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据了解，这种食品酶包含来自猪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，用作婴儿配方食品和后续配方食品的成分、/div>
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 serine protease complex, co
ntaining 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. ba
sed on maximum use levels and the maximum permitted protein co
ntent in infant formulae, dietary exposure to the food enzymeCtotal organic solids (TOS) was estimated to be 18 mg TOS/kg body weight (bw) per day for infants. In the toxicological e
valuation, clinical studies with pharmaceutical preparations co
ntaining 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 co
nsidered that a risk of allergic sensitisation to this food enzyme after co
nsumption of products prepared by hydrolysis of milk cannot be excluded in infants, but co
nsiders the likelihood to be low. ba
sed on the origin of the food enzyme from edible parts of animals, the data provided by the applicant, supported by the e
valuation of clinical studies with pharmaceutical preparations ba
sed on pancreatic enzymes, the Panel co
ncluded that the porcine pancreatic enzymes do not give rise to safety co
ncern under the intended co
nditions of use.
鲁公网安 37060202000128叶/a>