QSAR Lab will soon start its B+R activity in two H2020 projects: NanoSolveIT and RiskGone.
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 The focus of RiskGONE will be to produce nano-specific draft guidance documents for application to ENM RA; or, alternatively, to suggest ameliorations to OECD, ECHA, and ISO/CEN SOPs or guidelines.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. A transparent, self-sustained RG council, 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 RG council, which will act as a science-based governance body for ENMs safety and
provide responsible 2-way communication with stakeholders and civil society, based on high quality information.
NanoSolveIT aspires to introduce a groundbreaking in silico Integrated Approach to Testing and Assessment (IATA) of the environmental health and safety of Nanomaterials (NM) that will be implemented through a decision support system packaged as both a stand-alone open software and via a Cloud platform. NanoSolveIT will develop and deliver: (i) a reliable user friendly knowledge-based infrastructure for data hosting, sharing and exploitation, (ii) NM fingerprints, i.e., sets of nanodescriptors and properties that can be predictively linked to NM functionality, exposure and hazard thereby supporting NM grouping, safe-by-design (SbD) and regulatory risk assessment (RA), (iii) innovative methodologies for NMs predictive (eco)toxicology underpinned by artificial intelligence (AI) and state-of-the-art in silico techniques, and, (iv) integration with currently developing multi-scale modelling, RA and governance frameworks. NanoSolveIT will develop and deliver a validated, sustainable, multi-scale nanoinformatics IATA, tested and demonstrated at TLR6 to serve the needs of diverse stakeholders at each stage of the NMs value chain, for the assessment of adverse effects of NM on human health and the environment.