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Veröffentlichung Pharmaceuticals in the environment(2014) Küster, Anette; Adler, NicoleDuring the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for human and veterinary pharmaceutical products before they are marketed. The results show that approximately 10% of pharmaceutical products are of note regarding their potential environmental risk. For human medicinal products, hormones, antibiotics, analgesics, antidepressants and antineoplastics indicated an environmental risk. For veterinary products, hormones, antibiotics and parasiticides were most often discussed as being environmentally relevant. These results are in good correlation with the results within the open scientific literature of prioritization approaches for pharmaceuticals in the environment. UBA results revealed that prospective approaches, such as ERA of pharmaceuticals, play an important role in minimizing problems caused by pharmaceuticals in the environment. However, the regulatory ERA framework could be improved by (i) inclusion of the environment in the risk-benefit analysis for human pharmaceuticals, (ii) improvement of risk management options, (iii) generation of data on existing pharmaceuticals, and (iv) improving the availability of ERA data. In addition, more general and integrative steps of regulation, legislation and research have been developed and are presented in this article. In order to minimize the quantity of pharmaceuticals in the environment these should aim to (i) improve the existing legislation for pharmaceuticals, (ii) prioritize pharmaceuticals in the environment and (iii) improve the availability and collection of pharmaceutical data.
Quelle: http://www.researchgate.net/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 Managing science-policy interfaces for impact: Interactions within the environmental governance meshwork(2019) Sarkki, Simo; Balian, Estelle; Heink, Ulrich; Neßhöver, CarstenScience-policy interface organizations and initiatives (SPIORG) are a key component of environmental governance designed to make links between science and society. However, the science-policy interface literature lacks a structured approach to explaining the impacts of context on and by these initiatives. To better understand these impacts on and interactions with governance, this paper uses the concept of the governance 'meshwork' to explore how dynamic processes - encompassing prior, current and anticipated interactions - coproduce knowledge and impact via processes, negotiation and networking activities at multiple governance levels. To illustrate the interactions between SPIORGs and governance meshwork we use five cases representing archetypal SPIORGs. These cases demonstrate how all initiatives and organizations link to their contexts in complex and unique ways, yet also identifies ten important aspects that connect the governance meshwork to SPIORGs. These aspects of the meshwork, together with the typology of organizations, provide a comprehensive framework that can help make sense how the SPIORGs are embedded in the surrounding governance contexts. We highlight that SPIORGs must purposively consider and engage with their contexts to increase their potential impact on knowledge co-production and policy making. © 2019 The Author. Published by Elsevier Ltd.Veröffentlichung Substitutes mimic the exposure behaviour of REACH regulated phthalates(2021) Apel, Petra; Kolossa-Gehring, Marike; Lange, Rosa; Lemke, Nora; Debiak, Malgorzata; Murawski, Aline; Weber, TillThe population is constantly exposed to potentially harmful substances present in the environment, including inter alia food and drinking water, consumer products, and indoor air. Human biomonitoring (HBM) is a valuable tool to determine the integral, internal exposure of the general population, including vulnerable subgroups, to provide the basis for risk assessment and policy advice. The German HBM system comprises of five pillars: (1) the development of suitable analytical methods for new substances of concern, (2) cross-sectional population-representative German Environmental Surveys (GerES), (3) time trend analyses using archived samples from the Environmental Specimen Bank (ESB), (4) the derivation of health-based guidance values as a risk assessment tool, and (5) transfer of data into the European cooperation network HBM4EU. The goal of this paper is to present the complementary elements of the German HBM system and to show its strengths and limitations on the example of plasticizers. Plasticizers have been identified by EU services and HBM4EU partners as priority substances for chemical policy at EU level. Using the complementary elements of the German HBM system, the internal exposure to classical phthalates and novel alternative plasticizers can be reliably monitored. It is shown that market changes, due to regulation of certain phthalates and the rise of substitutes, are rapidly reflected in the internal exposure of the population. It was shown that exposure to DEHP, DiBP, DnBP, and BBzP decreased considerably, whereas exposure to the novel substitutes such as DPHP, DEHTP, and Hexamoll®DINCH has increased significantly. While health-based guidance values for several phthalates (esp. DnBP, DiBP, DEHP) were exceeded quite often at the turn of the millennium, exceedances today have become rarer. Still, also the latest GerES reveals the ubiquitous and concurrent exposures to many plasticizers. Of concern is that the youngest children showed the highest exposures to most of the investigated plasticizers and in some cases their levels of DiBP and DnBP still exceeded health-based guidance values. Over the last years, mixture exposures are increasingly recognized as relevant, especially if the toxicological modes of action are similar. This is supported by a cumulative risk assessment for four endocrine active phthalates which confirms the still concerning cumulative exposure in many young children. Given the adverse health effects of some phthalates and the limited toxicological knowledge of substitutes, exposure reduction and surveillance are needed on German and EU-level. Substitutes need to be monitored, to intervene if exposures are threatening to exceed acceptable levels, or if new toxicological data question their appropriateness. It is strongly recommended to reconsider the use of plastics and plasticizers. © 2021 Published by Elsevier GmbH.Veröffentlichung Corrigendum to "Substitutes mimic the exposure behaviour of REACH regulated phthalates - A review of the German HBM system on the example of plasticizers"(2022) Apel, Petra; Kolossa-Gehring, Marike; Lange, Rosa; Lemke, Nora; Debiak, Malgorzata; Murawski, Aline; Weber, TillVeröffentlichung Digging deep - implementation, standardisation and interpretation of a total oxidisable precursor (TOP) assay within the regulatory context of per- and polyfluoroalkyl substances (PFASs) in soil(2022) Göckener, Bernd; Bandow, Nicole; Lange, Frank Thomas; Biegel-Engler, Annegret; Lesmeister, LukasOver the past decades, thousands of different per- and polyfluoroalkyl substances (PFASs) have been produced and applied in various industrial processes and consumer products. Their structural diversity has reached a level that cannot be covered by classical target screening methods for individual compounds. Large-scale contaminations of soil, however, require the need to adapt new analytical methods that can describe a contamination more comprehensively. While sum parameters such as the total oxidisable precursor (TOP) assay have been developed in the past years, they are not yet applied in the regulatory context of PFASs. In this commentary, we provide an overview on different approaches of the TOP assay as well as its benefits and disadvantages to other sum parameters for PFASs in soil samples. Furthermore, we elaborate its opportunities and its challenges that need to be tackled to implement the TOP assay as a regulatory tool. With several different approaches of the TOP assay being available, a sound and standardised method needs to be agreed upon and more research is necessary to better describe the method. Although the complexity of PFAS contaminations in soil cannot be fully covered by any analytical method alone, the TOP assay can provide valuable data to detect and characterise soil contamination as an inventory for subsequent remediation measures. Therefore, the TOP assay should be implemented as a useful tool both in research and in the regulatory context of PFASs. © The Author(s) 2022.Veröffentlichung Applicability of ISO standard 3744 to UA(2022) Foerster, Jan; Treichel, Julia; Volkert, AndreasUnmanned Aircraft Systems (UAS) are used for a variety of purposes. Especially the industrial or professional use of unmanned aircraft (UA) will lead to an increasing number of possible applications. The steadily rising number of UA raises the question of noise impact on the society from these vehicles. For the first time, an EU regulation provides a uniform noise rating for UA. It involves the introduction of a label for the guaranteed sound power level. This level is to be determined via EN ISO 3744:2010 by means of an enveloping surface method. Manufacturers are required to document the guaranteed sound power level as part of their CE marking. In addition, the EU regulation specifies a maximum permissible sound power level. The permitted level depends on the weight of the UA. Therefore, the German Environment Agency has started with acoustic investigations of UA. Various small multicopter) were used for the measurements in accordance with the EU regulation. This paper presents the results of the measurements and shows whether the requirements of the EU regulation are complied with. The challenges for users of the applicable measurement standard are also highlighted.