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, Herman Lieve, Aguilera Jaime, Andryszkiewicz Magdalena, Liu Yi, Chesson Andrew
EFSA J. 2023 Jan 20;21(1):e07750. doi: 10.2903/j.efsa.2023.7750. eCollection 2023 Jan.
The food enzyme β-galactosidase (β-D-galactoside galactohydrolase, EC 3.2.1.23) is produced with the non-genetically modified strain GD-YNL by Godo Shusei Co., Ltd. The food enzyme is intended to be used for the hydrolysis of lactose in milk processing, production of fermented milk products and whey processing. The food enzyme is also intended for lactose hydrolysis in milk products at home. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 54 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the qualified presumption of safety approach of safety assessment and as no issue of concern raised from the production process, no toxicological studies other than assessment of allergenicity were necessary. 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β-半乳糖苷酶（β-D-半乳糖苷半乳糖水解酶，EC 3.2.1.23）由日本协同株式会社使用非转基因菌株GD-YNL生产。该食品酶旨在用于牛奶加工中乳糖的水解、发酵乳制品的生产以及乳清加工。该食品酶也用于家庭中乳制品的乳糖水解。据估计，欧洲人群通过膳食接触该食品酶的总有机固体（TOS）最高可达每天54毫克TOS/千克体重。由于生产菌株符合安全性评估的合格假定安全性方法，且生产过程未引发任何关注问题，因此除了致敏性评估外，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进行了相似性搜索，未发现匹配情况。专家小组认为，在预期使用条件下，不能排除膳食接触引起过敏反应的风险，但可能性较低。根据所提供的数据，专家小组得出结论，该食品酶在预期使用条件下不会引起安全问题。
