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, Liu Yi, Nielsen Elsa, Nørby Karin, de Sousa Rita Ferreira, Chesson Andrew
EFSA J. 2023 Jan 20;21(1):e07751. doi: 10.2903/j.efsa.2023.7751. eCollection 2023 Jan.
The food enzyme endo-1,3(4)-β-glucanase (3-(1-3,1-4)-β-d-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) is produced with the non-genetically modified 427-FS strain by Kerry Ingredients & Flavours Ltd. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in six manufacturing processes, i.e. baking processes, other cereal-based processes, brewing processes, grain treatment for the production of starch and gluten fractions, distilled alcohol production and yeast processing. Since residual amounts of total organic solids (TOS) are removed by distillation and during grain processing, dietary exposure was calculated only for the remaining four processes. It was estimated to be up to 0.809 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 866 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 1,070. 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, under the intended conditions of use, the 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.
食品酶内切-1,3(4)-β-葡聚糖酶（3-(1-3,1-4)-β-D-葡聚糖3(4)-葡聚糖水解酶；EC 3.2.1.6）由嘉利达配料与香精有限公司使用非转基因的427-FS菌株生产。该食品酶不含生产微生物的活细胞。该食品酶拟用于六个制造工艺，即烘焙工艺、其他谷物基工艺、酿造工艺、用于生产淀粉和麸质组分的谷物处理、蒸馏酒精生产和酵母加工。由于总有机固体（TOS）的残留量通过蒸馏和谷物加工过程被去除，仅对其余四个工艺计算膳食暴露量。据估计，欧洲人群每天的膳食暴露量高达0.809毫克TOS/千克体重（bw）。遗传毒性试验未表明存在安全问题。通过对大鼠进行的重复剂量90天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866毫克TOS/千克bw，这是测试的最高剂量，与估计的膳食暴露量相比，得出的暴露限值至少为1070。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，在预期的使用条件下，不能排除因膳食暴露引起过敏反应的风险，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，这种食品酶不会引起安全问题。
