The overarching aim is to develop a proof of concept of an efficient and effective risk gover­nance process for nano­technologies, dealing with the legacy as well as future technological de­velopments.

Gov4Nano will work towards a resilient and adaptive form of risk governance covering the needs of a continually developing technology and addressing the needs of all involved stakeholders across all relevant disciplines, including civil society.

The main objectives of Gov4Nano are listed below, together with a commentary on how the work carried out in the first 18 months is contributing to their achievement. It should be noted that during this period, not all objectives are equally dealt with yet.


Although establishing a Nano Risk Governance Council (NRGC) is an appealing concept, currently it is nothing more than just a concept, an idea for which support has to be won. The NRGC will gain credibility by a participative and pro-active form of governance involving all relevant stakeholders, by stressing their needs and creating incentives to contribute and by stimulating dialogue thus overcoming any inherent barriers. To achieve this overall aim of Gov4Nano to create the NRGC, a number of specific objectives were defined and the results of the project can be measured against the achievement of these objectives.

Objective 1: To improve the FAIRness of the nano-EHS data infrastructure, eventually leading to machine-readable data
At project start

Gov4Nano will work to improve the Findability, Accessibility, Interoperability and Reusability of databases in order to support a science-based risk governance of nanomaterials (including elucidation of the mode of action, grouping, read across, development of quantitative structure-activity relationships, Safe by Design). A first goal is the establishment of a NanoSafety Implementation Network under the European GO-FAIR initiative, in which key players agree on ways to improve the FAIRness of databases and on the stepwise implementation of these. The implementation of FAIR principles eventually aims at machine-readable data, thereby opening the potential to highly improve the efficiency of investigations.

After 18 months

During the first 18 months, WP1 has developed a manifesto for the GO FAIR Implementation Network called ‘AdvancedNano’. The manifesto has been approved by the GO FAIR International Office in July 2020. In addition, an online Visual Guide to Fairness was developed, with an interactive explanation of FAIR data concepts and queries to the eNanoMapper database. A number of case studies were defined which will be used to demonstrate the important steps to be taken in the FAIRification process and to identify hurdles in this process.
Key Deliverable D1.1. ‘Inception Report with recommendations for a network of FAIR nanoEHS databases’ has been completed. This deliverable outlines the Gov4Nano strategy for the initiation of a sustainable Implementation Network (IN), stimulating the generation of Findable, Accessible, Interoperable, and Re-useable (FAIR) data on manufactured nanomaterials (MNMs) and their Environmental Health Safety (NanoEHS).

Link to FAIR Principles – GO FAIR

Objective 2: Harmonized guidance for characterization and testing of nanomaterials
At project start

Expanding the state of the art knowledge and data with laboratory research to support the initiation and updating of a selected number of OECD Guidance Documents (GDs) and Test Guidelines (TGs) as part of European input in the OECD WPMN and TGP (so-called Malta Initiative). More specifically, new or refined regulatory test methods and strategies as well as relevant parameters such as accuracy, reproducibility, detection limits for these methods will be assessed and the results communicated to enable the assessment of nanomaterials in European regulations like REACH.

After 18 months

During the first 18 months, WP2 developed/advanced test methods and respective SOPs to fit the requirements of NMs and the OECD. The status of the current advancement varies within the different WP2 tasks for their respective endpoints. These validated, standardised and harmonised test methods, such as OECD TGs/GDs for nanomaterials are a prerequisite for a meaningful regulatory risk assessment. WP2 develops the scientific background for seven different OECD TGs/GDs.

Objective 3: To understand how risk perception on nanotechnologies is formed in (a) civil society and (b) (re-) insurance industry
At project start

Characterising and understanding particular information needs and concerns about nanotechnology of (a) civil society, and (b) (re-)insurance industry, will help identifying indicators that influence and form public risk perception on nanotechnologies. Therefore, one objective is to identify, analyse and understand their needs when it comes to possible risks and how to deal with them. Indicators will be created and further translated into criteria that form different perceived risk levels, which will enable the monitoring of public risk perception through the project runtime. Moreover, this will allow the evaluation of the impact of stakeholder engagement activities (e.g., informative workshops, training, dialogues, etc.) on public acceptance of nanotechnologies. Specific focus will be given to dedicated training sessions as well as education and out-of-the-box thinking activities, in order to elaborate how training and education can help non-experts to build their own unbiased opinion. The aim is to raise awareness of civil society concerns while addressing the insurance issues which will ensure that the needs of (a) civil society and (b) (re-)insurance industry are appropriately addressed and included into the NRGC’s mission and activities.

After 18 months

The first results of WP3 regarding public risk perception and how it is influenced are described in Deliverable D3.1 ‘Report on parameters, elements and information forming and influencing the risk-perception of different civil society groups’. Together with NANORIGO and RiskGONE, a survey to study public risk perception was developed and tested with an initial group representing the general public. Outcomes of the investigation on the (re-)insurance industry sector’s needs are presented in Deliverable D3.3 Report on the (re-)insurance industry’s knowledge about and provisions towards nanotechnology and its applications and on the industry’s information needs. Together with other H2020 projects of the NanoSafetyCluster, the programme and setting of a joint “Nano Training School” was prepared.

Objective 4: To develop a Nano-Risk Governance Portal (NRGP) with tools, data, and guidance
At project start

A web-based NanoSafety Governance Portal (NSGP) will be developed and established, consolidating state-of-the-art and future-looking nanosafety governance tools (e.g. human and environmental risk assessment and management and SbD tools, databases, communication and knowledge transfer tools), as well as various technical and procedural guidance materials (Figure 2) The NSGP will enable assessment and guidance support to the NRGC. In addition to risk-governance, the NSGP will facilitate systematic procedures to monitor, organize, evaluate and structure (according to the Safe Innovation approach; SIA) available resources to assess and manage risks related to nanomaterials along the life cycle and the innovation chain. An essential focus is to align with and reach regulatory and industry acceptance of the NSGP and its supporting tools and functions. This will be aimed at through stakeholder dialogue in collaboration with e.g., WP3, 5 and 6. Starting points for the objective are the web-based caLIBRAte nano-risk innovation governance framework and the NanoReg2 Safe Innovation Approach tools, as well as the eNanoMapper-data infrastructure. Emerging next generation tools with high future potential are included.

After 18 months

In the first 18 months, WP4 completed the mapping and categorizing of nano-risk governance tools which resulted in a library with 145 nano-specific tools, guidance and data resources out of a total of 160 relevant items in the library. This work is provided in Deliverable D4.1 ‘Review of existing and near-future next generation tools and models to support the nano-risk governance council and industrial safer-by-design’ . In parallel, mapping of existing knowledge on stakeholder needs and requirements from an NRGP is available in Deliverable D4.2 ‘State-of-the-art review on existing data on stakeholder needs in regard to support tools for safer-by-design and the overall nano-risk governance’ as a result of work conducted in Task 4.1.2. Deliverable D4.2 lists 20 key priorities for the NRGP.

Classification of 160 tools in terms of criteria.

Objective 5: To build a Risk Governance Council for nano (NRGC) to coordinate and harmonize transdisciplinary international efforts toward safe and sustainable nano-related products
At project start

Establishment of a science based, NRGC, coordinating efforts of the broad range of organizations dealing with risk governance issues across EU and at international level, supporting business decision making in innovation and the development of sustainable nano-products. Furthermore, the NRGC needs to meet the demand for efficient and transparent adaptive risk governance, to evolve concepts, taking into account existing approaches (such as Safe-by-Design). The consortium is fully aware of the threat experienced by some stakeholders of a not yet well described Council and thus the establishment of the Council will follow an inclusive, well-balanced and carefully designed process. The creation of the NRGC will lead to the utilisation of risk research for nanomaterials and products, comparable to the valorisation of research for innovation. The NRGC will convey the efforts and outcomes of all other activities of Gov4Nano, to lead to widely accepted options for decision-making on governance, regulatory developments, and safety research on nanotechnologies.

After 18 months

In the first 18 months of the Gov4Nano project, several meetings contributed to Deliverable D5.2 ‘Initial NRGC operational plan: mission (mandate), operational structure and recruited initial members’ as well as the Joint Milestone 8 ‘Agreed mode of operation and structure for Risk Governance Council’ (not achieved yet).

Collaboration with NMBP-13 sister projects RiskGONE and NANORIGO resulted in the implementation of common milestones across all 3 projects, leading to increased alignment of activities towards development of options for the council.

How the work and WPs of Gov4Nano interacts with RiskGONE and NANORIGO.

Objective 6: From stakeholder engagement to stakeholder involvement in the NRGC
At project start

Stakeholders are a vital copoint of the NRGC whose full engagement is vital to its sustainability. There is a need for significant investments in dialogues with stakeholders, awareness raising for the added value of their input and having an eye (and ear!) for incentives and barriers stakeholders experience or foresee. The project will include stakeholders in developing the NRGC, with WP3 bringing in civil society and insurers and WP6 focussing on industry and authorities. Gov4Nano will begin with an inventory of stakeholder goals and an analysis of their critical needs within risk governance covering both existing and new risk governance structures. A representative stakeholder community will be designed and established, and a subscription mechanism will be used to measure active involvement in the NRGC, which is critical for the sustainability of the NRGC. This will help ensure the long-term relevance and global ownership of the NRGC, based on the principles of participation, transparency and inclusiveness. It builds on trust in governance, providing “responsible communication” based on good quality information and feedback.

After 18 months

In the first 18 months of the project a database of stakeholders has been achieved in collaboration with the sister NMBP13 projects NANORIGO and RiskGONE. A stakeholder matrix has been designed and is being utilised in categorising stakeholders from a wide range of sectors. Next to that a forcefield analysis (D6.2) has provided major input to WP5 and the design of the NRGC.
Finally, support was given in setting up a new Governance WG in the Nanosafety Cluster, while a state-of-the-art overview of nano-applicable standards and OECD test guidelines currently (2019) available or under development has been prepared.

Objective 7: To equip the NRGC with the mechanisms and tools to monitor the progress on implementation of risk governance for nanotechnology across different regulatory sectors (i.e. chemicals, biocides, cosmetics, food, medicine) in Europe and beyond
At project start

One of the important activities in this regard is the elucidation of so-called minimum data standards. Those reflect the minimum completeness and quality of information that needs to be known about each nanomaterial or product for risk governance across sectors. These data standards form the core for FAIR databases and will become an item for the NRGC to monitor as an indicator for transdisciplinary, (cross)sectorial governance. More indicators will be developed to describe progress not only in the development and implementation of data, but also in maturity of governance tools, establishing trust, transdisciplinary collaboration, regulatory preparedness and industrial initiative beyond regulatory compliance.

After 18 months

In the first 18 months of the project, a draft roadmap has been developed on the regulatory issues to be addressed in order to streamline the regulatory review of nanomaterials. To equip the NRGC with the mechanisms and tools to monitor the progress on implementation of risk governance for nanotechnology across the key regulatory sectors (i.e., chemicals, biocides, cosmetics, food, medicine), a “dashboard of monitoring instruments” has been developed. The monitoring dashboard will be tested not only in Europe, but also abroad in collaboration with our partners from Republic of Korea, South Africa, USA, China and Mexico.