Titre :

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

Auteur(s) :

Silano, Vittorio [Auteur]
Barat Baviera, Jose Manuel [Auteur]
Bolognesi, Claudia [Auteur]
Cocconcelli, Pier Sandro [Auteur]
Crebelli, Riccardo [Auteur]
Gott, David Michael [Auteur]
Grob, Konrad [Auteur]
Lambre, Claude [Auteur]
Lampi, Evgenia [Auteur]
Mengelers, Marcel [Auteur]
Mortensen, Alicja [Auteur]
Riviere, Gilles [Auteur]
Steffensen, Inger-Lise [Auteur]
Tlustos, Christina [Auteur]
van Loveren, Henk [Auteur]
Vernis, Laurence [Auteur]
Zorn, Holger [Auteur]
Gundert-Remy, Ursula [Auteur]
Herman, Lieve [Auteur]
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Kovalkovicova, Natalia [Auteur]
Liu, Yi [Auteur]
Maia, Joaquim [Auteur]
Rainieri, Sandra [Auteur]
Chesson, Andrew [Auteur]

Titre de la revue :

EFSA Journal

Nom court de la revue :

EFSA J.

Numéro :

19

Date de publication :

2021-01-01

ISSN :

1831-4732

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [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 Neova Technologies Inc. The serine protease complex is intended to be used ...
Lire la suite >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 Neova Technologies Inc. The serine protease complex is intended to be used for hydrolysis of whey proteins employed as ingredients of infant formulae and follow-on formulae. Based on maximum use levels and the maximum permitted protein content in infant formulae, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be 18 mg TOS/kg body weight (bw) per day for infants. In the toxicological evaluation, clinical studies with pharmaceutical preparations containing 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 cannot be excluded in infants, but considers the likelihood to be low. Based on the origin of the food enzyme from edible parts of animals, the data provided by the applicant, supported by the evaluation of clinical studies with pharmaceutical preparations based on pancreatic enzymes, the Panel concluded that the porcine pancreatic enzymes do not give rise to safety concern under the intended conditions of use.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

CHU Lille
Inserm
Université de Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Date de dépôt :

2021-07-06T12:44:13Z
2024-01-30T14:35:43Z