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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 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 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 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