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, Boinowitz Erik, Gomes Ana, Kovalkovicova Natalia, Liu Yi, de Sousa Rita Ferreira, Chesson Andrew
EFSA J. 2023 Oct 6;21(10):e08254. doi: 10.2903/j.efsa.2023.8254. eCollection 2023 Oct.
The food enzyme asparaginase (l-asparagine amidohydrolase, EC 3.5.1.1) is produced with the genetically modified strain NZYM-SP by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used to prevent acrylamide formation in food processing. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.101 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 880 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 8,713. 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 a 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）使用转基因菌株NZYM-SP生产。基因改造不存在安全问题。该食品酶被认为不含有生产生物的活细胞及其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）量高达每天0.101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880毫克TOS/千克bw，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8713。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，在预期的使用条件下，这种食品酶不存在安全问题。
