Literature DB >> 30182766

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

A Mech1, K Rasmussen1, P Jantunen1, L Aicher2, M Alessandrelli3, U Bernauer4, E A J Bleeker5, J Bouillard6, P Di Prospero Fanghella3, R Draisci3, M Dusinska7, G Encheva8, G Flament9, A Haase4, Y Handzhiyski8, F Herzberg4, J Huwyler2, N R Jacobsen10, V Jeliazkov11, N Jeliazkova11, P Nymark12,13, R Grafström12,13, A G Oomen5, M L Polci3, C Riebeling4, J Sandström2, B Shivachev8, S Stateva8, S Tanasescu14, R Tsekovska8, H Wallin15, M F Wilks2, S Zellmer4, M D Apostolova8.   

Abstract

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.

Entities:  

Keywords:  EU legislation; Nanomaterials; biocides; chemicals legislation; cosmetics; food legislation; grouping; pesticides; read-across

Mesh:

Year:  2018        PMID: 30182766     DOI: 10.1080/17435390.2018.1513092

Source DB:  PubMed          Journal:  Nanotoxicology        ISSN: 1743-5390            Impact factor:   5.913


  7 in total

Review 1.  Overview of Adverse Outcome Pathways and Current Applications on Nanomaterials.

Authors:  Dora Rolo; Ana Tavares; Nádia Vital; Maria João Silva; Henriqueta Louro
Journal:  Adv Exp Med Biol       Date:  2022       Impact factor: 2.622

2.  Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology.

Authors:  Costanza Rovida; Tara Barton-Maclaren; Emilio Benfenati; Francesca Caloni; P. Charukeshi Chandrasekera; Christophe Chesné; Mark T D Cronin; Joop De Knecht; Daniel R Dietrich; Sylvia E Escher; Suzanne Fitzpatrick; Brenna Flannery; Matthias Herzler; Susanne Hougaard Bennekou; Bruno Hubesch; Hennicke Kamp; Jaffar Kisitu; Nicole Kleinstreuer; Simona Kovarich; Marcel Leist; Alexandra Maertens; Kerry Nugent; Giorgia Pallocca; Manuel Pastor; Grace Patlewicz; Manuela Pavan; Octavio Presgrave; Lena Smirnova; Michael Schwarz; Takashi Yamada; Thomas Hartung
Journal:  ALTEX       Date:  2020-04-30       Impact factor: 6.250

Review 3.  Translating Scientific Advances in the AOP Framework to Decision Making for Nanomaterials.

Authors:  James D Ede; Vladimir Lobaskin; Ulla Vogel; Iseult Lynch; Sabina Halappanavar; Shareen H Doak; Megan G Roberts; Jo Anne Shatkin
Journal:  Nanomaterials (Basel)       Date:  2020-06-24       Impact factor: 5.076

4.  Safe- and sustainable-by-design: The case of Smart Nanomaterials. A perspective based on a European workshop.

Authors:  Agnieszka Mech; Stefania Gottardo; Valeria Amenta; Alessia Amodio; Susanne Belz; Søren Bøwadt; Jana Drbohlavová; Lucian Farcal; Paula Jantunen; Aleksandra Małyska; Kirsten Rasmussen; Juan Riego Sintes; Hubert Rauscher
Journal:  Regul Toxicol Pharmacol       Date:  2021-12-02       Impact factor: 3.271

5.  Regulatory safety evaluation of nanomedical products: key issues to refine.

Authors:  Wim H De Jong; Robert E Geertsma; Gerrit Borchard
Journal:  Drug Deliv Transl Res       Date:  2022-07-30       Impact factor: 5.671

6.  Read-across predictions of nanoparticle hazard endpoints: a mathematical optimization approach.

Authors:  Dimitra-Danai Varsou; Antreas Afantitis; Georgia Melagraki; Haralambos Sarimveis
Journal:  Nanoscale Adv       Date:  2019-07-09

7.  Potential Role of Soluble Metal Impurities in the Acute Lung Inflammogenicity of Multi-Walled Carbon Nanotubes.

Authors:  Dong-Keun Lee; Soyeon Jeon; Jiyoung Jeong; Il Je Yu; Kyung Seuk Song; Aeyeon Kang; Wan Soo Yun; Jong Sung Kim; Wan-Seob Cho
Journal:  Nanomaterials (Basel)       Date:  2020-02-21       Impact factor: 5.076

  7 in total

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