Project Management

WP1 deals with the coordination and management of all project activities and communication between partners and with the EC. The project will be coordinated by LEI, responsible for coordinating the overall running of the whole project, with the assistance of the Management and Scientific Committees. All planned activities will be closely monitored and, if necessary, corrective measures will be taken in order to ensure the correct completion of the project. The main objectives of WP1 are to:

1. Coordinate and manage the project and the efficient, smooth and timely execution of all activities;
2. Ensure an accurate and on time communication flow among the project partners and with the EC in order to track the project progress and meet its objectives;
3. Revise and maintain the project work plan;
4. Complete the project within the agreed time schedule and budget.

Streamlined methodologies, models and tools to facilitate release, fate & exposure assessment of NFs/ NEPs for SbD purposes.

This work package has four main objectives, which are:

(1)To distil elements from existing resources (databases, methods and tools) based on their reliability, robustness, cost-effectiveness and user-friendliness that can support the estimation of release and exposure along the life cycle, particularly at the early stages of the innovation process;

(2) To improve usability of data, methods, models and tools by streamlining and optimizing workflows and interconnections and by tailoring them to the needs of stakeholders;

(3) To develop sector-specific methodologies for the paint and 3D Printing industry to assess release and exposure at the early stages of the innovation process in SAbyNA case studies;

(4) To provide to WP3 released NFs from NEPs, as relevant exposure materials during use and end-of-life to establish relevant and optimized methodology for hazard assessment of NFs along the life cycle. Within this WP, both human exposure, including occupational and consumer exposure, and environmental release, fate and exposure will be considered.

Streamlined methodologies, models and tools to facilitate hazard assessment of NFs/ NEPs for SbD purposes

The overall objective of this WP is to identify and facilitate the use of a set of easy-to-use, robust and cost-effective approaches for the prediction of nanoforms (NFs) hazards, compatible with early stages of product development for the purpose of developing nano-enabled products (NEPs) that are safer-by-design throughout the life cycle.

Specific objectives are:

1. To identify and distil existing resources (databases, tools and testing methods) into hazard predictive key elements suitable for safe innovation of NFs and NEPs.
2. To streamline and aid the use of these identified resources in the early stages of the design process, enabling screening for the critical modulators of hazard of NFs and NEPs.
3. To develop a hazard assessment strategy facilitating SbD decisions. This involves integrating the optimized resources as well as optimizing experimental testing methods for their applicability to NFs under relevant use conditions and/or end-of-life, including product-relevant matrices.
4. To appraise and refine this hazard assessment strategy using case studies.

Towards SAFER PRODUCTS (NFs /NEPs): Managing risks along the NF/NEP life cycle applying SbD strategies and other RMM.

The main objective is to propose and evaluate design strategies towards safer NFs and NEPs, by reducing exposure and/or hazard potential in critical scenarios identified throughout the product (NF or NEP) life cycle. The proposed SbD strategies will be then optimized towards their implementation in SAbyNA case studies by industrial partners in WP7.

SbD strategies will be proposed to minimize the release/exposure/hazard of NFs from NEPs, without impairing their performances and functionalities. In this WP, SbD strategies will be product oriented, meaning that the solutions will imply tuning of the NF physico-chemical properties, or the matrix composition (potential interactions between NF and the matrix), and/or the NEP characteristics. Strategies will aim at:

1. Reducing the NF/NEP hazard (e.g. replacement, coating…)
2. Reducing the NF exposure potential before incorporation in NEP (e.g. granulation, encapsulation…)
3. Reducing the NF release/ exposure from the NEP (e.g. NF/matrix compatibility & interactions, NF load & dispersion…)

Towards SAFER nanoPROCESSES: Managing risks of nanoprocesses along the NF/ NEP life cycle applying SbD strategies and other RMM

The general objective when it comes to safety of machinery/processes is that they should be designed and constructed in a way that can be operated (performing its intended function), adjusted, maintained and disabled avoiding any impact in human and environmental health. In this context, the “principles of safety integration” and the “three-step method” guide the European SbD framework for the design and construction of new machinery/processes (MD 2006/42/EC and EN ISO 12100:2010).

SAbyNA focus on providing SbD strategies to reduce or mitigate risks associated to NFs/ NEPs (e.g. exposure to hazardous substances, fire, explosion, among others). However, there are many other non-nanorelated risks associated with machinery/processes and not covered by SAbyNA (e.g. mechanical, electrical, noise, EMF, …), that the designer should also take into account for the design of safer nanoprocesses.

The objective of this WP is to develop and customize a SAbyNA strategy and a set of associated resources, aimed at achieving safer nanoprocesses (NFs and NEPs) along their life cycle, including end-of-life processes. The strategical approach will follow a dual vision, combining the perspective of the designer/manufacturer of nanoprocesses and vision of the end user. This approach will be supported by the safety integration (SbD) and STOP principles, as well as the “three step method”, to design out hazards or minimize risks from the design stage of nanoprocesses. For residual risks, a hierarchy of prevention and protection measures will be considered along their life cycle (Substitution, Technical measures, Organizational measures and Personal Protective Equipment (PPEs)).

SAbyNA Guidance Platform for risk management at early stages of NFs/ NEPs development process

The main objective of this WP is to provide an interactive guidance platform to support the implementation of SbD of NFs and NEPs. The guidance will:

1. Facilitate industry in choosing the optimal pathway to identify risks and the appropriate strategies to reduce or mitigate those risks.
2. Provide customized guidance for SbD implementation in different industrial sectors in their innovation models.
3. Provide resources to support industry balancing safety with technical functionality and overall life cycle costs.
4. Be based mostly on existing approaches and resources, with optimized usability for SbD purposes provided by WP2, WP3, WP4 and WP5.
5. Allow integrating future developments from other nanosafety projects and relevant initiatives.
6. Be compatible with NFs and NEPs of various complexities.
7. Demonstrate the benefits of sector-specific enhanced functionalities, by implementing such sector specific solutions for two industrial sectors: paints and 3D Printing.

Multiple resources will be embedded in the SAbyNA Guidance. Those resources will include existing RA tools such as those evaluated under the caLIBRAte project for their utility along the innovation chain of NFs and NEPs. Among these, the GUIDEnano tool was selected as one of the most adequate tools (due to its nano-specific nature accounting for NF dynamic changes and its high accuracy of exposure predictions) for late stages of NFs and NEPs development.

Within SAbyNA, WP6 will develop sector-specific tailored versions of the GUIDEnano tool, consolidating this European nanosafety investment, extending its current SbD functionalities and incorporating new sector-specific default parameters and a user-friendly, streamlined data input process. Hence, the usability for early stages of development will be increased. Paints and 3D printing sector-specific GUIDEnano modules will be developed as proof of concept to demonstrate the value of the approach. Additionally, the lessons learnt from those modules development will allow future efficient development of other sector-specific GUIDEnano modules.

Implementation and verification of SAbyNA Guidance Platform in sector-specific case studies

• The main objectives of this WP are:
  1.  to provide sector-specific relevant information that can allow other WPs to simplify SbD approaches, models and tools for the paint and 3D printing sectors;
  2.  to implement the SAbyNA SbD Guidance into a number of representative sector-specific case studies.
• In order to reach the first of these goals, the nanosafety scientists in the different WPs will guide the industrial partners to collect the sector-specific operational context, typical relevant exposure scenarios with range of possible exposure control alternatives, most commonly used type of nanoadditives and generic NEP matrix chemical composition, etc. Relevant national and international industry associations will also be approached to ensure that the data collected is representative of the selected industrial sectors. All this information will be exploited by WP2 to WP6 in order to simplify models and tools, improve existing databases with sector-specific parameters, identify most relevant test methods to fill in information gaps, and overall optimize the SbD approach for these sectors.
• In order to reach the second goal of this WP, the industrial project partners (ALLIOS, NOUR, LATI and LEITAT through its access to the IAM3D-Hub), will make available relevant case studies, with contextual information (e.g., intended use of NEP), materials (NF, NEP, NEP matrix), equipment (e.g. 3D printers), access to facilities, and will apply the SAbyNA Guidance to identify SbD opportunities and implement some of them in these case studies, as a proof of concept of the robustness and added value of the SAbyNA Guidance. During this process, WP7 will closely collaborate with WP2-5, particularly when the implementation of SbD requires experimental testing, or modification of raw materials. The lessons learnt during this demonstration process will be leveraged to WP6.

Communication, Dissemination, Exploitation and RRI

WP8 supports the project with a broad and integrated programme of dissemination and exploitation to maximise the reach and achieving the impacts of the project In light of RRI objectives, WP8 also ensures that a critical and reflexive stance will be adopted in the development and dissemination of guidance, training and other messages that will be received by different stakeholders and broader societal groups. The new knowledge obtained through SAbyNA RRI study actions will be co-constructed with industrial and regulatory stakeholders, with a triple outcome: a) directly improving the SAbyNA guidance for its sustainable adoption, b) generating content for broader communication to civil society and consumers, thereby improving access and education, and c) reinforcing RRI culture and knowledge in the nano sector.