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, Pesce Francesco, Chesson Andrew
EFSA J. 2023 Jul 26;21(7):e08151. doi: 10.2903/j.efsa.2023.8151. eCollection 2023 Jul.
The food enzyme with the declared activities endo-polygalacturonase ((1-4)-α-D-galacturonan glycanohydrolase; EC 3.2.1.15) and pectin lyase ((1-4)-6-O-methyl-α-D-galacturonan lyase; EC 4.2.2.10) is produced with the non-genetically modified strain NZYM-PE by Novozymes A/S. It is intended to be used in four food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, refined olive oil production and wine and wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during production, dietary exposure was not calculated for refined olive oil production. For the remaining three food processes, it was estimated to be up to 0.132 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 repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of 1,430 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure above 10,833. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 13 matches were found, including one food allergen (papaya). The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya, but that the risk will not exceed that of consumption of papaya. In addition, oral allergy reactions cannot be excluded in pollen-sensitised individuals. 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.
这种具有宣称活性的食品酶，即内切多聚半乳糖醛酸酶（(1-4)-α-D-半乳糖醛酸聚糖水解酶；EC 3.2.1.15）和果胶裂解酶（(1-4)-6-O-甲基-α-D-半乳糖醛酸裂解酶；EC 4.2.2.10），由诺维信公司（Novozymes A/S）使用非转基因菌株NZYM-PE生产。它拟用于四种食品制造工艺：用于果汁生产的果蔬加工、用于非果汁产品的果蔬加工、精炼橄榄油生产以及葡萄酒和葡萄酒醋生产。由于在生产过程中会去除总有机固体（TOS）的残留量，因此未对精炼橄榄油生产进行膳食暴露量计算。对于其余三种食品加工工艺，估计欧洲人群每天的膳食暴露量高达0.132毫克TOS/千克体重（bw）。遗传毒性试验未表明存在安全问题。通过对大鼠进行为期90天的重复剂量口服毒性研究来评估全身毒性。专家小组确定未观察到有害作用水平（NOAEL）为每天1430毫克TOS/千克体重，这是测试的最高剂量，与估计的膳食暴露量相比，暴露界限高于10833。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，发现了13个匹配项，其中包括一种食品过敏原（木瓜）。专家小组认为，在预期的使用条件下，不能排除膳食接触这种食品酶时发生过敏反应的风险，特别是对于对木瓜过敏的个体，但该风险不会超过食用木瓜的风险。此外，花粉过敏个体也不能排除发生口腔过敏反应的可能性。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。
