據(jù)了解，這種食品酶包含來自豬胰腺中的胰蛋白酶和胰凝乳蛋白酶，旨在用于水解乳清蛋白，用作嬰兒配方食品和后續(xù)配方食品的成分。

 

　　經(jīng)過評估，專家小組認(rèn)為，不能排除嬰兒在食用水解乳制得的產(chǎn)品后對該食物酶產(chǎn)生過敏性致敏的風(fēng)險，但認(rèn)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(jié)論，在預(yù)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 serine protease complex, containing trypsin (EC 3.4.21.4) and chymotrypsin (EC 3.4.21.1), obtained from porcine pancreas by Neova Technologies Inc. The serine protease complex is intended to be used for hydrolysis of whey proteins employed as ingredients of infant formulae and follow‐on formulae. based on maximum use levels and the maximum permitted protein content in infant formulae, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be 18 mg TOS/kg body weight (bw) per day for infants. 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, allergic reactions to porcine pancreatic enzymes in hydrolysed foods have not been reported. The Panel considered that a risk of allergic sensitisation to this food enzyme after consumption of products prepared by hydrolysis of milk cannot be excluded in infants, but considers the likelihood 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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