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Veröffentlichung Why are nanomaterials different and how can they be appropriately regulated under REACH?(2014) Schwirn, Kathrin; Beer, Inga; Tietjen, LarsBackgroundFor nanomaterials, not only their chemical composition but also their morphological properties and surface properties determine their characteristics. These properties do not only differ in comparison to the corresponding bulk material but also between different nanoforms of the same substance. Changes in these physico-chemical characteristics can cause changes in chemical properties, reactivity, (photo-) catalytic activities and energetic properties and in turn alter their (eco-) toxicity, fate and behaviour in environmental media and toxico-kinetics. Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) deals with chemical substances in general and although there are no special provisions that explicitly refer to nanomaterials, they are principally covered by REACH. In October 2012, the European Commission published the Second Regulatory Review on Nanomaterials. In February 2013, the REACH Review from the European Commission was published. Both papers address questions about the regulation of nanomaterials in REACH. The Commission proposes to improve the future situation by adaptation of the REACH Regulation. However, the European Commission plans to revise the annexes only and not the main text of the regulation.
Results and conclusions
In this publication, the authors present their considerations and recommendations on how REACH can adequately be adapted to nanomaterials. In the author's view, the bulk form and nanoforms of the same chemical composition should be treated as the same substance in the context of REACH. However, the regulation of nanomaterials under REACH has to meet specific requirements. Taking into account the plurality of physico-chemical characteristics and resulting changes in the hazard profile, an approach must be found to adequately cover nanomaterials under REACH. Accordingly, the REACH information requirements have to be adapted. This includes lower tonnage thresholds for different REACH obligations (e.g. registration, chemical safety report) which are justified by highly dispersed use together with low mass application, linked with the uncertainties regarding (eco-) toxicity, environmental fate and exposure. If the physico-chemical characteristics of different nanoforms of the same substance differ in a relevant manner they have to be considered separately for further test performance and REACH requirements.
Quelle: http://www.enveurope.com/Veröffentlichung Nanopharmaceuticals - tiny challenges for the environmental risk assessment of pharmaceuticals(2015) Berkner, Silvia; Schwirn, Kathrin; Völker, DorisMany new developments and innovations in health care are based on nanotechnology. The field of nanopharmaceuticals is diverse and not as new as one might think; indeed, nanopharmaceuticals have been marketed for many years, and the future is likely to bring more nanosized compounds to the market. Therefore, it is time to examine whether the environmental risk assessment for human pharmaceuticals is prepared to assess the exposure, fate, and effects of nanopharmaceuticals in an adequate way. Challenges include the different definitions for nanomaterials and nanopharmaceuticals, different regulatory frameworks, the diversity of nanopharmaceuticals, the scope of current regulatory guidelines, and the applicability of test protocols. Based on the current environmental risk assessment for human medicinal products in the European Union, necessary adaptations for the assessment procedures and underlying study protocols are discussed and emerging solutions identified. Environ Toxicol Chem 2015;9999:1-8. © 2015 The Authors. Environmental Toxicology & Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.Veröffentlichung Test strategy for assessing the risks of nanomaterials in the environment considering general regulatory procedures(2015)Background:
Engineered nanomaterials (ENMs) are marketed as a substance or mixtures and are additionally used due to their active agent properties in products such as pesticides or biocides, for which specific regulations apply. Currently, there are no specific testing strategies for environmental fate and effects of ENMs within the different regulations. An environmental test and risk assessment strategy for ENMs have been developed considering the general principles of chemical assessment.
Results:
The test strategy has been developed based on the knowledge of national and international discussions. It also takes into account the conclusions made by the OECD WPMN which held an expert meeting in January 2013. For the test strategy development, both conventional and alternative endpoints were discussed and environmental fate and effects were addressed separately.
Conclusion:
A tiered scheme as commonly used in the context of precautionary environmental risk assessment was suggested including the use of mathematical models and trigger values to either stop the procedure or proceed to the next tier. There are still several gaps which have to be filled, especially with respect to fate, to develop the test strategy further. The test strategy features a general approach. It is not specified to fulfil the information requirements of certain legislation (e.g. plant protection act, biocide regulation, REACH). However, the adaption of single elements of the strategy to the specific needs of certain legislation will provide a valuable contribution in relation to the testing of nanomaterials.Quelle: http://enveurope.springeropen.com/Veröffentlichung Hazard grouping of nanomaterials for daphnia and algae toxicity: lessons learned from scientific projects for regulatory applicability(2019) Schwirn, Kathrin; Völker, DorisGiven the numerous manufactured nanomaterials already on the market and expected in future, the effort for the individual investigation of hazard and risk would be enormous. To overcome this challenge, grouping of nanomaterials has been identified as one critical issue by the European Commission as well as the Organisation for Economic Co-operation and Development (OECD). In that context, several research projects have been carried out to deliver scientific input and develop approaches. This publication discusses experiences from several cases of two scientific projects with the aims to develop and review analogy hypotheses for grouping of different nanoforms of same substances for endpoints related to aquatic ecotoxicity from a regulatory point of view. Furthermore, by presenting examples of grouping attempts, it outlines the need for considerations of further aspects beside key physicalâ€Ìchemical parameters for grouping nanomaterials regarding environmental endpoints. The results substantiate previous educated guesses with strategically collected experimental data on issues that needs to be considered for grouping nanomaterials in regulatory context. Still, grouping of nanomaterials for the aim of joint assessment of ecotoxicity of nanoforms in a regulatory context is in its infants compared to grouping approaches of nanoforms for human health assessment. This publication features important aspects on possibilities and challenges of grouping nanomaterials for environmental hazard assessment. Quelle: https://enveurope.springeropen.comVeröffentlichung Closing gaps for environmental risk screening of engineered nanomaterials(2019) Kühnel, Dana; Hellack, Bryan; Nickel, Carmen; Kussatz, Carola; Zalm, Esther van der; Zalm, Esther van derEngineered nanomaterials (ENM) have a widespread presence in human life and are components of many products and applications. This warrants an easy and fast evaluation of potential environmental risks. However, so far this is hampered by the multitude of different nanomaterials on the markets in addition to the many variations in form, size and surface modifications. Testing of each variation of ENM is not manageable, and hence the development and application of fast risk screening tools for ENMs is discussed. Here, we present the development of a scoring scheme with regard to ENM environmental risks under consideration of the two compartments water and soil. It allows for the ranking of ENM according to their environmental fate and hazard by taking into account criteria that are meaningful and relevant for ENM. The selection of the criteria is based on conceptual considerations, existing knowledge, and experimental work including transport and transformation studies as well as aquatic and terrestrial toxicity tests. The allocation of the ENM to the scores informs on the potential for transport and transformation and the hazard potential. Fate and hazard scores are subsequently combined into one risk score (1â€Ì10 for aquatic compartment, 1â€Ì7 for terrestrial compartment). The risk score has the intention to indicate which ENM may need prioritization for further action, i.e. with regard to the degree of detail for further testing or modelling. The applicability and consistency of the scoring schemes were assessed by taking different chemical species (e.g. of Ag, TiO2, SiO2, Cu, Fe) of ENM in various modifications (e.g. different shapes and coatings) into account. In conclusion, the established scoring schemes were found to be applicable to rank ENM according to their environmental fate and hazard potential, and thus to their environmental risk potential. © 2019 The Authors. Published by Elsevier B.V.Veröffentlichung 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 The impact of water released from boehmite nanoparticles during curing in epoxy-based nanocomposites(2021) Waniek, Tassilo; Braun, Ulrike; Sielbernagl, DorotheeThe enhancing effect on mechanical properties of boehmite (y-AlOOH)nanoparticles (BNP) in epoxy-based nanocomposites on the macroscopic scaleencouraged recent research to investigate the micro- and nanoscopic proper-ties. Several studies presented different aspects relatable to an alteration of theepoxy polymer network formation by the BNP with need for further experi-ments to identify the mode of action. With FTIR-spectroscopic methods thisstudy identifies interactions of the BNP with the epoxy polymer matrix duringthe curing process as well as in the cured nanocomposite. The data reveals thatnot the BNP themselves, but the water released from them strongly influencesthe curing process by hydrolysis of the anhydride hardener or protonation ofthe amine accelerator. The changes of the curing processes are discussed indetail. The changes of the curing processes enable new explanation for thechanged material properties by BNP discussed in recent research like alowered glass transition temperature region (Tg) and an interphase formation. © AuthorsVeröffentlichung Testing the bioaccumulation potential of manufactured nanomaterials in the freshwater amphipod Hyalella azteca(2021) Kühr, Sebastian; Kaegi, Rälf; Maletzki, DirkStandardized experimental approaches for the quantification of the bioaccumulation potential of nanomaterials in general and in (benthic) invertebrates in particular are currently lacking. We examined the suitability of the benthic freshwater amphipod Hyalella azteca for the examination of the bioaccumulation potential of nanomaterials. A flow-through test system that allows the generation of bioconcentration and biomagnification factors was applied. The feasibility of the system was confirmed in a 2-lab comparison study. By carrying out bioconcentration and biomagnification studies with gold, titanium dioxide and silver nanoparticles as well as dissolved silver (AgNO3) we were able to assess the bioaccumulation potential of different types of nanomaterials and their exposure pathways. For this, the animals were examined for their total metal body burden using inductively coupled mass spectroscopy (ICP-MS) and for the presence of nanoparticulate burdens using single-particle ICP-MS. The role of released ions was highlighted as being very important for the bioavailability and bioaccumulation of metals from nanoparticles for both examined uptake paths examined (bioconcentration and biomagnification). In 2018 a tiered testing strategy for engineered nanomaterials was proposed by Handy et al. that may allow a waiver of bioaccumulation fish studies using inter alia invertebrates. Data gained in studies carried out with invertebrates like the developed Hyalella azteca test may be included in this proposed tiered testing strategy. © 2020 The Author(s)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 Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety - a proposal for further actions(2023) Bleeker, Eric A.J.; Swart, Elmer; Braakhuis, Hedwig; Schwirn, KathrinOver the recent years, EU chemicals legislation, guidance and test guidelines have been developed or adapted for nanomaterials to facilitate safe use of nanomaterials. This paper provides an overview of the information requirements across different EU regulatory areas. For each information requirement, a group of 22 experts identified potential needs for further action to accommodate guidance and test guidelines to nanomaterials. Eleven different needs for action were identified, capturing twenty-two information requirements that are specific to nanomaterials and relevant to multiple regulatory areas. These were further reduced to three overarching issues: 1) resolve issues around nanomaterial dispersion stability and dosing in toxicity testing, in particular for human health endpoints, 2) further develop tests or guidance on degradation and transformation of organic nanomaterials or nanomaterials with organic components, and 3) further develop tests and guidance to measure (a)cellular reactivity of nanomaterials. Efforts towards addressing these issues will result in better fit-for-purpose test methods for (EU) regulatory compliance. Moreover, it secures validity of hazard and risk assessments of nanomaterials. The results of the study accentuate the need for a structural process of identification of information needs and knowledge generation, preferably as part of risk governance and closely connected to technological innovation policy. © 2023 The Authors