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, Van Loveren Henk, Vernis Laurence, Pasch Jeroen, Liu Yi
EFSA J. 2025 Aug 27;23(8):e9620. doi: 10.2903/j.efsa.2025.9620. eCollection 2025 Aug.
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non-genetically modified strain AGS 430 by Kerry Ingredients & Flavours Ltd. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in 11 food manufacturing processes. Subsequently, the applicant has requested to extend its use to include one additional process. In the present assessment, EFSA has updated the safety evaluation of this food enzyme when used in a total of 12 food manufacturing processes. As the food enzyme-total organic solids (TOS) are removed from the final foods in two food manufacturing processes, the dietary exposure to the food enzyme-TOS was estimated only for the remaining 10 processes. It was calculated to be up to 7.111 mg TOS/kg body weight per day in European populations. Based on the revised dietary exposure estimates and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.
食品酶杆菌溶素(EC 3.4.24.28)由嘉利达配料与香料有限公司使用非转基因菌株AGS 430生产。此前已对这种食品酶进行了安全性评估,欧洲食品安全局(EFSA)得出结论,该食品酶在11种食品制造工艺中使用时不会引发安全问题。随后,申请人请求扩大其使用范围,增加一种工艺。在本次评估中,欧洲食品安全局更新了该食品酶在总共12种食品制造工艺中使用时的安全性评估。由于在两种食品制造工艺中食品酶中的总有机固体(TOS)会从最终食品中去除,因此仅对其余10种工艺估计了膳食中食品酶-TOS的暴露量。经计算,欧洲人群每天膳食中食品酶-TOS的暴露量最高可达7.111毫克TOS/千克体重。根据修订后的膳食暴露量估计值和先前的评估结果,专家小组得出结论,在修订后的预期使用条件下,这种食品酶不会引发安全问题。