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Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation.
Nanotoxicology ( IF 5 ) Pub Date : 2018-09-05 , DOI: 10.1080/17435390.2018.1513092
A Mech 1 , K Rasmussen 1 , P Jantunen 1 , L Aicher 2 , M Alessandrelli 3 , U Bernauer 4 , E A J Bleeker 5 , J Bouillard 6 , P Di Prospero Fanghella 3 , R Draisci 3 , M Dusinska 7 , G Encheva 8 , G Flament 9 , A Haase 4 , Y Handzhiyski 8 , F Herzberg 4 , J Huwyler 2 , N R Jacobsen 10 , V Jeliazkov 11 , N Jeliazkova 11 , P Nymark 12, 13 , R Grafström 12, 13 , A G Oomen 5 , M L Polci 3 , C Riebeling 4 , J Sandström 2 , B Shivachev 8 , S Stateva 8 , S Tanasescu 14 , R Tsekovska 8 , H Wallin 15 , M F Wilks 2 , S Zellmer 4 , M D Apostolova 8
Affiliation  

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.

中文翻译:

深入了解欧盟化学品法规中纳米材料的分组和交叉读取的可能性。

本文对有关化学物质安全的欧盟(EU)立法进行了全面回顾,并在每部立法中提出了应用分组和交叉阅读方法评估纳米材料(NMs)的可能性。因此,本次审查考虑了REACH(关于化学品注册,评估,授权和限制的第1907/2006号法规)和CLP(关于分类,标签的第1272/2008号法规)的总体化学法规以及物质和混合物的包装)以及化妆品,植物保护和杀菌产品的特定行业法规,以及涉及食品,新型食品和食品接触材料的法规。相关证明文件(例如 参照相关的技术和科学文献,确定并审查了有关每项立法的指导文件)。确定了在评估NMs中实施分组的预期监管需求,并回答了每个特定法规是否允许使用分组和交叉阅读来解决信息空白的问题。
更新日期:2018-09-05
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