Zorn Holger, Barat Baviera José Manuel, Bolognesi Claudia, Catania Francesco, Gadermaier Gabriele, Greiner Ralf, Mayo Baltasar, Mortensen Alicja, Roos Yrjö Henrik, L M Solano Marize, Sramkova Monika, Van Loveren Henk, Vernis Laurence, Andryszkiewicz Magdalena, Cavanna Daniele, Fernàndez-Fraguas Cristina, Peluso Silvia, Liu Yi
EFSA J. 2025 May 7;23(5):e9419. doi: 10.2903/j.efsa.2025.9419. eCollection 2025 May.
The food enzyme acetolactate decarboxylase (α-acetolactate decarboxylase; EC 4.1.1.5) is produced with the genetically modified strain DP-Ezz65 by Genencor International B.V. The genetic modifications do not give rise to safety concerns. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of brewed products. Dietary exposure was estimated to be up to 0.001 mg total organic solids/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 acetolactate decarboxylase 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.
食品酶乙酰乳酸脱羧酶（α-乙酰乳酸脱羧酶；EC 4.1.1.5）由杰能科国际有限公司（Genencor International B.V.）使用转基因菌株DP-Ezz65生产。这些基因改造不会引发安全问题。生产菌株符合合格安全推定（QPS）方法的要求。该食品酶被认为不含有生产生物体的活细胞及其DNA。它拟用于谷物和其他谷物的加工，以生产酿造产品。据估计，欧洲人群的膳食暴露量高达每天0.001毫克总有机固体/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问题，专家小组认为无需进行毒性测试。已对乙酰乳酸脱羧酶的氨基酸序列与已知过敏原进行同源性搜索，未发现匹配情况。专家小组认为，不能排除膳食接触该食品酶会引发过敏反应的风险，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，这种食品酶不会引发安全问题。
