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EFSA J. 2023 Jul 25;21(7):e08094. doi: 10.2903/j.efsa.2023.8094. eCollection 2023 Jul.
3
Safety evaluation of the food enzyme glucose oxidase from the genetically modified strain AR-352.来自转基因菌株AR-352的食品酶葡萄糖氧化酶的安全性评估。
EFSA J. 2022 Jul 28;20(7):e07372. doi: 10.2903/j.efsa.2022.7372. eCollection 2022 Jul.
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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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来自转基因菌株AR-352的食品酶葡萄糖氧化酶的修订安全性评估

Revised safety evaluation of the food enzyme glucose oxidase from the genetically modified strain AR-352.

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, Aguilera Jaime, Liu Yi

出版信息

EFSA J. 2024 Dec 11;22(12):e9122. doi: 10.2903/j.efsa.2024.9122. eCollection 2024 Dec.

DOI:10.2903/j.efsa.2024.9122
PMID:39664788
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11632242/
Abstract

The food enzyme glucose oxidase (β-d-glucose: oxygen 1-oxidoreductase; EC 1.1.3.4) is produced with the genetically modified strain AR-352 by AB Enzymes GmbH. In a previous opinion, the Panel on Food Contact Materials, Enzymes and Processing Aids of the European Food Safety Authority could not conclude on the absence of recombinant DNA from the production strain in the food enzyme due to uncertainties about the limit of detection of the applied methodology. New data provided by the applicant showed that no DNA from the production strain was found in the food enzyme with a limit of detection meeting the requirements of the applicable guidance. Based on the new data provided, the Panel concludes that this food enzyme is free from recombinant DNA from the production strain.

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AB Enzymes GmbH公司的转基因菌株AR-352生产。在先前的一份意见中,由于所应用方法的检测限存在不确定性,欧洲食品安全局食品接触材料、酶和加工助剂小组无法就食品酶中不存在来自生产菌株的重组DNA得出结论。申请人提供的新数据表明,在食品酶中未发现来自生产菌株的DNA,其检测限符合适用指南的要求。基于所提供的新数据,该小组得出结论,这种食品酶不含来自生产菌株的重组DNA。