The SABYDOMA programme addresses developments in the safety by design (SbD) paradigm by examining four industrial case studies in detail where the TRLs will advance from 4 to 6. Each TRL activity will progress from being lab based at TRL4 to being industry based at TRL6. The TRL4 activity will involve only innovation with regular industrial communication whereas the TRL6 activity will involve industrially located activities with innovation communication. One of the novel themes of this study is to use system control and optimisation theory including the Model Predictive Control (MPC) philosophy to bind the whole subject of SbD from laboratory innovation to the industrial production line and from decision making processes to project governance. An equally important innovative step is the building of high throughput online platforms where nanomaterial (NM) is manufactured and screened at the point of production. The screening signal controls the NM redesign and production in a feedback loop. Screens will involve (a) physiochemical sensing elements (b) in-vitro targets of increasing complexity from the 2D biomembrane to cell-line and more complex cell-line elements; and, (c) multiple in-vitro targets with multiple end-points; developed in current H2020 projects. Two of the industrial studies include composite coating manufacture where the coating’s stability and toxicity will be tested using a flow through microfluidic flow cell system coupled to online screens. This is part of the release and ageing investigations on the NM and NM coatings and the results of these will feed back to the production line design. At every step on the TRL ladder the in-silico modelling will be applied to optimise and redefine the relevant activities. By the same token regulatory and governance principles of SbD will be used to refine the technological development. The final deliverable will be four distinct technologies applying SbD to the four industrial processes respectively.

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.