Periodic Reporting for period 2 - SAbyNA (Simple, robust and cost-effective approaches to guide industry in the development of safer nanomaterials and nano-enabled products)
Berichtszeitraum: 2021-09-01 bis 2023-02-28
In the absence of specific and integrated regulatory guidelines for the management of risks associated to the use of nanomaterials (NMs) and nano-enabled products (NEP), numerous organizations have produced guidance documents with the aim of covering management gaps that exist in the different application domains (i.e. workers, consumers, environment). There is still a need to provide industry with easy to use and integrative guidance with clear workflows exploiting the most relevant resources for each evaluation case, so that industry can efficiently manage the potential risks associated to NMs and NEPs. The challenge is to distil and integrate available resources (methods, models, frameworks, and tools) to reduce their complexity, costs and delocalization. To address this challenge, the main objective of SAbyNA is to develop an overarching integrative and interactive web-based guideline “The SAbyNA Guidance Platform” to support the development of safer NEP (and safer processes along the product life cycle), with advanced functionalities tailored to different industrial sectors (Paints and Additive Manufacturing). A continuous dialogue with different stakeholders and end-users will maximize the added value of the SAbyNA Guidance Platform, which will also be demonstrated in industrial case studies.
The work carried out during the first reporting period towards the achievement of this main goal has been performed in the context of hazard and exposure assessment strategies for Safe-by-Design (SbD) purposes (WP2 & WP3) by:
- Collecting models, databases, tools, and methods both for hazard and exposure perspectives for NMs and NEPs.
- Selecting resources for assessing human and environmental hazard and exposure for the purpose of SbD which will be included in the GUIDEnano tool.
- Promoting the use of in vitro data and grouping approaches for the hazard assessment.
- Improving existing models for exposure assessment including approaches to link with relevant data libraries.
- Performing experimental work by testing NEPs transformations throughout their life cycle connected with their toxicological effects.
- Implementing the hazard assessment strategy in SAbyNA case studies using benchmark materials, including the creation of SOPs for hazard methods to test NEPs.
In the context of managing risks along the NEP life cycle applying SbD strategies (WP4 & WP5), the state-of-the-art on SbD strategies towards safer products was provided by analysing more than 100 sources (i.e. research articles, guidelines, projects’ outcomes). From this analysis, SbD strategies as basis for developing the module of the SAbyNA Platform were identified in which the user will be guided to solutions that will i) minimize risks, and ii) preserve the function of the NEP. Furthermore, a list of physical-chemical drivers of nano-risks were analysed and recommendations were generated for their efficient implementation in the Platform. SbD strategies and safe operation of nanoprocesses were added in the Platform to provide sector-specific solutions.
Related to the SAbyNA Guidance Platform (WP6), the main structure of the Guidance platform was generated, and it consists in two parts: Part 1 for the screening assessment, and Part 2, the advanced level of assessment. In Part 1, by answering to questions related to the physico-chemical characteristics, hazard and exposure data of the investigated NM/NEP, the user can perform a qualitative assessment on any potential safety concerns related to the use of the NM and/or the NEP. If safety concerns are raised, more in deep inputs are requested to the user in the Part 2 of the Platform. In Part 2, the user is guided on how to use the existing data sources (e.g. eNanoMapper database) or, in alternative, on the most suitable method/tool to be used to generate the data needed. If risks are identified, the user is guided through the application of SbD strategies for products and processes to reduce or mitigate those risks.
SAbyNA successfully initiate the interactions with stakeholders at an early stage of the project to involve them already in defining the structure of the SAbyNA Guidance Platform. The second SAbyNA Guidance Platform was released, including resources for life cycle thinking, cost analysis and sustainability assessment.
For the identification of sector-specific nanosafety practices and Stage -Gate processes (WP7), sector-specific activities were identified for the paint and 3D printing sectors through the active collaboration with industrial partners working in these sectors. Additionally, a literature review was performed, collecting: The list of activities commonly taking place for the Paint and 3D printing sectors along with information on their release potential, key release determinant factors and existing data on on-site measurements. Furthermore, SAbyNA industrial partners provided the description on Stage-to-Gate processes used by these companies along the value chain of the two selected sectors.
A list of case study materials and products were selected and some of the materials were already delivered to initiate the experimental work: Industrial partners provided the first batches of case study materials to RTD partners. During the life-cycle studies of the produced NEPs, process parameters optimization was associated with safer conditions and the effect of the products functionality will be demonstrated.
The identification of data needs to be generated and support the selection of the most appropriate SbD action is provided by industrial partners, to demonstrate the feasibility of solutions suggested by the tool, and to give suggestions on how to increase the added value of the SAbyNA Guidance.
- Collecting models, databases, tools, and methods both for hazard and exposure perspectives for NMs and NEPs.
- Selecting resources for assessing human and environmental hazard and exposure for the purpose of SbD which will be included in the GUIDEnano tool.
- Promoting the use of in vitro data and grouping approaches for the hazard assessment.
- Improving existing models for exposure assessment including approaches to link with relevant data libraries.
- Performing experimental work by testing NEPs transformations throughout their life cycle connected with their toxicological effects.
- Implementing the hazard assessment strategy in SAbyNA case studies using benchmark materials, including the creation of SOPs for hazard methods to test NEPs.
In the context of managing risks along the NEP life cycle applying SbD strategies (WP4 & WP5), the state-of-the-art on SbD strategies towards safer products was provided by analysing more than 100 sources (i.e. research articles, guidelines, projects’ outcomes). From this analysis, SbD strategies as basis for developing the module of the SAbyNA Platform were identified in which the user will be guided to solutions that will i) minimize risks, and ii) preserve the function of the NEP. Furthermore, a list of physical-chemical drivers of nano-risks were analysed and recommendations were generated for their efficient implementation in the Platform. SbD strategies and safe operation of nanoprocesses were added in the Platform to provide sector-specific solutions.
Related to the SAbyNA Guidance Platform (WP6), the main structure of the Guidance platform was generated, and it consists in two parts: Part 1 for the screening assessment, and Part 2, the advanced level of assessment. In Part 1, by answering to questions related to the physico-chemical characteristics, hazard and exposure data of the investigated NM/NEP, the user can perform a qualitative assessment on any potential safety concerns related to the use of the NM and/or the NEP. If safety concerns are raised, more in deep inputs are requested to the user in the Part 2 of the Platform. In Part 2, the user is guided on how to use the existing data sources (e.g. eNanoMapper database) or, in alternative, on the most suitable method/tool to be used to generate the data needed. If risks are identified, the user is guided through the application of SbD strategies for products and processes to reduce or mitigate those risks.
SAbyNA successfully initiate the interactions with stakeholders at an early stage of the project to involve them already in defining the structure of the SAbyNA Guidance Platform. The second SAbyNA Guidance Platform was released, including resources for life cycle thinking, cost analysis and sustainability assessment.
For the identification of sector-specific nanosafety practices and Stage -Gate processes (WP7), sector-specific activities were identified for the paint and 3D printing sectors through the active collaboration with industrial partners working in these sectors. Additionally, a literature review was performed, collecting: The list of activities commonly taking place for the Paint and 3D printing sectors along with information on their release potential, key release determinant factors and existing data on on-site measurements. Furthermore, SAbyNA industrial partners provided the description on Stage-to-Gate processes used by these companies along the value chain of the two selected sectors.
A list of case study materials and products were selected and some of the materials were already delivered to initiate the experimental work: Industrial partners provided the first batches of case study materials to RTD partners. During the life-cycle studies of the produced NEPs, process parameters optimization was associated with safer conditions and the effect of the products functionality will be demonstrated.
The identification of data needs to be generated and support the selection of the most appropriate SbD action is provided by industrial partners, to demonstrate the feasibility of solutions suggested by the tool, and to give suggestions on how to increase the added value of the SAbyNA Guidance.
Impacts in which the project progress has contributed to are:
- Engagement of different stakeholders through stakeholders workshops, where feedbacks collected from them were included in the Platform.
- SAbyNA Guidance Platform will guide the user (e.g. manufacturers, consumers, regulators) on identifying critical exposure scenarios and providing the tools to be able to identify the potential risks along the life cycle of NEP.
- SAbyNA advances are efficiently communicated to all stakeholders, including the regulatory bodies and agencies via specific workshops, conferences, targeted meetings, website, and social media news.
- SAbyNA established a strong collaboration with NMBP15 projects - ASINA, SABYDOMA and SbD4Nano and to NMBP16 projects that recently started on the identification of SbD approaches for NEPs.
- SAbyNA’s partners involved in different nanosafety projects facilitate the transferability of key achievements and exploit them for SbD purposes (e.g. NanoFASE, SERENADE, NANOREG2, GUIDEnano, caLIBRAte, NanoCommons, GRACIOUS).
- Engagement of different stakeholders through stakeholders workshops, where feedbacks collected from them were included in the Platform.
- SAbyNA Guidance Platform will guide the user (e.g. manufacturers, consumers, regulators) on identifying critical exposure scenarios and providing the tools to be able to identify the potential risks along the life cycle of NEP.
- SAbyNA advances are efficiently communicated to all stakeholders, including the regulatory bodies and agencies via specific workshops, conferences, targeted meetings, website, and social media news.
- SAbyNA established a strong collaboration with NMBP15 projects - ASINA, SABYDOMA and SbD4Nano and to NMBP16 projects that recently started on the identification of SbD approaches for NEPs.
- SAbyNA’s partners involved in different nanosafety projects facilitate the transferability of key achievements and exploit them for SbD purposes (e.g. NanoFASE, SERENADE, NANOREG2, GUIDEnano, caLIBRAte, NanoCommons, GRACIOUS).