Regulatory Developments

European Focus on PMT and vPvM Substances Increases

July 20, 2020 PRINT

On May 9, 2020, the European Commission (EC) began a public consultation on a roadmap for “Chemicals Strategy for Sustainability.” The roadmap states that the regulatory framework on chemicals needs to be strengthened to increase further the level of protection of human health and the environment -- in particular from exposure to endocrine disruptors; combinations of chemicals; hazardous chemicals in products, including in imports; and very persistent chemicals. The regulatory framework also needs “to rapidly reflect scientific evidence on the risk posed by endocrine disruptors, hazardous chemicals in products including imports, combination effects of different chemicals and very persistent chemicals.” Comments were due June 20, 2020, and the EC is working to adopt a communication on the “Chemicals Strategy for Sustainability” in the third quarter of 2020.

The European Chemicals Agency (ECHA) notes on its website that the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation pays specific attention to the management of persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances. According to ECHA, one aim of REACH is the substitution of PBT and vPvB substances where suitable technically and economically viable alternatives are available. REACH does not address persistent, mobile, and toxic (PMT) and very persistent and very mobile (vPvM) substances, however. To address this, in 2019 the German Federal Environment Agency (UBA) submitted to the EC a document on the criteria for identifying PMT and vPvM substances under REACH. The document notes that since 2010, UBA has funded research projects, performed two written consultations, and held several workshops concerning the identification of PMT and vPvM substances. The document presents the result of UBA’s scientific and technical development of the PMT/vPvM criteria.

UBA prepared the document to achieve the following aims:

  • To seek consensus on the need to prevent undue emissions into the environment by REACH-registered substances that have intrinsic properties indicating a hazard to sources of drinking water;
     
  • To establish REACH criteria to identify PMT/vPvM substances that potentially pose a hazard to sources of drinking water; and
     
  • To minimize emissions of PMT/vPvM substances into the aquatic environment.
     

A recent presentation on the preliminary conclusions from a technical report being prepared by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) task force on the issue states that available groundwater monitoring data show that PMT/vPvM criteria are not predictive of the occurrence of substances in groundwater, however, suggesting that UBA’s proposed criteria may not achieve the goal of identifying the substances most likely to pose a hazard to sources of drinking water. The presentation also notes that the substances detected in groundwater are not REACH-regulated substances, indicating that amending REACH to include criteria to identify PMT/vPvM substances will be insufficient to regulate the substances contaminating groundwater. The ECETOC task force recommends a risk-based approach that uses chemical properties combined with information on emissions and use patterns to identify potential substances of concern.

The EC’s “Chemicals Strategy for Sustainability” communication could address the issue of PMT/vPvM substances by designating them as substances of very high concern (SVHC) under REACH. Even if the forthcoming communication does not address PMT/vPvM substances, companies should continue to monitor activity in the EU to regulate them.

Commentary

The class of chemicals most often cited as most likely to display PMT and vPvM properties are short-chain per- and polyfluoroalkyl substances (PFAS), which are very much the subject of international regulatory and scientific focus. The property of concern is their physicochemical properties allowing them high aqueous solubility. This attribute makes water bodies, and in particular drinking water supplies, susceptible to contamination.

That REACH is being considered as a suitable regulatory construct to regulate what amounts to a new category of chemical substances is a logical extension of the regulation. Given the ubiquity of PFAS and the heightened concern globally with their potential to contaminate drinking water resources, stakeholders are urged to monitor this ECHA initiative closely. It could well have precedent-setting implications that are replicated in other venues.

Additional Resources

EPA’s CompTox Chemicals Dashboard includes NORMAN: Potential Persistent, Mobile and Toxic (PMT) substances, a list of REACH substances that could fulfill PMT/vPvM criteria proposed by UBA;

UBA, Assessment of persistence, mobility and toxicity (PMT) of 167 REACH registered substances (2018); and

UBA, Protecting the sources of our drinking water: The criteria for identifying persistent, mobile and toxic (PMT) substances and very persistent and very mobile (vPvM) substances under EU Regulation REACH (EC) No 1907/2006 (2019).


 
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