Last reviewed 31 May 2018
Substances which are persistent, mobile and toxic (PMT) have been identified as a concern equivalent to persistent, bioaccumulative and toxic (PBT) chemicals currently regulated under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Christine Lepisto of Chemical Safety Consulting, Germany, shares news on the proposed PMT/vPvM chemical lists and recommended actions to avoid the imposition of burdensome regulatory measures under REACH.
The German Environment Agency (UBA) and the Norwegian Geotechnical Institute (NGI) hosted a two-day workshop in March 2018 on using REACH to manage PMT and very persistent, very mobile (vPvM) substances in a manner similar to how PBT/vPvB substances are regulated. Lists of candidate substances have been published. High-level representatives of the European Chemicals Agency (ECHA) and the European Commission reviewed how regulatory actions could be taken either under the REACH Regulation, with or without amendments.
Criteria for persistence, mobility and toxicity
Work has been ongoing since 2009, cumulating in defined criteria for identifying substances that are persistent or mobile or toxic.
Persistence: the criteria match the definitions for water-based persistence as set out in Annex XIII of REACH in the context of PBT and vPvB substances.
Mobility: screening is done based on Koc (or log Dow if Koc data is not available). At the environmentally relevant pH range of 4–9, a log Koc (or log Dow) ≤ 4.0 qualifies as “mobile” and ≤ 3.0 as “very mobile”.
Toxicity: the toxicity characteristics differ controversially from those used in REACH for toxicity in the context of persistent, bioaccumulative substances. For protection of drinking water, the proposal retains the criteria used in Annex XIII:
NOEC or EC10 ≤ 0.01 mg/L
classification as carcinogenic, germ cell mutagenic, or toxic for reproduction in categories 1A or 1B, or as specific target organ toxicity in category 1 or 2.
But it goes beyond those currently used characteristics, adding:
carcinogenic, germ cell mutagenic or toxic for reproduction in category 2
classification for effects on or through lactation
DNEL ≤ 9μg/kg/d (oral, long term, general population)
substances which act as endocrine disruptors in humans and/or wildlife.
Candidate list of substances from screening of REACH data
A candidate list of 240 substances was made available in the background document to the workshop: Preliminary Assessment of Substances Registered under REACH that could Fulfil the Proposed PMT/vPvM Criteria. NGI Consultant Prof. Dr. Hans-Peter Arp described how the criteria have been applied to REACH registered substances. It is worth noting that 3863 substances had insufficient data for any conclusion. Three thousand nine hundred and two substances could be dismissed as not or low potential PMT/vPvM and 1736 substances with potential are not prioritised for addition to this preliminary candidate list.
Dr. Arp further presented how they examined 70 substances with high tonnages and uses that indicate emissions. NGI detected 45 of these substances in 50 water samples collected from five EU countries. Twenty-eight of the substances were found in over 50% of the samples. The levels of contamination were not quantified, but the detection of these substances — the majority “novel” in the context of drinking water analysis — demonstrates a correlation between the criteria and a real-world concern.
Industry response to the proposals
Dr. Ronald Bock of Chemours was invited to reflect the CEFIC position. Dr. Bock warned against rushing into regrettable regulation. He presented a number of examples which indicate caution is required with the candidate list, finding that some of the substances were listed either based on erroneous data or on classifications/data not supported by industry consensus, or in spite of extensive risk assessment done under REACH by which the safe use (lack of exposure/lack of risk) has been established.
(Subsequent to the workshop, the UBA confirmed that the CEFIC examples are based on an older UBA proposal, and a corrected version incorporating the input from CEFIC will be published soon.)
The path to action: how REACH may be used if voluntary actions do not suffice
The traditional instrument for protecting drinking water quality is the EU Water Framework Directive (2000/60/EC) or WFD. The groundwater working group under the Common Implementation Strategy for the WFD targets release in 2019 of a voluntary Groundwater Watch List (GWWL), which was presented at the workshop by Dr. Ronald Kozel of the Swiss Bundesamt für Umwelt (BAFU).
But the six-year planning cycle and other drawbacks create a risk that ecological boundaries might be crossed irreversibly without a more proactive approach, which has led the UBA to push using REACH to spur action by industry. To underline the point, Prof. Thomas Knepper of the Hochschule Fresenius and Dr. Wolfgang Körner of the Bavarian state EPA presented case studies showing how difficult control of serious contaminants has been historically.
Therefore, UBA invited Dr. Watze de Wolf, Chairman of the Member State Committee at the ECHA and Dr. Sylvain Bintein, Policy Coordinator for the European Commission Directorate General for the Environment, to close out the workshop with their viewpoints on how PMTs/vPvMs can be addressed in the current or future REACH and CLP regulatory schemes.
Dr. de Wolf confirmed that if sufficient data supports a finding of equivalent level of concern for any PMT or vPvM substance, the identification as a substance of very high concern (SVHC) can proceed, potentially leading to authorisation requirements. But a legal analysis is needed to establish whether the PMT or vPvM cases meet the REACH article 57(f) requirements for what constitutes an equivalent level of concern. In particular, is there sufficient “scientific evidence of probable serious effects to human health or the environment”? This legal analysis cannot be initiated until the first case is brought forward by a Member State.
Dr. Bintein presented his personal survey of all the possible regulatory options. He suggested that a good first step would be to add a PM hazard class to the UN Globally Harmonized System, similar to how ozone was added, because this triggers communication or hazards and risk management measures, requires industry to monitor their own data for self-classifications, and promotes substitution. Alternatively, a PM or PMT class could be created in CLP without the leadership of the UN, or amendments to REACH could add PMT criteria.
Dr. Bintein also presented an exhaustive list of options for applying provisions currently in REACH to PMT/vPvM characteristics.
Address drinking water contamination as “secondary poisoning” in dossiers.
Interpret section 0.10 of Annex I of REACH on particular effects such as ozone depletion or strong odors to improve evaluations of data for persistence and mobility.
Case-by-case designation of PMT/vPvM substances as candidate SVHC under article 57(f) provisions on equivalent level of concern.
As a last resort: the precautionary principle could be applied; it has not yet been used under REACH.
Dr. Neumann of the German EPA emphasises that: “most important is that our proposal is a tool for industry to identify substances of concern. And they then may use risk mitigation measures to minimise emissions into the environment” (edited for clarity).
As a next step, the German Environment Agency will update their position paper on Protecting the Sources of Our Drinking Water as a basis to continue discussion.
Companies will need to plan voluntary action to avoid regulation.
Track the proposed list for substances in the company portfolio.
Assess all REACH registered substances against the PMT criteria.
Amend Chemical Safety Assessments and Reports, as well as extended safety data sheets, to indicate any operating conditions or management measures necessary to minimise release to the environment of all substances determined to fit the PMT or vPvM criteria.
Protecting the Sources of Our Drinking Water from Mobile Chemicals (update planned for later in 2018)
NGI screening of REACH dossier data:
Preliminary Assessment of Substances Registered under REACH that could Fulfil the Proposed PMT/vPvM Criteria (update planned for later in 2018)
Further information is available in English on the webpage of the Protecting Water Resources from Mobile Trace Chemicals (PROMOTE) Project and in German at the UBA Page on Mobile Chemicals.
An excellent peer-reviewed paper on the topic by Thorsten Reemtsma et al appeared in the journal Environmental Science & Technology: Mind the Gap: Persistent and Mobile Organic Compounds — Water Contaminants That Slip Through.