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, van Loveren Henk, Želježic Davor, Aguilera-Gómez Margarita, Andryszkiewicz Magdalena, Arcella Davide, Kovalkovičová Natália, Liu Yi, Engel Karl-Heinz
EFSA J. 2018 May 2;16(5):e05171. doi: 10.2903/j.efsa.2018.5171. eCollection 2018 May.
The food enzyme considered is a maltogenic amylase (glucan 1,4-α-maltohydrolase; EC 3.2.1.133) produced with the genetically modified strain NZYM-SM by Novozymes A/S. The food enzyme contains neither the production organism nor recombinant DNA. The maltogenic amylase is intended for use in baking processes and starch processing for glucose syrups production. Based on the maximum use levels recommended for the food processes 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 0.168 mg TOS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosomal aberrations in human lymphocytes. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (320 mg TOS/kg bw per day), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens. Three matches to occupational respiratory allergens were found, however, the Panel considered that there are no indications for food allergic reactions to the food enzyme. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concluded that the food enzyme maltogenic amylase from strain NZYM-SM does not give rise to safety concerns under the intended conditions of use.
所考虑的食品酶是一种麦芽糖淀粉酶（葡聚糖1,4-α-麦芽糖水解酶；EC 3.2.1.133），由诺维信公司使用转基因菌株NZYM-SM生产。该食品酶既不包含生产生物体，也不包含重组DNA。麦芽糖淀粉酶旨在用于烘焙过程以及葡萄糖浆生产的淀粉加工。根据食品加工推荐的最大使用水平以及欧洲食品安全局综合欧洲食品消费数据库的个体消费数据，估计欧洲人群通过饮食接触该食品酶的总有机固体（TOS）最高可达每天0.168毫克TOS/千克体重（bw）。该食品酶在细菌中未诱导基因突变，在人类淋巴细胞中也未诱导染色体畸变。通过对啮齿动物进行为期90天的重复剂量口服毒性研究来评估亚慢性毒性。得出了未观察到不良影响水平（NOAEL）（每天320毫克TOS/千克bw），与饮食接触量相比，这导致了足够高的接触安全边际。通过搜索氨基酸序列与已知过敏原的相似性来评估致敏性。发现了与职业性呼吸道过敏原的三个匹配，但专家小组认为没有迹象表明该食品酶会引发食物过敏反应。基于所进行的基因改造、制造工艺、提供的成分和生化数据、饮食接触评估、毒理学研究结果和致敏性评估，专家小组得出结论，在预期使用条件下，来自菌株NZYM-SM的食品酶麦芽糖淀粉酶不会引起安全问题。
