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European Centre for Risk Management and Safe Innovation in Nanomaterials Nanotechnologies

Periodic Reporting for period 2 - EC4SafeNano (European Centre for Risk Management and Safe Innovation in Nanomaterials Nanotechnologies)

Reporting period: 2018-05-01 to 2019-10-31

A significant challenge to ensure sustainable production/use of nanotechnologies is to understand safety and health risks of the technology and its end-products, and to implement practical strategies to manage these risks. Knowledge is growing rapidly, but effective use of this knowledge for risk management is lagging behind. We therefore need to bridge the gap between knowledge on hazard and risk, and ‘fit-for-purpose’ risk management tools and strategies supported by measurement and control methods.
EC4SafeNano bridges this gap by setting up an independent, science-based, managed Centre to act at the interface between researchers, industry, regulatory bodies, and civil society. The objective of the project was to define and validate the operating principles, governance strategy and sustainability model for such Centre of European organisations for Risk Management and Safe Innovation in the field of Nanomaterials & Nanotechnologies in support of industry, safety service providers, regulators and public stakeholders. The structure of the Centre relies on a networked organization functioning as a hub operated by a core group of public-oriented organisations providing risk management and safe innovation support to all stakeholders. The aim was to understand the needs of the stakeholders in the field of nanosafety, and to offer them services addressing their specific business requirements.
The project consortium has developed the following exploitable results:
- Mapping of the needs and resources available:
The project aimed to make an inventory of current and future needs of member states, EC & EU agencies, private stakeholders and NGOs regarding nanosafety as well as to identify services for nanosafety assessment based on available competence and equipment. The D1.1 describes the initial inventory of needs and services based on a survey which asked stakeholders to specify critical issues.
- Inventories of available tools, methods, training courses, standards and standard operating procedures (SOPs), guidance documents and best practices
Many resources which aim to improve human and environmental nanosafety have been developed. These resources include tools and methods, training, standards, SOPs, guidance documents and best practices. In D2.3 a non-exhaustive but useful overview of these resources is provided which could be published on the EC4SafeNano platform in an adjusted form.
The Excel library accompanying D2.3 includes a description of 31 tools and methods, 13 trainings, 77 standards, 136 SOPs and 52 Guidance and Best practice documents. To make the library in line with its use in the FGA tool, each resource is classified as per 12 service chapters and 27 service categories. This would assist FGA tool user to select the appropriate chapter(s) and service category(ies) for each resource to make a fair assessment of fit and gap for these resources.
- A fit-and-gap analysis tool to match the customer needs with the available resources, and identify uncovered or poorly covered customer demand
Based on the data from a Needs and/or Resources survey, the FGA tool allows the selection of a type of analysis, the configuration of an analysis scenario, and the calculation and visualization of results. The FGA Tool allows three types of analysis for each scenario considered: 1. Needs analysis: analysis developed considering only the data corresponding to the Needs; 2. Resources analysis: analysis developed considering only the data corresponding to the Resources, and finally, 3. Fit and Gap analysis (FGA): analysis developed matching the information available from Needs and Resources. The FGA analysis can classify the demand in three levels: Non-Covered Demand (NCD), Covered Demand (CD) or Fully Covered Demand (FCD). Uncovered or poorly-covered customer demand (NCD) is a relevant information to develop/update the offer of the EC4Safenano Center.
- Catalogue of Services
The Catalogue of Services is structured in 12 Service Categories and 27 Service Topics. Each type of service/group of services is described, in a simple and friendly way, by means of a Service Data Sheet (EC4-SDS). The 1st version of the Catalogue of Services (CoS 2019) deploys a map of services consisting of a set of 100 SDSs, covering 7 of the 12 Service Categories and 17 of the 27 Service Topics. It represents one of the main outcomes produced by EC4Safenano. The CoS 2019 is available to any interested party for consultation and download in English, French and Spanish on the project website.
- Operating procedures and business model
The business model and the governance mechanisms applicable to a future European Centre for Risk Management and Safe Innovation in Nanomaterials and Nanotechnologies have been defined.
The EC4SafeNano project was driven by demand (the stakeholder’s needs) and aimed to develop tangible and competitive results (harmonised expertise supporting service provision for safe innovation) as part of the Centre’s strategy (the Centre’s competencies, structure and governance). The Customers are both, Civil Society (public organizations, EU, MS, NGOs, Trade Unions…) and Economy (industry, research organisations and service providers). Therefore, the Centre will serve efficiently the society and economy, with the following impacts:
- Societal impact, notably on the Quality of life, Health, and Environment in terms of more effective risk assessment and management, improved Understanding and Education through training and dissemination activities as well as enhanced Public services, Policy and Public engagement through support to regulatory activities in the field of risk management,
- Economic impact, notably on Innovations, Competitiveness, Growth, Employment and Business thanks to the development of harmonized services supporting safe innovation and integrating risk evaluation in the industrial innovation value chain with optimized cost-benefit analyses,
- Technological and Academic impact, notably on Knowledge, Technology development, Training and Education thanks to the gathering of existing knowledge and the development of tools to translate science into expertise through optimised harmonisation processes.

The EC4SafeNano main objectives are to define the structure, governance and capabilities of a one-stop-shop that will serve the society and will support the economy as:
- An independent science-based EU nanosafety reference platform for all stakeholders in nanotechnology that collates information into a comprehensive and accessible European network portal and provides a solution to the problem of data accessibility and transferability, by removing barriers which currently limit knowledge distribution;
- A European Hub to provide services and support for stakeholders (e.g. industry, governments, researchers etc.) to create in a sustainable way marketable, societal approved products and goods;
- A system to ensure regular gathering of stakeholders’ needs and mapping of all technical resources and to conduct fit-and-gap analyses on needs and resources
- An efficient network able to: i) enhance the link between society and economy, ii) provide collective review of services, iii) facilitate access to dedicated instruments and platforms and iv) to identify capabilities ready to answer stakeholder demands;
- A tool to disseminate significant research outputs efficiently disseminated to national and international communities.
online catalogue
EC4SafeNano entity
EC4SafeNano WebPortal
EC4SafeNano WebTool for resource mapping