Persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances pose an equivalent level of concern to persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances under REACH

Sarah E Hale,Michael Neumann,Ivo Schliebner,Hans Peter H Arp

doi:10.1186/s12302-020-00440-4

Abstract

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

Highlights

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
The registration process of substances under REACH should reflect that PMT/very persistent and very mobile (vPvM) substances pose an equivalent level of concern to PBT/very persistent and very bioaccumulative (vPvB) substances
Clear that substances that are persistent in the environment, mobile in the aquatic environment as well as being toxic (PMT) or substances that are very persistent in the environment and very mobile in the aquatic environment have specific combinations of intrinsic substance properties that cause them to pose an inherent hazard to drinking water resources [2]

Summary

Introduction

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. Important factors controlling the overall threat are the scale of environmental emissions and whether the substance, or its transformation products, are sufficiently persistent in the environment and enough mobile in the aquatic environment to survive such a journey It is, clear that substances that are persistent in the environment, mobile in the aquatic environment as well as being toxic (PMT) or substances that are very persistent in the environment and very mobile in the aquatic environment (vPvM) have specific combinations of intrinsic substance properties that cause them to pose an inherent hazard to drinking water resources [2]. It is most commonly described using hazard classification criteria and/or reported adverse human effects (e.g., carcinogenic, germ cell mutagenic, toxic for reproduction, etc.) [4]

Methods

Results

Conclusion