Skip to main content
Environmental Sciences Europe
Download PDF

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

Environmental Sciences Europe volume 32, Article number: 155 (2020) Cite this article

Abstract

Background

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. 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.

Results

In 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.

Conclusion

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

Background

Persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances

For a chemical substance emitted into the environment to pose a threat to drinking water resources, it must be transported from the point of emission through natural barriers such as soils, riverbanks and aquifers, and in some cases through artificial barriers [1]. The time scales for this can vary from days, to weeks, to months and to years. 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, therefore, 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]. A persistent substance can be defined as one that remains in the same substance form in the environment over long periods of time. For regulatory standards, persistency is most often described as an inherent substance property: a degradation half-life in a given environmental media (e.g., air, water, soil, and/or sediment) under a specified set of environmental conditions (e.g., 12 °C [3]). A mobile compound is one that sorbs poorly to sediments and soils, resulting in a high potential to move and be transported through river banks, ground water and to drinking water extraction wells and remote aquatic ecosystems. Toxicity is a central consideration in chemical hazard and risk assessment and encompasses various modes of toxic action. 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].

There are many recent research developments and monitoring studies that have bought persistent and mobile substances to the forefront of worldwide scientific discussion [5,6,7,8]. As early as the 1990s, the scientific community realized the real hazard posed by persistent chemicals that are mobile in the aquatic environment [9,10,11]. These substance have previously gone by different acronyms: polar persistent pollutants (P3), polar persistent organic pollutants (polar-POPs) [12] and persistent, mobile organic contaminants (PMOC) [11], but all terms describe the problematic intrinsic fate and hazard properties of persistence in combination with mobility. Neumann et al., [13] first presented the names persistent, mobile and toxic substances and very persistent and very mobile substances and the corresponding acronyms PMT and vPvM in 2015. Since then, the German Environment Agency has led efforts to establish criteria to identify PMT and vPvM substances under the EU chemicals regulation REACH (EC 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals) [2]. The similarity with the acronyms persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) is not accidental. It was designed to indicate from the outset the equivalency in the hazardous nature of these two sets of substances [2] and the necessity of the adoption of a hazard based regulation.

Many PMT/vPvM substances can breakthrough artificial barriers in waste water treatment plants (WWTP) [14] and drinking water treatment facilities, including through granular activated carbon (GAC) filtration, ultrafiltration, advanced oxidation processes (like ozonation) and reverse osmosis [15]. Stackelberg et al. [16] reported that even after clarification, disinfection (chlorination) and GAC filtration, many mobile substances were not effectively removed from WWTP. In their study, the removal of four mobile substances: N,N-Diethyl-meta-toluamide, nonylphenol, camphor and bisphenol A varied between 25 and 76%. Substances that are even more persistent and mobile than these, would, by definition, more easily survive disinfection and breakthrough GAC filters in fewer bed volumes. This implies that in cases, where there are both ongoing emissions of PMT/vPvM substances and incomplete removal during water treatment, environmental concentrations will increase over time as these substances circulate in the water cycle [17] and potentially become irreversible [18, 19].

The unknown extent of PMT/vPvM substances in our water resources

The EU drinking water directive (98/83/EC, amended 2015/1787) has the objective "to protect human health from the adverse effects of any contamination of water […] by ensuring that it is wholesome and clean". The EU's groundwater directive (2006/118/EC) states, "groundwater is a valuable natural resource and as such should be protected from […] chemical pollution". Moreover, the EU's water framework directive (2000/60/EC) states that "member States shall ensure the necessary protection for the bodies of water identified with the aim of avoiding deterioration in their quality to reduce the level of purification treatment required in the production of drinking water". Thus, ensuring that the sources of our drinking water are secure from any threats caused by chemicals is of the utmost importance.

The wider environmental problem related to PMT/vPvM substances is likely larger than it appears at first glance. There are many examples of substances that are ubiquitously detected in the water cycle that can be considered as PMT/vPvM substances [1], such as melamine [20], sulfanilic acid [21] and trifluoroacetic acid [22], but owing to their differences in terms of structure and sources, they are not conceptually linked in this way. An important concern for the most mobile substances are the so-called "analytical gap" and "monitoring gap" that exist. Current analytical measurements for the most mobile substances are not widely available (the "analytical gap") and thus many go unnoticed and undetected in the water cycle ("the monitoring gap"). However, progress has been made to address this analytical gap and methods such as hydrophilic interaction liquid chromatography [23], supercritical fluid chromatography [24], mixed-mode liquid chromatography [25] and capillary electrophoresis [26] have now made it possible to analyse some of the most mobile substances. This progress also contributes to closing the monitoring gap as more of the most mobile substances can be detected. However, a recent series of studies has demonstrated that the monitoring gap is still very prevalent. In the studies, the first ranked industrial substances based on their properties of persistency and mobility, [27] second selected some of the top 57 ranked PM substances based on high emissions likelihood and for which analytical methods were rare but could be developed, and third conducted monitoring in surface and groundwater samples throughout Europe [28]. Out of these 57 substances chosen based on these considerations, 43 PM substances were detected in environmental waters, 23 of which had never been reported previously (including near ubiquitous ones, like methyl sulfate, 2-acrylamino-2-methylpropane sulfonate, benzyltrimethylammonium, benzyldimethylamine, trifluoromethanesulfonic acid, and 1,3-di-o-tolylguanidine [28]). These studies both directly demonstrated the ubiquity of PM substances and that the "monitoring gap" is a real issue. As a consequence of these two gaps the most mobile substances in the aquatic environment remain undetected, unmonitored and consequently unregulated [23, 28]. It becomes clear that a more holistic approach is needed to protect water quality and monitor, assess and manage chemical pollution of European surface waters [29].

Recent regulatory advances of PMT/vPvM substances in Europe

In the 2017 report, "Study for the strategy for a non-toxic environment of the 7th Environment Action Programme", prepared by Directorate-General for Environment (European Commission) strong concerns were raised about persistent substances that are hydrophilic, and thus mobile in water, meaning they pose particular threats to the quality of water resources [30]. The report emphasized that mobility could be considered of equivalent concern to bioaccumulation. Regulatory advances for PMT/vPvM substances have also been taken into REACH. REACH aims to ensure a high level of protection of human health and the environment" (Article 1,1) and is "underpinned by the precautionary principle" (Article 1,3). REACH provides a legislative basis to investigate hazardous properties of chemicals before market [31, 32] Through REACH, it becomes the responsibility of registrants to characterize the intrinsic hazard of substances and the risk of each of their uses over the complete life cycle. Based on this input, the European Member States and the European Chemicals Agency (ECHA) can then assess whether registered substances fulfil the criteria to be identified as substances of very high concern (SVHC) following Article 57 of REACH. Listing a substance as a SVHC is one possible pathway for authorisation or restriction under REACH.

In 2019, two substances were identified as SVHC based on their equivalent level of concern (ELoC) to persistent, bioaccumulative and toxic and/or very persistent and very bioaccumulative (PBT/vPvB) substances. One of these substances, perfluorobutane sulfonic acid (and its salts, PFBS) was identified as a SVHC owing to "very high persistence, high mobility in water and soil, high potential for long-range transport, and difficulty of remediation and water purification as well as moderate bioaccumulation in humans". These properties combined led the Member State Committee (MSC) under REACH to conclude that there is a very high potential for irreversible effects [33, 34]. The second substance HFPO-DA, commonly referred to as Gen-X, was acknowledged by the MSC to have a high potential to cause effects on wildlife and humans due to its very high persistence, mobility in water, potential for long-range transport, accumulation in plants and previously observed effects on human health and the environment [35]. In this case, the MSC unanimously agreed that in isolation, these factors are not enough to give rise to ELoC, however, that in combination, they show that there is scientific evidence of probable serious effects to the environment and humans. The same year, the organization ChemSec published an update of the SIN list (Substitute It Now list) and added a new category for PMT/vPvM substances [36]. This list is designed to flag substances they encourage industry to substitute for others and now includes 16 PMT/vPvM substances.

Methods

Based on the aforementioned identification of these two PMT/vPvM substances, this work investigated whether a general case could be made to show that all PMT/vPvM substances can be considered as ELoC to PBT/vPvB substances and as such identified as SHVC under REACH. To achieve this, categories were developed based on previous recommendations to identify SVHC under the 'equivalent level of concern' route (for example as has been done for skin sensitizers [37] and neurotoxicants and immunotoxicants [38]).

These recommendations introduce four human health effect categories (i. possible serious health effects, ii. irreversibility of health effects, iii. delay of health effects, and iv. quality of life impacted), as well as two other effect factors (i. societal concern, and ii. is derivation of a safe concentration possible). To compare the ELoC of PMT/vPvM substances to PBT/vPvB substances, the assessment categories for human health were used directly; however, the other factor categories were altered and new categories were added. The other factors categories were changed to the following: (i. increased societal costs, (ii) negative effect on resources, and (iii) do emissions need to be minimized. Nine "environmental effect" categories were developed as follows: (i) irreversible exposure, (ii) irreversible effect, (iii) intergenerational exposure and effect, (iv) unknown/uncertain spatial scale, (v) disparity between point of release and point of effect, (vi) unknown/uncertain temporal scale, (vii) uncertain/difficult to predict long term fate and toxic effects, (viii) harmful to the aquatic environment, and, (ix) potential to reach remote pristine areas.

The development of these 16 categories covering health effects (4 categories), environment effects (9 categories) and other effects (3 categories) was aided by discussions and written consultations with a broad group of stakeholders during scientific and regulatory meetings and workshops. The following were of significance for the dialogue: the 16th meeting of ECHA’s PBT expert group in September 2017, the Risk Management Expert Meeting in October 2017, the Society of Environmental Toxicology and Chemistry Europe Conferences in 2015, 2016, 2017, 2018 and 2020 and several workshops organised by the German Environmental Agency.

These 16 categories were then applied to three case study substances: PFBS, HFPO-DA and 1,4-dioxane. The first two substances were chosen due to their recent identification as SHVC and 1,4-dioxane owing to its listing in the public activities coordination tool (PACT) in 2019 for regulation under REACH. Following this, a general conceptual comparison using the defined categories was carried out to assess the ELoC between PMT/vPvM substances and PBT/vPvB substances.

Results and discussion

Case study I: Perfluorobutanesulfonic acid (PFBS) and its salts

PFBS belongs to the compound class of per- and polyfluoroalkyl substances (PFAS) that have a hydrophobic, alkylated, fluorine-saturated carbon-chain with a hydrophilic head attached at a terminal end [39]. A recent report has stated that over 4600 CAS registry numbers are associated with PFAS that may have been on the global market, including many that have at least one perfluoroalkyl moiety but were not commonly recognised as PFASs previously [40]. The use of PFAS has become more stringent in recent years, and currently C11-14 perfluoroalkyl carboxylic acids (PFCAs), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), perfluorohexane sulfonic acid and its salts (PFHxS) are all under some form of regulation. As a result of this, long chain PFAS have been replaced with short chain PFAS. Short chain PFAS [41] are less bioaccumulative, but their high persistence, aquatic mobility [42] and unknown ecotoxicological effects renders them of concern. PFBS contains 4 carbon atoms and was introduced to market following the phase out of perfluorooctanesulfonic acid (PFOS) [43]. In water, PFBS is a strong acid which is predominantly dissociated as an anion.

In December 2019, PFBS and its salts were identified as SVHC in accordance with Article 57(f) based on scientific evidence of probable serious effects to the environment and human health which give rise to an ELoC to substances listed in Articles 57 (d) and (e) of REACH. Table 1 presents a summary of the argumentation agreed upon by the MSC [33, 34] to show that PFBS and its salts present an ELoC to PBT/vPvB substances.

Table 1 ELoC of PFBS (IUPAC name (1,1,2,2,3,3,4,4,4-Nonafluorobutane-1-sulfonic acid) compared to PBT/vPvB substances
Full size table

REACH dossiers were used to prepare the table, and literature references to support statements can be found within these dossiers [33, 34]. Both the neutral and potassium salt forms have been registered under REACH (EC numbers 206–793-1 and 249–616-3, respectively).

Case study II: HFPO-DA (3: 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoic acid) its salts and its acyl halides (tradename GenX)

HFPO-DA also belongs to the PFAS compound class and is used as a processing aid for producing fluoropolymers with many applications, such as fluoropolymer resins, wire cables and coatings. The production history and volumes of HFPO-DA are unknown, although it has been suggested that production began in 2009 [45]. HFPO-DA was first detected in environmental samples from the Cape Fear River, North Carolina in 2018, likely from a point source release from a production plant [46]. HFPO-DA has also been detected in other countries in relation to known local production and use. HFPO-DA has been detected in the Xiaoqing River System in China [47], in America [48], in the Lower Rhine River [47] and in rivers in close proximity to a production plant in the Netherlands [49].

QSAR modelling and ready or inherent biodegradability tests have shown that HFPO-DA does not exhibit any primary biodegradation, is not readily or inherently biodegradable and is not structurally transformed under the experimental test conditions. Experimental data is limited, and the bioaccumulation potential of HFPO-DA is uncertain. HFPO-DA has a very low adsorption potential to organic carbon and other solids and a low volatility meaning it has a highly mobility in the aquatic environment and can be transported to areas far from the point of release. According to the classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008), HFPO-DA has the hazard classifications Acute Toxicity 4, Skin Corrosion/Irritation 1B, Eye Damage/Irritation 1, and specific target organ toxicity – single exposure (STOT SE) 3.

In June 2019, HFPO-DA and its salts were identified as SVHC in accordance with Article 57(f). The MSC acknowledged that HFPO-DA has a high potential to cause effects in wildlife and in humans through the environment due to its very high persistence, mobility in water, potential for long-range transport, accumulation in plants and observed effects on human health and the environment. Table 2 presents the argumentation used by the MSC to show how HFPO-DA present an ELoC to PBT/vPvB substances [35].

Table 2 ELoC of HFPO-DA compared to PBT/vPvB substances
Full size table

REACH dossiers were used to prepare the table, and literature references to support statements can be found within these dossiers [35].

Case Study III: 1,4-dioxane CAS No. 123–91–1

1,4-dioxane has a plethora of uses. It is a solvent in the production of lacquers, varnishes, cleaning and detergent preparations, dyes, antifreeze, adhesives, cosmetics, deodorant fumigants, shampoos, emulsions and polishing compositions, polyester manufacturing, pulping of wood, extraction medium for animal and vegetable oils, laboratory chemical (eluent in chromatography), cassettes, plastic and rubber, insecticides as well as a stabilizer for 1,1,1-trichloroethane [7, 50] 1,4-dioxane is prevalent in groundwater at industrial due to its historic use as a stabilizer [51] and in sewage water resulting from consumer use of surfactants.

1,4-dioxane is non-volatile with a very low Henry's Law constant (4.8 × 10 − 6 atm·m3/mol at 25 °C). However, 1,4-dioxane has a high water solubility (100 mg/mL), a low octanol–water partitioning coefficient (log Kow =  − 0.27) and adsorbs only weakly to organic matter with a log Koc of 0.42 [50]. 1,4-dioxane has a half life of 2 to 5 years in groundwater and 56 days in surface water highlighting the persistent nature of this substance [52]. Taken together these properties imply that 1,4-dioxane is readily leached into water systems and transport through even subsurface environment, which has been demonstrated by point-source releases of 1,4-dioxane causing plumes which have the potential to contaminate both nearfield and distal water bodies [53].

1,4-dioxane is currently listed with the hazard classes under the Classification and labelling in accordance with the CLP Regulation: "Flammable liquids 2", "Carcinogenic 2", "Eye Damage/Irritation 2", and "STOT SE 3". In addition, a recent opinion from the Committee for Risk Assessment (RAC) has proposed that 1,4-dioxane should be classified as Carcinogenic 1B [50]. The properties suspected of causing cancer, may cause respiratory inhalation and causes serious eye irritation are properties of ecotoxicological concern. Table 3 shows the ELoC of 1,4-dioxane to PBT/vPvB substances.

Table 3 ELoC of 1,4-dioxane compared to PBT/vPvB substances
Full size table

PBT/vPvB substances as precedent for the identification of PMT/vPvM substances under REACH

When concerns were raised about the identification and unintended ecotoxicological effects of DDT [66] and the detection of PCBs in top predators [67] it became clear that such PBT/vPvB substances can reach threshold concentrations at which (eco)toxic effects occur, unless emissions are controlled or minimized. Since then, PBT/vPvB substances have been included in a large amount of regulation [4] including REACH. Annex XIII provides criteria to be used to identify PBT/vPvB substances and these should be applied to all substances manufactured or produced at 10 or more tonnes per year and for all constituents present greater than 0.1% (though certain substances are exempted, such as isolated intermediates, as described in Article 14(2)). In ECHA’s PBT/vPvB guidance it is stated that: "PBT or vPvB substances may have the potential to contaminate remote areas that should be protected from further contamination by hazardous substances resulting from human activity because the intrinsic value of pristine environments should be protected" […] "the effects of such accumulation are unpredictable in the long-term" […] "such accumulation is in practice difficult to reverse as cessation of emission will not necessarily result in a reduction in substance concentration" [68]. PBT/vPvB substances have also been acknowledged to present a planetary boundary threat if released in substantial quantities, as their removal from the environment can be irreversible [69].

The same is true for PMT/vPvM substances; however, there is a regulatory gap in REACH to address these substances. The case studies above show that PMT/vPvM substances have an ELoC to PBT/vPvB substances due to the scientific evidence of probable serious effects to human health or the environment. The difference between these substance groups is their exposure route. In cases, where emissions are continuous, mobile substances can accumulate in (semi-)closed drinking water cycles as waste water is recycled to drinking water and as well as in pristine remote environments, far from the site of release, via surface water and groundwater transport. Similarly, under prolonged emissions, bioaccumulative substances are able to accumulate in the food chain and also in pristine remote environments via migrating biota and in some cases atmospheric transport [70]. For both PMT/vPvM and PBT/vPvB substances, the long term and long-range transport and risk of exposure is very difficult to determine in advance and with sufficient accuracy. Owing to the complex nature of water systems and food chains as well as a lack of modelling tools, risks posed by these substances are most often identified retrospectively. In addition, reversing emissions (and, therefore, effects) is difficult due to the high persistence of these substances. Reservoirs of emitted substances in commercial products, landfills, polluted soil and aquifers, for instance, can act as continuous sinks to the environment over long time scales. Thus, there is the potential for risks to persist over multiple generations. In extreme cases, where exposure of either PMT/vPvM or PBT/vPvB substances reaches harmful levels, such as chronic toxicity, they would pose irreversible health and environmental effects that could result in impaired quality of life or ecosystem function. Releases of both PMT/vPvM and PBT/vPvB substances places pressure on society from an economic and resource point of view, since a cessation of emissions does not necessarily lead to a reduction in concentrations in the long term. Based on this, Table 4 provides a summary of the criteria that can be used to demonstrate that all PMT/vPvM substances can be considered an ELoC as PBT/vPvB substances, and as such should be identified as SVHC under Article 57(f).

Table 4 Conceptual comparison showing that PMT/vPvM substances pose an equivalent level of concern as PBT/vPvB substances
Full size table

Conclusion

The conceptual comparison using the 16 categories developed here supports the assumption that PMT/vPvM substances cause an equivalent level of concern as PBT/vPvB substances and as such should be regulated under Article 57 in REACH. Currently this can be done using Article 57 (f) as shown above, or it could be achieved via the introduction of two new articles: Article 57 (g) for PMT substances and Article 57 (h) for vPvM substances. At the time of writing, a Motion for Resolution has been put forward by the European Parliament for such an inclusion [71]. For practical guidance towards this inclusion, the German Environment Agency has recently published criteria and an assessment procedure that can be used under REACH to identify PMT/vPvM substances [2]. These criteria could be added to Annex XIII of REACH and used by ECHA to publish a Guidance on Information Requirements and Chemical Safety Assessment for a PMT/vPvM assessment. Using these established PMT/vPvM substance criteria in Article 57 and Annex XIII would allow the distinct and unambiguous identification of PMT/vPvM substances as SVHCs. This would provide the chemical industry with a defined framework to follow, as for PBT/vPvB substances, and would allow the substitution of hazardous substances and uses under REACH.

Availability of data and materials

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.

Abbreviations

B:

Bioaccumulative

BAF:

Bioaccumulation factor

BCF:

Bioconcentration factors

CLP:

Classification, labelling and packaging regulation

CMR:

Carcinogens, mutagens and/or reproductive toxicants

CTD:

Characteristic travel distance

ECHA:

European Chemicals Agency

EDC:

Endocrine disrupting compounds

ELoC:

Equivalent level of concern

EU:

European Union

GAC:

Granular activated carbon

GC:

Gas chromatography

HFPO-DA:

2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)-propanoic acid

LOEC:

Lowest observed effects concentration

M:

Mobile

MTBE:

Methyl tert-butyl ether

MSC:

Member State Committee

NOEC:

No observed effects concentration

P:

Persistent

PBT:

Persistent, bioaccumualtive and toxic

PFAS:

Per- and polyfluoroalkyl substances

PFBS:

Perfluorobutane sulfonic acid

PFCA:

Perfluoroalkyl carboxylic acid

PFHxA:

Perfluorohexanoic acid

PFOA:

Perfluorooctanoic acid

PFOS:

Perfluorooctanesulfonic acid

PFNA:

Perfluorononanoic acid

PMT:

Persistent, mobile and toxic

REACH:

Registration, Evaluation, Authorization and Restriction of Chemicals

RPLC:

Reverse phase liquid chromatography

STOT RE:

Specific target organ toxicity—repeat exposure

STOT SE:

Specific target organ toxicity (single exposure)

SVHC:

Substance of very high concern

T:

Toxicty

vB:

Very bioaccumulative

vP:

Very persistent

vPvB:

Very persistent and very bioaccumulative

vPvM:

Very persistent and very mobile

WWTP:

Wastewater treatment plant

QSAR:

Quantitative structure activity relationship

References

  1. Arp HPH, Hale SE (2019) REACH: Improvement of guidance methods for the identification and evaluation of PM/PMT substances. UBA TEXTE 126/2019. German Environment Agency (UBA), Dessau-Roßlau, Germany. ISBN: 1862–4804. 130 pages. https://www.umweltbundesamt.de/en/publikationen/reach-improvement-of-guidance-methods-for-the

  2. Neumann M, Schliebner I (2019) 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. UBA TEXTE 127/2019. Ger Environ Agency (UBA), Dessau-Roßlau, Ger ISBN 1862–4804 87.

  3. Shrestha P, Junker T, Fenner K et al (2016) Simulation studies to explore biodegradation in water-sediment systems: from OECD 308 to OECD 309. Environ Sci Technol 50:6856–6864. https://doi.org/10.1021/acs.est.6b01095

    Article  CAS  Google Scholar 

  4. Matthies M, Solomon K, Vighi M et al (2016) The origin and evolution of assessment criteria for persistent, bioaccumulative and toxic (PBT) chemicals and persistent organic pollutants (POPs). Environ Sci Process Impacts 18:1114–1128. https://doi.org/10.1039/c6em00311g

    Article  CAS  Google Scholar 

  5. Hale SE, Arp HPH, Schliebner I, Neumann M (2020) Whats in a name: persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances. Accept Environ Sci Technol. 32(1):1–1

    Google Scholar 

  6. Jin B, Huang C, Yu Y et al (2020) The need to adopt an international PMT strategy to protect drinking water resources. Environ Sci Technol 54:11651–11653

    Article  CAS  Google Scholar 

  7. Rüdel H, Körner W, Letzel T et al (2020) Persistent, mobile and toxic substances in the environment: a spotlight on current research and regulatory activities. Environ Sci Eur 32:5

    Article  Google Scholar 

  8. Bieber S, Greco G, Grosse S, Letzel T (2017) RPLC-HILIC and SFC with Mass Spectrometry: Polarity-Extended Organic Molecule Screening in Environmental (Water) Samples. Anal Chem 89:7907–7914. https://doi.org/10.1021/acs.analchem.7b00859

    Article  CAS  Google Scholar 

  9. Schröder AH (1991) Polar, hydrophilic compounds in drinking water produced from surface water: determination by liquid chromatography-mass spectrometry. J Chromatogr 554:251–266

    Article  Google Scholar 

  10. Knepper T, Sacher F, Lange F, Brauch H (1999) Detection of polar organic substances relevant for drinking water. Waste Manag 19:77–99

    Article  CAS  Google Scholar 

  11. Reemtsma T, Berger U, Arp HPH et al (2016) Mind the gap: persistent and mobile organic compounds - water contaminants that slip through. Environ Sci Technol 50:10308–10315. https://doi.org/10.1021/acs.est.6b03338

    Article  CAS  Google Scholar 

  12. Loos R, Gawlik BM, Locoro G et al (2009) EU-wide survey of polar organic persistent pollutants in European river waters. Environ Pollut 157:561–568. https://doi.org/10.1016/j.envpol.2008.09.020

    Article  CAS  Google Scholar 

  13. Neumann M, Schwarz M., Sättler D, et al (2015) A proposal for a chemical assessment concept for the protection of raw water resources under REACH. Extended Abstract for the Oral presentation at the 25th SETAC annual meeting.

  14. Sjerps RMA, Vughs D, van Leerdam JA et al (2016) Data-driven prioritization of chemicals for various water types using suspect screening LC-HRMS. Water Res 93:254–264. https://doi.org/10.1016/j.watres.2016.02.034

    Article  CAS  Google Scholar 

  15. van der Hoek JP, Bertelkamp C, Verliefde A, Singhal N (2014) Drinking water treatment technologies in Europe: state of the art–challenges–research needs. J Water Supply Res Technol 63:1

    Article  Google Scholar 

  16. Stackelberg PE, Gibs J, Furlong ET, Meyer MT, Zaugg SD, Lippincott RL (2007) Efficiency of conventional drinking-water-treatment processes in removal of pharmaceuticals and other organic compounds. Sci Total Environ 377(255–272):377

    Google Scholar 

  17. Steinhäuser KG, Richter S (2006) Assessment and management of chemicals-how should persistent polar pollutants be regulated? Org Pollut Water Cycle Prop Occur Anal Environ Relev Polar Compd 311:1

    Google Scholar 

  18. Plumlee MH, Larabee J, Reinhard M (2008) Perfluorochemicals in water reuse. Chemosphere 72:1

    Article  Google Scholar 

  19. Filipovic M, Berger U (2015) Are perfluoroalkyl acids in waste water treatment plant effluents the result of primary emissions from the technosphere or of environmental recirculation? Chemosphere 129:74–80

    Article  CAS  Google Scholar 

  20. Beltrán-Martinavarro B, Peris-Vicente J, Mbla-Alegre MR et al (2013) Quantification of melamine in drinking water and wastewater by micellar liquid chromatography. J AOAC Int 96:870–874. https://doi.org/10.5740/jaoacint.12-248

    Article  CAS  Google Scholar 

  21. Holm JV, Rugge K, Bjerg PL, Christensen TH (1995) Occurrence and distribution of pharmaceutical organic compounds in the groundwater downgradient of a landfill (Grindsted, Denmark). Environ Sci Technol 29:1415–1420. https://doi.org/10.1021/es00005a039

    Article  CAS  Google Scholar 

  22. Scheurer M, Nödler K, Freeling F et al (2017) Small, mobile, persistent: Trifluoroacetate in the water cycle – overlooked sources, pathways, and consequences for drinking water supply. Water Res 126:460–471. https://doi.org/10.1016/j.watres.2017.09.045

    Article  CAS  Google Scholar 

  23. Zahn D, Neuwald IJ, Knepper TP (2020) Analysis of mobile chemicals in the aquatic environment—current capabilities, limitations and future perspectives. Anal Bioanal Chem 412:4763–4784. https://doi.org/10.1007/s00216-020-02520-z

    Article  CAS  Google Scholar 

  24. Schulze S, Paschke H, Meier T et al (2020) A rapid method for quantification of persistent and mobile organic substances in water using supercritical fluid chromatography coupled to high-resolution mass spectrometry. Anal Bioanal Chem 412:4941–4952. https://doi.org/10.1007/s00216-020-02722-5

    Article  CAS  Google Scholar 

  25. Montes R, Rodil R, Placer L et al (2020) Applicability of mixed-mode chromatography for the simultaneous analysis of C1–C18 perfluoroalkylated substances. Anal Bioanal Chem 412:4849–4856. https://doi.org/10.1007/s00216-020-02434-w

    Article  CAS  Google Scholar 

  26. Höcker O, Bader T, Schmidt TC et al (2020) Enrichment-free analysis of anionic micropollutants in the sub-ppb range in drinking water by capillary electrophoresis-high resolution mass spectrometry. Anal Bioanal Chem 412:4857–4865. https://doi.org/10.1007/s00216-020-02525-8

    Article  CAS  Google Scholar 

  27. Arp HPH, Brown TN, Berger U, Hale SE (2017) Ranking REACH registered neutral, ionizable and ionic organic chemicals based on their aquatic persistency and mobility. Environ Sci Process Impacts 19:939–955. https://doi.org/10.1039/c7em00158d

    Article  CAS  Google Scholar 

  28. Schulze S, Zahn D, Montes R et al (2019) Occurrence of emerging persistent and mobile organic contaminants in European water samples. Water Res 153:80–90. https://doi.org/10.1016/j.watres.2019.01.008

    Article  CAS  Google Scholar 

  29. Posthuma L, Munthe J, van Gils J et al (2019) A holistic approach is key to protect water quality and monitor, assess and manage chemical pollution of European surface waters. Environ Sci Eur 31:1–5. https://doi.org/10.1186/s12302-019-0243-8

    Article  Google Scholar 

  30. Goldenman G, Holland M, Lietzmann J, Meura L (2017) Study for the strategy for a non-toxic environment of the 7th Environment Action Programme Final Report. 1–132. https://doi.org/https://doi.org/10.2779/025

  31. ECHA European Chemicals Agency Authorization List, Annex XIV of REACH. https://www.echa.europa.eu/authorisation-list

  32. ECHA European Chemicals Agency (2011) Annex XIII Criteria for the identification of persistent, bioaccumulative and toxic substances, and very persistent and very bioaccumulative substances. https://reachonline.eu/reach/en/annex-xiii.html

  33. ECHA European Chemicals Agency (2019) Annex XV report PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57 Substance Name: Perfluorobutane sulfonic acid (PFBS) and its salts

  34. ECHA (2019) AGREEMENT OF THE MEMBER STATE COMMITTEE ON THE IDENTIFICATION OF Perfluorobutane sulfonic acid and its salts AS SUBSTANCES OF VERY HIGH CONCERN. https://echa.europa.eu/documents/10162/ad9e2050-48b7-137f-22d0-2b4c692e9308

  35. ECHA European Chemicals Agency (2019) Annex XV report PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57 Substance Name(s): 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoic acid, its salts and its acyl halides. https://echa.europa.eu/documents/10162/41086906-eeb6-a963-f0b9-af1d0e27efc2

  36. ChemSec Substitute It Now list (SINList). https://sinlist.chemsec.org/

  37. ECHA European Chemicals Agency Identification of substances as SVHCs due to equivalent level of concern to CMRs (Article 57(f)) – sensitisers as an example. https://echa.europa.eu/documents/10162/13657/svhc_art_57f_sensitisers_en.pdf

  38. Pesudo LQ, Aschberger K (2015) Identification of Substances of Very High Concern (SVHC) under the “equivalent level of concern” route (REACH Article 57(f)) – neurotoxicants and immunotoxicants as examples. https://publications.jrc.ec.europa.eu/repository/bitstream/JRC96572/jrc96572-identification%20svhc%20reach%20article%2057f.pdf

  39. Ahrens L, Bundschuh M (2014) Fate and effects of poly- and perfluoroalkyl substances in the aquatic environment: a review. Environ Toxicol Chem 33:1921–1929. https://doi.org/10.1002/etc.2663

    Article  CAS  Google Scholar 

  40. OECD (2018) Environment directorate joint meeting of the chemicals committee and the working party on chemicals, pesticides and biotechnology toward a new comprehensive global database of per-and polyfluoroalkyl substances (PFASs): summary report on updating the OECD. https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV-JM-MONO(2018)7&doclanguage=en

  41. Buck R, Franklin J, Berger U et al (2011) Perfluoroalkyl and polyfluoroalkyl substances in the environment: terminology, classification, and origins. Integr Environ Assess Manag 7:513–541

    Article  CAS  Google Scholar 

  42. Vierke L, Staude C, Biegel-Engler A et al (2012) Perfluorooctanoic acid (PFOA)-main concerns and regulatory developments in Europe from an environmental point of view. Environ Sci Eur 24:1–11. https://doi.org/10.1186/2190-4715-24-16

    Article  CAS  Google Scholar 

  43. Knutsen H, Mæhlum T, Haarstad K et al (2019) Leachate emissions of short- And long-chain per- And polyfluoralkyl substances (PFASs) from various Norwegian landfills. Environ Sci Process Impacts 21:1970–1979. https://doi.org/10.1039/c9em00170k

    Article  CAS  Google Scholar 

  44. Goldenman G, Fernandes M, Holland M et al (2019). The cost of inaction A socioeconomic analysis of environmental and health impacts linked to exposure to PFAS. https://doi.org/10.6027/TN2019-516

    Article  Google Scholar 

  45. Xiao F (2017) Emerging poly- and perfluoroalkyl substances in the aquatic environment: a review of current literature. Water Res 124:482–495. https://doi.org/10.1016/j.watres.2017.07.024

    Article  CAS  Google Scholar 

  46. Strynar M, Dagnino S, McMahen R, Liang S, Lindstrom A, Andersen E, McMillan L, Thurman M, Ferrer I, Ball C (2015) Identification of novel per- fluoroalkyl ether carboxylic acids (PFECAs) and sulfonic acids (PFESAs) in natural waters using accurate mass time-of-flight mass spectrometry (TOFMS). Environ Sci Technol 49:11622–11630

    Article  CAS  Google Scholar 

  47. Heydebreck F, Tang JH, Xie ZY, Ebinghaus R (2015) Alternative and Legacy Perfluoroalkyl Substances: differences between European and Chinese River/Estuary Systems. Environ Sci Technol 49:8386–8395

    Article  CAS  Google Scholar 

  48. Sun, M.; Arevalo, E.; Strynar, M.; Lindstrom, A.; Richardson M., Kearns, B.; Pickett, A.; Smith, C.; Knappe DRU (2016) Legacy and Emerging Perfluoroalkyl Substances Are Important Drinking Water Contaminants in the Cape Fear River Watershed of North Carolina. Environ Sci Technol Lett 3:

  49. Gebbink WA, Van Asseldonk L, Van Leeuwen SPJ (2017) Presence of Emerging Per- and Polyfluoroalkyl Substances (PFASs) in river and drinking water near a fluorochemical production plant in the Netherlands. Environ Sci Technol 51:11057–11065. https://doi.org/10.1021/acs.est.7b02488

    Article  CAS  Google Scholar 

  50. ECHA European Chemicals Agency (2019) Committee for Risk Assessment RAC Annex 1 Background document to the Opinion proposing harmonised classification and labelling at EU level of 1,4-dioxane. https://echa.europa.eu/documents/10162/2b8d3dc0-76f1-f749-a621-a12441049a14

  51. Anderson RH, Anderson JK, Bower PA (2012) Co-Occurrence of 1 , 4-Dioxane with Trichloroethylene in Chlorinated Solvent Groundwater Plumes at US Air Force Installations : Fact or Fiction. 8:731–737. https://doi.org/https://doi.org/10.1002/ieam.1306

  52. Adamson DT, Piña EA, Cartwright AE et al (2017) 1, 4-Dioxane drinking water occurrence data from the third unregulated contaminant monitoring rule. Sci Total Environ 596–597:236–245. https://doi.org/10.1016/j.scitotenv.2017.04.085

    Article  CAS  Google Scholar 

  53. Adamson DT, Mahendra S, Walker KL, et al (2014) A Multisite Survey To Identify the Scale of the 1,4-Dioxane Problem at Contaminated Groundwater Sites. 1:254–258

  54. Abe A (1999) Distribution of 1 , 4-dioxane in relation to possible sources in the water environment. 227:41–47

  55. Karges U, Becker J, Püttmann W (2018) 1, 4-Dioxane pollution at contaminated groundwater sites in western Germany and its distribution within a TCE plume. Sci Total Environ 619–620:712–720. https://doi.org/10.1016/j.scitotenv.2017.11.043

    Article  CAS  Google Scholar 

  56. Kasai T, Kano H, Umeda Y et al (2009) Two-year inhalation study of carcinogenicity and chronic toxicity of 1,4-dioxane in male rats 2-yr inhalation study of 1,4-dioxane in rats. Inhal Toxicol 21:889–897. https://doi.org/10.1080/08958370802629610

    Article  CAS  Google Scholar 

  57. Kano H, Umeda Y, Saito M et al (2008) Thirteen-week oral toxicity of 1, 4-dioxane in rats and mice. J Toxicol Sci 33:141–153

    Article  CAS  Google Scholar 

  58. McElroy A, Hyman M, Knappe D (2019) 1, 4-Dioxane in drinking water: emerging for 40 years and still unregulated. Curr Opin Environ Sci Heal 7:117–125

    Article  Google Scholar 

  59. Zenker MJ, Borden RC, Barlaz M (2003) Occurrence and Treatment of 1,4Dioxane in Aqueous Environments Comparison of Field Measurements to Methane Emissions Models at a New Landfill View project. liebertpub.com 20:423–432. https://doi.org/https://doi.org/10.1089/109287503768335913

  60. Isaacson C, Mohr TKG, Field JA (2006) Quantitative determination of 1,4-dioxane and tetrahydrofuran in groundwater by solid phase extraction GC/MS/MS. Environ Sci Technol 40:7305–7311. https://doi.org/10.1021/es0615270

    Article  CAS  Google Scholar 

  61. Mohr TKG (2010) Environmental Investigation and Remediation: 1, 4-Dioxane and other Solvent Stabilizers. In: CRC Press Taylor Fr. Group,. https://www.amazon.com/Environmental-Investigation-Remediation-4-Dioxane-Stabilizers/dp/1566706629. Accessed 12 Aug 2020

  62. Eckhardt A (2018) Positive Trends Emerge in Reducing Exposure to 1,4-Dioxane. J Am Water Works Assoc 110:54–59. https://doi.org/10.1002/awwa.1116

    Article  Google Scholar 

  63. Stepien DK, Regnery J, Merz C, Püttmann W (2013) Behavior of organophosphates and hydrophilic ethers during bank fi ltration and their potential application as organic tracers. A fi eld study from the Oderbruch. Germany Sci Total Environ 458–460:150–159. https://doi.org/10.1016/j.scitotenv.2013.04.020

    Article  CAS  Google Scholar 

  64. Godri KJ, Kim J, Peccia J et al (2019) 1, 4-Dioxane as an emerging water contaminant : State of the science and evaluation of research needs. Sci Total Environ 690:853–866. https://doi.org/10.1016/j.scitotenv.2019.06.443

    Article  CAS  Google Scholar 

  65. Schoonenberg Kegel F, Rietman BM, Verliefde ARD (2010) Reverse osmosis followed by activated carbon filtration for efficient removal of organic micropollutants from river bank filtrate. Water Sci Technol 61:2603–2610. https://doi.org/10.2166/wst.2010.166

    Article  CAS  Google Scholar 

  66. Carson R (1962) Silent Spring. Fawcett Crest

  67. Jensen S, Johnels AG, Olsson M, Otterlind G (1969) DDT and PCB in marine animals from Swedish waters. Nature 224:247–250. https://doi.org/10.1038/224247a0

    Article  CAS  Google Scholar 

  68. ECHA European Chemicals Agency (2012) Guidance on information requirements and chemical safety assessment Chapter R . 11 : PBT Assessment November 2012. https://echa.europa.eu/documents/10162/13632/information_requirements_r11_en.pdf 1–99

  69. Persson LM, Breitholtz M, Cousins IT et al (2013) Confronting unknown planetary boundary threats from chemical pollution. Environ Sci Technol 47:12619–12622. https://doi.org/10.1021/es402501c

    Article  CAS  Google Scholar 

  70. Brown TN, Wania F (2008) Screening chemicals for the potential to be persistent organic pollutants: A case study of Arctic contaminants. Environ Sci Technol 42:5202–5209. https://doi.org/10.1021/es8004514

    Article  CAS  Google Scholar 

  71. Spyraki M, Arena M, Ries F, et al (2020) MOTION FOR A RESOLUTION further to Question for Oral Answer B9–0013/2020 pursuant to Rule 136(5) of the Rules of Procedure on the Chemicals Strategy for Sustainability (2020/2531(RSP))

Download references

Acknowledgements

The authors thank Lena Vierke, German Environment Agency for helpful discussions during initial idea discussions.

Funding

Funding was obtained from the European Union Joint Programming Initiative ‘Water Challenges for a Changing World’ (Water JPI) with financial support by The Norwegian Research Council (project no. 241358/E50). Additional funding was done through the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety of Germany. Research projects FKZ 3716 67 416 0 and FKZ 3719 65 408 0.

Author information

Authors and Affiliations

  1. Norwegian Geotechnical Institute (NGI), Ullevål Stadion, P.O. Box 3930, 0806, Oslo, Norway

    Sarah E. Hale & Hans Peter H. Arp

  2. Department of Chemistry, Norwegian University of Science and Technology (NTNU), 7491, Trondheim, Norway

    Hans Peter H. Arp

  3. German Environment Agency (UBA), Section IV 2.3 Chemicals, Wörlitzer Platz 1, 06844, Dessau-Roßlau, Germany

    Ivo Schliebner & Michael Neumann

Authors
  1. Sarah E. Hale
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Hans Peter H. Arp
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Ivo Schliebner
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Michael Neumann
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

SH and MN conceived the idea. SH, HPHA, MN, IS all contributed to the writing. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Sarah E. Hale.

Ethics declarations

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hale, S.E., Arp, H.P.H., Schliebner, I. et al. 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. Environ Sci Eur 32, 155 (2020). https://doi.org/10.1186/s12302-020-00440-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1186/s12302-020-00440-4

Keywords