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 OPUS4-39145 Zeitschriftenartikel Wohlleben, W.; Mielke, Johannes; Bianchin, A.; Ghanem, A.; Freiberger, H.; Rauscher, H.; Gemeinert, Marion; Hodoroaba, Vasile-Dan Reliable nanomaterial classification of powders using the volume-specific surface area method The volume-specific surface area (VSSA) of a particulate material is one of two apparently very different metrics recommended by the European Commission for a definition of "nanomaterial" for regulatory purposes: specifically, the VSSA metric may classify nanomaterials and non-nanomaterials differently than the median size in number metrics, depending on the chemical composition, size, polydispersity, shape, porosity, and aggregation of the particles in the powder. Here we evaluate the extent of agreement between classification by electron microscopy (EM) and classification by VSSA on a large set of diverse particulate substances that represent all the anticipated challenges except mixtures of different substances. EM and VSSA are determined in multiple labs to assess also the level of reproducibility. Based on the results obtained on highly characterized benchmark materials from the NanoDefine EU FP7 project, we derive a tiered screening strategy for the purpose of implementing the definition of nanomaterials. We finally apply the Screening strategy to further industrial materials, which were classified correctly and left only borderline cases for EM. On platelet-shaped nanomaterials, VSSA is essential to prevent false-negative classification by EM. On porous materials, approaches involving extended Adsorption isotherms prevent false positive classification by VSSA. We find no false negatives by VSSA, neither in Tier 1 nor in Tier 2, despite real-world industrial polydispersity and diverse composition, shape, and coatings. The VSSA screening strategy is recommended for inclusion in a technical guidance for the implementation of the definition. Springer Nature 2017 Journal of Nanoparticle Research 19 2 Article 61, 1 16 urn:nbn:de:kobv:b43-391450 10.1007/s11051-017-3741-x http://creativecommons.org/licenses/by/3.0/de/deed.de 2017-02-14 OPUS4-51091 Zeitschriftenartikel Mech, A.; Wohlleben, W.; Ghanem, A.; Hodoroaba, Vasile-Dan; Weigel, S.; Babick, F.; Brüngel, R.; Friedrich, C. M.; Rasmussen, K.; Rauscher, H. Nano or Not Nano? A Structured Approach for Identifying Nanomaterials According to the European Commission's Definition Identifying nanomaterials (NMs) according to European Union Legislation is challenging, as there is an enormous variety of materials, with different physico-chemical properties. The NanoDefiner Framework and its Decision Support Flow Scheme (DSFS) allow choosing the optimal method to measure the particle size distribution by matching the material properties and the performance of the particular measurement techniques. The DSFS leads to a reliable and economic decision whether a material is an NM or not based on scientific criteria and respecting regulatory requirements. The DSFS starts beyond regulatory requirements by identifying non-NMs by a proxy Approach based on their volume-specific surface area. In a second step, it identifies NMs. The DSFS is tested on real-world materials and is implemented in an e-tool. The DSFS is compared with a decision flowchart of the European Commission's (EC) Joint Research Centre (JRC), which rigorously follows the explicit criteria of the EC NM definition with the focus on identifying NMs, and non-NMs are identified by exclusion. The two approaches build on the same scientific basis and measurement methods, but start from opposite ends: the JRC Flowchart starts by identifying NMs, whereas the NanoDefiner Framework first identifies non-NMs. Weinheim Wiley-VCH 2020 Small 2002228-1 2002228-16 urn:nbn:de:kobv:b43-510917 10.1002/smll.202002228 https://creativecommons.org/licenses/by-nc/4.0/deed.de 2020-08-17 OPUS4-50425 Handbuch Friedrich, C. M.; Weigel, S.; Marvin, H.; Rauscher, H.; Wohlleben, W.; Babick, F.; Löschner, K.; Mech, A.; Brüngel, R.; Hodoroaba, Vasile-Dan; Gilliland, D.; Rasmussen, K.; Ghanem, A. The NanoDefine Methods Manual This document is a collection of three JRC Technical Reports that together form the "NanoDefine Methods Manual", which has been developed within the NanoDefine project 'Development of an integrated approach based on validated and standardized methods to support the implementation of the EC recommendation for a definition of nanomaterial', funded by the European Union's 7th Framework Programme, under grant agreement 604347. The overall goal of the NanoDefine project was to support the implementation of the European Commission Recommendation on the definition of nanomaterial (2011/696/EU). The project has developed an integrated empirical approach, which allows identifying a material as a nano- or not a nanomaterial according to the EC Recommendation. The NanoDefine Methods Manual consists of three parts: Part 1: The NanoDefiner Framework and Tools, which covers the NanoDefiner framework, general information on measurement methods and performance criteria, and tools developed by NanoDefine such as a materials categorisation system, a decision support flow scheme and an e-tool. Part 2: Evaluation of Methods, which discusses the outcome of the evaluation of the nanomaterials characterisation methods for measuring size. Part 3: Standard Operating Procedures (SOPs), which presents the 23 Standard Operating Procedures developed within the NanoDefine project. In this combined document, these three parts are included as stand-alone reports, each having its own abstract, table of contents, page, table and figure numbering, and references. Luxembourg Publications Office of the European Union 2020 JRC117501 978-92-76-12335-4 1 451 urn:nbn:de:kobv:b43-504250 10.2760/79490 https://creativecommons.org/licenses/by/4.0/deed.de 2020-02-20 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 OPUS4-50370 Handbuch Mech, A.; Rauscher, H.; Rasmussen, K.; Babick, F.; Hodoroaba, Vasile-Dan; Ghanem, A.; Wohlleben, W.; Marvin, H.; Brüngel, R.; Friedrich, C. M. The NanoDefine Methods Manual - Part 2: Evaluation of methods The present series of reports, the NanoDefine Methods Manual, has been developed within the NanoDefine project 'Development of an integrated approach based on validated and standardized methods to support the implementation of the EC recommendation for a definition of nanomaterial', funded by the European Union's 7th Framework Programme, under grant agreement 604347. In 2011 the European Commission (EC) published a recommendation for a definition of the term 'nanomaterial', the EC NM Definition, as a reference to determine whether an unknown material can be considered as a 'nanomaterial' for regulatory purposes1. One challenge is the development of methods that reliably identify, characterize and quantify nanomaterials (NM) both as substances and in various products and matrices. The overall goal of NanoDefine was to support the implementation of the EC NM Definition. It can also support the implementation of any NM definition based on particle size. The project has developed an integrated approach, which allows identifying any material as a nano- or not a nanomaterial according to the EC NM Definition. NanoDefine explicitly supported the governance challenges associated with the implementation of legislation concerning nanomaterials by: - addressing the issues on availability of suitable measuring techniques, reference materials, validated methods, acceptable to all stakeholders (authorities, policy makers, commercial firms), - developing an integrated and interdisciplinary approach and a close international co-operation and networking with academia, commercial firms and standardization bodies. Thus, the NanoDefine Methods Manual provides guidance on practical implementation of the EC NM Definition throughout the nanomaterial characterization process, and on the characterization techniques employed as well as their application range and limits. It assists the user in choosing the most appropriate measurement method(s) to identify any substance or mixture for a specific purpose, according to the EC NM Definition of a nanomaterial. The NanoDefine project also explored how to assess a material against the criteria of the definition through proxy solutions, i.e. by applying measurement techniques that indirectly determine the x50. Those findings were developed through empirically based scientific work and are included in Part 1 of this Manual. As they go beyond the text of the EC NM Definition, they may be used as practical approach to indicate whether a material is a nanomaterial or not, but keeping in mind that they should not be taken as recommendation for the implementation of the EC NM Definition in a regulatory context. The NanoDefine Methods Manual consists of the following three parts:  Part 1: The NanoDefiner Framework and Tools  Part 2: Evaluation of Methods  Part 3: Standard Operating Procedures (SOPs) Part 1 covers the NanoDefiner framework, general information on measurement methods and performance criteria and tools developed by NanoDefine such as a materials categorisation system, a decision support flow scheme and an e-tool. Part 2 discusses the outcome of the evaluation of the nanomaterials characterisation methods for measuring size. Part 3 presents the 23 Standard Operating Procedures developed within the NanoDefine project. The current document is part 2. Luxembourg Publications Office of the European Union 2020 The NanoDefine Methods Manual JRC117501 978-92-76-11953-1 1 133 urn:nbn:de:kobv:b43-503708 10.2760/071877 https://creativecommons.org/licenses/by/4.0/deed.de 2020-02-12 OPUS4-50371 Handbuch Mech, A.; Rauscher, H.; Rasmussen, K.; Babick, F.; Hodoroaba, Vasile-Dan; Ghanem, A.; Wohlleben, W.; Marvin, H.; Brüngel, R.; Friedrich, C. M.; Löschner, K.; Gilliland, D. The NanoDefine Methods Manual - Part 3: Standard Operating Procedures (SOPs) The present series of reports, the NanoDefine Methods Manual, has been developed within the NanoDefine project 'Development of an integrated approach based on validated and standardized methods to support the implementation of the EC recommendation for a definition of nanomaterial'1 funded by the European Union's 7th Framework Programme, under grant agreement 604347. In 2011 the European Commission (EC) published the recommendation (2011/696/EU) for a definition of the term 'nanomaterial'1, the EC NM Definition, as a reference to determine whether an unknown material can be considered as a 'nanomaterial' for regulatory purposes. One challenge is the development of methods that reliably identify, characterize and quantify nanomaterials (NM) both as substances and in various products and matrices. The overall goal of NanoDefine was to support the implementation of the EC NM Definition. It can also support the implementation of any NM definition based on particle size. The project has developed an integrated approach, which allows identifying any material as a nano or non-nano material according to the EC NM Definition. NanoDefine explicitly supported the governance challenges associated with the implementation of legislation concerning nanomaterials by: - addressing the issues on availability of suitable measuring techniques, reference materials, validated methods, acceptable to all - developing an integrated and interdisciplinary approach and a close international co-operation and networking with academia, commercial firms and standardization bodies. Thus, the NanoDefine Methods Manual provides guidance on practical implementation of the EC NM Definition throughout the nanomaterial characterization process, and on the characterization techniques employed as well as their application range and limits. It assists the user in choosing the most appropriate measurement method(s) to identify any substance or mixture for a specific purpose, according to the EC NM Definition of a nanomaterial. The NanoDefine project also explored how to assess a material against the criteria of the definition through proxy solutions, i.e. by applying measurement techniques that indirectly determine the D50. Those findings were developed through empirically based scientific work and are included in Part 1 of this Manual. As they go beyond the text of the EC NM Definition, they may be used as practical approach to indicate whether a material is a nanomaterial or not, but keeping in mind that they should not be taken as recommendation for the implementation of the EC NM Definition in a regulatory context. The NanoDefine Methods Manual consists of the following three parts:  Part 1: The NanoDefiner Framework and Tools  Part 2: Evaluation of Methods  Part 3: Standard Operating Procedures (SOPs) Part 1 covers the NanoDefiner framework, general information on measurement methods and performance criteria and tools developed by NanoDefine such as a materials categorisation system, a decision support flow scheme and an e-tool. Part 2 discusses the outcome of the evaluation of the nanomaterials characterisation methods for measuring size. Part 3 presents the 23 Standard Operating Procedures developed within the NanoDefine project. The current document is part 3. Luxembourg Publications Office of the European Union 2020 NanoDefine Methods Manual JRC117501 978-92-76-11955-5 1 215 urn:nbn:de:kobv:b43-503710 10.2760/02910 https://creativecommons.org/licenses/by/4.0/deed.de 2020-02-12 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 OPUS4-43540 Forschungsbericht Rauscher, H.; Mech, A.; Gaillard, C.; Stintz, M.; Wohlleben, W.; Weigel, St.; Ghanem, A.; Hodoroaba, Vasile-Dan; Babick, F.; Mielke, Johannes Recommendations on a revision of the EC definition of nanomaterial based on analytical possibilities; updated In October 2011 the European Commission (EC) published a "Recommendation on the definition of na-nomaterial" (2011/696/EU), to promote consistency in the interpretation of the term "nanomaterial" for legislative and policy purposes in the EU. The EC NM Definition includes a commitment to its review in the light of experience and of scientific and technological developments. This review is ongoing in 2017 and as a contribution to the review the Joint Research Centre of the European Commission (JRC) has already developed a series of three scientific-technical reports with the title: "Towards a review of the EC Recommendation for a definition of the term nanomaterial" which provides to the EC policy services sci-ence-based options on how the definition could be revised or supported with additional guidance. The overarching nature and wide scope of the EC NM Definition, as it does not exclude a priori any particulate material regardless the state, form and size, creates many analytical challenges in its imple-mentation for all stakeholders, including enterprises and regulators. The NanoDefine project has as core objective to support the implementation of the EC NM Definition. In an earlier report1 key aspects of the EC NM Definition were addressed, with the goal to improve the implementability of the EC NM Definition. Based on further developments and results obtained in NanoDefine project that first report was updated and is presented here. The key aspects are discussed based on the results of four years of research performed within the framework of the project. As a result this report assesses how well the requirements of the EC NM Definition can be fulfilled with currently available analytical possibilities. It presents recommendations and options on a revision of the EC NM Definition to improve the implementability of the definition based on currently available analytical possi-bilities, according to the state of the art in 2017. Of the technical issues considered in this report, the following seem to deserve the most attention in terms of clarification of the definition and/or provision of additional implementation guidance: 'external dimension', 'number based particle size distribution', 'polydispersity' and 'upper size limit', the term 'particle', the 'means to prove that a material is not a nanomaterial' and 'the role of the volume specific sur-face area (VSSA)', and "particulate materials'. Wageningen, The Netherlands The NanoDefine Consortium 2017 D7.10, 1 D7.10, 71 2017-12-22 OPUS4-43233 Forschungsbericht Rauscher, H.; Mech, A.; Gaillard, C.; Stintz, M.; Wohlleben, W.; Weigel, St.; Ghanem, A.; Hodoroaba, Vasile-Dan; Babick, F.; Mielke, Johannes Recommendations on a Revision of the EC Definition of Nanomaterial Based on Analytical Possibilities In October 2011 the European Commission (EC) published a "Recommendation on the definition of nanomaterial" (2011/696/EU), to promote consistency in the interpretation of the term "nanomaterial" for legislative and policy purposes in the EU. The EC NM Definition includes a commitment to its review in the light of experience and of scientific and technological developments. This review is ongoing in 2015 and as a contribution to the review the Joint Research Centre of the European Commission (JRC) has already developed a series of three scientific-technical reports with the title: "Towards a review of the EC Recommendation for a definition of the term nanomaterial" which provides to the EC policy services science-based options on how the definition could be revised or supported with additional guidance. The overarching nature and wide scope of the EC NM Definition, as it does not exclude a priori any particulate material regardless the state, form and size, creates many analytical challenges in its imple-mentation for all stakeholders, including enterprises and regulators. The NanoDefine project has as core objective to support the implementation of the EC NM Definition. In this report key aspects of the EC NM Definition are addressed, with the goal to improve the implement-ability of the EC NM Definition. These aspects are presented and discussed based on the results of two years of research performed within the framework of the project. As a result this report assesses how well the requirements of the EC NM Definition can be fulfilled with currently available analytical possi-bilities. It presents recommendations and options on a revision of the EC NM Definition to improve the implementability of the definition based on currently available analytical possibilities, according to the state of the art of mid-2015. Of the technical issues considered in this report, the following seem to deserve the most attention in terms of clarification of the definition and/or provision of additional implementation guidance:  The term 'external dimension'. A clear definition of 'External dimension' should be included in the text of the EC NM definition and more precise guidance on what is considered as an external dimension and how to properly character-ise it should be provided.  The 'number based particle size distribution'. The EC NM Definition uses a threshold related to the number based size distribution of particles. Yet most of the easily available techniques provide a mass-, volume- or scattered light intensity-based size distribution which needs to be converted into a number based distribution to be used for regulatory pur-poses. A specific guidance on the conditions under which these methods can be used to identify a na-nomaterial by employing appropriate quantity or metrics conversion should be provided.  The 'polydispersity' and 'upper size limit' Polydispersity is a challenge for the measurement of particle size distribution for the EC NM definition, specifically for materials with high polydispersity index and broad size distribution especially when the volume or mass of the fraction containing particles below 100 nm is very small. Therefore a dedicated guidance should be provided that allows applying an upper size limit in measurements and particle statistics. Wageningen, The Netherlands The NanoDefine Consortium RIKILT, 6708 WB Wageningen, The Netherlands 2015 1 68 urn:nbn:de:kobv:b43-432339 http://www.gesetze-im-internet.de/urhg/index.html 2017-12-04 OPUS4-47162 Zeitschriftenartikel Gaillard, C.; Mech, A.; Wohlleben, W.; Babick, F.; Hodoroaba, Vasile-Dan; Ghanem, A.; Weigel, S.; Rauscher, H. A technique-driven materials categorisation scheme to support regulatory identification of nanomaterials Worldwide there is a variety of regulatory provisions addressing nanomaterials. The identification as nanomaterial in a regulatory context often has the consequence that specific legal rules apply. In identifying nanomaterials, and to find out whether nanomaterial-specific provisions apply, the external size of particles is globally used as a criterion. For legal certainty, its assessment for regulatory purposes should be based on measurements and methods that are robust, fit for the purpose and ready to be accepted by different stakeholders and authorities. This should help to assure the safety of nanomaterials and at the same time facilitate their international trading. Therefore, we propose a categorisation scheme which is driven by the capabilities of common characterisation techniques for particle size measurement. Categorising materials according to this scheme takes into account the particle properties that are most important for a determination of their size. The categorisation is exemplified for the specific particle number based size metric of the European Commission's recommendation on the definition of nanomaterial, but it is applicable to other metrics as well. Matching the performance profiles of the measurement techniques with the material property profiles (i) allows selecting the most appropriate size determination technique for every type of material considered, (ii) enables proper identification of nanomaterials, and (iii) has the potential to be accepted by regulators, industry and consumers alike. Having such a scheme in place would facilitate the regulatory assessment of nanomaterials in regional legislation as well as in international relations between different regulatory regions assuring the safe trade of nanomaterials. The Royal Society of Chemistry 2019 Nanoscale Advances 1 11 urn:nbn:de:kobv:b43-471623 10.1039/C8NA00175H https://creativecommons.org/licenses/by-nc/4.0/deed.de 2019-01-09