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, Herman Lieve, Aguilera Jaime, Andryszkiewicz Magdalena, Cavanna Daniele, Fernàndez-Fraguas Cristina, Liu Yi, Rainieri Sandra, Roos Yrjö, Chesson Andrew
EFSA J. 2024 Jul 15;22(7):e8874. doi: 10.2903/j.efsa.2024.8874. eCollection 2024 Jul.
The food enzyme asparaginase (l-asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified strain ASP by DSM Food Specialties 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 prevention of acrylamide formation in foods and in the processing of yeast and yeast products. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.792 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 at the highest dose tested 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 1311. 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 upon 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（DSM Food Specialties B.V.）使用转基因菌株ASP生产。基因改造不会引发安全问题。该食品酶被认为不含有生产生物体的活细胞及其DNA。该食品酶旨在用于预防食品中丙烯酰胺的形成以及酵母和酵母产品的加工。据估计，欧洲人群通过饮食接触该食品酶的总有机固体（TOS）量高达每天0.792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评估了全身毒性。专家小组确定，在最高测试剂量为每天1038毫克TOS/千克bw时未观察到不良影响水平，与估计的饮食接触量相比，得出的接触边际至少为1311。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，饮食接触时发生过敏反应的风险不能排除，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。
