Safety evaluation of a food enzyme containing trypsin and chymotrypsin from porcine pancreas

[EN] 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...

Descripción completa

Detalles Bibliográficos
Autores: Lambré, Claude, 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, Barat Baviera, José Manuel|||0000-0001-8487-7114
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universitat Politècnica de València (UPV)
Repositorio:RiuNet. Repositorio Institucional de la Universitat Politécnica de Valéncia
Idioma:inglés
OAI Identifier:oai:riunet.upv.es:10251/185280
Acceso en línea:https://riunet.upv.es/handle/10251/185280
Access Level:acceso abierto
Palabra clave:Trypsin
Chymotrypsin
EC 3.4.21.4
EC 3.4.21.1
Pig pancreas
TECNOLOGIA DE ALIMENTOS
Descripción
Sumario:[EN] 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