Silano Vittorio, Barat Baviera José Manuel, Bolognesi Claudia, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lambré Claude, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Glandorf Boet, Herman Lieve, Liu Yi, Chesson Andrew
EFSA J. 2021 Feb 19;19(2):e06434. doi: 10.2903/j.efsa.2021.6434. eCollection 2021 Feb.
The food enzyme maltogenic α-amylase (4-α-d-glucan α-maltohydrolase; EC 3.2.1.133) is produced with the genetically modified strain LALL-MA by Lallemand Baking Solutions. 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. The food enzyme is intended to be used in baking processes. Based on the maximum use level recommended for the baking processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure was estimated to be up to 0.059 mg total organic solids (TOS)/kg body weight per day in European populations. As the production strain of meets the requirements for a Qualified Presumption of Safety (QPS) approach, no toxicological data are required. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and six matches 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 concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
食品酶麦芽ogenicα-淀粉酶（4-α-D-葡聚糖α-麦芽糖水解酶；EC 3.2.1.133）由乐斯福烘焙解决方案公司的转基因菌株LALL-MA生产。基因改造不会引发安全问题。该食品酶不含生产生物体的活细胞及其DNA。该食品酶旨在用于烘焙过程。根据烘焙过程推荐的最大使用量以及欧洲食品安全局综合欧洲食品消费数据库的个体数据，估计欧洲人群的膳食暴露量高达每天0.059毫克总有机固体（TOS）/千克体重。由于生产菌株符合合格安全推定（QPS）方法的要求，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的序列进行了相似性搜索，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，这种食品酶不会引发安全问题。
