Gaillard Claire, Mech Agnieszka, Wohlleben Wendel, Babick Frank, Hodoroaba Vasile-Dan, Ghanem Antoine, Weigel Stefan, Rauscher Hubert
European Commission, Joint Research Centre 21027 Ispra (VA) Italy
BASF SE, Material Physics Research 67056 Ludwigshafen Germany.
Nanoscale Adv. 2018 Nov 13;1(2):781-791. doi: 10.1039/c8na00175h. eCollection 2019 Feb 12.
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.
全球范围内有各种针对纳米材料的监管规定。在监管背景下被认定为纳米材料通常会导致适用特定的法律规则。在识别纳米材料以及确定是否适用纳米材料特定规定时，颗粒的外部尺寸在全球范围内被用作一项标准。为确保法律确定性，出于监管目的对其进行评估应基于可靠、适用且能被不同利益相关者和监管机构接受的测量方法。这应有助于确保纳米材料的安全性，同时促进其国际贸易。因此，我们提出一种分类方案，该方案由粒度测量常用表征技术的能力驱动。根据此方案对材料进行分类会考虑对确定其尺寸最为重要的颗粒特性。该分类以欧盟委员会关于纳米材料定义的建议中基于特定颗粒数的尺寸度量为例进行说明，但它也适用于其他度量。将测量技术的性能概况与材料特性概况相匹配：（i）能够为每种所考虑的材料类型选择最合适的尺寸测定技术；（ii）有助于正确识别纳米材料；（iii）有可能被监管机构、行业和消费者共同接受。制定这样一个方案将有助于在区域立法以及不同监管区域之间的国际关系中对纳米材料进行监管评估，确保纳米材料的安全贸易。
