Periodic Reporting for period 3 - SUNSHINE (Safe and sUstainable by desigN Strategies for HIgh performance multi-component NanomatErials)
Reporting period: 2024-01-01 to 2024-12-31
Major industrial sectors such as construction, structural and functional materials, active ingredients, food, healthcare, energy, cosmetics and electronics are investing into research and technological development of multi-component nanomaterials (MCNMs), including high aspect ratio nanomaterials (HARNs). These advanced hybrid materials are formed by two or more functional components (e.g. nanoparticles, nanocrystals, organic molecules) conjugated by strong molecular bonds, or by a nanomaterial (NM) with a unique chemical origin modified by hard or soft coatings. Some of the most widely used components are (combinations of) carbonaceous (e.g. fullerenes, carbon nanotubes, graphene) or metallic (metal or metal oxide) NMs with or without organic coatings (e.g. polymers, macromolecules and enzymes).
These new materials offer unprecedented technological benefits as the integration of different components in a unique system can produce new or improved functionalities. However, MCNMs also pose substantial design challenges as well as environmental, health and safety (EHS) concerns. The latter are particularly complex due to the differing rates of degradation and toxicities of the separate and interacting components, and their more complex interactions with biological and environmental systems. These concerns are magnified by the lack of fundamental research and regulatory guidance addressing the unique properties of these advanced materials.
To address these issues, the main goal of SUNSHINE is to develop and validate SSbD strategies for products enabled by MCNMs (including HARNs) and facilitate their implementation at industrial scale. To this end, the project generated essential new knowledge, tools and data to fill the gaps in our current understanding of the exposure, hazard and functionality characteristics of these materials, especially those arising from their unique properties and interactions. To support the uptake and utilization of the SSbD strategies by industry, especially SMEs, we delivered them as part of a user-friendly Safe and Sustainable Innovation Approach (SSIA) e-infrastructure.
SUNSHINE has promoted a two-way dialogue between industry and regulators, which can help to raise awareness and address regulatory concerns in the early stages of innovation. Ideally, this can shorten the time of novel MCNM-based products to reach the market. In addition, the project will provide recommendations on improvement and adaptation of the current regulatory hazard, exposure and risk assessment guidance (e.g. REACH, Biocides, Consumer Products, Food and Feed, Medical Technologies) and standard guidelines (i.e. OECD, ISO and CEN) for MCNMs. This will contribute towards increasing Regulatory Preparedness, which refers to the capacity of regulators to anticipate any EHS challenges posed by the emerging MCNMs early enough to take appropriate action, thus ensuring high levels of health and environmental protection.
These new materials offer unprecedented technological benefits as the integration of different components in a unique system can produce new or improved functionalities. However, MCNMs also pose substantial design challenges as well as environmental, health and safety (EHS) concerns. The latter are particularly complex due to the differing rates of degradation and toxicities of the separate and interacting components, and their more complex interactions with biological and environmental systems. These concerns are magnified by the lack of fundamental research and regulatory guidance addressing the unique properties of these advanced materials.
To address these issues, the main goal of SUNSHINE is to develop and validate SSbD strategies for products enabled by MCNMs (including HARNs) and facilitate their implementation at industrial scale. To this end, the project generated essential new knowledge, tools and data to fill the gaps in our current understanding of the exposure, hazard and functionality characteristics of these materials, especially those arising from their unique properties and interactions. To support the uptake and utilization of the SSbD strategies by industry, especially SMEs, we delivered them as part of a user-friendly Safe and Sustainable Innovation Approach (SSIA) e-infrastructure.
SUNSHINE has promoted a two-way dialogue between industry and regulators, which can help to raise awareness and address regulatory concerns in the early stages of innovation. Ideally, this can shorten the time of novel MCNM-based products to reach the market. In addition, the project will provide recommendations on improvement and adaptation of the current regulatory hazard, exposure and risk assessment guidance (e.g. REACH, Biocides, Consumer Products, Food and Feed, Medical Technologies) and standard guidelines (i.e. OECD, ISO and CEN) for MCNMs. This will contribute towards increasing Regulatory Preparedness, which refers to the capacity of regulators to anticipate any EHS challenges posed by the emerging MCNMs early enough to take appropriate action, thus ensuring high levels of health and environmental protection.
SUNSHINE developed the SSIA e-infrastructure in a co-creation process involving stakeholders from industry (incl. SMEs), policy and regulation. The e-infrastructure is designed to facilitate exchange of ideas, knowledge, tools and data between supply chain actors (SMEs and large industries) in order to support the development and validation of Safe and Sustainable by Design (SSbD) strategies for MCNM-based materials and products. This web platform can also facilitate exchange of information with regulators in the early stages of innovation to raise awareness and ensure that the SSbD strategies are developed according to regulatory requirements. To enable controlled and secure exchange of information along the supply chain, as well as between industries and regulators (in a trusted environment), we implemented blockchain technology in the platform. To provide access to high quality environmental, health and safety (EHS), functionality and sustainability data for SSbD decision making, we developed the SUNSHINE Open and FAIR database and connected it to the e-infrastructure. To enable cost-efficient acquisition/generation of new data, we developed guidance in the form of Integrated Approaches for Testing and Assessment (IATA). In addition, we included similarity assessment, grouping and read-across tools as well as access to more that 50 computational models via connection to the NanoInformaTIX platform. The SSIA e-infrastrucure also includes a software module to assess the safety-functionality-sustainability balance of the SSbD-modified materials/products at each Gate of the Agile Stage-Gate innovation process to inform ‘Go to development’ and ‘Go to market’ business decisions. This module is based on a tiered SSbD approach, which was developed in alignment with the 5 steps of the EC-JRC SSbD Framework. The robustness of these functionalities of the e-infrastrucure was demonstrated in the project’s case studies as well as in a joint case study of quantum dots (QDots) with our sister projects HARMLESS and DIAGONAL. These cases clearly showed the added value of applying digital tools for SSbD decision making. They were also instrumental for demonstrating the e-infrastructure to stakeholders in a series of workshops and training sessions and for assessing its performance based on Key Performance Indicators.
The overall impact of SUNSHINE has been to develop fundamental knowledge, data and tools to address these challenges. The project has transformed the state-of-the-art knowledge, tools and data on the exposure and hazard characteristics of advanced MCNMs, especially those arising from their unique properties and interactions, into SSbD strategies for specific materials/products that are implementable at industrial scale. To facilitate this, the project established a user-friendly e-infrastructure to foster dialogue, collaboration and information exchange between supply actors, and to provide the industries with easy access to the newly produced knowledge, data and methods, so that they can apply those for designing safer and more sustainable materials/products.