<br>关于在食品安全评估中使用毒理学关注阈值方法的指南。,EFSA Journal

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关于在食品安全评估中使用毒理学关注阈值方法的指南。
EFSA Journal ( IF 3.3 ) Pub Date : 2019-06-06 , DOI: 10.2903/j.efsa.2019.5708
, Simon J More , Vasileios Bampidis , Diane Benford , Claude Bragard , Thorhallur I Halldorsson , Antonio F Hernández‐Jerez , Susanne Hougaard Bennekou , Kostas P Koutsoumanis , Kyriaki Machera , Hanspeter Naegeli , Søren S Nielsen , Josef R Schlatter , Dieter Schrenk , Vittorio Silano , Dominique Turck , Maged Younes , Ursula Gundert‐Remy , George E N Kass , Juliane Kleiner , Anna Maria Rossi , Rositsa Serafimova , Linda Reilly , Heather M Wallace

科学委员会确认毒理学关注阈值 (TTC) 是用于食品安全评估的务实筛选和优先排序工具。本指南为使用 TTC 方法提供了清晰的分步说明。定义了纳入和排除标准，并解释了 TTC 决策树的使用。当物质的化学结构已知、化学特异性毒性数据有限并且可以估计暴露量时，可以使用该方法。 TTC 方法不应用于欧盟食品/饲料立法要求提交毒性数据的物质，或者当有足够的数据可用于风险评估时，或者如果所考虑的物质属于排除类别之一。根据证据权重，对于可能成为 DNA 反应性诱变剂和/或致癌剂的物质，相关 TTC 值为每天 0.0025 微克/千克体重 (bw)。对于有机磷酸酯或氨基甲酸酯，相关的 TTC 值为每天 0.3 微克/千克体重。所有其他物质均根据克莱默分类进行分组。 Cramer I、II 和 III 类的 TTC 值分别为每天 30 微克/公斤体重、每天 9 微克/公斤体重和每天 1.5 微克/公斤体重。对于暴露量低于 TTC 值的物质，它们对健康造成不良影响的可能性很低。如果某种物质的估计暴露量高于相关 TTC 值，则需要采用非 TTC 方法来得出潜在不利健康影响的结论。

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Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment.

The Scientific Committee confirms that the Threshold of Toxicological Concern (TTC) is a pragmatic screening and prioritisation tool for use in food safety assessment. This Guidance provides clear step‐by‐step instructions for use of the TTC approach. The inclusion and exclusion criteria are defined and the use of the TTC decision tree is explained. The approach can be used when the chemical structure of the substance is known, there are limited chemical‐specific toxicity data and the exposure can be estimated. The TTC approach should not be used for substances for which EU food/feed legislation requires the submission of toxicity data or when sufficient data are available for a risk assessment or if the substance under consideration falls into one of the exclusion categories. For substances that have the potential to be DNA‐reactive mutagens and/or carcinogens based on the weight of evidence, the relevant TTC value is 0.0025 μg/kg body weight (bw) per day. For organophosphates or carbamates, the relevant TTC value is 0.3 μg/kg bw per day. All other substances are grouped according to the Cramer classification. The TTC values for Cramer Classes I, II and III are 30 μg/kg bw per day, 9 μg/kg bw per day and 1.5 μg/kg bw per day, respectively. For substances with exposures below the TTC values, the probability that they would cause adverse health effects is low. If the estimated exposure to a substance is higher than the relevant TTC value, a non‐TTC approach is required to reach a conclusion on potential adverse health effects.

更新日期：2019-06-06

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