RT Journal Article
T1 Safety evaluation of food enzyme trypsin from porcine pancreas.
A1 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
A1 Lambré, Claude
A1 Barat Baviera, José Manuel
A1 Bolognesi, Claudia
A1 Cocconcelli, Pier Sandro
A1 Crebelli, Riccardo
A1 Gott, David Michael
A1 Grob, Konrad
A1 Lampi, Evgenia
A1 Mengelers, Marcel
A1 Mortensen, Alicja
A1 Rivière, Gilles
A1 Steffensen, Inger-Lise
A1 Tlustos, Christina
A1 Van Loveren, Henk
A1 Vernis, Laurence
A1 Zorn, Holger
A1 Gundert-Remy, Ursula
A1 Herman, Lieve
A1 Turck, Dominique
A1 Engel, Karl-Heinz
A1 Aguilera-Gómez, Margarita
A1 Andryszkiewicz, Magdalena
A1 Kovalkovicova, Natalia
A1 Liu, Yi
A1 Maia, Joaquim
A1 Rainieri, Sandra
A1 Chesson, Andrew
K1 EC 3.4.21.4
K1 Food enzyme
K1 pig
K1 porcine pancreas
K1 trypsin
AB 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.
YR 2021
FD 2021-06-16
LK https://hdl.handle.net/10668/26739
UL https://hdl.handle.net/10668/26739
LA en
DS RISalud
RD Apr 7, 2025