Public consultation on the PMT/vPvM criteria | Umweltbundesamt

<– go back: First PMT Workshop 2011 | –> go forward: Second PMT Workshop 2018

The UBA submitted a first proposal of the criteria persistence in the environment ("P"), mobility in the aquatic environment ("M") and toxicity to humans ("T") to both the Risk Management Expert Meeting (RiME) and the 15th meeting of ECHAs PBT expert group at the start of 2017. Following comments and suggestions, the proposal was revised and submitted again to the 16th meeting of ECHAs PBT expert group and the Risk Management Expert Meeting at the end of 2017. Scientific and technically descriptive comments were received from 119 people, 13 member states, various European regulators and chemical companies.

The UBA began their consultations with chemical industry in 2017 through the workshop: "⁠REACH⁠ in der Praxis: PMT-Stoffe erkennen und ihre Emissionen vermeiden" (REACH in practice: Identifying PMT substances and avoiding their emissions). Following this, all European stakeholders were invited to join the discussions through two additional workshops: "Persistent and mobile organic chemicals in the water cycle: Linking science, technology and regulation to protect drinking water quality" in 2017 and "PMT/vPvM substances under REACH. Voluntary measures and regulatory options to protect the sources of drinking water" in 2018. Both workshops were very well attended by a wide variety of stakeholders, who provided key input regarding, amongst other concerns, the integration of monitoring data and a discussion of false positives and negatives in relation to the criteria.

The consultation phase was formally supported by UBA project "FKZ 3716 67 416 0 REACH: Improvement of a guidance for the identification and evaluation of PM/PMT substance ". The scientific and regulatory considerations within the development of the PMT/vPvM criteria included (1) monitoring data, (2) simulation and model studies and (3) impact considerations.

Key changes were made to the originally proposed criteria from 2015. Most importantly, a screening criterion for mobility bases on the log D value was added. In addition, the final assessment criterion for mobility is now only considered in terms of the organic carbon-water partitioning coefficient (KOC). The public consultation proved that this parameter is the most robust intrinsic substance property for all types of substances (including ionics) and all soil/sediment types.

The threshold for the vM criterion of log KOC <= 3, was established to be protective for ground water, based on the groundwater ubiquity score by Gustafssen (1989), as well as several lines of empirical and modelling evidence. The threshold for the M criterion of log KOC <= 4, was established based on protection from bank filtrate breakthrough and empirical observations of drinking water contaminants.

The final PMT/vPvM criteria resulting from the scientific and technical development under the EU´s chemical legislation REACH, were presented and discussed during the 30th Caracal meeting (Doc. CACS/MS/19/2019; CARACAL-30; 01 - 02 July 2019) and published as UBA TEXTE 127/2019. They can be considered as a ready-to-use tool for industry to identify PMT/vPvM substances.

In addition to these consultations, there were three original research activities that were commissioned or done with the cooperation of UBA that were instrumental to the scientific bases on the criteria.

The first was a compilation of monitoring data of chemicals that had recently been detected in drinking water and groundwater. A literature review of 25 studies published between 2000 and 2018 was performed. In total 333 chemicals were identified, of which 246 were detected in drinking water and 187 were detected in groundwater, including 100 detected in both. Of these 333 chemicals, 142 (43%) corresponded to substances that were registered under REACH (as of May 2017) of which 32 are also used as pharmaceuticals and 5 are also used as pesticides. The REACH registered substances comprised 113 (46%) of the 246 total drinking water contaminants and 75 (40%) of the 187 total groundwater contaminants. It can therefore be considered factual that a substantial portion of drinking water and groundwater contaminants are substances registered under REACH. This literature search was a key part of the investigation of false negatives with the PMT/vPvM criteria (Hyperlink see UBA Texte 126/2019) - https://www.umweltbundesamt.de/publikationen/reach-improvement-of-guidan...)

Another study was a manual assessment of the persistence, mobility and toxicity of 167 REACH registered substances. This work concluded that 8 substances were PMT substances, 21 were PM substances with suspected T and 105 were suspected PMT substances. Consequently, a total of 134 substances based on their PMT properties and expected environmental emissions were recommended for further investigation and scientific and regulatory scrutiny.

A third study, which was done in cooperation with the UBA, was the JPI Water funded project "Protecting Water Resources from Mobile Trace Chemicals", PROMOTE. Within this project highly polar and persistent organic pollutants (persistent and mobile organic chemicals, PMOC) were focused on in three major phases. The first was to rank REACH registered substances from the most persistent and mobile to the least (HYPERLINK Arp et al. 2017 https://pubs.rsc.org/--/content/articlehtml/2017/em/c7em00158d). The second step was to develop a way to use REACH registered data to estimate emissions of all substances, regardless of their P and M properties (HYPERLINK Schulze et al 2018 https://www.sciencedirect.com/science/article/pii/S0048969717337385?casa...). The third step was to monitor and analyse selected substances with the highest P and M ranking, as well as emission ranking, for which novel analytical techniques developed in the PROMOTE project could detect or quantify. In this final step, 57 substances were selected and analysed for in surface and groundwater samples throughout Europe. Out of these 57 substances, 43 PM substances were detected in environmental waters, 23 of which had never been reported previously. The most prevalent were methyl sulfate, 2-acrylamino-2-methylpropane sulfonate, benzyltrimethylammonium, benzyldimethylamine, trifluoromethanesulfonic acid, melamine, and 1,3-di-o-tolylguanidine (Hyperlink Schulze et al 2019 https://www.sciencedirect.com/science/article/pii/S0043135419300363?casa...). The data from Schulze et al. was very important for the investigation of false positive from the criteria, as it was the direct scientific proof that the PMT/vPvM criteria can be used alongside emission information to predict PMT/vPvM substances in the environment. (Hyperlink Texte 126 - https://www.umweltbundesamt.de/publikationen/reach-improvement-of-guidan...)

go back: First PMT Workshop 2011 | –> go forward: Second PMT Workshop 2018

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