Next generation tools for risk governance of nanomaterials

Specific challenge: The conventional risk assessment approach, i.e. deriving no-effect levels or limit values from dose-effect relationships is inadequate for enabling safe use for newly developed materials in the fast moving market of nanomaterials. The challenge is to build a state-of-the art and flexible risk banding tool to keep pace with developments in innovation and risk research by harvesting and implementing results from concluded, ongoing and planned research in next generation risk governance frameworks. For nanotechnology, as with any new and rapidly evolving technology, analysis of risk is technically and methodologically limited, and thus associated with a high degree of uncertainty which should be understood and quantified. Stakeholders' concerns, including those of the insurance sector, and risk perception should be understood and communicated. Risk acceptance is strongly affected by a clear understanding of the risks, the benefits and the uncertainties perceived on equity and trust.

Scope: Research should focus on the testing, the calibration and the further development of risk prioritisation (or banding) tools for both human and environmental risks, with emphasis on:

a) the use of inputs from computational toxicology and/ or ‘high concern grouping approaches’ in risk banding tools to identify potential hot spots for risk,

b) Scientific foundation of the ‘risk bands’, by linking the hazard based with ‘dose’ relevant exposure banding,

c) Inclusion of data and monitoring strategies on the efficacy of risk mitigation measures and

d) Alignment with user capacities and needs, including ensuring the ability of the nanomaterial sector to avail of risk transfer/insurance. 

The selected project should identify the major processes of individual and societal decision making, placing particular attention on the aspect of uncertainty. To ensure the highest possible quality in regulatory decision making, emphasis should be given to the development of guidance for important issues in Risk Assessment, based on in-depth analysis of the current scientific basis concerning the addressed hazards and the possible exposure, and joining forces with other projects

Activities expected to focus on Technology Readiness Level 5.

The Commission considers that proposals requesting a contribution from the EU between EUR 6 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. No more than one proposal will be funded.

Expected impact:

•  A framework for the risk governance of nanomaterials entering the market by developing tools for risk appraisal, risk transfer and guidance for risk communication;

•  Demonstration in specific industrial settings or industrial sectors of the feasibility of the developed approaches and tools through worked examples as case studies and pilots with outcomes as guidance, good practices and tools for risk management and risk communication;

•  Leveraging and building on current knowledge related to hazard mapping, exposure and control banding and risk prioritization as well on inter/national and company level risk governance and risk dialogue efforts with key stakeholders including regulators and insurers.

Type of action: Research & Innovation Actions