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, Lunardi Simone, Andryszkiewicz Magdalena, Di Piazza Giulio, Kovalkovicova Natalia, Liu Yi
EFSA J. 2025 May 19;23(5):e9420. doi: 10.2903/j.efsa.2025.9420. eCollection 2025 May.
The food enzyme 4-α-glucanotransferase (1,4-α-d-glucan:1,4-α-d-glucan 4-α-d-glycosyltransferase; EC2.4.1.25) is produced with the genetically modified strain MAS by Koninklijke Cooperatie Avebe U.A. The production strain contains multiple copies of known 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 the production of enzymatically treated starch. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.012 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 83,333. A search for homology of the amino acid sequence of the 4-α-glucanotransferase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure 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4-α-葡聚糖转移酶（1,4-α-D-葡聚糖：1,4-α-D-葡聚糖4-α-D-糖基转移酶；EC2.4.1.25）由Koninklijke Cooperatie Avebe U.A.使用转基因菌株MAS生产。生产菌株包含多个已知的抗微生物抗性基因拷贝。然而，基于食品酶中生产生物体的活细胞和DNA不存在，这不被视为一种风险。该食品酶旨在用于酶处理淀粉的生产。据估计，欧洲人群通过饮食接触该食品酶的总有机固体（TOS）最高可达每天0.012毫克TOS/千克体重（bw）。遗传毒性试验未表明存在安全问题。通过在大鼠中进行的重复剂量90天口服毒性研究评估了全身毒性。专家小组确定未观察到有害作用水平为每天1000毫克TOS/千克bw，这是测试的最高剂量，与估计的饮食接触量相比，得出的接触范围至少为83333。对4-α-葡聚糖转移酶的氨基酸序列与已知过敏原进行了同源性搜索，未发现匹配项。专家小组认为，不能排除饮食接触后发生过敏反应的风险，但可能性较低。根据提供的数据，专家小组得出结论，在预期的使用条件下，这种食品酶不会引起安全问题。
