Safety evaluation of a food enzyme containing ...
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Article dans une revue scientifique: Article original
DOI :
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Title :
Safety evaluation of a food enzyme containing trypsin and chymotrypsin from porcine pancreas.
Author(s) :
Lambré, C. [Auteur]
European Food Safety Authority [EFSA]
Barat Baviera, J. M. [Auteur]
Bolognesi, C. [Auteur]
Cocconcelli, P. S. [Auteur]
Crebelli, R. [Auteur]
Gott, D. M. [Auteur]
Grob, K. [Auteur]
Lampi, E. [Auteur]
Mengelers, M. [Auteur]
Mortensen, A. [Auteur]
Rivière, G. [Auteur]
Steffensen, I. L. [Auteur]
Tlustos, C. [Auteur]
Van Loveren, H. [Auteur]
Vernis, L. [Auteur]
Zorn, H. [Auteur]
Gundert-Remy, U. [Auteur]
Herman, L. [Auteur]
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Engel, K. H. [Auteur]
Aguilera-Gómez, M. [Auteur]
Andryszkiewicz, M. [Auteur]
Kovalkovicova, N. [Auteur]
Liu, Y. [Auteur]
Maia, J. [Auteur]
Rainieri, S. [Auteur]
Chesson, A. [Auteur]
European Food Safety Authority [EFSA]
Barat Baviera, J. M. [Auteur]
Bolognesi, C. [Auteur]
Cocconcelli, P. S. [Auteur]
Crebelli, R. [Auteur]
Gott, D. M. [Auteur]
Grob, K. [Auteur]
Lampi, E. [Auteur]
Mengelers, M. [Auteur]
Mortensen, A. [Auteur]
Rivière, G. [Auteur]
Steffensen, I. L. [Auteur]
Tlustos, C. [Auteur]
Van Loveren, H. [Auteur]
Vernis, L. [Auteur]
Zorn, H. [Auteur]
Gundert-Remy, U. [Auteur]
Herman, L. [Auteur]
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Engel, K. H. [Auteur]
Aguilera-Gómez, M. [Auteur]
Andryszkiewicz, M. [Auteur]
Kovalkovicova, N. [Auteur]
Liu, Y. [Auteur]
Maia, J. [Auteur]
Rainieri, S. [Auteur]
Chesson, A. [Auteur]
Journal title :
EFSA Journal
Abbreviated title :
EFSA J
Volume number :
19
Pages :
e06640
Publication date :
2021-07-03
ISSN :
1831-4732
English keyword(s) :
Trypsin
chymotrypsin
EC 3.4.21.4
EC 3.4.21.1
pig pancreas
chymotrypsin
EC 3.4.21.4
EC 3.4.21.1
pig pancreas
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
The food enzyme is a serine protease complex containing trypsin (EC 3.4.21.4) and chymotrypsin (EC3.4.21.1) obtained from porcine pancreas by Paninkret Chem.-Pharm. Werk GmbH. The food enzyme iscurrently only used in protein ...
Show more >The food enzyme is a serine protease complex containing trypsin (EC 3.4.21.4) and chymotrypsin (EC3.4.21.1) obtained from porcine pancreas by Paninkret Chem.-Pharm. Werk GmbH. The food enzyme iscurrently only used in protein processing to hydrolyse milk proteins. Milk protein hydrolysates andpeptides are mainly used in formulae intended to have reduced allergenicity. Based on the recommendeduse level and the high consumption of formulae in very young babies, dietary exposure to the foodenzyme–total organic solids (TOS) was estimated to be 180 mg TOS/kg body weight (bw) per day forinfants and toddlers. Toxicological evaluation was based on the available clinical studies with pancreaticenzymes. Hypersensitivity to the product was identified as the major side effect. However, the intactenzymes are inactivated during preparation of food products; therefore, the Panel considered that thelikelihood of adverse effects of the intact enzyme to occur is low. The Panel considered that a risk ofallergic sensitisation to these protein hydrolysates after consumption cannot be excluded, but thelikelihood of occurrence was considered to be low. Based on the origin of the food enzyme from edibleparts of animals, the data provided and the evaluation of clinical studies with pancreatic enzymes and theestimated dietary exposure, the Panel concluded that the food enzyme does not give rise to safetyconcerns when used in the production of infant formulae based on milk protein hydrolysates.Show less >
Show more >The food enzyme is a serine protease complex containing trypsin (EC 3.4.21.4) and chymotrypsin (EC3.4.21.1) obtained from porcine pancreas by Paninkret Chem.-Pharm. Werk GmbH. The food enzyme iscurrently only used in protein processing to hydrolyse milk proteins. Milk protein hydrolysates andpeptides are mainly used in formulae intended to have reduced allergenicity. Based on the recommendeduse level and the high consumption of formulae in very young babies, dietary exposure to the foodenzyme–total organic solids (TOS) was estimated to be 180 mg TOS/kg body weight (bw) per day forinfants and toddlers. Toxicological evaluation was based on the available clinical studies with pancreaticenzymes. Hypersensitivity to the product was identified as the major side effect. However, the intactenzymes are inactivated during preparation of food products; therefore, the Panel considered that thelikelihood of adverse effects of the intact enzyme to occur is low. The Panel considered that a risk ofallergic sensitisation to these protein hydrolysates after consumption cannot be excluded, but thelikelihood of occurrence was considered to be low. Based on the origin of the food enzyme from edibleparts of animals, the data provided and the evaluation of clinical studies with pancreatic enzymes and theestimated dietary exposure, the Panel concluded that the food enzyme does not give rise to safetyconcerns when used in the production of infant formulae based on milk protein hydrolysates.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
Inserm
CHU Lille
Inserm
CHU Lille
Submission date :
2024-01-12T06:40:51Z
2024-03-01T13:34:12Z
2024-03-01T13:34:12Z
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