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来自非转基因sp. 菌株DEA 56 - 111的食品酶AMP脱氨酶的安全性评估。

Safety evaluation of the food enzyme AMP deaminase from non-genetically modified sp. strain DEA 56-111.

作者信息

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, Cavanna Daniele, Kovalkovičová Natália, Liu Yi, Lunardi Simone, Chesson Andrew

出版信息

EFSA J. 2024 Apr 10;22(4):e8718. doi: 10.2903/j.efsa.2024.8718. eCollection 2024 Apr.

Abstract

The food enzyme AMP deaminase (AMP aminohydrolase; EC 3.5.4.6) is produced with the non-genetically modified microorganism sp. strain DEA 56-111 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.005 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The Panel identified a no observed adverse effect level of 1984 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 396,800. 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 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.

摘要

食品酶AMP脱氨酶(AMP氨基水解酶;EC 3.5.4.6)由日本新化学株式会社使用非转基因微生物sp.菌株DEA 56-111生产。该食品酶被认为不含生产用微生物的活细胞。它拟用于酵母及酵母产品的加工。据估计,欧洲人群通过膳食接触该食品酶的总有机固体(TOS)量高达每天0.005毫克TOS/千克体重(bw)。遗传毒性试验未表明存在安全问题。专家小组确定未观察到有害作用水平为每天1984毫克TOS/千克bw,这是测试的最高剂量,与估计的膳食接触量相比,得出的接触界限至少为396,800。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,不能排除膳食接触引起过敏反应的风险,但可能性较低。根据所提供的数据,专家小组得出结论,在预期的使用条件下,这种食品酶不会引起安全问题。

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