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, Aguilera Jaime, Andryszkiewicz Magdalena, Liu Yi, Chesson Andrew
EFSA J. 2023 Feb 17;21(2):e07468. doi: 10.2903/j.efsa.2023.7468. eCollection 2023 Feb.
The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain AR-651 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 1.19 mg TOS/kg body weight (bw) per day in European populations. The production strain carries known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concludes 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AB Enzymes公司的转基因菌株AR-651生产。基因改造不存在安全问题。该食品酶被认为不含生产生物体的活细胞及其DNA。它拟用于烘焙过程。据估计，欧洲人群通过饮食接触该食品酶的总有机固体（TOS）量高达每天1.19毫克TOS/千克体重（bw）。生产菌株携带已知的抗菌抗性基因，因此，它不完全符合安全评估的合格假定安全性（QPS）方法的要求。然而，考虑到该食品酶中不存在生产生物体的活细胞和DNA，这不被视为一种风险。由于未发现微生物来源及其后续基因改造或制造过程产生的其他问题，专家小组认为，评估该食品酶不需要进行毒理学试验。对该食品酶的氨基酸序列与已知过敏原进行了相似性搜索，发现与呼吸道过敏原存在三次匹配。专家小组认为，在预期的使用条件下，不能排除饮食接触引起过敏致敏和激发反应的风险，但认为发生这种情况的可能性较低。根据提供的数据，专家小组得出结论，在预期的使用条件下，这种食品酶不存在安全问题。
