Safety evaluation of a food enzyme containing ...
Document type :
Article dans une revue scientifique: Article original
DOI :
PMID :
Permalink :
Title :
Safety evaluation of a food enzyme containing trypsin, chymotrypsin, elastase and carboxypeptidase from porcine pancreas
Author(s) :
Silano, Vittorio [Auteur]
European Food Safety Authority [EFSA]
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
Engel, Karl-Heinz [Auteur]
Aguilera-Gomez, Margarita [Auteur]
Andryszkiewicz, Magdalena [Auteur]
Kovalkovicova, Natalia [Auteur]
Liu, Yi [Auteur]
Maia, Joaquim [Auteur]
Rainieri, Sandra [Auteur]
Chesson, Andrew [Auteur]
European Food Safety Authority [EFSA]
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
Engel, Karl-Heinz [Auteur]
Aguilera-Gomez, Margarita [Auteur]
Andryszkiewicz, Magdalena [Auteur]
Kovalkovicova, Natalia [Auteur]
Liu, Yi [Auteur]
Maia, Joaquim [Auteur]
Rainieri, Sandra [Auteur]
Chesson, Andrew [Auteur]
Journal title :
EFSA Journal
Abbreviated title :
EFSA J
Volume number :
19
Pages :
e06368
Publication date :
2021-01-01
ISSN :
1831-4732
Keyword(s) :
pancreatic elastase
pig
carboxypeptidase
pancreas
chymotrypsin
Trypsin
pig
carboxypeptidase
pancreas
chymotrypsin
Trypsin
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
The food enzyme is a protease complex, containing trypsin (EC 3.4.21.4), chymotrypsin (EC 3.4.21.1), pancreatic elastase (EC 3.4.21.36) and carboxypeptidase B (EC 3.4.17.2), obtained from porcine pancreas by Neova Technologies ...
Show more >The food enzyme is a protease complex, containing trypsin (EC 3.4.21.4), chymotrypsin (EC 3.4.21.1), pancreatic elastase (EC 3.4.21.36) and carboxypeptidase B (EC 3.4.17.2), obtained from porcine pancreas by Neova Technologies Inc. The food enzyme is intended to be used for hydrolysis of whey proteins employed as ingredients of infant formulae, follow-on formulae and in food for special medical purposes (tube feeding). 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 36 mg TOS/kg body weight (bw) per day for infants. The Panel estimates that this value covers all population groups. 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, the intact enzymes are removed during preparation of food products; therefore, the Panel considers that the likelihood of adverse effects of the intact enzyme to occur is small. Low molecular weight peptides derived from the enzyme are still likely to be present in the protein hydrolysate. The Panel considered that a risk of allergic sensitisation to these peptides after consumption of products prepared by hydrolysis of milk, cannot be excluded in infants, but the likelihood to occur is considered 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.Show less >
Show more >The food enzyme is a protease complex, containing trypsin (EC 3.4.21.4), chymotrypsin (EC 3.4.21.1), pancreatic elastase (EC 3.4.21.36) and carboxypeptidase B (EC 3.4.17.2), obtained from porcine pancreas by Neova Technologies Inc. The food enzyme is intended to be used for hydrolysis of whey proteins employed as ingredients of infant formulae, follow-on formulae and in food for special medical purposes (tube feeding). 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 36 mg TOS/kg body weight (bw) per day for infants. The Panel estimates that this value covers all population groups. 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, the intact enzymes are removed during preparation of food products; therefore, the Panel considers that the likelihood of adverse effects of the intact enzyme to occur is small. Low molecular weight peptides derived from the enzyme are still likely to be present in the protein hydrolysate. The Panel considered that a risk of allergic sensitisation to these peptides after consumption of products prepared by hydrolysis of milk, cannot be excluded in infants, but the likelihood to occur is considered 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.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
Inserm
Université de Lille
Inserm
Université de Lille
Submission date :
2021-07-06T12:49:12Z
2024-03-04T15:18:09Z
2024-03-04T15:18:09Z
Files
- EFSA Journal - 2021 - - Safety evaluation of a food enzyme containing trypsin chymotrypsin elastase and carboxypeptidase.pdf
- Version éditeur
- Open access
- Access the document
Except where otherwise noted, this item's license is described as Attribution-NoDerivs 3.0 United States