經(jīng)過(guò)評(píng)估，專(zhuān)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(guò)敏反應(yīng)的風(fēng)險(xiǎn)，但這種可能性被認(rèn)為很低。根據(jù)所提供的數(shù)據(jù)，評(píng)估小組得出結(jié)論，這種食品酶在預(yù)期使用條件下不會(huì)引起安全問(wèn)題。部分原文報(bào)道如下：
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non-genetically modified Bacillus amyloliquefaciens strain AE-NP by Amano Enzyme Inc. The production strain meets the requirements for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in 14 food manufacturing processes. Since residual amounts of total organic solids (TOS) are removed in three manufacturing processes, dietary exposure was calculated only for the remaining 11 food manufacturing processes in which the food enzyme-TOS is retained. It was estimated to be up to 35.251 mg TOS/kg body weight (bw) per day in European populations. As the production strain qualifies for the QPS approach and no issue of concern arising from the production process of the food enzyme were identified, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but 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.
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