Journal article 142 views 7 downloads
Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives
Danail Hristozov,
Elena Badetti,
Paolo Bigini,
Andrea Brunelli,
Susan Dekkers,
Luisa Diomede,
Shareen Doak 
,
Wouter Fransman,
Agnieszka Gajewicz-Skretna,
Elisa Giubilato,
Laura Gómez-Cuadrado,
Roland Grafström,
Arno C. Gutleb,
Sabina Halappanavar,
Roland Hischier,
Neil Hunt,
Alberto Katsumiti,
Ali Kermanizadeh,
Antonio Marcomini,
Elisa Moschini,
Agnes Oomen,
Lisa Pizzol,
Carlos Rumbo,
Otmar Schmid,
Neeraj Shandilya,
Vicki Stone,
Stella Stoycheva,
Tobias Stoeger,
Blanca Suarez Merino,
Lang Tran,
Georgia Tsiliki,
Ulla Birgitte Vogel,
Wendel Wohlleben,
Alex Zabeo
,
Wouter Fransman,
Agnieszka Gajewicz-Skretna,
Elisa Giubilato,
Laura Gómez-Cuadrado,
Roland Grafström,
Arno C. Gutleb,
Sabina Halappanavar,
Roland Hischier,
Neil Hunt,
Alberto Katsumiti,
Ali Kermanizadeh,
Antonio Marcomini,
Elisa Moschini,
Agnes Oomen,
Lisa Pizzol,
Carlos Rumbo,
Otmar Schmid,
Neeraj Shandilya,
Vicki Stone,
Stella Stoycheva,
Tobias Stoeger,
Blanca Suarez Merino,
Lang Tran,
Georgia Tsiliki,
Ulla Birgitte Vogel,
Wendel Wohlleben,
Alex Zabeo
NanoImpact, Volume: 35, Start page: 100523
Swansea University Author:
Shareen Doak
-
PDF | Version of Record
© 2024 The Authors. This is an open access article under the CC BY-NC-ND license.
Download (3.04MB)
DOI (Published version): 10.1016/j.impact.2024.100523
Abstract
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...
| Published in: | NanoImpact |
|---|---|
| ISSN: | 2452-0748 |
| Published: |
Elsevier BV
2024
|
| Online Access: |
Check full text
|
| URI: | https://cronfa.swan.ac.uk/Record/cronfa67277 |
| first_indexed |
2024-08-01T06:36:51Z |
|---|---|
| last_indexed |
2024-11-25T14:19:52Z |
| id |
cronfa67277 |
| recordtype |
SURis |
| fullrecord |
<?xml version="1.0"?><rfc1807><datestamp>2024-09-17T13:48:13.2539089</datestamp><bib-version>v2</bib-version><id>67277</id><entry>2024-08-01</entry><title>Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives</title><swanseaauthors><author><sid>8f70286908f67238a527a98cbf66d387</sid><ORCID>0000-0002-6753-1987</ORCID><firstname>Shareen</firstname><surname>Doak</surname><name>Shareen Doak</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2024-08-01</date><deptcode>MEDS</deptcode><abstract>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.</abstract><type>Journal Article</type><journal>NanoImpact</journal><volume>35</volume><journalNumber/><paginationStart>100523</paginationStart><paginationEnd/><publisher>Elsevier BV</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>2452-0748</issnPrint><issnElectronic/><keywords>Next Generation Risk Assessment (NGRA); New Approach Methodologies (NAMs); Advanced materials; Nanomaterials; Regulatory readiness; GroupingIn vitro approaches; In vitro-in vivo extrapolation (IVIVE); In silico approachesIn chemico approaches</keywords><publishedDay>31</publishedDay><publishedMonth>7</publishedMonth><publishedYear>2024</publishedYear><publishedDate>2024-07-31</publishedDate><doi>10.1016/j.impact.2024.100523</doi><url/><notes/><college>COLLEGE NANME</college><department>Medical School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>MEDS</DepartmentCode><institution>Swansea University</institution><apcterm>Another institution paid the OA fee</apcterm><funders>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).</funders><projectreference/><lastEdited>2024-09-17T13:48:13.2539089</lastEdited><Created>2024-08-01T07:35:26.9796342</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Biomedical Science</level></path><authors><author><firstname>Danail</firstname><surname>Hristozov</surname><order>1</order></author><author><firstname>Elena</firstname><surname>Badetti</surname><order>2</order></author><author><firstname>Paolo</firstname><surname>Bigini</surname><order>3</order></author><author><firstname>Andrea</firstname><surname>Brunelli</surname><order>4</order></author><author><firstname>Susan</firstname><surname>Dekkers</surname><order>5</order></author><author><firstname>Luisa</firstname><surname>Diomede</surname><order>6</order></author><author><firstname>Shareen</firstname><surname>Doak</surname><orcid>0000-0002-6753-1987</orcid><order>7</order></author><author><firstname>Wouter</firstname><surname>Fransman</surname><order>8</order></author><author><firstname>Agnieszka</firstname><surname>Gajewicz-Skretna</surname><order>9</order></author><author><firstname>Elisa</firstname><surname>Giubilato</surname><order>10</order></author><author><firstname>Laura</firstname><surname>Gómez-Cuadrado</surname><order>11</order></author><author><firstname>Roland</firstname><surname>Grafström</surname><order>12</order></author><author><firstname>Arno C.</firstname><surname>Gutleb</surname><order>13</order></author><author><firstname>Sabina</firstname><surname>Halappanavar</surname><order>14</order></author><author><firstname>Roland</firstname><surname>Hischier</surname><order>15</order></author><author><firstname>Neil</firstname><surname>Hunt</surname><order>16</order></author><author><firstname>Alberto</firstname><surname>Katsumiti</surname><order>17</order></author><author><firstname>Ali</firstname><surname>Kermanizadeh</surname><order>18</order></author><author><firstname>Antonio</firstname><surname>Marcomini</surname><order>19</order></author><author><firstname>Elisa</firstname><surname>Moschini</surname><order>20</order></author><author><firstname>Agnes</firstname><surname>Oomen</surname><order>21</order></author><author><firstname>Lisa</firstname><surname>Pizzol</surname><order>22</order></author><author><firstname>Carlos</firstname><surname>Rumbo</surname><order>23</order></author><author><firstname>Otmar</firstname><surname>Schmid</surname><order>24</order></author><author><firstname>Neeraj</firstname><surname>Shandilya</surname><order>25</order></author><author><firstname>Vicki</firstname><surname>Stone</surname><order>26</order></author><author><firstname>Stella</firstname><surname>Stoycheva</surname><order>27</order></author><author><firstname>Tobias</firstname><surname>Stoeger</surname><order>28</order></author><author><firstname>Blanca Suarez</firstname><surname>Merino</surname><order>29</order></author><author><firstname>Lang</firstname><surname>Tran</surname><order>30</order></author><author><firstname>Georgia</firstname><surname>Tsiliki</surname><order>31</order></author><author><firstname>Ulla Birgitte</firstname><surname>Vogel</surname><order>32</order></author><author><firstname>Wendel</firstname><surname>Wohlleben</surname><order>33</order></author><author><firstname>Alex</firstname><surname>Zabeo</surname><order>34</order></author></authors><documents><document><filename>67277__31350__4790bbcfd9034dfe96d1f07fb6aff985.pdf</filename><originalFilename>67277.VoR.pdf</originalFilename><uploaded>2024-09-17T13:46:33.5513309</uploaded><type>Output</type><contentLength>3185284</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>© 2024 The Authors. This is an open access article under the CC BY-NC-ND license.</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>http://creativecommons.org/licenses/by-nc-nd/4.0/</licence></document></documents><OutputDurs/></rfc1807> |
| spelling |
2024-09-17T13:48:13.2539089 v2 67277 2024-08-01 Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives 8f70286908f67238a527a98cbf66d387 0000-0002-6753-1987 Shareen Doak Shareen Doak true false 2024-08-01 MEDS 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. Journal Article NanoImpact 35 100523 Elsevier BV 2452-0748 Next Generation Risk Assessment (NGRA); New Approach Methodologies (NAMs); Advanced materials; Nanomaterials; Regulatory readiness; GroupingIn vitro approaches; In vitro-in vivo extrapolation (IVIVE); In silico approachesIn chemico approaches 31 7 2024 2024-07-31 10.1016/j.impact.2024.100523 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Another institution paid the OA fee 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). 2024-09-17T13:48:13.2539089 2024-08-01T07:35:26.9796342 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science Danail Hristozov 1 Elena Badetti 2 Paolo Bigini 3 Andrea Brunelli 4 Susan Dekkers 5 Luisa Diomede 6 Shareen Doak 0000-0002-6753-1987 7 Wouter Fransman 8 Agnieszka Gajewicz-Skretna 9 Elisa Giubilato 10 Laura Gómez-Cuadrado 11 Roland Grafström 12 Arno C. Gutleb 13 Sabina Halappanavar 14 Roland Hischier 15 Neil Hunt 16 Alberto Katsumiti 17 Ali Kermanizadeh 18 Antonio Marcomini 19 Elisa Moschini 20 Agnes Oomen 21 Lisa Pizzol 22 Carlos Rumbo 23 Otmar Schmid 24 Neeraj Shandilya 25 Vicki Stone 26 Stella Stoycheva 27 Tobias Stoeger 28 Blanca Suarez Merino 29 Lang Tran 30 Georgia Tsiliki 31 Ulla Birgitte Vogel 32 Wendel Wohlleben 33 Alex Zabeo 34 67277__31350__4790bbcfd9034dfe96d1f07fb6aff985.pdf 67277.VoR.pdf 2024-09-17T13:46:33.5513309 Output 3185284 application/pdf Version of Record true © 2024 The Authors. This is an open access article under the CC BY-NC-ND license. true eng http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| 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 Shareen Doak |
| 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_id_str_mv |
8f70286908f67238a527a98cbf66d387 |
| author_id_fullname_str_mv |
8f70286908f67238a527a98cbf66d387_***_Shareen Doak |
| author |
Shareen Doak |
| author2 |
Danail Hristozov Elena Badetti Paolo Bigini Andrea Brunelli Susan Dekkers Luisa Diomede Shareen Doak Wouter Fransman Agnieszka Gajewicz-Skretna Elisa Giubilato Laura Gómez-Cuadrado Roland Grafström Arno C. Gutleb Sabina Halappanavar Roland Hischier Neil Hunt Alberto Katsumiti Ali Kermanizadeh Antonio Marcomini Elisa Moschini Agnes Oomen Lisa Pizzol Carlos Rumbo Otmar Schmid Neeraj Shandilya Vicki Stone Stella Stoycheva Tobias Stoeger Blanca Suarez Merino Lang Tran Georgia Tsiliki Ulla Birgitte Vogel Wendel Wohlleben Alex Zabeo |
| format |
Journal article |
| container_title |
NanoImpact |
| container_volume |
35 |
| container_start_page |
100523 |
| publishDate |
2024 |
| institution |
Swansea University |
| issn |
2452-0748 |
| doi_str_mv |
10.1016/j.impact.2024.100523 |
| publisher |
Elsevier BV |
| college_str |
Faculty of Medicine, Health and Life Sciences |
| hierarchytype |
|
| hierarchy_top_id |
facultyofmedicinehealthandlifesciences |
| hierarchy_top_title |
Faculty of Medicine, Health and Life Sciences |
| hierarchy_parent_id |
facultyofmedicinehealthandlifesciences |
| hierarchy_parent_title |
Faculty of Medicine, Health and Life Sciences |
| department_str |
Swansea University Medical School - Biomedical Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Biomedical Science |
| document_store_str |
1 |
| active_str |
0 |
| 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. |
| published_date |
2024-07-31T08:33:16Z |
| _version_ |
1821393705100115968 |
| score |
11.047501 |