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, Roos Yrjö, Andryszkiewicz Magdalena, Kovalkovicova Natalia, Liu Yi, Lunardi Simone, Chesson Andrew
EFSA J. 2023 Mar 23;21(3):e07908. doi: 10.2903/j.efsa.2023.7908. eCollection 2023 Mar.
The food enzyme asparaginase (l-asparagine amidohydrolase EC 3.5.1.1) is produced with the genetically modified strain NZYM-CK 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 various food manufacturing processes to prevent acrylamide formation. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.361 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 a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,207 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 3,343. 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, under the intended conditions of use, 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 this food enzyme does not give rise to safety concerns under the intended conditions of use.
食品酶天冬酰胺酶（L-天冬酰胺酰胺水解酶，EC 3.5.1.1）由诺维信公司（Novozymes A/S）采用转基因菌株NZYM-CK生产。基因改造不会引发安全问题。该食品酶不含生产生物体的活细胞及其DNA。它旨在用于各种食品制造过程中以防止丙烯酰胺的形成。据估计，欧洲人群通过饮食接触该食品酶总有机固体（TOS）的量高达每天0.361毫克TOS/千克体重（bw）。遗传毒性测试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有害作用水平为每天1,207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，得出的暴露边际至少为3,343。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，未发现匹配项。专家小组认为，在预期的使用条件下，不能排除因饮食接触而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，这种食品酶不会引发安全问题。
