Background

Under the EU chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals EC 1907/2006), registrants are not obliged to provide information related to intrinsic substance properties for substances that pose a threat to the drinking water resources. In 2019, perfluorobutane sulfonic acid (PFBS) and 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)-propanoic acid (HFPO-DA trade name GenX) were demonstrated to have an equivalent level of concern (ELoC) to persistent, bioaccumulative and toxic or very persistent and very bioaccumulative (PBT/vPvB) substances owing to their persistent, mobile and toxic (PMT) substance properties and very persistent and very mobile (vPvM) substance properties, respectively. They were both subsequently identified as substances of very high concern (SVHC) applying Article 57(f) in REACH. This work follows up on this regulatory decision by presenting a science based, conceptual level comparison that all PMT/vPvM substances pose an ELoC to PBT/vPvB substances. Using the two cases named above, as well as 1,4-dioxane, 16 categories were developed to evaluate a) serious effects on human health, b) serious effects on the environment and c) additional effects. 1,4-dioxane has recently been proposed to be classified as Carcinogenic 1B by the Committee for Risk Assessment (RAC). The aim was to enable an objective and scientifically justified conclusion that these classes of substances have an equivalent level of concern for the environment and human health.

Results

In all of the categories related to human health, the environment and other effects, the PMT/vPvM case study substances exhibited comparable effects to PBT/vPvB substances. A difference in the human and environmental exposure pathways of PMT/vPvM and PBT/vPvB substances exists as they vary temporally and spatially. However, effects and impacts are similar, with PMT/vPvM substances potentially accumulating in (semi-)closed drinking water cycles and pristine aquatic environments, and PBT/vPvB substances accumulating in humans and the food chain. Both PMT/vPvM and PBT/vPvB substances share the common difficulty that long term and long-range transport and risk of exposure is very difficult to determine in advance and with sufficient accuracy.

Conclusion

The registration process of substances under REACH should reflect that PMT/vPvM substances pose an equivalent level of concern to PBT/vPvB substances.

中文翻译：

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持久性，移动性和毒性（PMT）物质以及非常持久性和非常移动性（vPvM）物质对REACH中的持久性，生物蓄积性和毒性（PBT）以及非常持久性和生物蓄积性（vPvB）物质的关注程度相同

背景

根据欧盟化学品法规REACH（化学品注册，评估，授权和限制EC 1907/2006），注册人没有义务提供与对饮用水资源构成威胁的物质的内在物质特性有关的信息。在2019年，全氟丁烷磺酸（PFBS）和2,3,3,3-四氟-2-（七氟丙氧基）-丙酸（HFPO-DA商标GenX）被证明具有与持久性相同的关注水平（ELoC） ，生物蓄积性和毒性或非常持久性和非常生物蓄积性（PBT / vPvB）物质，分别是由于它们具有持久性，流动性和毒性（PMT）物质特性以及非常持久性和非常流动性（vPvM）物质特性。随后，根据REACH第57（f）条，它们都被确定为高度关注物质（SVHC）。这项工作是根据该法规决定提出的，基于科学的概念水平比较，即所有PMT / vPvM物质对PBT / vPvBB物质构成ELoC。使用上述两个案例以及1,4-二恶烷，开发了16个类别来评估a）对人类健康的严重影响，b）对环境的严重影响和c）其他影响。1，4-二恶烷最近被风险评估委员会（RAC）归类为致癌物质1B。目的是得出客观和科学合理的结论，即这些类别的物质对环境和人类健康的关注程度相同。使用上述两个案例以及1,4-二恶烷，开发了16个类别来评估a）对人类健康的严重影响，b）对环境的严重影响和c）其他影响。1，4-二恶烷最近被风险评估委员会（RAC）归类为致癌物质1B。目的是得出客观和科学合理的结论，即这些类别的物质对环境和人类健康的关注程度相同。使用上述两个案例以及1,4-二恶烷，开发了16个类别来评估a）对人类健康的严重影响，b）对环境的严重影响和c）其他影响。1，4-二恶烷最近被风险评估委员会（RAC）归类为致癌物质1B。目的是得出客观和科学合理的结论，即这些类别的物质对环境和人类健康的关注程度相同。

结果

在与人类健康，环境和其他影响有关的所有类别中，PMT / vPvM案例研究物质显示出与PBT / vPvB物质可比的作用。PMT / vPvM和PBT / vPvB物质在人类和环境中的暴露途径存在差异，因为它们在时间和空间上会发生变化。但是，效果和影响是相似的，PMT / vPvM物质可能在（半）封闭的饮用水循环和原始水生环境中蓄积，而PBT / vPvBB物质则在人和食物链中蓄积。PMT / vPvM和PBT / vPvB物质都有共同的困难，即长期和远距离运输以及暴露的风险很难预先确定并具有足够的准确性。

结论

根据REACH进行的物质注册过程应反映出PMT / vPvM物质与PBT / vPvB物质的关注程度相同。