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

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

doi:10.2903/j.efsa.2020.6304

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

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

The Rowett Institute of Nutrition and Health

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

4 Downloads (Pure)

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 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.

Original language	English
Article number	e06304
Number of pages	12
Journal	EFSA Journal
Volume	18
Issue number	11
DOIs	https://doi.org/10.2903/j.efsa.2020.6304
Publication status	Published - 28 Nov 2020

Bibliographical note

Acknowledgments: The Panel also wishes to thank the following EFSA staff members for the support provided to this scientific output: Domenico Azzolini, Ester Artau Cortacans, Federico Morreale, Charlotte Salgaard Nielsen and Ermolaos Ververis.

Keywords

Protein hydrolysate
characterisation
formula
nutritional safety
suitability
clinical trial
infants

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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. / EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA).
In: EFSA Journal, Vol. 18, No. 11, e06304, 28.11.2020.

Research output: Contribution to journal › Article › peer-review

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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",

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 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.",

keywords = "Protein hydrolysate, characterisation, formula, nutritional safety, suitability, clinical trial, infants",

author = "Jacqueline Castenmiller and {de Henauw}, Stefaan and Karen-Ildico Hirsch-Ernst and John Kearney and Knutsen, {Helle Katrine} and Alexandre Maciuk and Inge Mangelsdorf and McArdle, {Harry J} and Androniki Naska and Carmen Pelaez and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Jean-Louis Bresson 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 = "Acknowledgments: The Panel also wishes to thank the following EFSA staff members for the support provided to this scientific output: Domenico Azzolini, Ester Artau Cortacans, Federico Morreale, Charlotte Salgaard Nielsen and Ermolaos Ververis. ",

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AU - de Henauw, Stefaan

AU - Hirsch-Ernst, Karen-Ildico

AU - Kearney, John

AU - Knutsen, Helle Katrine

AU - Maciuk, Alexandre

AU - Mangelsdorf, Inge

AU - McArdle, Harry J

AU - Naska, Androniki

AU - Pelaez, Carmen

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

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

N1 - Acknowledgments: The Panel also wishes to thank the following EFSA staff members for the support provided to this scientific output: Domenico Azzolini, Ester Artau Cortacans, Federico Morreale, Charlotte Salgaard Nielsen and Ermolaos Ververis.

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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 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.

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 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.

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KW - characterisation

KW - formula

KW - nutritional safety

KW - suitability

KW - clinical trial

KW - infants

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