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转基因生物分析的认证参考材料——欧盟委员会联合研究中心25年以上的转基因生物认证参考物质生产经验

Certified reference materials for GMO analysis-more than 25 years of GMO CRM production at EC JRC.

作者信息

Trapmann Stefanie, Linsinger Thomas P J, Koeber Robert

机构信息

European Commission, Joint Research Centre, Directorate F - Health and Food, Geel, Belgium.

出版信息

Anal Bioanal Chem. 2025 May;417(12):2387-2403. doi: 10.1007/s00216-024-05713-y. Epub 2025 Jan 23.

Abstract

Certified reference materials (CRMs) play a crucial role in ensuring the quality of analytical measurements. Particularly, the EU labelling legislation on genetically modified organisms (GMOs) in food and feed products explicitly requires CRMs for its implementation. The CRMs are used to calibrate and control the quantitative real-time polymerase chain reaction (qPCR) method and support official control laboratories, such as National Reference Laboratories (NRLs), in maintaining their ISO/IEC 17025 accreditation. The Joint Research Centre of the European Commission (EC JRC) is specialized in the production of reference materials and has been producing GMO CRMs since 1998. Together with a validated event-specific qPCR method, these GMO CRMs form the EU reference system for the quantification of EU-authorized GMO events in food and feed products and ensure a common GMO labelling threshold. This article gives a retrospective view on the more than 25 years of GMO CRM production at JRC. It describes requirements for GMO CRMs in view of an EU market authorization under (EC) No. 1829/2003. The evolution and major improvements of the production of GMO CRMs at JRC are summarized as well as the current understanding of the EU's GMO reference system for GMO quantification and its impact on commutability. It provides insights into GMO CRM sales and their worldwide distribution. This information may be useful for policymakers and researchers in understanding the current EU GMO measurement landscape and to anticipate possible future demands related to GMO events based on new genomic techniques (NGTs).

摘要

有证标准物质(CRMs)在确保分析测量质量方面发挥着关键作用。特别是,欧盟关于食品和饲料产品中转基因生物(GMOs)的标签法规明确要求使用有证标准物质来实施该法规。这些有证标准物质用于校准和控制定量实时聚合酶链反应(qPCR)方法,并支持官方控制实验室,如国家参考实验室(NRLs)维持其ISO/IEC 17025认可。欧盟委员会联合研究中心(EC JRC)专门从事标准物质的生产,自1998年以来一直在生产转基因生物有证标准物质。这些转基因生物有证标准物质与经过验证的特定事件qPCR方法一起,构成了欧盟用于定量食品和饲料产品中欧盟授权转基因生物事件的参考系统,并确保了通用的转基因生物标签阈值。本文回顾了JRC超过25年的转基因生物有证标准物质生产历程。它描述了根据(EC)No. 1829/2003获得欧盟市场授权时对转基因生物有证标准物质的要求。总结了JRC转基因生物有证标准物质生产的演变和主要改进,以及目前对欧盟转基因生物定量参考系统及其对互换性影响的理解。它提供了有关转基因生物有证标准物质销售及其全球分布的见解。这些信息可能有助于政策制定者和研究人员了解当前欧盟转基因生物测量格局,并预测基于新基因组技术(NGTs)与转基因生物事件相关的未来可能需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/12003584/09cbfcded284/216_2024_5713_Fig1_HTML.jpg

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