Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives
This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2024 |
| País: | España |
| Institución: | Universidad de Burgos (UBU) |
| Repositorio: | Repositorio Institucional de la Universidad de Burgos (RIUBU) |
| OAI Identifier: | oai:riubu.ubu.es:10259/9803 |
| Acceso en línea: | http://hdl.handle.net/10259/9803 |
| Access Level: | acceso abierto |
| Palabra clave: | Next Generation Risk Assessment (NGRA) New Approach Methodologies (NAMs) Advanced materials Nanomaterials Regulatory readiness Grouping In vitro approaches In vitro-in vivo extrapolation (IVIVE) In silico approaches In chemico approaches Nanotecnología Química orgánica Química Nanotechnology Chemistry, Organic Chemistry |
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oai:riubu.ubu.es:10259/9803 |
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Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives Hristozov, Danail Badetti, Elena Bigini, Paolo Brunelli, Andrea Dekkers, Susan Diomede, Luisa Doak, Shareen H. Fransman, Wouter Gajewicz-Skretna, Agnieszka Giubilato, Elisa Gómez Cuadrado, Laura Grafström, Roland Gutleb, Arno C. Halappanavar, Sabina Hischier, Roland Hunt, Neil Katsumiti, Alberto Kermanizadeh, Ali Marcomini, Antonio Moschini, Elisa Oomen, Agnes Pizzol, Lisa Rumbo Lorenzo, Carlos Schmid, Otmar Shandilya, Neeraj Stone, Vicki Stoycheva, Stella Stoeger, Tobias Merino, Blanca Suarez Tran, Lang Tsiliki, Georgia Vogel, Ulla Birgitte Wohlleben, Wendel Zabeo, Alex Next Generation Risk Assessment (NGRA) New Approach Methodologies (NAMs) Advanced materials Nanomaterials Regulatory readiness Grouping In vitro approaches In vitro-in vivo extrapolation (IVIVE) In silico approaches In chemico approaches Nanotecnología Química orgánica Química Nanotechnology Chemistry, Organic Chemistry This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional risk assessment paradigm. This framework is exposure-driven, endpoint-specific, makes best use of pre-existing information, and can be implemented in tiers of increasing specificity and complexity of the adopted NAMs. The tiered structure of the approach, which effectively combines the use of existing data with targeted testing will allow safety to be assessed cost-effectively and as far as possible with even more limited use of vertebrates. The regulatory readiness of state-of-the-art emerging NAMs is assessed in terms of Transparency, Reliability, Accessibility, Applicability, Relevance and Completeness, and their appropriateness for AdNMs is discussed in relation to each step of the risk assessment paradigm along with providing perspectives for future developments in the respective scientific and regulatory areas. This work was supported by the European Union's Horizon 2020 Programme under grant agreements 952924 (SUNSHINE project), 953183 (HARMLESS project) and 953152 (DIAGONAL project), and by the European Union's Horizon Europe Programme under grant agreements 101092901 (POTENTIAL project) and 101137324 (SUNRISE project). Elsevier http://hdl.handle.net/10259/9803 |
| title |
Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives |
| spellingShingle |
Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives Hristozov, Danail Next Generation Risk Assessment (NGRA) New Approach Methodologies (NAMs) Advanced materials Nanomaterials Regulatory readiness Grouping In vitro approaches In vitro-in vivo extrapolation (IVIVE) In silico approaches In chemico approaches Nanotecnología Química orgánica Química Nanotechnology Chemistry, Organic Chemistry |
| title_short |
Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives |
| title_full |
Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives |
| title_fullStr |
Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives |
| title_full_unstemmed |
Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives |
| title_sort |
Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives |
| author |
Hristozov, Danail |
| author_facet |
Hristozov, Danail Badetti, Elena Bigini, Paolo Brunelli, Andrea Dekkers, Susan Diomede, Luisa Doak, Shareen H. Fransman, Wouter Gajewicz-Skretna, Agnieszka Giubilato, Elisa Gómez Cuadrado, Laura Grafström, Roland Gutleb, Arno C. Halappanavar, Sabina Hischier, Roland Hunt, Neil Katsumiti, Alberto Kermanizadeh, Ali Marcomini, Antonio Moschini, Elisa Oomen, Agnes Pizzol, Lisa Rumbo Lorenzo, Carlos Schmid, Otmar Shandilya, Neeraj Stone, Vicki Stoycheva, Stella Stoeger, Tobias Merino, Blanca Suarez Tran, Lang Tsiliki, Georgia Vogel, Ulla Birgitte Wohlleben, Wendel Zabeo, Alex |
| author_role |
author |
| author2 |
Badetti, Elena Bigini, Paolo Brunelli, Andrea Dekkers, Susan Diomede, Luisa Doak, Shareen H. Fransman, Wouter Gajewicz-Skretna, Agnieszka Giubilato, Elisa Gómez Cuadrado, Laura Grafström, Roland Gutleb, Arno C. Halappanavar, Sabina Hischier, Roland Hunt, Neil Katsumiti, Alberto Kermanizadeh, Ali Marcomini, Antonio Moschini, Elisa Oomen, Agnes Pizzol, Lisa Rumbo Lorenzo, Carlos Schmid, Otmar Shandilya, Neeraj Stone, Vicki Stoycheva, Stella Stoeger, Tobias Merino, Blanca Suarez Tran, Lang Tsiliki, Georgia Vogel, Ulla Birgitte Wohlleben, Wendel Zabeo, Alex |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| topic |
Next Generation Risk Assessment (NGRA) New Approach Methodologies (NAMs) Advanced materials Nanomaterials Regulatory readiness Grouping In vitro approaches In vitro-in vivo extrapolation (IVIVE) In silico approaches In chemico approaches Nanotecnología Química orgánica Química Nanotechnology Chemistry, Organic Chemistry |
| topic_facet |
Next Generation Risk Assessment (NGRA) New Approach Methodologies (NAMs) Advanced materials Nanomaterials Regulatory readiness Grouping In vitro approaches In vitro-in vivo extrapolation (IVIVE) In silico approaches In chemico approaches Nanotecnología Química orgánica Química Nanotechnology Chemistry, Organic Chemistry |
| description |
This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional risk assessment paradigm. This framework is exposure-driven, endpoint-specific, makes best use of pre-existing information, and can be implemented in tiers of increasing specificity and complexity of the adopted NAMs. The tiered structure of the approach, which effectively combines the use of existing data with targeted testing will allow safety to be assessed cost-effectively and as far as possible with even more limited use of vertebrates. The regulatory readiness of state-of-the-art emerging NAMs is assessed in terms of Transparency, Reliability, Accessibility, Applicability, Relevance and Completeness, and their appropriateness for AdNMs is discussed in relation to each step of the risk assessment paradigm along with providing perspectives for future developments in the respective scientific and regulatory areas. |
| publishDate |
2024 |
| format |
article |
| status_str |
publishedVersion |
| url |
http://hdl.handle.net/10259/9803 |
| eu_rights_str_mv |
openAccess |
| publisher |
Elsevier |
| institution |
Universidad de Burgos (UBU) |
| collection |
Repositorio Institucional de la Universidad de Burgos (RIUBU) |
| reponame_str |
Repositorio Institucional de la Universidad de Burgos (RIUBU) |
| instname_str |
Universidad de Burgos (UBU) |
| _version_ |
1878731503344549888 |
| publishDateSort |
2024 |
| author_browse |
Badetti, Elena Bigini, Paolo Brunelli, Andrea Dekkers, Susan Diomede, Luisa Doak, Shareen H. Fransman, Wouter Gajewicz-Skretna, Agnieszka Giubilato, Elisa Grafström, Roland Gutleb, Arno C. Gómez Cuadrado, Laura Halappanavar, Sabina Hischier, Roland Hristozov, Danail Hunt, Neil Katsumiti, Alberto Kermanizadeh, Ali Marcomini, Antonio Merino, Blanca Suarez Moschini, Elisa Oomen, Agnes Pizzol, Lisa Rumbo Lorenzo, Carlos Schmid, Otmar Shandilya, Neeraj Stoeger, Tobias Stone, Vicki Stoycheva, Stella Tran, Lang Tsiliki, Georgia Vogel, Ulla Birgitte Wohlleben, Wendel Zabeo, Alex |
| publisherStr |
Elsevier |
| score |
6,8972664 |