Lambré Claude, Barat Baviera José Manuel, Bolognesi Claudia, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Gundert-Remy Ursula, Herman Lieve, Turck Dominique, Engel Karl-Heinz, Aguilera-Gómez Margarita, Andryszkiewicz Magdalena, Kovalkovicova Natalia, Liu Yi, Maia Joaquim, Rainieri Sandra, Chesson Andrew
EFSA J. 2021 Jun 16;19(6):e06637. doi: 10.2903/j.efsa.2021.6637. eCollection 2021 Jun.
The food enzyme trypsin (EC 3.4.21.4) is extracted from porcine pancreas by Novozymes A/S. The food enzyme is intended to be used for hydrolysis of whey proteins employed as ingredients in infant formulae, follow-on formulae and in food for special medical purposes. 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 32 mg TOS/kg body weight (bw) per day for infants. The Panel considered that this value covers all population groups consuming these formulae. In the toxicological evaluation, clinical studies with 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 could not be excluded in infants but considered the likelihood to be low. Based on the origin of the food enzyme from edible parts of animals, the data provided by the applicant and supported by the evaluation of clinical studies based on pancreatic enzymes and the estimated dietary exposure, the Panel concluded that the trypsin from porcine pancreas does not give rise to safety concern under the intended conditions of use.
食品酶胰蛋白酶（EC 3.4.21.4）由诺维信公司从猪胰腺中提取。该食品酶旨在用于水解婴儿配方食品、较大婴儿配方食品和特殊医学用途食品中用作成分的乳清蛋白。根据婴儿配方食品中的最大使用量和最大允许蛋白质含量，估计婴儿每日通过膳食接触该食品酶的总有机固体（TOS）为32毫克TOS/千克体重。专家小组认为该值涵盖了食用这些配方食品的所有人群。在毒理学评估中，考虑了胰酶的临床研究。对药物的超敏反应被确定为主要副作用。然而，尚未有关于水解食品中猪胰酶过敏反应的报道。专家小组认为，婴儿食用经牛奶水解制备的产品后，对这种食品酶发生过敏致敏的风险不能排除，但认为可能性较低。基于该食品酶来自动物可食用部分的来源、申请人提供的数据以及基于胰酶的临床研究评估和估计的膳食暴露量，专家小组得出结论，在预期使用条件下，猪胰腺来源的胰蛋白酶不会引起安全问题。
