Research

The planned work is to contribute significantly to structuring the area of synthetic biology, which is still unclear with regard to its dual use potential (in particular in interaction with the associated converging technologies) with the aid of a future-oriented risk analysis and assessment. Based on this, a scientifically sound prognosis of the corresponding biosafety risks is to be drawn up. In addition, this work is intended to lay the foundation for a continuation of such an analysis by operationalizing the procedure for analysis and assessment in the sense of a tool.

The main goal of SUNRISE is to develop an overarching Integrated Impact Assessment Framework (IIAF) of chemicals and advanced materials, based on lifecycle thinking and designed to support SSbD decision making along supply chains of AdMa and their products. The IIAF will be fully aligned to the EC-JRC SSbD framework. It will be a 3-tiered approach with each tier corresponding to an integrated methodology (supported by a toolbox) for health, environmental, social and economic impact assessment targeting different groups of users at different stages of the innovation process and requiring a different level of data and expertise. The definition and integration of EHS and sustainability criteria and indicators to support SSbD decision making cannot be a technocratic task: we will involve key actors along entire value chains in a co-creative process that balances the perspectives and interests of stakeholders from industry (including SMEs), regulation, policy, consultants (and CROs), academia, and the civil society. To support generation of robust input data for the integrated methodologies we will develop and apply Integrated Approaches to Testing and Assessment (IATA), New Approach Methods (NAMs) as well as screening level and more advanced sustainability assessment tools based on Environmental Life Cycle Assessment (e-LCA), Social Life Cycle Assessment (s-LCA), Life Cycle Costing (LCC), Cost-benefit Analysis (CBA), and circularity analysis on a global scale. The IIAF, its 3 integrated impact assessment methodologies and the toolboxes of newly proposed methods will be thoroughly tested and demonstrated in case studies corresponding to AdMa provided by our industry partners. The goal is to foster acceptance and shared support for the developed approaches in order to ensure their adoption and implementation by the stakeholders. To facilitate the IIAF implementation, we will deliver it as a userfriendly open web application and a guidance document. The process of developing and testing the IIAF in cocreation with the stakeholders within a trusted real-world environment will improve our understanding of potential safety and sustainability trade-offs. This new knowledge will be transferred to regulators and policy makers at EU and national level to support them in the implementation of SSbD-related policies for chemicals and materials.

The project considers nanocarriers as a case study for novel materials that pose challenges for chemical regulation and regulatory risk assessment. To this end, the project will conduct extensive research on existing and newly developed nanocarriers and their (potential) applications. On this basis, a systematic compilation will be prepared. From the overview thus obtained, exemplary nanocarriers are to be selected for further investigation which, with regard to their appearance or their application, are expected to pose particular challenges for environmental assessment. For these selected nanocarriers, test strategies are to be developed and implemented that will enable an investigation of their environmental behavior and the possible release of the transported active ingredient under environmentally relevant conditions. In this way, the influence of encapsulation on the change in the environmental behavior of active substances will be determined as an example and the implications for an appropriate evaluation of the environmental behavior in the context of risk assessment will be described in more detail.