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, Glandorf Boet, Herman Lieve, Aguilera Jaime, Arcella Davide, Maia Joaquim, Liu Yi, Rainieri Sandra, Chesson Andrew
EFSA J. 2019 Oct 22;17(10):e05837. doi: 10.2903/j.efsa.2019.5837. eCollection 2019 Oct.
The food enzyme triacylglycerol acylhydrolase (EC 3.1.1.3) is produced with a genetically modified strain RF10625 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The food enzyme is intended to be used in baking processes and cereal-based processes. Based on the maximum use levels, dietary exposure to the food enzyme Total Organic Solids (TOS) was estimated to be up to 0.119 mg 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 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 8,400. Similarity of the amino acid sequence to those of known allergens was searched and no matches 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 to occur is considered to be 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.
食品酶三酰甘油酰基水解酶（EC 3.1.1.3）由AB Enzymes公司使用转基因菌株RF10625生产。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和重组DNA。该食品酶拟用于烘焙工艺和谷物加工工艺。根据最大使用量，估计欧洲人群通过饮食接触该食品酶的总有机固体（TOS）最高可达每天0.119毫克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。专家小组确定未观察到有害作用水平为每天1000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，得出的接触边际至少为8400。搜索了该氨基酸序列与已知过敏原的相似性，未发现匹配项。专家小组认为，在预期的使用条件下，不能排除通过饮食接触引起过敏致敏和激发反应的风险，但认为发生的可能性较低。根据提供的数据，专家小组得出结论，在预期的使用条件下，这种食品酶不会引发安全问题。
