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, Roos Yrjö, Aguilera Jaime, Andryszkiewicz Magdalena, Kovalkovicova Natalia, Liu Yi, Marini Eleonora, Chesson Andrew
EFSA J. 2024 Mar 4;22(3):e8606. doi: 10.2903/j.efsa.2024.8606. eCollection 2024 Mar.
The food enzyme α-galactosidase (α-d-galactoside galactohydrolase; EC 3.2.1.22) is produced with the genetically modified strain CBS 615.94 by Kerry Ingredients & Flavours Ltd. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. 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. As no other concerns arising from the genetically modified microbial source or from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. The food enzyme is intended to be used in guar gum processing. The dietary exposure was estimated to be up to 0.828 mg TOS/kg body weight per day in European populations. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a 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α-半乳糖苷酶（α-D-半乳糖苷半乳糖水解酶；EC 3.2.1.22）由嘉利达配料与香料有限公司使用转基因菌株CBS 615.94生产。该食品酶的生产菌株含有一个已知抗微生物抗性基因的多个拷贝。然而，基于食品酶中不存在来自生产生物体的活细胞和DNA，这不被视为一种风险。由于未发现转基因微生物来源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测试。该食品酶拟用于瓜尔胶加工。据估计，欧洲人群的膳食暴露量高达每天0.828毫克TOS/千克体重。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，未发现匹配项。专家小组认为，不能排除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，在预期使用条件下，这种食品酶不会引起安全问题。
