NanoDefiner Framework and e-Tool Revisited According to the European Commission's Nanomaterial Definition 2022/C 229/01

Raphael Brüngel; Johannes Rückert; Philipp Müller; Frank Babick; Christoph M Friedrich; Antoine Ghanem; Vasile-Dan Hodoroaba; Agnieszka Mech; Stefan Weigel; Wendel Wohlleben; Hubert Rauscher

doi:10.3390/nano13060990

NanoDefiner Framework and e-Tool Revisited According to the European Commission's Nanomaterial Definition 2022/C 229/01

Nanomaterials (Basel). 2023 Mar 9;13(6):990. doi: 10.3390/nano13060990.

Authors

Raphael Brüngel^{1

2

3}, Johannes Rückert¹, Philipp Müller⁴, Frank Babick⁵, Christoph M Friedrich^{1

2}, Antoine Ghanem⁶, Vasile-Dan Hodoroaba⁷, Agnieszka Mech⁸, Stefan Weigel⁹, Wendel Wohlleben⁴, Hubert Rauscher⁸

Affiliations

¹ Department of Computer Science, University of Applied Sciences and Arts Dortmund (FH Dortmund), 44227 Dortmund, Germany.
² Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University Hospital Essen, 45122 Essen, Germany.
³ Institute for Artificial Intelligence in Medicine (IKIM), University Hospital Essen, 45131 Essen, Germany.
⁴ Analytical and Material Science, BASF SE, 67056 Ludwigshafen, Germany.
⁵ Institute of Process Engineering and Environmental Technology, Technische Universität Dresden (TU Dresden), 01062 Dresden, Germany.
⁶ R&I Centre Brussels, Solvay S.A., 1120 Brussels, Belgium.
⁷ Division 6.1 Surface Analysis and Interfacial Chemistry, Bundesanstalt für Materialforschung und -prüfung (BAM), 12205 Berlin, Germany.
⁸ European Commission, Joint Research Centre (JRC), 21027 Ispra, Italy.
⁹ Department Safety in the Food Chain, German Federal Institute for Risk Assessment (BfR), 10589 Berlin, Germany.

Abstract

The new recommended definition of a nanomaterial, 2022/C 229/01, adopted by the European Commission in 2022, will have a considerable impact on European Union legislation addressing chemicals, and therefore tools to implement this new definition are urgently needed. The updated NanoDefiner framework and its e-tool implementation presented here are such instruments, which help stakeholders to find out in a straightforward way whether a material is a nanomaterial or not. They are two major outcomes of the NanoDefine project, which is explicitly referred to in the new definition. This work revisits the framework and e-tool, and elaborates necessary adjustments to make these outcomes applicable for the updated recommendation. A broad set of case studies on representative materials confirms the validity of these adjustments. To further foster the sustainability and applicability of the framework and e-tool, measures for the FAIRification of expert knowledge within the e-tool's knowledge base are elaborated as well. The updated framework and e-tool are now ready to be used in line with the updated recommendation. The presented approach may serve as an example for reviewing existing guidance and tools developed for the previous definition 2011/696/EU, particularly those adopting NanoDefine project outcomes.

Keywords: FAIRification; decision support; nanomaterial categorisation; nanomaterial definition; nanomaterial legislation; nanomaterial regulation.

Grants and funding

This research was funded by the Joint Research Centre (JRC) through the European Union’s Horizon 2020 (H2020) Research and Innovation Programme. The original work upon which this research is based received funding from the NanoDefine project within the European Community’s 7th Framework Programme (FP7) under Grant Agreement No. 604347. The work of Raphael Brüngel was partially funded by a PhD grant from the University of Applied Sciences and Arts Dortmund (FH Dortmund), Dortmund, Germany.