Suchergebnisse

AbstractPersistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances have gained significant attention in recent years. The substances do not break down in the environment over appreciable time scale, can travel long distances with water bodies and can cause toxic effects on the environment and human health. Hazard classes for these substances were introduced into the Classification, Labelling and Packaging Regulation in March 2023. A key preventative measure to reduce manufacture, use and emissions of PMT/vPvM substances, is a market transition away from these substances to less harmful alternatives. Companies may be unaware of which of their products contain PMT/vPvM substances. The Horizon Europe research project ZeroPM: Zero pollution of persistent, mobile substances is seeking to support this market transition by developing and further extending tools including the Substitute It Now (SIN) List, the Marketplace and a PFAS Guide for companies. These tools will be discussed.

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.

There are substances with a specific combination of intrinsic substance properties that cause them to pose an inherent hazard to remote aquatic environments and the sources of our drinking water. These are substances that are very persistent in the environment and very mobile in the aquatic environment (vPvM); or, substances that are persistent in the environment, mobile in the aquatic environment and toxic (PMT). A review of substances detected in drinking water and groundwater found that 43% of them are REACH registered. Further, REACH registered substances were the most likely to be found at higher concentrations (above 0.1 μg/L). The German Environment Agency (UBA) has over several years, and most recently via this project, further discussed, developed, justified and decided upon the proposed criteria for identifying PMT and vPvM substances in the regulatory context of the EU REACH Regulation (EC) No 1907/2006 (Neumann and Schliebner, 2019). To assist implementation of these criteria, this report presents updated guidelines to prospectively or retrospectively use the REACH registration process to identify PMT/vPvM substances. Special considerations for data uncertainty are presented via the implementation of a "traffic light" system. The guidance was applied to all 15469 REACH registered substances as of May 2017. Of these, 260 met the PMT/vPvM criteria (Red), 224 met the PM criteria (Dark Yellow), 2377 had screening or low-quality data requiring further investigation (Yellow), 3665 did not meet the PMT/vPvM criteria (Green) and 3216 had insufficient data to make a conclusion (White). The list of PMT/vPvM substances is provided and discussed in terms of monitoring data, emission likelihood and current restrictions or regulations. Of the complete list, 122 chemical constituents are prioritized for further investigation to assess the need for introducing risk management measures. Without acting, the cost of clean-up and drinking water purification in Europe could be well into several billions of Euros.

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.

Abstract
Background
Persistent, mobile and toxic (PMT), or very persistent and very mobile (vPvM) substances are a wide class of chemicals that are recalcitrant to degradation, easily transported, and potentially harmful to humans and the environment. Due to their persistence and mobility, these substances are often widespread in the environment once emitted, particularly in water resources, causing increased challenges during water treatment processes. Some PMT/vPvM substances such as GenX and perfluorobutane sulfonic acid have been identified as substances of very high concern (SVHCs) under the European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. With hundreds to thousands of potential PMT/vPvM substances yet to be assessed and managed, effective and efficient approaches that avoid a case-by-case assessment and prevent regrettable substitution are necessary to achieve the European Union's zero-pollution goal for a non-toxic environment by 2050.

Main
Substance grouping has helped global regulation of some highly hazardous chemicals, e.g., through the Montreal Protocol and the Stockholm Convention. This article explores the potential of grouping strategies for identifying, assessing and managing PMT/vPvM substances. The aim is to facilitate early identification of lesser-known or new substances that potentially meet PMT/vPvM criteria, prompt additional testing, avoid regrettable use or substitution, and integrate into existing risk management strategies. Thus, this article provides an overview of PMT/vPvM substances and reviews the definition of PMT/vPvM criteria and various lists of PMT/vPvM substances available. It covers the current definition of groups, compares the use of substance grouping for hazard assessment and regulation, and discusses the advantages and disadvantages of grouping substances for regulation. The article then explores strategies for grouping PMT/vPvM substances, including read-across, structural similarity and commonly retained moieties, as well as the potential application of these strategies using cheminformatics to predict P, M and T properties for selected examples.

Conclusions
Effective substance grouping can accelerate the assessment and management of PMT/vPvM substances, especially for substances that lack information. Advances to read-across methods and cheminformatics tools are needed to support efficient and effective chemical management, preventing broad entry of hazardous chemicals into the global market and favouring safer and more sustainable alternatives.

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.

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

Abstract
Background
The NORMAN Association (https://www.norman-network.com/) initiated the NORMAN Suspect List Exchange (NORMAN-SLE; https://www.norman-network.com/nds/SLE/) in 2015, following the NORMAN collaborative trial on non-target screening of environmental water samples by mass spectrometry. Since then, this exchange of information on chemicals that are expected to occur in the environment, along with the accompanying expert knowledge and references, has become a valuable knowledge base for "suspect screening" lists. The NORMAN-SLE now serves as a FAIR (Findable, Accessible, Interoperable, Reusable) chemical information resource worldwide.

Results
The NORMAN-SLE contains 99 separate suspect list collections (as of May 2022) from over 70 contributors around the world, totalling over 100,000 unique substances. The substance classes include per- and polyfluoroalkyl substances (PFAS), pharmaceuticals, pesticides, natural toxins, high production volume substances covered under the European REACH regulation (EC: 1272/2008), priority contaminants of emerging concern (CECs) and regulatory lists from NORMAN partners. Several lists focus on transformation products (TPs) and complex features detected in the environment with various levels of provenance and structural information. Each list is available for separate download. The merged, curated collection is also available as the NORMAN Substance Database (NORMAN SusDat). Both the NORMAN-SLE and NORMAN SusDat are integrated within the NORMAN Database System (NDS). The individual NORMAN-SLE lists receive digital object identifiers (DOIs) and traceable versioning via a Zenodo community (https://zenodo.org/communities/norman-sle), with a total of > 40,000 unique views, > 50,000 unique downloads and 40 citations (May 2022). NORMAN-SLE content is progressively integrated into large open chemical databases such as PubChem (https://pubchem.ncbi.nlm.nih.gov/) and the US EPA's CompTox Chemicals Dashboard (https://comptox.epa.gov/dashboard/), enabling further access to these lists, along with the additional functionality and calculated properties these resources offer. PubChem has also integrated significant annotation content from the NORMAN-SLE, including a classification browser (https://pubchem.ncbi.nlm.nih.gov/classification/#hid=101).

Conclusions
The NORMAN-SLE offers a specialized service for hosting suspect screening lists of relevance for the environmental community in an open, FAIR manner that allows integration with other major chemical resources. These efforts foster the exchange of information between scientists and regulators, supporting the paradigm shift to the "one substance, one assessment" approach. New submissions are welcome via the contacts provided on the NORMAN-SLE website (https://www.norman-network.com/nds/SLE/).