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.

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.