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, Andryszkiewicz Magdalena, Arcella Davide, Liu Yi, Ferreira de Sousa Rita, Chesson Andrew
EFSA J. 2022 Jun 16;20(6):e07366. doi: 10.2903/j.efsa.2022.7366. eCollection 2022 Jun.
The food enzyme glucan 1,4-α-maltohydrolase (4-α-d-glucan α-maltohydrolase; 3.2.1.133) is produced with the genetically modified strain NZYM-CY by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking and brewing processes and starch processing for glucose syrup production 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 baking and brewing processes. Dietary exposure was estimated to be up to 0.45 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. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4-α-maltohydrolase produced with the genetically modified strain NZYM-CY does not give rise to safety concerns under the intended conditions of use.
食品酶1,4-α-葡聚糖麦芽水解酶（4-α-D-葡聚糖α-麦芽水解酶；3.2.1.133）由诺维信公司使用转基因菌株NZYM-CY生产。这些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。该食品酶不含生产生物体的活细胞及其DNA。该食品酶拟用于三种食品制造工艺，即烘焙、酿造工艺以及用于生产葡萄糖浆和其他淀粉水解产物的淀粉加工。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，因此仅针对烘焙和酿造工艺计算膳食暴露量。据估计，欧洲人群的膳食暴露量高达每天0.45毫克TOS/千克体重（bw）。鉴于生产菌株的QPS状态以及食品酶制造过程未产生危害，认为无需进行毒理学研究。搜索了该氨基酸序列与已知过敏原的相似性，发现了四处匹配。专家小组认为，在预期使用条件下，不能排除膳食接触这种食品酶后发生过敏致敏和激发反应的风险，但认为此类反应发生的可能性较低。根据提供的数据、生产菌株的QPS状态以及生产过程未出现问题，专家小组得出结论，使用转基因菌株NZYM-CY生产的食品酶1,4-α-葡聚糖麦芽水解酶在预期使用条件下不会引发安全问题。
