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, Andryszkiewicz Magdalena, Boinowitz Erik, Glandorf Boet, Kovalkovicova Natalia, Di Piazza Giulio, Liu Yi, Lunardi Simone, Cavanna Daniele, Roos Yrjö, Chesson Andrew
EFSA J. 2024 Apr 17;22(4):e8717. doi: 10.2903/j.efsa.2024.8717. eCollection 2024 Apr.
The food enzyme leucyl aminopeptidase (EC 3.4.11.1) is produced with the genetically modified strain NZYM-BU by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes. Dietary exposure to the food enzyme TOS was estimated to be up to 1.508 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 4,928 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 3,268. 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 the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.
食品酶亮氨酰氨基肽酶（EC 3.4.11.1）由诺维信公司（Novozymes A/S）使用转基因菌株NZYM - BU生产。基因改造不存在安全问题。该食品酶不含生产生物体的活细胞及其DNA。它拟用于五种食品制造工艺。据估计，欧洲人群通过膳食接触该食品酶TOS的量高达每天1.508毫克TOS/千克体重（bw）。遗传毒性试验未表明存在安全问题。通过对大鼠进行为期90天的重复剂量口服毒性研究来评估全身毒性。专家小组确定未观察到有害作用水平为每天4928毫克TOS/千克体重，这是所测试的最高剂量，与估计的膳食接触量相比，得出的接触范围至少为3268。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。专家小组认为，不能排除通过膳食接触引起过敏反应的风险，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，该食品酶不存在安全问题。
