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来自转基因菌株ZGL的食品酶葡萄糖氧化酶使用范围扩展的安全性评估。

Safety evaluation of an extension of use of the food enzyme glucose oxidase from the genetically modified strain ZGL.

作者信息

Zorn Holger, Barat Baviera José Manuel, Bolognesi Claudia, Catania Francesco, Gadermaier Gabriele, Greiner Ralf, Mayo Baltasar, Mortensen Alicja, Roos Yrjö Henrik, Solano Marize L M, Sramkova Monika, Van Loveren Henk, Vernis Laurence, Cavanna Daniele, Liu Yi

出版信息

EFSA J. 2025 Jan 29;23(1):e9224. doi: 10.2903/j.efsa.2025.9224. eCollection 2025 Jan.

DOI:10.2903/j.efsa.2025.9224
PMID:39882186
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11775514/
Abstract

The food enzyme glucose oxidase (β-d-glucose: oxygen 1-oxidoreductase, EC 1.1.3.4) is produced with the genetically modified strain ZGL by DSM Food Specialties B.V. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in one food manufacturing process. Subsequently, the applicant has requested to extend its use to include one additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of two food manufacturing processes. Dietary exposure was calculated to be up to 0.025 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level (NOAEL) previously reported (1038 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 41,520. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

摘要

食品酶葡萄糖氧化酶(β - d - 葡萄糖:氧1 - 氧化还原酶,EC 1.1.3.4)由帝斯曼食品特种产品有限公司使用转基因菌株ZGL生产。此前已对这种食品酶进行了安全性评估,欧洲食品安全局(EFSA)得出结论,该食品酶在一种食品制造工艺中使用时不会引起安全问题。随后,申请人请求扩大其使用范围,以包括另外一种工艺。在本次评估中,EFSA更新了该食品酶在总共两种食品制造工艺中使用时的安全性评估。经计算,欧洲人群的膳食暴露量高达每天0.025毫克总有机硫/千克体重(bw)。当与先前报告的未观察到不良反应水平(NOAEL,每天1038毫克总有机硫/千克体重,为测试的最高剂量)相结合时,专家小组得出的暴露边际至少为41520。基于新数据、修订后的暴露边际和先前的评估,专家小组得出结论,在修订后的预期使用条件下,这种食品酶不会引起安全问题。

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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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Food Chem. 2017 Jun 15;225:107-113. doi: 10.1016/j.foodchem.2017.01.010. Epub 2017 Jan 5.
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