Identify and define regulatory requirements, build safe-orientated grouping approaches linked with Intelligent Testing and non-testing strategies (ITS). “Grouping approaches” are well established for chemicals, for example through the identification of chemical categories (“category approach”) or analogues (“analogue approach”). It can largely reduce the amount of tests and furthermore should strongly facilitate Regulatory Risk Assessment and Management. For MNMs, as reported recently, grouping concepts are mostly unavailable and their development pose additional (i.e. nano-specific) challenges as MNMs are defined according to their physical size and synthesized in a huge variety of different chemistries, sizes, shapes and surfaces which might change during their life cycle, influencing their behaviour and toxicological effects. Thus, identifying grouping needs and possibilities for current and future regulations, defining criteria addressing physical and chemical descriptors and toxicological end-points and evaluating results from a socio-economic point of view should be done. Such approach will be place in a global Intelligent non-Testing (eg. grouping and prediction tools) and Testing (eg. high throughputs screening, in-vitro models, short term in-vivo) Strategies (ITS) designed for toxicological, eco-toxicological and physical hazards.
Identify and select materials as candidates for value chain demonstrators in collaboration with industry, then develop life cycle maps and identify existing and potential exposure scenarios (based on work carried out in other projects). A structured approach will be developed and applied that allows for grouping of similar release and exposure scenarios, taking into account the nanomaterial, the product, the process and environmental conditions. This will help to define the framework for evaluating changes in environmental and human health risk and to identify “hot spots” where exposure and/or risks appear to be relatively high.
Evaluate the relative change in environmental and human health risk, following implementation of the SbD process (for occupational and product (consumers and environment) safety), estimate any residual risk following SbD and recommend additional risk mitigation/management measures as appropriate.
Develop and adapt supportive technical and organizational tools for Safe by Design, based on regulatory orientated grouping approaches. Based on grouping approaches placed in a general ITS, and based on a defined value chain, develop a comprehensive model supporting SbD principles to reduce uncertainties regarding safety along the value chain and therefore promoting safer innovations. This will be relevant when marketing should be balanced with competitiveness and social constraints.
Develop supportive tools for identifying and integrating efficient hazard and functionality testing during the innovation process that aims to minimize uncertainty on health risks for workers, consumers and the environment, analyze present SbD approaches applied in the processes extending from basic research to the market and illustrate added value of experimentally obtained safety data during the innovation process; Adapt currently applied stage-gate innovation models for use between organizations/actors wanting to facilitate the introduction of safety aspects for nanomaterials, nanoproducts at an early stage thereby supporting responsible innovation, and at the same time evaluate options to share information between players; Develop an action plan to achieve dedicated multi-stakeholder interactions (in any form) and define required actions aiming to facilitate responsible innovation.
Identify and overcome barriers to the application of SbD concepts, including development of approaches to adequately address such barriers, taking into consideration grouping approaches and Risk Management (RM) requirements, with a view to ultimately eliminate the barriers and provide examples of guidance towards achieving SbD.
Disseminate Safe by Design tools and SOPs, promoting regulatory orientated guidelines. The final objective is to establish viable grouping and SbD approaches, through the provision of industrial SbD-tools and Standard Operation Procedures (SOPs) that can become standards, the development of specific tools to help sharing knowledge between stakeholders (e.g. Newsletters, training support, web platform, helpdesk and public-private-partnership based platforms), and the provision of Grouping approaches that can become regulatory tools or guidelines for regulators. More precisely, standardization can support the regulatory process by providing the necessary measurement procedures and appropriate guides and specifications for products and processes. Public-private partnerships (PPP) such as helpdesk on SbD or such as pre-validation platform on non-testing and testing methods are techniques promoting innovation by developing instruments to anticipate regulations.