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, Roos Yrjö, Andryszkiewicz Magdalena, Apergi Kyriaki, Kovalkovičová Natália, Liu Yi, Lunardi Simone, di Piazza Giulio, Chesson Andrew
EFSA J. 2024 Feb 26;22(2):e8612. doi: 10.2903/j.efsa.2024.8612. eCollection 2024 Feb.
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non-genetically modified strain DP-Cyb74 by Genencor International B.V. The production strain met all requirements for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in six food manufacturing processes. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 1.536 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the QPS approach and no issue of concern arose from the production process of the food enzyme, the Panel considered that no toxicological studies other than the 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 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.
食品酶芽孢杆菌溶素（EC 3.4.24.28）由杰能科国际有限公司使用非转基因菌株DP - Cyb74生产。生产菌株符合安全评估的合格假定安全性（QPS）方法的所有要求。该食品酶拟用于六种食品制造工艺。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1.536毫克TOS/千克体重。由于生产菌株符合QPS方法，且食品酶的生产过程未出现任何令人担忧的问题，专家小组认为除了评估致敏性外，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，未发现匹配项。专家小组认为，不能排除通过膳食接触引发过敏反应的风险，但可能性较低。根据提供的数据，专家小组得出结论，在预期使用条件下，这种食品酶不会引起安全问题。
