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, Fraguas Cristina Fernandez, Kovalkovičová Natália, Liu Yi, Peluso Silvia, di Piazza Giulio, de Sousa Rita Ferreira, Chesson Andrew
EFSA J. 2023 Jul 10;21(7):e08017. doi: 10.2903/j.efsa.2023.8017. eCollection 2023 Jul.
The food enzyme endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified microorganism strain XAN by DSM Food Specialties B.V. 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 production strain of the food enzyme contains antimicrobial resistance genes. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in baking processes and cereal-based processes. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.02 mg TOS/kg body weight (bw) per day in European populations. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considered 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 no match was 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.
食品酶内切-1,4-β-木聚糖酶（4-β-D-木聚糖木聚糖水解酶，EC 3.2.1.8）由帝斯曼食品特种产品公司通过转基因微生物菌株XAN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。该食品酶的生产菌株含有抗微生物抗性基因。然而，鉴于食品酶中不存在生产生物体的活细胞和DNA，这并不被视为一种风险。该食品酶拟用于烘焙工艺和谷物加工工艺。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0.02毫克TOS/千克体重。由于未发现微生物来源及其后续基因改造或制造工艺产生的其他问题，专家小组认为评估该食品酶无需进行毒理学试验。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，未发现匹配情况。专家小组认为，在预期使用条件下，不能排除膳食接触引起过敏反应的风险，但可能性较低。根据所提供的数据，专家小组得出结论，在预期使用条件下，该食品酶不存在安全问题。
