Periodic Reporting for period 1 - HARMLESS (Advanced High Aspect Ratio and Multicomponent materials: towards comprehensive intelLigent tEsting and Safe by design Strategies)
Período documentado: 2021-01-01 hasta 2022-07-31
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 consist of complex mixtures 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 safe and 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. The HARMLESS SSIA will be aligned with the strategy of the European Commission on Safe-and-Sustainable-by-Design (SSbD) (DOI: 10.2760/879069). It will be useful for both regulatory risk assessment and design of safer and more sustainable products containing AdMa.
To establish an evidence-based, user-friendly SSIA the HARMLESS project consortium will address following aspects:
1 – Develop 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 – Build large databases on hazard, release and fate of AdMa and perform comprehensive data analysis to support mode-of-action based grouping of AdMa.
3 – Develop a conceptual framework for selection of specific safety assessment methods for different AdMa.
4 – Provide user-friendly SSbD tools for AdMa for seamless integration in the process of product development.
5 – Verify the HARMLESS SSIA by application to real-world industry scenarios from different industry sectors.
6 – Engage with stakeholder groups from society, regulatory bodies and industry and harmonize the HARMLESS SSIA with other SSbD initiatives.
The HARMLESS consortium is developing a structured approach towards the innovation of safe and 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. The HARMLESS SSIA will be aligned with the strategy of the European Commission on Safe-and-Sustainable-by-Design (SSbD) (DOI: 10.2760/879069). It will be useful for both regulatory risk assessment and design of safer and more sustainable products containing AdMa.
To establish an evidence-based, user-friendly SSIA the HARMLESS project consortium will address following aspects:
1 – Develop 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 – Build large databases on hazard, release and fate of AdMa and perform comprehensive data analysis to support mode-of-action based grouping of AdMa.
3 – Develop a conceptual framework for selection of specific safety assessment methods for different AdMa.
4 – Provide user-friendly SSbD tools for AdMa for seamless integration in the process of product development.
5 – Verify the HARMLESS SSIA by application to real-world industry scenarios from different industry sectors.
6 – Engage with stakeholder groups from society, regulatory bodies and industry and harmonize the HARMLESS SSIA with other SSbD initiatives.
During its first 19 months, HARMLESS has taken important steps towards reaching the overall goal of providing a reliable, user-friendly approach to address safety and sustainability concerns of AdMa during the entire process of product development.
This includes:
• Identification of the main stakeholders and establishment of the key channels of communication and dissemination (C&D) including webpage, social media, project video, regular newsletters, organization of events/webinars/workshops, and knowledge transfer activities). Stakeholder engagement also includes collaborations with EU-wide networks on nanosafety (EU NanoSafety Cluster) and an invitation by the OECD Steering Group for AdMa (Organisation for Economic Co-operation and Development) - an internationally relevant regulatory body – to organize a joint workshop on AdMa-related safety assessment schemes.
• Review of available literature, data and new approach methodologies (NAM) – i.e. not animal-based methods - for assessing the risk of AdMa have led to the development of a strategy to fill the most critical gaps in safety data and NAMs.
• A large body of existing nanomaterial risk data from previous EU-funded projects was made accessible to state-of-the-art methods 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).
• 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 forms the basis for the MoA based HARMLESS SSIA.
• Essential gaps with respect to the availability of data and NAMs have been identified and a strategy towards filling these gaps has been developed.
• More than one hundred thousand hazard data points for 45 materials were generated with our in vitro cell-based high throughput screening assay (NAM) filling a significant part of the aforementioned data gaps. Computational modelling approaches are currently developed for predicting AdMa safety from risk data obtained with NAMs.
• A draft of the architecture of the entire HARMLESS SSIA was developed. It has three levels of complexity to ensure seamless integration in the 3-stage process of product development adopted by industry. This architecture considers safety and sustainability aspects throughout the entire life cycle of a product from manufacturing through wear-and-tear during use and disposal/recycling. The HARMLESS SSIA builds on elements of the previous EU projects including NanoReg2, CaLIBRAte, and GRACIOUS, as well as the SSbD report provided by the Joint Research Center (JRC) of the European Commission (DOI: 10.2760/879069).
• For easy adoption of the HARMLESS SSIA by industry a large set of user-friendly tools was developed in support of decision making. This system contains information-technology-based tools for easy translation of available safety and sustainability data into recommendations of for selection of safe and sustainable types of AdMa.
• For validation of the HARMLESS SSIA five case studies from different industry sectors were selected: silica-organics for paints, elongated silica for papermaking, perovskite for catalysts, modified imogolite for plant protection, and fiber-aerogel-mats for facade insulation. First results of the HARMLESS SSIA for selection of safe and sustainable silica-organics mixtures contained in paints are available.
This includes:
• Identification of the main stakeholders and establishment of the key channels of communication and dissemination (C&D) including webpage, social media, project video, regular newsletters, organization of events/webinars/workshops, and knowledge transfer activities). Stakeholder engagement also includes collaborations with EU-wide networks on nanosafety (EU NanoSafety Cluster) and an invitation by the OECD Steering Group for AdMa (Organisation for Economic Co-operation and Development) - an internationally relevant regulatory body – to organize a joint workshop on AdMa-related safety assessment schemes.
• Review of available literature, data and new approach methodologies (NAM) – i.e. not animal-based methods - for assessing the risk of AdMa have led to the development of a strategy to fill the most critical gaps in safety data and NAMs.
• A large body of existing nanomaterial risk data from previous EU-funded projects was made accessible to state-of-the-art methods 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).
• 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 forms the basis for the MoA based HARMLESS SSIA.
• Essential gaps with respect to the availability of data and NAMs have been identified and a strategy towards filling these gaps has been developed.
• More than one hundred thousand hazard data points for 45 materials were generated with our in vitro cell-based high throughput screening assay (NAM) filling a significant part of the aforementioned data gaps. Computational modelling approaches are currently developed for predicting AdMa safety from risk data obtained with NAMs.
• A draft of the architecture of the entire HARMLESS SSIA was developed. It has three levels of complexity to ensure seamless integration in the 3-stage process of product development adopted by industry. This architecture considers safety and sustainability aspects throughout the entire life cycle of a product from manufacturing through wear-and-tear during use and disposal/recycling. The HARMLESS SSIA builds on elements of the previous EU projects including NanoReg2, CaLIBRAte, and GRACIOUS, as well as the SSbD report provided by the Joint Research Center (JRC) of the European Commission (DOI: 10.2760/879069).
• For easy adoption of the HARMLESS SSIA by industry a large set of user-friendly tools was developed in support of decision making. This system contains information-technology-based tools for easy translation of available safety and sustainability data into recommendations of for selection of safe and sustainable types of AdMa.
• For validation of the HARMLESS SSIA five case studies from different industry sectors were selected: silica-organics for paints, elongated silica for papermaking, perovskite for catalysts, modified imogolite for plant protection, and fiber-aerogel-mats for facade insulation. First results of the HARMLESS SSIA for selection of safe and sustainable silica-organics mixtures contained in paints are available.
The HARMLESS SIAA to optimize safety and sustainability of AdMa during product design will
• initiate new and strengthen already existing stakeholders’ networks dedicated to the development of safe and sustainable products containing AdMa,
• inform regulatory bodies on how to guide industry towards the development of safe and sustainable products containing AdMa,
• expand the publicly available, high quality (FAIR) database relevant for risk assessment of AdMa as foundation of evidence-based risk assessment by European regulators, industry, and other stakeholders,
• reduce the need for animal-based hazard testing by developing NAMs for obtaining risk-related data on AdMa,
• develop minimum requirements to evaluate human and environmental safety, climate change, resource use & circularity, and pollution prevention at different product development stages,
• foster the development of products containing AdMa which are safe for human health and the environment,
• support seamless integration of the HARMLESS SSIA by industry by alignment with industry’s 3-stage product development process and by provision of a user-friendly decision support system,
• provide guidance to regulatory bodies regarding oversight on safety of AdMa-containing products
• improve the position of the European industry in the global market via the development of safe and sustainable products containing AdMa which are superior to other products by combining high functionality of the product with protection of the environment, natural resources, and human health.
• initiate new and strengthen already existing stakeholders’ networks dedicated to the development of safe and sustainable products containing AdMa,
• inform regulatory bodies on how to guide industry towards the development of safe and sustainable products containing AdMa,
• expand the publicly available, high quality (FAIR) database relevant for risk assessment of AdMa as foundation of evidence-based risk assessment by European regulators, industry, and other stakeholders,
• reduce the need for animal-based hazard testing by developing NAMs for obtaining risk-related data on AdMa,
• develop minimum requirements to evaluate human and environmental safety, climate change, resource use & circularity, and pollution prevention at different product development stages,
• foster the development of products containing AdMa which are safe for human health and the environment,
• support seamless integration of the HARMLESS SSIA by industry by alignment with industry’s 3-stage product development process and by provision of a user-friendly decision support system,
• provide guidance to regulatory bodies regarding oversight on safety of AdMa-containing products
• improve the position of the European industry in the global market via the development of safe and sustainable products containing AdMa which are superior to other products by combining high functionality of the product with protection of the environment, natural resources, and human health.