Open AccessNutritional 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,
Henauw Stefaan,
HirschErnst KarenIldico,
Kearney John,
Knutsen Helle Katrine,
Maciuk Alexandre,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
Pelaez Carmen,
Pentieva Kristina,
Siani Alfonso,
Thies Frank,
Tsabouri Sophia,
Vinceti Marco,
Bresson JeanLouis,
Castle Laurence,
Fewtrell Mary,
Przyrembel Hildegard,
Dumas Céline,
Titz Ariane,
Turck Dominique
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6304
Subject(s) - hydrolysate , infant formula , food science , whey protein , protein quality , european commission , whey protein isolate , chemistry , hydrolysis , european union , business , biochemistry , economic policy
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 .