Concept: NanoFASE will deliver an integrated Exposure Assessment Framework, including methods, parameter values, model and guidance that will allow Industry to assess the full diversity of industrial nano-enabled products to a standard acceptable in regulatory registrations. Methods to assess how use phases, waste streams and environmental compartments (air, soil, water biota) act as “reactors” in modifying and transporting ENMs will be developed and used to derive parameter values. Our nanospecific models will be integrated with the existing multi-media fate model SimpleBox4Nano for use in EUSES and also develop into a flexible multi-media model for risk assessment at different scales and complexities. Information on release form, transformation and transport processes for product relevant ENMs will allow grouping into Functional Fate Groups according to their “most probable” fate pathways as a contribution to safe-by-design based on fate. Methodology: Inventories of material release forms along the product value chain are established. We then study how released ENMs transform from initial reactive states to modified forms with lower energy states in which nanospecific properties may be lost. Transport studies assess material fluxes within/between compartments. The experimental work underpins models describing ENM transformation and transport. Open access is provided to the models suitable for incorporation into existing exposure assessment tools (e.g. SimpleBox4Nano) and for more detailed assessment. Framework completeness is validated by case studies. Impact: Identified links between ENM material properties and fate outcome (e.g. safe-by-design). Improved representation of nanospecific processes in existing key fate and exposure assessment tools (e.g. SimpleBox4Nano in EUSES). Contribution to standardization. GIS framework to support predictive assessment, catchment and point source management of ENM releases.

The main objective of NANORIGO (NANOtechnology RIsk GOvernance) is to develop and implement a transparent, transdisciplinary and science-based Risk Governance Framework (RGF) for managing nanotechnology risks regarding social, environmental and economic benefits. A new risk management approach is formed based on available and new high-quality data and advanced scientific tools developed for industry and regulators decision-making, and on communication with all stakeholders (regulators, industries, politicians, the civil society). The RGF will use a life-cycle perspective and integrate available knowledge on ethical, social, environmental and economic concerns into a user-friendly format that can be easily adapted and transferred into regulation for hazard, exposure and risk assessment and management of nanomaterials. It will consist of: (i) risk management strategies based on reinforced tools for guidance and decision-making developed for risk assessment, (ii) validated methodologies to identify potential hazard and exposure, and (iii) a web-based information and communication platform to facilitate access to good quality data and a clear understanding of risks for all stakeholders, and their valuable feedback. The NANORIGO work plan consists of 8 work packages covering all major risk governance aspects. A self-sustained European Nanotechnology Risk Governance Council (NRGC) will be installed to implement the RGF, embedded in relevant international structures and in close cooperation with the International Risk Governance Center (IRGC). Case studies will demonstrate the sustainability of solutions and their consistent integration into regulatory applications under real conditions. Bringing all stakeholders together under a common umbrella will allow to share and integrate the most appropriate governance tools, frameworks and plans for future science and regulatory research and foster consistency of management approaches in the EU and synergies internationally.