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

Author:

Brüngel Raphael123ORCID,Rückert Johannes1ORCID,Müller Philipp4ORCID,Babick Frank5ORCID,Friedrich Christoph M.12ORCID,Ghanem Antoine6,Hodoroaba Vasile-Dan7ORCID,Mech Agnieszka8ORCID,Weigel Stefan9ORCID,Wohlleben Wendel4ORCID,Rauscher Hubert8ORCID

Affiliation:

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.

Publisher

MDPI AG

Subject

General Materials Science,General Chemical Engineering

Reference36 articles.

1. (2022). European Commission. Commission Recommendation of 10 June 2022 on the definition of nanomaterial (2022/C 229/01). Off. J. Eur. Union, C 229, 1.

2. (2011). European Commission. Commission Recommendation of 18 October 2011 on the definition of nanomaterial (2011/696/EU). Off. J. Eur. Union, L 275, 38.

3. Rauscher, H., Roebben, G., Amenta, V., Sanfeliu, A.B., Calzolai, L., Emons, H., Gaillard, C., Gibson, N., Linsinger, T., and Mech, A. (2014). Towards a Review of the EC Recommendation for a Definition of the Term “Nanomaterial”, Part 1: Compilation of Information Concerning the Experience with the Definition, Publications Office of the European Union. EUR 26567 EN, JRC89369.

4. Roebben, G., Rauscher, H., Amenta, V., Aschberger, K., Sanfeliu, A.B., Calzolai, L., Emons, H., Gaillard, C., Gibson, N., and Holzwarth, U. (2014). Towards a Review of the EC Recommendation for a Definition of the Term “Nanomaterial”, Part 2: Assessment of Collected Information Concerning the Experience with the Definition, Publications Office of the European Union. EUR 26744 EN, JRC91377.

5. Rauscher, H., Roebben, G., Sanfeliu, A.B., Emons, H., Gibson, N., Koeber, R., Linsinger, T., Rasmussen, K., Sintes, J.R., and Sokull-Klüttgen, B. (2015). Towards a review of the EC Recommendation for a definition of the term “nanomaterial”, Part 3: Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation, Publications Office of the European Union. EUR 27240 EN, JRC95675.

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