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.

Lysosomal storage disorders (LSD) diseases are a group of rare diseases that currently lack a definitive cure. LSD incidence is about 1:5,000 - 1:10,000, representing a serious global health problem. In the case of Fabry LSD Disease (FD), the deficiency in α-Galactosidase A (GLA) enzyme activity results in the cellular accumulation of neutral glycosphingolipids, leading to widespread vasculopathy with particular detriment to the kidneys, heart and nervous system. The current treatment for FD is the Enzyme Replacement Therapy (ERT), in which free GLA recombinant protein is administered intravenously to patients. ERT exhibits several drawbacks mainly related to the instability, high immunogenicity and low efficacy of the exogenously administered GLA to cross biological barriers, such as cell membranes and BBB.The aim of Samrt-4-Fabry project is to achieve excellent quality control over the assembly of the different molecular components of a new liposomal nanoformulation of GLA, nano-GLA, for the treatment of Fabry disease. Nanoformulated GLA has already shown to have better PK/PD profile than free GLA and higher efficacy in vivo. Smart-4-Fabry project will advance nano-GLA from an experimental PoC (TRL3) to preclinical regulatory phase (TRL5-6). A one-step method based on the use of green cCO2, will be used for the manufacturing of this novel nanoformulation under GMPs. The final GLA nanoformulation will have tailored transport of GLA through cell membranes and BBB. Fulfillment of Smart-4-Fabry will impact on a major health problem, the existence of new therapies for rare diseases, which constitutes a priority societal challenge as shown in the H2020 Work Programmes. Another important impact is related to its contribution to support the European Strategy for KETs, which aims to reverse the decline in manufacturing as this will stimulate growth and jobs. Smart-4-Fabry is strongly focusing on three KETs: nanotechnology, industrial biotechnology and advanced materials.

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.

SSbD4ChEM brings together stakeholders from industry, government, academia, and civil society to develop and promote best practices for safe and sustainable product and process design, through demonstration in 3 case studies. SSbD4CheM aims to meet the EU's strategic objectives for digital, enabling, and emerging technologies, sectors, and value chains by developing a comprehensive Safe and Sustainable by Design (SSbD) framework that uses new science-based approaches to identify and address potential hazards and risks, and innovative technologies to support the design of safer and more sustainable products and processes. SSbD4CheM objectives include: 1) SSbD framework to facilitate development of the next generation of chemicals and materials applicable to renewable composites in automotive value chain, PFAS-free coatings for textile and cellulose nanofibers as additive in cosmetics to replace plastic microbeads, 2) Development of efficient hazard screening tools for alternative assessment of next generation chemicals/materials/products combining in silico tools and multicriteria analysis, 3) Advanced explorative ex-ante LCA method supported by molecular and data-driven modelling to fill data gaps for (novel) materials and chemicals, 4) Integration of chemical/(nano-)material characterization methods to assess products’ environmental safety, quantify emissions to support occupational and consumer safety limits, 5) Development of alternative, in vitro models, as part of New Approach Methodologies for adequate exposure scenarios, 6) Harmonization and validation of analytical and toxicological methods for proposition to regulatory and standardization bodies to contribute to the development of new standards and facilitate market acceptance of SSbD4CheM project results, and 7) Enhance overall SSbD4CheM impact through stakeholder engagement, training, dissemination and exploitation and drive industrial innovation.