Nanomaterials in the European chemicals legislation-methodological challenges for registration and environmental safety assessment
(2021) In Environmental Science: Nano 8(3). p.731-747- Abstract
In the European Union the Annexes of its chemical legislation (REACH) were revised and now clarify the technical data requirements for nanomaterials (NMs). These new provisions, effective from January 1, 2020, introduce requirements for manufacturers, importers and downstream users regarding registration and safety assessment of NMs. This study aims to assess the availability and suitability of methods needed to comply with the new regulatory provisions on NMs for physico-chemical characterisation and environmental fate and effects. The scientific literature and relevant test guideline frameworks were reviewed to identify applicable methods. These were subsequently evaluated and categorised as either: 'internationally accepted test... (More)
In the European Union the Annexes of its chemical legislation (REACH) were revised and now clarify the technical data requirements for nanomaterials (NMs). These new provisions, effective from January 1, 2020, introduce requirements for manufacturers, importers and downstream users regarding registration and safety assessment of NMs. This study aims to assess the availability and suitability of methods needed to comply with the new regulatory provisions on NMs for physico-chemical characterisation and environmental fate and effects. The scientific literature and relevant test guideline frameworks were reviewed to identify applicable methods. These were subsequently evaluated and categorised as either: 'internationally accepted test guideline or standard (TGS)', 'internationally accepted test guideline or standard under development (TGSUD)', 'established as standard methods in scientific literature (SCI)', 'other methods and/or more research needed (O)' or 'no method (N)'. We find that 80% of the information requirements and a bit more than 40% of the waiving criteria in the new REACH Annexes are supported by methods that are available as TGS, TGSUD or SCI. Most of the relevant methods in the scientific literature are included in recent OECD guidance documents or ECHA guidance. We recommend that a targeted effort is made to develop protocols and guidelines for methods to determine NM adsorption/desorption, degradation, exposure scenarios and ability to cross biological membranes. Here methods to fulfil the information requirements and waiving criteria are currently lacking. Furthermore, we recommend that increasing attention is directed towards regulatory reliability and relevance of the information that is submitted by the registrants.
(Less)
- author
- organization
- publishing date
- 2021
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Environmental Science: Nano
- volume
- 8
- issue
- 3
- pages
- 17 pages
- publisher
- Royal Society of Chemistry
- external identifiers
-
- scopus:85103358663
- ISSN
- 2051-8153
- DOI
- 10.1039/d0en01123a
- language
- English
- LU publication?
- yes
- id
- f2b9f312-7957-4bf8-988b-0a8ad0d96322
- date added to LUP
- 2021-04-08 09:04:47
- date last changed
- 2023-11-08 12:26:24
@article{f2b9f312-7957-4bf8-988b-0a8ad0d96322,
abstract = {{<p>In the European Union the Annexes of its chemical legislation (REACH) were revised and now clarify the technical data requirements for nanomaterials (NMs). These new provisions, effective from January 1, 2020, introduce requirements for manufacturers, importers and downstream users regarding registration and safety assessment of NMs. This study aims to assess the availability and suitability of methods needed to comply with the new regulatory provisions on NMs for physico-chemical characterisation and environmental fate and effects. The scientific literature and relevant test guideline frameworks were reviewed to identify applicable methods. These were subsequently evaluated and categorised as either: 'internationally accepted test guideline or standard (TGS)', 'internationally accepted test guideline or standard under development (TGSUD)', 'established as standard methods in scientific literature (SCI)', 'other methods and/or more research needed (O)' or 'no method (N)'. We find that 80% of the information requirements and a bit more than 40% of the waiving criteria in the new REACH Annexes are supported by methods that are available as TGS, TGSUD or SCI. Most of the relevant methods in the scientific literature are included in recent OECD guidance documents or ECHA guidance. We recommend that a targeted effort is made to develop protocols and guidelines for methods to determine NM adsorption/desorption, degradation, exposure scenarios and ability to cross biological membranes. Here methods to fulfil the information requirements and waiving criteria are currently lacking. Furthermore, we recommend that increasing attention is directed towards regulatory reliability and relevance of the information that is submitted by the registrants. </p>}},
author = {{Nielsen, Maria Bille and Baun, Anders and Mackevica, Aiga and Thit, Amalie and Odnevall Wallinder, Inger and Gallego, Julián Alberto and Westergaard Clausen, Lauge Peter and Rissler, Jenny and Skjolding, Lars and Castro Nilsson, Alejandra and Cedervall, Tommy and Foss Hansen, Steffen}},
issn = {{2051-8153}},
language = {{eng}},
number = {{3}},
pages = {{731--747}},
publisher = {{Royal Society of Chemistry}},
series = {{Environmental Science: Nano}},
title = {{Nanomaterials in the European chemicals legislation-methodological challenges for registration and environmental safety assessment}},
url = {{http://dx.doi.org/10.1039/d0en01123a}},
doi = {{10.1039/d0en01123a}},
volume = {{8}},
year = {{2021}},
}