Silano Vittorio, Barat Baviera José Manuel, Bolognesi Claudia, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Aguilera Jaime, Di Piazza Giulio, de Sousa Rita Ferreira, Liu Yi, Chesson Andrew
EFSA J. 2022 Aug 3;20(8):e07466. doi: 10.2903/j.efsa.2022.7466. eCollection 2022 Aug.
The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified strain by Chr. Hansen. 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 milk processing for cheese production and for the production of fermented milk products. Dietary exposure was estimated to be up to 0.09 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 of 1,000 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 10,600. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and two matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered 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.
食品酶凝乳酶（EC 3.4.23.4）由科汉森公司的转基因菌株生产。这些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。它旨在用于牛奶加工以生产奶酪和发酵乳制品。据估计，欧洲人群的膳食暴露量高达每天0.09毫克总有机固体（TOS）/千克体重（bw）。遗传毒性试验未引发安全问题。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。专家小组确定在最高测试剂量每天1000毫克TOS/千克bw时未观察到不良影响水平，与估计的膳食暴露量相比，得出的暴露边际至少为10600。对该食品酶的氨基酸序列与已知过敏原的氨基酸序列进行了相似性搜索，发现与呼吸道过敏原存在两个匹配。专家小组认为，在预期的使用条件下，不能排除因膳食暴露引起过敏致敏和激发反应的风险，但认为发生这种情况的可能性较低。根据提供的数据，专家小组得出结论，在预期的使用条件下，这种食品酶不存在安全问题。
