Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation

Mech, A. and Rasmussen, K. and Jantunen, P. and Aicher, L. and Alessandrelli, M. and Bernauer, U. and Bleeker, E. A. J. and Bouillard, J. and Di Prospero Fanghella, P. and Draisci, R. and Dusinska, M. and Encheva, G. and Flament, G. and Haase, A. and Handzhiyski, Y. and Herzberg, F. and Huwyler, J. and Jacobsen, N. R. and Jeliazkov, V. and Jeliazkova, N. and Nymark, P. and Grafström, R. and Oomen, A. G. and Polci, M. L. and Riebeling, C. and Sandström, J. and Shivachev, B. and Stateva, S. and Tanasescu, S. and Tsekovska, R. and Wallin, H. and Wilks, M. F. and Zellmer, S. and Apostolova, M. D.. (2018) Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation. Nanotoxicology. pp. 1-23.

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This paper presents a comprehensive review of European Union (EU) legislation addressing the safety of chemical substances, and possibilities within each piece of legislation for applying grouping and read-across approaches for the assessment of nanomaterials (NMs). Hence, this review considers both the overarching regulation of chemical substances under REACH (Regulation (EC) No 1907/2006 on registration, evaluation, authorization, and restriction of chemicals) and CLP (Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures) and the sector-specific pieces of legislation for cosmetic, plant protection and biocidal products, and legislation addressing food, novel food, and food contact materials. The relevant supporting documents (e.g. guidance documents) regarding each piece of legislation were identified and reviewed, considering the relevant technical and scientific literature. Prospective regulatory needs for implementing grouping in the assessment of NMs were identified, and the question whether each particular piece of legislation permits the use of grouping and read-across to address information gaps was answered.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmaceutical Technology (Huwyler)
UniBasel Contributors:Huwyler, Jörg
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Taylor & Francis
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:28 Feb 2022 18:08
Deposited On:30 Oct 2018 16:32

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