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Veröffentlichung Short-chain perfluoroalkyl acids: environmental concerns and a regulatory strategy under REACH(2018) Biegel-Engler, Annegret; Fetter, Èva; Brendel, Stephan; Fetter, Éva; Staude, Claudia; Vierke, LenaBackground Short-chain PFASs (per- and polyfluoroalkyl substances) are widely used as alternatives to long-chain PFASs. Long-chain PFASs become gradually regulated under REACH (EC No. 1907/2006) and other international regulations, due to having persistent, bioaccumulative and toxic properties and/or being toxic for reproduction. The increasingly used short-chain PFASs are assumed to have a lower bioaccumulation potential. Nonetheless, they have other properties of concern and are already widely distributed in the environment, also in remote regions. The REACH Regulation does not directly address these emerging properties of concern, complicating the implementation of regulatory measures. Therefore, this study illustrates these environmental concerns and provides a strategy for a regulation of short-chain PFASs within REACH. Results Short-chain PFASs have a high mobility in soil and water, and final degradation products are extremely persistent. This results in a fast distribution to water resources, and consequently, also to a contamination of drinking water resources. Once emitted, short-chain PFASs remain in the environment. A lack of appropriate water treatment technologies results in everlasting background concentrations in the environment, and thus, organisms are permanently and poorly reversibly exposed. Considering such permanent exposure, it is very difficult to estimate long-term adverse effects in organisms. Short-chain PFASs enrich in edible parts of plants and the accumulation in food chains is unknown. Regarding these concerns and uncertainties, especially with respect to the precautionary principle, short-chain PFASs are of equivalent concern to PBT substances. Therefore, they should be identified as substances of very high concern (SVHC) under REACH. The SVHC identification should be followed by a restriction under REACH, which is the most efficient way to minimize the environmental and human exposure of short-chain PFASs in the European Union. Conclusion Due to an increasing use of short-chain PFASs, an effective regulation is urgently needed. The concerns of short-chain PFASs do not match the "classical" concerns as defined under REACH, but are not of minor concern. Therefore, it is of advantage to clearly define the concerns of short-chain PFASs. This might facilitate the following restriction process under REACH. © The Author(s) 2018Veröffentlichung An ecotoxicological view on neurotoxicity assessment(2018) Legradi, J. B.; Paolo, C. Di; Kuckelkorn, Jochen; Kraak, M. H. S.; Grummt, TamaraThe numbers of potential neurotoxicants in the environment are raising and pose a great risk for humans and the environment. Currently neurotoxicity assessment is mostly performed to predict and prevent harm to human populations. Despite all the efforts invested in the last years in developing novel in vitro or in silico test systems, in vivo tests with rodents are still the only accepted test for neurotoxicity risk assessment in Europe. Despite an increasing number of reports of species showing altered behaviour, neurotoxicity assessment for species in the environment is not required and therefore mostly not performed. Considering the increasing numbers of environmental contaminants with potential neurotoxic potential, eco-neurotoxicity should be also considered in risk assessment. In order to do so novel test systems are needed that can cope with species differences within ecosystems. In the field, online-biomonitoring systems using behavioural information could be used to detect neurotoxic effects and effect-directed analyses could be applied to identify the neurotoxicants causing the effect. Additionally, toxic pressure calculations in combination with mixture modelling could use environmental chemical monitoring data to predict adverse effects and prioritize pollutants for laboratory testing. Cheminformatics based on computational toxicological data from in vitro and in vivo studies could help to identify potential neurotoxicants. An array of in vitro assays covering different modes of action could be applied to screen compounds for neurotoxicity. The selection of in vitro assays could be guided by AOPs relevant for eco-neurotoxicity. In order to be able to perform risk assessment for eco-neurotoxicity, methods need to focus on the most sensitive species in an ecosystem. A test battery using species from different trophic levels might be the best approach. To implement eco-neurotoxicity assessment into European risk assessment, cheminformatics and in vitro screening tests could be used as first approach to identify eco-neurotoxic pollutants. In a second step, a small species test battery could be applied to assess the risks of ecosystems. Quelle: VerlagsinformationVeröffentlichung Environmental risk assessment of nanomaterials in the light of new obligations under the REACH regulation: which challenges remain and how to approach them?(2020) Schwirn, Kathrin; Galert, Wiebke; Völker, DorisWithin the European regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH, EC No 1907/2006) specific provisions for nanomaterials were included, which have become effective on 1 January 2020. Although knowledge on the peculiarities of testing and assessing fate and effects of nanomaterials in the environment strongly increased in the last years, uncertainties about how to perform a reliable and robust environmental risk assessment for nanomaterials still remain. These uncertainties are of special relevance in a regulatory context, challenging both industry and regulators. The present paper presents current challenges in regulatory hazard and exposure assessment under REACH, as well as classification of nanomaterials, and makes proposals to address them. Still, the nanospecific considerations made here are expected to also be valid for environmental risk assessment approaches in other regulations of chemical safety. Inter alia, these proposals include a way forward to account for exposure concentrations in aquatic toxicity test systems, a discussion of how to account for availability of dissolving nanomaterials in aquatic test systems, and a pragmatic proposal to deduce effect data for soil organisms. Furthermore, it specifies how to potentially deal with nanoforms under the European regulation on Classification, Labelling and Packaging of substances and mixtures (CLP) and outlines the needs for proper exposure assessments of nanomaterials from a regulatory perspective. Integr Environ Assess Manag 2020;16:706-717. © 2020 The Authors.Veröffentlichung An evaluation of the proposal to regulate lead in hunting ammunition through the European Union's REACH regulation(2020) Drost, Wiebke; Treu, Gabriele; Stock, FraukeBackground Despite extensive evidence that exposure to lead from ingested ammunition harms humans and wildlife, and in contravention of European statesâ€Ì commitments under multilateral environmental agreements to minimize lead emissions, lead in hunting ammunition is still poorly regulated in Europe. The proposed restriction on lead gunshot under the REACH regulation is currently discussed for adoption to protect birds in wetlands from lead poisoning. Based on a subsequent investigation report concluding that additional measures are warranted to control the use of lead ammunition in terrestrial environments, ECHA is preparing a new restriction until October 2020. To help inform this process, we describe REACH management instruments and evaluate the effectiveness and enforceability of different legislative alternatives as well as socio-economic aspects of restricting lead shot in comparison to a total ban. We further discuss how the risks and environmental emissions of lead in rifle bullets can be most effectively controlled by legislative provisions in the future. Results Among different management tools, restriction was shown to be most effective and appropriate, since imports of lead ammunition would be covered. The partial restriction of lead gunshot limited to wetlands covers only a minor proportion of all lead used in hunting ammunition in the European Union, leaving multiple wildlife species at risk of being poisoned. Moreover, lead shot will be still purchasable throughout the EU. Within Europe, the costs associated with impacts on wildlife, humans and the environment would be considerably lower when switching to alternative gunshot and rifle bullets. Conclusion We argue that there is sufficient evidence to justify more effective, economic, and practical legislative provisions under REACH, i.e., restricting the use and placing on the market of lead in hunting ammunition. The enforcement would be significantly facilitated and hunters could easier comply. A crucial step is to define a realistic phasing-out period and chemical composition standards for non-lead substitutes while engaging all stakeholders to improve acceptance and allow adaptation. Until the total restriction enters into force, Member States could consider imposing more stringent national measures. A total restriction would reduce wildlife poisoning, harmonize provisions of national and European laws, and foster any efforts to decelerate loss of biodiversity. © The Author(s) 2020Veröffentlichung Environmental Risk Assessment of Technical Mixtures Under the European Registration, Evaluation, Authorisation and Restriction of Chemicals(2021) Galert, Wiebke; Hassold, EnkenThe European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation has been in force since 2007 and is intended to ensure a high level of protection for human health and the environment. The REACH regulation is based on the principle that manufacturers, importers, and downstream users take responsibility for their chemicals. Currently about 23 000 single chemicals are registered within the REACH legislation. A large proportion of substances registered under REACH end up in technical mixtures, intentionally manufactured as such, or generated mixtures containing byproducts of processes. Such mixtures that contain a number of different components are, for example, ink, paint, lacquer, mortar, or cleaning agents. However, REACH focuses on single substances and addresses the safe use of substances as such (e.g., bisphenol A) or substances in mixtures (e.g., bisphenol A used as an antioxidant in mixtures) and in articles (e.g., bisphenol A used as a monomer for polycarbonate production from which greenhouse sheets may be made). In contrast to other substance regulations, under REACH the registrants and downstream users of chemicals are responsible for the risk assessment. According to the REACH regulation, they also have the obligation to derive and communicate safe use conditions for their technical mixtures. Currently, no guidance document and no distinct obligations for an assessment of technical mixtures exist. In light of the available evidence for the joint exposures and effects of chemicals due to co-exposures, the need for approaches for a mixture assessment and improved data communications were highlighted by various stakeholders from industry, European member states, and the European Chemicals Agency (ECHA). The lead component identification (LCID) methodology and the safe use of mixtures information (SUMI) tool were proposed by the European Chemical Industry Council (Cefic) as working tools for the evaluation of the hazard potential, derivation of safe use conditions, and data communication for mixtures along the supply chain. The present paper analyzes the workability and pitfalls of these proposed methodologies from a regulatory perspective, aiming at a safe use of technical mixtures which considers the joint effects and exposures of its components. Integr Environ Assess Manag 2021;17:498-506. © 2021 UmweltbundesamtVeröffentlichung Options for an environmental risk assessment of intentional and unintentional chemical mixtures under REACH(2021) Galert, Wiebke; Hassold, Enken; Schulze, JonaIt is acknowledged that a variety of chemicals enter the environment and may cause joint effects. Chemicals regulated under the European Chemicals Regulation REACH are often part of formulated mixtures and during their processing and use in various products they can be jointly released via sewage treatment plants or diffuse sources, and may combine in the environment. One can differentiate between intentional mixtures, and unintentional mixtures. In contrast to other substance-oriented legislations, REACH contains no explicit requirements for an assessment of combined effects, exposures and risks of several components. Still, it requires ensuring the safe use of substances on their own, in mixtures, and in articles. The available options to address intentional as well as unintentional mixtures are presented and discussed with respect to their feasibility under REACH, considering the responsibilities, communication tasks and information availability of the different actors (registrants, downstream-user and authorities). Specific mixture assessments via component-based approaches require a comprehensive knowledge on substances properties, uses, fate and behaviour, and the composition of the mixture under consideration. This information is often not available to the responsible actor. In principle, intentional mixtures of known composition can be assessed by the downstream-user. But approaches have to be improved to ensure a transparent communication and sound mixture assessment. In contrast, unintentional mixtures appear to be better addressable via generic approaches such as a mixture allocation factor during the chemical safety assessment, although questions on the magnitude, implementation and legal mandates remain. Authorities can conduct specific mixture risk assessments in well-defined and prioritized cases, followed by subsequent regulatory measures. In order to address intentional and unintentional mixtures within the current REACH framework, legal mandates together with guidance for the different actors are needed. Furthermore, further data on mixture compositions, uses and co-exposures need to be made accessible via shared databases. © The Author(s) 2021.Veröffentlichung Too advanced for assessment? Advanced materials, nanomedicine and the environment(2022) Berkner, Silvia; Schwirn, Kathrin; Völker, DorisAdvanced materials, and nanomaterials, are promising for healthcare applications and are in particular in the spotlight of medical innovation since rapidly developed nano-formulated vaccines provide relief in the SARS-CoV-2 pandemic. Further increased rapid growth is to be expected as more and more products are in development and reach the market, beneficial for human health. However, the human body is not a dead end and these products are likely to enter the environment, whereas their fate and effects in the environment are unknown. This part of the life-cycle of advanced medicinal products tends to be overlooked, if the perspective is human-centered and excludes the connectedness of human activity with, and consequences for our environment. Gaps are reviewed that exist in awareness, perspective taking, inclusion of environmental concerns into research and product development and also in available methodologies and regulatory guidance. To bridge these gaps, possible ways forward start to emerge, that could help to find a more integrative way of assessing human and environmental safety for advanced material medicinal products and nanomedicines. © The Author(s) 2022.Veröffentlichung Development of new QSAR models for water, sediment, and soil half-life(2022) Lombardo, Anna; Arning, Jürgen; Manganaro, AlbertoChecking the persistence of a chemical in the environment is extremely important. Regulations like REACH, the European one on chemicals, require the measurements or estimates of the half-life of the chemical in water, sediment, and soil. The use of non-testing methods, like quantitative structure-activity relationship (QSAR) models, is encouraged because it reduces costs and time. To our knowledge, there are very few freely available models for these properties and some are for specific chemical classes. Here, we present three new semi-quantitative models, one for each of the required environmental compartments (water, sediment, and soil). Using literature and REACH registration data, we developed three new counter-propagation artificial neural network models using the CPANNatNIC tool. We calculated the VEGA descriptors, and selected the relevant ones using an internal method in R based on the forward selection technique. The best model for each compartment was implemented in two open-source stand-alone tools, the VEGA platform, and the JANUS tool (https://www.vegahub.eu/). These models were also used by ECHA to build their PBT profiler available in the OECD QSAR toolbox (https://qsartoolbox.org/). Screening and prioritization are also our main target. The models perform well, with R2 always above 0.8 in training and validation. The only exception is the validation set of the soil compartment, with R2 0.68, that is above 0.8 only for compounds inside the applicability domain (automatically calculated by the system). The root mean square error (RMSE) is good, 0.34 or less in log units (again, for soil validation it is higher but it reaches 0.21 when considering only the compounds in the applicability domain). Compared with one of the most widely used tools, BIOWIN3, the proposed models give better results in terms of R2 and RMSE. For the classification, the performance is better for water and soil, and comparable or lower for sediment. © 2022 Elsevier