Multidimensional Integrated Quantitative Approach To Assess Safety And Sustainability Of Nanomaterials In Real Case Life Cycle Scenarios Using Nanospecific Impact Categories

Project Information

INTEGRANO

Grant agreement ID: 101138414

DOI

10.3030/101138414

EC signature date 23 November 2023

Start date 1 January 2024

End date 31 December 2027

Funded under

• Digital, Industry and Space

Total cost

€ 4 140 133,35

EU contribution

€ 3 985 648,75

Coordinated by

UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA
Italy

Periodic Reporting for period 1 - INTEGRANO (Multidimensional Integrated Quantitative Approach To Assess Safety And Sustainability Of Nanomaterials In Real Case Life Cycle Scenarios Using Nanospecific Impact Categories)

Reporting period: 2024-01-01 to 2025-06-30

Summary of the context and overall objectives of the project

As part of the European Green Deal, the EU Chemicals Strategy for Sustainability seeks to minimize the harmful effects of chemicals and materials on both human health and the environment, while promoting their safer and more sustainable use. The ambition is to phase out the use of harmful substances and to substitute or minimise the use of substances of concern. To achieve these goals the Safe and Sustainable by Design (SSbD) framework has been developed that consists of (re-)design and assessment phases to enable comparison of chemicals across all their life cycle stages. Using the SSbD framework as a reference, the INTEGRANO project aims to establish a quantitative approach to assess the safety and sustainability of nanomaterials (NMs). NMs and their derived products are a promising class of materials with high potential and application across many industrial sectors but the assessment of their safety and sustainability is hampered by gaps in available data and deficits in collection methods. INTEGRANO will provide the methodology to fully assess NMs safety, sustainability and functionality in a quantitative manner and enable the application of the SSbD framework in their development. Through custom software the collected safety, sustainability and functionality data for the NMs under design will be evaluated using artificial intelligence to enable the human user to make informed design decisions based on comparable quantitative evidence. The INTEGRANO digital-supported design process minimises the quantity of experimental data required to be collected, dramatically reducing Research & Development effort and approval lead-time, increasing the sustainability and viability of the industrial uptake of nanotechnologies.

The INTEGRANO project will enable the SSbD of NMs and NEPs which translates into a faster commercialisation of valuable end-products. The INTEGRANO project directly addresses NMs which constitute 43% of all registered NEPs and which are manufactured by 3000 companies in 64 countries. INTEGRANO will spur industrial uptake of SSbD NEPs in the Automotive, Construction, Health, Textile, Cosmetics, Energy and Water treatment sectors in which more than 50% of such products are found. INTEGRANO will directly engage stakeholders by establishing a web-based SSbD community for sharing of data, methodologies and engagement to enhance the uptake and reach of the SSbD framework

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

At the 18M point, the INTEGRANO project has:

Fully defined the goals and scope of the 6 case studies within the project, including setting the Key Decision Factors (KDFs) and Key Performance Indicators (KPIs) which are the experimental variables and the areas of performance to be evaluated for each case study element.
Identified the multioptimal set of safe and sustainable solutions for the first few nanomaterial design cases.
Has designed and implemented a bespoke Data Management Tool (DMT) for the management of case study activities and for the collection and curation of data produced within the project in a manner complies with FAIR data principles. The DMT has broad applicability and will be promoted for application in future research projects.
Has made progress towards the development of new toxicological and eco-toxicological assessment methods through the preliminary definition of new approach methodology protocols required for the assessment of the (eco)toxicological hazards of nanomaterials,
Has defined possible nano-ecotoxicity and nano-toxicity impact indicators from already available data and has defined possible eco-toxicity endpoints for the marine environment based on ecotoxicological experimental work performed with INTEGRANO nanomaterials.
Has started to defined possible relationships between nanomaterials physicochemical properties and hazard profiles.
New Life Cycle Impact Assessment (LCIA) approach to the assessment of safety and sustainability of NMs with incorporation of a MCDA tool.
Investigated quality criteria for regulatory exposure models by ECHA. Recommendations for establishing quality criteria were provided for ECHA and OECD WPMN SG8.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

INTEGRANO is moving beyond the state of the art by defining new standards for detection, quantification and characterisation of NMs in connection with their p-chem properties and intended application within their whole LC. The preliminary definition of new approach methodology protocols required for the assessment of the (eco)toxicological hazards of nanomaterials and the association of p-chem properties with hazard profiles moves the project beyond the state of the art and is establishing to a new paradigm in nanomaterials development. Further research is ongoing to fully implement the new paradigm, which will be fully implemented over the remainder of the project duration.

The INTEGRANO Data Management Tool is a highly innovative approach towards case study management and ensuring data treatment in line with the FAIR data principles. The first reporting period has seen the development and implementation of the tool, with subsequent periods being used to fully demonstrate the DMT functionality and capability, with commercialisation and implementation within other projects being actively investigated.