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Advanced High Aspect Ratio and Multicomponent materials: towards comprehensive intelLigent tEsting and Safe by design Strategies

Periodic Reporting for period 2 - HARMLESS (Advanced High Aspect Ratio and Multicomponent materials: towards comprehensive intelLigent tEsting and Safe by design Strategies)

Reporting period: 2022-08-01 to 2024-01-31

In the past decade public and private researchers have spent great efforts upon nanosafety research. This has helped to inspire nano-specific regulatory approaches and establish nanotechnology in key markets. For risk assessment, focus has been on single-component nanomaterials as the first step, whilst more complex, advanced (nano-)materials (AdMa) have become more widely used in consumer products. These AdMa can consist of complex mixtures of nanomaterials and they potentially exhibit different interactions with biological and environmental systems requiring an adapted safety evaluation framework. Moreover, the increasing awareness for limited natural resources enhances the urgency for also considering the sustainability of AdMa in product design.
The HARMLESS consortium is developing a structured approach towards the innovation of safer and more sustainable products containing AdMa. This Safe and Sustainable Innovation Approach (SSIA) is designed for seamless integration into the various stages of product development in industry and it is aligned with the strategy of the European Commission on Safe-and-Sustainable-by-Design (SSbD) (DOI: 10.2760/879069). Thus, it will be useful for both regulatory risk assessment and design of safer and more sustainable products containing AdMa.
The HARMLESS SSIA will be evidence-based, user-friendly and verified with real-world case studies by:
1 – Developing a systematic approach to safety and sustainability assessment of AdMa, which is based on safety data, computational modelling and understanding of the interaction mechanisms of AdMa with biological organisms (“mode of action”).
2 – Building large databases on hazard, release and fate of AdMa and perform comprehensive data analysis to support mode-of-action based grouping of AdMa.
3 – Developing a conceptual framework for selection of specific safety assessment methods for different AdMa.
4 – Providing user-friendly SSbD tools for AdMa for seamless integration in the process of product development.
5 – Verifying the HARMLESS SSIA by application to real-world industry scenarios from different industry sectors.
6 – Engaging with stakeholder groups from society, regulatory bodies and industry and harmonize the HARMLESS SSIA with other SSbD initiatives.
During its first 37 months, HARMLESS has taken important steps towards reaching the overall goal of providing a reliable, user-friendly SSIA to AdMa during product development.
This includes:
• We have established active interaction with representatives of the main stakeholder groups and harnessed key channels of communication and dissemination (C&D) including webpage, social media, project video, regular newsletters, organization of events/webinars/workshops. This includes interaction with EU-wide networks on nanosafety (e.g. EU NanoSafety Cluster), organization of workshops targeted to small and medium enterprises (SMEs) or regulatory bodies (e.g. OECD Steering Group for AdMa (Organisation for Economic Co-operation and Development), training of young scientists and information of the general public via easily understandable videos and articles.
• We have developed new approach methodologies (NAM) – i.e. not animal-based methods – to close critical gaps in data required for risk assessment of AdMa.
• We contributed to prepare regulatory bodies to AdMa risk assessment by providing feedback to regulatory bodies on the applicability of certain NAMs for AdMa and by working on an early-warning system for regulatory relevant AdMa.
• A large body of nanomaterial/AdMa risk data from HARMLESS and from previous EU-funded projects was made accessible for risk prediction via integration into the eNanoMapper database, which follows the FAIR data principles, i.e. data are Findable, Accessible, Interoperable and Reusable (DOI: 10.3390/nano10101908). This comprises hundreds of thousands hazard data points for 70+ materials.
• Computational modelling approaches are currently developed for predicting AdMa safety from risk data obtained with NAMs.
• Twenty Modes-of-Action (MoA), which are relevant for AdMa, were identified and organized into 32 pathways potentially leading to different adverse outcome for human health and ecological systems. This effort is aligned with AOP-Wikipedia (aopwiki.org) and forms the basis for the MoA-based HARMLESS SSIA.
• The architecture of the entire HARMLESS SSIA was developed. It has three levels of complexity matching the 3-stage process of product development for seamless adoption by industry. This architecture considers safety and sustainability aspects throughout the entire life cycle of a product from manufacturing through use and disposal/recycling. The HARMLESS SSIA builds on elements of numerous previous EU projects and is aligned with on the SSbD strategy of the European Commission (DOI: 10.2760/879069).
• For easy application of the HARMLESS SSIA by industry a large set of user-friendly tools was developed and integrated into an e-infrastructure to support decision making on safer and more sustainable AdMa. This decision support system contains information-technology-based tools for easy translation of available safety and sustainability data into recommendations for selection of safe and sustainable types of AdMa.
• For performance assessment of the HARMLESS SSIA five case studies from different industry sectors were selected ranging from paints and papermaking, over automotive catalysts and plant protection to facade insulation.
• Close interaction with our industry and small medium enterprise partners has facilitated the development of an industry-relevant and powerful HARMLESS SSIA, which is currently undergoing final verification and optimization.
The HARMLESS SSIA has:
• initiated new and strengthened already existing stakeholder networks dedicated to the development of safe and sustainable products containing AdMa
• informed regulatory bodies on how to guide industry towards the development of safe and sustainable products containing AdMa
• substantially expanded publicly available, high quality (FAIR) databases relevant for risk assessment of AdMa as foundation of evidence-based risk assessment
• improved risk assessment of AdMa by combining quality-monitored large databases with multi-scale computational modelling, artificial intelligence and neural network approaches
• reduced the need for animal-based hazard testing by developing NAMs for obtaining risk-related data on AdMa,
• supported seamless integration of the HARMLESS SSIA by industry via alignment with the product development process in industry and by provision of a user-friendly decision support system
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