Nutritional safety and suitability of a specific protein hydrolysate derived from sources of skimmed cow's milk and whey protein concentrates and used in infant and follow‐on formula manufactured from hydrolysed protein by Healthcare Reckitt B.V.

The European Commission (EC) requested the European Food Safety Authority to evaluate the nutritional safety and suitability of a specific protein hydrolysate derived from sources of skimmed cow's milk (including non-fat) and whey protein concentrates for use in infant and follow-on formula manufactured by Healthcare Reckitt B.V. Healthcare Reckitt B.V. submitted a dossier to the EC seeking an amendment to Regulation (EU) 2016/127 regarding the protein sources permissible 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 2.3 g/100 kcal and consumed as the sole source of nutrition for 3 months led to growth that is similar to an infant formula manufactured from intact cow's milk protein with a protein content of 1.9 g/100 kcal. Data on adverse events and 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 can be 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 2.3 g/100 kcal protein and complies with the compositional criteria of Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.