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, Aguilera Jaime, Andryszkiewicz Magdalena, Liu Yi, Chesson Andrew
EFSA J. 2024 Feb 20;22(2):e8617. doi: 10.2903/j.efsa.2024.8617. eCollection 2024 Feb.
The food enzyme asparaginase (l-asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified strain AGN by DSM Food Specialties B.V. 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 to prevent acrylamide formation in food processing. The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 1.434 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with an asparaginase from (strain ASP). The Panel considered this food enzyme as a suitable substitute for the asparaginase to be used in the toxicological studies, because the genetic differences between the production strains are not expected to result in a different toxigenic potential, and the raw materials and manufacturing processes of both food enzymes are comparable. 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 1038 mg TOS/kg bw per day, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 724. 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 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）由帝斯曼食品特种产品公司使用转基因菌株AGN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。其旨在用于防止食品加工过程中丙烯酰胺的形成。据估计，欧洲人群通过膳食接触该食品酶的总有机固体（TOS）最高可达每天1.434毫克TOS/千克体重（bw）。毒性研究使用的是来自（菌株ASP）的天冬酰胺酶。专家小组认为该食品酶可作为毒理学研究中所用天冬酰胺酶的合适替代品，因为预计生产菌株之间的基因差异不会导致不同的产毒潜力，且两种食品酶的原材料和生产工艺具有可比性。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1038毫克TOS/千克bw，与估计的膳食接触量相比，得出的接触边际至少为724。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，不能排除因膳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，在预期使用条件下，这种食品酶不会引发安全问题。
