文章基本信息

标题：Safety evaluation of a food enzyme containing trypsin and chymotrypsin from porcine pancreas
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作者：Vittorio Silano ; José Manuel Barat Baviera ; Claudia Bolognesi 等
期刊名称：EFSA Journal
印刷版ISSN：1831-4732
出版年度：2021
卷号：19
期号：1
页码：1-13
DOI：10.2903/j.efsa.2021.6369
出版社：European Food Safety Authority (EFSA), Parma
摘要：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.
关键词：trypsin;chymotrypsin;pig;pancreas