據(jù)了解，這種食品酶是由Collariella gracilis 菌株AE-DX生產(chǎn)的，旨在用于從糖用甜菜或甘蔗生產(chǎn)精制糖。
經(jīng)過評(píng)估，專家小組認(rèn)為，在預(yù)期的使用條件下，不能排除飲食暴露引起過敏和誘發(fā)反應(yīng)的風(fēng)險(xiǎn)，但這種情況發(fā)生的可能性很低。根據(jù)提供的數(shù)據(jù)，小組得出結(jié)論，該食品酶在預(yù)期的使用條件下不會(huì)引起安全問題。部分原文報(bào)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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