Safety evaluation of a food enzyme containing trypsin, chymotrypsin, elastase and carboxypeptidase from porcine pancreas.
Trypsin
carboxypeptidase
chymotrypsin
pancreas
pancreatic elastase
pig
Journal
EFSA journal. European Food Safety Authority
ISSN: 1831-4732
Titre abrégé: EFSA J
Pays: United States
ID NLM: 101642076
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
entrez:
18
1
2021
pubmed:
19
1
2021
medline:
19
1
2021
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 33456553
doi: 10.2903/j.efsa.2021.6368
pii: EFS26368
pmc: PMC7792021
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e06368Informations de copyright
© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Références
N Engl J Med. 1975 May 15;292(20):1050-3
pubmed: 47609
Dtsch Arztebl Int. 2014 May 23;111(21):367-75
pubmed: 24939374
J Cyst Fibros. 2015 Mar;14(2):275-81
pubmed: 25066363
Clin Ther. 2010 Jan;32(1):89-103
pubmed: 20171415
Allergy. 2005 Nov;60(11):1440-5
pubmed: 16197479
Acta Paediatr. 2000 Jan;89(1):18-21
pubmed: 10677051
Ann Allergy Asthma Immunol. 2018 Sep;121(3):360-365
pubmed: 29860051
EFSA J. 2020 Nov 10;18(11):e06266
pubmed: 33204307
Am J Gastroenterol. 2010 Oct;105(10):2276-86
pubmed: 20502447
Cochrane Database Syst Rev. 2020 Aug 5;8:CD008227
pubmed: 32761612
J Allergy Clin Immunol. 1999 Sep;104(3 Pt 1):700-1
pubmed: 10482849
Pancreas. 2013 Aug;42(6):983-9
pubmed: 23587850
Clin Pediatr (Phila). 2014 Jun;53(6):585-92
pubmed: 24662422
Expert Opin Drug Saf. 2011 Mar;10(2):197-203
pubmed: 21342076
J Pediatr. 1991 Apr;118(4 Pt 1):520-5
pubmed: 2007924
JOP. 2012 Sep 10;13(5):476-81
pubmed: 22964953
Allergy. 2008 Aug;63(8):1071-6
pubmed: 18691309
Aliment Pharmacol Ther. 2011 May;33(10):1152-61
pubmed: 21418260
Pediatr Pulmonol. 1991;10(2):79-85
pubmed: 2030925
EFSA J. 2017 May 31;15(5):e04849
pubmed: 32625502
Arch Dis Child. 1996 May;74(5):464-8
pubmed: 8669970