The caLIBRAte nano-risk innovation governance framework and tools with demonstration of its use for risk management along a stage-gate innovation funnel

Introduction
Nano-risk governance entails the ability to perform adequate nanospecific risk assessment and management. While performing nano-risk innovation governance, numerous risk and benefit aspects, societal acceptance, policies and regulations may need to be considered during the innovation process. Safer-by-Design, circular economy and green chemistry play an increasing role in policies and industrial production. Consequently, development and production of nanomaterials and associated products enter a multidimensional landscape of unknown, poorly known and known risks and requirements. The caLIBRAte project developed a Nano-Risk Innovation Governance (NRIG) Framework and a Project tool to help innovators in making a thorough and transparent risk exploration and nano-specific pre-risk assessment and decisions during their material and product development (http://www.nanoriskgov-portal.org).

Results
The NRIG framework was developed considering a Cooper-like stage-gate innovation framework, and elements from existing CEN, ISO, and OECD standards, and guidances, which were prioritized based on stakeholder needs and trending perspectives in research and policy (Safer-by-Design, Green Chemistry, Circular Economy). The result is an operational framework consisting of a governance leader/board layer and a governance project leader layer, which work together to complete the NRIG project. Governance tools were identified or developed to cover the most critical NRIG needs. Tools were accepted based on stakeholder criteria and good performance. Whenever possible, risk assessment and -management tools were tested against measured high-quality toxicological and/or exposure/release data. Horizon scanning and risk-benefit tools could only be demonstrated due to lack of suitable data. High-quality case study examples demonstrate the framework

Conclusions
A NRIG Framework, guidance and a project tool has been developed and demonstrated. It enables governance project leaders to perform a flexible and adaptive nano-risk governance during materials and product innovation.

Acknowledgements
This work was supported by caLIBRAte Project which was funded by the European Union's Horizon 2020 research and innovation programme under grant agreement No 686239