Barat Baviera José Manuel, Bolognesi Claudia, Chesson Andrew, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lambré Claude, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Herman Lieve, Andryszkiewicz Magdalena, Cavanna Daniele, Nielsen Elsa, Norby Karin, Liu Yi, Lunardi Simone, de Sousa Rita Ferreira, Chesson Andrew
EFSA J. 2023 Jul 24;21(7):e08153. doi: 10.2903/j.efsa.2023.8153. eCollection 2023 Jul.
The food enzyme ribonuclease P (EC 3.1.26.5) is produced with the non-genetically modified strain AE-RP-4 by Amano Enzyme Inc. It is intended to be used in yeast processing only for the production of yeast extract. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.153 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise safety concerns. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of 134.7 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 880. 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 upon 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.
食品酶核糖核酸酶P（EC 3.1.26.5）由天野酶制剂公司使用非转基因菌株AE-RP-4生产。其仅用于酵母加工以生产酵母提取物。据估计，欧洲人群通过饮食接触该食品酶的总有机固体（TOS）最高可达每天0.153毫克TOS/千克体重（bw）。遗传毒性试验未引发安全担忧。通过对大鼠进行的90天重复剂量经口毒性研究评估了全身毒性。专家小组确定未观察到有害作用水平（NOAEL）为每天134.7毫克TOS/千克bw，与估计的饮食接触量相比，得出的接触界限至少为880。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，在预期使用条件下，不能排除饮食接触时发生过敏反应的风险，但可能性较低。根据提供的数据，专家小组得出结论，该食品酶在预期使用条件下不会引发安全担忧。
