Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Co‐operative Group Ltd derived from a whey protein concentrate and used in infant formula and follow‐on formula
Abstract The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability for use in infant and follow‐on formula of a specific protein hydrolysate from whey protein concentrate manufactured by Fonterra Co‐operative Group Ltd. Fonterra Co‐operative Group Ltd. submit...
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| Language: | English |
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Wiley
2025-01-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2025.9160 |
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| author | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Torsten Bohn Montaña Cámara Jacqueline Castenmiller Stefaan de Henauw Karen‐Ildico Hirsch‐Ernst Angeles Jos Alexandre Maciuk Inge Mangelsdorf Breige McNulty Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Laurence Castle Mary Fewtrell Hildegard Przyrembel Ariane Titz Dominique Turck |
| author_facet | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Torsten Bohn Montaña Cámara Jacqueline Castenmiller Stefaan de Henauw Karen‐Ildico Hirsch‐Ernst Angeles Jos Alexandre Maciuk Inge Mangelsdorf Breige McNulty Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Laurence Castle Mary Fewtrell Hildegard Przyrembel 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 for use in infant and follow‐on formula of a specific protein hydrolysate from whey protein concentrate manufactured by Fonterra Co‐operative Group Ltd. Fonterra Co‐operative Group Ltd. 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 hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 2.0 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to a growth similar to a formula manufactured from intact cow's milk with the same protein content. 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 follow‐on formula 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 young 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 2.0 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 | Article |
| id | doaj-art-40b9fc7d867f4852b5feb511577db355 |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-40b9fc7d867f4852b5feb511577db3552025-01-31T12:06:04ZengWileyEFSA Journal1831-47322025-01-01231n/an/a10.2903/j.efsa.2025.9160Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Co‐operative Group Ltd derived from a whey protein concentrate and used in infant formula and follow‐on formulaEFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)Torsten BohnMontaña CámaraJacqueline CastenmillerStefaan de HenauwKaren‐Ildico Hirsch‐ErnstAngeles JosAlexandre MaciukInge MangelsdorfBreige McNultyAndroniki NaskaKristina PentievaAlfonso SianiFrank ThiesLaurence CastleMary FewtrellHildegard PrzyrembelAriane TitzDominique TurckAbstract The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability for use in infant and follow‐on formula of a specific protein hydrolysate from whey protein concentrate manufactured by Fonterra Co‐operative Group Ltd. Fonterra Co‐operative Group Ltd. 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 hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 2.0 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to a growth similar to a formula manufactured from intact cow's milk with the same protein content. 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 follow‐on formula 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 young 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 2.0 g/100 kcal protein and complies with the compositional criteria of Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.https://doi.org/10.2903/j.efsa.2025.9160characterisationclinical trialfollow‐on formulainfant formulanutritional safetyprotein hydrolysate |
| spellingShingle | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Torsten Bohn Montaña Cámara Jacqueline Castenmiller Stefaan de Henauw Karen‐Ildico Hirsch‐Ernst Angeles Jos Alexandre Maciuk Inge Mangelsdorf Breige McNulty Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Laurence Castle Mary Fewtrell Hildegard Przyrembel Ariane Titz Dominique Turck Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Co‐operative Group Ltd derived from a whey protein concentrate and used in infant formula and follow‐on formula EFSA Journal characterisation clinical trial follow‐on formula infant formula nutritional safety protein hydrolysate |
| title | Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Co‐operative Group Ltd derived from a whey protein concentrate and used in infant formula and follow‐on formula |
| title_full | Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Co‐operative Group Ltd derived from a whey protein concentrate and used in infant formula and follow‐on formula |
| title_fullStr | Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Co‐operative Group Ltd derived from a whey protein concentrate and used in infant formula and follow‐on formula |
| title_full_unstemmed | Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Co‐operative Group Ltd derived from a whey protein concentrate and used in infant formula and follow‐on formula |
| title_short | Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Co‐operative Group Ltd derived from a whey protein concentrate and used in infant formula and follow‐on formula |
| title_sort | nutritional safety and suitability of a specific protein hydrolysate manufactured by fonterra co operative group ltd derived from a whey protein concentrate and used in infant formula and follow on formula |
| topic | characterisation clinical trial follow‐on formula infant formula nutritional safety protein hydrolysate |
| url | https://doi.org/10.2903/j.efsa.2025.9160 |
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