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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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Why can patients with baker's asthma tolerate wheat flour ingestion? Is wheat pollen allergy relevant?为什么患面包师哮喘的患者能耐受摄入小麦粉?小麦花粉过敏与之有关吗?
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Allergy assessment of foods or ingredients derived from biotechnology, gene-modified organisms, or novel foods.对源自生物技术、基因改造生物或新型食品的食品或成分进行过敏评估。
Mol Nutr Food Res. 2004 Nov;48(6):413-23. doi: 10.1002/mnfr.200400029.
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Occupational asthma caused by cellulase and lipase in the detergent industry.洗涤剂行业中纤维素酶和脂肪酶引起的职业性哮喘。
Occup Environ Med. 2004 Sep;61(9):793-5. doi: 10.1136/oem.2003.011288.
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Clinical responses to ingested fungal alpha-amylase and hemicellulase in persons sensitized to Aspergillus fumigatus?对烟曲霉致敏者摄入真菌α-淀粉酶和半纤维素酶后的临床反应?
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来自转基因菌株LALL-LI2的食品酶三酰基甘油脂肪酶的安全性评估。

Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified strain LALL-LI2.

作者信息

Zorn Holger, Baviera José Manuel Barat, 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, Cavanna Daniele, Fernàndez-Fraguas Cristina, Liu Yi

出版信息

EFSA J. 2025 Jun 12;23(6):e9486. doi: 10.2903/j.efsa.2025.9486. eCollection 2025 Jun.

DOI:10.2903/j.efsa.2025.9486
PMID:40510567
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12159548/
Abstract

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified strain LALL-LI2 by Danstar Ferment AG. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure was estimated to be up to 0.071 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the triacylglycerol lipase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

摘要

食品酶三酰甘油脂肪酶(三酰甘油酰基水解酶,EC 3.1.1.3)由Danstar Ferment AG公司的转基因菌株LALL-LI2生产。生产菌株符合安全合格假定(QPS)的要求。该食品酶被认为不含有生产生物体的活细胞及其DNA。它拟用于谷物和其他谷物的加工,以生产烘焙食品。据估计,欧洲人群的膳食暴露量高达每天0.071毫克三酰甘油脂肪酶/千克体重。鉴于生产菌株的QPS状态以及食品酶制造过程不存在问题,专家小组认为无需进行毒性测试。对三酰甘油脂肪酶的氨基酸序列与已知过敏原进行了同源性搜索,未发现匹配情况。专家小组认为,不能排除膳食接触该食品酶会引发过敏反应的风险,但可能性较低。根据所提供的数据,专家小组得出结论,在预期的使用条件下,这种食品酶不会引起安全问题。