- WPMN and member of the Malta Initiative Board besides other..

        15:05 – 15:20

        Closing of the meeting by OECD

        Mar Gonzalez (OECD)

        Mar Gonzalez is responsible for implementing the OECD’s nanosafety and advanced materials program. Her work focuses on enhancing regulatory preparedness and timely decision-making for nanomaterials and advanced materials. She coordinates the development of tools to assess the hazards of these materials, implements the Safer and Sustainable Innovation approach, and advances knowledge of emerging materials to improve anticipatory risk governance. This aligns with strategies for managing industrial chemicals.