Silano Vittorio, Barat Baviera José Manuel, Bolognesi Claudia, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lambré Claude, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, van Loveren Henk, Vernis Laurence, Zorn Holger, Glandorf Boet, Engel Karl-Heinz, Penninks André, Želježic Davor, Andryszkiewicz Magdalena, Arcella Davide, Gomes Ana, Kovalkovicova Natalia, Liu Yi, Chesson Andrew
EFSA J. 2021 Jan 6;19(1):e06365. doi: 10.2903/j.efsa.2021.6365. eCollection 2021 Jan.
The food enzyme cellulase (4-(1,3;1,4)-β-d-glucan 4-glucanohydrolase; EC 3.2.1.4) is produced with the non-genetically modified strain Lzc35 by Danisco US Inc. The cellulase is intended to be used in distilled alcohol production, baking and brewing processes. Since residual amounts of total organic solids (TOS) are removed by distillation, dietary exposure was only calculated for baking and brewing processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme-TOS was estimated to be up to 0.416 mg TOS/kg body weight (bw) per day. 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 84 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 200. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and no 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 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.
食品酶纤维素酶（4-(1,3;1,4)-β-D-葡聚糖4-葡聚糖水解酶；EC 3.2.1.4）由丹尼斯克美国公司使用非转基因菌株Lzc35生产。该纤维素酶拟用于蒸馏酒精生产、烘焙和酿造工艺。由于总有机固体（TOS）的残留量通过蒸馏去除，因此仅计算了烘焙和酿造工艺中的膳食暴露量。根据提议的最大使用量，估计食品酶-TOS的膳食暴露量高达每天0.416毫克TOS/千克体重（bw）。遗传毒性试验未引发安全担忧。通过对大鼠进行的90天重复剂量经口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84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，得出的暴露边际至少为200。搜索了该食品酶与已知过敏原的氨基酸序列相似性，未发现匹配。专家小组认为，在预期的使用条件下，不能排除膳食暴露引起过敏致敏和激发反应的风险，但认为可能性较低。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担忧。
