University of Vienna, Department of Environmental Geosciences, Vienna, Austria.
University of Vienna, Department of Business Law, Vienna, Austria.
Nat Nanotechnol. 2019 Mar;14(3):208-216. doi: 10.1038/s41565-019-0396-z. Epub 2019 Mar 5.
The European Union (EU) has adopted nano-specific provisions for cosmetics, food and biocides, among others, which include binding definitions of the term "nanomaterial". Here we take an interdisciplinary approach to analyse the respective definitions from a legal and practical perspective. Our assessment reveals that the definitions contain several ill-defined terms such as "insoluble" or "characteristic properties" and/or are missing thresholds. Furthermore, the definitions pose major and so far unsolved analytical challenges that, in practice, make it nearly impossible to classify nanomaterials according to EU regulatory requirements. An important purpose of the regulations, the protection of human health and the environment, may remain unfulfilled and the development of innovative applications of nanomaterials may be facing a path full of (legal) uncertainties. Based on our findings, we provide five recommendations for a more coherent and practical approach towards the regulation of nanomaterials.
欧盟（EU）针对化妆品、食品和生物杀灭剂等产品采用了专门针对纳米技术的规定，其中包括对“纳米材料”一词的具约束力的定义。在此，我们从法律和实际角度出发，采用跨学科方法来分析各自的定义。我们的评估表明，这些定义包含几个定义不明确的术语，例如“不溶”或“特性”，或者缺少阈值。此外，这些定义还带来了重大的、迄今尚未解决的分析挑战，实际上，根据欧盟监管要求对纳米材料进行分类几乎是不可能的。这些法规的一个重要目的是保护人类健康和环境，而这一目的可能无法实现，纳米材料的创新应用的发展可能面临充满（法律）不确定性的道路。基于我们的研究结果，我们为更一致和更实际的纳米材料监管方法提供了五项建议。
