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Environmental Risk Assessment of Nanomaterials in the Light of New Obligations Under the REACH Regulation: Which Challenges Remain and How to Approach Them?

Within 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 fat...

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Autores principales: Schwirn, Kathrin, Voelker, Doris, Galert, Wiebke, Quik, Joris, Tietjen, Lars
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7497025/
https://www.ncbi.nlm.nih.gov/pubmed/32175661
http://dx.doi.org/10.1002/ieam.4267
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author Schwirn, Kathrin
Voelker, Doris
Galert, Wiebke
Quik, Joris
Tietjen, Lars
author_facet Schwirn, Kathrin
Voelker, Doris
Galert, Wiebke
Quik, Joris
Tietjen, Lars
author_sort Schwirn, Kathrin
collection PubMed
description Within 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. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC)
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spelling pubmed-74970252020-09-25 Environmental Risk Assessment of Nanomaterials in the Light of New Obligations Under the REACH Regulation: Which Challenges Remain and How to Approach Them? Schwirn, Kathrin Voelker, Doris Galert, Wiebke Quik, Joris Tietjen, Lars Integr Environ Assess Manag Health & Ecological Risk Assessment Within 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. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC) John Wiley and Sons Inc. 2020-04-28 2020-09 /pmc/articles/PMC7497025/ /pubmed/32175661 http://dx.doi.org/10.1002/ieam.4267 Text en © 2020 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC) This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Health & Ecological Risk Assessment
Schwirn, Kathrin
Voelker, Doris
Galert, Wiebke
Quik, Joris
Tietjen, Lars
Environmental Risk Assessment of Nanomaterials in the Light of New Obligations Under the REACH Regulation: Which Challenges Remain and How to Approach Them?
title Environmental Risk Assessment of Nanomaterials in the Light of New Obligations Under the REACH Regulation: Which Challenges Remain and How to Approach Them?
title_full Environmental Risk Assessment of Nanomaterials in the Light of New Obligations Under the REACH Regulation: Which Challenges Remain and How to Approach Them?
title_fullStr Environmental Risk Assessment of Nanomaterials in the Light of New Obligations Under the REACH Regulation: Which Challenges Remain and How to Approach Them?
title_full_unstemmed Environmental Risk Assessment of Nanomaterials in the Light of New Obligations Under the REACH Regulation: Which Challenges Remain and How to Approach Them?
title_short Environmental Risk Assessment of Nanomaterials in the Light of New Obligations Under the REACH Regulation: Which Challenges Remain and How to Approach Them?
title_sort environmental risk assessment of nanomaterials in the light of new obligations under the reach regulation: which challenges remain and how to approach them?
topic Health & Ecological Risk Assessment
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7497025/
https://www.ncbi.nlm.nih.gov/pubmed/32175661
http://dx.doi.org/10.1002/ieam.4267
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