据了解，这种食品酶是由Collariella gracilis 菌株AE-DX生产的，旨在用于从糖用甜菜或甘蔗生产精制糖。

 

　　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和诱发反应的风险，但这种情况发生的可能性很低。根据提供的数据，小组得出结论，该食品酶在预期的使用条件下不会引起安全问题。部分原文报道如下：

 

　　The food enzyme dextranase (6-α-d-glucan 6-glucanohydrolase, EC 3.2.1.11) is produced with the non-genetically modified Collariella gracilis strain AE-DX by Amano Enzyme Inc. The food enzyme is considered free from viable cells of the production organism. The food enzyme is intended to be used in refined sugar production from sugar beet or sugar cane. Since residual amounts of total organic solids (TOS) are removed by crystallisation during the production of refined white sucrose, dietary exposure was not considered necessary for refined sugars. However, beet molasses and cane syrups, by-products from sugar production, could enter the food chain. based on the maximum use levels recommended, dietary exposure was estimated to be up to 0.39 mg TOS/kg body weight (bw) per day via the consumption of unrefined sugars. 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 lowest observed adverse effect level (LOAEL) of 940.5 mg TOS/kg bw per day, the lowest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of more than 800. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be 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.

 

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