Dokument-ID Dokumenttyp Autoren/innen Persönliche Herausgeber/innen Haupttitel Abstract Auflage Verlagsort Verlag Herausgeber (Institution) Erscheinungsjahr Titel des übergeordneten Werkes Jahrgang/Band ISBN Veranstaltung Veranstaltungsort Beginndatum der Veranstaltung Enddatum der Veranstaltung Ausgabe/Heft Erste Seite Letzte Seite URN DOI Lizenz Datum der Freischaltung OPUS4-57161 Zeitschriftenartikel Brüngel, R.; Rückert, J.; Müller, P.; Babick, F.; Friedrich, C. M.; Ghanem, A.; Hodoroaba, Vasile-Dan; Mech, A.; Weigel, S.; Wohlleben, W.; Rauscher, H. NanoDefiner Framework and e-Tool Revisited According to the European Commission's Nanomaterial Definition 2022/C 229/01 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. Basel, CH MDPI 2023 Nanomaterials 13 6 - Special Issue "Identification and Quantification of Nanomaterials" 1 16 urn:nbn:de:kobv:b43-571618 10.3390/nano13060990 https://creativecommons.org/licenses/by/4.0/deed.de 2023-03-16 OPUS4-49244 Zeitschriftenartikel Brüngel, R.; Rückert, J.; Wohlleben, W.; Babick, F.; Ghanem, A.; Gaillard, C.; Mech, A.; Rauscher, H.; Hodoroaba, Vasile-Dan; Weigel, S.; Friedrich, C. M. NanoDefiner e-Tool: An Implemented Decision Support Framework for Nanomaterial Identification The European Commission's recommendation on the definition of nanomaterial (2011/696/EU) established an applicable standard for material categorization. However, manufacturers face regulatory challenges during registration of their products. Reliable categorization is difficult and requires considerable expertise in existing measurement techniques (MTs). Additionally, organizational complexity is increased as different authorities' registration processes require distinct reporting. The NanoDefine project tackled these obstacles by providing the NanoDefiner e-tool: A decision support expert system for nanomaterial identification in a regulatory context. It providesMT recommendations for categorization of specific materials using a tiered approach (screening/confirmatory), and was constructed with experts from academia and industry to be extensible, interoperable, and adaptable for forthcoming revisions of the nanomaterial definition. An implemented MT-driven material categorization scheme allows detailed description. Its guided workflow is suitable for a variety of user groups. Direct feedback and explanation enable transparent decisions. Expert knowledge is Held in a knowledge base for representation of MT performance criteria and physicochemical particle type properties. Continuous revision ensured data quality and validity. Recommendations were validated by independent case studies on industry-relevant particulate materials. Besides supporting material identification and registration, the free and open-source e-tool may serve as template for other expert systems within the nanoscience domain. Basel, CH MDPI 2019 Materials 12 19 3247 urn:nbn:de:kobv:b43-492449 10.3390/ma12193247 https://creativecommons.org/licenses/by/4.0/deed.de 2019-10-14 OPUS4-49992 Beitrag zu einem Tagungsband Mech, A.; Gaillard, C.; Marvin, H.; Wohlleben, W.; Hodoroaba, Vasile-Dan; Babick, F.; Friedrich, C. M.; Brüngel, R.; Rückert, J.; Ghanem, A.; Weigel, S. The NanoDefine Decision Framework and NanoDefiner e-Tool: a practical guide to the identification of nanomaterials The European Commission's recommendation on the definition of nanomaterial [2011/696/EU] is broadly applicable across different regulatory sectors and requires the quantitative size Determination of constituent particles in samples down to 1 nm. A material is a nanomaterial if 50 % or more of the particles are in the size range 1-100 nm. The implementation of the definition in a regulatory context challenges measurement methods to reliably identify nanomaterials and ideally also nonnanomaterials as substance or product ingredient as well as in various matrices. The EU FP7 NanoDefine project [www.nanodefine.eu] addressed these challenges by developing a robust, readily implementable and cost-effective measurement strategy to decide for the widest possible range of materials whether it is a nanomaterial or not. It is based on existing and emerging particle measurement techniques evaluated against harmonized, material-dependent performance criteria and by intra- and inter-lab comparisons. Procedures were established to reliably measure the size of particles within 1-100 nm, and beyond, taking into account different shapes, coatings and chemical compositions in industrial materials and consumer products. Case studies prove their applicability for various sectors, including food, pigments and cosmetics. A main outcome is the establishment of an integrated tiered approach including rapid screening (Tier 1) and confirmatory methods (tier 2), a decision support flow scheme and a user manual to guide end-users, such as manufacturers, in selecting appropriate methods. Another main product is the "NanoDefiner" e-Tool which implements the flow scheme in a user-friendly software and guides the user in a semi-automated way through the entire decision procedure. It allows a cost-effective selection of appropriate methods for material classification according to the EC's nanomaterial definition and provides a comprehensive report with extensive explanation of all decision steps to arrive at a transparent identification of nanomaterials as well as non-nanomaterials for regulatory purposes. Braunschweig und Berlin Physikalisch-Technische Bundesanstalt 2019 PTB-Bericht F-61 - NanoWorkshop 2018: Workshop on Reference Nanomaterials F-61 978-3-95606-440-1 NanoWorkshop 2018: Workshop on Reference Nanomaterials Berlin, Germany 14.05.2018 15.05.2018 114 124 2019-12-11