Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety – A proposal for further actions

Recently, international collaborative activities (e.g. within the OECD, EU programmes and ISO) were conducted to develop/adjust test guidelines and guidance document for regulatory testing of nanomaterials. These efforts address some of the EU regulatory needs for nanomaterial testing, though some regulatory issues may still be outstanding. To identify these, regulatory requirements for different regulatory areas in the EU were compared to find commonalities. For each regulatory requirement, international nanosafety experts were consulted to identify associated scientific issues for nanomaterials that may require further action. Overarching regulatory needs that are relevant for multiple regulatory requirements and across multiple regulatory areas include the needs to 1) resolve issues around nanomaterial dispersion stability and dosing in toxicity testing for human health endpoints, 2) further develop tests/guidance on nanomaterial degradation, and 3) further develop tests/guidance to measure (a)cellular reactivity of nanomaterials. Efforts towards these issues could resolve some of the most urgent outstanding scientific and regulatory issues for nanomaterials. The overview may guide further necessary actions towards improved safety assessment of (advanced) nanomaterials, help prioritise these actions and identify the essential actors (e.g. scientists, regulators, method developers, etc.).

BLEEKER Eric;  SWART Elmer;  BRAAKHUIS Hedwig;  FERNÁNDEZ-CRUZ María Luisa;  FRIEDRICHS Steffi;  GOSENS Ilse;  HERZBERG F.;  JENSEN Keld Astrup;  VON DER KAMMER Frank;  KETTELARIJ Jolinde;  NAVAS Jose M;  RASMUSSEN Kirsten;  SCHWIRN Kathrin;  VISSER Maaike; 

2023-04-21

ACADEMIC PRESS INC ELSEVIER SCIENCE

JRC130178

0273-2300 (online),   

https://www.sciencedirect.com/science/article/pii/S0273230023000284,    https://publications.jrc.ec.europa.eu/repository/handle/JRC130178,   

10.1016/j.yrtph.2023.105360 (online),