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, Glandorf Boet, Herman Lieve, Andryszkiewicz Magdalena, Gomes Ana, Liu Yi, Rainieri Sandra, Chesson Andrew
EFSA J. 2022 Mar 4;20(3):e07181. doi: 10.2903/j.efsa.2022.7181. eCollection 2022 Mar.
The food enzyme glucose oxidase (β-D-glucose:oxygen 1-oxidoreductase; EC 1.1.3.4) is produced with the genetically modified strain DP-Aze23 by Danisco US, Inc. 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 in baking processes, cereal-based processes and egg processing. Based on the maximum use levels, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.05 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 19.55 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure above 380. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was 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 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.
食品酶葡萄糖氧化酶（β-D-葡萄糖：氧1-氧化还原酶；EC 1.1.3.4）由丹尼斯克美国公司使用转基因菌株DP-Aze23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体的活细胞及其DNA。它拟用于烘焙工艺、谷物加工工艺和蛋类加工。根据最大使用量，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0.05毫克TOS/千克体重。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天的重复剂量经口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19.55毫克TOS/千克体重，这是所测试的最高剂量，与估计的膳食接触量相比，得出的接触界限高于380。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，发现了一个匹配项。专家小组认为，在预期的使用条件下，不能排除通过膳食接触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。
