Italy – Research and development services and related consultancy services – Developing provisions for guidance on New Approach Methodologies (NAMs) data integration and implementing hypothesis-driven Next Generation Risk Assessment (NGRA), with specific focus on the area of food nanotechnology

The call aims at developing recommendations and first provisions for guidance on New Approach Methodologies (NAMs) data integration and implementing hypothesis-driven Next Generation Risk Assessment (NGRA) for risk assessment of regulated products in the food chain, with specific focus on the area of food nanotechnology. The work will build on experience gained from selected case studies of EFSA’s relevance with the aim to develop best practices on the integration of NAMs-based data together with animal/human data to fill data gaps in the risk assessment. The awarded organisation(s) will be requested to: 1. Collect lessons learnt from EFSA's published case studies on NAMs (e.g. https://doi.org/10.2903/sp.efsa.2023.EN-7793, https://doi.org/10.2903/sp.efsa.2023.EN-7794, https://doi.org/10.2903/sp.efsa.2023.EN-8258, https://doi.org/10.2903/sp.efsa.2023.EN-8230, https://doi.org/10.2903/sp.efsa.2024.EN-8820, https://doi.org/10.2903/sp.efsa.2024.EN-8926) and other relevant international activities (e.g. OECD Integrated Approaching to Testing and Assessment (IATA) Case Studies) to develop best practices for a general framework on the integration of NAMs-based data together with animal/human data (when available) to fill data gaps in the risk assessment; 2. Develop provisions for cross-cutting guidance for assessing and integrating NAMs data in EFSA risk assessments, focusing specifically on nanomaterials risk assessment.