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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.
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 t...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2023
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10352869/ https://www.ncbi.nlm.nih.gov/pubmed/37469354 http://dx.doi.org/10.2903/j.efsa.2023.8063 |
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| author | Bohn, Torsten Castenmiller, Jacqueline de Henauw, Stefaan Hirsch‐Ernst, Karen‐Ildico Knutsen, Helle Katrine Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Bresson, Jean‐Louis Castle, Laurence Fewtrell, Mary Przyrembel, Hildegard Dumas, Céline Titz, Ariane Turck, Dominique |
| author_facet | Bohn, Torsten Castenmiller, Jacqueline de Henauw, Stefaan Hirsch‐Ernst, Karen‐Ildico Knutsen, Helle Katrine Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Bresson, Jean‐Louis Castle, Laurence Fewtrell, Mary Przyrembel, Hildegard Dumas, Céline Titz, Ariane Turck, Dominique |
| collection | PubMed |
| description | 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. |
| format | Online Article Text |
| id | pubmed-10352869 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2023 |
| publisher | John Wiley and Sons Inc. |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-103528692023-07-19 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 Hirsch‐Ernst, Karen‐Ildico Knutsen, Helle Katrine Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Bresson, Jean‐Louis Castle, Laurence Fewtrell, Mary Przyrembel, Hildegard Dumas, Céline Titz, Ariane Turck, Dominique EFSA J Scientific Opinion 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. John Wiley and Sons Inc. 2023-07-18 /pmc/articles/PMC10352869/ /pubmed/37469354 http://dx.doi.org/10.2903/j.efsa.2023.8063 Text en © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
| spellingShingle | Scientific Opinion Bohn, Torsten Castenmiller, Jacqueline de Henauw, Stefaan Hirsch‐Ernst, Karen‐Ildico Knutsen, Helle Katrine Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Bresson, Jean‐Louis Castle, Laurence Fewtrell, Mary Przyrembel, Hildegard Dumas, Céline Titz, Ariane Turck, Dominique 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. |
| 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | 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. |
| topic | Scientific Opinion |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10352869/ https://www.ncbi.nlm.nih.gov/pubmed/37469354 http://dx.doi.org/10.2903/j.efsa.2023.8063 |
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