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关于暴露边际方法的使用与解读的声明

Statement on the use and interpretation of the margin of exposure approach.

作者信息

Bennekou Suzanne Hougaard, Allende Ana, Bearth Angela, Casacuberta Josep, Castle Laurence, Coja Tamara, Crépet Amélie, Halldorsson Thorhallur, Hoogenboom Laurentius Ron, Knutsen Helle, Lambré Claude, Nielsen Søren, Turck Dominique, Civera Antonio Vicent, Villa Roberto, Jokelainen Pikka, Zorn Holger, Benford Diane, Fitzgerald Rex, Meek Bette, Mortensen Alicja, Sand Salomon, Testai Emanuela, Manini Paola, Paini Alicia, Schrenk Dieter

出版信息

EFSA J. 2025 Aug 8;23(8):e9606. doi: 10.2903/j.efsa.2025.9606. eCollection 2025 Aug.

DOI:10.2903/j.efsa.2025.9606
PMID:40786114
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12332500/
Abstract

The margin of exposure (MOE) is a risk assessment tool used to evaluate the safety of substances in food and feed. Adopted by the European Food Safety Authority (EFSA) in 2005, the MOE is calculated as the ratio between a Reference Point (RP) and the estimated exposure. While some regulatory bodies use 'margin of safety' (MOS) interchangeably with MOE, others define it differently, leading to inconsistencies in interpretation. To address this, EFSA has standardised its terminology, establishing MOE as a primary metric for safety assessments across human and animal health evaluations. In addition, the meaning and interpretation of terms used to qualify a 'concern' is elaborated. The EFSA definitions will come into force from when this statement is published. By refining these definitions and ensuring consistent terminology across sectors, EFSA aims to improve clarity and transparency in its risk assessments, facilitating effective communication.

摘要

暴露边际(MOE)是一种用于评估食品和饲料中物质安全性的风险评估工具。欧洲食品安全局(EFSA)于2005年采用了MOE,它被计算为参考点(RP)与估计暴露量之间的比率。虽然一些监管机构将“安全边际”(MOS)与MOE互换使用,但其他机构对其定义不同,导致解释上的不一致。为了解决这个问题,EFSA对其术语进行了标准化,将MOE确立为人类和动物健康评估中安全评估的主要指标。此外,还阐述了用于限定“关注”的术语的含义和解释。EFSA的定义将自本声明发布之日起生效。通过完善这些定义并确保各部门术语的一致性,EFSA旨在提高其风险评估的清晰度和透明度,促进有效沟通。

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本文引用的文献

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Scientific opinion on the renewal of the authorisation of Fumokomp (SF-009) as a smoke flavouring Primary Product.关于Fumokomp(SF-009)作为烟熏调味料初级产品授权续期的科学意见。
EFSA J. 2023 Nov 16;21(11):e08370. doi: 10.2903/j.efsa.2023.8370. eCollection 2023 Nov.
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Re-evaluation of behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 - for permanent exemption from labelling.根据欧盟第1169/2011号法规第21(2)条,对用于制造某些乳化剂的芥菜籽山嵛酸进行重新评估,以获得永久标签豁免。
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Follow-up of the re-evaluation of indigo carmine (E 132) as a food additive.靛蓝胭脂红(E 132)作为食品添加剂的重新评估后续跟进。
EFSA J. 2023 Jul 26;21(7):e08103. doi: 10.2903/j.efsa.2023.8103. eCollection 2023 Jul.
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Follow-up of the re-evaluation of sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228).二氧化硫(E 220)、亚硫酸钠(E 221)、亚硫酸氢钠(E 222)、焦亚硫酸钠(E 223)、焦亚硫酸钾(E 224)、亚硫酸钙(E 226)、亚硫酸氢钙(E 227)和亚硫酸氢钾(E 228)重新评估的后续跟进。
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Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals.关于将化学品分组以进行多种化学品联合暴露的人体风险评估的评估组的科学标准指导文件。
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Scientific Guidance for the submission of dossiers on Food Enzymes.食品酶制剂资料提交的科学指南。
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Guidance on Uncertainty Analysis in Scientific Assessments.科学评估中的不确定性分析指南。
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