據(jù)了解，這種食品酶包含來自豬胰腺中的胰蛋白酶、胰凝乳蛋白酶、胰彈性蛋白酶和羧肽酶B，旨在用于水解乳清蛋白，用作嬰兒配方食品、后續(xù)配方食品和特殊醫(yī)療用途食品（管飼）的成分。

 

　　經(jīng)過評估，專家小組認為，不能排除嬰兒在食用水解乳制得的產品后對該食物酶產生過敏性致敏的風險，但認為可能性很低。根據(jù)動物可食用部位食物酶的來源、申請人提供的數(shù)據(jù)以及對基于胰酶的藥物制劑進行臨床研究評估的支持下，專家小組得出結論，在預期的使用條件下，豬胰酶不會引起安全性問題。部分原文報道如下：

 

　　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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