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Publikationstyp
Wissenschaftlicher Artikel
Erscheinungsjahr
2023
Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety - a proposal for further actions
Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety - a proposal for further actions
Herausgeber
Quelle
Regulatory Toxicology and Pharmacology
139 (2023)
139 (2023)
Schlagwörter
Nanomaterialien
Forschungskennzahl (FKZ)
Verbundene Publikation
Zitation
BLEEKER, Eric A.J., Elmer SWART, Hedwig BRAAKHUIS und Kathrin SCHWIRN, 2023. Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety - a proposal for further actions. Regulatory Toxicology and Pharmacology [online]. 2023. Bd. 139 (2023). DOI 10.60810/openumwelt-1781. Verfügbar unter: https://openumwelt.de/handle/123456789/1478
Zusammenfassung englisch
Over 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