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, Herman Lieve, Roos Yrjö, Andryszkiewicz Magdalena, Liu Yi, Lunardi Simone, Chesson Andrew
EFSA J. 2023 Jul 4;21(7):e08089. doi: 10.2903/j.efsa.2023.8089. eCollection 2023 Jul.
The food enzyme glucan-1,4-α-maltohydrolase (4-α-d-glucan α-maltohydrolase; EC 3.2.1.133) is produced with the genetically modified strain AR-453 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure was estimated to be up to 0.262 mg TOS/kg body weight per day in European populations. As the production strain of strain AR-453 qualifies for the qualified presumption of safety (QPS) approach to safety assessment and no issue of concern arose from the production process, no toxicological data were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and six matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, 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.
食品酶葡聚糖-1,4-α-麦芽水解酶（4-α-D-葡聚糖α-麦芽水解酶；EC 3.2.1.133）由AB Enzymes GmbH公司使用转基因菌株AR-453生产。基因改造不存在安全问题。该食品酶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，欧洲人群的膳食暴露量高达每天0.262毫克总有机硫/千克体重。由于菌株AR-453的生产菌株符合安全评估的合格假定安全性（QPS）方法，且生产过程未出现任何问题，因此不需要毒理学数据。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，发现了六个匹配项。专家小组认为，在预期的使用条件下，不能排除因膳食暴露引起过敏反应的风险，但可能性较低。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。
