Silano Vittorio, Bolognesi Claudia, Castle Laurence, Chipman Kevin, Cravedi Jean-Pierre, Fowler Paul, Franz Roland, Grob Konrad, Gürtler Rainer, Husøy Trine, Kärenlampi Sirpa, Mennes Wim, Milana Maria Rosaria, Pfaff Karla, Riviere Gilles, Srinivasan Jannavi, Tavares Poças Maria de Fátima, Tlustos Christina, Wölfle Detlef, Zorn Holger, Chesson Andrew, Glandorf Boet, Herman Lieve, Jany Klaus-Dieter, Marcon Francesca, Penninks André, Smith Andrew, Želježić Davor, Aguilera-Gómez Margarita, Andryszkiewicz Magdalena, Arcella Davide, Kovalkovičová Natália, Liu Yi, Engel Karl-Heinz
EFSA J. 2018 May 2;16(5):e05170. doi: 10.2903/j.efsa.2018.5170. eCollection 2018 May.
The food enzyme considered in this opinion is aqualysin 1 (EC 3.4.21.111), produced from the genetically modified strain LMGS 25520 by Puratos NV. The production strain was not detected in the food enzyme. Aqualysin 1 is intended to be used in baking processes. Based on the maximum use level recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 2.13 mg TOS/kg body weight per day in European populations. Genotoxicity tests indicated no genotoxic concerns. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens and 23 matches were found (20 respiratory and 3 dermal allergens). However, the Panel considered that there are no indications for food allergic reactions to the food enzyme. The genetic modifications performed, the manufacturing process, the compositional and biochemical data, the allergenicity and the genotoxicity assessment did not raise safety concerns. The Panel considered the margin of exposure (MOE) calculated from the no observed adverse effect level (NOAEL) determined from the repeated dose 90-day oral toxicity study and the estimated dietary exposure as insufficient to conclude that there is no safety concern for this food enzyme under the intended conditions of use. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested.
本意见所考虑的食品酶是嗜热栖热菌蛋白酶1（EC 3.4.21.111），由Puratos NV公司的转基因菌株LMGS 25520生产。在该食品酶中未检测到生产菌株。嗜热栖热菌蛋白酶1拟用于烘焙过程。根据欧洲食品安全局综合欧洲食品消费数据库推荐的最大使用水平和个体消费数据，估计欧洲人群通过膳食接触该食品酶的总有机固体（TOS）最高可达每天2.13毫克TOS/千克体重。遗传毒性试验表明不存在遗传毒性问题。通过搜索氨基酸序列与已知过敏原的相似性对致敏性进行了评估，发现有23个匹配项（20种呼吸道过敏原和3种皮肤过敏原）。然而，专家小组认为没有迹象表明对该食品酶会发生食物过敏反应。所进行的基因改造、制造工艺、成分和生化数据、致敏性和遗传毒性评估均未引发安全问题。专家小组认为，根据重复剂量90天经口毒性研究确定的未观察到不良作用水平（NOAEL）计算得出的暴露边际（MOE）以及估计的膳食暴露量，不足以得出在预期使用条件下该食品酶不存在安全问题的结论。专家小组注意到，在所有测试批次的食品酶中均存在重组DNA。
