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, Aguilera Jaime, Cavanna Daniele, Fernàndez-Fraguas Cristina, Kovalkovicova Natalia, Lunardi Simone, Liu Yi
EFSA J. 2025 May 7;23(5):e9418. doi: 10.2903/j.efsa.2025.9418. eCollection 2025 May.
The food enzyme prolyl oligopeptidase (EC 3.24.21.26) is produced with the genetically modified strain DP-Nyq99 by Genencor international B.V. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme 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 0.041 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 body weight (bw) per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 24,390. A search for the homology of the amino acid sequence of the prolyl oligopeptidase 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.
食品酶脯氨酰寡肽酶（EC 3.24.21.26）由杰能科国际有限公司使用转基因菌株DP-Nyq99生产。基因改造不会引起安全问题。该食品酶被认为不含有生产生物体的活细胞及其DNA。该食品酶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0.041毫克总有机硫/千克体重。遗传毒性试验未表明存在安全问题。通过对大鼠进行的为期90天的重复剂量口服毒性研究评估了全身毒性。专家小组确定未观察到不良作用水平为每天1000毫克总有机硫/千克体重，这是测试的最高剂量，与估计的膳食暴露量相比，得出的暴露边际至少为24390。对脯氨酰寡肽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，在预期的使用条件下，这种食品酶不会引起安全问题。
