欧盟评估一种食品酶的安全性

 

　　据了解，这种食品酶包含来自猪胰腺中的胰蛋白酶、胰凝乳蛋白酶、胰弹性蛋白酶和羧肽酶B，旨在用于水解乳清蛋白，用作婴儿配方食品、后续配方食品和特殊医疗用途食品（管饲）的成分。

 

　　经过评估，专家小组认为，不能排除婴儿在食用水解乳制得的产品后对该食物酶产生过敏性致敏的风险，但认为可能性很低。根据动物可食用部位食物酶的来源、申请人提供的数据以及对基于胰酶的药物制剂进行临床研究评估的支持下，专家小组得出结论，在预期的使用条件下，猪胰酶不会引起安全性问题。部分原文报道如下：

 

　　The food enzyme is a protease complex, containing trypsin (EC 3.4.21.4), chymotrypsin (EC 3.4.21.1), pancreatic elastase (EC 3.4.21.36) and carboxypeptidase B (EC 3.4.17.2), obtained from porcine pancreas by Neova Technologies Inc. The food enzyme is intended to be used for hydrolysis of whey proteins employed as ingredients of infant formulae, follow‐on formulae and in food for special medical purposes (tube feeding). based on maximum use levels and the maximum permitted protein content in infant formula, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be 36 mg TOS/kg body weight (bw) per day for infants. The Panel estimates that this value covers all population groups. In the toxicological evaluation, clinical studies with pharmaceutical preparations containing pancreatic enzymes were considered. Hypersensitivity to the pharmaceuticals was identified as the major side effect. However, the intact enzymes are removed during preparation of food products; therefore, the Panel considers that the likelihood of adverse effects of the intact enzyme to occur is small. Low molecular weight peptides derived from the enzyme are still likely to be present in the protein hydrolysate. The Panel considered that a risk of allergic sensitisation to these peptides after consumption of products prepared by hydrolysis of milk, cannot be excluded in infants, but the likelihood to occur is considered to be low. based on the origin of the food enzyme from edible parts of animals, the data provided by the applicant, supported by the evaluation of clinical studies with pharmaceutical preparations based on pancreatic enzymes, the Panel concluded that the porcine pancreatic enzymes do not give rise to safety concern under the intended conditions of use.?

 

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