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, Andryszkiewicz Magdalena, Criado Ana, Liu Yi, Lunardi Simone, Nielsen Elsa, Nørby Karin, di Piazza Giulio, Chesson Andrew
EFSA J. 2023 Nov 17;21(11):e08395. doi: 10.2903/j.efsa.2023.8395. eCollection 2023 Nov.
The food enzyme α-l-rhamnosidase (-l-rhamnoside rhamnohydrolase; EC 3.2.1.40) is produced with the non-genetically modified strain AE-HP by Amano Enzymes Inc. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in the processing of fruits and vegetables for the production of juices and other fruit products. The dietary exposure to the food enzyme-TOS was estimated to be up to 0.022 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 300 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 13,636. 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 a risk of allergic reactions upon dietary exposure to this food enzyme 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α-L-鼠李糖苷酶（α-L-鼠李糖鼠李水解酶；EC 3.2.1.40）由天野酶制剂公司使用非转基因菌株AE-HP生产。该食品酶被认为不含生产生物的活细胞。它旨在用于水果和蔬菜加工以生产果汁和其他水果产品。据估计，欧洲人群通过膳食接触该食品酶-TOS的量高达每天0.022毫克TOS/千克体重。遗传毒性试验未表明存在安全问题。通过对大鼠进行的90天口服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为每天300毫克TOS/千克体重，这是测试的最高剂量，与估计的膳食接触量相比，得出的接触范围至少为13636。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，不能排除膳食接触这种食品酶会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。
