Rasmussen Kirsten, Sayre Phil, Kobe Andrej, Gonzalez Mar, Rauscher Hubert
European Commission, Joint Research Centre (JRC), Ispra, Italy.
nanoRisk Analytics LLC, Auburn, CA, United States.
Front Toxicol. 2025 Jul 10;7:1629813. doi: 10.3389/ftox.2025.1629813. eCollection 2025.
This paper examines the global communities' regulatory and scientific advancements in nanotechnology and nanomaterials since 2000. It explores some similarities and differences in nanomaterial safety compared to general chemical safety. The paper provides an overview of the encountered challenges and how far they have been resolved, as well as information on how different countries' legislators have addressed nanomaterials, including safety assessment in (new) legislation. Challenges arose due to the unique physico-chemical properties of some nanomaterials and included the lack of i) a regulatory definition, ii) applicable regulatory test methods, including methods for physico-chemical characterization and for ecotoxicological effects, as well as sample preparation and dosimetry, iii) assessment and modelling of human, especially occupational, and environmental exposure to nanomaterials, iv) quantification of nanomaterial in complex media, v) systems for collecting the data generated and ensuring FAIR (Findable, Accessible, Interoperable and Re-usable) and quality data, vi) reference nanomaterials, and vii) a frame for nanotechnology governance. The paper highlights the role of the Organisation for Economic Co-operation and Development (OECD) in building a global, regulatory understanding of nanotechnology and nanomaterials, as well as the OECD's achievements of developing nano-specific test guidelines. The paper identifies areas, such as alternative test methods, availability of reference nanomaterials, comparable data and FAIR data, analytical tools for quantifying nanomaterials in (complex) matrices that are still under-addressed. It gives a wider perspective of Governance of Advanced Materials including nanomaterials, also illustrated by carbon nanotubes used in batteries for electric vehicles, to also aid their commercialization. In the EU, the policy context is moving towards a holistic governance approach embracing sustainability dimensions.
本文考察了自2000年以来全球各界在纳米技术和纳米材料方面的监管及科学进展。探讨了纳米材料安全性与一般化学品安全性相比的一些异同。本文概述了所遇到的挑战以及这些挑战在多大程度上得到了解决，还介绍了不同国家的立法者如何处理纳米材料，包括（新）立法中的安全评估。由于某些纳米材料独特的物理化学性质而产生了挑战，这些挑战包括：一、缺乏监管定义；二、缺乏适用的监管测试方法，包括物理化学表征方法、生态毒理学效应方法以及样品制备和剂量测定方法；三、对人类，尤其是职业接触以及环境接触纳米材料的评估和建模；四、复杂介质中纳米材料的量化；五、用于收集所产生数据并确保数据具有FAIR（可查找、可访问、可互操作和可再利用）及质量的数据系统；六、缺乏参考纳米材料；七、缺乏纳米技术治理框架。本文强调了经济合作与发展组织（OECD）在建立全球对纳米技术和纳米材料的监管理解方面所发挥的作用，以及经合组织在制定纳米特定测试指南方面所取得的成就。本文指出了一些仍未得到充分解决的领域，如替代测试方法、参考纳米材料的可用性、可比数据和FAIR数据、用于量化（复杂）基质中纳米材料的分析工具。本文从更广泛的角度阐述了包括纳米材料在内的先进材料治理，以电动汽车电池中使用的碳纳米管为例进行说明，这也有助于其商业化。在欧盟，政策背景正朝着涵盖可持续性维度的整体治理方法转变。
