Title :

Nutritional safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and used in an infant and follow-on formula manufactured from hydrolysed protein by Danone Trading ELN B.V.

Author(s) :

Castenmiller, Jacqueline [Auteur]
De Henauw, Stefaan [Auteur]
Hirsch-Ernst, Karen Ildico [Auteur]
Kearney, John [Auteur]
Knutsen, Helle Katrine [Auteur]
Maciuk, Alexandre [Auteur]
Mangelsdorf, Inge [Auteur]
Mcardle, Harry J. [Auteur]
Naska, Androniki [Auteur]
Pelaez, Carmen [Auteur]
Pentieva, Kristina [Auteur]
Siani, Alfonso [Auteur]
Thies, Frank [Auteur]
Tsabouri, Sophia [Auteur]
Vinceti, Marco [Auteur]
Bresson, Jean-Louis [Auteur]
Castle, Laurence [Auteur]
Fewtrell, Mary [Auteur]
Przyrembel, Hildegard [Auteur]
Dumas, Celine [Auteur]
Titz, Ariane [Auteur]
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Journal title :

EFSA Journal

Abbreviated title :

EFSA J

Volume number :

18

Pages :

e06304

Publication date :

2020-11

ISSN :

1831-4732

Keyword(s) :

Protein hydrolysate
infants
clinical trial
suitability
nutritional safety
formula
characterisation

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from whey protein concentrate and used in an infant and follow-on formula ...
Show more >The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from whey protein concentrate and used in an infant and follow-on formula by Danone Trading ELN 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. This opinion does not cover the assessment of the safety of the food enzymes used in the manufacture of the protein hydrolysate. 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 2.3 g/100 kcal and consumed as the sole source of nutrition by infants for 3.5 months led to growth equivalent to a formula manufactured from intact cow's milk protein (2 g protein/100 kcal). No experimental data have been provided on the nutritional safety and suitability of this protein source in follow-on formula. However, given that it is consumed with complementary foods and the protein source is considered 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 2.3 g/100 kcal protein and complies with the compositional criteria of Commission Delegated Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
Inserm
Université de Lille

Collections :

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

Submission date :

2021-07-06T12:49:49Z
2024-01-11T11:30:32Z