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Implementation of risk governance: meeting the needs of nanotechnology

Project number: F 2477 Institution: Federal Institute for Occupational Safety and Health (BAuA) Status: Ongoing Project Planned end: 2023-08-31

Description:

The Horizon 2020 project Gov4Nano aims at enabling and promoting dialogue on best practices in risk analysis and risk management concerning nanomaterials. The active involvement of all nanotechnology stakeholders (science, industry, regulation and civil society) in the process of implementing Risk Governance is crucial.

One way to achieve this goal is the conceptual development and establishment of a Nano Risk Governance Council (NRGC), which is pursued in the Gov4Nano project together with two partner projects (RiskGone and NanoRIGO). All stakeholders (including regulators, such as the European Chemicals Agency (ECHA) or the OECD) are involved in the development of the NRGC. An important task of the NRGC will be to develop and propose rules for the safe handling of nanomaterials. Rules will be developed with a maximum consensus of all stakeholders and may comprise laws, general obligations and/or declarations of intent. Further tasks of the NRGC will be defined throughout the project.

In addition, the Gov4Nano project has set itself the task of promoting the development of harmonised Test Guidelines and Guidance Documents for the characterisation of nanomaterials that are suitable for all legal frameworks. For this, good data management according to the FAIR principle [https://www.go-fair.org/] shall be ensured. Another focus will be on the promotion of safe-by-design, a precautionary measure that ensures the safest options are being chosen at an early stage of the design process of materials and products.

In Gov4Nano, BAuA is leading work package 2 "Research and Development towards
guidance and guidelines for testing of nanomaterials". The work package accelerates and supports the development of comprehensive and specific guidelines as well as standardised and harmonised Test Guidelines. Specific endpoints for which methods will be developed and tested include surface chemistry, solubility, reactivity and the dustiness. The work package includes experimental work and the transposition of the scientific results into regulatory methodological applications. All work will be carried out in close cooperation with the OECD Working Party on Manufacturing Nanomaterials. The developed Standard Operating Procedures will be validated by intralaboratory comparisons where appropriate. This ensures their applicability and reproducibility, since data quality is crucial for the acceptance of scientific contributions to test methods for nanomaterials. It provides the basis for comparability and use of data for regulatory purposes and the derivation of appropriate protective measures.

Contact

Unit 4.6 "Hazardous Substances Management"

Phone: +49 231 9071-1971 Fax: +49 231 9071-2070

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