TY - JOUR
T1 - Safety evaluation of a food enzyme containing trypsin and chymotrypsin from porcine pancreas
AU - Lambre, Claude
AU - Barat Baviera, Jose Manuel
AU - Bolognesi, Claudia
AU - Cocconcelli, Pier Sandro
AU - Crebelli, Riccardo
AU - Gott, David Michael
AU - Grob, Konrad
AU - Lampi, Evgenia
AU - Mengelers, Marcel
AU - Mortensen, Alicja
AU - Riviere, Gilles
AU - Steffensen, Inger-Lise
AU - Tlustos, Christina
AU - Van Loveren, Henk
AU - Vernis, Laurence
AU - Zorn, Holger
AU - Gundert-Remy, Ursula
AU - Herman, Lieve
AU - Turck, Dominique
AU - Engel, Karl-Heinz
AU - Aguilera-Gomez, Margarita
AU - Andryszkiewicz, Magdalena
AU - Kovalkovicova, Natalia
AU - Liu, Yi
AU - Maia, Joaquim
AU - Rainieri, Sandra
AU - Chesson, Andrew
PY - 2021/6
Y1 - 2021/6
N2 - 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 Paninkret Chem.-Pharm. Werk GmbH. The food enzyme is currently only used in protein processing to hydrolyse milk proteins. Milk protein hydrolysates and peptides are mainly used in formulae intended to have reduced allergenicity. Based on the recommended use level and the high consumption of formulae in very young babies, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be 180 mg TOS/kg body weight (bw) per day for infants and toddlers. Toxicological evaluation was based 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 considered that the likelihood of adverse effects of the intact enzyme to occur is low. The Panel considered that a risk of allergic sensitisation to these protein hydrolysates after consumption cannot be excluded, but the likelihood of occurrence was considered to be low. Based on the origin of the food enzyme from edible parts of animals, the data provided and the evaluation of clinical studies with pancreatic enzymes and the estimated dietary exposure, the Panel concluded that the food enzyme does not give rise to safety concerns when used in the production of infant formulae based on milk protein hydrolysates.
AB - 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 Paninkret Chem.-Pharm. Werk GmbH. The food enzyme is currently only used in protein processing to hydrolyse milk proteins. Milk protein hydrolysates and peptides are mainly used in formulae intended to have reduced allergenicity. Based on the recommended use level and the high consumption of formulae in very young babies, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be 180 mg TOS/kg body weight (bw) per day for infants and toddlers. Toxicological evaluation was based 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 considered that the likelihood of adverse effects of the intact enzyme to occur is low. The Panel considered that a risk of allergic sensitisation to these protein hydrolysates after consumption cannot be excluded, but the likelihood of occurrence was considered to be low. Based on the origin of the food enzyme from edible parts of animals, the data provided and the evaluation of clinical studies with pancreatic enzymes and the estimated dietary exposure, the Panel concluded that the food enzyme does not give rise to safety concerns when used in the production of infant formulae based on milk protein hydrolysates.
KW - Trypsin
KW - chymotrypsin
KW - EC 3.4.21.4
KW - EC 3.4.21.1
KW - pig pancreas
U2 - 10.2903/j.efsa.2021.6640
DO - 10.2903/j.efsa.2021.6640
M3 - Article
SN - 1831-4732
VL - 19
JO - EFSA Journal
JF - EFSA Journal
ER -