Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Mar 9;20(3):e07141.
doi: 10.2903/j.efsa.2022.7141. eCollection 2022 Mar.

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 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 Panel on Nutrition, Novel Foods and Food Allergens (NDA) et al. EFSA J. .

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.

Keywords: Protein hydrolysate; characterisation; clinical trial; formula; infants; nutritional safety; suitability.

PubMed Disclaimer

References

    1. ■■■■■
    1. ■■■■■
    1. Delatour T, Hegele J, Parisod V, Richoz J, Maurer S, Steven M and Buetler T, 2009. Analysis of advanced glycation endproducts in dairy products by isotope dilution liquid chromatography‐electrospray tandem mass spectrometry. The particular case of carboxymethyllysine. Journal of Chromatography A, 1216, 2371–2381. 10.1016/j.chroma.2009.01.011 - DOI - PubMed
    1. EFSA CEF Panel (EFSA Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids) , 2009. Guidance of the Scientific Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes for Safety Evaluation by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids. EFSA Journal 2009;7(8):1305, 26 pp. 10.2903/j.efsa.2009.1305 - DOI
    1. EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids) , 2016. Panel statement on the exposure assessment of food enzymes. EFSA Journal 2016;14(11):4581, 9 pp. 10.2903/j.efsa.2016.4581 - DOI

LinkOut - more resources