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, Liu Yi, Criado Ana, Apergi Kyriaki, Andryszkiewicz Magdalena, Cavanna Daniele, Marini Eleonora
EFSA J. 2024 Dec 12;22(12):e9127. doi: 10.2903/j.efsa.2024.9127. eCollection 2024 Dec.
The food enzyme endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase; EC 3.2.1.8) is produced with strain HBI-TX01 by HBI Enzymes Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two food manufacturing processes, dietary exposure was calculated only for the remaining two processes. It was estimated to be up to 1.488 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 1101 mg TOS/kg bw, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 740. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. Known sources of food allergens were used in the manufacturing process. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme 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-1,4-β-木聚糖酶（4-β-D-木聚糖木聚糖水解酶；EC 3.2.1.8）由HBI酶业公司的HBI-TX01菌株生产。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。由于在两种食品制造工艺中可去除食品酶总有机固体（TOS）的残留量，因此仅针对其余两种工艺计算膳食暴露量。据估计，欧洲人群的膳食暴露量高达每天1.488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全身毒性。专家小组确定未观察到有害作用水平为1101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740。对该食品酶的氨基酸序列与已知过敏原进行了同源性搜索，未发现匹配项。制造过程中使用了已知的食品过敏原来源。专家小组认为，不能排除膳食接触这种食品酶后发生过敏反应的风险，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。
