Lambré Claude, Barat Baviera José Manuel, Bolognesi Claudia, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Roos Yrjö, Peluso Silvia, Andryszkiewicz Magdalena, Apergi Kyriaki, di Piazza Giulio, Liu Yi, Chesson Andrew
EFSA J. 2023 Oct 11;21(10):e08255. doi: 10.2903/j.efsa.2023.8255. eCollection 2023 Oct.
The food enzyme -amylase (4--d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism strain LMG-S 32676 by Enmex SA de CV, a Kerry Company. The food enzyme under assessment is intended to be used in six food manufacturing processes: baking processes, brewing processes, distilled alcohol production, starch processing for the production of glucose syrups and other starch hydrolysates, refined and unrefined sugar production and yeast processing. Since residual amounts of total organic solids (TOS) are removed in distilled alcohol production and starch processing for glucose syrups production and other starch hydrolysates, the dietary exposure estimation was made only for the remaining four food processes. It was estimated to be up to 2.998 mg TOS/kg body weight per day in European populations. The production strain meets the requirements for the QPS approach. As no concerns arising from the manufacturing process were identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), 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.
食品酶α-淀粉酶（4-α-D-葡聚糖葡聚糖水解酶；EC 3.2.1.1）由嘉利公司旗下的Enmex SA de CV采用非转基因微生物菌株LMG-S 32676生产。所评估的食品酶拟用于六种食品制造工艺：烘焙工艺、酿造工艺、蒸馏酒精生产、用于生产葡萄糖浆和其他淀粉水解产物的淀粉加工、精制糖和粗糖生产以及酵母加工。由于在蒸馏酒精生产以及用于葡萄糖浆生产和其他淀粉水解产物的淀粉加工过程中会去除总有机固体（TOS）的残留量，因此仅对其余四种食品工艺进行了膳食暴露评估。据估计，欧洲人群每天的膳食暴露量高达2.998毫克TOS/千克体重。生产菌株符合合格假定安全（QPS）方法的要求。由于未发现制造过程中产生的任何问题，专家小组认为评估该食品酶无需进行毒理学测试。对该食品酶的氨基酸序列与已知过敏原的相似性进行了搜索，发现与呼吸道过敏原存在两个匹配项。专家小组认为，不能排除膳食接触该食品酶会引发过敏反应的风险（蒸馏酒精生产除外），但可能性较低。根据所提供的数据，专家小组得出结论，在预期使用条件下，该食品酶不会引起安全问题。
