Open AccessSafety evaluation of a food enzyme containing trypsin and chymotrypsin from porcine pancreas
Author(s) -
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 IngerLise,
Tlustos Christina,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
GundertRemy Ursula,
Herman Lieve,
Turck Dominique,
Engel KarlHeinz,
AguileraGómez Margarita,
Andryszkiewicz Magdalena,
Kovalkovicova Natalia,
Liu Yi,
Maia Joaquim,
Rainieri Sandra,
Chesson Andrew
Publication year - 2021
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2021.6640
Subject(s) - trypsin , chymotrypsin , enzyme , food science , hydrolysate , protease , proteases , lipase , chemistry , serine protease , biochemistry , hydrolysis
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.