Franco Antonio, Hansen Steffen Foss, Olsen Stig Irving, Butti Luciano
Institute of Environment & Resources, Technical University of Denmark, Building 113, NanoDTU Environment, DK 2800 Kgs. Lyngby, Denmark.
Regul Toxicol Pharmacol. 2007 Jul;48(2):171-83. doi: 10.1016/j.yrtph.2007.03.007. Epub 2007 Apr 14.
Scientific uncertainty involved in evaluating potentially harmful properties of engineered nanoparticles complicates and hampers the implementation of proportionate regulative measures by legislators. The European Commission has adopted a so-called "incremental approach", which focuses on adapting existing laws to regulate nanotechnologies, and therefore this paper aims to test the effectiveness of the "incremental approach". Three commercially available products containing fullerenes (C(60) and carbon nanotubes) were analysed in a life cycle perspective in order to (1) map current applicable regulations, (2) analyse their applicability to nanomaterials, (3) identify their gaps, and (4) suggest proper solutions. After mapping the life cycle of the three products, we analysed applicable regulations in the order in which they became relevant in their life cycle, i.e.: The Safety at Workplace Directives. Directive 61/1996 on the Integrated Pollution Prevention and Control. The European Union's Directive on the Registration, Evaluation, Authorization and Restriction of Chemicals, and The Waste Management Directives. It was found that the applicability of environmental laws is limited due to difficulties in generating sufficient data on the nanomaterials residing in the products according to their life cycles. Further, metrology tools are unavailable; thresholds are not tailored to the nanoscale; and toxicological data and occupational exposure limits cannot be established with existing methodologies. We conclude that the "incremental approach" can only be applicable with the implementation of due amendments.
评估工程纳米颗粒潜在有害特性时涉及的科学不确定性，使立法者制定相称的监管措施变得复杂并受到阻碍。欧盟委员会采用了一种所谓的“渐进式方法”，该方法侧重于调整现有法律以规范纳米技术，因此本文旨在检验“渐进式方法”的有效性。从生命周期的角度分析了三种含有富勒烯（C(60)）和碳纳米管的市售产品，以便（1）梳理当前适用的法规，（2）分析其对纳米材料的适用性，（3）找出其中的差距，以及（4）提出适当的解决方案。在梳理了这三种产品的生命周期后，我们按照它们在生命周期中变得相关的顺序分析了适用的法规，即：《工作场所安全指令》、关于综合污染预防与控制的第61/1996号指令、欧盟关于化学品注册、评估、授权和限制的指令，以及《废物管理指令》。结果发现，由于难以根据产品生命周期生成有关其中纳米材料的足够数据，环境法律的适用性受到限制。此外，计量工具不可用；阈值未针对纳米尺度进行调整；并且现有方法无法确定毒理学数据和职业接触限值。我们得出结论，只有在进行适当修订后，“渐进式方法”才能适用。
