Nutritional safety and suitability of a specific protein hydrolysate derived from a whey protein concentrate and used in an infant formula and follow-on formula manufactured from hydrolysed protein by FrieslandCampina Nederland B.V.
characterisation
clinical trial
follow‐on formula
infant formula
nutritional safety
protein hydrolysate
suitability
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:
Jul 2023
Jul 2023
Historique:
medline:
20
7
2023
pubmed:
20
7
2023
entrez:
20
7
2023
Statut:
epublish
Résumé
The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from a whey protein concentrate and used in an infant and follow-on formula manufactured by FrieslandCampina Nederland B.V., which submitted a dossier to the European Commission to request an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in the manufacture of infant and/or follow-on formula. The protein hydrolysate under evaluation is sufficiently characterised with respect to the fraction of the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 2.4 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to a growth equivalent to a formula manufactured from intact cow's milk protein with a protein content of 2.1 g/100 kcal. Data on gastrointestinal tolerance of the formula did not raise any concerns. No experimental data have been provided on the nutritional safety and suitability of this protein source in follow-on formula. Given that it is consumed with complementary foods and the protein source is nutritionally safe and suitable in an infant formula that is the sole source of nutrition of infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow-on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow-on formula, as long as the formula in which it is used contains a minimum of 2.4 g/100 kcal protein and complies with the compositional criteria of Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.
Identifiants
pubmed: 37469354
doi: 10.2903/j.efsa.2023.8063
pii: EFS28063
pmc: PMC10352869
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e08063Informations de copyright
© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
Références
J Am Coll Nutr. 1994 Aug;13(4):357-63
pubmed: 7963141
J Perinatol. 2009 Feb;29(2):106-11
pubmed: 18716627
Eur J Nutr. 2000 Aug;39(4):145-56
pubmed: 11079734
J Pediatr. 2009 Apr;154(4):521-526.e1
pubmed: 19054528
Am J Clin Nutr. 2009 Jun;89(6):1846-56
pubmed: 19369380
EFSA J. 2019 Jun 11;17(6):e05741
pubmed: 32626359
Clin Pediatr (Phila). 2015 Oct;54(12):1167-74
pubmed: 25758425
J Pediatr Gastroenterol Nutr. 2003 Mar;36(3):343-51
pubmed: 12604972
J Chromatogr. 1988 Oct 14;431(2):271-84
pubmed: 3243784
Am J Clin Nutr. 2011 Dec;94(6 Suppl):1803S-1807S
pubmed: 21849601
Clin Pediatr (Phila). 2014 Dec;53(14):1375-82
pubmed: 25009115