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.

Torsten Bohn; Jacqueline Castenmiller; Stefaan de Henauw; 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; EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

doi:10.2903/j.efsa.2023.8063

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.

Torsten Bohn, Jacqueline Castenmiller, Stefaan de Henauw, 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 TitzDominique Turck, EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

NutriHealth

Research output: Contribution to journal › Article › Research

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.

Original language	English
Article number	e08063
Pages (from-to)	e08063
Journal	EFSA Journal
Volume	21
Issue number	7
DOIs	https://doi.org/10.2903/j.efsa.2023.8063
Publication status	Published - 18 Jul 2023

Keywords

characterisation
clinical trial
follow-on formula
infant formula
nutritional safety
protein hydrolysate
suitability

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Bohn, T., Castenmiller, J., de Henauw, S., Hirsch-Ernst, K. I., Knutsen, H. K., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Naska, A., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Bresson, J. L., Castle, L., Fewtrell, M., Przyrembel, H., Dumas, C., ... EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) (2023). 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. EFSA Journal, 21(7), e08063. Article e08063. https://doi.org/10.2903/j.efsa.2023.8063

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title = "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 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.",

keywords = "characterisation, clinical trial, follow-on formula, infant formula, nutritional safety, protein hydrolysate, suitability",

author = "Torsten Bohn and Jacqueline Castenmiller and {de Henauw}, Stefaan and Hirsch-Ernst, {Karen Ildico} and Knutsen, {Helle Katrine} and Alexandre Maciuk and Inge Mangelsdorf and McArdle, {Harry J.} and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Bresson, {Jean Louis} and Laurence Castle and Mary Fewtrell and Hildegard Przyrembel and C{\'e}line Dumas and Ariane Titz and Dominique Turck and {EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)}",

note = "Publisher Copyright: {\textcopyright} 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.",

year = "2023",

month = jul,

day = "18",

doi = "10.2903/j.efsa.2023.8063",

language = "English",

volume = "21",

pages = "e08063",

journal = "EFSA Journal",

issn = "1831-4732",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "7",

}

Bohn, T, Castenmiller, J, de Henauw, S, Hirsch-Ernst, KI, Knutsen, HK, Maciuk, A, Mangelsdorf, I, McArdle, HJ, Naska, A, Pentieva, K, Siani, A, Thies, F, Tsabouri, S, Vinceti, M, Bresson, JL, Castle, L, Fewtrell, M, Przyrembel, H, Dumas, C, Titz, A, Turck, D & EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) 2023, '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.', EFSA Journal, vol. 21, no. 7, e08063, pp. e08063. https://doi.org/10.2903/j.efsa.2023.8063

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. / Bohn, Torsten; Castenmiller, Jacqueline; de Henauw, Stefaan et al.
In: EFSA Journal, Vol. 21, No. 7, e08063, 18.07.2023, p. e08063.

Research output: Contribution to journal › Article › Research

TY - JOUR

T1 - 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.

AU - Bohn, Torsten

AU - Castenmiller, Jacqueline

AU - de Henauw, Stefaan

AU - Hirsch-Ernst, Karen Ildico

AU - Knutsen, Helle Katrine

AU - Maciuk, Alexandre

AU - Mangelsdorf, Inge

AU - McArdle, Harry J.

AU - Naska, Androniki

AU - Pentieva, Kristina

AU - Siani, Alfonso

AU - Thies, Frank

AU - Tsabouri, Sophia

AU - Vinceti, Marco

AU - Bresson, Jean Louis

AU - Castle, Laurence

AU - Fewtrell, Mary

AU - Przyrembel, Hildegard

AU - Dumas, Céline

AU - Titz, Ariane

AU - Turck, Dominique

AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

PY - 2023/7/18

Y1 - 2023/7/18

N2 - 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.

AB - 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.

KW - characterisation

KW - clinical trial

KW - follow-on formula

KW - infant formula

KW - nutritional safety

KW - protein hydrolysate

KW - suitability

UR - http://www.scopus.com/inward/record.url?scp=85165593300&partnerID=8YFLogxK

UR - https://pubmed.ncbi.nlm.nih.gov/37469354

U2 - 10.2903/j.efsa.2023.8063

DO - 10.2903/j.efsa.2023.8063

M3 - Article

C2 - 37469354

SN - 1831-4732

VL - 21

SP - e08063

JO - EFSA Journal

JF - EFSA Journal

IS - 7

M1 - e08063

ER -

Bohn T, Castenmiller J, de Henauw S, Hirsch-Ernst KI, Knutsen HK, Maciuk A et al. 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. EFSA Journal. 2023 Jul 18;21(7):e08063. e08063. doi: 10.2903/j.efsa.2023.8063

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.

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Keywords

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