HARMLESS Final Webinar (11.03.2025)
Creators: name: Schmid, Otmar
name: Suarez-Merino, Blanca
name: Dekkers, Susan
name: Grafström, Roland
name: Dumit, Verónica
name: Gajewicz-Skretna, Agnieszka
name: Baun, Anders
name: Jeliazkova, Nina
name: Haase, Andrea
Publisher: name: Zenodo
Year: 2025
Subjects: NAMs
SSIA
DSS
IATAs
AOPs
AdMa
hazard assessment
toxicity
omics
modelling
ecotoxicity
eNanoMapper
EWS

description: More than 90 people attended on 11th March 2025 the final webinar organised by the H2020 project HARMLESS, marking the culmination of four years of groundbreaking work in developing a Safe-and-Sustainable-by-Design (SSbD) approach for Advanced Materials (AdMa) in product development.

Under the title “HARMLESS major achievements - Using New Approach Methodologies (NAMs) in the Safe and Sustainable Innovation Approach (SSIA)”, the webinar showcased the key outcomes of the project, with a special focus on the HARMLESS SSIA and its innovative Decision Support System (DSS). In addition, the webinar featured dynamic pitch presentations of selected project results, offering a comprehensive view of the progress made in the past four years (e.g., high throughput in vitro toxicity screening, proteomics, in vivo predictive NAM modelling, ecotoxicity, solutions for integration, analysis and visualization of large data sets, and the Early Warning System (EWS) for regulatory preparedness). The applicability of the HARMLESS SSIA was verified with four real-world industry case studies.

The webinar was targeted to all interested parties willing to get more insight into the HARMLESS project, primarily consultancy companies working in the SSbD field for advanced (nano)materials, small and medium sized enterprises (SMEs) and large industry developing products containing AdMa, as well as researchers working on safety and sustainability of AdMA  and all people potentially interested in using the HARMLESS tools. 

After an overview of the major results by project coordinator Otmar Schmid (HMGU) ranging from Integrated Approaches to Testing and Assessment (IATAs) and the role of Adverse Outcome Pathways (AOPs), over important contributions to harmonization of test methods, to the creation of the largest publicly available in vivo anchored dataset on industrial relevant AdMa (and related benchmark materials), Blanca Suárez Merino (TEMASOL) & Susan Dekkers (TNO) presented the HARMLESS SSIA and user-friendly DSS, respectively. Dynamic pitch presentations of specific HARMLESS results followed:





Roland Grafström (KI) presented on the HARMLESS tiered approach for hazard assessment of advanced materials with a focus on high-throughput in vitro toxicity screening and omics-based AOP (adverse outcome pathway) anchoring analysis. 




Verónica Dumit (BfR) showed the analytical adaptation of a proteomic protocol designed to accelerate reliable measurements in a cost-effective manner for toxicological screenings. The advanced protocol has been optimized for both in vivo and in vitro samples, enabling omics data integration and facilitating the correlation between in vitro and in vivo results.




Agnieszka Gajewicz-Skretna (UG) described key elements of the extensive body of in vivo predictive NAM modelling. These efforts included derivation of more than 1000 molecular predictors per AdMa and validation of more than 100 models for prediction of in vivo toxicity from the large body of in vivo-anchored  HARMLESS NAM data.




Anders Baun (DTU) presented a summary of the ecotoxicity studies performed in HARMLESS. They were directed towards method development and testing of the persistence, bioaccumulation and toxicity of nanomaterials. A novel "point-of-entry" approach for AdMa bioaccumulation testing was introduced, and the findings were linked to the HARMLESS SSbD approach.




Nina Jeliazkova (IDEA) presented the eNanoMapper database, which ensures well-documented, structured, and interoperable data for AdMa by providing tools for co-creating data entry templates and integrating extensive physicochemical, in vitro, in vivo, and in silico data. It aims to enable researchers to create FAIR datasets, store them in any repository, and transform complex data into reusable insights, models, and predictions.




Andrea Haase (BfR) summarised the key achievements of the project from a (pre-)regulatory perspective. The HARMLESS early warning system (EWS), which is closely aligned with the HARMLESS DSS, is a practically applicable tool for screening of materials in the context of a pre-regulatory assessment to effectively support regulatory preparedness. It is organized in two tiers (Tier 0: Categorization; Tier 1: Screening), each underpinned by a specific methodology and facilitated by a dedicated online tool. Its relevance for OECD activities towards regulatory preparedness for AdMa is currently under consideration.



To foster collaboration and deeper discussions, the webinar participants joined interactive breakout rooms focused  on the specific topics and results previously presented. This allowed for direct and meaningful exchange of thoughts and practical insights.

The SSIA/DSS breakout group started with a poll for participants to choose a “favorite” topic or tool within the DSS. A presentation followed by TNO on the tools available from the DSS. Eugene van Someren (TNO) showed the participants how the DSS guides the user to the tools throughout the different innovation stages, covering performance, exposure, hazard, and sustainability aspects. Participants were encouraged to register under the Diamonds Platform for a test trial.

The webinar ended with an outlook to the future perspectives of the project which included information on an upcoming OECD workshop on leveraging the HARMLESS EWS for pre-regulatory assessment of AdMa, the proposed path towards harnessing AdMa stratification in different AOPs for mechanistic clustering of AdMa, and an invitation to consider using the tools provided by HARMLESS.

The participants of this workshop represented a wide range of stakeholder groups, including the scientific community (60%), SMEs (13%), large industry (16%), SSbD consultants (10%), and regulators (6%).

 

Agenda of the webinar availble here.

Recording of the webinar available here.