NanoDefiner e-Tool: An Implemented Decision Support Framework for Nanomaterial Identification

Brüngel, Raphael; Rückert, Johannes; Wohlleben, Wendel; Babick, Frank; Ghanem, Antoine; Gaillard, Claire; Mech, Agnieszka; Rauscher, Hubert; Hodoroabă, Vasile-Dan; Weigel, Stefan; Friedrich, Christoph M.

doi:10.3390/ma12193247

Cited by 10 publications

(10 citation statements)

References 35 publications

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“…A hands-on training prior to the summit (September 24) on determining size distributions of nanomaterials was provided to 28 participants from 12 countries. Participants had the opportunity to deepen their knowledge on nanoparticle size distributions, to apply specific measurement techniques and to discover the capabilities of the NanoDefiner e-tool, a decision support framework for the characterisation of potential nanomaterials developed in the European Union NanoDefine project ( Mech et al, 2020a ; Brüngel et al, 2019 ). Furthermore, 29 participants of the 2019 GSRS attended a short course on the use of reference materials including the estimation of measurement uncertainty organised by the JRC and another 40 attendees of 2019 GSRS visited several laboratories at the JRC-Ispra site on September 27.…”

Section: Introductionmentioning

confidence: 99%

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Jacqueline¹,

Belz

Hoeveler

et al. 2021

Regulatory Toxicology and Pharmacology

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140

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Nanotechnology and more particularly nanotechnology-based products and materials have provided a huge potential for novel solutions to many of the current challenges society is facing. However, nanotechnology is also an area of product innovation that is sometimes developing faster than regulatory frameworks. This is due to the high complexity of some nanomaterials, the lack of a globally harmonised regulatory definition and the different scopes of regulation at a global level. Research organisations and regulatory bodies have spent many efforts in the last two decades to cope with these challenges. Although there has been a significant advancement related to analytical approaches for labelling purposes as well as to the development of suitable test guidelines for nanomaterials and their safety assessment, there is a still a need for greater global collaboration and consensus in the regulatory field. Furthermore, with growing societal concerns on plastic litter and tiny debris produced by degradation of littered plastic objects, the impact of micro- and nanoplastics on humans and the environment is an emerging issue. Despite increasing research and initial regulatory discussions on micro- and nanoplastics, there are still knowledge gaps and thus an urgent need for action. As nanoplastics can be classified as a specific type of incidental nanomaterials, current and future scientific investigations should take into account the existing profound knowledge on nanotechnology/nanomaterials when discussing issues around nanoplastics. This review was conceived at the 2019 Global Summit on Regulatory Sciences that took place in Stresa, Italy, on 24–26 September 2019 (GSRS 2019) and which was co-organised by the Global Coalition for Regulatory Science Research (GCRSR) and the European Commission's (EC) Joint Research Centre (JRC). The GCRSR consists of regulatory bodies from various countries around the globe including EU bodies. The 2019 Global Summit provided an excellent platform to exchange the latest information on activities carried out by regulatory bodies with a focus on the application of nanotechnology in the agriculture/food sector, on nanoplastics and on nanomedicines, including taking stock and promoting further collaboration. Recently, the topic of micro- and nanoplastics has become a new focus of the GCRSR. Besides discussing the challenges and needs, some future directions on how new tools and methodologies can improve the regulatory science were elaborated by summarising a significant portion of discussions during the summit. It has been revealed that there are still some uncertainties and knowledge gaps with regard to physicochemical properties, environmental behaviour and toxicological effects, especially as testing described in the dossiers is often done early in the product development process, and the material in the final product may behave differently. The harmonisation of methodologies for quantification and risk assessment of nanomaterials and micro/nanoplastics, the documentation...

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Section: Introductionmentioning

confidence: 99%

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Jacqueline¹,

Belz

Hoeveler

et al. 2021

Regulatory Toxicology and Pharmacology

Self Cite

140

View full text Add to dashboard Cite

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“…Especially at the tedious manual analysis, the minimum Feret diameter (distance between parallel tangents, corresponds to the “breadth” of the particle) is mostly measured, hence, being also in line with a basic requirement of the EC definition of nanomaterial, which specifies the smallest dimension of particles as defining if a material is nano or not-nano. Meanwhile, there are also software packages available as support for users in categorization of a material as nano or non-nano [ 42 ]. The accurate determination of the smallest dimension of particles constitutes a valuable strength of electron microscopy in comparison to other sizing methods when measuring particles of complex shape.…”

Section: Resultsmentioning

confidence: 99%

Reliable Surface Analysis Data of Nanomaterials in Support of Risk Assessment Based on Minimum Information Requirements

Radnik

Kersting²,

Hagenhoff³

et al. 2021

Nanomaterials

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The minimum information requirements needed to guarantee high-quality surface analysis data of nanomaterials are described with the aim to provide reliable and traceable information about size, shape, elemental composition and surface chemistry for risk assessment approaches. The widespread surface analysis methods electron microscopy (SEM), energy dispersive X-ray spectroscopy (EDS), X-ray photoelectron spectroscopy (XPS) and secondary ion mass spectrometry (SIMS) were considered. The complete analysis sequence from sample preparation, over measurements, to data analysis and data format for reporting and archiving is outlined. All selected methods are used in surface analysis since many years so that many aspects of the analysis (including (meta)data formats) are already standardized. As a practical analysis use case, two coated TiO2 reference nanoparticulate samples, which are available on the Joint Research Centre (JRC) repository, were selected. The added value of the complementary analysis is highlighted based on the minimum information requirements, which are well-defined for the analysis methods selected. The present paper is supposed to serve primarily as a source of understanding of the high standardization level already available for the high-quality data in surface analysis of nanomaterials as reliable input for the nanosafety community.

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“…It builds on three pillars: i) a Methods Knowledge Base (MKB), [16] ii) a techniquedriven Materials Categorization Scheme (MCS), [24] and iii) the DSFS. [16] The Methods Knowl edge Base, the Material Categorization Scheme, and the DSFS are also implemented in a newly developed software solution, the NanoDefiner etool, [25] which is available online. [26] All ele ments of the framework are interlinked and fed by the results and knowledge acquired during the application of the other parts of the framework.…”

Section: The Nanodefiner Framework: An Intelligent Strategy For the Imentioning

confidence: 99%

“…Within the NanoDefine project, case studies were performed to test the DSFS, the MCS, [24] and the etool. [25] Details can be found in a NanoDefine Technical Report. [27] Here, we present a summary of three case studies that illustrate the application of the NanoDefiner Framework.…”

Section: Examples For the Application Of The Nanodefiner Frameworkmentioning

confidence: 99%

Nano or Not Nano? A Structured Approach for Identifying Nanomaterials According to the European Commission’s Definition

Mech

Wohlleben

Ghanem

et al. 2020

Small

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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.

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NanoDefiner e-Tool: An Implemented Decision Support Framework for Nanomaterial Identification

Cited by 10 publications

References 35 publications

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Reliable Surface Analysis Data of Nanomaterials in Support of Risk Assessment Based on Minimum Information Requirements

Nano or Not Nano? A Structured Approach for Identifying Nanomaterials According to the European Commission’s Definition

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