BIORIMA stands for Biomaterial Risk Management. BIORIMA aims to develop an integrated risk management (IRM) framework for nano-biomaterials (NBM) used in Advanced Therapeutic Medicinal Products (ATMP) and Medical Devices (MD). The BIORIMA RM framework is a structure upon which the validated tools and methods for materials, exposure, hazard and risk identification/assessment and management are allocated plus a rationale for selecting and using them to manage and reduce the risk for specific NBM used in ATMP and MD. Specifically, the IRM framework will consist of: (i) Risk Management strategies and systems, based on validated methodologies, tools, and guidance, for monitoring and reducing the risks together with methods for evaluating them; (ii) Validated methodologies and tools to identify the potential Exposure and Hazard posed by NBM to humans and the environment; (iii) A strategy for Intelligent Testing (ITS) and Tiered Risk Assessment for NBM used in ATMP and MD. BIORIMA workplan consists of 7 workpackages covering the major themes: Materials, Exposure, Hazard and Risk. BIORIMA will generate methods and tools for these themes for use in risk evaluation and reduction. The BIORIMA toolbox will consist of validated methods/tools for materials synthesis; reference materials bank; methods for human/environment exposure assessment and monitoring; (eco)-toxicology testing protocols; methods for prevention of accidental risks – massive release or explosion – A tiered risk assessment method for humans/environment; An intelligent testing strategy for NBM and risk reduction measures, including the safer-by-design approach. BIORIMA will deliver a web-based Decision Support System to help users, especially SME, evaluate the risk/benefit profile of their NBM products and help to shorten the time to market for NBM products.

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.