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.
Objective
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 The focus of RiskGONE will be to produce nano-specific draft guidance documents for application to ENM RA; or, alternatively, to suggest ameliorations to OECD, ECHA, and ISO/CEN SOPs or guidelines.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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Funding Scheme
RIA - Research and Innovation actionCoordinator
2027 Kjeller
Norway
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Participants (22)
4362 Esch Sur Alzette
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10000 Zagreb
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28006 Madrid
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5020 Bergen
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B15 2TT Birmingham
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SA2 8PP Swansea
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80-172 Gdansk
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3000 Leuven
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30123 Venezia
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1000 Bruxelles / Brussel
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1000 Sofia
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
20014 San Sebastian
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6200 MD Maastricht
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1070 Nicosia
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
PIRAEUS
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V42V384 Limerick
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
60486 Frankfurt
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1455693981 TEHRAN
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1050 143 Lisboa
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
94700 Maisons Alfort
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5020 Bergen
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