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 HIPP‐Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH)

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 infant and follow‐on formula by HIPP‐Werk Georg Hipp OHG. The dossier that was submitted to the Europ...

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Main Authors: EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Torsten Bohn, Jacqueline Castenmiller, Stefaan de Henauw, Karen‐Ildico Hirsch‐Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, 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
Format: Article
Language:English
Published: Wiley 2022-03-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2022.7141
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author EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
Torsten Bohn
Jacqueline Castenmiller
Stefaan de Henauw
Karen‐Ildico Hirsch‐Ernst
Helle Katrine Knutsen
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Carmen Pelaez
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
author_facet EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
Torsten Bohn
Jacqueline Castenmiller
Stefaan de Henauw
Karen‐Ildico Hirsch‐Ernst
Helle Katrine Knutsen
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Carmen Pelaez
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
author_sort EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
collection DOAJ
description 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 infant and follow‐on formula by HIPP‐Werk Georg Hipp OHG. The dossier that was submitted to the European Commission aimed at requesting an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in 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 1.9 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to growth equivalent to a formula manufactured from intact cow’s milk protein with the same protein content. 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 1.9 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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spelling doaj.art-300461b139ac47b0986d4028ba824c012023-03-14T04:16:02ZengWileyEFSA Journal1831-47322022-03-01203n/an/a10.2903/j.efsa.2022.7141Nutritional 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 HIPP‐Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH)EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)Torsten BohnJacqueline CastenmillerStefaan de HenauwKaren‐Ildico Hirsch‐ErnstHelle Katrine KnutsenAlexandre MaciukInge MangelsdorfHarry J McArdleAndroniki NaskaCarmen PelaezKristina PentievaAlfonso SianiFrank ThiesSophia TsabouriMarco VincetiJean‐Louis BressonLaurence CastleMary FewtrellHildegard PrzyrembelCéline DumasAriane TitzDominique TurckAbstract 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 infant and follow‐on formula by HIPP‐Werk Georg Hipp OHG. The dossier that was submitted to the European Commission aimed at requesting an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in 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 1.9 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to growth equivalent to a formula manufactured from intact cow’s milk protein with the same protein content. 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 1.9 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.https://doi.org/10.2903/j.efsa.2022.7141Protein hydrolysatecharacterisationformulanutritional safetysuitabilityclinical trial
spellingShingle EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
Torsten Bohn
Jacqueline Castenmiller
Stefaan de Henauw
Karen‐Ildico Hirsch‐Ernst
Helle Katrine Knutsen
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Carmen Pelaez
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
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 HIPP‐Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH)
EFSA Journal
Protein hydrolysate
characterisation
formula
nutritional safety
suitability
clinical trial
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 HIPP‐Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH)
title_full 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 HIPP‐Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH)
title_fullStr 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 HIPP‐Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH)
title_full_unstemmed 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 HIPP‐Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH)
title_short 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 HIPP‐Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH)
title_sort 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 hipp werk georg hipp ohg dossier submitted by meyer science gmbh
topic Protein hydrolysate
characterisation
formula
nutritional safety
suitability
clinical trial
url https://doi.org/10.2903/j.efsa.2022.7141
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