Periodic Reporting for period 2 - SUNSHINE (Safe and sUstainable by desigN Strategies for HIgh performance multi-component NanomatErials)
Berichtszeitraum: 2022-07-01 bis 2023-12-31
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 will generate 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 will deliver them as part of a user-friendly e-infrastructure designed to:
•facilitate collaboration and information exchange between actors along nanotechnology supply chains (developers, producers, downstream users) to promote the development and implementation of SSbD strategies for MCNM-based materials, products and processes;
•support SMEs and large industries in the selection and application of simple, robust and cost-effective experimental, modelling and grouping/read-across approaches to acquire/generate the data needed to test the effectiveness of the SSbD strategies;
•enable risk-benefit analysis of the SSbD-modified materials/products at each stage of the innovation process to ensure that they are safe without compromising their technical and/or commercial probability of success.
SUNSHINE will promote 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 will generate 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 will deliver them as part of a user-friendly e-infrastructure designed to:
•facilitate collaboration and information exchange between actors along nanotechnology supply chains (developers, producers, downstream users) to promote the development and implementation of SSbD strategies for MCNM-based materials, products and processes;
•support SMEs and large industries in the selection and application of simple, robust and cost-effective experimental, modelling and grouping/read-across approaches to acquire/generate the data needed to test the effectiveness of the SSbD strategies;
•enable risk-benefit analysis of the SSbD-modified materials/products at each stage of the innovation process to ensure that they are safe without compromising their technical and/or commercial probability of success.
SUNSHINE will promote 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.
WP1 has made significant progress in developing the SIA e-infrastructure in co-creation with stakeholders from industry and regulators. To enable generation of new EHS knowledge and data for SSbD decision making, WP2 is applying a range of experimental methods adapted for NMs, to evaluate the EHS implications of MCNMs. WP3 has made significant progress in the development and use of computational models to predict MCNM properties, interactions, release/exposure, fate, and toxicity. WP4 has advanced in adapting the GRACIOUS framework for grouping and read across of NMs for MCNMs. WP5 activities are focussed on development, validation, and implementation of the SUNSHINE SSbD strategies along the life cycle stages of MCNMs. WP6 has collaborated with WP8 to promote a two-way dialogue between innovators and regulators to facilitate that (1) the concerns of regulators regarding the EHS risks from MCNMs are addressed in early stages of innovation, and (2) to increase the current state of Regulatory Preparedness. WP7 has the objective to establish close scientific cooperation with non-European countries (especially with USA, but also with Asian Pacific and African countries). The focus has been so far on collaboration with USA on topics relevant to SSbD and MCNMs. The SUNSHINE dissemination, communication and stakeholder engagement strategy has been executed by WP8 as planned with no delays. The project has a fully developed brand identity, is well findable on the internet and social media channels and all progress has been reported in press releases and newsletters. WP9 has had a significant impact on research cohesion and integration with other relevant projects. Further intensive collaboration has taken place with the SUNSHINE sister NMBP-16 projects HARMLESS and DIAGONAL.
The overall impact of SUNSHINE is to develop fundamental knowledge, data and tools to address these challenges. We aim to transform 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 has 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.