据了解,这种食品酶是由转基因里氏木霉菌株AR-201生产的,旨在用于七种食品生产过程。
经过评估,专家小组认为,在预期的使用条件下,不能排除饮食暴露引起过敏反应的风险。根据所提供的数据,评估小组得出结论,这种食品酶在预期使用条件下不会引起安全问题。部分原文报道如下:
The food enzyme thermomycolin (EC 3.4.21.65) is produced with the genetically modified Trichoderma reesei strain AR-201 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in seven food manufacturing processes. Dietary exposure was estimated to be up to 0.461 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2169. A search for the homology of the amino acid sequence of the thermomycolin to known allergens was made and matches with 1 food allergen, 19 respiratory allergens and 3 contact allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. 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.
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