From management to governance: risk and the needs of nanotechnology (Gov4Nano)

01/2019-12/2022

This third-party funded project is conducted in the framework of the BfR research programme on nanotechnology.

EC Grant agreement number: 814401

Project homepage: -

Project description:

Gov4Nano will design and establish a well-positioned and broadly supported Nano Risk Governance Council (NRGC). Organizing, connecting and engaging are key activities in Gov4Nano and its creation of a sustainable NRGC. Gov4nano will develop an operational transdisciplinary Nano Risk Governance Model (NRGM) for nanotechnologies, building on an established governance framework developed by the International Risk Governance Council (IRGC). One major aim is to engage all stakeholders (including regulators) to proactively address nano-specific safety and to seek a dialogue for joint activities. This covers all relevant areas where nanomaterials are applied such as chemicals, biocides, food and feed, pharma and medical devices. To boost the quality of the dialog Gov4Nano will create a platform for dialogues between stakeholders including the civil society in a “trusted environment”.

The NRGC core business is to coordinate, guide and harmonize in order to overcome the fragmentation of current knowledge, information and needs over various sectors and disciplines (workers, consumers/patients, environmental safety) and to prepare the transfer of this knowledge.

To that end, the NRGC will be equipped with a self-sustainable NanoSafety Governance Portal (NSGP) consolidating state-of-the-art and progressive nanosafety governance tools including ones for dialogues and measuring risk perception. Major efforts will be towards requirements for data harmonization and data curation to be defined and laid down in guidance on obtaining harmonized and standardized quality-scored data collections promoting a big data approach for nano-toxicology. Research activities will be initiated for regulatory sound knowledge in support of harmonized (OECD) guidance for characterization and testing of nanomaterials.

BfR part of the project:

BfR is Co-lead for Work Package (WP) 1 “Establishing a sustainable and FAIR nano-EHS infrastructure”. The aim of WP 1 is to establish a sustainable infrastructure of nano-EHS data based on FAIR (Findable, Accessible, Interoperable and Reusable) principles. This infrastructure is needed to support the following goals: hazard and risk assessment of nanomaterials, grouping and read-across, safe-by-design, development of in silico approaches (e.g. QSARs) and development of nano-Adverse Outcome Pathways (AOPs)-approach. This infrastructure has to accommodate data on physico-chemical characteristics of Nano Materials (NMs), release of NMs and exposure, toxicity, functionality and modelling data. These data may originate from data generated in the EU Framewirk Programme for Research “Horizon 2020”, Framework Programme 9 (FP9), from national research projects, regulatory bodies and publication databases (e.g. PubMed).

BfR contributes to tasks in WP2 “Research and Development towards guidance and guidelines for testing of nanomaterials”. The main objective of WP2 is to work on and fill the remaining gaps that hamper method development for several different nano-related test endpoints. A common activity by the EU member states on standardisation was started on this task in parallel to ensure a link between this research and the standardisation work.

Project partners:

• National Institute for Public Health and the Environment, RIVM, NL
• Ministry of Infrastructure and Water Management, IenW, NL
• Federal Institute for Occupational Safety and Health, BAuA, DE
• BioNanoNet Forschungsgesellschaft mbH, BNN, DE
• Det Nationale Forskningscenter for Arbejdsmiljo, NRCWE, DK