A European nano-registry as a reliable database for quantitative risk assessment of nanomaterials? A comparison of national approaches,NanoImpact

当前位置： X-MOL 学术 › NanoImpact › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

A European nano-registry as a reliable database for quantitative risk assessment of nanomaterials? A comparison of national approaches
NanoImpact ( IF 4.7 ) Pub Date : 2021-01-01 , DOI: 10.1016/j.impact.2020.100276
Anna Pavlicek ₁ , Florian Part ₂ , Gloria Rose ₃ , Antonia Praetorius ₄ , Martin Miernicki ₅ , André Gazsó ₃ , Marion Huber-Humer ₆

Affiliation

Abstract Despite the fact that nanomaterials have been in use for decades and chemicals legislation is largely harmonised within the EU, quantitative and safety-relevant information on nanomaterials is still scarce. In particular, information about production volumes, their unique physicochemical properties (size, specific surface area, etc.) and nanomaterial exposure, which may lead to adverse effects on human health and the environment, is still lacking. While the latest amendments of the REACH Annexes have led to certain improvements, a harmonised EU-wide nano-registry would provide additional quantitative data for risk assessment but is not foreseeable for the near future. Since the European Commission, the European Parliament and some member states take contrasting approaches to the regulation of nanomaterials, France, Belgium, Denmark, Sweden and Norway (as a country of the European Economic Area), launched national mandatory reporting systems to collect quantitative information, thus fostering early risk assessment of nanomaterials. In this study, we compare national registries – based on a literature review and expert interviews – and show differences between the regulations under the respective national laws and REACH regulation. These include, for instance, thresholds for notification and level of detail on the specification of the nanomaterial, mixture and/or product, the definition of exceptions for the requirement to register and the timing of registration. As this heterogenous regulatory framework hinders comparability and potentially creates trade barriers, we argue that a harmonised EU-wide nano-registry would substantially improve the current situation by promoting the safe and sustainable handling of nanomaterials, increasing transparency and trust, and consequently nurturing innovation. Such an EU-wide nano-registry should both cover nanomaterials as substances or mixtures, such as in REACH registration, and the semi−/finished products they will be used in, since the exposure, and thus the hazardous potential of released nanomaterials during their life cycle, depends largely on the scope of application.

中文翻译：

一个欧洲纳米登记作为纳米材料定量风险评估的可靠数据库？国家方法的比较

摘要尽管纳米材料已经使用了几十年，并且欧盟内部的化学品立法在很大程度上得到了协调，但关于纳米材料的定量和安全相关信息仍然很少。特别是，关于产量、其独特的物理化学性质（尺寸、比表面积等）和可能对人类健康和环境造成不利影响的纳米材料暴露的信息仍然缺乏。虽然 REACH 附件的最新修订导致了某些改进，但统一的欧盟范围内的纳米登记将为风险评估提供额外的定量数据，但在不久的将来是不可预见的。由于欧盟委员会、欧洲议会和一些成员国对纳米材料的监管采取了不同的方法，法国、比利时、丹麦、瑞典和挪威（作为欧洲经济区的一个国家）启动了国家强制性报告系统以收集定量信息，从而促进纳米材料的早期风险评估。在这项研究中，我们根据文献回顾和专家访谈比较了国家注册机构，并显示了各自国家法律和 REACH 法规下的法规之间的差异。例如，通知门槛和纳米材料、混合物和/或产品规格的详细程度、注册要求的例外定义和注册时间。由于这种异质的监管框架阻碍了可比性并可能造成贸易壁垒，我们认为，通过促进纳米材料的安全和可持续处理，提高透明度和信任度，从而培育创新，一个统一的欧盟范围内的纳米登记将大大改善当前的情况。这种欧盟范围内的纳米注册应涵盖纳米材料作为物质或混合物，例如在 REACH 注册中，以及它们将用于的半成品/成品，因为暴露，因此释放的纳米材料在其释放过程中的潜在危险生命周期，很大程度上取决于应用范围。

更新日期：2021-01-01

点击分享查看原文

点击收藏

公开下载

阅读更多本刊最新论文