CHIASMA will establish, test and in-project validate a safety and environmental impact assessment framework based on a combination of in silico New Approach Methodologies (NAMs) and approaches to gather and reuse existing safety and environmental impact data for chemicals and materials. In parallel, experimental NAMs representative of relevant human biological barriers, organs and systems will be developed and in-project validated for their relevance in answering specific regulatory needs and fill the knowledge gap for chemicals/materials. The CHIASMA framework will at first apply chemocentric approaches (e.g. knowledge graph, read across, textual mining, etc.) to gather and infer new information from existing data. If the amount of data is not sufficient for a regulatory decision, the CHIASMA framework will make use of biocentric approaches (e.g. PBPK modelling, AOP models, MoA models, etc.) to attempt filling gaps from the first step. If data gaps preventing regulatory decision still persist after the second iteration, experimental NAMs will be used to generate new experimental results and fill the knowledge gap to reach regulatory decisions. The experimental NAMs developed in CHIASMA will include models for human external barriers, such as lung, skin and intestine, models for internal barriers, such as blood-brain-barrier and blood-placental foetus barrier, models for developmental, reproductive toxicity and endocrine systems, models for kidneys, brain and liver.  The entire CHIASMA framework will be applied to 3 groups of chemicals and materials, such as (nano-)pesticides, PFAS and 2D materials for energy applications, with the aim to demonstrate the applicability of the CHIASMA framework and its relevance for regulators and industrial stakeholders. It is envisaged that the individual NAMs and the overall CHIASMA framework will be subjected to approval by public and private stakeholders and, whenever relevant, individual NAMs will be submitted for formal validation, i.e. to OECD and ECVAM. This will also be supported by dedicated inter-laboratory transferability in -project validation activities.  To support the formal validation activities and boost the uptake and implementation of the CHIASMA methodologies and methods, the project will develop dedicated activities to ensure the compliance to FAIR principles (FAIRfication activities) and to present results, documents and SOPs in a way that is as close as possible to regulatory standards (GLPfication activities).

CHIASMA’s Central Objective is to:

• Develop new and improved in-vitro and in-silico methods and data for the next generation of hazard- & risk assessment of chemicals and materials.
• Demonstration of the new & improved methods and models in at least three chemicals / chemical groups, supported by the assessment of socio-economic aspects and gap analyses in the context of existing methods.
• Integration of the new & improved methods for expressing safety and health parameter into existing life-cycle and sustainability assessments methodologies and tools, as well as into the relevant applicable regulatory frameworks (incl. the SSbD framework).
• Provision of accessible data for industry and public authorities, in order to ultimately support the wider implementation of the SSbD framework and its criteria

1.1.2024 – 31.12.2027