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Risk Governance of Nanotechnology

Project description

New guidelines to assess the risk of engineered nanomaterials

The risk assessment approach used for conventional chemicals may not be 100 % applicable to engineered nanomaterials (ENMs). As such, a new framework for risk governance of ENMs is needed. With this in mind, the EU-funded RiskGONE project will recommend adjustments to current guidelines or develop nano-specific guidance documents for the risk assessment of ENMs. Specifically, it will evaluate, optimise and pre-validate standard operating procedures and test guidelines and integrate them into a framework for risk governance. Relying on current strategies for risk assessment of conventional chemicals, this new framework will comprise modular tools. It will incorporate ethical aspects and societal risk perception, and also manage acceptable and unacceptable risks through transfer or mitigation.


Engineered nanomaterials (ENMs) are covered by REACH/CLP regulations; the general opinion is that the risk assessment (RA) approach routinely used for conventional chemicals is also applicable to ENMs. However, as acknowledged by OECD and ECHA, the OECD and ISO Test Guidelines (TGs) and Standard Operating Procedures (SOPs) need to be verified and adapted to be applicable to ENMs. RiskGONE will support the standardization and validation process for ENM by evaluating, optimizing and pre-validating SOPs and TGs and integrating them into a framework for risk governance (RG) of ENMs. The framework will comprise modular tools and will rely heavily on current strategies for the RA of conventional chemicals, complemented by methods for estimating environmental, social and economic benefits. It will incorporate ethical aspects and societal risk perception and will manage acceptable and unacceptable risks through transfer or mitigation. The focus of RiskGONE will be to produce nano-specific draft guidance documents for application to ENM RA; or, alternatively, to suggest ameliorations to OECD, ECHA, and ISO/CEN SOPs or guidelines. Rather than producing assays and methods ex novo, this will be achieved through Round Robin exercises and multimodal testing of OECD TGs and ECHA methods supporting the “Malta-project”, and on methods not yet considered by OECD. This process will be accelerated by guidance documents for data storage/curation/accessibility optimisation, applied to well-characterized reference ENMs typifying the main physicochemical and toxicological features of ENMs. The conditions for a transparent and self-sustained organisational form for science-based RG, representing EU stakeholders, member states, industry and civil society, will be established. The RG framework and methods developed by RiskGONE will be transferred to the organisational form for RG.

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Net EU contribution
€ 946 208,44

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Norge Oslo og Viken Viken
Activity type
Research Organisations
Total cost
€ 946 208,44

Participants (22)