Utilization of the criteria to identify PMT/vPvM substances | Umweltbundesamt

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Implementing the PMT/vPvM criteria under the EU´s chemical legislation ⁠REACH⁠ will help ensure the protection of Europe's drinking water and freshwater environments for future generations. In order to apply the final criteria to REACH registered substances, the first step in the assessment process is to identify those substances with volumes > 10 tons/y, for uses other than an intermediate, and containing organic or organometallic chemical constituents, including impurities, additives, or transformation product precursors, greater than 0.1% abundance (i.e. as for a PBT/vPvB assessment). Following this, these constituents are assessed for their PMT/vPvM properties according to the PMT/vPvM criteria.

Within a research project by UBA substances are identified according to a traffic light system, where "white" substances are those with missing or insufficient data to draw a conclusion, "dark red" are vPvM substances, "red" are PMT substances, "dark yellow" are substances suspected to meet the PMT/vPvM criteria, "yellow" are substances where available data is insufficient to conclude whether the substance is or is not PMT/vPvM, and "green" are substances that are proved not to be PMT/vPvM.

The PMT/vPvM criteria and the developed guideline were applied to all REACH registered substances as of May 2017. The ECHA database of REACH registered substances contained 15469 substances at the time queried, of which organic structures could be identified for 9742 substances, whether they were required for a PBT/vPvB assessment or not. In summary, there were 260 REACH registered substances (i.e. 1.7%) that met the PMT/vPvM criteria (Red/Dark red), 224 met the PM criteria (Dark yellow), 2377 had screening data requiring further assessment (Yellow), 3665 did not meet the criteria (Green) and 3216 had missing or insufficient data to make a conclusion (White). This is illustrated in the figure below.

Several of the 260 PMT/vPvM substances that were identified from ⁠REACH⁠ registrations up to May 2017 have subsequently been placed under the spotlight from an industrial and regulatory perspective. The non-governmental organization ChemSec, which publishes the Substitute It Now list (SINlist), added a new category for PMT/vPvM substances in 2019. The SINlist is designed to flag substances they encourage industry to substitute for others and includes 16 from the 260 of the identified PMT/vPvM substances. Two PMT/vPvM substances have been recently identified as substances posing an equivalent level of concern as PBT/vPvB substances, under Article 57 (f) of REACH. These were Perfluorobutane sulfonic acid (PFBS) which was proposed as substance of very high concern (SVHC) by the Norwegian Competent Authority (NO CA) and HFPO-DA chemicals (trade name GenX) which was proposed as SVHC by the Dutch Competent Authority (NL CA).

The concern of persistent and mobile substances has been brought up as part of the European Green Deal Chemicals Strategy for Sustainability and as part of the recent Horizon 2020 research call related to a zero-pollution ambition for a toxic-free environment.

The concern of persistent and mobile substances is not just restricted to Europe. The United States Environmental Protection Agency (US EPA) has addressed the growing concern of the occurrence of per- and polyfluoroalkyl substances (PFAS) substances in drinking water through a new action plan, released in 2020. In China, several actions are ongoing related to both monitoring and chemical hazard perspectives of persistent and mobile substances. The Chinese Ministry of Ecology and Environment (MEE), together with the Ministry of Water Resources have begun a national survey with the goal of prevention and remediation of contaminated drinking water sources. In addition, the MEE is putting forward new regulation to control emissions of hazardous chemicals into the environment where, as part of this, new chemicals not yet included in the Inventory of Existing Chemical Substances of China (IECSC) must be evaluated. From this, a list of water polluting chemicals was put forth by the MEE and the Chinese National Health Commission. This action together could lead to further steps in China and other countries resulting in the adoption of a pro-active strategy to prevent pollution of the water cycle with persistent and mobile substances.

There are several ways to demonstrate that PMT/vPvM substances have "scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern" to PBT/vPvB substances. For persistent and bioaccumulative substances it is stated that "the level of uncertainty in identifying long-term risk cannot be estimated with sufficient accuracy". Once these risks manifest, "consequences of an underestimation of adverse effects are not easily reversible by regulatory action" (ECHA, 2014). This is true for persistent and mobile substances as long-term risks are often only identified retrospectively. The persistent nature of these substances means that action taken to reduce emissions would be slow to take effect thus negative consequences would be felt on intergenerational time scales. In addition, deriving "safe" concentrations of both PBT/vPvB and PMT/vPvM substances in the environment is difficult using the methods currently available.

There are several regulatory options that could be used in order to protect the sources of our drinking water. Persistent and mobile substances may be classified as Aquatic Chronic 4, H 413 under the ⁠CLP⁠ regulation (Regulation (EC) No 1272/2008). New hazard classes for P, vP, B, vB, M and vM could also be implemented separately in Annex I of the CLP regulation. Under REACH, Annex I could require an assessment of PMT/vPvM properties during registration at a low tonnage level. Article 14(4) could also include PMT/vPvM substances and ask for an exposure assessment and a risk characterisation. Another option would be to identify all PMT/vPvM substances as substances of very high concern (SVHC) following Article 57 in REACH. This could be achieved by expanding Article 57 and Annex XIII to include the PMT/vPvM criteria, or using Article 57 (f).

Building on the work already carried out, a new applied research project is underway (FKZ 3719 65 408 0) that will update the list of identified PMT/vPvM substances by applying the criteria to REACH registered substances as of May 2019 as well as transformation products. In addition, the project will use emissions likelihood in order to rank the substances. A literature review will identify positive detections of PMT/vPvM substances and monitoring in Germany will provide further proof of concept. Technical water treatment methods that are able to remediate water for selected PMT/vPvM substances will be identified. Risk management option analyses (RMOA) for PMT/vPvM substances will be prepared.

In fall of 2021 a new research project “ZeroPM” will start. ZeroPM will interlink and synergize prevention, prioritization and removal strategies to protect the environment and human health from PM substances. To this end, ZeroPM will establish an evidence-based multilevel framework to guide policy, technological and market incentives to minimize use, emissions and pollution of entire groups of PM substances.

The European Commission is funding the ZeroPM project with funds from the Horizon2020 research and innovation program which is intended to support Europe's efforts towards a pollution-free environment.

ZeroPM will link prevention, prioritization and removal strategies with the aim of protecting the environment and human health from persistent and mobile substances.

The German Environment Agency will participate in the project in a dedicated Policy work package via the analysis of political goals and targets at European and international levels. Through the analysis of legal texts, strategy papers and other political documents, as well as sectoral and environmental policy guidelines, position papers, studies on the evaluation of politics, scientific papers and data from surveys and position papers, recommendations for policy action will be developed. These actions are intended to complement the current ambitions outlined in the Chemicals Strategy for Sustainability towards a toxic free environment where a key goal is to prevent emissions of persistent and mobile substances. To this end, UBA will be able to build on its work to develop criteria for the identification of persistent (P), mobile (M) and toxic (T) chemicals. In addition, UBA will support the work on prioritizing chemicals with the most urgent need for action drawing on its many years of experience in identifying chemicals requiring regulation.

The ZeroPM partners are: Stockholm University: Sweden, Vrije Universiteit Amsterdam: The Netherlands, DVGW-Technologiezentrum Wasser (German Water Centre): Germany, Milieu Law and Policy Consulting: Belgium, ChemSec: Sweden, German Environment Agency: Germany, ETH Zurich: Switzerland, University of Luxembourg: Luxembourg, University of the Aegean: Greece, TG Environmental Research: UK, Chalmers: Sweden, Norwegian Water Research Institute: Norway, University of Vienna: Austria and Fraunhofer Institute for Toxicology and Experimental Medicine: Germany.

<– go back: Second PMT Workshop 2018 | –> go forward: Third PMT Workshop 2021

Read the full story related to the development of the PMT/vPvM criteria under the EU´s chemical legislation ⁠REACH⁠ to identify PMT/vPvM substances: (01) –> Introduction to PMT/vPvM substances, (02) –> Emergence (2009 – 2015) of the PMT/vPvM criteria, (03) –> First PMT Workshop 2011 (04) –> Public Consultation (2016 – 2019) on the PMT/vPvM criteria, (05) –> Second PMT Workshop 2018, (06) –> Utilization (2019 – ongoing) of the PMT/vPvM criteria, (07) –> Third PMT Workshop 2021, (08) –> Media coverage and dissemination, (09) –> Frequently Asked Question (FAQ), (10) –> The final PMT/vPvM criteria