欧盟评估非转基因米黑根毛霉菌株M19-21生产的粘蛋白酶的安全性

 

　　据了解，这种食品酶是由非转基因米黑根毛霉菌株M19-21生产的，旨在用于乳制品加工，以生产奶酪和发酵乳制品。

 

　　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，尤其是对芥末蛋白过敏的人。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 mucorpepsin (EC 3.4.23.23) is produced with the non-genetically modified Rhizomucor miehei strain M19-21 by Meito Sangyo Co., Ltd. The enzyme is chemically modified to produce a thermolabile form. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in the processing of dairy products for the production of cheese and fermented dairy products. based on the maximum use levels, dietary exposure was estimated to be up to 0.108 mg 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 226 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 2093. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches to respiratory allergens and one match to a food allergen (mustard) were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to mustard proteins, 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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