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Anticipating Safety Issues at the Design Stage of NAno Product Development

Periodic Reporting for period 2 - ASINA (Anticipating Safety Issues at the Design Stage of NAno Product Development)

Periodo di rendicontazione: 2021-09-01 al 2022-12-31

Nanotechnology is a key enabling technology and has great potential for addressing societal challenges including energy supply, health care, environment protection. Nevertheless, concerns about safety and sustainability still remain open, due to the complexity and dynamic behavior that nanomaterials show in their life-cycle exposure scenarios. In response to EU Chemicals' Strategy for promoting sustainable economy and boosting innovation for safe and sustainable chemicals, ASINA MISSION is that to promote safe and sustainable nano-practices at the design stage of product development, by considering all the nano enabled products (NEPs) design for X dimensions: Functionality, Production Technologies, Economic Viability, Environmental Sustainability, Safety and Regulatory Requirements.

The following overall objectives are addressed:
1) To improve a comprehensive knowledge and identify the DESIGN VARIABLES that make a nanomaterials, a process, a product more safe or more sustainable.
2) To implement the above knowledge into an industrial innovation process in a more structured manner through a pilot action
3) To communicate this knowledge and support the information exchange between stakeholders.
4) To eliminate uncertainity in production, use and waste (towards possible certification)
The ASINA SMM is implemented through 6 technical workpackages,
In the first 18 months we achieved the following Deliverables and Milestones:
• Deliverables D1.1; D3.1 about the state of the art of ASINA target materials and processes design solutions;
• Internal deliverable (ID 3.1) collecting process pilot facilities analysis for the implementation of Digitl Twins;
• Deliverable 4.1 showing the ASINA Data Management Plan (DMP) and internal documents for ASINA data capturing procedures;
• Deliverables D6.1-6.4 including PEDR, Communication activities, plan for the Stakeholder Networking and Training events;
• MS2 and MS4: Describing facilities and technologies available through ASINA Testbeds and Pilot Plants.

In the second 18 months we achieved the following Deliverables and Milestones:
• Deliverables D1.2 defining the pchem identity of NMs and products developed in ASINA;
• Deliverable D2.2 (MS7) performing a low-tier risk assessment of the nano-enabled products (NEP) produced within ASINA;
• Deliverable D2.4 identifying the physicochemical (pchem) properties of nanomaterials (NMs) driving their toxicity, itself being analysed through the prism of the Adverse Outcome Pathway (AOP) framework.
• Deliverables D3.2 mapping ASINA pilot lines to identify the most appropriate to implement the ASINA digital solution (Digital Twin), and D3.3 (MS8) on the development of specifications for use, to facilitate the application of the resources inventoried in the ASINA P-SbD Library, for the design of safe nanoprocesses.
• Deliverables D4.5 (MS11) showing architecture and features of two ASINA-ES architecture versions.
• Deliverable D6.5 setting a preliminary draft of the business plan to demonstrate the excellence and commercial potential of the ASINA Data Driven Management Methodology (ASINA-SMM) and Expert System Tool (ASINA-ES).
• Deliverable D6.6 providing information on ASINA 1st stakeholder workshop that aimed to spot a common message, revealing current challenges and issues faced towards the implementation of SSbD (nano) manufacturing.

In the 2nd reporting period we maximised the dissemination/comunication/training efforts. We disseminated the ASINA methodology and results by presenting them at 88 events (scientific conference, workshop, webinars, training sessions). The high quality of scientific results is now shown by 30 ISI peer reviewed papers (26 of them already published in Open Access).
In Period 1 ASINA moved some important steps beyond state-of-the-art, for each step of ASINA-SMM (Define-Measure-Analyse-(Re)Design-Verify). We describe in the following some of the pragmatic and exploitable SSbD solutions provided so far:
- we implemented a material strategy in close collaboration with industrial partners, identifying the main design features of the materials and processes. We collected and distributed raw materials and a first set of NEPs. In agree with Design of Experiment (DoE) maps we developed some design alternatives for the synthesis and integration of materials within NEPs and compared the functionalities.
- we implemented the ASINA testing strategy for the collection of safety attributes. The potential life-cycle release scenarios of ASINA’s VC1 and VC2 products has been defined; a literature mining for AOP development allowed to define the hazard assessment strategy based on in vitro and in vivo models; two experimental field campaigns has been carried out and data collected for filling into mass flow and deposition models; finally a low tier risk assessment has been already performed and documented in D2.2 adapting SUNDS model, after making a screening of existing risk assessment models.
- the ASINA data shepherd engaged a collaboration with Nanocommons to share information and operationalize ASINA data FAIRification process; many data case templates and data description questionnaires have been already collected for capturing any data produced by data generators in ASINA.

In period 2, ASINA advanced further beyond the state of the art, achieving important results:
New materials/products (M-SbD) and process (P-SbD) safe-by-design solutions have been developed:
In terms of key performance indicators (KPI):
- we assessed functional and techno-economic properties and their connection with design and manufacturing strategies adopted to obtain nano-enabled products for VC1 and VC2.
- we measured the release potential during the use phase of textile materials (Ag-HEC and TiO2-N coated) and air purifying systems (TiO2-N coated).
- we tested in vitro the safety of target and benchmarking NMs following the AOP oriented testing strategy defined and proposed in ASINA.
- we built an Environmental Risk Assessment case study for Ag-HEC textile within the high-tier GUIDEnano tool. Input parameters and definitions of the relevant environmental scenarios were selected considering the release factors during washing simulations and the most relevant environmental exposure compartments.
ASINA data shepherd successfully continued the data management and curation process for all the data generated within the consortium.
ASINA-ES relevant architecture was implemented according to the modular design devised in the first reporting period. The beta version operation was tested on specific case studies based on ASINA available experimental data and on LCA and LCC analyses carried out for assessing the sustainability profile of addressed solutions.

To improve the innovation potential of the proposed design solutions:
- we initiated the elaboration of a CEN Workshop Agreement and established important connections with EC funded NMBP15 and 16 projects related to the implementation of SSbD nanotechnologies
- we have initiated the elaboration of ASINA’s general roadmap for the development, implementation, and validation of SbD solutions.
- we have organized the first ASINA Stakeholder Workshop, with the aim to gather information about stakeholders’ expectations and specific feedback about how the tools developed by ASINA could optimize to meet all endures expectations.
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Scheme showing the contents of ASINA ROADMAP