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.

Abstract 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 th... Mehr ...

Verfasser: EFSA Panel on Nutrition
Novel Foods and Food Allergens (NDA)
Torsten Bohn
Jacqueline Castenmiller
Stefaan deHenauw
Karen‐Ildico Hirsch‐Ernst
Helle Katrine Knutsen
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Kristina Pentieva
Alfonso Siani
Frank Thies
Sophia Tsabouri
Marco Vinceti
Jean‐Louis Bresson
Laurence Castle
Mary Fewtrell
Hildegard Przyrembel
Céline Dumas
Ariane Titz
Dominique Turck
Dokumenttyp: Artikel
Erscheinungsdatum: 2023
Reihe/Periodikum: EFSA Journal, Vol 21, Iss 7, Pp n/a-n/a (2023)
Verlag/Hrsg.: Wiley
Schlagwörter: protein hydrolysate / characterisation / infant formula / follow‐on formula / nutritional safety / suitability / Nutrition. Foods and food supply / TX341-641 / Chemical technology / TP1-1185
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-27565065
Datenquelle: BASE; Originalkatalog
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Link(s) : https://doi.org/10.2903/j.efsa.2023.8063

Abstract 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.