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, Herman Lieve, Jany Klaus-Dieter, Marcon Francesca, Penninks André, Smith Andrew, Arcella Davide, Gomes Ana, Kovalkovičová Natália, Liu Yi, Maia Joaquim, Engel Karl-Heinz
EFSA J. 2018 May 2;16(5):e05168. doi: 10.2903/j.efsa.2018.5168. eCollection 2018 May.
The food enzyme considered in this opinion is a glucan 1,4-α-maltohydrolase (maltogenic α-amylase; EC 3.2.1.133) produced with the genetically modified strain MAM by the company DSM Food Specialties B. V. The food enzyme contains neither the production microorganism nor recombinant DNA; therefore, no environmental risk assessment is required. However, the Panel emphasises that this conclusion only covers the food enzyme recovered via filter press. The glucan 1,4-α-maltohydrolase is intended for use in baking processes. Based on the maximum use levels 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 0.175 mg TOS/kg body weight (bw) per day in European populations. The systemic 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 (986 mg TOS/kg bw per day for both males and females), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; one match was found. However, the Panel considered that there are no indications for food allergic reactions to this glucan 1,4-α-maltohydrolase by dietary exposure. No safety concerns were identified in relation to the genetic modifications, the manufacturing process, the compositional data provided, as well as the exposure, allergenicity and systemic toxicity assessments. However, owing to the incompleteness of the genotoxicity data, the Panel is not able to conclude on the safety of the food enzyme.
本意见所涉及的食品酶是一种由帝斯曼食品特种产品有限公司使用转基因菌株MAM生产的葡聚糖1,4-α-麦芽水解酶（产麦芽α-淀粉酶；EC 3.2.1.133）。该食品酶既不包含生产微生物，也不包含重组DNA；因此，无需进行环境风险评估。然而，专家小组强调，这一结论仅适用于通过压滤机回收的食品酶。葡聚糖1,4-α-麦芽水解酶拟用于烘焙过程。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量和个体消费数据，估计欧洲人群通过膳食接触该食品酶总有机固体（TOS）的量高达每天0.175毫克TOS/千克体重（bw）。通过在啮齿动物中进行的重复剂量90天口服毒性研究评估了全身毒性。得出了未观察到不良影响水平（NOAEL）（雄性和雌性均为每天986毫克TOS/千克bw），与膳食接触量相比，得出了足够高的接触安全边际。通过将氨基酸序列与已知过敏原的序列进行比较来评估致敏性；发现了一个匹配项。然而，专家小组认为，没有迹象表明通过膳食接触该葡聚糖1,4-α-麦芽水解酶会引发食物过敏反应。在基因改造、制造过程、提供的成分数据以及接触、致敏性和全身毒性评估方面均未发现安全问题。然而，由于遗传毒性数据不完整，专家小组无法就该食品酶的安全性得出结论。
