The main goal of PlasticsFatE (Plastics Fate and Effects in the Human Body) is to improve our present understanding of the impact of micro- and nano-plastics (MP/NP) and associated additives/adsorbed contaminants (A/C) in the human body. Human exposure to MP/NP may result from the widespread use of plastic products and their release to the environment, where they degrade to MP/NP particles. But plastics particles reach natural systems also as secondary by-products, e.g., from tyre wear or abrasion of textiles. As a consequence, these particles are found in food, drinking water, air and environmental media (food chain, soils). Despite recent efforts to assess the real dimension of human risks associated with MP/NP, our current knowledge is still insufficient. One of the reasons is the lack of reliable and validated methods that are able to generate the science-based data we need. PlasticsFatE will address this challenge and associated uncertainties by implementing a comprehensive measurement and testing program ("test the test"), including inter-laboratory studies, to improve and validate the performance and applicability of available methods and tools to MP/NP. The tested and validated approaches will be used to (1) identify and detect MP/NP and A/C in a variety of complex matrices, such as food (vegetables, fruits, beverages, fish etc.), human tissues and consumer products (tooth paste, beauty products), as well as relevant environmental media (air, drinking water, soils), and to (2) assess their (also long-term) fate and toxicity in the human body by using advanced cell culture and organ models that simulate real exposure to MP/NP in the respiratory and gastro-intestinal tract. The newly developed innovative approaches will be integrated into a novel risk assessment strategy specifically designed for MP/NP to provide the policy relevant and scientifically sound data needed to support the health-relevant aims of European strategies for plastics. PlasticsFatE is part of the European MNP cluster on human health.

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.

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.