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, Roos Yrjö, Cavanna Daniele, Liu Yi, de Nijs Roos Anna, de Sousa Rita Ferreira, Chesson Andrew
EFSA J. 2024 Jul 11;22(7):e8869. doi: 10.2903/j.efsa.2024.8869. eCollection 2024 Jul.
The food enzyme laccase (benzenediol:oxygen oxidoreductase, i.e. EC 1.10.3.2) is produced with the non-genetically modified strain AE-OR by Amano Enzyme Inc. 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 six food manufacturing processes. Subsequently, the applicant has requested to extend its use to include three additional processes and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of nine food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was calculated to be up to 0.030 mg TOS/kg body weight (bw) per day in European populations. Using the no observed adverse effect level previously reported (862 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 28,733. Based on the data provided for the previous evaluation and the revised margin of exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.
食品酶漆酶（苯二酚：氧氧化还原酶，即EC 1.10.3.2）由天野酶制剂公司使用非转基因菌株AE-OR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，在六种食品制造工艺中使用这种食品酶不会引发安全问题。随后，申请人请求将其使用范围扩大至另外三种工艺，并修订使用水平。在本次评估中，欧洲食品安全局更新了这种食品酶在总共九种食品制造工艺中使用时的安全性评估。经计算，欧洲人群通过膳食摄入该食品酶的总有机固体（TOS）量最高可达每天0.030毫克TOS/千克体重（bw）。根据先前报告的未观察到不良影响水平（每天862毫克TOS/千克bw，为测试的最高剂量），专家小组得出的暴露限量至少为28,733。根据先前评估提供的数据以及本次评估中修订后的暴露限量，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。
