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.

The POLYRISK project aims unraveling the risks of microplastic and nanoplastic particles (MNP) that are ubiquitous in our environment and are likely to be entering the human body via inhalation and ingestion. The most bioavailable low-micron and nano-sized MNP, pose the biggest analytical challenges or today’s analytical chemists. Existing knowledge about the adverse pro-inflammatory effects of airborne particulate matter and nanoparticles, combined with pro-inflammatory evidence of MNP exposure observed in animal models and in vitro pilot tests with human immune cells, suggests that MNP may cause immunotoxicity in humans. Occupational exposure of workers to fibrous MNP can indeed lead to granulomatous lesions, causing respiratory irritation, functional abnormalities and flock worker’s lung. Currently, human health risk assessment protocols specific to MNP are not available and key data is missing. This hampers science-based decision making. On this backdrop, POLYRISK’s human risk assessment strategy will combine highly advanced sampling, sample pretreatment and analytical methods to detect MNP in complex matrices, up-to-date fit-for-purpose hazard assessment technologies and multiple real-life human exposure scenarios. We will focus on key toxic events linked to several chronic inflammatory diseases. The consortium uniquely brings together interdisciplinary experience and know-how on quality-controlled chemical analyses of MNP and additives, intestinal and respiratory toxicity models, human exposure epidemiology, immunotoxicology and real-life high-exposure studies. POLYRISK’s novel human risk assessment strategy is based on mechanistic reasoning and pragmatically accommodates the complexity of the MNP toxicant class. Building with ground-breaking science, stakeholder engagement and strong communication, POLYRISK aims to rapidly reduce current MNP risk uncertainties and support EU efforts to ensure public health is adequately protected from the potential risks of MNP pollution. POLYRISK is a part of the European cluster on Health Impacts of Micro- and Nanoplastics.

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.

Engineered nanomaterials (ENMs) are covered by REACH/CLP regulations; the general opinion is that the risk assessment (RA) approach routinely used for conventional chemicals is also applicable to ENMs. However, as acknowledged by OECD and ECHA, the OECD and ISO Test Guidelines (TGs) and Standard Operating Procedures (SOPs) need to be verified and adapted to be applicable to ENMs. RiskGONE will support the standardization and validation process for ENM by evaluating, optimizing and pre-validating SOPs and TGs and integrating them into a framework for risk governance (RG) of ENMs. The framework will comprise modular tools and will rely heavily on current strategies for the RA of conventional chemicals, complemented by methods for estimating environmental, social and economic benefits. It will incorporate ethical aspects and societal risk perception and will manage acceptable and unacceptable risks through transfer or mitigation. The focus of RiskGONE will be to produce nano-specific draft guidance documents for application to ENM RA; or, alternatively, to suggest ameliorations to OECD, ECHA, and ISO/CEN SOPs or guidelines. Rather than producing assays and methods ex novo, this will be achieved through Round Robin exercises and multimodal testing of OECD TGs and ECHA methods supporting the “Malta-project”, and on methods not yet considered by OECD. This process will be accelerated by guidance documents for data storage/curation/accessibility optimisation, applied to well-characterized reference ENMs typifying the main physicochemical and toxicological features of ENMs. The conditions for a transparent and self-sustained organisational form for science-based RG, representing EU stakeholders, member states, industry and civil society, will be established. The RG framework and methods developed by RiskGONE will be transferred to the organisational form for RG.

Agrochemicals (i.e., fertilizers and pesticides) are responsible for doubling crop yields over the last century. However, they cause multiple negative impacts on environmental and human health. To lessen their effects, the EU aims at reducing by 50% fertilizer losses and use of chemical pesticides by 2030. Controlled polymer-based delivery systems preventing agrochemical losses (e.g., lixiviation, volatilization) and resulting excessive inputs are available. However, they are based on non-biodegradable polymers and generate plastic pollution. Other agricultural plastics (mulch films and growth foams) are used to maintain a prosperous plant environment and prevent agrochemical wash-off, minimizing the quantities to be applied. However, they also result in significant amounts of non-biodegradable plastics being released into environment. PHAntastic tackles the reduction of agrochemicals and plastics pollution using PHAs, a family of bio-based biodegradable polymers. PHAntastic will develop two families of delivery systems (mulch films and growth foams) based on PHAs containing active bioproducts (amino acids & hydrolyzed proteins, microelements, elicitors and plant growth promoting rhizobacteria -PGPR) instead of synthetic agrochemicals. Products will be demonstrated with end users (TRL6) on horticultural crops and trees in Northern and Southern Europe. Experts in the Safe and Sustainable by Design framework will guarantee compliance. Market acceptance will be guaranteed through the development of business cases and exploitation strategies. PHAntastic will contribute to a significant reduction of agrochemicals (minimum 25% in fertilizers, 50% in pesticides, resulting in 23 K tons less of agrochemicals by 2050) and plastic (680 T microplastics less by 2050) in our agricultural systems. PHAntastic will thus contribute to a secure supply chain of food and a less impactful agriculture, boosting the sustainability, autonomy and competitiveness of vital EU value chains.