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, Liu Yi, Ferreira de Sousa Rita, Chesson Andrew
EFSA J. 2022 Jun 14;20(6):e07359. doi: 10.2903/j.efsa.2022.7359. eCollection 2022 Jun.
The food enzyme pullulanase (pullulan 6-α-glucanohydrolase, EC 3.2.1.41) is produced with the genetically modified strain NZYM-LU by Novozyme A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in brewing processes and in starch processing for production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for the brewing processes. It was estimated to be up to 0.59 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. The similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. Based on the data provided, the QPS status of the production strain and the absence of issues of concern arising from the production process, the Panel concluded that the food enzyme pullulanase produced with the genetically modified strain NZYM-LU does not give rise to safety concerns under the intended conditions of use.
食品酶普鲁兰酶（支链淀粉6-α-葡聚糖水解酶，EC 3.2.1.41）由诺维信公司（Novozyme A/S）使用转基因菌株NZYM-LU生产。基因改造未引发安全问题。生产菌株已被证明符合安全合格假定（QPS）状态。该食品酶被认为不含生产生物体的活细胞及其DNA。它拟用于酿造过程以及淀粉加工中，以生产葡萄糖浆和其他淀粉水解产物。由于在葡萄糖浆生产过程中应用的纯化步骤可去除总有机固体（TOS）的残留量，因此仅针对酿造过程计算膳食暴露量。据估计，欧洲人群中每日膳食暴露量高达0.59毫克TOS/千克体重。鉴于生产菌株的QPS状态以及食品酶制造过程未产生危害，因此认为无需进行毒理学研究。研究了该氨基酸序列与已知过敏原的相似性，未发现匹配情况。专家小组认为，在预期使用条件下，不能排除膳食暴露引发过敏致敏和激发反应的风险，但发生这种情况的可能性较低。根据所提供的数据、生产菌株的QPS状态以及生产过程未出现令人担忧的问题，专家小组得出结论，使用转基因菌株NZYM-LU生产的食品酶普鲁兰酶在预期使用条件下不会引发安全问题。
