Zorn Holger, Barat Baviera José Manuel, Bolognesi Claudia, Catania Francesco, Gadermaier Gabriele, Greiner Ralf, Mayo Baltasar, Mortensen Alicja, Roos Yrjö Henrik, Solano Marize L M, Sramkova Monika, Van Loveren Henk, Vernis Laurence, Chesson Andrew, Herman Lieve, Andryszkiewicz Magdalena, Cavanna Daniele, Gomes Ana, Kovalkovičová Natália, de Nijs Roos Anna, di Piazza Giulio, Liu Yi
EFSA J. 2024 Oct 9;22(10):e9033. doi: 10.2903/j.efsa.2024.9033. eCollection 2024 Oct.
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 strain PF8 by Erbslöh Geisenheim AG. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was calculated to be up to 0.110 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 2229 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 20,264. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory or contact allergens were found. The Panel considered that the risk of allergic reactions upon 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）由埃尔布施洛厄盖森海姆股份公司使用非转基因菌株PF8生产。该食品酶不含生产生物体的活细胞。它拟用于四种食品制造工艺。据计算，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0.110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90天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2229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，得出的接触界限至少为20264。对该食品酶氨基酸序列与已知过敏原的同源性进行了搜索，并发现了与呼吸道或接触性过敏原的四处匹配之处。专家小组认为，饮食接触后发生过敏反应的风险不能排除，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该食品酶不会引起安全问题。
