据了解,这种食品酶来自猪胰腺,旨在用于蛋白质加工以及水解乳蛋白中、/div>
经过评估,专家小组得出结论,该食用酶在用于生产基于乳蛋白水解物的婴儿配方奶粉时不会引起安全问题。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 Paninkret Chem.-Pharm. Werk GmbH. The food enzyme is currently o
nly used in protein processing to hydrolyse milk proteins. Milk protein hydrolysates and peptides are mainly used in formulae intended to have reduced allergenicity. ba
sed on the recommended use level and the high co
nsumption of formulae in very young babies, dietary exposure to the food enzymeCtotal organic solids (TOS) was estimated to be 180 mg TOS/kg body weight (bw) per day for infants and toddlers. Toxicological e
valuation was ba
sed on the available clinical studies with pancreatic enzymes. Hypersensitivity to the product was identified as the major side effect. However, the intact enzymes are inactivated during preparation of food products; therefore, the Panel co
nsidered that the likelihood of adverse effects of the intact enzyme to occur is low. The Panel co
nsidered that a risk of allergic sensitisation to these protein hydrolysates after co
nsumption cannot be excluded, but the likelihood of occurrence was co
nsidered to be low. ba
sed on the origin of the food enzyme from edible parts of animals, the data provided and the e
valuation of clinical studies with pancreatic enzymes and the estimated dietary exposure, the Panel co
ncluded that the food enzyme does not give rise to safety co
ncerns when used in the production of infant formulae ba
sed on milk protein hydrolysates.
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