Zorn Holger, Barat Baviera José Manuel, Bolognesi Claudia, Catania Francesco, Gadermaier Gabriele, Greiner Ralf, Mayo Baltasar, Mortensen Alicja, Roos Yrjö Henrik, Solano Marize L M, Sramkova Monika, Van Loveren Henk, Vernis Laurence, Andryszkiewicz Magdalena, Cavanna Daniele, Liu Yi
EFSA J. 2025 Jun 18;23(6):e9490. doi: 10.2903/j.efsa.2025.9490. eCollection 2025 Jun.
The food enzyme sucrose:sucrose fructosyltransferase (sucrose:sucrose 1'-β-d-fructosyltransferase; EC 2.4.1.99) is produced with the genetically modified strain E4772 by SEQENS. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is free from viable cells of the production organism, but not free from recombinant DNA. The food enzyme is intended to be used in the processing of sugars for the production of fructo-oligosaccharides. The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.088 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the sucrose: sucrose fructosyltransferase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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.
蔗糖果糖基转移酶（蔗糖：蔗糖1'-β-D-果糖基转移酶；EC 2.4.1.99）由SEQENS公司使用转基因菌株E4772生产。生产菌株符合安全合格假定（QPS）方法的要求。该食品酶不含生产生物体的活细胞，但含有重组DNA。该食品酶旨在用于糖类加工以生产低聚果糖。据估计，欧洲人群通过膳食接触该食品酶的总有机固体（TOS）量高达每天0.088毫克TOS/千克体重。鉴于生产菌株的QPS状态以及食品酶制造过程未引发担忧，专家小组认为无需进行毒性试验。对蔗糖：蔗糖果糖基转移酶的氨基酸序列与已知过敏原进行了同源性搜索，未发现匹配。专家小组认为，不能排除膳食接触该食品酶后发生过敏反应的风险，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，这种食品酶不会引发安全问题。
