Integrative Toxicology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
Department of Philosophy and History, Royal Institute of Technology, Stockholm, Sweden.
Arch Toxicol. 2019 May;93(5):1187-1200. doi: 10.1007/s00204-019-02439-0. Epub 2019 Apr 16.
Derived no-effect levels for workers (wDNELs) under the European REACH legislation have many aspects in common with occupational exposure limits (OELs). In an attempt to examine under which circumstances wDNELs might be used as exposure guidance outside their intended application, we compared derivation methods, coverage of substances and numerical values of wDNELs against two regulatory OEL lists (European Commission and Sweden) and three sets of recommendations (European SCOEL, German MAK and US ACGIH). Finally, we looked closer at wDNELs where SCOEL concluded that data were insufficient to derive an OEL. Major differences between wDNELs and OELs include regulatory background, intended use, actors involved, substance selection criteria, transparency and procedure of derivation, and operationalisation in terms of risk management measures. As of summer 2018, approximately five times more substances were covered by wDNELs than by the five sets of OELs examined herein. Meanwhile, many occupationally relevant pollutants were not covered by wDNELs, e.g. one-third of Swedish OELs lack corresponding wDNELs. We also note that wDNELs and OELs for the same substance may vary considerably, up to several orders of magnitude. In conclusion, with extensive substance coverage, wDNELs extend the landscape beyond the OELs. That said, important limitations are (1) that many air pollutants relevant for workers' health are not covered by REACH, and (2) concerns for inconsistencies in the derivation of wDNELs and in their level of protection. In particular, that route-to-route extrapolation is a common practice that may be grossly misleading when the effect of concern is local, e.g. sensitisation.
根据欧盟 REACH 法规制定的工人无作用水平(wDNEL)与职业接触限值(OEL)有许多共同之处。为了研究在何种情况下 wDNEL 可以超出预期应用范围用作接触指导,我们将 wDNEL 的制定方法、物质涵盖范围和数值与两份法规 OEL 清单(欧盟委员会和瑞典)以及三套建议(欧洲 SCOEL、德国 MAK 和美国 ACGIH)进行了比较。最后,我们更详细地研究了 SCOEL 认为数据不足以制定 OEL 的 wDNEL。wDNEL 和 OEL 之间的主要区别包括监管背景、预期用途、涉及的角色、物质选择标准、透明度和制定程序,以及风险管理措施方面的实施。截至 2018 年夏季,wDNEL 涵盖的物质大约是本文研究的五套 OEL 的五倍。同时,许多与职业相关的污染物未被 wDNEL 涵盖,例如,瑞典 OEL 中有三分之一缺乏相应的 wDNEL。我们还注意到,同一物质的 wDNEL 和 OEL 可能有很大差异,甚至相差几个数量级。总之,wDNEL 以广泛的物质涵盖范围扩展了 OEL 的范围。也就是说,重要的局限性在于 (1) 许多与工人健康相关的空气污染物不受 REACH 管制,以及 (2) 对 wDNEL 的制定和保护水平的不一致性表示担忧。特别是,当关注的效应是局部的,例如致敏,途径到途径的外推法是一种常见的做法,但可能会产生严重的误导。