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.

Gov4Nano will design and establish a well-positioned and broadly supported Nano Risk Governance Council (NRGC). Organizing, connecting and engaging are key activities in Gov4Nano and its creation of a sustainable NRGC. Gov4Nano will develop an operational trans disciplinary Nano Risk Governance Model (NRGM) for nanotechnologies, building on an established governance framework developed by the International Risk Governance Council (IRGC). Engaging stakeholders (including regulators) to proactively address nano-specific safety and seek dialogue for joint activities. NRGC and its precursor project Gov4Nano will engage, in order to support these activities, with the broad variety of stakeholders across all relevant nano-disciplines (chemical, biocides, food and feed, pharma and medical devices and materials development) and draft a review on our knowledge progress over the last decade whilst initiating dialog. To boost the quality of the dialog it will create a platform for dialogues between stakeholders in a “trusted environment” inclusive of civil society. The NRGC core business is to coordinate, guide and harmonize in order to overcome the fragmentation of current knowledge, information and needs over various sectors and disciplines (workers, consumers/patients, environmental safety) and to prepare the transfer of this knowledge. To that end, the NRGC will be equipped with a self-sustainable NanoSafety Governance Portal (NSGP) consolidating state-of-the-art and progressive nanosafety governance tools including ones for dialogues and measuring risk perception. Major efforts will be towards requirements for data harmonization and data curation to be defined and laid down in guidance on obtaining harmonized and standardized quality-scored data collections promoting a big data approach for nano-toxicology. Research activities will be initiated for regulatory sound knowledge in support of harmonized (OECD) guidance for characterization and testing of nanomaterials.

Nanocomposites are promising for many sectors, as they can make polymers stronger, less water and gas permeable, tune surface properties, add functionalities such as antimicrobial effects. In spite of intensive research activities, significant efforts are still needed to deploy the full potential of nanotechnology in the industry. The main challenge is still obtaining a proper nanostructuring of the nanoparticles, especially when transferring it to industrial scale, further improvements are clearly needed in terms of processing and control. The OptiNanoPro project will develop different approaches for the introduction of nanotechnology into packaging, automotive and photovoltaic materials production lines. In particular, the project will focus on the development and industrial integration of tailored online dispersion and monitoring systems to ensure a constant quality of delivered materials. In terms of improved functionalities, nanotechnology can provide packaging with improved barrier properties as well as repellent properties resulting in easy-to-empty features that will on the one hand reduce wastes at consumer level and, on the other hand, improve their acceptability by recyclers. Likewise, solar panels can be self-cleaning to increase their effectiveness and extend the period between their maintenance and their lifetime by filtering UV light leading to material weathering. In the automotive sector, lightweight parts can be obtained for greater fuel efficiency. To this end, a group of end-user industries from Europe covering the supply and value chain of the 3 target sectors and using a range of converting processes such as coating and lamination, compounding, injection/co-injection and electrospray nanodeposition, supported by selected RTDs and number of technological SMEs, will work together on integrating new nanotechnologies in existing production lines, while also taking into account nanosafety, environmental, productivity and cost-effectiveness issues.

A major challenge for the global nanotechnology sector is the development of safe and functional engineered nanomaterials (ENMs) and nano-enabled products (NEPs). In this context, the application of the Safe-by-Design (SbD) concept has been adopted recently by the nanosafety community as a means to dampen human health and environmental risks, applying preventive safety measures during the design stage of a facility, process, material or product. However and despite its importance, SbD prescriptions are still in their infancy, and are hampered among other things by the lack of comprehensive data about the performance, hazard and release potential of the great variety of NEPs in use. SbD4Nano addresses that problem creating a comprehensive new e-infrastructure to foster dialogue and collaboration between all actors in the supply chain for a knowledge-driven definition of SbD setups that optimize hazard, technical performance and economic costs. Our project developes a validated rapid hazard profiling module, coupled to a new exposure-driven modelling framework to reduce toxicity. This safe-born material also undergoes a cost-benefit analysis algorithm to find the best compromise between safety and a industrially convenient technical performance. Finally, a new software interface where product information can be exchanged between the supply chain participants is the tool that wraps up, finishing the collaborative spirit of SbD4Nano between regulators, researchers and industry. Coherently with its goals, our SbD4Nano project is international and open-scienced in essence, with the clear aim of impacting the EU policies as well as directly and clearly benefiting the citizen.