Chemicals with a specific combination of intrinsic substance properties pose a hazard to the sources of our drinking water, including substances that are very persistent (vP) in the environment and very mobile (vM) in the aquatic environment as well as substances that are persistent (P), mobile (M), and toxic (T). This publication presents the result of the scientific and technical development of the PMT/vPvM criteria under EU REACH Regulation (EC) No 1907/2006. The scientific and regulatory considerations include (1) monitoring data, (2) simulation and model studies and (3) impact considerations. This can be considered a ready-to-use tool for industry to identify PMT/vPvM substances.
Die Ressourcen von Trinkwässern in Europa vor Chemikalien zu schützen, ist von größter Wichtigkeit. Eine Strategie ist erforderlich, die der chemischen Industrie weiterhin Innovationen ermöglicht und gleichzeitig den Schutz der Gewässer und der Ressourcen unserer Trinkwässer sicherstellt. Das Umweltbundesamt (UBA) schlägt mit dieser Initiative Kriterien und ein Bewertungskonzept zur Identifizierung von Stoffen vor, die persistent (P) in der Umwelt, mobil (M) im Wasserkreislauf (PM-Stoffe) und zusätzlich toxisch (T) für den Menschen (PMT-Stoffe) sind. Die vorgeschlagenen Kriterien unterstützen Registranten bei der Erfüllung ihrer Verpflichtung zur sicheren Verwendung von Chemikalien im Rahmen der EU-Chemikalienverordnung "REACH" (Verordnung EG Nr. 1907/2006).
Zugriffsoptionen:
Die folgenden Links führen aus den jeweiligen lokalen Bibliotheken zum Volltext:
Protecting the sources of our drinking water from any threats caused by chemicals is of the utmost importance. A strategy is needed in order to allow Europe's chemical industry to continue to innovate while ensuring the protection of the water cycle. The German Environment Agency (UBA) is carrying out an initiative to identify those substances that are persistent (P) in the environment, mobile (M) in the water cycle (PM substances), and additionally toxicity (T) to human health (PMT substances). The proposed criteria will assist registrants in fulfilling their responsibility of guaranteeing the safe use of chemicals under the EU's chemical regulation "REACH" (Regulation EC No 1907/2006).
Zugriffsoptionen:
Die folgenden Links führen aus den jeweiligen lokalen Bibliotheken zum Volltext:
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.
Protection of drinking water resources from PMT/vPvM substances: Revised guidance for REACH registrants on the identification of these substances of very high concern (SVHC). Only 1.9 % of the unique chemical structures in the REACH registration database fall in the new CLP hazard classes PMT and vPvM. However, for a total of 64 % no final assessment was achieved, either due to lack of test data (41 %) or due to ambiguous assessment (23 %). These guidance and methods can be used immediately by REACH registrants to ensure the safety of their substances, to close data gaps and, if necessary, to use safer alternatives, or to implement risk mitigation measures (RMMs).
A broad literature review (55 studies published between 2000 and 2019) now shows that 639 chemicals are already known as contaminants in river bank filtrate (114 substances), groundwater (338 substances), raw water (212 substances) or drinking water (385 substances). The literature review carried out by the German Environment Agency reveals: Every second substance that contaminates our drinking water resources is registered under REACH, of which 24 % fall in the new CLP hazard classes PMT and vPvM. Considering only the raw water, the proportion even rises to 32 %. In the REACH registration database, the proportion of PMT/vPvM substances based on CLP criteria is only 1.9 %.
The updated UBA list comprising of 343 PMT/vPvM substances (unique chemical structures), belonging to 474 registered substances in the REACH registration database, is presented. This is the first update to the UBA list of PMT/vPvM substances as of May 2017 originally published as UBA TEXTE 126/2019. This update is based on the REACH registration database as of September 2019. The UBA list is split into three priority categories, based on whether the registration volume is > 10 tpa and whether the substance is currently subject to any regulation in Europe. The High-Priority Category A comprises of 173 PMT/vPvM substances. The two Moderate-priority Categories B and C comprise of 142 and 29 PMT/vPvM substances, respectively. Of these 343 PMT/vPvM substances, only 259 substances meet the less stringent PMT/vPvM criteria proposed in 2021 by the European Commission for new hazard classes under the CLP regulation. An additional 421 unique chemical structures (belonging to 474 registered substances) are presented, that were assessed to be persistent and mobile but with currently no high-quality consensus conclusions that the criteria for toxicity is met. The prioritised UBA list of 343 PMT/vPvM substances in the REACH registration database is ready to use for registrants and downstream users. They can immediately act to reduce and minimise emissions throughout the whole life cycle of their substances, to ultimately increase the safety of drinking water resources and to safeguard freshwater environments for future generations.
AbstractIn 2020, the European Commission released its Chemicals Strategy for Sustainability towards a Toxic Free Environment (CSS) as part of the European Union's zero pollution ambition, which is a key commitment of the European Green Deal. One group of substances highlighted in the CSS is persistent, mobile and toxic and very persistent and very mobile (PMT/vPvM) substances. This article focuses on the current, broad European political landscape that applies to PMT/vPvM substances as well as looking into gaps and opportunities within this policy framework. To look at the political landscape, strategies and action plans published in the context of the European Green Deal, as well as a small number of other strategies adopted prior to the European Green Deal, were reviewed. A template was developed to identify actions related to PMT/vPvM substances and the actions were split between the following categories: "Prevent & Reduce", "Prioritize", and "Remediation". Following this, opportunities and gaps were identified.The current overarching strategy governing environmental policy is the European Green Deal which aims to achieve carbon neutrality and zero pollution by 2050. The CSS is the main and most focused Green Deal strategy addressing chemical pollution and uses a hierarchy tailored to chemicals management called the Toxic Free Hierarchy. The potential sources and exposure pathways of PMT/vPvM substances which result in environmental emissions are vast. This has the resultant effect that the relevant legal framework to address PMT/vPvM substances spans policies and legislation with different aims. Broadly, these policies and legislations are related to prevention, minimization/control and remediation, as reflected by the toxic-free hierarchy. There are many gaps and opportunities in the current policy framework which have primarily arisen due to the bold ambition of the CSS and the subsequent introduction of new hazard classes for PMT/vPvM substances. One such gap is related to a lack of harmonization across European Chemicals Policy demonstrated via the Cosmetics Regulation and the Biocidal Products Regulation (BPR) which are currently not aligned. The Cosmetics Regulation does not require a re-evaluation of a substance even in light of new scientific information, whilst the BPR requires new scientific evidence to be considered. In addition, REACH (SVHC criteria) and other legislation using hazard classes for triggering risk management measures (BPR, PPPR, pharmaceutical legislation, Water Framework Directive) may be expected to be revised or are currently being revised based on the new hazard class. The regulation of PMT/vPvM substances is in its infancy. While many EU action plans exhibit gaps and opportunities for chemical regulation as a whole, only certain policies refer to PMT/vPvM substances directly. It is up to policymakers, regulators and academia to highlight those gaps and corresponding emerging windows of opportunity that reflect potential regulatory engagement. The introduction of new hazard classes for PMT/vPvM substances in the Classification, Labelling and Packaging (CLP) regulation provides a first step as these substances are identified, however, regulatory consequences need to be implemented in all other legislation in the future. This will need strong commitment from the European Commission and the EU Member States.
Chemicals that are persistent in the environment, mobile in the aquatic environment and toxic may be critical for the quality of raw waters. In the present study, a list of 167 REACH registered substances were assessed with respect to their intrinsic substance properties persistence in the aquatic environment (Paq), mobility in the aquatic environment (M) and toxicity (T) using modified criteria earlier defined by Kalberlah et al. (2014). This was done by comprehensive manual research of all relevant information and data in all available data sources including mathematical models. Additionally, the substances were assessed and ranked with respect to their potential for environmental emissions based on the evaluation approach developed by Schulze et al. (2018). The present study provides a consolidated list of substances assessed according to the above criteria, including 8 substances assessed as Paq MT substances and 21 substances assessed as Paq M substances with suspected T. Further 105 suspected Paq MT substances were identified. Consequently, a total of 134 substances based on suspected Paq MT properties combined with expected environmental emissions are recommended to the German Environment Agency (UBA) for further investigation and scientific and regulatory scrutiny. However, this result may not be suitable to indicate the need for regulatory measures. The study identified considerable data gaps (especially for experimental data) that in many cases hampered the assessment of the criteria, especially for M and T. Manufacturers, importers and downstream users of substances should strive to obtain and report data of better quality in order to carry out a more accurate assessment. Further, the results of this project will support the ongoing discussion to define PMT criteria under REACH.
PFAS only the tip of the iceberg: Each water sample was contaminated with mobile forever chemicals such as TFA, PFPrA or TFMS. But also 26 of the 34 non-fluorinated PMT/vPvM substances analysed were detected, including 1H benzotriazole, 1,4-dioxane, melamine, cyanuric acid and diphenyl guanidine. A representative survey of 27 water laboratories in Germany (twelve commercial laboratories, eleven laboratories of a federal state and 4 laboratories of water suppliers) now shows that out of 79 requested PMT/vPvM substances 60 % are not monitored due to lack of analytics ("analytical gap") or lack of monitoring ("monitoring gap"). At the same time, the research project of the German Environment Agency shows that 51 % of these 79 PMT/vPvM substances cannot be removed from raw water with activated carbon filters or ozone. The PMT/vPvM prioritisation framework supports REACH registrants, regulators, researchers and the water sector to take immediate action to protect drinking water resources.
The study describes the intermediate uses of 53 petroleum and coal stream (PetCo) substances and assesses the potential for their constituents with properties of concern to transfer within the supply chain and into the environment. The study focuses on 15 marker constituents that have been shortlisted based on a screening of CMR (carcinogenic, mutagenic, reprotoxic), PBT (persistent, bioaccumulative and toxic) and ED (endocrine disrupting) properties. The study relies on a combination of five approaches. Approach 0 considers the reactivity of the relevant constituent groups to assess how likely they are to be converted in one of the relevant processes. Approach 1 relies on literature review to assess likelihood of the marker constituents being converted in the relevant process based on thermodynamic and other factors such as the presence of catalysts. Approach 2 modifies the results of Approach 1 by adding information collected through consultation for this study. Approach 3 further adds the dimension of supply chain interactions to screen out the products that are subject to high-temperature processes further downstream. Approach 4 takes an upstream perspective and includes a review of the literature on the presence of some of the relevant constituents in the relevant end-products. Each of these approaches has its advantages and disadvantages and, for this reason, the results of all five approaches are presented in the report. In addition, the report provides an overview of the potential for the constituents that are not converted to be emitted into the environment.
Abstract Background Safe and clean drinking water is essential for human life. Persistent, mobile and toxic (PMT) substances and/or very persistent and very mobile (vPvM) substances are an important group of substances for which additional measures to protect water resources may be needed to avoid negative environmental and human health effects. PMT/vPvM substances do not sufficiently biodegrade in the environment, they can travel long distances with water and are toxic (those that are PMT substances) to the environment and/or human health. PMT/vPvM substance research and regulation is arguably in its infancy and in order to get in control of these substances the following (non-exhaustive list of) knowledge gaps should to be addressed: environmental occurrence; the suitability of currently available analytical methods; the effectiveness and availability of treatment technologies; the ability of regional governance and industrial stewardship to contribute to safe drinking water while supporting innovation; the ways in which policies and regulations can be used most effectively to govern these substances; and, the identification of safe and sustainable alternatives.
Methods The work is the outcome of the third PMT workshop, held in March 2021, that brought together diverse scientists, regulators, NGOs, and representatives from the water sector and the chemical sector, all concerned with protecting the quality of our water resources. The online workshop was attended by over 700 people. The knowledge gaps above were discussed in the presentations given and the attendees were invited to provide their opinions about knowledge gaps related to PMT/vPvM substance research and regulation.
Results Strategies to closing the knowledge, technical and practical gaps to get in control of PMT/vPvM substances can be rooted in the Chemicals Strategy for Sustainability Towards a Toxic Free Environment from the European Commission, as well as recent advances in the research and industrial stewardship. Key to closing these gaps are: (i) advancing remediation and removal strategies for PMT/vPvM substances that are already in the environment, however this is not an effective long-term strategy; (ii) clear and harmonized definitions of PMT/vPvM substances across diverse European and international legislations; (iii) ensuring wider availability of analytical methods and reference standards; (iv) addressing data gaps related to persistence, mobility and toxicity of chemical substances, particularly transformation products and those within complex substance mixtures; and (v) advancing monitoring and risk assessment tools for stewardship and regulatory compliance. The two most effective ways to get in control were identified to be source control through risk governance efforts, and enhancing market incentives for alternatives to PMT/vPvM substances by using safe and sustainable by design strategies.
Background: Safe and clean drinking water is essential for human life. Persistent, mobile and toxic (PMT) substances and/or very persistent and very mobile (vPvM) substances are an important group of substances for which additional measures to protect water resources may be needed to avoid negative environmental and human health effects. PMT/vPvM substances do not sufficiently biodegrade in the environment, they can travel long distances with water and are toxic (those that are PMT substances) to the environment and/or human health. PMT/vPvM substance research and regulation is arguably in its infancy and in order to get in control of these substances the following (non-exhaustive list of) knowledge gaps should to be addressed: environmental occurrence; the suitability of currently available analytical methods; the effectiveness and availability of treatment technologies; the ability of regional governance and industrial stewardship to contribute to safe drinking water while supporting innovation; the ways in which policies and regulations can be used most effectively to govern these substances; and, the identification of safe and sustainable alternatives. Methods: The work is the outcome of the third PMT workshop, held in March 2021, that brought together diverse scientists, regulators, NGOs, and representatives from the water sector and the chemical sector, all concerned with protecting the quality of our water resources. The online workshop was attended by over 700 people. The knowledge gaps above were discussed in the presentations given and the attendees were invited to provide their opinions about knowledge gaps related to PMT/vPvM substance research and regulation. Results: Strategies to closing the knowledge, technical and practical gaps to get in control of PMT/vPvM substances can be rooted in the Chemicals Strategy for Sustainability Towards a Toxic Free Environment from the European Commission, as well as recent advances in the research and industrial stewardship. Key to closing these gaps are: (i) advancing remediation and removal strategies for PMT/vPvM substances that are already in the environment, however this is not an effective long-term strategy; (ii) clear and harmonized definitions of PMT/vPvM substances across diverse European and international legislations; (iii) ensuring wider availability of analytical methods and reference standards; (iv) addressing data gaps related to persistence, mobility and toxicity of chemical substances, particularly transformation products and those within complex substance mixtures; and (v) advancing monitoring and risk assessment tools for stewardship and regulatory compliance. The two most effective ways to get in control were identified to be source control through risk governance efforts, and enhancing market incentives for alternatives to PMT/vPvM substances by using safe and sustainable by design strategies. ; ISSN:2190-4715 ; ISSN:2190-4707
