2025-06-112025-06-112025-01-29Bohn, T., Cámara, M., Castenmiller, J., Henauw, S.d., Hirsch-Ernst, K.I., Jos Gallego, Á.M. y Turck, D. (2025). Nutritional safety and suitability of a specific protein hydrolysate derived from sources of skimmed cow's milk andwhey protein concentrates and used in infant and follow-onformula manufactured from hydrolysed protein by Healthcare Reckitt B.V.. Efsa Journal, 23 (3), e9278. https://doi.org/10.2903/j.efsa.2025.9278.1831-4732https://hdl.handle.net/11441/174192The European Commission (EC) requested the European Food Safety Authority toevaluate the nutritional safety and suitability of a specific protein hydrolysate de-rived from sources of skimmed cow's milk (including non-fat) and whey proteinconcentrates for use in infant and follow-on formula manufactured by HealthcareReckitt B.V. Healthcare Reckitt B.V. submitted a dossier to the EC seeking an amend-ment to Regulation (EU) 2016/127 regarding the protein sources permissible in themanufacture of infant and/or follow-on formula. The protein hydrolysate underevaluation is sufficiently characterised with respect to the hydrolysed protein. Inthe pertinent intervention study provided, an infant formula manufactured fromthe protein hydrolysate with a protein content of 2.3 g/100 kcal and consumed asthe sole source of nutrition for 3 months led to growth that is similar to an infantformula manufactured from intact cow's milk protein with a protein content of1.9 g/100 kcal. Data on adverse events and tolerance of the formula did not raiseany concerns. No experimental data have been provided on the nutritional safetyand suitability of this protein source in follow-on formula. Given that follow-onformula is consumed with complementary foods and the protein source is nutri-tionally safe and suitable in an infant formula that can be the sole source of nu-trition of young infants, the Panel considers that the protein hydrolysate is alsoa nutritionally safe and suitable protein source for use in follow-on formula. ThePanel concludes that the protein hydrolysate under evaluation is a nutritionallysafe and suitable protein source for use in infant and follow-on formula, as longas the formula in which it is used contains a minimum of 2.3 g/100 kcal proteinand complies with the compositional criteria of Regulation (EU) 2016/127 and theamino acid pattern in its Annex IIIA.application/pdf11 p.engAttribution-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nd/4.0/CharacterisationClinical trialFollow- on formulaInfant formulaNutritional safetyProteinhydrolysateSuitabilityinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccesshttps://doi.org/10.2903/j.efsa.2025.9278