TY - CONF A1 - Mech, A. A1 - Gaillard, C. A1 - Marvin, H. A1 - Wohlleben, W. A1 - Hodoroaba, Vasile-Dan A1 - Babick, F. A1 - Friedrich, C. M. A1 - Brüngel, R. A1 - Rückert, J. A1 - Ghanem, A. A1 - Weigel, S. T1 - The NanoDefine Decision Framework and NanoDefiner e-Tool: a practical guide to the identification of nanomaterials T2 - PTB-Bericht F-61 - NanoWorkshop 2018: Workshop on Reference Nanomaterials N2 - 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. T2 - NanoWorkshop 2018: Workshop on Reference Nanomaterials CY - Berlin, Germany DA - 14.05.2018 KW - Definition of nanomaterial KW - Regulation PY - 2019 SN - 978-3-95606-440-1 SN - 0179-0609 VL - F-61 SP - 114 EP - 124 PB - Physikalisch-Technische Bundesanstalt CY - Braunschweig und Berlin AN - OPUS4-49992 LA - eng AD - Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin, Germany ER - TY - JOUR A1 - Gaillard, C. A1 - Mech, A. A1 - Wohlleben, W. A1 - Babick, F. A1 - Hodoroaba, Vasile-Dan A1 - Ghanem, A. A1 - Weigel, S. A1 - Rauscher, H. T1 - A technique-driven materials categorisation scheme to support regulatory identification of nanomaterials JF - Nanoscale Advances N2 - 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. KW - Nanomaterial KW - Nanoparticles KW - Categorisation scheme KW - EC definition of a nanomaterial KW - Regulatory identification of nanomaterials PY - 2019 UR - https://nbn-resolving.org/urn:nbn:de:kobv:b43-471623 DO - https://doi.org/10.1039/C8NA00175H SN - 2516-0230 SP - 1 EP - 11 PB - The Royal Society of Chemistry AN - OPUS4-47162 LA - eng AD - Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin, Germany ER -