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, Aguilera Jaime, Andryszkiewicz Magdalena, Criado Ana, Liu Yi, Nielsen Elsa, Norby Karin, Zorn Holger
EFSA J. 2024 Oct 16;22(10):e8937. doi: 10.2903/j.efsa.2024.8937. eCollection 2024 Oct.
The food enzyme, a triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3), is produced with the non-genetically modified strain AE-LAYH (B) by Amano Enzyme Inc. It is intended to be used in six food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 0.315 mg TOS/kg body weight (bw) per day in European populations. As the production strain qualifies for the quality presumption of safety (QPS) approach of safety assessment and no issue of concern arising from the production process of the food enzyme were identified, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A homology search for the amino acid sequence of the food enzyme to those of known allergens was made and one match with a honeybee venom allergen was found. The Panel considered that a risk of allergic reactions by dietary exposure, particularly in individuals allergic to honey, cannot be excluded, but is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues of concern arising from the food enzyme manufacturing process, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
这种食品酶是一种三酰基甘油脂肪酶（三酰基甘油酰基水解酶；EC 3.1.1.3），由天野酶制剂公司使用非转基因菌株AE-LAYH (B) 生产。它拟用于六种食品制造工艺。由于在其中一种工艺中会去除食品酶总有机固体（TOS）的残留量，因此仅针对其余五种食品制造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0.315毫克TOS/千克体重（bw）。由于生产菌株符合安全评估的质量推定安全（QPS）方法，并且未发现食品酶生产过程中存在任何令人担忧的问题，因此专家小组认为除了评估致敏性之外，无需进行其他毒理学研究。对该食品酶的氨基酸序列与已知过敏原的氨基酸序列进行了同源性搜索，发现与一种蜜蜂毒液过敏原存在一个匹配。专家小组认为，不能排除因膳食暴露引起过敏反应的风险，尤其是对蜂蜜过敏的个体，但认为这种风险较低。根据所提供的数据、生产菌株的QPS状态以及食品酶制造过程中不存在令人担忧的问题，专家小组得出结论，在预期使用条件下，这种食品酶不会引起安全问题。
