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欧盟对纳米生物杀灭剂的监管:实施生物杀灭产品法规(BPR)面临的挑战。

EU Regulation of Nanobiocides: Challenges in Implementing the Biocidal Product Regulation (BPR).

作者信息

Brinch Anna, Hansen Steffen Foss, Hartmann Nanna B, Baun Anders

机构信息

Faculty of Science, University of Copenhagen, Bülowsvej 17, DK-1870 Frederiksberg C, Denmark.

Department of Environmental Engineering, Technical University of Denmark, DTU-Building 113, DK-2800 Copenhagen, Denmark.

出版信息

Nanomaterials (Basel). 2016 Feb 16;6(2):33. doi: 10.3390/nano6020033.

DOI:10.3390/nano6020033
PMID:28344290
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5302488/
Abstract

The Biocidal Products Regulation (BPR) contains several provisions for nanomaterials (NMs) and is the first regulation in the European Union to require specific testing and risk assessment for the NM form of a biocidal substance as a part of the information requirements. Ecotoxicological data are one of the pillars of the information requirements in the BPR, but there are currently no standard test guidelines for the ecotoxicity testing of NMs. The overall objective of this work was to investigate the implications of the introduction of nano-specific testing requirements in the BPR and to explore how these might be fulfilled in the case of copper oxide nanoparticles. While there is information and data available in the open literature that could be used to fulfill the BPR information requirements, most of the studies do not take the Organisation for Economic Co-operation and Development's nanospecific test guidelines into consideration. This makes it difficult for companies as well as regulators to fulfill the BPR information requirements for nanomaterials. In order to enable a nanospecific risk assessment, best practices need to be developed regarding stock suspension preparation and characterization, exposure suspensions preparation, and for conducting ecotoxicological test.

摘要

生物杀灭剂产品法规(BPR)包含了多项针对纳米材料(NMs)的规定,并且是欧盟首个要求将生物杀灭物质的纳米形式作为信息要求的一部分进行特定测试和风险评估的法规。生态毒理学数据是BPR中信息要求的支柱之一,但目前尚无针对纳米材料生态毒性测试的标准测试指南。这项工作的总体目标是研究在BPR中引入纳米特定测试要求的影响,并探讨在氧化铜纳米颗粒的情况下如何满足这些要求。虽然公开文献中有可用于满足BPR信息要求的信息和数据,但大多数研究并未考虑经济合作与发展组织的纳米特定测试指南。这使得公司和监管机构都难以满足纳米材料的BPR信息要求。为了进行纳米特定风险评估,需要制定有关储备悬浮液制备与表征、暴露悬浮液制备以及进行生态毒理学测试的最佳实践。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d266/5302488/3e1e1e325d16/nanomaterials-06-00033-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d266/5302488/e4c8ec049f5c/nanomaterials-06-00033-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d266/5302488/3e1e1e325d16/nanomaterials-06-00033-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d266/5302488/e4c8ec049f5c/nanomaterials-06-00033-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d266/5302488/3e1e1e325d16/nanomaterials-06-00033-g002.jpg

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